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Gabapentin (Generic Neurontin ) was developed to treat epilepsy, but it is now used to treat various forms of chronic pain. It works by reducing the number of signals sent through the nerves. If the signals are reduced then the pain will be reduced. Research has shown that Gabapentin can help in treating various types of nerve pain.
Some Research Team performed searches to look for clinical trials where gabapentin was used to treat neuropathic pain or fibromyalgia. They found that 5633 participants had been involved in 37 studies of reasonable quality. They tested gabapentin against placebo for four weeks or more. Studies lasting only one or two weeks are unhelpful when pain can last for years.
Neuropathic pain is pain coming from damaged nerves. It differs from pain messages carried along healthy nerves from damaged tissue (a fall, cut, or arthritic knee). Neuropathic pain is treated by different medicines than pain from damagedtissue. Medicines like paracetamol or ibuprofen are not effective in neuropathic pain, while medicines that are sometimes used to treat depression or epilepsy can be very effective in some people with neuropathic pain. Our understanding of fibromyalgia (a condition of persistent, widespread pain and tenderness, sleep problems, and fatigue) is poor, but fibromyalgia can respond to the same medicines as neuropathic pain.
Gabapentin is helpful for some people with chronic neuropathic pain or fibromyalgia. Gabapentin comes as a capsule, tablet, or solution. You take it by mouth. Gabapentin is available as the brand-name drugs Neurontin, Gralise, and Horizant. It’s also available as a generic drug.
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How long will I have to take Gabapentin for?
This is different for different people. In general, Gabapentin will have to be taken for as long as you are requiring pain relief for nerve pain. Do not stop taking your Gabapentin suddenly if you have been taking it for a while. Your body will be used to the Gabapentin and stopping it suddenly may cause withdrawal symptoms. Reducing the dose slowly as advised by your pain specialist or GP will help stop withdrawal symptoms happening. You may wish to reduce the dose every so often, to check nerve pain is still a problem.
How to take Gabapentin ?
The dose of gabapentin required varies from person to person. To avoid side effects we build up to the dose gradually. The tables in this leaflet show you how this can be done. Some patients can put their dose up faster than others. We call this faster way the FAST TRACK (see table 1).
If you find you are getting side effects with the fast track way of putting your dose up, you can switch to the SLOWER METHOD. ( see table 2).
Other people will need to put their dose up less quickly over a number of weeks. This is THE SLOWER METHOD (see table 2).
As with any medication it is important to check how well it works. With gabapentin this can be in a few days but for most patients may take 4-8 weeks to assess the full benefit. If you feel you are getting no benefit from this medication please discuss this with your GP or pain specialist.
By Drugs.com, Gabapentin Can be used for a lot of Nerve Pain related health conditions.
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A lot of Patients use Gabapentin (Neurontin) to treat Hot Flashes, Anxiety, Bipolar Disorder, Migraine, Insomnia, Restless Legs Syndrome, Peripheral Neuropathy, Fibromyalgia, Neuropathic Pain. Fe patients use gabapentin to treat Pruritus, Cough, Occipital Neuralgia, Benign Essential Tremor, ement Disorder, Spondylolisthesis, Burning Mouth Syndrome, Pudendal Neuralgia, Small Fiber Neuropathy.
There are totally 1359 reviews on Gabapentin, only eleven reviews are on Epilepsy whereas 1348 reviews are on Gabapentin Off-label usage. The most widely usage of Gabapentin is for Anxiety ( 243 Reviews ), Pain Relief ( 241 Reviews ), Fibromyalgia ( 137 Reviews ), Peripheral Neuropathy (119 reviews ), Bipolar Disorder ( 83 reviews ), Migraine ( 79 reviews), Neuropathic Pain ( 75 reviews ), Hot Flashes (70 reviews ), Restless Legs Syndrome (61 Reviews ) and Insomnia ( 59 reviews). The most effective usage of Gabapentin is for Pruritus and Cough.
