Justeen Pharmaceauticals Limited

Pomex

Justeen

Pomex

POMEX

Artemether and Lumefantrine Tablets

  • COMPOSITION

    Each uncoated tablet contains:
    Artemether : 20mg
    Lumefantrine : 120mg
    Excipients : Q.S.

  • INDICATIONS

    Pomex is It fixed combination of artemether and lumefantrine, which acts as a blood schizontocide.

    It is for:
    Treatment, including stand by emergency treatment of adult and children with acute and uncomplicated infections due to Plasmodium Falciparum or mixed infections including P. falciparum. Because Pomex is effective against both drug sensitive and drug resistant P. falciparum it is also recommended for malaria infections acquired in areas where the parasites may be resistant to other antimalarials.

  • DOSAGE AND ADMINISTRATION

    Tablets for oral administration. Patients with acute malaria are frequently averse to food. The dose may be taken with fluids. Patients should be encouraged to resume normal eating as soon as food can be tolerated since this improves absorption of artemether and lumefantrine.

    In the event of vomiting within 1 hour of administration a repeat dose should be taken.

      DOSAGE IN ADULTS:
    • For tablets as a single dose at the time of initial diagnosis and then 8, 24 and 48 hours 'hereafter (total course comprises 16 tablets).
      • DOSAGE IN CHILDREN:
    • ->5-<15 Kg body weight One tablet at the time of initial diagnosis and then 8, 24 and 48 hours thereafter (total course comprises 4 tablets).
    • ->15-<25 Kg body weight Two tablet at the time of initial diagnosis and then 8, 24 and 48 hours thereafter (total course comprises 8 tablets).
    • -> 25-<35 Kg body weight: Three tablet at the tune of initial diagnosis and then 8, 24 and 48 hours thereafter (total course comprises 12 tablets).
      • DOSAGE IN ELDERLY PATIENTS
    • Although no studies have been carried out in the elderly, no special precautions or dosage adjustments are considered necessary in such patients.
      • DOSAGE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT
    • Although no studies have been carried out in the elderly, no special precautions or dosage are considered necessary in such patients.

  • PREGNANCY AND LACTATION

      Pregnancy
    • The safe use of artemether and lumefantrine during pregnancy has not been established. Reproductive toxicity studies in rats and rabbits have shown no evidence of teratogenicity (or the combination or for the individual components lumefantrine and artemether.
      • Lactation
    • Animal data suggest excretion into breast milk but no data are available in humans, Breast-feeding women should not take Pomex. Due to the long elimination half-life of lumefantrine (4 to 6 days), it is recommended that breast-feeding should not resume before day 28 unless potential benefits to mother and child outweigh the risks of Pomex treatment.

  • EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

    Patients receiving Pomex should be warned that dizziness of fatigue/asthenia might occur in which case they should not drive or use machines.

  • UNDESIRABLE EFFECTS

    The frequency of adverse events reported during clinical trials with Pomex was similar than that of other antimalarials drugs as comparators.

  • OVERDOSE

    In case of suspected overdosage, symptomatic and supportive therapy should be given as appropriate. ECG and blood potassium levels should be monitored.

  • INSTRUCTION FOR USE AND HANDLING

    Note: Pomex should be kept out of reach and sight of children.