Neuropain medicine 100mg S.P.M Treatment of pain caused by inflammation of peripheral nerves, muscle pain caused by fibrosis (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Pregabalin

Ingredient

Composition information	Content
Pregabalin	100mg

Uses

indications

Neuropain medicine for treatment in the following cases:

Pain due to neurological causes: peripheral neuritis due to diabetes, neuropathy after Herpes. Study force

ATC code: N03AX16

Pregabalin is an anti -convulsed and analgesic drug. Pregabalin has a structure similar to the central neurological inhibitor GABA, but is not directly attached to the Gabaa, GABAB, or Benzodiazepine receptors, does not increase GABAA's response on cultured neurons, nor does it change GABA levels in the mouse brain, does not affect GABA recovery as well as gaba. On cultured nerve cells, long -term use of pregabalin will increase the density of transport proteins and increase GABA transport speed. Pregabalin is attached to central nerve tissues with high affinity at the position of α2-Δ (a subunit of the calcium channel depending on the voltage). Although Pregabalin's exact mechanism has not been fully known, the attachment to subunit α2-she may be related to pregabalin analgesic and anti-convulsions effects.

In vitro, pregabalin reduces the release of calcium -dependent neurotransmitters such as glutamat, norepinephrin, peptides related to calcitonin regulating genes, and P can be via the function of calcium channel.

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 when hungry, the peak concentration in plasma is achieved after 1 hour in both single and multi -dose. Pregabalin's oral bioactivity is about 90% and depends on the dose. In repeated use, stable status achieved in 24 - 48 hours. Pregabalin's absorption rate decreases when used with food, leading to CMAX by about 25 - 30% and lasts 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 studies, pregabalin easily through the bloody brain 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 is pregabalin in the form of unprover. Pregabalin's n-methylat derivatives, Pregabalin's main metabolites are found in urine, accounting for about 0.9% of the dose. In preclinical studies, there are no signs of converting the co -pregabalin described into an isomer.

Elimination

Pregabalin is eliminated from the circulatory system mainly due to excretion through the original kidney.

The average pregabalin disposal time is 6.3 hours. Leaving plasma cregabalin and kidney clearance proportional to creatinine clearance.

Adjusting the dose in patients with reduced kidney function or hemorrhage is necessary.

Before taking Neuropain medicine 100mg S.P.M Treatment of pain caused by inflammation of peripheral nerves, muscle pain caused by fibrosis (3 blisters x 10 tablets)

How to use

Neuropain medicine is taken with food or not.

Dosage

The dose range is 150 - 600 mg daily is divided into 2 or 3 times.

epilepsy

Pregabalin can be started at a dose of 150mg daily divided into 2 or 3 times. Based on the response and intake of each patient, the dose may increase to 300mg daily after 1 week. The maximum dose of 600mg per day is achieved after another week.

Disseminated anxiety disorders

The dose is 150 - 600mg daily is divided into 2 or 3 times. Treatment needs should be re -evaluated periodically.

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

Pain due to neuritis, pain after herpes

Adults: The recommended dose of 150 - 300mg/day, divided into 2 or 3 times. Pregabalin can be started at a dose of 150mg daily. Based on the response and intake of each patient, the dose may increase to 300mg daily after 1 week. If still does not help after 2-4 weeks of treatment at a dose of 300mg/day, can increase to a dose of 600mg/day divided into 2 or 3 times. The dose of 300mg/day is only for people who are still painful and tolerated with a dose of 300mg/day, because of the potential of many ADR due to high doses.

Diabetes nerve pain

Adults: The starting dose of 150mg/day, divided into 3 times; The dose may increase in the next 1 week of the maximum recommendation 300mg/day divided into 3 times. Increasing the dose does not increase benefits, but more ADR.

muscle pain due to fibrosis

The starting dose of 150mg/day, increasing after a week depending on the response to 300mg/day, then 450mg/day if necessary.

Stop Pregabalin

According to the current clinical practice, if you have to stop Pregabalin, this should be done slowly at least 1 week regardless of indications.

Patients with renal failure:

Pregabalin is excreted mainly through the kidneys, clearing pregabalin proportional to creatinine clearance, reducing the dose in patients with renal function damage must depend on individuals and according to the creatinine clearance ratio (CICR), presented in Table 1 using the formula:

CLCR (ml/min) = [1.23 x (140 - age) x Weight (kg)]/Creatinine serum (μmol/l) (x 0.85 for female patients)

Pregabalin is effectively removed from serum thanks to the hemorrhage (50% of the drug after 4 hours). For patients who are getting hematoma, pregabalin's daily dose should be adjusted depending on the kidney function. Besides daily dose, the dosage should be used immediately after every 4 hours of hemorrhage (see Table 1).

