Perindopril arginine, amlodipine besylate

Perindopril arginine, amlodipine besylate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: AKT

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Black Box Warning

FETAL TOXICITY See full prescribing information for complete Boxed Warning. When pregnancy is detected, discontinue PRESTALIA as soon as possible Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

Overview

Perindopril arginine, amlodipine besylate is a combination of an angiotensin converting enzyme inhibitor and a dihydropyridine calcium channel blocker that is FDA approved for the treatment of hypertension to lower blood pressure in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, cough, peripheral edema, and pulmonary edema.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

PRESTALIA contains perindopril arginine, an angiotensin converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension, to lower blood pressure. PRESTALIA may be used in patients whose blood pressure is not adequately controlled on monotherapy or as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Dosing Information

• The recommended starting dose of PRESTALIA is 3.5/2.5 mg once daily.
• Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps.
• The maximum recommended dose is 14/10 mg once daily.
• Consider use in patients unable to achieve adequate antihypertensive effect with amlodipine monotherapy because of dose-limiting peripheral edema caused by amlodipine. Administered as monotherapy, perindopril erbumine is an effective treatment for hypertension in once-daily doses ranging from 4 mg to 16 mg daily. Amlodipine is effective in once-daily doses of 5 mg and 10 mg. Adverse reactions related to perindopril are generally uncommon and independent of dose, while those related to amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter.
• Dosage adjustment in renal impairment
  • PRESTALIA is not recommended in patients with creatinine clearances <30 mL/min. For patients with creatinine clearance between 30 and 80 mL/min (mild or moderate renal impairment), do not exceed 7/5 mg.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Perindopril arginine, amlodipine besylate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Perindopril arginine, amlodipine besylate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Perindopril arginine, amlodipine besylate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Perindopril arginine, amlodipine besylate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Perindopril arginine, amlodipine besylate in pediatric patients.

Contraindications

• PRESTALIA tablets are contraindicated in patients with:
  • Hereditary or idiopathic angioedema, with or without previous ACE inhibitor treatment
  • In patients who are hypersensitive to perindopril, to any other ACE inhibitor, or to amlodipine.
• Do not co-administer aliskiren with ACE inhibitors, including PRESTALIA, in patients with diabetes

Warnings

FETAL TOXICITY See full prescribing information for complete Boxed Warning. When pregnancy is detected, discontinue PRESTALIA as soon as possible Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

• Fetal toxicity
  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue PRESTALIA as soon as possible.

• Anaphylactoid and Possibly Related Reactions
  • Angiotensin converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin. Patients taking ACE inhibitors (including the one in PRESTALIA) may, therefore, be subject to a variety of bradykinin- or prostaglandin-mediated adverse reactions, some of them serious. Black patients receiving ACE inhibitors have a higher incidence of angioedema compared with non-blacks.
  • Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors (0.1% of patients treated with perindopril in U.S. clinical trials). Angioedema associated with involvement of the tongue, glottis or larynx may be fatal. In such cases, discontinue perindopril treatment immediately and observe until the swelling disappears. When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, administer appropriate therapy, such as subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 mL), promptly.
  • Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema.
  • Intestinal Angioedema: Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting), and the angioedema was diagnosed by imaging studies such as abdominal CT or ultrasound, or at surgery. In some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. 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.
• Increased Angina and/or Myocardial Infarction
  • Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of PRESTALIA, particularly in patients with severe obstructive coronary artery disease.
• Hypotension
  • PRESTALIA can cause symptomatic hypotension. Symptomatic hypotension is most likely to occur in patients who have been volume- or salt-depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting.
  • In patients at risk of excessive hypotension, start PRESTALIA therapy under close medical supervision. Follow patients closely for the first 2 weeks of treatment and whenever the dose of PRESTALIA is increased or a diuretic is added or its dose increased.
  • If excessive hypotension occurs, immediately place patient in a supine position and, if necessary, treat patient with an intravenous infusion of physiological saline. PRESTALIA treatment can usually be continued following restoration of volume and blood pressure.
  • Patients with severe aortic stenosis may be more likely to experience symptomatic hypotension. Because of the gradual onset of action, acute hypotension is unlikely.
  • Surgery/Anesthesia
    • In patients undergoing major surgery or during anesthesia with agents that produce hypotension, PRESTALIA may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
• Hyperkalemia
  • Elevations of serum potassium have been observed in some patients treated with ACE inhibitors, including PRESTALIA.

Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of agents such as potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.

• • Monitor serum potassium periodically in patients receiving PRESTALIA.
• Cough
  • Presumably because of the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, generally resolving after discontinuation of therapy. Consider ACE inhibitor-induced cough in the differential diagnosis of cough.
• Impaired Renal Function
  • Monitor renal function periodically in patients receiving PRESTALIA. Drugs that affect the renin-angiotensin system can cause reductions in renal function, including acute renal failure. Patients whose renal function may depend in part on the activity of the renin-angiotensin system—(e.g., patients with renal artery stenosis, severe heart failure, post-myocardial infarction or volume depletion) or who are on non-steroidal anti-inflammatory agents (NSAIDS) or angiotensin receptor blockers—may be at particular risk of developing acute renal failure on PRESTALIA.
  • Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on PRESTALIA.
• Hepatic Failure
  • Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, 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.

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Postmarketing Experience

There is limited information regarding Perindopril arginine, amlodipine besylate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Perindopril arginine, amlodipine besylate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): D There is no FDA guidance on usage of Perindopril arginine, amlodipine besylate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Perindopril arginine, amlodipine besylate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Perindopril arginine, amlodipine besylate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Perindopril arginine, amlodipine besylate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Perindopril arginine, amlodipine besylate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Perindopril arginine, amlodipine besylate in geriatric settings.

Gender

There is no FDA guidance on the use of Perindopril arginine, amlodipine besylate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Perindopril arginine, amlodipine besylate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Perindopril arginine, amlodipine besylate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Perindopril arginine, amlodipine besylate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Perindopril arginine, amlodipine besylate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Perindopril arginine, amlodipine besylate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Perindopril arginine, amlodipine besylate Administration in the drug label.

Monitoring

There is limited information regarding Perindopril arginine, amlodipine besylate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Perindopril arginine, amlodipine besylate and IV administrations.

Overdosage

There is limited information regarding Perindopril arginine, amlodipine besylate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Perindopril arginine, amlodipine besylate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Perindopril arginine, amlodipine besylate Mechanism of Action in the drug label.

Structure

There is limited information regarding Perindopril arginine, amlodipine besylate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Perindopril arginine, amlodipine besylate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Perindopril arginine, amlodipine besylate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Perindopril arginine, amlodipine besylate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Perindopril arginine, amlodipine besylate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Perindopril arginine, amlodipine besylate How Supplied in the drug label.

Storage

There is limited information regarding Perindopril arginine, amlodipine besylate Storage in the drug label.

Images

Drug Images

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Patient Counseling Information

There is limited information regarding Perindopril arginine, amlodipine besylate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Perindopril arginine, amlodipine besylate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Perindopril arginine, amlodipine besylate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Perindopril arginine, amlodipine besylate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.