Neurontin hard capsules 300mg Pfizer treatment support in local epilepsy (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Gabapentin

Ingredient

Composition information	Content
Gabapentin	300mg

Uses

Indications

Neurontin 300mg is indicated in the following cases:

epilepsy

Gabapentin is indicated as a single therapy in the treatment of local seizures whether or not there are secondary bonds in adults and children over 12 years old. Accompanied by secondary attacks in adults and children 3 years and older. The safety and effectiveness of the supporting treatment regimen, using gabapentin in pediatric patients under 3 years old have not been established.

Gabapentin is indicated for neurological pain in adults aged 18 and over. Gabapentin's safety and effectiveness in patients under 18 years of age have not been established.

Pharmacokology

Gabapentin pharmacological properties easily enter the brain and prevent convulsions in some animal epilepsy models. Gabapentin has no affinity for both Gabaa and Gabab receptors and does not change the transformation of GABA. Gabapentin is not associated with other neurotransmitter receptors in the brain and does not interact with sodium channels. Gabapentin is associated with high pressure on the subunit α2 (Alpha - 2 - Delta) of voltage transmission sluice gates of calcium channels and gabapentin attached to subunit α2 is thought to be related to gabapentin convulsions effects in animal. Screening at transmission citizens does not suggest any other effect of the drug outside α2.

Evidence from many preclinical models shows that Gabapentin's pharmacological effects may be due to the attachment to the α2 receptor, thereby reducing the release of stimulating neurotransmitters in the central nervous system areas. This may be the cause of gabapentin convulsions. The relationship between the activity of gabapentin and anti -convulsions on humans has not been set up.

pharmacokinetics

Gabapentin's bioavailability is not proportional to the dose. This means that when increasing the dose, its bioavailability decreases. After drinking, the peak concentration of Gabapentin in plasma is achieved within 2-3 hours. The absolute bioavailability of Gabapentin capsules is approximately 60%. Food, including a high -fat diet, does not affect Gabapentin's dynamics. Gabapentin elimination from plasma is most clearly described by linear pharmacokinetic properties.

Gabapentin waste sale time in plasma does not depend on the dose and is within the average from 5 - 7 hours.

In epilepsy patients, gabapentin concentrations in cerebrospinal fluid are approximately 20% of its lowest concentration in the corresponding constant concentration state in plasma.

There is no evidence of gabapentin metabolism in Gabapentin people who do not induce oxidase enzymes that have a mixed function in the liver responsible for drug metabolism.

gabapentin only excreted through the kidneys. Gabapentin is excluded from plasma by dialysis. Therefore, the dose adjustment in patients with renal function decline or patients are dialysis.

Before taking Neurontin hard capsules 300mg Pfizer treatment support in local epilepsy (10 blisters x 10 tablets)

How to use

gabapentin is used orally or drinking with food.

Dosage

General

When evaluating clinically, it is necessary to reduce the dose, stop the drug or replace it with another optioned drug, this job should be done slowly within a minimum of 1 week.

In the treatment of epilepsy

For adults and pediatric patients over 12 years old

Clinical trials show that the effective dose of Gabapentin is from 900 to 3600mg/day. It is possible to start treatment using 300mg, 3 times/day (TID) on day 1, or by standard dose as described in Table 1. After that, the dose may be increased to a maximum dose of 3600mg/day divided into 3 times equal. Dosage up to 4800mg/day has been well tolerated in open, long -term clinical studies. The maximum time between doses in the dose regimen 3 times/day (TID) should not exceed 12 hours to avoid outbreaks. Table 1 Dosage table - Initial dose standard 900mg 300mg qda 300mg BIDB 300mg TIDC

Pediatric patients aged 3-12 years old

Initial dose should be in the range of 10-15mg/kg/day divided into equal doses (3 times/day), and the effective dose is achieved by the standard dose for about 3 days. The age of less than 5 years old is 40 mg/kg/day divided into equal doses (3 times/day). The maximum distance between doses should not exceed 12 hours. Moreover, Gabapentin can be used in combination with other anti -epileptic drugs without having to pay attention to the change of gabapentin concentration or the concentration of other anti -epileptic drugs in plasma.

