Atovaquone and Proguanil Hydrochloride Pediatric 62.5 mg/1
Atovaquone and Proguanil Hydrochloride Pediatric · TABLET, FILM COATED · Glenmark Pharmaceuticals Inc.,USA
Atovaquone and Proguanil Hydrochloride Pediatric is a tablet, film coated containing atovaquone and proguanil hydrochloride pediatric at 62.5 mg/1, taken oral. Manufactured by Glenmark Pharmaceuticals Inc.,USA.
Key Facts
- Brand Name
- Atovaquone and Proguanil Hydrochloride Pediatric
- Generic Name
- Atovaquone and Proguanil Hydrochloride Pediatric
- NDC Code (Product)
68462-402- Manufacturer
- Glenmark Pharmaceuticals Inc.,USA
- Strength
- 62.5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091211
- Drug Class
- Antimalarial [EPC]; Antiprotozoal [EPC]
- Marketing Start
- 04/08/2015
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Atovaquone and proguanil hydrochloride tablets are 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 Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria 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.
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. 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. • Atovaquone and proguanil hydrochloride tablets 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 atovaquone and proguanil hydrochloride tablets 1 or 2 da…
Contraindications
4 CONTRAINDICATIONS • 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 ) • Atovaquone and proguanil hydrochloride 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 )]. • 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 [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )].
Drug Interactions
7 DRUG INTERACTIONS • Administration with rifampin or rifabutin is known to reduce atovaquone concentrations; concomitant use with atovaquone and proguanil hydrochloride is not recommended. ( 7.1 ) • Proguanil may potentiate anticoagulant effect of warfarin and other coumarin-based anticoagulants. Caution advised when initiating or withdrawing atovaquone and proguanil hydrochloride 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 atovaquone and proguanil hydrochloride 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 atovaquone and proguanil hydrochloride in patients on continuous…
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 atovaquone and proguanil hydrochloride 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 Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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 c…
Frequently Asked Questions
What is Atovaquone and Proguanil Hydrochloride Pediatric used for?
Atovaquone and Proguanil Hydrochloride Pediatric contains Atovaquone and Proguanil Hydrochloride Pediatric. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Atovaquone and Proguanil Hydrochloride Pediatric a controlled substance?
Atovaquone and Proguanil Hydrochloride Pediatric is not classified as a controlled substance by the DEA.
What is the generic name for Atovaquone and Proguanil Hydrochloride Pediatric?
The generic name for Atovaquone and Proguanil Hydrochloride Pediatric is Atovaquone and Proguanil Hydrochloride Pediatric. There are no other listed brand versions of Atovaquone and Proguanil Hydrochloride Pediatric.
What is the NDC code for Atovaquone and Proguanil Hydrochloride Pediatric 62.5 mg/1?
The NDC (National Drug Code) for Atovaquone and Proguanil Hydrochloride Pediatric 62.5 mg/1 is 68462-402, listed by Glenmark Pharmaceuticals Inc.,USA.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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