mph Bangladesh


Amlodipine with Benazepril

(am loe' di peen) (ben ay' ze pril)

PCI - Contraindicated in pregnancy

LCI - Contraindicated in lactation

Molecule Info

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Indication(s) & Dosage

HYPERTENSION  Adult: As capsules containing amlodipine /benazepril HCl: 2. 5/10, 5/10, 5/20, 5/40, 10/20, 10/40.  Amlodipine component: 2. 5-10 mg once daily; benazepril component: 10-40 mg once daily.  Titrate dose gradually according to response. Elderly: Initiate with 2. 5 mg Amlodipine component once daily. Renal impairment: Avoid usage in patients with CrCl <30ml/min/1. 73m<207>2<209>. Hepatic impairment: Initiate with 2. 5 mg Amlodipine component once daily.  Titrate combination slowly in severe hepatic impairment.

Administration

May be taken with or without food.  May be taken w/ meals to minimise GI discomfort.  Do not take with antacids, Fe or dairy products.

Overdosage

Symptoms: Most likely hypotension and tachycardia due to vasodilation.  Treatment: May include replenishment of central fluid volume and/or the use of pressor agents.  Benazeprilat is slightly dialysable; haemodialysis may not be useful in removing Amlodipine as it is highly-bound to plasma proteins.

Contraindications

Patients with history of angioedema; pregnancy, lactation.

Special Precautions

Discontinue Amlodipine+Benazepril as soon as possible if pregnancy is detected.  Caution in elderly, renal or hepatic impairment, congestive heart failure, severe aortic stenosis, unilateral or bilateral renal artery stenosis, use during surgery or anaesthesia.  Amlodipine+Benazepril can cause symptomatic hypotension, especially in patients with salt/volume depletion.  ACE inhibitors have been associated with cholestatic jaundice and fulminant hepatic necrosis; discontinue treatment if patient develops jaundice/marked elevation of liver enzymes.  Monitor renal function and serum potassium periodically.  Angioedema of the face, extremities, lips, tongue, glottis, larynx and intestinal angioedema have been reported in ACEi-treated patients.  As with all ACEi, may cause persistent dry cough.  Safety and efficacy in paediatric patients have not been established.

Adverse Drug Reaction(s)

Cough, oedema, headache, dizziness, flushing, dry mouth, nausea, diarrhoea, constipation, asthenia, fatigue, hyperkalaemia, hypotension, orthostatic hypotension, musculoskeletal pain, skin rash, insomnia, anxiety, decreased libido, acute renal disease, palpitation, angina pectoris, bradycardia, chest pain, jaundice, hepatic enzymes elevations, increased creatinine and BUN, haemolytic anaemia, neutropenia, thrombocytopenia, pancreatitis, pemphigus. Potentially Fatal: Analphylactoid reactions, angioedema, Stevens-Johnson syndrome.

Drug Interactions

NSAIDs may decrease effect of ACE inhibitors.  Concurrent admin with diuretics may increase the hypotensive effect.  Benazepril may increase risk of hyperkalaemia when used with potassium supplements or potassium-sparing diuretics.  Concurrent use of Benazepril and interferons may increase risk of granulocytopenia.  Hypersensitivity, neutropenia and serious infection have occurred following concomitant use of ACEi and allopurinol.  Indinavir and ritonavir may increase serum levels of Amlodipine.  Concurrent use with lithium may increase serum levels of lithium and risk of lithium toxicity.

Pregnancy Category (FDA)

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk.

Storage

Oral:  Store at 25°C, excursions permitted to 15-30°C.

Pharmacology

Amlodipine is a dihydropyridine calcium antagonist.  It lowers BP by relaxing the coronary vascular smooth muscles and producing coronary vasodilation; through inhibition of transmembrane Ca ion influx into vascular smooth muscle and cardiac muscle.  It is also a peripheral vascular vasodilator.  Benazepril and its active metabolite benazeprilat inhibit ACE, which results in decreased plasma angiotensin II and thus leading to decreased aldosterone secretion. Onset: Antihypertensive effect is largely attained within 2 wk.  Absorption: About 64-90% and at least 37%.  Distribution: Vd: 21 L/kg; 0. 7 L/kg.  Protein binding: About 93%.  Metabolism: Benazepril: Almost completely metabolised to benazeprilat by cleavage of the ester group, mainly in the liver.  Amlodipine: Extensively metabolised in the liver.  Excretion: Amlodipine: 10% of parent compound and 60% of the metabolites are removed in urine.  Benazeprilate: Excreted in urine as benazeprilat, benazeprilat glucuronide, benazepril glucuronide and trace amount as unchanged drug.  Elimination half life: 10-11 hr; about 2 days.

mph Class

ACE Inhibitors/Direct Renin Inhibitors / Calcium Antagonists

ATC Classification

C08CA01 - amlodipine; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects.  Used in the treatment of cardiovascular diseases.  C09AA07 - benazepril; Belongs to the class of ACE inhibitors.  Used in the treatment of cardiovascular disease.

