Albuminar-20

albumin human

Dosage Form: injection
Albuminar®-20

Albumin (Human) USP, 20%

Rx only

Albuminar-20 Description

Albuminar®-20, Albumin (Human) 20% is a sterile aqueous solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.016 M sodium acetyltryptophanate and 0.016 M sodium caprylate and heated at 60°C for 10 hours.

All Source Plasma used in the manufacture of this product was tested by FDA-licensed Nucleic Acid Tests (NAT) for HCV and HIV-1 and found to be nonreactive (negative).

An investigational NAT for HBV was also performed on all Source Plasma used in the manufacture of this product and found to be nonreactive (negative). The aim of the HBV test is to detect low levels of viral material, however, the significance of a nonreactive (negative) result has not been established.

Albuminar®-20 is a solution containing in each 100 mL 20 grams of human albumin, osmotically equivalent to 400 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium 130-160 mEq; and potassium-n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia. Albuminar®-20 is to be administered by the intravenous route.

The heat treatment step employed in the manufacture of Albuminar®-20, pasteurization of the final container at 60°C for 10 hours, has been validated in a series of in vitro experiments for its capacity to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV - an enveloped virus used as a model for hepatitis C virus), Pseudorabies (PrV - a large, enveloped virus), and Encephalomyocarditis Virus (EMC - a small non-enveloped virus). For each virus studied, three independent experiments were conducted using Albuminar®-5, Albumin (Human) 5% and Albuminar®-25, Albumin (Human) 25% with the following results. 1

Pasteurization (60°C for 10 hours) Viral Reduction Studies (log10 reduction)

Virus	Albuminar®-5, Albumin (Human) 5%
HIV-1	>5.44, >6.38 and >6.31
BVDV	>6.01, >6.76 and >6.55
PrV	>7.30, >7.68 and >7.63
EMC	>7.38, >7.97 and >7.97
Virus	Albuminar®-25, Albumin (Human) 25%
HIV-1	>5.50, >6.57 and >6.64
BVDV	>5.99, >5.81 and >5.32
PrV	>7.32, >7.20 and >7.42
EMC	>7.10, >7.89 and >7.87

Albuminar-20 - Clinical Pharmacology

Albuminar®-20 is active osmotically and is therefore important in regulating the volume of circulating blood. When injected intravenously, 50 mL of 20% albumin draws approximately 140 mL of additional fluid into the circulation within 15 minutes, except in the presence of marked dehydration. This extra fluid reduces hemoconcentration and blood viscosity. The degree of volume expansion is dependent on the initial blood volume. When the circulating blood volume has been depleted, the hemodilution following albumin administration persists for many hours. In individuals with normal blood volume, it usually lasts only a few hours.

Albumin (Human), unlike whole blood or plasma, is considered free of the danger of viral hepatitis because it is heated at 60°C for 10 hours. Albuminar®-20 may be given in conjunction with other parenteral fluids such as saline, dextrose or sodium lactate. It is convenient to use since no cross-matching is required and the absence of cellular elements removes the danger of sensitization with repeated infusions.

Indications and Usage for Albuminar-20

SHOCK

Albuminar®-20 is indicated in the emergency treatment of shock due to burns, trauma, operations and infections, in the treatment of injuries of such severity that shock, although not immediately present, is likely to ensue and in other similar conditions where the restoration of blood volume is urgent. If there has been considerable loss of red blood cells, transfusion with packed red blood cells is indicated.

BURNS

Albuminar®-20 is indicated in conjunction with adequate infusions of crystalloid to counteract hemoconcentration and the loss of protein, electrolytes and water that usually follow severe burns. Because of changes in permeability, little administered albumin is likely to be retained intravascularly in the first 12 hours after a major burn. However, an optimum regimen for the use of colloid, electrolytes and water in the treatment of burns has not been established.

HYPOPROTEINEMIA

Albuminar®-20 may be used in acutely hypoproteinemic patients in the presence or absence of edema.

Contraindications

Albuminar®-20 is contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.

Warnings

Infusion of protein-containing solutions such as Albuminar®-20 that have been excessively or inappropriately diluted with hypotonic solutions such as sterile water for injection may result in severe hemolysis and acute renal failure. Please refer to the DOSAGE AND ADMINISTRATION section for information about the recommended diluents for Albuminar®-20, which are normal saline and 5% dextrose.

Do not use if the solution is turbid. Since this product contains no antimicrobial preservative, do not begin administration more than 4 hours after the container has been entered.

Albuminar®-20 is made from human plasma. Products made from human plasma may contain infectious agents such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacture. The manufacturing procedure for Albuminar®-20 includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. Albuminar®-20 is pasteurized in the final container at 60.0 +/- 0.5°C for 10-11 hours. Virus elimination/inactivation is also achieved by the cold alcohol fractionation process. (See DESCRIPTION section for further information on viral reduction measures.) Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents cannot be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 800-504-5434. The physician should discuss the risks and benefits of this product with the patient.

