Altace Capsules

What Is Altace Capsules?

Altace Capsules (ramipril capsules) is an angiotensin converting enzyme (ACE) inhibitor used to treat high blood pressure (hypertension). Altace is available in generic form.

What Are Side Effects of Altace Capsules?

Common side effects of Altace include:

• dizziness,
• spinning sensation,
• lightheadedness,
• headache, or
• tiredness as your body adjusts to the medication.

Dry cough, nausea, or vomiting may also occur. Serious swelling of the lips, tongue, and throat called angioedema may occur with drugs of this class (ACE inhibitors). Tell your doctor if you have unlikely but serious side effects of Altace including:

• fainting,
• symptoms of a high potassium blood level (such as muscle weakness, slow or irregular heartbeat),
• signs of infection (such as fever, chills, persistent sore throat), or
• changes in the amount of urine.

Dosage for Altace Capsules

The recommended initial dose for Altace is 2.5 mg once per day initially. Dosage may be gradually increased as needed and if tolerated.

What Drugs, Substances, or Supplements Interact with Altace Capsules?

Medications that may interact with this drug include diuretics (water pills), lithium, potassium supplements, salt substitutes containing potassium, aspirin or other NSAIDs such as ibuprofen and naproxen. A very serious reaction may occur if you are getting injections for bee/wasp sting allergy and are also taking Altace. Tell your doctor all medicines you are using.

Altace Capsules During Pregnancy or Breastfeeding

This medication is not recommended for use during pregnancy as it may harm a developing fetus. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Altace Capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Altace Capsules Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• jaundice (yellowing of your skin or eyes);
• little or no urination;
• fever, chills, sore throat; or
• high potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects may include:

• headache;
• cough; or
• dizziness, weakness, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Altace Capsules (Ramipril Capsules)

 

Altace Capsules Professional Information

SIDE EFFECTS

Hypertension

ALTACE (ramipril capsules) has been evaluated for safety in over 4,000 patients with hypertension; of these, 1,230 patients were studied in US controlled trials, and 1,107 were studied in foreign controlled trials. Almost 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in ALTACE (ramipril capsules) and placebo patients. The most frequent clinical side effects (possibly or probably related to study drug) reported by patients receiving ALTACE (ramipril capsules) in US placebo-controlled trials were: headache (5.4%), "dizziness" (2.2%) and fatigue or asthenia (2.0%), but only the last was more common in ALTACE (ramipril capsules) patients than in patients given placebo. Generally, the side effects were mild and transient, and there was no relation to total dosage within the range of 1.25 to 20 mg. Discontinuation of therapy because of a side effect was required in approximately 3% of US patients treated with ALTACE (ramipril capsules) . The most common reasons for discontinuation were: cough (1.0%), "dizziness" (0.5%), and impotence (0.4%). Of observed side effects considered possibly or probably related to study drug that occurred in US placebo-controlled trials in more than 1% of patients treated with ALTACE (ramipril capsules) , only asthenia (fatigue) was more common on Altace (ramipril capsules) than placebo (2% vs. 1%).

PATIENTS IN US PLACEBO CONTROLLED STUDIES

	ALTACE		Placebo
	(n=651)		(n=286)
	n	%	n	%
Asthenia (Fatigue)	13	2	2	1

In placebo-controlled trials, there was also an excess of upper respiratory infection and flu syndrome in the ramipril group, not attributed at that time to ramipril. As these studies were carried out before the relationship of cough to ACE inhibitors was recognized, some of these events may represent ramipril-induced cough. In a later 1-year study, increased cough was seen in almost 12% of ramipril patients, with about 4% of patients requiring discontinuation of treatment.

Heart Failure Post Myocardial Infarction

Adverse reactions (except laboratory abnormalities) considered possibly/probably related to study drug that occurred in more than one percent of patients and more frequently on ramipril are shown below. The incidences represent the experiences from the AIRE study. The follow-up time was between 6 and 46 months for this study.

Percentage of Patients with Adverse Events Possibly/ Probably Related to Study Drug
Placebo-Controlled (AIRE) Mortality Study

Adverse Event	Ramipril	Placebo
	(n=1004)	(n=982)
Hypotension	11	5
Cough Increased	8	4
Dizziness	4	3
Angina Pectoris	3	2
Nausea	2	1
Postural Hypotension	2	1
Syncope	2	1
Vomiting	2	0.5
Vertigo	2	0.7
Abnormal Kidney Function	1	0.5
Diarrhea	1	0.4

HOPE Study:

Safety data in the HOPE trial were collected as reasons for discontinuation or temporary interruption of treatment. The incidence of cough was similar to that seen in the AIRE trial. The rate of angioedema was the same as in previous clinical trials (see WARNINGS).

