A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Malarone Indications, Dosage, Storage, Stability - Atovaquone and Proguanil Hcl
Malarone Indications, Dosage, Storage, Stability - Atovaquone and Proguanil Hcl
INDICATIONS AND USAGE
Prevention of Malaria
MALARONE is indicated for the prophylaxis of P. falciparum malaria, including in areas where chloroquine resistance has been reported (see CLINICAL STUDIES).
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.
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.
Prevention of Malaria
Prophylactic treatment with MALARONE should be started 1 or 2 days before entering a malaria-endemic area and continued 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 5).
|
Table 5. 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 dose daily |
31-40 |
187.5 mg/75 mg |
3 MALARONE Pediatric Tablets as a single dose daily |
>40 |
250 mg/100 mg |
1 MALARONE Tablet (adult strength) as a single dose daily |
Treatment of Acute Malaria
Adults: Four MALARONE Tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single dose daily for 3 consecutive days.
Pediatric Patients: The dosage for treatment of acute malaria in pediatric patients is based upon body weight (Table 6).
|
Table 6. 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 dose daily for 3 consecutive days |
31-40 |
750 mg/300 mg |
3 MALARONE Tablets (adult strength) as a single dose daily for 3 consecutive days |
>40 |
1 g/400 mg |
4 MALARONE Tablets (adult strength) as a single dose daily for 3 consecutive days |
MALARONE Tablets may be crushed and mixed with condensed milk just prior to administration for children who may have difficulty swallowing tablets.
Patients With Renal Impairment
MALARONE should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). MALARONE may be used with caution for the treatment of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min), only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment). No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 50 mL/min) renal impairment (see CLINICAL PHARMACOLOGY: Special Populations).
Patients With Hepatic Impairment
No dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations: Hepatic Impairment).
HOW SUPPLIED
MALARONE Tablets, containing 250 mg atovaquone and 100 mg proguanil hydrochloride, are pink, film-coated, round, biconvex tablets engraved with "GX CM3" on one side.
Bottle of 100 tablets with child-resistant closure (NDC 0173-0675-01).
Unit Dose Pack of 24 (NDC 0173-0675-02).
MALARONE Pediatric Tablets, containing 62.5 mg atovaquone and 25 mg proguanil hydrochloride, are pink, film-coated, round, biconvex tablets engraved with "GX CG7" on one side.
Bottle of 100 tablets with child-resistant closure (NDC 0173-0676-01).
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
ANIMAL TOXICOLOGY
Fibrovascular proliferation in the right atrium, pyelonephritis, bone marrow hypocellularity, lymphoid atrophy, and gastritis/enteritis were observed in dogs treated with proguanil hydrochloride for 6 months at a dose of 12 mg/kg/day (approximately 3.9 times the recommended daily human dose for malaria prophylaxis on a mg/m2 basis). Bile duct hyperplasia, gall bladder mucosal atrophy, and interstitial pneumonia were observed in dogs treated with proguanil hydrochloride for 6 months at a dose of 4 mg/kg/day (approximately 1.3 times the recommended daily human dose for malaria prophylaxis on a mg/m2 basis). Mucosal hyperplasia of the cecum and renal tubular basophilia were observed in rats treated with proguanil hydrochloride for 6 months at a dose of 20 mg/kg/day (approximately 1.6 times the recommended daily human dose for malaria prophylaxis on a mg/m2 basis). Adverse heart, lung, liver, and gall bladder effects observed in dogs and kidney effects observed in rats were not shown to be reversible.
GlaxoSmithKline, Research Triangle Park, NC 27709, ©2004, GlaxoSmithKline. All rights reserved. November 2004, RL-2133
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