Davyca 75mg Davipharm Treatment Treatment of Lonemism Disorders (28 Tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Pregabalin
Ingredient Mental disorders, epilepsy, peripheral tk disease

Ingredient

Composition information	Content
Pregabalin	75mg

Uses

indications

Davyca drugs are indicated in the following cases:

coordinate with anti -convulsions to treat local epilepsy in adults.

Treatment of spreading anxiety disorders.

Treatment of pain due to neuritis: peripheral neuritis due to diabetes, neuropathy after Herpes.

Treatment of muscle pain caused by fibrosis.

Treatment of neurological pain due to spinal cord damage.

Pharmacy

Pregabalin is an anti -convulsions and pain relief. 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 neurons, long -term use of pregabalin will increase the density of transport proteins and increase GABA shipping 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-Δ may be related to pregabalin pain 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 substances, can be through the function of the calcium channel.

pharmacokinetics

Pharmacokinetics The stable state of Pregabalin is similar in healthy volunteers, epilepsy patients who are taking anti -epileptic drugs and chronic pain patients.

absorption

Pregabalin is quickly absorbed when used at hunger, the peak concentration in plasma is achieved within 1 hour after the single dose and the dose repeats. Pregabalin's oral bioavailability is predicted about> 90% and does not depend on the dose.

After the dose is repeated, the stable state is reached within 24 - 48 hours. Pregabalin's absorption rate decreases when drinking with food, leading to a decrease in CMAX by about 25-30% and an increase of TMAX by 2.5 hours. However, sharing Pregabalin with food does not significantly affect the level of absorption of pregabalin.

Distribution

In preclinical trials, pregabalin passes the brain barrier in the mouse and when pregabalin passes the placenta and is present in milk in mice. In humans, Pregabalin's apparent distribution is about 0.56 l/kg. Pregabalin does not bind to plasma proteins.

Metabolism

Pregabalin is not significant in humans. After using the radioactive marker, about 98% of the radioactive dose is recovered in urine in a constant form. Pregabalin's n-methylization is the main metabolite of pregabalin found in urine, accounting for about 0.9% of the dose. In preclinical trials, there is no sign that the racemicization of S - Pregabalin isomers into R - Pregabalin.

Elimination

Pregabalin is excreted mainly through the renal in a constant form. The average disposal time of pregabalin is 6.3 hours. Plasma clearance and kidney clearance of pregabalin are proportional to creatinine clearance.

Need to adjust the dose in patients with impaired renal function or dialysis. The pharmacokinetic linear of linear Pregabalin is in the daily dose range.

The pharmacokinetic difference of pregabalin between low individuals (

Special subjects

Gender

Clinical trial shows that gender does not significantly affect clinically to the plasma concentration of Pregabalin.

kidney failure

The clearance of pregabalin is proportional to creatinine clearance. In addition, pregabalin is removed from plasma effectively with hemolysis (after the treatment of 4 -hour blood decrease in the plasma concentration of Pregabalin decreases by about 50%). Because the kidneys are the main elimination path, the dosage is needed in patients with renal impairment and the additional dose after dialysis.

Hepatic failure

There is no specific pharmacokinetic research which has been conducted in patients with impaired liver function. Because pregabalin is not significantly metabolized and is eliminated mainly in the form of unchanged urine, impaired liver function does not significantly change the plasma concentration of pregabalin.

Children

Pregabalin's

pharmacokinetics are evaluated in children with epilepsy (in age groups: 1 - 23 months, 2 - 6 years old, 7 - 11 years old and 12 - 16 years old) at a dose of 2.5; 5; 10 and 15mg/kg/day. After taking oral pregabalin in children when they are hungry, in general, TMAX is similar between age groups and achieved in the range of 0.5 - 2 hours after drinking.

CMAX and AUC of Pregabalin increases linearly when increasing the dose in each age group. The scope decreases by about 30% in children under 30 kg due to increased calibration clearance according to weight about 43% compared to children> 30 kg. The average pregabalin sale time is about 3-4 hours in children 7 years old.

The semi -waste time analysis shows the relevant creatinine clearance of the oral pregabalin, the weight significantly related to the oral pregabalin distribution volume, which are similar in children and adults. Pregabalin's pharmacokinetics in children under 3 months of age have not been studied.

