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Amatem Capsule

Elbe Pharma Nig. Ltd
1, African Church close, off Coker Road, Ilupeju, Lagos, Nigeria
Email: elbepharma@gmail.com
Tel: 01-773-1473, 01-8179648, 08033160649
Fax: 01-452-8219

Brand Name

Amatem Capsule

Manufacturer

Olive HEALTHCARE 197/2, Athiyawad, Dabhel Village. DAMAN – 396210 (U.T). India.

URL: www.olivehearthcare.co.in Email: export depertment@olivehearthcare.co.in

Therapeutic Class

Antimalarial drugs

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsule (NRN: B4-0953): Each Soft Gelatin Capsule contains Artemether Ph. Int. 20 mg, Lumefantrine Ph. Int. 120 mg Excipients q.s.

Pack Size: Blister packs of 3 x 8 Soft Gelatin Capsules

Amatem Capsule

Pharmacology

Artemether and Lumefantrine combination is a fixed dose artemisinin-based combination therapy (ACT) combining artemether, an artemisinin derivative and lumefantrine, a synthetic antimalarial drug.

Artemether is absorbed with peak plasma concentrations reached about 2 hours after dosing. Absorption of lumefantrine, a highly lipophilic compound, starts after a lag-lime of up to 2 hours, with peak plasma concentrations about 6 to 8 hours after administration.

Artemether and lumefantrine are both highly bound to human serum proteins in vitro (95.4% and 99.7%, respectively).

Artemether are cleared from plasma with an elimination half-life of about 2 hours. Lumefantrine is eliminated more slowly, with a terminal half-life of 3-6 days.

No specific pharmacokinetic studies have been performed in patients older than 65 years of age.

Indications

Effective against malaria caused by P. falciparum

Contra-indications

• Hypersensitivity to any of the Ingredients

• Patients who are taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine,   amitriptyline, clomipramine).

• Patients with disturbances of electrolyte balance e.g hypokalemia.

Precautions/Warnings

• It must not be used in first Trimester of Pregnancy.

• It has not been evaluated for treatment of severe malaria

• It is not indicated for, and has not been evaluated in the treatment of malaria due to P. vivax, P.malariae, P.ovale.

Interactions

It has the interactions with other antimalerials, CYP450 3A4 inhibitors, Protease Inhibitor and anti retroviral Drugs.

PREGNANCY AND LACTATION

Pregnancy

There is insufficient data from the use of artemether and lumefantrine in pregnant women. Based on animal data, it is suspected to cause serious birth defects when administered during the first trimester of pregnancy. During the second' and third trimester, treatment should only be considered if the expected benefit to the· mother outweighs the risk to the foetus.

Lactation

Animal data suggest excretion into breast milk but no data are available in humans. Women taking the product should not breast-feed during their treatment. Due to the long elimination half-life of lumefantrine (4 to 6 days), it is recommended that breastfeeding should not resume until at least one week after the last dose unless potential benefits to the mother and child outweigh the risks of treatment.

Adverse Effects

Dosage & Administration

Dosage in Adult Patients (>16 years of age)

A 3-day treatment schedule with a total of 6 doses is recommended for adult patients with a bodyweight of 35 kg and above:
Four capsules as a single initial dose, 4 capsules again after 8 hours and then 4 capsules twice daily (morning arid evening) for the following two days (total course of 24 capsules).

Dosage in Pediatric Patients

A 3-day treatment schedule with a total of 6 doses as recommended as below:

15 kg to less than 25 kg bodyweight : Two capsules as an initial dose, 2 capsules again after 8 hours and then 2 capsules twice daily (morning and evening) for the following two days (total course of 12 capsules).

25 kg to less than 35 kg bodyweight : Three capsules as an initial dose, 3 capsules again after 8 hours and then 3 capsules twice daily (morning and evening) for the following two days (total course of 18 capsules).

35 kg bodyweight and above: Four capsules as an initial dose, 4 capsules again after 8 hours and then 4 capsules twice daily (morning and evening) for the following two days (total course of 24 capsules}.

Warning: This medicine is for only those Children/Patients that can swallow the soft gelatin capsules.

OVERDOSE

In case of suspected Overdosage symptomatic and supportive Therapy should be given as appropriate which including ECG and blood potassium monitoring

Storage/Handling Recommendations

Store below 25°C in cool & dry place.

Review Date

2015-09-24 07:07:45