Lyrica 75mg hard capsules pfizer treat nerve pain, local epilepsy (4 blisters x 14 tablets)

Dosage form Box of 4 blisters x 14 tablets
Specifications Pregabalin

Ingredient

Composition information	Content
Pregabalin	75mg

Uses

Indications

lyrica medicine are indicated in the following cases:

Neurological pain: Pregabalin is indicated in the treatment of nerve pain in adults. In adults. ATC code: N03AX16.

Main active ingredients, Pregabalin, is a substance similar to gamma acid - aminobutyric (GABA) (acid (s) - 3 - (Aminomethyl - 5 - Methylhexanoic).

Mechanism of action

Pregabalin is attached to a sub -unit (α2 - Δ protein) of the voltage gate channel in the central nervous system.

Evidence from a nervous animal model indicates that pregabalin release neurotransmitters that perceive pain depends on the calcium in the spinal cord, which can be through the blocking of calcium transport and/or decrease in calcium. Evidence from other animal models with nerve damage shows that pregabalin analgesic activity can also be indirectly through interactions with sympathetic and serotonin.

Clinical experience

Mental pain:

The effect of drugs has been shown from studies in diabetes and neurological pain after shingles. The effectiveness of the drug has not been studied in other neurological pain models.

Pregabalin has been studied in 9 controlled clinical studies for up to 13 weeks with a dose of 2 times/day and up to 8 weeks with a dose of 3 times/day. In general, the safety and effectiveness of the dosage mode 2 times/day and 3 times/day are similar.

In clinical trials for a maximum of 13 weeks, it has been observed with pain relief in the first week and maintained during treatment.

In control clinical trials, 35% of patients treated with pregabalin and 18% of patients treated with placebo have achieved 50% improvement at the pain point. For patients without drowsiness, the improvement of the pain point has also been observed in 33% of patients treated with Pregabalin and 18% of patients use placebo. For patients who have had drowsiness, the response rate is 48% for pregabalin and 16% for placebo.

Pain of muscle fibrosis:

Pregabalin treatment was studied in 5 placebo -control studies, due to 3 studies in 12 weeks with fixed dose, a 7 -week study with a fixed dose and a 6 -month study to evaluate long -term effectiveness. Pregabalin treatment in all studies with a fixed dose has achieved significant pain relief in fibrous muscle pain at the dose of 300 to 600mg (2 times/day).

In 3 studies with a fixed dose for 12 weeks, 40% of patients using pregabalin achieved the improvement of pain points of 30% or more compared to 28% of placebo patients, 23% of patients treated the improvement of pain points of 50% or more compared to 15% of placebo patients.

Pregabalin achieved a higher overall review point than a placebo in the PCIC scale (Patient Global Impression of Change - the feeling of the patient's overall change) in 3 fixed dose studies for 12 weeks (41% of patients using Pregabalin feel a lot better or much better than 29% of the placebo patients). In the FIQ scale (questionnaire on the effect of fibrosis), compared to placebo, Pregabalin achieved improvement levels with statistical statistical significance in 2 out of 3 studies with fixed dose.

Pregabalin treatment significantly improves sleep quality according to patients' evaluation in 4 fixed dose studies calculated according to the sleep evaluation scale in medical results research (MOS - SS). The side evaluation of sleep disorders, sleep problems in general MOS - SS and daily sleep quality diary.

In 6 months of study, the improvement of pain, overall assessment (PGIC), Function (total FIQ score) and sleep (MOS - SS Auxiliary evaluation of sleep disorders) are maintained in patients using Pregabalin with a longer period of placebo. Use Pregabalin at a dose of 600mg/day for a higher improvement in sleep quality as evaluated by the patient compared to the dose of 300mg and 450mg/day; The average analgesic effect, the overall assessment, and the FIQ index are similar to the dose of 450mg and 600mg/day, although the dose of 600mg/day is worse.

epilepsy:

Pregabalin was studied in 3 controlled clinical studies during 12 weeks of treatment with a dose of 2 times/day or 3 times/day. In general, the safety and effectiveness of the dose modes 2 times/day and 3 times/day are similar.

Observed a decrease in the frequency of seizures at the first week.

