Rhelafen

Rhelafen may be available in the countries listed below.

Ingredient matches for Rhelafen

Ibuprofen

Ibuprofen is reported as an ingredient of Rhelafen in the following countries:

• Indonesia

International Drug Name Search

Aminocaproic Acid Syrup

Pronunciation: a-mee-noe-ka-PROE-ik
Generic Name: Aminocaproic Acid
Brand Name: Amicar

Aminocaproic Acid Syrup is used for:

Preventing and treating severe bleeding in patients with medical conditions that cause blood clots to dissolve faster than normal and lead to severe bleeding, including hemophilia; aplastic anemia; lung, prostate, stomach and cervical cancer; cirrhosis; and certain complications of surgery.

Aminocaproic Acid Syrup is an antifibrinolytic. It works by blocking the breakdown of blood clots.

Do NOT use Aminocaproic Acid Syrup if:

• you are allergic to any ingredient in Aminocaproic Acid Syrup


• you are experiencing blood clots

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

Before using Aminocaproic Acid Syrup:

Some medical conditions may interact with Aminocaproic Acid Syrup. 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 upper urinary tract bleeding, kidney problems, liver problems, certain blood disorders (eg, hemophilia, uremia), blood clotting problems (active intravascular clotting), undiagnosed bleeding disorder, heart problems, or a history of seizures

Some MEDICINES MAY INTERACT with Aminocaproic Acid Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Factor IX complex concentrates or anti-inhibitor coagulant concentrates because the risk of blood clots may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aminocaproic Acid Syrup 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 Aminocaproic Acid Syrup:

Use Aminocaproic Acid Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Aminocaproic Acid Syrup may be taken with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Do not miss any doses.


• If you miss a dose of Aminocaproic Acid Syrup, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Aminocaproic Acid Syrup.

Important safety information:

• Aminocaproic Acid Syrup may cause dizziness or changes in vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Aminocaproic Acid Syrup. Using Aminocaproic Acid Syrup alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• LAB TESTS, including creatine phosphokinase levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Aminocaproic Acid Syrup is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Aminocaproic Acid Syrup during pregnancy. It is unknown if Aminocaproic Acid Syrup is excreted in breast milk. If you are or will be breast feeding while you are using Aminocaproic Acid Syrup, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Aminocaproic Acid Syrup:

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:

Confusion; decreased vision; diarrhea; dizziness; fatigue or tiredness; general body discomfort; headache; lightheadedness; muscle aches or swelling; nausea; pain; ringing in the ears; stomach pain; stuffy nose; swelling; vomiting; watery eyes.

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); delirium; fainting; fever; hallucinations; muscle pain or weakness; seizures; slow heartbeat; sore throat; stroke; sudden change in the amount of urine you are producing; swelling of ankles, feet, or hands; unusual bleeding or bruising.

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: Aminocaproic Acid 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 fainting; seizures; severe or unusual weakness; sudden change in amount of urine you produce.

Proper storage of Aminocaproic Acid Syrup:

Store Aminocaproic Acid Syrup at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Aminocaproic Acid Syrup out of the reach of children and away from pets.

General information:

• If you have any questions about Aminocaproic Acid Syrup, please talk with your doctor, pharmacist, or other health care provider.


• Aminocaproic Acid Syrup 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 Aminocaproic Acid Syrup. 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 Aminocaproic Acid resources

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

Compare Aminocaproic Acid with other medications

• Fibrinolytic Bleeding

Amphotericin B

Amphotericin B for Injection USP

Rx Only

FOR INTRAMUSCULAR AND INTRAVENOUS USE

BOXED WARNING

This drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal infections; it should not be used to treat noninvasive forms of fungal disease such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts.

Amphotericin B for Injection should no be given in doses greater than 1.5 mg/kg.

EXERCISE CAUTION to prevent inadvertent overdosage, which may result in potentially fatal cardiac or cardiopulmonary arrest (see WARNINGS, OVERDOSAGE and DOSAGE AND ADMINISTRATION). Verify the product name and dosage pre-administration, especially if dose exceeds 1.5 mg/kg.

DESCRIPTION

Amphotericin B for Injection USP contains Amphotericin B, an antifungal polyene antibiotic obtained from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R- (1R*, 3S*, 5R*, 6R*, 9R*, 11R*, 15S*, 16R*, 17R*, 18S*, 19E, 21E, 23E, 25E, 27E, 29E, 31E, 33R*, 35S*, 36R*, 37S*)] -33-[(3-Amino-3, 6 - dideoxy - β - D - mannopyranosyl) - oxy] - 1,3,5,6,9,11,17,37 - octahydroxy - 15,16,18 - trimethyl - 13 - oxo - 14,39 - dioxabicyclo [33.3.1] nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid. Structural formula:

Each vial contains a sterile, nonpyrogenic, lyophilized cake (which may partially reduce to powder following manufacture) providing 50 mg Amphotericin B and 41 mg sodium desoxycholate buffered with 20.2 mg sodium phosphates (consisting of mono and dibasic sodium phosphate, phosphoric acid and sodium hydroxide). Crystalline Amphotericin B is insoluble in water; therefore, the antibiotic is solubilized by the addition of sodium desoxycholate to form a mixture which provides a colloidal dispersion for intravenous infusion following reconstitution.

At the time of manufacture the air in the vial is replaced by nitrogen.

CLINICAL PHARMACOLOGY

Microbiology

Amphotericin B shows a high order of in vitro activity against many species of fungi. Histoplasma capsulatum, Coccidioides immitis, Candida species, Blastomyces dermatitidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenckii, Mucor mucedo, and Aspergillus fumigatus are all inhibited by concentrations of Amphotericin B ranging from 0.03 to 1.0 mcg/mL in vitro. While Candida albicans is generally quite susceptible to Amphotericin B, non-albicans species may be less susceptible. Pseudallescheria boydii and Fusarium sp. are often resistant to Amphotericin B. The antibiotic is without effect on bacteria, rickettsiae, and viruses.

Susceptibility Testing

Standardized techniques for susceptibility testing for antifungal agents have not been established and results of susceptibility studies have not been correlated with clinical outcomes.

PHARMACOKINETICS

Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus. The drug acts by binding to sterols in the cell membrane of susceptible fungi with a resultant change in membrane permeability allowing leakage of intracellular components. Mammalian cell membranes also contain sterols and it has been suggested that the damage to human cells and fungal cells may share common mechanisms.

An initial intravenous infusion of 1 to 5 mg of Amphotericin B per day, gradually increased to 0.4 to 0.6 mg/kg daily, produces peak plasma concentrations ranging from approximately 0.5 to 2 mcg/mL. Following a rapid initial fall, plasma concentrations plateau at about 0.5 mcg/mL. An elimination half-life of approximately 15 days follows an initial plasma half-life of about 24 hours. Amphotericin B circulating in plasma is highly bound (>90%) to plasma proteins and is poorly dialyzable. Approximately two thirds of concurrent plasma concentrations have been detected in fluids from inflamed pleura, peritoneum, synovium, and aqueous humor. Concentrations in the cerebrospinal fluid seldom exceed 2.5% of those in the plasma. Little Amphotericin B penetrates into vitreous humor or normal amniotic fluid. Complete details of tissue distribution are not known.

