Loperamide 2 mg TC-(10 capsules)

The instruction for medical use of LOPERAMIDE medicine - shopping Mall the Trade name Loperamide - The unlicensed name Loperamide Dosage Form of the Capsule of 2.0 mg Structure One capsule supports shopping mall Mezhdunarodnoye: active agent – loperamide a hydrochloride of 2 mg excipients: lactoses monohydrate, magnesium stearate, structure of a lid of the capsule: ferrous oxide black (E 172), titan dioxide (E 171), gelatin, structure of the body of the capsule: the titan dioxide (E 171), yellow quinolinic (E 104), red crimson (E 124), patent blue (E 131), diamond black (E 151), gelatin the Description Solid gelatin capsules of 4 in size, with the body of green color and a lid of gray color. Contents of capsules - powder of white color Pharmacotherapeutic group Antidiarrheal drugs. The drugs reducing motility of digestive tract. Loperamide the ATX A07D A03 Code the Pharmacological Pharmacokinetics At properties loperamide intake a hydrochloride is quickly soaked up. In the zheludochno-a intestinal path (ZIP) about 40% are absorbed. After reception of capsules in a dose of 0.004 g the maximum concentration in blood plasma is reached in 2.5 - 3 hours and makes 1-3 mg/ml. In blood there are 95-97% in the state connected with proteins of plasma. Selectively collects in smooth muscle structures and neuroplexes of a wall of intestines. A half-life period – 9 - 14 hours. Of 5% of loperamide the hydrochloride is removed with urine in the form of metabolites, 25% - with a stake, 70% are again soaked up in intestines. After absorption of 40% it is metabolized in a liver and in the form of conjugates it is allocated with bile. At normal function of a liver hydrochloride loperamide level in blood plasma and urine low, and in a liver failure the increase in its content in blood plasma is possible. In system circulation only 0.3% of the accepted dose are defined. Due to the intensive presisitemny metabolism practically does not get through a blood-brain barrier and does not give the central side effects. It is excreted generally by a liver and kidneys in the form of glucuronic metabolites. In not changed look 1-2% of the accepted dose are excreted. The pharmacodynamics Loperamide shopping mall has antidiarrheal (konstipatsionny) effect. The mechanism of action is connected with ability of Loperamide shopping mall to contact opiodny receptors of walls of intestines, to inhibit release of acetylcholine and E2α prostaglandin thanks to what the vermicular movement of intestines and advance of its contents slows down, time of absorption of water and electrolytes increases, anti-secretory action is shown. Loperamide shopping mall raises a tone of an anal sphincter that promotes the best deduction of stool and reduction of desires to defecation, besides it reduces slime hypersecretion in a large intestine. Action develops quickly and 4-6 hours after reception proceed. Loperamide shopping mall connects protein the calmodulin regulating intestinal transport of ions and is deprived of morfinopodobny action that distinguishes it from other opiate antagonists. It reduces secretion of gastric juice, juice of a pancreas and intestines. Indications - acute and chronic diarrhea of non-infectious genesis (allergic, psychosomatic, medicinal, beam, at change of a diet and qualitative structure of food) - regulation of a chair at patients with ileostomy Accept the Route of administration and doses inside, without chewing, washing down with a small amount of water. The adult in acute diarrhea originally appoint 4.00 mg (2 capsules) in one step and further 2:00 mg (1 capsule) after each act of defecation in case of a liquid chair. In chronic diarrhea the initial dose for adults makes 4.00 mg of 1 times a day, then establish a maintenance dose – 2.00 mg 1-2 times a day. The maximum daily dose – 16.00 mg (8 capsules). Duration of treatment should not exceed 2 days. After normalization of a chair or in the absence of the act of defecation within 12 hours, drug is cancelled. Side effects Sometimes - allergic reactions (skin rash, an itching) - a constipation and/or an abdominal distension, intestinal colic Seldom - a gastralgia, feeling of dryness in a mouth, nausea, vomiting - a headache, dizziness, insomnia or drowsiness, fatigue - a hypovolemia, disturbance of electrolytic balance, an ischuria Very seldom - lengthening of an interval QT, a sudden cardiac death, serious ventricular arrhythmias - the accelerated formation of toxic megacolon - an acute anaphylaxis and anaphylactoid reactions - intestinal impassability at long reception in high doses - bullous rashes, including Stephens-Johnson's syndrome, a multiformny erythema, a toxic epidermal necrolysis of the Contraindication - hypersensitivity to any component of drug and to loperamide - the acute dysentery and other infections of a GIT (caused, including Salmonella spp., Shigella spp., Campylobacter spp.) - intestinal impassability, constipations - chronic ulcer colitis, a diverticulitis - pseudomembranous colitis - children's and teenage age up to 18 years - pregnancy, the lactation period - the heavy liver failure Medicinal interactions is not recommended to appoint Loperamide shopping mall along with m - cholinolytic drugs (atropine) - in avoidance of mutual strengthening of effect. Special instructions Patients with an abnormal liver function have to be under observation of the doctor for the purpose of early detection of signs of toxic damage of central nervous system. Use of drug does not replace causal and rehydration treatment. At emergence of a hypovolemia and electrolytic disturbances it is necessary to begin replacement therapy with completion of deficiency of liquid and correction of electrolytic disturbances. At development of a constipation, a meteorism, phenomena of intestinal impassability the use of drug is stopped. In the absence of effect after 48 hours of use it is necessary to specify the diagnosis and to exclude infectious genesis of diarrhea. During treatment the observance of a diet and completion of liquid of Feature of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms during treatment is recommended it is necessary to refrain from driving of transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and high speed of psychomotor reactions. Overdose Symptoms: oppression of the central nervous system (stupor, lack of coordination, drowsiness, miosis, hyper tone of skeletal muscles, respiratory depression), paralytic intestinal impassability. Treatment: drug withdrawal, gastric lavage, intake of activated carbon (if from the moment of poisoning there passed no more than 3 hours). If necessary carry out symptomatic therapy and artificial ventilation of the lungs. Antidote - Naloxonum (intravenously, in a dose of 0.4 mg/ml, repeatedly, with 2-3-minute intervals). The patient has to be under constant medical observation within not less than 48 hours. A form of release and packing On 10 capsules in blister strip packaging from a film of the polyvinylchloride and/or printing aluminum foil varnished. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard for a retail container of subgroup chrome ersatz. Packing on 140 blister strip packagings together with the corresponding number of instructions for medical use in the state and Russian languages in a group container without investment in a pack is allowed in coordination with the consumer. To Store storage conditions in the dry, protected from light place, at a temperature not above 25 °C. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Organization – Shopping Mall Pharm Aktobe LLP producer, the Republic of Kazakhstan, Aktobe New of the village of the lake, uch. No. 467, phone number / fax: 8 (7132) 21-72-15, e-mail: dir-tkpharm@mail.ru the Owner of the registration certificate of Shopping Mall Pharm Aktobe LLP, the Republic of Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration safety of medicine: Shopping Mall Pharm Aktobe LLP, Republic of Kazakhstan, Aktobe New of the village of the lake, uch. No. 467, phone number / fax: 8 (7132) 21-72-1