Gabapentin is one drug that researchers have studied for preventing migraines. It has a high safety profile and few side effects. This makes it a good option for Migraine prevention. Results from some clinical trials have shown a modest benefit from the use of gabapentin for migraine prevention. However, the American Academy of Neurology (AAN), the organization that provides guidance for the use of drugs to prevent migraines, has stated that there is not enough evidence at this time to support the use of gabapentin for migraine prevention. Healthcare professionals can choose to prescribe gabapentin when other prevention therapies have not worked, however.
Gabapentin has been proven to be effective for people who have hard-to-treat depression or other mood disorders. Neurontin is not your traditional anxiety drug. It’s a drug primarily described to those with bipolar disorder, not anxiety. Bipolar disorder is a complicated mental health problem. Gabapentin was successful in helping with rapid cycling and mixed bipolar states in people who have not received relief from valproate or carbamazepine. It appeared that Gabapentin helped more with anxiety and agitation than the other two drugs. It has also been shown that Gabapentin could aid people with certain types of tardive dyskinesia. That’s why anyone that has been prescribed Neurontin should strongly consider taking it, despite the side effects above and questions about its effectiveness. Bipolar disorder is not something that should be left to chance.
The total number of patients treated with NEURONTIN in controlled clinical trials in patients with postherpetic neuralgia was 336, of which 102 (30%) were 65 to 74 years of age, and 168 (50%) were 75 years of age and older. There was a larger treatment effect in patients 75 years of age and older compared with younger patients who received the same dosage. Since gabapentin is almost exclusively eliminated by renal excretion, the larger treatment effect observed in patients ≥ 75 years may be a consequence of increased gabapentin exposure for a given dose that results from an age-related decrease in renal function. However, other factors cannot be excluded. The types and incidence of adverse reactions were similar across age groups except for peripheral edema and ataxia, which tended to increase in incidence with age.
Clinical studies of NEURONTIN in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
What form(s) does this medication come in?
100 mg – Each hard gelatin Coni-Snap capsule, with white opaque body and cap printed with “PD” on one side and “Neurontin/100 mg” on the other, contains gabapentin 100 mg.
300 mg – Each hard gelatin Coni-Snap capsule, with yellow opaque body and cap printed with “PD” on one side and “Neurontin/300 mg” on the other, contains gabapentin 300 mg.
400 mg – Each hard gelatin Coni-Snap capsule, with orange opaque body and cap printed with “PD” on one side and “Neurontin/400 mg” on the other, contains gabapentin 400 mg.
600 mg – Each white, elliptical, film-coated tablet with “Neurontin 600” printed on one side contains gabapentin 600 mg.
800 mg – Each white, elliptical, film-coated tablet with “Neurontin 800” printed on one side contains gabapentin 800 mg.
We do not sell Gabapentin to all patients!
Normally Gabapentin is suitable for all adult and children bigger than six years old. But you are not allowed to order Gabapentin online especially in our online pharmacies if you have any of following health conditions (But you are OK to order in your local street pharmacies):
- You are younger than 18 years old;
- You have kidney disease;
- Alcohol – you are addictive to alcohol, gabapentin may cause alcohol intolerance;
- diabetes – Gabapentin may affect blood sugar levels, you must find a local doctor to prescribe you Gabapentin.
- kidney disease,liver disease and heart diseases;
- a history of depression, mood disorder, drug abuse, or suicidal thoughts or actions;
- (for patients with RLS) if you are a day sleeper or work a night shift;
- You are breastfeeding mother or you are pregnant;
- have thoughts about suicide.
- If you are allergy to Gabapentin
Stop immediately if you have any thoughts about suicide. Donot order Gabapentin online if you have suicide thoughts. Please go to your doctor to have you completely checked.
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Gabapentin WARNINGS AND PRECAUTIONS
Neurontin (gabapentin) is not considered effective in the treatment of absence seizures and should therefore be used with caution in patients who have mixed seizure disorders that include absence seizures.
