DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)95. NITRATESThe following statements shall be included in the package inserts of all“NITRATES FOR STABLE ANGINA PECTORIS”:An appropriate statement concerning the development of tolerance(under precaution section). A suggested statement would be asfollows: „Development of tolerance may occur with all forms of nitratetherapy particularly with the long acting preparations that maintaincontinuously high plasma nitrate concentration‟.An appropriate recommendation on dosage regimens. Therecommended dosage regimens should be one that is able to provide alow-nitrate period or a nitrate-free period of 8-12 hours every 24 hoursto prevent the development of tolerance and thus maintain theantianginal effects.96. NITRAZEPAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTS97. NORFLOXACINThe following statement shall be included in the package inserts of productscontaining Norfloxacin:PRECAUTIONi. Should not be used in children or pregnant womenii. Phototoxicity may occur98. NORMAL GLOBULININTRAMUSCULAR (IM)The following statement shall be included in the package inserts of Normalglobulin IM preparations:WARNINGDo not administer this preparation intravenously because of potential forserious hypersensitivity reactions.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 401