Pagalin hard capsules 75mg longevity to treat neurological pain, 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

Pagalin drugs are indicated in the following cases:

Neurological pain: Pregabalin is indicated in the treatment of mental pain for adults.

Pharmacokology

Mechanism of action

In vitro studies have shown pregabalin attached to a sub -subunite (A2 - Δ protein) of the charged calcium line in the central nervous system, replacing (3H) Gabapentin. The two evidence shows the cohesion of pregabalin into A2 - Δ protein is necessary for an animal -resistant and anti -seizure effect.

Studies for non -activity isomers and pregabalin structure derivatives and mice studies with rats with quite dynamic drugs attached to A2 - δ poor protein.

In addition, pregabalin reduces a number of neurotransmitters, including glutamate, noradrenaline.

The importance of these clinical effects of Pregabalin is not known.

Pregabalin has no affinity for receptive receptors or response associated with the effects of some drugs commonly used in the treatment of epilepsy or pain.

Pregabalin does not interact with GABAA inhibitors; or gabab. Do not be converted into GABAA, or Gabab inhibitors. Pregabalin is not an inhibitor of the formation and decomposition of GABA.

Pregabalin prevents pain-related pain on animal activity with nerves or postoperative pain, including increased pain and pain caused by pregabalin stimulation on a animal, including epilepsy due to electromechanical shock in mice, seizures with Pentyle-netetrazol, behavior and electrical seizures in the rats are stimulated in the rat region.

pharmacokinetics

Pregabalin's stable pharmacokinetics are the same on healthy volunteers, epilepsy patients taking anti -epileptic drugs and chronic pain patients.

absorption

Pregabalin is absorbed quickly when drinking when hungry, the peak concentration in plasma is achieved after 1 hour in both single and multi -dose.

The oral bioavailability of pregabalin 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 barrier in the mice, rats and monkeys. Pregabalin passes the placenta in mice and appears in mouse milk.

In people with pregabalin distribution after oral use of about 0.56L/kg. Pregabalin does not bind to plasma proteins.

Tourization

Pregabalin is negligible in the human body. After using radioactive pregabalin, about 98% is found in the urine. Pregabalin is in the form of unchanged. Pregabalin n-methylale derivatives of 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 -division pregabalin transmitted into transmission isomers.

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 pregabalin and kidney clearance proportional to creatinine clearance. Adjusting the dose in patients with reduced kidney function or hemorrhage is necessary.

linear/non -linear

Pregabalin pharmacokinetics are linearly in the daily dose range. Pregabalin's dynamic variation is low (

Pharmacokinetics in special patients

Sex: Clinical trials have shown no significant clinical effects on the plasma concentration of Pregabalin.

Renal failure: Pregabalin clearance is proportional to the clearinin clearance. In addition, pregabalin is effectively removed from plasma thanks to the hemorrhage (after 4 hours of blood absorbent plasma concentration of pregabalin decreased by about 50%). Because elimination through the kidneys is the main elimination sugar, reducing the dose for patients with renal impairment and taking additional doses with patients with hemorrhage is necessary.

Hepatic failure: There are no specific pharmacokinetic studies conducted on liver failure. Because pregabalin is negligible and excreted mainly through urine in the whole form, patients with hepatic impairment have not changed significantly to the pregabalin plasma concentration.

Elderly> 65 years old: Pregabalin clearance tends to decrease with the increase of age. The decrease in oral pregabalin clearance does not depend on the reduction of creatinine clearance related to the increase of age. Pregabalin dose should be reduced in patients with adolescent kidney function.

Before taking Pagalin hard capsules 75mg longevity to treat neurological pain, epilepsy (3 blisters x 10 tablets)

How to use

Pagalin 75mg drug used orally. Can be used with food or not.

Dosage

The dose range of 150mg - 600mg per day is divided into 2-3 times.

Neurological pain

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

General anxiety disorders

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

Patients with renal failure

Dose reduction in patients with renal function damage must be depending on the individual and according to the evaporation coefficient of creatinine (CLCR) presented in Table 1 using the formula:

Clcr (ml/minute) =

(140 - Age (year) x weight (kg)

(x.85 for female patients)

Besides daily dosage, the dosage should be used immediately after 4 hours of absorbing blood (see Table 1).

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

Creatinine clearance

(CLCR) (ml/min)

Total dose of Pregabalin

Treatment regime

(mg/day)

Maximum dose

(mg/day)

150

600

BID or TID

≥ 30 -

300

BID or TID

≥ 15 -

25 - 50

150

qd or bid

100

Single dose +

BLD = divided 2 times/day; QD = Single dose/day.

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

Supporting dose is an additional dose.

Take drugs in patients with hepatic impairment: No dose adjustment in patients with liver failure.

Use drugs for children and teenagers (12-17 years old): Pregabalin's safety and effectiveness in children under 12 years old and unpaid teenagers. Do not take medicine in children.

Using drugs for the elderly (over 65 years old): Elderly can reduce the dose of pregabalin 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 using overdose?

In the reports after circulating the drug, the most common side effects are reported when overdose of Pregabalin including emotional disorders, chicken sleep, confusion, depression, anxiety, restlessness.

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

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

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 pagalin, you may experience unwanted effects (ADR).

