Adult Dosing

Uncomplicated p. falciparum malaria

• >16 yrs: 648 mg PO tid for 7 days

Pediatric Dosing

• Safety and effectiveness in pediatric patients <16 yrs of age have not been established

Malaria [Non FDA-Approved]

• 10 mg/kg PO tid for 7 days

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of uncomplicated Plasmodium falciparum malaria

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to mefloquine
• Hypersensitivity to quinidine
• Quinine-associated blackwater fever
• Quinine-associated thrombocytopenia
• Quinine-associated hemolytic uremic syndrome
• Prolongation of QT interval
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Myasthenia gravis
• Optic neuritis
• Treatment of severe or complicated P. falciparum malaria
• Prevention of malaria
• Treatment or prevention of nocturnal leg cramps

• Serious and fatal hematologic reactions including thrombocytopenia, hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP) have occurred on using the drug for prevention of nocturnal leg cramps
• Chronic renal impairment associated with the development of TTP has occurred
• Risk associated with use for treatment of nocturnal leg cramp in absence of evidence of efficacy does not outweigh any potential benefit

Renal Dose Adjustment

• Mild to moderate renal impairment: Dose adjustments not defined
• Severe chronic renal failure: Loading dose of 648 mg PO then 324 mg PO q12 hrs

Hepatic Dose Adjustment

• Child Pugh A/B: No dose adjustments; monitor for adverse events
• Child Pugh C: Avoid use

• Do not use for the prevention or treatment of nocturnal leg cramps as serious and fatal adverse reactions have occurred, discontinue drug on occurrence of thrombocytopenia, including ITP and HUS/TTP, on reexposure patient with quinine-dependent antibodies could develop thrombocytopenia more rapid in onset and more severe than the original episode
• Serious adverse events may require medical intervention and hospitalization
• Fatal chronic renal impairment associated with the development of TTP have occurred
• Risk associated with use for treatment of nocturnal leg cramp in the absence of any evidence of efficacy does not outweigh any potential benefit
• Avoid concurrent use with drugs known to prolong QT interval as QT prolongation and serious cardiac arrhythmias including torsades de pointes have occurred
• Avoid concurrent use with rifampin as failure of therapy with quinine have occurred
• Avoid concurrent use with neuromuscular blocking agents as quinine may potentiate neuromuscular blockade leading to respiratory depression
• Discontinue drug on occurrence of serious and fatal hypersensitivity reactions
• Paradoxical increase in ventricular rate have occurred, closely monitor digoxin levels on concomitant use with quinine
• Monitor for signs and symptoms of hypoglycemia

Cautions: Use cautiously in:

• Renal impairment
• Atrial fibrillation
• Atrial flutter
• Arrhythmias
• Bradycardia
• Hypokalemia
• Hypoglycemia
• QTc prolongation
• Recurrent or interrupted malaria therapy

Pregnancy Category:C

Breastfeeding: Safety unknown. Since quinine is excreted in low levels in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. However quinine should not be used by mothers with an infant who is G6PD deficient. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT)This drug is compatible with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 01 December 2010). Manufacturer advises caution if administering to nursing woman

• HEMA: 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, lupus anticoagulant, severe/life-threatening thrombocytopenia (TTP), hemolysis/hemolytic anemia (G6PD deficiency), cinchonism
• CNS: Headache, confusion, restlessness, coma, tremors, ataxia, dizziness, vertigo, asthenia
• PSYCHIATRIC: Altered mental status, seizures, disorientation, acute dystonic reaction, aphasia and suicide
• AUTOIMMUNINE: Myasthenia gravis
• DERM: Cutaneous rashes including urticarial, papular, 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, skin reactions, lupus erythematosus, sweating, flushing
• RESP: Asthma, dyspnea, pulmonary edema, bronchospasm
• CV: 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, arrhythmias, torsades de pointes, cardiac arrest, angioedema
• GI: Nausea, vomiting, diarrhea, abdominal pain, gastric irritation and esophagitis
• HEPA: Granulomatous hepatitis, hepatitis, jaundice and abnormal liver function tests
• MUSC: Myalgias, muscle weakness
• GU: Hemoglobinuria, renal failure, renal impairment, acute interstitial nephritis
• EENT: Optic neuritis, blindness, altered color perception hearing impairment, deafness, 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, diplopia
• GI: Chronic hepatitis, vomiting, diarrhea, abdominal pain
• METABOLIC: Hypoglycemia, anorexia
• MISC: Hypersensitivity, photosensitivity, fever, chills

• Antimalarial; precise mechanism of action unknown, inhibits nucleic acid, protein synthesis and glycolysis in Plasmodium falciparum, binds with hemazoin in parasitized erythrocytes
• Bioavailability: 76 to 88%
• Metabolized by liver(80%); CYP450: 3A4 (primary), minimally by 1A2, 2C8, 2C9, 2C19, 2D6, 2E1
• Excreted in urine (20% unchanged)
• Half life: 9.7-12.5 hrs, 18.4 hrs (geriatrics)

US Trade Name(s)

• Qualaquin

US Availability

quinine (generic)

• CAPS: 324 mg

Qualaquin

• CAPS: 324 mg

Canadian Trade Name(s)

• Only generic available

Canadian Availability

quinine (generic)

• CAPS: 200, 300 mg
• TABS: 300 mg

UK Trade Name(s)

• Only generic available

UK Availability

quinine (generic)

• TABS: 200, 300 mg

Australian Trade Name(s)

• Quinbisul
• Quinate
• Quinsul

Australian Availability

Quinbisul, Quinate, Quinsul

• TABS: 300 mg

[Outline]

Antimicrobials

Antimalarials

Quinolones

Infectious Disease

Antimalarials

Quinolones

Pricing data from www.DrugStore.com in U.S.A.

• Qualaquin 324 MG CAPS [Bottle] (AR SCIENTIFIC)
  30 mg = $194.93
  90 mg = $543.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Qualaquin 324 MG Oral Capsule

Ingredient(s): Quinine

Imprint: AR;102

Color(s): White

Shape: Capsule

Size (mm): 22.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
AR Scientific, Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Qualaquin 324 MG Oral Capsule

Ingredient(s): Quinine

Imprint: AR;102

Color(s): White

Shape: Capsule

Size (mm): 22.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
STAT RX USA LLC

DEA Schedule:
Non-Scheduled