Elderly

Pregabalin's clearance tends to decrease as the age increases, related to the reduction of creatinine clearance as the age increases. The dose may be needed in patients with damage to the age -related kidney.

breastfeeding women

breastfeeding does not affect Pregabalin's pharmacokinetics. Pregabalin secreted through breast milk, the average concentration in a stable state is about 76% of plasma concentrations in the mother. The reception of children is predicted by about 7% of the total daily dose in the mother calculated by mg/kg.

Before taking Davyca 75mg Davipharm Treatment Treatment of Lonemism Disorders (28 Tablets)

How to use

Pregabalin is used by oral, divided 2-3 times daily, used or not with food.

Dosage

Davyca dose with 75mg.

Local epilepsy treatment

The starting dose is 150mg, taken daily, then gradually increases the dose after week depending on the response, up to 300mg/day and 600mg/day.

Disseminated anxiety disorders

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

Pain due to neuritis, pain after herpes

Adults: Doses recommended: 150 - 300mg/day, divided into 2-3 times.

Starting dose: 150mg/day, can increase to 300mg/day for 1 week, depending on the efficiency and tolerance. 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 2-3 times. The dose exceeds 300mg/day 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. However, in Pregabalin clinical test of 600mg/day, the effectiveness does not increase significantly and the patient taking this dose has a higher unwanted effect ratio. The dose of 600mg/day must not continue research and are not recommended.

muscle pain due to fibrosis

The starting dose of 150mg/day, increasing after 1 week depending on the response to 300mg/day and 450mg/day if necessary.

Neurological pain due to spinal cord damage

Pregabalin's recommended dose in the treatment of neuropathy due to spinal cord damage is from 150 - 600mg/day. The recommended starting dose is 75mg 2 times/day (150mg/day). The dose can be increased to 150mg 2 times/day (300mg/day) within 1 week based on efficiency and tolerance. If the patient is not effective after 2-3 weeks of treatment with a dose of 150mg x 2 times/day and good tolerance, can increase the dose of pregabalin to 300mg x 2 times/day. Because pregabalin is eliminated by the kidneys, the dose adjustment in patients with impaired renal function.

For patients with renal failure

Need to adjust the dose by CLCR, specifically as follows:

Creatinine clearance (ml/minute) Total daily pregabalin dose (mg/day) Dosage mode or 3 times/day

30 - 60 75

150 225 300 2 times/day or 3 times/day 150 150 1 - 3 times/day (mg)

Patients taking the dose of 25 - 50mg x 1 time/day: taking an additional dose of 50 - 75mg

Patients with dose of 50 - 75mg x 1 time/day: take an additional dose of 75 - 100mg

Patients taking dose 75mg x 1 time/day: Taking a dose of additional dose from 100 - 150mg

No dose adjustments in patients with liver failure.

Use children's drugs

Pregabalin's efficiency and safety in patients under 18 years of age has not been established.

Take medicine for the elderly (over 65 years old)

No dose adjustments to the elderly except in the case of kidney function damage.

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:

After bringing the drug to the market, the common symptoms when using the overdose of pregabalin include drowsiness, disorders, agitation, and restlessness. The epilepsy is also reported. In some rare cases, coma has also been reported.

Management:

There is no specific antidote. If indicated, cause vomiting or gastric lavage, maintain airway if needed. Symptomatic treatment, support. Hematoparoology if indicated (eliminating pregabalin is about 50% in 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. Note that it should not be used double the prescribed dose.

Side Effects

When using Davyca, you may experience unwanted effects (ADR).

Very common, ADR> 1/10

Neurological: dizziness, drowsiness, headache.

Common, 1/100

Infections and parasites: Nasomitis.

Metabolism and nutrition: Increasing appetite.

Mental: The mood of excitement, confusion, discomfort, disorientation, insomnia, reduced libido.

nerve: loss of air conditioning, unusual coordination, tremor, dysfunction, memory loss, memory impairment, attention disorders, abnormalities, sensory reduction, sedation, balancing disorders, coma.