Amphotericin B is excreted very slowly (over weeks to months) by the kidneys with 2 to 5% of a given dose being excreted in the biologically active form. Details of possible metabolic pathways are not known. After treatment is discontinued, the drug can be detected in the urine for at least 7 weeks due to the slow disappearance of the drug. The cumulative urinary output over a 7 day period amounts to approximately 40% of the amount of drug infused.

INDICATIONS & USAGE

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts.

Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis.

Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

CONTRAINDICATIONS

This product is contraindicated in those patients who have shown hypersensitivity to Amphotericin B or any other component in the formulation unless, in the opinion of the physician, the condition requiring treatment is life-threatening and amenable only to Amphotericin B therapy.

WARNINGS

Amphotericin B is frequently the only effective treatment available for potentially life-threatening fungal disease. In each case, its possible life-saving benefit must be balanced against its untoward and dangerous side effects.

EXERCISE CAUTION to prevent inadvertent Amphotericin B overdose, which may result in potentially fatal cardiac or cardiopulmonary arrest (see OVERDOSAGE and DOSAGE AND ADMINISTRATION). Verify the product name and dosage especially if dose exceeds 1.5 mg/kg.

PRECAUTIONS

General

Amphotericin B should be administered intravenously under close clinical observation by medically trained personnel. It should be reserved for treatment of patients with progressive, potentially life-threatening fungal infections due to susceptible organisms (see INDICATIONS AND USAGE).

Acute reactions including fever, shaking chills, hypotension, anorexia, nausea, vomiting, headache, and tachypnea are common 1 to 3 hours after starting an intravenous infusion. These reactions are usually more severe with the first few doses of Amphotericin B and usually diminish with subsequent doses.

Rapid intravenous infusion has been associated with hypotension, hypokalemia, arrhythmias, and shock and should, therefore, be avoided (see DOSAGE AND ADMINISTRATION).

Amphotericin B should be used with care in patients with reduced renal function; frequent monitoring of renal function is recommended (see PRECAUTIONS: Laboratory Tests and ADVERSE REACTIONS). In some patients hydration and sodium repletion prior to Amphotericin B administration may reduce the risk of developing nephrotoxicity. Supplemental alkali medication may decrease renal tubular acidosis complications.

Since acute pulmonary reactions have been reported in patients given Amphotericin B during or shortly after leukocyte transfusions, it is advisable to temporarily separate these infusions as far as possible and to monitor pulmonary function (see PRECAUTIONS: Drug Interactions).

Leukoencephalopathy has been reported following use of Amphotericin B. Literature reports have suggested that total body irradiation may be a predisposition.

Whenever medication is interrupted for a period longer than seven days, therapy should be resumed by starting with the lowest dosage level, e.g., 0.25 mg/kg of body weight, and increased gradually as outlined under DOSAGE AND ADMINISTRATION.

LABORATORY TESTS

Renal function should be monitored frequently during Amphotericin B therapy (see ADVERSE REACTIONS).

It is also advisable to monitor on a regular basis liver function, serum electrolytes (particularly magnesium and potassium), blood counts, and hemoglobin concentrations. Laboratory test results should be used as a guide to subsequent dosage adjustments.

DRUG INTERACTIONS

When administered concurrently, the following drugs may interact with Amphotericin B:

Antineoplastic agents: may enhance the potential for renal toxicity, bronchospasm and hypotension. Antineoplastic agents (e.g., nitrogen mustard, etc.) should be given concomitantly only with great caution.

Corticosteroids and Corticotropin (ACTH): may potentiate Amphotericin B-induced hypokalemia which may predispose the patient to cardiac dysfunction. Avoid concomitant use unless necessary to control side effects of Amphotericin B. If used concomitantly, closely monitor serum electrolytes and cardiac function (see ADVERSE REACTIONS).

Digitalis glycosides: Amphotericin B-induced hypokalemia may potentiate digitalis toxicity. Serum potassium levels and cardiac function should be closely monitored and any deficit promptly corrected.

Flucytosine: while a synergistic relationship with Amphotericin B has been reported, concomitant use may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion.

Imidazoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.): in vitro and animal studies with the combination of Amphotericin B and imidazoles suggest that imidazoles may induce fungal resistance to Amphotericin B. Combination therapy should be administered with caution, especially in immnocompromised patients.

Other nephrotoxic medications: agents such as aminoglycosides, cyclosporine, and pentamidine may enhance the potential for drug-induced renal toxicity, and should be used concomitantly only with great caution. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications (see PRECAUTIONS: Laboratory Tests).

Skeletal muscle relaxants: Amphotericin B-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g., tubocurarine). Serum potassium levels should be monitored and deficiencies corrected.

Leukocyte transfusions: acute pulmonary toxicity has been reported in patients receiving intravenous Amphotericin B and leukocyte transfusions (see PRECAUTIONS: General).

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

No long-term studies in animals have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

Teratogenic Effects

Pregnancy Category B:    Reproduction studies in animals have revealed no evidence of harm to the fetus due to Amphotericin B for injection. Systemic fungal infections have been successfully treated in pregnant women with Amphotericin B for injection without obvious effects to the fetus, but the number of cases reported has been small. Because animal reproduction studies are not always predictive of human response, and adequate and well-controlled studies have not been conducted in pregnant women, this drug should be used during pregnancy only if clearly indicated.

NURSING MOTHERS

It is not known whether Amphotericin B is excreted in human milk. Because many drugs are excreted in human milk and considering the potential toxicity of Amphotericin B, it is prudent to advise a nursing mother to discontinue nursing.

PEDIATRIC USE

Safety and effectiveness in pediatric patients have not been established through adequate and well-controlled studies. Systemic fungal infections have been successfully treated in pediatric patients without reports of unusual side effects. Amphotericin B for Injection when administered to pediatric patients should be limited to the smallest dose compatible with an effective therapeutic regimen.

ADVERSE REACTIONS

Although some patients may tolerate full intravenous doses of Amphotericin B without difficulty, most will exhibit some intolerance, often at less than the full therapeutic dose.

Tolerance may be improved by treatment with aspirin, antipyretics (e.g., acetaminophen), antihistamines, or antiemetics. Meperidine (25 to 50 mg IV) has been shown in some patients to decrease the duration of shaking chills and fever that may accompany the infusion of Amphotericin B.

Administration of Amphotericin B on alternate days may decrease anorexia and phlebitis.

Intravenous administration of small doses of adrenal corticosteroids just prior to or during the Amphotericin B infusion may help decrease febrile reactions. Dosage and duration of such corticosteroid therapy should be kept to a minimum (see PRECAUTIONS: Drug Interactions).

