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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
COZAAR DESCRIPTION
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1
CLINICAL PHARMACOLOGY
Mechanism of ActionPHARMACOKINETICS
GeneralSpecial 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
Adult HypertensionPediatric Hypertension
DOSAGE AND ADMINISTRATION, Preparation of Suspension
Reduction in the Risk of Stroke
**
Race
Nephropathy in Type 2 Diabetic Patients
INDICATIONS & USAGE
HypertensionHypertensive 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
WARNINGS
Fetal/Neonatal Morbidity and MortalityHypotensionVolume-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
PRECAUTIONS, Drug Interactions
DRUG INTERACTIONS
CLINICAL PHARMACOLOGY, Drug InteractionsCARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
WARNINGS, Fetal/Neonatal Morbidity and MortalityNURSING MOTHERS
PEDIATRIC USE
CLINICAL PHARMACOLOGY, Pharmacokinetics, Special PopulationsPharmacodynamics and Clinical EffectsDOSAGE AND ADMINISTRATIONGERIATRIC USE
COZAAR 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
DOSAGE & ADMINISTRATION
Adult Hypertensive PatientsWARNINGS, 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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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
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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?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
CozaarCozaar TABLET, FILM COATED
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
