Generic name: ramipril

Brand name: Altace

Mechanism of action: ACE inhibitor

Indication: hypertension, heart failure, myocardial infarction

Altace is an ACE inhibitor. It works by relaxing blood vessels so that blood can flow more easily.

Altace is used to treat high blood pressure (hypertension) and congestive heart failure, and to improve survival after a heart attack.

Pharmacokinetics

  • Absorption
    Bioavailability: poorly absorbed from the gastrointestinal tract (≤5%); peak plasma concentrations achieved 3-4 hours after oral administration.
  • Distribution
    Metabolism: extensively metabolized in the liver by CYP3A4 to active and inactive metabolites.
  • Elimination
    Half-life: 18 hours.
    Excretion: urine (84%), feces (11%).

Altace may interact with other medications. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Altace should be used only when prescribed. This medication passes into breast milk. Consult your doctor before breastfeeding.

ACE inhibitors, including Altace, may cause fetal and neonatal morbidity and mortality when administered to pregnant women. Several mechanisms, such as inhibition of ACE activity, have been proposed. If Altace is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Neonates exposed to ACE inhibitors early in life (i.e., the first trimester of pregnancy) have an increased risk of developing renal impairment later in life. This has been seen in animal studies but has not been reported in humans.

ACE inhibitors may increase the risk of hypotension and renal impairment in patients with cardiovascular disease or renovascular disease. These effects are more likely to occur in patients with pre-existing renal impairment or those who are volume- and/or salt-depleted (e.g., those receiving high doses of diuretics).

ACE inhibitors may cause a non-productive cough that resolves when the drug is discontinued. This effect is seen more often in women than men.

ACE inhibitors may increase the risk of hyperkalemia, especially in patients with renal impairment, diabetes mellitus, or those taking potassium supplements or potassium-sparing diuretics.

Patients treated with ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the drug and receive appropriate medical treatment.

Side effects

The most common side effects of Altace are headache, dizziness, fatigue, and dry cough. Other side effects include:

  • Hypotension
  • Renal impairment
  • Hyperkalemia
  • Non-productive cough

Rare but serious side effects include:

  • Angioedema
  • Hepatic impairment

Patients should be advised to promptly report any signs or symptoms of angioedema (e.g., swelling of the face, lips, tongue, or throat; difficulty swallowing or breathing) or hepatotoxicity (e.g., jaundice, dark urine, clay-colored stools, itching, or right upper quadrant pain) to their healthcare provider.

Dosage and Administration

Altace is available as 2.5 mg, 5 mg, and 10 mg capsules for oral administration. The recommended starting dose is 2.5 mg once daily. The dosage may be increased to a maximum of 10 mg once daily, depending on the patient’s blood pressure response.

The recommended starting dose in patients with mild-to-moderate hepatic impairment is 2.5 mg once daily. The dosage should be adjusted according to the patient’s blood pressure response.

Patients should be advised to take Altace at the same time each day, with or without food. Capsules should not be opened, crushed, or chewed.

Overdose

Symptoms of overdose include:

  • Hypotension
  • Dizziness
  • Fatigue
  • Headache

Storage and Handling

Altace capsules should be stored at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Dispense in a tight, light-resistant container as defined in the USP.