Cozaar description, usages, side effects, indications, overdosage, supplying and lots more!

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Cozaar

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

USE IN PREGNANCY
WARNINGS, Fetal/Neonatal Morbidity and Mortality

COZAAR DESCRIPTION

1

Cozaar





1




CLINICAL PHARMACOLOGY

Mechanism of Action



PHARMACOKINETICS

Pharmacokinetics

General







Special Populations



****



DOSAGE AND ADMINISTRATION, Preparation of Suspension
DOSAGE AND ADMINISTRATION
PRECAUTIONS, RaceCLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of StrokeRace
WARNINGS, HypotensionVolume-Depleted PatientsDOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION

Drug Interactions


PHARMACODYNAMICS

Pharmacodynamics and Clinical Effects

Adult Hypertension








Pediatric Hypertension
DOSAGE AND ADMINISTRATION, Preparation of Suspension

Reduction in the Risk of Stroke



Cozaar


Cozaar





**







Cozaar



Race


Nephropathy in Type 2 Diabetic Patients





Cozaar












INDICATIONS & USAGE

INDICATIONS AND USAGE

Hypertension


Hypertensive Patients with Left Ventricular Hypertrophy
PRECAUTIONS, RaceCLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of StrokeRace

Nephropathy in Type 2 Diabetic Patients
CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects

COZAAR CONTRAINDICATIONS

CONTRAINDICATIONS


WARNINGS

WARNINGS

Fetal/Neonatal Morbidity and Mortality









HypotensionVolume-Depleted Patients
DOSAGE AND ADMINISTRATION

PRECAUTIONS

General
ADVERSE REACTIONS, Post-Marketing Experience

Impaired Hepatic Function
DOSAGE AND ADMINISTRATIONCLINICAL PHARMACOLOGY, Pharmacokinetics

Impaired Renal Function




Electrolyte Imbalance
ADVERSE REACTIONS

INFORMATION FOR PATIENTS

Information for Patients

PRECAUTIONS, Drug Interactions

DRUG INTERACTIONS

Drug Interactions
CLINICAL PHARMACOLOGY, Drug Interactions





CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis, Mutagenesis, Impairment of Fertility




PREGNANCY

WARNINGS, Fetal/Neonatal Morbidity and Mortality

NURSING MOTHERS

Nursing Mothers


PEDIATRIC USE

Pediatric Use
CLINICAL PHARMACOLOGY, Pharmacokinetics, Special PopulationsPharmacodynamics and Clinical EffectsDOSAGE AND ADMINISTRATION

GERIATRIC USE

Geriatric Use


Race


COZAAR ADVERSE REACTIONS

ADVERSE REACTIONS

Hypertension










*
*






Hypertensive Patients with Left Ventricular Hypertrophy


Nephropathy in Type 2 Diabetic Patients



Post-Marketing Experience











Laboratory Test Findings

PRECAUTIONS, Impaired Renal Function



OVERDOSAGE

OVERDOSAGE




DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION

Adult Hypertensive Patients

WARNINGS, HypotensionVolume-Depleted PatientsPRECAUTIONS, General
CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension
CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension


Pediatric Hypertensive Patientsyears of age
Preparation of SuspensionCLINICAL PHARMACOLOGY, Pharmacokinetics, Special PopulationsPharmacodynamics and Clinical EffectsWARNINGS, HypotensionVolume-Depleted Patients
CLINICAL PHARMACOLOGY, Pharmacokinetics, Special PopulationsPharmacodynamics and Clinical EffectsPRECAUTIONS

Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension)
22

2


Hypertensive Patients with Left Ventricular Hypertrophy
CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke

Nephropathy in Type 2 Diabetic Patients
CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Nephropathy in Type 2 Diabetic Patients

HOW SUPPLIED













STORAGE AND HANDLING





SPL PATIENT PACKAGE INSERT

PATIENT PACKAGE INSERT





3

3




What is the most important information I should know about COZAAR?


What is COZAAR?

  • ●     alone or with other blood pressure medicines to lower high blood pressure (hypertension).
  • ●     to lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy. COZAAR may not help Black patients with this problem.
  • ●     to slow the worsening of diabetic kidney disease (nephropathy) in patients with type 2 diabetes who have or had high blood pressure.





Who should not take COZAAR?
  • ●      Do not take COZAAR if you are allergic to any of the ingredients in COZAAR. See the end of this leaflet for a complete list of ingredients in COZAAR.

What should I tell my doctor before taking COZAAR?

  • ●     are pregnant or planning to become pregnant. SeeWhat is the most important information I should know about COZAAR?
  • ●     are breast-feeding. It is not known if COZAAR passes into your breast milk. You should choose either to take COZAAR or breast-feed, but not both.
  • ●     are vomiting a lot or having a lot of diarrhea
  • ●     have liver problems
  • ●     have kidney problems

  • ●     potassium supplements
  • ●     salt substitutes containing potassium
  • ●     water pills (diuretics)
  • ●     medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors

How should I take COZAAR?
  • ●      Take COZAAR exactly as prescribed by your doctor. Your doctor may change your dose if needed.
  • ●     COZAAR can be taken with or without food.
  • ●     If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
  • ●     If you take too much COZAAR, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.

What are the possible side effects of COZAAR?

  • ●     Injury or death of unborn babies. SeeWhat is the most important information I should know about COZAAR?
  • ●     Allergic reaction. Symptoms of an allergic reaction are swelling of the face, lips, throat or tongue. Get emergency medical help right away and stop taking COZAAR.
  • ●     Low blood pressure (hypotension). Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy. Call your doctor right away.
  • ●     For people who already have kidney problems, you may see a worsening in how well your kidneys work. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain.

  • ●     colds(upper respiratory infection)
  • ●     dizziness
  • ●     stuffy nose
  • ●     back pain

  • ●     diarrhea
  • ●     tiredness
  • ●     low blood sugar
  • ●     chest pain
  • ●     high blood potassium
  • ●     low blood pressure



How do I store COZAAR?
  • ●      Store COZAAR tablets at 59to 86(15to 30
  • ●     Keep COZAAR in a tightly closed container that protects the medicine from light.
  • ●     Keep COZAAR and all medicines out of the reach of children.

General information about COZAAR



What are the ingredients in COZAAR?









This is a representative sample of the packaging. Please see How Supplied section for a complete list of available packaging.

PRINCIPAL DISPLAY PANEL - Bottle Label 25 mg

















INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
CELLULOSE, MICROCRYSTALLINE

LACTOSE MONOHYDRATE
STARCH, CORN
magnesium stearate
hydroxypropyl cellulose
HYPROMELLOSES
titanium dioxide
CARNAUBA WAX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Cozaar

Cozaar

Cozaar

Cozaar TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-138(NDC:0006-0951-54)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM LOSARTAN 25 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
lactose monohydrate
STARCH, CORN
MAGNESIUM STEARATE
hydroxypropyl cellulose
HYPROMELLOSES
titanium dioxide
carnauba wax

Product Characteristics

Color Size Imprint Code Shape
white 8 mm 951 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-138-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020386 2011-04-07


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Be sure to consult your doctor before taking any medication!
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