Atovaquone And Proguanil Hydrochloride (Malarone)

Trade Name : MALARONE

GlaxoSmithKline 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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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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

Atovaquone And Proguanil Hydrochloride (Malarone) 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

Packaging and Delivery

Validated Cold Chain Shipment

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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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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About GNH

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.

Read more
  • No data
  • MALARONE is an antimalarial indicated for:
  • Plasmodium falciparum
  • P.u00a0falciparum
  • The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1u00a0hour after dosing, a repeat dose should be taken.
  • MALARONE may be crushed and mixed with condensed milk just prior to administration to patients who may have difficulty swallowing tablets.
  • 2.1
  • 2.2
  • (2.3
  • Each MALARONE tablet (adult strength) contains 250u00a0mg atovaquone and 100u00a0mg proguanil hydrochloride. MALARONE tablets are pink, film-coated, round, biconvex tablets engraved with u201cGX CM3u201d on one side.
  • Each MALARONE pediatric tablet contains 62.5u00a0mg atovaquone and 25u00a0mg proguanil hydrochloride. MALARONE pediatric tablets are pink, film-coated, round, biconvex tablets engraved with u201cGX CG7u201d on one side.
  • No data
  • P. falciparum
  • No data
  • P.u00a0falciparumn- Plasmodium vivaxn- P.u00a0vivax
  • P.u00a0falciparum
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .
  • No data
  • Renal impairment: contraindicated for prophylaxis of malaria in patients with severe renal impairment. ()
  • There is no information on overdoses of MALARONE substantially higher than the doses recommended for treatment.
  • There is no known antidote for atovaquone, and it is currently unknown if atovaquone is dialyzable. Overdoses up to 31,500u00a0mg 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 1,500u00a0mg have been followed by complete recovery, and doses as high as 700u00a0mg twice daily have been taken for over 2u00a0weeks without serious toxicity. Adverse experiences occasionally associated with proguanil hydrochloride doses of 100 to 200u00a0mg/day, such as epigastric 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.
  • MALARONE (atovaquone and proguanil hydrochloride) tablets (adult strength) and MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets, for oral administration, contain a fixedu2011dose 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 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 CHClNu2022HCl. The compound has the following structural formula:
  • Each MALARONE tablet (adult strength) contains 250u00a0mg of atovaquone and 100u00a0mg of proguanil hydrochloride and each MALARONE pediatric tablet contains 62.5u00a0mg of atovaquone and 25u00a0mg of proguanil hydrochloride. The inactive ingredients in both tablets are low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycolu00a0400, polyethylene glycolu00a08000, red iron oxide, and titanium dioxide.
  • No data
  • No data
  • No data
  • MALARONE tablets, containing 250u00a0mg atovaquone and 100u00a0mg proguanil hydrochloride.
  • MALARONE pediatric tablets, containing 62.5u00a0mg atovaquone and 25u00a0mg proguanil hydrochloride.
  • Storage Conditions
  • Store at 25u00b0C (77u00b0F). Temperature excursions are permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) (see USP Controlled Room Temperature).
  • Patients should be instructed:
  • Trademark is owned by or licensed to the GSK group of companies.
  • GlaxoSmithKlineResearch Triangle Park, NC 27709n
  • u00a92019 GSK group of companies or its licensor.
  • MLR:8PIn
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0675-01
  • MALARONEn
  • (atovaquone and proguanil HCl)
  • Tablets
  • Each tablet containsatovaquone andproguanil HCl.
  • R only
  • 100 Tablets
  • See accompanying prescribing information for Dosage and Administration.
  • Store at 25C (77F); excursions permitted to 15 to 30C (59to 86F) (see USP Controlled Room Temperature).
  • Do not use if printed safety seal under cap is broken or missing.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in Canada
  • Rev. 10/16
  • A142937
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0676-01
  • MALARONEn
  • (atovaquone and proguanil HCl)
  • Pediatric Tablets
  • Each tablet containsatovaquone andproguanil HCl.
  • R only
  • 100 Tablets
  • See accompanying prescribing information for Dosage and Administration.
  • Store at 25C (77F); excursions permitted to 15 to 30C (59to 86F) (see USP Controlled Room Temperature).
  • Do not use if printed safety seal under cap is broken or missing.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in Canada
  • Rev. 9/16
  • A142938

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