Demencur 100 Davipharm medicine for central and peripheral neuropathy (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Pregabalin
Ingredient Savi Pharmaceutical Joint Stock Company
Ingredient
| Composition information | Content |
| Pregabalin | 100mg |
Uses
indications
Demencur 100 drugs are indicated in the following cases:
ATC code: N03AX16.
Mechanism of action
Pregabalin is linked to auxiliary subunit (α2 - Δ protein) of a calcium channel carrying voltage in the central nervous system. Pregabalin's mechanism of action has not been fully explained. Research results on genetically modified mice and substances are similar to pregabalin (such as gabapentin) show that the link with α2 - Δ protein may be associated with anti -seizures and pain relief in Pregabalin animal. On the model of animal damage, pregabalin reduces the release of calcium dependence of neurotransmitters that cause pain in the spinal cord, this effect may be due to the disruption of transportation through calcium channels with α2 - Δ protein linked by pregabalin and/or reducing calcium current. Evidence from other persistent painful animal models that show pregabalin analgesic effects can also be indirectly through a decrease in noradrenergic and serotonergic systems (derived from the brain) to regulate pain in the spinal cord.
Pregabalin is the derivative of GABA (gamma aminobutyric acid), not directly linked to GABA, GABA, or Benzodiazepine, does not increase the response to GABA, in cultured neurons, does not change the GABA level in the mouse brain, does not affect the absorption or Christmas of GABA. However, in culture nerve cells, Pregabalin when used for prolonged use increases the density of GABA transport proteins and increases GABA transport rate. Pregabalin does not block the sodium channel, does not activate the Opiat receptor and does not change the activity of the cyclooxygenase enzyme. Pregabalin causes reception of serotonin and dopamine, does not inhibit the reabsorption of dopamine, serotonin or noradrenalin.
Dynamic pharmacokinetics
Pharmacokinetic pharmacokinetics in the same saturation state between volunteers, epilepsy patients are using anti -epileptic drugs and patients with chronic pain.
absorption
Pregabalin is quickly absorbed after drinking at hunger, the peak concentration of plasma is achieved within 1 hour after the single dose or the dose is repeated. Pregabalin's oral bioavailability is estimated at ≥ 90% and does not depend on the dose. After taking the dose repeated, the stable state reached within 24 - 48 hours. Pregabalin absorption rate decreases when used with food, leading to maximum concentration (CMAX) decreased by about 25-30% and the maximum concentration time lasts about 2.5 hours. However, pregabalin when used with food does not have a significant effect on clinical absorption of the drug.
distribution
In preclinical studies, pregabalin through the bloody barrier in mice, rats and monkeys. Pregabalin passes the placenta and is excreted into milk in the rat. In humans, Pregabalin's apparent distribution is about 0.56 l/kg. Pregabalin is not linked to plasma proteins.
transformation
In humans, pregabalin is negligible. After using Pregabalin, which is marked with radioactive substances, shows about 98% found in urine in the form of unchanged pregabalin. Pregabalin's main metabolites are n - methylate derivatives found in urine, accounting for about 0.9% of the dose. In preclinical studies, there is no racemicization of pregabalin from op optical isomers S to optical isomers r.
Elimination
Pregabalin is eliminated from the cycle mainly through the kidneys in the form of unchanged. The average selling time of pregabalin is about 6.3 hours. The clearance in plasma and the kidney clearance of pregabalin is proportional to the clearine clearance. Needs to adjust the dose in patients with renal failure or hemorrhage.
linear/non -linear
Pregabalin'spharmacokinetics are linearly within daily recommended dose. Differences in pharmacokinetics among low drug users (
Sex
Clinical trials indicate that gender does not significantly affect pregabalin levels in plasma.
kidney failure
The clearance of pregabalin is proportional to the clearance of creatinin. In addition, pregabalin is effectively eliminated from plasma by hemorrhage (after 4 hours of hemorrhage, pregabalin levels in plasma decreased by about 50%). The kidney is the main discharge path, so it is necessary to reduce the dose of pregabalin in patients with renal impairment and need to supplement the dose after hemorrhage.
liver failure
There are no pharmacokinetic studies in patients with liver failure. Because pregabalin is not significantly metabolized and is excreted mainly in the form of non -change through the kidneys, the decline in liver function is said to not significantly change the pregabalin level in plasma.
Children
In a pharmacokinetic study and pregabalin's tolerance and pharmacokinetics are assessed in children with epilepsy (age groups: 1 - 23 months old, 2 - 6 years old, 7 - 11 years old and 12 - 16 years old) with a dose of 2.5; 5; 10 and 15 mg/kg/day.
After taking pregabalin when hungry in children, generally the maximum concentration of the same plasma between all ages groups is about 0.5 - 2 hours after drinking. CMAX and AUC (Area Under Curve) are assessed linearly when increasing the dose in each age group. AUC (Area Under Curve) decreased by 30% in children
Pharmacokinetic analysis shows that creatinine clearance is significantly related to the clearance, body weight significantly regarded the apps of pregabalin's apparent distribution. This relationship is similar to children and adults.
