Orphenadrine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of orphenadrine hydrochloride
Drugs List
Therapeutic Indications
Uses
Treatment of Parkinson's disease and symptomatic parkinsonism
Treatment of all forms of Parkinsonism including drug-induced extra-pyramidal symptoms (neuroleptic syndrome)
Dosage
Adults
Initially 150 mg daily in divided doses increasing by 50mg every 2 to 3 days until maximum benefit is obtained.
Optimal dosage is usually:
250 to 300 mg daily in divided doses in idiopathic and post-encephalitic parkinsonism
100 to 150 mg daily in divided doses in arteriosclerotic parkinsonism
100 to 300 mg daily in neuroleptic syndrome.
Maximum dose 400 mg daily in divided doses.
Elderly
(See Dosage; Adult)
The elderly may be more susceptible to side effects at doses which are clinically optimal.
Contraindications
Children under 18 years
Benign prostatic hyperplasia
Gastrointestinal obstruction
Myasthenia gravis
Narrow angle glaucoma
Paralytic ileus
Porphyria
Pyloric obstruction
Tardive dyskinesia
Untreated urinary retention
Precautions and Warnings
Elderly
Pyrexia
Breastfeeding
Cardiac failure
Cardiac impairment
Cardiovascular disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
Hypertension
Lactose intolerance
Pregnancy
Psychosis
Renal impairment
Tachycardia
Thyrotoxicosis
Urinary obstruction
Advise ability to drive/operate machinery may be affected by side effects
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Some formulations contain sucrose
Some formulations contain sunset yellow (E110); may cause allergic reaction
Potential for drug abuse
Avoid abrupt withdrawal
Elderly males
When used alone or with analgesics, pain or skeletal muscle spasm have been reported.
Some formulations contain methyl and propyl hydroxybenzoates which may cause allergic reactions (possibly delayed) .
Some formulations contain E110, E102 and E123 which may cause allergic reactions.
Pregnancy and Lactation
Pregnancy
Use orphenadrine with caution in pregnancy.
There is inadequate evidence of safety in pregnancy and so should only be used if there is no safer alternative. It has been widely used for many years without apparent ill consequence.
Animal studies have not revealed any hazard.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use orphenadrine with caution in breastfeeding.
It is not known whether orphenadrine passes into breast milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Anxiety
Blurred vision
Confusion
Constipation
Convulsions
Difficulty in micturition
Disturbances in accommodation
Dizziness
Dry mouth
Euphoria
Gastro-intestinal symptoms
Glaucoma (closed angle)
Hallucinations
Hypersensitivity reactions
Impaired memory
Inco-ordination
Insomnia
Light-headedness
Muscle spasm
Nausea
Nervousness
Pain
Rash
Restlessness
Sedation
Tachycardia
Urinary retention
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2014
Reference Sources
Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com Accessed on August 19, 2014.
Martindale: The Complete Drug Reference, 35th edition (2007) ed. Sweetman, S. Pharmaceutical Press, London.
The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.
Summary of Product Characteristics: Biorphen. Alliance Pharmaceuticals. Revised May 2008
Summary of Product Characteristics: Orphenadrine Oral Solution. Rosemont Pharmaceuticals. Revised November 2007
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