Cododamed 75mg Adamed medicine for neuropathy, epilepsy, and anxiety disorder (4 blisters x 14 tablets)
Dosage form Box of 4 blisters x 14 tablets
Specifications Pregabalin
Ingredient Pharmaceutical Works Adamed Pharma Joint Stock Company - Poland
Ingredient
| Composition information | Content |
| Pregabalin | 75mg |
Uses
Indications
Cododamed 75mg drug is indicated in the following case:
Pharmacy
Mechanism of action
In vitro studies show that pregabalin is attached to the sub-subunite (
Pregabalin has no affinity for reception receptors or response associated with the effects of some drugs commonly used for epilepsy or pain. Pregabalin does not interact with GABAA or GABB inhibitors; 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 animals with neuropathy or postoperative pain, including increased pain and irritating pain.
Pregabalin is active in animal animals, including epilepsy due to an electromechanical shock stretching on mice, epilepsy vibration with pentylenetetrazol, behavioral epilepsy and electrical in mice are stimulated by the Hai Ma region.
pharmacokinetics
Pregabalin's stable pharmacokinetics are the same in the group of healthy volunteers, epilepsy patients who are taking anti -epileptic drugs, patients with chronic pain.
absorption
Pregabalin is quickly absorbed when drinking, with a peak in plasma achieved within 1 hour after drinking in a single or multiple dosage mode. Pregabalin's oral bioavailability is estimated at ≥ 90% and independent of the dose. In repeated use, the stable state of pregabalin is achieved after 24 - 48 hours. Pregabalin's absorption rate decreases when drinking with food, the peak concentration in the CMAX serum decreases by approximately 25 - 30% and delayed the time to achieve the peak concentration in TMAX serum serum approximately 2.5 hours. However, taking Pregabalin with a significant clinical meal on Pregabalin absorption.
Distribution
In preclinical studies, pregabalin passes through the brain barrier in mice, rats and monkeys. And Pregabalin has passed the placenta in the rat, which appears in rat milk. In humans, the distribution voltage of pregabalin is taken orally approximately 0.56L/kg. Pregabalin is not linked to plasma proteins.
Metabolism
In humans, pregabalin metabolizes negligible. When injecting Pregabalin dose with radioactive marking, approximately 98% pregabalin excreted through urine in non -variable form. Preadebalin's n-methylated derivatives are the main metabolites of pregabalin found in urine, and account for 0.9% compared to pregabalin dose. In preclinical studies, there is no sign of pregabalin transformation from isomorphic S to isomers r.
Elimination
Pregabalin is eliminated from the overall circulatory cycle in the unchanged urine form. The half -life of pregabalin is 6.3 hours. Pregabalin clearance in plasma and kidney clearance is proportional to creatinin.
Adjusting the dose in patients with impaired renal function or being clinical is necessary.
linear and non -linear
Pregabalin'spharmacokinetics is linearly in the daily dose of single treatment. Pregabalin's dynamic variation is very low (
Gender
Clinical trials indicate that gender does not affect plasma pregabalin levels.
kidney failure
Pregabalin clearance is proportional to creatinine clearance. Pregabalin is eliminated from hemorrhage plasma plasma (after 4 hours of hemorrhage, plasma pregabalin concentration decreased by 50%). Because the excretion through the kidney is the main secretion path, the reduction of the dose in patients with renal impairment and the dose supplements in the competent patient is needed (see the dose section, how to use).
Hepatic failure
There is no important change in pharmacokinetics in patients with impaired liver function. Because pregabalin is insignificant metabolized and excreted mainly through urine in the form of unchanged, in patients with liver failure, plasma pregabalin concentration has not changed significantly.
Pediatric patients
Pregabalin pharmacokinetics research and tolerance are evaluated in patients with epilepsy (groups: 1 to 23 months old, 2 to 6 years old, 7 to 11 years old, 12 to 16 years old) in doses of 2.5; 5; 10 and 15mg/kg/day.
After taking pregabalin when hungry, the time to achieve the peak concentration in plasma is similar between age groups and 0.5 to 2 hours. CMAX and AUC indicators increase linear with increased drug dose in age groups. The lower AUC in the group of children under 30kg is 30%, in groups of children of over 30kg is 43%, due to the increase in body weight adjustment.
