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Manufacturers: Nycomed Austria GmbH
Active ingredients
- Distigmine bromide
Disease class
- Dystonia
- Myasthenia gravis and other neuromuscular junction disorders
- Upper limb diplegia
- Constipation
- Megacolon, not elsewhere classified
- Postoperative intestinal obstruction
- Neurogenic bladder weakness, not elsewhere classified
Clinical and pharmacological group
- Centrally acting cholinomimetics
Pharmacological action
- Anticholinesterase
Pharmacological group
- m-, n-cholinomimetics, incl. anticholinesterase drugs
Solution for injection Ubretid (Ubretid)
Instructions for medical use of the drug
Description of pharmacological action
Inhibits (reversibly) acetylcholinesterase in the synaptic cleft and leads to the accumulation of acetylcholine.
Indications for use
Postoperative atony and paralytic ileus (prevention and treatment), postoperative atony of the bladder and ureters, functional insufficiency of the bladder sphincter and hypotension of the bladder (including neurogenic bladder), chronic hypotonic and atonic constipation, megacolon, peripheral striated muscle paralysis, myasthenia gravis (myasthenia gravis).
Release form
1 ampoule with 1 ml of solution for injection - 0.5 or 1 mg; There are 5 ampoules in a cardboard box.
Pharmacodynamics
Long-acting acetylcholinesterase inhibitor. Reversibly inhibits acetylcholinesterase, which hydrolyzes the cholinergic transmission mediator acetylcholine, which leads to prolongation of its action; prevents the rapid inactivation of acetylcholine. The clinical effect develops within 1-1.5 hours after oral administration. Increases the tone and peristalsis of the gastrointestinal tract, the tone of the bladder and its sphincter, ureters, skeletal muscles (especially with myasthenia gravis); causes moderate vasodilation, a decrease in heart rate, and a moderate increase in the function of the exocrine glands.
Pharmacokinetics
1–1.5 hours after administration, it enhances secretion and increases the tone and peristalsis of the intestines, ureters, and bladder. The increase in gastrointestinal tone reaches a maximum after 8–10 hours and persists for 20 hours; tones skeletal muscles - with myasthenia gravis, a noticeable effect appears after 1-2 days.
Use during pregnancy
Permissible, but only under strict indications.
Contraindications for use
Severe vagotonia (predominance of the tone of the parasympathetic nervous system) with symptoms of severe bradycardia, bronchial asthma, arterial hypotension, hyperacidity of gastric juice, hypermotility of the gastrointestinal tract, excessive salivation, hypertonicity of the intestines, biliary and urinary tracts, gastric ulcers, inflammatory bowel diseases, postoperative vascular crisis, chronic heart failure, myocardial infarction, peripheral circulatory disorders, increased muscle tone, tetany, epilepsy, parkinsonism.
Side effects
Nausea, vomiting, diarrhea, intestinal cramps, increased gastric motility or intestinal peristalsis, bronchospasm, bradycardia (less than 60 beats per minute), constriction of the pupil, increased sweating, hypersalivation, lacrimation, muscle spasms, tremor, difficulty swallowing and other manifestations of hyperexcitation m - and n-cholinergic receptors.
Directions for use and doses
IM, in a single dose of 0.5 mg; repeated administration is possible no earlier than after 24 hours; for long-term treatment, take breaks of 2–3 days. If necessary, the dose can be increased to 0.1 mg per 10 kg of body weight. For special indications: postoperative intestinal atony - 0.5 mg intramuscularly 24–72 hours after surgery; if necessary, the dose can be increased to 0.1 mg per 10 kg of body weight. Repeated administration at the same dose after 1–3 days. Postoperative atony of the bladder and ureters - 0.5 g IM 36–48 hours after surgery (usually in the morning on the second day after surgery), if necessary, the dose can be increased to 0.1 mg per 10 kg of body weight and administered every 3 days within 27 days. During postoperative X-ray irradiation until its completion, it is recommended to take 5 mg/day orally. Functional insufficiency of the bladder sphincter - at the beginning, 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 until the effect occurs. Subsequent therapy can be given orally. Hypotonic chronic stool retention and megacolon - 0.5 mg IM 2 times a week. Myasthenia gravis - 0.5–0.75 mg IM with an interval of 2 days.