Discontinuation of Treatment with Neurontin
As with other anticonvulsant agents, abrupt withdrawal is not recommended because of the possibility of increased seizure frequency. There have been post-marketing reports of adverse events such as anxiety, insomnia, nausea, pain and sweating following abrupt discontinuation of treatment. (See ADVERSE REACTIONS, Post-Market Adverse Drug Reactions). When in the judgement of the clinician there is a need for dose reduction, discontinuation or substitution with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
Patients with uncontrolled epilepsy should not drive or handle potentially dangerous machinery. During clinical trials, the most common adverse reactions observed were somnolence, ataxia, fatigue, and nystagmus. Patients should be advised to refrain from activities requiring mental alertness or physical coordination until they are sure that Neurontin does not affect them adversely.
Central Nervous System Depression
Gabapentin has been associated with central nervous system (CNS) depression including sedation, somnolence, loss of consciousness as well as serious cases of respiratory depression. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment and the elderly are at higher risk of experiencing these severe adverse effects. Concomitant use of CNS depressants with gabapentin is also a contributing factor.
Concomitant Use With Opioids
Concomitant use of opioids with NEURONTIN potentiates the risk of respiratory depression, profound sedation, syncope, and death. Gabapentin concentrations may also increase in patients receiving concomitant opioid (See DRUG INTERACTIONS).
Patients who require concurrent treatment with opioids or other CNS depressants should be observed carefully for signs and symptoms of CNS depression, and the dose of gabapentin or opioid should be reduced accordingly. See also DOSAGE AND ADMINISTRATION, Dosing Considerations.
Carcinogenesis and Mutagenesis
Gabapentin produced an increased incidence of acinar cell adenomas and carcinomas in the pancreas of male rats, but not female rats or in mice, in oncogenic studies with doses of 2000 mg/kg which resulted in plasma concentrations 14 times higher than those occurring in humans at a dose of 2400 mg/day. The relevance of these pancreatic acinar cell tumours in male rats to humans is unknown, particularly since tumours of ductal rather than acinar cell origin are the predominant form of human pancreatic cancer. (See TOXICOLOGY, Carcinogenicity Studies).
The abuse and dependence potential of gabapentin has not been evaluated in human studies. Cases of abuse and dependence have been reported in the post-marketing database. These individuals were taking higher than recommended doses of gabapentin for unapproved uses. Most of the individuals described in these reports had a history of polysubstance abuse or used gabapentin to relieve symptoms of withdrawal from other substances. As with any CNS active drug, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of abuse or misuse of Neurontin (e.g. development of tolerance, self-dose escalation, and drug-seeking behavior).
There are rare post-marketing reports of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended doses of gabapentin used to treat illnesses for which the drug is not indicated. Such symptoms included agitation, disorientation and confusion after suddenly discontinuing gabapentin that resolved after restarting gabapentin. Most of these individuals had a history of poly-substance abuse or used gabapentin to relieve symptoms of withdrawal from other substances.
Serious Dermatological Reactions
There have been post-marketing reports of Stevens-Johnson syndrome (SJS) and Erythema multiforme (EM) in patients during treatment with gabapentin. Should signs and symptoms suggest SJS or ER, gabapentin should be discontinued immediately. (see Post-Marketing Adverse Drug Reactions)
There have been reports in the post-marketing experience of hypersensitivity including systemic reactions and cases of urticaria and angioedema. (see Post-Marketing Adverse Drug Reactions)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Severe, life-threatening, systemic hypersensitivity reactions such as Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients taking antiepileptic drugs including gabapentin.
It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Gabapentin should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
Prior to initiation of treatment with gabapentin, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity such as fever or lymphadenopathy may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
Gabapentin can cause anaphylaxis. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat and tongue and hypotension requiring emergency treatment. Patients should be instructed to discontinue gabapentin and seek immediate medical care should they experience signs or symptoms of anaphylaxis.
