GMP Artemether+Lumefantrine Dry Suspension 180mg+1080mg/60ml

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Product Description

Overview

1.3.1 Summary of Product Characteristics (SmPC)
1.3.1.1 Name of the Medicinal Product
International Non– Proprietary Name (INN): Artemether
1.3.1.2 ATC and Forensic Classification
ATC Classification: Antimalarial.
1.3.1.3. Qualitative and quantitative composition
Each 1 ml Ampoule contains Artemether 80mg
1.3.1.4. Pharmaceutical form
Liquid injection ;
1ml Ampoule containing a colourless or yellowish clear oily liquid
1.3.1.5. Clinical particulars
1.3.1.5.1 Therapeutic indications
It is indicated for the treatment of all kinds of malarial including the chloroquine-resistant P.
falciparum malarial and the first aid of critical malaria.
1.3.1.5.2 Posology and method of administration
The drug is used for intramuscular injection, five days course with the initial dose of 3.2mg/kg,
followed by 1.6 mg/kg for the following 4 days.
The initial dose of adults is 160 mg (2 ampoules), followed by 80 mg (1 ampoule) every time
from the 2 nd to 5 th day. The dose for children or overweight patients should be decreased or
increase on the basis of the individual weight or under the doctor’s prescription.
Administration for children:
For children, the dose should be chosen as follows:
Artemether Injection 80 mg