Table 1: Adjust the dose of pregabalin by kidney function.

Creatinin purification (Clcr) (ML/min)

Total daily dose *

Daily use every day Maximum (mg/day) TID (mg)

qd = single/day

*: Total daily dose (mg/day) should be divided as designated 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:

The safety and effectiveness of pregabalin in children under 12 years old have not been established.

Take medicine on teenagers (12 - 17 years old):

Teenagers with epilepsy may take the dose like adults.

Efficiency and safety of pregabalin in patients under 18 years of age with unprocessed neuropathy.

Take medicine for the elderly:

No dose adjustments to the elderly except in the case of kidney function damage (see Table 1).

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?

On rare occasions, coma has been reported.

Overdose treatment of pregabalin should include general support and may include hemorrhage.

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

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

In table 2 below are all harmful reactions, with frequency (very common (1/10); or meet (> 1/100 to 1/1,000 to 1/10,000 to Harmed reactions listed may also be related to the disease and/or simultaneous medications.

Harmful reactions in patients with spinal cord damage

In general, the proportion of harmful reactions, harmful reactions to the central nervous system, especially drowsiness increases in the treatment of central nerve pain due to spinal cord damage. This is thought to be due to the additional effects of simultaneous medications (for example, anti -spasms).

Table 2: The harmful reactions of pregabalin

Agency system

Harmful reactions Blood

Not common neutrophilia > Metabolic and nutrition disorders

or meet increase the appetite feeling Like, reduce sexuality, disorientation, insomnia Feeling

rare Conditioned reflexes Language, forgetting, reducing memory, concentrated disorders, paresthesia, tactile reduction, sedation, balancing disorders, sleeping The taste, weakness rare convulsions, movement reduction, smell disorders, difficult to write The edge, visual disorders, eye swelling, visual loss, strong vision loss, eye pain, eye fatigue due to regulating b, dizziness, dry eyes, increased tears, eye irritation Tao

or meet dizziness Blood

rare extends the QT interval, fast sinus rhythm, sinus arrhythmia Chest and mediastinum

Not often encountered Difficulty breathing, nosebleeds, cough, nose bleeding, rhinitis, snoring, dry nose Meet vomiting, nausea, dry mouth, constipation, diarrhea, flatulence, abdominal stretch > Skin and subcutaneous disorders Not often encountered Ban nodules, sweating a lot, urticaria, itching Concluding

or meeting muscle spasticity, joint pain, back pain, pain, neck spasms > Kidney and urinary disorders are not common Hard Meet

abnormal gait, drunkenness, fatigue, edema, edema, fall, abnormal feeling

Meet weight gain Weight

rare The number of white blood cells decreases The following reactions are mentioned: insomnia, headache, nausea, anxiety, diarrhea, influenza syndrome, convulsions, restlessness, depression, pain, increased sweating and dizziness due to physical dependence. Patients should be informed about this at the beginning of treatment.

Regarding the long -term pregabalin treatment discontinuation, data shows that the proportion and severity of the drug stop symptoms related to the dose.

Child patients:

Pregabalin's safety summary is observed in two studies in children (pharmacokinetics research and tolerance, n = 65; Label open 1 followed by safety research, n = 54) is similar to what is observed in adult studies.

Instructions on how to handle ADR:

Notify the physician the 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

Contraindicated neuropain in the following cases:

Hypersensitivity to any ingredients of the drug.

Caution when using

Patients with diabetes

According to the current clinical practice, some patients with diabetes gain weight when treated with pregabalin. May need to adjust hypoglycemic drugs for these patients.

Sensitive reactions

There are reports during circulation on sensitive reactions, including cases of edema. Pregabalin should be stopped immediately if the symptoms on the face, the mouth or the upper respiratory tract occur.

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

Pregabalin treatment is related to dizziness and drowsiness. They can increase the incident of injury due to an accident (fall) in the elderly group. There are also reports in the circulation process of loss of consciousness, confusion and mental impairment. Therefore, patients are advised carefully until they get used to the potential side effects of the drug.

Visual effects

In control tests, a higher rate than patients treated with pregabalin is reported fuzzy compared to patients treated with placebo; and is restored in most cases that are further treated. In clinical trials when the medical examination tests are conducted, the rate of acute visual reduction and higher vision changes in patients treated with pregabalin than patients treated with placebo; Higher rate of eye -hallucinations in patients treated with placebo.

Experience in the circulation of drugs, harmful reactions are also reported, including visual loss, blurred vision or other visual changes, some of which are temporary.