Addition of heparin (1000 units per infusion), and the use of a pediatric scalp-vein needle may lessen the incidence of thrombophlebitis. Extravasation may cause chemical irritation.

The adverse reactions most commonly observed are:

General (body as a whole): fever (sometimes accompanied by shaking chills usually occurring within 15 to 20 minutes after initiation of treatment); malaise; weight loss.

Cardiopulmonary: hypotension; tachypnea.

Gastrointestinal: anorexia; nausea; vomiting; diarrhea; dyspepsia; cramping epigastric pain.

Hematologic: normochromic, normocytic anemia.

Local: pain at the injection site with or without phlebitis or thrombophlebitis.

Musculoskeletal: generalized pain, including muscle and joint pains.

Neurologic: headache.

Renal:  decreased renal function and renal function abnormalities including: azotemia, hypokalemia, hyposthenuria, renal tubular acidosis; and nephrocalcinosis. These usually improve with interruption of therapy. However, some permanent impairment often occurs, especially in those patients receiving large amounts (over 5 g) of Amphotericin B or receiving other nephrotoxic agents. In some patients hydration and sodium repletion prior to Amphotericin B administration may reduce the risk of developing nephrotoxicity. Supplemental alkali medication may decrease renal tubular acidosis.

The following adverse reactions have also been reported:

General (body as a whole): flushing.

Allergic: anaphylactoid and other allergic reactions; bronchospasm; wheezing.

Cardiopulmonary: cardiac arrest; shock; cardiac failure; pulmonary edema; hypersensitivity pneumonitis; arrhythmias, including ventricular fibrillation; dyspnea; hypertension.

Dermatologic: rash, in particular maculopapular; pruritus. Skin exfoliation, toxic epidermal necrolysis, and Stevens-Johnson syndrome have been reported during post-marketing surveillance.

Gastrointestinal: acute liver failure; hepatitis; jaundice; hemorrhagic gastroenteritis; melena.

Hematologic: agranulocytosis; coagulation defects; thrombocytopenia; leukopenia; eosinophilia; leukocytosis.

Neurologic: convulsions; hearing loss; tinnitus; transient vertigo; visual impairment; diplopia; peripheral neuropathy; encephalopathy (see PRECAUTIONS); other neurologic symptoms.

Renal: acute renal failure; anuria; oliguria. Nephrogenic diabetes insipidus has been reported during post-marketing surveillance.

Altered Laboratory Findings

Serum Electrolytes: Hypomagnesemia; hypo- and hyperkalemia; hypocalcemia.

Liver Function Tests: Elevations of AST, ALT, GGT, bilirubin, and alkaline phosphatase.

Renal Function Tests: Elevations of BUN and serum creatinine.

OVERDOSAGE

Amphotericin B overdoses can result in potentially fatal cardiac or cardiopulmonary arrest (see WARNINGS and DOSAGE AND ADMINISTRATION). If an overdose is suspected, discontinue therapy and monitor the patient's clinical status (e.g., cardiorespiratory, renal, and liver function, hematologic status, serum electrolytes) and administer supportive therapy, as required. Amphotericin B is not hemodialyzable.

Prior to reinstituting therapy, the patient's condition should be stabilized (including correction of electrolyte deficiencies, etc.).

DOSAGE & ADMINISTRATION

**VERIFY PRODUCT NAME AND DOSAGE.**

CAUTION: Under no circumstances should a total daily dose of 1.5 mg/kg be exceeded.

Amphotericin B overdoses can result in potentially fatal cardiac or cardiopulmonary arrest (see WARNINGS and OVERDOSAGE).

Amphotericin B for Injection should be administered by slow intravenous infusion. Intravenous infusion should be given over a period of approximately 2 to 6 hours (depending on the dose) observing the usual precautions for intravenous therapy (see PRECAUTIONS: General). The recommended concentration for intravenous infusion is 0.1 mg/mL (1mg/10mL).

Since patient tolerance varies greatly, the dosage of Amphotericin B must be individualized and adjusted according to the patient's clinical status (e.g., site and severity of infection, etiologic agent, cardio-renal function, etc.).

A single intravenous test dose (1 mg in 20 mL of 5% dextrose solution) administered over 20 to 30 minutes may be preferred. The patient's temperature, pulse, respiration, and blood pressure should be recorded every 30 minutes for 2 to 4 hours.

In patients with good cardio-renal function and a well tolerated test dose, therapy is usually initiated with a daily dose of 0.25 mg/kg of body weight. However, in those patients having severe and rapidly progressive fungal infection, therapy may be initiated with a daily dose of 0.3 mg/kg of body weight. In patients with impaired cardio-renal function or a severe reaction to the test dose, therapy should be initiated with smaller daily doses (i.e., 5 to 10 mg).

Depending on the patient's cardio-renal status (see PRECAUTIONS: Laboratory Tests), doses may gradually be increased by 5 to 10 mg per day to final daily dosage of 0.5 to 0.7 mg/kg.

There are insufficient data presently available to define total dosage requirements and duration of treatment necessary for eradication of specific mycoses. The optimal dose is unknown. Total daily dosage may range up to 1.0 mg/kg per day or up to 1.5 mg/kg when given on alternate days.

Sporotrichosis: Therapy with intravenous Amphotericin B for sporotrichosis has ranged up to nine months with a total dose up to 2.5 g.

Aspergillosis: Aspergillosis has been treated with Amphotericin B intravenously for a period up to 11 months with a total dose up to 3.6 g.

Rhinocerebral phycomycosis: This fulminating disease generally occurs in association with diabetic ketoacidosis. It is, therefore, imperative that diabetic control be restored in order for treatment with Amphotericin B for Injection to be successful. In contradistinction, pulmonary phycomycosis, which is more common in association with hematologic malignancies, is often an incidental finding at autopsy. A cumulative dose of at least 3 g of Amphotericin B is recommended to treat rhinocerebral phycomycosis. Although a total dose of 3 to 4 g will infrequently cause lasting renal impairment, this would seem a reasonable minimum where there is clinical evidence of invasion of deep tissue. Since rhinocerebral phycomycosis usually follows a rapidly fatal course, the therapeutic approach must necessarily be more aggressive than that used in more indolent mycoses.

Preparation of Solutions

Reconstitute as follows: An initial concentrate of 5 mg Amphotericin B per mL is first prepared by rapidly expressing 10 mL Sterile Water for Injection USP without a bacteriostatic agent directly into the lyophilized cake, using a sterile needle (minimum diameter: 20 gauge) and syringe. Shake the vial immediately until the colloidal solution is clear. The infusion solution, providing 0.1 mg Amphotericin B per mL, is then obtained by further dilution (1:50) with 5% Dextrose Injection USP of pH above 4.2. The pH of each container of Dextrose Injection should be ascertained before use. Commercial Dextrose Injection usually has a pH above 4.2; however, if it is below 4.2, then 1 or 2 mL of buffer should be added to the Dextrose Injection before it is used to dilute the concentrated solution of Amphotericin B. The recommended buffer has the following composition:

Dibasic sodium phosphate (anhydrous)                             1.59

Monobasic sodium phosphate (anhydrous)                       0.96 g

Water for Injection USP                                                  qs 100.0 mL

The buffer should be sterilized before it is added to the Dextrose Injection, either by filtration through a bacterial retentive stone, mat, or membrane, or by autoclaving for 30 minutes at 15 lb pressure (121˚C).

