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quinine sulfate

Tablets 300 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Singapore
GMP approvals
PICS
Manufacturer #20928
It is celebrating over 50 years of continued success. It is one of the largest manufacturers of generic pharmaceuticals and provides a comprehensive suite of fully integrated "one-stop" contract manufacturing solutions. It owns and operates in more than one PIC/S GMP-certified manufacturing facility.

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QUININE SULFATE     

   Quinine Sulfate, known as antimalarial, is a medication used alone or with others in the treatment of malaria caused by mosquito bites in countries where malaria is common. Mosquito parasites can enter the body through bites, and live in body tissues like red blood cells or the liver. Quinine Sulfate is effective in killing the malaria parasites living inside red blood cells. It is not prescribed in the prevention of malaria. Quinine Sulfate is a prescription- only drug meant for uncomplicated plasmodium falciparum malaria. However, the medicine’s real efficacy lies in its success around the world. It has widely used to bring malaria outbreaks under control in underdeveloped regions of the world like Africa.

BOXED WARNING WARNING: HEMATOLOGIC REACTIONS

The use of Quinine Sulfate Capsules for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. The risk associated with Quinine Sulfate Capsules use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential. In the early 19th century, Quinine was first isolated from the bark of a cinchona tree and learnt that it had been used to treat malaria since the 17th century. Jesuit missionaries introduced it to Spain in 1636. Due to its stellar record around the world, especially in the African and Asian regions, It has earned a place on the World Health Organization's List of Essential Medicines. Quinine Sulfate is sold under the brand names like Qualaquin, QM-260 among others.

Usage and Dosage:

This medication should be taken by mouth preferably with food else there is a chance of developing an upset stomach. This medicine should strictly be taken exactly as prescribed by the doctor. It is usually taken every 8 hours for 3 to 7 days or as directed by the doctor. The dose for treating uncomplicated P. falciparum malaria in adults is 648 mg, two capsules, taken every 8 hours for one week. The patients are also advised to take antacids before or after taking this medicine. Also, note that any food with that binds with quinine will prevent it from getting fully absorbed in the body.

The price of Quinine Sulfate:

In the USA, the consumers have to pay an average cost of $217.99 for 30 Capsules of 324mg each of the generic quinine sulfate. However, this medicine is significantly cheaper in Asia and Africa. In India, the supply of 30 tablets costs USD2.

How does it work?

Quinine is toxic to the malarial pathogen, Plasmodium falciparum. It works by interfering with the ability of the parasite to dissolve and metabolize haemoglobin. Like other quinoline antimalarials, the precise mechanism of action has not been fully resolved. However, in vitro studies show that it prevents nucleic acid and protein synthesis and inhibits glycolysis in P. falciparum. 

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