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

Precautions

GENERAL

If dehydration is present additional fluids must accompany or follow the administration of albumin. Administration of large quantities of albumin should be supplemented with red blood cells or replaced by whole blood to combat the relative anemia which would follow such use. The quick response of blood pressure which may follow the rapid administration of concentrated albumin necessitates careful observation of the injured patient to detect bleeding points which failed to bleed at lower blood pressure. Albumin (Human) 20% should be administered with caution to patients with low cardiac reserve or with no albumin deficiency because a rapid increase in plasma volume may cause circulatory embarrassment (e.g. hypertension, hypotension, or pulmonary edema). In cases of hypertension, a slower rate of administration is desired - 200 mL of albumin solution may be mixed with 200 mL of 10% dextrose solution and administered at a rate of 10 grams of albumin (100 mL) per hour.

If anaphylactic or severe anaphylactoid reactions occur, discontinue infusion immediately. Infusion rates and the patient's clinical state should be monitored closely during infusion.

INFORMATION FOR PATIENT

Some viruses, such as parvovirus B19 or hepatitis A are particularly difficult to remove or inactivate at this time. Parvovirus B19 may most seriously affect pregnant women, or immune-compromised individuals. The majority of parvovirus B19 and hepatitis A infections are acquired by environmental (community acquired) sources.

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Albuminar®-20. It is also not known whether Albuminar®-20 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Albuminar®-20 should be given to a pregnant woman only if clearly needed.

PEDIATRIC USE

No clinical studies using Albuminar®-20 have been conducted in pediatric patients. Safety and effectiveness in pediatric patients have not been established. However, extensive experience in patients suggests that children respond to Albuminar®-20 in the same manner as adults.

Adverse Reactions

The incidence of untoward reactions to Albuminar®-20 is low. Reports have been received of anaphylaxis, which may be severe, and hypersensitivity reactions (including urticaria, skin rash, pruritus, edema, erythema, hypotension and bronchospasm). Nausea, vomiting, increased salivation, chills and febrile reactions have also been reported (see also PRECAUTIONS).

Albuminar-20 Dosage and Administration

Albuminar®-20 may be given intravenously without dilution or it may be diluted with normal saline or 5% dextrose before administration. 250 mL per liter gives a solution which is approximately isotonic and iso-osmotic with citrated plasma.

When undiluted albumin solution is administered in patients with normal blood volume, the rate of infusion should be slow enough to prevent too rapid expansion of plasma volume.

In the treatment of shock, an initial dose of 100 mL of the 20% albumin solution is given as rapidly as tolerated. If response within 30 minutes is inadequate, an additional 100 mL of 20% albumin solution may be given. Therapy should be guided by the clinical response, blood pressure and an assessment of relative anemia. If more than 250 mL are given, or if hemorrhage has occurred, the administration of packed red blood cells may be desirable.

In severe burns, immediate therapy should include large volumes of crystalloid with lesser amounts of 20% albumin solution to maintain an adequate plasma volume and protein content. After the first 24 hours, the ratio of albumin to crystalloid may be increased to establish and maintain a plasma albumin level of about 2.5 g/100 mL or a total serum protein level of about 5.2 g/100 mL.

The infusion of Albumin (Human) as a nutrient in the treatment of chronic hypoproteinemia is not recommended. In acute hypoproteinemia 250-350 mL of 20% albumin may be required to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, the rate of administration should not be greater than 3 mL per minute to avoid circulatory embarrassment.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How is Albuminar-20 Supplied

Albuminar®-20 is supplied as a 20% solution in:

50 mL vials containing 10 grams of albumin (NDC 0053-7695-33)

100 mL vials containing 20 grams of albumin (NDC 0053-7695-34)

Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

REFERENCES

1. Data on file.

BIBLIOGRAPHY

Finlayson, J.S.: Albumin Products. Seminars in Thrombosis and Hemostasis 6:85-120, 1980.

Tullis, J.L.: Albumin. JAMA 237: 355-360 and 460-463, 1977.

Rudolf, A.M.: Pediatrics. 18th ED., p. 1839, Appleton and Lange, 1987.

Manufactured by:

CSL Behring LLC

Kankakee, IL 60901 USA

Revised May, 2008

12480-04

Package Label - Principal Display Panel - 50 mL Carton

NDC 0053-7695-33

20%

50 mL

Albuminar®-20

Albumin (Human)

USP 20%

For Intravenous Administration Only.

10 g in 50 mL solution osmotically equivalent to 200 mL of plasma.

Do not use if turbid.

Do not begin administration more than 4 hours after the container has been entered.

Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

RX only

Manufactured by:

CSL Behring LLC

Kankakee, IL 60901 USA

US License No. 1767

CSL Behring

Package Label - Principal Display Panel - 100 mL Carton

NDC 0053-7695-34

20%

100 mL

Albuminar®-20

Albumin (Human)

USP 20%

For Intravenous Administration Only.

20 g in 100 mL solution osmotically equivalent to 400 mL of plasma.

Do not use if turbid

Do not begin administration more than 4 hours after the container has been entered.

Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

RX only

Manufactured by:

CSL Behring LLC

Kankakee, IL 60901 USA

US License No. 1767

CSL Behring

Albuminar-20  albumin human  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0053-7695 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Albumin Human (Albumin Human) Albumin Human 20 g  in 100 mL

Inactive Ingredients Ingredient Name Strength sodium chloride   Sodium bicarbonate   Sodium hydroxide   Acetic Acid

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0053-7695-33 1 VIAL In 1 CARTON contains a VIAL, GLASS 1 50 mL In 1 VIAL, GLASS This package is contained within the CARTON (0053-7695-33) 2 0053-7695-34 1 VIAL In 1 CARTON contains a VIAL, GLASS 2 100 mL In 1 VIAL, GLASS This package is contained within the CARTON (0053-7695-34)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103955	01/06/2009

Labeler - CSL Behring LLC (931896963)

Establishment
Name	Address	ID/FEI	Operations
CSL Behring LLC		931896963	MANUFACTURE

Revised: 01/2009CSL Behring LLC

More Albuminar-20 resources

• Albuminar-20 Side Effects (in more detail)
• Albuminar-20 Use in Pregnancy & Breastfeeding
• Albuminar-20 Support Group
• 0 Reviews for Albuminar-20 - Add your own review/rating

Compare Albuminar-20 with other medications

• Burns, External
• Hypoproteinemia
• Pancreatitis
• Peritonitis
• Postoperative Albumin Loss
• Shock

histamine phosphate Intradermal

HIS-ta-meen

Commonly used brand name(s)

In the U.S.

• Histatrol

Available Dosage Forms:

• Solution


• Injectable

Therapeutic Class: Diagnostic Agent

Uses For histamine phosphate

Histamine is used to help diagnose problems or disease of the stomach. This test determines how much acid your stomach produces.

How the stomach test is done: Before histamine phosphate is given, the stomach contents are emptied through a tube. Then the dose of histamine, which is based on body weight, is injected under the skin. Five minutes later, the stomach contents are emptied and tested for acidity. This procedure may be repeated several times. An antihistamine medicine may be given before the histamine is injected to prevent a possible unwanted effect.

Histamine is to be used only under the supervision of a doctor.

Before Using histamine phosphate

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to histamine phosphate 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

There is no specific information comparing the use of histamine 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 histamine in the elderly with use in other age groups.

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

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.

Other Medical Problems

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or


• High blood pressure (severe) or


• Low blood pressure or


• Lung disease (especially asthma)—May make these conditions worse.

• Kidney disease (severe)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Pheochromocytoma—Histamine may cause serious damage to the brain and blood vessels.

Proper Use of histamine phosphate

A nurse or other trained health professional will give you histamine phosphate in a hospital. histamine phosphate is given through a needle placed under the skin.

Precautions While Using histamine phosphate

Do not swallow saliva during the test. The saliva may affect the results of the test.

histamine phosphate 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 or nurse immediately if any of the following side effects occur:

More common

• Dizziness


• fainting


• fast or pounding heartbeat


• headache (continuing or severe)


• lightheadedness


• nervousness

Less common or rare

• Bluish coloration of face


• blurred vision


• chest discomfort or pain


• convulsions (seizures)


• decrease in blood pressure (sudden)


• diarrhea (severe)


• difficulty with breathing


• flushing or redness of the face


• nausea and vomiting (severe)

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

• Abdominal spasms or cramps


• diarrhea


• metallic taste


• nausea or vomiting


• stomach pain


• swelling or redness at the place of injection

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: histamine phosphate Intradermal 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 histamine phosphate Intradermal resources

• Histamine phosphate Intradermal Side Effects (in more detail)
• Histamine phosphate Intradermal Drug Interactions
• Histamine phosphate Intradermal Support Group
• 0 Reviews · Be the first to review/rate this drug

Fluticasone/Salmeterol Inhaler

Pronunciation: floo-TIK-a-sone/sal-MEE-ter-ol
Generic Name: Fluticasone/Salmeterol
Brand Name: Advair HFA Inhaler

Long-acting beta-agonists, such as one of the active ingredients in Fluticasone/Salmeterol Inhaler (salmeterol), have been rarely associated with an increased risk of asthma-related death. They may also increase the risk of asthma-related hospitalizations in CHILDREN and TEENAGERS. Fluticasone/Salmeterol Inhaler should only be used to treat asthma patients who are not controlled by using other long-term asthma-control medicine. Fluticasone/Salmeterol Inhaler should not be used in patients whose asthma can be controlled by inhaled corticosteroids (eg, fluticasone).

Fluticasone/Salmeterol Inhaler is used for:

Treating asthma in certain patients. It may also be used to treat other breathing conditions as determined by your doctor.

Fluticasone/Salmeterol Inhaler is an inhaled corticosteroid and long-acting bronchodilator combination. The corticosteroid works by reducing inflammation and the bronchodilator works by widening the airways in the lungs. This helps you breathe more easily.

Do NOT use Fluticasone/Salmeterol Inhaler if:

• you are allergic to any ingredient in Fluticasone/Salmeterol Inhaler


• you are having an asthma attack (eg, sudden, severe onset or worsening of asthma symptoms, such as wheezing, cough, chest tightness, shortness of breath)


• you are using another type of long-acting inhaled bronchodilator (eg, formoterol, salmeterol)


• you are taking certain azole antifungals (eg, itraconazole, ketoconazole), a macrolide antibiotic (eg, clarithromycin), protease inhibitors (eg, atazanavir, boceprevir, indinavir, ritonavir), nefazodone, or telithromycin


• you have asthma that is already well controlled with the use of a long-term asthma-control medicine (eg, inhaled corticosteroid)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluticasone/Salmeterol Inhaler:

Some medical conditions may interact with Fluticasone/Salmeterol Inhaler. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of diabetes, eye problems (eg, cataracts, glaucoma, or increased pressure in the eye), heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), high blood pressure, liver problems, low blood potassium levels, high blood acid levels (eg, ketoacidosis), nervous system problems, seizures, thyroid problems, or an adrenal gland tumor


