Tems A5 mg+80 mg

Tems A is a fixed-dose combination of a dihydropyridine calcium channel blocker (amlodipine) and an angiotensin II receptor blocker (telmisartan), indicated for:

• Established/first-line use: Treatment of hypertension, used alone or as an add-on with other antihypertensive agents, in patients whose blood pressure is not adequately controlled on monotherapy with either component.
• Initial combination therapy: May be used as initial therapy in patients likely to need multiple drugs to reach their blood pressure goal, based on their baseline blood pressure and overall cardiovascular risk.
• Cardiovascular risk reduction (guideline-supported): By lowering blood pressure, Tems A reduces the risk of fatal and non-fatal cardiovascular events such as stroke and myocardial infarction in appropriate patients.

Tems A is not indicated as initial therapy in patients 75 years of age or older, or in patients with hepatic impairment; in these groups, the individual components should be titrated separately first.

Each tablet of Amlodipine Besilate + Telmisartan contains two active ingredients:

• Amlodipine Besilate — equivalent to amlodipine 5 mg or 10 mg, a dihydropyridine calcium channel blocker.
• Telmisartan — 40 mg or 80 mg, an angiotensin II receptor blocker (ARB).

Common fixed-dose strength combinations include 40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg (telmisartan/amlodipine). Available strengths may vary by market and manufacturer.

Tems A is an oral fixed-dose combination antihypertensive tablet that pairs two complementary mechanisms of blood pressure lowering in a single dosage form. It combines amlodipine besilate, a long-acting dihydropyridine calcium channel blocker, with telmisartan, a selective angiotensin II receptor (AT1) blocker.

This combination is used for the management of hypertension, allowing many patients to achieve blood pressure control with a single tablet instead of two separate medications, which can improve adherence.

Tems A belongs to the therapeutic class of antihypertensive combination agents, specifically a fixed-dose combination of a calcium channel blocker (CCB) and an angiotensin II receptor blocker (ARB).

Amlodipine Besilate + Telmisartan 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 found 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.
• Amlodipine (CCB component): Inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, with a predominant effect on vascular smooth muscle. This produces peripheral arterial vasodilation and reduces peripheral vascular resistance.

Together, the two components produce an additive antihypertensive effect. Peak plasma concentrations of telmisartan occur within 0.5–1 hour, while amlodipine peaks at 6–12 hours; telmisartan has an elimination half-life of about 24 hours and amlodipine 30–50 hours, supporting once-daily dosing. Telmisartan is eliminated mainly by biliary excretion of unchanged drug; amlodipine undergoes extensive hepatic metabolism to inactive metabolites.

Tems A 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.

Tems A has the following clinically significant drug interactions:

Related to the Telmisartan (ARB) Component

• Aliskiren: Combined use increases the risk of hypotension, hyperkalemia, and changes in renal function. Contraindicated in patients with diabetes; avoid in patients with renal impairment (GFR <60 mL/min).
• ACE inhibitors: Dual blockade of the renin-angiotensin system increases risk of hypotension, hyperkalemia, and renal impairment without added cardiovascular benefit; avoid combination except in specific, closely monitored situations.
• Digoxin: Telmisartan can increase peak and trough digoxin concentrations; monitor digoxin levels.
• Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported; monitor lithium levels closely if co-administered.
• NSAIDs (including COX-2 inhibitors): May reduce the antihypertensive effect and increase the risk of renal impairment, particularly in elderly, volume-depleted, or renally impaired patients.
• Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium: Increased risk of hyperkalemia.

Related to the Amlodipine (CCB) Component

• Simvastatin: Amlodipine increases simvastatin exposure; limit simvastatin dose to 20 mg daily when co-administered.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir): May increase amlodipine plasma concentrations, raising the risk of hypotension and edema.
• Strong CYP3A4 inducers (e.g., rifampin): May reduce amlodipine's antihypertensive effect.
• Cyclosporine or tacrolimus: Amlodipine may increase systemic exposure of these immunosuppressants; monitor drug levels.

