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Pilocarpine hydrochloride oral

Presentation

Oral formulation of pilocarpine hydrochloride

Drugs List

  • pilocarpine 5mg tablets
  • SALAGEN 5mg tablets
  • Therapeutic Indications

    Uses

    Treatment of symptoms of dry mouth/eyes in patients with Sjogren's syndrome
    Xerostomia after radiotherapy to head/neck

    Dosage

    Adults

    Head and neck cancer patients
    5 mg three times a day with fluid, during or directly after meals. The last dose should always be taken with the evening meal.

    The maximal therapeutic effect is normally obtained after 4 to 8 weeks. For patients who have not responded sufficiently after 4 weeks and who tolerate the dose of 5 mg three times a day, doses of up to a maximum of 30 mg daily may be considered. However, higher daily doses are probably accompanied by an increase in drug-related adverse effects. Therapy should be discontinued if no improvement in xerostomia is noted after 2 to 3 months of therapy.

    Sjogren's syndrome
    5 mg four times a day with a glass of water at mealtimes and bedtime.

    For patients who have not responded sufficiently to a dosage of 5 mg four times a day and who tolerate this dosage, increasing the dose up to a maximum of 30 mg daily, divided over the day, may be considered.
    Therapy should be discontinued if no improvement in the symptoms of dry mouth and dry eyes is noted after 2 to 3 months.

    Elderly

    See Dosage; Adult

    Patients with Renal Impairment

    Pilocarpine may increase ureteral smooth muscle tone and could precipitate renal colic, particularly in patients with nephrolithiasis.

    Patients with Hepatic Impairment

    Patients with moderate and severe cirrhosis should commence treatment on a reduced daily dosage schedule. Depending on the safety and tolerability, the dosage may gradually be increased to the normal daily dosage schedule of 5 mg three times a day.

    Contraindications

    Children under 18 years
    Acute iritis
    Breastfeeding
    Pregnancy
    Uncontrolled asthma
    Uncontrolled cardio-renal disorder
    Uncontrolled chronic obstructive pulmonary disease

    Precautions and Warnings

    Excessive fluid loss without oral replacement
    Asthma
    Biliary tract disorder
    Cholelithiasis
    Chronic bronchitis
    Chronic obstructive pulmonary disease
    Hepatic impairment
    Narrow angle glaucoma
    Nephrolithiasis
    Peptic ulcer
    Psychiatric disorder
    Renal impairment
    Severe cardiovascular disorder

    Advise ability to drive/operate machinery may be impaired in reduced light
    Advise patient dizziness may affect ability to drive or operate machinery
    Excessive sweating or low fluid intake may cause dehydration
    Discontinue if an adequate response not achieved within 3 months
    May cause impaired fertility

    Pregnancy and Lactation

    Pregnancy

    Pilocarpine is contraindication in pregnancy

    No reports of developmental toxicity attributable to the drug have been located. However, animal reproduction studies have observed toxicity with oral doses less than or equal to 10 times the human dose.

    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

    Pilocarpine is contraindicated in breastfeeding.

    It is not known if pilocarpine enters milk, but if probably does in low levels due to its minimal plasma level. It is not likely that an infant would receive a clinical dose via milk, but this is presently unknown. Side effects would largely include diarrhoea, gastric upset, excessive salivation, and other typical cholinergic symptoms.

    The manufacturer notes that a decision must be made whether to discontinue breast-feeding or to discontinue this medication.

    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

    Abdominal pain
    Abnormal vision
    Acute respiratory distress
    Agitation
    Allergic reaction
    Asthenia
    Atrioventricular block
    Blurred vision
    Bradycardia
    Cardiac arrhythmias
    Chills
    Confusion
    Conjunctivitis
    Constipation
    Diarrhoea
    Dizziness
    Dyspepsia
    Eye pain
    Flatulence
    Flushing
    Gastrointestinal spasm
    Hallucinations
    Headache
    Hypersalivation
    Hypertension
    Hypotension
    Increased sweating
    Influenza-like syndrome
    Lability of affect
    Lacrimation
    Memory loss
    Nausea
    Palpitations
    Pruritus
    Rash
    Rhinitis
    Shock
    Tachycardia
    Tremor
    Urinary frequency
    Urinary urgency
    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: December 2015

    Reference Sources

    Joint Formulary Committee. British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2015.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Salagen. Novartis. Revised February 2015.

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