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Atovaquone And Proguanil Hydrochloride (Atovaquone And Proguanil Hydrochloride)

Trade Name : Atovaquone and Proguanil Hydrochloride

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 62.525 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 (Atovaquone And Proguanil Hydrochloride) which is also known as Atovaquone and Proguanil Hydrochloride and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 62.5; 25 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

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
  • Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for:
  • Plasmodium falciparum
  • P. falciparum
  • 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
  • 2.2
  • 2.3
  • Atovaquone and Proguanil Hydrochloride Tablets are available containing 250 mg of atovaquone, USP and 100 mg of proguanil hydrochloride, USP.
  • Atovaquone and Proguanil Hydrochloride Pediatric Tablets are available containing 62.5 mg of atovaquone, USP and 25 mg of proguanil hydrochloride, USP.
  • No data
  • P. falciparum
  • No data
  • P. falciparumn- Plasmodium vivaxn- P. vivax
  • P. falciparum
  • 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.
  • Arrayn- Array
  • No data
  • No data
  • u00a0
  • P. falciparum
  • 8.6
  • There is no information on overdoses of atovaquone and proguanil hydrochloride tablets 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 31,500 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 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.
  • Atovaquone and proguanil hydrochloride tablets (adult strength) and atovaquone and proguanil hydrochloride pediatric tablets, for oral administration, contain a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride.
  • The chemical name of atovaquone is 2-[-4-(-Chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthoquinone. Atovaquone, USP is a yellow powder 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-(1-methylethyl)biguanide hydrochloride. Proguanil hydrochloride, USP is a white or almost white crystalline powder that is sparingly soluble in water. It has a molecular weight of 290.19 and the molecular formula CHClNu2022HCl. 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 and each atovaquone and proguanil hydrochloride pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride. The inactive ingredients in both tablets are black iron oxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, povidone, red iron oxide, titanium dioxide and yellow iron oxide.
  • No data
  • No data
  • No data
  • Atovaquone and Proguanil Hydrochloride Tablets are available containing 250 mg of atovaquone, USP and 100 mg of proguanil hydrochloride, USP.
  • The 250 mg/100 mg tablets are buff, film-coated, round, unscored tablets debossed with over on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4162-01bottles of 100 tablets
  • Atovaquone and Proguanil Hydrochloride Pediatric Tablets are available containing 62.5 mg of atovaquone, USP and 25 mg of proguanil hydrochloride, USP.
  • The 62.5 mg/25 mg tablets are buff, film-coated, round, unscored tablets debossed with over on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4160-01bottles of 100 tablets
  • Arrayn- Storage Conditions:
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Patients should be instructed:
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n n Hyderabad u2014 500 096, India
  • Revised: 3/201975067629MX:ATPRO:R4
  • NDC 0378-4160-01
  • Atovaquone andn- Proguanil HCln- Pediatric Tabletsn- 62.5 mg/ n- 25 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each film-coated tablet contains:Atovaquone, USPu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a062.5 mgProguanil hydrochloride, USPu00a0u00a0u00a0u00a0u00a025 mg
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Do not use if safety sealunder cap is broken or missing.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX4160A5
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89u00a0u00a0u00a0
  • NDC 0378-4162-01
  • Atovaquone andn- Proguanil HCln- Tabletsn- 250 mg/ n- 100 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each film-coated tablet contains:Atovaquone, USPu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0250 mgProguanil hydrochloride, USPu00a0u00a0u00a0u00a0u00a0100 mg
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Do not use if safety seal under cap is broken or missing.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX4162A5
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89u00a0u00a0

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