Elderly
Pregabalin clearance decreases when age increases. The reduction of linearly orally pregabalin clearance with a decrease in creatinine clearance is associated with an increase in age. Pregabalin dose should be reduced in elderly patients with reduced kidney function.
Before taking Demencur 100 Davipharm medicine for central and peripheral neuropathy (3 blisters x 10 tablets)
How to use
oral tablets, or non -food. Take the tablet with a glass of water.
Patients do not stop taking this medication on their own, unless the doctor is prescribed. If you need to stop treatment, it is necessary to reduce the dose slowly for at least 1 week.
After stopping short -term and long -term treatment with this drug, some unwanted effects may occur, including: sleep disorders, headaches, nausea, felt anxiety, diarrhea, symptoms like influenza, convulsions, stress, depression, pain, sweat and dizziness. These symptoms can occur more often or worse if the patient is taking the drug for a long time.
Dosage
Pregabalin dose is 150 - 600 mg/day, divided into 2-3 times.
Neurological pain
Starting for treatment: 150 mg/day, divided into 2-3 times (*).
Based on the treatment and tolerance of each patient, the dose can be increased to 300 mg/day after 3-7 days. If necessary, it can increase to a maximum dose of 600 mg/day after 7 days.
epilepsy
Starting for treatment: 150 mg/day, divided into 2-3 times (*).
Based on the response and tolerance of each patient, the dose can be increased to 300 mg/day after 1 week. Can increase to the maximum dose of 600 mg/day after 1 week.
Landing anxiety disorders
The dose is 150 - 600 mg/day, dividing the dose into 2-3 times. The need for treatment should be re -evaluated regularly.
Starting for treatment: 150 mg/day, divided into 2-3 times (*).
Based on the response and tolerance of each patient, the dose can be increased to 300 mg/day after 1 week. The dose can be increased to 450 mg/day after 1 week. Then can increase to a maximum dose of 600 mg/day after 1 week.
Crossing Pregabalin treatment
According to the current clinical treatment instructions, if it is necessary to stop Pregabalin, the recommendation to reduce the dose slowly after at least 1 week.
Specific dose depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
kidney failure
Pregabalin is eliminated from the circulatory cycle mainly because the kidneys in the form of unchanged. Due to the clearance of pregabalin proportional to creatinine clearance, the decrease in the dose in patients with renal failure should be individualized based on creatinine clearance (CLCR) in the following table:
Side Effects
When using Demencur 100, you may experience unwanted effects (ADR) such as:
Cases of notifying doctors, pharmacists:
Swelling of the face or tongue, red skin and begins to blister or peeling.
Summary of ADR:
In a clinical program, including 8,900 patients who use pregabalin, of which 5,600 patients from double blind clinical trials, have a control with Placebo, shows that unwanted effects are most commonly reported dizziness and drowsiness. Unwanted effects are often mild to moderate. In all controlled studies, the percentage of drug stops due to unwanted effects is 12% in the prefabalin group compared to 5% in the placebo group. The most common unwanted effects leading to stopping drugs in patients taking pregabalin are dizzy and drowsiness.
The unwanted effects are listed below according to the frequency: Very common (≥ 1/10), common (1/100 Sadr
In each group classified by frequency, unwanted effects are listed according to the degree of severity decreasing.
Unwanted effects listed may be related to the attached diseases or with the same as.
When used to treat central nerve pain due to spinal cord damage, the rate of unwanted effects, central nervous system and especially drowsiness increases.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Demencur 100 contraindications in the following cases:
Be cautious when using
need to be very careful when taking the drug for patients in the following cases:
diabetes
According to the current clinical experience, some patients with diabetes gain weight when treated with pregabalin may need to adjust the hypoglycemic drug.
Hypersensitivity reaction
There have been reports on hypersensitivity reactions from the actual use of drugs, including circuit suitable cases. It is necessary to immediately stop using pregabalin if the angioedema symptoms (such as swelling of the upper respiratory tract, around the mouth and face).
dizziness, drowsiness, distraction, confusion and weakness
Pregabalin treatment is related to dizziness, drowsiness, which can lead to an increase in damage caused by an accident (fall) in the elderly. There were also reports of distraction, confusion and weakness. Therefore, patients need to be cautious when exercising until familiar with the effect of the drug.
affects the vision
In control clinical trials, the proportion of patients treated with pregabalin is reported higher than those of placebo patients, this condition is overcome in most cases of maintenance dose. In clinical trials, there are tests on ophthalmology, evidence of vision reduction and visible area changes in groups of patients treated with pregabalin higher than placebo -treated groups.
In fact, there is a report on unwanted effects on the ability to see vision, blurred vision or other changes in terms of vision, many of these cases are only transient. Stop using pregabalin can resolve or improve these symptoms.
kidney failure
There have been reports on cases of renal failure, including some cases when stopping pregabalin does not reverse this unwanted effect.
