Baclofen is a gamma-aminobutyric acid-ergic agonist sold in the U.S. under 7 brand and generic names, for neurogenic urinary bladder, cerebral palsy and hiccup. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Lyvispah (application NDA215422). Other baclofen products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
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,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $2 | View → | |
| 2 | 70/100 | Prescription | Powder | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| KP02;10 | 10 mg | white | round | — |
| 024 | 10 mg | white | round | — |
| I114 | 10 mg | white | round | — |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
LYVISPAH is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen ( 4 )
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) ].
| $2 |
| View → |
| 3 | 68/100 | Prescription | Injectable | Generic | $2 | View → |
| 4 | Not yet rated | Prescription | Injectable | Generic | $2 | View → |
| 5 | Not yet rated | Prescription | Injectable | Generic | $2 | View → |
| 6 | Not yet rated | Prescription | Solution | Generic | $2 | View → |
| 7 | Not yet rated | Prescription | Solution | Generic | $2 | View → |