LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE  - losartan potassium and hydrochlorothiazide tablet, film coated 
Greenstone LLC

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losartan potassium and hydrochlorothiazide tablets, USP

USE IN PREGNANCY


When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, losartan potassium and hydrochlorothiazide should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

DESCRIPTION


1

p- o H 22 22 6
Losartan Potassium Chemical Structure





H 7 8 3 4 2
Hydrochlorothiazide Chemical Structure





CLINICAL PHARMACOLOGY

Mechanism of Action


1 2 1 1 2 In vitro 1 1





Pharmacokinetics

General

Losartan Potassium




max



14 In vitro

14 14

Special Populations

Pediatric


PRECAUTIONS, Pediatric Use

Geriatric and Gender


Race


PRECAUTIONS, Race  CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke, Race

Renal Insufficiency

Losartan

Hydrochlorothiazide



DOSAGE AND ADMINISTRATION

Hepatic Insufficiency


DOSAGE AND ADMINISTRATION

Drug Interactions

Losartan Potassium


Hydrochlorothiazide




Pharmacodynamics and Clinical Effects

Losartan Potassium

Hypertension












Reduction in the Risk of Stroke










Race


Losartan Potassium and Hydrochlorothiazide






Severe Hypertension (Sitting Diastolic Blood Pressure [SiDBP] ≥110 mmHg)








ADVERSE REACTIONS, Severe Hypertension

INDICATIONS AND USAGE

Hypertension


CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects DOSAGE AND ADMINISTRATION

Hypertensive Patients with Left Ventricular Hypertrophy


PRECAUTIONS, Race, CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke, Race, DOSAGE AND ADMINISTRATION

CONTRAINDICATIONS




WARNINGS

Fetal/Neonatal Morbidity and Mortality














in utero



Hypotension — Volume-Depleted Patients


DOSAGE AND ADMINISTRATION

Impaired Hepatic Function

Losartan Potassium and Hydrochlorothiazide


Hydrochlorothiazide


Hypersensitivity Reaction


Systemic Lupus Erythematosus


Lithium Interaction


PRECAUTIONS, Drug Interactions, Hydrochlorothiazide, Lithium

PRECAUTIONS

General

Hypersensitivity


ADVERSE REACTIONS, Post-Marketing Experience

Losartan Potassium and Hydrochlorothiazide


Hydrochlorothiazide


























Impaired Renal Function








Information for Patients

Pregnancy


Symptomatic Hypotension




Potassium Supplements


PRECAUTIONS, Drug Interactions, Losartan Potassium

Drug Interactions

Losartan Potassium


CLINICAL PHARMACOLOGY, Drug Interactions

PRECAUTIONS, Information for Patients, Potassium Supplements

Lithium


Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors




Hydrochlorothiazide




Alcohol, barbiturates, or narcotics 


Antidiabetic drugs


Other antihypertensive drugs


Cholestyramine and colestipol resins


Corticosteroids, ACTH


Pressor amines (e.g., norepinephrine)


Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine)


Lithium


Non-steroidal Anti-inflammatory Drugs including Selective Cyclooxygenase-2 Inhibitors

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Losartan Potassium and Hydrochlorothiazide




in vitro in vitro

Losartan Potassium




in vitro in vitro in vivo in vitro in vitro

Hydrochlorothiazide




in vitro Salmonella typhimurium in vivo Drosophila in vitro Aspergillus nidulans

Pregnancy


WARNINGS, Fetal/Neonatal Morbidity and Mortality

Nursing Mothers


Pediatric Use


Geriatric Use


CLINICAL PHARMACOLOGY, Special Populations

Race


CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects; Losartan Potassium, Reduction in the Risk of Stroke

ADVERSE REACTIONS







 
   Losartan Potassium and    
   Hydrochlorothiazide   
(n=858)
   Placebo   
   (n=173)   
   Body as a Whole
 
 
      Abdominal pain
1.2
0.6
      Edema/swelling
1.3
1.2
   Cardiovascular
 
 
      Palpitation
1.4
0
   Musculoskeletal
 
 
      Back pain
2.1
0.6
   Nervous/Psychiatric
 
 
      Dizziness
5.7
2.9
   Respiratory
 
 
      Cough
2.6
2.3
      Sinusitis
1.2
0.6
      Upper respiratory infection 
6.1
4.6
   Skin
 
 
       Rash
1.4
0







Losartan Potassium




Body as a Whole:
Cardiovascular: Digestive: General disorders and administration site conditions: Hematologic: Metabolic: Musculoskeletal: Nervous System/Psychiatric: Respiratory: Skin: Special Senses: Urogenital:

Hydrochlorothiazide




Body as a Whole: 
Digestive: Hematologic: Hypersensitivity: Metabolic: Musculoskeletal: Nervous System/Psychiatric: Renal: Skin: Special Senses:

*
Demographics = (89% Caucasian, 64% female)
Demographics = (90% Caucasian, 51% female)
Study 1*
   HCTZ   
   Losartan   
   Lisinopril   
Cough
   25%   
   17%   
   69%   
Study 2
   Placebo   
   Losartan   
   Lisinopril   
Cough
   35%   
   29%   
   62%   



Severe Hypertension


CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Severe Hypertension

Post-Marketing Experience




Digestive: 


