GabeTin 300 Sun Pharma medicine for neuropathy after herpes infection (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Gabapentin

Ingredient

Composition information	Content
Gabapentin	300mg

Uses

indications

GabeTin drug is indicated in the following cases:

The treatment of neuropathy after the herpes infection in adults. The impact of gabapentin on anti -seizures is not well known. It shows anti -epileptic effects in mice and rats in both electrical epilepsy models and epilepsy with pentylenetetrazole and preclinical research model (for example, similar to genetic epilepsy). Gabapentin is related to the structure with GABA neurotransmitters, but it does not replace GABA or links to GABA receptors; And it is not an inhibitor or reducing GABA absorption.

The determination and function of the remaining bond position of Gabapentin are still clarified and to establish the relationship of its different activity with anti -convulsions. Analgesic effects have been shown in inflammatory and nervous pain models in animal.

Dynamic pharmacokinetics

Birth of gabapentin about 60%, 34%, 33% and 27% correspond to 900, 1200, 2400, 3600 and 4800 mg/day are divided into 3 corresponding doses. Food only affects the ratio and absorption level of Gabapentin (up 14% AUC and CMAX). Born and dose is not proportional to each other, such as increasing the dose, the bioavailability decreases. Less than 3% of gabapentin circulation in the form of plasma proteins.

For patients with epilepsy, the stabilization of Predose (cmin) concentration of gabapentin in cerebrospinal fluid is about 20% of the corresponding concentration in plasma. Gabapentin metabolic in humans. It is excreted from the circulatory system by the excretion of the kidneys in the form of constant. The sale time is 5-7 hours and does not change by the dose or multi-dose medication afterwards. The rate of constant elimination, plasma clearance and renal clearance in direct ratio with creatinine clearance.

For older patients, and patients have reduced renal function, the clearance in the blood of gabapentin decreases. Gabapentin can be removed from plasma by dialysis. It is recommended to reduce the dose in patients with kidney function damage or use blood separation method.

Before taking GabeTin 300 Sun Pharma medicine for neuropathy after herpes infection (3 blisters x 10 tablets)

How to use

gabapentin is taken with food or not with food. The decrease in the dose, stopped or replaced gabapentin with another epilepsy treatment should be done slowly for at least a week (longer time can be weighed under the decision of the physician).

Dosage

HEREPES Neuro Pain

Adults: Start with a single dose of 300 mg of gabapentin day on the first day; 600 mg/ day of the second day (divided into 2 oral time) and 900 mg/ day of the third day (divided into 3 drinks). The dose may then be redefined to relieve pain when necessary with daily dose of 1800 mg (divided into 3 oral time). In clinical studies evaluating the comparative treatment effect of the drug in the dose ranging from 1800 mg/day to 3600 mg/day, the results show that the benefits of using doses greater than 1800 mg/day are not confirmed.

Used for children: Gabapentin's effectiveness and safety in the treatment of herpes neuropathy in unpaid pediatric patients.

epilepsy

Gabapentin is recommended to be used as a therapy to support epilepsy for patients 3 years and older. The effectiveness of gabapentin in children under 3 years old has not been established.

Patient> 12 years old: Gabapentin effective dose is from 900 to 1800 mg/day, divided into 3 times, using 600 mg capsules. The starting dose is 300 mg/time x 3 times/day. If necessary, the dose may increase to 1800 mg/day. In some long -term forestry studies, 2400 mg/ day is well tolerated. The dose of 3600 mg/day has also been used for a few patients in a number of short studies and recorded well the patient. The maximum time between the use in the drug mode is 3 times/ day must not be more than 12 hours apart.

Children 3 - 12 years old: The starting dose is 10 -15 mg/ kg/ day divided into 3 times, and effective treatment dose is achieved by adjusting after 3 days of use. The usual dosage of Gapapentin in patients ≥ 5 years old is 25 - 35 mg/kg/day and is divided into 3 times a day. The usual dosage on children from 3-4 years old is 40 mg/ kg/ day and is also divided into 3 times. In some long -term clinical studies in children, the tolerance do the tolerance can be up to 50 mg/ kg/ day. The maximum time between use should not exceed 12 hours.