Disseminated anxiety disorders:

Pregabalin has been studied in 6 controlled clinical studies within 4-6 weeks of treatment, a study in older patients for 8 weeks and a long -term prevention of recurrence and a period of prevention of double blindness during 6 months of treatment.

Observed a decrease in the symptoms of anxiety disorders spreading according to the scale of Hamilton anxiety (Ham - A) in the first week.

In control clinical studies (4 - 8 weeks of treatment), 52% of patients treated with pregabalin and 38% of placebo patients have achieved at least 50% of the total score according to the Ham -A anxiety evaluation scale before treatment until the end of treatment

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 hungry, the peak concentration in plasma is achieved after 1 hour in both single and multi -dose mode. The oral bioavailability of Pregabalin is about> 90% and does not depend on the dose. When used repeated, stable status is reached in the range of 24 - 48 hours. Pregabalin's absorption rate decreases when used with food leads to CMAX by about 25-30% and TMAX is about 2.5 hours behind. However, using pregabalin along with food does not have any significant clinical effects to the level of pregabalin absorption.

Distribution

In preclinical studies, Pregabalin easily passes through the blood -barrier in mice, rats and monkeys. Pregabalin passes the placenta in the rat and appears in mouse milk, in humans, the appointed distribution of pregabalin after oral use is about 0.56L/kg. Pregabalin is not attached to plasma proteins.

Metabolism

Pregabalin is negligible in the human body. After using Pregabalin with radioactive markers, about 98% of radioactive activity found in urine is of pregabalin in unprovered form. N - methylat derivatives of pregabalin, the main metabolites of pregabalin are found in urine, accounting for about 0.9% of the dose. In preclinical studies, there are no signs of converting underlying pregabalin transmission into conveyed isomers.

Elimination

Pregabalin is eliminated from the circulatory system mainly due to the excretion through the kidneys in the form of non -metabolic.

The average pregabalin disposal time is 6.3 hours. The speed of plasma pregabalin and kidney clearance rate is proportional to the rate of creatinine clearance (see pharmacokinetic and pharmacokinetic properties in special patients, kidney failure).

Needs to adjust the dose for patients with renal impairment or hemorrhage must (see the dose section and the method of using table 1).

linear/non -linear

Pregabalin's

pharmacokinetics is linearly within daily recommended dose. The variation of pharmacokinetics among Pregabalin objects is low (

Pharmacokinetics in special patients

Sex:

Clinical trials have shown that gender has no significant clinical effects on pregabalin concentrations in plasma.

kidney failure:

Pregabalin clearance rate is proportional to the rate of creatinine clearance. In addition, pregabalin is effectively removed from plasma through hemorrhage (after 4 hours of hemorrhage of pregabalin concentration in plasma decreased by about 50%). Because excretion through the kidneys is the main elimination sugar, it is necessary to reduce the dose for patients with renal failure and use additional doses for patients with hemorrhage (see the dose and method of use, Table 1).

Hepatic failure:

There is no specific pharmacokinetic study conducted in patients with liver failure. Because pregabalin is insignificant metabolized and excreted mainly in urine in the form of non -metabolic, patients with liver failure are expected to have no significant change in the concentration of pregabalin in plasma.

Elderly (over 65 years):

Pregabalin clearance rate tends to decrease when high age. The decrease of pregabalin clearance rate is uniformly with a decrease in the rate of creatinine at high age. Pregabalin dose may be reduced for patients with renal function damage due to age (see the dose and methods of use, Table 1).

breastfeeding women;

The pharmacokinetics of the Pregabalin 150mg dose used 12 hours/time (daily dose of 300mg) has been surveyed in 10 women who are living in milk, these women are at the stage of at least 12 weeks of birth. The lactation is less affected or does not affect Pregabalin's pharmacokinetics. Pregabalin is secreted into milk with an average stable concentration of about 76% compared to the concentration of the drug in the mother's plasma. The average pregabalin dose from breast milk that children receive daily (assuming the average amount of milk consumption is 150ml/kg/day) is 0.31mg/kg/day, this dose calculated by mg/kg will be about 7% compared to the mother's dose.

