Prescription Drugs

CLINICAL PHARMACOLOGY ACTION: Furoxone (furazolidone) has a broad antibacterial spectrum covering the majority of gastrointestinal tract pathogens including E. coli, staphylococci, Salmonella, Shigella, Proteus, Aerobacter aerogenes, Vibrio cholerae and Giardia lamblia. Its bactericidal activity is based upon its interference with several bacterial enzyme systems; this antimicrobial action minimizes the development of resistant organisms. It neither significantly alters the normal bowel flora nor results- in fungal overgrowth. The brown color found in the urine with adequate dosage is of no clinical significance.

Find Lowest Prices on DESCRIPTION Furoxone (furazolidone) is one of the synthetic antimicrobial nitrofurans. It is a stable, yellow, crystalline compound 3-(5-nitrofurfurylideneamino)-2-oxazolidinone . Inactive Ingredients: Furoxone (furazolidone) tablets contain calcium pyrophosphate, FD& C Blue #2, magnesium stearate, starch, and sucrose. Furoxone (furazolidone) liquid contains carboxy methylcellulose sodium, flavors, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, and saccharin sodium.

INDICATIONS Indicated in the specific and symptomatic treatment of bacterial or protozoal diarrhea and enteritis caused by susceptible organisms. Furoxone (furazolidone) products are well tolerated, have a very low incidence of adverse reactions. DOSAGE AND ADMINISTRATION FUROX-ONE TABLETS, 100 mg each, are green and scored to facilitate adjustment of dosage. Average Adult Dosage: One 100-mg tablet four times daily. Average Dosage for Children: Those 5 years of age or older should receive 25 to 50 mg (¼ to ½ tablet) four times daily. The tablet dosage may be crushed and given in a spoonful of corn syrup. FUROXONE (furazolidone) LIQUID composition: each 15 ml tablespoonful contains Furoxone (furazolidone) 50 mg per 15 ml (3. 33 mg per ml) in a light-yellow aqueous vehicle. Suitable flavoring, suspending and preservative agents complete the formulation. (See Inactive Ingredients.) It is stable in storage. Prior to administering Furoxone (furazolidone) Liquid shake the bottle vigorously. It should be dispensed in amber bottles. Average Adult Dosage: Two tablespoonfuls four times daily. Average Dosage for Children: 5 years or older † ½ to 1 tablespoonful four times daily (7.515. 0 ml) 1 to 4 years old † 1 to 1½ teaspoonfuls four times daily (5.07.5 ml) 1 month to 1 year † ½ to 1 teaspoonful four times daily (2. 5- 5.0 ml) This dosage is based on an average dose of 5 mg of Furoxone (furazolidone) per Kg (2.3 mg per lb) of body weight given in four equally divided doses during 24 hours. The maximal dose of 8.8 mg of Furoxone (furazolidone) per Kg (4 mg per lb) of body weight per 24 hours should probably not be exceeded because of the possibility of producing nausea or emesis. If these are severe, the dosage should be reduced. The average case of diarrhea treated with Furoxone (furazolidone) will respond within 2 to 5 days of therapy. Occasional patients may require a longer term of therapy. If satisfactory clinical response is not obtained within 7 days it indicates that the pathogen is refractory to Furoxone (furazolidone) and the drug should be discontinued. Adjunctive therapy with other antibacterial agents or bismuth salts is not contraindicated. (N. B. Refer to WARNINGS.) In order to administer furazolidone in doses larger than recommended or in excess of five days the indications must be weighed against the possible hazards of hypertensive crisis related to the accumulation of monoamine oxidase inhibition. If indications are sufficient, the patient should be informed of drugs and foods which predispose to hypertensive crises. (See PRECAUTIONS.) HOW SUPPLIED Furoxone (furazolidone) Tablets, 100 mg each, coded "Roberts 130", are supplied in amber bottles containing 20 and 100 tablets. (Should be dispensed in amber bottles.) Furoxone (furazolidone) Liquid is supplied in amber bottles containing 60 ml and 473 ml. (Should be dispensed in amber bottles.)

