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Orphenadrine oral

Presentation

Oral formulations of orphenadrine hydrochloride

Drugs List

  • orphenadrine 50mg/5ml oral solution sugar-free
  • 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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