Premilin 75mg Hasan Treatment Treatment of local epilepsy (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Pregabalin
Ingredient
| Composition information | Content |
| Pregabalin | 75mg |
Uses
Indications
Premilin 75mg drug are indicated in the following cases:
Mechanism of action
Pregabalin is an anti -convulsed and analgesic drug.
Pregabalin has the same structure as the central nerve inhibitor GABA, but is not directly attached to the GABAA, GABAB receptor, or Benzodiazepine's receptor, does not increase the response of GABAA, on cultured nerve cells, nor does it change GABA concentration in the mouse brain, does not affect GABA recovery as well as gaba. On cultured neurons, long -term use of pregabalin will increase the density of transport proteins and increase GABA shipping speed.
Pregabalin is attached to the central nerve tissue with high affinity at the position of α2-Δ (a subunit of an electrical calcium channel). Although Pregabalin's exact mechanism has not been fully known, it may be associated with Pregabalin's pain and anti-convulsions effects.
In vitro, pregabalin reduces the release of neurotransmitters dependent calcium such as glutamat, norepinephrin, peptides related to calcitonin and P regulating genes, can be through the functional regulation of the calcium channel.
Pregabalin does not block the sodium channel, does not work with the Opiat receptor and does not change the activity of the cyclooxygenase enzyme.
Pregabalin does not work with serotonin and dopamine receptors, does not inhibit the regeneration of dopamine, serotonin or noradrenalin.
pharmacokinetic
absorption
Pregabalin is quickly absorbed when drinking hungry, the top concentration of plasma is achieved within 1 hour after taking the dosage and multiple dose. The oral bioavailability of pregabalin is over 90% and does not depend on the dose. After the dose is repeated, the stable concentration is reached within 24 - 48 hours. Food reduces pregabalin absorption rate, resulting in a decrease in the peak concentration by about 25-30% and the time of reaching the peak concentration lasts longer, about 2.5 hours. Food does not affect the absorption level of pregabalin, but this is not clinically significant.
Distribution
In preclinical studies, Pregabalin has been shown by the blood -barrier in mice and monkeys. Pregabalin also crosses the placenta in the mouse and is found in the mother's milk. In humans, the distribution of pregabalin after taking about 0.56L/kg. Pregabalin is not associated with plasma protein.
Metabolism
Pregabalin is not significant in humans. After taking 1 dose of pregabalin marked radiation, about 98% of the radioactive amount found in urine in the form of unchanged. Pregabalin's n-methylization is the main metabolite found in urine, about 0.9%. In clinical advanced studies, there is no optical conversion from the form of isomers S to isomers R.
Elimination
Pregabalin is excreted mainly through the renal in a constant form. The average selling time is 6.3 hours. The plasma clearance and the clearance of the kidneys are favorable to the clearinine clearance. Need to adjust the dose dose in patients with impaired renal function or patients who are hemolysis.
linear
The pharmacokinetics of linear Pregabalin within the recommended dose range. Differences are dynamic between low individuals (
Pharmacokinetics on special clinical subjects
Race: Pregabalin's pharmacokinetics change is not significant by race.
Sex: Clinical trials show that Pregabalin's dynamics are not significantly different by gender.
Elderly (> 65 years): Pregabalin clearance tends to decrease when age increases, suitable for reducing creatinine clearance by age. Needs to reduce the dose in the elderly with impaired renal function.
Children: Pregabalin's pharmacokinetics are assessed in patients with epilepsy (divided into age groups: 1 - 23 months, 2 - 6 years old, 7 - 11 years old and 12 - 16 years old) in doses of 2.5; 5; 10 and 15mg/kg/day in a pharmacokinetic study and tolerance.
After taking pregabalin, the time reaches the peak concentration at all the same age groups and between 0.5 - 2 hours after drinking. The value of CMAX and AUC increases the line with concentrations in all ages groups. AUC in the group of children weighing 30kg lower than 30% because the body weight increases, changing the clearance of 43% when compared to patients with 30kg weight.
The semi -exhaust time of pregabalin averages from 3-4 hours in children ≤ 6 years old, and 4-6 hours in children ≥ 7 years old. The pharmacokinetic analysis shows that creatinine clearance is the co -variable of pregabalin clearance, body weight is the co -variable of the distribution volume and this correlation is the same in children and adults.
