Pegaset 50 Aurobindo medicine for neuropathy, local epilepsy (4 blisters x 7 tablets)
Dosage form Box of 4 blisters x 7 tablets
Specifications Pregabalin
Ingredient
| Composition information | Content |
| Pregabalin | 50mg |
Uses
indications
Pegaset 50 drugs are indicated in the following cases:
Neurological pain
Pregabalin is indicated in the treatment of neurological pain in adults.
epilepsy
Pregabalin is indicated for treatment of local epilepsy support, with or not accompanied by secondary epilepsy in adults.
Disseminated anxiety disorders
Pregabalin is indicated for the treatment of spreading anxiety (GAD) in adults.
Pharmacology
Pharmacological group: anti -epilepsy drugs.
ATC code: N03AX16.
Main active ingredients, pregabalin, is a substance similar to gamma acid-aminobutyric (GABA) (acid (s) -3- (aminomethyl) -5-methylhexanoic).
Mechanism of action
Pregabalin is attached to a subunit subunit (A2 - 8 protein) of the voltage gate channel in the central nervous system.
Evidence from a nervous animal model indicates that pregabalin release neurotransmitters perceived pain depends on calcium in the spinal cord, which can be through calcium transportation blocking and or reducing calcium. Evidence from other animal models with nerve damage shows that pregabalin analgesic activity can also be indirectly through interactions with sympathetic and serotonin.
pharmacokinetics
Pregabalin's stable pharmacokinetics are the same on healthy volunteers, epilepsy patients taking anti -epileptic drugs and chronic pain patients.
absorption
Pregabalin is quickly absorbed when drinking hungry, the peak concentration in plasma is achieved after 1 hour in both single and multi -dose mode. The oral bioavailability of Pregabalin is about> 90% and does not depend on the dose. When used repeated, stable status is reached in the range of 24 - 48 hours. Pregabalin's absorption rate decreases when used with food leads to CMAX by about 25-30% and TMAX is about 2.5 hours behind. However, using pregabalin along with food does not have any significant clinical effects to the level of pregabalin absorption.
distribution
In preclinical studies, pregabalin easily passes through the bloody barrier in mice, rats and monkeys.
Pregabalin passes the placenta in the rat and appears in mouse milk. In humans, Pregabalin's apparent distribution is about 0.56 l/kg. Pregabalin is not attached to plasma proteins.
transformation
Pregabalin is negligible in the human body. After using Pregabalin with radioactive markers, about 98% of radioactive activity found in urine is of pregabalin in unprovered form. N - methylated derivatives of pregabalin, the main metabolite of pregabalin is found in urine, accounting for about 0.9% of the dose. In preclinical studies, there are no signs of converting pregabalin in the form of isomorphic description into a tamidal isomer.
Elimination
Pregabalin is eliminated from the circulatory system mainly due to the excretion through the kidneys in the form of non -metabolic.
The average pregabalin disposal time is 6.3 hours. Plasma pregabalin clearance speed and renal clearance rate are proportional to the rate of creatinine.
Needs to adjust the dose for patients with renal impairment or hemorrhage.
linear/non -linear
Pregabalin'spharmacokinetics is linearly within daily recommended dose. The variation of pharmacokinetics among Pregabalin objects is low (
Sex
Clinical trials have shown that gender has no significant clinical effects on pregabalin concentrations in plasma.
kidney failure
Pregabalin clearance rate is proportional to the rate of creatinine clearance. In addition, pregabalin is effectively removed from plasma through hemorrhage (after 4 hours of hemorrhage of pregabalin concentration in plasma decreased by about 50%). Because excretion through the kidney is the main elimination sugar, it is necessary to reduce the dose for patients with renal impairment and use additional doses for patients with hemorrhage.
liver failure
There is no specific pharmacokinetic study conducted in patients with liver failure. Because pregabalin is insignificant metabolized and excreted mainly in urine in the form of non -metabolic, patients with liver failure are expected to have no significant change in the concentration of pregabalin in plasma.
Elderly (65 years old)
Pregabalin clearance rate tends to decrease when elderly. The decrease of pregabalin clearance rate is uniformly with a decrease in the rate of creatinine when elderly. Pregabalin dose may be reduced for patients with renal function damage.
breastfeeding women
The pharmacokinetics of the pregabalin 150 mg doses/time (daily 300 mg dose) have been surveyed in 10 women who are living in milk, these women are at the stage of at least 12 weeks of birth. The lactation is less affected or does not affect Pregabalin's pharmacokinetics. Pregabalin is secreted into milk with an average stable concentration of about 76% compared to the concentration of the drug in the mother's plasma. The average pregabalin dose from breast milk that children receive daily (assuming the average amount of milk consumption is 150 ml/kg/day) is 0.31 mg/kg/day, this dose calculated by mg/kg will be about 7% compared to the dosage of breast milk.
