Amlodipine and benazepril

Name: Amlodipine and benazepril

What are the side effects of amlodipine and benazepril?

Lotrel causes the same side effects as benazepril and amlodipine.

Common side of Lotrel include

  • water retention (edema) in legs and arms,
  • edema in the lungs
  • stomach pain,
  • nausea,
  • dizziness,
  • fatigue,
  • headache,
  • muscle cramps,
  • sexual problems, and
  • drowsiness.

Other side effects of Lotrel include

  • kidney failure,
  • indigestion,
  • blood disorders,
  • overgrowth of gums,
  • heart palpitations,
  • anemia,
  • reduced number of platelets in the blood, and
  • serious skin reactions also may occur.

Amlodipine and Benazepril Overview

Amlodipine and benazepril is a prescription medication used to treat high blood pressure. It is a single product containing 2 medications: amlodipine and benazepril. Amlodipine is in a class of medications called calcium channel blockers. It works by relaxing the blood vessels so the heart does not have to pump as hard. Benazepril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors.  It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly.

This medication comes in capsule form and is taken once a day, with or without food.

Common side effects of amlodipine and benazepril include dizziness, cough, and swelling of the feet, ankles, or hands. Do not drive or operate heavy machinery until you know how amlodipine and benazepril affects you.

Other Requirements

  • Store amlodipine and benazepril at room temperature.
  • Keep amlodipine and benazepril in a closed container in a dry place.
  • Keep this and all medicines out of the reach of children.

What is the most important information I should know about amlodipine and benazepril?

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

You should not use this medicine if you have ever had angioedema (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction).

If you have diabetes, do not use amlodipine and benazepril together with any medication that contains aliskiren (Tekturna, Tekamlo).

Proper Use of amlodipine and benazepril

In addition to using amlodipine and benazepril, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Remember that amlodipine and benazepril will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, strokes, or kidney disease.

You may take amlodipine and benazepril with or without food. Take amlodipine and benazepril at the same time each day.

amlodipine and benazepril comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of amlodipine and benazepril will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of amlodipine and benazepril. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For high blood pressure:
      • Adults—At first, one capsule containing amlodipine 2.5 milligrams (mg) and benazepril 10 mg once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than amlodipine 10 mg and benazepril 40 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of amlodipine and benazepril, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If more than 12 hours have passed since you missed your last dose, then skip the missed dose and take the next dose when you normally would.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Uses of Amlodipine and Benazepril

  • It is used to treat high blood pressure.
  • It may be given to you for other reasons. Talk with the doctor.

How do I store and/or throw out Amlodipine and Benazepril?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take amlodipine and benazepril or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to amlodipine and benazepril. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Amlodipine and Benazepril Dosage and Administration

General Considerations

The recommended initial dose of Amlodipine and Benazepril hydrochloride capsules is 1 capsule of amlodipine 2.5 mg and benazepril 10 mg orally once-daily.

It is usually appropriate to begin therapy with Amlodipine and Benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema. 

The antihypertensive effect of Amlodipine and Benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg and benazepril 40 mg once-daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of Amlodipine and Benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

Dosage Adjustment in Renal Impairment

Renal Impairment: Amlodipine and Benazepril hydrochloride capsules are not recommended in patients with creatinine clearance (CrCl) less than or equal to  30 mL/min. No dose adjustment of Amlodipine and Benazepril hydrochloride capsules is required in patients with CrCl greater than 30 mL/min/1.73m2 (serum creatinine roughly less than or equal to 3 mg/dL or 265 micromol/L) [see Warnings and Precautions (5.7), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

Replacement Therapy


Amlodipine and Benazepril hydrochloride capsules may be substituted for the titrated components.

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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.


Amlodipine and Benazepril hydrochloride has been evaluated for safety in over 2,991 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 400 were treated for more than 1 year.


In a pooled analysis of 5 placebo-controlled trials involving Amlodipine and Benazepril hydrochloride doses up to 5/20, the reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy.


