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

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Captopril

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

USE IN PREGNANCY
WARNINGS: Fetal/Neonatal Morbidity and Mortality

CAPTOPRIL DESCRIPTION



Captopril





CLINICAL PHARMACOLOGY

Mechanism of Action






PHARMACOKINETICS


DOSAGE AND ADMINISTRATION

PHARMACODYNAMICS














INDICATIONS & USAGE

Hypertension

WARNINGS



Heart Failure


Left Ventricular Dysfunction After Myocardial Infarction


Diabetic Nephropathy

WARNINGS: Head and Neck AngioedemaIntestinal Angioedema

CAPTOPRIL CONTRAINDICATIONS



WARNINGS

Anaphylactoid and Possibly Related Reactions


Head and Neck Angioedema

PRECAUTIONS: Information for PatientsADVERSE REACTIONS

Intestinal Angioedema


Anaphylactoid reactions during desensitization


Anaphylactoid reactions during membrane exposure


Neutropenia/Agranulocytosis














Proteinuria


Hypotension
PRECAUTIONS: Drug Interactions




Fetal/Neonatal Morbidity and Mortality








Hepatic Failure


PRECAUTIONS

General

Impaired Renal Function

Hypertension


Heart Failure

SeeCLINICAL PHARMACOLOGY,DOSAGE AND ADMINISTRATION,ADVERSE REACTIONS: Altered Laboratory Findings.

Hyperkalemia
PRECAUTIONS: Information for PatientsandDrug InteractionsADVERSE REACTIONS: Altered Laboratory Findings.)

Cough
Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough.

Valvular Stenosis
There is concern, on theoretical grounds, that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators because they do not develop as much afterload reduction as others.

Surgery/Anesthesia
In patients undergoing major surgery or during anesthesia with agents that produce hypotension, captopril will block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.

Hemodialysis
Recent clinical observations have shown an association of hypersensitivity-like (anaphylactoid) reactions during hemodialysis with high-flux dialysis membranes (e.g., AN69) in patients receiving ACE inhibitors. In these patients, consideration should be given to using a different type of dialysis membrane of a different class medication. (SeeWARNINGS: Anaphylactoid reactions during membrane exposure.)

INFORMATION FOR PATIENTS

WARNINGS: Head and Heck AngioedemaIntestinal Angioedema


PRECAUTIONS: GeneralDrug InteractionsADVERSE REACTIONS.)
Patients should be warned against interruption or discontinuation of medication unless instructed by the physician.
Heart failure patients on captopril therapy should be cautioned against rapid increases in physical activity.
Patients should be informed that captopril should be taken one hour before meals (seeDOSAGE AND ADMINISTRATION).

Pregnancy
Female patients of childbearing age should be told about the consequences of second- and third-trimester exposure to ACE-inhibitors, and they should also be told that these consequences do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physicians as soon as possible.

DRUG INTERACTIONS

Hypotension-Patients on Diuretic Therapy



Agents Having Vasodilator Activity


Agents Causing Renin Release


Agents Affecting Sympathetic Activity


Agents Increasing Serum Potassium


Inhibitors of Endogenous Prostaglandin Synthesis


Lithium


Cardiac Glycosides


Loop Diuretics


Allopurinol


Gold


DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY




ANIMAL PHARMACOLOGY & OR TOXICOLOGY







PREGNANCY

Teratogenic Effects: Categories C (first trimester) and D (second and third trimesters)
WARNINGS: Fetal/Neonatal Morbidity and Mortality

NURSING MOTHERS

PRECAUTIONS: Pediatric Use

PEDIATRIC USE





CAPTOPRIL ADVERSE REACTIONS




WARNINGS

WARNINGS


WARNINGSPRECAUTIONS: Drug Interactions



WARNINGS: Head and Neck AngioedemaIntestinal AngioedemaPRECAUTIONS: Information for Patients
PRECAUTIONS: General: Cough




WARNINGS: Anaphylactoid and Possible Related ReactionsPRECAUTIONS: Hemodialysis














Fetal/Neonatal Morbidity and Mortality
WARNINGS: Fetal/Neonatal Morbidity and Mortality

Altered Laboratory Findings
PRECAUTIONS





OVERDOSAGE




DOSAGE & ADMINISTRATION



Hypertension



WARNINGSPRECAUTIONS: Drug Interactions



PRECAUTIONS: Drug Interactions

Heart Failure
WARNINGS: Hypotension
For most patients the usual initial daily dosage is 25 mg tid. After a dose of 50 mg tid is reached, further increases in dosage should be delayed, where possible, for at least two weeks to determine if a satisfactory response occurs. Most patients studied have had a satisfactory clinical improvement at 50 or 100 mg tid. A maximum daily dose of 450 mg of captopril should not be exceeded.
Captopril should generally be used in conjunction with a diuretic and digitalis. Captopril therapy must be initiated under very close medical supervision.

Left Ventricular Dysfunction After Myocardial Infarction
The recommended dose for long-term use in patients following a myocardial infarction is a target maintenance dose of 50 mg t.i.d.
Therapy may be initiated as early as three days following a myocardial infarction. After a single dose of 6.25 mg, captopril therapy should be initiated at 12.5 mg t.i.d. Captopril should then be increased to 25 mg t.i.d. during the next several days and to a target dose of 50 mg t.i.d. over the next several weeks as tolerated (seeCLINICAL PHARMACOLOGY).
Captopril may be used in patients treated with other post-myocardial infarction therapies, e.g., thrombolytics, aspirin, beta blockers.

Diabetic Nephropathy
The recommended dose of captopril for long term use to treat diabetic nephropathy is 25 mg t.i.d.
Other antihypertensives such as diuretics, beta blockers, centrally acting agents or vasodilators may be used in conjunction with captopril if additional therapy is required to further lower blood pressure.

Dosage Adjustment in Renal Impairment
Because captopril is excreted primarily by the kidneys, excretion rates are reduced in patients with impaired renal function. These patients will take longer to reach steady-state captopril levels and will reach higher steady-state levels for a given daily dose than patients with normal renal function. Therefore, these patients may respond to smaller or less frequent doses.
Accordingly, for patients with significant renal impairment, initial daily dosage of captopril should be reduced, and smaller increments utilized for titration, which should be quite slow (one- to two-week intervals). After the desired therapeutic effect has been achieved, the dose should be slowly back-titrated to determine the minimal effective dose. When concomitant diuretic therapy is required, a loop diuretic (e.g., furosemide), rather than a thiazide diuretic, is preferred in patients with severe renal impairment. (See alsoWARNINGS: Anaphylactoid reactions during membrane exposureandPRECAUTIONS: Hemodialysis.)

HOW SUPPLIED




STORAGE AND HANDLING




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Captopril

Captopril

Captopril

Captopril TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-306(NDC:64679-904)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CAPTOPRIL CAPTOPRIL 50 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
white 8 mm W;904 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-306-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074532 2011-06-16


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