Gabapentin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall). There have also been postmarketing reports of agitation, confusion, loss of consciousness and mental impairment. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication. (See DOSAGE AND ADMINISTRATION, Dosing Considerations and Special Patient Populations).
Suicidal ideation and behaviour
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
All patients treated with antiepileptic drugs, irrespective of indication, should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
An FDA meta-analysis of randomized placebo controlled trials, in which antiepileptic drugs were used for various indications, has shown a small increased risk of suicidal ideation and behaviour in patients treated with these drugs. The mechanism of this risk is not known.
There were 43,892 patients treated in the placebo controlled clinical trials that were included in the meta-analysis. Approximately 75% of patients in these clinical trials were treated for indications other than epilepsy and, for the majority of non-epilepsy indications the treatment (antiepileptic drug or placebo) was administered as monotherapy. Patients with epilepsy represented approximately 25% of the total number of patients treated in the placebo controlled clinical trials and, for the majority of epilepsy patients, treatment (antiepileptic drug or placebo) was administered as adjunct to other antiepileptic agents (i.e., patients in both treatment arms were being treated with one or more antiepileptic drug). Therefore, the small increased risk of suicidal ideation and behaviour reported from the meta-analysis (0.43% for patients on antiepileptic drugs compared to 0.24% for patients on placebo) is based largely on patients that received monotherapy treatment (antiepileptic drug or placebo) for non-epilepsy indications. The study design does not allow an estimation of the risk of suicidal ideation and behaviour for patients with epilepsy that are taking antiepileptic drugs, due both to this population being the minority in the study, and the drug-placebo comparison in this population being confounded by the presence of adjunct antiepileptic drug treatment in both arms.
Pregnant Women: Based on animal data, gabapentin may cause fetal harm (see TOXICOLOGY – Reproduction Studies). In non-clinical studies in mice, rats and rabbits, gabapentin was developmentally toxic (e.g., increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses lower than the maximum recommended human dose (MRHD) of 3600 mg/day on a body surface area (mg/m2) basis.
Teratogenic Potential: Gabapentin crosses the human placental barrier. Although there are no adequate and well-controlled studies in pregnant women, congenital malformations and adverse pregnancy outcomes have been reported with gabapentin use, both from literature and Pregnancy Registries. Since the potential risk for humans is uncertain, gabapentin should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus. If women decide to become pregnant while taking NEURONTIN, the use of this product should be carefully re-evaluated.
Pregnancy Registry: Physicians are advised to recommend that pregnant patients taking NEURONTIN enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the following website: http://www.aedpregnancyregistry.org/.
Nursing Women: Gabapentin is excreted in human milk. There are no controlled studies on the effects of gabapentin on breast-fed infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made as to whether to discontinue nursing or to discontinue NEURONTIN, taking into account the benefit of the drug to the mother.
Pediatrics: The safety and efficacy in patients under the age of 18 have not been established.
Safety data in 39 patients between the ages of 12 and 18 years included in the double-blind, placebo-controlled trials showed that, at doses of 900 to 1200 mg/day, the incidence of adverse events in this group of patients was similar to that observed in older individuals.
In controlled clinical trials involving patients, 3 to 12 years of age (N=323), psychiatric adverse events such as emotional lability, hostility, hyperkinesia and thought disorder were reported at a higher frequency in patients treated with gabapentin compared to placebo.
Geriatrics: Systematic studies in geriatric patients have not been conducted. Adverse clinical events reported among 59 patients over the age of 65 years treated with Neurontin did not differ from those reported for younger individuals. The small number of individuals evaluated and the limited duration of exposure limits the strength of any conclusions reached about the influence of age, if any, on the kind and incidence of adverse events associated with the use of Neurontin.
As Neurontin is eliminated primarily by renal excretion, dosage adjustment may be required in elderly patients because of declining renal function. (See DOSAGE AND ADMINISTRATION, Dosing Considerations; ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Gabapentin Side Effects
Adverse Drug Reaction Overview
Commonly Observed Adverse Events
The most commonly observed adverse events associated with the use of Neurontin (gabapentin) in combination with other antiepileptic drugs, not seen at an equivalent frequency in placebo-treated patients, were somnolence, dizziness, ataxia, fatigue, nystagmus and tremor
(See Table 1).