PATIENT INFORMATION See WARNINGS, CONTRAINDICATIONS and PRECAUTIONS.

OVERDOSE No information provided. CONTRAINDICATIONS 1. To obviate an Antabus® (disulfiram)- like reaction which may occur in some patients, the ingestion of alcohol should be avoided during or within four days after Furoxone (furazolidone) therapy (see ADVERSE REACTIONS). 2. IN GENERAL, M.O. DRUGS, TYRAMINE- CONTAINING FOODS AND INDIRECTLY- ACTING SYMPATHOMIMETIC AMINES ARE CONTRAINDICATED OR SHOULD BE USED WITH CAUTION IN PATIENTS RECEIVING FUROXONE (SEE PRECAUTIONS). 3. INFANTS UNDER 1 MONTH SHOULD NOT RECEIVE FUROXONE (SEE- ADVERSE REACTIONS AND DOSAGE FOR CHILDREN). THE FUROXONE (furazolidone) CONCENTRATION IN THE BREAST MILK OF LACTATING WOMEN HAS NOT BEEN DETERMINED, THEREFORE THE SAFETY IN THIS CIRCUMSTANCE HAS NOT BEEN ESTABLISHED. 4. Prior sensitivity to Furoxone (furazolidone) is a contraindication.

WARNINGS (See CONTRAINDICATIONS.) Use in Pregnancy: The safety of Furoxone (furazolidone) during the childbearing age has not been established; as with any potent antibacterial, Furoxone (furazolidone) must be administered with caution during the childbearing age. However, animal breeding studies have revealed no evidence of teratogenicity following the administration of Furoxone (furazolidone) for long periods of time and at doses far in excess of those recommended for the human. There have been no clinical reports regarding this possible adverse effect on the fetus or the newborn infant. PRECAUTIONS Monoamine Oxidase Inhibition Effective inhibition of monoamine oxidase by furazolidone has been demonstrated experimentally in man by the enhancement of tyramine and amphetamine sensitivity and by the directly measured monoamine oxidase inhibition. A period of five days of furazolidone administration in the recommended doses in these patients was required to give an enhancement of the tyramine and amphetamine sensitivities by two to threefold. Administration of furazolidone in the recommended dose of 400 mg/day for a period of five days should not subject the adult patient to an undue hazard of hypertensive crisis due to monoamine oxidase inhibition. Hypertensive crises have never been reported even after the peroral administration of larger doses and/or for longer periods of time. Controlled studies reveal no signs or symptoms of hypertensive crisis even after the peroral administration of Furoxone (furazolidone) in doses of 400 mg/day in excess of 48 consecutive months. If administered in doses larger than recommended or in excess of five days, the indications must be weighed against the possible hazards of hypertensive crisis related to the accumulation of monoamine oxidase inhibition. If indications are sufficient, the patients should be informed of drugs and foods which predispose to hypertensive crises: (A) Other known M.O. drugs; however, when indicated they should be prescribed with caution and at a reduced dosage. (B) Tyramine-containing foods such as broad beans, yeast extracts, strong unpasteurized cheeses, beer, wine, pickled herring, chicken livers, and fermented products are contraindicated. (C) Indirectly-acting sympathomimetic amines such as those found in nasal decongestants (phenylephrine, ephedrine) and anorectics (amphetamines) are contraindicated. (D) Likewise, sedatives, antihistamines, tranquilizers, and narcotics should be used in reduced dosages and with caution. Orthostatic hypotension and hypoglycemia may occur. Carcinogenesis, Mutagenesis, Impairment of Fertility Furazolidone has shown evidence of tumorigenic activity in several studies involving chronic, high- dose oral administration to rodents. Promotion of the development of mammary neoplasia has been demonstrated in rats of two strains. Prominent among the findings in mice was that furazolidone caused significant increases in malignant lung tumors. The relevance of these animal findings, particularly in relationship to short-term therapy in humans, is not established.