Duspatalin long-acting capsules 200mg №15×2

Name:
Duspatalin caps prolong.d-iya 200mg in bl. in pack. No. 15×2
Description:
Hard gelatin capsules No. 1, opaque, white, marked “245” on the capsule body. The contents of the capsules are white or almost white granules. The main active ingredient Mebeverine hydrochloride Release form 15 capsules in a blister of aluminum foil and PVC film. 2 blisters in a cardboard box along with instructions for use. Dosage 200mg in bl. in pack. №15×2 Pharmacodynamics Mebeverine is a myotropic antispasmodic that has a direct effect on the smooth muscles of the gastrointestinal tract, eliminating spasm without affecting normal intestinal motility. Since the action of the drug does not extend to the autonomic nervous system, there are no typical anticholinergic side effects. Pediatric population Clinical studies of the drug in the form of tablets or capsules have been conducted only in adult patients. Pharmacokinetics Absorption Mebeverine is rapidly and completely absorbed after oral administration of tablets. The extended release dosage form allows for a 2x daily dosing regimen. Distribution When taking repeated doses of the drug, significant accumulation does not occur. Metabolism Mebeverine hydrochloride is mainly metabolized by esterases, which in the first step break down the ester into veratric acid and mebeverine alcohol. The main metabolite circulating in plasma is demethylated carboxylic acid (DMCA). The steady-state half-life of DMCA is 5.77 hours. For the 200 mg extended-release capsules, the sustained-release properties were confirmed with respect to LOW Cmax and longer tmax. When taking repeated doses (200 mg twice a day), the maximum concentration (Cmax) of DMCA is 804 ng / ml, the time to reach the maximum concentration (tmax) is about 3 hours. The relative bioavailability of the extended release capsules is optimal with an average of 97%. Excretion Mebeverine as such is not excreted from the body, but is completely metabolized; its metabolites are almost completely eliminated from the body. Veratric acid is excreted by the kidneys. Mebeverine alcohol is also excreted by the kidneys, partly as a carboxylic acid and partly as a demethylated carboxylic acid. Pediatric population Pharmacokinetic studies of any dosage forms of mebeverine in children have not been conducted. Indications for use Symptomatic treatment of pain and discomfort associated with functional disorders of the intestines and biliary tract. Dosage and administration The drug is taken orally. Capsules should be swallowed with a sufficient amount of water (at least 100 ml). Capsules should not be chewed as the shell is designed to provide a sustained release mechanism. Adults: One 200 mg capsule twice a day, morning and evening. The duration of admission is not limited. If one or more dose(s) are missed, the patient should continue taking the drug as directed and should not take the missed dose(s). Use during pregnancy and lactation Studies conducted on animals did not reveal a teratogenic effect. Thus, in humans, teratogenic effects on the fetus are also not expected. At the moment, there is not enough data to make a decision about the presence of a possible teratogenic or fetotoxic effect of mebeverine when administered during pregnancy. Duspatalin® is not recommended for use throughout pregnancy. It is not known whether mebeverine or its metabolites are excreted in human breast milk. Duspatalin® should not be taken during lactation. Interaction with other drugs There are no data on the interaction of mebeverine with other drugs. Contraindications hypersensitivity to the active substance or to any of the inactive components of the drug; use in children and adolescents under 18 years of age. Composition Active substance: 1 capsule contains 200 mg of mebeverine hydrochloride. Excipients: magnesium stearate -13.1 mg, methyl methacrylate and ethyl acrylate copolymer 2:1 -10.4 mg, talc – 4.9 mg, hypromellose – 0.1 mg, methacrylic acid and ethacrylate copolymer 1:1 -15.2 mg, triacetin – 2.9 mg. Hard gelatin capsule: gelatin – 75.9 mg, titanium dioxide (E171) – 1.5 mg. Ink composition: shellac (E904), propylene glycol, concentrated ammonia solution, potassium hydroxide, black iron oxide (E172). Overdose In case of overdose, an increase in the excitability of the central nervous system is possible. In cases of overdose of mebeverine, the symptoms were either absent or were minor and, as a rule, quickly reversible. There were clinical manifestations of the nervous and cardiovascular systems. The specific antidote is unknown. Symptomatic treatment is recommended. Gastric lavage is necessary only if intoxication is detected within approximately one hour after taking several doses of the drug. Measures to reduce the level of absorption are not required. Side effects The following adverse reactions have been reported during post-marketing use and have been spontaneous. The available data are insufficient to accurately estimate the incidence of cases. Allergic reactions were observed mainly from the skin, but other manifestations of allergy were also noted. Skin and subcutaneous tissue disorders: Urticaria, angioedema, including face, exanthema. Immune system disorders: Hypersensitivity reactions (anaphylactic reactions). In the event of the occurrence of the listed adverse reactions, as well as a reaction not mentioned in the instructions for use, you should consult a doctor. Storage conditionsStore in the original packaging at temperatures between 5°C and 25°C. Keep out of the reach of children. Buy Duspatalin long-acting capsules 200mg №15×2