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

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Ramipril

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus.
WARNINGS: Fetal/neonatal morbidity and mortality

RAMIPRIL DESCRIPTION



Ramipril





CLINICAL PHARMACOLOGY

Mechanism of Action
PRECAUTIONS




PHARMACOKINETICS AND METABOLISM









DOSAGE AND ADMINISTRATION


PHARMACODYNAMICS AND CLINICAL TRIALS

Hypertension
WARNINGS
DOSAGE AND ADMINISTRATION






INDICATIONS & USAGE

Hypertension

WARNINGS
WARNINGSAngioedema

RAMIPRIL CONTRAINDICATIONS



WARNINGS

Anaphylactoid and Possibly Related Reactions


Head and Neck Angioedema
CONTRAINDICATIONS
ADVERSE REACTIONS

Intestinal Angioedema





Hypotension




Hepatic Failure


Neutropenia/Agranulocytosis


Fetal/Neonatal Morbidity and Mortality








PRECAUTIONS

Impaired Renal Function


DOSAGE AND ADMINISTRATION

Hyperkalemia
Drug Interactions

Cough


Impaired Liver Function


Surgery/Anesthesia


INFORMATION FOR PATIENTS








DRUG INTERACTIONS


DOSAGE AND ADMINISTRATION




CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

WARNINGS: Fetal/Neonatal Morbidity and Mortality.

NURSING MOTHERS



GERIATRIC USE




PEDIATRIC USE



RAMIPRIL ADVERSE REACTIONS

Hypertension



RAMIPRIL (n=651)Placebo (n=286)n%n%

WARNINGS
WARNINGSPRECAUTIONS

WARNINGS
WARNINGS




WARNINGSFetal/Neonatal Morbidity and Mortality


Post-Marketing Experience


Clinical Laboratory Test Findings

Creatinine and Blood Urea Nitrogen
WARNINGSPRECAUTIONSWARNINGSPRECAUTIONS

Hemoglobin and Hematocrit


Other (causal relationships unknown)


OVERDOSAGE






DOSAGE & ADMINISTRATION



Hypertension

WARNINGSPRECAUTIONS, Drug Interactions

PRECAUTIONS
WARNINGS


Dosage Adjustment in Renal Impairment
CLINICAL PHARMACOLOGY


HOW SUPPLIED









STORAGE AND HANDLING



INFORMATION FOR PATIENTS

Angioedema

Neutropenia

Symptomatic Hypotension


Pregnancy

Hyperkalemia





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Ramipril

Ramipril

Ramipril

Ramipril CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-313(NDC:0054-0109)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ramipril RAMIPRILAT 10 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 28
FD&C BLUE NO. 1
GELATIN
STARCH, CORN
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
blue 1 mm 54;602 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-313-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077900 2011-08-22


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Be sure to consult your doctor before taking any medication!
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