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Friday, 21 September 2012

Viazem XL 240mg

1. Name Of The Medicinal Product

VIAZEM XL

2. Qualitative And Quantitative Composition

Diltiazem hydrochloride: 240 mg capsule.

For excipients, see section 6.1

3. Pharmaceutical Form

Prolonged release capsule, hard.

Blue-green and lavender opaque colourless. Each capsule is printed on the cap and body, in white ink, with Viazem XL 240.

4. Clinical Particulars

4.1 Therapeutic Indications

VIAZEM XL is indicated for the management of stable angina pectoris and the treatment of mild to moderate hypertension.

4.2 Posology And Method Of Administration

Dosage requirements may differ between patients with angina and patients with hypertension. In addition individual patients response may vary, necessitating careful titration. The range of strengths facilitates titration to the optimal dose.

One capsule of VIAZEM XL is to be taken before or during a meal. The dose should be taken at approximately the same time each day.

The capsule should not be chewed but swallowed whole, with a glass of water.

Due to the variability of release profile in individual patients, when changing from one type of sustained release diltiazem preparation to another, it may be necessary to adjust the dose.

Adults:

Hypertension: The usual starting dose is 180 mg once daily. The dose may be increased after 2-4 weeks according to the patient's response and the usual maintenance dose is 240mg-360mg once daily. The maximum daily dose is 360 mg. However, the single daily doses of 300 mg and 360 mg should only be administered to patients when no satisfactory therapeutic effect has been effected with lower doses and after the benefit risk-ratio has been carefully assessed by the doctor.

Angina: Care should be taken when titrating patients with stable angina in order to establish the optimal dose. The usual starting dose is 180 mg once daily. The dose may be increased after 2-4 weeks according to the patient's response. The maximum daily dose is 360 mg. However, the single daily doses of 300 mg and 360 mg should only be administered to patients when no satisfactory therapeutic effect has been effected with lower doses and after the benefit risk-ratio has been carefully assessed by the doctor.

Elderly and patients with impaired hepatic or renal function:

Plasma levels of diltiazem can be increased in the elderly, and in patients with impaired hepatic renal or hepatic function. In these cases, the starting dose should be one 120mg VIAZEM XL capsule once daily. Heart rate should be monitored and if it falls below 50 beats per minute, the dose should not be increased. Dose adjustment may be required to obtain a satisfactory clinical response.

Children:

Safety and efficacy in children have not been established.

4.3 Contraindications

Diltiazem depresses atrioventricular node conduction and is therefore contraindicated in patients with severe bradycardia (less than 50 bpm), sick sinus syndrome, congestive heart failure, and left ventricular failure with second or third degree AV or sino-atrial block, except in the presence of a functioning pacemaker. Diltiazem is also contraindicated in left ventricular failure with pulmonary stasis as diltiazem may have mild negative effects on contractility.

Diltiazem is contraindicated in acute complicated myocardial infarction (e.g. bradycardia hypotension, congestive heart failure/reduced LV function), pulmonary congestion, hypotension (<90 mmHg systolic) cerebrovascular accident, cardiac shock and unstable angina pectoris.

Diltiazem is contraindicated in pre-excitation syndrome (e.g. WPW) accompanied with atrial flutter, fibrillation and in digitalis intoxication, as diltiazem may precipitate ventricular tachycardia.

Diltiazem should not be used in patients with known hypersensitivity to diltiazem.

Diltiazem should not be used during pregnancy, by women of child-bearing potential, or by women who are breastfeeding.

4.4 Special Warnings And Precautions For Use

Patients treated with beta-adrenoreceptor blocking drugs and patients with conduction disturbances (bradycardia, bundle branch block, first degree AV block, prolonged PR interval) should only be treated with VIAZEM XL after special consideration due to the risk of serious bradyarrhythmias.

This product should be used with caution in patients with hepatic dysfunction. Abnormalities of liver function may appear during therapy. The higher single daily doses of VIAZEM XL capsules 300mg and 360mg should not be administered to patients with impaired renal and/or hepatic function and to elderly patients (prolonged half life of elimination) because there is no experience on the use of such high dosages in these patient categories.

In patients undergoing long-term therapy with cyclosporin, plasma levels of cyclosporin should be monitored when concurrent administration of diltiazem is initiated, or discontinued or if the dose of diltiazem is changed.

Abnormally short transit time through the gastrointestinal tract could lead to incomplete release of contents of the capsule e.g. in chronic conditions with associated diarrhoea such as Crohns disease or ulcerative colitis.

Patients with rare heriditary problems of fructose intolerances, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicines.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Combinations contraindicated as a safety measure:

In animals, fatal ventricular fibrillations are constantly seen during administration of verapamil and dantrolene via the i.v. route. The combination of a calcium antagonist and dantrolene is therefore potentially dangerous. The concurrent iv administration of beta-adrenergic blocking agents with diltiazem should be avoided because an additive effect on SA and AV conduction and ventricular function will occur. The use of such a combination requires ECG monitoring especially at the beginning of treatment.

Combinations requiring safety precautions:

In common with other calcium antagonists, when diltiazem is used with drugs which may induce bradycardia or with antiarrhythmic drugs (e.g. amiodarone) or other antihypertensive drugs, the possibility of an additive effect should be borne in mind. Inhalation anaesthetics should be used with caution during diltiazem therapy. Tri/tetracyclic antidepressants and neuroleptics may increase the antihypertensive effects of diltiazem whilst the concomitant use of lithium with diltiazem may lead to neurotoxicity (extrapyramidal effects). Rifampin and other hepatic enzyme inducers may reduce the bioavailability of diltiazem and high doses of Vitamin D and/or high intake of calcium salts leading to elevated serum calcium levels may reduce the response to diltiazem.

Diltiazem is metabolised by CYP3A4 and could, by competitive inhibition of CYP3A4, affect the pharmacokinetics of other drugs metabolised by this enzyme. In addition inhibitors and inducers of CYP3A4 may affect the pharmacokinetics of diltiazem.

Diltiazem prolongs the sedative effect of medazolam and triazolam via metabolic interaction and decreases nifedipine clearance by 50%. Diltiazem may cause increases in the levels of digitoxin. Diltiazem has been shown to increase the bioavailability of imipramine by 30% probably due to inhibition of its first pass metabolism.

Diltiazem has been used safely in combination with diuretics, ACE-inhibitors and other anti-hypertensive agents. It is recommended that patients receiving these combinations should be regularly monitored. Concomitant use of diltiazem with alpha-blockers such as prazosin should be strictly monitored because of the possible synergistic hypotensive effect of the combination.

Case reports have suggested that blood levels of carbamazepine, cyclosporin, theophylline and phenytoin may be increased when given concurrently with diltiazem. Care should be exercised in patients taking these drugs. In common with other calcium antagonists diltiazem may cause small increases in plasma levels of digoxin. In patients taking H₂-antagonists concurrently with diltiazem there may be increased levels of diltiazem.

Magnification of the hypotensive and lipothymic effects (summation of vasodilator properties) of nitrate derivatives can occur. In patients on calcium inhibitors, prescriptions of nitrate derivatives should be made at progressively increasing doses. Diltiazem treatment has been continued without problem during anaesthesia, but diltiazem may potentiate the activity of curare-like and depolarising neuromuscular blocking agents, therefore the anaesthetist should be informed that the patient is receiving a calcium antagonist.

4.6 Pregnancy And Lactation

Pregnancy:

Diltiazem should not be taken during pregnancy. Women of child bearing-potential should exclude the possibility of pregnancy before commencing treatment by taking suitable contraceptive measures if necessary. In animal tests, Diltiazem was found to have a tetratogenic effects in some species of animal.

Diltiazem may suppress the contractility of the uterus. Definite evidence that this will prolong partus in full-term pregnancy is lacking. A risk of hypoxia in the foetus may arise in the event of hypotension in the mother and reduced perfusion of the uterus due to redistribution of blood flow due to peripheral vasodilatation. In animal experiments diltiazem has exhibited teratogenic effects in some animal species. In the absence of adequate evidence of safety in human pregnancy, VIAZEM XL should not be used in pregnancy or in women of childbearing potential.

