Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Baclofen Oral Suspension contains 25 mg per 5 mL (5 mg/mL) baclofen. It is a white to off white viscous suspension and is supplied in high-density polyethylene (HDPE) bottles with white, polypropylene, child-resistant closures with a foam liner and tamper evident band. It is available as: 120 mL bottle NDC 62559-204-12 250 mL bottle NDC 62559-204-25 300 mL bottle NDC 62559-204-03 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86° F) (see USP Controlled Room Temperature). Discard unused portion 2 months after first opening.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Baclofen Oral Suspension 25 mg per 5 mL (5 mg/mL) Concentrated Formulation ATTENTION: This is a concentrated baclofen formulation of 25 mg/5 mL (5 mg/mL). Baclofen is available in different concentrations . Rx only 120 mL 120mL_carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Baclofen Oral Suspension contains 25 mg per 5 mL (5 mg/mL) baclofen. It is a white to off white viscous suspension and is supplied in high-density polyethylene (HDPE) bottles with white, polypropylene, child-resistant closures with a foam liner and tamper evident band. It is available as: 120 mL bottle NDC 62559-204-12 250 mL bottle NDC 62559-204-25 300 mL bottle NDC 62559-204-03 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86° F) (see USP Controlled Room Temperature). Discard unused portion 2 months after first opening.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Baclofen Oral Suspension 25 mg per 5 mL (5 mg/mL) Concentrated Formulation ATTENTION: This is a concentrated baclofen formulation of 25 mg/5 mL (5 mg/mL). Baclofen is available in different concentrations . Rx only 120 mL 120mL_carton
Overview
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 10 H 12 C1NO 2 . Molecular Weight is 213.66 g/mol. 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 baclofen oral suspension inactive ingredients are artificial grape flavor, hydrochloric acid, hypromellose, methyl paraben, propyl paraben, purified water, simethicone emulsion, sodium hydroxide, sucralose, and xanthan gum. Structure
Indications & Usage
Baclofen oral suspension 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. Baclofen oral suspension may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen oral suspension is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. • Baclofen oral suspension 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. ( 1 ) • Baclofen oral suspension may also be of some value in patients with spinal cord injuries and other spinal cord diseases. ( 1 ) Limitations of Use Baclofen oral suspension is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. ( 1 )
Dosage & Administration
• Baclofen oral suspension is a concentrated formulation. Verify the dose of the product prior to dispensing. ( 2.1 ) • Initiate baclofen oral suspension with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. ( 2.2 ) • The maximum dosage is 80 mg daily (20 mg four times a day). ( 2.2 ) • When discontinuing, reduce the dosage slowly. ( 2.3 ) 2.1 Important Information Baclofen oral suspension is a concentrated formulation. Verify the strength and the dose of the product prior to prescribing, dispensing, and administering. 2.2 Recommended Dosage Initiate baclofen oral suspension with a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability: 1 mL (5 mg) three times a day for three days 2 mL (10 mg) three times a day for three days 3 mL (15 mg) three times a day for three days 4 mL (20 mg) three times a day for three days Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily [4 mL (20 mg) four times a day]. 2.3 Administration Instructions Shake well baclofen oral suspension before administration. Discard unused portion 2 months after first opening. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. 2.4 Discontinuation of Baclofen Oral Suspension When discontinuing baclofen oral suspension, reduce the dosage slowly and avoid abrupt withdrawn from the drug to help minimize the risk of adverse reactions [see Warnings and Precautions ( 5.1 )] .
Warnings & Precautions
• Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen oral suspension is discontinued. ( 5.1 ) • Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue baclofen oral suspension before delivery. ( 5.2 ) • Baclofen oral suspension can cause drowsiness and sedation. Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system effects of baclofen oral suspension may be additive to those of alcohol and other CNS depressants. ( 5.3 ) • Baclofen oral suspension can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions. ( 5.5 , 5.6 , 5.7 ) 5.1 Adverse Reactions from Abrupt Withdrawal of Baclofen Oral Suspension Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the dosage slowly when baclofen oral suspension is discontinued, unless the clinical situation justifies a rapid withdrawal. 5.2 Neonatal Withdrawal Symptoms Withdrawal symptoms in neonates whose mothers were treated with oral baclofen throughout pregnancy have been reported starting hours to days after delivery. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and baclofen oral suspension is continued during pregnancy, gradually reduce the dosage and discontinue baclofen oral suspension before delivery. If slow withdrawal is not feasible, advise the parents or caregivers of the exposed neonate of the potential for neonatal withdrawal. 5.3 Drowsiness and Sedation Drowsiness and sedation have been reported in up to 63% of patients taking baclofen, the active ingredient in baclofen oral suspension [see Adverse Reactions ( 6.1 )] . Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting baclofen oral suspension or increasing the dose until they know how the drug affects them. Advise patients that the central nervous system depressant effects of baclofen oral suspension may be additive to those of alcohol and other CNS depressants. 5.4 Poor Tolerability in Stroke Patients Baclofen oral suspension should be used with caution in patients who have had a stroke. Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug. 5.5 Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Baclofen oral suspension should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with baclofen oral suspension, these patients should be kept under careful surveillance because exacerbations of these conditions have been observed with oral baclofen administration. 5.6 Exacerbation of Autonomic Dysreflexia Baclofen oral suspension should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of baclofen oral suspension may cause an autonomic dysreflexic episode. 5.7 Exacerbation of Epilepsy Baclofen oral suspension should be used with caution in patients with epilepsy. Deterioration in seizure control has been reported in patients taking baclofen. 5.8 Posture and Balance Effects Baclofen oral suspension should be used with caution in patients where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function. 5.9 Ovarian Cysts A dose-related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral baclofen. Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients who were treated with oral baclofen for up to one year. In most cases, these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.
Contraindications
Baclofen oral suspension is contraindicated in patients with hypersensitivity to baclofen. • Hypersensitivity to baclofen ( 4 )
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: • Adverse Reactions from Abrupt Withdrawal of Baclofen Oral Suspension [see Warnings and Precautions ( 5.1 )] • Neonatal Withdrawal Symptoms [see Warnings and Precautions ( 5.2 )] • Drowsiness and Sedation [see Warnings and Precautions ( 5.3 )] • Poor Tolerability in Stroke Patients [see Warnings and Precautions ( 5.4 )] • Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see Warnings and Precautions ( 5.5 )] • Exacerbation of Autonomic Dysreflexia [see Warnings and Precautions ( 5.6 )] • Exacerbation of Epilepsy [see Warnings and Precautions ( 5.7 )] • Posture and Balance Effects [see Warnings and Precautions ( 5.8 )] • Ovarian Cysts [see Warnings and Precautions ( 5.9 )] • The most common (up to 15% or more) adverse reactions in patients were drowsiness, dizziness, and weakness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 ADVERSE REACTION PERCENT Drowsiness 10-63% Dizziness 5-15% Weakness 5-15% Nausea 4-12% Confusion 1-11% Hypotension 0-9% Headache 4-8% Insomnia 2-7% Constipation 2-6% Urinary Frequency 2-6% Fatigue 2-4% 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.
Drug Interactions
7.1 CNS Depressants and Alcohol Baclofen oral suspension can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol [see Warnings and Precautions ( 5.3 )].
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