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Drug Details

SALAGEN Film-Coated Tablets

• Drug Class Description
  Parasympathominetic
• Generic Name
  Pilocarpine hydrochloride
• Presentation
  Film-coated tablet Salagen film-coated tablets are white, round biconvex tablets, marked “SAL” on one side and “5 mg” on the other side.
• Description
  Each film coated tablet contains 5 mg of pilocarpine hydrochloride
• Indications
  • Alleviation of symptoms of salivary gland hypofunction in patients with severe xerostomia following irradiation for head and neck cancer. • Treatment of symptoms of dry mouth and dry eyes in patients with Sjögren's syndrome.
• Adult Dosage
  

  For head and neck cancer patients:

  The recommended initial dose for adults is 1 tablet of 5 mg three times daily. Tablets should be taken with a glass of water during or directly after meals. The last tablet should always be taken in conjunction with the evening meal. The maximal therapeutic effect is normally obtained after 4–8 weeks of therapy. For patients who have not responded sufficiently after 4 weeks and who tolerate the dose of 5 mg three times daily, 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 2–3 months of therapy.

  For Sjögren's syndrome patients:

  The recommended dose for adults is one tablet of 5 mg four times daily. Tablets should be taken with a glass of water at mealtimes and bedtime. For patients who have not responded sufficiently to a dosage of 5 mg four times daily 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 - 3 months.

  Use in patients with impaired hepatic function:

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

• Child Dosage
  

  The safety and efficacy of this medicinal product in children have not been established.

• Elderly Dosage
  

  There is no evidence to suggest that dosage should be different in the elderly.

• Contra Indications
  

  Hypersensitivity to the active substance or to any of the excipients.

  Salagen is contraindicated in patients with clinically significant, uncontrolled cardiorenal disease, uncontrolled asthma and other chronic disease at risk for cholinergic agonists.

  Salagen is contraindicated in cases where miosis is undesirable, such as in acute iritis.

• Special Precautions
  

  Pilocarpine has been reported to increase airway resistance in asthmatic patients. Also, patients with significant cardiovascular disease may be unable to compensate for transient changes in haemodynamics or heart rhythm induced by pilocarpine. Therefore, Salagen should be administered to patients with controlled asthma or significant cardiovascular disease only if the benefits are believed to outweigh the risks, and under close medical supervision.

  Salagen should be used with caution in patients with the following illnesses/pathologies:

  • chronic bronchitis and/or chronic obstructive pulmonary disease. These patients have hyperactive airways and may experience adverse effects due to increased bronchial smooth muscle tone and increased bronchial secretions.

  • known or suspected cholelithiasis or biliary tract disease. Contractions of the gallbladder or biliary smooth muscle could precipitate complications including cholecystitis, cholangitis and biliary obstruction.

  • peptic ulceration, due to the risk of increased acid secretion.

  • underlying cognitive or psychiatric disturbances. Cholinergic agonists, like pilocarpine hydrochloride, may have dose-related central nervous system effects.

  • renal insufficiency. Insufficient information is available to determine the importance of renal excretion of pilocarpine and its metabolites in relation to metabolic inactivation so as to recommend dosage adjustments for these patients. Pilocarpine may increase ureteral smooth muscle tone and could theoretically precipitate renal colic (or “ureteral reflux”), particularly in patients with nephrolithiasis.

  Salagen should be administered with caution in patients with narrow-angle glaucoma.

  Caution should be exercised in patients who are known or expected to sweat excessively and who cannot drink enough liquids, since dehydration could develop.

• Interactions
  

  Salagen should be administered with caution to patients taking beta adrenergic antagonists because of the possibility of conduction disturbances.

  Concurrent administration of Salagen and drugs with parasympathomimetic effects is expected to result in additive pharmacologic effects.

  Pilocarpine might antagonise the anticholinergic effects of other drugs used concomitantly (e.g. atropine, inhaled ipratropium).

  While no formal drug interaction studies have been performed, the following concomitant drugs were used in at least 10% of patients in either or both Sjögren's efficacy studies: acetylsalicylic acid, artificial tears, calcium, conjugated estrogens, hydroxychloroquine sulfate, ibuprofen, levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole, paracetamol, and prednisone. There were no reports of drug toxicities during either efficacy study.

• Adverse Drug Reactions
  

  Most of the adverse experiences observed during Salagen treatment were a consequence of exaggerated parasympathetic stimulation. These adverse experiences were dose-dependent and usually mild and self-limited. However, severe adverse experiences might occasionally occur and therefore careful monitoring of the patient is recommended.

  In controlled clinical trials the following adverse reactions were observed:

  Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

  Very common ( 1/10); common ( 1/100, < 1/10); uncommon ( 1/1,000, < 1/100); rare ( 1/10,000, < 1/1,000); very rare ( < 1/10,000), not known (cannot be estimated from the available data).

  Nervous system disorders

  Very common: headache

  Common: dizziness

  Eye disorders

  Common: lacrimation; blurred vision; abnormal vision; conjunctivitis; eye pain

  Cardiac disorders

  Common: flushing (vasodilatation); hypertension; palpitations

  Respiratory, thoracic and mediastinal disorders

  Common: rhinitis

  Gastrointestinal disorders

  Common: dyspepsia; diarrhoea; abdominal pain; nausea, vomiting; constipation, increased salivation

  Uncommon: flatulence

  Skin and subcutaneous tissue disorders

  Very common: sweating

  Common: allergic reactions, including rash; pruritus

  Renal and urinary disorders

  Very common: increased urinary frequency

  Uncommon: urinary urgency

  General disorders and administration site conditions

  Very common: flu syndrome

  Common: asthenia; chills

  There is no indication of a difference between older and younger patients receiving Salagen as regards reporting adverse experiences, except for dizziness, which was reported significantly more often by patients aged over 65 years.

  The following adverse effects, which are due to the intrinsic pharmacological properties of pilocarpine, have been published in the medical literature: respiratory distress, gastro-intestinal spasm, atrioventricular block, tachycardia, bradycardia, cardiac arrhythmia, hypotension, shock, tremors, and mental status changes including memory loss, hallucinations, lability of affect, confusion, agitation.