Atovaquone And Proguanil Hcl
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Atovaquone and Proguanil Hydrochloride Tablets are indicated for the prophylaxis of Plasmodiumfalciparum malaria, including in areas where chloroquine resistance has been reported.
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.
History
There is currently no drug history available for this drug.
Other Information
Atovaquone and Proguanil Hydrochloride Tablets (adult strength), for oral administration, contain a fixed‑dose combination of the antimalarial agents atovaquone and proguanil hydrochloride.
The chemical name of atovaquone is trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula:
The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C11H16ClN5•HCl. The compound has the following structural formula:
Each Atovaquone and Proguanil Hydrochloride Tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride. The inactive ingredients are low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide and titanium dioxide.
Sources
Atovaquone And Proguanil Hcl Manufacturers
- Bryant Ranch Prepack
![Atovaquone And Proguanil Hcl (Atovaquone And Proguanil Hydrochloride) Tablet, Film Coated [Bryant Ranch Prepack]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Atovaquone And Proguanil Hcl | Bryant Ranch Prepack
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.
2.1 Prevention of MalariaStart prophylactic treatment with Atovaquone 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: OneAtovaquone and Proguanil Hydrochloride Tablet(adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
2.2 Treatment of Acute MalariaAdults: Four Atovaquone and Proguanil Hydrochloride Tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive days.
2.3 Renal ImpairmentDo not use Atovaquone and Proguanil Hydrochloride Tablets for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min) [see Contraindications (4.2)]. 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. [See Clinical Pharmacology (12.3).]
- Pd-rx Pharmaceuticals, Inc.
Atovaquone And Proguanil Hcl | Liddell Laboratories, Inc.
Adults and children over 12: Spray twice under the tongue 3 times per day. Children 12 and under: Consult a doctor prior to use.
- Prasco Laboratories
Atovaquone And Proguanil Hcl | Prasco Laboratories
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.
2.1 Prevention of MalariaStart prophylactic treatment with Atovaquone 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: OneAtovaquone and Proguanil Hydrochloride Tablet(adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
2.2 Treatment of Acute MalariaAdults: Four Atovaquone and Proguanil Hydrochloride Tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive days.
2.3 Renal ImpairmentDo not use Atovaquone and Proguanil Hydrochloride Tablets for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min) [see Contraindications (4.2)]. 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. [See Clinical Pharmacology (12.3).]
![Atovaquone And Proguanil Hcl (Atovaquone And Proguanil Hydrochloride) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=61c7e82e-eb4d-43ac-aacb-2a9ae23bd51e&name=LIDL20CaffeineFree5-20-13.jpg)
![Atovaquone And Proguanil Hcl (Atovaquone And Proguanil Hydrochloride) Tablet, Film Coated [Prasco Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7069521a-c7f9-4e8d-99b8-0cb5c971e7cf&name=image-03.jpg)
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