Description and Composition of FevacombFevacomb is an anti malarial drug that contains artesunate and amodiaquine as its active pharmaceutical ingredient. Its dosage form is in tablet or powder for dissolution before adminstration.
Pharmacology and Mechanism of Action of FevacombFevacomb is a synergistic combination of artemisinin derivative (artesunate) and an antimalarial (amodiaquine). It is very potent against the asexual forms of plasmodium, schizonts and gametocytes. The schizonticidal action of fevacomb Insures a rapid clearance of, parasitaemia, ensuring a rapid clinical recovery, and its gametocidal action prevents the infestation. The half life of artesunate is short whereas amodiaquine is long. The absorption of Fevacomb after oral administration is rapid and complete; it is extensively distributed in all tissues.
Indications and Uses of FevacombFevacomb is indicated for the treatment of acute uncomplicated malarial attacks, including multi drug resistant strains of Plasmodium Falciparum.
Contraindications of FevacombLinking to Amodiaquine: Fevacomb must not be used in the following cases namely: hypersensitivity to one of the constituents, history of fever disease or blood impairment during an anterior treatment with amodiaquine and retinopathy (in the event of frequent treatment). Do not use this medicine during the pregnancy and the lactation. Linking to Artesunate: For now no recorded contraindication is reported, however, this drug must not be used in case of hypersensitivity to one of the constituents.
Interactions of FevacombThere have been no reports of negative drug interactions to date. For the combination with Amodiaquine, there was a significant improvement of the cure rates at different stages of the clinical tests.
Warnings and Precautions on Fevacomb
Use in PregnancyThe use of camosunate is not recommended during the organogenesis period except if, in the doctor’s opinion, the benefits outweigh the risks as seen with cerebral malaria. Administration of the drug during the first trimester must be avoided.
Breast feedingArtesunate is not known to cross into maternal milk. Do not exceed the recommended dose without seeking further medical advice. Keep this medicine out of the reach of children.
Side Effects of FevacombUndesirable effects of Artesunate are generally rare at the therapeutic recommended dose. In rare cases, however, slight changes to haematology values have been seen, including a reduction in the number of reticulocytes as well as a slight increase in transaminase. These signs, however, do not generally give rise to any noticeable clinical manifestations. In rare cases, a slight but transient reduction in sinus heart has been observed. Abdominal cramps and mild diarrhoea have been reported at elevated doses. Since amodiaquine may concentrate in the liver, the drug should be used with uti in patients with hepatic diseases or alcoholism, and patients receiving hepatic drugs. After the intake of Amodiaquine neurological effects such as lethargy and drowsiness have been reported at therapeutic doses. Also patients can experience involuntary movements Patients with hypersensitivity to Amodiaquine can develop hepatitis. Nausea, vomiting and diarrhoea have also been reported. In a number of cases it has been seen that Amodiaquine causes agranulocytosis and other blood dyscrasias.
Symptoms of Overdose of FevacombYou should stop the treatment and consult immediately a Doctor or a Pharmacist in case of headache, dizziness, visual disturbances, convulsions. These symptoms usually indicate an overdose.
Dosage and Administration of Fevacomb
Under one yearEach paediatric sachet containing Artesunate 25 mg and Amodiaquine base 75 mg should be dissolved in 10 ml clean water and taken daily for 3 days
1-6 yearsEach children sachet containing Artesunate 50 mg and Amodiaquine base 150 mg should be dissolved in 30 ml clean water and taken daily for 3 days
7-13 yearsOne tablet of each white tablet (Artesunate 100 mg) and one tablet of each yellow tablet (Amodiaquine hydrochloride equivalent to Amodiaquine base 300 mg) daily for 3 days.
14 years and aboveOne tablet of each white tablet (Artesunate 100 mg) and One tablet of each yellow tablet (Amodiaquine hydrochloride equivalent to Amodiaquine base 300 mg) in the morning and evening daily for 3 days.
Preparation for UseUnder one year – Each paediatric sachet containing Artesunate 25 mg and Amodiaquine 75 mg should be dissolved into 10 ml clean water and taken base daily for 3 days. 1-6 years Each children sachet containing Artesunate 50 mg and Amodiaquine base 150 mg should be dissolved in 30 ml clean water and taken daily for 3 days.
Pharmaceutical forms and Presentations of Fevacomb
Tablet1 blister of 12 tablets contains 6 white Artesunate tablets and 6 yellow Amodiaquine tablets. (ADULT) 1 blister of 6 tablets contains 3 white Artesunate tablets and 3 yellow Amodiaquine tablets. (JUNIOR).
SachetsOne box of 6 sachets contains 3 white labelled Artesunate sachets and 3 black labelled Amodiaquine sachets.
Storage Conditions of FevacombDo not exceed the expired date indicated on the outside packaging. Keep it in the original packet and store dry below 30°C.
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