In the treatment of neurological pain in adults

The starting dose is 900mg/kg divided into 3 small doses and increases if necessary, depending on the response, related to the maximum dose of 3600mg/day. Treatment should be started by the standard dose as described in Table 1.

Adjust the dose in patients with neurological pain or epilepsy with renal function impaired

The dose should be adjusted in patients with impaired renal function as described in Table 2 or patients being dialysis. Table 2 80

900 - 3600 150B - 30000 Doses used to treat patients with normal kidney function (Creatinine clearance> 80ml/minute) are between 900 to 3600mg/day. The dose is reduced in patients with renal impairment (creatinine clearance

Should be used 300mg daily.

Dosage adjustment in patients being dialysis

For patients who are being dialysis that have never been used for gabapentin, the starting dose of 300 - 400mg should be used, then reduced to 200 - 300mg of gabapentin after every 4 hours of dialysis.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Symptoms of overdose include dizziness, double look, tongue, sleepy, sleep, and mild diarrhea. All of these patients recover completely after being supported. Gabapentin's absorption decrease in high doses can limit the absorption of the drug at the time the patient is overdose and this minimizes the level of poisoning due to overdose. Although Gabapentin can be removed from the body by dialysis method, according to the existing experiences, it is usually no need for this method. However, for patients with severe renal failure, dialysis can be indicated.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using the drug, you may experience unwanted effects (ADR).

There are suddenly unexplained deaths that have been reported, in those cases, the causal relationship between deaths and Gabapentin has not been set up.

Additional side effects after the drug has been reported, including: Acute renal failure, allergens including urticaria, hair loss, vasoconstriction, changing blood glucose concentration in patients with diabetes, large breasts, chest pain, oral hypernage and eosinian hyperglycemia and systemic symptoms, hyper enzymes, diverse breast enzymes, over -the -body, bustful, energetic, over -the -mistreats, enhancer Stems, movement disorders such as jerking and dancing, movement disorders and tone disorders, muscle spasms, fast heartbeat, pancreatitis , Stevens - Johnson syndrome, sub -sentence, sinusitis , bedwetting, hepatitis and jaundice.

Side effects when stopping suddenly Gabapentin have also been reported. The following phenomena most often reported are anxiety, insomnia, nausea, pain and pouring tissue.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Neurontin drug is contraindicated in the following cases: Patients with hypersensitivity to gabapentin or any ingredients of the drug.

Precautions when using

epilepsy

Although there is no evidence of the epilepsy outbreak due to gabapentin, the sudden stop of anti -convulsions in epilepsy patients can appear epilepsy in patients. Like other anti -epileptic drugs, some patients may have increased convulsions or a new type of convulsions with Gabapentin. Like other anti -epileptic drugs, trying to stop using anti -epileptic drugs simultaneously in patients does not respond to treatment therapy using more than one anti -epileptic drug, in order to proceed to only use alone Gabapentin has a low success rate.

Gabapentin is not considered effective against the whole body seizures, such as a consciousness or may cause severe seizures in some patients. Therefore, Gabapentin should be used cautiously in patients with mixed convulsions including consciousness. Gabapentin treatment is associated with dizziness and sleeping, this may increase the risk of an accident due to an accident (falling). There are also reports after the drug is circulated for confusion, unconsciousness and mental decline. Therefore, it is necessary to recommend that patients use the drug carefully until the patient is familiar with the possible effects of the drug.

Simultaneously used with opioid

Concentrated with opioids in patients must treat gabapentin at the same time with opioids that can lead to increased gabapentin levels. Need to monitor patients carefully about the signs of inhibiting the central nervous system (CNS) such as chicken sleep, reducing alertness and respiratory inhibition and reducing gabapentin or opioid dose appropriately.

The rash is caused by the same eosin -loving leukemia and systemic symptoms (dress). The hypersensitivity reactions, serious, life -threatening as a rash due to drugs and eosinophilia and miraculous symptoms (dress) have been reported in patients using anticoagulant drugs including gabapentin.

It should be noted that the beginning of hypersensitivity reactions, such as fever or lymph nodes, may appear whether not rash. If these signs or symptoms appear, it is necessary to assess the condition of the patient immediately. Gabapentin should be discontinued if they have not found other causes of these signs and symptoms.

