Novitropan (tablets 0.25 g)

 

International nonproprietary name

Oxybutynin.

Pharmacotherapeutic  Group

Spasmolytic, miotropic agent.

Pharmacotherapeutic Formulation

Active agent: oxibutinin chloride – 5 mg;

Additives: lactose, corn starch, calcium carboxylcellulose, magnesium stearate.

Pharmacological Action

Pharmacodynamics

Novitropan possesses a direct spasmolytic action to smooth muscles, blocks cholinergic receptor. Eliminates spasms and reduces tone of smooth muscles (gastrointestinal tract, bile-excreting and urinary tracts, uterus, especially smooth muscles of urinary bladder). For patients with neurogenetic urinary bladder Novitropan increases capacity of urinary bladder, reduces contractions number of detrusor, restricts and reduces urination frequency (voluntary and involuntary ones).

Pharmacokinetics

Maximum concentration of active agent in plasma is achieved in 1 hour after oral enteral introduction of drug. Bioavailability is 6% due to presystemic metabolism. The period of semi- excretion is about 2 hours. It penetrates through hematoencephalitic barrier. It is detected in mother’s breast milk.

Therapeutic Indications

Neurogenetic urinary bladder, involuntary urination (of idiopathic nature), hyperreflexia and   detrusor disfunction, night enuresis and neurogenic bladder function abnormality for children upwards 5 years.

Direction for Use and Dosage Schedule

The drug is taken before meal. Adults are prescribed to take drug in initial dose of 5 mg (1 tablet) 2-3 times a day. Maximum daily dosage is 20 mg ( 1 tablet 4 times a day). At night enuresis final administration is made before sleep.

Particular Indications

During treatment it is not recommended to drive vehicles and to perform other potentially dangerous kinds of works requiring heightened attention and fast response in psychological and motion activity due to appearance of sleepiness and poor eyesight.

Adverse Reaction

Dry mouth, vomiting, nausea, impairment of gastric motor activity and  intestinal motility, urination disorder (urinary retention), general weakness, giddiness, tachycardia, sleepiness, visual impairment (mydriasis, amblyopia, accommodative paralysis), elevation of intraocular pressure, sweating impairment, impotency, galactischia, allergic reactions (appearance of skin rash).

Contraindications

Children under 5 years. Pregnancy, breast-feeding. Hightened sensitivity to drug. Angle-closure and open-angle glaucoma, obstruction of gastrointestinal tract, bowels atony, colon dilatation (toxic, caused by), myasthenia, bleedings. Drug safety when using Oxybutynin during pregnancy is not ascertained.

Precautions

Novitropan should be prescribed  with care at compromised liver and kidneys function. It is necessary to be careful with patients suffering hernia of esophagus opening, connected with gastroesophagal reflux. Bering prescribed to patients with ulcerative colitis novitropan suppresses intestinal peristalsis that may cause paralytic bowel obstruction. Using novitropan may increase hyperthyrea symptoms, neurocirculatory dystonia, coronary heart disease, congestive heart failure, cardiac arrhythmia, arterial hypertension, prostatic hypertrophy.

At high ambient temperature Novitropan may cause appearance of fever and cardiac asthenia (sweating impairment).

Restrictions to Use

During the period of lactation the drug should be prescribed with care.

Interaction with other drugs

Simultaneous use of drug with sedatives and alcohol may cause increase of sleepiness and giddiness.

OverDose

Symptoms:  excitation of central nervous system – anxiety, irritability, tremor,  cramps, delusion, hallucinations, nausea, vomiting, reddening of face, tachycardia, hyper- and hypotensia, respiratory failure, coma.

Treatment: to maintain breathing, to bring on vomiting followed by gastric lavage and using absorbed carbon and purgatives. For regression of symptoms of anticholinergic intoxication there is prescribed physostigmine (choline esterase blocker), at hyperpyrexia there are administered cold compresses (including ice, spirit rub-downs).

Form of  Production

Tablels of 5 mg.10 tablets in blister. 2 contour cellular packs together with operating instructions in a package.

Novitropan is manufactured in collaboration with CTC Chemical Industries Ltd. Co., Israel.