CAUTION: Aseptic technique must be strictly observed in all handling, since no preservative or bacteriostatic agent is present in the antibiotic or in the materials used to prepare it for administration. All entries into the vial or into the diluents must be made with a sterile needle. Do not reconstitute with saline solutions. The use of any diluent other than the ones recommended or the presence of a bacteriostatic agent (e.g., benzyl alcohol) in the diluent may cause precipitation of the antibiotic. Do not use the initial concentrate or the infusion solution if there is any evidence of precipitation or foreign matter in either one.

An in-line membrane filter may be used for intravenous infusion of Amphotericin B; however, the mean pore diameter of the filter should not be less than 1.0 micron in order to assure passage of the antibiotic dispersion.

HOW SUPPLIED

Amphotericin B for Injection USP

Available as single vials providing 50 mg Amphotericin B as a yellow to orange lyophilized cake (which may partially reduce to powder following manufacture). NDC 39822-1055-5. Retain in carton until time of use.

STORAGE AND HANDLING

Prior to reconstitution Amphotericin B for Injection USP should be stored under refrigeration, 2˚ to 8˚C (36˚to 46˚F), protected against exposure to light. The concentrate (5 mg Amphotericin B per mL after reconstitution with 10 mL Sterile Water for Injection USP) may be stored in the dark, at room temperature for 24 hours, or at refrigerator temperatures for one week with minimal loss of potency and clarity. Any unused material should then be discarded. Solutions prepared for intravenous infusion (0.1 mg or less Amphotericin B per mL) should be used promptly after preparation and should be protected from light during administration.

Rx Only

Manufactured for

X-Gen Pharmaceuticals, Inc.

Big Flats, NY 14814

Revised December 2009

AM-PI-04

Printed in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 39822-1055-5

Amphotericin B for Injection, USP

50mg

For Intravenous Infusion Only

Rx Only

1 Vial

X-GEN Pharmaceuticals, Inc.

STOP: Verify product name & dosage if dose exceeds 1.5 mg/kg

NDC 39822-1055-5

Amphotericin B for Injection, USP

50mg

For Intravenous Infusion Only

Rx Only

1 Vial

X-GEN Pharmaceuticals, Inc.

STOP: Verify product name & dosage if dose exceeds 1.5 mg/kg

Amphotericin B  Amphotericin B  injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 39822-1055 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Amphotericin B (Amphotericin B) Amphotericin B 50 mg  in 10 mL

Inactive Ingredients Ingredient Name Strength DEOXYCHOLIC ACID 38.75 mg  in 10 mL SODIUM PHOSPHATE, DIBASIC 18.85 mg  in 10 mL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.02 mg  in 10 mL PHOSPHORIC ACID   SODIUM HYDROXIDE   NITROGEN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 39822-1055-5 10 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA063206	04/29/1992

Labeler - X-GEN Pharmaceuticals, Inc. (790169531)

Revised: 11/2011X-GEN Pharmaceuticals, Inc.

More Amphotericin B resources

• Amphotericin B Use in Pregnancy & Breastfeeding
• Amphotericin B Drug Interactions
• Amphotericin B Support Group
• 0 Reviews for Amphotericin B - Add your own review/rating

• Amphotericin B Professional Patient Advice (Wolters Kluwer)


• Amphotericin B MedFacts Consumer Leaflet (Wolters Kluwer)


• Amphotericin B Monograph (AHFS DI)


• amphotericin B Concise Consumer Information (Cerner Multum)


• amphotericin b Intravenous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information

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• Aspergillosis, Aspergilloma
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• Candida Urinary Tract Infection
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• Cryptococcal Meningitis, Immunocompetent Host
• Cryptococcal Meningitis, Immunosuppressed Host
• Cryptococcosis
• Esophageal Candidiasis
• Fungal Endocarditis
• Fungal Infection Prophylaxis
• Histoplasmosis, Immunocompenent Host
• Histoplasmosis, Meningitis
• Leishmaniasis
• Oral Thrush
• Paracoccidioidomycosis
• Sporotrichosis

Inhiplex

Inhiplex may be available in the countries listed below.

Ingredient matches for Inhiplex

Omeprazole

Omeprazole is reported as an ingredient of Inhiplex in the following countries:

• Greece

International Drug Name Search

Prednisone

Pronunciation: PRED-ni-sone
Generic Name: Prednisone
Brand Name: Generic only. No brands available.

Prednisone is used for:

Treating severe allergies, arthritis, asthma, multiple sclerosis, and skin conditions. It may also be used for other conditions as determined by your doctor.

Prednisone is a corticosteroid. It works by decreasing or preventing tissues from responding to inflammation. It also modifies the body's response to certain immune stimulation.

Do NOT use Prednisone if:

• you are allergic to any ingredient in Prednisone


• you have a systemic fungal infection


• you are currently taking mifepristone

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

Before using Prednisone:

Some medical conditions may interact with Prednisone. 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 are scheduled for a vaccination with a live virus vaccine (eg, smallpox)


• if you have an underactive thyroid, liver or kidney problems, diabetes, or ulcerative colitis


• if you have heart problems, esophagitis, gastritis, stomach obstruction or perforation, or an ulcer


• if you have a history of mental problems, such as depression


• if you have a herpes infection in your eye or any other type of infection (bacterial, fungal, or viral); have or recently had tuberculosis (TB) or tested positive for TB, measles, or chickenpox

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

• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because the effectiveness of Prednisone may be decreased


• Clarithromycin azole antifungals (eg, ketoconazole), steroidal contraceptives (eg, desogestrel), or troleandomycin because side effects, such as weakness, confusion, muscle aches, joint pain, or low blood sugar, may occur


• Methotrexate or ritodrine because the actions and side effects of these medicines may be increased


• Hydantoins (eg, phenytoin), mifepristone, or live vaccines because the effectiveness of these medicines may be decreased


• Anticoagulants (eg, warfarin) or aspirin because the actions and side effects of these medicines may be increased or decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prednisone 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 Prednisone:

Use Prednisone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Prednisone by mouth with food.


• Prednisone comes as a dose pack with specific instructions as to when to take the medicine or how much to take each time. It is very important to follow these instructions as closely as possible. Do not miss any doses.


• If you miss a dose of Prednisone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prednisone.

Important safety information:

• Patients on long-term steroid therapy should carry an ID card at all times that says they take Prednisone.


