lyvispah
Pharmaranks rates Lyvispah 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Lyvispah (Baclofen) is a gamma-aminobutyric acid-ergic agonist used to treat Neurogenic Urinary Bladder, Cerebral Palsy, Hiccup, Huntington Disease.
Baclofen · by Strides Pharma Intl
Available as a generic: Baclofen
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Baclofen
- Drug class
- Gamma-Aminobutyric Acid-Ergic Agonist
- Form
- Powder
- Strength
- Baclofen 10MG/PACKET · Baclofen 20MG/PACKET · Baclofen 5MG/PACKET
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- neurogenic urinary bladder, cerebral palsy, hiccup
- Manufacturer
- Strides Pharma Intl
- 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
- NDA215422
- Availability
- Discontinued (per FDA)
What is Lyvispah?
From the FDA label:LYVISPAH (baclofen) oral granules is a gamma-aminobutyric acid (GABA-ergic) agonist available as 5 mg, 10 mg, or 20 mg of baclofen oral granules in a packet. Its chemical name is 4-amino-3-(4- chlorophenyl)-butanoic acid and its structural formula is: Molecular formula is C10H12ClNO2 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. LYVISPAH (baclofen) oral granules inactive ingredients include amino methacrylate copolymer, calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, mannitol, saccharin sodium, strawberry flavor, talc, and xylitol. chem structure
How to use
Initiate LYVISPAH with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. ( 2.1 ) The maximum dosage is 80 mg daily (20 mg four times a day). ( 2.1 ) LYVISPAH can be taken with or without water. ( 2.2 ) LYVISPAH oral granules can be mixed with soft food for administration within 2 hours. ( 2.2 ) LYVISPAH oral granules can be administered via enteral feeding tubes. ( 2.2 ) When discontinuing, reduce the dose slowly. ( 2.2 ) 2.1 Recommended Dosage Initiate LYVISPAH 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 three times a day for three days 10 mg three times a day for three days 15 mg three times a day for three days 20 mg 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 times a day). Multiple packets or multiple strengths can be used to achieve the prescribed dosage. 2.2 Administration Instructions The entire contents of the packet should be emptied into the mouth. The granules will dissolve in the mouth or can be swallowed. LYVISPAH can be taken with liquids or soft foods if needed . Administration with Liquids or Soft Foods LYVISPAH can be administered…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Adverse Reactions from Abrupt Withdrawal of LYVISPAH [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 adverse reactions (up to 15% or more) in patients were drowsiness, dizziness, and weakness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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,…
Warnings
Important safety information
Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when LYVISPAH is discontinued. ( 5.1 ) Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue LYVISPAH before delivery. ( 5.2 ) LYVISPAH 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 LYVISPAH may be additive to those of alcohol and other CNS depressants. ( 5.3 ) LYVISPAH 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 LYVISPAH 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 LYVISPAH 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 LYVISPAH is continued during pregnancy, gradually reduce the dosage, and discontinue LYVISPAH 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 LYVISPAH [see Adverse Reactions (6.1) ]. Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting LYVISPAH or increasing the dosage until they know how the drug affects them. Advise patients that the central nervous system depressant effects of LYVISPAH may be an additive to those of alcohol and other CNS depressants. 5.4 Poor Tolerability in Stroke Patients LYVISPAH 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 LYVISPAH should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with LYVISPAH, 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 LYVISPAH should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of LYVISPAH may cause an autonomic dysreflexic episode. 5.7 Exacerbation of Epilepsy LYVISPAH 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 LYVISPAH 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 continue 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 Lyvispah
LYVISPAH 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 With overdose of baclofen, 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 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 (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 Lyvispah ranks — best-rated gamma-aminobutyric acid-ergic agonist for:
Dosage forms
Powder
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 Lyvispah treat?
- Lyvispah (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 is Lyvispah rated?
- pharmaranks gives Lyvispah a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Lyvispah 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 Lyvispah?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lyvispah. 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 Lyvispah?
- Lyvispah is marketed by Strides Pharma Intl. You can see Strides Pharma Intl's full profile, rating, and other products on pharmaranks.
- Is Lyvispah a brand-name or generic drug?
- Lyvispah is a brand-name product with the active ingredient Baclofen. Lower-cost generic equivalents containing Baclofen are available — ask your pharmacist.
- Is Lyvispah available over the counter?
- No. Lyvispah 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 Lyvispah come in?
- Lyvispah is currently marketed as powder, per the FDA's National Drug Code Directory.
- What class of drug is Lyvispah?
- Lyvispah is classified as gamma-aminobutyric acid-ergic agonist, per the FDA's Established Pharmacologic Class.
- Is Lyvispah FDA-registered?
- Lyvispah is on record with the U.S. FDA under application number NDA215422. You can verify this on its official FDA label.
- Has Lyvispah been recalled by the FDA?
- Lyvispah has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Lyvispah safe?
- There's no single safe-or-not verdict. pharmaranks gives Lyvispah a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Lyvispah?
- Lyvispah'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 LYVISPAH [see Warnings and Precautions (5.1)] Neonatal Withdrawal Symptoms [see Warnings and Precautions (5.2)] Drowsiness and Sedation [see Warnings and Precau… 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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lyvispah
70/100