Lactation:

Diltiazem is excreted in breast milk in concentrations similar to those in serum. If the use of diltiazem is considered essential, an alternative method of infant feeding should be instituted.

4.7 Effects On Ability To Drive And Use Machines

There are no studies on the effect of diltiazem when driving vehicles or operating machines. It should be taken into account that occasionally asthenia/fatigue and dizziness may occur. Treatment of hypertension with this medicinal product requires regular monitoring. Individual different reactions may affect the ability to drive. This risk should be considered especially at the beginning of treatment, when changing the drug, or in combination with alcohol.

4.8 Undesirable Effects

Certain undesirable effects may lead to suspension of treatment: sinus bradycardia, sino-atrial heart block, 2nd and 3rd degree atrioventricular heart block, skin rash, oedema of the lower limbs.

In hypertensive patients, adverse effects are generally mild and transient and are most commonly vasodilatory related events.

The following have been described in decreasing order of frequency: lower limb oedema, headache, hot flushes/flushing, asthenia/fatigue, palpitations, malaise, minor gastro-intestinal disorders (dyspepsia, abdominal pain, dry mouth, nausea, vomiting, diarrhoea, constipation) and skin rash. Erythema multiform and Stevens Johnson syndrome have been reported infrequently in patients receiving diltiazem hydrochloride. Vasodilatory related events (in particular, oedema) are dose-dependent and appear to be more frequent in elderly subjects.

Rare cases of symptomatic bradycardia and exceptionally sino-atrial block and atrioventricular block, hypotension, syncope, reduced left ventricular function have also been recorded. Isolated cases of hallucinations, depression, insomnia, hyperglycaemia and impotence have been reported.

Experience with use in other indications and with other formulations has shown that skin rashes are usually localised and are limited to cases of erythemia, urticaria or occasionally desquamative erthema, with or without fever, which regress when treatment is discontinued.

Isolated cases of moderate and transient elevations of liver transaminases have been observed at the start of treatment. Isolated cases of clinical hepatitis have been reported which resolved with cessation of therapy.

Dizziness, pruritis, nervousness, paraesthesia, articular/muscular pain, photo sensitisation, hypotension, gingival hyperplasia, and gynaecomastia, have also been observed.

4.9 Overdose

The clinical consequences of overdose can be severe hypotension leading to collapse, and sinus bradycardia which may be accompanied by isorhythmic dissociation and atrioventricular conduction disturbances. Observation in a coronary care unit is advisable. Vasopressors such as adrenaline may be indicated in patients exhibiting profound hypotension. Calcium gluconate may help reverse the effects of calcium entry blockade. Atropine administration and temporary cardiac pacing may be required to manage bradycardia and/or conduction disturbances.

Glucagon can be used in cases of established hypoglycaemia.

Diltiazem and its metabolites are very poorly dialysable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Diltiazem is classified as a calcium channel blocker, benziothiazepine derivative, C08DB01, under the ATC classification. It selectively reduces calcium entry through voltage-dependent calcium-n channels into vascular smooth muscle cells and myocardial cells. This lowers the concentration of intracellular calcium which is available to activate contractile proteins. This action of diltiazem results in dilation of coronary arteries causing an increase in myocardial oxygen supply. It reduces cardiac work by moderating the heart rate and by reducing systemic vasculary resistance thus reducing oxygen demand. Diltiazem also prolongs AV conduction and has mild effects on contractility. Clinical data on morbidity and mortality are not available.

5.2 Pharmacokinetic Properties

Multiple dose pharmacokinetic studies have shown that the kinetics of VIAZEM XL are non-linear within the 120mg-360mg dosage range. Diltiazem is well absorbed, but has a highly saturable first pass effect leading to a variable absolute bioavailability, which is on average 35%. The saturable first pass effect results in higher than expected systemic exposure with increasing doses.

The protein binding is 80 to 85% and the volume of distribution is 5.0 l/kg.

Diltiazem is metabolised by CYP3A4 in the liver and 70% of the dose is excreted in urine, mainly as metabolites. The plasma levels of the two main metabolites, N-monodesmethyldiltiazem and desacetyldiltiazem, represent 35% and 15% of diltiazem levels respectively. The metabolites contribute around 50% of the clinical effect. Plasma clearance of diltiazem is approximately 0.5 l/h/kg. Plasma half-life of diltiazem is approximately 5-7 hours.

VIAZEM XL capsules allow a prolonged absorption of diltiazem and maximum levels are reached within 6 to 12 hours. Concomitant food intake with VIAZEM XL does not influence the pharmacokinetics of diltiazem. For most patients, chronic administration of VIAZEM XL 300mg once daily, results in therapeutic diltiazem levels (50-200ng/ml) over 24 hours. However, the inter-individual variability is high and individual dose adjustment based on therapeutic response is therefore necessary.

5.3 Preclinical Safety Data

Tests on reproductive functions in animals show that diltiazem decreases fertility in rats and that it is teratogenic in mice, rats and rabbits. Exposure during late pregnancy induces dystocia and a decrease in the number of live newborns in rats.

Detailed mutagenicity and carcinogenicity tests proved negative.

6. Pharmaceutical Particulars

6.1 List Of Excipients

- Sucrose Stearate

- Microcrystalline cellulose

- Povidone

- Magnesium Stearate

- Talc

- Titanium dioxide

- Hypromellose

- Polysorbate 80

- Polyacrylate dispersion 30% (dry)

- Simethicone emulsion

- Gelatine capsule

Gelatin capsule colours

Gelatin capsule markings:

White printing ink contains:

Shellac, Ethyl Alcohol, Isopropyl Alcohol, n-Butyl, Propylene Glycol, Sodium Hydroxide, Polyvinylpyrrolidone, Titanium Dioxide

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 25°C. Store in original package in a dry place away from any heat source, e.g. direct sunlight, heaters, steam, etc.

6.5 Nature And Contents Of Container

The capsules are packed in PVC/aluminium blisters. Pack sizes are 28 capsules per blister.

6.6 Special Precautions For Disposal And Other Handling

Swallow capsules whole, with a glass of water do not chew.

7. Marketing Authorisation Holder

Genus Pharmaceuticals Limited

T/A Genus Pharmaceuticals

Park View House

65 London Road

Newbury

Berkshire RG14 1JN

United Kingdom

8. Marketing Authorisation Number(S)

PL 06831/0230

9. Date Of First Authorisation/Renewal Of The Authorisation

10 June 2009

10. Date Of Revision Of The Text

25 August 2011

Wednesday, 19 September 2012

Cleocin Vaginal

Generic Name: clindamycin (Vaginal route)

klin-da-MYE-sin

Commonly used brand name(s)

In the U.S.

Cleocin Vaginal

ClindaMax

Clindesse

Available Dosage Forms:

Suppository

Cream

Therapeutic Class: Antibiotic

Chemical Class: Lincosamide

Uses For Cleocin Vaginal

Clindamycin is used to treat certain vaginal infections. It works by killing the bacteria. This medicine will not work for vaginal fungus or yeast infections.

Clindamycin is available only with your doctor's prescription.

Before Using Cleocin Vaginal

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of vaginal clindamycin in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of vaginal clindamycin in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Erythromycin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Atracurium

Metocurine

Tubocurarine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of clindamycin

This section provides information on the proper use of a number of products that contain clindamycin. It may not be specific to Cleocin Vaginal. Please read with care.

Wash your hands before and after using this medicine.

Avoid getting this medicine in your eyes. If this medicine does get into your eyes, rinse them immediately with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

Vaginal clindamycin usually comes with patient directions. Read them carefully before using this medicine.

Use clindamycin vaginal cream exactly as directed by your doctor.

To fill the applicator if you are not using a pre-filled applicator
- Remove cap from the tube.
- Screw one of the applicators onto the tube. Always use a new applicator. Never use one that has been used before.
- Squeeze the medicine into the applicator slowly until it is full.
- Remove the applicator from the tube. Replace the cap on the tube.

