Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
BACLOFEN
Generics (UK) Limited
25 Milligram
Tablets
1989-11-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Baclopar 25 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of Baclofen For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet A white tablet, marked “BN” breakline “25” on one side and “G” on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 4.1.1 Relief of voluntary muscle spasticity as occurs in conditions such as multiple sclerosis and spinal cord lesions including syringomelia, transverse myelitis and motor neurone disease. 4.1.2 Management of spasticity of cerebral origin including meningitis, cerebral palsy, traumatic head injury, cerebrovascular accident. Baclofen is of most benefit in relief of spasticity which is seriously interfering with activity. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For oral administration only. Relief of voluntary muscle spasticity in spinal cord lesions and management of spasticity of cerebral origin. _ADULTS: _A gradually increasing dosage regimen of baclofen is recommended which should be adjusted to achieve satisfactory symptom control. 5mg three times a day for three days 10mg three times a day for three days 15mg three times a day for three days 20mg three times a day for three days 25mg three times a day for three days Symptoms are usually adequately controlled with doses up to 60mg daily. However, in order to meet individual patient needs, dosage adjustments should be slow and careful. The dose should not exceed 100mg per day unless the patient is in hospital under medical supervision. If therapeutic effect is not achieved within 6 weeks of reaching the maximum recommended dose, a decision of whether to continue with therapy should be taken. In some cases, mobility is improved with small frequent doses, especially if given 1 hour prior to performing manual task Baca dokumen lengkapnya