Cardotel 5 mg+40 mg

Description

Interaction

• Telmisartan does not significantly interact with common medications such as acetaminophen, Amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. It is not metabolized by the cytochrome P450 system, though it may mildly inhibit the CYP2C19 enzyme.

• Amlodipine has been safely combined with various drugs, including thiazide diuretics, beta-blockers, ACE inhibitors, nitrates, digoxin, warfarin, NSAIDs, and oral hypoglycemics. Additionally, substances like cimetidine, grapefruit juice, and sildenafil do not have clinically significant effects on Amlodipine’s pharmacokinetics.

Contraindications

Cardotel should not be used in patients with:

• Known hypersensitivity to any component of the product.
• Pregnancy and lactation.
• Severe hepatic impairment, biliary obstruction, hypotension, cardiogenic shock, and left ventricular outflow tract obstruction.

Side Effects

Common side effects of Cardotel may include:

• Dizziness, peripheral edema (swelling of the limbs), and headaches.
• Digestive issues like nausea, diarrhea, abdominal pain, or indigestion.
• Other effects such as fatigue, pruritus (itching), muscle pain, and erectile dysfunction may also occur.
• Rarely, patients may experience bradycardia (slow heart rate), palpitations, cough, or chest pain.

Pregnancy & Lactation

• Pregnancy: Cardotel is classified as Category C in the first trimester and D in the second and third trimesters. It should only be used during pregnancy if absolutely necessary, considering the potential risks to the fetus.
• Lactation: It is not known if Telmisartan and Amlodipine are excreted in human breast milk. Because of potential risks to the infant, breastfeeding should be discontinued if Cardotel is prescribed, unless the drug is deemed essential by the healthcare provider.

Precautions & Warnings

• Fetal and Neonatal Exposure: Avoid using Cardotel during pregnancy, particularly in the second and third trimesters, due to the risk of fetal harm.
• Hypotension: Correct any volume depletion or low salt levels before starting treatment. Monitor for signs of hypotension after initiation of therapy.
• Hepatic and Renal Impairment: Titrate the dose carefully in patients with severe liver or renal conditions.
• Heart Failure: Patients with heart failure should be monitored closely for any worsening of symptoms.
• Myocardial Infarction: Caution is advised when starting a calcium channel blocker like Amlodipine in patients with severe coronary artery disease, as it may trigger a myocardial infarction or worsen angina.

Use in Special Populations

• Pediatric Use: The safety and efficacy of the Telmisartan & Amlodipine combination have not been established in children.
• Geriatric Use: Initial therapy with Cardotel is not recommended for patients aged 75 years or older.
• Hepatic Impairment: Cardotel is not recommended for patients with severe hepatic impairment.

Overdose Effects

• Telmisartan: Overdose may result in hypotension, dizziness, and tachycardia. In such cases, supportive treatment should be provided. Telmisartan is not dialyzable.

• Amlodipine: Overdose may lead to excessive vasodilation and hypotension. In severe cases, cardiovascular and respiratory support, including vasopressors, may be required. Amlodipine is also not removed by hemodialysis.

Therapeutic Class

Cardotel belongs to the combined antihypertensive preparations class.

Storage Conditions

Store Cardotel in a cool, dry place, away from light and high humidity. Do not store above 30°C and keep out of reach of children.