• if you have recently been to an emergency room for asthma, have a history of frequent hospitalizations for asthma, or have ever had a life-threatening asthma attack


• if you have a fungal, bacterial, or parasitic infection; a viral infection (eg, chickenpox, measles, shingles); herpes virus infection of the eye; tuberculosis (TB); a history of a positive TB skin test; an immune system problem or if you are taking a medicine to suppress the immune system (eg, tacrolimus); or if you have had a recent vaccination


• if you have weak bones (osteoporosis) or have risk factors of osteoporosis (eg, a family history of osteoporosis, tobacco use, long-term alcohol use, long-term use of corticosteroids or certain seizure medicines, limited physical exercise, poor nutrition)


• if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping


• if you are taking an oral corticosteroid (eg, prednisone) or an inhaled corticosteroid (eg, fluticasone)


• if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days

Some MEDICINES MAY INTERACT with Fluticasone/Salmeterol Inhaler. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) or other long-acting inhaled bronchodilators (eg, formoterol inhalation powder, salmeterol inhalation powder) because the risk of low blood potassium or irregular heartbeat may be increased


• Azole antifungals (eg, fluconazole), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), delavirdine, linezolid, macrolide antibiotics (eg, clarithromycin), MAOIs (eg, phenelzine), nefazodone, protease inhibitors (eg, atazanavir, boceprevir, indinavir, ritonavir), short-acting beta-agonist bronchodilators (eg, albuterol), telithromycin, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Fluticasone/Salmeterol Inhaler's side effects


• Beta-blockers (eg, propranolol) because they may decrease Fluticasone/Salmeterol Inhaler's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluticasone/Salmeterol Inhaler may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluticasone/Salmeterol Inhaler:

Use Fluticasone/Salmeterol Inhaler as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fluticasone/Salmeterol Inhaler comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fluticasone/Salmeterol Inhaler refilled.


• You must prime the inhaler before you use it for the first time. To prime the inhaler, shake it well for 5 seconds, then pump 1 test spray into the air away from your face. Repeat this 3 more times to be sure the inhaler is fully primed.


• You will need to reprime the inhaler if you drop it or if you have not used it in more than 4 weeks. To reprime the inhaler, shake it well for 5 seconds, then pump 1 test spray into the air away from your face. Repeat this step 1 more time to be sure the inhaler is fully primed.


• Before using Fluticasone/Salmeterol Inhaler, be sure that the canister is properly placed in the inhaler unit. Be sure the medicine is at room temperature and that there are no foreign objects inside the inhaler unit. Shake well for 5 seconds before each use. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from your open mouth or to use a special spacing device. As you start to take a slow, deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Fluticasone/Salmeterol Inhaler. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If you are using more than 1 inhalation, wait about 30 seconds. Shake the inhaler again and repeat the above steps. Keep the spray away from your eyes.


• Place the cap over the mouthpiece of the inhaler after use.


• Rinse your mouth with water after using Fluticasone/Salmeterol Inhaler. Do NOT swallow the rinse solution. Spit the rinse water out.


• Clean the inhaler once a week according to the directions in the Medication Guide.


• Do NOT put Fluticasone/Salmeterol Inhaler in water to estimate how much medicine is left in the canister. Fluticasone/Salmeterol Inhaler is made to deliver either 60 or 120 sprays. Be sure you know how many sprays your canister holds. Keep track of how many sprays you use. Throw Fluticasone/Salmeterol Inhaler away after you have used the appropriate number of sprays, even if the canister is not empty. You may no longer get the right amount of medicine in each spray.


• You may breathe more easily after you use the first dose of Fluticasone/Salmeterol Inhaler; however, it may take 1 week or longer before you get the most benefit.


• Use Fluticasone/Salmeterol Inhaler on a regular schedule to get the most benefit from it. Using Fluticasone/Salmeterol Inhaler at the same time each day will help you remember to use it. Do not stop using Fluticasone/Salmeterol Inhaler even if you feel better unless your doctor tells you to.


• If you miss a dose of Fluticasone/Salmeterol Inhaler, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluticasone/Salmeterol Inhaler.

Important safety information:

• Fluticasone/Salmeterol Inhaler may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Fluticasone/Salmeterol Inhaler with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Fluticasone/Salmeterol Inhaler will not stop an asthma attack once one has started. Be sure to carry a short-acting bronchodilator inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of Fluticasone/Salmeterol Inhaler (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.


• If you have been regularly using a short-acting bronchodilator inhaler, talk with your doctor about how to use it with Fluticasone/Salmeterol Inhaler. Short-acting bronchodilators are normally used only with Fluticasone/Salmeterol Inhaler to treat breathing problems that may occur between doses.


• Fluticasone/Salmeterol Inhaler should be used to treat asthma only if your asthma is not well controlled while you are using a certain long-term asthma-control medicine (eg, inhaled corticosteroid) or if you have severe asthma. Contact your doctor if you have questions about this information.


• Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Your doctor may make changes to your asthma-control medicines once your asthma is well controlled. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.


• If your symptoms do not get better within 1 week or if they get worse after you start using Fluticasone/Salmeterol Inhaler, check with your doctor.


