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Gebether

GBGL Pharma Ltd.
16, Oguntona Crescent Phase 1, Gbagada, Lagos, Nigeria
Email: uday@gbglpharma.com
Tel: 0810-540-6002; 0814-503-9010
Website: http://gbpharma.co.uk

Brand Name

Gebether

Manufacturer

Lincoln Pharmaceuticals Ltd.
Trimul Estate, At & Post- Khatraj, TaI, KaIoI, Dist· Gandhinagar, Gujarat, India

Manufactured For:
GB PHARMA LIMITED
65 Chatsworth Road, London NW2 4BG, United Kingdom
Tel.: +44 (0)20 8830 1057, Fax: +44 (0) 20 8830 4807, email: Info@gbpharma,co.uk

Distributed by:
GBGL PHARMA LIMITED 16, 09untona Crescent, Gbagada- LAGOS, Nigeria

Therapeutic Class

Antimalarial drugs

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Injection (NRN: ): Each ampoule of artemether 80 mg contains 80 mg of artemether. Excipients: Butylated hydroxytoluene, butylated hydroxy anisole, propyl gallate, ethyl oleate.

Pack Size: Solution for intramuscular injection (IM). Box of 6 ampoules

 GEBETHER

Pharmacology

PHARMACOLOGICAL PROPERTIES 

This medicine RI product is a synthetic antimalarial agent derived from artemisinin.

The schizonticidal activity of artemether is due to the destruction of the asexual erythrocytic forms of P. falciparum and P. vivax. Artemether is effective against strains resistant to the other antimalarial agents. No cross resistance was detected with chloroquine.

The antimalarial activity of artemether consists in rapid destruction of plasmodia by the inhibition of the protein synthesis when trophozoites grow.

At therapeutic doses, half-life is approximately 7 hours, Plasma protein binding is approximately 77%. Artemether is mainly converted into an active metabolite, dihydroartemisinin.

Indications

Treatment of serious episodes of malaria due to Plasmodium falciparum, or when resistance to other antimalarial agents is suspected.

Contra-indications

Artemether must not be used: 

- During pregnancy, unless there is vital necessity (as in the case of cerebral malaria), where the physician will decide on the basis of the clinical context. 

- In case of allergy to artemether. In case of any doubt, you must consult your physician or pharmacist.

Precautions/Warnings

Do not exceed the prescribed dose.

Interactions

Despite the fact that no drug interaction has been reported, but since electrocardiographic or prolongation has been reported in some patients treated with artemether, it is recommended to avoid prescription of medicines known to produce a prolongation of the QT interval or to carefully monitor patients receiving such medicines: erythromycin, terfenadine, astemizole, probucol, anti-arrhythmic agents of class J (quinidine, procainamide, disopyramide), anti-arrhythmic agents of class III (amiodarone, bretylium), bepridil, sotalol, tricyclic antidepressants, some neuroleptics and phenothiazines. 

In case of doubt do not hesitate to consult your physician or pharmacist. 
In order to avoid possible interactions with other medicinal products. you must inform your physician or pharmacist about any other current treatment.

PREGNANCY AND LACTATION 

Pregnancy: see «Contra-indications»

Lactation: It is not known whether artemether is excreted in human milk, therefore, breast-feeding should be avoided daring treatment with artemether. 
As a general rule. you must always ask the advice of your physician or pharmacist before taking any medicine during pregnancy or lactation.

Adverse Effects

Like any active substance, this medicine may induce, in some patients’ undesirable effects to a greater or lesser degree.

Artemether may induce a decrease in reticulocyte count, and more rarely in leucocyte count. Some cases of nausea. vomiting, and abdominal pain have been reported. 

Very rarely: transient and moderate elevation in liver transaminases (ASAT, ALAD, bradycardia, first degree atrio-ventricular block.

Do not hesitate to ask your physician or pharmacist for advice and to report any undesirable effect nor mentioned.

Dosage & Administration

In all cases, strictly follow the physician's prescription. 
The total dose to be administered by I.M injection for 5 days, or for 3 days, is 480 mg (6 ampoules of 80 mg) in adults and 9.6 mg/kg in children. 
ln case it is not possible to comply with a 5 day treatment, 3 day treatment should be administered;

- 5-day treatment: 

Adults:
On the first day: 80 mg twice a day (i.e. 160 mg per day). 
From the 2nd to the 5th day: 80 mg once a day (i.e. 80 mg per day). 

Children:
On the first day: 1.6 mg/kg twice a day. 
From the 2nd to the 5th day: 1.6 mg/kg once a day.

- 3-day treatment: 

Adults: 80 mg twice a day (i.e. 160 mg per day) for 3 days. 
Children: 1.6 mg/kg twice a day for3 days.

METHOD OF Administration: for deep intramuscular use only. 

The injection must be done strictly in aseptic conditions in the upper- external quadrant of the buttock. Associations with other medicines in the syringe should be avoided.

OVERDOSAGE 

In case of overdosage, urgent symptomatic treatment in a specialized unit is required.

Storage/Handling Recommendations

Review Date

2018-01-11 08:23:39