Half of the excretion of pregabalin average 3 - 4 hours in pediatric patients to 6 years old and 4 - 6 hours in patients from 7 years of age or older.
Dynamic pharmacokinetic analysis in pediatric patients indicates that creatinine clearance is an important factor in pregabalin clearance, body mass is an important factor in the orally used prefabalin distribution integral and the same relationships are similar in both children and adults. Pharmacokinetics in patients with children under 3 months have not been studied
Elderly
Pregabalin clearance tends to decrease when age increases. The decrease in this oral pregabalin clearance is reasonable because the relaxinine clearance has decreased with age, so the decrease in the dose of pregabalin can be required in patients related to renal function reduction (see the dose section, usage).
breastfeeding women
pharmacokinetics of 150mg Pregabalin every 12 hours (ie 300mg per day) are assessed in 10 breastfeeding women, women at least after birth 12 weeks. Breastfeeding has a little effect on pregabalin pharmacokinetics. Pregabalin is exempted with breast milk, and the average stable concentration is approximately 76% compared to the concentration in the mother's plasma. The estimated dosage of newborns received from breast milk (assuming the amount of milk consumed is 150ml/kg/day) for the mother receiving the Pregabain dose of 300mg/day and a maximum of 600mg/day may correspond to 0.31 and 0.62mg/kg/day. The estimated dose is about 7% of the daily mother's total daily dose calculated by mg/kg.
Before taking Cododamed 75mg Adamed medicine for neuropathy, epilepsy, and anxiety disorder (4 blisters x 14 tablets)
How to use
Take orally, can be taken or not with food.
Dosage
Pregabalin dose is about 150 - 600mg on day, divided from 2-3 times.
Neurological pain
Pregabalin can start treatment from a dose of 150mg/day, divided from 2-3 times. Based on the response of each patient, pregabalin can increase to 300mg/day after about 3-7 days of treatment, and if necessary, can be up to 600mg/day after the following week.
epilepsy
Pregabalin can be treated at a dose of 150mg/day, divided from 2-3 times. Based on each patient response, the pregabalin dose may increase to 300mg/day after 1 week of treatment and a maximum dose of 600mg/day after the following week.
Disseminated anxiety disorders
Pregabalin dose is about 150 - 600mg, divided 2-3 times. Necessary re -evaluation periodically therapy of pregabalin.
Pregabalin can be treated at a dose of 150mg/day. Based on the response of each patient, the pregabalin dose may increase to 300mg/day after 1 week of treatment and up to 450mg/day after the next week of treatment. The maximum dose is 600mg/day after the next week of treatment.
used for pregabalin
According to clinical documents, if it is necessary to stop treating with pregabalin, it must be reduced by at least 1 week.
For patients with renal failure
Pregabalin excreted mainly out of the overall cycle through the kidney in the formless form. Pregabalin dose is calculated based on the degree of creatinine of each patient.
Remove pregabalin from plasma by hemolytic method (50% of the drug is excluded within 4 hours). For patients who are getting hemorrhage, pregabalin's daily dose should be adjusted based on kidney function. In addition to the daily dose, pregabalin should be taken immediately after every 4 hours of blood separator (such as Table 1).
Table 1
Creatinine clearance (CLCR) (ml/min)
Total daily Pregabalin dose*
Dosage mode
Maximum doses (mg/day)
≥60
150
600
2 - 3 times/day
≥ 30 - 75
300
2 - 3 times/day
≥ 15 - 25 - 50 150 1 time/day or 3 times/day
25 75
1 time/day
100
Single dose +
+ Additional dose is an additional dose.
Patients with heart failure
No dose adjustment for patients with liver failure.
Pediatric patients
Pregabalin's efficiency and safety in children under 12 years old and in adolescents (12 - 17 years old) have not been set up. The current data is described in Section 2 and 8 and is not recommended by this dose.
Elderly (greater than 65 years old)
Dosage in older adults may have to decrease depending on the degree of impaired renal function (refer to "use Pregabalin in kidney failure").
