Nem Amodiaquine Hydrochloride Tablets

AMODIAQUINE TABLETS U.S.P. 200MG

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory.

 

Each Film coated tablet contains

Amodiaquine Hydrochloride USP equivalent to Amodiaquine (Base) 200 mg.

 

INDICATION

Treatment of malaria.

Amodiaquine is active on numerous strains of chloroquine-resistant Plasmodium falciparum.

 

METHOD OF ADMINISTRATION

Oral use: Strictly follow your Doctor’s advice.

For use in adults and children weighing more than 20 kg (i.e. approximately 6 years of age) only.

Tablets should be swallowed with a little water after a meal. The dose should be adjusted to body weight, corresponding to 35 mg/kg of amodiaquine base to be taken over 3 days, i.e. on the first day 15 mg/kg given in 2 doses allowing an interval of hours between the doses, then the foflowing 2 days: 10 mg/kg given in 2 doses allowing an interval of 12 hours between the doses.

 

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients. History of hepatic and (or) haematological impairment during treatment with amodiaquine. Retinopathy (for frequent treatment).

 

WARNINGS and PRECAUTIONS FOR USE

NB This medicinal product may cause hepatitis and (or) agranulocytosis. Symptoms suggesting any of the following should be carefully monitored: hepatitis in the pre-icteric phase (anorexia, marked asthenia, abdominal pain, abnormal weight loss, fever, nausea, vomiting), jaundice a fortiori; agranulocytosis (fever and/or sore throat and/or mouth ulcers). If there is any of the above symptoms discontinue treatment and do liver function test and complete blood count test. Initiate replacement treatment with another antimalarial.

 

PREGNANCY AND LACTATION

No particular teratogenic or fetotoxic effects have been observed in clinical practice.

However, the follow-up of pregnancies exposed to this medicinal product is insufficient to rule out any risk.

Treatment of amodiaquine should only be envisaged during pregnancy if necessary.

Lactation

As there is no data available on exertion in breast milk, use of amodiaquine in breast-feeding women should be avoided.

 

UNDESIRABLE EFFECTS

Several cases of hepatitis, fatal, and leukopenia, agranulocytosis have been reported.

Other side effects are pruritus, skin rash grey pigmentation, neuromyopathy, retinopathy and eye disorders.

 

OVERDOSAGE

Dangerous dose

Symptoms of overdose are headache, dizziness, visual disturbances, cardiovascular collapse and seizures, followed by sudden, early respiratory and cardiac arrest.

Actions to be taken

Emergency transfer to a specialised unit.

 

PHARMACODYNAMIC

Amodiaquine is a synthetic antimalarial.

Its activity is characterised by a schizonticidal action on Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale and Plasmodium maIariae, hence its use in the treatment of acute episodes, through the destruction of intraerythrocytic forms. Certain strains of Plasmodium falciparum are resistant to 4-aminoquinolines, in numerous regions in which geographical distribution is constantly changing.

 

PHARMACOKINETICS

Studies following intravenous administration have shown that amodiaquine is rapidly eliminated from plasma with an apparent elimination half-life ranging from 0.5 to 6 hours, according to different authors. Its volume of distribution is around 20 to 40 l/kg on average, and plasma clearance is approximately 2 to 20 I/kg/h with high interindividual variability. Amodiaquine is mainly eliminated by biotransformation. Only negligible quantities of amodiaquine are found unchanged in the urine. Amodiaquine is rapidly absorbed following oral administration. After oral administration of a dose of 200, 400 or 600 mg, the kinetic profile of the parent compound is linear.

Monodesethylamodiaquine, the main active metabolite of amodiaquine, is essentially found in the blood, at concentrations much higher than those observed for  amodiaquine.

The apparent elimination half-life of monodesethylamodiaquine varies greatly: from 1 to more than 10 days.

 

Presentation

1 x 3 Tablets blister

1 x 1000 tablets Plastic container

 

Storage

Store in cool dark place, keep the container tightly closed.

Keep all medicines out of reach of children.

 

Manufactured in India by

NEM LABORATORIES PVT LTD.

Fac.: 133, Vasai Rd., (E), 401 210.

Regd. Office: 162, S.B. Marg,

Lower parel, Mumbai – 400 013

 

Marketed by

Great Timec Pharma Co. Ltd.

No. 19 B, Niger Bridge Head,

Housing Estate, Fege Onitsha,

Nigeria.