| Transport Package: | Carton |
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| Specification: | Gabapentin |
| Trademark: | Focus |
| Origin: | China |
| Customization: |
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Audited Supplier | Product name | Gabapentin Capsulespentin Capsule |
| Main Ingredients | Gabapentin |
| Dosage form | Capsule |
| Adaptation disease | 1. Post-herpetic neuralgia: used for the treatment of post-herpetic neuralgia in adults. 2. Epilepsy: Adjunctive therapy for partial seizures in adults and children over 12 years of age with or without secondary systemic seizures. It can also be used for the adjunctive treatment of partial seizures in children aged 3 ~ 12 years. |
| Character | The content of this product is white or quasi-white powder or particles. |
| Specification | (1)0.1g; (2)0.3g; (3)0.4g |
| Usage and dosage | 1. Adult neuralgia after herpes infection: one dose of 0.3g gabapentin on the first day, 0.6g on the second day, divided into two doses; On the third day, take 0.9g in three doses. The dose can then be gradually increased to 1.8g per day in three doses, depending on the need for pain relief. In foreign clinical studies, the efficacy was comparable in the 1.8g to 3.6g daily dose range, and no additional benefit was shown at doses above 1.8g daily. 2. Epilepsy: Gabapentin may be used in combination with other antiepileptic drugs. Gabapentin is administered orally in divided doses (3 times daily). The method of administration is gradually increased from an initial low dose to an effective dose. Patients over 12 years old: 0.3g each time, once a day, on the first day of administration; On the second day, 0.3g, twice a day, on the third day, 0.3g, three times a day, and then maintain the same dose. According to foreign literature, the dosage of gabapentin can be increased to 1.8g per day, and some patients can tolerate the dosage up to 2.4g per day. The safety of doses beyond 2.4g/day is uncertain. Pediatric patients aged 3 to 12 years: the initial dose should be 10 to 15mg/kg/d, 3 times daily, reaching an effective dose in approximately 3 days. The effective dose of gabapentin is 25 to 35mg/kg/d, three times daily, in patients over 5 years of age. The effective dose for pediatric patients aged 3 to 4 years is 40mg/kg/d, three times daily. If necessary, the dose can be increased to 50mg/kg/d. Long-term clinical studies have shown that doses up to 50mg/kg/d are well tolerated. The maximum interval between doses should not exceed 12 hours. In order to reduce the occurrence of dizziness, drowsiness and other adverse reactions, the first day of medication can be taken before going to bed. There is no need to monitor gabapentin blood concentration during gabapentin administration. Moreover, since gabapentin has no significant pharmacokinetic interaction with other conventional antiepileptics, combination therapy with gabapentin does not alter the plasma concentration of these conventional antiepileptics. Discontinuation of gabapentin or the introduction of a new regimen should be phased in gradually for at least one week during treatment. Creatinine clearance is difficult to measure in outpatients. Creatinine clearance (CCr) in patients with stable renal function can be reasonably estimated based on Cockcroft and Gault's equation: Female CCr =(0.85)(140-age)(weight)/[(72)(SCr)] Male CCr =(140-age)(weight)/[(72)(SCr)] where the age unit is years, the weight unit is kg,SCr is serum creatinine, the unit is mg/dL. The following dose adjustments are recommended for patients over 12 years of age with renal impairment or undergoing hemodialysis: Table 1. Adjustment of gabapentin dose according to patients' renal function a. Administration on alternate days. B. Patients who did not receive gabapentin received an initial dose of 0.3 to 0.4g, followed by 0.2 to 0.3g of gabapentin every 4 hours of dialysis. No studies have been conducted on gabapentin in patients under 12 years of age with renal impairment. Dosing in elderly patients: Because elderly patients are likely to have reduced renal function, dosing should be carefully selected and should be adjusted for creatinine clearance in these patients. |
| Storage | seal preservation |
| Origin | China |
| Validity | 24 months |
| Tatoo | Gabapentin is contraindicated in persons with a known allergy to any of its ingredients. Gabapentin is contraindicated in patients with acute pancreatitis. Gabapentin is not effective in patients with primary systemic seizures, such as absence seizures. |