Symptoms of drug stopping
After stopping treatment with short -term and long -term pregabalin, symptoms of drug stops occur in some patients. The following events are noted: insomnia, headache, nausea, anxiety, diarrhea, influenza syndrome, anxiety, depression, pain, convulsions, sweating and dizziness. It is necessary to warn this patient before starting treatment.
Seism (including serious epilepsy and seizures) may occur while taking pregabalin or in a short time after stopping the drug.
Regarding long -term pregabalin suspension, data shows that the proportion and severity of the stop symptom may be related to the dose.
congestive heart failure
There have been reports on some cases of congestive heart failure from actual use of pregabalin. These reactions are mostly in the elderly with cardiovascular disease while being prescribed pregabalin to treat nerve pain. Preced prudent prudity should be used on elderly patients. Stopping the drug can solve this unwanted effect.
Treatment of central nerve pain due to spinal injuries
When treating central nerve pain due to spinal cord lesions, there is an increase in unexpected effect rate, central nervous system and especially drowsiness. This may be due to the effect of simultaneous use (such as anti -spasms) to treat this condition, so it should be considered when prescribing Pregabalin.
behavior and suicide thoughts
The reality has reported on behavior and suicide thoughts on patients treated with anti -epileptic drugs. A meta analysis of random clinical trials with a placebo for anti -epileptic drugs shows a slight increase in risk of behavior and suicide thoughts. The mechanism of this risk is not known and the available data does not exclude the possibility of increasing the risk due to pregabalin.
Therefore, patients need to monitor signs of behavior and suicide thoughts and consider appropriate treatment. Patients and family members should be consulted on signs of suicide thoughts and behaviors.
Reduce the lower gastrointestinal function
In fact, there have been reports on events on lower gastrointestinal function (such as small intestinal obstruction, intestinal paralysis, constipation) when using simabalin simultaneously with drugs that can cause constipation such as opioid analgesic. When using pregabalin simultaneously with opioid, it is necessary to consider preventing constipation (especially in women and the elderly).
Abuse, abuse and drug dependency
There have been reports on cases of abuse and drug dependence. Be cautious for patients with a history of drug abuse; Patients should be monitored for symptoms of abuse or drug dependence (increased tolerance threshold, increased dose, acts of searching drugs).
There have been reports on brain disease, mostly in patients who are having a condition that can cause brain disease.
Women have the ability to reproduce
Due to the unknown risk of a person, it is necessary to use effective contraception for fertility women.
excipients
The ingredient with Sunset Yellow Dye can cause allergic reactions.
The effect of the drug on driving and operating machinery
Pregabalin may affect the average weakness to the ability to drive and operate machinery. Pregabalin can cause dizziness and drowsiness, so it can affect the ability to drive and operate machinery. Patients should not drive, operate complex machinery or participate in other dangerous activities until they know whether the drug affects the ability to operate or not.
Use drugs for women during pregnancy and lactation
Pregnant women
There is no data on pregabalin on pregnant women.
Animal studies show that there is toxicity on reproduction. The risk may occur in unknown people.
Do not use pregabalin for pregnant women except for the actual case (if the benefit of the mother is higher than the risk of the fetus).
breastfeeding women
Pregabalin is secreted into breast milk. The effect of pregabalin on breastfed babies is not known. It is necessary to decide to stop breastfeeding or stop treatment with pregabalin after evaluating the maternal treatment benefits and the risk of breastfeeding.
fertility
There is no clinical data on the effect of pregabalin on fertility in women.
In a clinical trial evaluating the effect of pregabalin on sperm's ability to move in healthy men using pregabalin dose of 600 mg/day shows: After 3 months of treatment, there is no effect on sperm movement.
A study showed that there was an unwanted effect on the fertility in Cai mice. Studies on fertility on male mice have shown unwanted effects on fertility and affecting development. Clinically related relationship of this result is not known.
Drug interaction
Pregabalin is eliminated mainly in the form of non -change in urine, less metabolized in humans ( Dynamic pharmacokinetic analysis and in vivo studies
According to In Vivo studies, there is no clinical pharmacokinetic interaction between pregabalin and phenytoin, carbamazepin, valproic acid, lamotrigin, gabapentin, lorazepam, oxycodon or ethanol. The pharmacokinetics analysis shows that drugs to treat oral diabetes, diuretics, insulin, phenobarbital, Tiagabin and Topiramat do not significantly affect the clearance of pregabalin.
Oral contraceptives, norethisteron and/or ethinyl oestradiol
Simultaneous use of pregabalin along with oral contraceptive oral contraceptives Norethisteron and/or ethinyl oestradiol does not affect the pharmacokinetics in the stable state of both Pregabalin and these drugs.
Elderly
There are no studies on pharmacological interaction on healthy elderly people. Interactive studies are only conducted on young people.
Tyeum of drugs
Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.
Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
To be out of reach of children, read the instructions carefully before use.
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