Sandbox Captopril tablet2
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
Sandbox Captopril tablet2 is {{{aOrAn}}} {{{drugClass}}} drug that is FDA approved for the treatment of {{{indication}}}. Adverse reactions include {{{adverseReactions}}}.
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)
Postmarketing 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)
Drug Interactions
- (Drug 1)
- (Description)
- (Drug 2)
- (Description)
- (Drug 3)
- (Description)
Use in Specific Populations
Pregnancy
There is no FDA guidance on usage of Sandbox Captopril tablet2 in women who are pregnant.
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.