Pregabalin pharmacokinetics in children
Renal failure and hemolysis: Pregabalin clearance is proportional to creatinine clearance. In addition, pregabalin in plasma is also eliminated by the process of hemolysis (after 4 hours of hemolysis, pregabalin concentration in plasma decreased by about 50%). Because the drug is excreted mainly through the kidney, it is necessary to reduce the dose in patients with renal impairment and supplement the dose after hemolysis.
Hepatic failure: There is no specialized pharmacokinetic test in patients with liver failure. Pregabalin is largely not metabolized and excreted mainly in urine in a constant form, so the liver failure does not significantly change pregabalin levels in plasma.
Lactating women: Evaluating pharmacological pharmacological more than 12 breastfeeding women (having been born at least 12 weeks) taking pregabalin dose of 150mg every 12 hours (300mg/day). Milk secretion does not affect the pharmacokinetics of Pregabalin.
Pregabalin is excreted in breast milk with a stable concentration of about 76%. The amount of newborn pregabalin received from milk (the average amount of milk for the baby used is 150ml/kg/day) of the mother using Pregabalin 300mg/day or a maximum dose of 600mg/day, equivalent to 0.31 or 0.62mg/kg/day, about 7% of the total daily doses use, on mg/kg.
Before taking Premilin 75mg Hasan Treatment Treatment of local epilepsy (3 blisters x 10 tablets)
How to use
Premilin 75mg medicine is used orally, divided into 2-3 times daily, can be used or not with meals.
Need to reduce Pregabalin dose slowly for at least 1 week before stopping the drug.
The important thing is that patients should take medication regularly at the same time between days.
There is no special requirement on drug treatment after use.
Do not throw away drugs in wastewater or domestic waste. Consult the pharmacist how to quit unused. These measures will help protect the environment.
Dosage
Adults
epilepsy
Starting dose: 75mg x 2 times/day.
Depending on the tolerance and response of each patient, the dose may be increased to 300 mg/day after 1 week. Maximum dose can be increased to 600mg/day after the next week.
Disseminated anxiety disorders
Starting dose: 75mg x 2 times/day.
Can increase the dose step by step 150 mg/week to a maximum of 600 mg/day depending on the response and tolerance of the patient. The necessity of treatment should be evaluated regularly.
Pain due to neurological causes
Starting dose: 75mg x 2 times/day.
Depending on the tolerance and response of each patient, the dose can be increased to 300mg/day after 3-7 days, and if necessary, the dose may increase a maximum dose of 600mg/day after the next 7 days.
Pain due to fibrosis
Starting dose: 75mg x 2 times/day.
Depending on the tolerance and response of each patient, the dose can be increased to 300mg/day, divided 2 times/day after 1 week. The dose can be increased to 450mg/day if necessary.
Special clinical objects
Patients with kidney failure and patients with hemolysis
Dosage adjustment in patients with impaired renal function or being given blood separation according to the clearinine clearance (CLCR) is recommended in the following table:
Clcr (ml/min)
Total dose of Pregabalin (mg/day)
Treatment regime
Maximum dose
150
600
Divide 2-3 times/day.
≥ 30 - 75
300
Divide 2-3 times/day.
≥15 -
25 - 50
150
1 time/day or divided 2 times/day.
25 75 1 time/day.
100 Single dose*
Patients with hemolysis should be received an additional dose of 25 - 100mg Pregabalin right after each 4 -hour session.
Patients with liver failure
No dose adjustments in patients with hepatic failure.
Children
The safety and effectiveness of pregabalin with children
Elderly (over 65 years old)
may need to reduce the dose of pregabalin due to impaired renal function in the elderly.
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
Experience overdose Pregabalin is limited. The highest dosage was reported to be 800mg, not seeing any significant consequences clinically. After -sales data shows the most unwanted effects when overdose of Pregabalin including drowsiness, confusion, agitation, restlessness. The epilepsy has also been reported. In some rare cases, there is also a coma.
How to handle
There is no specific antidote. If indicated, cause vomiting or gastric lavage, maintain airway if needed. Symptomatic treatment. Hematoparology if indicated (eliminating pregabalin is about 50% in 4 hours).