Eyes: blurred vision, team look.

ears and mesmerizing (inner ears): dizziness.

digestive: vomiting, nausea, constipation, diarrhea, flatulence, bloating, dry mouth.

Bone muscle and connective tissue: cramps, joint pain, back pain, pain in the limb, cervical spasms.

Genital and mammary glands: erectile dysfunction.

Body and sugar used: Peripheral edema, edema, abnormal gait, falling, feeling of drunkenness, abnormal feeling, fatigue.

Testing: weight gain.

Uncommon, 1/1,000

Blood and lymphatic system: leukopenia.

Extremely hypersensitivity.

Metabolism and nutrition: anorexia, hypoglycemia.

Mental: Illusion, panic, restlessness, agitation, depression, feeling depressed, increasing emotions, extreme, emotional changes, loss of personality, difficulty communicating, abnormal dreams, increased sexual desire, no orgasm, indifferent. Neurological: unconscious, stunned, muscle convulsions, loss of consciousness, excessive activity nerves, dysplasia, dizziness posture, tremor when making intentional movements, vibration of eyeball, cognitive disorders, mental weakness, language disorders, reflex impairment, increased sensation, burn sensation, loss of taste, discomfort. Eye: Missing vision, visual disorders, swelling of the eye, reducing the market, reducing sharpness when looking, eye pain, myopia, dizziness, dry eyes, increased tear secretion, eye discomfort.

ears and mesmerizing (inner ears): increasing hearing.

heart: Heart beat fast, atrial block 1, slow sinus rhythm, congestive heart failure. blood vessels: lower blood pressure, hypertension, hot, flushed, peripheral cold.
Respiratory, chest and mediastinum: Difficulty breathing, nosebleeds, cough, stuffy nose, rhinitis, snoring, dry nose.
digestive: gastroesophageal reflux disease, increased salivation, reducing sensation in the mouth.
Skin and subcutaneous tissue: Red rash, urticaria, increased sweat, itching.

Bone muscle and connective tissue: joint swelling, muscle pain, muscle convulsions, neck pain, muscle stiffness.

kidneys and urinary tract: urinary incontinence, difficulty urinating.

Genital system and mammary glands: Genital dysfunction, slow ejaculation, dysmenorrhea, breast pain.

Systemic and sugar used: Systemic edema, face edema, chest pain, pain, fever, feeling thirsty, cold, weak.

Testing: increased blood phosphokinase, hyperlang aminotransferase, increased aspartat aminotransferase, hyperglycemia, platelets, increased blood creatinine, decreased potassium potassium, weight loss.

Rare, 1/10,000
Immune: Evala, allergic reactions.

Mental: inhibited state.

nerve: convulsions, smell disorders, reduced mobility, difficult to write.

Eye: loss of vision, keratitis, wavering, changing the perception of the depth of the eye, dilating pupils, squinting, looking bright.

heart: extends the QT range, fast sinus rhythm, sinus arrhythmia.

Respiratory, chest and mediastinum: pulmonary edema, throat.
digestive: ascites, pancreatitis, tongue swelling, difficulty swallowing.
Skin and subcutaneous tissue: Stevens-Johnson syndrome, cold sweat.

Bone muscle and connective tissue: Muscle pattern.

kidney and urinary: kidney failure, urethra, urinary retention.

Genital and mammary glands: amenorrhea, abnormal milk secretion, large breasts, female mammary glands.

Testing: Reducing the number of white blood cells. After stopping short -term or long -term treatment with pregabalin, the symptoms of cessation may appear in some patients.

The following reactions have been reported: insomnia, headache, b anxiety, diarrhea, influenza syndrome, convulsions, stress, depression, pain, increased sweating and dizziness, physical signs. The patient should be notified before treatment.
When stopping long -term treatment, pregabalin, the rate and severity of the symptom of cessation may depend on the dose.
Children
Safety information when researching in children is similar to adults.
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

Davyca drugs are contraindicated in cases of sensitivity to pregabalin or any component of the drug.

Precautions when using

Diabetes patients

Some patients with diabetes gain weight when taking pregabalin may need to adjust the dose of hypoglycemic drugs.