Adverse Events Leading to Discontinuation of Treatment
Approximately 6.4% of the 543 patients who received Neurontin in the placebo-controlled studies withdrew due to adverse events. In comparison, approximately 4.5% of the 378 placebo-controlled participants withdrew due to adverse events during these studies. The adverse events most commonly associated with withdrawal were somnolence (1.2%), ataxia (0.8%), fatigue, nausea and/or vomiting and dizziness (all at 0.6%).
Clinical Trial Adverse Drug Reactions
Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
Incidence in Controlled Clinical Trials
Multiple doses of Neurontin were administered to 543 subjects with partial seizures in placebo controlled clinical trials of 12 weeks duration. In these studies, either Neurontin (at doses of 600, 900, 1200 or 1800 mg/day) or placebo was added to the patient’s current antiepileptic drug therapy. Treatment-emergent signs and symptoms that occurred in at least 1% of patients participating in these studies are listed in Table 1.
n= 543 (%)
n= 378 (%)
|Body as a Whole|
|Mouth or Throat Dry||1.7||0.5|
|Hematologic and Lymphatic Systems:|
|Skin and Appendages|
Dose-Related Treatment Emergent Adverse Events
Among the treatment-emergent adverse events occurring in Neurontin-treated patients, somnolence and ataxia appeared to exhibit a positive dose-response relationship. Patients treated with 1800 mg/day (n=54, from one controlled study) experienced approximately a two-fold increase, as compared to patients on lower doses of 600 to 1200 mg/day (n=489, from several controlled studies), in the incidence of nystagmus (20.4%), tremor (14.8%), rhinitis (13%), peripheral edema (7.4%), coordination abnormal, depression and myalgia (all at 5.6%). Adverse events were usually mild to moderate in intensity, with a median time to resolution of 2 weeks.
Data from long-term, open, uncontrolled studies shows that Neurontin treatment does not result in any new or unusual adverse events.
Other Adverse Events Observed in All Clinical Trials
Adverse events that occurred in at least 1% of the 2074 individuals who participated in all clinical trials, only some of which were placebo-controlled, are described below. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified COSTART dictionary terminology. These categories are used in the listing below. The frequencies presented represent the proportion of the 2074 patients exposed to Neurontin who experienced an event of the type cited on at least one occasion while receiving Neurontin. All reported events are included except those already listed in Table 1, those too general to be informative, and those not reasonably associated with the use of the drug.
Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.
Body As A Whole: Frequent: asthenia, malaise, face edema; Infrequent: allergy, generalized edema, weight decrease, chill; Rare: strange feelings, lassitude, alcohol intolerance, hangover effect.
Cardiovascular System: Frequent: hypertension; Infrequent: hypotension, angina pectoris, peripheral vascular disorder, palpitation, tachycardia, migraine, murmur; Rare: atrial fibrillation, heart failure, thrombophlebitis, deep thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular extrasystoles, bradycardia, premature atrial contraction, pericardial rub, heart block, pulmonary embolus, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis.
Digestive System: Frequent: anorexia, flatulence, gingivitis; Infrequent: glossitis, gum hemorrhage, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly; Rare: dysphagia, eructation, pancreatitis, peptic ulcer, colitis, blisters in mouth, tooth discolor, Perleche, salivary gland enlarged, lip hemorrhage, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal hemorrhage, esophageal spasm.
Endocrine System: Rare: hyperthyroid, hypothyroid, goiter, hypoestrogen, ovarian failure, epididymitis, swollen testicle, cushingoid appearance.
Hematologic and Lymphatic System: Frequent: purpura most often described as bruises resulting from physical trauma; Infrequent: anemia, thrombocytopenia, lymphadenopathy; Rare: WBC count increased, lymphocytosis, non-Hodgkin’s lymphoma, bleeding time increased.