Before taking Lyrica 75mg hard capsules pfizer treat nerve pain, local epilepsy (4 blisters x 14 tablets)

How to use

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

Pregabalin can drink with food or not.

Dosage

Neurological pain

Pregabalin treatment may start at a dose of 150mg daily. Depending on the response and tolerance of each patient, the dose may increase to 300mg/day after a period of 3-7 days, and if necessary, it may increase to a maximum dose of 600mg/day after about 7 days of additional treatment.

Pain

The usual dose for most patients is from 300mg to 450mg/day is divided into 2 times. Some patients can achieve better treatment effects at a dose of 600mg/day. Should start at a dose of 75mg, 2 times/day (ie 150mg/day) and can increase to 150mg, 2 times/day (ie 300mg/day) within 1 week depending on the efficiency and tolerance. Patients do not have a full response to a dose of 300mg/day may increase to 225mg, 2 times/day (ie 450mg/day).

If necessary, in some patients, depending on the response and tolerance of each patient, may increase to a maximum dose of 600mg/day after 1 week of additional treatment.

epilepsy

Can start treatment with pregabalin at a dose of 150mg daily. Depending on the response and tolerance of each patient, the dose may increase to 300mg/day after 1 week. Can increase to a maximum dose of 600mg/day after 1 week of additional treatment.

Disseminated anxiety disorders

The dose range from 150mg - 600mg per day is divided into two or three times. Need to regularly review the needs of treatment.

Can start treatment with pregabalin at a dose of 150mg/day. Based on the response and tolerance of each patient, the dose can be increased to 300mg/day after 1 week of treatment. After an additional 1 week of treatment, the dose may increase to 450mg/day. Can increase to a maximum dose of 600mg/day after 1 week of additional treatment.

Stop using Pregabalin

If you have to stop using pregabalin, it is necessary to reduce the dose slowly for a minimum of 1 week.

Patients with renal failure

Dosage reduction in patients with renal function damage must depend on the individual and at the rate of creatinine clearance (CLCR) (see the pharmacokinetic, pharmacokinetic properties in special patients, renal failure), presented in Table 1, using the formula below:

lyrica 75mg

Side Effects

Clinical trial program with pregabalin is conducted on more than 12,000 patients using pregabalin, of which over 7,000 people participate in double blind tests with placebo. The most common unwanted effects are reported including dizziness and drowsiness. Unwanted effects are often mild to moderate. In all controlled studies, the drug suspension rate due to unwanted effects is 14% in patients using Pregabalin and 5% in patients with placebo. The unwanted effects that lead to the most stopped drug in the pregabalin group are dizzy and drowsiness.

Unwanted effects related to the selected treatment through gross analysis from the data of clinical studies are listed below according to the system classification - Agency (System Organ Class - Soc). The frequency of the following terms is based on the unwanted effects of pure cause and effect in the clinical test data set (very common (≥ 1/10), common (≥ 1/100,

The undesirable effects of lyrica 75mg listed below may be related to hidden diseases and/or combined drugs.

Unwanted effects occur in clinical trials:

Infections and parasites

Common

: Hau rhinitis.

Blood disorders and lymphatic systems

Uncommon: Neutral leukemia.

Nutrition and metabolic disorders

Common: Increasing appetite.

Less: anorexia, hypoglycemia.

Mental disorders

Common: Hung, confusion, irritability, depression, orientation disorders, insomnia, reduced libido.

Less: hallucinations, awake, restlessness, depression, manic, erratic temperament, difficult to express with words, increase libido, lose the ability to achieve orgasm.

Rare: panic, loss of condition, indifferent.

Nervous system disorders

Very common: dizziness, drowsiness.

Common: loss of air conditioning, abnormal coordination, tremor, lingle, memory loss, memory loss, distraction, abnormalities, sensory reduction, pain relief, balance disorders, sleep.

Uncommon: fainting, muscle shock, increased mental activity, movement disorders, posture dizziness, intentional tremor, eyeball shake, cognitive disorders, language disorders, reflexes, increased tactile, hot feeling.

Rare: Stunned, olfactory, reducing motor, loss of taste, difficult to write.

eye disorders

common: blurred vision.

