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
Tuesday, October 25, 2016
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 | ||||||||||||||||||||
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| 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) |
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- Amphotericin B Support Group
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- amphotericin B Concise Consumer Information (Cerner Multum)
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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
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Monday, October 24, 2016
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
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