Label Changes for:
Zantac (ranitidine hydrochloride) Syrup, USP
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
- Drug Interactions
- ...in another interaction study in 8 volunteers receiving IV midazolam, a 300 mg oral dose of ranitidine increased midazolam exposure by about 9%. Monitor patients for excessive or prolonged sedation when ranitidine is coadministered with oral midazolam
- the addition of "acute interstitial nephritis".
The latest label (approved 02/17/2009) is not available on this site