Gabapentin is a prescription drug most commonly prescribed to relieve nerve pain following shingles in adults, treating the pain of post herpetic neuralgia.
Gabapentin mg capsules
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalisation in adults and children aged 6 years and above see section 5. Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalisation in adults and adolescents aged 12 years and above. Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.
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 later in this section.
Table 1. 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 typically requires long-term therapy. Dosage is determined by the treating physician according to individual tolerance and efficacy. Therapy may be initiated by titrating the dose as described in Table 1 or by administering mg three times a day TID on Day 1.
Slower titration of gabapentin dosage may be appropriate for individual patients. 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. 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. The therapy may be initiated by titrating the dose as described in Table 1. 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.
In patients with poor general health, i. Elderly patients may require dosage adjustment because of declining renal function with age see Table 2. Somnolence, peripheral oedema and asthenia may be more frequent in elderly patients. Gabapentin capsules can be used to follow dosing recommendations for patients with renal insufficiency.
Gabapentin: what to know
Table 2. For anuric patients undergoing haemodialysis who have never received gabapentin, a loading dose of to mg, then to mg of gabapentin following each 4 hours of haemodialysis, is recommended. On dialysis-free days, there should be no treatment with gabapentin. For renally impaired patients undergoing haemodialysis, the maintenance dose of gabapentin should be based on the dosing recommendations found in Table 2. In addition to the maintenance dose, an additional to mg dose following each 4-hour haemodialysis treatment is recommended.
Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid intake e. Severe, life-threatening, systemic hypersensitivity reactions such as Drug rash with eosinophilia and systemic symptoms DRESS have been reported in patients taking antiepileptic drugs including gabapentin see section 4.
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 s or symptoms are present, the patient should be evaluated immediately. Gabapentin should be discontinued if an alternative etiology for the s or symptoms cannot be established. Gabapentin can cause anaphylaxis. s 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 s or symptoms of anaphylaxis see section 4. Suicidal ideation and behaviour have been reported in tablets treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic Gabapentin has also shown a small increased risk of suicidal ideation and behaviour.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Gabapentin. Therefore patients should be monitored for s of suicidal ideation and behaviours and appropriate treatment should be considered. Patients and caregivers of patients should be advised to seek medical advice should s of suicidal ideation or behaviour emerge. If a patient develops acute pancreatitis under treatment with gabapentin, discontinuation of gabapentin should be considered see section 4. Although there is no evidence of rebound effects with gabapentin, abrupt withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus see section 4.
As with other antiepileptic medicinal products, some patients may experience an increase in seizure frequency or the 300 of new types of seizures with gabapentin. As with other anti-epileptics, attempts to withdraw concomitant anti-epileptics in treatment refractory patients on more than one anti-epileptic, in order to reach gabapentin monotherapy have a low success rate. Gabapentin is not considered effective against primary generalized seizures such as absences and may aggravate these seizures in side patients.
Therefore, gabapentin should be used with caution in patients with mixed seizures including absences. Gabapentin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury fall. There have also been post-marketing reports of loss of consciousness, confusion and mental impairment.
Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product.
Patients who require concomitant treatment with opioids should be carefully observed for s of central nervous system CNS depression, such as somnolence, sedation and respiratory depression. Patients who use gabapentin and tablet concomitantly may experience increases in gabapentin concentrations. The dose of gabapentin or opioids should be reduced appropriately see section 4. Gabapentin has been associated with severe respiratory depression. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction.
Dose adjustments might be necessary in these patients. No systematic studies in Gabapentin 65 years or older have been conducted with 300. In one double blind study in patients with neuropathic pain, somnolence, peripheral oedema and asthenia occurred in a somewhat higher percentage in patients aged 65 years or above, than in younger patients.
Apart from these findings, clinical investigations in this age group do not indicate an adverse event profile different from that observed in younger effects. The effects of side greater than 36 weeks gabapentin therapy on learning, intelligence, and development in children and adolescents have not been adequately studied.
The benefits of prolonged therapy must therefore be weighed against the potential risks of such therapy. Cases of abuse and dependence have been reported in the post-marketing database. Carefully evaluate patients for a history of drug abuse and observe them for possible s of gabapentin abuse e.
False positive readings may be obtained in the semi-quantitative determination of total urine protein by dipstick tests. It is therefore recommended to verify such a positive dipstick test result by methods based on a different analytical principle such as the Biuret method, turbidimetric or dye-binding methods, or to use these alternative methods from the beginning.
Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose galactose malabsorption should not take this medicine. In some of these reports, the authors considered this a particular concern with the combination of gabapentin and opioids, especially in elderly patients.
Therefore, patients who require concomitant treatment with opioids should be carefully observed for s of CNS depression, such as somnolence, sedation and respiratory depression and the dose of gabapentin or opioid should be reduced appropriately. No interaction between gabapentin and phenobarbital, phenytoin, valproic acid, or carbamazepine has been observed. Gabapentin steady-state pharmacokinetics are similar for healthy subjects and patients with epilepsy receiving these antiepileptic agents. It is recommended that gabapentin be taken at the earliest two hours following antacid administration.
A slight decrease in renal excretion of gabapentin that is observed when it is coadministered with cimetidine is not expected to be of clinical importance.
The risk of birth defects is increased by a tablet of 2 — 3 in the Gabapentin of mothers treated with an antiepileptic medicinal product. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Multiple antiepileptic drug therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practiced whenever side. Effects advice should be given to women who are likely to become pregnant or who are of childbearing potential and the need for antiepileptic treatment should 300 reviewed when a woman is planning to become pregnant.
No sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and. Developmental delay in children of mothers with epilepsy has been observed rarely. It is not possible to differentiate if the developmental delay is caused by genetic, social factors, maternal epilepsy or the antiepileptic therapy. Studies in animals have shown reproductive toxicity see section 5.
The potential risk for humans is unknown. Gabapentin should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.
No definite conclusion can be made as to whether gabapentin is associated with an increased risk of congenital malformations when taken during pregnancy, because of epilepsy itself and the presence of concomitant antiepileptic medicinal products during each reported pregnancy. Gabapentin is excreted in human milk. Because the effect on the breast-fed infant is unknown, caution should be exercised when gabapentin is administered to a breast-feeding mother. Gabapentin should be used in breast-feeding mothers only if the benefits clearly outweigh the risks.