• Tell your doctor or dentist that you take Fluticasone/Salmeterol Inhaler before you receive any medical or dental care, emergency care, or surgery.


• Tell your doctor at once if you notice your short-acting bronchodilator inhaler does not work as well, if you need to use it more often (eg, more than 4 times a day for more than 2 days in a row, or 1 whole canister within 8 weeks' time), or if you have a decrease in your peak meter flow results.


• The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Fluticasone/Salmeterol Inhaler in high doses. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Fluticasone/Salmeterol Inhaler may sometimes cause severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator inhaler. Seek medical care at once if your breathing does not improve after you use the short-acting bronchodilator. Tell your doctor about this reaction.


• Use caution if you switch from an oral steroid (eg, prednisone) to Fluticasone/Salmeterol Inhaler. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, a sudden asthma attack, or severe fluid or electrolyte loss. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.


• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Contact your doctor at once if you have contact with anyone who has these infections.


• Check with your doctor before you receive any vaccine while you are using Fluticasone/Salmeterol Inhaler.


• Diabetes patients - Fluticasone/Salmeterol Inhaler may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including lung function, bone density, and eye exams, may be performed while you use Fluticasone/Salmeterol Inhaler. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Fluticasone/Salmeterol Inhaler with caution in the ELDERLY; they may be more sensitive to its effects, especially pneumonia, decreased bone density, and effects on the heart.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Fluticasone/Salmeterol Inhaler.


• Fluticasone/Salmeterol Inhaler should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluticasone/Salmeterol Inhaler while you are pregnant. It is not known if Fluticasone/Salmeterol Inhaler is found in breast milk. If you are or will be breast-feeding while you use Fluticasone/Salmeterol Inhaler, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluticasone/Salmeterol Inhaler:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; mild muscle or bone pain; nausea; nervousness; throat irritation; tremor; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); behavior changes; blurred vision or other vision changes; burning, numbness, or tingling; chest pain; choking; fast or irregular heartbeat; hoarseness; overexcitement; seizures; severe muscle weakness, cramps, or spasms; severe or persistent bone pain; severe or persistent dizziness, headache, nervousness, or tremor; signs of infection (eg, fever, chills, cough, persistent sore throat, ear pain, increased mucus production or change in mucus color); swelling or tightness in the throat; symptoms of high blood sugar (eg, confusion; increased thirst, urination, or hunger; unusual weakness or drowsiness); trouble sleeping; unusual tiredness or weakness; vaginal odor or discharge; weight gain; white patches or sores on the tongue or mouth; worsening of asthma symptoms (eg, chest tightness, coughing, increased wheezing, shortness of breath).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fluticasone/Salmeterol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; fast or irregular heartbeat; muscle cramping, pain, or weakness; seizures; severe or persistent dizziness, dry mouth, headache, nausea, nervousness, tremor, or trouble sleeping.

Proper storage of Fluticasone/Salmeterol Inhaler:

Store Fluticasone/Salmeterol Inhaler at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store the inhaler with the mouthpiece down. Store away from heat, direct sunlight, and open flame. Do not puncture, break, or burn the canister, even if it appears to be empty. Do not store in the bathroom. Keep Fluticasone/Salmeterol Inhaler out of the reach of children and away from pets.

General information:

• If you have any questions about Fluticasone/Salmeterol Inhaler, please talk with your doctor, pharmacist, or other health care provider.


• Fluticasone/Salmeterol Inhaler is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fluticasone/Salmeterol Inhaler. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fluticasone/Salmeterol resources

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

Compare Fluticasone/Salmeterol with other medications

• Asthma, Maintenance
• COPD, Maintenance

tacrolimus Intravenous

ta-KROE-li-mus

Intravenous route(Solution)

Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe, and they should have complete information requisite for the follow-up of the patient .

Commonly used brand name(s)

In the U.S.

• Prograf

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Suppressant

Pharmacologic Class: Calcineurin Inhibitor

Uses For tacrolimus

Tacrolimus injection is used together with other medicines to prevent the body from rejecting a transplanted organ (e.g., kidney, liver, or heart). tacrolimus may be used with steroids, azathioprine (Imuran®), or mycophenolate mofetil (Cellcept®). Tacrolimus belongs to a group of medicines known as immunosuppressive agents.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Tacrolimus works by suppressing the immune system to prevent the white blood cells from trying to get rid of the transplanted organ.

Tacrolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also decrease the body's ability to fight infections. You and your doctor should talk about the benefits of tacrolimus as well as the risks of using it.

tacrolimus is to be given only by or under the direct supervision of a doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in the product labeling, tacrolimus is used in certain patients with the following medical conditions:

• Bone marrow transplant.


• Pancreas transplant.

Before Using tacrolimus

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 tacrolimus, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tacrolimus 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tacrolimus injection in children with liver transplants.

Appropriate studies have not been performed on the relationship of age to the effects of tacrolimus injection in children with kidney and heart transplants. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tacrolimus injection in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving tacrolimus injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	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.

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. When you are receiving tacrolimus, 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 tacrolimus with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ziprasidone

Using tacrolimus 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.