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

Most patients tolerate Tems A well. Reported adverse effects include:

Common

• Peripheral (ankle/leg) edema — a dose-related effect of the amlodipine component
• Dizziness
• Back pain
• Headache
• Fatigue
• Flushing

Less Common but Clinically Important

• Symptomatic hypotension, particularly after the first dose or a dose increase (see Precautions)
• Hyperkalemia (see Precautions)
• 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
• Rhabdomyolysis (rare)
• Hepatic dysfunction, jaundice
• Gynecomastia

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

Pregnancy

Tems A 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, Tems A should be discontinued as soon as possible, and the patient should be switched to an alternative antihypertensive under physician guidance. Any patient of childbearing potential should discuss reliable contraception and pregnancy planning with her physician before starting this medicine.

Lactation

It is not known whether telmisartan or amlodipine pass into human breast milk in clinically significant amounts. Because of the potential for adverse effects in a nursing infant, a decision should be made, in consultation with a physician, whether to discontinue breastfeeding or discontinue Tems A, taking into account the importance of the drug to the mother.

The following precautions should be observed with Tems A:

• 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.
• Hyperkalemia and renal function: Telmisartan can raise serum potassium and affect renal function, especially in patients with renal impairment, diabetes, heart failure, or those taking potassium supplements, potassium-sparing diuretics, or NSAIDs. Periodic monitoring of renal function and serum electrolytes is recommended.
• Renal artery stenosis: In patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney, drugs affecting the renin-angiotensin system can cause oliguria, progressive azotemia, and acute renal failure. Use with caution and monitor renal function closely.
• Hepatic impairment/biliary obstruction: Telmisartan is eliminated mainly through biliary excretion; patients with biliary obstructive disorders or hepatic insufficiency may have reduced clearance of telmisartan. Use with caution, start at a low dose, and titrate slowly in these patients.
• Peripheral edema: A dose-related effect of the amlodipine component; usually mild to moderate and may require dose reduction if bothersome.
• Dual blockade of the renin-angiotensin system: Avoid combining Tems A with ACE inhibitors or aliskiren, as this increases the risk of hypotension, hyperkalemia, and renal dysfunction without added benefit.
• Worsening angina or myocardial infarction: Rarely, patients (particularly those with severe obstructive coronary artery disease) may experience increased frequency, duration, or severity of angina or acute myocardial infarction after starting therapy or on dose increase.
• Angioedema: Discontinue immediately and seek emergency care if swelling of the face, lips, tongue, or throat, or difficulty breathing occurs.
• Heart failure: Use calcium channel blockers with caution in patients with heart failure due to a potential increased risk of cardiovascular events.

Overdose of Tems A may cause marked hypotension, dizziness, and reflex or vagally-mediated tachycardia or bradycardia due to the combined vasodilatory effects of both components.

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 monitoring, frequent blood pressure checks, and supportive measures as needed; do not attempt to manage a suspected overdose at home. Neither component is effectively removed by hemodialysis due to high protein binding and large volume of distribution.

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.

Pediatric Use

Safety and efficacy of Tems A in pediatric patients have not been established. It is not recommended for use in children.

Geriatric Use (65 years and older)

No overall differences in effectiveness were observed between elderly and younger patients. However, amlodipine clearance is reduced in patients 75 years and older, requiring a lower starting dose; Tems A is not recommended as initial therapy in this age group.

Renal Impairment

No dosage adjustment is generally required in mild-to-moderate renal impairment. In severe renal impairment, titrate slowly and monitor renal function and serum potassium closely.

Hepatic Impairment

Not recommended as initial therapy; if used, initiate at a low amlodipine dose and titrate slowly (see Precautions).

Tems A is typically used long-term for chronic management of hypertension. 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.

Antihypertensive combination; Calcium channel blocker (dihydropyridine) + Angiotensin II receptor blocker (ARB)

Amlodipine Besilate + Telmisartan combines two complementary antihypertensive mechanisms: telmisartan selectively blocks the AT1 angiotensin II receptor, preventing angiotensin II-induced vasoconstriction and aldosterone release, while amlodipine blocks L-type calcium channels in vascular smooth muscle, reducing peripheral vascular resistance through arterial vasodilation. The combined effect produces greater blood pressure reduction than either agent alone.

D

Tems A 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.