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Atovaquone And Proguanil Hydrochloride (Atovaquone And Proguanil Hydrochloride)

Trade Name : Atovaquone and Proguanil Hydrochloride

Aidarex Pharmaceuticals LLC

TABLET, FILM COATED

Strength 250100 mg/1mg/1

ATOVAQUONE; PROGUANIL HYDROCHLORIDE Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Atovaquone And Proguanil Hydrochloride (Atovaquone And Proguanil Hydrochloride) which is also known as Atovaquone and Proguanil Hydrochloride and Manufactured by Aidarex Pharmaceuticals LLC. It is available in strength of 250; 100 mg/1; mg/1 per ml. Read more

Atovaquone And Proguanil Hydrochloride (Atovaquone And Proguanil Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx only
  • Atovaquone and proguanil hydrochloride is a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is -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 CHClO. The compound has the following structural formula:
  • The chemical name of proguanil hydrochloride USP is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride USP is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula CHClNu2022HCl. The compound has the following structural formula:
  • Atovaquone and proguanil hydrochloride tablets are for oral administration. Each atovaquone and proguanil hydrochloride tablet contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride USP. The inactive ingredients in the tablet are colloidal silicon dioxide, ferric oxide red, hypromellose 2910, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, polyethylene glycol 400, polyethylene glycol 8000, sodium starch glycolate, titanium dioxide.u00a0
  • No data
  • No data
  • Atovaquone and proguanil hydrochloride is contraindicated in individuals with known hypersensitivity to atovaquone or proguanil hydrochloride or any component of the formulation. Rare cases of anaphylaxis following treatment with atovaquone/proguanil have been reported.
  • Atovaquone and proguanil hydrochloride is contraindicated for prophylaxis of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min) (see ).
  • No data
  • Because atovaquone and proguanil hydrochloride contains atovaquone and proguanil hydrochloride, the type and severity of adverse reactions associated with each of the compounds may be expected. The higher treatment doses of atovaquone and proguanil hydrochloride were less well tolerated than the lower prophylactic doses.
  • Among adults who received atovaquone and proguanil hydrochloride for treatment of malaria, attributable adverse experiences that occurred in u22655% of patients were abdominal pain (17%), nausea (12%), vomiting (12%), headache (10%), diarrhea (8%), asthenia (8%), anorexia (5%), and dizziness (5%). Treatment was discontinued prematurely due to an adverse experience in 4 of 436 adults treated with atovaquone and proguanil hydrochloride.
  • Among pediatric patients (weighing 11 to 40 kg) who received atovaquone and proguanil hydrochloride for the treatment of malaria, attributable adverse experiences that occurred in u22655% of patients were vomiting (10%) and pruritus (6%). Vomiting occurred in 43 of 319 (13%) pediatric patients who did not have symptomatic malaria but were given treatment doses of atovaquone and proguanil hydrochloride for 3 days in a clinical trial. The design of this clinical trial required that any patient who vomited be withdrawn from the trial. Among pediatric patients with symptomatic malaria treated with atovaquone and proguanil hydrochloride, treatment was discontinued prematurely due to an adverse experience in 1 of 116 (0.9%).
  • In a study of 100 pediatric patients (5 to <11 kg body weight) who received atovaquone and proguanil hydrochloride for the treatment of uncomplicated malaria, only diarrhea (6%) occurred in u22655% of patients as an adverse experience attributable to atovaquone and proguanil hydrochloride. In 3 patients (3%), treatment was discontinued prematurely due to an adverse experience.
  • Abnormalities in laboratory tests reported in clinical trials were limited to elevations of transaminases in malaria patients being treated with atovaquone and proguanil hydrochloride. The frequency of these abnormalities varied substantially across studies of treatment and were not observed in the randomized portions of the prophylaxis trials.
  • In one phase III trial of malaria treatment in Thai adults, early elevations of ALT and AST were observed to occur more frequently in patients treated with atovaquone and proguanil hydrochloride compared to patients treated with an active control drug. Rates for patients who had normal baseline levels of these clinical laboratory parameters were: Day 7: ALT 26.7% vs. 15.6%; AST 16.9% vs. 8.6%. By day 14 of this 28-day study, the frequency of transaminase elevations equalized across the 2 groups.
  • In this and other studies in which transaminase elevations occurred, they were noted to persist for up to 4 weeks following treatment with atovaquone and proguanil hydrochloride for malaria. None were associated with untoward clinical events.
  • Among subjects who received atovaquone and proguanil hydrochloride for prophylaxis of malaria in placebo-controlled trials, adverse experiences occurred in similar proportions of subjects receiving atovaquone and proguanil hydrochloride or placebo (Table 3). The most commonly reported adverse experiences possibly attributable to atovaquone and proguanil hydrochloride or placebo were headache and abdominal pain. Prophylaxis with atovaquone and proguanil hydrochloride was discontinued prematurely due to a treatment-related adverse experience in 3 of 381 adults and 0 of 125 pediatric patients.
