ALGINOR ® Cimetropio Bromide

ALGINOR ® is a drug based on cimetropium bromide

THERAPEUTIC GROUP: spasmolytics, anticholinergics.

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications ALGINOR ® Cimetropio Bromide

ALGINOR® is indicated in the symptomatic treatment:

of spastic painful manifestations of the gastro-intestinal and genitourinary system

of irritable bowel syndrome

and in the premedication phase of the gastro-intestinal diagnostic and operative endoscopy intervention.

ALGINOR ® is also indicated in pediatric age for the symptomatic treatment of pain due to abdominal colic and spasms of the gastro-intestinal tract.

Mechanism of action ALGINOR ® Cimetropio Bromide

ALGINOR ® owes its therapeutic efficacy to the anticholinergic action of cimetropium bromide. This quaternary ammonium compound, poorly absorbed orally, concentrates mainly at the intestinal and hepatic level, where - competing with acetyl-choline for binding to muscarinic receptors of smooth muscle fibrocells - prevents excitation and subsequent contraction.

The spasmolytic action of ALGINOR ® is also supported by the direct myolitic effect of the active ingredient (it causes the release of some muscles such as those of the intestine).

After having carried out its action, cimetropium bromide is eliminated, about 50%, through the urine in unchanged form.

Studies carried out and clinical efficacy

1 BROMURO CEMETROPIO IN THE TREATMENT OF CHILD COLICRISTS

This Italian study conducted on 96 children with colic, showed how 1.2 mg / kg (0.4 mg / kg 3 times a day) of cimetropium bromide (active ingredient of ALGINOR ®, can guarantee a reduction of colic pain and crying in 74% of the children treated The only side effect observed was an increase in sleepiness.

2. BUTIL-BROMURO SCOPOLAMINE AND BROMURO CIMETROPIO IN THE KIDNEY COLICA.

This study of about 200 patients has shown that cimetropium bromide can guarantee a better pain-relieving effect during episodes of renal colic due to stones, compared to scopolamine butyl-bromide. The side effects observed were in most cases characterized by dry mouth, excessive abdominal distension and nausea.

3. CIMETROPIO BROMURO AND IRRITABLE COLON SYNDROME

This metanalysis study conducted on about 28 studies with hundreds of patients enrolled, shows how cimetropium bromide, together with other muscle relaxants, can guarantee a significant reduction of pain in individuals suffering from irritable bowel syndrome. Only 6% of enrolled patients showed the side effects typical of muscle relaxants.

Method of use and dosage

ALGINOR ® 50 mg coated tablets: for adults and children over the age of 14, 1 - 2 tablets every 12 hours.

ALGINOR ® suppositories of 50 mg: 1 suppository for 2-3 times a day.

ALGINOR ® adult drops: each drop has an active ingredient content of about 2.5 mg; we recommend 20 every 12 hours.

ALGINOR ® solution for injection 5mg / ml: in the treatment of acute pain an intramuscular or intravenous injection of a vial is used.

ALGINOR ® pediatric drops: each drop has an active ingredient content of about 0.4 mg, and 3 to 5 are recommended per kilogram of body weight for 4/6 times a day.

Warnings ALGINOR ® Cimetropio Bromide

Given the biological action of cimetropium bromide contained in ALGINOR ® it is necessary to remember that the drug could:

cause episodes of gastro-esophageal reflux, particularly intense for those suffering chronically of this condition;
worsen respiratory capacity and develop obstructive respiratory symptoms;
determining the onset of tremor, irritability and agitation, with rare seizures in particular predisposed subjects (when taken at high doses);
cause addiction and dependence.

Consequently, the use of ALGINOR ® must be carried out with caution and under strict medical supervision in the case of disorders of the autonomic nervous system, of liver and / or kidney diseases, of chronic obstructive inflammatory diseases of the respiratory system, in hyperthyroidism, in coronary heart disease, in congestive heart failure, in cardiac arrhythmias, in hypertension and, especially in children, in the presence of hyperpyrexia.

ALGINOR ® could alter the normal perceptive capacities and reduce the state of attention, causing drowsiness; for this reason it is not recommended for those who plan to drive vehicles.

PREGNANCY AND BREASTFEEDING

Several studies carried out on ALGINOR ® on its active principle have not shown the presence of teratogenic effects on the fetus or negative on women's health. Nevertheless, during pregnancy and lactation it would be advisable to use these drugs only if actually necessary and always after consulting your doctor.

Interactions ALGINOR ® Cimetropio Bromide

ALGINOR ® can interact with:

Tricyclic antidepressants, accentuating their effect.
Anticholinergics of various kinds, enhancing their effects;
Antihistamines, capable of interfering with the normal functioning of the drug;
Parasipathomimetic agents, which cancel the therapeutic effect.

Contraindications ALGINOR ® Cimetropio Bromide

ALGINOR ® is contraindicated in patients with prostatic hypertrophy, glaucoma, urinary retention syndromes or intestinal obstruction (pyloric stenosis), paralytic ileus, ulcerative colitis, megacolon, reflux oesophagitis, myasthenia gravis and hypersensitivity to one of the components of the product.

Undesirable effects ALGINOR ® Cimetropio Bromide

The administration of ALGINOR ® especially if carried out parenterally, can determine:

dry mucosa of the oral cavity;
alteration of sweating;
alterations of ocular tone and visual disturbances.

High doses of ALGINOR ® could be responsible for:

difficulty with urination and drowsiness;
Tachycardia;
constipation, nausea;
headache and dizziness;
interactions with the central nervous system and consequent irritability, a sense of agitation, tremors and seizures.

In case of hypersensitivity to ALGINOR ® to one of its products, skin reactions of various kinds, itching and difficulty breathing may occur.