Adult Dosing

Spasticity

• Start 5 mg tid x 3 days, may increase 5 mg/dose q3 days
• Max: 80 mg daily
• Note: Taper dose gradually to discontinue

Pediatric Dosing

• Note: Safety and effectiveness in pedatric patients <12 yrs have not been established

Spasticity

Child >12 yrs

• Start 10-15 mg/day in divided dose or 5 mg tid x 3days, may increase 5 mg/dose q3 days
• Max: 80 mg daily
• Note: Taper dose gradually to discontinue

[Outline]

• Adult Dosing
• Pediatric Dosing

• Alleviation of signs and symptoms of spasticity resulting from multiple sclerosis
• Spinal cord injuries and other spinal cord diseases

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal dose adjustment (Based on CrCl)

• Renal impairment: Use with caution, dose reduction may be required

Hepatic dose adjustment

• Hepatic impairment: Dose adjustment not defined

• Avoid abrupt withdrawal of the drug; except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued
• Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders, cerebral palsy, and parkinson's disease
• Poor tolerability to the drug has been shown by patients with stroke
• May cause CNS depression; patients must be cautioned about performing tasks which require mental alertness
• Monitor clinical state and electroencephalogram at regular intervals for patients with epilepsy

Cautions: Use cautiously in

• Renal Impairment
• Stroke
• Phenylalanine-containing products
• schizophrenia
• Diabetes mellitus
• Epilepsy or a history of convulsive disorders
• Children
• Elderly patients
• Use of CNS depressant
• Spasticity-dependent upright posture
• Spasticity-dependent balance in locomotion
• Spasticity to obtain increased function
• Abrupt withdrawl

Pregnancy Category:C

Breastfeeding: Limited data indicates that baclofen has low levels in milk; unxpected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Monitor newborn infants for signs of sedation. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 November 2010). According to manufacturer's data, baclofen should be administered during pregnancy only when the potential benefits outweigh the possible hazards.

• CNS: Transient drowsiness, fatigue, confusion, headache, insomnia, euphoria, excitement, depression, syncope hallucinations, visual or auditory hallucinations, psychiatric disturbances, spasticity exacerbation, dizziness, weakness, epileptic seizure
• NEURO: Paresthesia, slurred speech, muscle pain, tinnitus, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, dysarthria, mydriasis, diplopia, miosis, coma
• CV: Hypotension
• Gl: Nausea, constipation
• GU: Urinary frequency
• DERM: Rash, pruritis, ankle edema, excessive perspiration
• RESP: Nasal congestion, respiratory depression, dyspnea
• METABOLIC: Weakness, weight gain
• LABTESTS: Increased SGOT, elevated alkaline phosphatase, elevation of blood sugar

• Muscle relaxant and antispastic; precise mechanism of action unknown; inhibits both monosynaptic and polysynaptic reflexes at the spinal level, relaxes muscles by acting specifically at spinal end of upper motor neurons
• Rapidly absorbed
• Partially metabolized by liver
• Excreation: Renally (primarily) 70-80% in urine (unchanged)
• Half-life: 2.5–4 hr

US Trade Name(s)

• Only generic available

US Availability

baclofen (generic)

• TABS: 10, 20 mg

Canadian Trade Name(s)

• Lioresal
• NU-Baclo

Canadian Availability

baclofen (generic)

• TABS: 10, 20 mg

Lioresal, NU-Baclo

• TABS: 10, 20 mg

UK Trade Name(s)

• Lioresal
• Lyflex

UK Availability

baclofen (generic)

• TABS: 10 mg

Lioresal

• LIQ: 5mg/5ml
• TABS: 10 mg

Lyflex

• LIQ: 5mg/5ml

Australian Trade Name(s)

• Clofen
• Lioresal

Australian Availability

Baclofen (geneic)

• TABS: 10, 25 mg

Clofen, Lioresal

• TABS: 10, 25 mg

[Outline]

Analgesics

Skeletal Muscle Relaxants

• Baclofen 10 MG Oral Tablet (ALPHAPHARM PTY LTD)
• Baclofen 10 MG Oral Tablet (CARACO PHARMACEUTICAL LABORATORIES, LTD.)
• Baclofen 10 MG Oral Tablet (Caremark L.L.C.)
• Baclofen 10 MG Oral Tablet (IVAX Pharmaceuticals, Inc.)
• Baclofen 10 MG Oral Tablet (Lannett Company, Inc.)
• Baclofen 10 MG Oral Tablet (McKesson Packaging Services Business Unit of McKesson Corporation)
• Baclofen 10 MG Oral Tablet (Mylan Pharmaceuticals Inc.)
• Baclofen 10 MG Oral Tablet (Northstar Rx LLC)
• Baclofen 10 MG Oral Tablet (Physicians Total Care, Inc.)
• Baclofen 10 MG Oral Tablet (Piramal Healthcare Limited)
• Baclofen 10 MG Oral Tablet (Qualitest Pharmaceuticals)
• Baclofen 10 MG Oral Tablet (Rebel Distributors Corp.)
• Baclofen 10 MG Oral Tablet (Upsher-Smith Laboratories, Inc.)
• Baclofen 10 MG Oral Tablet (Watson Laboratories, Inc.)
• Baclofen 20 MG Oral Tablet (ALPHAPHARM PTY LTD)
• Baclofen 20 MG Oral Tablet (CARACO PHARMACEUTICAL LABORATORIES, LTD.)
• Baclofen 20 MG Oral Tablet (IVAX Pharmaceuticals, Inc.)
• Baclofen 20 MG Oral Tablet (Lannett Company, Inc.)
• Baclofen 20 MG Oral Tablet (McKesson Packaging Services Business Unit of McKesson Corporation)
• Baclofen 20 MG Oral Tablet (Mylan Pharmaceuticals Inc.)
• Baclofen 20 MG Oral Tablet (Northstar Rx LLC)
• Baclofen 20 MG Oral Tablet (Physicians Total Care, Inc.)
• Baclofen 20 MG Oral Tablet (Piramal Healthcare Limited)
• Baclofen 20 MG Oral Tablet (Qualitest Pharmaceuticals)
• Baclofen 20 MG Oral Tablet (Rebel Distributors Corp.)
• Baclofen 20 MG Oral Tablet (Upsher-Smith Laboratories, Inc.)
• Baclofen 20 MG Oral Tablet (Watson Laboratories, Inc.)
• Kemstro 10 MG Disintegrating Tablet (Schwarz Pharma)
• Kemstro 20 MG Disintegrating Tablet (Schwarz Pharma)
• Lioresal 10 MG Oral Tablet (Novartis Pharmaceuticals Corporation)
• Lioresal 20 MG Oral Tablet (Novartis Pharmaceuticals Corporation)