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Retensin

Retensin

valsartan

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma
Full Prescribing Info
Contents
Valsartan.
Description
Contains Valsartan 80, 160 mg.
Indications/Uses
Hypertension. Heart failure (NYHA class II-IV) in patients receiving standard therapy eg, diuretics, digitalis & either ACE inhibitors or β-blockers but not both. Improves survival following myocardial infarction in clinically stable patients w/ signs, symptoms or radiological evidence of left ventricular failure &/or w/ left ventricular dysfunction.
Dosage/Direction for Use
Hypertension: 80 mg or 160 mg once daily. May be increased to 320 mg, or add a diuretic if blood pressure is inadequately controlled.
Heart failure: 40 mg twice daily. May be up-titrated to 80 mg & 160 mg twice daily as tolerated. Max daily dose: 320 mg in divided doses.
Post-myocardial infarction: Initially 20 mg twice daily as early as 12 hours after myocardial infarction. Titrate to 40 mg, 80 mg, & 160 mg twice daily over next few weeks, or until a dose level of 80 mg twice daily 2 weeks after treatment initiation is achieved. Target max dose in 3 months: 160 mg twice daily.
Contraindications
Hypersensitivity. Concomitant use of angiotensin receptor antagonists or ACE inhibitors w/ aliskiren in patients w/ type 2 diabetes. Pregnancy.
Special Precautions
Discontinue if angioedema occurs. Patients with biliary obstructive disorders. Correct sodium &/or volume depletion prior to starting treatment. Monitor BUN & serum creatinine in patients with bilateral or unilateral renal artery stenosis. Perform assessment of renal function in patients with heart failure or post-myocardial infarction. Concomitant use with ACE inhibitors & β-blocker in patients with heart failure; drugs blocking renin-angiotensin system eg, ACE inhibitors or aliskiren. Avoid concomitant use with aliskiren in patients with severe renal impairment (GFR <30 mL/min).
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
Use with caution in women of childbearing potential.
Use in Children: Use with caution in children & adolescents <18 yr.
Use In Pregnancy & Lactation
Pregnancy: Not to be used during pregnancy.
Lactation: Use with caution.
Adverse Reactions
Dizziness, postural dizziness; hypotension, orthostatic hypotension; renal failure & impairment.
Drug Interactions
Increased incidence of hypotension, hyperkalemia & renal function changes with other drugs acting on renin-angiotensin system (eg, ARBs, ACE inhibitors, or aliskiren). Increased serum potassium & creatinine with potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes or other drugs increasing potassium level (eg, heparin). Attenuated antihypertensive effect with NSAIDs including selective COX-2 inhibitors. Increased serum lithium concentration & toxicity. Increased systemic exposure with hepatic uptake transporter OATP1B1 inhibitors (eg, rifampin, ciclosporin) & efflux transporter MRP2 inhibitors (eg, ritonavir).
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA03 - valsartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Retensin FC tab 160 mg
Packing/Price
10 × 10's
Form
Retensin FC tab 80 mg
Packing/Price
10 × 10's
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