Quindec Injection

Quinine sulfate 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) ] . Limitations of Use: Quinine sulfate capsules 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) ] . Quinine sulfate is an antimalarial indicated for treatment of uncomplicated Plasmodium falciparum malaria. …

• 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
• Adults: Orally, 648 mg (two capsules) every 8 hours for 7 days [see Clinical Studies ]
• Quinine sulfate capsules 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 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 and 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 and Clinical Pharmacology ]

Quinine Sulfate Capsules USP, 324 mg are supplied as clear transparent size ‘0’ hard gelatin capsule filled with white to off-white powder and imprinting ‘AMNEAL’ on the cap and ‘811’ on the body. Capsules: 324 mg. (3)

• Advise the patient to read the FDA-approved patient labeling (Medication Guide) Important Administration Instructions Instruct patients 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
• Missed Doses Advise patients that if a dose is missed, patients should not 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
• Manufactured by: Amneal Pharmaceuticals Pvt
• Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2024-04

• Quinine sulfate capsules are contraindicated in patients with the following: Prolonged QT interval
• One case of a fatal ventricular arrhythmia was reported in an
• Elderly patient with a prolonged QT interval at baseline, who received quinine sulfate intravenously for P. falciparum malaria [see Warnings and Precautions ]
• Known hypersensitivity reactions to quinine. …

Table 1 below presents clinically significant drug interactions with quinine sulfate. Table 1: Clinically Significant Drug Interactions with Quinine Sulfate Drug(s) Clinical Impact Recommendation Effects of Drugs and Other Substances on Quinine Pharmacokinetics Antacids Antacids containing aluminum and/or magnesium may delay or decrease absorption of quinine. Concomitant administration of these antacids with quinine sulfate should be avoided. Antiepileptics (AEDs) (carbamazepine, phenobarbital, and phenytoin) Carbamazepine, phenobarbital, and phenytoin are CYP3A4 inducers and may decrease quinine plasma concentrations if used concurrently with quinine sulfate. …

Thrombocytopenia, including ITP and HUS/TTP, has been reported. Discontinue drug. (5.2) Hemolytic Anemia: Monitor hemoglobin and hematocrit. Discontinue drug if hemolytic anemia occurs. (5.3) QT Prolongation and Ventricular Arrhythmias: Avoid concomitant use with drugs known to prolong QT interval. (5.4) Avoid concomitant use with rifampin. Quinine sulfate treatment failures have been reported. (5.5) Avoid concomitant use with neuromuscular blocking agents. Quinine sulfate may potentiate neuromuscular blockade and cause respiratory depression. (5.6) Serious and Life-Threatening Hypersensitivity Reactions: Discontinue drug. …

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 Amneal Pharmaceuticals at 1-877-835-5472 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 reactions. Quinine should not be administered in patients with severe (Child-Pugh C) hepatic impairment. …

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.