Atovaquone and Proguanil Hydrochloride

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE- atovaquone and proguanil hydrochloride tablet, film coated
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC- atovaquone and proguanil hydrochloride tablet, film coated
Glenmark Pharmaceuticals Inc.,USA

1 INDICATIONS AND USAGE

1.1 Prevention of Malaria

Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.

1.2 Treatment of Malaria

Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.

2 DOSAGE AND ADMINISTRATION

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.

Atovaquone and proguanil hydrochloride tablets may be crushed and mixed with condensed milk just prior to administration to patients who may have difficulty swallowing tablets.

2.1 Prevention of Malaria

Start prophylactic treatment with atovaquone and proguanil hydrochloride tablets 1 or 2 days before entering a malaria-endemic area and continue daily during the stay and for 7 days after return.

Adults

One atovaquone and proguanil hydrochloride tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.

Pediatric Patients

The dosage for prevention of malaria in pediatric patients is based upon body weight (Table 1).

Table 1. Dosage for Prevention of Malaria in Pediatric Patients

Weight (kg)

Atovaquone/ Proguanil HCl Total Daily Dose

Dosage Regimen

11 to 20

62.5 mg/25 mg

1 Atovaquone and proguanil hydrochloride pediatric tablet daily

21 to 30

125 mg/50 mg

2 Atovaquone and proguanil hydrochloride pediatric tablets as a single daily dose

31 to 40

187.5 mg/75 mg

3 Atovaquone and proguanil hydrochloride pediatric tablets as a single daily dose

> 40

250 mg/100 mg

1 Atovaquone and proguanil hydrochloride tablet (adult strength) as a single daily dose

2.2 Treatment of Acute Malaria

Adults

Four atovaquone and proguanil hydrochloride tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive days.

Pediatric Patients

The dosage for treatment of acute malaria in pediatric patients is based upon body weight (Table 2).

Table 2. Dosage for Treatment of Acute Malaria in Pediatric Patients

Weight (kg)

Atovaquone/ Proguanil HCl Total Daily Dose

Dosage Regimen

5 to 8

125 mg/50 mg

2 Atovaquone and proguanil hydrochloride pediatric tablets daily for 3 consecutive days

9 to 10

187.5 mg/75 mg

3 Atovaquone and proguanil hydrochloride pediatric tablets daily for 3 consecutive days

11 to 20

250 mg/100 mg

1 Atovaquone and proguanil hydrochloride tablet (adult strength) daily for 3 consecutive days

21 to 30

500 mg/200 mg

2 Atovaquone and proguanil hydrochloride tablets (adult strength) as a single daily dose for 3 consecutive days

31 to 40

750 mg/300 mg

3 Atovaquone and proguanil hydrochloride tablets (adult strength) as a single daily dose for 3 consecutive days

>40

1 g/400 mg

4 Atovaquone and proguanil hydrochloride tablets (adult strength) as a single daily dose for 3 consecutive days

2.3 Renal Impairment

Do not use atovaquone and proguanil hydrochloride tablets for malaria prophylaxis in patients with severe renal impairment (creatinine clearance < 30 mL/min) [see Contraindications (4)]. Use with caution for the treatment of malaria in patients with severe renal impairment, only if the benefits of the 3 day treatment regimen outweigh the potential risks associated with increased drug exposure. No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) or moderate (creatinine clearance 30 to 50 mL/min) renal impairment. [See Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Each atovaquone and proguanil hydrochloride tablet (adult strength) contains 250 mg atovaquone USP and 100 mg proguanil hydrochloride USP. Atovaquone and proguanil hydrochloride tablets are pinkish brown to brown colored, circular, biconvex beveled edge, film-coated tablets with ‘404’ debossed on one side and ‘G’ debossed on the other side.

Atovaquone and proguanil hydrochloride pediatric tablets contain 62.5 mg atovaquone USP and 25 mg proguanil hydrochloride USP. Atovaquone and proguanil hydrochloride pediatric tablets are pinkish brown to brown colored, circular, biconvex beveled edged, film coated tablets with ‘70’ debossed on one side and ‘G’ debossed on the other side.

4 CONTRAINDICATIONS

Atovaquone and proguanil hydrochloride is contraindicated in individuals with known hypersensitivity reactions (e.g., anaphylaxis, erythema multiforme or Stevens-Johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation.
Atovaquone and proguanil hydrochloride is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance < 30 mL/min) because of pancytopenia in patients with severe renal impairment treated with proguanil [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

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