Atovaquone and Proguanil Hydrochloride (Page 6 of 6)

17 PATIENT COUNSELING INFORMATION

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 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, 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 is prematurely discontinued for any reason.
that protective clothing, insect repellents, and bednets 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:

Glenmark Pharmaceuticals Ltd

Colvale-Bardez, Goa 403 513, India

For BluePoint Laboratories

Questions? 1 (888)721-7115

Rev December 2019

Package/Label Display Panel

Bottle Label

Atovaquone and Proguanil Hydrochloride Tablets 250 mg/100 mg

NDC 68001-245-00, 100 Tablets

Atovaquone and Proguanil HCl Tablets 250_100mg 100CT Label Rev 03/17
(click image for full-size original)
Atovaquone and Proguanil HCL rev 05 20 Label
(click image for full-size original)

Package/Label Display Panel

Carton Label

Atovaquone and Proguanil Hydrochloride Tablets 250 mg/100 mg

NDC 68001-245-15, 24 (2 x 12) Unit Dose Tablets

Atovaquone and Proguanil HCl Tablets 250_100mg 24 Unit Dose Tablets Carton Label Rev 02/17
(click image for full-size original)
Atovaquone and Proguanil HCL Tablets rev 05 20 carton
(click image for full-size original)
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
atovaquone and proguanil hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-245
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOVAQUONE (ATOVAQUONE) ATOVAQUONE 250 mg
PROGUANIL HYDROCHLORIDE (PROGUANIL) PROGUANIL HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
POLOXAMER 188
POVIDONE K30
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK (pinkish brown to brown) Score no score
Shape ROUND (circular, biconvex, beveled edge) Size 11mm
Flavor Imprint Code 404;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-245-00 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68001-245-15 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68001-245-14)
2 NDC:68001-245-14 12 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68001-245-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091211 03/13/2014
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
Glenmark Generics Limited 677318665 ANALYSIS (68001-245), MANUFACTURE (68001-245)

Revised: 06/2020 BluePoint Laboratories

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