Atovaquone And Proguanil Hydrochloride Pediatric
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FDA Labeling Changes
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Uses
Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of P. falciparum malaria, including in areas where chloroquine resistance has been reported (see CLINICAL STUDIES).
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.
History
There is currently no drug history available for this drug.
Other Information
Atovaquone and Proguanil Hydrochloride Pediatric Tablets are a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula:
The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C11H16ClN5•HCl. The compound has the following structural formula:
Atovaquone and Proguanil Hydrochloride Pediatric Tablets are for oral administration. Each Atovaquone and Proguanil Hydrochloride Pediatric Tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride. The inactive ingredients are low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide, and titanium dioxide.
Sources
Atovaquone And Proguanil Hydrochloride Pediatric Manufacturers
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Glenmark Generics Inc
![Atovaquone And Proguanil Hydrochloride Pediatric (Atovaquone And Proguanil Hydrochloride) Tablet, Film Coated [Glenmark Generics Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Atovaquone And Proguanil Hydrochloride Pediatric | Glenmark Generics Inc
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 MalariaProphylactic treatment with atovaquone and proguanil hydrochloride 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.
Pediatric PatientsThe dosage for prevention of malaria in pediatric patients is based upon body weight (Table 5).
Table 5. Dosage for Prevention of Malaria in Pediatric PatientsWeight
(kg)
Atovaquone/
Proguanil HCl
Total Daily Dose
Dosage Regimen
11-20
62.5 mg/25 mg
1 Atovaquone and Proguanil Hydrochloride Pediatric Tablet daily
21-30
125 mg/50 mg
2 Atovaquone and Proguanil Hydrochloride Pediatric Tablets as a single dose daily
31-40
187.5 mg/75 mg
3 Atovaquone and Proguanil Hydrochloride Pediatric Tablets as a single dose daily
>40
250 mg/100 mg
1 Atovaquone and Proguanil Hydrochloride Tablet (adult strength) as a single dose daily
See prescribing information for Atovaquone and Proguanil Hydrochloride Tablets (adult strength).
Treatment of Acute Malaria Pediatric PatientsThe 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 PatientsWeight
(kg)
Atovaquone/
Proguanil HCl
Total Daily Dose
Dosage Regimen
5-8
125 mg/50 mg
2 Atovaquone and Proguanil Hydrochloride Pediatric Tablets daily for 3 consecutive days
9-10
187.5 mg/75 mg
3 Atovaquone and Proguanil Hydrochloride Pediatric Tablets daily for 3 consecutive days
11-20
250 mg/100 mg
1 Atovaquone and Proguanil Hydrochloride Tablet (adult strength) daily for 3 consecutive days
21-30
500 mg/200 mg
2 Atovaquone and Proguanil Hydrochloride Tablets (adult strength) as a single dose daily for 3 consecutive days
31-40
750 mg/300 mg
3 Atovaquone and Proguanil Hydrochloride Tablets (adult strength) as a single dose daily for 3 consecutive days
>40
1 g/400 mg
4 Atovaquone and Proguanil Hydrochloride Tablets (adult strength) as a single dose daily for 3 consecutive days
See prescribing information for Atovaquone and Proguanil Hydrochloride Tablets (adult strength).
Atovaquone and proguanil hydrochloride tablets may be crushed and mixed with condensed milk just prior to administration for children who may have difficulty swallowing tablets.
Patients With Renal ImpairmentAtovaquone and proguanil hydrochloride tablets should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Atovaquone and proguanil hydrochloride tablets 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 ImpairmentNo 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).
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