To insert the vaginal cream using the applicator
- Relax while lying on your back with your knees bent.
- Hold the full applicator in one hand. Insert it slowly into the vagina. Stop before it becomes uncomfortable.
- Slowly press the plunger until it stops.
- Withdraw the applicator. The medicine will be left behind in the vagina.

To care for the applicator
- Throw the applicator away after you use it.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, continue using this medicine even if your menstrual period starts during the time of treatment .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For vaginal cream dosage form:
- For bacterial vaginosis:
  - Adults and teenagers who are not pregnant—One applicatorful (100 milligrams [mg]) inserted into the vagina once a day, usually at bedtime, for three or seven days.
  - Adults and teenagers who are pregnant—One applicatorful (100 milligrams [mg]) inserted into the vagina once a day, usually at bedtime, for seven days.
  - Children—Use and dose must be determined by your doctor.

For vaginal cream prefilled applicator dosage form:
- For bacterial vaginosis:
  - Adults and teenagers—One applicatorful (100 milligrams [mg]) inserted into the vagina one time at any time of the day. This is a one-day treatment.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Cleocin Vaginal

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

It is important that you visit your doctor after you have used all your medicine to make sure that the infection is gone.

This medicine may cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.

It is important that you tell your doctor right away if diarrhea occurs while you are using this medicine or after you have finished your treatment. It could be a symptom of a serious condition that your doctor will need to diagnose and treat.

Vaginal medicines usually leak out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a minipad or sanitary napkin. Do not use tampons since they may soak up the medicine.

To help clear up your infection completely and make sure it does not return, good health habits are also required.

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon or rayon) panties.

Wear only freshly washed panties daily.

Do not have sexual intercourse while you are using this medicine. Having sexual intercourse may reduce the strength of the medicine. This may cause the medicine to not work as well.

Do not use latex (rubber) contraceptive products such as condoms, diaphragms, or cervical caps for 72 hours after stopping treatment with vaginal clindamycin cream. The cream contains oils that weaken or harm the latex products, causing them to not work properly to prevent pregnancy. If you have any questions about this, check with your health care professional.

Cleocin Vaginal Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Itching of the vagina or genital area

pain during sexual intercourse

thick, white vaginal discharge with no odor or with mild odor

Less common

Diarrhea

dizziness

headache

nausea or vomiting

stomach pain or cramps

Rare

Burning, itching, rash, redness, swelling or other signs of skin problems not present before use of this medicine

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Itching of the vagina or genital area

pain during sexual intercourse

thick, white vaginal discharge with no odor or with mild odor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Cleocin Vaginal side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Cleocin Vaginal resources

Cleocin Vaginal Side Effects (in more detail)
Cleocin Vaginal Use in Pregnancy & Breastfeeding
Cleocin Vaginal Drug Interactions
Cleocin Vaginal Support Group
0 Reviews for Cleocin Vaginal - Add your own review/rating

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Compare Cleocin Vaginal with other medications

Bacterial Vaginitis

Tuesday, 18 September 2012

crotamiton topical

Generic Name: crotamiton topical (crow TA mi ton)

Brand Names: Eurax

What is crotamiton topical?

Crotamiton is a scabicide. The exact way that crotamiton works is unknown.

Crotamiton topical is used to treat scabies and to reduce itching associated with certain conditions.

Crotamiton topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about crotamiton topical?

Do not take this medication by mouth.

Do not use more of this medication than is recommended.

Avoid application to the mouth, nose, or eyes.

Treat sexual and other close contacts who are also infected.

To prevent reinfection, wash all clothing, hats, bed clothes, bed linens, hair brushes, and combs with a strong cleanser in hot water to remove any mites or eggs.

Who should not use crotamiton topical?

Do not use this medication if you have ever had an allergic reaction to it. Crotamiton topical is in the pregnancy category C. This means that it is not known whether crotamiton topical will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether crotamiton passes into breast milk. Do not use crotamiton topical without first talking to your doctor if you are breast-feeding a baby.

How should I use crotamiton topical?

Use crotamiton topical exactly as directed by your doctor, or follow the directions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Never use more of this medication than is recommended.

To treat scabies:

Shake the lotion well before use. Apply a thin layer of the cream or lotion to all body parts from the neck down to the soles of your feet (scabies does not usually infect the head). Apply the medication to dry skin and rub it in well. Leave the medication on for 24 hours, then, without washing, apply a second dose. Thoroughly wash off the medication 48 hours after the last application.

To treat itching:

Massage the medication into the affected areas until it is completely absorbed. Repeat as necessary or as directed.

Do not apply this medication to the eyes, nose, or mouth. Flush with water if you get medication in any of these areas.

Do not apply crotamiton topical to open cuts or wounds. Doing so could cause too much medication to be absorbed by your body, which could be very dangerous.

To prevent reinfection, wash all clothing, hats, bed clothes, bed linens, hair brushes, and combs with a strong cleanser in hot water to remove any mites or eggs.

Store crotamiton topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Two doses of crotamiton topical, 24 hours apart, are recommended. If the second dose is messed, retreatment may be necessary. Contact your doctor or pharmacist if you miss a dose.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a crotamiton topical overdose (after ingestion) include a burning feeling in the mouth; irritation or inflammation of the mouth, throat, and stomach lining; nausea; vomiting; and abdominal pain.

What should I avoid while taking crotamiton?

Avoid sexual or intimate contact with others until the infection has been cured. Also avoid sharing hair combs, hair accessories, hats, clothing, bed linens, and other articles of personal use. The infections are highly contagious.

Do not use more of this medication than is directed, and do not apply it to the facial area. Using too much of this medication could be very dangerous.

Do not apply crotamiton topical to open cuts or wounds. Doing so could cause too much medication to be absorbed by your body, which could be very dangerous.

Crotamiton side effects

Serious side effects are not likely to occur. Stop using crotamiton topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Mild itching, burning, or stinging may occur upon application.

Notify your doctor if your condition worsens or if unusual itching, redness, swelling, burning, or a rash occurs.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Crotamiton topical Dosing Information

Usual Adult Dose for Scabies:

Apply topically to entire body starting at the chin and working downwards. Be certain to apply to all folds and creases. Repeat application 24 hours after initial application. Change clothing and bed linen the following morning. Take a cleansing bath 48 hours after final application.

Usual Adult Dose for Pruritus:

Apply topically to affected area(s) massaging gently until completely absorbed. Repeat application as necessary.

What other drugs will affect crotamiton?

Do not apply other topical preparations to the affected area during treatment with crotamiton topical.

Drugs other than those listed here may also interact with crotamiton topical. Ask your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Compare crotamiton topical with other medications

Pruritus
Scabies

Where can I get more information?

Your pharmacist has additional information about crotamiton topical written for health professionals that you may read.

See also: crotamiton side effects (in more detail)

Forteo

Generic Name: Teriparatide
Class: Parathyroid
ATC Class: H05AA02
VA Class: HS600
Chemical Name: l-Seryl-l-valyl-l-seryl-l- α - glutamyl - l - isoleucyl - l - glutaminyl - l - leucyl - l - methionyl - l - histidyl - l - asparaginyl - l - leucylglycyl - l - lysyl - l - histidyl - l - leucyl - l - asparaginyl - l - seryl - l - methionyl - l - α - glutamyl - l - arginyl - l - valyl - l - α - glutamyl - l - tryptophyl - l - leucyl - l - arginyl - l - lysl - l - lysl - l - leucyl - l - glutaminyl - l - α - aspartyl - l - valyl - l - histidyl - l - asparaginyl - l - phenylalanine
Molecular Formula: C₁₈₁H₂₉₁N₅₅O₅₁S₂
CAS Number: 52232-67-4

Increased risk of osteosarcoma in rats receiving high doses of teriparatide; dependent on dose and treatment duration.¹

Use only in patients for whom the benefits outweigh the risks.¹

Do not use in patients with an increased baseline risk for osteosarcoma (i.e., patients with Paget’s disease of bone or unexplained increases in serum alkaline phosphatase concentrations, pediatric patients or young adults with open epiphyses, and patients who received prior radiation therapy involving the skeleton).¹

REMS:

FDA approved a REMS for teriparatide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of teriparatide and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

A biosynthetic (rDNA origin) fragment of human parathyroid hormone (parathormone, PTH), stimulates bone formation.¹ ² ³

Uses for Forteo

Osteoporosis in Postmenopausal Women

Used in the treatment of osteoporosis in postmenopausal women who are at high risk for fractures (including those with a history of osteoporotic fracture, those with multiple risk factors for fractures, and those intolerant of or failing to respond to prior therapy for osteoporosis).¹ Reduces the risk of new vertebral fractures and nonvertebral fractures.¹ ³ Increases total body bone mass density (BMD) and BMD in the lumbar spine, femoral neck, total hip, trochanter, intertrochanter, and Ward’s triangle.¹ ³

Should not be used to prevent osteoporosis or treat patients not considered to be at high risk for fracture.^c

Osteoporosis in Men

Used in the treatment of osteoporosis in men with primary or hypogonadal osteoporosis who are at high risk for fractures (including those with a history of osteoporotic fracture, those with multiple risk factors for fractures, and those intolerant of or failing to respond to prior therapy for osteoporosis).¹ In men with primary or hypogonadal osteoporosis, increases lumbar spine and femoral neck BMD.¹

Should not be used to prevent osteoporosis or treat patients not considered to be at high risk for fracture.^c

Forteo Dosage and Administration

General

Because safety and efficacy of teriparatide beyond 2 years have not been established, use of the drug for more than 2 years is not recommended.¹

Use adjunctively with other measures (e.g., weight-bearing exercise, reduction in smoking and alcohol use) to retard further bone loss.¹ ^c

Supplemental calcium and vitamin D recommended if daily dietary intake is inadequate.¹ ^a ^b ^c

Administration

Sub-Q Administration

Commercially available as a prefilled injection pen that delivers 20 mcg of teriparatide per actuation.¹ ^d Use each injection pen for up to 28 days after the first injection and then dispose of properly, even if the pen is not empty.¹

Administer into the thigh or abdominal wall.¹

Dosage

Adults

Osteoporosis in Postmenopausal Women

Sub-Q

20 mcg once daily.¹ ^c

Osteoporosis in Men

Sub-Q

20 mcg once daily.¹ ^c

Cautions for Forteo

Contraindications

Known hypersensitivity to teriparatide or any ingredient in the formulation.¹

Bone metastases, a history of skeletal malignancy, or metabolic bone disease other than osteoporosis.¹

Not studied in patients with preexisting hypercalcemia (e.g., primary hyperparathyroidism).¹ Should not be used because of the possibility of exacerbation of hypercalcemia.¹

Difficulty with injection and a caregiver is not available.¹

Warnings/Precautions

Warnings

Endocrine and Metabolic Effects

Possible transient hypercalcemia; discontinue pending further evaluation if persistent hypercalcemia is detected.¹

If preexisting hypercalcemia is suspected, consider measurement of urinary calcium.¹ (See Contraindications.)

Sensitivity Reactions

Although hypersensitivity to teriparatide has not been reported to date, antibodies to parathyroid hormone that cross-react with teriparatide are first detected following 12 months of treatment.¹ Antibody titers decrease following discontinuance of therapy.¹

General Precautions

Renal Effects

If active urolithiasis is suspected, consider measurement of urinary calcium.¹ Use with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.¹

Cardiovascular Effects

Relieve transient orthostatic hypotension (occurring within the first several doses) by reclining.¹ In clinical studies, did not preclude continued treatment.¹

Specific Populations

Pregnancy

Category C.¹ Not indicated for use in pregnancy.¹

Lactation

Not indicated in nursing women; not studied.¹

Pediatric Use

Not indicated in pediatric patients; safety and efficacy not established.¹

Geriatric Use

No substantial differences in efficacy and safety relative to younger adults, but increased sensitivity cannot be ruled out.¹

Hepatic Impairment

Limited information on safety available.¹

Renal Impairment

Limited information on safety available.¹

Common Adverse Effects

Pain, headache, asthenia, neck pain, hypertension, angina pectoris, syncope, nausea, constipation, diarrhea, vomiting, GI disorder, tooth disorder, arthralgia, leg cramps, dizziness, depression, insomnia, vertigo, rhinitis, increased cough, pharyngitis, dyspnea, pneumonia, hypercalcemia, rash, sweating.¹

Interactions for Forteo

Specific Drugs

Drug	Interaction	Comments
Digoxin	Hypercalcemia may predispose patients to digoxin toxicity¹	Use concomitantly with caution¹
Furosemide	Small increases in serum and urinary calcium with concurrent use¹	Not considered clinically important¹
Hydrochlorothiazide	Small reduction in urinary calcium excretion¹	Not considered clinically important¹

Forteo Pharmacokinetics

Absorption

Bioavailability

Approximately 95%.¹ Following sub-Q administration, peak serum drug concentrations usually attained at about 30 minutes.¹

Onset

Maximal increases in serum calcium observed at 4–6 hours following sub-Q administration.¹

Duration

Serum calcium concentrations return to or near baseline by 16–24 hours following sub-Q administration.¹

Special Populations

In men, systemic exposure is 20–30% lower than that in women; no dosage adjustments are necessary.¹

In patients with severe renal insufficiency (Cl_cr <30 mL/minute), the AUC is increased by 73%, but maximum serum drug concentrations were not increased.¹

Distribution

Extent

FollowingIV administration †, volume of distribution is approximately 0.12 L/kg.¹

Elimination

Metabolism

Metabolized by nonspecific proteolytic enzymes in the liver (possibly Kupffer cells).¹

Elimination Route

Excreted via the kidneys.¹

Half-life

Following sub-Q administration, approximately 1 hour.¹

Special Populations

In geriatric patients, no age-related differences observed.¹

In patients with severe renal insufficiency (Cl_cr <30 mL/minute), the half-life was increased by 77%.¹ Pharmacokinetics not studied in patients undergoing dialysis for chronic renal failure.¹ Pharmacokinetics not affected by mild to moderate renal insufficiency (Cl_cr 30–72 mL/minute).¹

In patients with heart failure (NYHA class I–III), pharmacokinetics not affected.¹

In patients with hepatic insufficiency, pharmacokinetics not studied.¹

Stability

Storage

Parenteral

Solution for Injection

2–8°C; do not freeze.¹

Actions

Same physiologic actions as PTH on bone and the kidneys.¹

Increases serum calcium and decreases serum phosphorus.¹ Increases urinary calcium excretion.¹ Produces transient phosphaturia, but hypophosphatemia not observed in clinical trials.¹

Increases the median serum concentration of 1,25-dihydroxyvitamin D.¹

Increases serum uric acid concentrations.¹

Stimulates new bone formation on trabecular and cortical bone surfaces by preferentially stimulating osteoblastic activity over osteoclastic activity.¹ ³

Increases bone turnover (markers of bone formation and resorption).¹

Increases BMD.¹

Advice to Patients

Provide patients a copy of the user manual provided by the manufacturer.¹

Instruct carefully in the use of the injection pen, including priming of the pen.¹

Inform patients that osteosarcoma was found in rats and that the clinical relevance is unknown.¹ (See Boxed Warning.)

Importance of sitting or lying down if symptoms of lightheadedness or palpitations occur following sub-Q injection.¹ If symptoms persist or worsen, importance of contacting a clinician before continuing treatment.¹

Importance of contacting a clinician if symptoms of hypercalcemia persist (e.g., nausea, vomiting, constipation, lethargy, muscle weakness).¹

Importance of other measures (e.g., diet, weight-bearing exercise, reduction in smoking and alcohol use) to retard further bone loss.¹ ^c

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹ ^c

Importance of advising patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Teriparatide
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection	250 mcg/mL (750 mcg)	Forteo (with metacresol in multiple-dose pen)	Lilly

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Forteo 600MCG/2.4ML Solution (LILLY): 2/$1,015.93 or 7/$2,989.81

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Eli Lilly and Company. Forteo (teriparatide recombinant DNA origin) injection. Indianapolis, IN; 2002 Nov.

