Atovaquone and Proguanil Hydrochloride

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Overview

What is Atovaquone and Proguanil Hydrochloride?

Atovaquone and proguanil hydrochloride tablets (adult strength) and Atovaquone and proguanil hydrochloride Pediatric Tablets, for oral administration, are a fixed-dose combination of the antimalarial agents atovaquone USP and proguanil hydrochloride USP.

The chemical name of atovaquone USP is -2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone USP is a yellow crystalline solid that is freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran; soluble in chloroform; sparingly soluble in acetone and dimethyl sulfoxide; slightly soluble in octanol, ethyl acetate, polyethylene glycol 200; very slightly soluble in 0.1N sodium hydroxide; insoluble in water. It has a molecular weight of 366.84 and the molecular formula CHClO. The compound has the following structural formula:

The chemical name of proguanil hydrochloride USP is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride USP is a white crystalline powder slightly soluble in water, sparingly soluble in alcohol, practically insoluble in methylene chloride. It has a molecular weight of 290.22 and the molecular formula CHClN•HCl. The compound has the following structural formula:

Each atovaquone and proguanil hydrochloride tablet contains 250 mg of atovaquone USP and 100 mg of proguanil hydrochloride USP and each atovaquone and proguanil hydrochloride Pediatric Tablet contains 62.5 mg of atovaquone USP and 25 mg of proguanil hydrochloride USP. The inactive ingredients in the tablet are colloidal silicon dioxide, ferric oxide red, hypromellose 2910, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol 400, polyethylene glycol 8000, povidone K30, sodium starch glycolate and titanium dioxide.

What does Atovaquone and Proguanil Hydrochloride look like?

What are the available doses of Atovaquone and Proguanil Hydrochloride?

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, containing 62.5 mg atovaquone USP and 25 mg proguanil hydrochloride USP, 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.

What should I talk to my health care provider before I take Atovaquone and Proguanil Hydrochloride?

How should I use Atovaquone and Proguanil Hydrochloride?

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

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

What interacts with Atovaquone and Proguanil Hydrochloride?

Sorry No Records found

What are the warnings of Atovaquone and Proguanil Hydrochloride?

Sorry No Records found

What are the precautions of Atovaquone and Proguanil Hydrochloride?

Sorry No Records found

What are the side effects of Atovaquone and Proguanil Hydrochloride?

Sorry No records found

What should I look out for while using Atovaquone and Proguanil Hydrochloride?

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4.1

P. falciparum

What might happen if I take too much Atovaquone and Proguanil Hydrochloride?

There is no information on overdoses of atovaquone and proguanil hydrochloridesubstantially higher than the doses recommended for treatment.

There is no known antidote for atovaquone, and it is currently unknown if atovaquone is dialyzable. Overdoses up to 31,500 mg of atovaquone have been reported. In one such patient who also took an unspecified dose of dapsone, methemoglobinemia occurred. Rash has also been reported after overdose.

Overdoses of proguanil hydrochloride as large as 1,500 mg have been followed by complete recovery, and doses as high as 700 mg twice daily have been taken for over 2 weeks without serious toxicity. Adverse experiences occasionally associated with proguanil hydrochloride doses of 100 to 200 mg/day, such as epigastric discomfort and vomiting would be likely to occur with overdose. There are also reports of reversible hair loss and scaling of the skin on the palms and/or soles, reversible aphthous ulceration, and hematologic side effects.

How should I store and handle Atovaquone and Proguanil Hydrochloride?

Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Product: 50090-1302NDC: 50090-1302-8 20 TABLET, FILM COATED in a BOTTLENDC: 50090-1302-9 30 TABLET, FILM COATED in a BOTTLEProduct: 50090-1302NDC: 50090-1302-8 20 TABLET, FILM COATED in a BOTTLENDC: 50090-1302-9 30 TABLET, FILM COATED in a BOTTLEProduct: 50090-1302NDC: 50090-1302-8 20 TABLET, FILM COATED in a BOTTLENDC: 50090-1302-9 30 TABLET, FILM COATED in a BOTTLE

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Atovaquone and proguanil hydrochloride, interfere with 2 different pathways involved in the biosynthesis of pyrimidines required for nucleic acid replication. Atovaquone is a selective inhibitor of parasite mitochondrial electron transport. Proguanil hydrochloride primarily exerts its effect by means of the metabolite cycloguanil, a dihydrofolate reductase inhibitor. Inhibition of dihydrofolate reductase in the malaria parasite disrupts deoxythymidylate synthesis.

Non-Clinical Toxicology

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4.1

P. falciparum

Pregnancy: Teratogenic Effects:

Absorption of atovaquone may be reduced in patients with diarrhea or vomiting. If atovaquone and proguanil hydrochloride is used in patients who are vomiting, parasitemia should be closely monitored and the use of an antiemetic considered. Vomiting occurred in up to 19% of pediatric patients given treatment doses of atovaquone and proguanil hydrochloride. In the controlled clinical trials, 15.3% of adults received an antiemetic when they received atovaquone/proguanil and 98.3% of these patients were successfully treated. In patients with severe or persistent diarrhea or vomiting, alternative antimalarial therapy may be required.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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