Essividine Boston treats epilepsy and pain relief due to neurological (4 blisters x 14 tablets)

Dosage form Box of 4 blisters x 14 tablets
Specifications Pregabalin

Ingredient

Composition information	Content
Pregabalin	75mg

Uses

indications

Essividine drugs are indicated in the following cases:

Combined with other anti -seizures in the treatment of local epilepsy in adults. Learning

Pregabalin is an anti -convulsed and analgesic drug.

Pregabalin has a structure similar to the central nerve inhibitor GABA, but is not directly attached to the GABA receptors, or the receptor of Benzodiazepin, does not increase the response of GABA, on cultured neurons, nor does it change GABA levels in the mouse brain, does not affect the recovery as well as gaba.

On cultured neurons, 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 may be related to the pain relief and anti -convulsions effect of Pregabalin.

In vitro, Pregabalin reduces the release of calcium -dependent neurotransmitters such as glutamat, norepinephrin, peptides related to calcitonin regulating genes, and P1 can be through the functional regulation of the calcium channel.

Pharmacokinetics

absorption

Pregabalin is quickly absorbed when drinking when hungry, the peak concentration in plasma is achieved within 1 hour after taking the single dose and multiple dose. Pregabalin's oral bioavailability is over 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 a reduction of cmax by about 25 - 30% and extending TMAX after about 2.5 hours. However, used with food has no significant clinical effects on pregabalin absorption.

Distribution

In preclinical studies, pregabalin passes through the brain barrier in mice and monkeys. Pregabalin passes through the placenta in the mouse and excreted through milk in the mother mouse. 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. About 98% of oral doses are found in urine in constant form. Premylate derivative of Pregabalin, the main metabolite is found in the urine, accounting for only about 0.9% of the dose. In preclinical studies, there is no sign of transmission transformation (S - Enantiomer) into transmission isomers (R - Enantiomer).

Elimination

Pregabalin is excreted mainly through the renal in a constant form. The average selling time is 6.3 hours. Plasma clearance and kidney clearance of pregabalin is proportional to the patient's creatinine clearance. Therefore, the dose adjustments need to be adjusted in patients with impaired renal function or being absorbed in blood.

Before taking Essividine Boston treats epilepsy and pain relief due to neurological (4 blisters x 14 tablets)

How to use

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

Dosage

adults

Combining anti -convulsions in the treatment of local epilepsy

The starting dose is 150 mg divided 2 times/day.

After 1 week of treatment, depending on the response and tolerance of the patient can increase the dose to 300 mg/day.

If necessary, the maximum dose is 600 mg/day after the next 1 week of treatment.

Diabetes nerve pain

The starting dose is 150 mg/day, which can increase in the next 1 week of the recommended maximum dose of 300 mg/day.

Increase the dose does not increase the benefits but more ADR (harmful reactions).

Pain due to neuritis, pain after herpes

The recommended dose is 150 - 300 mg/day.

may start at a dose of 150 mg/day, then increase the dose to 300 mg/day for 1 week depending on the efficiency and tolerance.

If it still does not help after 2-4 weeks of treatment at a dose of 300 mg/day, the dose can be increased to 600 mg/day.

The dose of over 300 mg/day is only for people who are still painful and tolerated with a dose of 300 mg/day because of the potential of multiple ADR due to high doses.

Disseminated anxiety disorders

The starting dose of 150 mg/day, can gradually increase the dose after week with a gap of 150 mg to the maximum dose of 600 mg/day.

muscle pain due to fibrosis

The starting dose is 150 mg/day, depending on the response and the ability to tolerate the patient, can increase the dose after 1 week to 300 mg/day and 450 mg/day if necessary.

Children

Pregabalin's safety and effectiveness for children has not been fully evaluated.

Patients with renal failure

Need to adjust the dose according to creatinine clearance (CLCR), specifically as follows:

Clcr (ml/minute)

Total daily Pregabalin dose

Dosage mode

Maximum doses (mg/day)

60 150 600 2 - 3 times/day 25 - 50 150 1 - 2 times/day Pregabalin immediately after each 4 -hour discrete.