What to do when forgetting a dose? If the time of remembering is close to the next dose time, skip the forgotten dose and continue taking the next dose as usual. Do not take double dose to compensate for the forgotten dose.
Side Effects
When using Premilin 75mg , you may experience unwanted effects (ADR).
The most common side effect has been reported as dizzy and drowsiness (mild to medium level). In control studies, the treatment rate due to unwanted effects is 12% in the pregabalin group and 5% in the placebo group.
Unwanted effects are separated by frequency: Very common (ADR ≥ 1/10), common (1/100 ≤ ADR ≤ 1/10), less encountered (1/1000 ≤ ADR ≤ 1/100), rare (1/10000 ≤ ADR ≤ 1/1000), very rare (ADR Infections and parasites: Rhinitis - Throat (common). Evala, allergic reactions (rare). Anorexia, hypoglycemia (rarely). The illusion, panic, restlessness, agitation, depression, depression, manic, like to cause aggression, change mood, dissolve personality, linguistic disorders, increase libido, have no ability to achieve orgasm, indifference (less common). Conditional reflexes (rare). Loss of air conditioning, loss of combination of movements, tremor, speech disorders due to neurological damage, memory loss, attention disorders, abnormalities, decreased sensations, vestibular disorders, indifference (common). Fainting, stunning, seizure, loss of consciousness, agitation, dysfunction, dizziness when changing posture, tremor when intentional movement, eyeball vibration, cognitive disorders, mental impairment, reflexes, increased sensation, burning sensation, loss of taste, weakness (less common). Severe seizures, olfactory disorders, physical activity decrease, difficult to read (rare).
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
Premilin 75mg drug contraindicated in the following cases:
Precautions when using
Feng shui:
The veins can be life -threatening and acute respiratory failure that needs emergency treatment that has been reported during the monitoring process in patients after taking the first dose and in patients treated with pregabalin for a long time. Patients with other drug -related drugs (angiotensin enzyme inhibitors) may increase angioed risk.Hypersensitivity reaction:
There has been a after -sales report on hypersensitivity reactions including angels. Stop using Pregabalin immediately if there are symptoms of angioedema (such as swelling of the face, around the mouth, upper respiratory tract).
Weight gain:
Pregabalin increases body weight related to the dose and drug time. However, weight gain is not related to the body mass index (BMI) before treatment, gender or age and also not due to edema. Although in short -term research, controlled, weight gain does not combine with important clinical changes in blood pressure, but long -term effects on cardiovascular has not been clarified. In addition, pregabalin does not lose blood glucose.
Patients with diabetes:
In clinical reality, some diabetes patients with weight gain during treatment with pregabalin may need to adjust the anti -diabetic drugs in use.
kidney failure:
Cases of renal failure have been reported when treated with pregabalin, in some cases, this effect can be reversed when stopping using the drug.
SECRETING HEART:
There have been after -sales reports on the effect of hemorrhagic heart failure in some patients who are being treated with pregabalin, especially in the elderly with cardiovascular diseases using pregabalin to treat pain due to neurological causes. This effect may be lost when stopping using the drug. Be careful when using pregabalin in these patients.
Thinking and suicide behavior:
Thinking and suicide behavior have been reported in patients treated with anti -epileptic drugs in some indications. A meta analysis of random studies with a placebuild control with anti -epileptic drugs also shows a slight increase in the risk of suicidal thoughts and behaviors. The mechanism of this risk is unknown and the available data does not exclude the possibility of this risk with Pregabalin. Therefore, patients need to be closely monitored about depression, the tendency to commit suicide, abnormal behaviors during the treatment process and need to notify the doctor as soon as the above signs appear.
affect the central nervous system (dizziness, drowsiness, loss of consciousness, confusion, mental impairment):
Pregabalin can cause dizziness and drowsiness, increasing the risk of unexpected accidents (falling) in the elderly. There are also after -sales reports of the possibility of causing loss of consciousness, confusion, mental impairment. Patients need to be carefully warned until they get used to unwanted effects of the drug.