Before taking Pegaset 50 Aurobindo medicine for neuropathy, local epilepsy (4 blisters x 7 tablets)
How to use
oral tablets. Can be taken with or without food.
Dosage
adults
The dose range from 150 mg to 600 mg daily is divided into 2-3 times.
Neurological pain
Treatment with pregabalin can start at a dose of 150 mg daily. Depending on the response and ability to tolerate each patient, the dose may increase to 300 mg/day after a period of 3-7 days, and if necessary, it may increase to a maximum dose of 600 mg/day after about 7 additional treatments.
epilepsy
Can start treatment with pregabalin at a dose of 150 mg daily. Depending on the response and tolerance of each patient, the dose may increase to 300 mg/day after 1 week. Can increase to a maximum dose of 600 mg/day after a week of additional treatment.
Disseminated anxiety disorders
The dose of 150 - 600 mg per day is divided into about 2-3 times. Need to regularly review the needs of treatment.
Can start treatment with pregabalin at a dose of 150 mg/day. Based on the response and tolerance of each patient, the dose can be increased to 300 mg/day after 1 week of treatment. After an additional treatment of a dose week, it may increase to 450 mg/day. Can increase to a maximum dose of 600 mg/day after a week of additional treatment.
Stop using Pregabalin
If you have to stop using pregabalin, it is necessary to reduce the dose slowly for a minimum of 1 week.
Patients with renal failure
Dose reduction in patients with renal function damage must be depending on the individual and at the rate of creatinine clearance, presented in Table 1, using the following formula:
x 0.85 for female patients
Table 1: Adjust the dose of pregabalin according to renal function
Side Effects
When using Pegaset 50 you may experience unwanted effects (ADR):
The unwanted effects are listed below by organ systems and frequency. The frequency is determined as follows: Very common (≥ 1/10), common (≥ 1/100 and Clinical trial program with pregabalin is conducted on more than 8900 patients using Pregabalin, of which over 5600 people participate in double blind tests with placebo. The most common unwanted effects are reported including dizziness and drowsiness. Unwanted effects are often mild to moderate. In all controlled studies, the rate of stopping medication due to unwanted effects is 12% in patients using Pregabalin and 5% in patients with placebo. The unwanted effects that lead to the most stopped drug in the pregabalin group are dizzy and drowsiness.
The unwanted effects of the drug listed in the table may be related to potential diseases and/or combined drugs.
Infections and parasites
Nutrition and metabolic disorders
Nervous system disorders
Ear disorders and vestibular
respiratory disorders, chest and mediastinum
Instructions on how to handle ADR: Notify the physician with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Pegaset 50 drug contraindicated in the following cases:
Be cautious when using
need to be very careful when taking the drug for patients in the following cases:
Patients with diabetes
Some diabetes patients with weight gain when using pregabalin may need to adjust the use of hypoglycemic drugs.
Hypersensitivity reactions
After circulating the drug, there have been reports on hypersensitivity reactions, including angioedema. Pregabalin should be stopped immediately if there is a symptom of angioedema, such as edema, edema around the mouth, or upper respiratory edema.
dizziness, drowsiness, loss of consciousness, confusion and mental decline
Pregabalin treatment often occurs dizziness and drowsiness, which may increase the risk of accidents due to injury (falling) in the elderly. There have been reports after circulation of drugs that lose consciousness, confusion and mental decline.
Therefore, patients must be instructed to be cautious until they get used to unwanted effects of the drug.
Reviews related to vision
After circulating the drug, there was a report on temporary blurring and some other vision changes in patients using Pregabalin. When stopping the drug, these vision symptoms may end or reduce.
kidney failure
Despite the effects of suspending drugs on renal failure that have not been systematically recovered, there has been reported that renal function is improved after stopping or reducing prefabalin dose.
Stop combining other anti -epileptic drugs
There is no complete data on discontinuation of pregabalin with other anti -epileptic drugs to achieve single therapy with pregabalin, after controlling seizures with combined treatment.