Patients with liver failure: No adjustment.

Elderly: Need to reduce pregabalin dose in the elderly according to creatinin coal (CLCR) as in the above table.

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 is still few. The highest pregabalin dose reported is 800 mg, which shows any significant consequences for clinical.

Management:

There is no specific antidote. If indicated, it may cause vomiting or gastric lavage, maintain airway if needed. Symptomatic treatment. Hematoparoa if indicated (can remove up to 50% pregabalin within 4 hours).

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.

Side Effects

When using EssIDIDINE, you may experience unwanted effects (ADR). Unwanted effect (ADR) is most common, dizziness, drowsiness.

Other effects have been reported in clinical trials and after the circulation is synthesized as in the table below. The frequency of encountering ADR may be affected by the dose or coordinated therapies. In clinical trials, the frequency of ADR on epilepsy patients is higher than that of patients with neuria.

Common, ADR> 10/100

Cardiovascular: peripheral edema.

Digestive system: weight gain, dry mouth.

muscle - bone: Run muscles.

Eye: blurred vision, Song Thi.

Other: infection.

Cardiovascular: chest pain, edema.

Central nerve: neuritis, abnormal thoughts, fatigue, confusion, refreshment, language disorders, attention disorders, loss of movement, loss of memory, pain, dizziness, abnormal sensation, anxiety, depression, loss of orientation, sleep, fever, personality loss, hyperpigmentation, stunning, dumbfounded. Purple, itching.

endocrine and metabolism: fluid fluid, reducing blood glucose.

Stomach - intestines: constipation, appetite, flatulence, vomiting, abdominal pain, gastritis.

Genital - Urinary: urinating a lot and urinary incontinence, loss of pleasure, reducing sex.

Blood: platelets.

muscle muscle: balancing disorders, abnormal gait, muscle weakness, joint pain, muscle jerky, back pain, muscle spasm, muscle vibration, abnormalities, increased CPK (creatinin phosphokinase), cramps, muscle pain, myasthenia gravis.

ears: hearing loss.

Respiratory: Sinusitis, shortness of breath, bronchitis, sore throat, larynx.

Other: influenza syndrome, allergic reactions.

Rare, ADR

ABSCESS (ARE - Vehicle), Acute renal failure, drug dependence, agitation, albuminuria, Anaphylaxis reaction, anemia, angioedema, language disorders, gastritis, apnea.

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

Essividine drugs are contraindicated in case of hypersensitivity to active ingredients or any excipients of the drug.

Caution when using

The conditions need to be cautious when taking the drug

Pregabalin can also cause peripheral angels. Simultaneous use of pregabalin with a thiazolidairee -group diabetes drug increases the risk of progressive and peripheral weight gain than individual drugs.

The peripheral edema is not related to cardiovascular complications (such as hypertension, congestion heart failure) and a decline in liver or kidney function. Neurological fleet can occur at the beginning of long -term treatment or treatment with pregabalin. Symptoms include: swelling of the face, mouth (such as tongue, lips, gums), and neck (such as throat, laryngeal), sometimes life -threatening.

It is necessary to stop using pregabalin as soon as patients with the above symptoms. Be careful when taking medication for patients with a history of nerveema or also taking other drugs that can also cause nerveema (such as enzyme inhibitors).

After circulating the drug, visual side effects have been recorded including vision reduction, blurred vision, sometimes fleeting. Therefore, treatment should be stopped with pregabalin to solve and improve the visual situation. Cases of renal failure have been recorded. In some cases, renal function is improved after stopping using pregabalin.

Pregabalin causes increased body weight related to the dose and duration of medication, but it is not related to the body weight index (BMI) before treatment, gender or age and unlimited in edema patients. Although in short -term studies with control, weight gain is not related to important clinical changes on blood pressure, the long -term cardiovascular effect of the drug has not been clarified. In addition, Pregabalin does not lose blood sugar control.

