سعر سامسكا 15مجم 10 اقراص 2026

Tolvaptan 15 mg tablets (Samsca, Otsuka); pack of 10 tablets.

• Clinically significant hypervolaemic and euvolaemic hyponatraemia (serum sodium <125 mEq/L, or less marked symptomatic hyponatraemia resistant to fluid restriction), including patients with heart failure and SIADH.Population: AdultsDailyMed (U.S. National Library of Medicine)

• Most common (≥5% over placebo): thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria, hyperglycaemia.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Contraindicated in patients unable to sense or respond to thirst; hypovolaemic hyponatraemia; concomitant strong CYP3A inhibitors; anuria; hypersensitivity to tolvaptan or components; ADPKD outside the FDA-approved REMS.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Boxed warning: too rapid correction of hyponatraemia (>12 mEq/L/24 h) can cause osmotic demyelination; initiate in hospital and monitor serum sodium. Not for use in ADPKD outside the REMS because of hepatotoxicity risk.International label, same formulation · DailyMed (U.S. National Library of Medicine)
• Liver injury: limit treatment to 30 days, avoid in underlying liver disease and stop if hepatic injury is suspected. Dehydration/hypovolaemia may need intervention; avoid hypertonic saline and moderate/strong CYP3A inhibitors; monitor potassium; ensure urinary outflow.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Strong CYP3A inhibitors (e.g. ketoconazole)Ketoconazole increased tolvaptan AUC 5.4-fold; concomitant use with strong CYP3A inhibitors is contraindicated.DailyMed (U.S. National Library of Medicine)
• Moderate CYP3A inhibitors and grapefruit juiceSubstantial increase in tolvaptan exposure expected; avoid co-administration.DailyMed (U.S. National Library of Medicine)
• Strong CYP3A inducersReduce tolvaptan exposure; avoid concomitant use.DailyMed (U.S. National Library of Medicine)

• Available human data are insufficient to determine a drug-associated risk; embryo-fetal effects (including malformations in rabbits) occurred in animals at maternally toxic doses.International label, same formulation · DailyMed (U.S. National Library of Medicine)
• No human milk data; tolvaptan is present in rat milk. Advise women not to breastfeed during treatment (risk of electrolyte abnormalities, hypotension and volume depletion in the infant).International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Tolvaptan: Selective, competitive antagonist of arginine vasopressin at V2 receptors, causing aquaresis (free-water excretion) and a rise in serum sodium.