Malacide Tablets_

Quinine sulfate capsule USP is a cinchona alkaloid indicated for treatment of uncomplicated Plasmodium falciparum malaria ( 1 ). 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 [see CLINICAL STUDIES ( 14 )] . 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 [see WARNINGS AND PRECAUTIONS ( 5.1 )] .

• 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 [see CLINICAL STUDIES ]
• Quinine sulfate capsules USP should be taken with food to minimize gastric upset [see CLINICAL PHARMACOLOGY ]
• Renal Impairment In patients with acute uncomplicated malaria and severe chronic renal impairment, the following dosage regimen is recommended: one loading dose of 648 mg quinine sulfate capsules USP followed 12 hours later by maintenance doses of 324 mg every 12 hours
• The effects of mild and moderate renal impairment on the safety and pharmacokinetics of quinine sulfate are not known [see USE IN SPECIFIC POPULATIONS , CLINICAL PHARMACOLOGY ]
• Hepatic Impairment Adjustment of the recommended dose is not required in mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, but patients should be monitored closely for adverse effects of quinine
• Quinine should not be administered in patients with severe (Child-Pugh C) hepatic impairment [see USE IN SPECIFIC POPULATIONS , CLINICAL PHARMACOLOGY ]

324 mg 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 ( 3 ). 324 mg 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.

• See FDA-approved patient labelling (Medication Guide) Dosing Instructions Patients should be instructed to: Take all of the medication as directed
• Take no more of the medication than the amount prescribed
• Take with food to minimize possible gastrointestinal irritation
• If a dose is missed, patients should also be instructed not to double the next dose
• If more than 4 hours has elapsed since the missed dose, the patient should wait and take the next dose as previously scheduled
• LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc
• Manufactured for: Lupin Pharmaceuticals, Inc
• Naples, FL 34108 United States
• Manufactured by: Lupin Limited Goa 403 722 INDIA. …

Quinine sulfate is contraindicated in patients with the following: Prolongation of QT interval ( 4 ) Glucose-6-phosphate dehydrogenase (G6PD) deficiency ( 4 ) Myasthenia gravis ( 4 ) Known hypersensitivity to quinine, mefloquine, or quinidine ( 4 ) Optic neuritis ( 4 ) Quinine sulfate is contraindicated in patients with the following: • Prolonged QT interval. …

Interacting Drug Interaction Drugs known to prolong QT interval (e.g., Class IA and Class III antiarrhythmic agents). Quinine sulfate prolongs QT interval, ECG abnormalities including QT prolongation and Torsades de Pointes. Avoid concomitant use ( 5.3 ). Other antimalarials (e.g., halofantrine, mefloquine). ECG abnormalities including QT prolongation Avoid concomitant use ( 5.3 , 7.2 ). CYP3A4 inducers or inhibitors Alteration in plasma quinine concentration. Monitor for lack of efficacy or increased adverse events of quinine ( 7.1 ). CYP3A4 and CYP2D6 substrates Quinine is an inhibitor of CYP3A4 and CYP2D6. …

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 ( 5.2 ). QT prolongation and ventricular arrhythmias. Avoid concomitant use with drugs known to prolong QT interval ( 5.3 ). Avoid concomitant use with rifampin. Quinine sulfate treatment failures have been reported ( 5.4 ). Avoid concomitant use with neuromuscular blocking agents. Quinine sulfate may potentiate neuromuscular blockade and cause respiratory depression ( 5.5 ). Serious and life threatening hypersensitivity reactions. Discontinue drug ( 4 , 5.6 ). …

Most common adverse reactions are a cluster of symptoms called "cinchonism", which occurs to some degree in almost all patients taking quinine: headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, disturbance in color perception, vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or www.lupinpharmaceuticals.com. or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Overall Quinine can adversely affect almost every body system. …

IN SPECIFIC POPULATIONS Renal impairment: Reduce dose and dosing frequency for patients with severe chronic renal impairment ( 2.2 , 8.6 , 12.3 ). Hepatic impairment: Closely monitor for adverse events. Quinine should not be administered in patients with severe (Child-Pugh C) hepatic impairment ( 2.3 , 8.7 , 12.3 ). Pregnancy: Based on animal data may cause fetal harm. Use only if the potential benefit justifies the risk ( 8.1 ). …

Quinine overdose can be associated with serious complications, including visual impairment, hypoglycemia, cardiac arrhythmias, and death. Visual impairment can range from blurred vision and defective color perception, to visual field constriction and permanent blindness. Cinchonism occurs in virtually all patients with quinine overdose. Symptoms range from headache, nausea, vomiting, abdominal pain, diarrhea, tinnitus, vertigo, hearing impairment, sweating, flushing, and blurred vision, to deafness, blindness, serious cardiac arrhythmias, hypotension, and circulatory collapse. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.