Procyclidine oral formulations
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing procyclidine hydrochloride
Drugs List
Therapeutic Indications
Uses
Acute dystonias
Extrapyramidal symptoms - drug induced
Parkinson's disease
Unlicensed Uses
Dystonias in children
Dosage
The variation in optimum dosage from one patient to another should be taken into consideration by the physician.
Adults
Parkinson's disease
Treatment is usually started at 2.5mg procyclidine three times per day, increasing by 2.5mg to 5mg per day at intervals of two or three days until the optimum clinical response is achieved.
The usual maintenance dose to achieve optimal response is 15mg to 30mg procyclidine per day.
Addition of a fourth dose before retiring has been seen to be beneficial in some patients. Doses up to 60mg procyclidine have been well tolerated, and at the discretion of the attending physician dosing to this level may be appropriate.
In general younger patients or those with postencephalitic parkinsonism may require higher doses for a therapeutic response than older patients and those with arteriosclerotic parkinsonism.
Neuroleptic-induced extrapyramidal symptoms:
Treatment is usually initiated at 2.5mg procyclidine three times per day increasing by 2.5mg daily until symptoms are relieved.
The effective maintenance dose is usually 10mg to 30mg procyclidine per day.
After a period of 3 to 4 months of therapy, procyclidine should be withdrawn and the patient observed to see whether the neuroleptic-induced extrapyramidal symptoms recur. If this is the case procyclidine should be reintroduced to avoid debilitating extra-pyramidal symptoms. Cessation of treatment periodically is to be recommended even in patients who appear to require the drug for longer periods.
Children
Children aged 12 to 18 years (unlicensed)
2.5mg three times daily.
Children aged 7 to 12 years (unlicensed)
1.25mg three times daily.
Additional Dosage Information
Procyclidine may be combined with levodopa or amantadine in patients who are inadequately controlled on a single agent.
Pharmacokinetic studies have indicated that the mean plasma elimination half life of procyclidine is sufficient to allow twice daily administration if more convenient.
Contraindications
Gastrointestinal obstruction
Myasthenia gravis
Narrow angle glaucoma
Untreated urinary retention
Precautions and Warnings
Children under 18 years
Elderly
Predisposition to gastrointestinal obstruction
Predisposition to glaucoma
Pyrexia
Benign prostatic hyperplasia
Breastfeeding
Cardiovascular disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
Hypertension
Lactose intolerance
Pregnancy
Psychiatric disorder
Renal impairment
Tardive dyskinesia
Advise ability to drive/operate machinery may be affected by side effects
Not all presentations are licensed for all indications
Oral liquid contains hydroxybenzoate: caution in hypersensitivity
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Potential for drug abuse
Consider discontinuation if signs of tardive dyskinesia occur
May cause activation of latent psychosis
Avoid abrupt withdrawal
Withdraw after 3-4 months to observe whether symptoms recur
Reduce dose in elderly
Elderly patients, especially those on high doses of anticholinergics may be more susceptible to the adverse events associated with such therapy. Specifically, the elderly patient may be particularly vulnerable to central nervous system disturbances such as confusion, impairment of cognitive function and memory, disorientation and hallucinations. These effects are usually reversible on reduction or discontinuation of anticholinergic therapy.
In a proportion of patients undergoing neuroleptic treatment, tardive dyskinesias will occur. While anticholinergic agents do not cause this syndrome, when given in combination with neuroleptics they may exacerbate the symptoms of tardive dyskinesia or reduce the threshold at which these symptoms appear in predisposed patients. In such individuals subsequent adjustment of neuroleptic therapy or reduction in anticholinergic treatment should be considered.
Patients with mental disorders occasionally experience a precipitation of a psychotic episode when procyclidine is administered for the treatment of the extrapyramidal side effects of neuroleptics.
Procyclidine has the potential to be abused and physicians should exercise caution in prescribing to patients with symptoms that may not be genuine.
Pregnancy and Lactation
Pregnancy
Use procyclidine with caution in pregnancy.
The safety of procyclidine has not been established in pregnancy. However, extensive clinical use has not given any evidence that it in any way compromises the normal course of pregnancy. Nevertheless, as with all drugs, use should be considered only when the expected benefit of treatment for the mother outweighs any possible risk to the developing foetus.
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 procyclidine with caution in breastfeeding.
Highly limited information is available on the passage of procyclidine into human 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
Agitation
Anxiety
Blurred vision
Cognitive impairment
Confusion
Constipation
Disorientation
Dizziness
Dry mouth
Euphoria
Gingivitis
Glaucoma (closed angle)
Hallucinations
Impaired memory
Nausea
Nervousness
Psychotic symptoms
Rash
Restlessness
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: November 2016
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Neonatal Formulary: Drug Use In Pregnancy And The First Year Of Life, Seventh Edition (2015), Wiley Blackwell, Chichester.
Summary of Product Characteristics: Kemadrin 5mg tablets. Aspen Pharma Trading Ltd. Revised May 2012.
Summary of Product Characteristics: Procyclidine 2.5mg/5ml Oral Solution. Rosemont Pharmaceuticals Ltd. Revised February 2016.
Summary of Product Characteristics: Procyclidine 5mg/5ml Oral Solution. Rosemont Pharmaceuticals Ltd. Revised February 2016.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 14 September 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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