Perindopril-Amlodipine

Perindopril-Amlodipine is a combination medication used for the treatment of hypertension.

• Perindopril-Amlodipine is available under various brand names: Prestalia

Common side effects of Perindopril-Amlodipine include:

• swelling of the legs and feet,
• cough,
• headache,
• dizziness,
• rash,
• nausea,
• diarrhea,
• weakness,
• high levels of potassium in the blood (hyperkalemia),
• muscle cramps,
• sexual dysfunction,
• shortness of breath,
• itching, and
• rash

Serious side effects of Perindopril-Amlodipine include:

• a light-headed feeling,
• swelling in the hands or feet, rapid weight gain;
• little or no urination;
• new or worsened chest pain;
• jaundice (yellowing of the skin or eyes); or
• high potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Rare side effects of Perindopril-Amlodipine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 3.5 mg/2.5 mg
• 7 mg/5 mg
• 14 mg/10 mg

Hypertension

Adult dosage

• Initial: 3.5 mg/2.5 mg orally every day with or without food
• Adjust dose according to blood pressure goals; wait 7-14 days between titration steps
• Not to exceed 14 mg/10 mg every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Perindopril-Amlodipine has severe interactions with the following drugs:
  • aliskiren
  • dantrolene
  • protein a column
• Perindopril-Amlodipine has serious interactions with at least 53 other drugs.
• Perindopril-Amlodipine has moderate interactions with at least 216 other drugs.
• Perindopril-Amlodipine has minor interactions with at least 64 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• History of hereditary or acquired angioedema associated with previous ACE inhibitor treatment
• Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hours of switching to or from sacubitril/valsartan
• Coadministration with aliskiren in patients with diabetes mellitus or with renal impairment (i.e., GFR below 60 mL/min/1.73 m²)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Perindopril-Amlodipine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Perindopril-Amlodipine?”

Cautions

• 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 (see Pregnancy)
• Worsening angina and acute MI can develop after starting or increasing the dose, particularly in patients with severe obstructive CAD
• Hyperkalemia reported; monitor serum potassium levels
• Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema
• Persistent cough reported with all ACE inhibitors, presumably because of the inhibition of the degradation of endogenous bradykinin; generally resolves after discontinuing
• Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death; patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up
• Hypotension
  • May cause symptomatic hypotension; 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
  • Patients with severe aortic stenosis may be more likely to experience symptomatic hypotension
  • Correct hypotension in patients undergoing major surgery or during anesthesia with agents that produce hypotension with volume expansion
  • In patients at risk of excessive hypotension, monitor closely for the first 2 weeks of treatment and whenever the therapeutic dose is increased or a diuretic is added or its dose increased
  • If excessive hypotension occurs, immediately place the patient in a supine position and, if necessary, treat the patient with an IV infusion of physiological saline; therapy can usually be continued following restoration of volume and blood pressure
• Renal impairment
  • Monitor renal function periodically
  • Perindoprilat elimination is decreased in renally impaired patients, with a marked increase in accumulation when creatinine clearance is less than 30 mL/min
  • 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
  • Anaphylactoid reactions
  • ACE inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin; therefore, patients taking ACE inhibitors may be subject to a variety of bradykinin- or prostaglandin-mediated adverse reactions, some of them serious
  • Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g. temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema
  • Black patients receiving ACE inhibitors have a higher incidence of angioedema compared with nonblack
• Intestinal angioedema
  • Presents as abdominal pain (with or without nausea or vomiting)
  • Diagnosed by imaging studies (e.g., abdominal CT or ultrasound) or at the surgery
  • Angioedema of the face, extremities, lips, tongue, glottis, and larynx
  • 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 promptly (e.g., SC epinephrine solution 1:1000 [0.3-0.5 mL])

Pregnancy & Lactation

• Use in LIFE-THREATENING emergencies when no safer drug is available
• Discontinue as soon as pregnancy is detected; during the second and third trimesters of pregnancy, drugs that act directly on the renin-angiotensin have been associated with a fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death
• Lactation
  • Unknown if distributed in human breast milk; because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug