Tenivasc 5mg+20mg

Tablet
Amlodipine + Olmesartan Medoxomil
Unimed Unihealth MFG. Ltd

Other Strength:

Alternative:
- Bizoran 5mg+20mg
- Orbapin 5mg+20mg
- Camlosart™ 5mg+20mg
- Olmevas AM 5mg+20mg
- Abecab 5mg+20mg
- Duoblock 5mg+20mg



Tenivasc
Presentation
Tenivasc 20/5 tablet: Light green, diamond shaped, scored on one side, U engraved on other side, film coated tablet; each tablet contains Olmesartan Medoxomil USP 20mg and Amlodipine Besilate BP equivalent to Amlodipine 5mg.

Indications
Treatment of essential hypertension. Tenivasc is indicated in adult patients whose blood pressure is not adequately controlled on Olmesartan Medoxomil or Amlodipine monotherapy.

Dosage & administration
Adults: The recommended dosage of Olmesartan Medoxomil-Amlodipine is 1 tablet per day. Tenivasc 20/5 may be administered in patients whose blood pressure is not adequately controlled by 20mg Olmesartan Medoxomil or 5mg Amlodipine alone. Tenivasc can be taken with or without food.

Older people (age 65 years or over): No adjustment of the recommended dose is generally required for older people but increase of the dosage should take place with care. If up-titration to the maximum dose of 40mg Olmesartan Medoxomil daily is required, blood pressure should be closely monitored.

Renal impairment: The maximum dose of Olmesartan Medoxomil in patients with mild to moderate renal impairment (creatinine clearance of 20-60 mL/min) is 20mg Olmesartan Medoxomil once daily, owing to limited experience of higher dosages in this patient group. The use of Olmesartan Medoxomil-Amlodipine in patients with severe renal impairment (creatinine clearance < 20 mL/min) is not recommended. Monitoring of potassium levels and creatinine is advised in patients with moderate renal impairment.

Hepatic impairment: Olmesartan Medoxomil-Amlodipine should be used with caution in patients with mild to moderate hepatic impairment. In patients with moderate hepatic impairment, an initial dose of 10mg Olmesartan Medoxomil once daily is recommended and the maximum dose should not exceed 20mg once daily. Close monitoring of blood pressure and renal function is advised in hepatically-impaired patients who are already receiving diuretics and/or other antihypertensive agents. There is no experience of Olmesartan Medoxomil in patients with severe hepatic impairment. As with all calcium antagonists, amlodipine’s half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established. Olmesartan Medoxomil-Amlodipine should therefore be administered with caution in these patients. The pharmacokinetics of Amlodipine has not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with impaired liver function. Use of Olmesartan Medoxomil-Amlodipine in patients with severe hepatic impairment is contra-indicated.

Paediatric population: The safety and efficacy of Olmesartan Medoxomil-Amlodipine in children and adolescents below 18 years has not been established. No data are available.

Contra-indications, warning etc.
Contra-indications: Hypersensitivity to the active substances, to dihydropyridine derivatives or to any of the excipients, second and third trimesters of pregnancy, severe hepatic insufficiency and biliary obstruction. Due to the component amlodipine, Olmesartan Medoxomil-Amlodipine is also contraindicated in patients with severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis), haemodynamically unstable heart failure after acute myocardial infarction.

Warnings:
Symptomatic hypotension may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting, especially after the first dose. Correction of this condition prior to administration of Olmesartan Medoxomil-Amlodipine or close medical supervision at the start of the treatment is recommended.

Use in Pregnancy and Lactation:
There are no data about the use of Olmesartan Medoxomil-Amlodipine in pregnant patients. Animal reproductive toxicity studies with Olmesartan Medoxomil-Amlodipine have not been performed. Olmesartan is excreted into the milk of lactating rats. However, it is not known whether Olmesartan passes into human milk. It is not known whether Amlodipine is excreted in breast milk. Similar calcium channel blockers of the dihydropyridine type are excreted in breast milk. Because no information is available regarding the use of Olmesartan and Amlodipine during breast-feeding, Olmesartan Medoxomil-Amlodipine is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

Drug Interactions:
The blood pressure lowering effect of Olmesartan Medoxomil-Amlodipine can be increased by concomitant use of other antihypertensive medicinal products (e.g. alpha blockers, diuretics). Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin, ACE inhibitors) may lead to increases in serum potassium. If medicinal products which affect potassium levels are to be prescribed in combination with Olmesartan Medoxomil-Amlodipine, monitoring of serum potassium levels is recommended. Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors and, rarely, with angiotensin-II antagonists. Therefore concomitant use of Olmesartan Medoxomil-Amlodipine and lithium is not recommended. If concomitant use of Olmesartan Medoxomil-Amlodipine and lithium proves necessary, careful monitoring of serum lithium levels is recommended. When angiotensin-II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Furthermore, concomitant use of angiotensin-II antagonists and NSAIDs may increase the risk of worsening of renal function and may lead to an increase in serum potassium. Therefore monitoring of renal function at the beginning of such concomitant therapy is recommended, as well as adequate hydration of the patient.

Side-effects:
The most commonly reported adverse reactions during treatment with Olmesartan Medoxomil-Amlodipine are peripheral oedema, headache and dizziness. Other common side effects are nausea, fatigue, oedema, hypertriglyceridaemia, hyperuricaemia, somnolence, abdominal pain, influenza-like symptoms.

Overdose:
There is no experience of overdose with Olmesartan Medoxomil-Amlodipine. The most likely effects of Olmesartan Medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred. Amlodipine overdosage can be expected to lead to excessive peripheral vasodilatation with marked hypotension and possibly a reflex tachycardia. Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome has been reported. If intake is recent, gastric lavage may be considered. In healthy subjects, the administration of activated charcoal immediately or up to 2 hours after ingestion of Amlodipine has been shown to reduce substantially the absorption of Amlodipine. Clinically significant hypotension due to an overdose of Olmesartan Medoxomil-Amlodipine requires active support of the cardiovascular system, including close monitoring of heart and lung function, elevation of the extremities, and attention to circulating fluid volume and urine output. A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contra-indication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Packaging quantity
Tenivasc 20/5 tablet: Carton containing 28 tablets in alu-alu blister.

এই পাতাটি ২২৩ বার দেখা হয়েছে