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

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Lisinopril and Hydrochlorothiazide

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

WARNINGS

USE IN PREGNANCY
WARNINGSPregnancyLisinopril, Fetal/Neonatal Morbidity and Mortality

LISINOPRIL AND HYDROCHLOROTHIAZIDE DESCRIPTION




Lisinopril and Hydrochlorothiazide









CLINICAL PHARMACOLOGY




DOSAGE AND ADMINISTRATION


PRECAUTIONS






DOSAGE AND ADMINISTRATION


WARNINGS




PRECAUTIONS






INDICATIONS & USAGE


DOSAGE AND ADMINISTRATION
WARNINGS
WARNINGSLisinopril

LISINOPRIL AND HYDROCHLOROTHIAZIDE CONTRAINDICATIONS



WARNINGS

Lisinopril

ADVERSE REACTIONS
INDICATIONS AND USAGECONTRAINDICATIONS

Anaphylactoid Reactions During Desensitization:


Anaphylactoid Reactions During Membrane Exposure:


Hypotension and Related Effects
PRECAUTIONSDrug InteractionsADVERSE REACTIONS
PRECAUTIONSDrug InteractionsADVERSE REACTIONSDOSAGE AND ADMINISTRATION



Leukopenia/Neutropenia/Agranulocytosis:


Hepatic Failure:


Pregnancy


Lisinopril, Fetal/Neonatal Morbidity and Mortality

Lisinopril

Fetal/Neonatal Morbidity and Mortality:








Hydrochlorothiazide

Teratogenic Effects:


Nonteratogenic Effects:


Hydrochlorothiazide




PRECAUTIONSDrug Interactions, LisinoprilHydrochlorothiazide

PRECAUTIONS

General


Aortic Stenosis/Hypertrophic Cardiomyopathy:


Impaired Renal Function:



DOSAGE AND ADMINISTRATION

Hyperkalemia:
Drug Interactions

Cough:


Surgery/Anesthesia:





Drug Interactions, Agents Increasing Serum Potassium








INFORMATION FOR PATIENTS

Information for Patients







DRUG INTERACTIONS

Lisinopril
WARNINGSDOSAGE AND ADMINISTRATIONDOSAGE AND ADMINISTRATION



Agents Increasing Serum Potassium:


Lithium:


Hydrochlorothiazide












CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY













PREGNANCY


WARNINGSPregnancyLisinopril, Fetal/Neonatal Morbidity and Mortality

NURSING MOTHERS



PEDIATRIC USE

Pediatric Use


GERIATRIC USE




LISINOPRIL AND HYDROCHLOROTHIAZIDE ADVERSE REACTIONS



WARNINGS




WARNINGS

WARNINGS
PRECAUTIONSCough

PRECAUTIONS
PRECAUTIONS
PRECAUTIONS

WARNINGSHepatic Failure

WARNINGSAnaphylactoid Reactions During Membrane ExposureWARNINGSHypotensionWARNINGSHepatic FailurePRECAUTIONSDOSAGE AND ADMINISTRATION

WARNINGSPregnancyLisinopril, Fetal/Neonatal Morbidity and Mortality
WARNINGSHepatic FailureWARNINGS

OVERDOSAGE



WARNINGSAnaphylactoid Reactions During Membrane Exposure


DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION

WARNINGS
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/HCTZ 10/12.5 or lisinopril/HCTZ 20/12.5, depending on current monotherapy dose. Further increases of either or both components could depend on clinical response with blood pressure measured at the interdosing interval to ensure that there is an adequate antihypertensive effect at that time. The hydrochlorothiazide dose should generally not be increased until 2-3 weeks have elapsed. After addition of the diuretic it may be possible to reduce the dose of lisinopril. 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 without electrolyte disturbance if they are switched to lisinopril/HCTZ 10/12.5.
In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of lisinopril. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with lisinopril to reduce the likelihood of hypotension. (SeeWARNINGS

WARNINGSPRECAUTIONSDrug Interactions
PRECAUTIONS



WARNINGSAnaphylactoid Reactions During Membrane Exposure

HOW SUPPLIED





STORAGE AND HANDLING














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Lisinopril and Hydrochlorothiazide



Lisinopril and Hydrochlorothiazide



Lisinopril and Hydrochlorothiazide

Lisinopril and Hydrochlorothiazide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-209(NDC:0591-0861)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LISINOPRIL LISINOPRIL ANHYDROUS 20 mg
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 2
MAGNESIUM STEARATE
mannitol
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
blue 10 mm WATSON;861 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-209-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076194 2011-04-22


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