Telmacal 10/80

Indications

Telma is indicated for managing essential hypertension in adults, either alone or in combination with other antihypertensive agents. It is also suitable for initial therapy in patients likely to need multiple medications to achieve blood pressure goals. Additionally, Telma reduces cardiovascular morbidity in adults with a history of atherothrombotic cardiovascular conditions or type 2 diabetes with documented target organ damage.

Pharmacology

Telmisartan is a non-peptide angiotensin II receptor blocker (ARB) that targets the AT1 receptor, blocking the vasoconstrictor and aldosterone-secreting effects of angiotensin II. This leads to a reduction in blood pressure without affecting the pulse rate. Telmisartan has a much higher affinity for the AT1 receptor compared to the AT2 receptor and does not affect bradykinin responses or other hormone receptors.

Amlodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the influx of calcium ions into vascular and cardiac muscle. This results in decreased peripheral vascular resistance and reduced blood pressure by directly acting on vascular smooth muscle.

Dosage & Administration

The usual starting dose of Telma is 40/5 mg once daily, with adjustments possible based on individual response, ranging up to 80/10 mg daily. Maximum effects are typically observed within 4 weeks. For patients requiring larger reductions in blood pressure, initial therapy may be adjusted accordingly. Initial therapy with Telma is not recommended for patients aged 75 years or older or those with hepatic impairment.

Telma can be used as add-on therapy for patients not adequately controlled with amlodipine alone or telmisartan alone. It may also replace separate amlodipine and telmisartan tablets with the same component doses once daily. Dosage should be individualized and can be increased after at least 2 weeks, with a maximum recommended dose of 80/10 mg once daily.

Interactions

Co-administration of Telmisartan generally does not result in significant interactions with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan does not significantly affect cytochrome P450 enzymes, except for some inhibition of CYP2C19. Amlodipine can be safely used with thiazide diuretics, beta-blockers, ACE inhibitors, and other medications.

Contraindications

Telma is contraindicated in patients with known hypersensitivity to any of its components. It should not be used during pregnancy, in patients with biliary obstructive disorders, severe hepatic impairment, hypotension, cardiogenic shock, or left ventricle outflow tract obstruction.

Side Effects

Common side effects include dizziness, peripheral edema, migraine, headache, paraesthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, pruritus, myalgia, spasm, erectile dysfunction, chest pain, and fatigue. Cardiovascular risk reduction may lead to intermittent claudication and skin ulcers.

Pregnancy & Lactation

Telma is classified as Pregnancy Category C in the first trimester and D in the second and third trimesters. The potential for adverse effects on the nursing infant must be considered. Discontinue nursing or the medication based on its importance to the mother.

Precautions & Warnings

Fetal or neonatal exposure should be avoided. Monitor for hypotension and correct any volume or salt depletion before starting therapy. Titrate slowly in patients with hepatic or severe renal impairment. Avoid the use of ACE inhibitors and angiotensin receptor blockers together. Caution is advised in patients with severe obstructive coronary artery disease due to potential increased risk of myocardial infarction or angina.

Use in Special Populations

The safety and effectiveness of Telmisartan and Amlodipine in pediatric patients have not been established. Initial therapy with this combination is not recommended for patients aged 75 years or older or those with hepatic impairment.

Overdose Effects

Overdosage of Telmisartan may lead to hypotension, dizziness, and tachycardia, with possible bradycardia from parasympathetic stimulation. Supportive treatment is advised, as Telmisartan is not removed by hemodialysis. Overdosage of Amlodipine may cause excessive vasodilation and hypotension, requiring active cardiac and respiratory monitoring. Fluid management and possibly vasopressors may be needed, with Amlodipine also not removed by hemodialysis.

Therapeutic Class

Telma belongs to the class of combined antihypertensive preparations.

Storage Conditions

Store Telma below 30°C, protect from light and high humidity, and keep out of reach of children.