HORIZANT- gabapentin enacarbil tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

gabapentin enacarbil (UNII: 75OCL1SPBQ) (gabapentin - UNII:6CW7F3G59X)

Available from:

Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)

INN (International Name):

gabapentin enacarbil

Composition:

gabapentin enacarbil 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. HORIZANT is indicated for the management of postherpetic neuralgia (PHN) in adults. None. Risk Summary There are no adequate data on the developmental risk associated with the use of HORIZANT in pregnant women. In nonclinical studies in rats and rabbits, administration of gabapentin enacarbil was developmentally toxic when administered to pregnant animals at doses and gabapentin exposures greater than those used clinically [see Data] . In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal data When pregnant rats were administered gabapentin enacarbil (oral d

Product summary:

HORIZANT Extended-Release Tablets containing 300 mg of gabapentin enacarbil are white to off-white, with occasional black/grey spots, oval-shaped tablets debossed with "GS TF7". HORIZANT Extended-Release Tablets containing 600 mg of gabapentin enacarbil are white to off-white, with occasional black/grey spots, oval-shaped tablets debossed with "GS LFG". They are supplied as follows: Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Protect from moisture. Do not remove desiccants.

Authorization status:

New Drug Application

Patient Information leaflet

Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
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MEDICATION GUIDE
HORIZANT® (ho-ri' zant) (gabapentin
enacarbil) Extended-Release Tablets
Read this Medication Guide before you start taking HORIZANT and each
time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment.
What is the most important information I should know about HORIZANT?
HORIZANT can cause serious side effects:
1.
Do not drive after taking your dose of HORIZANT until you know how
HORIZANT affects you,
including the morning after you take your dose. Do not operate heavy
machinery or do other
dangerous activities until you know how HORIZANT affects you. HORIZANT
can cause
sleepiness, dizziness, slow thinking, and can affect your
coordination. Ask your healthcare provider
when it would be okay to do these activities.
2.
HORIZANT may cause suicidal thoughts or actions in a very small number
of people, about 1 in
500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
•
thoughts about suicide or dying
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated
•
new or worse restlessness
•
panic attacks
•
new or worse trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
•
Call your healthcare provider between visits as needed, especially if
you are worried about
symptoms.
Do not stop HORIZANT without first talking to a healthcare provider.
Suicidal thoughts or actions

Summary of Product characteristics

HORIZANT- GABAPENTIN ENACARBIL TABLET, EXTENDED RELEASE
AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HORIZANT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HORIZANT.
HORIZANT (GABAPENTIN ENACARBIL) EXTENDED-RELEASE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
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)
DOSAGE AND ADMINISTRATION
Instruct patients to swallow tablets whole and not to cut, crush, or
chew tablets. Take with food. (2)
RLS: 600 mg once daily taken at about 5 PM. (2.1)
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. (2.1)
If the dose is not taken at the recommended time, the next dose should
be taken the following day as
prescribed. (2.1)
PHN: The starting dose is 600 mg in the morning for 3 days, then
increase to 600 mg twice daily beginning
on day 4. (2.2)
A daily dose greater than 1,200 mg provided no additional benefit.
(2.2)
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. (2.2)
Patients with renal impairment: Doses of HORIZANT must be adjusted in
accordance with renal function.
(2.3)
DOSAGE FORMS AND STRENGTHS
Extended-Release Tablets: 300 mg and 600 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Driving impairment: Warn patients not to drive until they have gained
sufficient experience with
HORIZANT to assess whether it will impair their ability to drive.
(5.1)
Somnolence/sedation and dizziness: May impair the patient's ability to
operate complex machinery.
(5.2)
HORIZANT is not interchangeable with other gabapentin products. (5.3)
Suicidal thoughts or behaviors: HORIZANT is a prodrug of gabapentin,
an antiepilept