pms-Baclofen Special Precautions





Full Prescribing Info
Special Precautions
Posture and Balance: pms-BACLOFEN should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion, or whenever spasticity is utilized to obtain increased function (see Dosage & Administration).
Hepatic Impairment: No studies have been performed in patients with hepatic impairment receiving baclofen therapy. As baclofen does not undergo predominant hepatic metabolism, its pharmacokinetics are unlikely to be altered to a clinically significant level in patients with hepatic impairment.
However, patients with severe hepatic impairment should be treated with caution, as they are, in general, more sensitive to therapeutic effects/adverse effects of drugs.
In rare instances, elevated SGOT, alkaline phosphatase and glucose levels in the serum have been recorded when using oral baclofen.
Others: Caution should also be used in treating the following populations: patients with peptic ulceration (or a history of); elderly patients with cerebrovascular disorders; and patients with respiratory impairment. Regarding patients with renal failure, see Renal Impairment under Warnings.
Since unwanted effects are more likely to occur, a cautious dosage schedule should be adopted in elderly and patients with spasticity of cerebral origin (see Dosage & Administration).
Urinary Disorders: pms-BACLOFEN should be used with caution in patients with underlying bladder sphincter hypertonia, since acute retention of urine may occur.
Psychiatric and Nervous System Disorders: Patients suffering from psychiatric disorders such as psychosis, schizophrenia, or confusional states should be treated cautiously with pms-BACLOFEN and kept under close surveillance, since exacerbation of these conditions may occur with baclofen treatment.
Laboratory Tests: The following laboratory tests have been found to be abnormal in a few patients receiving baclofen: aspartate aminotransferase, blood alkaline phosphatase and blood sugar (all elevated). Therefore, in patients with liver diseases or diabetes mellitus, appropriate laboratory tests should be performed periodically in order to ensure that no drug-induced changes in these underlying diseases have occurred.
Use in Children: Safe use of baclofen in children under age 12 has not been established and it is, therefore, not recommended for use in children.
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