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DRUGS & SUPPLEMENTS
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Amphotericin B:
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.
Fungispec (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. Verify the product name and dosage pre-administration, especially if dose exceeds 1.5 mg/kg.
Fungispec (Amphotericin B) for Injection USP contains Fungispec (Amphotericin B), an antifungal polyene antibiotic obtained from a strain of Streptomyces nodosus. Fungispec (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 Fungispec (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 Fungispec (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.
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Microbiology
Fungispec 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 Fungispec (Amphotericin B) ranging from 0.03 to 1.0 mcg/mL in vitro. While Candida albicans is generally quite susceptible to Fungispec (Amphotericin B), non-albicans species may be less susceptible. Pseudallescheria boydii and Fusarium sp. are often resistant to Fungispec (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.
Fungispec (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 Fungispec (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. Fungispec (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 Fungispec (Amphotericin B) penetrates into vitreous humor or normal amniotic fluid. Complete details of tissue distribution are not known.
Fungispec (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.
Fungispec (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.
Fungispec (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.
Fungispec (Amphotericin B) may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.
This product is contraindicated in those patients who have shown hypersensitivity to Fungispec (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 Fungispec (Amphotericin B) therapy.
Fungispec (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 Fungispec (Amphotericin B) overdose, which may result in potentially fatal cardiac or cardiopulmonary arrest. Verify the product name and dosage especially if dose exceeds 1.5 mg/kg.
Fungispec 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.
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 Fungispec (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.
Fungispec (Amphotericin B) should be used with care in patients with reduced renal function; frequent monitoring of renal function is recommended. In some patients hydration and sodium repletion prior to Fungispec (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 Fungispec (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.
Leukoencephalopathy has been reported following use of Fungispec (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.
Renal function should be monitored frequently during Fungispec (Amphotericin B) therapy.
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.
When administered concurrently, the following drugs may interact with Fungispec :
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 Fungispec (Amphotericin B). If used concomitantly, closely monitor serum electrolytes and cardiac function.
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 Fungispec (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 Fungispec (Amphotericin B) and imidazoles suggest that imidazoles may induce fungal resistance to Fungispec (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.
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 Fungispec (Amphotericin B) and leukocyte transfusions.
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 Category B: Reproduction studies in animals have revealed no evidence of harm to the fetus due to Fungispec for injection. Systemic fungal infections have been successfully treated in pregnant women with Fungispec (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.
It is not known whether Fungispec (Amphotericin B) is excreted in human milk. Because many drugs are excreted in human milk and considering the potential toxicity of Fungispec (Amphotericin B), it is prudent to advise a nursing mother to discontinue nursing.
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. Fungispec (Amphotericin B) for Injection when administered to pediatric patients should be limited to the smallest dose compatible with an effective therapeutic regimen.
Although some patients may tolerate full intravenous doses of Fungispec (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 Fungispec (Amphotericin B).
Administration of Fungispec (Amphotericin B) on alternate days may decrease anorexia and phlebitis.
Intravenous administration of small doses of adrenal corticosteroids just prior to or during the Fungispec (Amphotericin B) infusion may help decrease febrile reactions. Dosage and duration of such corticosteroid therapy should be kept to a minimum.
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 Fungispec (Amphotericin B) or receiving other nephrotoxic agents. In some patients hydration and sodium repletion prior to Fungispec (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 ; 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.
Fungispec (Amphotericin B) overdoses can result in potentially fatal cardiac or cardiopulmonary arrest. 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. Fungispec (Amphotericin B) is not hemodialyzable.
Prior to reinstituting therapy, the patient's condition should be stabilized (including correction of electrolyte deficiencies, etc.).
**VERIFY PRODUCT NAME AND DOSAGE.**
CAUTION: Under no circumstances should a total daily dose of 1.5 mg/kg be exceeded.
Fungispec (Amphotericin B) overdoses can result in potentially fatal cardiac or cardiopulmonary arrest.
Fungispec (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. The recommended concentration for intravenous infusion is 0.1 mg/mL (1mg/10mL).
Since patient tolerance varies greatly, the dosage of Fungispec (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, 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 Fungispec (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 Fungispec (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 Fungispec (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 Fungispec (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 Fungispec (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 Fungispec (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 Fungispec (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 Fungispec (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.
Fungispec for Injection USP
Available as single vials providing 50 mg Fungispec (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.
Prior to reconstitution Fungispec (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 Fungispec (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 Fungispec (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
Fludrocortisone Acetate:
Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals belongs to the type of drugs called steroids. The body naturally creates steroids that are similar to this medicine.
Sometimes the body experiences conditions in which they cannot or does not produce a sufficient amount of steroids, like Addison's disease, and salt-losing adrenogenital syndrome. Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals functions in the body by treating the said conditions. This drug could also be used in other purposes not mentioned here.
Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals lessens the body's ability to fight infection so avoid taking this medication if you have serious bacterial, viral, or fungal infection. Talk to your doctor first before taking this medication if you have kidney disease, diabetes mellitus, myasthenia gravis, ulcerative colitis, hypothyroidism, high blood pressure or heart disease, liver disease, tuberculosis, psychiatric conditions, stomach ulcers, osteoporosis, or any other medical conditions. Your doctor might not allow you to take the medication, adjust your dose or require you a specials monitoring during the treatment. This medication belongs to the FDA pregnancy category C. It is unknown whether this medication could cause harm to an unborn baby. Talk to your doctor first before taking Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals if you are pregnant. Talk to your doctor first before taking this medication if you are breast-feeding an infant because this passes in breast milk.