Overdose
Symptoms associated with the cholinomimetic effect - nausea, vomiting, diarrhea, abdominal pain, bronchospasm, bradycardia, miosis, heavy sweating, etc. Treatment - atropine is administered intravenously or subcutaneously at a dose of 0.5–1 mg.
Interactions with other drugs
The effect is weakened by anticholinergic (atropine), psychotropic, antihistamine, curare-like drugs, aminoglycosides (have a weak muscle relaxant effect).
Precautions for use
During treatment, you must refrain from driving a car, servicing machines and mechanisms (reaction speed decreases). Prescribe with caution to women with temporary dysmenorrhea (may cause bleeding similar to menstrual bleeding).
Storage conditions
List A.: In a place protected from light, at a temperature of 2–8 °C.
Best before date
60 months
ATX classification:
N Nervous system
N07 Other drugs for the treatment of diseases of the nervous system
N07A Parasympathomimetics
N07AA Anticholinesterase drugs
N07AA03 Distigmine bromide
Publications in the media
(Distigmini bromidum) INN
Synonyms. Ubretid.
Composition and release form. Distigmine bromide tablets 0.5 mg; 0.05% solution in ampoules of 1 ml.
Indications. Prevention and treatment of postoperative intestinal atony and paralytic intestinal obstruction; atony of the bladder and ureters; atonic and hypotonic constipation; megacolon; peripheral skeletal muscle paralysis; myasthenia gravis. Pharmachologic effect. Distigmine bromide reversibly blocks acetylcholinesterase, an enzyme that destroys acetylcholine, which leads to the accumulation of acetylcholine in the endings of cholinergic nerves and an increase in its action. As a result, the tone and peristalsis of the gastrointestinal tract, bladder, and ureters increase; the tone and contraction of skeletal muscles increases.
Pharmacokinetics.
Side effects. Gastrointestinal spasms, bronchospasm, diarrhea, nausea, bradycardia, hypersalivation.
Contraindications. Hypersensitivity to the drug, hypersensitivity to bromine; bronchial asthma; thyrotoxicosis; hypervagotonia; hypertonicity of the intestines, biliary and urinary tracts; hypotension; epilepsy; stomach ulcer; chronic heart failure, post-infarction period; postoperative and hemodynamic shock; Parkinson's disease.
Adverse reactions when interacting with other drugs. The effect of the drug is reduced by m-cholinergic blockers, antihistamines, psychotropic drugs that have an anticholinergic component in the spectrum of action, corticosteroids and aminoglycoside antibiotics. When using cimetidine, the effect of distigmine bromide may be increased.
Information for the patient. The drug is prescribed orally at a dose of 5 mg per day in the morning 30-40 minutes before breakfast. For intramuscular administration, a single dose is 0.5 mg. Repeated administration of the drug should not be carried out earlier than after 24 hours. It is unacceptable to double the missed dose due to the risk of overdose. Signs of an overdose may include nausea, diarrhea, blurred vision, increased salivation and sweating, bronchospasm; in this case, it is necessary to administer atropine intravenously and subcutaneously at a dose of 0.5-1 mg. With functional amenorrhea, the drug can cause menstrual-like bleeding. During treatment you should refrain from driving a car, because distigmine bromide reduces the speed of physical and mental reactions.
