Arbitel AM 5/80

Indications of Arbitel AM 5/80 Tablet

Arbitel AM 5/80 Tablet (Telmisartan & Amlodipine combination) is indicated for the treatment of hypertension alone or with other antihypertensive agents to lower blood pressure. Lowering blood pressure reduces the risk of fatal & nonfatal cardiovascular events, primarily stroke & myocardial infarction. This tablet is also indicated for initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goal.

 

Pharmacology of Arbitel AM 5/80 Tablet

This is a fixed-dose combination of telmisartan and amlodipine. Telmisartan, a non-peptide angiotensin receptor blocker (ARB), is a specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin II is the major stressor of the renineangiotensin system, with effects including vasoconstriction, stimulation of aldosterone synthesis and release, cardiac stimulation, and renal reabsorption of sodium, resulting in hypertension (increased blood pressure). blood pressure). Telmisartan blocks the vasoconstrictor and aldosterone-reducing effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Thus, telmisartan dilates the blood vessels and lowers blood pressure without affecting the pulse. Telmisartan has a much higher affinity (> 3000 times) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

 Amlodipine, a dihydropyridine calcium channel blocker (CCB), inhibits the transmembrane output of calcium ions in vascular and cardiac smooth muscle. Amlodipine is a peripheral vasodilator that acts directly on vascular smooth muscle causing a decrease in peripheral vascular resistance and a decrease in blood pressure.

 

Arbitel AM 5/80 Tablet Dosage & Administration

Initial Therapy: The patient may be initiated on these tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. Initial therapy with this is not recommended in patients 575 years old or with hepatic impairment.

Add-on Therapy: Patients not adequately controlled with amiodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amiodipine who experience adverse reactions such as edema, may be switched to these 40/5 mg tablets once daily, reducing the dose of amiodipine without reducing the overall expected antihypertensive response.

Replacement Therapy: Patients receiving amiodipine and telmisartan from separate tablets may instead receive this tablet containing the same component doses once daily. Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of this tablet is 80/10 mg once daily.

 

Interactions of Arbitel AM 5/80 Tablet

• The combination of telmisartan and acetaminophen, amlodipine, glibenclamide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen will not produce clinically significant interactions. Telmisartan is not metabolized by the cytochrome P450 system and has no effect on cytochrome P450 enzymes in vitro, except for some inhibitory effects on CYP2C19.
• Telmisartan is not expected to interact with drugs that inhibit cytochrome P450 enzymes or are metabolized by cytochrome P450 enzymes unless it is possible to inhibit the metabolism of drugs metabolized by CYP2C19.
• In clinical trials, aminedipine and thiazide diuretics, beta receptor blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic agents are safely administered together.
• The following have no clinically relevant effects on amlodipine pharmacokinetics: cimetidine, grapefruit juice, sildenafil. Amlodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following drugs: atorvastatin, digoxin, warfarin.

 

Contraindications of Arbitel AM 5/80 Tablet

Arbitel AM 5/80 Tablet Known hypersensitivity to this product or any of its components. Pregnancy & lactation, Biliary obstructive disorders, severe hepatic impairment, hypotension, cardiogenic shock, left ventricle outflow tract obstruction.

 

Arbitel AM 5/80 Tablet Side Effects

Arbitel AM 5/80 Tablet is used to treat hypertension alone or in combination with other antihypertensive drugs. It can also be used as an initial treatment for patients who may need multiple medications to reach their blood pressure goals.

 

Pregnancy & Lactation

Pregnancy: When pregnancy is detected, Arbitel AM 5/80 Tablet should be discontinued as soon as possible. Pregnancy Categories C (first trimester) and D (second and third trimesters).

Lactation: It is not known whether Telmisartan and Amlodipine is excreted in human milk. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue the drug after taking into account the importance of the drug to the mother. 

 

Precautions & Warnings

• Avoid fetal or newborn exposure
• Hypotension: Correct any loss of volume or salt before starting treatment. Observe the signs and symptoms of hypotension
• Slowly titrate patients with severe liver or renal insufficiency
• Heart failure-monitor deterioration
• Avoid simultaneous use of ACE inhibitors and angiotensin receptor blockers
• Myocardial infarction: rare, in obstruction Initiation of CCB coronary artery disease in sexual patients can lead to myocardial infarction or worsening of angina pectoris.

 

Therapeutic Class

Combined antihypertensive preparations

 

Storage Conditions

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

 

Pharmaceutical Name of Arbitel AM 5/80 Tablet

ACI Limited

 

Generic

Amlodipine Besilate + Telmisartan

 

Related Products

• Telmacal 5/80
• Telmitan Max 5/80