| Notice | 1. Drug reactions with eosinophilia and systemic symptoms (DRESS)/ multi-organ hypersensitivity, also known as multi-organ hypersensitivity, have been reported in patients treated with antiepileptic drugs, including gabaptin. Some of these incidents were fatal or life-threatening. The typical but nonspecific presentation of DRESS is fever, rash, and/or lymphadenopathy with involvement of other organ systems, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis (sometimes similar to an acute viral infection). Eosinophilia is often present. Due to the variable presentation of the disease, other organ systems not listed here may also be involved. It is important to note that early manifestations of hypersensitivity may occur, such as fever or lymphadenopathy, although the rash is not yet apparent. If such signs or symptoms are present, the patient should be evaluated immediately. Gabapentin should be discontinued if other causes of these signs or symptoms cannot be determined. Anaphylaxis and edema gabapentin may develop anaphylaxis and angioedema during the first dose or at any time during treatment. Reported signs and symptoms include difficulty breathing, swelling of the lips, throat and tongue, and low blood pressure requiring urgent treatment. Inform patients to discontinue gabapentin and seek immediate medical attention at the onset of signs or symptoms of anaphylaxis or angioedema. Effects on driving and operating heavy machinery Patients taking gabapentin should not drive a vehicle until they have gained sufficient experience to assess whether gabapentin impairs their ability to drive. Drivability studies using gabapentin prodrugs have shown that gabapentin may cause severe impaired driving. Physicians and patients should be aware that patients do not have the ability to assess their own driving ability and to assess the level of drowsiness caused by gabapentin. The duration of driving injury after treatment with gabapentin is unknown. Whether this damage is related to drowsiness or other effects of gabapentin is unclear. In addition, because gabapentin can cause drowsiness and dizziness, patients are advised not to operate complex mechanical devices until they have gained sufficient experience to assess whether gabapentin will impair their ability to perform such tasks. Drowsiness/sedation and dizzy in > 12 control of epilepsy patients in the study, patients with a daily dose of 1800 mg of gabapentin, drowsiness, dizziness, ataxia, significantly higher than the placebo group, the incidence of sleepiness, incidence of gabapentin group and placebo group were 19% and 9% respectively, dizziness were 17% and 7% respectively, ataxia were 13% and In these studies, drowsiness, ataxia, and fatigue were the most common adverse events leading to drug discontinuation in patients older than 12 years of age, at 1.2%, 0.8%, and 0.6%, respectively. In clinical trials of patients with postherpetic neuralgia, the incidence of drowsiness and dizziness was higher in the gabapentin group than in the placebo group at a dose of 3600mg, with drowsiness occurring in 21% and 5% of gabapentin and dizziness occurring in 28% and 8% of placebo, respectively. Dizziness and drowsiness were the most common adverse reactions leading to drug withdrawal. Gabapentin may have a potential synergistic effect when combined with other sedative agents and should be closely watched for signs of inhibition of the central nervous system, such as drowsiness and sedation. In addition, if morphine is used with gabapentin, the blood concentration of gabapentin may increase, requiring dose adjustment. Antiepileptic drugs should not be stopped abruptly as they may increase the frequency of seizures. In placebo-controlled studies in patients >12 years of age, the incidence of epileptic persistence was 0.6%(3/543) in patients receiving gabapentin versus 0.5%(2/378) in patients receiving placebo. Among 2074 patients >12 years of age treated with gabapentin in all studies (control and non-control),31 (1.5%) had persistent epilepsy. Fourteen of the patients had no prior history of epileptic persistence (prior to treatment or while taking other medications). Due to the lack of adequate medical history, it is not possible to determine whether gabapentin patients had a higher or lower incidence of epileptic persistence compared to similar patients who did not receive gabapentin. Suicidal behavior and ideation In patients treated with antiepileptics (AED) for any indication, antiepileptics (including gabapentin) increase the risk of suicidal thoughts or behavior. During AED treatment, patients should be monitored for symptoms or exacerbations of depression, suicidal thoughts or behavior, and/or any abnormal changes in mood or behavior. A pooled analysis of 199 placebo-controlled clinical trials that included 11 different AEDs (monotherapy and adjuvant therapy) found that the risk of suicidal thoughts or behavior in patients treated with AED was approximately double that in those treated with placebo (adjusted relative risk: 1.8,95% confidence interval: 1.2, 2.7). The median treatment time in these trials was 12 weeks, and the estimated incidence of suicidal behaviors or thoughts was 0.43% for 27,863 patients in the AED group and 0.24% for 16,029 patients in the placebo group, indicating an increase of approximately 1 patient for every 530 patients treated with suicidal thoughts or behaviors. There were 4 suicides in the drug