This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Propantheline bromide oral

Presentation

Oral formulations of propantheline bromide

Drugs List

  • PRO-BANTHINE 15mg tablets
  • propantheline bromide 15mg tablets
  • Therapeutic Indications

    Uses

    Adjunct in gastric smooth muscle spasm
    Enuresis
    Hyperhidrosis

    Dosage

    Adults

    15 mg to be taken three times daily at least one hour before meals AND 30 mg to be taken at bedtime (total daily dose of 75 mg).

    This initial dose may be adjusted according to the patient's individual response and tolerance.

    The maximum total daily dose of 120 mg should not be exceeded.

    Elderly

    15 mg to be taken three times daily at least one hour before meals AND 30 mg to be taken at bedtime (total daily dose of 75 mg).

    This initial dose may be adjusted according to the patient's individual response and tolerance.

    The maximum total daily dose of 120 mg should not be exceeded.

    Contraindications

    Children under 18 years
    Haemorrhage with cardiovascular instability
    Benign prostatic hyperplasia
    Gastrointestinal atony
    Gastrointestinal obstruction
    Hiatus hernia
    Myasthenia gravis
    Narrow angle glaucoma
    Paralytic ileus
    Pyloric stenosis
    Reflux oesophagitis
    Severe ulcerative colitis
    Shallow anterior chamber of eye
    Toxic megacolon
    Urinary obstruction

    Precautions and Warnings

    Diarrhoea
    Down's syndrome
    Elderly
    Pyrexia
    Autonomic neuropathy
    Breastfeeding
    Cardiac arrhythmias
    Congestive cardiac failure
    Coronary arteriosclerosis
    Gastroesophageal reflux
    Hepatic impairment
    Hypertension
    Hyperthyroidism
    Ischaemic heart disease
    Myocardial infarction
    Partial gastrointestinal obstruction
    Pregnancy
    Renal impairment
    Ulcerative colitis

    Advise patient blurred vision may affect ability to drive/operate machinery
    Advise patient drowsiness may affect ability to drive or operate machinery
    Monitor cardiac function in patients with cardiac disease
    Elderly: may be more susceptible to antimuscarinic side effects
    May cause heat prostration when used in high environmental temperatures

    Pregnancy and Lactation

    Pregnancy

    Propantheline bromide should not be administered during pregnancy unless considered essential.

    Animal and teratogenicity studies have not been performed. There may be a possible association with minor malformations based on cohort studies on parasympatholytics.

    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 14-17 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

    Propantheline bromide should not be administered during breast feeding unless considered essential.

    It is not known whether propantheline bromide is excreted in human breast milk. No animal studies have been performed. Parasympatholytics may suppress lactation.

    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

    Counselling

    Take one hour before food or on an empty stomach at night.

    Drowsiness or blurred vision may occur with propantheline bromide therapy and if affected, patients should not drive or operate machinery.

    Side Effects

    Arrhythmias
    Bradycardia
    Confusion
    Constipation
    Decreased bronchial secretions
    Decreased sweating
    Difficulty in micturition
    Difficulty in swallowing
    Dilatation of pupils
    Disturbances in accommodation
    Dry mouth
    Dry skin
    Flushing
    Giddiness
    Heat stroke
    Increased intra-ocular pressure
    Increased thirst
    Nausea
    Palpitations
    Photophobia
    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: February 2013

    Reference Sources

    British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

    Summary of Product Characteristics: Pro-Banthine tablets. Archimedes Pharma UK Ltd. Revised April 2009.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.