Uncommon: loss of peripheral vision, vision disorders, eye swelling, market reduction, vision loss, eye pain, eye strain, dizziness, dry eyes, increased tears, eye irritation.

Rare: Verification of vision, changing feelings about the depth of the image, dilating pupils, squint, the image is bright.

Disorders of ear and internal ears

Common: loss of balance.

Uncommon: Hearing increases.

Heart disorders

Uncommon: tachycardia, atrial block of grade 1, sinus slow pace.

Rare: sinus tachycardia, sinus arrhythmia.

circuit disorders

Uncommon: Hypotension, hypertension, hot, flushing, cold limbs.

Respiratory, chest and mediastinum disorders

Uncommon: shortness of breath, nosebleeds, cough, nasal congestion, rhinitis, snoring.

Rare: obstruction of the throat, dry nose.

Gastrointestinal disorders

Common: vomiting, constipation, flatulence, bloating, dry mouth.

Uncommon: Esophageal disease, increased salivation, tactile reduction in the mouth.

Rare: peritoneal effusion, pancreatitis, difficulty swallowing.

Skin and tissue disorders

Less: Red nodules, hives, sweating.

Rare: cold sweat.

Disorders of musculoskeletal and connective tissue system

Common: Cramps, joint pain, back pain, limb pain, cervical spasms.

Less: swelling of joints, muscle pain, muscle vibration, neck pain, muscle hard.

Rare: Pepper pattern.

Kidney and urinary disorders

Uncommon: Urine is not controlled, urinary retention.

Rare: kidney failure, minimum.

Disorders of mammary glands and reproductive systems

Uncommon: erectile dysfunction, sexual disorders, delayed crystallization, dysmenorrhea.

Rare: Breast pain, menstruation, breast secretion, big breasts.

Systemic and local disorders

Common: Peripheral edema, edema, abnormal gait, falling, drunkenness, abnormal feeling, fatigue.

Less: Systemic edema, chest tightness, pain, fever, thirst, chilling, weakness.

Examination

Common: weight gain.

Uncommon: increased blood phosphokinase, hypernotransperase alanine, hyperplanded aminotransferase, hyperlemor of blood glucose, reducing the number of platelets, reducing potassium, weight loss.

Rare: Reducing leukemia, increased blood creatinine.

The following undesirable effects are reported during monitoring after circulation:

immune system disorders

Less: hypersensitivity.

Rare: Evala, allergic reactions.

Nervous system disorders

Very common: headache.

Less: unconscious, mental decline.

Eye disorders

Rarely: keratitis.

Heart disorders

Rare: congestive heart failure.

Respiratory, chest and mediastinum disorders

Rare: pulmonary edema.

Digestive disorders

Common: Nausea, diarrhea.

Rare: Tongue swelling.

Skin and tissue disorders

Less: face swelling, itching.

Kidney and urinary disorders

Rarely: Restilification.

Breeding disorders and reproductive systems

Rare: Big breasts in men.*

Systemic and local disorders

Less: annoying.

*The frequency of unwanted effects is estimated by using "rule 3".

"Rule 3", also known as Hanley formula, is used to estimate the upper limit of 95% confidence interval of probability of unwanted effects that have never been observed in clinical trials. This rule suggests that "if no one of the n patients occur the event that we care about, then we can trust 95% that the probability of this event is up to 3 of the patients (ie 3/n). In other words, the upper limit of 95% confidence interval with a rate of 0/n is about 3/n". This rule is also recommended in the Summary of Product Characteristics of EMA (EMA SMPC), September 2009.

Warnings

Before using lyrica 75mg, you need to read the instructions carefully and refer to the information below.

Contraindications

Hypersensitivity to active ingredients or any excipients of the drug.

Prisable when taking drugs

Patients with rare genetic diseases about galactose tolerance disorders, Lapp lactase enzyme deficiency or glucose - galactose should not be used.

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

After circulating the drug, there have been reports on hypersensitivity reactions, including angioedema, need to stop using Pregabalin immediately if there is a symptom of angioedema, such as edema, edema around the mouth, or upper respiratory edema.