The clinical trial program with pregabalin is conducted on over 9000 patients using Pregabalin, of over 5,000 controlled placebo blind tests.

Unwanted effects are often reported by reports: dizziness and drowsiness. Unwanted effects are usually light and medium.

In all controlled studies. The drug suspension rate due to unwanted effects is 13% for patients using pregabalin and 7% for patients with placebo. The unwanted effects mainly lead to the pregabalin group are dizzy and drowsiness.

Very common, 1/10

Dizziness, drowsiness.

Meet, 1/

Increasing appetite, mixed mood, reducing libido, irritability, loss of air conditioning, distraction, abnormal coordination, memory impairment, tremor, speech, abnormal, blurred vision, but granted, balanced.

dry mouth, constipation, vomiting, flatulence.

erectile dysfunction.

Fatigue, pagan edema, drunkenness, edema, abnormal gait, weight gain.

Uncommon, 1/1000

Anorexia, feeling of loss of personality, not achieving orgasm, awakening, depression, restlessness, oscillation of temperament, insomnia, difficulty expressing, hallucinations, dreaming, increasing libido, fear of being attacked, indifferent.

Cognitive disorders, market reduction, eyeball vibration, speech disorders, mechanical machines, reflexes. Increasing mental activity, anti -posture, increasing tactile, losing taste, feeling burning intentionally, bewildered, fainting.

vision disorders, dry eyes, swelling of the eyes, reducing sharpness when looking, eye pain, eye strain, watery eyes.

fast pace of search, flushing, hot redness, shortness of breath, dry nose.

bloating, increased salivation, esophageal diseases, reducing tactile mouth.

Sweating, red nodules.

muscle, swollen joints, cramps, muscle pain, joint pain, back pain, limb pain, muscle stiffness.

Patriarch, not marshal.

Slow output, sexual disorders.

weakness, fall, thirst, chest.

Increase alanin aminotransferase, increase phosphokinase enzyme, increase aspatat aminotranferase enzyme, reduce platelets.

Rare, ADR

Neutral leukopenia.

Hypoglycemia.

Conditional reflexes, joy.

Reducing motor movement, olfactory, difficult to write.

Dizziness, eye irritation, pupils fluctuating physically, changing the feelings of the depth of the image, losing the image of the periphery, squinting, the image is bright.

Hearing increase.

Atrial atria, fast sinus heartbeat, arrhythmia, slow sinus heartbeat.

Hypotension, peripheral cold, hypertension.

Nasal throat, cough, stuffy nose, nosebleeds, rhinitis, snoring, obstruction.

Abdominal effusion, difficulty swallowing, pancreatitis.

Cold sweat, hives.

stiff neck, neck pain, musculoskeletal cell rupture.

Digestation, kidney failure.

Menstrual loss, breast pain, milk, dysmenorrhea, mammary glands.

Pain severe pain in the whole body, fever, cold tremor.

Hyperglycemia, hypertreatinine, hypokalemia, weight gain, reduction of white blood cell count.

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

Pagalin 75mg drug contraindicated to those sensitive to any ingredients of the drug.

Caution when using

Patients with rare genetic diseases in galactose tolerance, Lapp lactase enzyme deficiency or absorbent 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 an injury accident in the elderly.

There is no complete data on 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 reach single therapy with pregabalin.

After stopping the drug in short -term and long -term treatment with pregabalin, the signs of remedy are observed in some patients, the effects mentioned include: insomnia, headache, nausea and diarrhea.

Despite the effects of medication on recovery renewal failure, which has not been studied in a systematic way, 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 congestive heart failure is limited to use prearly pregabalin in these patients.

The ability to drive and operate machinery

Pregabalin can cause dizziness and drowsiness when using the drug. Therefore, patients should not drive, operate complicated machinery or participate in adventure activities until determining the drug does not affect the performance of these movements.

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 clearly more important than the risks that may occur to the fetus. Effective contraception must be used for women of reproductive age.

Breastfeeding period

It is unknown whether pregabalin is excreted through human milk, but the drug appears in mouse milk. Therefore, do not breastfeed with breast milk while using therapy with pregabalin.

Drug interaction

because Pregabalin is excreted mainly through urine in the form of unprocessed, an insignificant amount of metabolic (

In invivo studies, do not observe the clinical pharmacokinetic interaction between pregabalin and phenyitoin, carbamazepine, valproic acid, lamotrigine, gamapentine, lorazepam, oxycodone, hodc ethanol. The object of pharmacokinetic evaluation has shown that oral diabetes treatment, diuretics, insulin, phenobarbrtal, Tigabine, Topiramate has no significant clinical effects on Pregabalin clearance.

Pregabalin shares with oral contraceptives oral norethisterone and/or ethinyl oestradiol does not shape the pharmacokinetics stability of both drugs. Pregabalin can affect the effects of ethanol and lorazepam. In controlled clinical trials, oral doses, pregabalin combined with Oxcodone, Lorazepam, or ethanol has no important clinical effects on respiration. In the reports on the circulation of drugs, 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 interaction conducted in elderly patients volunteering.

Storage

Store drugs in a dry place, the temperature does not exceed 30⁰C, avoiding light.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.