Medical Editor: John P. Cunha, DO, FACOEP
What Is Lyvispah?
Lyvispah (baclofen) is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Lyvispah may also be of some value in patient with spinal cord injuries and other spinal cord diseases.
What Are Side Effects of Lyvispah?
Side effects of Lyvispah include:
- low blood pressure (hypotension),
- urinary frequency, and
Dosage for Lyvispah
Lyvispah should be initiated with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. The maximum dosage of Lyvispah is 80 mg daily (20 mg four times a day).
Lyvispah In Children
Safety and effectiveness of Lyvispah in pediatric patients below the age of 12 have not been established.
What Drugs, Substances, or Supplements Interact with Lyvispah?
Lyvispah may interact with other medicines such as:
- other central nervous system (CNS) depressants or
Tell your doctor all medications and supplements you use.
Lyvispah During Pregnancy and BreastfeedingTell your doctor if you are pregnant or plan to become pregnant before using Lyvispah; it may harm a fetus. Lyvispah may increase the risk of late-onset neonatal withdrawal symptoms. At recommended oral doses, Lyvispah is present in breast milk. Withdrawal symptoms can occur in breastfed infants when maternal administration of Lyvispah is stopped, or when breastfeeding is stopped. Other possible effects of Lyvispah on breastfed infants are unknown. Consult your doctor before breastfeeding.
Additional InformationOur Lyvispah (baclofen) Oral Granules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Adverse Reactions from Abrupt Withdrawal of LYVISPAH [see WARNINGS AND PRECAUTIONS]
- Neonatal Withdrawal Symptoms [see WARNINGS AND PRECAUTIONS]
- Drowsiness and Sedation [see WARNINGS AND PRECAUTIONS]
- Poor Tolerability in Stroke Patients [see WARNINGS AND PRECAUTIONS]
- Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see WARNINGS AND PRECAUTIONS]
- Exacerbation of Autonomic Dysreflexia [see WARNINGS AND PRECAUTIONS]
- Exacerbation of Epilepsy [see WARNINGS AND PRECAUTIONS]
- Posture and Balance Effects [see WARNINGS AND PRECAUTIONS]
- Ovarian Cysts [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reaction is transient drowsiness. In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions (up to 15%) are dizziness and weakness. Adverse reactions with a frequency of ≥1% are listed in Table 1.
Table 1: Common (≥1%) Adverse Reactions in Patients Treated with Baclofen for Spasticity
The following adverse reactions not included in Table 1, classified by body system, were also reported:
Neuropsychiatric: euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure
Cardiovascular: dyspnea, palpitation, chest pain, syncope
Gastrointestinal: dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool
Genitourinary: enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria
Other: rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion
The following laboratory tests have been found to be abnormal in patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.
CNS Depressants And Alcohol
LYVISPAH can cause CNS depression, including drowsiness and sedation, which may be an additive when used concomitantly with other CNS depressants or alcohol [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Lyvispah (Baclofen Oral Granules)
© Lyvispah Patient Information is supplied by Cerner Multum, Inc. and Lyvispah Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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