Oral-

CNS- Euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, coordination doisorders tremor, rigidity, dystonia, ataxia, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthia (rare)

Cardiovascular- Dyspnea, palpitations, chest pain, syncope (rare)

GI- Dry mouth, anorexia, taste disorder, abdominal pain, diarrhea, positive test for occult blood in stool (rare)

GU- Rnuresis, urinary retension, dysuria, impotence, inability to  ejaculate, nocturia, hematuria (rare)

Misceallaneous- Rash, pruritus, anide edema, excessive perspoiration, weight gain, nasal congestion

Lab test abnormalities- Increased AST, elevated alkaline phosphatase, elevation of blood sugar.

Hypersensitivity to baclofen.

Special precautions:

Cerebrovascular disorders,epilepsy,psychotic disorders, confusional states, peptic ulcer, respiratory depression, hepatic or renal impairment,elderly,pregnancy especially first trimester. Avoid sudden withdrawal. Hallucinations and seizures have occured on sudden withdrawal.

Warning-

Intrathecal administration- Because of the possibility of potentailly life-threatening CNS depression cardiovacular collapse, repiratory failure, physicians must be adequately trained and educated in chronic intrathecal therapy.

Infection- Patients should be infection free prior to the screening with baclofen injection because of the presence of a systemic infection may interfere with an assessment of the patients response.

Abrupt drug withdrawal- Hallucinations and seizures have occured on abrupt withdrawal. Except in cases of serious adverse reactions, reduce dosage slowly when drug is discontinued.

Stroke- Biclofen has not significantly benefited patients with stroke, they have also have poor drug tolerance

Renal function impairment- Because baclofen is primarily excreted unchanged through the kidneys, administer with caution to patients with impaired renal function. Dosage reduction may be necessary.

Pregnancy- Use only when clearly needed and when potential benefits justifies the potential risks to the infant.

Lactation- As a rule nursing should be undertaken while a patient is receiving intrathecal baclofen only if the potential benefit justifies the potential risks to infant.

Children- Safety for use in children < 12 years of age has not been established. Oral baclofen is not recommended for use in children.

 Indications:

Spasticity resulting from multiple sclerosis.

Dosage:

Individualise dosage. Start at low dosage and increase gradually (usually) 40 to 80mg daily. 5 mg 3 times/day for 3 days. 10mg 3 times/day for 3 days. 20mg 3 times/day for 3 days. But total daily dose must not exceed 80mg/day (20mg 4 times daily).

Overdosage-

Symptoms Oral- Vomiting, muscular hypotonia, muscle twitching, drowsiness, accomodation disorders, coma, respiratory depression, seizures.

Treatment

1. In alert patient, empty the stomach promptly by induced emesis followed by lavage.

2. In obtunded patient secure airway with a cuffed endothecal tube before beginning lavage ( do not induce emesis)

3. Maintain adequate respiratory exchange ,do not use respiratory stimulants.

4. Atropine has been used to improve ventilation, heart rate, blood pressure and core body temperature Intrathecal - Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia, loss of consciousness progressing to coma of upto 24 hour duration. Treatment 1. There is no specific antidote. 2. Remove residual solution from the pump as soon as possible 3. Intubate patients respiratory depression if necessary, until the drug is eliminated.

Missed dose-

1. If you miss a dose of this medicine, take it as soon as possible.

2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.

3. Do not double doses.

BACLOFEN- MUSCLE RELAXANTS- CENTRALLY ACTING 

1. May cause drowsiness,dizziness,and fatigue. Patients should observe caution while driving or performing other tasks requiring alertness.

2.Avoid alcohol and other CNS depressants.

3.Do not discontinue therapy except on advice of physician.

4. May cause frequent urge to urinate or painful urination,constipation,nausea ,headache,insomnia or confusioin.Notify physician if these effects persists.

5. Allergy- Tell our doctorif youhad any unusual reactions to Baclofe, food substances, preservatives etc.

6. Pregnancy- Studies on birth defects with baclofen not done in humans. Studies in animals have shown that baclofen given in large doses increases chances of herinas and incomplete or slow develpment of bones in the fetus and lower birth weight.

7. Children- Studies on this medcines done only in adults patients and no specific information comparing use of baclofen in chilren with use in other age groups

8. Older adults- Side effects such as hallucinations, confusion, or mental depression other mood or mental changes and severe drowsiness may be especially likely to occur in elderly patients

9. Other medicines- Tell your doctor if youtaking any of the following medicines- Antidrepessants tricycli- or

10. Other medical problems- Tell your doctor if you are having any ofthe following medical problems- Diabetes melitus - baclofen my raise blood sugar levels Epilepsy or Kidney disease or Mental or emotional problems or Stroke or other brain disease - chance of side effects may be increased Central nervous system depressant - chance of side effects may be increased

11. Dosing- Follow the doctors instructions

12. Missed dose- if you taking this medicine regularly and you miss a dose, take it as soon as possible. However if it is amost time for the next dose, skip the missed dose and go back to your normal schedule Do no double doses.

13. Storage- Keep the medicines away from children Do not store the capsule or tablets in the bath room or near the sink or in damp places. Dampness and heat will cause the medicine to break down Do not keep outdated or unwanted medicines. Make sure that all discarded medicines are kept out of reach of children.

Pharmacolgy:

The precise mechanism of action is unknown. Baclofen can inhibit both monosynaptic and polysynaptic reflexes at the spinal level. Baclofen has CNS and depressant properties as indicated by production of sedation and tolerance,somnolance,ataxia,and respiratory and cardiovascular depression.

Pharmacokinetics:

Baclofen is rapidly and extensively absorbed. Peak serum levels are reached in approximately 2 hours;half-life is 3to 4 hours. Excreted primarily by the kidneys in unchanged form.

Take with food
 

Pregnancy:

There are no studies in pregnant women. Use only when required.

Lactation:

Active substance is known to pass into the breast milk. Nursing should be undertaken while the patient is receiving intrathecal baclofen only, and that too,only if the potential benefit justifies the potential risks to the infant.

Children:

Safety for use in children < 12 years of age has not been established. Oral baclofen is not recommended for use in children.