Crossing Pregabalin can recover or improve these visual symptoms.

kidney failure

Cases of kidney failure have been reported, and in some cases of pregabalin stops showing the recovery of these reactions. Stopping anti -epileptic drugs used simultaneously

There is no enough data on the stopping of anti -epileptic drugs used simultaneously when the control of convulsions with pregabalin in the case of combined combination has been achieved, to reach a pre -pregabalin monotherapy.

Symptoms of drug stops

After short -term or long -term treatment with pregabalin, the symptoms of stopping drugs are observed in some patients. The following problems are mentioned: insomnia, headache, nausea, anxiety, diarrhea, influenza syndrome, restlessness, depression, pain, convulsions, sweating a lot and dizziness. Patients should be informed about this at the beginning of treatment.

Convulsions, including epilepsy and large convulsions, during the use of pregabalin or after stopping pregabalin in a short time related to pregabalin treatment stop for a long time, data shows that the proportion and weight of the drug stop symptoms related to the dose.

SECRETING HEART

There are reports during circulation of congestion heart failure in some patients using pregabalin. These reactions are mostly seen in elderly patients with cardiovascular disease. Pregabalin should be used carefully in these patients. Pregabalin stop can solve this reaction.

Harmful reactions in patients with spinal cord damage

The rate of harmful reactions in general, the reactions are harmful to the nervous system and especially drowsiness increases in the treatment of central nervous system pain due to spinal cord damage. This may be due to the additional effects of the drugs used simultaneously (for example, anti -spasms) used in this treatment. This should be considered when pregabalin is used in this treatment.

intentions and suicide behavior

The intention and suicide behavior have been reported in patients treated with anti -epileptic drugs in some cases. A comprehensive analysis of random fatigue studies also shows that the risk of increasing at low intentions and suicide behavior. The mechanism of this risk is not known and the available data does not rule out the possibility of increasing risk with pregabalin.

Therefore patients should be monitored signs of intentions and suicide behaviors. And the appropriate treatment should be considered. Patients (and patient care) should be consulted to find signs of intentions or suicidal behavior.

The function of the lower digestive organs is reduced

There have been reports in the circulation process on the function of the lower digestive organs (for example, intestinal obstruction, intestinal paralysis, constipation) when pregabalin is used simultaneously with drugs that can cause constipation such as opium -based painkillers. When pregabalin and opium -based drugs are used, measures to prevent constipation should be considered (especially in female patients and the elderly).

Abuse, abuse or dependence

Cases of abuse and dependence have been reported. Precautions should be prudent for patients with a history of drug abuse and patients should be monitored the symptoms of abgabalin abuse. Abuse or dependence (Development of tolerance, dose increase in escalator -style, drug search behavior).

Administration

Cases of brain disease have been reported. Most patients undergo conditions that can cause brain disease.

Patients with rare genetic diseases in galactose tolerance, lapp lapp lapp or absorbent glucose-galatose without using this drug.

The effect of the drug on the ability to drive and operate machinery

Pregabalin may cause dizziness or drowsiness. Therefore, patients are advised not to drive, operate machinery or participate in other adventure activities until determining whether the drug affects the performance of these movements.

Using 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 partial fertility.

The risk of human risk is not known. Therefore, Pregabalin is not used during pregnancy unless the benefits gives the mother clearly more important than the risks that may occur to the fetus.

Breastfeeding period:

It is unknown whether the pregabalin is excreted in human milk, however, the drug appears in mouse milk. Therefore, do not breastfeed by breast milk.

Drug interaction

Because most of the pregabalin is excreted in a constant form in the urine, undergoing negligible metabolism in the body ( Human studies and kinetic analysis in patients

According to human studies, there are no clinical pharmacokinetic interactions observed between pregabalin and phenytoin, carbamazepin, valproic acid, lamotrigin, gabapentin, lorazepam, oxycodon or ethanol. Analysis of kinetics in patients using drugs shows that oral diabetes treatment, diuretics, insulin, phenobarbital, Tiagabin and Topiramat have no clinically significant effects on pregabalin's clearance.

Oral contraceptives, norethisteron and/or ethinyl oestradiol

Simultaneous use Pregabalin with oral contraceptives used by Norethisteron and/or ethinyl oestradiol does not affect pharmacokinetics in the stable state of both drugs.

The effects on the central nervous system (CNS)

Pregabalin has the ability to increase the effects of ethanol and Lorazepam. In controlled clinical trials, Pregabalin multi -dose doses are simultaneously used with Oxycodon, Lorazepam, or ethanol does not cause great effects on respiration.

Experience in the circulation process, there are reports on respiratory failure and coma in patients taking pregabalin and other central neurological inhibitors. Pregabalin shows additional cognitive reduction and coordinated movement function caused by Oxycodon.

Interactions and elderly people

There are no specialized pharmacotable interactive studies conducted in elderly volunteers. Interactive studies are only done in adults.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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