treatment group and none in the placebo group. But the number of cases is too small to draw any conclusions about the effects of the drugs on suicide. An increased risk of suicidal thoughts or behavior was observed one week after initiation of AED treatment and persisted throughout the treatment evaluation period. The risk of suicidal thoughts or behavior after 24 weeks was not assessed because most of the clinical trials included in the analysis were not longer than 24 weeks. The risk of suicidal thoughts or behaviors associated with the drugs included in the data analysis was consistent. The risk was found across AEDs with different mechanisms of action and for multiple indications, suggesting that this risk is prevalent across all INDICATIONS for AEDs. No significant change in risk with age (5-100 years) was found in the clinical trials analyzed. Table 5 shows the absolute and relative risks of the ASSESSED AEDs for different indications. Table 5 Combined risk analysis of antiepileptic drugs for different indications The relative risk of suicidal thoughts or behaviors in epilepsy clinical trials was higher than in psychosis or other clinical trials, but the absolute risk difference for epilepsy and psychosis was similar. When considering prescribing gabapentin or any other AED, the risk of suicidal thinking or behavior must be weighed against the risk of untreated disease. Epilepsy, and many other conditions for which AEDs are used, are already at higher risk of suicidal thoughts and behaviors due to their morbidity and mortality. So, if suicidal thoughts and behaviors occur during treatment, the prescriber needs to consider whether the patient with these symptoms is related to the illness he or she is treating. Patients, caregivers and family members should be informed that gabapentin and other aeDs increase the risk of suicidal thoughts and behavior. They were advised to watch for the onset or worsening of signs and symptoms of depression, any abnormal mood or behavioral changes, or the occurrence of suicidal thoughts and behaviors, or the appearance of thoughts of self-harm. Report suspicious behavior to medical personnel immediately. Neuropsychiatric adverse reactions (children aged 3 to 12 years) Gabapentin used in epileptic children aged 3 to 12 years is associated with central nervous system-related adverse reactions. The most notable incidents fall into the following categories: 1) emotional instability (primarily behavioral problems),2) hostility, including aggressive behavior,3) thinking disorders, including difficulty concentrating and changes in school performance, and 4) hyperactivity (primarily restlessness and hyperactivity). In patients treated with gabapentin, most adverse reactions were mild to moderate. In controlled trials in children aged 3 to 12, the incidence of these adverse events was: mood instability in 6% of gabapentin patients and 1.3% of placebo patients; Hostility 5.2% and 1.3%; Overactive 4.7% and 2.9%; And thinking disorders 1.7% and 0%. One of the reports of hostility was considered serious. 1.3% of patients who reported mood instability and hyperactivity discontinued gabapentin treatment, and 0.9% of patients who reported hostility and trouble thinking discontinued gabapentin treatment. One placebo-treated patient (0.4%) discontinued medication due to mood instability. Potential carcinogenic effects In an oral carcinogenicity study, gabapentin increased the incidence of pancreatic acinar cell tumors in rats. The clinical significance of this finding is unclear. Clinical experience in premarket development of gabapentin does not provide a direct way to evaluate its potential carcinogenic effects in humans. A clinical study of adjuvant epilepsy in patients >12 years of age included 2085 patient years of exposure. During treatment with gabapentin or within 2 years after withdrawal,10 patients reported new tumors (2 in the breast,3 in the brain,2 in the lung,1 in the adrenal gland,1 in non-Hodgkin's lymphoma, and 1 in situ endometrioma), and 11 patients reported prior tumor progression (9 in the brain,1 in the breast, and 1 in the prostate). Lack of background information on incidence and recurrence rates in similar populations not treated with gabapentin makes it impossible to determine whether the rates observed in the study cohort are treaty-related. Sudden unexplained deaths in patients with epilepsy During the premarket development phase of gabapentin, eight sudden unexplained deaths were recorded in 2203 patients treated (2103 patient-years of exposure). Some of these seizure-related deaths were not observed as seizures, for example, occurring at night. The incidence of death was 0.0038 per patient year. Although this rate exceeded what would be expected in a healthy population (age - and sex-matched), sudden unexplained mortality was greater than that in patients with epilepsy who did not receive gabapentin (range: 0.0005 in the general epilepsy population; Clinical trial population similar to the population studied with Gabapentin. Patients with refractory epilepsy. 