Hypersensitivity reaction

There have been reports that occur hypersensitive reactions, including circuit suitable cases. Pregabalin should be stopped immediately if there is an angioedema symptom, such as face, mouth or upper respiratory tract.

Serious skin reactions

There has been a rare report on serious skin reactions, including Stevens Johnson (SJS) syndrome, poisoned epidermal necrosis (Ten), flaking dermatitis, skin glossy reaction, and diverse roses in patients using Pregabalin. Most cases are in patients who use with drugs that can cause serious skin reactions. Therefore, in most cases, the cause of pregabalin cannot be clearly set. Patients should be advised that if the skin rash should be stopped pregabalin and contact the doctor for treatment and advice.

Tu Tu/The intention to commit suicide

Anti -convulsions, including pregabalin, often increases the risk of suicide behavior. Therefore, patients need to be closely monitored about depression, the tendency to commit suicide, abnormal changes in the treatment process and should be instructed to notify the doctor as soon as the signs appear.

Peripheral edema

Be cautious when using pregabalin because it can cause peripheral edema. There is no clear combination of peripheral edema with cardiovascular complications (such as hypertension, congestion heart failure) and non -kidney or liver failure. When used in combination, pregabalin with thiazolidinedion (anti -diabetes drugs) are at higher risk of increasing body weight and edema than using a single pregabalin.

weight gain

Pregabalin causes increased body weight related to the dose and time of drug use; However, weight gain is not related to the body mass index (BMI) before treatment, gender, or age, and not due to edema. Although in short -term research, controlled, weight gain does not combine with important clinical changes in blood pressure, but long -term effects on cardiovascular has not been clarified. In addition, pregabalin does not lose blood glucose control.

heart failure

For patients who have had heart disease before, be cautious when taking the drug because it can increase the risk of heart failure.

Central nerve

The medication that affects the central nervous system includes: drowsiness, dizziness, which can reduce both the physical and mental of the patient, so it is necessary to be cautious on driving objects or operating the machine.

muscle disease

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

Symptoms of drug stops

After the end of the short -term or long -term treatment with pregabalin, symptoms of drug stops may appear: insomnia, headache, nausea, anxiety, diarrhea, flu symptoms, suspense, depression, pain, seizures, increased sweating and dizziness.

Convulsions, including epilepsy and spasms, may occur during pregabalin or after stopping the drug for a short time. The frequency and the severity of the drug stop symptom may be related to the dose.

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 anti -convulsions in general.

wrong use, abuse or drug dependence

Be careful with patients with a history of drug addiction. Monitor the signs of drug abuse (such as greasy, the trend of increasing the dose or the act of searching for drugs). In control clinical studies, the proportion of patients using pregabalin has a refreshing manifestation of 4% compared to 1% in the control group. In studies on patient populations, this rate is greater, from 1 - 12%. When stopping the drug quickly and suddenly, the symptoms of drug dependence such as insomnia, vomiting, headache, diarrhea.

kidney failure

There have been reports on kidney failure and recovery when stopping pregabalin.

Discontinue anti -epileptic drugs used simultaneously

There is no sufficient data on the stopping of anti -epileptic drugs simultaneously to switch to monobalin therapy for epilepsy when epilepsy is controlled by coordination therapy with pregabalin.

Central neuropathy treatment due to spinal cord injury

Treatment of central nerve pain due to spinal injuries increases the unwanted frequency of Pregabalin, increasing unwanted effects on the central nervous system, especially drowsiness. The cause may be due to the use of copper with the drug needed in this pathology (such as anti -spasms). Consider when specifying Pregabalin in this case.

impact on vision

In control studies, a group of patients treated with pregabalin has a higher visual fuzzy rate than the Placebo. In clinical studies with visual examination, visual loss and market change, eye -hall transformation in patients using pregabalin larger than the Placebo group. Unwanted effects on the eyes include loss of vision, blurred vision or vision change, most of them are fleeting. The above symptoms may decrease or recover when discontinuing pregabalin.

Reduce the lower digestive tract function

There has been a report on the reduction of lower digestive tract function (intestinal obstruction, intestinal paralysis, constipation) when using Pregabalin with the potential drugs that cause constipation such as opioid analgesic.

Administration

There has been a report on brainstorming, mainly in patients at risk of gain disease.

