Atovaquone And Proguanil Hcl Recall
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Atovaquone and Proguanil Hydrochloride Tablets are indicated for the prophylaxis of Plasmodiumfalciparum malaria, including in areas where chloroquine resistance has been reported.
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.
There is currently no drug history available for this drug.
Atovaquone and Proguanil Hydrochloride Tablets (adult strength), for oral administration, contain 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:
Each Atovaquone and Proguanil Hydrochloride Tablet (adult strength) contains 250 mg of atovaquone and 100 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.