Benazepril-Amlodipine

Benazepril-Amlodipine is a combination of prescription medicines used for the treatment of hypertension.

• Benazepril-Amlodipine is available under the following different brand names: Xcopri

Adult dosage

Capsule

• 10mg/2.5mg
• 10mg/5mg
• 20mg/5mg
• 20mg/10mg
• 40mg/5mg
• 40mg/10mg

Hypertension

Adult dosage

• 1 tablet (2.5-10 mg amlodipine; 10-40mg benazepril) orally every day; titrate with appropriate dosage combination to control BP; not to exceed 10 mg/day amlodipine, 80 mg/day benazepril

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Benazepril-Amlodipine include:

• cough,
• dizziness, and
• swelling in the hands or feet.

Serious side effects of the Benazepril-Amlodipine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe stomach pain,
• lightheadedness,
• swelling in the hands or feet,
• rapid weight gain,
• new or worsened chest pain,
• fever,
• chills,
• sore throat,
• body aches,
• nausea,
• weakness, tingly feeling,
• chest pain,
• irregular heartbeats,
• loss of movement,
• nausea,
• stomach pain (upper right side),
• itching,
• unusual tiredness,
• flu-like symptoms,
• dark urine, and
• yellowing of the skin or urine (jaundice).

Rare side effects of the Benazepril-Amlodipine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result 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.

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.

• Benazepril-Amlodipine has severe interactions with the following drugs:
  • aliskiren
  • dantrolene
  • sacubitril/valsartan
• Benazepril-Amlodipine has serious interactions with at least 53 other drugs.
• Benazepril-Amlodipine has moderate interactions with at least 292 other drugs.
• Benazepril-Amlodipine has minor interactions with at least 75 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 the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• History of angioedema with or without previous ACE inhibitor therapy
• Hereditary or idiopathic angioedema
• Coadministration of neprilysin inhibitors (e.g., sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hours of switching to or from sacubitril/valsartan
• Concomitant use with Aliskiren in patients with diabetes mellitus

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Use with caution in CHF
• Use with caution in patients with aortic stenosis, ischemic heart disease, or cerebrovascular disease
• Use with caution in patients with unstented unilateral/bilateral renal artery stenosis; avoid use due to elevated risk of deterioration in renal function
• Persistent, progressive dermatologic reactions
• Exacerbation of angina (during initiation of treatment, after a dose increase, or withdrawal of beta-blocker)
• Use caution in hepatic impairment (may require a lower starting dose)
• Excessive hypotension if concomitant diuretics, hypovolemia, hyponatremia
• Risk of hyperkalemia, especially with renal impairment or DM or in patients taking concomitant K+-elevating drugs; assess for hypotension and hyperkalemia
• Dual blockade of the renin-angiotensin system with ARBs, ACE inhibitors, or aliskiren is associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure), compared with monotherapy; most patients receiving a combination of two renin-angiotensin systems (RAS) inhibitors do not obtain additional benefit compared to monotherapy; in general, avoid combined use of RAS inhibitors
• Titrate slowly with hepatic impairment; amlodipine extensively metabolized by the liver (half-life is 56 hours with hepatic impairment)
• Rare reports of cholestatic hepatitis and acute liver failure (some fatal)
• Myocardial infarction or increased angina in patients with obstructive coronary artery disease may occur
• Avoid with severe renal impairment (i.e., CrCl is less than 30 mL/min); avoid in patients with severe heart failure, whose renal function may depend on the activity of the renin-angiotensin-aldosterone system; treatment with ACE inhibitor causes oliguria or progressive azotemia and (rarely) with acute renal failure and/or death
• Hypotension
  • Therapy can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure, or death
  • Symptomatic hypotension is most likely to occur in patients who have heart failure, severe aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy, or have been volume or salt depleted as a result of diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting;
  • Correct volume and salt depletion before starting therapy with benazepril; if hypotension occurs, place the patient in a supine position and give physiological saline intravenously if needed; continue treatment with therapy once blood pressure and volume have returned to normal
• Angioedema
  • Angioedema may occur at any time during treatment; angioedema associated with edema of the larynx, tongue, or glottis can compromise the airway and be fatal; if laryngeal stridor or angioedema of face, tongue, or glottis occurs, discontinue treatment with Lotrel and treat immediately
  • Patients with a history of angioedema may be at increased risk for angioedema while receiving therapy
  • Black patients receiving ACE inhibitors have a higher incidence of angioedema compared with nonblacks
  • 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

Pregnancy and Lactation

• Therapy can cause fetal harm when administered to a pregnant woman; the use of drugs that act on RAS during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
• Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the RAS from other antihypertensive agents;
• When pregnancy is detected, discontinue therapy as soon as possible; the estimated background risk of major birth defects and miscarriage for the indicated population is unknown; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes
• Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage); hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly
• Reactions oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death
• Perform serial ultrasound examinations to assess the intra-amniotic environment; fetal testing may be appropriate, based on the week of gestation
• Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury
• If oligohydramnios is observed, consider alternative drug treatment;
• Closely observe neonates with histories of in utero exposure to drugs for hypotension, oliguria, and hyperkalemia
• In neonates with a history of in utero exposure to therapy, if oliguria or hypotension occurs, support blood pressure and renal perfusion
• Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing the renal function
• Lactation
  • Minimal amounts of unchanged benazepril and benazeprilat are excreted into the breast milk of lactating women treated with benazepril so that a newborn child ingesting nothing but breast milk would receive less than 0.1% of maternal doses of benazepril and benazeprilat
  • Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%; no adverse effects of amlodipine on breastfed infants have been observed; there is no available information on the effects of amlodipine or benazepril on milk production