2. Reeve J. Recombinant human parathyroid hormone: osteoporosis is proving amenable to treatment. BMJ. 2002; 324:435-6. [PubMed 11859030]

3. Neer RM, Arnaud CD, Zanchetta JR et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001; 344:1434-41. [IDIS 463195] [PubMed 11346808]

a. National Osteoporosis Foundation. Physician’s guide to prevention and treatment of osteoporosis. Washington, DC; 2003.

b. American Association of Clinical Endocrinologists. Medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2001 edition with selected updates for 2003. Endocrine Practice. 2003; 9:545-64.

c. Eli Lilly and Company. Forteo (teriparatide recombinant DNA orgin) injection mediation guide. Indianapolis, IN; 2002 Nov.

d. Eli Lilly and Company. Forteo (teriparatide recombinant DNA orgin) user manual. Indianapolis, IN; 2003 Oct 20.

More Forteo resources

Forteo Side Effects (in more detail)
Forteo Use in Pregnancy & Breastfeeding
Forteo Drug Interactions
Forteo Support Group
12 Reviews for Forteo - Add your own review/rating

Forteo Prescribing Information (FDA)

Forteo Consumer Overview

Forteo Advanced Consumer (Micromedex) - Includes Dosage Information

Forteo MedFacts Consumer Leaflet (Wolters Kluwer)

Teriparatide Professional Patient Advice (Wolters Kluwer)

Compare Forteo with other medications

Osteoporosis

Saturday, 15 September 2012

ketorolac Ophthalmic

kee-toe-ROLE-ak

Commonly used brand name(s)

In the U.S.

Acular

Acular LS

Acular PF

Acuvail

Available Dosage Forms:

Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For ketorolac

Ophthalmic ketorolac is an anti-inflammatory medicine. It is used in the eye to treat itching caused by seasonal allergic conjunctivitis (an allergy that occurs at only certain times of the year). Ophthalmic ketorolac is also used to treat inflammation of the eye following cataract surgery.

ketorolac may also be used to prevent or treat other conditions, as determined by your ophthalmologist (eye doctor).

Before Using ketorolac

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ketorolac, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ketorolac or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on ketorolac have been done only in adult patients, and there is no specific information comparing use of ophthalmic ketorolac in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of ophthalmic ketorolac in the elderly with use in other age groups, ketorolac is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Proper Use of ketorolac

To use:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.

If you think you did not get the drop of medicine into your eye properly, use another drop.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Dosing

The dose of ketorolac will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ketorolac. If your dose is different, do not change it unless your doctor tells you to do so.

For ophthalmic solution (eye drops) dosage form:
- For itching of the eye
  - Adults—Use one drop in each eye four times a day for up to one week or as directed by your doctor.
  - Children—Use and dose must be determined by your doctor.
- For inflammation of the eye following cataract surgery
  - Adults—Use one drop in the affected eye(s) four times a day beginning twenty-four hours after surgery and continuing for two weeks.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of ketorolac, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using ketorolac

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

While applying ketorolac, your eyes will probably sting or burn for a short time. This is to be expected.

ketorolac Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Burning, itching, redness, swelling, tearing, or other sign of eye irritation not present before therapy or becoming worse during therapy

skin rash around eye

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Stinging or burning of eye when medicine is applied

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

More ketorolac Ophthalmic resources

Ketorolac Ophthalmic Use in Pregnancy & Breastfeeding
Ketorolac Ophthalmic Drug Interactions
Ketorolac Ophthalmic Support Group
2 Reviews for Ketorolac Ophthalmic - Add your own review/rating

Acular eent Monograph (AHFS DI)

Acular Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Acular Prescribing Information (FDA)

Acular LS Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Acular LS Prescribing Information (FDA)

Acular PF Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Acular PF Prescribing Information (FDA)

Acuvail Prescribing Information (FDA)

Acuvail Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Acuvail Consumer Overview

Compare ketorolac Ophthalmic with other medications

Corneal Refractive Surgery
Postoperative Ocular Inflammation
Seasonal Allergic Conjunctivitis

Friday, 14 September 2012

Vicks Cough Syrup with Honey for Dry Coughs

1. Name Of The Medicinal Product

Vicks Cough Syrup with Honey for Dry Coughs

2. Qualitative And Quantitative Composition

ACTIVE INGREDIENTS

	%w/v	Specification
Dextromethorphan hydrobromide	0.133	Ph. Eur.

3. Pharmaceutical Form

Syrup for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Cough suppressant to relieve acute non-productive cough associated with upper respiratory tract infection and soothe the throat

4.2 Posology And Method Of Administration

Adults and children over 12 years: 3 x 5ml spoonfuls

Children (6-12 years): 1 x 5ml spoonful

Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor, seek medical attention if the child's condition deteriorates during treatment.

Vicks Cough Syrup with Honey for Dry coughs is contraindicated under 6 years of age (see section 4.3)

Keep out of reach and sight of children

Repeat every 6 hours as needed.

No more than 4 doses a day

Do not exceed the stated dose

4.3 Contraindications

Not to be used in children under the age of 6 years

Hypersensitivity to the active substance(s) or to any of the excipients.

Severe liver disease.

Patients currently receiving monoamine oxidase inhibitors (MAOIs) or within 14days of stopping such treatment

Patients with a productive cough.

Patients in, or at risk of developing respiratory failure.

Patients taking selective serotonin reuptake inhibitors (SSRIs, see section 4.5)

4.4 Special Warnings And Precautions For Use

Do not exceed the stated dose.

Ask a doctor before use if you suffer from liver disease, chronic or persistent cough, if you have asthma, suffering from an acute asthma attack or where cough is accompanied by excessive secretions

Should be used with caution in atopic children due to histamine release

Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

If symptoms persist, consult your doctor.

Keep out of reach and sight of children.

Children age 6-12: do not take with any other cough and cold medicine

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome (pyrexia, hypertension, arrhythmias) when MAOIs are taken in combination with dextromethorphan.

Dextromethorphan is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6; the possibility of interactions with inhibitors of this enzyme, including amiodarone, haloperidol, propafenone, quinidine, SSRIs, and thioridazine, should be borne in mind.

Dextromethorphan might exhibit additive CNS depressant effects when co-administered with alcohol, antihistamines, psychotropics, and other CNS depressant drugs.

4.6 Pregnancy And Lactation

There is no literature evidence of hazard due to dextromethorphan hydrobromide but, as with all medicines, use is not recommended during the first trimester and during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None expected.

4.8 Undesirable Effects

Reactions are rare but the following side effects may be associated with the use of dextromethorphan:

occasional drowsiness, dizziness, and gastrointestinal disturbances (nausea, vomiting and diarrhoea).

Hypersensitivity: rarely, skin reactions including rash may occur

Excitation, mental confusion, respiratory depression or convulsions may occur very rarely under normal conditions of use or after overdosage (see Section 4.9)

4.9 Overdose

It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms: These include nausea and vomiting, CNS depression, dizziness, dysarthria (slurred speech), nystagmus, somnolence (drowsiness), excitation, mental confusion, psychotic disorder (psychosis), and respiratory depression.

Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully to reverse central or peripheral opioid effects of dextromethorphan in children (0.01mg/kg body weight).

4.9.1 Symptoms

Mild to moderate overdose may cause dizziness and gastrointestinal disturbances. Very high doses may produce excitation, confusion, and respiratory depression.

4.9.2 Management of an overdose

Treatment involves gastric lavage and general supportive measures. Intravenous naloxone is a specific antidote. Naloxone has been used successfully to reverse central or peripheral opioid effects of dextromethorphan in children (0.01mg/kg body weight).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Dextromethorphan hydrobromide is a cough suppressant with a central action on the cough centre of the medulla.

