Atovaquone and Proguanil Hydrochloride 62.5 mg/1
atovaquone and proguanil hydrochloride · TABLET, FILM COATED · Mylan Pharmaceuticals Inc.
Atovaquone and Proguanil Hydrochloride is a tablet, film coated containing atovaquone and proguanil hydrochloride at 62.5 mg/1, taken oral. Manufactured by Mylan Pharmaceuticals Inc..
Key Facts
- Brand Name
- Atovaquone and Proguanil Hydrochloride
- Generic Name
- atovaquone and proguanil hydrochloride
- NDC Code (Product)
0378-4160- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 62.5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202362
- Drug Class
- Antimalarial [EPC]; Antiprotozoal [EPC]
- Marketing Start
- 05/28/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full 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 days before ent…
Contraindications
4 CONTRAINDICATIONS Atovaquone and proguanil hydrochloride tablets are 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. Atovaquone and proguanil hydrochloride tablets are 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 atovaquone and proguanil hydrochloride tablets 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 tablets 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 tablets 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 tablets …
Adverse Reactions
6 ADVERSE REACTIONS 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 tablets 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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Because atovaquone and proguanil hydrochloride tablets contain atovaquone and proguanil hydrochloride,…
Frequently Asked Questions
What is Atovaquone and Proguanil Hydrochloride used for?
Atovaquone and Proguanil Hydrochloride contains atovaquone and proguanil hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Atovaquone and Proguanil Hydrochloride a controlled substance?
Atovaquone and Proguanil Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Atovaquone and Proguanil Hydrochloride?
The generic name for Atovaquone and Proguanil Hydrochloride is atovaquone and proguanil hydrochloride. There are 5 other brand versions of atovaquone and proguanil hydrochloride.
What is the NDC code for Atovaquone and Proguanil Hydrochloride 62.5 mg/1?
The NDC (National Drug Code) for Atovaquone and Proguanil Hydrochloride 62.5 mg/1 is 0378-4160, listed by Mylan Pharmaceuticals Inc..