Product Overview
【Drug Name】
Brand Name: Pinaverium Bromide Tablets
English Name: Pinaverium Bromide Tablets
Pinyin: PiWeiXiuAnPian
【Ingredients】
Chemical Name: N(2-bromo-4,5-dimethylbenzyl)-N(2-[2-dimethyl-2-norpinel]ethoxy)ethyl)morpholine bromide.
【Appearance】
Film-coated tablets
【Indications】
Abdominal pain, bowel disturbances, and intestinal discomfort associated with irritable bowel syndrome. Preparation for barium enema.
【Dosage and Administration】
Adults: The usual recommended dose is 3-4 tablets/day. In rare cases, this may be increased to 6 tablets/day if necessary. When preparing for a barium enema, start medication 3 days prior to the examination at a dose of 4 tablets/day. Do not chew or break the tablets; swallow with water with meals. Do not take while lying down or before bedtime.
【Adverse Reactions】
Abdominal pain, diarrhea, constipation; occasionally itching, rash, nausea, dry mouth, etc. Foreign reports indicate that two patients experienced heartburn and dysphagia after oral administration of pinaverium bromide between meals; endoscopic examination revealed acute esophageal ulceration, which resolved upon discontinuation of the drug.
【Contraindications】
Contraindicated in pregnant women, breastfeeding women, and children. Tablets should not be chewed; they should be taken in an upright position. Pinaverium bromide does not have significant anticholinergic adverse reactions; therefore, this product can be used in patients with irritable bowel syndrome due to benign prostatic hyperplasia, urinary retention, and glaucoma.
【Precautions】
Pregnancy: No teratogenic effects have been observed in animal studies. Current clinical data during pregnancy are insufficient; therefore, use is contraindicated during pregnancy. Breastfeeding: Due to a lack of clinical data, use should be avoided during breastfeeding. No teratogenic effects were observed in animal studies during pregnancy and lactation. However, sufficient data on the teratogenic or fetal toxicity of pinaverium bromide tablets (Descholate) are currently lacking for clinical application; therefore, it is contraindicated during pregnancy. Additionally, ingestion of bromides in late pregnancy may affect the neonatal nervous system (hypopnea and sedation). Since there is no data on whether it enters breast milk, it should be avoided during lactation.
【Special Populations】
Children's Precautions: Contraindicated in children.
Pregnancy and Lactation Precautions: Contraindicated in pregnant women.
【Drug Interactions】
Not yet clear.
【Pharmacological Action】
Pinaverium bromide is a calcium channel blocker with highly selective antispasmodic effects on the gastrointestinal tract. Its mechanism of action on smooth muscle is similar to other calcium channel blockers, but it exhibits high selectivity for colonic smooth muscle. Pinaverium bromide achieves its antispasmodic effect by blocking calcium ion inflow into intestinal wall smooth muscle cells, preventing excessive muscle contraction, eliminating intestinal smooth muscle hyperresponsiveness, and increasing intestinal motility. Pinaverium bromide has extremely low affinity for cardiovascular smooth muscle cells; a single oral dose of 1200 mg daily does not cause changes in blood pressure. Pinaverium bromide does not affect the pressure of the lower esophageal sphincter or cause duodenal reflux, but it has a relaxing effect on the sphincter of Oddi. In vitro studies have shown that this product has a dose-dependent inhibitory effect on smooth muscle contractions induced by barium chloride, acetylcholine, norepinephrine, carbacholine, and electrical stimulation. The in vivo action of pinaverium bromide is achieved through the activation of calcium channels. There are two different types of calcium channels on the cell membrane of gastrointestinal smooth muscle: (1) receptor-managed channels, activated by changes in the structure of specific membrane-bound receptors; and (2) voltage-managed channels, whose opening and closing depend on membrane potential. In vitro studies have shown that pinaverium bromide produces an antispasmodic effect by blocking voltage-dependent calcium currents.
【Storage】
Store in a sealed container.
【Specifications】
50mg * 15 tablets
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number HJ20160396