• Aceclofenac


• Acemetacin


• Alclofenac


• Amikacin


• Amiloride


• Amiodarone


• Apazone


• Atazanavir


• Bacillus of Calmette and Guerin Vaccine, Live


• Basiliximab


• Benoxaprofen


• Bromfenac


• Bufexamac


• Carbamazepine


• Carprofen


• Caspofungin


• Cisplatin


• Clometacin


• Clonixin


• Colchicine


• Crizotinib


• Cyclosporine


• Darunavir


• Dexketoprofen


• Dibekacin


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Efavirenz


• Etodolac


• Etofenamate


• Etravirine


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gentamicin


• Ibuprofen


• Indomethacin


• Indoprofen


• Infliximab


• Isoxicam


• Itraconazole


• Kanamycin


• Ketoprofen


• Ketorolac


• Lornoxicam


• Measles Virus Vaccine, Live


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mumps Virus Vaccine, Live


• Nabumetone


• Naproxen


• Nefazodone


• Nelfinavir


• Neomycin


• Netilmicin


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Pazopanib


• Phenobarbital


• Phenylbutazone


• Phenytoin


• Pirazolac


• Piroxicam


• Pirprofen


• Poliovirus Vaccine, Live


• Posaconazole


• Propyphenazone


• Proquazone


• Rifabutin


• Rifampin


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Sirolimus


• Smallpox Vaccine


• Spironolactone


• St John's Wort


• Streptomycin


• Sulindac


• Suprofen


• Telaprevir


• Tenidap


• Tenofovir


• Tenoxicam


• Tiaprofenic Acid


• Tobramycin


• Tolmetin


• Triamterene


• Typhoid Vaccine


• Varicella Virus Vaccine


• Vemurafenib


• Voriconazole


• Yellow Fever Vaccine


• Zomepirac

Using tacrolimus 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.

• Amprenavir


• Chloramphenicol


• Clarithromycin


• Clotrimazole


• Dalfopristin


• Danazol


• Diltiazem


• Erythromycin


• Fluconazole


• Fosphenytoin


• Ketoconazole


• Metoclopramide


• Metronidazole


• Mibefradil


• Nevirapine


• Nifedipine


• Quinupristin


• Rifapentine


• Ritonavir


• Saquinavir


• Schisandra sphenanthera


• Theophylline

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.

Other Medical Problems

The presence of other medical problems may affect the use of tacrolimus. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to polyoxyl 60 hydrogenated castor oil—Should not be used in patients with this condition.

• Diabetes or


• Hyperkalemia (high potassium in the blood) or


• Hypertension (high blood pressure) or


• Myocardial hypertrophy (heart is larger than normal), history of or


• Paresthesias (numbness or tingling in the hands, arms, legs, or feet), history of or


• Seizures (convulsions), history of or


• Tremors—Use with caution. May make these conditions worse.

• Infection, active (eg, bacteria, fungus, or virus)—May decrease your body's ability to fight an infection.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of tacrolimus

A nurse or other trained health professional will give you tacrolimus in a hospital. tacrolimus is given through a needle placed in one of your veins.

You will only receive tacrolimus for a few days. Then your doctor will switch you to the oral (by mouth) form of tacrolimus.

tacrolimus comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using tacrolimus

It is very important that your doctor check your progress while you are receiving tacrolimus to make sure that tacrolimus is working properly. Blood and urine tests may be needed to check for unwanted effects.

Tacrolimus injection may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor or nurse right away if you have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive tacrolimus.

tacrolimus may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

tacrolimus may increase your risk of developing infections. Avoid being near people who are sick while you are receiving tacrolimus. Wash your hands often. Tell your doctor if you have any kind of infection before you start using tacrolimus. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

While you are being treated with tacrolimus, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Tacrolimus may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

tacrolimus may increase your risk for developing a rare and serious virus infection with the BK polyoma virus. This virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.

tacrolimus may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, confusion, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

tacrolimus may cause serious nervous system problems. Tell your doctor right away if you have the following symptoms while using tacrolimus: blurred vision, dizziness, headache, mental changes, seizures, high blood pressure, or a fast heartbeat.

Hyperkalemia (high potassium in the blood) may occur while you are using tacrolimus. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Tacrolimus may cause a condition called pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat; pale skin; unusual bleeding or bruising; or unusual tiredness or weakness.

tacrolimus 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 or nurse immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• abnormal dreams


• agitation


• anxiety


• chills


• confusion


• convulsions (seizures)


