PMS-Pregabalin 75mg pharmascascism, epilepsy (4 blisters x 15 capsules)

Dosage form Box of 4 blisters x 15 tablets
Specifications Pregabalin

Ingredient

Composition information	Content
Pregabalin	75mg

Uses

Indications

PMS-Pregabalin 75 mg is indicated in the following cases:

Central and peripheral neuropathy treatment in adults.

Pregabalin is linked to a sub-unit (α2 -Δ protein) of calcium channel electrodes in the central nervous system, can be replaced [3H] -Gabapentin.

pharmacokinetics

Pregabalin pharmacokinetics in a stable state is the same in healthy volunteers, patients treated with anti -epileptic drugs and patients with chronic pain.

absorption

Pregabalin is quickly absorbed when used in fasting, with peak plasma concentrations within 1 hour after using single and multiple doses. Pregabalin's oral bioavailability is estimated at 90% and does not depend on the dose.

After the dose is repeated, the stable state is reached within 24 to 48 hours. Pregabalin absorption rate is reduced when used with food, resulting in a reduction in CMAX by about 25-30% and slowing TMAX by about 2.5 hours. However, the use of pregabalin with food does not have a significant clinical effect on the level of Pregabalin absorption.

distribution

In preclinical studies, Pregabalin has been shown by the bloody barrier in mice, rats and monkeys. Pregabalin has been shown by the placenta in the mice and is present in milk in nursing mice. In humans, the distribution of pregabalin after drinking is about 0.56 l/kg. Pregabalin does not bind to plasma proteins.

transformation

Pregabalin undergo insignificant metabolism in humans. After a dose of pregabalin marking radioactive, about 98% of the recovered radioactive substance in urine is a constant pregabalin.

Pregabalin n-methyl derivatives, Pregabalin's main metabolites have been found in urine, accounting for 0.9% of the dose.

In preclinical studies, there is no sign of racemic of Pregabalin S-Enantiomer into R-Enantiomer.

Elimination

Pregabalin is eliminated from the circulatory system mainly due to the excretion through the renal in the form of constant.

Pregabalin has an average selling time of 6.3 hours. Plasma pregabalin purification and dialysis is proportional to creatinine purification.

Needs to adjust the dose in patients to reduce kidney function or dialysis.

pharmacokinetics in special subjects

Gender

Clinical trials show that gender does not significantly affect clinical effects on pregabalin concentrations in plasma.

kidney failure

Pregabalin purification is proportional to creatinine purification. In addition, pregabalin is effectively eliminated from plasma by dialysis (after 4 hours of dialysis, plasma pregabalin concentration decreases by about 50%). Because the kidney is the main elimination sugar, the dose is needed in the patient of renal impairment and the dosage after dialysis.

Hepatic failure

There is no specialized pharmacokinetic research conducted in patients with liver function impairment. Because pregabalin is not significantly metabolized and excreted mainly in urine in constant form, liver function is expected to not significantly change pregabalin levels in plasma.

Elderly (over 65 years old)

Purification of Pregabalin Co trends in older patients. This reduction is suitable for reducing creatinine purification in older patients. Pregabalin should be reduced in older patients with kidney damage.

Before taking PMS-Pregabalin 75mg pharmascascism, epilepsy (4 blisters x 15 capsules)

How to use

PMS-Predgabalin 75 mg is only used by oral, can be used or not with food.

Dosage

Dosage from 150 to 600 mg daily, divided into two or three times.

Neurological pain

Pregabalin can be started at a dose of 150 mg daily is divided into two or three times. Based on the response and tolerance of each patient, the dose can be increased to 300 mg daily after 3-7 days, and if needed, increase to the maximum dose of 600 mg daily after 7 days.

epilepsy

Pregabalin can be started at a dose of 150 mg daily divided two or three times. Based on the response and tolerance of each patient, the dose may increase to 300 mg daily after 1 week. The maximum dose of 600 mg per day can be achieved after another week.

All anxiety disorders

Dosage from 150 to 600 mg daily is divided into two or three times. The necessity of treatment should be re -evaluated regularly.

Pregabalin can be started at a dose of 150 mg daily. Based on the response and tolerance of each patient, the dose may increase to 300 mg daily after 1 week. The following week, the dose can be increased to 450 mg daily. The maximum dose of 600 mg per day can be achieved after another week.