What to do when overdose?
Symptoms
Confused state.
Overdose treatment
Includes common support and can be clinical if necessary.
What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
The most unwanted side effect when using cododamed is dizzy and drowsiness.
In the treatment of central neurological pain due to spinal injuries, the unwanted side effect rate in the central nervous system as well as drowsiness also increased.
The following side effects are listed in groups and with the following frequency. The frequency is defined as follows: Very common (≥ 1/10); Common (≥ 1/100,
Infections and parasites
Very common (≥ 1/10): nasopharyngitis.
Blood disorders and lymphatic systems
Uncommon (≥ 1/1000,
Metabolic and nutrition disorders
Less (≥ 1/1000,
Rare (≥ 1/10000,
Nervous system disorders
Very common (≥ 1/10): dizziness, drowsiness, headache.
Common (≥ 1/100,
Less (≥ 1/1000,
Rare (≥ 1/10000,
Eye disorders
Common (≥ 1/100,
Uncommon (≥ 1/1000,
Rare (≥ 1/10000,
Disorders on ears and in ears
Common (≥ 1/100,
Uncommon (≥ 1/1000,
Tima disorders
Uncommon (≥ 1/1000,
Rare (≥ 1/10000,
Blood vessel disorders
Uncommon (≥ 1/1000,
Disorders on respiratory, chest and mediastinum
Uncommon (≥ 1/1000,
Rare (≥ 1/10000,
Gastrointestinal disorders
Common (≥ 1/100, Uncommon (≥ 1/1000,
Rare (≥ 1/10000,
Skin and soft tissue disorders
Uncommon (≥ 1/1000,
Rare (≥ 1/10000,
Musculoskeletal and connective tissue disorders
Common (≥ 1/100, Less (≥ 1/1000,
Rare (≥ 1/10000,
Disorders on kidney and urinary tract
Uncommon (≥ 1/1000,
Rarely (≥ 1/10000,
Disorders on reproductive and mammary systems
Common (≥ 1/100,
Uncommon (≥ 1/1000, Rarely (≥ 1/10000,
Systemic disorders and in use
Common (≥ 1/100,
Uncommon (≥ 1/1000,
Testing
Common (≥ 1/100,
Uncommon (≥ 1/1000,
Rare (≥ 1/10000,
Warnings
Solded drugs. Read the user manual carefully before use.
Leave the medicine out of reach of children. If you need more information, please consult your doctor.
Contraindicated
sensitive to the main active ingredient or any ingredient of the drug.
Precautions when using
used in diabetes patients
In clinical practice, some patients with diabetes have weight gain, when using Pregabalin may need to adjust some hypoglycemic drugs.
Hypersensitivity reactions
There have been post -commercial reports on the hypersensitivity reactions of the drug, including cases of circuit. Pregabalin should be stopped immediately if there are symptoms of angioedema, such as on the face, around the mouth, the upper respiratory tract is edema.
Dizziness, loss of consciousness, confusion, mental impairment.
Pregabalin treatment may be related dizziness, and may increase the risk of falling for the elderly. There have been post -commercial reports on loss of consciousness, confusion and mental impairment. Therefore, patients prescribed Pregabalin should be carefully advised until the patient is familiar with these effects of the drug.
affects the ability to see
In control tests, high proportion of patients treated with pregabalin is reported to be more blurry than patients using placebo, this side effect will end if they continue to use the drug. In clinical studies, the rate of vision reduction and change in patients using pregabalin is greater than patients only use placebo.
In post -commercial reports, side effects on the ability to see the report, including loss of visibility, blurred view or change the ability to see, most of them are fleeting. Stop using Pregabalin can reduce this side effect.
kidney failure
Renal failure has been reported when using pregabalin and recovered when stopped using the drug.
Stop using anti -epileptic drugs
Not enough data to recommend stopping the use of epilepsy drugs in use, taking Pregabalin is considered as an additional supportive therapy and without being used alone.