5.2 Pharmacokinetic Properties

Dextromethorphan HBr is well absorbed from the gastrointestinal tract, metabolised in the liver and is excreted in the urine as unchanged dextromethorphan and demethylated metabolites.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance which are additional to that already included in other sections of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose.

Sodium saccharin.

Propylene glycol.

Ethanol 96%.

Sodium citrate, hydrous.

Citric acid, anhydrous.

Carboxymethylcellulose sodium.

Polyethylene oxide.

Honey flavour L-166952

Menthoxypropanediol (TK10).

Polyoxyl 40 stearate.

Sodium benzoate.

Verveine Flavour

Purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf life (unopened): 2 years

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

Amber cylindrical glass bottle (pharmaceutical type III) with a high density polyethylene screw thread closure.

Bottles containing 15ml, 30ml, 100ml, 120ml, 180ml and 250ml of product are available.

6.6 Special Precautions For Disposal And Other Handling

No specific instructions required.

7. Marketing Authorisation Holder

Procter & Gamble (Health & Beauty Care) Ltd.,

The Heights,

Brooklands,

Weybridge,

Surrey,

KT13 0XP.

8. Marketing Authorisation Number(S)

PL 0129/0079

9. Date Of First Authorisation/Renewal Of The Authorisation

13 February 1995

10. Date Of Revision Of The Text

July 2009

Thursday, 13 September 2012

Viracept Film-coated Tablets (Roche Products Limited)

1. Name Of The Medicinal Product

VIRACEPT 250 mg film-coated tablets.

2. Qualitative And Quantitative Composition

Each film-coated tablet contains nelfinavir mesilate corresponding to 250 mg of nelfinavir.

Excipients:

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Blue, oblong biconvex film-coated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

VIRACEPT is indicated in antiretroviral combination treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children of 3 years of age and older.

In protease inhibitor (PI) experienced patients the choice of nelfinavir should be based on individual viral resistance testing and treatment history.

See section 5.1.

4.2 Posology And Method Of Administration

Therapy with VIRACEPT should be initiated by a physician experienced in the management of HIV infection.

VIRACEPT is administered orally and should always be ingested with food (see section 5.2).

Patients older than 13 years: the recommended dose of VIRACEPT 250 mg film-coated tablets is 1250 mg (five tablets) twice a day (BID) or 750 mg (three tablets) three times a day (TID) by mouth.

The efficacy of the BID (twice daily) regimen has been evaluated versus the TID (three times daily) regimen primarily in patients naïve to PIs (see section 5.1).

Patients aged 3 to 13 years: for children, the recommended starting dose is 50-55 mg/kg BID or, if using a TID regimen, 25 – 30 mg/kg body weight per dose. For children unable to take tablets, VIRACEPT oral powder may be administered instead (see Summary of Product Characteristics for VIRACEPT oral powder).

The recommended dose of VIRACEPT film-coated tablets to be administered BID to children aged 3 to 13 years is as follows:

Dose to be administered two times a day to children aged 3 to 13
Body Weight of the patient in kg	Number of VIRACEPT 250 mg film-coated tablets per dose*
18 to 22 kg	4
over 22	5

The recommended dose of VIRACEPT film-coated tablets to be administered TID to children aged 3 to 13 years is as follows:

Dose to be administered three times a day to children aged 3 to 13
Body Weight of the patient in kg	Number of VIRACEPT 250 mg film-coated tablets per dose*
18 to 22 kg	2
over 22	3

*see Summary of Product Characteristics for VIRACEPT oral powder for patients with less than 18 kg body weight.

Renal and hepatic impairment: there are no data specific for HIV positive patients with renal impairment and therefore specific dosage recommendations cannot be made (see section 4.4). Nelfinavir is principally metabolised and eliminated by the liver. There are not sufficient data from patients with liver impairment and therefore specific dose recommendations cannot be made (see section 5.2). Caution should be used when administering VIRACEPT to patients with impaired renal or hepatic function.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Co-administration with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4 [e.g., terfenadine, astemizole, cisapride, amiodarone, quinidine, pimozide, triazolam, orally administered midazolam (for caution on parenterally administered midazolam, see section 4.5), ergot derivatives, alfuzosin, and sildenafil when used for treatment of pulmonary arterial hypertension hypertension (for the use of sildenafil and other PDE-5 inhibitors in patients with erectile dysfunction, see section 4.5)].

Potent inducers of CYP3A (e.g., rifampicin, phenobarbital and carbamazepine) reduce nelfinavir plasma concentrations.

Co-administration with rifampicin is contra-indicated due to a reduction in exposure to nelfinavir.

Physicians should not use potent inducers of CYP 3A4 in combination with Viracept and should consider using alternatives when a patient is taking VIRACEPT (see section 4.5).

Herbal preparations containing St. John's wort (Hypericum perforatum) must not be used while taking nelfinavir due to the risk of decreased plasma concentrations and reduced clinical effects of nelfinavir (see section 4.5).

VIRACEPT should not be co-administered with omeprazole due to a reduction in exposure to nelfinavir and its active metabolite M8 (Tert-butyl hydroxy nelfinavir). This may lead to a loss of virologic response and possible resistance to VIRACEPT (see section 4.5).

4.4 Special Warnings And Precautions For Use

Patients should be instructed that VIRACEPT is not a cure for HIV infection, that they may continue to develop infections or other illnesses associated with HIV disease, and that VIRACEPT has not been shown to reduce the risk of transmission of HIV disease through sexual contact or blood contamination.

Immune Reactivation Syndrome: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary.

Liver Disease: The safety and efficacy of nelfinavir has not been established in patients with significant underlying liver disorders. Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.

Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. The use of nelfinavir in patients with moderate hepatic impairment has not been studied. In the absence of such studies, caution should be exercised, as increases in nelfinavir levels and/or increases in liver enzymes may occur.

Patients with hepatic impairment should not be given colchicine with VIRACEPT.

Osteonecrosis: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.

Renal Impairment: Since nelfinavir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodiaylisis or peritoneal dialysis. Therefore, no special precautions or dose adjustments are required in these patients.

Patients with renal impairment should not be given colchicine with VIRACEPT.

Diabetes mellitus and hyperglycaemia: New onset diabetes mellitus, hyperglycaemia or exacerbation of existing diabetes mellitus has been reported in patients receiving PIs. In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis. Many patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes or hyperglycaemia.

Patients with haemophilia: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with PIs. In some patients additional factor VIII was given. In more than half of the reported cases, treatment with PIs was continued or reintroduced if treatment had been discontinued. A causal relationship has been evoked, although the mechanism of action has not been elucidated. Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.

Lipodystrophy: Combination antiretroviral therapy has been associated with the redistribution of body fat (acquired lipodystrophy) in HIV patients. The long-term consequences of these events are currently unknown. Knowledge about the mechanism is incomplete. A connection between visceral lipomatosis and PIs and lipoatrophy and nucleoside analogue reverse transcriptase inhibitors (NRTIs) has been hypothesised. A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances. Clinical examination should include evaluation for physical signs of fat redistribution. Consideration should be given to the measurement of fasting serum lipids and blood glucose. Lipid disorders should be managed as clinically appropriate (see section 4.8).

PDE5 inhibitors: particular caution should be used when prescribing sildenafil, tadalafil or vardenafil for the treatment of erectile dysfunction in patients receiving Viracept. Co-administration of Viracept with these medicinal products is expected to increase their concentrations and may result in associated adverse events such as hypotension, syncope, visual changes and prolonged erection (see section 4.5). Concomitant use of sildenafil prescribed for the treatment of pulmonary arterial hypertension with Viracept is contraindicated (see section 4.3).

Concurrent administration of salmeterol with VIRACEPT is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Nelfinavir is primarily metabolised via the cytochrome P450 isoenzymes CYP3A4 and CYP2C19 (see section 5.2). Nelfinavir is also an inhibitor of CYP 3A4. Based on in vitro data, nelfinavir is unlikely to inhibit other cytochrome P450 isoforms at concentrations in the therapeutic range.

Combination with other medicinal products: Caution is advised whenever VIRACEPT is co-administered with agents that are inducers or inhibitors and/or substrates of CYP3A4; such combinations may require dose adjustment (see also sections 4.3 and 4.8).

