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Generic Name
Baclofen
Brand Names
Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax
FDA approval date: July 21, 1988
Classification: gamma-Aminobutyric Acid-ergic Agonist
Form: Injection, Tablet, Kit, Granule, Suspension, Solution
What is Fleqsuvy (Baclofen)?
FLEQSUVY is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. FLEQSUVY is a gamma-aminobutyric acid 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. FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
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Brand Information
FLEQSUVY (baclofen)
1INDICATIONS AND USAGE
FLEQSUVY is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Limitations of Use
FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
2DOSAGE FORMS AND STRENGTHS
Oral Suspension: 25 mg per 5 mL (5 mg/mL) baclofen as a concentrated orange to yellow- colored, grape-flavored suspension.
3CONTRAINDICATIONS
FLEQSUVY is contraindicated in patients with hypersensitivity to baclofen.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Adverse Reactions from Abrupt Withdrawal of FLEQSUVY
- Neonatal Withdrawal Symptoms
- Drowsiness and Sedation
- Poor Tolerability in Stroke Patients
- Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States
- Exacerbation of Autonomic Dysreflexia
- Exacerbation of Epilepsy
- Posture and Balance Effects
- Ovarian Cysts
4.1Clinical 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
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.
5DESCRIPTION
FLEQSUVY (baclofen oral suspension) is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is:
Molecular formula is C
Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform.
The FLEQSUVY (baclofen oral suspension) inactive ingredients are: artificial grape flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, hydroxyethyl cellulose, propylene glycol, purified water, simethicone emulsion, sodium benzoate, and sucralose.
6CLINICAL STUDIES
The efficacy of FLEQSUVY is based upon a bioavailability study in healthy adults comparing baclofen oral tablets to FLEQSUVY
7PATIENT COUNSELING INFORMATION
Administration Instructions
Inform patients that FLEQSUVY is a concentrated formulation. Instruct patients or caregivers to use an oral dosing syringe and not to use a household teaspoon to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes may be obtained from their pharmacy. Instruct patients to shake before using
Risks Related to Sudden Withdrawal of FLEQSUVY
Advise patients and caregivers not to discontinue use of FLEQSUVY without consulting with their healthcare provider because sudden withdrawal of FLEQSUVY can result in serious complications that include hallucinations, seizures, high fever, confusion, muscle stiffness, multiple organ-system failure, and death
Neonatal Withdrawal Symptoms
Advise patients to notify their healthcare provider if they are pregnant, plan to become pregnant, or plan to breastfeed
Increased Risk of Drowsiness with Alcohol and Other CNS Depressants
Advise patients that FLEQSUVY may cause drowsiness, and that they should avoid the operation of automobiles or other dangerous machinery, or activities made hazardous by decreased alertness when starting FLEQSUVY or increasing the dose until they know how the drug affects them
Storage
Instruct patients to store FLEQSUVY at room temperature and to discard unused portion 2 months after first opening
8PRINCIPAL DISPLAY PANEL - Bottle Label
NDC 52652-6001-1 Rx Only
FLEQSUVY (baclofen oral suspension)
25 mg per 5 mL (5 mg/mL)
Concentrated Formulation
Concentrated Formulation
ATTENTION:This is a concentratedbaclofen
formulation of 25 mg/5 mL (5 mg/mL).
formulation of 25 mg/5 mL (5 mg/mL).
Manufactured for:
120 mL
KEEP THIS AND ALL
Each mL contains 5 mg of baclofen USP
Recommended Dosage: See prescribing information.
Store at 20°C to 25°C (68°F to 77°F)
Date of first opening _______ / _______ / _______
SHAKE BEFORE USING