• Prednisone makes you more susceptible to illnesses, especially if you take it for an extended period of time. Prevent infection by avoiding contact with people who have colds or other infections. If you are exposed to chickenpox, measles, or TB while taking Prednisone or within 12 months after stopping Prednisone, call your doctor. Report any injuries or signs of an infection (fever, sore throat, pain during urination, or muscle aches) that occur during treatment and within 12 months after stopping Prednisone. Your dose may need to be adjusted or you may need to start taking Prednisone again.


• Tell your doctor or dentist that you take Prednisone before you receive any medical or dental care, emergency care, or surgery.


• Prednisone may cause an elevation in blood pressure, salt and water retention, and increased potassium loss. You may need to restrict the use of salt and take a calcium supplement.


• Prednisone can cause calcium loss and promote the development of osteoporosis. Take adequate calcium and vitamin D supplements.


• Do not receive a live vaccine, especially smallpox, while you are taking Prednisone.


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


• Lab tests may be performed while you use Prednisone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Infants and CHILDREN on long-term therapy must be closely monitored by a health care provider.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Prednisone.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prednisone while you are pregnant. Prednisone is found in breast milk. If you are or will be breast-feeding while you use Prednisone, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Prednisone:

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:

Difficulty sleeping; feeling of a whirling motion; increased appetite; increased sweating; indigestion; mood changes; nervousness.

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); appetite loss; black, tarry stools; changes in menstrual periods; convulsions; depression; diarrhea; dizziness; exaggerated sense of well-being; fever; general body discomfort; headache; increased pressure in the eye; joint or muscle pain; mood swings; muscle weakness; personality changes; prolonged sore throat, cold, or fever; puffing of the face; severe nausea or vomiting; swelling of feet or legs; unusual weight gain; vomiting material that looks like coffee grounds; weakness; weight loss.

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: Prednisone 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.

Proper storage of Prednisone:

Store Prednisone at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prednisone out of the reach of children and away from pets.

General information:

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


• Prednisone 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 Prednisone. 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 Prednisone resources

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

Compare Prednisone with other medications

• Acute Lymphocytic Leukemia
• Adrenocortical Insufficiency
• Adrenogenital Syndrome
• Allergic Reactions
• Ankylosing Spondylitis
• Aspiration Pneumonia
• Asthma
• Atopic Dermatitis
• Autoimmune Hemolytic Anemia
• Berylliosis
• Bullous Pemphigoid
• Bursitis
• Chorioretinitis
• Cluster Headaches
• Cogan's Syndrome
• Conjunctivitis, Allergic
• Corneal Ulcer
• Dermatitis Herpetiformis
• Dermatomyositis
• Eczema
• Epicondylitis, Tennis Elbow
• Erythroblastopenia
• Fibromyalgia
• Gouty Arthritis
• Graft-versus-host disease
• Hay Fever
• Herpes Zoster
• Herpes Zoster Iridocyclitis
• Hypercalcemia of Malignancy
• Idiopathic Thrombocytopenic Purpura
• Immunosuppression
• Inflammatory Bowel Disease
• Inflammatory Conditions
• Iridocyclitis
• Iritis
• Juvenile Rheumatoid Arthritis
• Keratitis
• Leukemia
• Lichen Planus
• Lichen Sclerosus
• Loeffler's Syndrome
• Lymphoma
• Multiple Sclerosis
• Mycosis Fungoides
• Nephrotic Syndrome
• Neurosarcoidosis
• Osteoarthritis
• Pemphigoid
• Pemphigus
• Pharyngitis
• Polymyositis/Dermatomyositis
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Sarcoidosis
• Seborrheic Dermatitis
• Sinusitis
• Skin Rash
• Synovitis
• Systemic Lupus Erythematosus
• Systemic Sclerosis
• Thrombocytopenia
• Toxic Epidermal Necrolysis
• Tuberculosis, Extrapulmonary
• Tuberculous Meningitis
• Ulcerative Colitis
• Uveitis, Posterior

Azor

Generic Name: amlodipine and olmesartan (am LOE de peen ol me SAR tan)

Brand Names: Azor

What is amlodipine and olmesartan?

Amlodipine is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels.

Olmesartan is an angiotensin II receptor antagonist. Olmesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

The combination of amlodipine and olmesartan is used to treat high blood pressure (hypertension).

Amlodipine and olmesartan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about amlodipine and olmesartan?

Do not use amlodipine and olmesartan if you are pregnant. Amlodipine and olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Stop using this medication and tell your doctor right away if you become pregnant.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use potassium supplements or salt substitutes while you are taking amlodipine and olmesartan, unless your doctor has told you to. Call your doctor at once if you have swelling in your hands or feet, rapid weight gain, pounding heartbeats or fluttering in your chest, urinating less than usual, jaundice (yellowing of the skin or eyes), chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling, or if you feel like you might pass out. In rare cases, amlodipine and olmesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

What should I discuss with my healthcare provider before taking amlodipine and olmesartan?

You should not use this medication if you are allergic to amlodipine (Norvasc) or olmesartan (Benicar).

To make sure you can safely take amlodipine and olmesartan, tell your doctor if you have any of these other conditions:

• kidney disease (or if you are on dialysis);


• liver disease;


• 
  

  angina (chest pain);

  
  


• 
  

  coronary artery disease;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  if you are 75 years or older; or

  
  


• 
  

  if you have recently had a heart attack.

  
  

FDA pregnancy category D. Do not use amlodipine and olmesartan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Amlodipine and olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking amlodipine and olmesartan. If you are also taking a beta-blocker (such as Betapace, Coreg, Corgard, Dutoprol, Inderal, InnoPran, Lopressor, Normodyne, Tenormin, Tenoretic, Toprol, Trandate, and others), do not suddenly stop using the beta blocker without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping a beta blocker too quickly can cause serious heart problems that will not be prevented by amlodipine and olmesartan. It is not known whether amlodipine and olmesartan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using amlodipine and olmesartan.

How should I take amlodipine and olmesartan?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

You may take this medication with or without food.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking amlodipine and olmesartan. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Your kidney function may also need to be tested. Visit your doctor regularly.

If you need kidney dialysis or surgery, tell the doctor ahead of time that you are using amlodipine and olmesartan. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture and heat.

See also: Azor dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fast heart rate, warmth or tingling, feeling light-headed, or fainting.

What should I avoid while taking amlodipine and olmesartan?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use potassium supplements or salt substitutes while you are taking amlodipine and olmesartan, unless your doctor has told you to.

Amlodipine and olmesartan side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. In rare cases, amlodipine and olmesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine. Call your doctor at once if you have any other serious side effects, such as:

• 
  

  feeling like you might pass out;

  
  


• 
  

  swelling in your hands or feet, rapid weight gain;

  
  


• 
  

  pounding heartbeats or fluttering in your chest;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  jaundice (yellowing of the skin or eyes); or

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

  
  

Less serious side effects include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  flushing (warmth, redness, or tingly feeling);

  
  


• 
  

  hair loss; or

  
  


• 
  

  mild skin rash or itching.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect amlodipine and olmesartan?

