Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
Gabapentin (UNII: 6CW7F3G59X) (Gabapentin - UNII:6CW7F3G59X)
Aphena Pharma Solutions - Tennessee, LLC
Gabapentin
Gabapentin 800 mg
ORAL
PRESCRIPTION DRUG
Postherpetic Neuralgia Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults. Epilepsy Gabapentin tablets 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 tablets USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. Gabapentin tablets USP 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.
Gabapentin Tablets, USP 600 mg: White colored film coated, Modified Capsule shaped, biconvex tablets de-bossed with '1' on the left side of the bisect and '2' on the right side of the bisect on one side and bisect on other; supplied in bottles of 90's count (NDC 76282-405-90), 100's count (NDC 76282-405-01) and 500’s count (NDC 76282-405-05). Gabapentin Tablets, USP 800 mg: White colored film coated, Modified Capsule shaped, biconvex tablets de-bossed with '1' on the left side of the bisect and '3' on the right side of the bisect on one side and bisect on other; supplied in bottles of 90's count (NDC 76282-406-90), 100's count (NDC 76282-406-01) and 500’s count (NDC 76282-406-05). Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Rev: 10/12.
Abbreviated New Drug Application
Aphena Pharma Solutions - Tennessee, LLC ---------- SPL MEDGUIDE Gabapentin Tablets, USP Read the Medication Guide before you start taking gabapentin 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? Do not stop taking gabapentin without first talking to your healthcare provider. Stopping gabapentin suddenly can cause serious problems. Gabapentin can cause serious side effects including: 1. Like other antiepileptic drugs, gabapentin 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 without first talking to a healthcare provider. • Stopping gabapentin 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 ca সম্পূর্ণ নথি পড়ুন
GABAPENTIN - GABAPENTIN TABLET, FILM COATED APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- GABAPENTIN TABLETS, USP RX ONLY DESCRIPTION Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. Each tablet for oral administration contains the following inactive ingredients: Mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium Stearate and Aquarius BP18114 Cool Vanilla. 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. This product(Gabapentin Tablets, USP 600 mg and 800 mg) meets the USP Dissolution Test 1. 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, but in animal test systems designed সম্পূর্ণ নথি পড়ুন