Ubretid (Tablets, Solution) Instructions for Use

ATC Code

N07AA03 (Distigmine bromide)

Active Substance

Distigmine bromide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Cholinesterase inhibitor

Pharmacotherapeutic Group

Anticholinesterase agent

Pharmacological Action

Inhibitor of acetylcholinesterase and pseudocholinesterase. It has an indirect cholinomimetic effect due to reversible inhibition of cholinesterase and potentiation of the action of endogenous acetylcholine.

It improves neuromuscular transmission, enhances the tone and motility of the gastrointestinal tract, increases the tone of the bladder, bronchi, and the secretion of exocrine glands.

It causes bradycardia and lowers blood pressure. It constricts the pupil, lowers intraocular pressure, and causes spasm of accommodation.

Being a quaternary ammonium compound, Distigmine bromide penetrates poorly through cell membranes, does not cross the blood-brain barrier and does not affect the neurotransmitter acetylcholine in the central nervous system.

It also does not have a significant effect on impulse transmission in the ganglia of the autonomic nervous system. It has a longer duration of action than neostigmine.

Pharmacokinetics

After oral administration, it is metabolized by hydrolysis. It does not cross the blood-brain barrier. Metabolites are excreted in the urine.

Indications

Prevention and treatment of postoperative intestinal atony and paralytic ileus; atony of the bladder and ureters, functional insufficiency of the bladder sphincter, hypotension of the bladder; atonic and hypotonic constipation, megacolon; peripheral paralysis of striated muscles; myasthenia gravis.

ICD codes

Dosage Regimen

Administer Ubretid orally or by intramuscular injection. Select the route and dosage based on the specific medical indication and individual patient response.

For oral administration, take 5 mg to 10 mg once daily. The tablet should be swallowed whole with a sufficient amount of water, typically in the morning before breakfast.

For intramuscular injection, administer 500 micrograms (0.5 mg) once daily. Inject deeply into a large muscle mass, observing strict aseptic technique.

Adjust the duration of therapy individually. Continue treatment until the desired therapeutic effect is achieved, such as restoration of normal bladder or intestinal function. Do not exceed the recommended daily dose.

In cases of postoperative atony, initiate therapy as soon as clinically indicated after surgery. For chronic conditions like myasthenia gravis, use as part of a long-term management plan under strict medical supervision.

Monitor for signs of cholinergic excess, particularly with long-term use. Reduce the dosage or discontinue treatment if adverse reactions such as severe bradycardia, excessive salivation, or muscle twitching occur.

Adverse Reactions

From the cardiovascular system bradycardia.

From the digestive system nausea, vomiting, diarrhea, spasmodic abdominal pain, increased salivation.

Other twitching of the tongue muscles and skeletal muscles.

Contraindications

Hypersensitivity to distigmine bromide and to bromine; hypervagotonia, intestinal hypertonus, marked arterial hypotension, chronic heart failure, recent myocardial infarction, thyrotoxicosis, iritis, bronchial asthma, myotonia, tetany, epilepsy, Parkinson’s disease, postoperative and hemodynamic shock.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Special Precautions

Use with caution in bradycardia, arrhythmia, arterial hypotension, Addison’s disease, hyperthyroidism, gastric and duodenal ulcer.

In cases of temporary functional amenorrhea, Distigmine bromide may cause menstrual-like bleeding.

Effect on ability to drive vehicles and operate machinery

During treatment, one should refrain from driving vehicles and other potentially hazardous activities that require rapid psychomotor reactions.

Drug Interactions

With simultaneous use with m-cholinoblockers, psychotropic agents, antihistamines, peripheral muscle relaxants, corticosteroids, antiarrhythmic agents, aminoglycosides, the clinical efficacy of distigmine bromide is reduced.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.