Product Description

**Temcard-A (Telmisartan + Amlodipine) Summary**

**Indications**

* Treatment of hypertension (high blood pressure), used alone or in combination with other antihypertensive agents.

* Can be used as initial therapy in patients who likely require multiple medications to meet their target blood pressure goals.

**Mechanism & Pharmacology**

* **Class:** Combination Antihypertensive (Angiotensin II Receptor Blocker + Dihydropyridine Calcium Channel Blocker).

* **Telmisartan (ARB):** Selectively blocks the binding of Angiotensin II to $AT_1$ receptors in vascular smooth muscle and adrenal tissues. This inhibits vasoconstriction and aldosterone secretion, dilating blood vessels without affecting heart rate.

* **Amlodipine (CCB):** Inhibits the transmembrane influx of calcium ions into vascular smooth and cardiac muscle cells, causing direct relaxation of peripheral arterial smooth muscle and reducing total peripheral vascular resistance.

**Dosage & Administration**

* **Initial Therapy:** Typically 40/5 mg once daily. For patients requiring larger blood pressure reductions, start at 80/5 mg once daily. *(Not recommended as initial therapy in patients $\ge$75 years or with hepatic impairment).*

* **Add-On Therapy:** For patients insufficiently controlled on Telmisartan or Amlodipine monotherapy. Patients experiencing peripheral edema on 10 mg Amlodipine can switch to 40/5 mg Temcard-A once daily to lower the Amlodipine dose without losing antihypertensive efficacy.

* **Replacement Therapy:** Patients already stabilized on separate Telmisartan and Amlodipine tablets can transition to the equivalent fixed-dose combination.

* **Dose Titration:** Adjust individually; titrate after at least 2 weeks if needed. Maximum dose is 80/10 mg once daily.

**Key Interactions**

* **CYP450 Metabolism:** Telmisartan shows no major CYP enzyme interactions (minor $CYP2C19$ inhibition potential). Amlodipine does not show clinically relevant pharmacokinetic interactions with common drugs (such as digoxin, warfarin, or statins).

* **Renal/RAS Blockade:** Concomitant use with ACE inhibitors should be avoided to limit dual blockade risks.

**Contraindications**

* Hypersensitivity to Telmisartan, Amlodipine, or any formulation components.

* Pregnancy and lactation.

* Biliary obstructive disorders, severe hepatic impairment, severe hypotension, cardiogenic shock, and left ventricular outflow tract obstruction.

**Side Effects & Safety Precautions**

* **Common Side Effects:** Dizziness, peripheral edema, headache, flushing, fatigue, abdominal pain, nausea, and hypotension.

* **Pregnancy Warning:** Contraindicated in pregnancy (Category C in 1st trimester; Category D in 2nd/3rd trimesters) due to severe fetal/neonatal injury risks. Discontinue breastfeeding during treatment.

* **Precautions:** Correct volume or salt depletion prior to starting therapy to prevent severe hypotension. Use caution and slow titration in severe renal or hepatic impairment. Monitor patients with heart failure or severe obstructive coronary artery disease for worsening symptoms or angina.

**Overdose Management**

* **Symptoms:** Severe peripheral vasodilation, marked hypotension, dizziness, and tachycardia (or parasympathetic bradycardia).

* **Management:** Continuous cardiovascular and respiratory monitoring with frequent blood pressure tracking. Elevate extremities and administer judicious intravenous fluids; consider vasopressors (e.g., phenylephrine) if hypotension remains refractory. Neither Telmisartan nor Amlodipine is clearance-effective via hemodialysis.

**Storage**

* Store below 30°C. Protect from light and high humidity. Keep out of reach of children.