Altace

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• Consumer Information
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Altace Side Effects Center

What Is Altace?

Altace (ramipril) is an angiotensin-converting enzyme (ACE) inhibitor that reduces high blood pressure by reducing or relaxing blood vessels. Altace is used to lower blood pressure and to reduce the risk of stroke, heart attack, and increase survival in heart failure patients after a heart attack. Altace is available as a generic termed ramipril.

What Are Side Effects of Altace?

Some common side effects of Altace include:

• headache,
• cough,
• tired feeling,
• dizziness,
• spinning sensation,
• malaise,
• nausea,
• vomiting, and
• stomach discomfort.

Dosage for Altace

Altace is available in 1.5, 2.5, 5 and 10 mg strength tablets.

What Drugs, Substances, or Supplements Interact with Altace?

Altace may interact with diuretics (water pills), gold injections, lithium, potassium supplements, salt substitutes that contain potassium, or aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs).

Altace During Pregnancy and Breastfeeding

Tell your doctor all medications and supplements you use.

Additional Information

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

 

Altace 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 (Ramipril Tablets)

 

Altace Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Hypertension

ALTACE has been evaluated for safety in over 4000 patients with hypertension; of these, 1230 patients were studied in U.S. controlled trials, and 1107 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 and placebo patients. The most frequent clinical side effects (possibly or probably related to study drug) reported by patients receiving ALTACE in placebo-controlled trials were: headache (5.4%), dizziness (2.2%), and fatigue or asthenia (2.0%), but only the last one was more common in ALTACE 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 mg–20 mg. Discontinuation of therapy because of a side effect was required in approximately 3% of U.S. patients treated with ALTACE. 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 U.S. placebo-controlled trials in more than 1% of patients treated with ALTACE, only asthenia (fatigue) was more common on ALTACE than placebo (2% [n=13/651] vs. 1% [n=2/286], respectively).

In placebo-controlled trials, there was also an excess of upper respiratory infection and flu syndrome in the ALTACE 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 ALTACE patients, with about 4% of patients requiring discontinuation of treatment.

Reduction in the Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes

HOPE Study

Safety data in the Heart Outcomes Prevention Evaluation (HOPE) study were collected as reasons for discontinuation or temporary interruption of treatment. The incidence of cough was similar to that seen in the Acute Infarction Ramipril Efficacy (AIRE) trial. The rate of angioedema was the same as in previous clinical trials [see WARNINGS AND PRECAUTIONS].

Table 1:Reasons for Discontinuation or Temporary Interruption of Treatment—HOPE Study

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

Heart Failure Post-Myocardial Infarction

AIRE Study

Adverse reactions (except laboratory abnormalities) considered possibly/probably related to study drug that occurred in more than 1% of patients and more frequently on ALTACE are shown below. The incidences are from the AIRE study. The follow-up time was between 6 and 46 months for this study.

Table 2: Percentage of Patients with Adverse Events Possibly/ Probably Related to Study Drug—Placebo-Controlled (AIRE) Mortality Study

Adverse Event	Placebo (N=982)	ALTACE (N=1004)
Hypotension	5%	11%
Cough increased	4%	8%
Dizziness	3%	4%
Angina pectoris	2%	3%
Nausea	1%	2%
Postural hypotension	1%	2%
Syncope	1%	2%
Vomiting	0.5%	2%
Vertigo	0.7%	2%
Abnormal kidney function	0.5%	1%
Diarrhea	0.4%	1%

Other Adverse Reactions

Other adverse reactions reported in controlled clinical trials (in less than 1% of ALTACE patients), or rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug is uncertain):

Body as a whole: Anaphylactoid reactions [see WARNINGS AND PRECAUTIONS ].

Cardiovascular: Symptomatic hypotension (reported in 0.5% of patients in U.S. trials) [see WARNINGS AND PRECAUTIONS ],syncope, and palpitations.

Hematologic: Pancytopenia, hemolytic anemia, and thrombocytopenia.

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 alone and in 1.5% of patients receiving ALTACE plus a diuretic.

Renal: Acute renal failure. 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, particularly when ALTACE was given concomitantly with a diuretic [see WARNINGS AND PRECAUTIONS].

Angioneurotic edema: Angioneurotic edema has been reported in 0.3% of patients in U.S. clinical trials of ALTACE [see WARNINGS AND PRECAUTIONS ].

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.

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

Post-Marketing Experience

In addition to adverse reactions reported from clinical trials, there have been rare reports of hypoglycemia reported during ALTACE 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 alone, and in 1.5% of patients receiving ALTACE and a diuretic. Increases in blood urea nitrogen levels occurred in 0.5% of patients receiving ALTACE alone and in 3% of patients receiving ALTACE 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]. As ramipril decreases aldosterone secretion, elevation of serum potassium can occur. Use potassium supplements and potassium sparing diuretics with caution, and monitor the patient's serum potassium 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 alone and in 1.5% of patients receiving ALTACE 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 administration. Elevations of liver enzymes, serum bilirubin, uric acid, and blood glucose have been reported, as have cases of hyponatremia and scattered incidents of leucopenia, 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 (Ramipril Tablets)

&Copy; Altace Patient Information is supplied by Cerner Multum, Inc. and Altace Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.