Pregabakib drug 100mg Kern prescribed treatment for neuropathy, epilepsy, general anxiety disorders (6 blisters x 14 tablets)
Dosage form Box of 6 blisters x 14 tablets
Specifications Pregabalin
Ingredient
| Composition information | Content |
| Pregabalin | 100mg |
Uses
indications
Pregabakern drug indications for treatment in the following cases:
ATC code: N03AX16
Pregabalin active ingredient is a substance similar to gamma-aminobutyric acid || S) -3- (aminomethyl) -5-methylhexanoic acid].
Mechanism of action
Pregabalin is attached to a sub-group (A2-8 protein) of the electrical carrier line in the central nervous system.
Clinical effectiveness and clinical safety
Neurological pain
Effective has been shown in diabetic neuropathy tests. The end of the wire after herpes and the spinal cord injury. The effect has not been studied in other types of neuropathy.
Pregabalin has been studied in 10 controlled clinical trials up to 13 weeks with a dose mode 2 times/day and 8 weeks with a dose mode 3 times/day. Overall, data on safety and efficiency for both doses is similar.
In clinical trials up to 12 weeks for both peripheral and central nerve pain, pain relief effects have been seen after 1 week and maintained during treatment.
In clinical trials that control peripheral neuropathy, 35% of the patients received with pregabalin and 18% of patients who have been pounded have improved 50% of the scores of pain. For patients not being drowsy, this improvement has been observed in 33% of patients treated with pregabalin and 18% of patients use placebo. For patients with drowsy this ratio is 48% for patients taking pregabalin and 16% for patients who use fake.
In clinical trials that control central nerve pain, 22% of patients treated with pregabalin and 7% of the placebo patients have an improvement of 50% of the pain score.
epilepsy
Auxiliary treatment:
Pregabalin has been studied in 3 controlled clinical trials for a period of 12 weeks with a dosage mode 2 times/day or 3 times/day. Overall, data on safety and efficiency for these two doses is similar.
Observed that the frequency of epilepsy decreased after the first week of treatment.
Children's subjects
Pregabalin effectiveness and safety to treat fathers for epilepsy in children under 12 years of age and teenagers have not been established. Side effects are observed in a pharmacokinetic study and tolerance recorded in patients from 3 months to 16 years old (1 = 65) with local starting seizures similar to observations in adults. The result of a fake control study is extended in 12 Tuan's tuan of 205 young patients from 4 to 16 years old to evaluate the effect and safety of Pregabaln such as supplementary treatment therapy to treat local starting convulsions and open safety research in 1 year in 54 patients from 3 months to 10 years old with epilepsy shows that side effects have been observed more frequently than those who have been observed more frequently than those who have been observed more frequently than those who have been observed more frequently than people with large research people have been observed more frequently than people studying the researchers. Kinh.
In the fake control study for 12 weeks, the child is indicated for pregabalin 2.5 ng / kg / day (maximum 150 mg / day), pregabalin 10 mg / kg / day (maximum 600 mg / day) or fake. The proportion of objects decreased by at least 50% of the set of the set compared to the basic road is 40.6% of the subjects treated with Pregabalin 10 mg / kg / day (P = 0.006 compared to the placebo), 29.1% of the subjects treated with pregabalin 2.5 mg / kg / day (P = 0.2800 compared to fake) and 22.6% of fake users.Unit:
Pregabalin was studied in a controlled clinical trial for a period of 56 weeks with tents twice a day. Pregabalin is effective not inferior to Lamotrigine. Pregabalin and lamotrigine are similarly safe and tolerated.
General anxiety disorders
Pregabalin was studied in 6 control trials during a week, a study for the elderly for an 8 -week period and long -term prevention research and a long -term period of prevention of recurrence in a period of 6 months.
The decrease in the symptoms of general anxiety disorders shown through the score of Harillon depression evaluation (Ham-A) were observed after the first week.
In control clinical trials (4-8 weeks period 52% of patients using pregabalin and 38% of placebo patients have improved 50% of the total score in the Hamilton depression evaluation scale from the beginning to the end of treatment.
In control studies, the proportion of patients treated with pregabalin has been reported more eye fat than patients treated with fake treatment in most cases with the next dose. Testing the ophthalmology (including vision testing, official visual examination and expansion eye examination) conducted in more than 3600 patients in controlled clinical trials. In these patients, vision decreases in 6.5% of patients treated with pregabalin and 4.8% of patients treated with placebo.
Visitable changes detected in 12.4% of patients treated with pregabalin and 11.7% of patients treated with placebo. Basic changes have been observed in 1.7% of pregabalin treatment and 2.1% of patients treated with placebo.
