GRALISE- gabapentin tablet, film coated GRALISE STARTER PACK- gabapentin kit

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)

Beschikbaar vanaf:

Assertio Therapeutics, Inc.

INN (Algemene Internationale Benaming):

GABAPENTIN

Samenstelling:

GABAPENTIN 300 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

GRALISE is indicated for the management of postherpetic neuralgia. GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. GRALISE is contraindicated in patients with demonstrated hypersensitivity to the drug or its ingredients. Pregnancy Category C: Gabapentin has been shown to be fetotoxic in rodents, causing delayed ossification of several bones in the skull, vertebrae, forelimbs, and hindlimbs. These effects occurred when pregnant mice received oral doses of 1000 or 3000 mg/kg/day during the period of organogenesis, or approximately 3 to 8 times the maximum dose of 1800 mg/day given to PHN patients on a mg/m2 basis. The no effect level was 500 mg/kg/day representing approximately the maxi

Product samenvatting:

GRALISE (gabapentin) Tablets are supplied as follows: 300 mg tablets: GRALISE 300 mg tablets are white, oval shaped tablets debossed with "SLV" on one side and "300" on the other side. NDC 13913-004-19 (Bottle of 90) 600 mg tablets: GRALISE 600 mg tablets are beige, oval shaped tablets debossed with "SLV" on one side and "600" on the other side. NDC 13913-005-19 (Bottle of 90) Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Autorisatie-status:

New Drug Application

Bijsluiter

GRALISE- GABAPENTIN TABLET, FILM COATED
GRALISE STARTER PACK- GABAPENTIN
Assertio Therapeutics, Inc.
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MEDICATION GUIDE
GRALISE® (gra leez')
(gabapentin) Tablets
Read this Medication Guide before you start taking GRALISE 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. If you have any questions about
GRALISE, ask your healthcare provider or
pharmacist.
What is the most important information I should know about GRALISE?
Do not stop taking GRALISE without first talking with your healthcare
provider. Stopping GRALISE
suddenly can cause serious problems.
Like other antiepileptic drugs, gabapentin, the active ingredient in
GRALISE, may cause suicidal thoughts or
actions in a very small number of people, about 1 in 500. However, it
is not known if GRALISE is safe and
effective in people with seizure problems (epilepsy). Therefore,
GRALISE should not be used in place of
other gabapentin products.
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
•
attempts to commit suicide
•
serious breathing problems
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
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.
Serious breathing problems
•
Serious breathing problems can occur when GRALI

Productkenmerken

GRALISE- GABAPENTIN TABLET, FILM COATED
GRALISE STARTER PACK- GABAPENTIN
ASSERTIO THERAPEUTICS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GRALISE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GRALISE.
GRALISE (GABAPENTIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions
(5.2)
04/2020
INDICATIONS AND USAGE
GRALISE is indicated for the management of Postherpetic Neuralgia
(PHN).
IMPORTANT LIMITATION: GRALISE IS NOT INTERCHANGEABLE WITH OTHER
GABAPENTIN PRODUCTS
BECAUSE OF DIFFERING PHARMACOKINETIC PROFILES THAT AFFECT THE
FREQUENCY OF
ADMINISTRATION_(See Warnings and Precautions)_
DOSAGE AND ADMINISTRATION
GRALISE should be titrated to an 1800 mg dose taken orally,
once-daily, with the evening meal.
GRALISE tablets should be swallowed whole. Do not crush, split, or
chew the tablets. (2.1)
If GRALISE dose is reduced, discontinued, or substituted with an
alternative medication, this should be
done gradually over a minimum of 1 week or longer (at the discretion
of the prescriber). (2.1)
Renal impairment: Dose should be adjusted in patients with reduced
renal function. GRALISE should not
be used in patients with CrCl less than 30 or in patients on
hemodialysis. (2.2)
DOSAGE FORMS AND STRENGTHS
300 and 600 mg tablets (3)
CONTRAINDICATIONS
GRALISE is contraindicated in patients who have demonstrated
hypersensitivity to the drug or its
ingredients. (4)
WARNINGS AND PRECAUTIONS
GRALISE is not interchangeable with other gabapentin products
Antiepileptic drugs, including gabapentin, the active ingredient in
GRALISE, increase the risk of suicidal
thoughts or behavior (5.1)
Respiratory depression may occur with GRALISE when used with
concomitant CNS depressants or in the
setting of underlying respiratory impairment. Monitor patients and
adjust dosage as appropriate. (5.2)
Increased seizure frequency may occur in patients with seizure
disorders if GRALISE is rapidly
discontinued. Withdraw G