Instruction for use: Ubretid

Active substance: Distigmine bromide

Code ATX N07AA03 Distigmine bromide

Pharmacological group

Cholinesterase inhibitor [m-, n-cholinomimetics, incl. Anticholinesterase drugs]

Nosological classification (ICD-10)

G24 Dystonia

Violation of muscle tone

G70 Myasthenia gravis and other disorders of the neuromuscular synapse

Myasthenic syndrome, Myasthenic syndromes, Myasthenia gravis, Myasthenic syndrome, Severe myasthenia gravis (Myasthenia gravis)

G83 Other paralytic syndromes

Paralysis, Peripheral paralysis, Brown-Sekara Syndrome, Brown-Sekar Syndrome, Hemiparaplegic syndrome, Syndrome of half damage to the spinal cord, Peripheral paralysis of striated muscles

K59.0 Constipation

Painful defecation, Age-related constipation, Secondary Constipation,. Discease, Constipation when breastfeeding, Constipated constipation, Constipation in adults, Constipation chronic, Idiopathic constipation, Cataract obstruction, Colostasis, Constipation, Common constipation, Rectal coprostasis, Tendency to constipation, Occasional constipation, Decrease in motor-evacuation function of the digestive tract, Functional constipation, Chronic constipation, Constipation in infants

K59.3 Megacolon, not elsewhere classified

Toxic megacolon, Ogilvy Syndrome

K91.3 Postoperative intestinal obstruction

Postoperative paralytic ileus

N31.2 neurogenic bladder weakness, not elsewhere classified

Urinary incontinence in a stressful situation, Atony of bladder, Atony of the bladder (the sphincter) (neurogenic), Impaired function of the sphincter of the bladder, Neurogenic bladder disorders, Neurogenic bladder disorder, Neurogenic bladder, Functional insufficiency of the sphincter of the bladder, Imperative incontinence

Composition

1 tablet contains 5 mg dystigmine bromide; In the blister 10 pcs., In the box 2 blisters.

1 ampoule with 1 ml solution for injection - 0.5 or 1 mg; In a cardboard box 5 ampoules.

pharmachologic effect

Pharmacological action - m-n-cholinomimetic indirect.

Inhibits (reversibly) acetylcholinesterase in the synaptic cleft and leads to the accumulation of acetylcholine.

Clinical Pharmacology

After 1-1.5 hours after ingestion, it increases secretion and increases the tone and peristalsis of the intestine and ureters, the bladder. Increase in the tone of the gastrointestinal tract reaches a maximum after 8-10 hours and persists for 20 hours; Tones the skeletal muscles - with myasthenia, a noticeable effect appears after 1-2 days.

Indications

Postoperative atony and paralytic obstruction of the intestine (prevention and treatment), postoperative atony of the bladder and ureters, functional deficiency of the bladder sphincter and bladder hypotension (including the neurogenic bladder), chronic hypotonic and atonic constipation, megacolon, peripheral paralysis of striated muscles, myasthenia gravis (Myasthenia gravis).

Contraindications

Expressed vagotonia (predominance of the tone of the parasympathetic nervous system) with the phenomena of pronounced bradycardia, bronchial asthma, arterial hypotension, gastric juice hyperacidity, gastrointestinal hypertension, excessive salivation, hypertonus of the intestine, biliary and urinary tract, stomach ulcer, inflammatory bowel disease, postoperative vascular crisis, Chronic heart failure, myocardial infarction, peripheral circulatory disorders, increased muscle tone, tetany, epilepsy, parkinsonism.

pregnancy and lactation

It is permissible, but only on strict indications.

Side effects

Nausea, vomiting, diarrhea, intestinal cramps, increased motility of the stomach or intestinal motility, bronchospasm, bradycardia (less than 60 beats per minute), pupil constriction, increased sweating, hypersalivation, lacrimation, muscle spasms, tremor, difficulty swallowing, etc. manifestations of hyperexcitation m - and n-holinoretseptorov.

Interaction

The effect is weakened by anticholinergic (atropine), psychotropic, antihistamine, curare-like drugs, aminoglycosides (have a weak muscle relaxant effect).

Dosing and Administration

Usually inside, in / m.

Inside, at one time, on an empty stomach, before breakfast, with a small amount of water in an initial dose of 5 mg; Depending on the results of the first week of treatment, the dose is increased to 10 mg / day or reduced to 5 mg in 2-3 days.

In / m, in a single dose of 0.5 mg; Repeated administration is possible not earlier than 24 hours; At long treatment do breaks in 2-3 days. If necessary, the dose can be increased to 0.1 mg per 10 kg of body weight.

According to special indications:

Postoperative intestinal atony - 0.5 mg IM in 24-72 hours after the operation, if necessary, the dose can be increased to 0.1 mg per 10 kg of body weight. Repeated administration in the same dose after 1-3 days.

Postoperative atony of the bladder and ureters - 0.5 g IM in 36-48 h after the operation (usually in the morning on the second day after the operation), if necessary, the dose can be increased to 0.1 mg per 10 kg of body weight and administered every 3 days for 27 days. When postoperative X-ray irradiation before its end is recommended by mouth at 5 mg / day.

Functional deficiency of the sphincter of the bladder - at the beginning of 0.5 mg IM, if necessary, the dose can be increased to 0.1 mg per 10 kg of body weight and administered every 3-4 days before the onset of the effect. Follow-up therapy can be performed by oral administration.

Hypotonic chronic stool and megacolon delay is 0.5 mg IM twice a week.

Myasthenia gravis 0.5-0.75 mg IM with an interval of 2 days.

Overdose

Symptoms associated with cholinomimetic effect - nausea, vomiting, diarrhea, abdominal pain, bronchospasm, bradycardia, miosis, tormentative perspiration, etc. Treatment - iv or s / c inject atropine in a dose of 0.5-1 mg.

Precautionary measures

During treatment it is necessary to refrain from driving a car, servicing machines and mechanisms (the reaction rate decreases). Caution is prescribed for women with temporary dysmenorrhea (may cause menstrual bleeding). If the pill does not show up during the use of the pill because of previous or simultaneous eating, avoid repeated use of the drug for several hours (because of possible cumulation).

Storage conditions

In the dark place at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life

5 years.

Do not use after the expiry date printed on the package.