What should I Know Regarding Pregnancy, Nursing and Administering Sitagliptin-Simvastatin Tablet to Children or the Elderly?
If you are PREGNANT
- Possibly Safe:
- Absolute Contraindication:
If you are NURSING
- Precaution: INSUFFICIENT HUMAN DATA; POTENTIAL FOR EXCRETION BASED ON DRUG PROPERTIES
- Absolute Contraindication: CONTRAINDICATED PER MANUFACTURER; OTHER HMG REDUCTASE INHIB 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 efficacy not established age under 10 years and in pre-menarche girls.
- management or monitoring precaution: Safety and efficacy in pediatrics not established.
- management or monitoring precaution: Manufacturer recommends post-menarche females be counseled on appropriate contraception.