Teana AM 80/5mg Tablet

✔️ Uses

Hypertension

✔️ Dosage and Administration:

Initial Therapy:

• Starting Dose: The usual starting dose is 40/5 mg once daily. For patients who require a larger reduction in blood pressure, the dose may be increased to 80/5 mg once daily.
• Age and Hepatic Impairment: Initial therapy is not recommended for patients aged ≥75 years or those with hepatic impairment.

Add-on Therapy:

• For Patients Not Controlled by Monotherapy: This tablet can be used for patients who are not adequately controlled with amlodipine (or another dihydropyridine calcium-channel blocker) alone, or telmisartan (or another ARB) alone.
• Switching: Patients currently on 10 mg amlodipine and experiencing adverse reactions (such as edema) may switch to Teana AM 40/5 mg tablets once daily, effectively reducing the dose of amlodipine while maintaining the expected antihypertensive response.

Replacement Therapy:

• For patients already receiving separate amlodipine and telmisartan tablets, Teana AM offers a convenient combination form with the same doses. Dosage must be individualized, and doses may be adjusted after at least 2 weeks. The maximum recommended dose of Teana AM is 80/10 mg once daily.

✔️ Elderly Patients and Hepatic Impairment:

Caution is advised when using Teana AM in elderly patients and those with hepatic impairment, as initial therapy, is not recommended in these groups.

✔️ Renal Impairment:

Monitoring is recommended for patients with kidney issues, and dose adjustments may be required.

✔️ Drug Interactions:

Telmisartan:

• Co-administration with other drugs:
  • Telmisartan does not show significant interactions with common medications such as acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen.
  • Telmisartan does not interact with cytochrome P450 (CYP) enzymes significantly, except for some inhibition of CYP2C19. This means it may slightly affect the metabolism of drugs that are processed by CYP2C19.
  • Since Telmisartan is not metabolized by the CYP450 system, it is unlikely to interact with drugs that inhibit or are metabolized by these enzymes, except for those affected by CYP2C19.

Amlodipine:

• In clinical trials, amlodipine has been safely administered with a variety of drugs, including thiazide diuretics, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, NSAIDs, antibiotics, and oral hypoglycemic drugs.
• Drugs with no clinically relevant effect on amlodipine pharmacokinetics:
  • Cimetidine, grapefruit juice, and sildenafil have no significant effect on how amiodipine is absorbed or processed in the body.
• Amiodipine's effect on other drugs:
  • Amlodipine does not alter the pharmacokinetics or pharmacodynamics of atorvastatin, digoxin, or warfarin.

✔️ Telmisartan and Amlodipine Combination should not be used in patients who have:

• Known hypersensitivity to Telmisartan, amiodipine, or any component of the product.
• Pregnancy or lactation (due to potential harm to the fetus or infant).
• Biliary obstructive disorders or severe hepatic impairment.
• Hypotension or cardiogenic shock.
• Left ventricle outflow tract obstruction, as this can be exacerbated by the vasodilating effects of Telmisartan and amlodipine.

✔️ Precautions & Warnings

• Avoid fetal or neonatal exposure
• Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension
• Titrate slowly in patients with hepatic or severe renal impairment
• Heart failure: Monitor for worsening
• Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker
• Myocardial infarction: Uncommonly, initiating a CCB in patients with severe obstructive coronary artery disease may precipitate myocardial infarction or increased angina.

✔️ Storage:

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.