Discontinuation of therapy due to side effects was required in approximately 4% of patients treated with Amlodipine and Benazepril hydrochloride and in 3% of patients treated with placebo.


The most common reasons for discontinuation of therapy with Amlodipine and Benazepril hydrochloride in these studies were cough and edema (including angioedema).


The peripheral edema associated with amlodipine use is dose-dependent. When benazepril is added to a regimen of amlodipine, the incidence of edema is substantially reduced.


The addition of benazepril to a regimen of amlodipine should not be expected to provide additional antihypertensive effect in African-Americans. However, all patient groups benefit from the reduction in amlodipine-induced edema.


The side effects considered possibly or probably related to study drug that occurred in these trials in more than 1% of patients treated with Amlodipine and Benazepril hydrochloride are shown in the table below. Cough was the only adverse event with at least possible relationship to treatment that was more common on Amlodipine and Benazepril hydrochloride (3.3%) than on placebo (0.2%).

Percent Incidence in U.S. Placebo-controlled Trials
*Edema refers to all edema, such as dependent edema, angioedema, facial edema.
Benazepril and Amlodipine
Benazepril
Amlodipine 
Placebo 
N=760
N=554
N=475
N=408
Cough
3.3
1.8
0.4
0.2
Headache
2.2
3.8
2.9
5.6
Dizziness
1.3
1.6
2.3
1.5
Edema*
2.1
0.9
5.1
2.2

The incidence of edema was greater in patients treated with amlodipine monotherapy (5.1%) than in patients treated with Amlodipine and Benazepril hydrochloride (2.1%) or placebo (2.2%).


Other side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials of patients treated with Amlodipine and Benazepril hydrochloride or in postmarketing experience were the following:


Body as a Whole: Asthenia and fatigue.


CNS: Insomnia, nervousness, anxiety, tremor, and decreased libido.


Dermatologic: Flushing, hot flashes, rash, skin nodule, and dermatitis.


Digestive: Dry mouth, nausea, abdominal pain, constipation, diarrhea, dyspepsia, and esophagitis.


Hematologic: Neutropenia.


Metabolic and Nutritional: Hypokalemia.


Musculoskeletal: Back pain, musculoskeletal pain, cramps, and muscle cramps.


Respiratory: Pharyngitis.


Urogenital: Sexual problems such as impotence, and polyuria.


Monotherapies of benazepril and amlodipine have been evaluated for safety in clinical trials in over 6,000 and 11,000 patients, respectively. The observed adverse reactions to the monotherapies in these trials were similar to those seen in trials of Amlodipine and Benazepril hydrochloride.

Postmarketing Experience


Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In postmarketing experience with benazepril, there have been rare reports of Stevens-Johnson syndrome, pancreatitis, hemolytic anemia, pemphigus, thrombocytopenia, paresthesia, dysgeusia, orthostatic symptoms and hypotension, angina pectoris and arrhythmia, pruritus, photosensitivity reaction, arthralgia, arthritis, myalgia, blood urea nitrogen (BUN) increase, serum creatinine increase, renal impairment,  vision impairment, agranulocytosis, neutropenia.

Rare reports in association with use of amlodipine: gingival hyperplasia, tachycardia, jaundice, and hepatic enzyme elevations (mostly consistent with cholestasis severe enough to require hospitalization), leukocytopenia, allergic reaction, hyperglycemia, dysgeusia, hypoesthesia, paresthesia, syncope, peripheral neuropathy, hypertonia, visual impairment, diplopia, hypotension, vasculitis, rhinitis, gastritis, hyperhidrosis, pruritus, skin discoloration, urticaria, erythema multiform, muscle spasms, arthralgia, micturition disorder, nocturia, erectile dysfunction, malaise, weight decrease or gain.

Other potentially important adverse experiences attributed to other ACE inhibitors and calcium channel blockers include: eosinophilic pneumonitis (ACE inhibitors) and gynecomastia (CCBs). Other infrequently reported events included chest pain, ventricular extrasystole, gout, neuritis, tinnitus, alopecia, upper respiratory tract infection, palpitations and somnolence.

