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ATOVAQUONE AND PROGUANIL HCL- atovaquone and proguanil hydrochloride tablet, film coated


  1. Patients Should Be Instructed:
  2. Manufactured By:
  3. Manufactured For:
  4. Revised: 8/2019document Id:

Patients Should Be Instructed: 

  • to take Atovaquone and Proguanil Hydrochloride tablets at the same time each day with food or a milky drink.
  • to take a repeat dose of Atovaquone and Proguanil Hydrochloride tablets if vomiting occurs within 1 hour after dosing.
  • to take a dose as soon as possible if a dose is missed, then return to their normal dosing schedule. However, if a dose is skipped, the patient should not double the next dose.
  • that rare serious adverse events such as hepatitis, severe skin reactions, neurological events, and hematological events have been reported when atovaquone and proguanil hydrochloride was used for the prophylaxis or treatment of malaria.
  • to consult a healthcare professional regarding alternative forms of prophylaxis if prophylaxis with Atovaquone and Proguanil Hydrochloride tablets is prematurely discontinued for any reason.
  • that protective clothing, insect repellents, and bed nets are important components of malaria prophylaxis.
  • that no chemoprophylactic regimen is 100% effective; therefore, patients should seek medical attention for any febrile illness that occurs during or after return from a malaria endemic area and inform their healthcare professional that they may have been exposed to malaria.
  • that falciparum malaria carries a higher risk of death and serious complications in pregnant women than in the general population. Pregnant women anticipating travel to malarious areas should discuss the risks and benefits of such travel with their physicians.

Manufactured By: 

GlaxoSmithKline

Research Triangle Park, NC 27709

Manufactured For: 

Prasco Laboratories

Mason, OH 45040 USA

APH-PS:3PI

PRINCIPAL DISPLAY PANEL

Atovaquone and Proguanil HCl

Tablets

Each tablet contains 250 mg atovaquone and 100 mg proguanil HCl.

Rxonly

See accompanying prescribing information for Dosage and Administration.

Do not use if printed safety seal under cap is broken or missing.

image

ATOVAQUONE AND PROGUANIL HCL
atovaquone and proguanil hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43063-522(NDC:66993-060)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOVAQUONE(UNII: Y883P1Z2LT) (ATOVAQUONE - UNII:Y883P1Z2LT)ATOVAQUONE250 mg
PROGUANIL HYDROCHLORIDE(UNII: R71Y86M0WT) (PROGUANIL - UNII:S61K3P7B2V)PROGUANIL HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient NameStrength
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLOXAMER 188(UNII: LQA7B6G8JG)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeGX;CM3
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43063-522-077 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2015
2NDC:43063-522-1414 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2015
3NDC:43063-522-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2015
4NDC:43063-522-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2015
5NDC:43063-522-68190 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2015
6NDC:43063-522-69280 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2015
7NDC:43063-522-73375 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02107807/27/2012
Labeler -PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant -PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-522)

Revised: 8/2019document Id: 

90cffdc5-5f5f-4f6a-e053-2995a90ac30cSet id: dcf43cbd-fc97-4dc1-a258-afad6cf4cabfVersion: 17Effective Time: 20190823PD-Rx Pharmaceuticals, Inc.



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