Telmitan Plus

• Approved Indications:
• Essential hypertension: for the management of high blood pressure when monotherapy with either telmisartan or hydrochlorothiazide is insufficient.
• Off-label/Clinically Accepted Uses:
• Resistant hypertension requiring combination therapy.
• Patients at risk of cardiovascular complications needing effective blood pressure control.

• Adults:
• Starting dose: One tablet containing telmisartan 40 mg and hydrochlorothiazide 12.5 mg once daily.
• Maintenance dose: May increase to telmisartan 80 mg plus hydrochlorothiazide 25 mg once daily based on response.
• Maximum dose: Telmisartan 80 mg + hydrochlorothiazide 25 mg daily.
• Elderly:
• Initiate with standard adult dosing; monitor renal function and blood pressure closely.
• Renal Impairment:
• Use with caution in mild to moderate impairment.
• Hydrochlorothiazide contraindicated in severe renal impairment (creatinine clearance <30 mL/min).
• Hepatic Impairment:
• Use cautiously in mild to moderate hepatic impairment.
• Avoid in severe hepatic dysfunction or cholestasis.
• Route: Oral administration, with or without food.

Telmisartan acts as a selective antagonist of angiotensin II type 1 (AT1) receptors, blocking the effects of angiotensin II, which leads to vasodilation and decreased aldosterone secretion, resulting in reduced blood pressure and volume. Hydrochlorothiazide, a thiazide diuretic, inhibits sodium and chloride reabsorption in the distal renal tubules, increasing urine output and reducing plasma volume. The combined effects reduce peripheral vascular resistance and circulating blood volume, thereby lowering blood pressure synergistically.

• Telmisartan:
• Absorption: Rapid, peak plasma concentration in ~0.5–1 hour.
• Bioavailability: 42–58%.
• Distribution: Highly protein bound (~99.5%).
• Metabolism: Minimal hepatic metabolism via glucuronidation.
• Elimination half-life: Approximately 24 hours.
• Excretion: Primarily fecal (~90%), renal (~7%).
• Hydrochlorothiazide:
• Absorption: Peak plasma concentration within 1.5–5 hours.
• Bioavailability: 60–80%.
• Protein binding: Low.
• Metabolism: Not metabolized.
• Half-life: 6–15 hours.
• Excretion: Excreted unchanged via kidneys.

• Pregnancy:
• Telmisartan: Category D — contraindicated due to fetal toxicity risk (especially in 2nd and 3rd trimesters).
• Hydrochlorothiazide: Category B — use only if clearly needed.
• Lactation:
• Both drugs are excreted in breast milk; breastfeeding not recommended during treatment due to potential infant effects.

• Antihypertensive combination.
• Telmisartan: Angiotensin II receptor blocker (ARB).
• Hydrochlorothiazide: Thiazide diuretic.

• Known hypersensitivity to telmisartan, hydrochlorothiazide, or formulation excipients.
• Pregnancy.
• Severe renal impairment (especially hydrochlorothiazide).
• Anuria.
• History of hypersensitivity to sulfonamide derivatives (hydrochlorothiazide).
• Concurrent use with aliskiren in diabetic or renal impaired patients.

• Monitor for hypotension, particularly in volume-depleted patients.
• Electrolyte monitoring necessary due to risks of hyperkalemia (telmisartan) and hypokalemia (hydrochlorothiazide).
• Caution in renal or hepatic impairment.
• Watch for angioedema symptoms; discontinue immediately if occurs.
• Hydrochlorothiazide may increase photosensitivity.
• Regular renal function and electrolyte monitoring recommended.

• Common:
• Dizziness, headache, fatigue, increased urination, hypotension.
• Electrolyte disturbances:
• Hyperkalemia, hypokalemia, hyponatremia.
• Serious but rare:
• Angioedema, pancreatitis, severe hypotension, severe electrolyte imbalances.
• Skin:
• Rash, photosensitivity reactions.

• Potassium supplements or potassium-sparing diuretics may cause hyperkalemia.
• NSAIDs may reduce antihypertensive effect and increase risk of renal impairment.
• Lithium toxicity risk increased.
• Additive hypotensive effects with other antihypertensives.
• Minimal CYP450 interactions.
• Alcohol may enhance blood pressure lowering effects.

• Combination therapy recommended for patients inadequately controlled on monotherapy.
• Strict avoidance during pregnancy emphasized by regulatory agencies.
• Electrolyte and renal function monitoring strongly advised.
• Supported by hypertension guidelines (JNC 8, ESC/ESH) as effective dual therapy.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Do not freeze.
• Keep out of reach of children.
• No special reconstitution or refrigeration required.