Follow the exact direction given to you by your doctor in taking Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals. In case you did not understand the instructions, do not hesitate to ask your doctor, pharmacist or nurse to explain them to you. It is advisable to take every dose of this medication with a full glass of water. To reduce stomach upset, you may take this medication with milk or food. If possible, take this medication at the same time every day. If you are taking this medication for several weeks, talk to your doctor first before you stop taking this medication.
You may obtain the dose of Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals from your doctor. Follow the exact dose given to you by your doctor.
Some of the signs of overdose with Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals are weight gain, swelling or water retention, high blood pressure and low levels of potassium in the blood. Look for emergency medical attention if you suspect an overdose or experience any of the said signs of overdose. Taking a large dose of this medication, even once is unlikely to cause symptoms or death.
In case you miss a dose of this medication, take the missed dose as soon as you recall but if it is almost time for the next dose, skip the missed dose and take the next dose that was regularly scheduled. Avoid taking a double dose of this medication.
Some of the serious side effects of Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals are allergic reactions such as closing of your throat, difficulty in breathing, swelling of the lips and hives; severe or continuing headache; sudden weight gain; dizziness or fainting; swelling of the feet or ankles; increased blood pressure; and difficulty in breathing. If you experience any of the said serious side effects, stop taking Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals and look for emergency medical attention.
Some other side effects of this medication are muscle weakness or joint pain, glaucoma, cataracts, thinning of your skin, nausea or stomach upset, fatigue, increased hunger or thirst, problems with diabetes control, osteoporosis, round face, and changes in behavior. If you experience any of the said side effects, inform your doctor about it. Some side effects that are not mentioned here may also occur. Talk to your doctor if you experience any unusual or bothersome side effects.
Talk to your doctor first before taking Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals if you are taking other medicines like barbiturate like amobarbital, secobarbital, pentobarbital or phenobarbital; birth control pills like Ortho Novum, Ovral, Lo-Ovral, Triphasil, Levlen, Tri-Levlen, Alesse, Desogen, and others; diuretic like furosemide, ethacrynic acid, bumetanide, or torsemide; estrogen like Premarin, Ogen, Estratest, Estraderm, Vivelle, Climara, Fempatch, and others; insulin or an oral diabetes medicine like chlorpropamide or glyburide; anabolic steroid like oxymetholone, nandrolone, and others phenytoin or ethotoin; rifampin; digoxin; amphotericin B; warfarin; and aspirin. Your doctor might adjust your dose or require you a special monitoring during the treatment with Fungispec (Fludrocortisone Acetate) West-Ward Pharmaceuticals if you are taking the said medicines. Other drugs not mentioned here may also affect the medicine. Talk to your doctor first before taking other medicines or over-the-counter medicines.
Neomycin Sulfate:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fungispec (Neomycin Sulfate) tablets and other antibacterial drugs, Fungispec (Neomycin Sulfate) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Suppression of Intestinal Bacteria
Fungispec (Neomycin Sulfate) tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ).
Hepatic Coma (Portal-Systemic Encephalopathy)
Fungispec (Neomycin Sulfate) has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
Fungispec (Neomycin Sulfate) oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.
Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin. Fungispec (Neomycin Sulfate) oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.
Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman.
Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Prescribing Fungispec tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antibiotics, use of oral neomycin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.
Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of neomycin.
Cross-allergenicity among aminoglycosides has been demonstrated.
Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.
Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.
There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of neomycin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.
An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.
Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.
Patients should be counseled that antibacterial drugs including Fungispec (Neomycin Sulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Fungispec (Neomycin Sulfate) tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Fungispec (Neomycin Sulfate) tablets or other antibacterial drugs in the future.
Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.
Patients with renal insufficiency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve function.
Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.
Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin (see boxed WARNINGS ).
Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects.
Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.
Oral Fungispec (Neomycin Sulfate) may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.
No long-term animal studies have been performed with Fungispec to evaluate carcinogenic or mutagenic potential or impairment of fertility.
See WARNINGS section.
It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The safety and efficacy of oral Fungispec (Neomycin Sulfate) in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.
The most common adverse reactions to oral Fungispec (Neomycin Sulfate) are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).
Because of low absorption, it is unlikely that acute overdosage would occur with oral Fungispec (Neomycin Sulfate). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.
Hemodialysis will remove Fungispec (Neomycin Sulfate) from the blood.
To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.
Hepatic Coma
For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:
Preoperative Prophylaxis for Elective Colorectal Surgery
Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.
Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.
Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.
Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Fungispec (Neomycin Sulfate) (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.
Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.
Fungispec (Neomycin Sulfate) tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in:
Bottles of 100 (NDC 0527-1210-01)
Store at 20° to 25°C (68° to 77°F).
Dispense in tight containers as defined in the USP/NF.
Distributed By:
Lannett Company, Inc.
Philadelphia, PA 19154
Made in the USA
Rev. 01/17
CIB71710A
Depending on the reaction of the Fungispec after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Fungispec not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Fungispec addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Visitors | % | ||
---|---|---|---|
1-5mg | 1 | 100.0% |
In Belgium Fungispec is not for sale anymore. Is it replaced by a similar product? Please let me know. Thanks and kind regards. Gerard Noteboom |
The information was verified by Dr. Rachana Salvi, MD Pharmacology