TEVA-QUININE 300 MG

What is TEVA-QUININE?

TEVA-QUININE 300 MG contains QUININE SULFATE : 300 MG. It is listed in the Health Canada Drug Product Database under DIN 00021016, held by TEVA CANADA LIMITED, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 26-Nov-2011. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is TEVA-QUININE used for?

TEVA-QUININE (quinine sulfate) is indicated (in combination with a second antimalarial drug) for the treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented. Strains of P. falciparum with decreased susceptibility to quinine can be selected in vivo. P. falciparum malaria that is clinically resistant to quinine has been reported in some areas of South America, Southeast Asia, and Bangladesh.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Recommended Dose and Dosage Adjustment Adults (≥ 16 years of age): Quinine sulfate 600 mg (500 mg quinine base) every 8 hours for 3 to 7 days. Children (< 16 years of age): Quinine sulfate 9 mg/kg (7.5 mg quinine base/kg) to a maximum of 600 mg (500 mg quinine base) every 8 hours for 3 to 7 days. The pharmacist will prepare the children's dosage from the capsules. Patients with severe chronic renal impairment: One loading dose of 600 mg quinine sulfate followed 12 hours later by 300 mg quinine sulfate every 12 hours for 7 days. Missed Dose: If a dose is missed, patients should 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. 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 using antacids, take them 2 hours before or 2 hours after TEVA-QUININE.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at room temperature 15 to 30°C. Keep out of reach and sight of children.

How is it supplied?

200 mg capsules: White powder in clear body / clear cap, hard gelatin capsules with imprint of NOVO and 200 on opposing cap and body portions of the capsules. 300 mg capsules: White powder in clear body / clear cap, hard gelatin capsules with imprint of NOVO and 300 on opposing cap and body portions of the capsules. Available in bottles of 100 and 500 capsules.

Contraindications

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. Hypersensitivity reactions include, but are not limited to the following: Thrombocytopenia, Idiopathic thrombocytopenia purpura (ITP) and Thrombotic thrombocytopenic purpura (TTP), Hemolytic uremic syndrome (HUS), Blackwater fever (acute intravascular hemolysis, hemoglobinuria, and hemoglobinemia). TEVA-QUININE is also 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 sulphate is not approved for: Treatment of severe or complicated P. falciparum malaria, Prevention of malaria, Treatment or prevention of nocturnal leg cramps.

Warnings and precautions

TEVA-QUININE 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. The risk associated with quinine sulfate use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit. TEVA-QUININE may cause unpredictable serious and life-threatening hematologic reactions including thrombocytopenia and hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP) in addition to hypersensitivity reactions, QT prolongation, serious cardiac arrhythmias including torsades de pointes, and other serious adverse events requiring medical intervention and hospitalization. Chronic renal impairment associated with the development of TTP and fatalities have also been reported. The risk associated with the use of TEVA-QUININE in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps outweighs any potential benefit in treating and/or preventing this benign, self-limiting condition. QT interval prolongation has been a consistent finding in studies which evaluated electrocardiographic changes with oral or parenteral quinine administration, regardless of age, clinical status, or severity of disease. The maximum increase in QT interval has been shown to correspond with peak quinine plasma concentration. Quinine sulfate has been rarely associated with potentially fatal cardiac arrhythmias, including torsades de pointes and ventricular fibrillation. TEVA-QUININE is not recommended for use with other drugs known to cause QT prolongation, including Class IA antiarrhythmic agents (e.g. quinidine, procainamide, disopyramide) and Class III antiarrhythmic agents (e.g. amiodarone, sotalol, dofetilide). The use of macrolide antibiotics such as erythromycin should be avoided in patients receiving TEVA-QUININE. Fatal torsades de pointes was reported in an elderly patient who received concomitant quinine, erythromycin, and dopamine. Although a causal relationship between a specific drug and the arrhythmia was not established in this case, erythromycin is a CYP3A4 inhibitor and could potentially increase quinine plasma levels when used concomitantly. Concomitant administration of TEVA-QUININE with the antimalarial drugs, mefloquine or halofantrine, may result in electrocardiographic abnormalities, including QT prolongation and increase the risk for torsades de pointes or other serious ventricular arrhythmias. TEVA-QUININE should also be avoided in patients with known prolongation of QT interval and in patients with clinical conditions known to prolong the QT interval, such as uncorrected hypokalemia, bradycardia, and certain cardiac conditions.

What can be used instead?

Other Canadian products sharing ATC code P01BC01 QUININE. 4 of 19 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies QUININE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. QUININE appears in 4 registered pack listings across 2 markets, published on 2 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.