Amatem soft gel Forte side effects, Uses, Dosage & Price

Amatem soft gel Forte side effects, Uses, composition, effectiveness, indication, contraindication, dosage for adults and children , and price.

AMATEM SOFT GEL FORTE
(Artemether 80mg + Lumefantrine 480mg)

Composition: Amatem soft gel ingredients

Each soft Gelatin Capsule contains;

Artemether ph. Int. 80mg

Lumefantrine ph. Int. 480mg

Excipients q.s

Clinical uses of amatem soft gel

1. To treat malaria

2. To treat chloroquine resistant malaria

3. In cases malaria treatment failure especially with chloroquine, amatem forte may be the new drug of choice.

Please note that there are fake amatem soft gel in the market, and fake amatem will not give you the desired result aa it will not clear the malaria parasite in your blood. Always make sure you buy from trusted pharmacies that you know stock original amatem soft gel. Beware of fake and adulterated amatem soft gel. To get original amatem, always look out for the code on the packet.

CLINICAL PHARMACOLOGY

Mechanism of Action :

Amatem soft gel forte contains Artemether and Lumefantrine whose combination is a fixed dose aretemisinin-based combination therapy (ACT) combining artemether, an artemisinin derivative and lumefantrine, a synthetic antimalarial drug.

Pharmacokinetics:

Artemether is adsorbed with peak plasma concentration reached about 2 hours after dosing. Absorption of lumefantrine, a highly lipophilic compound about 6 to 8 hours after administration. Artemether and lumefantrine are both highly bound to human serum protein 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.

How to take Amatem soft gel forte

Dosage in Adult parents (>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:

Take 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 Kgs: 35kg- above

Total capsules : 6

Dosage Regimen;

Day -1

0 Hours 8 Hours
(Initial dose) (after dose)
1 capsule. 1 capsule.

Day -2

24 Hours 36 Hours
1 capsule. 1 capsule.

Day -3

48 Hours 60 Hour
1 capsule. 1 capsule.

INDICATION

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

CONTRAINDICATIONS TO AMATEM SOFT GEL

– 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, amitryptyline, clomipramine).

– Patients with disturbances of electrolyte balance eg hypokalemia.

Amatem soft gel Forte side effects

Common side effects may include:

👉Tiredness/fatigue

👉headache, dizziness;

👉Palpitations/fast heart beat

👉Diarrhoea (runny stomach)

👉Insomnia (poor sleep)

👉Hallucinations or nightmares in some persons as reported.

👉Cough

👉fever, cough, feeling weak or tired;

👉muscle pain (myalgia), tenderness, or weakness;

👉joint pain (arthralgia);

👉vomiting, nausea; or

👉loss of appetite(anorexia).

👉Abdominal pains

👉Pruritus

👉Change in colour of urine

👉Allergies which could be severe and life threatening.

SPECIAL PRECAUTIONS AND WARNING FOR USE

– Amatem must not be used in first Trimester of Pregnancy.

– It has not been evaluated for treatment of severe malaria. Amatem is not really that effective in the treatment of severe malaria.

– For the treatment of most forms and resistant type of malaria.

DRUG INTERACTIONS

It has the interactions with other antimalarials, CYP450 3A4 Inhibitors, Protease Inhibitor and anti-retroviral drugs.

Amatem soft gel in pregnancy and breastfeeding mothers.

Pregnancy

There is insufficient data from the use of amatem soft gel forte (artemether and lumefantrine) in pregnant women.

Based on animal data, it is suspected to cause serious birth defects when administered during first trimester of Pregnancy.

During the second and third trimester, treatment should only be considered if the expected benefits to the mother outweighs the risk to the foetus.

Lactation

Can a nursing mother take amatem soft gel? Animal data suggest excretion into breast milk but no data are available in humans. Women taking amatem should not breastfeed 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.

Can amatem soft gel cause miscarriage?

No. Amatem is a safe drug in the second trimester of pregnancy and do not cause miscarriage.

Can an ulcer patient take Amatem soft gel?

Yes you can…Amatem does not cause ulcer or worsen ulcer. Amatem is safe in in ulcer patients.

Can a pregnant woman take amatem soft gel in third trimester?

Yes. Amatem soft gel is contra-indicated in the first trimester but it is safe in the second and third trimester.

Can a nursing mother take Amatem soft gel?

Yes. Amatem is safe in nursing or breastfeeding mothers.

Price

Amatem malaria drug price in Nigeria is between #1,800 – #2,000 naira depending on the location and pharmacy.

STORAGE

Store below 25°C in cool & dry place.

PRESENTATION

Blister packs of 1×6 soft gelatin capsule.

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