Pregasafe 75 MSN medicine for neuropathy, 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

Pregasafe 75 mg drug is indicated in the following cases:

Treatment of neuropathy: Pregabalin is indicated in the treatment of neurological pain for adults.

Epilepsy treatment: Pregabalin is indicated as a supplementary therapy in adults in local seizures, with or without secondary epilepsy.

Treatment of general anxiety disorders: Pregabalin is indicated for treatment of general anxiety disorders in adults.

Pharmacokinetics

absorption

Pregabalin is quickly absorbed when drinking when hungry, the peak concentration in plasma is achieved after 1 hour in both single and multi -dose. Pregabalin's oral use is about 90% and depends on the dose. When used repeated, stable status achieved in 24 - 48 hours.

Pregabalin's absorption rate decreases when used with food, resulting in CMAX decreased by about 25 - 30% and stretching TMAX after about 2.5 hours. However, using pregabalin and food has no significant clinical effects to the level of absorption of pregabalin.

Distribution

In preclinical study, pregabalin easily through the bloody barrier in mice, rats and monkeys. Pregabalin passes the placenta in the rat and appears in mouse milk. In humans, the distribution of pregabalin 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 radioactive Pregabalin, about 98% found in urine in the form of unchanged pregabalin. N - methylated derivatives of pregabalin, the main metabolite of pregabalin is found in urine, accounting for about 0.9% of the dose. In preclinical study, there is no sign of converting the co -division pregabalin into the isomer.

Elimination

Pregabalin is eliminated from the circulatory system mainly due to the excretion through the kidney in the form of constant. The average selling time of pregabalin is about 6.3 hours. Leaving plasma pregabalin and kidney clearance proportional to creatinine clearance. Adjusting the dose on patients with kidney function or hemorrhage is necessary.

linear/non -linear

Pregabalin's

pharmacokinetics is linearly within a single daily dose. The variation of pharmacokinetics of low pregabalin (

Before taking Pregasafe 75 MSN medicine for neuropathy, epilepsy (3 blisters x 10 tablets)

How to use

Pregabalin is used by oral, can be used with food or not.

Dosage

Dosage range from 150 mg - 600 mg daily is divided into 2-3 times.

Neurological pain

Pregabalin treatment can start at a dose of 150 mg daily. Depending on the response of each individual and tolerance, the dose may increase to 300 mg/day after a period of 3-7 days, and if necessary, the dose may increase a maximum dose of 600 mg/day after about 7 days of additional treatment. However, the dose of 600 mg does not increase the effectiveness of treatment and increases side effects.

epilepsy

Pregabalin treatment can start at a dose of 150 mg daily. Depending on the response of each individual and tolerance, the dose may increase to 300 mg/day after a period of 1 week, and if necessary, the dose is maximum dose of 600 mg/day after about 1 week of additional treatment.

General anxiety disorders

About 150 - 600 mg per day is divided into 2 or 3 times. Dosage needed for therapy should be re -evaluated regularly. Treatment with pregabalin can start at a dose of 150 mg daily. Depending on the response of each individual and tolerance, the dose may increase to 300 mg/day after 1 week of treatment. After an additional 1 week of treatment, the dose may increase to 450 mg/day. Maximum dose of 600 mg/day can be achieved after 1 week of additional treatment.

Stop using Pregabalin

If you have to stop using pregabalin, it is necessary to gradually decrease for a minimum of 1 week.

Patients with renal failure

Dosage reduction in patients with renal function damage must be depending on the individual and according to the evaporation coefficient of creatinine (CLCR).

For patients who are doing hemorrhage, pregabalin daily should be adjusted depending on the kidney function. Besides daily dose, supplementary dose should be used immediately after every 4 hours of hemorrhage.

Adjust the dose by kidney function:

Creatinine clearance (ml/min)

Total daily Pregabalin dose*

Treatment regime

Maximum doses (mg/day)

150

600

BID or TID

≥ 30 -

300

BID or TID

≥ 15 -

25 - 50

150

qd or bid

100

Single dose+

*Total daily dose (mg/day) should be divided as indicated by the dose mode to provide mg/dose.

+Additional dose is an additional dose.

Take drugs in patients with liver failure

No dose adjustments in patients with liver failure.

Use drugs for children and teenagers (12 - 17 years old)

The safety and effectiveness of pregabalin in children under 12 years old and unpaid teenagers.

Take medicine for the elderly (over 65 years old)

Elderly people may need to reduce pregabalin dose due to renal function.

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? In the reports after circulation, the most common side effects are reported when overdose of Pregabalin include: emotional disorders, sleeping, confusion, depression, anxiety, restlessness.

Overdose treatment Pregabalin should take additional measures that may include hemorrhage if necessary.

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 Pregasafe 75 mg you may experience unwanted effects (ADR).

Very common, ADR> 1/10

Neurological: dizziness, drowsiness.

Common, ADR> 1/100

Neurological: Increasing appetite, refreshing mood, irritability, reduced libido, disorientation, insomnia, loss of air conditioning, abnormal coordination, tremor, poor body, distraction, distraction, abnormalities, loss of balance, sleeping, blurred vision, dizziness, dizziness.

digestive: vomiting, dry mouth, constipation, flatulence. Body: erectile dysfunction, abnormal gait, drunkenness, fatigue, peripheral edema, edema, weight gain.

Uncommon, 1/1000

Respiratory: Nasomitis.

