Clotrimazole

Prescription

Nomes comerciais: Clotrimazole

Forma Farmacêutica

Tablet

Via de Administração

ORAL

Fabricante

Hikma Pharmacuticals USA USA Inc.

About This Medication

DESCRIPTION Each Clotrimazole Troche (lozenge) USP contains 10 mg clotrimazole USP [1-(o-chloro-α,α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth. Structural Formula: C 22 H 17 ClN 2 The troche dosage form is a large, slowly dissolving tablet (lozenge) containing 10 mg of clotrimazole USP dispersed in croscarmellose sodium, dextrates, magnesium stearate, microcrystalline cellulose and povidone. chemical structure.jpg

Princípios Ativos

Ingrediente	Concentração
Clotrimazole	-

Indicações e Uso

INDICATIONS AND USAGE Clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole is also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION .)

Posologia e Administração

DOSAGE AND ADMINISTRATION Clotrimazole is administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one troche five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole troche after prolonged administration; therefore, therapy should be limited to short term use, if possible. For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation, the recommended dose is one troche three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.

Side Effects Overview

ADVERSE REACTIONS Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See PRECAUTIONS ). Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the troche.

Advertências e Precauções

WARNING Clotrimazole is not indicated for the treatment of systemic mycoses including systemic candidiasis.

Contraindicações

CONTRAINDICATIONS Clotrimazole is contraindicated in patients who are hypersensitive to any of its components.

Frequently Asked Questions

INDICATIONS AND USAGE Clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole is also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product …

DOSAGE AND ADMINISTRATION Clotrimazole is administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one troche five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole troche after prolonged administration; therefore, therapy should be limited to short term use, if possible. For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid …

WARNING Clotrimazole is not indicated for the treatment of systemic mycoses including systemic candidiasis.

CONTRAINDICATIONS Clotrimazole is contraindicated in patients who are hypersensitive to any of its components.

Clotrimazole is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Clotrimazole drug label (National Library of Medicine)
• openFDA — Clotrimazole label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 309371 (NLM Normalized Drug Names)
• NDC Directory — Clotrimazole (FDA National Drug Code)

Aviso Médico

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Sempre busque o aconselhamento do seu médico ou outro profissional de saúde qualificado para quaisquer dúvidas que você possa ter sobre uma condição médica ou medicamento.

Fontes de dados: DailyMed (NLM), openFDA, MFDS