Tell your doctor about all other medicines you use, especially:

• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

  
  


• 
  

  heart medication;

  
  


• 
  

  potassium supplements or salt substitutes;

  
  


• 
  

  diuretics (water pills); or

  
  


• 
  

  other medications that lower blood pressure.

  
  

This list is not complete and other drugs may interact with amlodipine and olmesartan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Azor resources

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

• Azor Prescribing Information (FDA)


• Azor Advanced Consumer (Micromedex) - Includes Dosage Information


• Azor MedFacts Consumer Leaflet (Wolters Kluwer)


• Azor Consumer Overview

Compare Azor with other medications

• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about amlodipine and olmesartan.

See also: Azor side effects (in more detail)

Poviderm

Poviderm may be available in the countries listed below.

Ingredient matches for Poviderm

Povidone Iodine

Povidone-Iodine is reported as an ingredient of Poviderm in the following countries:

• Italy

International Drug Name Search

Asmanex

Generic Name: Mometasone Furoate
Class: Adrenals
VA Class: RE101
Chemical Name: (11β,16α) - 9,21 - Dichloro - 17 - [(2 - furanylcarbonyl)oxy] - 11 - hydroxy - 16 - methyl - pregna - 1,4 - diene - 3,20 - dione
Molecular Formula: C₂₇H₃₀Cl₂O₆
CAS Number: 83919-23-7

REMS:

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

Introduction

Synthetic nonfluorinated glucocorticoid.^{1 2 4}

Uses for Asmanex

Asthma

Long-term prevention of bronchospasm in patients with asthma.^{1 2}

In corticosteroid-dependent patients, may permit a substantial reduction in the daily maintenance dosage or discontinuance of the systemic corticosteroid.^{1 6}

Do not use for rapid relief of bronchospasm.^{1 2 8}

Asmanex Dosage and Administration

General

• 
  

  Adjust dosage carefully according to individual requirements and response.¹

  
  


• 
  

  After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response.¹ Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth. (See Pediatric Use under Cautions.)¹

  
  


• 
  

  Base initial and maximum dosages in adults and children ≥12 years of age on previous asthma therapy.¹

  
  

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

• 
  

  When switching from systemic corticosteroids to orally inhaled mometasone furoate, asthma should be reasonably stable before initiating treatment with oral inhalation.^{13 14}

  
  


• 
  

  Initially, administer oral inhalation concurrently with the maintenance dosage of the systemic corticosteroid.¹ After at least 1 week, gradually withdraw the systemic corticosteroid.¹

  
  


• 
  

  Decrements usually should not exceed 2.5 mg daily of prednisone (or its equivalent) each week in patients receiving the oral inhalation.¹ Once oral corticosteroids are discontinued and symptoms of asthma have been controlled, titrate the dosage to the lowest effective level.¹

  
  


• 
  

  Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.¹ (See Withdrawal of Systemic Corticosteroid Therapy under Cautions.)

  
  

Administration

Oral Inhalation

Administer by oral inhalation using the Twisthaler breath-actuated dry powder inhalation device.^{1 2 8}

When administered once daily, use at the same time each day, preferably in the evening for optimal efficacy.^{1 2 5}

Removal of the cap of the device (by twisting in a counterclockwise direction) releases a single 220-mcg dose of drug from the drug storage unit into the inhalation channel, making the dose available for administration via inhalation through the mouthpiece.^{1 8} A dose counter will decrement by 1 each time the cap is removed.⁸

Remove the cap with the inhaler in an upright position.¹ Before inhaling the dose, exhale as completely as possible, but not into the Twisthaler device.^{1 8} Place the mouthpiece of the inhaler between the lips and inhale quickly and deeply through the inhaler.⁸ Do not cover the ventilation holes on either side of the inhaler while inhaling the dose.⁸ Remove the inhaler from the mouth, hold breath for about 10 seconds, then exhale slowly.⁸ Do not take extra doses despite not being able to taste, smell, or feel the released powder, unless otherwise instructed by a clinician.⁸

After inhalation, rinse mouth to minimize potential systemic or local adverse effects.^{1 8} Wipe the mouthpiece dry with a dry cloth or tissue.^{1 8} Close and reload the Twisthaler device for the next dose by twisting the cap in a clockwise direction until a click is heard.^{1 8}

Do not wash the inhaler; store in a dry place.⁸ Discard the inhaler when every inhalation has been used (when the dose indicator reads “00”) or 45 days after removal from its foil overwrap pouch, whichever comes first.^{1 8}

Dosage

Available as mometasone furoate; dosage expressed in terms of the salt.¹

Dose of mometasone furoate administered as an oral inhalation powder is expressed as the nominal (labeled) dose contained in the Twisthaler device.¹ The amount of drug delivered to the lungs depends on factors such as the patient’s inspiratory flow.¹

Each actuation of the Twisthaler inhaler contains 110 or 220 mcg of mometasone furoate inhalation powder and delivers approximately 100 or 200 mcg of mometasone furoate, respectively, per activation from the mouthpiece.¹

Pediatric Patients

Asthma

Oral Inhalation

Children 4–11 years of age: Initial and maximum dosage is 110 mcg once daily in the evening, regardless of prior therapy.¹

Children ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Initially, 220 mcg once daily in the evening.¹ If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, a higher dosage may provide additional asthma control.¹ If required, dosage may be increased to a maximum 440 mcg daily, given once daily or in 2 divided doses.¹

Children ≥12 years of age previously receiving oral corticosteroids: Initial and maximum dosage is 880 mcg daily, given in 2 divided doses.¹

Adults

Asthma

Oral Inhalation

Previously receiving bronchodilators alone or inhaled corticosteroids: Initially, 220 mcg once daily in the evening.¹ If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, a higher dosage may provide additional asthma control.¹ If required, dosage may be increased to a maximum 440 mcg daily, given once daily or in 2 divided doses.¹

Previously receiving oral corticosteroids: Initial and maximum dosage is 880 mcg daily, given in 2 divided doses.¹

Prescribing Limits

Pediatric Patients

Asthma

Oral Inhalation

Children 4–11 years of age: Maximum 110 mcg daily.¹

Children ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg daily.¹

Children ≥12 years of age previously receiving oral corticosteroids: Maximum 880 mcg daily.¹

Adults

Asthma

Oral Inhalation

Previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg daily.¹

Previously receiving oral corticosteroids: Maximum 880 mcg daily.¹

Special Populations

No special population dosage recommendations at this time.¹

Cautions for Asmanex

Contraindications

• 
  

  Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids⁹ ) are required.¹

  
  


• 
  

  Known hypersensitivity to mometasone furoate or any ingredient (e.g., lactose) in the formulation.¹

  
  

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Possible life-threatening adrenal insufficiency in patients being switched from systemic corticosteroids to orally inhaled mometasone furoate.¹