• diarrhea


• dizziness


• fever and sore throat


• flu-like symptoms


• frequent urination


• headache


• infection


• itching


• loss of appetite


• loss of energy or weakness


• mental depression


• muscle trembling or twitching


• nausea


• nervousness


• pale skin


• seeing or hearing things that are not there


• shortness of breath


• skin rash


• swelling of the feet or lower legs


• tingling


• trembling and shaking of the hands


• trouble with sleeping


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting

Less common

• Blurred vision


• chest pain


• increased sensitivity to pain


• muscle cramps


• numbness or pain in the legs


• ringing in the ears


• sweating

Rare

• Enlarged heart


• flushing of the face or neck


• general feeling of discomfort or illness


• weight loss


• wheezing

Incidence not known

• Black, tarry stools


• blistering, peeling, or loosening of the skin


• bloating


• bloody urine


• blurred vision


• constipation


• cough


• drowsiness


• fainting


• fast, slow, or irregular heartbeat


• heartburn


• increased blood pressure


• increased thirst


• indigestion


• joint or muscle pain


• lightheadedness


• loss of appetite


• lower back or side pain


• nausea


• pinpoint red spots on skin


• pounding or rapid pulse


• red, irritated eyes


• red skin lesions, often with a purple center


• shortness of breath


• skin sores


• stomach pain


• troubled breathing


• ulcers or white spots in mouth or on lips


• weakness


• weight gain


• yellow eyes or skin

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

• Acid or sour stomach


• belching


• difficulty with moving


• lack or loss of strength


• muscle pain or stiffness


• unable to sleep

Less common

• Body aches or pain


• burning or stinging of the skin


• cracks in the skin


• crying


• delusions


• dementia


• depersonalization


• dysphoria


• euphoria


• excessive muscle tone


• feeling of constant movement of self or surroundings


• feeling that others are watching you or controlling your behavior


• feeling that others can hear your thoughts


• increased sensitivity of the skin to sunlight


• large, flat, blue or purplish patches in the skin


• loss of strength or energy


• muscle tension or tightness


• painful blisters on the trunk of the body


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• redness or other discoloration of the skin


• restlessness


• scaly skin


• sensation of spinning


• severe mood or mental changes


• severe sunburn


• sleepiness or unusual drowsiness


• sore mouth or tongue


• sores on the skin


• swelling or inflammation of the mouth


• tender, swollen glands in the neck


• unusual behavior


• white patches in the mouth, tongue, or throat

Incidence not known

• Change in color vision


• decreased weight


• difficulty seeing at night


• feeling hot and cold


• hearing loss


• sudden sweating

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.

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.

Magnacet

Generic Name: oxycodone and acetaminophen (Oral route)

a-seet-a-MIN-oh-fen, ox-i-KOE-done hye-droe-KLOR-ide

Oral route(Tablet)

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg/day, and often involve more than one acetaminophen-containing product .

Commonly used brand name(s)

In the U.S.

• Endocet


• Magnacet


• Narvox


• Percocet


• Perloxx


• Primalev


• Roxicet


• Roxilox


• Tylox


• Xolox

Available Dosage Forms:

• Tablet


• Solution


• Capsule

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Oxycodone

Uses For Magnacet

Oxycodone and acetaminophen combination is used to relieve moderate to moderately severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Oxycodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using Magnacet

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

Appropriate studies have not been performed on the relationship of age to the effects of oxycodone and acetaminophen combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving oxycodone and acetaminophen combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	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.

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. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone

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.

• Acetophenazine


• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Aprobarbital


• Atazanavir


• Brofaromine


• Bromazepam


• Brotizolam


• Buprenorphine


• Buspirone


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorzoxazone


• Clarithromycin


• Clobazam


• Clonazepam


• Clorazepate


• Clorgyline


• Codeine


• Dantrolene


• Desflurane


• Dexmedetomidine


• Dezocine


• Diazepam


• Diphenhydramine


• Doxylamine


• Enflurane


• Erythromycin


• Escitalopram


• Estazolam


• Eszopiclone


• Ethchlorvynol


• Ethopropazine


• Fentanyl


• Flumazenil


• Flunitrazepam


• Fluphenazine


• Flurazepam


• Fluvoxamine


• Fospropofol


• Furazolidone


• Halazepam


• Halothane


• Hydrocodone


• Hydromorphone


• Hydroxyzine


• Indinavir


• Iproniazid


• Isocarboxazid


• Isoflurane


• Itraconazole


• Ketamine


• Ketazolam


• Ketoconazole


• Lazabemide


• Levorphanol


• Linezolid


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Mesoridazine


• Metaxalone


• Methdilazine


• Methocarbamol


• Methohexital


• Midazolam


• Moclobemide


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nefazodone


• Nelfinavir


• Nialamide


• Nitrazepam


• Nitrous Oxide


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pargyline


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenelzine


• Phenobarbital


• Prazepam


• Procarbazine


• Prochlorperazine


• Promazine


• Promethazine


• Propiomazine


• Propofol


• Propoxyphene


• Quazepam


• Ramelteon


• Rasagiline


• Remifentanil


• Ritonavir


• Saquinavir


• Secobarbital


• Selegiline


• Sertraline


• Sevoflurane


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Telithromycin


• Temazepam


• Thiethylperazine


• Thiopental


• Thioridazine


• Toloxatone


• Tranylcypromine


• Triazolam


• Trifluoperazine


• Triflupromazine


• Trimeprazine


• Zaleplon


• Zolpidem

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.

• Acenocoumarol


• Carbamazepine


• Isoniazid


• Miconazole


• Phenytoin


• Rifampin


• St John's Wort


• Voriconazole


• Warfarin


• Zidovudine

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or


• Alcohol abuse, history of or


• Brain tumor, history of or


• Chronic obstructive pulmonary disease (COPD) or


• CNS depression or


• Cor pulmonale (serious heart condition) or


• Drug dependence, especially with narcotics, or history of or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Head injuries, history of or


• Hypothyroidism (an underactive thyroid) or


• Hypovolemia (low blood volume) or


• Kyphoscoliosis (curvature of the spine with breathing problems) or


• Mental illness or


• Problems with passing urine—Use with caution. May increase risk for more serious side effects.