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 dosage doses
Pregabalin's biochemistry is about 90% and depends on the dose, in Dung repeated, the stability is achieved in 24 - 48 hours. Pregabalin's absorption rate is reduced when used with food, leading to C, down about 25-30% and prolonging boys after about 2.5 hours. However, using pregabalin and food does not have any significant sieve to absorb Pregabalin.Distribution
Pregabalin's apparent distribution volume after oral use is about 0.56 l/kg. Pregabalin does not bind to plasma proteins.
Metabolism
Pregabalin is negligible in the human body. After using pregabalin marking radioactive. About 98% found in urine is pregabalin in the form of unprovered. Pregabalin's n-methylat derivatives, the main metabolites of Pregabalin 'are found in urine, accounting for about 0.9% of the dose. In cash studies, there is no sign of converting the co -molecular pregabalin into a gland isomer
Elimination
Pregabalin is eliminated from the circulatory system mainly due to excretion through the battle in the original form. The average selling time of pregabalin is 6.3 hours. Leaving plasma pregabalin and kidney clearance proportional to creatinine clearance.
Adjusting the dose in patients with reduced kidney function or hemorrhage is necessary.
linear/non -linear
Pregabalin pharmacokinetics is linearly within the daily dose range.
The mental variable range of pregabalin is low (
pharmacokinetics in special patients
kidney failure
Pregabalin clearance is proportional to creatinine clearance. In addition, pregabalin is effectively removed from plasma thanks to the hemorrhage (after 4 hours of hemorrhagic plasma concentration of pregabalin decreased by about 50%). Because excretion through the kidney is the main elimination sugar, reducing the dose for patients with renal impairment to use additional dose for patients with hematoma is necessary
Hepatic failure
There are no specific studies conducted in patients with liver failure. Because pregabalin is insignificant metabolized and excreted mainly through urine in the whole form, patients with hepatic failure have not changed significantly in plasma concentrations.
Children
Pregabalin'spharmacokinetics are evaluated in patients with epilepsy (age group 1 to 23 months. 2 to 6 years old, 7 to 11 years old and 12 to 16 years old) at a dose of 2.5, 5, 10 and 15 mg/kg/day in a pharmacokinetic study and tolerance.
After taking pregabalin for children in fasting, generally, the time to reach the same concentration in plasma is similar in the entire age group and occurs 0.5 hours to 2 hours after taking the drug.
Pregabalin's cmax and AUC parameters increase linearly with increasing dose in each age group. AUC is 30% lower in patients under 30 kg of weight due to increased body weight, which changes 43% of the bar in these rings compared to patients with 230 kg. Pregabalin's end -stage selling time is about 3 to 4 hours in patients with children to 6 years old and from 4 to 6 hours in children from 7 years of age and older. Objective pharmacokinetic analysis shows that creatinine clearance is a significant variable of oral pregabalin clearance, body weight is a significant variable of the oral pregabalin distribution, and these relationships are similar in children and adults.
Pregabalin pharmacokinetics in patients under 3 months of age have not been studied.
Older people
Pregabalin clearance tends to decrease with an increase in age. The decrease in oral pregabalin is not dependent on the reduction of creatinine relevance to the increase of age.
Need to reduce pregabalin dose in patients with renal function damage due to age.
breastfeeding women
The pharmacokinetics of 150 mg Pregabalin used every 12 hours (300 mg daily) is assessed in 10 breastfeeding women at least 12 weeks after birth. Breastfeeding less or does not affect Pregabalin kinetics. Pregabalin is excreted into breast milk with concentrations in an average stable state of about 76% of the mother's plasma concentrations. The dosage of infants is estimated to receive from breast milk (assuming the average milk consumption of 150 ml/kg/day) when the mother uses Pregabalin 300 mg/day or a maximum dose of 600 mg/day will be 0.31 or 0.62 mg/kg/day, respectively. These estimates are about 7% of the total daily dosage on the basis of mg/kg.
Before taking Pregabakib drug 100mg Kern prescribed treatment for neuropathy, epilepsy, general anxiety disorders (6 blisters x 14 tablets)
How to use
Pregabalin hard capsules can be with or not with food.
Dosage
Dosage from 150 to 800 mg daily, divided into two or three times.
Mental pain:Pregabalin may be started at a dose of 150mg daily divided into two or three times. Based on the response and tolerance of each patient, the dose can be increased to 300mg daily after 3-7 days, and if necessary, increase to a maximum dose of 600mg daily after 7 days.
epilepsy:
Pregabalin can be started at a dose of 150mg daily divided two or three times. Based on the response and tolerance of each patient, the dose can increase to 300 ng daily after 1 week. The maximum dose of 600mg per day can be achieved after another week.
General anxiety disorders:
Dosage from 150 to 600mg per day is divided into two or three times. The necessity of treatment should be re -evaluated regularly.