Visual effects:
In control tests, patients treated with pregabalin have a higher blurred rate than patients treated with placebo. In clinical studies conducting eye exams shows that the rate of vision reduction and market change is much larger in the patient group of pregabalin eagles compared to placebo, the rate of changing the eye -shaping glass is higher than the Placebo. There have been reports on unwanted effects on the vision (loss of vision, blurred vision, other changes in sensitivity of the eye), many symptoms of airy manifestations and improved when stopping Pregabalin.
Stop coordinating with other anti -epileptic drugs:
There is no enough data on the use of other anti -epileptic drugs in the coordination regimen in combination with pregabalin to switch to a single therapy Pregabalin when the seizure has been controlled.
Cet Syndrome:
After stopping treatment with pregabalin, the symptoms of drug suspension may be encountered such as insomnia, headache, nausea, fatigue, diarrhea, influenza syndrome, nervous tension, depression, pain, seizures, sweating, dizziness (suggestive signs of drug dependence). It is necessary to notify the patient about the above problem at the beginning of the therapy. The seizures, including epilepsy and large seizures, can also occur during and immediately after stopping using pregabalin. Stop using pregabalin during long -term treatment, data shows that the proportion and severity of the cessation syndrome may be related to the dose. Reducing Pregabalin dose from 1 week.
When treating central nerve pain due to spinal cord injury:
The ratio of unwanted effects in general, on the central nervous system and especially the increase in drowsiness can be the additional effect of the drug used and the necessary condition for the condition (such as spasticity). Need to consider when using pregabalin.
Reduce gastrointestinal function:
There have been after -sales reports on lowering the lower digestive tract function (obstruction of the intestinal tract, intestinal paralysis, constipation) when using Pregabalin in combination with drugs that can cause constipation (Opioid analgesic). When combining the above drugs, it may be necessary to prevent constipation, especially in female patients and the elderly.
Abuse and drug dependence:
Cases of abuse and drug dependency have been reported. Precautions should be prudent for patients with a history of drug abuse and monitoring symptoms of abuse or drug dependence (such as greasy, the trend of increasing dose or searching for drugs).
Breeding:
Cases of brainstorms have been reported, mainly in patients at risk of potential brain disease.
Okay:
Premilin 75mg preparations contain lactose excipients, patients with rare genetic disorders in galactose intolerance, lactase deficiency or glucose-galactose absorption disorders should not use this drug.
The ability to drive and operate machinery
Pregabalin may cause dizziness and drowsiness, slightly affecting the ability to drive, operate machinery. Patients should not drive, operate machinery.
Pregnancy
There is no adequate data on pregabalin on pregnant women. The potential risk in people is not known. Therefore, pregabalin should not be used when pregnant unless it is really necessary (the benefits bring the mother over the risk of potential for the fetus). Using effective contraception for female patients who can conceive during medication.
Breastfeeding period
Pregabalin is excreted into breast milk. The effect of pregabalin on infants/young children is unknown. It is necessary to consider the benefits of breastfeeding for children and the benefits of treatment for the mother who decided to stop breastfeeding or stop using the drug.
Medicinal interaction
Because Pregabalin is excreted mainly through urine in the form of unaccompleted, negligible amounts of metabolic (
In vivo research 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 pharmacokinetics analysis also shows that diabetic medications (glyburid, insulin, metformin), diuretics (Furosemid), Phenobarbital, Tiagabin and Topiramat also do not have a significant clinical effect on pregabalin clearance.
Oral contraceptives, norethisteron and/or ethinyl estradiol:
Concomitance Pregabalin use with oral contraceptives oral norethisteron and/or ethinyl estradiol does not affect the stable pharmacodynamic state of both substances.
Medications affect the central nervous system:
Pregabalin may increase the effects of ethanol and Lorazepam. In control clinical trials, taking multiple doses of pregabalin in combination with Oxycodon, Lorazepam or ethanol does not cause clinical important effects on the respiratory system. After -sales data shows respiratory failure and coma in patients with pregabalin and central neurological inhibitors.
Pregabalin increases the ability to reduce cognitive and motor function of oxycodon. There is no study of separate pharmacokinetics interactions conducted on elderly volunteers. Studies on drug interaction are only conducted in adults.
Storage
in a dry place, less than 30 ° C. Avoid light.
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