Sandbox Captopril tablet2

Sandbox Captopril tablet2
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2], Amr Marawan, M.D. [3]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1

• Dosing Information

(Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1

• Developed by: (Organization)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

• Dosing Information

• There is limited information about Off-Label Non–Guideline-Supported Use of Sandbox Captopril tablet2 in adult patients.==Pediatric Indications and Dosage==

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

• Dosing Information

(Dosage)===Off-Label Use and Dosage (Pediatric)===

Guideline-Supported Use

Condition 1

• Developed by: (Organization)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)====Non–Guideline-Supported Use====

Condition 1

• Dosing Information

• There is limited information about Off-Label Non–Guideline-Supported Use of Sandbox Captopril tablet2 in pediatric patients.

Contraindications

• Condition 1
• Condition 2
• Condition 3
• Condition 4
• Condition 5

Warnings

Fetal Toxicity

Pregnancy Category: D

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue captopril as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mothers and fetus.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue, captopril unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to captopril for hypotension, oliguria, and hyperkalemia.

When captopril was given to rabbits at doses about 0.8 to 70 times (on a mg/kg basis) the maximum recommended human dose, low incidences of craniofacial malformations were seen. No teratogenic effects of captopril were seen in studies of pregnant rats and hamsters. On a mg/kg basis, the doses used were up to 150 times (in hamsters) and 625 times (in rats) the maximum recommended human dose.

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Condition 2

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Postmarketing Experience

(Description)

Drug Interactions

• (Drug 1)

• (Description)

• (Drug 2)

• (Description)

• (Drug 3)

• (Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

There is no FDA guidance on usage of Sandbox Captopril tablet2 in women who are pregnant.

Pregnancy Category (AUS):

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sandbox Captopril tablet2 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sandbox Captopril tablet2 during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sandbox Captopril tablet2 in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Sandbox Captopril tablet2 in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Sandbox Captopril tablet2 in geriatric settings.

Gender

There is no FDA guidance on the use of Sandbox Captopril tablet2 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sandbox Captopril tablet2 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sandbox Captopril tablet2 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sandbox Captopril tablet2 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sandbox Captopril tablet2 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sandbox Captopril tablet2 in patients who are immunocompromised.