GRALISE- gabapentin tablet, film coated GRALISE- gabapentin kit

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Almatica Pharma LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to gabapentin, including GRALISE, during pregnancy. Encourage women who are taking GRALISE during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting https://www.aedpregnancyregistry.org/. Risk Summary Available data from published prospective and retrospective cohort studies, and case reports over decades of use with gabapentin during pregnancy have not identified a drug-associated risk of major birth defects. The avai

Ringkasan produk:

GRALISE (gabapentin) Tablets are supplied as follows: • 300 mg tablets : GRALISE 300 mg tablets are white, oval, debossed with "SLV" on one side and "300" on the other side. NDC 52427-803-90 (Bottle of 90) • 450 mg tablets : GRALISE 450 mg tablets are red, oval, debossed with “ALM” on one side and “450” on the other side. NDC 52427-804-60 (Bottle of 60) • 600 mg tablets : GRALISE 600 mg tablets are beige, oval, debossed with "SLV" on one side and "600" on the other side. NDC 52427-806-90 (Bottle of 90) • 750 mg tablets : GRALISE 750 mg tablets are yellow, oval, debossed with “ALM” on one side and “750” on the other side. NDC 52427-850-60 (Bottle of 60) • 900 mg tablets : GRALISE 900 mg tablets are pink, oval, debossed with “ALM” on one side and “900” on the other side. NDC 52427-890-60 (Bottle of 60) Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Status otorisasi:

New Drug Application

Selebaran informasi

GRALISE- GABAPENTIN
Almatica Pharma LLC
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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 GRALISE is taken with other
medicines that can
cause severe sleepi

Karakteristik produk

GRALISE- GABAPENTIN TABLET, FILM COATED
GRALISE- GABAPENTIN
ALMATICA PHARMA LLC
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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
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 1,800 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
Tablets: 300 mg, 450 mg, 600 mg, 750 mg, and 900 mg (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 GRALISE gradually over a minimum of 1 week.
(5.3)
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