ADDOFIX ® is a drug based on Scopolamine butyl bromide.
THERAPEUTIC GROUP: Antispasmodics, antiemetics.
Indications ADDOFIX ® Scopolamine butylbromide
ADDOFIX ® is indicated in the relief of painful symptoms, of a spastic nature, of the gastrointestinal and genitourinary tract.
Mechanism of action ADDOFIX ® Scopolamine butylbromide
The therapeutic action of ADDOFIX ® is due to its active principle: scopolamine butyl-bromide. This quaternary ammonium compound, with anticholinergic characteristics, is able to compete with acetylcholine for binding to the muscarinic receptors of the smooth muscle of the gastrointestinal and genitourinary tract, reducing their contraction and consequent painful symptoms of a spastic nature.
Furthermore, the chemical structure of this active principle hinders the crossing of the blood-brain barrier, avoiding side effects on the central nervous system.
Studies carried out and clinical efficacy
1. SCOPOLAMINE BUTYL-BROMIDE IN THE DIAGNOSIS OF INTESTINAL POLYPOSIS
Hepatogastroenterology. 2010 Jan-Feb; 57: 90-4.
Effects of Hyosine N-butyl bromide on the detection of polyps during colonoscopy.
Lee JM, Cheon JH, Park JJ, Moon CM, Kim ES, Kim TI, Kim WH.
New studies on Scopolamine butyl bromide have highlighted a new application of this active principle in the search for intestinal polyps and in the correct diagnostic and prognostic evaluation of the patient. More precisely, it has been observed how the distension of the muscular wall induced by this anticholinergic can significantly improve the visual field of the operator, and allow a more careful examination of the intestinal mucosa during colonoscopy.
2. SCOPOLAMINE BUTYL-BROMIDE IN THE REDUCTION OF NOISY BREATHING
Am J Health Syst Pharm. 2009 Mar 1; 66: 458-64.
Anticholinergic medications for managing noisy respirations in adult hospice patients.
Kintzel PE, Chase SL, Thomas W, Vancamp DM, Clements EA.
This recent study shows how scopolamine butyl bromide, more than other anticholinergics, may be particularly valuable in improving respiratory capacity in hospitalized patients.
3. BUTYL-BROMIDE SCOPOLAMINE AND GASTRO-ESOPHAGEAL REFLUX
Am J Gastroenterol. 2001 Aug; 96: 2306-11.
Effect of hyoscine N-butylbromide on gastroesophageal reflux in normal subjects and patients with gastroesophageal reflux disease.
Ciccaglione AF, Grossi L, Cappello G, Malatesta MG, Ferri A, Toracchio S, Marzio L.
The study carried out on healthy individuals and patients suffering from recurrent gastroesophageal reflux, has shown how scopolamine butyl bromide, unlike other anticholinergics such as atropine, causes a Worsening of symptoms, with an increase in episodes of gastro-reflux. esophageal in both healthy individuals and those affected by this condition.
This study focuses on the opportunity to reduce the use of products containing this active ingredient in patients with gastroesophageal reflux.
Method of use and dosage
ADDOFIX ® - 10 mg coated tablets: for adults and children over 14 years of age, 1 - 2 tablets 3 times a day.
For children between the ages of 6 and 14, medical advice is required before resorting to taking the medicine.
Warnings ADDOFIX ® Scopolamine butylbromide
ADDOFIX ® as well as other anticholinergics can:
- reduce the volume of bronchial secretions and aggravate the health conditions of subjects with obstructive affections of the respiratory system;
- prolong the gastric emptying time and determine stasis of the antrum;
- determine an increase in intraocular pressure in patients with acute angle glaucoma;
Furthermore, ADDOFIX ® must be used with particular caution in the elderly, in patients suffering from liver and kidney diseases, Tachycardia, hyperthyroidism and nervous system disorders.
It is not recommended to abruptly stop treatment with high doses.
The presence of sucrose in ADDOFIX ® could cause problems in patients suffering from fructose intolerance, glucose-galactose malabsorption and enzymatic deficiency of sucrase isomaltase (enzymes necessary for the correct digestion of sucrose).
ADDOFIX ® can interfere with normal attention and perception skills, making driving dangerous for oneself and for others.
PREGNANCY AND BREASTFEEDING
Clinical studies show that the active ingredient of ADDOFIX ® does not cause particular side effects in pregnant and lactating women. Animal studies have also shown the absence of teratogenic and carcinogenic effects on the fetus. Despite this, also considering the possibility that the active ingredient or its metabolites are secreted in breast milk, it is not recommended to use the medicine during the first trimester of pregnancy; it is also important to consult your doctor before taking ADDOFIX ® during later stages of pregnancy and in the lactation period.
Interactions
ADDOFIX ® can interact with:
- Tricyclic antidepressants, accentuating their effect.
- Dopamine antagonists, reducing the effects of both drugs.
- Beta-adrenergics, enhancing the tachycardic effect.
- Drugs that slow down gastric emptying, with alteration of the pharmacokinetic properties.
- Alcohol and antacids, capable of altering their normal metabolism.
Contraindications ADDOFIX ® Scopolamine butylbromide
ADDOFIX ® is contraindicated in case of hypersensitivity to one of its components or metabolites, acute angle glaucoma, prostatic hypertrophy or other causes of urinary retention, pyloric stenosis and other conditions stenosing the gastrointestinal tract, paralytic ileus, ulcerative colitis, hepatocellular insufficiency, megacolon , reflux esophagitis, intestinal atony in the elderly and in debilitated subjects, Myasthenia gravis and in children under the age of 6 and in the first trimester of pregnancy.
Undesirable Effects - Side Effects
Undesirable effects of ADDOFIX ® can also occur at therapeutic doses and not only in case of overdose. Among these the most frequent are:
- dryness of the mucous membrane of the oral cavity;
- alteration of sweating
- changes in eye tone
- difficulty urinating and sleepiness
- Tachycardia
- constipation
- hives, itching and rashes of various kinds, dyspnoea and shock in case of hypersensitivity to the active substance or to one of its metabolites.
- Interference with the central nervous system and alteration of the state of consciousness and cardio-respiratory function, when taken at high doses.
Notes: the drug ADDOFIX ® Scopolamine butylbromide is not subject to medical prescription
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