GABAPENTIN solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Akorn

INN (International Adı):

GABAPENTIN

Kompozisyon:

GABAPENTIN 250 mg in 5 mL

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Gabapentin oral solution is indicated for: Gabapentin oral solution is contraindicated in patients who have 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 antiepileptic drugs (AEDs), such as gabapentin oral solution, during pregnancy. Encourage women who are taking gabapentin oral solution 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 http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of gabapentin oral solution in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinic

Ürün özeti:

Gabapentin Oral Solution is supplied as follows: 250 mg/5 mL oral solution; Clear, colorless to slightly yellow solution; each 5 mL of oral solution contains 250 mg of gabapentin; available in: Bottles containing 470 mL, 5 mL unit dose, and 6 mL unit dose in trays of ten cups. Storage Store refrigerated, 2° - 8°C (36° - 46°F) Rx Only

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

GABAPENTIN- gabapentin solution
Akorn
----------
Medication Guide
Gabapentin Oral Solution
(GA-ba-PEN-tin)
What is the most important information I should know about Gabapentin
Oral Solution?
Do not stop taking Gabapentin Oral Solution without first talking to
your healthcare provider.
Stopping Gabapentin Oral Solution suddenly can cause serious problems.
Gabapentin Oral Solution can cause serious side effects including:
1.
Suicidal Thoughts. Like other antiepileptic drugs, Gabapentin Oral
Solution 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
•
attempts to commit suicide
•
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.
Do not stop taking Gabapentin Oral Solution without first talking to a
healthcare provider.
•
Stopping Gabapentin Oral Solution suddenly can cause serious problems.
Stopping a seizure medicine
suddenly in a patient who has epilepsy can cause seizures that will
not stop (status epilepticus).
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal
thoughts or actions, your healthcare provider may check for other
causes.
•
Changes in behavior and thinking - Using Gabapentin Oral Solution in
children 3 to 12 years of ag

Ürün özellikleri

GABAPENTIN- GABAPENTIN SOLUTION
AKORN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GABAPENTIN ORAL
SOLUTION.
GABAPENTIN ORAL SOLUTION
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions, Respiratory Depression (5.7) 4/2020
INDICATIONS AND USAGE
Gabapentin oral solution is indicated for: (1)
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with
and without secondary
generalization, in adults and pediatric patients 3 years and older
with epilepsy (1)
Postherpetic Neuralgia (2.1)
○ Dose can be titrated up as needed to a dose of 1800 mg/day
○ Day 1: Single 300 mg dose
○ Day 2: 600 mg/day (i.e., 300 mg two times a day)
○ Day 3: 900 mg/day (i.e., 300 mg three times a day)
Epilepsy with Partial Onset Seizures (2.2)
○ Patients 12 years of age and older: starting dose is 300 mg three
times daily; may be titrated up to
600 mg three times daily
○ Patients 3 to 11 years of age: starting dose range is 10 to 15
mg/kg/day, given in three divided
doses; recommended dose in patients 3 to 4 years of age is 40
mg/kg/day, given in three divided
doses; the recommended dose in patients 5 to 11 years of age is 25 to
35 mg/kg/day, given in three
divided doses. The recommended dose is reached by upward titration
over a period of approximately
3 days
Dose should be adjusted in patients with reduced renal function (2.3,
2.4)
Oral Solution: 250 mg/5 mL (3)
Known hypersensitivity to gabapentin oral solution or its ingredients
(4)
Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan
hypersensitivity): discontinue if
alternative etiology is not established (5.1)
Anaphylaxis and Angioedema: discontinue and evaluate patient
immed