Musculoskeletal System: Frequent: arthralgia; Infrequent: tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test; Rare: costochondritis, osteoporosis, bursitis, contracture.
Nervous System: Frequent: vertigo, hyperkinesia, paresthesia, decreased or absent reflexes, increased reflexes, anxiety, hostility; Infrequent: CNS tumors, syncope, dreaming abnormal, aphasia, hypesthesia, intracranial hemorrhage, hypotonia, dysesthesia, paresis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, decreased position sense, subdural hematoma, apathy, hallucination, decrease or loss of libido, agitation, paranoia, depersonalization, euphoria, feeling high, doped-up sensation, suicide attempt, psychosis; Rare: choreoathetosis, orofacial dyskinesia, encephalopathy, nerve palsy, personality disorder, increased libido, subdued temperament, apraxia, fine motor control disorder, meningismus, local myoclonus, hyperesthesia, hypokinesia, mania, neurosis, hysteria, antisocial reaction, suicide.
Respiratory System: Frequent: pneumonia; Infrequent: epistaxis, dyspnea, apnea; Rare: mucositis, aspiration pneumonia, hyperventilation, hiccup, laryngitis, nasal obstruction, snoring, bronchospasm, hypoventilation, lung edema.
Dermatological: Infrequent: alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cyst, herpes simplex; Rare: herpes zoster, skin discolor, skin papules, photosensitive reaction, leg ulcer, scalp seborrhea, psoriasis, desquamation, maceration, skin nodules, subcutaneous nodule, melanosis, skin necrosis, local swelling.
Urogenital System: Infrequent: hematuria, dysuria, urination frequency, cystitis, urinary retention, urinary incontinence, vaginal hemorrhage, amenorrhea, dysmenorrhea, menorrhagia, breast cancer, unable to climax, ejaculation abnormal; Rare: kidney pain, leukorrhea, pruritus genital, renal stone, acute renal failure, anuria, glycosuria, nephrosis, nocturia, pyuria, urination urgency, vaginal pain, breast pain, testicle pain.
Special Senses: Frequent: abnormal vision; Infrequent: cataract, conjunctivitis, eyes dry, eye pain, visual field defect, photophobia, bilateral or unilateral ptosis, eye hemorrhage, hordeolum, hearing loss, earache, tinnitus, inner ear infection, otitis, taste loss, unusual taste, eye twitching, ear fullness; Rare: eye itching, abnormal accommodation, perforated ear drum, sensitivity to noise, eye focusing problem, watery eyes, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, degenerative eye changes, blindness, retinal degeneration, miosis, chorioretinitis, strabismus, eustachian tube dysfunction, labyrinthitis, otitis externa, odd smell.
Post-Market Adverse Drug Reactions
Sudden, unexplained deaths in patients with epilepsy have been reported where a causal relationship to treatment with gabapentin has not been established.
Post-marketing adverse events that have been reported, which may have no causal relationship to gabapentin, are as follows: agitation, anaphylactic reaction, angioedema, blood creatine phosphokinase increased, blood glucose abnormal, drug rash with eosinophilia and systemic symptoms, fall, gynaecomastia, hepatic function abnormal, hepatitis, hepatitis cholestatic, hepatitis fulminant, hyperglycemia, hypoglycemia, hypersensitivity, hyponatremia, jaundice, loss of consciousness, pancreatitis, pulmonary oedema, renal failure acute, rhabdomyolysis, sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia), Stevens-Johnson syndrome.
Adverse events following the abrupt discontinuation of gabapentin have also been reported during postmarketing experience. The most frequently reported events were anxiety, insomnia, nausea, pain and sweating.