Stop 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

Pregabalin is removed from the circulatory system mainly due to the excretion of the kidneys in a constant form. 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 - year old] x Weight (kg) serum creatinine (µmol/l) x (0.85 for women).

Pregabalin is effectively removed from plasma by dialysis (50% of the drug for 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 (see Table 1).

Creatinine purification (CLCR) (ML/Min)

Total daily dose *

Maximum dose (mg/day)

150

600

Two or three times.

≥ 30 -

300

Two or three times.

≥ 15 -

25-50

150

one or twice.

Once.

100

A single dose.

(+) Additional dose is an additional dose.

Used in patients with liver failure

No need to do the dose of patients with liver failure.

Children

The effect and safety of PMS -Pregabalin in children under 12 years old and in teenagers (12-17 years old) have not been established. No research.

Used in older adults (over 65 years old)

Older patients may need to reduce prefabalin dose due to renal function (see patients with renal impairment).

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 using overdose? In post-marketing experiences, the most common side effects are recorded when using the overdose of Pregabalin including drowsiness, confusion, agitation, and restlessness.

Overdose treatment Pregabalin includes supportive measures and can be dialysis if needed.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using PMS-Pregabalin 75 mg, you may experience unwanted effects (ADR).

The serious adverse reactions are reported mostly dizziness and drowsiness, usually mild and moderate.

The adverse reactions listed may also be caused by basic diseases and/or medications used simultaneously.

In the treatment of central nerve pain due to spinal cord damage, the adverse reaction rate in general, adverse reactions in the central nervous system and especially drowsiness have increased.

Very popular

Dizziness, drowsiness.

popular

Increase appetite. vision, double look.

vomiting, dry mouth, constipation, flatulence.

Nasomitis, anorexia, hypoglycemia. Reduce sensory, memory loss, increase sensation, burning sensation. Abdominal, gastroesophageal reflux disease, increased salivation, decreased mouth feeling. Blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, reducing platelets.

Rare

Neutral leukemia, peripheral market loss, eye irritation, pupils, stretching. pattern.

Hypersensitivity, angioedema, allergic reactions.

itching.

Urine. The following reactions have been mentioned: insomnia, headache, nausea, anxiety, diarrhea, influenza syndrome, convulsions, stress, depression, pain, increased sweating and dizziness.

Patients should be informed about this at the beginning of treatment.

Regarding pregabalin's long -term stopping, there is no data on the incidence and severity of the smoking symptoms related to Pregabalin's dosage and dosage.

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

PMS-Pregabalin 75 mg contraindicated in the following cases:

Hypersensitivity to the active ingredient or any ingredient of the drug.

Precautions when using

Diabetes patients

Some patients with weight gain diabetes need to adjust hypoglycemic drugs when treated with pregabalin.

Hypersensitivity reaction

Pregabalin should be stopped immediately if the angioedema symptoms occur, such as the face, around the mouth, or the upper respiratory tract.

Dizziness, drowsiness, loss of consciousness, confusion, and mental impairment

Pregabalin is related to dizziness and drowsiness. There are also reports of loss of consciousness, confusion and mental impairment.

Therefore, patients should be cautious until they are familiar with the potential effects of the drug.

Visual effects

In control tests, a higher percentage of patients treated with pregabalin is reported to be visual reduction compared to patients treated with placebo, these symptoms are largely recovered from the continued dose.

In clinical studies conducted testing, the rate of vision reduction and market change in patients treated with pregabalin is larger than placebo, the rate of retinal changes is larger in patients treated with placebo.

The adverse visual reactions have also been reported, including visual loss, blurring or vision change, most of them are fleeting.

Pregabalin stops can recover or improve visual symptoms.

kidney failure

Cases of kidney failure have been reported and in some cases of pregabalin stops showing this adverse reaction.

Quit anti -epileptic drugs at the same time

Inadequate data shows that the removal of anti -epilepsy drugs simultaneously, when controlling epilepsy with pregabalin in the additional state, to achieve a single therapy with pregabalin.

Symptoms of cessation

Symptoms of cessation after short -term and long -term treatment with pregabalin have been recorded in some patients.

The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhea, influenza syndrome, stress, depression, pain, seizures, increased sweating and dizziness.

Patients should be informed of this at the beginning of treatment.

Convulsions, including epilepsy, great epilepsy, may occur during pregabalin or immediately after pregabalin.

