Diutropan

Each blue Diutropan tablet contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d, l (racemic) 4-diethylamine-2-butynyl-α-phenylcycloglycolate hydrochloride. The empirical formula of oxybutynin chloride is C₂₂H₃₁NO₃ HCl.
Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis.

Therapeutic category: Antispasmodic, anticholinergic.
Diutropan exerts direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. Diutropan exhibits only one fifth of the anticholinergic activity of atropine on the rabbit detrusor muscle, but four to ten times the antispasmodic activity. No blocking effects occur at skeletal neuromuscular junction or autonomic ganglia (antinicotinic effects).
Diutropan relaxes bladder smooth muscle. In patients with condition characterized by involuntary bladder contractions, cystometric studies have demonstrated that Diutropan increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle and delays the initial desire to void. Diutropan thus decreases urgency and the frequency of both incontinent episodes and voluntary urination.
Diutropan was well tolerated in patients administered with the drug in controlled studies of 30 days' duration and in uncontrolled studies in which some of the patients received the drug for 2 years.

Diutropan is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder, ie urgency, frequency, urinary leakage, urge incontinence and dysuria.

Adults: The usual dose is one 5 mg tablet two to three times a day. Do not exceed 3 tablets per day.
Children over 5 years of age: The usual dose is one 5 mg tablet two times a day. Do not exceed 3 tablets per day.

The symptoms of overdosage with Diutropan (oxybutynin chloride) may be any of those seen with other anticholinergic agents. Symptoms may include signs of central nervous system, excitation (eg, restlessness, tremor, irritability, convulsion, delirium, hallucination), flushing, fever, nausea, vomiting, tachycardia, hypotension or hypertension, respiratory failure, paralysis and coma.
In the event of an overdose or exaggerated response, treatment should be symptomatic and supportive. Maintain respiration and induce emesis or perform gastric lavage (emesis is contraindicated in precomatose, convulsive or psychotic state). Activated charcoal may be administered as well as cathartic. Physostigmine may be considered to reverse symptoms of anticholinergic intoxication. Hyperpyrexia may be treated symptomatically with ice bags or other cold applications and alcohol sponge.

Diutropan (oxybutynin chloride) is contraindicated in patients with untreated angle-closure glaucoma and in untreated narrow anterior chamber angles since anticholinergic drugs may aggravate these conditions.
It is also contraindicated in partial or complete obstruction of the gastrointestinal tract, paralytic ileus, intestinal atony of the elderly or debilitated patient, megacolon, toxic megacolon complicating ulcerative colitis, severe colitis, and myasthenia gravis. It is contraindicated in patients with obstructive uropathy and in patients with unstable cardiovascular status in acute haemorrhage.
Diutropan is contraindicated in patients who have demonstrated hypersensitivity to the product.

Diutropan (oxybutynin chloride), when administered in the presence of high environmental temperature, can cause heat prostration (fever and heat stroke due to decreased sweating).
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with Diutropan would be inappropriate and possibly harmful.
Diutropan may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. Alcohol or other sedative drugs may enhance the drowsiness caused by Diutropan.

Diutropan (oxybutynin chloride) should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease. Diutropan may aggravate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmia, hiatal hernia, tachycardia, hypertension, and may suppress intestinal motility to the point of producing a paralytic ileus and precipitate or aggravate toxic megacolon, a serious complication of the disease.
Carcinogenesis, Mutagenesis, Impairment of Fertility: A 24-month study in rat at dosage up to approximately 400 times the recommended human dosage showed no evidence of carcinogenicity.
Diutropan showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae and Salmonella typhimurium test systems. Reproduction studies in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility.
Use in Children: The safety and efficacy of Diutropan administration have been demonstrated for children 5 years of age and older (see Dosage & Administration). However, as there is insufficient clinical data for children under age of 5, Diutropan is not recommended for this age group.

Pregnancy: Category B. Reproduction studies in the hamster, rat, and mouse have shown no definite impairment of fertility or harm to the animal fetus. The safety of Diutropan administered to women who are or who may become pregnant has not been established, therefore, Diutropan should not be given to pregnant women unless, in the judgment of the physicians, the probable benefits outweigh the possible hazards.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Diutropan is administered to a nursing woman.

Following administration of Diutropan, the symptoms that can be associated with the use of other anticholinergic drugs may occur.
Cardiovascular: Palpitation, tachycardia and vasodilatation.
Dermatologic: Decreased sweating and rash.
Gastrointestinal/Genitourinary: Constipation, decreased gastrointestinal motility, dry mouth, nausea, urinary hesitance and retention.
Nervous system: Asthenia, dizziness, drowsiness, hallucination, insomnia and restlessness.
Ophthalmic: Amblyopia, cycloplegia, decreased lacrimation and mydriasis.
Other: Impotence and suppression of lactation.

Store below 30°C.

Drugs for Bladder & Prostate Disorders

G04BD04 - oxybutynin ; Belongs to the class of urinary antispasmodics.

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