Amlodipine + Benazepril Hydrochloride

Amlodipine + Benazepril Hydrochloride is used to treat hypertension (high blood pressure). This is a combination of two medicines that controls blood pressure when a single medication is not effective. It helps to lower high blood pressure and thus reduces the chances of future heart attack and stroke.

You can take Amlodipine + Benazepril Hydrochloride at any time of day, with or without food, but it is best to take it at the same time each day. Keep taking it for as long as advised by your doctor. Even if you feel well, do not stop this medicine on your own because high blood pressure often has no symptoms. If you stop taking it, your condition may get worse.

Keeping active with regular exercise, reducing your weight and eating a healthy diet will also help control your blood pressure. Follow your doctor's advice while taking this medicine. It may cause side effects like ankle swelling, headache, weakness, numbness of extremities, flushing (sense of warmth in the face, ears, neck, and trunk), and tiredness. It may also cause dizziness, so do not drive or do anything that requires mental focus until you know how this medicine affects you.

You may be asked for regular monitoring of blood pressure, kidney function, and electrolytes level while on the treatment. Before taking it, let your doctor know if you have any liver or kidney problems. Pregnant or breastfeeding women should also consult their doctor for advice before taking this medicine. You also need to tell your doctor what other medicines you are taking especially those used to treat high blood pressure or heart conditions.

• Hypertension (high blood pressure)
• Patients whose blood pressure is not adequately controlled with either monotherapy

Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and in animals. While the mechanism through which Benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin aldosterone system, Benazepril has an antihypertensive effect even in patients with low-renin hypertension.

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Amlodipine relaxes and widens blood vessels, lowering blood pressure and improving blood flow. Benazepril (an ACE inhibitor) blocks the formation of angiotensin II, helping lower blood pressure and reduce the workload on the heart. Together, they relax blood vessels so that blood flows more smoothly and the heart can pump blood more efficiently.

Adult Dose:

• Amlodipine 2.5-10 mg and Benazepril 10-80 mg once daily
• Usually started after monotherapy failure or when Amlodipine causes edema
• Discontinue as soon as pregnancy is detected
• Caution in elderly, renal or hepatic impairment, congestive heart failure, severe aortic stenosis
• Symptomatic hypotension may occur in patients with salt/volume depletion
• ACE inhibitors may cause cholestatic jaundice and fulminant hepatic necrosis; discontinue if jaundice or elevated liver enzymes
• Monitor renal function and serum potassium periodically
• Angioedema of face, extremities, lips, tongue, glottis, larynx and intestinal angioedema may occur
• Persistent dry cough may occur

Renal Dose: Dose adjustment may be needed for renal impairment.

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Amlodipine + Benazepril Hydrochloride may be taken with or without food, but it is better to take it at a fixed time.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose to catch up.

• Ankle swelling
• Headache
• Tiredness
• Palpitations
• Increased potassium level in blood
• Sleepiness
• Cough
• Taste change
• Flushing (sense of warmth in the face, ears, neck and trunk)
• Decreased blood pressure
• Upset stomach

[UNSAFE] Amlodipine + Benazepril Hydrochloride may cause side effects which could affect your ability to drive. May cause dizziness, headaches, nausea or tiredness, all of which could affect your ability to concentrate and drive.

Get up slowly when rising from a sitting or lying position. Let your doctor know if you are pregnant or planning for pregnancy.

Caution in patients with severe renal disease, hepatic impairment, high potassium levels, or those undergoing surgery. ACE inhibitor-induced cough should be reported to your doctor. During surgery or anesthesia, hypotension may occur.

• Hypersensitivity to Benazepril, any other ACE inhibitor, or Amlodipine
• Pregnancy (especially second and third trimesters)
• History of angioedema
• Safety and efficacy in paediatric patients have not been established

• Diuretics: Patients on diuretics, especially those recently initiated, may experience excessive reduction of blood pressure
• Potassium Supplements and Potassium-Sparing Diuretics: Benazepril can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics (Spironolactone, Amiloride, Triamterene) or potassium supplements increase risk of hyperkalemia
• Others: No clinically important adverse interactions with oral anticoagulants, beta-blockers, calcium blockers, Cimetidine, diuretics, Digoxin, Hydralazine, Naproxen
• Safely used with thiazide diuretics, beta blockers, ACE inhibitors, nitrates, Digoxin, Warfarin, NSAIDs, antibiotics, and oral hypoglycemic drugs

[UNSAFE] It is unsafe to consume alcohol with Amlodipine + Benazepril Hydrochloride.

[CONSULT YOUR DOCTOR] Amlodipine + Benazepril Hydrochloride is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby (Pregnancy Category D - second and third trimesters). However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. When pregnancy is detected, discontinue as soon as possible. Please consult your doctor.

[SAFE IF PRESCRIBED] Amlodipine + Benazepril Hydrochloride is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby. However, it is not known whether Amlodipine is excreted in human milk; if use is considered necessary, nursing should be discontinued.

Safety and effectiveness in pediatric patients have not been established.

Clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

[CAUTION] Amlodipine + Benazepril Hydrochloride should be used with caution in patients with kidney disease. Dose adjustment of Amlodipine + Benazepril Hydrochloride may be needed. Please consult your doctor. Regular monitoring of blood pressure is recommended for better dose adjustment.

[CAUTION] Amlodipine + Benazepril Hydrochloride should be used with caution in patients with liver disease. Dose adjustment of Amlodipine + Benazepril Hydrochloride may be needed. Please consult your doctor. Amlodipine + Benazepril Hydrochloride is started at a lower dose in patients with liver disease and further increased slowly with careful monitoring.

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. Overdose may cause hypotension. Unabsorbed drugs may be removed by gastric lavage or administration of activated charcoal. Symptomatic treatment is suggested.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.