What should I Know Regarding Pregnancy, Nursing and Administering Sitagliptin-Simvastatin Tablet to Children or the Elderly?
If you are PREGNANT
- Requires a Risk/Benefit Assessment:
- Known or Theoretical Risk:
If you are NURSING
- Precaution: INSUFFICIENT HUMAN DATA; POTENTIAL FOR EXCRETION BASED ON DRUG PROPERTIES
- Absolute Contraindication: MFR DOES NOT RECOMMEND; OTHER HMG-COA REDUCTASE INHIBITORS EXCRETED IN MILK
If you are an adult over 60
- Management or Monitoring Precaution: Musculoskeletal-Higher incidence of myopathy or rhabdomyolysis with age over 65 particularly with renal disease. Plasma levels in the elderly are 45% higher. FDA MedWatch(06/09/2011) recommends against the use of the 80mg dose for new drug starts regardless of age, and only allows for use in those patients stabilized on 80mg with no evidence for myopathy. Do not titrate beyond 40mg/day to achieve LDL-C goal. Alternative agents should be considered. Hepatic-Monitor LFTs; liver dysfunction.
- Management or Monitoring Precaution: Renal-Adjust dosage for moderate to severe renal impairment. Monitor renal function.
Giving Sitagliptin-Simvastatin Tablet to a child under 12
- Management or Monitoring Precaution: Safety and effectiveness not established for pediatric patients < 10 years; manufacturer did not study use in girls pre-menarche.
- Management or Monitoring Precaution: Safety and efficacy not established. Efficacy not statistically different from placebo in clinical trials.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.