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RX ITEM-Qualaquin 324Mg Cap 30 By Caraco Pharma

NDC 49708-0153-07 UPC/GTIN No.3-49708-15307-7 Mfg.Part No.15307BRAND: QUALAQUIN NDC: 49708-0153-07,49708015307 UPC: 3-49708-15307-7,349708153077 Caraco Pharm Labs/BrandedOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Qualaquin 324Mg Cap 30 By Caraco Pharma

$235.74$235.74

item No.:RX332411 NDC No.49708015307 UPC No.:349708153077 NDC No.49708-0153-07 UPC/GTIN No.3-49708-15307-7 MPN 15307 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx332411 Qualaquin 324mg Cap 30 by Caraco Pharma/ Item No.3332411 NDC No.49708015307 UPC No.349708153077 Other Name Qualaquin Therapeut

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QUININE SULFATE- quinine sulfate capsule
Ingenus Pharmaceuticals NJ, LLC

WARNING: HEMATOLOGIC REACTIONS

Quinine Sulfate Capsules 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 Capsules use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE



Quinine Sulfate, 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 oral 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) ].
2 DOSAGE AND ADMINISTRATION

2.1 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 (14) ].

Quinine Sulfate Capsules should be taken with food to minimize gastric upset [see Clinical Pharmacology (12.3) ].

2.2 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 (8.6), Clinical Pharmacology (12.3)].

2.3 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 (8.7), Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

324 mg capsules - size '0" capsules with white opaque body and cap, imprinted "201" with black ink on cap and body.

4 CONTRAINDICATIONS

Quinine Sulfate Capsules USP, 324 mg is 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 (5.3) ].
Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Hemolysis can occur in patients with G6PD deficiency receiving quinine.
Known hypersensitivity reactions to quinine.
These include, but are not limited to, the following [see Warnings and Precautions (5.6) ]:
Thrombocytopenia
Idiopathic thrombocytopenia purpura (ITP) and Thrombotic thrombocytopenic purpura (TTP)
Hemolytic uremic syndrome (HUS)
Blackwater fever (acute intravascular hemolysis, hemoglobinuria, and hemoglobinemia)
Known hypersensitivity to mefloquine or quinidine: cross-sensitivity to quinine has been documented [see Warnings and Precautions (5.6) ].
Myasthenia gravis. Quinine has neuromuscular blocking activity, and may exacerbate muscle weakness.
Optic neuritis. Quinine may exacerbate active optic neuritis [see Adverse Reactions (6) ].

NDC 49708-0153-07 UPC/GTIN No.3-49708-15307-7 Mfg.Part No.15307
RX ITEM-Qualaquin 324Mg Cap 30 By Caraco
NDC 49708-0153-07 UPC/GTIN No.3-49708-15307-7 Mfg.Part No.15307

BRAND: QUALAQUIN NDC: 49708-0153-07,49708015307 UPC: 3-49708-15307-7,349708153077 Caraco Pharm Labs/Branded
Qualaquin 324Mg Cap 30 By Caraco Pharma
BRAND: QUALAQUIN NDC: 49708-0153-07,49708015307 UPC: 3-49708-15307-7,349708153077 Caraco Pharm Labs/Branded

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
QUININE SULFATE ORAL CAPS
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.