Body: Anorexia, hypoglycemia, Red nodules, sweating, falling, thirst, chest tightness, weakness, thirst, chills.

Neurological: hallucinations, fear of attack, indifference, anxiety, depression, restlessness, oscillation of temperament, feeling of loss of personality, difficulty expressing, dreaming, increasing libido, apathy, fainting, dumb, vibration, increasing mental activity, losing taste, dizziness, pulses, trembling, trembling, trembling, trembling, trembling, trembling, trembling, trembling, trembling, trembling, trembling, trembling, trembling, trembling, shaking, vigor Memory loss, burning sensation. Eyes: vision disorders, swelling of the eye, reducing vision, reducing sharpness when visiting, eye pain, eye strain, dry eyes, watery eyes, hearing. Cardiovascular: tachycardia, atrial heart block 1.

Respiratory: Difficulty breathing, dry nose.

muscle - bone: muscle contraction, swelling of joints, cramps, muscle pain, joint pain, back pain, limb pain, muscle stiffness.

kidney - Urinary tract: no control of urinary tract, urinary retention. genitals: Slow output, sexual disorders.

Liver: Increased alanin aminotransferase, increased enzyme creatin phosphokinase in blood, increased enzyme aspatat aminotransferase.

blood: reduces the number of platelets.

Rare, ADR

Blood: neutral leukopenia.

Neurological: Conditional reflexes, joyful mood, reduced motor movement, sense of smell, difficult to write, loss of peripheral areas.

eyes: look fluttering, change the feelings of the depth of the image, dizziness, eye irritation, pupils, squint, look bright.

Cardiovascular: flushed, redness, hypotension, hypertension, fast sinus heartbeat, sinus arrhythmia, slow sinus heartbeat. digestive: abdominal distention, gastroesophageal reflux, increased salivation, loss of taste, pancreatitis, difficulty swallowing. Respiratory: Nosebleeds, obstruction, cough, stuffy nose, rhinitis, snoring.

Body: urticaria, cold sweat.

kidney: kidney failure, urinary discharge. genital: menstruation, milk, breast pain, dysmenorrhea, mammary hypertrophy. Metabolic: Hyperglycemia, decreased potassium. Blood: Reduce the number of white blood cells. Systemic: increased blood creatinine, weight gain, body edema, fever.

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

Pregasafe 75 mg drug is contraindicated in the following cases:

Sensitive to any ingredients of the drug.

Be cautious when used

Patients with rare genetic diseases in galactose tolerance, deficiency of lapp lactase enzymes or glucose - galactose without this drug.

Some diabetics patients gain weight when taking pregabalin need to adjust the use of hypoglycemic drugs.

Pregabalin treatment often occurs dizziness and drowsiness, which may increase the risk of trauma in the elderly.

There is no complete data on the combination with other anti -epileptic drugs, as soon as it is achieved epilepsy control with pregabalin in combined treatment, it is necessary to consider to achieve a single therapy with pregabalin. After stopping the drug in short -term and long -term treatment with pregabalin, the signs after the removal are observed in some patients, the effects mentioned include: insomnia, headache, nausea and diarrhea.

Despite the effects of drug use on recovery, unprocessed recovery, improved renal function after stopping or reducing the proper dose of pregabalin.

There are several reports after circulating medication on congestive heart failure on some patients using pregabalin. In some short -term trials in patients with no clinical signs of heart or peripheral vessels, there is no clear relationship between peripheral edema and cardiovascular complications such as high blood pressure or congestive heart failure. Because data on patients with severe congestion heart failure is limited to use prearly pregabalin in these patients.

The ability to drive and operate machinery

The drug can make patients dizzy, drowsiness and concentration. Therefore, patients should not drive, operate machinery, or participate in any activity that can be harmful to themselves until they know whether the drug affects these activities.

Pregnancy

There is no adequate data on pregabalin on pregnant women. Animal studies have shown toxic effects on fertility. The risk of human risk is not known. Therefore, do not use Pregabalin during pregnancy unless the benefits gives the mother more clearly more important than the risks that may occur to the fetus. Effective contraception must be used for women of reproductive age.

Nursing period

It is unknown whether pregabalin is excreted through human milk or not, however, the drug appears in mouse milk. Therefore, not breastfeeding when using therapy with pregabalin.

Drug interaction

Pregabalin is excreted mainly through urine in the form of inconceivable, an insignificant amount is metabolized (

In Vivo studies, it is not observed that clinical pharmacokinetic interactions between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol. The object of pharmacokinetic evaluation has shown that oral diabetes treatment drugs, diuretics, insulin, phernobarbital, Tiagabine and Topiramate, have no significant clinical influence on Pregabalin clearance.

Pregabalin sharing with oral contraceptives oral norethisterone and/or ethinyl oestradiol does not affect the pharmacokinetic stability of both drugs.

Pregabalin can affect the effects of ethanol and lorazepam. In controlled clinical trials, the oral dosage of Pregabalin combined with oxycodone, ethanol has no important clinical effects on respiration.

In post -circulation reports, there are reports on respiratory failure and coma in patients taking pregabalin and other central neurological inhibitors.

The presence of pregabalin increases cognitive disorders and motor function caused by oxycodone. There are no studies on specific pharmacological interactions conducted in elderly patients volunteering.

Storage

Store in a dry place, avoiding light and temperatures below 30 ° C.

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