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Pharmacological properties

dicyclomine hydrochloride has an antispasmodic effect (eliminates spasm of smooth muscles in the gastrointestinal tract, abdominal pain associated with this spasm or extension of the gastrointestinal wall) and antisecretory effect on excretory glands. the action of dicyclomine is a specific anticholinergic (antimuscarinic) effect on cholinergic receptors, as well as a direct antispasmodic effect on smooth muscles.

Simethicone is a surfactant, antifoam. The mechanism of action is based on a decrease in the surface tension of gas bubbles; it facilitates 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 digestive tract, Cmax in blood plasma is reached after 60–90 minutes, excreted mainly in urine (79.5% of the administered dose), partially with feces (8.4%). T½ - 1.8 hours. The average volume of distribution is 3.65 l / kg.

Physiologically and chemically, Simethicone is an inert substance, it is not absorbed and excreted unchanged after passing through the digestive tract.

Indications

Treatment for conditions accompanied by spasm of the 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 the complex treatment of organic diseases of the gastrointestinal tract with colitis, diverticulitis, enteritis, gastritis, peptic ulcer.

Application

Adults and children over the age of 12 years: the drug 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 drug, intestinal obstruction, obstructive urinary tract diseases, prostate adenoma with difficulty urinating, renal failure, obstructive gastrointestinal tract diseases, severe ulcerative colitis or toxic megacolon, reflux esophagitis, unstable state of the cardiovascular system 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: tinnitus, 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 the dose is reduced).

From the side of the organ of vision: blurred vision, double vision, dilated pupils, accommodation paralysis, increased intraocular pressure (short-term atropine-like effects that disappear after dicycloverin is canceled).

Skin side / allergic reactions: hypersensitivity reactions, including allergic dermatitis, itching, rash, urticaria, erythema, drug idiosyncrasy, angioedema, anaphylactic shock.

From the genitourinary system: difficulty urinating, urinary retention.

From the cardiovascular system: tachycardia, increased heart rate.

From the respiratory system: shortness of breath, apnea, nasal congestion.

Other effects: decreased sweating, nasal congestion, sneezing, swelling of the mucous membrane of the throat, suppression of lactation.

special instructions

The drug should be used with caution in patients with autonomic neuropathy, liver or kidney disease; with ulcerative colitis (use in high doses can cause paralytic bowel obstruction and the development or exacerbation of such a serious complication as toxic megacolon); with arterial hypertension, coronary heart disease, congestive heart failure, tachyarrhythmia, hiatal hernia and prostatic hypertrophy.

At a high ambient temperature during treatment, overheating of the body is possible (increase in body temperature and heat stroke due to a decrease in perspiration). If appropriate symptoms appear, discontinue use of the drug 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, drug treatment is unreasonable, and possibly harmful.

In individuals with individual hypersensitivity to anticholinergics, the drug can cause CNS effects such as confusion, disorientation, ataxia, increased fatigue, or vice versa - euphoria, agitation, insomnia, and affective state. Typically, these symptoms disappear within 12-24 hours after discontinuation of the drug.

Use during pregnancy and lactation. The safety of the drug in pregnant women has not been established, so it should not be used during pregnancy.

Since dicyclomine hydrochloride passes into breast milk, the drug is contraindicated during lactation.

Children. The drug is used in children over the age of 12 years.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Dicyclomine hydrochloride may cause drowsiness or blurred vision. When using the drug should not drive vehicles or work with other mechanisms.

Interactions

Amantadine, class I antiarrhythmic drugs (e.g. quinidine), antihistamines, antipsychotic drugs (e.g. phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g. meperidine), nitrates and nitrites, sympathomimetics, tricyclic antidepressants and other drugs with anticholinergic activity or increase the severity of side effects of dicyclomine.

Anticholinergics, including dicyclomine, can neutralize the effect of antiglaucoma drugs, therefore, the drug should be prescribed with caution with increased intraocular pressure and the simultaneous use of corticosteroids.

Anticholinergics, including dicyclomine, can alter the absorption of certain drugs in the digestive tract, in particular, long-acting digoxin, which can cause an increase in the concentration of digoxin in blood plasma.

Dicyclomine can neutralize the effects of drugs that alter the motility of the gastrointestinal tract, 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 drugs used in the treatment of patients with achlorhydria and for the study of gastric secretion.

Absorption of levothyroxine in the intestine may be impaired while taking it 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, a feeling of muscle weakness and paralysis).

Treatment: symptomatic, in the first hours it is indicated to induce vomiting, rinse the stomach.

Storage conditions

In the original packaging at a temperature not exceeding 25 ° C.

Tags: Dicyclomine, Simethicone