ORPHENADRINE HYDROCHLORIDE Oral solution (2013)
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Περιεχόμενα
Name of the medicinal product
Orphenadrine Hydrochloride 50mg/5ml Oral Solution.
Qualitative and quantitative composition
Orphenadrine hydrochloride 50mg/5ml.
Pharmaceutical form
Oral solution.
Therapeutic indications
Anticholinergic, for the treatment of all forms of Parkinsonism, including drug induced (neuroleptic syndrome).
Posology and method of administration
Adults and the elderly Initially, 150mg daily in divided doses, increasing by 50mg every two or three days until maximum benefit is obtained. Optimal dosage is usually 250mg to 300mg daily in divided doses ...
Contraindications
Hypersensitivity to orphenadrine or to any of the Excipients. In patients with prostatic hypertrophy, tardive dyskinesia, porphyria, urinary retention and must also be used with caution in elderly men. ...
Special warnings and precautions for use
Use with caution in the elderly (see Section 4.2). When used alone or with analgesics, pain or skeletal muscle spasms have been reported. Use with caution in conditions characterised by tachycardia. Anti-muscarinic ...
Interaction with other medicinal products and other forms of interaction
Effects may be enhanced by concomitant administration of anticholinergic drugs. May be provocation of dextropropoxyphene side effects during concurrent administration. As with other similar agents, the ...
Pregnancy and lactation
There is inadequate evidence of safety in human pregnancy, and, although it has been widely used for many years without apparent ill consequence, if considered necessary orphenadrine should be used with ...
Effects on ability to drive and use machines
Orphenadrine may cause blurred vision or slight euphoria. If patients experience these side effects, driving or operating machinery is not recommended.
Undesirable effects
Common >1/100 <1/10, Uncommon >1/1000 <1/100, Rare >1/10,000 <1/1000 Immune system disorder Uncommon: Hypersensitivity Nervous system disorder Common: Dizziness, restlessness Uncommon: Sedation, confusion, ...
Overdose
Toxicity Adults: 2–3 g can be fatal for an adult though patients have survived doses of 5 g and 7.5 g. Children: A 23 month old had severe toxicity after ingesting 300mg. Toxicity is mainly due to anticholinergic ...
Pharmacodynamic properties
Pharmacotherapeutic Group: Anti-Parkinson Drugs ATC Code: N04AB Orphenadrine, which is a congener of diphenhydramine without sharing its soporific effect, is an anti-muscarinic agent. It also works has ...
Pharmacokinetic properties
Orphenadrine is readily absorbed from the gastro-intestinal tract. It is rapidly distributed in tissues and most of a dose is metabolised to at least 8 metabolites and excreted in the urine along with ...
Preclinical safety data
Orphenadrine is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
List of excipients
Methyl hydroxybenzoate Propyl hydroxybenzoate Propylene glycol Liquid maltitol Sorbitol solution 70% Saccharin sodium Blackcurrant flavour Aniseed flavour Citric acid monohydrate Sodium citrate Purified ...
Incompatibilities
Incompatible with alkali, protect from light.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store below 25°C and avoid exposure to direct sunlight. Only dispense in amber glass bottles.
Nature and contents of container
Bottles: Amber (Type III) glass. Closures: HDPE, EPE wadded, tamper evident, child resistant closure. Capacity: 150ml
Special precautions for disposal and other handling
Keep out of the reach of children.
Marketing authorization holder
Rosemont Pharmaceuticals Ltd., Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK
Marketing authorization number(s)
PL 00427/0076
Date of first authorization / renewal of the authorization
15.05.90/09.04.97/8.4.02
Date of revision of the text
29 Jul 2013
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