Pregabalin may be started at a dose of 150mg daily. Based on the response and tolerance of each patient, the dose may increase to 300mg daily after 1 week. The following week, the dose can be increased to 450mg daily. The maximum dose of 600mg per day can be achieved after another week.
Stop using Pregabalin:
According to the current clinical practice, if the pregabalin stops, it is recommended to be done gradually, at least 1 week, regardless of indications.
Special subjects:
Patients with renal failure:
pragabalin is removed from the circulatory system mainly due to the excretion through the renal in the form of constant. Because pregabalin purification is proportional to creatinine purification, reducing the dose in patients with damaged kidney function must be specific according to the creatinine purification (CLCR, shown in Table 1, determined by using the following formula:
CLCR (ml/min) = (1.23 x (140 - age (year) x is still heavy (kg)/creatinin serum (micromol/l) (x 0.85 for women).
Pregabalin is effectively removed from plasma by dialysis (50% of 4 hours). For patients with dialysis, pregabalin dose daily should be adjusted based on kidney function. Besides daily dose, an additional dose should be used immediately every 4 hours after dialysis.
Side Effects
Clinical trial program with progabalin is conducted on more than 8900 patients using Progabalin, of over 5600 fake double blind tests. Unwanted effects are often reported by dizziness and drowsiness. Unwanted effects are usually small and medium. In all controlled studies, Ty Lo Ngung taken drugs due to unwanted effects of 12% for patients using Progabalin and 5% for patients who use fake. Unwanted effects that are weak to stop using pregabalin group are anti -face and drowsiness.
The adverse reactions are listed at very common frequencies (≥ 1/10), commonly 1/100 to
The listed adverse reactions may also be related to the potential disease and/or simultaneous drug products.
In the treatment of central neuropathy due to spinal cord damage, the adverse reaction rate in general, the adverse reaction of the central nervous system and especially drowsiness has increased. Additional reactions are reported from experience when circulating included in italic prints in the list below.
Infections and parasites:
immune system disorders:
Central nervous system disorders:
Eye disorders:
Regarding the long -term suspension of pregabalin, data shows that the incidence and severity of the symptoms of cessation may be related to the dose.
Children's subjects
Pregabalin safety records are observed in two pediatric studies (pharmacokinetic research and tolerance, n = 65; 1 year of opening according to safety research, n = 54) is similar to observations found in adult studies.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Pregabakib drugs contraindicated in the following cases:
Caution when using
Diabetes patient
Suitable for current clinical practice, some diabetics with weight gain when treated with pregabalin may need to adjust hypoglycemic drugs.
Hypersensitivity reaction
There have been reports that occur after circulation of drugs on hypersensitivity reactions, including circuit suitable cases. Pregabalin should be stopped immediately if the angioedema symptoms occur, such as covering the face, around the mouth, the upper respiratory tract or swelling.
dizziness, drowsiness, loss of consciousness, disorder, mental decline
Pregabalin treatment is related to dizziness and drowsiness, which can increase the appearance of an accident (falling) injury in elderly patients. There have been reports that occurred after circulating drugs to lose consciousness, confusion and mental decline. Therefore, it is advisable to advise patients to be cautious until they are important with the hidden effects of the drug,
Visual -related effects
In control tests, higher rates than patients treated with pregabalin have been reported to be open compared to those who have been treated by retained, these symptoms will end in most cases when continuing medication. In clinical studies with vision tests, the rate of vision and vision changes in patients who have been treated with pregabalin is greater in patients with placebo.
In experience after circulating the drug, the harmful response on the vision has also been reported, including loss of vision, blurred vision or other changes of vision, some of them are just fleeting. Pregabalin shy can resolve or improve visual symptoms.
kidney failure
Cases of kidney failure have been reported and in some cases of Pregabali stops do not show the reversal of this harmful reaction.
Stop in combination with other anti -epileptic drugs.
No even though the data is discontinued in combination with other anti -epileptic drugs, as soon as it is controlled with epilepsy with Pregabaln in combined treatment, it is necessary to consider that the ultimate treatment with pregabalin.
Symptoms of cessation
After stopping the drug in short -term and long -term treatment with pregabalin, the symptoms of cessation have been observed in some patients. Symptoms are mentioned: Sleeping eyes, headache, nausea, anxiety, diarrhea, influenza syndrome, stress, depression, pain, convulsions, increased sweating and dizziness. Patients need to be notified of this at the beginning of treatment.
Convulsions, including epilepsy, large seizures, may occur during pregabalin or immediately after pregabalin.
Regarding long -term stopping treatment with pregabalin, data shows that the incidence and severity of the symptoms of quitting smoking may be related to the dose.
