Davyca - F 150mg Davipharm Treatment of spreading anxiety disorders (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Pregabalin
Ingredient Dat Vi Pharmaceutical Joint Stock Company

Ingredient

Composition information	Content
Pregabalin	150mg

Uses

indications

Davyca F medicine is indicated in the following cases:

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

Disrail anxiety disorders.

Pain due to neuritis: peripheral neuritis due to diabetes, neurological pain after herpes.

muscle pain caused by fibrosis.

Neurological pain due to spinal cord damage.

Pharmacokinus

Pregabalin is an anti -convulsed and analgesic drug. Pregabalin has the same structure as the central neurological inhibitor GABA, but is not directly attached to the GABAA, GABAB receptors, or Benzodiazepin's receptors, 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 tissue 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 the subunit (α2 - Δ may be related to the pain relief and anti -convulsions effects of Pregabalin.

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

Dynamic pharmacokinetics

Pharmacokinetics The stable state of Pregabalin is similar in healthy volunteers, epilepsy patients who are taking anti -epilepsy drugs and chronic 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 repeated dose, 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 bloody barrier in mice and monkeys. 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 - methylation derivative 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 isomorphic S - Pregabalin 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 kidney or dialysis.

Before taking Davyca - F 150mg Davipharm Treatment of spreading anxiety disorders (2 blisters x 14 tablets)

How to use

use orally, divide 2-3 times/day, drink with or not with food.

Dosage

Supplementing local epilepsy treatment

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

Disseminated anxiety disorders

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

Pain due to neuritis, pain after herpes

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

Starting dose: 150 mg/day, can be increased to 300 mg for 1 week depending on the efficiency and tolerance. If it still does not help after 2-4 weeks of treatment with a dose of 300 mg, it can increase to 600 mg daily divided into 2-3 times. The dose exceeds 300 mg only for people who are still painful and tolerated 300 mg daily, as the potential of many ADR due to high doses.

Diabetes nerve pain

Adults: The starting dose of 150 mg day, divided into 3 times: The dose can increase in the next 1 week of the maximum dose recommended 300 mg daily divided into 3 times. However, in Pregabalin clinical trial, 600 mg daily does not give significant efficiency and the patient using this dose has an unwanted effect rate higher than the dose of 600 mg is not researched and not recommended.

muscle pain due to fibrosis

The starting dose of 150 mg/day, increases after 1 week depending on the response to 300 mg/day and 450 mg daily 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 - 600 mg/day. The recommended starting dose is 75 mg x 2 times/day (150 mg/day). The dose may be increased to 150 mg twice a day (300 mg) within 1 week based on efficiency and tolerance. If the patient is not effective for pain after 2-3 weeks of treatment with a dose of 150 mg x 2 times a day and well tolerated, the pregabalin dose can be increased to 300 mg twice a day. Because Pregabalin is excreted mainly through 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 (mg/day)

Dosage mode

150

300

450

600

2 times/day or 3 times/day.

30 - 60

150

225

300

2 times/day or 3 times/day.

15 - 30

25 - 50

100 - 150

150

1 - 3 times/day.

25 - 50

50 - 75

1 time/day.

Patients with a dose of 25 mg x 1 time/day: take an additional dose of 25 - 50 mg.

Patients taking dose 75 mg 1 time/day: Taking an additional dose of 100 - 150 mg.

No dose adjustment.

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 overdabalin overdose include drowsiness, exciting disorders, and restlessness. The epilepsy is also reported. In some rare cases, coma has also been reported.

Handling

There is no specific antidote. If indicated, cause vomiting or gastric lavage, maintain airway if needed. Symptomatic treatment, support. Hematoparology 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 F you may experience unwanted effects (ADR).

Very common, ADR> 1/10

Neurological: dizziness, drowsiness, headache.

Common, ADR> 1/100

Infections and parasites: Nasomitis.

Metabolism and nutrition: Increasing appetite.

Mental: confused mood, discomfort, disorientation, insomnia, reduced libido.

nerve: loss of air conditioning, unusual coordination, tremor of speech, loss of memory, memory impairment, attention disorders, paresthesia, reduced sense of sedation, balancing disorders, coma.

Eyes: blurred vision.

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, limb pain, 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, 1/1000

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 a purpose of vibrating eyeballs, cognitive disorders, mental weakness, language disorders reduced reflexes to increase 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, nearsightedness, dizziness, dry eyes.

ears and mesmerizing (inner ears): Sensitivity to sound.

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, decreased sensation in the mouth.
Skin and subcutaneous tissue: Red rash, urticaria, increased sweating, 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: hyperninery phosphokinase blood, hyperlemen aminotransferase, increased aspartat aminotransferase, hyperlemor of blood glucose, decreased number of pepper, hypertreatinine, reducing potassium, weight loss.

