FLEXIBAN ® - Ciclobenzaprina

FLEXIBAN ® is a medicinal product based on Ciclobenzaprine hydrochloride

THERAPEUTIC GROUP: Atropino similar to spasmolytic action of central type.

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

Indications FLEXIBAN ® - Ciclobenzaprina

FLEXIBAN ® is indicated in the treatment of muscle contractions of peripheral and central origin such as muscle tears, cervical and lumbosacral radiculopathy, peripheral arthrosis, muscle tension and local muscle pain.

Mechanism of action FLEXIBAN ® - Ciclobenzaprina

FLEXIBAN ® is a medicinal product based on Ciclobenzaprine hydrochloride, an active ingredient structurally related to tricyclic antidepressants, with both a decontracting and a direct analgesic action.

Taken orally and widely absorbed at the gastro-enteric level, Ciclobenzaprina on the one hand enhances the activity of the descending supraspinal pathways involved in the inhibition of the pain stimulus, on the other it performs its decontracting activity reducing upstream the activation of alpha motor neurons and gamma, probably through a mechanism of potentiation of GABAergic activity of central receptors, which takes the form of local reduction of excitatory neurotransmitters.

At the end of its therapeutic activity, and following extensive hepatic metabolism, Ciclobenzaprine is mainly excreted via the kidneys.

Studies carried out and clinical efficacy

Clinical study demonstrating the efficacy of Ciclobenzaprine in the treatment of tinnitus, in particular categories of patients at risk, resulting generally safe and well tolerated.

NEUROLOGICAL SIDE EFFECTS FROM CICLOBENZAPRINA

BMJ Case Rep. 2013 May 2; 2013. pii: bcr2013008997. doi: 10.1136 / bcr-2013-008997.

Case report that reveals the appearance of side effects, due to serotonin syndrome, following prolonged administration of Ciclobenzaprina, characterized by hyperkinesia and delirium.

CYCLOBENZAPRINE IN PREGNANCY AND PULMONARY HYPERTENSION IN THE NEONATE

J Matern Fetal Neonatal Med. 2013 Nov 5. [Epub ahead of print]

Recent study that demonstrates some of the possible side effects related to the use of Cyclobenzaprine during pregnancy on fetal health.

In this study, in fact, the appearance of pulmonary hypertension in the newborn is reported following the intake of the aforementioned active ingredient.

Method of use and dosage

FLEXIBAN ®

Ciclobenzaprine hydrochloride 10 mg coated tablets.

The therapeutic scheme should be defined by the physician, based on the physiopathological conditions of the patient and the severity of the clinical picture.

Considering the therapeutic purposes, mainly decontracting, the generally used range is between 20 and 40 mg per day in several administrations, for a duration not exceeding 2 weeks.

Warnings FLEXIBAN ® - Ciclobenzaprina

FLEXIBAN ® therapy, like tricyclic antidepressant therapy, must necessarily be preceded by a careful medical examination, and periodically supervised by expert personnel.

Given the particular mechanism of action at the central level, the use of this drug should be carried out with particular caution in patients suffering from cardiovascular diseases, urinary retention, glaucoma or increase in endocular pressure.

FLEXIBAN ® contains lactose among the excipients, therefore it is not indicated in patients with lactase enzyme deficiency, glucose-galactose malabsorption syndrome and galactosemia.

It is recommended to keep the medicine out of the reach of children.

PREGNANCY AND BREASTFEEDING

The absence of clinical studies able to fully characterize the safety profile of Ciclobenzaprine for fetal health, extend the aforementioned contraindications to the use of FLEXIBAN ® also to pregnancy and the subsequent breastfeeding period.

Interactions

The patient receiving FLEXIBAN ® should avoid the simultaneous intake of drugs and molecules active on the central nervous system, such as to alter the therapeutic characteristics of Ciclobenzaprina.

Contraindications FLEXIBAN ® - Ciclobenzaprina

The use of FLEXIBAN ® is contraindicated in patients who are hypersensitive to the active substance or to one of its excipients, in patients on therapy with MAO inhibitors and in patients suffering from cardiovascular diseases or hyperthyroidism.