Presentation:
- Box of 1 blister of 3 yellow tablets and 3 white tablets.
- Box of 1 blister of 6 yellow tablets and 6 white tablets.
- Box of 2 blister of 6 yellow tablets and 6 white tablets.
Composition:
1. Yellow tablet: Artesunate: 50mg
2. White tablet: Amodiaquine HCl: equivalent to 153 mg amodiaquine base
Excipients: .q.s: 1 tablet
Pharmaceutical form: Tablet.
Indications:
Ascoaquin 50/153 is indicated for the treatment of case of severe malaria, cerebral malaria caused by Plasmodium falciparum, including cases are resistant to other antimalarials.
Contraindications
- Known hypersensitivity to amodiaquine, artesunate, or artemisinin derivatives.
- Liver disorders.
- Pregnant woman with the first trimester of pregnancy.
Precautions
- This drug contains amodiaquine which is no longer recommended for prophylaxis of Plasmodium falciparum malaria because of being associated with hepatotoxicity, agranulocytosis.
- Large doses of amodiaquine higher than recommended dose have been reported to produce nervous disorders such as syncope, spasticity, convulsions and involuntary movements.
- Amodiaquine may cause blood dyscrasias, haemolytic anaemia, hepatitis, peripheral neuropathy. If long-term therapy is given, regular ophthalmic examination is recommended.
- Because amodiaquine may concentrate in the liver, the drug should be used with caution in patients with hepatic disease or alcoholism and in patients receiving hepatotoxic drugs.
- Patients with glucose 6 - phosphate dehydrogenase deficiency.
Drug interactions
- The incidence of agranulocytosis is higher when amodiaquine is combined with other antimalarials. Drug-induced involuntary movements have reported to occur when amodiaquine is combined with chloroquine.
- Magnesium trisilicate and kaolin are known to decrease the gastrointestinal absorption of amodiaquine when administered simultaneously.
- Artesunate has a minimal effect on hepatic cytochrome P450 activity and does not appear to influence the metabolism of mefloquine, a drug likely to be used in combination with artesunate.
- Artesunate does not inhibit the formation of carboxy-primaquine, a metabolite of primaquine.
Pregnancy - Lactation
- Caution should be observed before administering amodiaquine-artesunate combination in pregnancy as enough safety data is not available.
- It should not be used in pregnancy during the first trimester.
Effect of drug on ability to drive and operate machines
- Effect of drug on ability to drive and operate machine has not reported adequately.
Dosage
- Ascoquin 50/153 is suitable for children from 7 to 13 years of age
- The recommended dose is 1 yellow tablet and 1 white tablet, twice a day for 3 consecutive days.
Side effects
- Amodiaquine may cause undesired effects such as: Agranulocytosis, blood dyscrasias, haemolytic anaemia, hepatitis, peripheral neuropathy.
- In therapeutic doses used for malaria, amodiaquine may occasionally cause nausea, vomiting, diarrhoea, pruritus, vertigo and lethargy, abdominal pain, headache and photosensitivity.
- If given for long periods, it sometimes causes corneal deposits, visual disturbances and bluish-grey pigmentation of the finger nails, skin and hard palate. These reactions clear somewhat slowly, on stopping treatment. However, because of the occasional development of irreversible retinopathy, regular ophthalmic examinations should be carried out if the drug is used over a long period. The drug can also cause irregular heart beats.
- Artesunate and other related-artemisinin derivatives have not been reported any serious adverse reactions. Drug-induced fever can occur. Cardiotoxic has been observed following administration of high doses.
- Possible artesunate-related side effects include dizziness, itching, vomiting, abdominal pain, flatulence, headache, bodyache, diarrhoea, tinnitus and increased hair loss, macular rash, reduction in neutrophil counts and convulsions. However, it is likely that many of these effects are disease related rather than drug-induced.
Report any side effects to your physician or pharmacist during period of treatment
OVERDOSE
- In the amodiaquine - artesunate combination, overdose is mainly pertaining to amodiaquine.
- Intoxication with amodiaquine is far less frequent than chloroquine poisoning. However, large doses of amodiaquine have been reported to produce syncope, spasticity, convulsions and involuntary movements, headache, vertigo and vomiting, drowsiness. The most dramatic feature is cardiovascular disturbance, convulsions, coma, hypotension, impaired respiration, cardiac arrest, hypokalemia, visual disturbance, including sudden loss of vision, which is usually transitory, blurred vision, blindness.
- No data available for overdose of artesunate.
Treatment of overdose
- Reporting to physician or pharmacist is required as quickly as possible in the event of overdose, event if symptoms of overdose are not presented.
shelf-life: 36 months from the date of manufacturing.
Storage: Store in a cool and dry place below 280C, protect from light.
Specification: Manufacturer's.
