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ALTACE® Capsules (ramipril)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
ALTACE® Capsules Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Hypertension
ALTACE is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Hypertension
The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Adjust dose according to blood...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
ALTACE (ramipril) is supplied as hard gelatin capsules containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril.
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Contraindications
4 CONTRAINDICATIONS
ALTACE is contraindicated in patients who are hypersensitive to this product or any other ACE inhibitor (e.g., a patient who has experienced...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylactoid and Possibly Related Reactions
Presumably because drugs that act...
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Adverse Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Diuretics
Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal...
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Overdosage
10 OVERDOSAGE
Single oral doses of ramipril in rats and mice of 10 g/kg–11 g/kg resulted in significant lethality. In dogs, oral doses as high as 1 g/kg induced only mild gastrointestinal distress. Limited data on human...
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Description
11 DESCRIPTION
Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°–112°C...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Ramipril and ramiprilat inhibit ACE in human subjects and animals. Angiotensin converting enzyme is a peptidyl...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of a tumorigenic effect was found when ramipril was given by gavage to...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Hypertension
ALTACE has been compared with other ACE inhibitors, beta-blockers, and thiazide diuretics as monotherapy for hypertension. It...
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How Supplied/Storage and Handling
...
16 HOW SUPPLIED/STORAGE AND HANDLING
ALTACE is available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules. Descriptions of ALTACE capsules are summarized below.
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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Angioedema
Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.