ADDOFIX ® is a drug based on Scopolamine butyl-bromide.
THERAPEUTIC GROUP: Antispasmodics, anti-emetics.
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications ADDOFIX ® Scopolamine butylbromide
ADDOFIX ® is indicated in the relief of pain symptoms, of a spastic nature, of the gastro-intestinal and genito-urinary tract.
Mechanism of action ADDOFIX ® Scopolamine butylbromide
The therapeutic action of ADDOFIX ® is due to its active ingredient: scopolamine butyl-bromide. This quaternary ammonium compound, with anticholinergic characteristics, is able to compete with acetylcholine for binding to muscarinic receptors of the smooth muscle of the gastro-intestinal and genitourinary tract, reducing its contraction and the consequent painful symptoms of a spastic nature.
Furthermore, the chemical structure of this active principle hinders the crossing of the blood-brain barrier, avoiding collateral effects on the central nervous system.
Studies carried out and clinical efficacy
New studies on Scopolamine butyl-bromide have shown a new application of this active ingredient in the search for intestinal polyps and in the correct diagnostic and prognostic evaluation of the patient. More precisely, it has been observed that 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.
This recent study shows that scopolamine butyl bromide, more than other anticholinergics, may be particularly valuable in improving respiratory capacity in hospitalized patients.
The study carried out on healthy individuals and patients suffering from recurrent gastro-oesophageal reflux showed that scopolamine butyl-bromide, unlike other anticholinergics such as atropine, causes an AMAZING 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 reducing the use of products containing this active ingredient in patients suffering from gastro-oesophageal reflux.
Method of use and dosage
ADDOFIX ® - 10 mg coated tablets: for adults and children over the age of 14, 1 - 2 tablets 3 times a day.
For children between the ages of 6 and 14, medical advice is required before 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 time of gastric emptying 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 the treatment with high doses.
The presence of sucrose in ADDOFIX ® could cause problems in patients suffering from fructose intolerance, glucose-galactose malabsorption and enzyme deficiency of sucrase isomaltase (enzymes necessary for the correct digestion of sucrose).
ADDOFIX ® can interfere with normal attention and perception, making driving dangerous for oneself and others.
PREGNANCY AND BREASTFEEDING
Clinical studies show that the active ingredient of ADDOFIX ® does not cause particular side effects in pregnant and lactating women. Furthermore, animal studies have demonstrated the absence of teratogenic and carcinogenic effects on the fetus. Nevertheless, also considering the possibility that the active ingredient or its metabolites are secreted in breast milk, the use of the medicine during the first trimester of pregnancy is not recommended; it is also important to consult your doctor before taking ADDOFIX ® during the later stages of pregnancy and during breastfeeding.
ADDOFIX ® can interact with:
- Tricyclic antidepressants, accentuating their effect.
- Dopamine antagonists, reducing the effects of both drugs.
- Beta-adrenergic, enhancing the tachycardia effect.
- Drugs that slow gastric emptying, with alteration of pharmacokinetic properties.
- Alcohol and antacids, able to alter 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 canal, paralytic ileus, ulcerative colitis, hepatocellular insufficiency, megacolon, reflux oesophagitis, intestinal atony of the elderly and debilitated subjects, myasthenia gravis and in children under the age of 6 years and in the first trimester of pregnancy.
Undesirable effects - Side effects
Adverse effects of ADDOFIX ® may also occur at therapeutic doses and not only in the event of an overdose. Among these the most frequent are:
- dry mucosa of the oral cavity;
- alteration of sweating
- alterations of ocular tone
- difficulty with urination and drowsiness
- hives, itching and various types of skin rash, dyspnea 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