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Composition

active ingredient: 1 suppository contains Belladonna extract thick (Belladonnae extractum spissum) in terms of the amount of alkaloids (1:5) (extractant 20 % (v/v) ethanol) 0.23 mg-0.015 G;


excipients: phenol, solid fat.


Dosage form

Rectal suppositories.


Basic physical and chemical properties: suppositories from white with a Creamy Tint to light yellow with a brownish tint, with minor inclusions.


Pharmacotherapeutic group

Topical remedies for the treatment of hemorrhoids and anal fissures. ATX code C05A X03.


Pharmacological properties

Pharmacodynamics.


Suppositories with Belladonna extract have an antispasmodic (cholinolytic) effect. The pharmacological effect of the drug is due to the complex of alkaloids that make up its composition (atropine, scopolamine, etc.). Due to the M-holinoblocking effect of alkaloids, intestinal muscle spasm is eliminated, intestinal motility decreases.


Pharmacokinetics.


When the suppository is inserted into the rectum, the effect of the drug manifests itself in 15-90 minutes. The duration of resorption action of alkaloids varies from 2 to 6 hours. Phenol has a bactericidal and antifungal effect.


Indications

Hemorrhoids and anal fissures.


Contraindications

Hypersensitivity to belladonna and other components of the drug. Diseases of the cardiovascular system in which an increase in heart rate is undesirable: atrial fibrillation, tachycardia, chronic heart failure, coronary heart disease, mitral stenosis, severe arterial hypertension. Glaucoma. Urinary retention or predisposition to it. Myasthenia gravis. Diseases of the gastrointestinal tract, accompanied by obstruction. Hyperthermic syndrome. Thyrotoxicosis. Acute bleeding.


Special security measures

Use with caution in patients with prostatic hypertrophy without urinary tract obstruction, with Down's disease, with cerebral palsy, hepatic and renal failure, reflux esophagitis, hiatal hernia combined with reflux esophagitis, inflammatory bowel diseases, including ulcerative colitis and Crohn's disease, megacolon, patients with xerostomia, elderly patients or weakened patients, with chronic lung diseases without reversible obstruction, with chronic lung diseases, accompanied by low sputum production, which is difficult to separate, especially in weakened patients, with vegetative (autonomous) neuropathy, brain damage.


Interactions with other drugs and other types of interactions

When used with monoamine oxidase inhibitors, cardiac arrhythmia occurs, with quinidine, novocainamide – a summation of the cholinolytic effect is observed. The drug can reduce the duration and depth of action of narcotic drugs, weaken the analgesic effect of opiates.


When used concomitantly with diphenhydramine or diprazine, the effect of the drug increases, with nitrates, haloperidol, corticosteroids for systemic use – the probability of increasing intraocular pressure increases, with sertraline – the depressive effect of both drugs increases, with spironolactone, minoxidil – the effect of spironolactone and minoxidil decreases, with penicillins – the effect of both drugs increases, with nizatidine – the effect of nizatidine increases, with ketoconazole – the absorption of ketoconazole decreases, with ascorbic acid and atapulgite – reduces the effect of atropine, with pilocarpine – the effect of pilocarpine in the treatment of glaucoma decreases, with oxprenolone – the antihypertensive effect of the drug decreases. Under the action of octadine, it is possible to reduce the hyposecretory effect of atropine, which weakens the effect of M-cholinomimetics and anticholinesterase agents. When used concomitantly with sulfonamide preparations, the risk of kidney damage increases, with drugs containing potassium – intestinal ulcers may form, with nonsteroidal anti – inflammatory drugs-the risk of stomach ulcers and bleeding increases.


The effect of the drug can be enhanced with the simultaneous use of other drugs with an antimuscarinic effect: m-holinoblockers, antiparkinsonian drugs (amantadine), antispasmodics, some antihistamines, butyrophenone group drugs, phenothiazines, dyspiramides, quinidine and tricyclic antidepressants, non-selective inhibitors of neuronal reuptake of monoamines.


Inhibition of peristalsis under the action of atropine can lead to changes in the absorption of other drugs.


Application features

Use during pregnancy or lactation.


It is not recommended to use during pregnancy and lactation.


Ability to influence the reaction rate when driving vehicles or other mechanisms. Given the possibility of an adverse reaction such as dizziness, when using the drug, you should refrain from driving vehicles or working with other mechanisms.


Dosage and administration

Apply to adults. The suppository is released from the package by cutting it with scissors along the contour of the suppository, and inserted deep into the rectum 1 suppository 2-3 times a day.


The duration of the course of treatment is determined by the doctor individually, taking into account the course and severity of the disease, the achieved therapeutic effect, and the overall treatment tactics. The recommended duration of treatment is 5-7 days.


Children.


There are no data on the safety and efficacy of the drug in children.


Overdose

Symptoms: increased manifestations of adverse reactions, nausea, vomiting, tachycardia, decreased blood pressure, agitation, irritability, tremor, convulsions, insomnia, drowsiness, hallucinations, hyperthermia, central nervous system depression, suppression of the activity of the respiratory and vascular centers.


Treatment. Gastric lavage, parenteral administration of cholinomimetics and anticholinesterase agents. Treatment is symptomatic.


Side effects

From the gastrointestinal tract: dry mouth, thirst, taste disorders, dysphagia, decreased intestinal motility up to atony, decreased tone of the biliary tract and gallbladder.


From the kidneys and urinary tract: difficulty and retention of urination.


From the heart: palpitations, arrhythmia, including extrasystole, myocardial ischemia.


From the side of blood vessels: redness of the face, a feeling of hot flashes.


Nervous system disorders: headache, dizziness.


From the side of the visual organs: dilated pupils, photophobia, paralysis of accommodation, increased intraocular pressure.


From the respiratory system and mediastinal organs: a decrease in secretory activity and bronchial tone, which leads to the formation of viscous sputum, which is difficult to cough up.


From the skin and subcutaneous tissue: skin rash, urticaria, exfoliative dermatitis, hyperemia.


Immune system disorders: anaphylactic reactions, anaphylactic shock.


Others: reduced sweating, dry skin, dysarthria.

Tags: Belladonna extract