Driptan (oxybutinin hydrochloride) tablets 5 mg. №30

Description

Driptan №30 Storage
active substance: oxybutynin hydrochloride;

1 tablet contains oxybutynin hydrochloride 5 mg;

Driptan №30 excipients:

microcrystalline cellulose, calcium stearate, anhydrous lactose.

Driptan №30 Dosage form
Tablets.

Main physical and chemical properties: round white biconvex, divisible tablets with a notch on one side.

Pharmacotherapeutic group
Means used in urology. Antispasmodics that act on the urinary tract. ATX code G04B D04.

Pharmacological properties

Pharmacodynamics.

Oxybutynin has a direct antispasmodic effect on detrusor smooth muscle fibers, as well as an anticholinergic effect, blocking the effect of acetylcholine on smooth muscle M-cholinoreceptors. These properties cause the detrusor of the bladder to relax. In patients with unstable bladder, Driptan® increases bladder volume and decreases the frequency of spontaneous detrusor contractions.

Pharmacokinetics.

According to pharmacokinetic reports, after oral administration, oxybutynin is rapidly absorbed from the gastrointestinal tract, the maximum concentration in blood plasma is reached in less than 1 hour, and then decreases biexponentially with a half-life of 2 to 3 hours. The maximum effect is observed within 3-4 hours, the residual effect may appear after 10 hours.

Equilibrium concentration is reached after 8 days of oral administration of the drug. In elderly patients who lead an active lifestyle, oxybutynin does not show the ability to accumulate and its pharmacokinetics do not differ from that in other adult patients. However, in debilitated elderly patients, Cmax and AUC are significantly increased. Oxybutynin is extensively metabolized in the liver, primarily by enzymes of the cytochrome P450 system, in particular CYP 3A4, which is found mainly in the liver and intestinal wall; its metabolites also have an M-cholinoblocking effect. The main route of excretion is the kidneys; only 0.3-0.4% of the unchanged active substance is found in the urine of rats after 24 hours and 1% – in the urine of dogs after 48 hours. Thus, in rats and dogs, oxybutynin is almost completely metabolized.

Indication
Urinary incontinence, urges or accelerated urination in instability of bladder function due to neurogenic bladder dysfunction (detrusor hyperreflexia) observed in diseases such as multiple sclerosis and spina bifida, or due to idiopathic senescence in detoxification of detonator function. It can also be used to control bladder hyperactivity that occurs after surgery on the bladder or prostate or with concomitant cystitis.

Use in children

Oxybutynin hydrochloride is indicated for use in children over 5 years of age with:

urinary incontinence, urges or accelerated urination with instability of bladder function due to idiopathic bladder hyperactivity or neurogenic bladder dysfunction (detrusor hyperactivity);
nocturnal enuresis associated with detrusor hyperactivity, in combination with non-drug treatment, in case of ineffectiveness of other therapies.

Contraindication
Hypersensitivity to the active substance or to any of the other components of the drug;

myasthenia gravis;

narrow-angle glaucoma or shallow anterior chamber of the eye;

patients with fever or at elevated ambient temperature, due to the risk of provoking hyperpyrexia;

children under 5 years;

esophageal dysfunction, including esophageal hernia;

functional or organic gastrointestinal obstruction, including pylorostenosis, paralytic intestinal obstruction, intestinal atony;

patients with ileostomy, colostomy, toxic megacolon; severe ulcerative colitis;

patients with urinary tract obstruction, when urinary retention may be exacerbated, such as prostate hypertrophy.