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atovaquone and proguanil hydrochloride

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Overview

What is Atovaquone and Proguanil HCl?

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 -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 CHClO. 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 CHClN•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.



What does Atovaquone and Proguanil HCl look like?



What are the available doses of Atovaquone and Proguanil HCl?

Tablets (adult strength): 250 mg atovaquone and 100 mg proguanil hydrochloride. ()

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

How should I use Atovaquone and Proguanil HCl?

Atovaquone and Proguanil Hydrochloride Tablets are 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 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 HCl?

Sorry No Records found


What are the warnings of Atovaquone and Proguanil HCl?

Sorry No Records found


What are the precautions of Atovaquone and Proguanil HCl?

Sorry No Records found


What are the side effects of Atovaquone and Proguanil HCl?

Sorry No records found


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

•

4.1

P. falciparum

 


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

There is no information on overdoses of Atovaquone and Proguanil Hydrochloride Tablets substantially 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 HCl?

Store between 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Product: 50090-2980NDC: 50090-2980-0 7 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-1 12 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-2 14 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-3 16 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-4 24 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-5 5 TABLET, FILM COATED in a BOTTLEProduct: 50090-2980NDC: 50090-2980-0 7 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-1 12 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-2 14 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-3 16 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-4 24 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-5 5 TABLET, FILM COATED in a BOTTLEProduct: 50090-2980NDC: 50090-2980-0 7 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-1 12 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-2 14 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-3 16 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-4 24 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-5 5 TABLET, FILM COATED in a BOTTLEProduct: 50090-2980NDC: 50090-2980-0 7 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-1 12 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-2 14 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-3 16 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-4 24 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-5 5 TABLET, FILM COATED in a BOTTLEProduct: 50090-2980NDC: 50090-2980-0 7 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-1 12 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-2 14 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-3 16 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-4 24 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-5 5 TABLET, FILM COATED in a BOTTLEProduct: 50090-2980NDC: 50090-2980-0 7 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-1 12 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-2 14 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-3 16 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-4 24 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-5 5 TABLET, FILM COATED in a BOTTLEProduct: 50090-2980NDC: 50090-2980-0 7 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-1 12 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-2 14 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-3 16 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-4 24 TABLET, FILM COATED in a BOTTLENDC: 50090-2980-5 5 TABLET, FILM COATED in a BOTTLE


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The constituents, 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

 

Caution should be exercised when propranolol is administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Coadministration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see   in ).





Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.

Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension.

Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.

The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following coadministration with propranolol.

Caution should be exercised when administering propranolol with drugs that slow A-V nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers.

Digitalis Glycosides

Calcium Channel Blockers

There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers.

Coadministration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high-degree heart block, and heart failure.

ACE Inhibitors

The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol should be administered cautiously to patients withdrawing from clonidine.

Alpha Blockers

Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.

Reserpine





Isoproterenol and Dobutamine





Administration of indomethacin with propranolol may reduce the efficacy of propranolol in reducing blood pressure and heart rate.

Antidepressants

Anesthetic Agents

Warfarin

Neuroleptic Drugs

Thyroxine

Alcohol

Absorption of atovaquone may be reduced in patients with diarrhea or vomiting. If Atovaquone and Proguanil Hydrochloride Tablets are 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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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