Anaphylaxis

Gabapentin may cause anaphylaxis. Signs and symptoms in cases are reported including shortness of breath, swelling of the lips, throat, and tongue, and hypotension that requires emergency treatment. Patients should be instructed to stop using gabapentin and seek medical care immediately if there are signs or symptoms of anaphylaxis.

Pediatric patients' complex

The effect of gabapentin therapy lasts (more than 36 weeks) on the study, intelligence and development of children and minors have not been fully studied. Therefore, it is necessary to consider the benefits of prolonged therapy compared to the possible risk of this therapy.

Abuse and drug dependence

Cases of abuse and drug dependency have been reported after the drug circulated in the market. Just like other drugs that have the effect on the central nervous system, should carefully assess patients with a history of drug abuse and monitor these patients to detect possible signs of gabapentin abuse.

Information for patients

To ensure safe and effective use of gabapentin, you need to exchange the following information and instructions with patients:

Notice to the doctor about any drug, prescription or not prescribing, alcohol, drugs being used or planning to use during treatment with Gabapentin.

must notify the doctor if the patient is pregnant or is planning to get pregnant, or pregnant while taking Gabapentin.

gabapentin is excreted through breast milk, the influence of gabapentin on children in the breastfeeding period is not known, so the patient needs to notify the doctors if they are breastfeeding.

Gabapentin may reduce driving or operate dangerous machines. Therefore, there is no driving and operating dangerous machines until it is sure that this drug does not affect the ability to participate in these activities.

Do not allow the gap between the doses of gabapentin to exceed 12 hours to prevent the outbreak of seizures.

Before the beginning of gabapentin treatment, patients should be instructed that the phenomenon of rash or signs and symptoms of hypersensitivity such as fever or lymphadenopathy can lead to serious medical event. Patients need to report immediately to the doctor these signs if encountered.

The ability to drive and operate machinery

gabapentin may have a slight or medium impact on the ability to drive and use machines, gabapentin acting on the central nervous system and can cause drowsiness, dizziness or other relevant symptoms. Even if the level of effect is only mild or medium, these unwanted effects may be likely to endanger patients when driving or operating machinery. This is especially true when starting treatment and after increasing the dose.

Pregnancy

There are no adequate and verified studies in pregnant women. Because animal reproductive studies are not always true to the response on humans, it is only used in pregnancy when the treatment benefits bring greater risks than the risks on the embryo.

breastfeeding period

gabapentin is excreted in human milk. The influence of Gabapentin on children in the breastfeeding period is not known. Be careful when using gabapentin for mothers during breastfeeding. Gabapentin should only be used in mothers during breastfeeding if the treatment benefits bring greater than one that is compared to the possible risks.

Medicinal interaction

There have been spontaneous reports and reports in literature on respiratory inhibitors or reduced alertness associated with the use of gabapentin and opioids. In some reports, the authors think that it is necessary to pay special attention to this phenomenon when using a combination of gabapentin and opioid, especially in elderly patients.

Morphin's pharmacokinetics parameters are not affected when indicated for using gabapentin 2 hours after using morphine.

There is no observation that there is any interaction between gabapentin and phenobarbital, phenytoin , valproic acid, or carbamazepin . Gabapentin pharmacokinetic properties in a state of plasma concentration in plasma are similar to healthy subjects and epilepsy patients being treated with these anti -epileptic drugs.

Simultaneous use of gabapentin and birth control pills containing norethindron or ethinyl estradiol does not affect the pharmacokinetic properties in a state of constant concentration in plasma of both drugs.

Simultaneous use of gabapentin with antacids containing aluminum salt and magnesium salt reduces the bioavailability of gabapentin by about 20%, so gabapentin should be used for about 2 hours after taking antacids.

The excretion of gabapentin through the kidney is not affected by probenecid.

The excretion of the kidney gabapentin is slightly reduced when used in combination with cimetidine, but this is not clinically significant.

Test results

The fake positive result has been reported in tests using Ames N - Multistix SG dip rods when combining gabapentin with other anti -convulsions. Therefore, to determine the protein in the urine, it is recommended to precipitate sulfosalicylic acid.

Storage

Store under 30 ° C.

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