Pregabalin treatment often occurs dizziness and drowsiness, which may increase the risk of accidents due to injury (falling) in the elderly. There have been reports after circulating drugs to lose consciousness, confusion and mental decline. Therefore, patients must be instructed to be cautious until they get used to unwanted effects of the drug.

After circulating the drug, there was a report on temporary blurring and some other vision changes in patients using Pregabalin. When stopping the drug, these vision symptoms may end or reduce.

There is no complete data on discontinuation of pregabalin with other anti -epileptic drugs to achieve single therapy with pregabalin, after controlling seizures with combined treatment.

In short and long -term treatment with pregabalin, after stopping the drug, observing the cessation syndrome on some patients. The effects mentioned include: insomnia, headache, nausea, anxiety, sweating and diarrhea.

Pregabalin has not been determined whether it is impact on receptors related to abused drugs. There have been reports on cases of wrong drug use and drug abuse after circulation. Like any drug that acts on the central nervous system (CNS), careful assessment of patients to learn about the history of drug abuse and observe the signs of wrong use or abuse Pregabalin in patients (for example, expression of increased drug tolerance, increased drug dose, drug search behavior).

Despite the effects of stopping the medication on renal failure, which has not been systematically studied, there is a report that renal function is improved after stopping or reducing prefabalin dose.

Although the causal relationship is not identified between pregabalin and congestive heart failure, there have been some reports after circulating medication for congestive heart failure in 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 hypertension or congestive heart failure. Because data on patients with severe congestive heart failure is limited, caution should be used when using pregabalin in these patients (see the unwanted effect).

The ability to drive and operate machinery

Pregabalin can cause dizziness or drowsiness and thus can affect the ability to drive or operate machinery. Therefore, patients are advised not to drive, operate complicated machines or participate in other adventure activities until determining whether the drug affects the implementation of these activities.

Pregnancy and lactation

Pregnancy

There is no adequate data on pregabalin on pregnant women.

Animal studies have shown toxic effects on fertility (see the preclice safety data). It is unknown about the risk that may occur in humans. Therefore, pregabalin should not be used when pregnant unless the benefits give the mother superior to the risk of the fetus. Should use effective contraception for women of reproductive age.

Breastfeeding period

Pregabalin is excreted in milk in nursing women (see the pharmacokinetic properties). Due to the unknown pregabalin of pregabalin, breastfeeding is not recommended for breastfeeding while being treated with pregabalin. When deciding to stop breastfeeding or stop treatment with pregabalin, it is necessary to consider the benefits of breastfeeding with children and the benefits of this drug on the mother.

Drug interaction

because Pregabalin is excreted mainly through urine in the form of unprocessed, negligible amount of metabolic drug ( In Vivo studies, there is no clinical pharmacokinetic interaction between pregabalin and phenytoin, carbamazepin, valproic acid, lamotrigin, gabapentin, lorazepam, oxycodon or ethanol. Pharmacokinetic analysis on each group of objects has shown that oral diabetes treatment drugs, diuretics, insulin, phenobarbital, Tiagabin and Topiramat, have no significant clinical effects on pregabalin clearance speed.

Simultaneous use of pregabalin with oral contraceptives oral norethisteron and/or ethinyl estradiol does not affect the pharmacokinetics stability of both drugs. Pregabalin can affect the effects of ethanol and lorazepam. In controlled clinical trials, many doses of oral Pregabalin combined with oxycodon, Lorazepam or ethanol does not cause any important clinical impact on respiratory activity. Pregabalin seems to increase cognitive disorders and overall movement functions caused by Oxycodon.

After circulating the drug, there were reports on respiratory failure and coma in patients using pregabalin and other central neurological inhibitors. There have been reports after circulation of events related to lower gastrointestinal function (for example, intestinal obstruction, obstruction, constipation) when taking pregabalin with drugs that can cause constipation, such as Opioid group analgesic.

There has been no specific research on pharmacological interaction conducted on elderly volunteers.

Storage

You should store at room temperature, avoid moisture and avoid light. No storage in the bathroom or in the freezer.

You should remember that each drug may have different storage methods. Therefore, you should read carefully storage instructions on the packaging or ask the pharmacist.

Keep lyrica 75mg drugs out of reach of children and pets.

Expiry date: 36 months from the date of manufacture.

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