Telmisartan STELLA 80 mg

Rx

Indications:

• Treatment of essential hypertension.
• Cardiovascular prevention: Reduction of cardiovascular morbidity in adults with manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus with documented target organ damage.

Dosage:

Adult:

• Hypertension: 40 mg once daily (may be 20 mg once daily, use of suitable dosage forms), increase to a maximum of 80 mg once daily if the target blood pressure is not achieved, may be used in combination with thiazide.
• Cardiovascular prevention: 80 mg once daily, close monitoring of blood pressure and if appropriate adjustment of medications that lower blood pressure may be necessary.

Severe renal impairment: An initial dose of 20 mg once daily. The combination with thiazide is contraindicated when GFR < 30 ml/minute.

Mild to moderate hepatic impairment: A daily maximum dose 40 mg once daily.

Adolescents aged < 18 years: The safety and efficacy have not been established.

Usage:

Telmisartan STELLA 80 mg is administered orally, taken without regard to meals.

• Known hypersensitive to any of the active substance or excipients of the product.
• Second and third trimesters of pregnancy and lactation.
• Biliary obstructive disorders.
• Severe hepatic impairment.

These adverse reactions occur generally mild and transient.

Uncommon: Fatigue, headache, dizziness, limb edema, sweating. Agitation condition. Dry mouth, nausea, abdominal pain, acid reflux, indigestion, flatulence, loss of appetite, diarrhea. Reduce renal function, increase creatinine and blood urea nitrogen (BUN), urinary tract infection. Pharyngitis, sinusitis, upper respiratory tract infection. Back pain, painful and spasms muscle. Hyperkalemia.

• When pregnancy is detected, telmisartan should be discontinued as soon as possible.
• Use with caution in patients: mild to moderate hepatic impairment; bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney; vascular tone and renal function depend predominantly on the activity of the RAAS; aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy; diabetic patients; severe hypertension; ischaemic cardiovascular disease.
• Telmisartan is not to be given to patients with cholestasis; fructose intolerance.
• When using in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
• Not recommended for patients with primary aldosteronism.
• Intravascular hypovolaemia and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting should be corrected before the administration of telmisartan.
• Risk of porphyria and hyperkalaemia.
• The dose of 80 mg contains 3.864 mg sodium. This is equivalent to approximately 0.2% of the recommended maximum daily intake of sodium for an adult.
• Gastroduodenal ulcer can work or other stomach problems (increased risk of gastrointestinal bleeding).
• It should be taken into account when driving vehicles or operating machinery.