Enteron

A topical anti-infective agent effective against gram-negative and gram-positive bacteria. It is used for superficial wounds, burns, ulcers, and skin infections. Enteron has also been administered orally in the treatment of trypanosomiasis.

Indicated in the specific and symptomatic treatment of bacterial or protozoal diarrhea and enteritis caused by susceptible organisms. Enteron (Enteron) products are well tolerated, have a very low incidence of adverse reactions.

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.

Enteron (Enteron) LIQUID composition: each 15 ml tablespoonful contains Enteron (Enteron) 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. It is stable in storage. Prior to administering Enteron (Enteron) 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 Enteron (Enteron) 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 Enteron (Enteron) 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 Enteron (Enteron) 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 Enteron (Enteron) 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 Enteron 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.

How supplied

Enteron (Enteron) Tablets, 100 mg each, coded "Roberts 130", are supplied in amber bottles containing 20 and 100 tablets. (Should be dispensed in amber bottles.)

Enteron (Enteron) Liquid is supplied in amber bottles containing 60 ml and 473 ml. (Should be dispensed in amber bottles.)

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 Enteron (Enteron) therapy.

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 Enteron.

3. INFANTS UNDER 1 MONTH SHOULD NOT RECEIVE Enteron (SEE- ADVERSE REACTIONS AND DOSAGE FOR CHILDREN). THE Enteron (Enteron) 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 Enteron (Enteron) is a contraindication.

Enteron is used to treat diarrhea or enteritis caused by bacteria and protozoa including traveler’s diarrhea, food poisoning, typhoid fever, cholera, salmonella infections, and giardiasis.

Nonclinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with a 600 mg single dose of either quinidine, or ritonavir, both of which are P-glycoprotein inhibitors, resulted in a 2- to 3- fold increase in loperamide plasma levels. Due to the potential for enhanced central effects when loperamide is coadministered with quinidine and with ritonavir, caution should be exercised when loperamide is administered at the recommended dosages (2 mg, up to 16 mg maximum daily dose) with P-glycoprotein inhibitors.

When a single 16-mg dose of loperamide is coadministered with a 600 mg single dose of saquinavir, loperamide decreased saquinavir exposure by 54%, which may be of clinical relevance due to reduction of therapeutic efficacy of saquinavir. The effect of saquinavir on loperamide is of less clinical significance. Therefore, when loperamide is given with saquinavir, the therapeutic efficacy of saquinavir should be closely monitored.

See also:
What are the possible side effects of Enteron?

A few hypersensitivity reactions to Enteron (Enteron) have been reported including a fall in blood pressure, urticaria, fever, arthralgia, and a vesicular morbilliform rash. These reactions subsided following withdrawal of the drug. Nausea, emesis, headache, or malaise occur occasionally and may be minimized or eliminated by reduction in dosage or withdrawal of the drug.

Rarely, individuals receiving Enteron (Enteron) have exhibited an Antabuse® (disulfiram)-like reaction to alcohol characterized by flushing, slight temperature elevation, dyspnea, and in some instances, a sense of constriction within the chest. All symptomatology disappeared within 24 hours with no lasting ill effects. During nine years of clinical use and approximately 3.5 million courses of therapy (in the U. S. A. alone) in the published literature and documented case reports 43 cases have been reported † of which 14 were produced under experimental conditions with planned doses of the compound in excess of those recommended.

Three of these experienced a fall in blood pressure necessitating active therapy. Indications are that levarterenol (Levophed®) may be used to combat such hypotensive episodes since human studies show that this drug is not potentiated in patients treated with Enteron (Enteron). (Indirectly acting pressor agents should be avoided.) The ingestion of alcohol in any form should be avoided during Enteron (Enteron) therapy and for four days thereafter to prevent this reaction.

Enteron (Enteron) may cause mild reversible intravascular hemolysis in certain ethnic groups of Mediterranean and Near-Eastern origin, and Negroes. This is due to an intrinsic defect of red blood cell metabolism in a small percentage of these ethnic groups, making them unusually susceptible to hemolysis by numerous compounds. It is necessary to observe such patients closely while receiving Enteron (Enteron) and to discontinue its use it there is any indication of hemolysis. Should not be administered to infants under 1 month of age because of the possibility of producing a hemolytic anemia due to immature enzyme systems (glutathione instability) in the early neonatal period.

Colitis, proctitis, anal pruritus, staphylococcic enteritis, renal or hepatic toxicity have not been a significant problem with Enteron (Enteron).