Tems A

Approved Indications:

• Hypertension (Primary & Essential):
  Indicated for the treatment of high blood pressure in patients where monotherapy with either amlodipine or telmisartan is inadequate.
• Cardiovascular Risk Reduction:
  In hypertensive patients with additional cardiovascular risk factors (e.g., diabetes, dyslipidemia), this combination may help reduce cardiovascular morbidity.
• Stable Coronary Artery Disease (CAD):
  Off-label use in patients with hypertension and stable CAD not adequately controlled with either agent alone.

Adults:

• Starting Dose:
  One tablet daily (commonly 40 mg telmisartan + 5 mg amlodipine), orally, once daily.
• Titration:
  May be increased based on clinical response to maximum of 80 mg telmisartan + 10 mg amlodipine once daily.

Pediatrics:

• Safety and efficacy have not been established in children under 18 years.

Elderly:

• No dosage adjustment required. Start at the lowest effective dose and monitor blood pressure closely.

Renal Impairment:

• No initial dose adjustment is necessary. Monitor renal function periodically.

Hepatic Impairment:

• Use with caution. In mild-to-moderate hepatic impairment, start at lower doses. Contraindicated in severe hepatic impairment.

Administration Route:

• Oral, with or without food. Should be taken at the same time each day.

Amlodipine, a dihydropyridine calcium channel blocker, inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle, leading to vasodilation and decreased peripheral vascular resistance. Telmisartan, an angiotensin II receptor blocker (ARB), selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle, preventing vasoconstriction and aldosterone-mediated volume expansion. The combination produces complementary antihypertensive effects through dual mechanisms—vasodilation and inhibition of the renin-angiotensin-aldosterone system (RAAS).

Amlodipine:

• Absorption: Well absorbed; bioavailability 64–90%
• Onset: Gradual; peak plasma level in 6–12 hours
• Half-life: 30–50 hours
• Metabolism: Hepatic (CYP3A4)
• Excretion: 60% in urine (mainly as metabolites)

Telmisartan:

• Absorption: Oral bioavailability ~40–60%
• Peak Plasma Time: 0.5–1 hour
• Half-life: 20–24 hours
• Metabolism: Minor hepatic via glucuronidation (non-CYP pathway)
• Excretion: Primarily via feces (>97%)

• Pregnancy:
  Telmisartan is contraindicated during pregnancy. Drugs that act on the RAAS can cause fetal injury and death when administered during the second and third trimesters.
• Lactation:
  Amlodipine is excreted in human milk; telmisartan excretion is unknown. Use is not recommended during breastfeeding due to potential adverse effects on the infant.

• Primary Class: Antihypertensive Agent
• Subclass:
• Amlodipine: Dihydropyridine Calcium Channel Blocker
• Telmisartan: Angiotensin II Receptor Blocker (ARB), long-acting

• Known hypersensitivity to amlodipine, telmisartan, or excipients
• Pregnancy (especially 2nd and 3rd trimester)
• Severe hepatic impairment or biliary obstructive disorders
• Cardiogenic shock or unstable angina (amlodipine-specific)
• Co-administration with aliskiren in patients with diabetes

• Hypotension Risk: Especially in volume- or salt-depleted patients; correct imbalance before initiation.
• Renal Function Monitoring: Required in patients with renal impairment or those on nephrotoxic drugs.
• Hepatic Dysfunction: Use cautiously in hepatic impairment; telmisartan is primarily eliminated via the liver.
• Heart Failure Patients: Amlodipine may worsen angina or cause fluid retention.
• Electrolyte Imbalance: Monitor potassium levels; risk of hyperkalemia with telmisartan.

Common:

• Cardiovascular: Peripheral edema, hypotension, palpitations
• Nervous System: Dizziness, headache, fatigue
• Gastrointestinal: Nausea, abdominal pain, diarrhea

Less Common/Serious:

• Hyperkalemia
• Acute renal impairment
• Bradycardia or tachycardia
• Hepatic enzyme elevation
• Allergic reactions (rash, angioedema)

• Potassium-sparing Diuretics / Potassium Supplements: Risk of hyperkalemia
• NSAIDs: Reduced antihypertensive effect, possible renal impairment
• CYP3A4 Inhibitors (e.g., ketoconazole): May increase amlodipine levels
• Digoxin and Lithium: Monitor serum concentrations when used with telmisartan
• Aliskiren: Contraindicated in diabetic patients

Metabolism Involvement:

• Amlodipine: CYP3A4 substrate
• Telmisartan: Not significantly metabolized by CYP450 system

• Recent Hypertension Guidelines (e.g., AHA/ACC, ESC/ESH): Recommend use of combination therapy (including ARB + CCB) as first-line in Stage 2 hypertension or when BP >20/10 mmHg above target.
• Pregnancy Boxed Warning: Reinforced across multiple guidelines due to fetal risk.

• Temperature: Store below 30°C
• Humidity: Protect from moisture
• Light: Store in original packaging, away from direct sunlight
• Handling: Keep out of reach of children; do not use if packaging is damaged
• Reconstitution: Not applicable (oral tablet)