Lisinopril and Hydrochlorothiazide
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- LISINOPRIL AND HYDROCHLOROTHIAZIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- LISINOPRIL AND HYDROCHLOROTHIAZIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- LISINOPRIL AND HYDROCHLOROTHIAZIDE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
LISINOPRIL AND HYDROCHLOROTHIAZIDE DESCRIPTION
CLINICAL PHARMACOLOGY
Lisinopril-HydrochlorothiazideDOSAGE AND ADMINISTRATION
Lisinopril
Mechanism of Action
PRECAUTIONS
Pharmacokinetics and Metabolism
DOSAGE AND ADMINISTRATION
Pharmacodynamics
WARNINGS
PRECAUTIONS
Hydrochlorothiazide
INDICATIONS & USAGE
DOSAGE AND ADMINISTRATION
WARNINGS
WARNINGS, Head and Neck Angioedema
LISINOPRIL AND HYDROCHLOROTHIAZIDE CONTRAINDICATIONS
WARNINGS
GeneralLisinopril
Anaphylactoid and Possibly Related Reactions:
Head and Neck Angioedema:
ADVERSE REACTIONS
INDICATIONS AND USAGECONTRAINDICATIONS
Intestinal Angioedema:
Anaphylactoid reactions during desensitization:
Anaphylactoid reactions during membrane exposure:
Hypotension and Related Effects:
PRECAUTIONS, Drug InteractionsADVERSE REACTIONS
PRECAUTIONS, Drug InteractionsADVERSE REACTIONSDOSAGE AND ADMINISTRATION
Neutropenia/Agranulocytosis:
Hepatic Failure:
Hydrochlorothiazide
PRECAUTIONS, Drug InteractionsLisinoprilHydrochlorothiazide
Pregnancy
Lisinopril-Hydrochlorothiazide
Lisinopril, Fetal/Neonatal Morbidity and Mortality
Lisinopril
Fetal/Neonatal Morbidity and Mortality:
Hydrochlorothiazide
PRECAUTIONS
GeneralLisinopril
Aortic Stenosis/Hypertrophic Cardiomyopathy:
Impaired Renal Function:
DOSAGE AND ADMINISTRATION
Hyperkalemia:
Drug Interactions
Cough:
Surgery/Anesthesia:
Hydrochlorothiazide
Drug Interactions, Agents Increasing Serum Potassium
INFORMATION FOR PATIENTS
Angioedema:Symptomatic Hypotension:
Hyperkalemia:
Neutropenia:
Pregnancy:
DRUG INTERACTIONS
LisinoprilHypotensionPatients on Diuretic Therapy:
WARNINGSDOSAGE AND ADMINISTRATIONDOSAGE AND ADMINISTRATION
Non-steroidal Anti-inflammatory Agents Including Selective Cyclooxygenase-2 (COX-2) Inhibitors:
Other Agents:
Agents Increasing Serum Potassium:
Lithium:
Gold:
Hydrochlorothiazide
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Carcinogenesis, Mutagenesis, Impairment of FertilityLisinopril-Hydrochlorothiazide
Lisinopril
Hydrochlorothiazide
PREGNANCY
Teratogenic EffectsWARNINGS, Pregnancy, Lisinopril, Fetal/Neonatal Morbidity and Mortality
NURSING MOTHERS
PEDIATRIC USE
Pediatric UseGERIATRIC USE
DOSAGE AND ADMINISTRATION
LISINOPRIL AND HYDROCHLOROTHIAZIDE ADVERSE REACTIONS
WARNINGS
Lisinopril-HydrochlorothiazidePlacebo(n=930)(n=207)IncidenceIncidence(discontinuation)
WARNINGS
WARNINGS
PRECAUTIONS, Cough
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS
WARNINGS, Hepatic Failure
WARNINGS, Anaphylactoid and Possibly Related ReactionsWARNINGS, HypotensionWARNINGS, Hepatic FailurePRECAUTIONSDOSAGE AND ADMINISTRATION
WARNINGS, Pregnancy, Lisinopril, Fetal/Neonatal Morbidity and Mortality
WARNINGS
OVERDOSAGE
OVERDOSAGELisinopril
WARNINGS, Anaphylactoid reactions during membrane exposure
Hydrochlorothiazide
DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATIONWARNINGS
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
Dose Titration Guided by Clinical Effect
A patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg or lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2-3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve similar or greater blood pressure control with less potassium loss if they are switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg. Dosage higher than lisinopril 80 mg and hydrochlorothiazide 50 mg should not be used.
Replacement Therapy
The combination may be substituted for the titrated individual components.
Use in Renal Impairment
The usual regimens of therapy with lisinopril and hydrochlorothiazide tablets need not be adjusted as long as the patient's creatinine clearance is >30 mL/min/1.73 m2 (serum creatinine approximatelymg/dL or 265In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril and hydrochlorothiazide tablets are not recommended (seeWARNINGS, Anaphylactoid reactions during membrane exposure
HOW SUPPLIED
INACTIVE INGREDIENT
INACTIVE INGREDIENTS:ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
MANNITOL
STARCH, CORN
FERRIC OXIDE RED
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Lisinopril and HydrochlorothiazideLisinopril and Hydrochlorothiazide TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