There is no need to monitor Gabapentin concentration in plasma during treatment. Moreover, because there is no significant pharmacological interaction between Gabapentin and other common anti -epileptic drugs, the treatment of epilepsy support with Gabapentin does not change the plasma concentration of other anti -epileptic drugs.

If you stop using gabapentin or replace it with another anti -epileptic drug, this should be done slowly at least a week.

Dosage in patients with renal failure: Creatinine clearance is difficult to determine in outpatient patients. For patients with normal renal function, creatinine (CCR) clearance can be evaluated relatively accurately by using the Cockcroft and Gault formula:

Women: CCR = (0.85) (140-TUC (weight)/[(72) (SCR)]

Male: CCR = (140-TUU) (Weight)/[(72) (SCR)]

Dosage adjustment in patients ≥ 12 years old with renal failure or being treated for dialysis is as follows:

Renal function - Creatinine clearance
(ml/ minute)

Total daily dose (mg)

Dosage mode (Mg)

≥ 60

900 - 3600

300 TID

400 tid

600 tid

800 TID

1200 TID

30 - 59

400 - 1400

200 bid

300 BID

400 BID

500 BID

700 BID

15 - 29

200 - 700

200 qd

300 qd

400 qd

500 qd

700 qd

100 - 300

100 qd

125 qd

150 qd

200 qd

300 qd

Dosage after dialysis (mg) b

125B

150b

200b

250b

350B

BID: 2 times/day; OD: 1 time/day.

(A) For patients with creatinine clearance

(b) Patients with dialysis should use the dose based on the estimate of creatinine clearance as prescribed in the upper part of the table above and a dose of support after dialysis is used after the 4 -hour hemorrhage according to the prescribed dose in the lower part of her using gabapentin for patients

Dosage for older patients: generally should be cautious when taking drugs for older patients, usually the starting dose should be at the lowest level, due to the impaired renal and cardiovascular function, and due to the possible presence of other diseases, as well as other drugs. Gabapentin is excreted through the kidneys, and the risk of toxicity can be increased in patients with renal failure. Most older patients have renal function, so the selection and adjustment should be based on creatinine clearance.

Patients with liver failure:

Exposure to drugs increases the average to severe liver dysfunction. Therefore, be careful when using this drug in patients who drink a lot of alcohol or have a history of liver disease.

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? Signs of acute poisoning in animals include: loss of air conditioning, heavy breathing, eyelid prolapse, pain relief, and agitation.

Acute oral overdose Gabapentin when used up to 49g has been recorded, overdose symptoms: Song, stuttering, drowsiness, coma and diarrhea. All patients recover after supportive treatment.

Gabapentin can be excreted through hemorrhage, although there have been some cases of overdose treatment without using hemolytic methods. This procedure is indicated depending on the clinical condition of the patient, or in patients with signs of severe renal failure.

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 GabeTin, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: fatigue, headache, drowsiness, dizziness, loss of air conditioning, fever, nervous tension, vanity, forgetting, depression, abnormal thoughts, hostile behaviors, easy to change emotions, reduce sensation.

digestive: abdominal pain, diarrhea, flatulence, indigestion, dry mouth, constipation, appetite, nausea and/or vomiting. cardiovascular: peripheral edema, vasodilation. Respiratory: rhinitis, sore throat, bronchitis, cough, otitis media. Eye: Eye seizures, focal inflammation, vision loss, Song Thi disease.

Muscle muscle: back pain, muscle pain, fracture, tremor, muscle jerky

blood: leukopenia,

Other: weight gain, hyperglycemia, impotence, hyperactivity.

Uncommon, 1/1 000

No report.

Rare, ADR

No report.

Not determined frequency

Using Gabapentin in children 3 - 12 years old with epilepsy can occur side effects on the central nervous system. The most significant side effects can be divided into the following groups:

Easy to change emotions (Priority acts).

hostile behavior, including aggressive attitude.

In patients treated with gabapentin, the above side effects occur mild or medium.

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

GabeTin medicine is contraindicated in the following cases:

Hypersensitivity to Gabapentin or any ingredients of the drug.

Children under 3 years old.

Caution when using

should not suddenly stop anti -epileptic drugs due to the ability to increase the frequency of epilepsy again.

During the study before bringing the drug to the market, there were 8 cases of sudden death of unknown reasons in a 2,203 population of patients treated with Gabapentin (of which 2,103 patients were treated for many years).

