Precautions to be taken while Using Baclofen Information
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Type of Drug:

Skeletal muscle relaxant.

How the Baclofen Product Works:

Baclofen reduces the frequency and severity of muscle spasms that occur as a result of neurological disorders such as multiple sclerosis.

Uses of The Baclofen:

Tablets: To relieve the spasticity, pain, and rigidity from muscle spasms due to multiple sclerosis. May help with spinal cord injuries and other spinal cord diseases.

Injection: To manage severe spasticity of spinal cord origin in patients who do not respond to or have side effects from the tablets.

Unlabeled Uses: Occasionally doctors may prescribe oral baclofen for trigeminal neuralgia (tic douloureux), tardive dyskinesia in combination with neuroleptics, and intractable hiccoughs; the injection form may reduce spasticity in cerebral palsy in children.

Precautions:

Abrupt withdrawal: Hallucinations and seizures have occurred when treatment with baclofen has been stopped suddenly. Except in cases of serious side effects, the dose must be reduced slowly when the drug is discontinued.

Epilepsy: Increased frequency of seizures has occurred in epileptic patients taking baclofen. Frequent physical exams and neurological tests may be required.

Ovarian cysts: Ovarian cysts are sometimes found in women who have taken baclofen for up to one year. The cysts often disappom rlosplto continued treatment.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and potential benefits outweigh the possible risks to the fetus.

Breastfeeding: Oral baclofen appears in breast milk. It is not known if injectable baclofen appears in breast milk. Consult your doctor before you begin breastfeeding.

Baclofen: Safety and effectiveness in children younger than 12 years of age (oral) and in children younger than 4 years of age (injection) have not been established.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or if you are planning to take any over- the-counter or prescription medications or dietary supplements while taking this medicine. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. The following drugs and drug classes interact with this medicine.

  • Alcohol
  • Morphine
  • Narcotic pain relievers (eg, percodan)
  • Sleep aids (eg, flurazepam)
  • Tricyclic antidepressants (eg, amitriptyline)

Side Effects:

Every drug is capable of producing side effects. Many patients experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy and individual susceptibility. Possible side effects include:

Digestive Tract: Nausea; constipation; vomiting.

Nervous System: Drowsiness; dizziness; lightheadedness; weakness; tiredness; headache; seizures; sleeplessness; numbness; tingling; slurred speech.

Skin: Rash; itching; excessive sweating.

Other: Visual disturbances; ankle swelling (edema); weak muscles; weight gain; nasal congestion; difficulty breathing; frequent urination; low blood pressure.

Guidelines for Use:

  • Use exactly as prescribed.
  • If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose in order to “catch up” (unless advised to do so by your doctor). If more than one dose is missed or it is necessary to establish a new dosage schedule, contact your doctor or pharmacist.
  • May cause drowsiness, dizziness and tiredness. Use caution when driving or performing other tasks requiring alertness. Avoid alcohol and other drugs that cause drowsiness during use of baclofen.
  • Sudden discontinuation of baclofen can result in hallucinations. Discontinue only under doctor’s supervision.
  • Notify your doctor if frequent urges to urinate, painful urination, constipation, nausea, headache, insomnia, confusion, palpitations or chest pain Occurs and persists.
  • Injections – Not for IV, IM, subcutaneous, or epidermal use. Visually inspect solutions for particles or discoloration.
  • Store at room temperature. Do not freeze. Do not heat or sterilize solution.

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