Warning related to excipients

The drug contains lactose, patients with rare genetic diseases galactose, Lapp Lactase deficiency or glucose - galactose absorption disorders should not use this drug.

The ability to drive and operate machinery

The drug can cause drowsiness, dizziness, you need to be cautious when driving or operating machinery

Pregnancy

Research on animals (rats, rabbits) pregnant for pregabalin with a dose to create plasma pregabalin concentrations (AUC) 5 or more than 5 times the drug concentration in the maximum dose recommended 600mg/day, see increased rate of malformations in the fetus and the symptoms of poisoning for pregnancy development, including death, development Reproduction in pregnancy.

There is no complete research and good tests in pregnant women. Do not use for pregnant women unless the maternal benefits are greater than the risk for the fetus.

Breastfeeding period

Pregabalin secreted in milk. The influence of pregabalin on the infant fetus. It is necessary to decide to stop breastfeeding or stop pregabalin based on the benefit of breastfeeding and the benefits of the drug with the mother.

Medicinal interaction

Because pregabalin is excreted mainly in the form of unchanged urine, insignificant metabolism in humans (

In vivo research and pharmacokinetic analysis

In an in Vivo study, there is no significant pharmacokinetic interaction between pregabalin and phenytoin, carbamazepin, valproic acid, lamotrigin, gabapentin, lorazepam, oxycodon or ethanol. Pharmacokinetics analysis shows that oral diabetes, diuretics, insulin, phenobarbital, Tiagabin and Topiramat does not have a significant impact on clinically to pregabalin clearance.

Repeat the dose of 300mg x 2 times/day Pregabalin in healthy objects does not affect the speed and absorption level of Loazepam, Oxycodon, and Ethanol. The single dose of lorazepam 1mg, oxycodon 10mg and ethanol 0.7g/kg does not significantly affect pharmacokinetics in the stable state of Pregabalin.

Using the oral repeated doal pre -orally with oxycodon, Lorazepam or ethanol does not significantly affect clinical respiration. Pregabalin may increase the effects of ethanol and Lorazepam. Pregabalin has the effect of inhibiting cognitive ability and raw motor function caused by Oxycodon.

There has been reports of respiratory failure and fainting in patients using single pregabalin and coordinated with other central nervous system inhibitors.

The higher frequency of weight gain and peripheral edema is seen in patients who share pregabalin and thiazolidindion diabetes medication compared to patients who use only one drug. Most patients taking Thiazolidindion diabetes drugs are in a safe space when participating in peripheral neuropathy trial due to diabetes.

Because ThiazolidIndion or Pregabalin diabetes treatment may cause weight gain and/ or retain water when used alone or in combination, can be worse or lead to heart failure, should be cautious when used in coordination Pregabalin and these drugs.

There has been a report on complications related to the reduction of lower gastrointestinal function (such as bowel obstruction, intestinal paralysis, constipation) when sharing Pregabalin with drugs that can cause constipation such as opioid analgesic.

Oral contraceptives, Norethisteron and/or ethinyl estradiol

Shared Pregabalin and oral contraceptives Norethisteron and/ or ethinyl estradiol does not affect the pharmacokinetics in the stable state of both drugs. The drug affects the central nervous system Pregabalin may increase the effects of ethanol and lorazepam. In a clinical trial, when taking oral dose repeated Pregabalin with oxycodon, Lorazepam or ethanol, there was no important respiratory effect on clinical respiration. There was a report on respiratory failure and fainting in patients using Pregabalin along with other central nervous system inhibitors. Pregabalin has the effect of syllable with the effect of reducing cognition and raw movement function of Oxycodon.

Interaction in the elderly

There is no specific pharmacological interaction research in the elderly. Interactive research is only done in adults.

Pregabalin increases the concentration/ effect of selective Serotonin recovery inhibitors. The concentration/effect of pregabalin is increased by droperidol, hydroxyzin, methotrimeprazin. The concentration and effects of pregabalin are reduced by ketorolac, ketorolac (small nose), ketorolac (systemic line), mefloquin.

Storage

Leave the medicine in a dry place, avoid light, the temperature does not exceed 30 ° C.

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