Justeen Pharmaceauticals Limited

Atmal Plus

Justeen

Atmal Plus

ATMAL PLUS

(Artemether 80mg + Lumefantrine 480mg)

  • Composition

    Each soft gelatin capsule contains:
    Artemether Ph. lnt. 80 mg
    Lumefantrine Ph. lnt. 480 mg
    Excipients Q.S.

    Approved colour used in capsule shell.

  • CLINICAL PHARMACOLOGY

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

  • Pharmacokinetics

    Artemether is absorbed with peak plasma concentrations reached about 2 hours after dosing. Absorption of lumefantrine, a highly lipophilic compound, starts after a lag-time of up to 2 hours, with peak plasma concentrations about 6 to 8 hours after administration. Artemether and lurnefantrine are both highly bound to human serum proteins in vitro (95.4% and 99.7% respectively).

    Artemetner are cleared from plasma with an elimination half-life of about 2 hours. Lurnefantrine 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.

  • Dosage

    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: One capsule as an initial dose, 1 capsule again after 8 hours and then 1 capsule twice daily (morning and evening) for the following two days (total course of 6 capsules).

  • DO NOT EXCEED THE DOSAGE PRESCRIBED

    Weight in Total Dosage Regimen Kgs. Capsules Day-1 Day -2 Day -3 o Hours 8 Hours 24 36 48 60 35kg - (initial dose) I (after 1st dose) Hours Hours Hour Hours 6 above 1 Capsule 1 Capsule 1 Capsule 1 Capsule 1 Capsule 1 Capsule

  • INDICATION

    For the treatment of most forms and resistant types of malaria.

  • CONTRAINDICATIONS

    • Hypersensitivity to any of the Ingredients
    • Patients who are taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (e.g. fiecainide, metoprolol, imipramine, amitryptyline, clomipramine).
    • Patients with disturbances of electrolyte balance eg hypokalemia.

  • SPECIAL PRECAUTIONS AND WARNINGS FOR USE

    • It must not be used in first Trimester of Pregnancy.
    • It has not been evaluated for treatment of severe malaria
    • For the treatment of most forms and resistant types of malaria.

  • DRUG INTERACTIONS

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

  • PREGNANCY AND LACTATION

      Pregnancy
    • There is insufficient data from the use of artemether and lumetantrine 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.

  • OVERDOSE

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

  • STORAGE

    Store below 25?C in cool & dry place. Keep out of reach of children.

  • PRESENTATION

    Blister packs of 1x 6 soft gelatin capsules.

  • NAFDAC Reg. No.:

    B4-3788