INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo LENDITRO TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME:
(and dosage form)

LENDITRO TABLETS

COMPOSITION:
Each tablet contains:
Oxybutynin chloride 5 mg.

PHARMACOLOGICAL CLASSIFICATION:
A - 5.4: Medicines affecting autonomic functions. Cholinolytics (Anticholinergics).

PHARMACOLOGICAL ACTION:
LENDITRO tablets exert a direct antispasmodic effect on smooth muscle. Oxybutynin chloride inhibits the muscarinic action of acetylcholine on smooth muscle.
In patients with uninhibited neurogenic and reflex neurogenic bladder, cystometric studies have demonstrated that oxybutynin chloride increases vesical capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle and delays the initial desire to void. These effects are more consistently improved in patients with uninhibited neurogenic bladder.

INDICATIONS:
LENDITRO tablets are indicated for the relief of symptoms associated with voiding in patients with uninhibited neurogenic and reflex neurogenic bladder, (i.e. urgency, frequency, urinary leakage, urge incontinence, dysuria).
LENDITRO tablets are indicated for spastic neurogenic bladder (and not hypotonic neurogenic bladder - see Contra-indications).
LENDITRO is indicated for nocturnal enuresis.

CONTRA-INDICATIONS:
LENDITRO tablets are contra-indicated in patients with closed-angle glaucoma. They are also contra-indicated in patients with prostatic enlargement and should be used with caution in elderly men.
LENDITRO tablets are contra-indicated in partial or complete obstruction of the gastro-intestinal tract, paralytic ileus, intestinal atony of the elderly or debilitated patient, megacolon, toxic megacolon complicating ulcerative colitis, severe colitis and myasthenia gravis. They are also contra-indicated in patients with obstructive uropathy and in patients with unstable cardio-vascular status in acute haemorrhage. LENDITRO tablets are contra-indicated in hypotonic neurogenic bladder. They are also not recommended in children under 5 years of age.
* Safety during pregnancy and lactation has not been established.
* Lenditro should not be used in the presence of fever or when the ambient temperature is high. (see Warnings).
* Hypersensitivity to LENDITRO tablets.
* Patients with pyloric stenosis.

WARNING:
LENDITRO tablets, when administered in the presence of high environmental temperature, can cause heat prostration (fever and heat stroke due to decreased sweating), especially in children. It should be used cautiously in patients with fever.
The anticholinergic effects of LENDITRO may be enhanced by the concomitant administration of other medicines with anticholinergic properties. These include amantadine, some antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants, atropine and scopolamine.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
The usual dose is one 5 mg tablet two to three times a day. The maximum recommended dose is one 5 mg tablet four times a day.
Children over 5 years of age:
The usual dose is one 5 mg tablet two times a day. The maximum recommended dose is one 5 mg tablet three times a day. Pretreatment examination should include cystometry and other appropriate diagnostic procedures. Cystometry should be repeated at appropriate intervals to evaluate response to therapy. The appropriate antimicrobial therapy should be instituted in the presence of infection.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
LENDITRO may cause dry mouth, difficulty to swallow and talk, thirst, decreased sweating, flushing and dryness of the skin, urinary hesitancy and retention, blurred vision, photophobia, transient bradycardia followed by tachycardia, palpitations, arrhythmias, dilatation of the pupil, cycloplegia, increased ocular tension, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, constipation, retrosternal pain due to increased gastric reflux, bloated feeling, impotence, suppression of lactation, severe allergic reactions or drug idiosyncrasies including urticaria and other dermal manifestations.
LENDITRO tablets should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease. Administration of LENDITRO tablets in large doses to patients with ulcerative colitis may suppress intestinal motility to the point of producing a paralytic ileus and precipitate or aggravate “toxic megacolon,”a serious complication of the disease.
LENDITRO tablets should be used with caution in conditions characterised by tachycardia, such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery. The symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias and hypertension may be aggravated following the administration of LENDITRO tablets.
LENDITRO tablets should be administered with caution to patients with hiatus hernia associated with reflux oesophagitis, since anticholinergic agents may aggravate this condition.
LENDITRO tablets 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 medicine.
LENDITRO may cause mental confusion, especially in the elderly.
Reduced bronchial secretion associated with the formation of mucus plugs may occur.
Diarrhoea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with LENDITRO tablets would be inappropriate and possibly harmful.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms of overdosage with LENDITRO tablets progress from an intensification of the usual side-effect of central nervous system disturbances (restlessness, excitement and confusion) to psychotic behaviour, circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis and coma. A rash may appear on the face and upper trunk.
In the event of an overdose, the stomach should be emptied and activated charcoal administered to reduce absorption. Treatment is symptomatic and supportive.

IDENTIFICATION:
A round, white, biconvex tablet.

PRESENTATION:
Plastic containers containing 20 or 100 tablets, blister packs of 20 tablets, bank bags of 20 tablets.

STORAGE INSTRUCTIONS:
Store at room temperature (below 25°C). Keep container well closed.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER:
33/5.4/0411

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
Port Elizabeth
6020
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21 December 1999

                D408
                        A & S PRINTERS

Updated on this site: October 2001
Current: September 2004
Source: Community Pharmacy

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