Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Aphena Pharma Solutions - Tennessee, LLC
ORAL
PRESCRIPTION DRUG
Gabapentin capsules, USP are indicated for the management of postherpetic neuralgia in adults. Gabapentin capsules, USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin capsules, USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. The abuse and dependence potential of gabapentin has not been evaluated in human studies.
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Gabapentin Capsules USP, 100 mg are white/white size ‘3’ hard gelatin capsules imprinted with ‘D’ on white cap and ‘02’ on white body with black edible ink filled with white to off-white crystalline powder. Bottles of 90 NDC 52343-030-90 Bottles of 100 NDC 52343-030-01 Bottles of 180 NDC 52343-030-18 Bottles of 270 NDC 52343-030-27 Bottles of 500 NDC 52343-030-05 Bottles of 1000 NDC 52343-030-99 Gabapentin Capsules USP, 300 mg are yellow/yellow size ‘1’ hard gelatin capsules imprinted with ‘D’ on yellow cap and ‘03’ on yellow body with black edible ink filled with white to off-white crystalline powder. Bottles of 30 NDC 52343-031-30 Bottles of 60 NDC 52343-031-60 Bottles of 90 NDC 52343-031-90 Bottles of 100 NDC 52343-031-01 Bottles of 180 NDC 52343-031-18 Bottles of 270 NDC 52343-031-27 Bottles of 500 NDC 52343-031-05 Bottles of 1000 NDC 52343-031-99 Gabapentin Capsules USP, 400 mg are orange/orange size ‘0’ hard gelatin capsules imprinted with ‘D’ on orange cap and ‘04’ on orange body with black edible ink filled with white to off-white crystalline powder. Bottles of 90 NDC 52343-032-90 Bottles of 100 NDC 52343-032-01 Bottles of 270 NDC 52343-032-27 Bottles of 500 NDC 52343-032-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Maalox® is a registered trademark of Novartis Consumer Health, Inc. Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Cedardale Distributors D/B/A Gen-Source RX 620 Gotham Parkway Carlstadt, NJ 07072 USA Issued: 03/2013
Abbreviated New Drug Application
Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE Gabapentin Capsules, USP Rx only Read the Medication Guide before you start taking gabapentin capsules 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 gabapentin capsules? Do not stop taking gabapentin capsules without first talking to your healthcare provider. Stopping gabapentin capsules suddenly can cause serious problems. Gabapentin capsules can cause serious side effects including: 1. Like other antiepileptic drugs, gabapentin capsules 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 capsules without first talking to a healthcare provider. • Stopping gabapentin capsules 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 y Preberite celoten dokument
GABAPENTIN - GABAPENTIN CAPSULE APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- DESCRIPTION Gabapentin capsules, USP are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, titanium dioxide, and sodium lauryl sulfate. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C H NO and a molecular weight of 171.24. The structural formula of gabapentin is: Gabapentin is a white to off-white crystalline solid with a pK of 3.7 and a pK of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n- octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. CLINICAL PHARMACOLOGY MECHANISM OF ACTION The mechanism by which gabapentin exerts its analgesic action is unknown, but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). In particular, gabapentin prevents pain-related responses in several models of neuropathic pain in rats or mice (e.g., spinal nerve ligation models, streptozocin-induced diabetes model, spinal cord injury model, acute herpes zoster infection model). Gabapentin also decreases pain-related responses after peripheral inflammation (carrageenan footpad test, late phase of formalin test). Gabapentin did not alter immediate pain-related behaviors (rat tail flick test, formalin footpad acute phase, acetic acid abdominal constriction test, footpad heat irradiation test). The relevance of these models to human pain is not known. The mechanism by which gabapentin exerts its anticonvulsant action is unknown, Preberite celoten dokument