Finished product reference
Quinine Dihydrochloride
Injection · Parenteral · 300 mg/1mL · 2 mL
- List code
- 53325
WARNING: HEMATOLOGIC REACTIONS Quinine sulfate capsules use 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.
Indications
Quinine sulfate capsule USP is a cinchona alkaloid indicated for treatment of uncomplicated Plasmodium falciparum malaria . Quinine sulfate capsule USP is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented . Quinine sulfate capsules USP are not approved for: Treatment of severe or complicated P. falciparum malaria. Prevention of malaria. Treatment or prevention of nocturnal leg cramps .
Dosage and administration (summary)
Adults (≥ 16 years of age): 648 mg (two capsules) every 8 hours for 7 days . Patients with severe chronic renal impairment: one loading dose of 648 mg (two capsules) followed 12 hours later by 324 mg (one capsule) every 12 hours for 7 days . Treatment of Uncomplicated P. falciparum Malaria For treatment of uncomplicated P. falciparum malaria in adults: Orally, 648 mg (two capsules) every 8 hours for 7 days . Quinine sulfate capsules USP should be taken with food to minimize gastric upset .
Contraindications
Quinine sulfate is contraindicated in patients with the following: Prolongation of QT interval Glucose-6-phosphate dehydrogenase (G6PD) deficiency Myasthenia gravis Known hypersensitivity to quinine, mefloquine, or quinidine Optic neuritis Quinine sulfate is contraindicated in patients with the following: • Prolonged QT interval.
Warnings and precautions
Not indicated for the prevention or treatment of nocturnal leg cramps. Risk of serious and life-threatening adverse reactions ( 1 , 5.1 ). Thrombocytopenia, including ITP and HUS/TTP, has been reported. Discontinue drug . QT prolongation and ventricular arrhythmias. Avoid concomitant use with drugs known to prolong QT interval . Avoid concomitant use with rifampin. Quinine sulfate treatment failures have been reported . Avoid concomitant use with neuromuscular blocking agents. Quinine sulfate may potentiate neuromuscular blockade and cause respiratory depression .
Storage and supply
How Supplied Quinine sulfate capsules USP, 324 mg are available as size "0" capsules with clear transparent cap and clear transparent body imprinted with "LU" on cap and "Y51" on body in black ink, containing white to off white powder: Bottles of 30 NDC 68180-560-06 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Source: Quinine Sulfate (Quinine Sulfate) — US FDA prescribing information, 2025-10-31, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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