Welsh Assembly Government Written Statement - Swine Influenza, Wales
This statement updates Members on the swine flu outbreak and the latest developments in Wales and across the UK.
Cardiovascular
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FDA Approves SAMSCA(TM) (tolvaptan), The First And Only Oral Vasopressin Antagonist To Treat Patients With Clinically Significant Hypervolemic
who develop too rapid a rise in serum sodium, discontinue or interrupt treatment with SAMSCA and consider administration of hypotonic fluid. Fluid restriction during the first 24 hours with SAMSCA may increase the likelihood of overly-rapid correction of serum sodium, and should generally be avoided. -- Gastrointestinal Bleeding in Patients with Cirrhosis - Used only when the need to treat outweighs this risk -- Dehydration and Hypovolemia - In patients who develop medically significant signs or symptoms of hypovolemia, discontinuation is recommended. Dehydration and hypovolemia can occur, especially in potentially volume-depleted patients receiving diuretics or those who are fluid restricted. -- Co-administration with Hypertonic Saline - Not recommended -- Other Drugs Affecting Exposure to SAMSCA -- CYP 3A Inhibitors - Do not use with strong inhibitors of CYP 3A; avoid concomitant use with moderate CYP 3A inhibitors -- CYP 3A Inducers - Avoid concomitant use with CYP 3A inducers. If co-administered, the dose of SAMSCA may need to be increased -- P-gp Inhibitors - The dose of SAMSCA may have to be reduced if co-administered with P-gp inhibitors -- Hyperkalemia or Drugs that Increase Serum Potassium - Monitor serum potassium levels in patients with a serum potassium less than 5 mEq/L and in patients receiving drugs known to increase serum potassium levels Pregnancy and Nursing Mothers - SAMSCA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from SAMSCA, a decision should be made to discontinue nursing or SAMSCA, taking into consideration the importance of SAMSCA to the mother. Commonly observed adverse reactions - (incidence less than or equal to 5 percent more than placebo): thirst (16 percent vs 5 percent), dry mouth (13 percent vs 4 percent), asthenia (9 percent vs 4 percent), constipation (7 percent vs 2 percent), pollakiuria or polyuria (11 percent vs 3 percent) and hyperglycemia (6 percent vs 1 percent) Otsuka Pharmaceutical Co., LtdPages: 1 [2]