药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201222919411723.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Rectiv处方资料(仅供参考)
美FDA批准硝酸甘油0.4%油膏Rectiv治疗慢性肛裂相关中至重度疼痛 2011年6月,美国FDA批准了协和发酵-麒麟有限公司的子公司ProStrakan集团公司开发的硝酸甘油(nitroglycerin)0.4%油膏Rectiv,用于治疗成人慢性肛裂相关中至重度疼痛。Rectiv是迄今FDA批准用于这一适应证的第一个处方药物。肛裂属相对常见疾病,可因多种原因发生。
Rectiv (nitroglycerin) ointment 0.4% Company: ProStrakan Approval Status: Approved June 2011 Treatment for: chronic anal fissure Areas: Gastrointestinal
General Information Rectiv is a nitroglycerin-based topical ointment. Nitroglycerin is converted by the body into nitric oxide, which can aid in the relaxation of the internal anal sphincter muscle and may have a role in the natural relaxation of muscles in the entire gastrointestinal tract.
Rectiv is specifically indicated for the treatment of moderate to severe pain associated with chronic anal fissure.
Rectiv is supplied as an ointment for topical administration. The recommended dose of Rectiv is 1 inch of ointment (375 mg of ointment equivalent to 1.5 mg of nitroglycerin) applied intra-anally every 12 hours for up to three weeks.
Clinical Results FDA Approval The FDA approval of Rectiv was based on a three week double-blind, randomized, multi-center, placebo-controlled study. Subjects with a painful chronic anal fissure for at least six weeks and moderate or severe pain prior to treatment (≥50 mm on the 100mm visual analog scale, VAS) were randomized to receive 0.4% (1.5mg) nitroglycerin or placebo ointment applied to the anal canal every 12 hours. Pain as assessed by the change in VAS from baseline to Days 14-18 was lower in subjects receiving 0.4% ointment compared to placebo. The mean change from baseline was 44mm for Rectiv and 37mm for placebo. The difference in the mean change in pain between Rectiv and placebo was -7.0mm.
Side Effects Adverse events associated with the use of Rectiv may include, but are not limited to, the following: headache dizziness
Mechanism of Action Rectiv is a nitroglycerin-based topical ointment. Nitroglycerin forms free radical nitric oxide (NO), which activates guanylate cyclase, resulting in an increase of guanosine 3’,5’-monophosphate (cyclic GMP) in smooth muscle and other tissues. This leads to dephosphorylation of myosin light chains, which regulates the contractile state in smooth muscle and results in vasodilatation. The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle. Intra-anal application of nitroglycerin reduces sphincter tone and resting intra-anal pressure.
Additional Information For additional information regarding Rectiv or chronic anal fissures, please visit the Prostrakan web page.
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