Substrates for CYP3A: Co-administration is contraindicated with the following agents that are substrates for CYP3A4 and that have narrow therapeutic windows terfenadine, astemizole, cisapride, amiodarone, quinidine, ergot derivatives, pimozide, oral midazolam, triazolam, alfuzosin, and sildenafil when used to treat pulmonary arterial hypertension (see section 4.3).

Co-administration of a PI with sildenafil is expected to substantially increase sildenafil concentration and may result in an increase in sildenafil associated adverse events, including hypotension, visual changes, and priapism.

For other substrates of CYP3A4 a dose reduction or consideration of an alternative may be required (Table 1).

Coadministration of nelfinavir with fluticasone proprionate may increase plasma concentrations of fluticasone propionate. Consider alternatives that are not metabolised by CYP3A4 such as beclomethasone.

Concomitant use of trazodone and nelfinavir may increase plasma concentrations of trazodone and a lower dose of trazodone should be considered.

Coadministration of nelfinavir with simvastatin or lovastatin may result in significant increases in simvastatin and lovastatin plasma concentrations. Consider alternatives that are not substrates of CYP3A4 such as pravastatin or fluvastatin.

Coadministration of warfarin and VIRACEPT may affect concentrations of warfarin. It is recommended that the international normalized ratio (INR) be monitored carefully during treatment with VIRACEPT, especially when commencing therapy.

Metabolic enzyme inducers: Potent inducers of CYP3A4 (e.g., rifampicin, pehnobarbital and carbamazepine) may reduce nelfianvir plasma concentrations and their coadministration is contraindicated (see section 4.3). Caution should be used when co-administering other agents that induce CYP3A4.

Plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally and should therefore not be coadministered with nelfinavir. Parenteral midazolam should be coadministered with nelfinavir in an intensive care unit to ensure close clinical monitoring. Dose adjustment for midazolam should be considered if more than a single dose is administered (Table 1)

Metabolic enzyme inhibitors: Co-administration of nelfinavir with inhibitors of CYP2C19 (e.g., fluconazole, fluoxetine, paroxetine, lansoprazole, imipramine, amitriptyline and diazepam) may be expected to reduce the conversion of nelfinavir to its major active metabolite M8 (tert-butyl hydroxy nelfinavir) with a concomitant increase in plasma nelfinavir levels (see section 5.2). Limited clinical trial data from patients receiving one or more of these medicinal products with nelfinavir indicated that a clinically significant effect on safety and efficacy is not expected. However, such an effect cannot be ruled out.

Interactions of nelfinavir with selected agents that describe the impact of nelfinavir on the pharmacokinetics of the co-administered compound and the impact of other drugs on pharmacokinetics of nelfinavir are listed in Table 1.

Table 1: Interactions and dose recommendations with other medical products

Medicinal product by therapeutic areas (dose of nelfinavir used in study)	Effects on drug levels % Change	Recommendations concerning coadministration

