Pharmacological properties
Pharmacodynamics. Dicyclomine hydrochloride has an antispasmodic effect (eliminates spasm of smooth muscles in the gastrointestinal tract, abdominal pain associated with this spasm or stretching of the gastrointestinal wall) and an antisecretory effect on the excretory glands. the action of dicyclomine consists in a specific anticholinergic (antimuscarinic) effect on cholinergic receptors, as well as a direct antispasmodic effect on smooth muscles.
Simethicone is a surfactant, antifoam agent. The mechanism of action is based on a decrease in the surface tension of gas bubbles, promotes the free removal of gases from the gastrointestinal tract or their absorption by the intestinal wall. Simethicone improves the quality of radiographs and sonograms, provides a better distribution of contrast agents on the intestinal mucosa.
Pharmacokinetics. Dicyclomine hydrochloride, when taken orally, is rapidly absorbed in the gastrointestinal tract, Cmax in the blood plasma is reached after 60–90 minutes, excreted mainly in the urine (79.5% of the administered dose), partially in the feces (8.4%). T½ - 1.8 hours. The average volume of distribution is 3.65 l / kg.
Simethicone is physiologically and chemically an inert substance, it is not absorbed and is excreted unchanged after passing through the digestive tract.
Indications
Treatment for conditions accompanied by spasm of smooth muscles of the gastrointestinal tract and flatulence, as well as associated abdominal pain.
Treatment for spastic conditions of the gastrointestinal tract, including colitis, intestinal colic, irritable bowel syndrome, spastic constipation.
In complex treatment for organic diseases of the gastrointestinal tract with colitis, diverticulitis, enteritis, gastritis, peptic ulcer.
Application
Adults and children over the age of 12 years: the preparation is prescribed 1 tablet up to 4 times a day before or after meals. the maximum daily dose is 4 tablets. the duration of treatment is up to 5 days.
Contraindications
Hypersensitivity to active substances or other components of the preparation, intestinal obstruction, obstructive diseases of the urinary tract, prostate adenoma with difficulty urinating, renal failure, obstructive gastrointestinal diseases, severe ulcerative colitis or toxic megacolon, reflux esophagitis, unstable state of the cardiovascular system with acute bleeding, glaucoma, myasthenia gravis, thyrotoxicosis, heart failure.
Side effects
From the digestive system: dry mouth, loss of taste, anorexia, nausea, vomiting, indigestion, bloating, abdominal pain, constipation.
From the side of the central nervous system: ringing in the ears, headache, drowsiness, weakness, nervousness, psychosis, numbness, dizziness, coma, confusion and / or agitation (especially in the elderly), dyskinesia, insomnia, disorientation, short-term memory loss, hallucinations , dysarthria, ataxia, euphoria, inadequate emotional reactions (the severity of symptoms decreases 12-24 hours after dose reduction).
From the side of the organ of vision: blurred vision, double vision, dilated pupils, paralysis of accommodation, increased intraocular pressure (short-term atropine-like effects that disappear after discontinuation of dicycloverine).
Skin / allergic reactions: hypersensitivity reactions, including allergic dermatitis, pruritus, rash, urticaria, erythema, preparation-induced idiosyncrasy, angioedema, anaphylactic shock.
From the genitourinary system: difficulty urinating, urinary retention.
From the side of the cardiovascular system: tachycardia, increased heart rate.
From the respiratory system: shortness of breath, apnea, nasal congestion.
Other effects: reduced sweating, nasal congestion, sneezing, swelling of the throat, suppression of lactation.
Special instructions
The preparation should be used with caution in patients with autonomic neuropathy, liver or kidney disease; with ulcerative colitis (use in high doses can cause paralytic intestinal obstruction and the development or exacerbation of such a serious complication as toxic megacolon); with ag, ischemic heart disease, congestive heart failure, tachyarrhythmia, hiatal hernia and prostatic hypertrophy.
At high ambient temperatures during the treatment period, overheating of the body is possible (increase in body temperature and heat stroke due to decreased sweating). If symptoms appear, you should stop using the preparation and consult a doctor.
Diarrhea can be an early symptom of incomplete intestinal obstruction, especially in individuals with an ileostomy or colostomy. In such cases, preparation treatment is unreasonable, and possibly harmful.
In individuals with individual hypersensitivity to anticholinergics, the preparation can cause such effects from the central nervous system as confusion, disorientation, ataxia, fatigue, or vice versa - euphoria, agitation, insomnia, an affective state. Usually, these symptoms disappear within 12-24 hours after discontinuation of the preparation.
Use during pregnancy and lactation. The safety of using the preparation in pregnant women has not been established, so it should not be used during pregnancy.
Since dicyclomine hydrochloride passes into breast milk, the preparation is contraindicated during lactation.
Children. The preparation is used in children over the age of 12 years.
The ability to influence the reaction rate when driving or working with other mechanisms. Dicyclomine hydrochloride may cause drowsiness and blurred vision. When using the preparation, you should not drive vehicles or work with other mechanisms.
Interactions
Amantadine, class I antiarrhythmic preparations (eg quinidine), antihistamines, antipsychotics (eg phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (eg meperidine), nitrates and nitrites, sympathomimetics, tricyclic antidepressants and other preparations with anticholation or increase the severity of side effects of dicyclomine.
Anticholinergics, including dicyclomine, can neutralize the effect of antiglaucoma preparations, so the preparation should be prescribed with caution with increased intraocular pressure and the simultaneous use of corticosteroids.
Anticholinergics, including dicyclomine, can alter the absorption of certain preparations in the gastrointestinal tract, in particular long-acting digoxin, which can cause an increase in the concentration of digoxin in the blood plasma.
Dicyclomine can neutralize the effects of preparations that alter GI motility, such as metoclopramide.
Since antacids can reduce the absorption of anticholinergics, including dicyclomine, their simultaneous use should be avoided.
The inhibitory effect of anticholinergics, including dicyclomine, on the secretion of hydrochloric acid in the stomach can neutralize the preparations used in the treatment of patients with achlorhydria and for the study of gastric secretion.
The absorption of levothyroxine in the intestine can be impaired when taken simultaneously with simethicone.
Overdose
Symptoms: headache, nausea, vomiting, dry mouth, difficulty swallowing, blurred vision, dilated pupils, hot and dry skin, dizziness, tachycardia, change in respiratory rate, psychomotor agitation. a curariform effect is possible (neuromuscular blockade, muscle weakness and paralysis).
Treatment: symptomatic, in the first hours it is shown to induce vomiting, rinse the stomach.
Storage conditions
In its original packaging at a temperature not exceeding 25 ° C.