Symptoms of detoxification
Pregabalin treatment after a short or long time, when stopping treatment, observed symptoms of detoxification in some patients. Symptoms include: insomnia, headache, nausea, anxiety, diarrhea, influenza syndrome, anxiety, depression, pain, convulsions, dizziness, proposed symptoms are drug dependence. Patients should know this information before treatment.
Convulsions include both epilepsy and large epilepsy that may occur during the use of pregabalin or after stopping the use of the drug. Regarding the stop treatment of pregabalin after a long period of treatment, the proportional recommendations and severity of the detoxification symptom may be related to the dose.
SECRETING HEART
There has been a post -commercial report on side effects of congestion in some patients treated with pregabalin. Most of these side effects occur in older patients with cardiovascular lesions, prefabalin treatment for neurological pain. Pregabalin must be used cautiously in these patients. This side effect will go away if it stops pregabalin.
Treatment of central nerve pain in patients with spinal trauma
In the treatment of central nerve pain in patients with spinal trauma, unwanted effect rate, unwanted effect on the central nervous system and especially drowsiness increases. These unwanted effects may be due to the dynamic effect due to the sharing pregabalin with other drugs (for example, muscle relaxants) used in this case. Should consider Pregabalin in this case.
The intention to commit suicide and behavioral disorders
The intention of suicide and behavioral disorders have been reported on several cases of anti -epileptic drugs. The analysis of random studies controlled to the placebo of anti -epileptic drugs also shows that there is a slight increase in the risk of suicide and behavioral disorders. It is possible that the risk of suicide and behavioral disorders is unknown, and data does not rule out the possibility of increasing this risk when treated with pregabalin. Therefore, patients should be monitored signs of suicide intentions and behavioral disorders as well as consider treatment. Patients and patients should be carefully consulted to find medicine support if they see signs of suicide intentions and behavioral disorders.
Reduce the lower digestive tract function
There have been post -commercial reports related to lower gastrointestinal function (for example, intestinal obstruction, intestinal paralysis, constipation) when Pregabalin is used simultaneously with drugs that can cause constipation, for example opioid drugs. When using pregabalin combination and opioid drugs, constipation preventive measures (especially in female and older patients).
Abuse of drugs, abuse of drugs or drug dependencies
Be cautious when prescribing in patients with a history of drug abuse and patients should be monitored with symptoms of abuse or pregabalin dependence.
Brain pathology
Most patients with basic conditions can promote brain disease.
lactose
This drug contains lactose. Patients with rare genetic problems such as galactose intolerance, deficiency of lactase metabolic yeast or Glucose -Galactose should not be used.
The ability to drive and operate machinery
Pregabalin can affect small to medium to the ability to drive and operate machinery. Pregabalin can cause dizziness, drowsiness, so that affects the ability to drive or operate machinery. Patients should be advised not to drive, operate machinery until they know the effects of the drug on their ability to drive and operate their machines.
Pregnancy
There is no enough data on pregabalin for pregnant women. Pregabalin should not be used during pregnancy unless necessary (if the benefit above mother has a potential risk in pregnancy).
Breastfeeding period
Pregabalin is excreted through breast milk. The effect of Pregabllin on newborns is unknown. Need to consider the benefits and risks when treating pregabalin in nursing women.
Medicinal interaction
Because Pregabalin is excreted mainly in the form of no metabolism through urine, negligible metabolism ( Oral contraceptives, Norethisteron or oestradiol
Concomitance Pregabalin use with oral contraceptives for oral contraceptives norSthisteron or ethinyl oestradiol does not affect the pharmacokinetic stability of each drug.
Central painkillers
Pregabalin may increase the effects of ethanol and Lorazepam. In controlled, multi -dose clinical studies, pregabalin used simultaneously with Oxycodon, Lorazepam, Ethanol, no significant undesirable effect on the respiratory tract. There have been post -commercial reports on respiratory failure, coma in patients using pregabalin simultaneously and central painkillers. Pregabalin is as a combined effect on unwanted effects of mobility and awareness caused by Oxycodon.
Elderly
There is no study of pharmacological interaction in the elderly volunteering, studies are conducted in adults.
Storage
Store drugs at temperatures not exceeding 30 ° C. Store the drug in the original packaging to avoid light. Avoid moisture.
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