Artemet Tablet
Artemether + Lumefantrine
20mg + 120mg
Incepta Pharmaceuticals Ltd.
| Pack size | 24's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 20.00 AED |
Indications
Artemet Tablet is used for:
Acute uncomplicated malaria, Falciparum malaria
Adult Dose
Oral
Adults (weighing 35 kg and above): Administer 24 tablets over 3 days; use a 3-day treatment schedule with a total of 6 doses.
Day 1: Four (4) tablets initially and 4 tablets again after 8 hours.
Days 2 & 3: Four (4) tablets BID (morning & evening).
Child Dose
Oral
Children (weighing 35 kg and above): Administer 24 tablets over 3 days; use a 3-day treatment schedule with total of 6 doses.
Day 1: Four (4) tablets initially and 4 tablets again after 8 hours.
Days 2 & 3: Four (4) tablets BID (morning & evening).
Children:
5 to <15 kg: Administer 6 tablets over 3 days; 1 tablet initially and again after 8 hours on first day; follow by 1 tablet BID (morning & evening) for the next 2 days.
15 to <25 kg: Administer 12 tablets over 3 days; 2 tablets initially and again after 8 hours on the first day; followed by 2 tablets BID (morning & evening) for the next 2 days.
25 to <35 kg: Administer 18 tablets over 3 days; 3 tablets initially and again after 8 hr on 1st day; follow by 3 tablets BID (morning & evening) for the next 2 days.
Renal Dose
No specific pharmacokinetic studies have been performed in patients with renal impairment. No dose adjustment is necessary in patients with renal impairment is advised.
Administration
It should be taken with food.
If the patient vomits out the dose within 1-2 hours, give another dose
Contra Indications
Hypersensitivity.
Precautions
Avoid use in patients with known QT prolongation, those with hypokalemia or hypomagnesemia, and those taking other drugs that prolong the QT interval.
Halofantrine and Coartem Tablets should not be administered within one month of each other due to potential additive effects on the QT interval.
Antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data.
QT-prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets.
Substrates, inhibitors, or inducers of CYP3A4, including antiretroviral medications, should be used cautiously with Coartem Tablets, due to a potential loss of efficacy of the concomitant drug or additive QT prolongation.
Monitoring Parameters
Monitor patients unable to take food (greater risk of recrudescence).
Pregnancy-Lactation
Pregnancy
Published data from clinical studies and pharmacovigilance data have not established an association between drug use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes
Malaria during and after pregnancy increases risk for adverse pregnancy and neonatal outcomes, including maternal anemia, severe malaria, spontaneous abortion, stillbirths, preterm delivery, low birth weight, intrauterine growth restriction, congenital malaria, and maternal and neonatal mortality
Contraception
May reduce efficacy of hormonal contraceptives; advise patients using hormonal contraceptives to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment
Infertility
In animal fertility studies, administration of repeated doses to female rats (for 2 to 4 weeks) resulted in pregnancy rates that were reduced by one half
Male rats dosed for approximately 3 months, abnormal sperm cells, showed decreased sperm motility, and increased testes weight
Lactation
There are no data on presence of drug in human milk, effects on breastfed infant or on milk production; drug components are transferred into rat milk; when a drug is transferred into animal milk, it is likely that the drug will also be transferred into human milk
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Interactions
If mefloquine is administered immediately prior to this medication there may be a decreased exposure to lumefantrine, possibly due to a mefloquine-induced decrease in bile production; therefore, patients should be monitored for decreased efficacy and food consumption should be encouraged while taking this medication.
When coadministered with substrates of CYP3A4, may result in decreased concentrations of substrate and potential loss of substrate efficacy.
When coadministered with an inhibitor of CYP3A4, including grapefruit juice may result in increased concentrations of artemether and/or lumefantrine and potentiate QT prolongation.
When coadministered with inducers of CYP3A4 may result in decreased concentrations of artemether and/or lumefantrine and loss of antimalarial efficacy.
Therapy may reduce the effectiveness of hormonal contraceptives; patients using hormonal contraceptives should be advised to use alternative non-hormonal contraceptive methods or add barrier methods of contraception during therapy.
Administration with drugs that are metabolized by CYP2D6 may significantly increase plasma concentrations of coadministered drug and increase risk of adverse effects; many of the drugs metabolized by CYP2D6 can prolong QT interval and should not be administered with this drug due to potential additive effect on QT interval (eg, flecainide, imipramine, amitriptyline, clomipramine).
Contraindicated (30)
arsenic trioxide
bosentan
carbamazepine
chloroquine
clomipramine
dexamethasone
disopyramide
enzalutamide
eslicarbazepine acetate
etravirine
fluoxetine
fosphenytoin
goserelin
ibutilide
indapamide
leuprolide
nevirapine
oxcarbazepine
pentamidine
phenobarbital
phenytoin
pimozide
primidone
procainamide
quinidine
rifabutin
rifampin
rifapentine
sotalol
St John's Wort
Adverse Effects
Side effects of Artemether + Lumefantrine :
>10%
Abdominal pain (17%),Anorexia (40%),Arthralgia (34%),Asthenia (38%),Chills (23%),Dizziness (39%),Fatigue (17%),Headache (56%),Myalgia (32%),Nausea (26%),Palpitations (18%),Pyrexia (25%),Sleep disorder (22%),Vomiting(17%)
1-10%
Anemia (4%),Cough (6%),Diarrhea (7%),Hepatomegaly (9%),Malaise (3%),Nasopharyngitis (3%),Pruritus (4%),Rash (3%),Splenomegaly (9%),Vertigo (3%)
Mechanism of Action
Artemether is a potent and rapidly acting blood schizontocide. Artemether and active metabolite (DHA): via endoperoxide.
Lumefantrine: unknown; possibly inhibits beta-hematin formation
Both artemether and lumentantrine inhibit nucleic acid and protein synthesis
Note
Artemet 20mg + 120mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Artemether + Lumefantrine. Artemet is availble in Bangladesh.
Farmaco BD drug index information on Artemet Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.