MALARONE

MALARONE- atovaquone and proguanil hydrochloride tablet, film coated
PD-Rx Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

1.1 Prevention of Malaria

MALARONE is indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.

1.2 Treatment of Malaria

MALARONE is indicated for the treatment of acute, uncomplicated P. falciparum malaria. MALARONE has 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.

MALARONE 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 MALARONE 1 or 2 days before entering a malaria-endemic area and continue daily during the stay and for 7 days after return.

Adults

One MALARONE 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

11-20

62.5 mg/25 mg

1 MALARONE pediatric tablet daily

21-30

125 mg/50 mg

2 MALARONE pediatric tablets as a single daily dose

31-40

187.5 mg/75 mg

3 MALARONE pediatric tablets as a single daily dose

>40

250 mg/100 mg

1 MALARONE tablet (adult strength) as a single daily dose

2.2 Treatment of Acute Malaria

Adults

Four MALARONE 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

5-8

125 mg/50 mg

2 MALARONE pediatric tablets daily for 3 consecutive days

9-10

187.5 mg/75 mg

3 MALARONE pediatric tablets daily for 3 consecutive days

11-20

250 mg/100 mg

1 MALARONE tablet (adult strength) daily for 3 consecutive days

21-30

500 mg/200 mg

2 MALARONE tablets (adult strength) as a single daily dose for 3 consecutive days

31-40

750 mg/300 mg

3 MALARONE tablets (adult strength) as a single daily dose for 3 consecutive days

>40

1 g/400 mg

4 MALARONE tablets (adult strength) as a single daily dose for 3 consecutive days

2.3 Renal Impairment

Do not use MALARONE for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min) [see Contraindications ( 4.2)] . 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 MALARONE tablet (adult strength) contains 250 mg atovaquone and 100 mg proguanil hydrochloride. MALARONE tablets are pink, film-coated, round, biconvex tablets engraved with “GX CM3” on one side.

Each MALARONE pediatric tablet contains 62.5 mg atovaquone and 25 mg proguanil hydrochloride. MALARONE pediatric tablets are pink, film-coated, round, biconvex tablets engraved with “GX CG7” on one side.

4 CONTRAINDICATIONS

  • MALARONE 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.
  • MALARONE 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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