Withdraw systemic corticosteroid therapy gradually ¹ and monitor for objective signs of adrenal insufficiency (e.g., fatigue, lassitude, weakness, nausea, vomiting, hypotension) during withdrawal of systemic therapy.¹ Lung function (FEV₁ or PEFR), adjunctive β₂-adrenergic agonist use, and asthma symptoms also should be carefully monitored.¹ In most patients, several months are required for total recovery of HPA function following withdrawal of systemic corticosteroid therapy.¹ Patients who have been maintained on ≥20 mg of prednisone (or its equivalent) daily may be most susceptible to such adverse events, particularly during the later part of the transfer.¹

Monitor for corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression).¹

Monitor for acute adrenal insufficiency during exposure to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with acute electrolyte loss.¹

Possible unmasking of conditions previously controlled by systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions).¹

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs compared with healthy individuals.¹ Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients.¹

Take particular care to avoid exposure in susceptible patients.¹ If exposure to varicella or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled IM immunoglobulin (IG), respectively.¹ Consider treatment with an antiviral agent if varicella develops.¹

Respiratory Effects

Bronchospasm and/or wheezing may occur.¹

If bronchospasm occurs, treat immediately with a short-acting bronchodilator, discontinue treatment with mometasone furoate, and institute alternative therapy.^{1 8}

Acute Exacerbations of Asthma

Treat acute asthma symptoms with a short-acting β₂-agonist bronchodilator.^{1 8 12} If symptoms persist, promptly reevaluate and consider initiation of systemic corticosteroids.^{1 12}

Galactose Intolerance

Oral inhalation powder contains lactose and should not be used in those with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.^{1 2}

Sensitivity Reactions

Allergic reaction, facial edema, urticaria, hypersensitivity, and throat tightness reported.¹

General Precautions

Ocular Effects

Glaucoma, increased intraocular pressure, and cataracts reported rarely.¹ Carefully monitor patients who have a change in vision or those with a history of increased IOP, glaucoma and/or cataracts.¹

Systemic Corticosteroid Effects

Administration of higher than recommended dosages of inhaled mometasone furoate over prolonged periods of time, or in particularly sensitive individuals, may result in manifestations of hypercorticism and suppression of HPA function.¹ If such changes occur, reduce the dosage of mometasone furoate slowly, consistent with accepted procedures for reducing systemic corticosteroid dosage and management of asthma symptoms.¹

Take particular care in monitoring patients postoperatively or during periods of stress for evidence of inadequate adrenal response.¹

Musculoskeletal Effects

Long-term use may affect normal bone metabolism, resulting in a loss of bone mineral density (BMD).¹

Monitor patients with major risk factors for decreased BMD (e.g., family history of osteoporosis, prolonged immobilization, chronic use of drugs that can reduce bone mass [e.g., anticonvulsants, corticosteroids]) and treat with established standards of care.¹

Infections

Localized candidal infections of the mouth and pharynx reported.¹ If infection occurs, appropriate local or systemic treatment and/or discontinuance of therapy may be required.¹

Use with extreme caution, if at all, in patients with clinical or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether mometasone is distributed into milk;¹ however, other corticosteroids are distributed into milk.¹ Caution advised if used in nursing women.¹

Pediatric Use

Safety and efficacy of mometasone oral inhalation powder not established in children <4 years of age.¹

With prolonged use, may slow growth rate in children and adolescents.¹ Monitor routinely (e.g., via stadiometry) the growth and development of pediatric patients receiving corticosteroid therapy.¹ Weigh benefits of corticosteroid therapy versus possibility of growth suppression and the risks associated with alternative therapies.¹ Use the lowest possible dosage that effectively controls asthma.¹

Geriatric Use

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

Common Adverse Effects

Adults and children ≥12 years of age previously receiving bronchodilators and/or inhaled corticosteroids: Headache,^{1 3 4 7 8} allergic rhinitis,^{1 8} pharyngitis,^{1 3 4 5 7} upper respiratory tract infection,^{1 8} sinusitis,¹ oral candidiasis,^{1 3 4 5 7} dysmenorrhea,^{1 8} musculoskeletal pain,^{1 8} back pain,^{1 8} dyspepsia.^{1 7}

Adults and children ≥12 years of age previously receiving oral corticosteroids: Musculoskeletal pain, oral candidiasis, sinusitis, allergic rhinitis, upper respiratory infection, arthralgia, fatigue, depression, sinus congestion.¹

Children 4–11 years of age previously receiving bronchodilators and/or inhaled corticosteroids: Fever,¹ headache,¹¹ allergic rhinitis,¹ pharyngitis,¹¹ upper respiratory tract infection,¹¹ abdominal pain.^{1 11}

Interactions for Asmanex

Metabolized by CYP3A4 isoenzyme.¹

Drugs Affecting Hepatic Microsomal Enzymes

Potent inhibitors of CYP3A4: potential pharmacokinetic interaction (increased plasma mometasone furoate concentrations).¹

Specific Drugs

Drug	Interaction	Comments
Ketoconazole	Increased plasma mometasone furoate concentrations1

Asmanex Pharmacokinetics

Absorption

Bioavailability

<1% following oral inhalation of a single 440-mcg dose.^{1 2}

Onset

≥1–2 weeks of continuous therapy required to achieve optimum symptomatic relief.¹

Duration

When corticosteroids are discontinued, asthma control remains stable for several days or longer.¹

Distribution

Extent

Not known whether mometasone is distributed into milk;¹ however, other corticosteroids are distributed into milk.¹

Does not accumulate in red blood cells.¹

Plasma Protein Binding

98–99%.¹

Elimination

Metabolism

Extensively metabolized in the liver principally by CYP3A4 isoenzyme.^{1 2}

Elimination Route

Excreted principally in feces and to a lesser extent in urine.^{1 2}

Half-life

Following IV administration, approximately 5 hours.¹

Special Populations

In patients with hepatic impairment, plasma concentrations of the drug may be increased.¹

Stability

Storage

Oral Inhalation

Powder

25°C (may be exposed to 15–30°C) in a dry place.¹ Discard the inhaler 45 days after opening the foil pouch or when dose counter reads ‘00’, whichever comes first.¹

Actions

• 
  

  Reduces the inflammatory asthmatic response by inhibiting multiple cell types (e.g., mast cells, eosinophils, lymphocytes, neutrophils, macrophages).¹

  
  


• 
  

  Inhibits mediator production or secretion (e.g., eicosanoids, leukotrienes, cytokines, histamine) involved in the asthmatic response.¹

  
  


• 
  

  Improves lung function (e.g., forced expiratory volume in 1 second [FEV₁], morning and evening peak expiratory flow rate).^{1 3 4}

  
  

Advice to Patients

• 
  

  Importance of providing the patient a copy of the manufacturer's patient information.¹

  
  


• 
  

  Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the Twisthaler device.^{1 8}

  
  


• 
  

  Importance of pediatric patients receiving oral inhalation therapy under adult supervision.⁸

  
  


• 
  

  Importance of rinsing the mouth after oral inhalation.^{1 2 8}

  
  


