Vultin 100/Vultin 300

Vultin 100/Vultin 300

gabapentin

Manufacturer:

Unison

Distributor:

Health Alliance
Full Prescribing Info
Contents
Gabapentin.
Description
Each capsule contains: Gabapentin 100 mg.
Each capsule contains: Gabapentin 300 mg.
Action
Pharmacology: Systemic: Anticonvulsant action - Gabapentin does not interact with GABA receptors, is not metabolized to a GABA agonist or to GABA, and does not inhibit GABA uptake or degradation. In rats, Gabapentin interacts with a novel blinding site on cortical neurons that may be associated with the L-system amino acid transporter of brain cell membranes.
Analgesic action - Gabapentin prevents pain-related behavior in response to a normally innocuous stimulus (allodynia) and exaggerated response to painful stimuli (hyperalgesia) in animal models. In models of neuropathic pain in rats or mice, Gabapentin prevents pain-related responses. Pain-related responses after peripheral inflammation were also decreased by Gabapentin. Immediate pain-related behaviors (rat tail flick test, formalin footpad acute phase, acetic acid abdominal constriction test, footpad heat irradiation test) were not altered by Gabapentin.
Pharmacokinetics: Absorption: Rapid absorbed; Bioavailability: 27% to 60%; food increases absorption.
Distribution: Vd: 50 to 60 L.
Metabolism: Not metabolized.
Excretion: Renal: Entire absorbed dose unchanged.
Elimination Half-life: 5 to 7 hours.
Indications/Uses
Epilepsy: Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above.
Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
Treatment of peripheral neuropathic pain: Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.
Dosage/Direction for Use
Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid-intake (e.g. a glass of water).
For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading as follows. (See Table 1.)

Click on icon to see table/diagram/image

Discontinuation of Gabapentin: In accordance with current clinical practice, if Gabapentin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication.
Epilepsy: Epilepsy typically requires long-term therapy. Dosage is determined by the treating physician according to individual tolerance and efficacy.
Adults and adolescents: In clinical trials, the effective dosing range was 900 to 3600 mg/day. Therapy may be initiated by titrating the dose as described in Table 1 or by administering 300 mg three times a day (TID) on Day 1. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. Slower titration of Gabapentin dosage may be appropriate for individual patients. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks. Dosages up to 4800 mg/day have been well tolerated in long-term open-label clinical studies. The total daily dose should be divided in three single doses; the maximum time interval between the doses should not exceed 12 hours to prevent breakthrough convulsions.
Children aged 6 years and above: The starting dose should range from 10 to 15 mg/kg/day and the effective dose is reached by upward titration over a period of approximately three days. The effective dose of Gabapentin in children aged 6 years and older is 25 to 35 mg/kg/day. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The total daily dose should be divided in three single doses, the maximum time interval between doses should not exceed 12 hours.
It is not necessary to monitor Gabapentin plasma concentrations to optimize Gabapentin therapy. Further, Gabapentin may be used in combination with other antiepileptic medicinal products without concern for alteration of the plasma concentrations of Gabapentin or serum concentrations of other antiepileptic medicinal products.
Peripheral neuropathic pain: Adults: The therapy may be initiated by titrating the dose as described in Table 1. Alternatively, the starting dose is 900 mg/day given as three equally divided doses. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. Slower titration of Gabapentin dosage may be appropriate for individual patients. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks.
In the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia, efficacy and safety have not been examined in clinical studies for treatment periods longer than 5 months. If a patient requires dosing longer than 5 months for the treatment of peripheral neuropathic pain, the treating physician should assess the patient's clinical status and determine the need for additional therapy.
Instruction for all areas of indication: In patients with poor general health, i.e., low body weight, after organ transplantation etc., the dose should be titrated more slowly, either by using smaller dosage strengths or longer intervals between dosage increases.
Use in elderly patients (over 65 years of age): Elderly patients may require dosage adjustment because of declining renal function with age (see Table 2). Somnolence, peripheral edema and asthenia may be more frequent in elderly patients.
Use in patients with renal impairment: Dosage adjustment is recommended in patients with compromised renal function as described in Table 2 and/or those undergoing hemodialysis. Gabapentin 100 mg capsules can be used to follow dosing recommendations for patients with renal insufficiency. (See Table 2.)

Click on icon to see table/diagram/image

Use in patients undergoing hemodialysis: For anuric patients undergoing hemodialysis who have never received Gabapentin, a loading dose of 300 to 400 mg, then 200 to 300 mg of Gabapentin following each 4 hours of hemodialysis, is recommended. On dialysis-free days, there should be no treatment with Gabapentin.
For renally impaired patients undergoing hemodialysis, the maintenance dose of Gabapentin should be based on the dosing recommendations found in Table 2. In addition to the maintenance dose, an additional 200 to 300 mg dose following each 4-hour hemodialysis treatment is recommended.
Overdosage
Clinical effects of overdose: CNS effects appear to be the most prevalent and include somnolence, ataxia, dizziness, slurred speech, and double vision. Other effects have included gastrointestinal symptoms, especially diarrhea, and mild hypotension. Slurred speech and somnolence were the only reported clinical findings following an overdose of 108 grams. Withdrawal seizures were reported in an adult following a 2 day absence of seft-titrated dose of 8000 mg daily for 9 months.
Treatment of exposure: Decontamination: Consider activated charcoal if soon after ingestion and patient is able to protect their airway.
Support: Treatment is symptomatic and supportive.
Hypotensive episode: Monitor vital signs regularly. Administer 0.9% saline 10 to 20 mL/kg. Dopamine or norepinephrine if significant hypotension persists.
Seizure: IV henzodiazepines, barbiturates.
Monitoring of patient: Monitor mental status and vital signs carefully in symptomatic patients.
Hemodialysis: Gabapentin may be removed by hemodialysis; however since toxicity after acute overdose is generally mild it is unlikely to be necessary. Hemodialysis may be indicated by the patient's clinical status or in patients with significant renal impairment.
Contraindications
Hypersensitivity to Gabapentin.
Special Precautions
Abrupt discontinuation may precipitate status epilepticus.
Renal insufficiency.
Suicidality, increased risk of; based on data analysis of 199 placebo-controlled studies of 11 antiepileptic drugs, small elevated risk occurred as early as 1 week after starting therapy and continued to at least 24 weeks.
Adverse Reactions
Common: Cardiovascular: Peripheral edema.
Musculoskeletal: Myalgia.
Neurologic: Ataxia, Dizziness, Hyperactive behavior (1.8%), Nystagmus, Somnolence, Tremor.
Psychiatric: Disorder of form of thought (1.7%), Hostile behavior (4.9%), Mood swings (4.7%).
Other: Fatigue.
Serious: Dermatologic: Stevens-Johnson syndrome (rare).
Neurologic: Seizure (infrequent).
Drug Interactions
Moderate: Probable: Aluminium Carbonate (Basic), Aluminium Hydroxide, Aluminium Phosphate, Dihydroxyaluminium Aminoacetate, Dihydroxyaluminium Sodium Carbonate, Ginkgo, Magaldrate, Magnesium Carbonate, Magnesium Hydroxide, Magnesium Oxide, Magnesium Trisilicate.
Storage
Store at temperature not more than 25°C.
ATC Classification
N03AX12 - gabapentin ; Belongs to the class of other antiepileptics.
Presentation/Packing
Cap 100 mg x 10 x 10's. 300 mg x 10 x 10's.
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