• Asthma, severe or


• Hypercarbia (high carbon dioxide in the blood), severe or


• Paralytic ileus (bowels stop working and may be blocked) or


• Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or


• Pancreatitis (inflammation of the pancreas) or


• Seizures, history of or


• Stomach problems—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of oxycodone and acetaminophen

This section provides information on the proper use of a number of products that contain oxycodone and acetaminophen. It may not be specific to Magnacet. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming and cause mental or physical dependence. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

Measure the oral liquid using the patient cup that comes with the package.

Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

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 moderate to moderately severe pain:
  
  • For oral dosage form (capsules):
    
    • Adults—One capsule every 6 hours as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (solution):
    
    • Adults—5 milliliters (mL) or one teaspoonful every 6 hours as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—One tablet every 6 hours as needed. However, the dose is usually not more than 6 to 12 tablets per day.
    
    
    • 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Flush any unused capsules, liquid, or tablets down the toilet.

Precautions While Using Magnacet

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused tablets in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. 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 or not alert.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, irritability, nausea, restlessness, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, especially those containing acetaminophen (Tylenol (R)), and herbal or vitamin supplements.

Magnacet 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 immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• black, tarry stools


• chills


• dark urine


• dizziness


• fever


• headache


• itching


• light-colored stools


• loss of appetite


• nausea


• rash


• unpleasant breath odor


• unusual tiredness or weakness


• vomiting of blood


• yellow eyes or skin

Rare

• Cough or hoarseness


• fever with or without chills


• general feeling of tiredness or weakness


• lower back or side pain


• painful or difficult urination


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• unusual bleeding or bruising

Incidence not known

• Back, leg, or stomach pains


• bleeding gums


• bloating


• blood in the urine or stools


• blue lips and fingernails


• blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain or discomfort


• clay-colored stools


• cloudy urine


• clumsiness


• confusion


• constipation


• coughing that sometimes produces a pink frothy sputum


• decrease in the frequency of urination


• decrease in urine volume


• decreased awareness or responsiveness


• decreased frequency or amount of urine


• decreased urination


• difficult or labored breathing


• difficult or painful urination


• difficult, fast, noisy breathing, sometimes with wheezing


• difficulty in passing urine (dribbling)


• difficulty with swallowing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• drowsiness


• dry mouth


• extremely shallow or slow breathing


• fainting


• fast or deep breathing


• fast, slow, irregular, pounding, or racing heartbeat or pulse


• feeling of warmth


• general body swelling


• greatly decreased frequency of urination or amount of urine


• hives or welts


• increase in heart rate


• increased blood pressure


• increased sweating


• increased thirst


• indigestion


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lightheadedness


• low body temperature


• muscle aches


• muscle tremors


• muscle weakness


• nervousness


• noisy breathing


• nosebleeds


• numbness or tingling in the hands, feet, or lips


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


• pinpoint red spots on the skin


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid, deep breathing


• rapid, shallow breathing


• redness of the face, neck, arms, and occasionally, upper chest


• redness of the skin


• restlessness


• seizures


• severe constipation


• severe sleepiness


• severe vomiting


• shivering


• shortness of breath


• skin blisters


• skin rash


• sleepiness


• slow or irregular breathing


• sore throat


• stomach cramps


• stomach pain, continuing


• sudden decrease in the amount of urine


• sunken eyes


• sweating


• swelling in the legs and ankles


• swelling of the face, fingers, or lower legs


• thirst


• tightness in the chest


• tiredness


• troubled breathing


• unpleasant breath odor


• upper right abdominal or stomach pain


• vomiting


• vomiting of blood


• weak or feeble pulse


• weakness or heaviness of the legs


• weight gain


• wheezing


• wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Bluish lips or skin


• change in consciousness


• cold, clammy skin


• extreme sleepiness


• general feeling of discomfort or illness


• loss of consciousness


• no blood pressure or pulse


• not breathing


• stopping of heart


• unconsciousness

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

• Relaxed and calm

Incidence not known

• Acid or sour stomach


• agitation


• anxiety


• bad or unusual or unpleasant (after) taste


• belching


• change in taste


• cold sweats


• constricted, pinpoint, or small pupils (black part of the eye)


• continuing ringing or buzzing or other unexplained noise in the ears


• cool, pale skin


• depression


• diarrhea


• difficulty with moving


• disturbed color perception


• double vision


• excess air or gas in the stomach or intestines


• false or unusual sense of well-being


• flushed, dry skin


• fruit-like breath odor


• full feeling


• general feeling of discomfort or illness


• halos around lights


• hearing loss


• heartburn


• increased hunger


• increased thirst


• increased urination


• indigestion


• joint pain


• lack or loss of strength


• muscle cramps or spasms


• muscle pain or stiffness


• nervousness


• night blindness


• nightmares


• overbright appearance of lights


• passing gas


• rash


• red eye


• seeing, hearing, or feeling things that are not there


• seizures


• severe sleepiness


• shakiness


• sleepiness or unusual drowsiness


• sleeplessness


• slurred speech


• stomach discomfort, upset, or pain


• stomach fullness


• sweating


• swollen joints


• thirst


• trouble sleeping


• troubled breathing


• tunnel vision


• unable to sleep


• unexplained weight loss


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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: Magnacet side effects (in more detail)

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More Magnacet resources

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

• Magnacet Prescribing Information (FDA)


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• Roxicet Prescribing Information (FDA)


• Roxicet Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Roxicet Consumer Overview


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