Regarding Pregabalin's long -term discontinuation stops without data on the incidence and severity of the symptoms of quitting related to the time and bureaucracy of Pregabalin.

SECRETING HEART

There have been reports of congestive heart failure in some patients treated with pregabalin. These reactions are mainly in older patients with cardiovascular damage during pregabalin treatment for nerve pain indications. Pregabalin should be used carefully in these patients. Pregabalin stop can solve the reaction.

Central nerve pain due to spinal cord damage

In the treatment of central nerve pain due to spinal cord damage, the adverse reaction rate in general, adverse reactions on the central nervous system and especially drowsiness have increased. This may be due to a secondary effect due to simultaneous use of drugs (such as anti -spasms) necessary for this condition. Should consider when specifying pregabalin in this situation

thoughts and suicide behaviors

The suicide thoughts and behaviors have been reported in patients treated with anti -epileptic drugs in many indications.

A meta analysis of random studies that are controlled to the placebo of anti -epileptic drugs also shows a risk of slightly increasing the risk of suicide thoughts and behaviors.

The mechanism of this risk is not known and the existing data does not exclude the possibility of increasing risk due to pregabalin.

Therefore, patients should be monitored the signs of suicide thoughts and behaviors and should consider appropriate treatment.

Patients and patients should be consulted on signs of intentional or suicide behavior.

Reduce the lower gastrointestinal function

There are reports on events related to lower gastrointestinal function (for example, intestinal obstruction, intestinal paralysis, constipation) when treated with pregabalin with drugs that can cause constipation, such as opioid analgesic.

When using a combination of pregabalin and opioids, you should consider constipation prevention measures (especially in female patients and the elderly).

Abuse of abuse

The abuse cases have been reported. Caution should be careful in patients with a history of drug abuse and patients should be monitored the symptoms of abuse abuse.

Administration

Cases of brain disease have been reported, mainly in patients with basic conditions that can promote brain disease.

Lactose intolerance

PMS-Pregabalin contains lactose monohydrate. Patients with rare genetic problems without galactose, lactase lactase defects or malposive glucose-galactose should not take this drug.

The ability to drive and operate machinery

PMS-Pregabalin may have a small or medium influential effect on the ability to control the train and operate machinery.

PMS-Pregabalin can cause dizziness and drowsiness and therefore can affect the ability to control trains and operate machinery.

Patients are advised not to drive, operate complicated machines or participate in other dangerous activities until it is known whether this drug affects their ability to perform these activities.

Pregnancy

There is not enough data on the use of pregabalin in pregnant women.

Animal studies have shown reproductive toxicity. The potential risk in humans is unknown.

PMS-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).

Reproductive ability: There is no clinical data on the influence of pregabalin on female fertility.

Breastfeeding period

whether Pregabalin is excreted in breast milk or not, however, it is present in mouse milk. Therefore, breastfeeding is not recommended during treatment with pregabalin.

Medicinal interaction

because Pregabalin is mainly excreted in urine in constant form, through insignificant metabolism in humans ( In Vivo studies and pharmacokinetic analysis

Accordingly, in Vivo research, there is no clinical -related pharmacokinetic interaction recorded between pregabalin and phenytoin, carbamazepin, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.

Mobile pharmacokinetics analysis shows that treating oral diabetes, diuretics, insulin, phenobarbital, Tiagabine and Topiramate has no clinical influence on Pregabalin purification.

Oral contraceptives, Norethisterone and/or ethinyl estradiol

Simultaneous use of pregabalin with norethisterone oral contraceptives or/or ethinyl estradiol does not affect the pharmacokinetics in the stable state of each of these drugs.

ethanol, lorazepam, oxycodone

Pregabalin may increase the effects of ethanol and Lorazepam. In controlled clinical trials, the oral dosage several times pregabalin simultaneously with oxycodone, lorazepam, or ethanol does not lead to clinical important effects on the respiratory.

In the Post-Marketing experience, there are reports on respiratory failure and coma in patients using Pregabalin and other central nervous system inhibitors.

Pregabalin seems to increase the decrease in awareness and motor function, generally caused by oxycodone.

Interaction and elderly

There are no specialized pharmacokinetic interactive studies conducted in older volunteers.

Storage

Store in a dry place at a temperature of not more than 30 ° C.

Expiry date: 3 years from the date of manufacture. Do not use overdue drugs stated on the packaging.

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