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Ubretide instructions for use
INSTRUCTIONS for using the product
Ubretid
Release form
Tablets, ampoules
Pharmacological properties
Ubretide (distigmine bromide) is a long-acting inhibitor of acetylcholinesterase and pseudocholinesterase. Has a longer lasting effect than neostigmine. Ubretide has an indirect cholinomimetic effect due to reversible inhibition of cholinesterase and potentiation of the action of endogenous acetylcholine. Leads to the accumulation of acetylcholine in the synaptic cleft. Ubretide improves neuromuscular transmission, increases intestinal tone and motility, increases the tone of the bladder, bronchi, and the secretion of exocrine glands. Acts on the cardiovascular system: has a moderately pronounced vasodilator and negative chronotropic effect (causes bradycardia, lowers blood pressure). Ubretide increases the tone of skeletal muscles, especially in myasthenia gravis (a noticeable effect appears on the 1st–2nd day of administration). Constricts the pupil, lowers intraocular pressure, and causes a spasm of accommodation. Ubretide does not affect the neurotransmitter acetylcholine in the central nervous system. It also does not have a significant effect on the transmission of impulses in the ganglia of the autonomic nervous system. The clinical effect develops within 1–1.5 hours after oral administration. The increase in gastrointestinal tone reaches a maximum after 8–10 hours and persists for 20 hours.
Indications
Ubretide is recommended for use in the postoperative period for intestinal atony.
The medication is effective in the treatment of constipation caused by intestinal atony, megacolon and paralytic obstruction.
The high effectiveness of the drug is used for reduced tone and atony of the bladder, ureters, and functional abnormalities of the bladder sphincter.
Ubretide is indicated for myasthenia gravis and paralysis of the skeletal muscles of the limbs.
Contraindications
Ubretide should not be used by people allergic to bromine or the components of the drug.
The drug is contraindicated in case of increased tone of the intestines, biliary and urinary tracts, epilepsy, stomach and intestinal ulcers, enteritis, colitis, increased salivation, Parkinson's disease, increased acidity of gastric juice, arterial hypotension, bronchial asthma, bradycardia, myocardial infarction, circulatory disorders, thyrotoxicosis, iritis, myotonia and tetany.
Ubretide should not be used during the period of postoperative shock and intestinal obstruction of any etiology except paralytic.
Use during pregnancy and breastfeeding
Ubretide is strictly contraindicated during pregnancy and lactation.
Compound
The basis of the injection solution is distigmine bromide, the additional components are sodium chloride and water for injection.
Ubretide tablets are made on the basis of distigmine bromide using talc, corn starch, glucose and magnesium stearate.
Directions for use and doses
This drug Ubretide is used orally, on an empty stomach, 30 minutes before the morning meal.
The initial dosage is 1 tablet (5 mg) per day. If there is no reaction from the body, then you cannot take the drug on the same day, as this can cause uncontrolled cumulation.
Subsequent changes in dosage are determined by the attending physician, depending on the dynamics of treatment and the body’s response to the drug. If necessary, the dosage can be increased to 2 tablets per day or reduced to 1 tablet, which is taken every other day or every 3 days.
The duration of the treatment course is determined individually, depending on the severity of the disease and other indications of the body’s functioning.
Side effects
Side effects that may occur after taking this drug include:
- nausea, vomiting, diarrhea, intestinal spasms;
- increased gastric or intestinal motility;
- bronchospasms (if the patient suffers from bronchial asthma);
- bradycardia;
- constriction of the pupil;
- increased sweating;
- muscle spasms, tremors, muscle weakness;
- difficulty swallowing.
- vaginal bleeding.
Interaction with other drugs
The effect is weakened by anticholinergic (atropine), psychotropic, antihistamine, curare-like drugs, aminoglycosides (have a weak muscle relaxant effect).
Overdose
Symptoms associated with the cholinomimetic effect - nausea, vomiting, diarrhea, abdominal pain, bronchospasm, bradycardia, miosis, heavy sweating, etc. Treatment - atropine is administered intravenously or subcutaneously at a dose of 0.5–1 mg.
Storage conditions
In a place protected from light, at a temperature of 15–25 °C.
Best before date
No more than 5 years