Symptoms of cessation
In short -term and long -term treatment with pregabalin, after stopping the drug, observing a cessation syndrome on some patients. The effects mentioned include: insomnia, headache, nausea, anxiety, sweating and diarrhea.
congestive heart failure
Althoughalthough the causal relationship is not identified between pregabalin and patients with congestive heart failure, there have been some reports after circulating medication for congestive heart failure in some patients using pregabalin. In some short -term trials in patients with no clinical signs of heart or peripheral vessels, there is no clear connection between peripherals and cardiovascular complications such as hypertension or congestive heart failure. Because data on patients with severe congestive heart failure is limited, need to be cautious when taking pregabalin in these patients.
Treatment of central nerve damage due to spinal injury
The percentage of side effects in general, unwanted reactions of the central nervous system and especially sleepy symptoms increased during the treatment of central nerve damage due to spinal injury. This may be due to enhanced effects when using the drug simultaneously in treatment (such as anti -spasms). Consider when prescribing pregabalin in this case.
thoughts and behaviors
The suicidal thoughts and behaviors have been reported in patients treated with anti -epileptic drugs. The general analysis of random fatal control studies for anti -epileptic drugs also shows the risk of increased thoughts and suicide behaviors. It is still unclear about the mechanism of this risk, the available data does not rule out the possibility of increasing this risk when using pregabalin. Therefore, patients need to monitor signs of suicide thoughts and behaviors for appropriate treatment. Patients (and patient care) should be consulted by a doctor when the above signs appear.
Reduce the lower gastrointestinal function
There have been reports after circulation of events related to lower gastrointestinal function reduction (for example, intestinal obstruction, obstruction, constipation) when taking pregabalin with drugs that can cause constipation, such as Opioid group analgesic. When using pregabalin and opioid simultaneously, you can consider constipation prevention measures (especially in female patients and the elderly).
wrong use, abuse or drug dependence
Pregabalin has not been determined whether it is impacted on receptors related to abused drugs.
There have been reports on cases of wrong drug use and drug abuse after circulation. Like any drug that acts on the central nervous system (CNS), it is necessary to carefully assess the patient to learn about the history of drug abuse and observe the signs of wrong use or abuse Pregabalin in the patient (for example, manifestation of increased drug tolerance, increased drug dose, drug search behavior).
Cases of brain disease have been reported, mainly in patients with hidden conditions that can cause brain disease.
The effect of the drug on driving and operating machinery
Pregabalin can cause dizziness or drowsiness and thus, can affect the ability to drive and operate machinery. Therefore, patients do not drive, operate complicated machines or participate in other adventure activities until determining whether the drug affects the implementation of these activities.
Use drugs for women during pregnancy and lactation
Pregnancy
There is no adequate data on pregabalin on pregnant women.
Animal studies have shown toxic effects on fertility. It is unknown about the risk that may occur in humans. Therefore, do not use Pregabalin during pregnancy unless the benefits gives the mother superior to the risk that may occur to the fetus. Should use effective contraception for women of reproductive age.
breastfeeding women
Pregabalin is excreted in milk in nursing women. Due to the safety of pregabalin in young children, it is not known, not recommended to use the drug while breastfeeding. It is necessary to consider the benefits of breastfeeding for children and the benefits of drug treatment for the mother.
Interactive drug
because Pregabalin is excreted mainly through urine in the form of unprocessed, the amount of insignificant metabolism ( In Vivo studies and pharmacokinetic analysis
In Vivo studies, there is no clinical pharmacokinetic interaction between pregabalin and phenytoin, carbamazepin, valproic acid, lamotrigin, gabapentin, lorazepam, oxycodon or ethanol. The kinetic analysis indicates that oral diabetes, diuretics, insulin, phenobarbital, Tiagabin and Topiramat have no significant clinical effects on Pregabalin clearance speed.
Oral contraceptives, norethisterone and/or ethinyl oestradiol
Simultaneous use Pregabalin with oral contraceptives oral norethisteron and/ or ethinyl estradiol does not affect the pharmacokinetic stability of both drugs.
with drugs that affect the central nervous system
Pregabalin can affect the effects of ethanol and lorazepam. In controlled clinical trials, many doses of oral Pregabalin combined with oxycodon, Lorazepam or ethanol does not cause any important clinical impact on respiratory activity. Pregabalin seems to increase cognitive disorders and overall movement functions caused by Oxycodon.
After circulating the drug, there were reports on respiratory failure and coma in patients using Pregabalin and other central nerve suppositories. There have been reports after circulation of events related to lower gastrointestinal function (for example, intestinal obstruction, obstruction, constipation) when taking pregabalin with drugs that can cause constipation, such as Opioid group analgesic.
There has been no specific research on pharmacological interaction conducted on elderly volunteers.
Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
To be out of reach of children, read the instructions carefully before use.
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