Overdosage


Only a few cases of human overdose with amlodipine have been reported. One patient was asymptomatic after a 250 mg ingestion; another, who combined 70 mg of amlodipine with an unknown large quantity of a benzodiazepine, developed refractory shock and died.

Human overdoses with any combination of Amlodipine and Benazepril have not been reported. In scattered reports of human overdoses with benazepril and other ACE inhibitors, there are no reports of death.

Treatment: Patients should be admitted to hospital and, generally, should be managed in an intensive care setting, with continuous monitoring of cardiac function, blood gases, and blood biochemistry. Emergency supportive measures such as artificial ventilation or cardiac pacing should be instituted if appropriate.

In the event of a potentially life-threatening oral overdose, use induction of vomiting or gastric lavage and/or activated charcoal to remove the drug from the gastrointestinal tract (only if presented within 1 hour after ingestion of Amlodipine and Benazepril hydrochloride).

Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care.

To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison-Control Center. Telephone numbers of certified poison-control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and unusual drug kinetics in your patient.

The most likely effect of overdose with Amlodipine and Benazepril hydrochloride is vasodilation, with consequent hypotension and tachycardia. Simple repletion of central fluid volume (Trendelenburg positioning, infusion of crystalloids) may be sufficient therapy, but pressor agents (norepinephrine or high-dose dopamine) may be required. With abrupt return of peripheral vascular tone, overdoses of other dihydropyridine calcium channel blockers have sometimes progressed to pulmonary edema, and patients must be monitored for this complication.

Analyses of bodily fluids for concentrations of amlodipine, benazepril, or their metabolites are not widely available. Such analyses are, in any event, not known to be of value in therapy or prognosis.

No data are available to suggest physiologic maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of amlodipine, benazepril, or their metabolites. Benazeprilat is only slightly dialyzable; attempted clearance of amlodipine by hemodialysis or hemo-perfusion has not been reported, but amlodipine’s high protein binding makes it unlikely that these interventions will be of value.

Angiotensin II could presumably serve as a specific antagonist-antidote to benazepril, but angiotensin II is essentially unavailable outside of scattered research laboratories.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/10 mg (100 Capsules Bottle)


NDC 65862-583-01
Rx Only
Amlodipine and
Benazepril
Hydrochloride
Capsules USP 
5 mg*/10 mg
AUROBINDO           100 Capsules



  


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/20 mg (100 Capsules Bottle)


NDC 65862-584-01
Rx only
Amlodipine and
Benazepril
Hydrochloride
Capsules USP 
5 mg*/20 mg
AUROBINDO              100 Capsules



  


Index Terms

  • Amlodipine Besylate/Benazepril
  • Benazepril Hydrochloride and Amlodipine Besylate

Dosing Adult

Note: Dose is individualized; combination product may be substituted for individual components in patients currently maintained on both agents separately or in patients not adequately controlled with monotherapy (using one of the agents or an agent within same antihypertensive class).

Hypertension: Oral: Initial: Amlodipine 2.5 mg/benazepril 10 mg once daily; may titrate dose based on blood pressure response; Maximum: amlodipine 10 mg/benazepril 40 mg once daily

Dosing Hepatic Impairment

There are no specific dosage adjustments provided in the manufacturer's labeling; initiate with lowest dose and titrate slowly. Use with caution; amlodipine elimination prolonged.

Administration

Administer orally with or without food.

Usual Adult Dose for Hypertension

Initial dose: Amlodipine 2.5 mg-Benazepril 10 mg orally once a day
Maintenance dose: Amlodipine 2.5 to 10 mg-Benazepril 10 to 40 mg orally once a day
Maximum dose: Amlodipine: 10 mg/day; Benazepril 80 mg/day

Comments:
-May increase dose after 2 weeks as needed to achieve blood pressure goal.
-Adding benazepril to amlodipine should not be expected to provide additional blood pressure reduction in African Americans.

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