Quinine Dihydrochloride Injection 500mg/2ml I.M./I.V. COMPOSITION: It is a sterile solution of Quinine Dihydrochloride in water for injection. Each ampoule contains Quinine Dihydrochloride 600mg or Each ampoule contains Quinine Dihydrochloride 500mg, or each ampoule contains Quinine Dihydrochloride 300mg, or each ampoule contains Quinine Dihydrochloride 250mg, 400mg, 200mg. USES AND ADMINISTRATION: Quinine is a rapidly acting blood schizonticide with activity against plasmodium falciparum. It is active against the gametocytes of P. malaria and P.Vivax, but not against P. falciparum gametocytes. Since it has no activity against exoerythrocytic forms. quinine does not produce a radical cure in vivax or oval malaria. Injection is used by infusion or intramuscular for severe or complicated malaria. It was considered that intramuscular injection of Quinine could be useful in the absence of the equipment or skills necessary for intravenous infusion. Some clinicians recommend the use of a loading dose of 20 mg quinine dihydrochloride (16.7mg an-hydrous base) per kg given by intravenous infusion every 4 hours provided that the patient has not recently taken quinine and reliable hospital facilities are available. If intravenous infusion is not possible. Quinine Dihydrochloride may be given by intramuscular injection of 10mg per kg (8.3mg base), although this may cause pain and local irritation at the site of injection. Intravenous injection of quinine is no longer recommended because of the severe adverse cardiovascular effects. For children, a dose of quinine 25 to 30mg per Kg body weight daily in three divided doses has been recommended. ADVERSE EFFECTS AND PRÉCAUTIONS: The long-term administration of quinine in normal therapeutic doses may give rise to a train of symptoms known as cinchonism, characterized by tinnitus, headache, nausea, and disturbed vision in its mild form, with, in addition, vomiting, abdominal pain, diarrhea, vertigo, fever, pruritus, and rashes in its more severe manifestations. Some patients are hypersensitive to quinine and even small doses may give rise to cinchonism together with other hypersensitivity reactions including angioedema and asthma. Thrombocytopenia, hypoprothrombinemia, and hemolysis may occur and agranulocytosis has been reported. Renal impairment may be due to an immune mechanism or to circulatory failure. The symptoms of overdosage include gastro - intestinal, central nervous system, and cardiovascular disturbances. Visual disturbances are normally reversible but may be permanent, and may rarely include sudden blindness. Quinine can cause disturbances in cardiac conduction similar to those produced by quinidine, and reduction of blood pressure with syncope and circulatory failure. Severe hypotension can also follow rapid injection of quinine. Severe poisoning can produce convulsions, coma, respiratory depression and death. The average fatal dose in adults has been reported to be about 8g. Death may result in a few hours or may be delayed for 1 or 2 days. Large doses of quinine can induce abortion, and congenital malformations. Particularly of the optic and auditory nerves, have been reported after failure to induce abortion with quinine. However, quinine should not be withheld from pregnant women with life-threatening malaria if other less hazardous agents are unavailable or inappropriate. Quinine is contra - indicated in patients with a history of hypersensitivity to quinine, in the presence of hemolysis, and in patients with tinnitus or optic neuritis. It should be used with caution in patients with atrial fibrillation or other serious heart disease. Quinine may cause hypoprothrombinemia and enhance the effects of anticoagulants. Quinine may aggravate the symptoms of myasthenia gravis and should be used with care if at all in such patients. CONTRAINDICATION: Pregnancy in a patient with malaria is not generally to the use of quinine. PRESENTATION: Ampoule of 2ml - Box of 10 ampoules or 100 ampoules. STORAGE: Store in a dark place with well - closed containers. KEEP OUT OF REACH OF CHILDREN.
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