Atovaquone and proguanil hydrochloride: Difference between revisions

Atovaquone and proguanil hydrochloride
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

VisualWikitext

Revision as of 17:33, 10 February 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Overview

Atovaquone and proguanil hydrochloride is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Prevention of Malaria

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

Treatment of Malaria

Atovaquone and proguanil hydrochloride tabletsare 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.

Dosage

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

Start prophylactic treatment withatovaquone and proguanil hydrochloride tablets 1 or 2 days before entering a malaria-endemic area and continue daily during the stay and for 7 days after return.

Adults: One atovaquone and proguanil hydrochloride tablet(adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.

Treatment of Acute Malaria

Adults: Fouratovaquone and proguanil hydrochloride tablets(adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive day.

Renal Impairment

Do not useatovaquone and proguanil hydrochloride tablets for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Use with caution for the treatment of malaria in patients with severe renal impairment, only if the benefits of the 3 day treatment regimen outweigh the potential risks associated with increased drug exposure. No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) or moderate (creatinine clearance 30 to 50 mL/min) renal impairment.

DOSAGE FORMS AND STRENGTHS

Each atovaquone and proguanil hydrochloride tablets (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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Atovaquone and proguanil hydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Atovaquone and proguanil hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Atovaquone and proguanil hydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Atovaquone and proguanil hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Atovaquone and proguanil hydrochloride in pediatric patients.

Contraindications

Hypersensitivity

Atovaquone and proguanil hydrochloride is contraindicated in individuals with known hypersensitivity reactions (e.g., anaphylaxis, erythema multiforme or Stevens-Johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation.

Severe Renal Impairment

Atovaquone and proguanil hydrochloride is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min) because of pancytopenia in patients with severe renal impairment treated with proguanil.

Warnings

Vomiting and Diarrhea

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. [See Dosage and Administration (2).] 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.

Relapse of Infection

In mixed P. falciparum and Plasmodium vivax infections, P. vivax parasite relapse occurred commonly when patients were treated with atovaquone and proguanil hydrochloride alone.

In the event of recrudescent P. falciparum infections after treatment with atovaquone and proguanil hydrochloride or failure of chemoprophylaxis with atovaquone and proguanil hydrochloride, patients should be treated with a different blood schizonticide.

Hepatotoxicity

Elevated liver laboratory tests and cases of hepatitis and hepatic failure requiring liver transplantation have been reported with prophylactic use of atovaquone and proguanil hydrochloride.

Severe or Complicated Malaria

Atovaquone and proguanil hydrochloride has not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria, including hyperparasitemia, pulmonary edema, or renal failure. Patients with severe malaria are not candidates for oral therapy

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Atovaquone and proguanil hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Atovaquone and proguanil hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Atovaquone and proguanil hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Atovaquone and proguanil hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Atovaquone and proguanil hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Atovaquone and proguanil hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Atovaquone and proguanil hydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Atovaquone and proguanil hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Atovaquone and proguanil hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Atovaquone and proguanil hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Atovaquone and proguanil hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Atovaquone and proguanil hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Atovaquone and proguanil hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Atovaquone and proguanil hydrochloride in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Atovaquone and proguanil hydrochloride in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Atovaquone and proguanil hydrochloride in the drug label.

Pharmacology

There is limited information regarding Atovaquone and proguanil hydrochloride Pharmacology in the drug label.

Mechanism of Action

Structure

File:Atovaquone and proguanil hydrochloride01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Atovaquone and proguanil hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Atovaquone and proguanil hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Atovaquone and proguanil hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Atovaquone and proguanil hydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Atovaquone and proguanil hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Atovaquone and proguanil hydrochloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Atovaquone and proguanil hydrochloride in the drug label.

