SYNMETHASONE Tablet Ref.[28055] Active ingredients: Betamethasone

Source: Health Sciences Authority (SG)  Publisher: SYNCO (H.K.) LTD., HONG KONG

Contraindications

  • Osteoporosis.
  • Active peptic ulcer.
  • Psychoses or severe psychoneuroses.
  • Systematic fungal infection.
  • Acute infections unless effective, specific concurrent chemotherapy can be administered.
  • Tuberculosis, except as adjunctive treatment with tuberculostatic drugs.
  • Pregnancy and lactation.
  • Patients who are sensitive to the active ingredient of this preparation.

Special warnings and precautions for use

Patients on corticosteroids should not undergo immunisation.

Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.

Extreme caution in congestive heart failure, diabetes mellitus, chronic renal failure, hypertension, recent intestinal anastomoses, infectious diseases, uraemia, elderly persons, diverticulitis, myasthenia gravis, ocular herpes simplex and glaucoma.

History of peptic ulcer or psychotic tendencies, family history of diabetes mellitus, patients with previous tubercular infections, osteoporosis, rheumatoid arthritis.

Postmenopausal women, pregnancy, lactation and children.

Hepatic cirrhosis and hypothyroidism may enhance corticosteroid effects.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids

Interaction with other medicinal products and other forms of interaction

Response to corticosteroids is reduced by concurrent administration of barbiturates. Phenylbutazone. Phenytoin or rifampicin. Response to anticoagulants and salicylates is reduced by corticosteroids.

Pregnancy and lactation

Use in Pregnancy

The use of this drug in pregnant and nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.

Undesirable effects

Side effects

Fluid and electrolyte disturbances.

Musculoskeletal: muscle weakness and osteoporosis.

Gastro-intestinal: gastro-intestinal disturbances, peptic ulcer with possible perforation and haemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis.

Dermatologic: impaired wound healing.

Neurological: convulsions, mental disturbances and euphoria.

Endocrine: menstrual irregularities, development of Cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness; manifestation of latent diabetes mellitus.

Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.

Metabolic: negative nitrogen balance due to protein catabolism.

Adverse Reactions

Vision, blurred

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