Cozaar
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- COZAAR DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS
- PHARMACODYNAMICS
- INDICATIONS & USAGE
- COZAAR CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- COZAAR ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- SPL PATIENT PACKAGE INSERT
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
COZAAR DESCRIPTION
11
CLINICAL PHARMACOLOGY
Mechanism of ActionPHARMACOKINETICS
PharmacokineticsGeneral
Special Populations
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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 EffectsAdult Hypertension
Pediatric Hypertension
DOSAGE AND ADMINISTRATION, Preparation of Suspension
Reduction in the Risk of Stroke
**
Race
Nephropathy in Type 2 Diabetic Patients
INDICATIONS & USAGE
INDICATIONS AND USAGEHypertension
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
CONTRAINDICATIONSWARNINGS
WARNINGSFetal/Neonatal Morbidity and Mortality
HypotensionVolume-Depleted Patients
DOSAGE AND ADMINISTRATION
PRECAUTIONS
GeneralADVERSE REACTIONS, Post-Marketing Experience
Impaired Hepatic Function
DOSAGE AND ADMINISTRATIONCLINICAL PHARMACOLOGY, Pharmacokinetics
Impaired Renal Function
Electrolyte Imbalance
ADVERSE REACTIONS
INFORMATION FOR PATIENTS
Information for PatientsPRECAUTIONS, Drug Interactions
DRUG INTERACTIONS
Drug InteractionsCLINICAL PHARMACOLOGY, Drug Interactions
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Carcinogenesis, Mutagenesis, Impairment of FertilityPREGNANCY
WARNINGS, Fetal/Neonatal Morbidity and MortalityNURSING MOTHERS
Nursing MothersPEDIATRIC USE
Pediatric UseCLINICAL PHARMACOLOGY, Pharmacokinetics, Special PopulationsPharmacodynamics and Clinical EffectsDOSAGE AND ADMINISTRATION
GERIATRIC USE
Geriatric UseRace
COZAAR ADVERSE REACTIONS
ADVERSE REACTIONSHypertension
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*
Hypertensive Patients with Left Ventricular Hypertrophy
Nephropathy in Type 2 Diabetic Patients
Post-Marketing Experience
Laboratory Test Findings
PRECAUTIONS, Impaired Renal Function
OVERDOSAGE
OVERDOSAGEDOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATIONAdult 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)
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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 INSERT3
3
What is the most important information I should know about COZAAR?
What is COZAAR?
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● alone or with other blood pressure medicines to lower high blood pressure (hypertension).
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● 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.
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● 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?
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● 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?
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● are pregnant or planning to become pregnant. SeeWhat is the most important information I should know about COZAAR?
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● 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.
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● are vomiting a lot or having a lot of diarrhea
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● have liver problems
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● have kidney problems
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● potassium supplements
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● salt substitutes containing potassium
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● water pills (diuretics)
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● medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors
How should I take COZAAR?
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● Take COZAAR exactly as prescribed by your doctor. Your doctor may change your dose if needed.
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● COZAAR can be taken with or without food.
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● 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.
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● 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?
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● Injury or death of unborn babies. SeeWhat is the most important information I should know about COZAAR?
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● 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.
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● 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.
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● 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.
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● colds(upper respiratory infection)
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● dizziness
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● stuffy nose
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● back pain
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● diarrhea
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● tiredness
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● low blood sugar
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● chest pain
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● high blood potassium
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● low blood pressure
How do I store COZAAR?
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● Store COZAAR tablets at 59to 86(15to 30
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● Keep COZAAR in a tightly closed container that protects the medicine from light.
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● 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
CozaarCozaar TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!