Oxybin

Oxybin 

EIPICO
For For The Medical Profession Only
Oxybin
Tablets - Syrup (5 ml)
5 mg
Composition:
Each dosage unit contains:
Oxybutynin hydrochloride
Inactive ingredient:
Tablet
5 mg
Tablets: Microcrystalline Cellulose, Maize starch, sodium starch glycolate. magnesium
stearate, lactose monohydrate. aerosil 200.
Syrup: Citric acid anhydrous. sodium citrate anhydrous, sucrose, sorbitol 70 %
solution, methyl paraben, sucralose, sodium cyclamate, glycerol, purified water.
Therapeutic Indications:
Oxybin is indicated for urinary incontinence, urgency and frequency in unstable
bladder conditions due either to idiopathic detrusor instability or neurogenic
bladder disorders (detrusor hyperreflexia) in conditions such as spina bifida and
multiple sclerosis.
In addition, for children over 5 years of age, oxybutynin may be used in nocturnal
enuresis in conjunction with non-drug therapy where this alone, or in conjunction
with other drug treatment, has failed.
Posology and Method of Administration:
Adults: The usual dose is 5 mg two or three times a day. This may be increased to
a maximum dosage of 5 mg four times a day (20 mg) to obtain a satisfactory
clinical response provided that the side effects are tolerated.
Children under 5 years of age: Not recommended.
Children over 5 years of age:
Neurogenic bladder disorders: The usual dose js 5 mg twice a day. This may be
increased to a maximum of 5 mg three times a day to obtain a clinical response
provided that the side effects are tolerated.
Nocturnal enuresis: The usual dose is 5 mg two or three times a day. The last dose
should be given before bedtime.
In children, the maintenance dose may be achieved by upward titration from an
initial dose of 2.5 mg twice daily.
Elderly: The elimination half-life may be increased in some elderly patients,
therefore, dosage should be individually titrated commencing at 2.5 mg 2-3 times
a day. The final dosage will depend on response and tolerance to side effects. As
with other anticholinergic drugs caution should be observed in frail and elderly
patients.
Contraindications:
- Hypersensitivity to oxybutynin or to any component.
- Myasthenia gravis.
- Narrow-angle glaucoma or shallow anterior chamber.
- Gastrointestinal obstruction including paralytic ileus or intestinal atony.
- Patients With toxic megacolon, severe ulcerative colitis.
- Patients with bladder outflow obstruction, where urinary retention may be precipitated.
Special warnings and precautions for use:
Oxybutynin should be used with caution in the frail elderly and children who may be
neuropathy, hepatic or renal impairment or severe gastrointestinal motility disorders.
Oxybutynin may aggravate the symptoms of hyperthyroidisrn, congestive heart
failure, coronary heart disease, cardiac arrhythmia, tachycardia, hypertension and
prostatic hypertrophy
Oxybutynin can cause decreased sweating; in high environmental temperatures
this can lead to heat prostration.
The use of oxybutynin in children under 5 years of age is not recommended; it has
not been established whether oxybutynin can be safely used in this age group.
Special care should be taken in patients with hiatus hernia associated with reflux
oesophagitis, as anticholinergic drugs can aggravate this condition.
Lactose: The tablets contain lactose monohydrate. Patients with rare hereditary
problems of galactose intolerance, the Lapp deficiency or glucose-galactose
malabsorption should not receive this medicine.
Interaction with other medicinal products:
Care should be taken if other anticholinergic agents are administered together
With Oxybin, as potentiation of anticholinergic effects could occur.
Occasional cases of interaction between anticholinergics and clozapine, phenothiaz-
ines, amantidine, butyrophenones, L-dopa, digitalis and tricycllc antidepressants have
been reported and care should be taken if Oxybin is administered concurrently With
such drugs.
By reducing gastric motility, oxybutynin may affect absorption of other drugs.
Pregnahcy and lactation:
There is no experience of the use of oxybutynin during pregnancy in humans,
however, in foetal toxicity and fertility studies in animals. effects were seen on
reproductive processes at dosages associated with maternal toxicity. Oxybin
should, therefore, only be prescribed during pregnancy if considered essential.
Lactation:
Small amounts of oxybutynin have been found in mother's milk of lactating
animals. Breast-feeding while using Oxybin is therefore not recommended.
Effects on ability to drive and to use machines:
As Oxybin may produce drowsiness or blurred vision, the patient should be
cautioned regarding activities requiring mental alertness such as driving,
operating machinery or performing hazardous work while taking this drug.
