Horizant 300 mg/1
gabapentin enacarbil · TABLET, EXTENDED RELEASE · Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Horizant is a tablet, extended release containing gabapentin enacarbil at 300 mg/1, taken oral. Manufactured by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals).
Key Facts
- Brand Name
- Horizant
- Generic Name
- gabapentin enacarbil
- NDC Code (Product)
53451-0103- Manufacturer
- Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
- Strength
- 300 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA022399
- Marketing Start
- 05/01/2013
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE HORIZANT is indicated for: treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. ( 1.1 ) management of postherpetic neuralgia (PHN) in adults. ( 1.2 ) 1.1 Treatment of Restless Legs Syndrome HORIZANT ® is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. HORIZANT is not recommended for patients who are required to sleep during the daytime and remain awake at night. 1.2 Management of Postherpetic Neuralgia HORIZANT is indicated for the management of postherpetic neuralgia (PHN) in adults.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Instruct patients to swallow tablets whole and not to cut, crush, or chew tablets. Take with food. ( 2.1 ) RLS: 600 mg once daily taken at about 5 PM. ( 2.2 ) A dose of 1,200 mg once daily provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions. ( 2.2 ) If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed. ( 2.2 ) PHN: The starting dose is 600 mg in the morning for 3 days, then increase to 600 mg twice daily beginning on day 4. ( 2.3 ) A daily dose greater than 1,200 mg provided no additional benefit. ( 2.3 ) If the dose is not taken at the recommended time, skip this dose, and the next dose should be taken at the time of next scheduled dose. ( 2.3 ) Patients with renal impairment: Doses of HORIZANT must be adjusted in accordance with renal function. (2.4) 2.1 Dosage and Administration Overview Tablets should be swallowed whole and should not be cut, crushed, or chewed. Tablets should be taken with food. HORIZANT is not substitutable with other gabapentin products because of differing pharmacokinetic profiles [ see Warnings and Precautions (5.3) ]…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Gabapentin enacarbil is released faster from HORIZANT Extended-Release tablets in the presence of alcohol. Consumption of alcohol is not recommended when taking HORIZANT [see Clinical Pharmacology (12.3) ] . Morphine: HORIZANT taken in conjunction with morphine causes increased somnolence/sedation, dizziness, and nausea when compared with either drug alone [see Clinical Pharmacology (12.3) ].
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in more detail in the Warnings and Precautions section of the labeling: Effects on Driving [see Warnings and Precautions (5.1) ] Somnolence/Sedation and Dizziness [see Warnings and Precautions (5.2) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.4) ] Increased Risk of Seizures and Other Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.5) ] Respiratory Depression [see Warnings and Precautions (5.6) ] Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.7) ] RLS: Most common adverse reactions (≥10% and at least 2 times the rate of placebo) were somnolence/sedation and dizziness. ( 6.1 ) PHN: Most common adverse reactions (≥10% and greater than placebo) were dizziness, somnolence, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 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 obse…
Frequently Asked Questions
What is Horizant used for?
Horizant contains gabapentin enacarbil. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Horizant a controlled substance?
Horizant is not classified as a controlled substance by the DEA.
What is the generic name for Horizant?
The generic name for Horizant is gabapentin enacarbil. There are no other listed brand versions of gabapentin enacarbil.
What is the NDC code for Horizant 300 mg/1?
The NDC (National Drug Code) for Horizant 300 mg/1 is 53451-0103, listed by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals).
Other Horizant Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)