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  • Lyrinel
    / Janssen


    Active Ingredient
    Oxybutynin Chloride 5 mg, 10 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Prolonged-Release Tablets

    30 X 5 mg

    full basket chart 68557 12356

    Prolonged-Release Tablets

    30 X 10 mg

    full basket chart 68558 12357

    Related information


    Dosage

    This product is administered orally once daily. The recommended starting dose is 5 or 10 mg once daily. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals. Patients already taking immediate release oxybutynin may be switched to the nearest equivalent total daily dose of this product. This drug must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. It may be administered with or without food.
    Elderly [≥65 years old]: Same as for adults.


    Indications

    Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.


    Contra-Indications

    Hypersensitivity to oxybutynin or any of the excipients, Narrow-angle glaucoma or shallow anterior chamber, Myasthenia gravis, Urinary retention,
    Gastrointestinal obstructive disorder, paralytic ileus or intestinal atony, Severe ulcerative colitis, Toxic megacolon, Urinary frequency and nocturia due to heart or renal failure, Porphyria.


    Special Precautions

    Oxybutynin is associated with anticholinergic central nervous system (CNS) effects. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling has the potential to become life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. Heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin chloride are administered in the presence of high environmental temperature. Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence) or blurred vision, patients should be advised to exercise caution. this product should be given with caution in patients with the following conditions: Hepatic or renal impairment, Clinically significant bladder outflow obstruction because of the risk of urinary retention, Gastrointestinal obstructive and gastrointestinal motility disorders because of risk of gastric retention, Conditions such as ulcerative colitis due to the potential for decreased gastrointestinal motility, Myasthenia gravis due to the risk of symptom aggravation, Gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis, Preexisting severe gastrointestinal narrowing (pathologic or iatrogenic), Preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms. TRADENAME must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell is eliminated from the body; patients should not be concerned if they occasionally notice something that looks like a tablet in their stool.
    Paediatric population: Oxybutynin hydrochloride is not recommended for use in children below age 5 years due to insufficient data on safety and efficacy. There is limited evidence supporting the use of Oxybutynin in children with monosymptomatic nocturnal enuresis (not related to detrusor overactivity). In children over 5 years of age, Oxybutynin hydrochloride should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.
    For full details see prescribing information.


    Side Effects

    Adverse events were generally dose related. As with other oxybutynin formulations, dry mouth was the most frequently reported adverse reaction. However, in clinical studies, dry mouth has been less frequently reported with Lyrinel XL than with oxybutynin immediate release formulations. For patients who required final doses of 5 or 10 mg of Lyrinel XL, the relative incidence of dry mouth that occurred at any dose level was 1.8 times lower compared with patients who required final doses > 10 mg.
    For full details see prescribing information.


    Drug interactions

    The concomitant use of oxybutynin with other anticholinergic medicinal products or drugs with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian drugs (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines, butyrophenones, clozapine), quinidine, tricyclic antidepressants, atropine and related compounds like atropinic antispasmodics, dipyridamole, may increase the frequency or severity of dry mouth, constipation and drowsiness. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. They may also antagonize the gastrointestinal prokinetic effects of metoclopramide and domperidone. However, the interaction between prokinetics and oxybutynin has not been established. Sublingual nitrates may fail to dissolve under the tongue owing to dry mouth, resulting in reduced therapeutic effect.
    Oxybutynin is metabolised by cytochrome P450 isoenzyme CYP3A4. Mean oxybutynin chloride concentrations were approximately 2 fold higher when Lyrinel XL was administered with ketoconazole, a potent CYP3A4 inhibitor. Other inhibitors of cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g. itraconazole and fluconazole) or macrolide antibiotics (e.g. erythromycin), may alter oxybutynin pharmacokinetics. The clinical relevance of such potential interaction is not known. Caution should be used when such drugs are coadministered.


    Pregnancy and Lactation

    Pregnancy: Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility or harm to the animal fetus. The safety of this product administered to women who are or who may become pregnant has not been established. Consequently, risks and potential benefits should be considered before this drug is administered to pregnant patients.
    Lactation: It is not known whether oxybutynin is excreted in human milk. Caution should be exercised if this product is administered to a nursing woman.


    Overdose

    The symptoms of overdose with oxybutynin progress from an intensification of the usual 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: Administration of activated charcoal, Physostigmine by slow intravenous injection: Fever should be treated symptomatically with tepid sponging or ice packs.
    In pronounced restlessness or excitation, diazepam may be given by intravenous injection. Tachycardia may be treated with intravenous propranolol and urinary retention managed by bladder catheterisation. In the event of progression of curare-like effects to paralysis of the respiratory muscles, mechanical ventilation will be required. The continuous release of oxybutynin from Lyrinel XL should be considered in the treatment of overdose. Patients should be monitored for at least 24 hours.


    Manufacturer
    Janssen Cilag S.P.A., Italy
    Licence holder
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