Hemic: 


Hypersensitivity: 


Metabolic and Nutrition:


Musculoskeletal: 


Respiratory:  


Skin:

Laboratory Test Findings


Creatinine, Blood Urea Nitrogen


Hemoglobin and Hematocrit


Liver Function Tests


Serum Electrolytes


PRECAUTIONS

OVERDOSAGE

Losartan Potassium


2



Hydrochlorothiazide


50

DOSAGE AND ADMINISTRATION

Hypertension


WARNINGS, Hypotension — Volume-Depleted Patients WARNINGS, Impaired Hepatic Function





WARNINGS

Replacement Therapy


Dose Titration by Clinical Effect






Use in Patients with Renal Impairment


Patients with Hepatic Impairment


WARNINGS, Impaired Hepatic Function

Severe Hypertension


CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects WARNINGS, Impaired Hepatic Function WARNINGS, Hypotension —Volume-Depleted Patients

Hypertensive Patients with Left Ventricular Hypertrophy


CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke



HOW SUPPLIED


Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg




Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg




Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg




Store at

Patient Information


losartan potassium and hydrochlorothiazide tablets, USP
Rx only



What is the most important information I should know about losartan potassium and hydrochlorothiazide tablets?


Do not take losartan potassium and hydrochlorothiazide tablets if you are pregnant or plan to become pregnant. Losartan potassium and hydrochlorothiazide tablets can harm your unborn baby causing injury and even death. Stop taking losartan potassium and hydrochlorothiazide tablets if you become pregnant and call your doctor right away.

What are losartan potassium and hydrochlorothiazide tablets?




Losartan potassium and hydrochlorothiazide tablets have not been studied in children less than 18 years old.

High Blood Pressure (hypertension)

Left Ventricular Hypertrophy (LVH) is an enlargement


Who should not take losartan potassium and hydrochlorothiazide tablets?




What should I tell my doctor before taking losartan potassium and hydrochlorothiazide tablets?

Tell your doctor about all your medical conditions including if you:

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.




How should I take losartan potassium and hydrochlorothiazide tablets?


What are the possible side effects of losartan potassium and hydrochlorothiazide tablets?




not

How should I store losartan potassium and hydrochlorothiazide tablets?


General information about losartan potassium and hydrochlorothiazide tablets





What are the ingredients in losartan potassium and hydrochlorothiazide tablets?


Active ingredients:


Inactive ingredients:


GREENSTONE® BRAND
Distributed by:                     
Greenstone LLC




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg/12.5 mg (30 Tablet Bottle)


NDC 59762-0011-1
30 Tablets
GREENSTONE® BRAND
losartan potassium and
hydrochlorothiazide tablets, USP

50 mg/12.5 mg*
PHARMACIST: PLEASE DISPENSE WITH
ATTACHED PATIENT INFORMATION LEAFLET

Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg/12.5 mg (30 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg/12.5 mg (30 Tablet Bottle)


NDC 59762-0012-1
30 Tablets
GREENSTONE® BRAND
losartan potassium and
hydrochlorothiazide tablets, USP

100 mg/12.5 mg*
PHARMACIST: PLEASE DISPENSE WITH
ATTACHED PATIENT INFORMATION LEAFLET

Rx only
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg/12.5 mg (30 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg/25 mg (30 Tablet Bottle)


NDC 59762-0015-1
30 Tablets
GREENSTONE® BRAND
losartan potassium and
hydrochlorothiazide tablets, USP

100 mg/25 mg*
PHARMACIST: PLEASE DISPENSE WITH
ATTACHED PATIENT INFORMATION LEAFLET

Rx only
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg/25 mg (30 Tablet Bottle)

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 
losartan potassium and hydrochlorothiazide   tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59762-0011
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 50 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
HYDROXYPROPYL CELLULOSE  
HYPROMELLOSE 2910 (6 CPS)  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
TITANIUM DIOXIDE  
D&C YELLOW NO. 10  
Product Characteristics
Color YELLOW Score no score
Shape OVAL (Beveled Edge, Biconvex) Size 11mm
Flavor Imprint Code E;48
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 59762-0011-1 30 TABLET In 1 BOTTLE None
2 59762-0011-2 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091629 10/04/2010

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 
losartan potassium and hydrochlorothiazide   tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59762-0012
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 100 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
HYDROXYPROPYL CELLULOSE  
HYPROMELLOSE 2910 (6 CPS)  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape OVAL (Beveled Edge, Biconvex) Size 17mm
Flavor Imprint Code F;74
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 59762-0012-1 30 TABLET In 1 BOTTLE None
2 59762-0012-2 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091629 10/04/2010

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 
losartan potassium and hydrochlorothiazide   tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59762-0015
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 100 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
HYDROXYPROPYL CELLULOSE  
HYPROMELLOSE 2910 (6 CPS)  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
TITANIUM DIOXIDE  
D&C YELLOW NO. 10  
Product Characteristics
Color YELLOW Score no score
Shape OVAL (Beveled Edge, Biconvex) Size 17mm
Flavor Imprint Code E;49
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 59762-0015-1 30 TABLET In 1 BOTTLE None
2 59762-0015-2 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091629 10/04/2010

Labeler - Greenstone LLC (825560733)
Revised: 09/2010 Greenstone LLC