Patients should be recommended that gabapentin can cause dizziness, drowsiness and other signs as well as symptoms of central neurological inhibition. Therefore, when using the drug, you should not drive or operate machinery until you know for sure that there is no mental and mental side effect.

In patients who need treatment in combination with morphine, gabapentin levels should be noted. Patients should be monitored by central nerve inhibitors such as drowsiness, and the dose of gabapentin or morphine should be adjusted appropriately. When combined with gabapentin with other epilepsy medications, it has recorded a fake positive result with the hometown of Ames N-Multistix SG SG detecting proteinuria, so it is recommended to use a more specific sulfosalicylic acid to evaluate the presence of protein.

The ability to drive and operate machinery

gabapentin may have a slight or medium impact to the ability to drive and operate machinery. Gabapentin acts on the central nervous system and can cause drowsiness, dizziness or other related symptoms. Even at a light or medium degree, these side effects are likely to be dangerous to drivers or machinery operators. This is even more accurate at the beginning of treatment and after increasing the dose.

Pregnancy

Because there is no complete verification studies in pregnant women, using drugs only in pregnant women when they have considered the benefits and potential risks to the fetus.

The period of breastfeeding

gabapentin is excreted into breast milk when using oral, breastfed babies can be absorbed gabapentin at a maximum dose of about 1mg/kg/day. And due to the effects of drugs on infants, it is not well known, so they only allow breastfeeding women to use gabapentin after assessing the benefit of treatment greater than the risk may occur.

Drug interaction

In a study of single gabapentin (400 mg/day) and multiple doses (400 mg x 3 times/day) for epilepsy patients who have been treated for monatlearth with phenytoin for at least 2 months, noted that Gabapentin does not affect the stability concentration of phenytoin in plasma, and

phenytoin Gabapentin.

Stable plasma concentrations of carbamazepin and carbamazepin 10, 11 epoxid are not affected when combined with gabapentin (dose of 400 mg x 3 times/day). Similarly, Gabapentin's pharmacokinetics are not affected by carbamazepin.

Stable concentration in the plasma of Valproic acid before and during the coordination with gabapentin (400 mg x 3 times/day) there is no difference. Gabapentin pharmacokinetic parameters are also not affected by Valproic acid.

The estimates of pharmacokinetic parameters in a stable state for phenobarbital or gabapentin (300 mg x 3 times/ day) are still true whether the two drugs are used alone or together.

Simultaneous use of Naproxen sodium capsules (250 mg) with gabapentin (125 mg) increases gabapentin's absorption to 12-15%. Gabapentin does not affect naproxen pharmacy parameters. The dose of both drugs should be reduced when shared.

Simultaneous use Gabapentin (125 - 500 mg) reduces the maximum concentration (CMAX) and the value under the curve (AUC) of Hydrocodon (10 mg) is 3% and 4% after taking 125 mg of gabapentin, and reduces 21% and 22% after taking 500 mg of gabapentin.

If used with 300 mg of cimetidin once a day, gabapentin's average oral clearance drops by 14% and the creatinine clearance is reduced by 10%. So cimetidine seems to change the excretion through the kidneys of both gabapentin and creatinin - a substance as a sign that shows the kidney function. Reducing gabapentin excretion due to cimetidin at this small level is not considered to be clinically important. No evaluation of gabapentin on cimetidine.

Based on the area under the curve (AUC), the half -life, and the pharmacokinetic properties of Norethindron and Ethinyl Estradiol when using tablets containing 2.5 mg of Norethindron Acetate and 50 MCG Ethinyl Estradiol, showing nothing changing when used simultaneously or not simultaneously with Gabapentin (400 mg x 3 times/ day). But the maximum concentration of Norethindron (CMAX) is 13% higher when used simultaneously with Gabapentin; However, this interaction has no clinical significance.

Antacislets reduces about 20% of gabapentin's bioavailability. If gabapentin is taken after taking 2 -hour antacids, Gabapentin's bioavailability decreases by 5%. Gabapentin should be taken after taking antacids for at least 2 hours.

Probenecid is an inhibitor of the excretion in the renal tubules. Gabapentin pharmacokinetics parameters when there are or no use with probenecid is also not different. This proves that gabapentin's excretion is not affected by probenecid.

Storage

Store less than 30 ° C in a cool dry place. Avoid light.

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