  • In an additional placebo-controlled study of malaria prophylaxis with atovaquone and proguanil hydrochloride involving 330 pediatric patients in a malaria-endemic area (see ), the safety profile of atovaquone and proguanil hydrochloride was consistent with that described above. The most common treatment-emergent adverse events with atovaquone and proguanil hydrochloride were abdominal pain (13%), headache (13%), and cough (10%). Abdominal pain (13% vs. 8%) and vomiting (5% vs. 3%) were reported more often with atovaquone and proguanil hydrochloride than with placebo, while fever (5% vs. 12%) and diarrhea (1% vs. 5%) were more common with placebo. No patient withdrew from the study due to an adverse experience with atovaquone and proguanil hydrochloride. No routine laboratory data were obtained during this study.
  • Among subjects who received atovaquone and proguanil hydrochloride for prophylaxis of malaria in clinical trials with an active comparator, adverse experiences occurred in a similar or lower proportion of subjects receiving atovaquone and proguanil hydrochloride than an active comparator (Table 4). The mean durations of dosing and the periods for which the adverse experiences are summarized in Table 4, were 28 days (Study 1) and 26 days (Study 2) for atovaquone and proguanil hydrochloride, 53 days for mefloquine, and 49 days for chloroquine plus proguanil (reflecting the different recommended dosing regimens). Fewer neuropsychiatric adverse experiences occurred in subjects who received atovaquone and proguanil hydrochloride than mefloquine. Fewer gastrointestinal adverse experiences occurred in subjects receiving atovaquone and proguanil hydrochloride than chloroquine/proguanil. Compared with active comparator drugs, subjects receiving atovaquone and proguanil hydrochloride had fewer adverse experiences overall that were attributed to prophylactic therapy (Table 4). Prophylaxis with atovaquone and proguanil hydrochloride was discontinued prematurely due to a treatment-related adverse experience in 7 of 1,004 travelers.
  • In a third active-controlled study, atovaquone and proguanil hydrochloride (n = 110) was compared with chloroquine/proguanil (n = 111) for the prophylaxis of malaria in 221 non-immune pediatric patients (see ). The mean duration of exposure was 23 days for atovaquone and proguanil hydrochloride, 46 days for chloroquine, and 43 days for proguanil, reflecting the different recommended dosage regimens for these products. Fewer patients treated with atovaquone and proguanil hydrochloride reported abdominal pain (2% vs. 7%) or nausea (<1% vs. 7%) than children who received chloroquine/proguanil. Oral ulceration (2% vs. 2%), vivid dreams (2% vs. <1%), and blurred vision (0% vs. 2%) occurred in similar proportions of patients receiving either atovaquone and proguanil hydrochloride or chloroquine/proguanil, respectively. Two patients discontinued prophylaxis with chloroquine/proguanil due to adverse events, while none of those receiving atovaquone and proguanil hydrochloride discontinued due to adverse events.
  • In addition to adverse events reported from clinical trials, the following events have been identified during world-wide post-approval use of atovaquone and proguanil hydrochloride. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to atovaquone and proguanil hydrochloride.
  • Blood and Lymphatic System Disorders:
  • Immune System Disorders:
  • Nervous System Disorders:
  • Gastrointestinal Disorders:
  • Hepatobiliary Disorders:
  • Skin and Subcutaneous Tissue Disorders:
  • There is no information on overdoses of atovaquone and proguanil hydrochloride substantially higher than the doses recommended for treatment.
  • There is no known antidote for atovaquone, and it is currently unknown if atovaquone is dialyzable. The median lethal dose is higher than the maximum oral dose tested in mice and rats (1,825 mg/kg/day). Overdoses up to 31,500 mg of atovaquone have been reported. In one such patient who also took an unspecified dose of dapsone, methemoglobinemia occurred. Rash has also been reported after overdose.
  • Overdoses of proguanil hydrochloride as large as 1,500 mg have been followed by complete recovery, and doses as high as 700 mg twice daily have been taken for over 2 weeks without serious toxicity. Adverse experiences occasionally associated with proguanil hydrochloride doses of 100 to 200 mg/day, such as epigastria discomfort and vomiting would be likely to occur with overdose. There are also reports of reversible hair loss and scaling of the skin on the palms and/or soles, reversible aphthous ulceration, and hematologic side effects.
  • 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, containing 250 mg atovaquone and 100 mg proguanil hydrochloride, are pinkish brown to brown colored, circular, biconvex beveled edge, film-coated tablets with u2018404u2019 debossed on one side and u2018Gu2019 debossed on the other side.
  • Atovaquone and proguanil hydrochloride tablets 250 mg/100 mg
  • NDC 33261-900-01 unit dose pack of 24
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) (see USP Controlled Room Temperature)
  • Fibrovascular proliferation in the right atrium, pyelonephritis, bone marrow hypocellularity, lymphoid atrophy, and gastritis/enteritis were observed in dogs treated with proguanil hydrochloride for 6 months at a dose of 12 mg/kg/day (approximately 3.9 times the recommended daily human dose for malaria prophylaxis on a mg/m basis). Bile duct hyperplasia, gall bladder mucosal atrophy, and interstitial pneumonia were observed in dogs treated with proguanil hydrochloride for 6 months at a dose of 4 mg/kg/day (approximately 1.3 times the recommended daily human dose for malaria prophylaxis on a mg/m basis). Mucosal hyperplasia of the cecum and renal tubular basophilia were observed in rats treated with proguanil hydrochloride for 6 months at a dose of 20 mg/kg/day (approximately 1.6 times the recommended daily human dose for malaria prophylaxis on a mg/m basis). Adverse heart, lung, liver, and gall bladder effects observed in dogs and kidney effects observed in rats were not shown to be reversible.
  • No data
  • Manufactured by:
  • Glenmark Generics Ltd.
  • Manufactured for:
  • Glenmark Generics Inc., USA
  • Questions? 1 (888)721-7115n n
  • Repackaged By:Aidarex Pharmaceuticals, LLC.Corona, CA 92880
  • January 2011
  • No data
  • No data

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