Drugplain

MALARONE 250 mg/1

atovaquone and proguanil hydrochloride · TABLET, FILM COATED · GlaxoSmithKline LLC

1 Recall on Record
Plain English

MALARONE is a tablet, film coated containing atovaquone and proguanil hydrochloride at 250 mg/1, taken oral. Manufactured by GlaxoSmithKline LLC.

Key Facts

Brand Name
MALARONE
Generic Name
atovaquone and proguanil hydrochloride
NDC Code (Product)
0173-0675
Manufacturer
GlaxoSmithKline LLC
Strength
250 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA021078
Drug Class
Antimalarial [EPC]; Antiprotozoal [EPC]
Marketing Start
07/26/2000

Recall History

1 Recall on Record
Class II03/25/2016

Reliable Rexall-A Compounding Pharmacy

Lack of Processing Controls

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea170 reports
diarrhoea168 reports
pyrexia147 reports
vomiting137 reports
headache129 reports
malaria123 reports
drug ineffective117 reports
dizziness110 reports
fatigue104 reports
malaise100 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE MALARONE is an antimalarial indicated for: • prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. ( 1.1 ) • treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria MALARONE is indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria MALARONE is indicated for the treatment of acute, uncomplicated P. falciparum malaria. MALARONE has 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 & Administration

2 DOSAGE AND ADMINISTRATION 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. MALARONE may be crushed and mixed with condensed milk just prior to administration to patients who may have difficulty swallowing tablets. • MALARONE should be taken with food or a milky drink. Prophylaxis ( 2.1 ) : • Start prophylaxis 1 or 2 days before entering a malaria‑endemic area and continue daily during the stay and for 7 days after return. • Adults: One adult strength tablet per day. • Pediatric Patients: Dosage based on body weight (see Table 1 ). Treatment ( 2.2 ) : • Adults: Four adult strength tablets as a single daily dose for 3 days. • Pediatric Patients: Dosage based on body weight (see Table 2 ). Renal Impairment ( 2.3 ) : • Do not use for prophylaxis of malaria in patients with severe renal impairment. • Use with caution for treatment of malaria in patients with severe renal impairment. 2.1 Prevention of Malaria Start prophylactic treatment with MALARONE 1 or 2 days before entering a malaria‑endemic area and continue daily during the stay and for 7 days after return. Adu…

Contraindications

4 CONTRAINDICATIONS • MALARONE is contraindicated in individuals with known hypersensitivity reactions to atovaquone or proguanil hydrochloride or any component of the formulation [see Warnings and Precautions (5.4), Adverse Reactions (6.2)] . • MALARONE 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 [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . • Known serious hypersensitivity reactions to atovaquone or proguanil hydrochloride or any component of the formulation. ( 4 ) • Prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min). ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Administration with rifampin or rifabutin is known to reduce atovaquone concentrations; concomitant use with MALARONE is not recommended. ( 7.1 ) • Proguanil may potentiate anticoagulant effect of warfarin and other coumarin-based anticoagulants. Caution advised when initiating or withdrawing MALARONE in patients on anticoagulants; coagulation tests should be closely monitored. ( 7.2 ) • Tetracycline may reduce atovaquone concentrations; parasitemia should be closely monitored. ( 7.3 ) 7.1 Rifampin/Rifabutin Concomitant administration of rifampin or rifabutin is known to reduce atovaquone concentrations [see Clinical Pharmacology ( 12.3 )] . The concomitant administration of MALARONE and rifampin or rifabutin is not recommended. 7.2 Anticoagulants Proguanil may potentiate the anticoagulant effect of warfarin and other coumarin-based anticoagulants. The mechanism of this potential drug interaction has not been established. Caution is advised when initiating or withdrawing malaria prophylaxis or treatment with MALARONE in patients on continuous treatment with coumarin-based anticoagulants. When these products are administered concomitantly, coagulation tests sho…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in another section of the labeling: • Vomiting and Diarrhea [see Warnings and Precautions ( 5.1 )]. • Hepatotoxicity [see Warnings and Precautions ( 5.3 )]. • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.4 )]. • Prophylaxis: Common adverse reactions (≥4%) in adults were diarrhea, dreams, oral ulcers, and headache; these events occurred in a similar or lower proportion of subjects receiving MALARONE than an active comparator. Common adverse reactions (≥5%) in pediatric patients included abdominal pain, headache, cough, and vomiting. ( 6.1 ) • Treatment: Common adverse reactions (≥5%) in adolescents and adults were abdominal pain, nausea, vomiting, headache, diarrhea, asthenia, anorexia, and dizziness. Common adverse reactions (≥6%) in pediatric patients included vomiting, pruritus, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the …

Frequently Asked Questions

What is MALARONE used for?

MALARONE contains atovaquone and proguanil hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is MALARONE a controlled substance?

MALARONE is not classified as a controlled substance by the DEA.

What is the generic name for MALARONE?

The generic name for MALARONE is atovaquone and proguanil hydrochloride. There are 9 other brand versions of atovaquone and proguanil hydrochloride.

What is the NDC code for MALARONE 250 mg/1?

The NDC (National Drug Code) for MALARONE 250 mg/1 is 0173-0675, listed by GlaxoSmithKline LLC.

Product NDC

0173-0675

Package NDC

0173-0675-01

Other MALARONE Dosages

Other Atovaquone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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