Pregabalin can increase CPK (creatinin phosphokinase) and can cause muscle globin - urinary tract (although rare). Patients need to notify the doctor when symptoms such as pain, love muscles, increase pain sensitivity, especially when accompanied by fever and/or fatigue, discomfort. Must stop the drug as soon as there is a manifestation of muscle disease.

Need to stop slowly and reduce pregabalin doses for at least 1 week before stopping the drug to avoid increasing the frequency of epilepsy as for anticonvulsants.

There have been reports on drug abuse or dependence when using pregabalin. Therefore, it is necessary to be cautious when used for patients with a history of drug addiction. It is necessary to monitor the signs of drug abuse (such as greasy, the trend of increasing the dose or the behavior of searching for drugs). When the drug is stopped quickly and suddenly, it can be seen that the symptoms of dependence such as insomnia, nausea, headache, diarrhea.

There have been some notes after circulating medication for congestive heart failure on some patients using Pregabalin. These reactions are mainly found in older patients with cardiovascular damage when treated with pregabalin. Therefore, be careful when using pregabalin for these patients.

In the treatment of central nerve pain due to spinal cord damage, the general side effect rate and side effects on the central nervous system such as drowsiness increased. Anti -convulsions, including pregabalin, often increases the risk of suicide thoughts/behaviors. Patients and family members (or caregivers) should be notified of this effect of the drug and require immediately notification to the doctor when there are warning signs such as: the appearance or deterioration of depression manifestations; abnormal changes in personality and behavior; The trend of suicide or self -harm.

There have been some notes after circulating the drug about the impairment of the gastrointestinal tract function (such as bowel obstruction, intestinal paralysis, constipation) when used in a combination of pregabalin with opioid analgesics. It is necessary to consider constipation prevention measures when using pregabalin with opioid analgesics (especially in women and the elderly).

Products containing lactose. Do not use for patients with rare genetic problems with galactose, lactase deficiency, or Glucose - Galactose.

The ability to drive and operate machinery

EssIVIDINE can cause drowsiness, dizziness. If affected by patients, they should not operate machinery, drive, work on high or other cases.

Pregnancy

There is no adequate data on pregabalin in pregnant women. Animal studies have shown toxic effects on fertility, potential risks in humans are unknown. Therefore, ESSIVIDINE is not used during pregnancy unless the benefits gives the mother clearly more important than the risks that may occur to the fetus.

If using drugs for women of reproductive age must apply contraceptives.

Breastfeeding period

Pregabalin is excreted in milk. The influence of pregabalin in infants is unknown. Therefore, do not breastfeed by breast milk while taking the drug.

Interactive drug

Pregabalin is excreted mainly through urine in the form of unprocessed, an insignificant amount is metabolized ( In Vivo studies, there is no clinical pharmacokinetic interaction between pregabalin and phenytoin, carbamazepin, valproic acid, lamotrigin, gabapentin, lorazepam, oxycodon or ethanol. Pharmacokinetic assessments on subjects have shown that oral diabetes treatment drugs, diuretics, insulin, phenobarbital, Tiagabin and Topiramate are not significantly clinically affected by pregabalin clearance.

birth control pills, norethisteron and/or ethinyl oestradiol: sharing Pregabalin with Norethisteron contraceptives and Ethinyl oestradiol does not affect the pharmacy stability of both drugs.

Pregabalin can increase the effects of ethanol and lorazepam. In controlled clinical trials, the oral dosage of Pregabalin combined with Oxycodon, Lorazepam, or Ethanol has no important clinical effects on respiration. In the reports after the circulation of drugs, there are records of respiratory failure and coma in patients taking pregabalin and other central neurological inhibitors. The presence of Pregabalin reduces awareness and motor function caused by Oxycodon.

Elderly: There are no specific pharmacological interactive studies conducted in voluntary elderly patients.

Storage

Where dry, less than 30 ° C, avoid light.

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