 

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Brand/Product Info


Total Products : 15               
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
AMDOPRIL 10/20 Beximco Pharmaceuticals Ltd Amlodipine 10mg + Benazepril HCl 20mg Capsule 30's: 300.00 MRP
AMDOPRIL 2.5/10 Beximco Pharmaceuticals Ltd Amlodipine 2.5 mg + Benazepril HCl 10 mg Capsule 60's: 240.00 MRP
AMDOPRIL 5/10 Beximco Pharmaceuticals Ltd Amlodipine 5 mg + Benazepril HCl 10 mg Capsule 60's: 360.00 MRP
AMLOZEP-10 Beacon Pharmaceuticals Limited Amlodipine 5mg+ Benazepril Hydrochloride 10mg Capsule 30's: 180.00 MRP
AMOCAL-BZ 10/2.5 Opsonin Pharma Limited Amlodipine 2.5mg+ Benazepril Hydrochloride 10mg Capsule 30's: 120.00 MRP
AMOCAL-BZ 10/5 Opsonin Pharma Limited Amlodipine 5mg+ Benazepril Hydrochloride 10mg Capsule 30's: 180.60 MRP
AMOCAL-BZ 20/5 Opsonin Pharma Limited Amlodipine 5mg+ Benazepril Hydrochloride 20mg Capsule 20's: 160.00 MRP
BENADIP 10/2.5 Incepta Pharmaceuticals Limited Amlodipine 2.5mg + Benazepril Hydrochloride 10mg Capsule 28's: 112.00 MRP
BENADIP 10/5 Incepta Pharmaceuticals Limited Amlodipine 5 mg + Benazepril Hydrochloride 10 mg Capsule 28's:168.00 MRP
BENADIP 20/10 Incepta Pharmaceuticals Limited Amlodipine 10mg+ Benazepril Hydrochloride 20mg Capsule 28's: 280.00 MRP
BENADIP 20/5 Incepta Pharmaceuticals Limited Amlodipine 5mg + Benazepril Hydrochloride 20mg Capsule 28's: 224.00 MRP
CAMLOPRIL 42500 Square Pharmaceuticals Ltd. Amlodipine + Benazepril (5mg + 10mg) Capsule 5x6's: 181.20 MRP
LODIBEN 10/2.5 Eskayef Bangladesh Ltd Amlodipine 2.5mg + Benazepril Hydrochloride 10mg Capsule 36's MRP: 144.00
LODIBEN 10/5 Eskayef Bangladesh Ltd Amlodipine 5mg + Benazepril Hydrochloride 10mg Capsule 24's MRP: 144.00
LODIBEN 20/5 Eskayef Bangladesh Ltd Amlodipine 5mg + Benazepril Hydrochloride 20mg Capsule 16's MRP: 128.00

Gen. MedInfo

IMPORTANT WARNING:

Do not take amlodipine and benazepril if you are pregnant. If you become pregnant while taking amlodipine and benazepril, call your doctor immediately. Amlodipine and benazepril may harm the fetus.

Why this medication is prescribed?

The combination of amlodipine and benazepril is used to treat high blood pressure. 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.

How to use this medicine?

The combination of amlodipine and benazepril comes as a capsule to take by mouth. It is usually taken once a day. To help you remember to take amlodipine and benazepril, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amlodipine and benazepril exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Amlodipine and benazepril controls high blood pressure but does not cure it. Continue to take amlodipine and benazepril even if you feel well. Do not stop taking amlodipine and benazepril without talking to your doctor.

Other uses

This medication may be prescribed for other uses; ask your doctor for more information.

What special precautions to follow?

Before taking amlodipine and benazepril,

  • inform your doctor if you are allergic to amlodipine, benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril, or any other medications.
  • inform your doctor if you have diabetes  and you are taking aliskiren. Your doctor will probably inform you not to take amlodipine and benazepril if you have diabetes and you are also taking aliskiren.
  • inform your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: diuretics, lithium, and potassium supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • inform your doctor if you have recently had severe diarrhea or vomiting and if you have or have ever had heart failure; lupus; scleroderma; heart, liver, or kidney disease; or diabetes.
  • inform your doctor if you plan to become pregnant or are breast-feeding.
  • if you are having surgery, including dental surgery, inform the doctor or dentist that you are taking amlodipine and benazepril.

What special dietary instructions to follow?

Talk to your doctor before using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

What should be done if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects could appear?

Amlodipine and benazepril may cause side effects. inform your doctor if any of these symptoms are severe or do not go away:

  • cough
  • headache
  • dizziness
  • swelling of the hands, feet, ankles, or lower legs
  • swelling of the face, throat, tongue, lips, or eyes
  • hoarseness
  • difficulty swallowing or breathing
  • fainting
  • severe skin rash
  • yellowing of the skin or eyes
  • more frequent or more severe chest pain

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, consult your Doctor immediately:

Amlodipine and benazepril may cause other side effects. Consult your Doctor if you have any unusual problems while taking this medication.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture. Throw away any medication that is outdated or no longer needed. Talk to your Doctor about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, consult your Doctor. If the victim has collapsed or is not breathing, consultl local Medical Emergency Services.

What other information to know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to amlodipine and benazepril. Your doctor may order certain lab tests to check your body's response to amlodipine and benazepril.

It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ref: U.S. Natl. Library of Medicine

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