DIETHYLCARBAMAZINE Tablet Ref.[9604] Active ingredients: Diethylcarbamazine

Source: European Medicines Agency (EU)  Revision Year: 2013  Publisher: SUPPLIER: Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan, Phone: +81 3 3817 3684, Fax: +81 3 3811 2710, Email: mailto: Eisai-asia_safety@hhc.eisai.co.jp

Therapeutic indications

Diethylcarbamazine Citrate Tablets, in combination with albendazole, are indicated in adults and in children over 2 years for large scale preventative chemotherapy interventions for the control of lymphatic filariasis, following the recommendations of the WHO Global Programme to Eliminate Lymphatic Filariasis.

The mass drug administration (MDA) programme consists of administering a single annual dose of diethylcarbamazine citrate 6 mg/kg with albendazole 400 mg to affected communities, in areas where onchocerciasis is not co-endemic (see section 4.3).

Posology and method of administration

Use of Diethylcarbamazine Citrate Tablets is restricted to community-wide MDA programmes in lymphatic filariasis-endemic countries following the recommendations of the WHO Global Programme to Eliminate Lymphatic Filariasis. The primary objective of the MDA strategy is to interrupt transmission of disease by reducing microfilaraemia to below 1%. In countries where onchocerciasis is not co-endemic, annual single doses each of diethylcarbamazine citrate (6 mg/kg) and albendazole (400 mg) are co-administered for 4 to 6 years.

In order for MDA to be successful, at least 85% of the total population or 65% of the eligible population should receive the drugs every year for 4 to 6 years. MDA programmes that use diethylcarbamazine citrate and albendazole typically exclude children under 2 years, pregnant women and lactating mothers, the elderly, and those with chronic or debilitating illnesses. These groups account for approximately 15% of the endemic population.

Since the drugs used for MDA programmes have an established safety profile and are easy to administer, the community is not screened for the presence of microfilaraemia prior to drug administration. In view of the large number of people to be treated, MDA programmes utilize, for distribution of the drugs, the services of trained health care workers and community volunteers drawn from all sections of the society. Hence endemic communities do not usually receive drugs under direct medical supervision.

Posology

Diethylcarbamazine Citrate Tablets should be co-administered with a single dose of albendazole 400 mg tablets (refer to prescribing information for albendazole 400 mg tablets).

Adults

The usual dose is 6 mg per kg of body weight diethylcarbamazine citrate given as a single dose administered once per year for 4 to 6 years.

Children

In children over 2 years, the usual dose is 6 mg per kg of body weight diethylcarbamazine citrate given as a single dose administered once per year for 4 to 6 years.

Method of administration

Oral use.

Diethylcarbamazine Citrate Tablets should preferably be administered after meals.

Overdose

Symptoms

Overdose may cause nausea, vomiting, headache, vertigo, drowsiness and, in rare but serious cases, convulsions.

Management

Administration of activated charcoal may be of value. Monitor for adverse reactions, with symptomatic treatment and hospitalisation if necessary.

Shelf life

Shelf life: 60 months.

Special precautions for storage

Do not store above 30°C.

Keep the bottle tightly closed in order to protect from light and moisture.

Discard the product 30 days after initial opening.

Nature and contents of container

Diethylcarbamazine Citrate Tablets are supplied in bulk in a white 400 cc high density polyethylene bottle with a white polypropylene cap having an induction seal and with the inclusion of two 2 gram silica gel desiccant packets.

Each bottle contains 1000 tablets.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

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