Telma Plus40 mg+12.5 mg

Telma Plus is a fixed-dose combination of telmisartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a thiazide diuretic, indicated for:

• Established/guideline-supported use: Treatment of hypertension, in patients whose blood pressure is not adequately controlled on either component alone, used alone or together with other antihypertensive agents.
• Cardiovascular risk reduction (guideline-supported): By lowering blood pressure, Telma Plus helps reduce the risk of fatal and non-fatal cardiovascular events such as stroke and myocardial infarction.

Telma Plus is not indicated for initial (first-line) therapy of hypertension. It is intended for patients who have not achieved adequate blood pressure control on monotherapy with telmisartan or hydrochlorothiazide, or as a convenient replacement for patients already controlled on the individual components given separately.

Each tablet of Telmisartan + Hydrochlorothiazide contains two active ingredients:

• Telmisartan — an angiotensin II receptor blocker (ARB), available in 40 mg or 80 mg strengths within the combination.
• Hydrochlorothiazide — a thiazide diuretic, available in 12.5 mg or 25 mg strengths within the combination.

Common fixed-dose strength combinations (telmisartan/hydrochlorothiazide) include 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg tablets. Available strengths may vary by market and manufacturer.

Telma Plus is an oral fixed-dose combination antihypertensive tablet that pairs two complementary blood-pressure-lowering mechanisms in a single dosage form. It combines telmisartan, a selective angiotensin II receptor (AT1) blocker, with hydrochlorothiazide, a thiazide-type diuretic that promotes sodium and water excretion.

Telma Plus is used for the management of hypertension in patients not adequately controlled on either agent alone, allowing many patients to achieve blood pressure targets with a single tablet instead of two separate medicines, which can improve treatment adherence.

Telma Plus belongs to the therapeutic class of antihypertensive combination agents, specifically a fixed-dose combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic.

Telmisartan + Hydrochlorothiazide lowers blood pressure through two distinct and complementary mechanisms:

• Telmisartan (ARB component): Selectively and competitively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle and the adrenal gland, preventing angiotensin II-mediated vasoconstriction and aldosterone secretion. It does not inhibit ACE (kininase II) and therefore does not potentiate bradykinin.
• Hydrochlorothiazide (thiazide diuretic component): Inhibits sodium reabsorption in the distal convoluted tubule of the nephron, increasing excretion of sodium, chloride, and water. This initially reduces plasma volume, and with continued use contributes to a reduction in peripheral vascular resistance.

Together, the two components produce an additive antihypertensive effect. Telmisartan reaches peak plasma concentrations within 0.5–1 hour and has an elimination half-life of about 24 hours, supporting once-daily dosing; it is eliminated mainly by biliary excretion of unchanged drug, with minimal renal excretion. Hydrochlorothiazide is absorbed rapidly and eliminated largely unchanged by the kidneys, with a half-life of 6–15 hours.

Telma Plus is administered orally, once daily, with or without food, swallowed whole with water at approximately the same time each day for consistent blood pressure control. Keep tablets in the blister pack until immediately before dosing.

Telma Plus has the following clinically significant drug interactions:

Always inform your physician or pharmacist of all medications, supplements, and herbal products you are taking before starting Telma Plus.

Most patients tolerate Telma Plus well. Reported adverse effects include:

Common

• Upper respiratory tract infection
• Dizziness
• Sinusitis
• Fatigue
• Diarrhea
• Nausea
• Influenza-like symptoms

Less Common but Clinically Important

• Symptomatic hypotension, particularly after the first dose or a dose increase (see Precautions)
• Electrolyte disturbances — hypokalemia, hyponatremia, hyperkalemia (see Precautions)
• Hyperuricemia and gout flares
• Photosensitivity reactions (skin rash/sunburn-like reaction on sun-exposed areas)
• Worsening of renal function in susceptible patients

Rare/Serious

• Angioedema (swelling of the face, lips, tongue, or throat) — potentially life-threatening; seek emergency care immediately if it occurs
• Acute myopia and secondary angle-closure glaucoma (usually within hours to weeks of starting therapy) — stop the medicine and seek urgent eye care if sudden eye pain or vision changes occur
• Rhabdomyolysis
• Non-melanoma skin cancer with long-term, high cumulative hydrochlorothiazide exposure
• Blood disorders (rare) such as thrombocytopenia or leukopenia

Report any persistent, severe, or unusual side effect to your physician.

Pregnancy

Telma Plus is contraindicated in pregnancy. Drugs that act directly on the renin-angiotensin system, such as the telmisartan component, can cause injury and death to the developing fetus when used during the second and third trimesters, including oligohydramnios, fetal lung hypoplasia, skeletal deformations, and renal failure. When pregnancy is detected, Telma Plus should be discontinued as soon as possible, and the patient switched to an alternative antihypertensive considered appropriate in pregnancy under physician guidance. Any patient of childbearing potential should discuss reliable contraception and pregnancy planning with her physician before starting this medicine.

Lactation

Hydrochlorothiazide is known to pass into human breast milk, and thiazides in high doses can suppress lactation. It is not known whether telmisartan passes into human milk in clinically significant amounts. Because of the potential for serious adverse effects in a nursing infant, breastfeeding is not recommended during treatment with Telma Plus; a decision should be made, in consultation with a physician, whether to discontinue breastfeeding or use an alternative medicine.