The dose for the children out of the above ranges should be decreased or increase on the basis of
the individual weight or under the doctor’s prescription.
1.3.1.5.3 Contraindications
Artemether is contraindicated in patients with hypersensitivity to artemether or other artemisinin
compounds or any excipient in the injection.
Artemether is not recommended in the first trimester of pregnancy because of limited data.
1.3.1.5.4 Special warnings and precautions for use
Clinical dosage exhibits slight adverse reactions.
Artemether has been remarkably well-tolerated, and appears less toxic than quinine or chloroquine;
adverse effects include bradycardia, electrocardiogram abnormalities, gastrointestinal disturbances
(nausea, abdominal pain, diarrhoea - oral therapy only), dizziness, injection site pain, skin
reactions, and fever. Transient decreases in neutrophils and reticulocytes have been reported in
some patients treated with artemether.
Drug induced fever has been observed with artemether. Mild reactions were seen in patients to
whom artemether had been administered intramuscularly. These included nausea, hypotension,
dizziness and tinnitus. These side effects were also reported: dark urine, sweating, somnolence,
and jaundice. There were no deaths or any other side effects. No irreversible side effects were
seen.
Slight rise of SGOT and SGPT may occur in individual cases. Neurological side effects have not
yet been observed in clinical use but clinical trials suggest that coma may be prolonged in patients
treated with artemether and there was an increased incidence of convulsions in one trial in cerebral
malaria. Transient first degree heart block has been documented in three patients receiving
artemether
1.3.1.5.5 Interaction with other medicinal products and other forms of interaction
Specific untoward drug interactions have not been found. Potentialisation of other antimalarial
drugs is a common feature. Loading dose of Artemether followed by other antimalarial drugs have
shown strong beneficial potentialisation effects.
1.3.1.5.6 Pregnancy and lactation
Artemether is not recommended in the first trimester of pregnancy because of limited data.
1.3.1.5.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Due to
the occurrence of some adverse reactions (see section 4.8) the ability to drive and use machines
may be impaired.
1.3.1.5.8 Undesirable effects
Artemether has been remarkably well-tolerated, and appears less toxic than quinine or chloroquine;
adverse effects include bradycardia, electrocardiogram abnormalities, gastrointestinal disturbances
(nausea, abdominal pain, diarrhoea - oral therapy only), dizziness, injection site pain, skin
reactions, and fever. Transient decreases in neutrophils and reticulocytes have been reported in
some patients treated with artemether.
Drug induced fever has been observed with artemether. Mild reactions were seen in patients to
whom artemether had been administered intramuscularly. These included nausea, hypotension,
dizziness and tinnitus. These side effects were also reported: dark urine, sweating, somnolence,
and jaundice. There were no deaths or any other side effects. No irreversible side effects were
seen.
Slight rise of SGOT and SGPT may occur in individual cases. Neurological side effects have not
yet been observed in clinical use but clinical trials suggest that coma may be prolonged in patients
treated with artemether and there was an increased incidence of convulsions in one trial in cerebral
malaria. Transient first degree heart block has been documented in three patients receiving
artemether.
1.3.1.5.9 Overdose
There is no experience with overdosage with artemether. There is no specific antidote known for
the artemisinin derivatives.
However, experimental toxicological results obtained with large doses of artemisinin on the
cardiovascular system and the CNS should be considered. Overdosage could bring on cardiac
irregularities. An ECG should be taken before initiating treatment in cardiac patients. Irregularities
in the pulse should be looked for and cardiac monitoring carried out if necessary. The animal
results on the CNS suggest that overdose could result in changes in brain stem function. Clinicians
treating cases of overdosage should look for changes in gait, loss of balance, or changes in ocular
movements and reflexes.
In case of overdosage, symptomatic treatment is recommender under the instruction of doctors.
1.3.1.6 Pharmacological properties
1.3.2.6.1 Pharmacodynamic properties
Artemether is active against all Plasmodia including those which may be resistant to other
antimalarials.
Artemether has very rapid schizontocidal activity. The schizontocidal activity of artemether is
mainly due to destruction of the asexual erythrocytic forms of P. falciparum and P. vivax. There is
inhibition of protein synthesis during growth of trophozoites. There is no cross resistance with
chloroquine.
It is not hypnozoiticidal but it reduces gametocyte carriage.
There is no rationale at present for using artemether for chemoprophylaxis.
1.3.1.6.2 Pharmacokinetic properties
Intramuscular Artemether is rapidly absorbed reaching therapeutic levels within the first hour.
Cmax is obtained within 4-6 hours. It is metabolized in the liver to the demethylated derivative
dihydroartemisinin. The elimination is rapid, with a T1/2 of 1-3 hours. Dihydroartemisinin, being
a potent antimalarial itself, has a similar T1/2 of. The degree of binding to plasma proteins varied
markedly according to the species studied. The binding of β -Artemether with plasma protein is of
the order of 50 %. Distribution of radioactive-labelled β -Artemether was found to be equal
between cells and plasma.
1.3.1.6.3 Preclinical safety data
Animal studies on acute toxicity show that the LD50 of Artemether in mice is a single i.g.
administration of 895mg/kg and a single i.m. injection of 296mg/kg dose; in rats, the LD50 is a
single i.m. injection of 597mg/kg dose. This proves the quite low toxicity of Artemether.
Experimental toxicological results obtained with large doses of artemisinin on the cardiovascular
system and the CNS should be considered. Overdosage could bring on cardiac irregularities. An
ECG should be taken before initiating treatment in cardiac patients. Irregularities in the pulse
should be looked for and cardiac monitoring carried out if necessary. The animal results on the
CNS suggest that overdose could result in changes in brain stem function. Clinicians treating cases
of overdosage should look for changes in gait, loss of balance, or changes in ocular movements
and reflexes.
1.3.1.7 Pharmaceutical Particulars
1.3.1.7.1 Incompatibilities
Not applicable.
1.3.1.7 2 Shelf life: 36 Months
1.3.1.7.3 Special precautions for storage :
Store below 30°C. Protect from light.
1.3.1.7.4 Nature and contents of container
80mg/ ml – Clear Type II glass ampoule packs of 6 ampoules per box.
1.3.1.7.5 Special precautions for disposal
Single use only. Discard any unused contents.
1.3.1.8. Marketing authorisation holder
Ningbo Voice Biochemic Co., Ltd.
298 West Zhonghsan Road, Ningbo . P.R. China

Product Categories : Finished Drugs > Antiparasitic & Antimycotic

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