DOSAGE FORMS, COMPOSITION AND PACKAGING
Neurontin (gabapentin) capsules and tablets are supplied as follows:
Hard gelatin CONI-SNAP® capsules with white opaque body and cap printed with “PD” on one side and “Neurontin /100 mg” on the other. -bottles of 100 capsules
Hard gelatin CONI-SNAP® capsules with yellow opaque body and cap printed with “PD” on one side and “Neurontin /300 mg” on the other. -bottles of 100 capsules
Hard gelatin CONI-SNAP® capsules with orange opaque body and cap printed with “PD” on one side and “Neurontin /400 mg” on the other. -bottles of 100 capsules
600 mg tablets:
White, elliptical, biconvex, film-coated tablet with bisecting score on both sides and debossed with “NT” and “16” on one side. -bottles of 100 tablets
800 mg tablets:
White, elliptical biconvex, film-coated tablet with bisecting score on both sides and debossed “NT” and “26” on one side. -bottles of 100 tablets
Capsules contain : gabapentin, lactose, corn starch, and talc, Capsule shells may contain : gelatin, titanium dioxide, silicon dioxide, sodium lauryl sulfate, yellow iron oxide, red iron oxide, and FD&C Blue No. 2.
Tablets contain : gabapentin, poloxamer 407 NF, copolyvidone, corn starch, magnesium stearate, hydroxypropylcellulose, talc and candelilla wax.
ACTION AND CLINICAL PHARMACOLOGY
Mechanism of Action
Neurontin (gabapentin) readily enters the brain and prevents seizures in a number of animal models of epilepsy. Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid), but does not possess affinity for either GABAA or GABAB receptor.
Gabapentin binds with high affinity to the α2-δ (alpha-2-delta) subunit of voltage-gated calcium channels. Broad panel screening suggests it does not bind to other neurotransmitter receptors of the brain and does not interact with sodium channels.
The relevance of the binding activity of gabapentin to the anticonvulsant effects in animal models and in humans remains to be established (See DETAILED PHARMACOLOGY).
All pharmacological actions following gabapentin administration are due to the activity of the parent compound; gabapentin is not metabolized to a significant extent in humans.
Plasma gabapentin concentrations are dose-proportional at doses of 300 to 400 mg q8h, ranging between 1µg/mL and 10 µg/mL, but are less than dose-proportional above the clinical range (>600 mg q8h). There is no correlation between plasma levels and efficacy.
Gabapentin pharmacokinetics are not affected by repeated administration, and steady state plasma concentrations are predictable from single dose data. Gabapentin steady-state pharmacokinetics are similar for healthy subjects and patients with epilepsy receiving antiepileptic agents.
Absorption: Following oral administration of Neurontin (gabapentin), peak plasma concentrations are observed within 2 to 3 hours. Absolute bioavailability of a 300 mg dose of Neurontin capsules is approximately 59%. At doses of 300 and 400 mg, gabapentin bioavailability is unchanged following multiple dose administration.
Food has no effect on the rate or extent of absorption of gabapentin.
Distribution: Less than 3% of gabapentin is bound to plasma proteins. The apparent volume of distribution of gabapentin after 150 mg intravenous administration is 58+6 L (Mean + SD). In patients with epilepsy, gabapentin concentrations in cerebrospinal fluid are approximately 20% of corresponding steady-state trough plasma concentrations.
Metabolism: Gabapentin is not metabolized to a significant extent in humans. Gabapentin does not induce or inhibit hepatic mixed function oxidase enzymes responsible for drug metabolism and does not interfere with the metabolism of commonly coadministered antiepileptic drugs.
Excretion: Gabapentin is eliminated solely by renal excretion as unchanged drug, and can be removed from plasma by hemodialysis. Gabapentin elimination rate constant, plasma clearance and renal clearance are directly proportional to creatinine clearance. The elimination half-life of gabapentin is independent of dose and averages 5 to 7 hours in subjects with normal renal function.
Table 3 summarizes the mean steady-state pharmacokinetic parameters of Neurontin capsules.
|Pharmacokinetic Parameter||300 mg (N = 7)||400 mg (N = 11)|