Therapeutic Indications

Captopril is indicated for:

Type I diabetic nephropathy

Irrespective of gender only Elderly (65 years old or older)

Captopril is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 6.25-100 mg in 1-2 divided doses daily

Essential hypertension

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old)

Captopril is indicated for the treatment of essential hypertension.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 0.15-0.3 mg/kg in 3 divided doses daily

Type I diabetic nephropathy

Irrespective of gender only Adults (18 - 65 years old)

Captopril is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 6.25-150 mg in 1-2 divided doses daily

Myocardial infarction

Irrespective of gender only Adults (18 years old or older)

Short-term (4 weeks) treatment: captopril is indicated in any clinically stable patient within the first 24 hours of an infarction.

Long-term prevention of symptomatic heart failure: captopril is indicated in clinically stable patients with asymptomatic left ventricular dysfunction.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 6.25-150 mg in 1-2 divided doses daily

Chronic heart failure

Irrespective of gender only Adults (18 years old or older)

Captopril is indicated for the treatment of chronic heart failure.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 6.25-150 mg in 1-2 divided doses daily

Essential hypertension

Irrespective of gender only Adults (18 years old or older)

Captopril is indicated for the treatment of essential hypertension.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 6.25-150 mg in 1-2 divided doses daily

Contraindications

Active ingredient Captopril is contraindicated in the following cases:

Lactation

No gender/age discrimination

Limited pharmacokinetic data demonstrate very low concentrations in breast milk. Although these concentrations seem to be clinically irrelevant, the use of captopril in breastfeeding is not recommended for preterm infants and for the first few weeks after delivery, because of the hypothetical risk of cardiovascular and renal effects and because there is not enough clinical experience.

In the case of an older infant, the use of captopril in a breast-feeding mother may be considered if this treatment is necessary for the mother and the child is observed for any adverse effect.

Pregnancy

No gender/age discrimination

The use of ACE inhibitors is not recommended during the first trimester of pregnancy. The use of ACE inhibitors is contraindicated during the second and third trimesters of pregnancy.

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.

Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension.

Aliskiren in diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m²)

No gender/age discrimination

The concomitant use of captopril with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m²).

Angioedema

No gender/age discrimination

  1. History of angioedema associated with previous ACE inhibitor therapy.
  2. Hereditary/idiopathic angioneurotic oedema.

Angioedema of the extremities, face, lips, mucous membranes, tongue, glottis or larynx may occur in patients treated with ACE inhibitors including Captopril. This may occur anytime during treatment. However, in rare cases, severe angioedema may develop after long-term treatment with an ACE inhibitor. In such cases, Captopril should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patient. In those instances where swelling has been confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema involving the tongue, glottis or larynx may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution 1:1000 (0.3 ml to 0.5 ml) and/or measures to ensure a patent airway, should be administered promptly. The patient should be hospitalised and observed for at least 12 to 24 hours and should not be discharged until complete resolution of symptoms has occurred.

Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non- blacks.

Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor.

Intestinal angioedema has also been reported rarely in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan, or ultrasound or at surgery and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.