Rare, ADR
Immune: Evala, allergic reactions.

Mental: The state of inhibition.

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

Eye: Missing, corneal inflammation, certification of oscillation change the perception of the depth of the copper eye from 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 tract: kidney failure, urethra, pepper.

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, symptoms of cessation may appear in some patients. The following reactions have been reported: insomnia, headache, nausea, anxiety, diarrhea, influenza syndrome, convulsions, stress, depression, pain, increased sweating and dizziness, physical dependence. The patient should be notified before treatment. When stopping long -term treatment, pregabalin, the rate and severity of the symptoms of cessation may depend on the dose.
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 f drug is contraindicated in the following cases:

sensitive to pregabalin or any ingredients of the drug.

Caution when using

Patients with diabetes

Some patients with diabetes gain weight when using the drug, may need to adjust the dose of hypoglycemic drugs.

Hypersensitivity reaction

There have been reports that occur hypersensitivity reactions including veins. The drug should be stopped immediately if there are angioedema symptoms, such as edema, around the mouth, or upper respiratory tract.

Serious skin reactions

There have been rare reports that seriously reacted, including Stevens - Johnson (SJS) syndrome, poisoned epidermal necrosis (Ten), flaking dermatitis, skin glossy reactions, 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.

suicide the intention of suicide

Anti -convulsions, including pregabalin, often increases the risk of suicide behavior. Therefore, patients need to be closely monitored on depression manifestations, trends to commit suicide, abnormal behavior changes during the treatment process and need to be instructed to notify the doctor as soon as the above 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 there is muscle weakness, increased pain sensitivity, especially when accompanied by fever and uncomfortable fatigue. Must stop the drug when there is a manifestation of muscle disease.

Symptoms of cessation

After the end of the short -term or long -term treatment with pregabalin, the symptoms may appear: insomnia, headache, nausea anxiety, diarrhea, influenza symptoms, suspense, depression, pain, seizures, sweating and dizziness. Convulsions, including epilepsy and spasms, may occur during pregabalin or after stopping in a short time. The frequency and severity of the symptom of quitting can be associated with the dose. Need to stop slowly and reduce pregabalin dose 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 clinical studies, the proportion of patients using pregabalin has a refreshing manifestation of 4% compared to 1% in them. 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. Renal failure: There is a report 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 and converts to a single pregabalin therapy when epilepsy is controlled by a pregabalin combination therapy.

Central neuropathy treatment due to spinal cord injury

Central neuropathy treatment due to spinal injury increases the unwanted frequency of Pregabalin, increasing unwanted effects on the central bodies, especially drowsiness that may be due to dynamic use with drugs 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 tests, the rate of vision reduction and market change changes in the eye in patients using pregabalin larger than the Placebo group. Unwanted effects on the face 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 gastrointestinal tract function (intestinal obstruction, intestinal paralysis, constipation) when using pregabalin with drugs that can cause constipation such as opioid analgesic.

Administration

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

The ability to drive and operate machinery

Medicines that affect the central nervous system include: drowsiness, dizziness, which can reduce both the physical and mental of the patient, so be cautious on driving or operating objects.

Pregnancy

Research on animal (rats, rabbits) pregnant for pregabalin with a dose of plasma pregabalin concentrations (AUC) 5 or more than 5 times the drug concentration in the maximum dosage of 600 mg, seeing increased deformities in the fetus and manifestations of poisoning on pregnancy development, including: mortality, fetal damage, nervous system. There is no full research and good tests in pregnant women. Do not use for pregnant women unless the maternal benefits are greater than the risk of pregnancy.

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 benefits of breastfeeding and the benefits of the drug.

Drug interaction

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

Pharmacokinetics analysis shows that oral diabetes, diuretics, insulin, phenobarbital, Tiagabin and Topiramat does not affect clinically to pregabalin clearance. The repeated dose of 300 mg x 2 times/day Pregabalin in healthy objects does not affect the speed and absorption level of Loazepam, Oxycodon, and Ethanol single dose Lorazepam 1 mg, Oxycodon 10 mg and ethanol 0.7 g/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 tests.

Because thiazolidIndion or Pregabalin diabetes can cause weight gain and water retention when used alone or in combination, can 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.

Pregnancy contraception, Norethisteron and/or ethin 'estradiol: sharing pregabalin and oral contraceptives norethisteron and or Ethinyl estradiol does not affect the pharmacokinetics in the stable state of both drugs.

Medicines affect the central nervous system: Pregabalin can increase the effects of ethanol and lorazepam. In a clinical trial, when taking the oral dose repeated Pregabalin with oxycodon, Lorazepam or ethanol did not see an 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 effects of selective serotonin recovery inhibitors.

The acting concentration 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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