0.005) were still within its range. Therefore, whether these figures are reliable or require further attention depends on the comparability of the apentin group and the accuracy of the estimates included in the report. Abuse of gabapentin does not show affinity for benzodiazepine, opioid (μ, δ, or κ), or cannabinoid 1 receptor sites. A small number of post-marketing cases have reported misuse and abuse of gabapentin. These individuals were taking a higher than recommended dose of gabapentin for an unapproved use. Most of the individuals described in these reports had a history of multiple substance abuse or were using gabapentin to relieve withdrawal symptoms of other substances. When prescribing gabapentin, a patient's history of substance abuse should be carefully evaluated and signs and symptoms of misuse or abuse of gabapentin (e.g., tolerance development, self-dosing, and drug seeking behavior) should be observed. Drug dependence There have been few post-market reports of individuals who stopped taking a higher than recommended dose of gabapentin for an unapproved condition with withdrawal symptoms for a short period of time. The symptoms, which include agitation, disorientation and confusion, appear when gabapentin is abruptly stopped and resolve when the drug is resumed. Most of these individuals had a history of multiple substance abuse or were using gabapentin to relieve withdrawal symptoms of other substances. The potential dependence and abuse of gabapentin has not been evaluated in human studies. In controlled clinical studies,16% of patients had blood glucose fluctuations that could be clinically significant (< 3.3mmol/L or ≥7.8mmol/L, normal range 3.5 to 5.5mmol/L). Therefore, patients with diabetes need to monitor blood glucose frequently and adjust the dosage of hypoglycemic drugs at any time if necessary. There have been reports of hemorrhagic pancreatitis with gabapentin. Therefore, if clinical symptoms of pancreatitis (persistent abdominal pain, nausea, and repeated vomiting) occur, gabapentin should be stopped immediately and a comprehensive physical examination, clinical and laboratory tests should be performed to diagnose pancreatitis as soon as possible. The use of gabapentin in patients with chronic pancreatitis is not sufficiently experienced and should be determined by the physician. 2. Gabapentin is used by pregnant and lactating women. Currently, there is no experience of gabapentin being used by pregnant women. Gabapentin is secreted in breast milk and the possibility of serious adverse reactions in infants cannot be ruled out. Therefore, lactating women should discontinue breastfeeding or gabapentin when gabapentin must be used (in view of the need for antiepileptic treatment in the mother). 3. Medication for children. For the usage and dosage of children, see "Usage and dosage". The safety and efficacy of gabapentin in the treatment of postherpetic neuralgia in children has not been established. The safety and efficacy of gabapentin in the adjunctive treatment of partial epileptic epilepsy under 3 years of age has not been established. 4. Use of gabapentin for the elderly. In the controlled clinical trials of postherpetic neuralgia, a total of 336 patients were treated with gabapentin, of which 102 (30%) were 65-75 years old and 168 (50%) were over 75 years old. Patients 75 and older had a greater effect than younger patients who received the same dose. Since gabapentin is almost entirely eliminated by renal excretion, the greater therapeutic effect in patients over 75 years of age may be the result of higher plasma exposure at a given dose, which is associated with age-related renal decline. But other causes cannot be ruled out. With the exception of peripheral edema and ataxia, which increased with age, the types and incidence of other adverse events were similar across age groups. The gabapentin clinical trial in patients with epilepsy did not have a sufficient number of patients aged 65 and older to determine whether older patients responded differently from younger patients. Other reported clinical experience found no difference in response between older and younger adults. In general, due to the decline of liver function, kidney function and heart function in the elderly, as well as more concomitant diseases or medications, the elderly should be carefully selected, usually with a lower initial dose. Because gabapentin is excreted by the kidneys, patients with impaired kidney function are at increased risk of toxicity from gabapentin. Because elderly patients are more likely to have reduced renal function, the dose selection should be careful and should be adjusted according to creatinine clearance. |
Usage:
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Services we can provide:
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8.Raw materials from Chinese origin.
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