	RAMIPRIL	PLACEBO
	(N=4645)	(N=4652)
	%	%
Discontinuation at any time	34	32
Permanent discontinuation	29	28
Reasons for stopping Cough	7	2
Hypotension or Dizziness	1.9	1.5
Angioedema	0.3	0.1

Other adverse experiences reported in controlled clinical trials (in less than 1% of ramipril patients), or rarer events seen in postmarketing experience, include the following (in some, a causal relationship to drug use is uncertain):

Body As a Whole: Anaphylactoid reactions. (See WARNINGS.)

Cardiovascular: Symptomatic hypotension (reported in 0.5% of patients in US trials) (See WARNINGS and PRECAUTIONS ), syncope and palpitations.

Hematologic: Pancytopenia, hemolytic anemia and thrombocytopenia.

Renal: Some hypertensive patients with no apparent pre-existing renal disease have developed minor, usually transient, increases in blood urea nitrogen and serum creatinine when taking ALTACE (ramipril capsules) , particularly when ALTACE (ramipril capsules) was given concomitantly with a diuretic. (See WARNINGS.) Acute renal failure.

Angioneurotic Edema: Angioneurotic edema has been reported in 0.3% of patients in US clinical trials. (See WARNINGS.)

Gastrointestinal: Hepatic failure, hepatitis, jaundice, pancreatitis, abdominal pain (sometimes with enzyme changes suggesting pancreatitis), anorexia, constipation, diarrhea, dry mouth, dyspepsia, dysphagia, gastroenteritis, increased salivation and taste disturbance.

Dermatologic: Apparent hypersensitivity reactions (manifested by urticaria, pruritus, or rash, with or without fever), photosensitivity, purpura, onycholysis, pemphigus, pemphigoid, erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson syndrome.

Neurologic and Psychiatric: Anxiety, amnesia, convulsions, depression, hearing loss, insomnia, nervousness, neuralgia, neuropathy, paresthesia, somnolence, tinnitus, tremor, vertigo, and vision disturbances.

Miscellaneous: As with other ACE inhibitors, a symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia, photosensitivity, rash and other dermatologic manifestations. Additionally, as with other ACE inhibitors, eosinophilic pneumonitis has been reported.

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

Other: arthralgia, arthritis, dyspnea, edema, epistaxis, impotence, increased sweating, malaise, myalgia, and weight gain.

Post-Marketing Experience: In addition to adverse events reported from clinical trials, there have been rare reports of hypoglycemia reported during ALTACE (ramipril capsules) therapy when given to patients concomitantly taking oral hypoglycemic agents or insulin. The causal relationship is unknown.

Clinical Laboratory Test Findings

Creatinine and Blood Urea Nitrogen: Increases in creatinine levels occurred in 1.2% of patients receiving ALTACE (ramipril capsules) alone, and in 1.5% of patients receiving ALTACE (ramipril capsules) and a diuretic. Increases in blood urea nitrogen levels occurred in 0.5% of patients receiving ALTACE (ramipril capsules) alone and in 3% of patients receiving ALTACE (ramipril capsules) with a diuretic. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis. (See WARNINGS and PRECAUTIONS.) Since ramipril decreases aldosterone secretion, elevation of serum potassium can occur. Potassium supplements and potassium-sparing diuretics should be given with caution, and the patient's serum potassium should be monitored frequently. (See WARNINGS and PRECAUTIONS.)

Hemoglobin and Hematocrit: Decreases in hemoglobin or hematocrit (a low value and a decrease of 5 g/dl or 5% respectively) were rare, occurring in 0.4% of patients receiving ALTACE (ramipril capsules) alone and in 1.5% of patients receiving ALTACE (ramipril capsules) plus a diuretic. No US patients discontinued treatment because of decreases in hemoglobin or hematocrit.

Other (causal relationships unknown): Clinically important changes in standard laboratory tests were rarely associated with ALTACE (ramipril capsules) administration. Elevations of liver enzymes, serum bilirubin, uric acid, and blood glucose have been reported, as have cases of hyponatremia and scattered incidents of leukopenia, eosinophilia, and proteinuria. In US trials, less than 0.2% of patients discontinued treatment for laboratory abnormalities; all of these were cases of proteinuria or abnormal liver-function tests.

Read the entire FDA prescribing information for Altace Capsules (Ramipril Capsules)