SECRETING HEART
There was a report after circulating the mayor about congestive heart failure in some patients using pregabalin. These effects are mainly found in elderly patients who have had cardiovascular damage when taking pregabalin to treat a neurological disease, pregabalin should be used cautiously in these patients. Pregabalin stops can solve this situation.
Treatment of central nerve pain due to spinal cord damage
In the treatment of central nerve pain caused by spinal cord damage, the adverse reaction rate in general and adverse reactions on the central nervous system in particular, especially sleep, has been increased. These side effects can be attributed to a stop with other drugs (such as anti -spasms) to treat related symptoms. Should consider when men Pregabalin in this case.
intentions and suicide behaviors
The suicidal behavior has been reported in patients treated with anti -epileptic drugs. A random beting study of war drugs and no business has also shown the risk of slight increase in intentions and suicide behaviors. This risk mechanism is not known and existing data does not exclude the possibility of increasing risk due to pregabalin.
Therefore patients need to monitor the signs of intentions and suicide behavior, which should be considered appropriate treatment. Patients should be recommended (and patients who look for medical advice when signs of their intentions and suicide behaviors appear.
Demonstration of gastrointestinal tract function
There have been reports after circulating drugs about adverse reactions related to gastrointestinal function impairment (such as intestinal obstruction, intestinal paralysis, constipation) when treating pregabalin with drugs that can cause constipation, such as opioid analgesic. When combining pregabalin with opipid, it is necessary to consider measures to prevent constipation (especially in female and elderly patients).
wrong use, use or drug dependence
Cases of wrong use, abuse and drug dependence have been reported. It is necessary to be in patients with a history of drug abuse and patients need to be monitored with the wrong use, abuse or pregabalin dependence (tolerance, climbing, drug addiction).
Administration
Cases of brain disease have been reported, mainly in patients with conditions that can lead to brain disease.
Lactose intolerance
This product contains lactose monohydrate. Patients with rare genetic diseases in galactose tolerance or poor absorption of glucose-galactose do not take this drug.
The effect of the drug on driving and operating machinery
Pregabalin may have a small or moderate effect on the ability to drive and use the machine, Pregabalin can cause dizziness and drowsiness and thus can affect the ability to drive or use machines.
Patients are advised not to drive, operate complicated machinery or participate in other potential dangerous activities until determining whether the drug affects the performance of these movements.
Using drugs for women during pregnancy and lactation
Because the risk of potential for humans has not been known, should use effective contraception in women who are likely to become pregnant.
Pregnant women
There is no enough data on pregabalin in pregnant women.
Animal studies have shown reproductive toxicity. The potential risk in humans is unknown.
Pregabalin should not be used during pregnancy, unless it is really necessary (if the mother is more beneficial than the potential risks for the fetus.
breastfeeding women
Pregabalin is excreted into breast milk. The effect of pregabalin on infants is not well known. Must decide to stop breastfeeding or stop treatment with pregabalin takes into account the benefits of breastfeeding and the benefits of the mother's treatment.
fertility
There is no clinical data on the impact of pregabalin on women's fertility.
In a clinical trial to make pregabalin efficiency in the movement of the coincidence, healthy male objects have been used Pregabalin at a dose of 600 mg/day. After 3 months of treatment, there is no effect on the movement of sperm
A reproductive study in Cai mice shows adverse reproductive effects. Researching fertility in male mice has shown the breeding effect and adverse development. The clinical involvement of these findings is unknown.
Drug interaction
because Pregabalin is excreted mainly through urine in the form of unprocessed, an insignificant amount is metabolized ( In Vivo studies and dynamic analysis objects
Accordingly, in Vivo studies, there is no interaction with clinical relevant schools recorded between pregabalin and phenytoin, carbamazepin, valproic acid, lamotrigin. Gabapentin, Lorazepam, Oxycodon or Ethanol. The analysis of the kinetics shows that the treatment of oral diabetes, diuretics, insulin, phenobarbital, Tlagabin and Topiramat does not have a significant clinical effect on Pregabalin purification.
Oral contraceptives norethistern and/or ethinyl oestradiol
Simultaneous use of pregabalin with norethisterone or/or ethinyl estradiol does not affect the kinetics in the stable fruit status of each of these drugs.
Medications affect the central nervous system
Pregabalin can increase the effects of ethanol and Lorazeparn. In control tests, taking oral doses at the same time with pregabalin with oxycodon, lorazepam, or ethanol does not lead to important images of sieve on steamed lakes. In experience after circulation, there are reports on respiratory failure and coma in rings using Pregabain and the central nervous system inhibitors. Pragabalin seems to enhance cognitive decline and motor function, generally caused by Oxycodon.
Interaction and elderly
There are no specialized interactive studies conducted in older volunteers.Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
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