Gabapentin description, usages, side effects, indications, overdosage, supplying and lots more!

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Gabapentin

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

GABAPENTIN DESCRIPTION




Gabapentin




CLINICAL PHARMACOLOGY

Mechanism of Action:





Pharmacokinetics and Drug Metabolism

Oral Bioavailability:
Distribution:
Elimination:
Special Populations: Patients With Renal Insufficiency
DOSAGE AND ADMINISTRATION, Table 6
Special Populations:
DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION

PRECAUTIONS, Geriatric UseDOSAGE AND ADMINISTRATION



DOSAGE AND ADMINISTRATION



CLINICAL STUDIES







Gabapentin


Gabapentin



Gabapentin











Gabapentin







INDICATIONS & USAGE

Postherpetic Neuralgia

Epilepsy


GABAPENTIN CONTRAINDICATIONS



WARNINGS

Suicidal Behavior and Ideation








Neuropsychiatric Adverse EventsPediatric Patients 3-12 years of age


Withdrawal Precipitated Seizure, Status Epilepticus


Tumorigenic Potential
PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility

Sudden and Unexplained Death in Patients With Epilepsy



PRECAUTIONS

Information for patients



Drug Interactions
PRECAUTIONS, Pregnancy

LABORATORY TESTS



DRUG INTERACTIONS




Phenytoin:
Carbamazepine:
Valproic Acid:
Phenobarbital:
Naproxen:
Hydrocodone:
Morphine:PRECAUTIONS
Cimetidine:
Oral Contraceptive:
Antacid (Maalox
Effect of Probenecid:

DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY






PREGNANCY






NURSING MOTHERS



PEDIATRIC USE


CLINICAL PHARMACOLOGY, Clinical Studies

GERIATRIC USE



CLINICAL PHARMACOLOGYADVERSE REACTIONSDOSAGE AND ADMINISTRATION

GABAPENTIN ADVERSE REACTIONS

Postherptic Neuralgia


Incidence in Controlled Clinical Trials




Epilepsy
WARNINGS, Neuropsychiatric Adverse Events

Incidence in Controlled Clinical Trials









Other Adverse Events Observed During All Clinical Trials
Clinical Trials In Adults And Adolescents (Except Clinical Trials in Neuropathic Pain)



Body As A Whole:
Cardiovascular System:
Digestive System:
Endocrine System:
Hematologic And Lymphatic System:Rare:
Musculoskeletal System:
Nervous System:
Respiratory System:
Dermatological:
Urogenital System:
Special Senses:
Clinical Trials In Pediatric Patients With Epilepsy

Body As A Whole:
Digestive System:
Hemic And Lymphatic System:
Nervous System:
Psychobiologic Function:
Respiratory System:
Clinical Trials In Adults With Neuropathic Pain Of Various Etiologies


Body as A Whole:
Cardiovascular System:
Digestive System:
Endocrine System:
Hemic And Lymphatic System:
Metabolic And Nutritional:
Musculoskeletal:
Nervous System:
Respiratory System:
Skin And Appendages:
Special Senses:
Urogenital System:
Postmarketing and Other Experience



DRUG ABUSE AND DEPENDENCE



OVERDOSAGE





DOSAGE & ADMINISTRATION



Postherpetic Neuralgia

Epilepsy

Patients >12 years of age:
Pediatric Patients Age 312 years:CLINICAL PHARMACOLOGY, Pediatrics


Dosage in Renal Impairment








Dosage in Elderly


HOW SUPPLIED






STORAGE AND HANDLING



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Gabapentin

Gabapentin

Gabapentin

Gabapentin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-928(NDC:31722-222)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GABAPENTIN GABAPENTIN 300 mg

Inactive Ingredients

Ingredient Name Strength
mannitol
STARCH, CORN
talc
FD&C RED NO. 40
D&C YELLOW NO. 10
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
yellow 21 mm IG322;300mg CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-928-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090705 2012-03-23


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Be sure to consult your doctor before taking any medication!
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