Atovaquone Oral Suspension 750 mg/5mL
Atovaquone · SUSPENSION · KVK-Tech, Inc.
Atovaquone Oral Suspension is a suspension containing atovaquone at 750 mg/5mL, taken oral. Manufactured by KVK-Tech, Inc..
Key Facts
- Brand Name
- Atovaquone Oral Suspension
- Generic Name
- Atovaquone
- NDC Code (Product)
10702-223- Manufacturer
- KVK-Tech, Inc.
- Strength
- 750 mg/5mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210510
- Drug Class
- Antimalarial [EPC]; Antiprotozoal [EPC]
- Marketing Start
- 03/29/2019
Recall History
AvKARE
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Bionpharma Inc.
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
KVK-Tech, Inc.
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Camber Pharmaceuticals Inc.
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Side 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 oral suspension is a quinone antimicrobial drug indicated for: Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1) Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2) Limitations of Use (1.3): Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO 2 ] >45 mm Hg) with atovaquone oral suspension has not been studied. The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied. 1.1 Prevention of Pneumocystis jirovecii Pneumonia Atovaquone oral suspension is indicated for the prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). 1.2 Treatment of Mild-to-Moderate Pneumocystis jirovecii Pneumonia Atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX. 1.3 Limitations…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Prevention of PCP: 1,500 mg (10 mL) once daily with food. (2.1) Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days. (2.2) Supplied in Bottles: º Bottle: Shake bottle gently before use. (2.3) 2.1 Dosage for the Prevention of P. jirovecii Pneumonia The recommended oral dosage is 1,500 mg (10 mL) once daily administered with food. 2.2 Dosage for the Treatment of Mild-to-Moderate P. jirovecii Pneumonia The recommended oral dosage is 750 mg (5 mL) twice daily (total daily dose = 1,500 mg) administered with food for 21 days. 2.3 Important Administration Instructions Administer atovaquone oral suspension with food to avoid lower plasma atovaquone concentrations that may limit response to therapy [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3)]. Atovaquone oral suspension Bottle Shake bottle gently before administering the recommended dosage.
Contraindications
4 CONTRAINDICATIONS Atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension. Known serious allergic/hypersensitivity reaction (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension. (4)
Drug Interactions
7 DRUG INTERACTIONS Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with atovaquone oral suspension is not recommended. (7.1) Concomitant administration of tetracycline reduces atovaquone concentrations; use caution when coadministering. Monitor patients for potential loss of efficacy of atovaquone if coadministration of tetracycline is necessary. (7.2) Concomitant administration with metoclopramide reduces atovaquone concentrations; administer concomitantly only if other antiemetics are not available. (7.3) Concomitant administration of indinavir reduces indinavir trough concentrations; use caution when coadministering. Monitor patients for potential loss of efficacy of indinavir if coadministration is necessary. (7.4) 7.1 Rifampin/Rifabutin Concomitant administration of rifampin or rifabutin and atovaquone oral suspension is known to reduce atovaquone concentrations [see Clinical Pharmacology (12.3)]. Concomitant administration of atovaquone oral suspension and rifampin or rifabutin is not recommended. 7.2 Tetracycline Concomitant administration of tetracycline and atovaquone oral suspension has been associated with a reducti…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reaction is discussed in another section of the labeling: Hepatotoxicity [see Warnings and Precautions (5.2)]. PCP Prevention: The most frequent adverse reactions (≥25% that required discontinuation) were diarrhea, rash, headache, nausea, and fever. (6.1) PCP Treatment: The most frequent adverse reactions (≥14% that required discontinuation) were rash (including maculopapular), nausea, diarrhea, headache, vomiting, and fever. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact KVK-Tech, Inc. at 1-800-862-3895 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. Additionally, because many subjects who participated in clinical trials with atovaquone had complications of advanced human immunodeficiency virus (HIV) disease, it was often difficult to distinguish adverse reactions caused by atovaquone from those caused by underlying medical conditions. PCP…
Frequently Asked Questions
What is Atovaquone Oral Suspension used for?
Atovaquone Oral Suspension contains Atovaquone. It is a suspension taken oral. Consult your doctor for specific uses.
Is Atovaquone Oral Suspension a controlled substance?
Atovaquone Oral Suspension is not classified as a controlled substance by the DEA.
What is the generic name for Atovaquone Oral Suspension?
The generic name for Atovaquone Oral Suspension is Atovaquone. There are 11 other brand versions of Atovaquone.
What is the NDC code for Atovaquone Oral Suspension 750 mg/5mL?
The NDC (National Drug Code) for Atovaquone Oral Suspension 750 mg/5mL is 10702-223, listed by KVK-Tech, Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)