Chemical formula: C₁₀H₂₁N₃O Molecular mass: 199.293 g/mol PubChem compound: 3052
The potential risk to the fetus in humans is unknown. Diethylcarbamazine should not be used in pregnancy, and as such, pregnant women are normally excluded when diethylcarbamazine is used in MDA.
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.
The potential risk for humans is unknown. No specific studies with diethylcarbamazine citrate in humans have been conducted to evaluate effects on fertility.
Diethylcarbamazine may cause short term drowsiness which may impact on the ability to drive and use machines. Vehicle drivers and machine users should be informed of the risk of drowsiness related to using this medicinal product.
DIETHYLCARBAMAZINE 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.
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.
| System Organ Class | Reactions attributable to DEC (may be seen in subjects without microfilariae) | Reactions attributable to death of microfilariae (may be seen in subjects with microfilariae and/or adult worm infections) |
|---|---|---|
| Blood and lymphatic system disorders | Lymphadenitis, lymphangitis, lymph node abscess, lymph node pain, lymphoedema | |
| Gastrointestinal disorders | Nausea, vomiting, abdominal pain, diarrhoea | Abdominal pain, nausea, vomiting, diarrhoea |
| General disorders and administration site conditions | Pyrexia, chills, weakness, malaise | |
| Metabolism and nutrition disorders | Decreased appetite | Decreased appetite |
| Musculoskeletal and connective tissue disorders | Myalgia | Myalgia, arthralgia, chest pain |
| Nervous system disorders | Dizziness, somnolence, lethargy, headache | Dizziness, headache, lethargy |
| Renal and urinary disorders | Haematuria | |
| Reproductive system and breast disorders | Epididymitis, spermatic cord inflammation, hydrocele, scrotal mass | |
| Respiratory disorders | Dyspnoea, cough | |
| Skin and subcutaneous tissue disorders | Pruritus, papular rash | |
| Vascular disorders | Circulatory collapse, orthostatic hypotension | |
| Reactions only observed in subjects with loaisis or onchocerciasis infection (see section 4.3) | ||
| Cardiac disorders | Tachycardia | |
| Eye disorders | Optic neuritis, punctate keratitis, iridocyclitis, conjunctivitis, visual field defect, eye pain, lacrimation, photophobia, corneal oedema | |
| Immune system disorders | Mazotti reaction | |
| Infections and infestations | Meningoencephalitis helminthic | |
| Investigations | Increased intraocular pressure | |
| Nervous system disorders | Coma, allergic encephalitis, encephalopathy, vertigo, convulsion (isolated cases in patients with a history of epilepsy) | |
| Renal and urinary disorders | Proteinuria | |
NOTE: frequency of all reactions is unknown (cannot be estimated from the available data).
DEC = diethylcarbamazine citrate.
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
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