DIETHYLCARBAMAZINE Tablet Ref.[9604] Active ingredients: Diethylcarbamazine

Use of diethylcarbamazine citrate in patients without underlying filarial infestation

Diethylcarbamazine citrate must be used with care in patients who have a history of convulsions or who show factors that predispose them to convulsions (see section 4.8).

Severely ill persons

The frail, elderly and debilitated, especially those with cardiac or renal disease, are normally excluded when diethylcarbamazine citrate is used in MDA programmes. In the event of a concomitant disorder, the patient should be allowed to recover before taking diethylcarbamazine citrate.

Diethylcarbamazine Citrate Tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption may experience symptoms of intolerance.

Children

Children under the age of 2 years are normally excluded when diethylcarbamazine citrate is used in MDA programmes.

Use of diethylcarbamazine citrate in patients with underlying filarial infestation

Lymphatic filariasis

Patients with symptoms suggesting lymphatic filariasis (swelling of legs, arms, female breast or male genitalia) should be managed according to the relevant local or international treatment guidelines. For WHO options for treatment, see references at end of this SmPC, under Section 4.2.

Loa loa

The intensity and the severity of the undesirable effects that appear after administration of diethylcarbamazine citrate are associated with the level of microfilariae in the blood prior to treatment. In the event of Loa loa infestation, the level of microfilariae present in the blood is often very high, which predisposes the treated patients to an increased risk of serious side effects. Serious central nervous system problems such as encephalopathy and coma have been observed in patients with Loa loa infections that have been treated with diethylcarbamazine citrate, in particular.

Onchocerciasis

Diethylcarbamazine must not be administered in patients co-infected with onchocerciasis. Skin and/or systemic reactions of variable severity (Mazzotti reaction) and eye reactions have been observed after administration of drugs with rapid microfilariacidal action such as diethylcarbamazine citrate. If there is evidence of hypersensitivity to the eye, administration must be stopped due to potential sight loss. These manifestations are probably associated with an inflammatory process that is triggered following the death of microfilariae and the release of decomposition products.

Co-administration of diethylcarbamazine citrate with albendazole did not significantly alter the PK profile of either drug. Adequate absorption of both diethylcarbamazine and albendazole was observed in both adults and children aged over 5 years.

No other known interactions.

Pregnancy

The potential risk to the fetus in humans is unknown.

Diethylcarbamazine Citrate Tablets should not be used in pregnancy, and as such, pregnant women are normally excluded when diethylcarbamazine citrate is used in MDA.

Breastfeeding

It is unknown whether diethylcarbamazine or its metabolites are excreted in human milk. As a risk to the newborn or infant cannot be excluded, the product should not be given to breastfeeding women.

Fertility

The potential risk for humans is unknown. No specific studies with diethylcarbamazine citrate in humans have been conducted to evaluate effects on fertility.

Diethylcarbamazine Citrate Tablets may cause short term drowsiness which may impact on the ability to drive and use machines (see section 4.8). Vehicle drivers and machine users should be informed of the risk of drowsiness related to using this medicinal product.

DIETHYLCARBAMAZINE CITRATE TABLETS 100 MG USP SHOULD ONLY BE USED AS PART OF A MASS DRUG ADMINISTRATION PROGRAMME FOR ELIMINATION OF LYMPHATIC FILARIASISIN AREAS WHERE ONCHOCERCIASIS IS NOT CO-ENDEMIC. USE AS DIRECTED.

Summary of the safety profile

There is no clear information on the frequency of adverse reactions occurring as a result of diethylcarbamazine citrate administration. Mild to moderate adverse reactions are common,but the incidence of serious adverse reactions is considered to be very low.

In the absence of circulating microfilaraemia, the administration of diethylcarbamazine citrate, when given at the recommended dosage, may cause nausea, vomiting, abdominal pain, diarrhoea, loss of appetite, muscle pain, dizziness, drowsiness, fatigue and headache. These begin within one to two hours and may persist for several hours.

In patients with circulating microfilaraemia adverse reactions may be more common and severe, particularly in patients with a high parasite burden. Adverse reactions vary with the infecting filarial species, may be local and/or systemic, and may occur with or without fever. These are considered allergic reactions due to antigen-antibody reaction caused by dead microfilariae or adult filarial worms, and the intensity and the severity of adverse reactions are usually associated with the level of microfilariae in the blood prior to treatment. Usually such symptoms are transient and self-limiting, but when the symptoms are significant enough to interfere with daily life, the patient needs to be observed carefully and given clinically appropriate treatment. Steroids have been used. If there is evidence of hypersensitivity involving the eye, administration must be stopped due to potential sight loss (see section 4.4).

NOTE: frequency of all reactions is unknown (cannot be estimated from the available data).
DEC = diethylcarbamazine citrate.

Children

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

Not applicable.