The following precautions should be observed with Telma Plus:

• Fetal toxicity: See Pregnancy and Lactation; this is the most serious risk associated with this medicine and requires immediate discontinuation if pregnancy occurs.
• Hypotension: Symptomatic low blood pressure may occur, particularly in patients who are volume- or salt-depleted (e.g., from diuretic therapy, dietary salt restriction, vomiting, or diarrhea), and especially after the first dose or a dose increase. Correct volume depletion before starting therapy, or begin under close medical supervision.
• Electrolyte disturbances: The hydrochlorothiazide component can cause hypokalemia and hyponatremia, while the telmisartan component can cause hyperkalemia, especially in patients with renal impairment, diabetes, or those taking potassium supplements or potassium-sparing diuretics. Periodic monitoring of serum electrolytes is recommended.
• Renal function/renal artery stenosis: In patients with bilateral renal artery stenosis, stenosis of the artery to a single functioning kidney, or chronic kidney disease, drugs affecting the renin-angiotensin system can cause oliguria, progressive azotemia, and acute renal failure. Monitor renal function periodically, especially at initiation and after dose increases.
• Hepatic impairment/biliary obstruction: Telmisartan is eliminated mainly through biliary excretion; patients with biliary obstructive disorders or hepatic insufficiency may have markedly reduced clearance of telmisartan. Use with caution, start at the lowest dose, and titrate slowly in these patients; avoid in severe hepatic impairment.
• Photosensitivity: Hydrochlorothiazide can cause photosensitivity reactions; minimize sun/UV exposure and use sun protection while on treatment.
• Hyperuricemia/gout: Hydrochlorothiazide can raise serum uric acid and precipitate gout attacks in susceptible patients.
• Acute myopia and angle-closure glaucoma: Hydrochlorothiazide has been associated with acute transient myopia and secondary angle-closure glaucoma, typically within hours to weeks of starting the drug; discontinue promptly and seek urgent ophthalmologic care if symptoms occur.
• Dual blockade of the renin-angiotensin system: Avoid combining Telma Plus with ACE inhibitors or aliskiren, as this increases the risk of hypotension, hyperkalemia, and renal dysfunction without added benefit.
• Systemic lupus erythematosus: Thiazides have been reported to cause exacerbation or activation of systemic lupus erythematosus.
• Angioedema: Discontinue immediately and seek emergency care if swelling of the face, lips, tongue, or throat, or difficulty breathing occurs.
• Non-melanoma skin cancer: Long-term, high cumulative hydrochlorothiazide use has been associated with a small increased risk of non-melanoma skin cancer; limit sun exposure and report any new or changing skin lesions to a physician.

Overdose of Telma Plus may present with hypotension, dizziness, and tachycardia from the telmisartan component, along with electrolyte depletion (hypokalemia, hyponatremia, hypochloremia) and dehydration from excessive diuresis due to the hydrochlorothiazide component. If digoxin is also being taken, resulting hypokalemia may precipitate cardiac arrhythmias.

If an overdose is suspected, seek immediate medical attention or contact emergency services/a poison control center right away. Treatment is supportive and should be managed by medical professionals with active cardiovascular and electrolyte monitoring; do not attempt to manage a suspected overdose at home. Telmisartan is not effectively removed by hemodialysis; the effectiveness of dialysis for hydrochlorothiazide overdose has not been established.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. Do not remove tablets from the blister pack until immediately before use, as the tablets are moisture-sensitive.

Pediatric Use

Safety and efficacy of Telma Plus in pediatric patients have not been established. It is not recommended for use in children (see Pediatric Uses).

Geriatric Use

No overall differences in effectiveness were observed between elderly and younger patients in clinical trials; however, greater sensitivity to blood pressure lowering and electrolyte changes cannot be ruled out in some older individuals, so cautious dose selection and monitoring are advised.

Renal Impairment

No initial dosage adjustment is generally required in mild-to-moderate renal impairment. Telma Plus is not recommended in patients with severe renal impairment (creatinine clearance ≤30 mL/min) or anuria.

Hepatic Impairment

Use with caution; if used, initiate at the lowest dose (40 mg/12.5 mg) under close supervision, as telmisartan clearance is reduced (see Precautions). Not recommended in severe hepatic impairment or biliary obstructive disorders.

Pregnancy and Lactation

See Pregnancy and Lactation section — contraindicated in pregnancy; breastfeeding not recommended during treatment.

Telma Plus is typically used long-term for chronic management of hypertension, once blood pressure has not been adequately controlled on either individual component. Treatment duration is determined by the prescribing physician based on blood pressure control, cardiovascular risk, and tolerability, with regular follow-up visits to monitor blood pressure, renal function, and serum electrolytes. Do not stop taking this medicine abruptly without consulting your physician, and do not stop simply because blood pressure has normalized, as hypertension typically requires ongoing treatment.

Antihypertensive combination; Angiotensin II receptor blocker (ARB) + Thiazide diuretic

Telmisartan + Hydrochlorothiazide combines two complementary antihypertensive mechanisms: telmisartan selectively blocks the AT1 angiotensin II receptor, preventing angiotensin II-induced vasoconstriction and aldosterone release, while hydrochlorothiazide inhibits sodium and chloride reabsorption in the distal convoluted tubule, promoting diuresis and natriuresis that reduces plasma and extracellular fluid volume. The combined effect produces greater blood pressure reduction than either agent alone.

Category X (legacy FDA pregnancy category; contraindicated — may cause fetal harm)

Telma Plus is not indicated for use in pediatric patients. Safety and efficacy in children have not been established. If a neonate has been exposed to this medicine in utero, monitor closely for hypotension, oliguria, and hyperkalemia; supportive care including exchange transfusion or dialysis may rarely be required.