Malven Artesunate 60mg

Uses

Artesunate can quickly and reliably control the acute attack of malaria. It is suitable to salvage the patients with pernicious malaria and treat P. falciparum malaria and P. vivax malaria. It is effective against malaria caused by chloroquine resistant strain of plasmodium falciparum.

Management of acidosis in cardiac arrest.

Management of metabolic acidosis in:

• Severe renal disease
• Uncontrolled diabetes
• Circulatory insufficiency from shock or dehydration
• Severe primary lactic acidosis

Alkalinization of urine.

Malven Artesunate 60mg is also used to associated treatment for these conditions: Acute Uncomplicated Plasmodium Falciparum Malaria, Malaria, Cerebral, Severe MalariaAcid indigestion, Barbiturate intoxication, Breast Cancer, Constipation, Dental Decay, Duodenal Ulcer, Dyspepsia, Gastro-esophageal Reflux Disease (GERD), Gingival Bleeding, Heartburn, Helicobacter Infections, Hyperkalemia, Ischaemia, Metabolic Acidosis, Myocardial Infarction, Plaque, Dental, Pruritis of the skin, Skin Irritation, Upset stomach, Zollinger-Ellison Syndrome, Abdominal bloating, Benign, active Gastric Ulcer, Methyl alcohol poisoning, Prophylaxis of Contrast-induced nephropathy, Salicylate poisoning, Severe Diarrhea, Swelling of the gums, Bowel preparation therapy

How Malven Artesunate 60mg works

Artesunate is metabolized to the active DHA. the endoperoxide bridge of DHA reacts with heme, generating free radicals which inhibit protein and nucleic acid synthesis of the Plasmodium parasites during all erythrocytic stages. Reactions with these free radicals can also lead to alkylation of parasitic proteins such as a calcium adenosine triphosphatase and EXP1, a glutathione S-transferase.

Sodium bicarbonate is a systemic alkalizer, which increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It is also a urinary alkalizer, increasing the excretion of free bicarbonate ions in the urine, thus effectively raising the urinary pH. By maintaining an alkaline urine, the actual dissolution of uric acid stones may be accomplished. Sodium bicarbonate acts as an antacid and reacts chemically to neutralize or buffer existing quantities of stomach acid but has no direct effect on its output. This action results in increased pH value of stomach contents, thus providing relief of hyperacidity symptoms. [PharmGKB]

Dosage

Malven Artesunate 60mg dosage

Adult: 5 days treatment: on the 1st day 2 tablets twice and 2nd day onward 1 tablet twice daily for remaining 4 days

Children:

• 1-3 years: 5 days treatment: on the 1st day ½ tablet twice and 2nd day onward ¼ tablet twice daily for remaining 4 days
• 4-5 years: 5 days treatment: on the 1st day 1 tablet twice and 2nd day onward ½ tablet twice daily for remaining 4 days
• 6-12 years: 5 days treatment: on the 1st day ½ tablet twice, 2nd day 1 tablet twice and 3rd day onward ½ tablet twice daily for remaining 3 days

Prophylmcis: 100 mg tablet once a week, from 1 week before entering malarial areas, to 4 weeks after leaving the area.

Oral: The usual dose is 300 mg to 2 grams, 1 to 4 times daily.

Intravenous (Severe metabolic acidosis):

• Adult: By slow inj of a hypertonic solution of up to 8.4% (1000 mmol/L), or by continuous infusion of a weaker solution, usually 1.26% (150 mmol/L). For correction of acidosis during advanced cardiac life support procedures, 50 ml of an 8.4% solution may be given.
• Elderly: Dosage adjustments may be required.

Side Effects

Transient and reversible reticulocytopaenia, drug fever, rash, bradycardia, transient 1st-degree heart block and reversible elevation of serum transaminases.

This medication is generally well tolerated. However, high doses may cause headache, nausea or irritability. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: muscle weakness, slow reflexes, confusion, swelling of the feet or ankles, black tar-like stools, coffee-ground vomit. If you notice other effects not listed above, contact your doctor or pharmacist.

Toxicity

Data regarding overdoses of artesunate are rare. Patients experiencing an overdose may present with pancytopenia, melena, seizures, multiorgan failure, and death. Treat overdose with symptomatic and supportive measures.

Precaution

Hepatic or renal insufficiency; Pregnancy and lactation.

Pre-existing heart disease, kidney disease, liver disease, high blood pressure, any allergies.

Interaction

Antimalarial potentiating action seen with mefloquine, primaquine and tetracycline. Additive effect with chloroquine. Antagonistic effect with pyrimethamine and sulphonamides.

This medication has the potential to interact with many medications. Should not take any other medication within 1 to 2 hours of taking an antacid. Potentially hazardous interactions with Corticosteroids and Corticotropin, Alkalis, Calcium, Diuretics and Potassium.

Volume of Distribution

The volume of distribution of artesunate is 68.5L while the volume of distribution of DHA is 59.7L.

Elimination Route

The C_max of artesunate is 3.3µg/mL while the C_max of the active metabolite DHA is 3.1µg/mL. The AUC of artesunate is 0.7µg*h/mL while the AUC of DHA is 3.5µg*h/mL. After intravenous artesunate, DHA has a T_max of 0.5-15 minutes in adult patients and 21-64 minutes in pediatric patients. Intramuscular artesunate has a T_max of 8-12 minutes. Infants less than 6 months old will have a higher AUC due to an undeveloped UGT metabolic pathway.

Half Life

The elimination half life of artesunate is 0.3h with a range of 0.1-1.8h. The elimination half life of DHA is 1.3h with a range of 0.9-2.9h. Half life after intramuscular administration is 48 min in children and 41 min in adults.

Clearance

The clearance of artesunate is 180L/h while the clearance of DHA is 32.3L/h.

Elimination Route

The main route of elimination in humans is unknown. In rats, a dose of artesunate is 56.1% eliminated in the urine and 38.5% in the feces.

Pregnancy & Breastfeeding use

Pregnancy category is not classified. FDA has yet not classified the drug into a specific pregnancy catagory.

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Contraindication

Hypersensitivity.

This drug is contraindicated in hypoventilatory states, chloride depletion owing to continuous gastric fluid loss, metabolic and/or respiratory alkalosis, hypocalcemia and diuretics known to produce hypochloremic alkalosis.

Acute Overdose

If alkalosis results, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indication in severe alkalosis.

Storage Condition

Store in a cool & dry place protected from light. Keep out of reach of children.

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