NRTIs
		Clinically significant interactions have not been observed between nelfinavir and nucleoside analogues. At present, there is no evidence of inadequate efficacy of zidovudine in the CNS that could be associated with the modest reduction in plasma levels of zidovudine when co-administered with nelfinavir. Since it is recommended that didanosine be administered on an empty stomach, VIRACEPT should be administered (with food) one hour after or more than 2 hours before didanosine.
Protease Inhibitors
Ritonavir 500 mg single dose (nelfinavir 750 mg tid 6 days)	Ritonavir AUC ↔ Ritonavir Cmax ↔ Nelfinavir concentrations not measured	No dosage adjustment for needed for either product
Ritonavir 500 mg BID, 3 doses (nelfinavir 750 single dose)	Ritonavir concentrations not measured Nelfinavir AUC ↑ 152 %	No dosage adjustment for needed for either product
Ritonavir 100 mg or 200 mg BID (nelfinavir 1250 mg BID morning administration)	Ritonavir concentrations not measured Nelfinavir AUC ↑ 20% M8 metabolite AUC ↑ 74%	There were no significant differences between low doses of ritonavir (either 100 or 200 mg BID) for effects on AUCs of nelfinavir and M8. The clinical relevance of these findings has not been established.
Ritonavir 100 mg or 200 mg BID (nelfinavir 1250 mg BID evening administration)	Ritonavir concentrations not measured Nelfinavir AUC ↑ 39 % M8 metabolite AUC ↑ 86%
Indinavir 800 mg single dose (nelfinavir 750 mg TID X 7 days)	Indinavir AUC ↑ 51% Indinavir Cmax ↔ Nelfinavir concentrations not measured	The safety of the combination indinavir + nelfinavir has not been established
Indinavir 800 mg Q8H X 7 days (nelfinavir 750 mg single dose)	Indinavir concentrations not measured Nelfinavir AUC ↑ 83%
Saquinavir 1200 mg single dose (nelfinavir 750 mg TID X 4 days)	Saquinavir AUC ↑ 392% Nelfinavir concentrations not measured
Saquinavir 1200 mg TID (nelfinavir 750 mg single dose)	Saquinavir concentrations not measured Nelfinavir AUC ↑ 30%
Amprenavir 800 mg TID (nelfinavir 750 mg TID)	Amprenavir AUC ↔ Amprenavir Cmin ↑ 189 % Nelfinavir AUC ↔	No dosage adjustment for needed for either product
Non-nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs)
Efavirenz 600 mg QD (Nelfinavir 750 mg TID)	Efavirenz AUC ↔ Nelfinavir AUC	No dosage adjustment for needed for either product
Delavirdine 400 mg TID (Nelfinavir 750 mg TID)	Delavirdine AUC Nelfinavir AUC ↑ 107 %	Safety of combination not established; combination not recommended
Nevirapine		Dose adjustment is not needed when nevirapine is administered with nelfinavir.
Anti infective Agents
Rifabutin 300 mg QD (Nelfinavir 750 mg TID)	Rifabutin AUC ↑ 207 % Nelfinavir AUC	Dosage reduction of rifabutin to 150 mg QD is necessary when nelfinavir 750 mg TID or 1250 mg BID and rifabutin are co-administered.
Rifabutin 150 mg QD (Nelfinavir 750 mg TID)	Rifabutin AUC ↑ 83 % Nelfinavir AUC	Dosage reduction of rifabutin to 150 mg QD is necessary when nelfinavir 750 mg TID or 1250 mg BID and rifabutin are co-administered
Rifampicin 600 mg qd x 7 days (Nelfinavir 750 mg q8h x 5-6 days)	Rifampicin concentrations not measured Nelfinavir AUC	Concomitant use of rifampicin is contraindicated with nelfinavir
Ketoconazole	Ketoconazole concentrations not measured Nelfinavir AUC ↑35%	Coadministration of nelfinavir and a strong inhibitor of CYP3A, ketoconazole, resulted in a 35 % increase in nelfinavir plasma AUC.The changes in nelfinavir concentrations are not considered clinically significant and no dose adjustment is needed when ketoconazole and nelfinavir are co-administered.
Oral Contraceptives
17 α-Ethinyl estradiol 35 μg qd x 15 days (Nelfinavir 750 mg q8h x 7 days)	Ethinyl estradiol AUC Nelfinavir concentrations not measured	Contraceptives with ethinyl estradiol should not be coadministered with nelfinavir. Alternative contraceptive measures should be considered.
Norethindrone 0.4 mg qd x 15 days (Nelfinavir 750 mg q8h x 7 days)	Norethindrone AUC Nelfinavir concentrations not measured	Contraceptives with norethindrone should not be coadministered with nelfinavir. Alternative contraceptive measures should be considered.
HMG-CoA reductase inhibitors
		Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these medicinal products with nelfinavir is not recommended.
Simvastatin 20 mg qd (Nelfinavir 1250 mg bid)	Simvastatin AUC ↑ 505 % Nelfinavir AUC ↔ concentrations not measured	Combination of simvastatin and nelfinavir is not recommended.
Lovastatin	No data available; expected to be similar to simvastatin	Combination of lovastatin and nelfinavir is not recommended
Atorvastatin 10 mg qd (Nelfinavir 1250 mg bid)	Atorvastatin AUC ↑ 74 % Nelfinavir AUC concentrations not measured	Atorvastatin is less dependent on CYP3A4 for metabolism. When used with nelfinavir, the lowest possible dose of atorvastatin should be administered.
Pravastatin, fluvastatin, rosuvastatin		The metabolism of pravastatinand fluvastatinis not dependent on CYP3A4, and interactions are not expected with nelfinavir. If treatment with HMG-CoA reductase inhibitors is indicated in combination with nelfinavir, pravastatin or fluvastatin are recommended. Rosuvastatin may also be administered with nelfinavir but patients should be monitored.
Anticonvulsants
Phenytoin 300 mg qd x 7 days (Nelfinavir 1250 mg bid x 14 days)	Phenytoin AUC Free Phenytoin	No dose adjustment for nelfinavir is recommended. Nelfinavir may lead to decreased AUC of phenytoin; therefore phenytoin concentrations should be monitored during concomitant use with nelfinavir.
Proton Pump Inhibitors
Omeprazole 20 mg bid x 4 days administered 30 minutes before nelfinavir (Nelfinavir 1250 mg bid x 4 days)	Omeprazole concentrations not measured Nelfinavir AUC Nelfinavir Cmax Nelfinavir Cmin M8 metabolite AUC M8 metabolite Cmax M8 metabolite Cmin	Omeprazole should not be co-administered with nelfinavir. The absorption of nelfinavir may be reduced in situations where the gastric pH is increased irrespective of cause. Co-administration of nelfinavir with omeprazole may lead to a loss of virologic response and therefore concomitant use is contra-indicated. Caution is recommended when nelfinavir is co-administered with other proton pump inhibitors
Sedatives/Anxiolytics
Midazolam	No drug interaction study has been performed for the co-administration of nelfinavir with benzodiazepines.	Midazolam is extensively metabolised by CYP3A4. Co-administration of midazolam with nelfinavir may cause a large increase in the concentration of this benzodiazepine. Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally. Therefore nelfinavir should not be co-administered with orally administered midazolam. If nelfinavir is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered
H1 Receptor Antagonists, 5-HT Agonists
Terfenadine, astemizole, cisapride	Nelfinavir increases terfenadine plasma concentrations. Similar interactions are likely with astemizole and cisapride.	Nelfinavir must not be administered concurrently with terfenadine, astemizole or cisapride because of the potential for serious and/or life-threatening cardiac arrhythmias.
Endothelin receptor antagonists
Bosentan	Not studied. Concomitant use of bosentan and nelfinavir may increase plasma levels of bosentan.	When administered concomitantly with nelfinavir, the patient's tolerability of bosentan should be monitored.
Analgesics
Methadone 80 mg + 21 mg qd > 1 month (Nelfinavir 1250mg bid x 8 days	Methadone AUC	None of the subjects experienced withdrawal symptoms in this study; however, due to the pharmacokinetic changes, it should be expected that some patients who received this combination may experience withdrawal symptoms and require an upward adjustment of the methadone dose. Methadone AUC may be decreased when co-administered with nelfinavir; therefore upward adjustment of methadone dose may be required during concomitant use with nelfinavir.
Inhaled/nasal steroid
↑Fluticasone	↑ Fluticasone	Concomitant use of fluticasone propionate and VIRACEPT may increase plasma concentrations of fluticasone propionate. Use with caution. Consider alternatives to fluticasone propionate, that are not metabolised by CYP3A4, such as beclometasone, particularly for long-term use.
Antidepressants
Trazodone	↑ Trazodone	Concomitant use of trazodone and VIRACEPT may increase plasma concentrations of trazodone. The combination should be used with caution and a lower dose of trazodone should be considered.
PDE-5 inhibitors for the treatment of pulmonary arterial hypertension (PAH)
Tadalafil	Not studied. Concomitant use of tadalafil and nelfinavir may increase plasma levels of tadalafil.	Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with Viracept is not recommended.
Sildenafil	Not studied. Concomitant use of sildenafil and nelfinavir may increase plasma levels of sildenafil.	Sildenafil is contraindicated when coadministered with VIRACEPT (see contraindications).
PDE-5 inhibitors for the treatment of erectile dysfunction (ED)
Tadalafil	Not studied. Concomitant use of tadalafil and nelfinavir may increase plasma levels of tadalafil.	Use with increased monitoring for adverse events associated with increased exposure to tadalafil.
Sildenafil	Not studied. Concomitant use of sildenafil and nelfinavir may increase plasma levels of sildenafil.	Sildenafil at a starting dose not exceeding 25 mg in 48 hours. Use with increased monitoring for adverse events associated with increased exposure to sildenafil.
Vardenafil	Not studied. Concomitant use of vardenafil and nelfinavir may increase plasma levels of vardenafil	Use with increased monitoring for adverse events associated with increased exposure to vardenafil.
Antigout preparation
Colchicine	Not studied. Concomitant use of colchicine and nelfinavir may increase plasma levels of colchicine	A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with nelfinavir is required. Patients with renal or hepatic impairment should not be given colchicine with nelfinavir (see section 4.4).
Herbal Products
St. John's wort	Plasma levels of nelfinavir can be reduced by concomitant use of the herbal preparation St. John's wort (Hypericum perforatum). This is due to induction of drug metabolising enzymes and/or transport proteins by St. John's wort.	Herbal preparations containing St. John's wort must not be used concomitantly with nelfinavir. If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible nelfinavir levels. Nelfinavir levels may increase on stopping St. John's wort, and the dose of nelfinavir may need adjusting. The inducing effect of St. John's wort may persist for at least 2 weeks after cessation of treatment.

↑ Indicates increase,

4.6 Pregnancy And Lactation

No treatment-related adverse reactions were seen in animal reproductive toxicity studies in rats at doses providing systemic exposure comparable to that observed with the clinical dose. Clinical experience in pregnant women is limited. VIRACEPT should be given during pregnancy only if the expected benefit justifies the possible risk to the foetus.

It is recommended that HIV-infected women must not breast-feed their infants under any circumstances in order to avoid transmission of HIV. Studies in lactating rats showed that nelfinavir is excreted in breast milk. There is no data available on nelfinavir excretion into human breast milk. Mothers must be instructed to discontinue breast-feeding if they are receiving VIRACEPT.

4.7 Effects On Ability To Drive And Use Machines

VIRACEPT has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

The safety of the VIRACEPT 250 mg tablet was studied in controlled clinical trials with over 1300 patients. The majority of patients in these studies received either 750 mg TID either alone or in combination with nucleoside analogues or 1250 mg BID in combination with nucleoside analogues. The following adverse events with an at least possible relationship to nelfinavir (i.e. adverse reactions) were reported most frequently: diarrhoea, nausea, and rash. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse reactions from clinical trials with nelfinavir

Adverse reactions in clinical studies are summarised in Table 2. The list also includes marked laboratory abnormalities that have been observed with nelfinavir (at 48 weeks).

Table 2: Incidences of Adverse Reactions and marked laboratory abnormalities from the phase II and phase III studies. (Very common (

Body System Frequency of Reaction	Adverse Reactions
	Grades 3&4	All Grades
Gastrointestinal disorders
Very common		Diarrhoea
Common		Nausea, flatulence,
Skin and subcutaneous tissue disorders
Common		Rash
Investigations
Common		Increased alanine aminotransferase, increased aspartate aminotransferase, neutropenia, blood creatinine phosphokinase increased, neutrophil count decreased

Children and neonates:

A total of approximately 400 patients received nelfinavir in paediatric treatment trials (St

Friday, 21 September 2012

Viazem XL 240mg

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

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6. Pharmaceutical Particulars

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10. Date Of Revision Of The Text

Wednesday, 19 September 2012

Cleocin Vaginal

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Tuesday, 18 September 2012

crotamiton topical

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Forteo

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