ozobax
Ozobax (Baclofen) is a gamma-aminobutyric acid-ergic agonist used to treat Neurogenic Urinary Bladder, Cerebral Palsy, Hiccup, Huntington Disease.
Baclofen · by Metacel Pharms LLC
Available as a generic: Baclofen
Every strength approved under this FDA application (2)
- Ozobax (this page)Baclofen 5MG/5ML
- Ozobax DsBaclofen 10MG/5ML
Key facts
- Active ingredient
- Baclofen
- Drug class
- Gamma-Aminobutyric Acid-Ergic Agonist
- Form
- Solution
- Strength
- Baclofen 5MG/5ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- neurogenic urinary bladder, cerebral palsy, hiccup
- Manufacturer
- Metacel Pharms LLC
- Half-life
- about 5.7 hours (how long it stays in your system)
- What the pharmacy pays
- ~$1.55 for 30 — not your price
- FDA application
- NDA208193
What is Ozobax?
From the FDA label:Baclofen oral solution is a gamma-aminobutyric acid (GABA-ergic) agonist available as 10 mg/5 mL solution for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is: Molecular formula is C 1O H 12 CINO 2 . Molecular Weight is 213.66. 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 solution inactive ingredients are: glycerin, methylparaben, propylparaben, purified water, and sucralose. May also contain sodium hydroxide or hydrochloric acid for pH adjustment. bac structure
How to use
Baclofen oral solution is available in multiple concentrations; include both the total dose in mg and the total dose in volume on prescriptions ( 2.1 ) Initiate baclofen oral solution 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 Dosage Information Baclofen oral solution is available in multiple concentrations; ensure accuracy when prescribing, dispensing and administering baclofen oral solution to avoid dosing errors due to confusion between mg and mL, and with other baclofen oral solutions of different concentrations. When writing prescriptions, include both the total dose in mg and the total dose in volume. 2.2 Recommended Dosage Initiate baclofen oral solution 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: 5 mg (2.5 mL) three times a day for three days 10 mg (5 mL) three times a day for three days 15 mg (7.5 mL) three times a day for three days 20 mg (10 mL) three times a day for three days Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily (20 mg four…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Adverse Reactions from Abrupt Withdrawal of Baclofen Oral Solution [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 Palmetto Pharmaceuticals Inc. at 1-844-627-7696 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…
Warnings
Important safety information
Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen oral solution is discontinued. ( 5.1 ) Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue baclofen oral solution before delivery. ( 5.2 ) Baclofen oral solution 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 solution may be additive to those of alcohol and other CNS depressants. ( 5.3 ) Baclofen oral solution 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 Solution 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 solution 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 solution is continued during pregnancy, gradually reduce the dosage and discontinue baclofen oral solution 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 solution [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 solution or increasing the dose until they know how the drug affects them. Advise patients that the central nervous system depressant effects of baclofen oral solution may be additive to those of alcohol and other CNS depressants. 5.4 Poor Tolerability in Stroke Patients Baclofen oral solution 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 solution should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with baclofen oral solution, 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 solution should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of baclofen oral solution may cause an autonomic dysreflexic episode. 5.7 Exacerbation of Epilepsy Baclofen oral solution 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 solution 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.
Who should not take Ozobax
Baclofen oral solution is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen ( 4 )
Overdose — what happens if you take too much
10.1 Symptoms of Baclofen Overdose Patients may present in coma or with progressive drowsiness, lightheadedness, dizziness, somnolence, accommodation disorders, respiratory depression, seizures, or hypotonia progressing to loss of consciousness. 10.2 Treatment for Overdose The treatment of baclofen overdose includes gastric decontamination, maintaining an adequate airway and respirations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
7.1 CNS Depressants and Alcohol Baclofen oral solution 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)].
How long does Baclofen stay in your body?
The elimination half-life of baclofen is about 5.7 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the apparent elimination half-life of the parent drug. Baclofen is not a prodrug and has no active metabolite that outlasts it — the label states it is excreted primarily by the kidney in unchanged form, so the half-life reflects renal clearance directly. Because of that, elimination is slower in people with reduced kidney function (renal impairment) and in older adults, in whom the drug can accumulate and the dose may need to be reduced. The label also notes large intersubject variation in absorption and/or elimination, so individual half-life can differ. Half-life is not the same as a drug-test detection window: baclofen is essentially cleared within about 72 hours of a dose, but detectability depends on the test.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Baclofen oral solution — FDA label (DailyMed), Clinical Pharmacology.
Drug class
May treat (source: NIH RxClass)
See how Ozobax ranks — best-rated gamma-aminobutyric acid-ergic agonist for:
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Ozobax treat?
- Ozobax (Baclofen) may be used to treat neurogenic urinary bladder, cerebral palsy, hiccup, huntington disease, multiple sclerosis, muscle spasticity, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Ozobax cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.55 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Ozobax?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ozobax. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ozobax?
- Ozobax is marketed by Metacel Pharms LLC. You can see Metacel Pharms LLC's full profile, rating, and other products on pharmaranks.
- Is Ozobax a brand-name or generic drug?
- Ozobax is a brand-name product with the active ingredient Baclofen. Lower-cost generic equivalents containing Baclofen are available — ask your pharmacist.
- Is Ozobax available over the counter?
- No. Ozobax is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ozobax come in?
- Ozobax is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Ozobax?
- Ozobax is classified as gamma-aminobutyric acid-ergic agonist, per the FDA's Established Pharmacologic Class.
- Is Ozobax FDA-registered?
- Ozobax is on record with the U.S. FDA under application number NDA208193. You can verify this on its official FDA label.
- Is Ozobax safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Ozobax. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Ozobax?
- Ozobax's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Adverse Reactions from Abrupt Withdrawal of Baclofen Oral Solution [see Warnings and Precautions ( 5.1 )] Neonatal Withdrawal Symptoms [see Warnings and Precautions ( 5.2 )] Drowsiness and Sedation [see W… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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