QUININE SULFATE
Generic: QUININE SULFATE
Basic Information
Manufacturer
Lupin Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
1f32f05c-a215-40be-b951-e41a7b54a8a0
Indications & Usage
1 INDICATIONS AND USAGE 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 )] .
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 )] .
Adverse Reactions
6 ADVERSE REACTIONS 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.
The most common adverse events associated with quinine use are a cluster of symptoms called "cinchonism", which occurs to some degree in almost all patients taking quinine.
Symptoms of mild cinchonism include headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, and disturbance in color perception.
More severe symptoms of cinchonism are vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction.
Most symptoms of cinchonism are reversible and resolve with discontinuation of quinine.
The following ADVERSE REACTIONS have been reported with quinine sulfate.
Because these reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General Fever, chills, sweating, flushing, asthenia, lupus-like syndrome, and hypersensitivity reactions.
Hematologic Agranulocytosis, hypoprothrombinemia, thrombocytopenia, disseminated intravascular coagulation, hemolytic anemia; hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, petechiae, ecchymosis, hemorrhage, coagulopathy, blackwater fever, leukopenia, neutropenia, pancytopenia, aplastic anemia, and lupus anticoagulant.
Neuropsychiatric Headache, diplopia, confusion, altered mental status, seizures, coma, disorientation, tremors, restlessness, ataxia, acute dystonic reaction, aphasia, and suicide.
Dermatologic Cutaneous rashes, including urticarial, papular, or scarlatinal rashes, pruritus, bullous dermatitis, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption, photosensitivity reactions, allergic contact dermatitis, acral necrosis, and cutaneous vasculitis.
Respiratory Asthma, dyspnea, pulmonary edema.
Cardiovascular Chest pain, vasodilatation, hypotension, postural hypotension, tachycardia, bradycardia, palpitations, syncope, atrioventricular block, atrial fibrillation, irregular rhythm, unifocal premature ventricular contractions, nodal escape beats, U waves, QT prolongation, ventricular fibrillation, ventricular tachycardia, torsades de pointes, and cardiac arrest.
Gastrointestinal Nausea, vomiting, diarrhea, abdominal pain, gastric irritation, and esophagitis.
Hepatobiliary Granulomatous hepatitis, hepatitis, jaundice, and abnormal liver function tests.
Metabolic Hypoglycemia and anorexia.
Musculoskeletal Myalgias and muscle weakness.
Renal Hemoglobinuria, renal failure, renal impairment, and acute interstitial nephritis.
Special Senses Visual disturbances, including blurred vision with scotomata, sudden loss of vision, photophobia, diplopia, night blindness, diminished visual fields, fixed pupillary dilatation, disturbed color vision, optic neuritis, blindness, vertigo, tinnitus, hearing impairment, and deafness.
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.
The most common adverse events associated with quinine use are a cluster of symptoms called "cinchonism", which occurs to some degree in almost all patients taking quinine.
Symptoms of mild cinchonism include headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, and disturbance in color perception.
More severe symptoms of cinchonism are vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction.
Most symptoms of cinchonism are reversible and resolve with discontinuation of quinine.
The following ADVERSE REACTIONS have been reported with quinine sulfate.
Because these reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General Fever, chills, sweating, flushing, asthenia, lupus-like syndrome, and hypersensitivity reactions.
Hematologic Agranulocytosis, hypoprothrombinemia, thrombocytopenia, disseminated intravascular coagulation, hemolytic anemia; hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, petechiae, ecchymosis, hemorrhage, coagulopathy, blackwater fever, leukopenia, neutropenia, pancytopenia, aplastic anemia, and lupus anticoagulant.
Neuropsychiatric Headache, diplopia, confusion, altered mental status, seizures, coma, disorientation, tremors, restlessness, ataxia, acute dystonic reaction, aphasia, and suicide.
Dermatologic Cutaneous rashes, including urticarial, papular, or scarlatinal rashes, pruritus, bullous dermatitis, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption, photosensitivity reactions, allergic contact dermatitis, acral necrosis, and cutaneous vasculitis.
Respiratory Asthma, dyspnea, pulmonary edema.
Cardiovascular Chest pain, vasodilatation, hypotension, postural hypotension, tachycardia, bradycardia, palpitations, syncope, atrioventricular block, atrial fibrillation, irregular rhythm, unifocal premature ventricular contractions, nodal escape beats, U waves, QT prolongation, ventricular fibrillation, ventricular tachycardia, torsades de pointes, and cardiac arrest.
Gastrointestinal Nausea, vomiting, diarrhea, abdominal pain, gastric irritation, and esophagitis.
Hepatobiliary Granulomatous hepatitis, hepatitis, jaundice, and abnormal liver function tests.
Metabolic Hypoglycemia and anorexia.
Musculoskeletal Myalgias and muscle weakness.
Renal Hemoglobinuria, renal failure, renal impairment, and acute interstitial nephritis.
Special Senses Visual disturbances, including blurred vision with scotomata, sudden loss of vision, photophobia, diplopia, night blindness, diminished visual fields, fixed pupillary dilatation, disturbed color vision, optic neuritis, blindness, vertigo, tinnitus, hearing impairment, and deafness.