Medical network - March 24, according to the adverse drug reactions assessment results, in order to further ensure public security, state administration of food and drug supervision and administration of decision of nicotinic acid lipid drug (including: niacin sustained-release preparations (including zyban, sustained-release capsules), acyclovir preparation, including capsules, tablets, vitamin E nicotinate preparations, including capsule, capsule, soft capsule, inositol nicotinate preparations (including films, ointment), mannitol nicotinic acid ester) manual notes , such as drug interactions item revised. Now the matters related to notice the following:
A, all the nicotinic acid lipid drug manufacturing enterprise shall be in accordance with the relevant provisions of the "drug registration management measures" and so on, in accordance with the requirements for niacin sustained-release preparation manual revision (see appendix 1), acyclovir preparation manual revision requirements (see attachment 2) or vitamin E nicotinate preparations, preparations and mannitol nicotinic acid ester inositol nicotinate manual revision requirements (see annex 3), put forward to revise the description of the supplement, on May 15, 2017 at the provincial food and drug regulatory authorities for the record.
Revised content involves drug label, should be revised; Specification and other contents label shall be consistent with the original approval content. Within 6 months after the supplement for the record for the factory's instructions and labels to be replaced.
Nicotinic acid kind lipid drug production enterprise shall on new adverse reaction mechanism to carry out in-depth study, to take effective measures to make use and safety propaganda and training, to guide physicians rational drug use.
Second, clinicians should carefully read niacin class revision contents of lipid drug specifications, when choosing drugs, shall be amended according to the new instruction to fully benefit/risk analysis.
Third, the patients should strictly prescribed medication, should read the instructions carefully before using this drug.
Notice is hereby given that the.
Attachment: 1. Niacin sustained-release preparation manual revision requirements
This manual revision requirements applicable to our country has listed all the niacin sustained-release preparations, including niacin zyban, nicotinic acid sustained-release capsules.
One, increased [note] : "take niacin and statins (i.e., 3 - hydroxy - 3 - methyl glutaric acyl coenzyme A/HMG - CoA reductase inhibitors), muscle will increase the risk of toxicity. A study reported that Chinese patients taking nicotinic acid plus laropiprant joint after using simvastatin, the prevalence of myopathy and rhabdomyolysis compared to white high".
Second, increased [drug interaction] : "when the niacin and statin or Betty drugs combined with application should be careful, because with niacin and this kind of lipid-lowering combined use of skeletal muscle increase reported" event.
2. Acyclovir preparation manual revision requirements
This manual revision requirements applicable to our country has listed all the acyclovir therapy agents, including acyclovir therapy capsule, acyclovir therapy dispersible tablets.
taboo increase: "severe kidney damage (creatinine clearance is less than 30 ml/min) disabled".
Second, increased [note] : "the structure of acyclovir therapy is associated with niacin. At the same time taking nicotinic acid with statins (i.e., 3 - hydroxy - 3 - methyl glutaric acyl coenzyme A/HMG - CoA reductase inhibitors), muscle will increase the risk of toxicity. A study reported that Chinese patients taking nicotinic acid plus laropiprant joint after using simvastatin, the prevalence of myopathy and rhabdomyolysis compared to white high".
Three, pregnant women and nursing mothers medication clear: "pregnant women and nursing mothers to disable".
Four, increased [drug interaction] : when asimo and statin or Betty drugs should be cautious when joint application, because of nicotinic acid (asimo company structure analogue) associated with this type of lipid-lowering application event was increased when the skeletal muscle.
3. Vitamin E nicotinate preparations, preparations and mannitol nicotinic acid ester inositol nicotinate manual revision requirements
This manual revision requirements applicable to our country has listed all of the vitamin E nicotinate preparations, inositol nicotinate preparations, mannitol nicotinic acid ester, including vitamin E nicotinate capsule, vitamin E nicotinate capsule, soft capsule vitamin E nicotinate, inositol nicotinate piece, inositol nicotinate ointment and mannitol nicotinic acid ester.
One, increased [note] : "the structure of this product is associated with niacin. At the same time taking nicotinic acid with statins (i.e., 3 - hydroxy - 3 - methyl glutaric acyl coenzyme A/HMG - CoA reductase inhibitors), muscle will increase the risk of toxicity. A study reported that Chinese patients taking nicotinic acid plus laropiprant joint after using simvastatin, the prevalence of myopathy and rhabdomyolysis compared to white high";
Second, increased [drug interaction] : "the product structure is similar to niacin, when associated with statin or Betty drugs application should be cautious when, because of nicotinic acid and such lipid-lowering combined use of skeletal muscle increase reported" event.
The food and drug supervision bureau
On March 16, 2017 |