Undesirable effects:
Gastrointestinal disorders:
Nausea, diarrhoea, constipation, dry mouth, abdominal discomfort, anorexia, vomiting,
gastroesophageal reflux
CNS and psychiatric disorders:
Agitation, headache, dizziness, drowsiness, disorientation, hallucinations, nightmares,
convulsions.
Cardiovascular disorders:
Tachycardia, cardiac arrythmia.
Vision disorders:
Blurred vision, mydriasis, intraocular hypertension, onset of narrow-angle glaucoma,
dry eyes.
Renal and urinary disorders:
Urinary retention, difficulty in micturition.
Skin and appendages:
Facial flushing which may be more marked in children, dry skin, allergic reactions
such as rash, urticaria, angioedema, photosensitivity.
Overdose:
The symptoms of overdosage with oxybutynin progress from an intensification of
the usual side effects of CNS disturbances (from restlessness and excitement to
psychotic behaviour), circulatory changes (flushing, fall in blood pressure,
circulatory failure .. etc.), respiratory failure, paralysis and coma.
Measures to be taken are:
1- Immediate gastric lavage.
2- physostigmine by slow intravenous injection.
Adults: 0.5 to 2.0 mg of physostigmine by slow intravenous administration.
Repeat after 5 minutes, if necessary, up to a maximum total dose of 5 mg.
Children: 30 micrograms/kg of physostigmine by slow Intravenous administration.
Repeat after 5 minutes, if necessary, up to a maximum total dose of 2 mg.
Fever should be treated symptomatically with tepid sponging or ice packs.
In pronounced restlessness or excitation, diazepam 10 mg may be given by
intravenous injection. Tachycardia may be treated with intravenous propanolol
and urinary retention managed by bladder catheterization.
In the event of progression of the curare-like effect to paralysis of the respiratory
muscles, mechanical ventilation Will be required.
Pharmacological properties:
Pharmacodynamic properties:
Oxybutynin hydrochloride is an anticholinergjc agent which also exerts a direct
antispasmodic effect on smooth muscle. It inhibits bladder contraction and relieves spasm
induced by various stimuli; it increases bladder volume, diminishes the frequency of
contractions and delays the desire to avoid in the disturbance of neurogenic bladder. The
relaxation of smooth muscle results from the papaverine- like effect of the antagonism of
the processes distal to the neuromuscular junction in addition to the anticholinergic
blocking action of the muscarinic type receptors. In addition, oxybutynin hydrochloride
has local anaesthetic properties.
Pharmacokinetic properties:
Oxybutynin is rapidly absorbed from the gastrointestinal tract following oral
administration with maximum plasma concentrations reached in less than I hour
subsequently falling bioexponentially with a half-life of between 2 and 3 hours.
Maximum effect can be seen within 3-4 hours with some effect still evident after
10 hours.
Repeated oral administration achieved steady state after eight days. Oxybutynin
does not appear to accumulate in elderly patients and the pharmacokinetics are
similar to those in other adults. Some excretion via the biliary system has been
observed in the rabbit and partial first-pass metabolism occurred; the metabolites
also appearing to have antimuscarinic properties. The main elimination route is
via the kidneys with only 0.3 - 0.4% of unchanged drug appearing in the urine of
the rat after 24 hours and 1% appearing in the urine of the dog after 48 hours. In
rats and dogs therefore, oxybutynin appears to be almost completely absorbed.
Storage:
Tablets: Store in a dry place at a temperature not exceeding 30T.
Syrup: Store at a temperature not exceeding 30•C.
Packaging:
Oxybin Tablets: Carton box containing 2 strips (AL/PVC) of 10 scored tablets each
and insert leaflet.
Oxybin Syrup: Carton box containing an amber glass bottle of 120 ml with pilfer-
proof aluminum cap and insert leaflet.
Date of revision:
january 2014.
This is a Medicament.
•Medicament is a prodtrt which affects your and its consumption contrary to instructbns
is for
•Follow strictly the doctor's prescription, thE method of use, and the instructions of the pharrnacist
wt•w wkl the
•The are experts in its benefits and risks.
•Do mt interrupt the period of treatrnent prescribed by yourser.
•Do repeat sarne prescr$tbn wittout consulting your
•Keep out ot reach ot chMren.
issue date:june2014 PMS: Black C. 17 X 21 CM 56gh-n2 110 100 PAM 000001
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EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
10th OF RAMADAN CITY, INDUSTRIAL AREA Bl, P.o. BOX: 149 TENTH, EGYPr