Uticure

Uticure is indicated in the prophylaxis and treatment of urinary tract infactions.

As maintenance therapy after successful initial treatment of acute infections with antibiotics.

As long-term therapy in the prevention of recurrent cystitis.

To suppress urinary infection in patients with indwelling catheters and to reduce the incidence of catheter blockage.

To provide prophylaxis against the introduction of infection into the urinary tract during instrumental procedures.

Asymptomatic bacteriuria.

Methenamine is a heterocyclic organic compound with a cage-like structure similar to adamantane. In salt form it is used for the treatment of urinary tract infection (Example: methenamine hippurate which is the hippuric acid salt of methenamine).

One tablet (1 g) twice daily for adults and children over 12 years of age. One-half tablet or one tablet (0.5 or 1 g) twice daily for children 6 to 12 years of age. The antibacterial activity of Methenamine is greater in acid urine. Therefore, restriction of alkalinizing foods and medications is desirable. If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine may be instituted. The efficacy of therapy should be monitored by repeated urine cultures.

Methenamine is contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. It should not be used as the sole therapeutic agent in acute parenchymal infections causing systemic symptoms.

Adverse effects of Uticure have been reported in fewer than 3.5% of patients treated. These reactions have included the following, in decreasing order of frequency: nausea, vomiting, and rarely pruritus, rash, dysuria. Children have received Uticure at the recommended dosages as a prophylactic/suppressive regimen after initial treatment of acute episodes of pyuria. Side effects were encountered in only 1.1% of these children.

Teratogenic effects. Pregnancy category C. Oral administration of methenamine to pregnant dogs, at doses equivalent to the human dose, has been reported to cause a slight increase in the stillborn rate and slight impairment of weight gain and survival of live-born offspring. A4 teratogenicity study, in which Methenamine was administered to pregnant rabbits at doses approximately 3 times the human dose, revealed no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Methenamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Methenamine is excreted in human milk. Because of the potential for serious adverse reactions 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.

Prescribing Uticure 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. Care should be taken to maintain an acid pH of the urine, especially when treating infections due to urea-splitting organisms such as Proteus and strains of Pseudomonas. In a few instances in one study, the serum transaminase levels were slightly elevated during treatment but returned to normal while the patients were still taking Uticure. Because of this report, it is recommended that liver function studies be performed periodically on patients taking the drug, especially those with liver dysfunction.

Immediately after ingestion of an overdose, further absorption of the drug may be minimized by inducing vomiting or by gastric lavage, followed by administration of activated charcoal.Fluids, either oral or parenteral, should be forced to tolerance.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.