• 
  

  Importance of advising patients that mometasone furoate oral inhalation must be used at regular intervals to be therapeutically effective.^{1 8}

  
  


• 
  

  Importance of adherence to prescribed dosage regimen; do not increase the frequency of administration without consulting a clinician.⁸

  
  


• 
  

  Importance of advising patients that at least 1–2 weeks of continuous therapy may be required for optimum effects to be achieved.^{1 8} Importance of contacting a clinician if asthma symptoms do not improve in such a time frame.^{1 8}

  
  


• 
  

  Importance of advising patients that orally inhaled mometasone should not be used as a bronchodilator and that the drug is not indicated for emergency use (e.g., relief of acute bronchospasm).^{1 8}

  
  


• 
  

  Importance of availability and use of a short-acting β₂-adrenergic agonist for relief of acute asthma symptoms.^{1 8 12}

  
  


• 
  

  Importance of contacting a clinician immediately if asthmatic attacks that are not controlled by bronchodilator therapy occur.¹

  
  


• 
  

  Importance of gradual withdrawal from systemic corticosteroids during transfer to orally inhaled mometasone and of monitoring by a clinician during such transfer of therapy.⁸ (See Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids under Dosage and Administration.)

  
  


• 
  

  Importance of advising patients being transferred from systemic corticosteroid to mometasone oral inhalation therapy to carry special identification (e.g., card, bracelet) indicating the need for supplementary systemic corticosteroids during periods of stress or severe exacerbation of asthma.¹ Importance of advising patients to immediately resume therapy with large doses¹ of systemic corticosteroids and contact their clinician for further instructions during stressful periods (e.g., stress, severe asthmatic attack, surgery, trauma, infection).^{1 8}

  
  


• 
  

  Importance of informing patients that corticosteroids may decrease bone mineral density.^{1 8} (See Musculoskeletal Effects under Cautions.)

  
  


• 
  

  Risk of localized candidal infections of mouth and pharynx.^{1 8} (See Infections under Cautions.)

  
  


• 
  

  Risk of systemic corticosteroid effects (e.g., hypercorticism, potentially life-threatening adrenal suppression).¹ Importance of informing a clinician of fatigue, weakness, nausea, vomiting, dizziness, or fainting.^{1 8} (See Systemic Corticosteroid Effects under Cautions.)

  
  


• 
  

  Risk of reduction in growth velocity with orally inhaled corticosteroids.¹ (See Pediatric Use under Cautions.)

  
  


• 
  

  Importance of informing patients that long-term use of inhaled corticosteroids may increase the risk for development of some eye problems (e.g., cataracts, glaucoma).¹ (See Ocular Effects under Cautions.)

  
  


• 
  

  Importance of immunosuppressed patients avoiding exposure to chickenpox or measles, and, if exposed, of immediately consulting a clinician.^{1 8} (See Immunosuppressed Patients under Cautions.)

  
  


• 
  

  Importance of advising immunosuppressed patients of potential worsening of existing tuberculosis, fungal, bacterial, parasitic, or viral infections, or ocular herpes simplex.¹ Importance of immunosuppressed patients informing clinician of a history of infections.⁸

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., infections).^{1 8}

  
  


• 
  

  Importance of informing 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.

Mometasone Furoate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation	Powder for inhalation	110 mcg/inhalation (delivers 100 mcg/inhalation)	Asmanex Twisthaler	Schering
		220 mcg/inhalation (delivers 200 mcg/inhalation)	Asmanex Twisthaler	Schering

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.

Asmanex 120 Metered Doses 220MCG/INH Aerosol (SCHERING): 0/$233.99 or 1/$650.00

Asmanex 30 Metered Doses 110MCG/INH Aerosol (SCHERING): 0/$130.99 or 0/$362.96

Asmanex 30 Metered Doses 220MCG/INH Aerosol (SCHERING): 0/$148.00 or 1/$405.98

Asmanex 60 Metered Doses 220MCG/INH Aerosol (SCHERING): 0/$167.99 or 1/$462.97

Dulera 100-5MCG/ACT Aerosol (SCHERING): 13/$219.00 or 39/$636.94

Dulera 200-5MCG/ACT Aerosol (SCHERING): 13/$229.99 or 39/$659.98

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.

References

1. Schering Corporation. Asmanex Twisthaler (mometasone furoate) inhalation powder prescribing information. Kenilworth, NJ; 2008 Jan.

2. Sharpe M, Jarvis B. Inhaled mometasone furoate: a review of its uses in adults and adolescents with persistent asthma. Drugs. 2001; 61:1325-50. [PubMed 11511026]

3. Nayak AS, Banov C, Corren J et al. Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma. Ann Allergy Asthma Immunol. 2000; 84:417-24. [IDIS 445793] [PubMed 10795650]

4. Kemp JP, Berkowitz RB, Miller SD et al. Mometasone furoate administered once daily is as effective as twice-daily administration for treatment of mild-to-moderate persistent asthma. J Allergy Clin Immunol. 2000; 106:485-92. [IDIS 453105] [PubMed 10984368]

5. Noonan M, Karpel JP, Bensch GW et al. Comparison of once-daily to twice-daily treatment with mometasone furoate dry powder inhaler. Ann Allergy Asthma Immunol. 2001; 86:36-43. [IDIS 458309] [PubMed 11206236]

6. Fish JE, Karpel JP, Craig TJ et al. Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma. J Allergy Clin Immunol. 2000; 106:852-60. [IDIS 456665] [PubMed 11080706]

7. Bernstein DI, Berkowitz RB, Chervinsky P et al. Dose-ranging study of new steroid for asthma: mometasone furoate dry powder inhaler. Respir Med. 1999; 93:603-12. [PubMed 10542973]

8. Schering Corporation. Asmanex Twisthaler(mometasone furoate) inhalation powder patient instructions for use. Kenilworth, NJ; 2008 Jan.

9. National Asthma Education and Prevention Program. Expert panel report: guidelines for the diagnosis and management of asthma update on selected topics—2002. J Allergy Clin Immunol. 2002; 110 (Suppl 5):S141-219.

10. National Institutes of Health, National Heart, Lung, and Blood Institute. Global initiative for asthma: global strategy for asthma management and prevention NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 2005 Oct. NIH/NHLBI Publication No. 02-3659. Available at . Accessed Jan. 5, 2006.

11. Berger WE, Milgrom H, Chervinsky P et al. Effects of treatment with mometasone furoate dry powder in children with persistent asthma. Ann Allergy Asthma Immunol. 2006; 97:672-80. [PubMed 17165278]

12. National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma. Bethesda, MD: National Institutes of Health, National Heart, Lung and Blood Institute. Aug 28. 2007. Available at .

13. IVAX Laboratories. Qvar (beclomethasone dipropronate) HFA inhalation aerosol prescribing information. Miami, FL; 2005 Nov.

14. Schering Plough, Kenilworth, NJ: Personal communication.

More Asmanex resources

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

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