Precautions with Alcohol

Alcohol-Atovaquone and proguanil hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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[1] Empty citation (help)

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[1]

[2]

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 <!--FDA-Labeled Indications and Dosage (Adult)-->
-|fdaLIADAdult======Condition1=====
+|fdaLIADAdult===Indications==
-* Dosing Information
+'''Prevention of Malaria'''
-:* Dosage
+* Atovaquone and proguanil hydrochloride tabletsare indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.
-=====Condition2=====
+'''Treatment of Malaria'''
-* Dosing Information
+* Atovaquone and proguanil hydrochloride tabletsare 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.
-:* Dosage
+==Dosage==
-=====Condition3=====
+* 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.
-* Dosing Information
+'''Prevention of Malaria'''
-:* Dosage
+* Start prophylactic treatment withatovaquone and proguanil hydrochloride tablets 1 or 2 days before entering a malaria-endemic area and continue daily during the stay and for 7 days after return.
-=====Condition4=====
+* Adults: One atovaquone and proguanil hydrochloride tablet(adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
-* Dosing Information
+'''Treatment of Acute Malaria'''
-:* Dosage
+* Adults: Fouratovaquone and proguanil hydrochloride tablets(adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive day.
-<!--Off-Label Use and Dosage (Adult)-->
+'''Renal Impairment'''
-<!--Guideline-Supported Use (Adult)-->
+* Do not useatovaquone and proguanil hydrochloride tablets for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Use with caution for the treatment of malaria in patients with severe renal impairment, only if the benefits of the 3 day treatment regimen outweigh the potential risks associated with increased drug exposure. No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) or moderate (creatinine clearance 30 to 50 mL/min) renal impairment.
-|offLabelAdultGuideSupport======Condition1=====
-* Developed by:
+==DOSAGE FORMS AND STRENGTHS==
-* Class of Recommendation:
+* Each atovaquone and proguanil hydrochloride tablets (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.
-* Strength of Evidence:
+|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
-* Dosing Information
-:* Dosage
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-<!--Non–Guideline-Supported Use (Adult)-->
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-|offLabelAdultNoGuideSupport======Condition1=====
-* Dosing Information
-:* Dosage
-=====Condition2=====
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-<!--Pediatric Indications and Dosage-->
-<!--FDA-Labeled Indications and Dosage (Pediatric)-->
-|fdaLIADPed======Condition1=====
-* Dosing Information
-:* Dosage
-=====Condition2=====
-There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
-<!--Off-Label Use and Dosage (Pediatric)-->
 <!--Guideline-Supported Use (Pediatric)-->
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-* Developed by:
-* Class of Recommendation:
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-* Dosing Information
-:* Dosage
+|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
-=====Condition2=====
-There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
+|contraindications='''Hypersensitivity'''
-<!--Non–Guideline-Supported Use (Pediatric)-->
+* Atovaquone and proguanil hydrochloride is contraindicated in individuals with known hypersensitivity reactions (e.g., [[anaphylaxis]], [[erythema multiforme]] or [[Stevens-Johnson syndrome]], [[angioedema]], [[vasculitis]]) to atovaquone or proguanil hydrochloride or any component of the formulation.
-|offLabelPedNoGuideSupport======Condition1=====
-* Dosing Information
+'''Severe Renal Impairment'''
-:* Dosage
+* Atovaquone and proguanil hydrochloride is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min) because of pancytopenia in patients with severe renal impairment treated with proguanil.
+|warnings='''Vomiting and Diarrhea'''
-=====Condition2=====
+* 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. [See Dosage and Administration (2).] 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.
-There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
+'''Relapse of Infection'''
-<!--Contraindications-->
+* In mixed P. falciparum and Plasmodium vivax infections, P. vivax parasite relapse occurred commonly when patients were treated with atovaquone and proguanil hydrochloride alone.
-|contraindications=* Condition1
-<!--Warnings-->
+* In the event of recrudescent P. falciparum infections after treatment with atovaquone and proguanil hydrochloride or failure of chemoprophylaxis with atovaquone and proguanil hydrochloride, patients should be treated with a different blood schizonticide.
-|warnings=* Description
-====Precautions====
+'''Hepatotoxicity'''
-* Description
+* Elevated liver laboratory tests and cases of hepatitis and hepatic failure requiring liver transplantation have been reported with prophylactic use of atovaquone and proguanil hydrochloride.
-<!--Adverse Reactions-->
+'''Severe or Complicated Malaria'''
-<!--Clinical Trials Experience-->
+* Atovaquone and proguanil hydrochloride has not been evaluated for the treatment of [[cerebral malaria]] or other severe manifestations of complicated malaria, including hyperparasitemia, pulmonary edema, or [[renal failure]]. Patients with severe malaria are not candidates for oral therapy
 |clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.