Doucetz Mega We Care medicine treats painful to severe pain (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Paracetamol, tramadol HCl
Ingredient Mega Lifesciences Public Company Limited
Ingredient
Thành phần cho 1 viên
| Composition information | Content |
| Paracetamol | 325mg |
| Tramadol HCl | 37.5mg |
Uses
Indications
Duocetz drugs are indicated in cases of treatment of severe to severe pain.
Pharmacokology
tramadol
tramadol is an opioid synthetic analgesic with an analgesic effect according to the central mechanism and can be addictive as morphine. O-Desmethyltramadol (M1) drugs of tramadol attached to the gamma receptor of neurons and reducing the re-import of norepinephrin and serotenin into the cell should have analgesic effect. M1 metabolites have an affinity with Gama receptor 200 times higher and 6 times higher than tramadol.
Pain relief effects appear after 1 hour of use and reach the maximum effect after 2-3 hours. Unlike morphine, does not cause histamine release, does not affect the heart frequency and left ventricular function and at the dose of tramadol treatment less respiratory inhibitors than morphine.
paracetamol
Paracetamol is an active metabolic substance of phenacetin, an effective antipyretic analgesic, can replace aspirin; However, unlike aspirin, paracetamol is not effective in treating inflammation. With the equal dose calculated by grams, paracetamol has analgesic effects like Aspirin.
paracetamol reduces the body temperature in fever, but rarely reduces the body temperature in normal people. The drug affects the hypothalamus causing cooling, increasing heat due to vasodilation and increased peripheral blood flow.
paracetamol, with treatment dose, less impact on the cardiovascular and respiratory system, does not change the balance of acid-base, does not cause irritation, scratches or stomach bleeding as when using salicylate, because paracetamol does not work on cycloxygenase/ prostaglandin of the central nervous system. Paracetamol does not work on platelets or bleeding time.
pharmacokinetic
tramadol
absorption
Tramadol absorbs well through the digestive tract but has a strong metabolism through the strong liver, so the absolute bioavailability of the drug is only 75%. The maximum concentration time in the blood between tramadol and metabolites. Tramadol has a maximum concentration in the blood after use 2 hours, while M1 metabolic products are 3 hours. Food less affects the absorption of drugs.
Distribution
In the blood of the drug attached to protein about 20% and is distributed in all organs with an integral distribution of about 2.7 liters/kg.
Metabolism
In tramadol body is metabolized through N and O methyl reactions under the catalyst of 2 isenzyme CYP3A4 and CYP2D6. Under the catalyst of CYP2D6, tramadol converts into M1 and has analgesic effect, so when used with some substances that can cause this isoenzym, it will change the effect of tramadol.
The activity of Isoenzym CYP2D6 is inherited. The rate of weak enzyme activity accounts for about 7%. In addition to the metabolism through phase I, tramadol and metabolites are also metabolized through phase II through the reaction conjugated with glucuronic acid or sulfuric acid.
Elimination
The drug is eliminated with the kidneys (90%) and 10% in the feces, in the form of not metabolized accounting for a ratio of 30% and has been metabolized of 60%. The drug goes through the placenta and breast milk. The half -life of tramadol is 6.3 hours and M1 is 7.4 hours.
Tramadol's pharmacokinetics varies with little age. In people over 75 years old, half a lifetime increased slightly. In people with renal failure, the clearance of tramadol decreases in parallel with the clearine clearance; Half life is about 12 hours. In people with liver failure, tramadol clearance decreases depending on the severity of the liver failure.paracetamol
absorption
Paracetamol is quickly absorbed and almost completely through the gastrointestinal tract. The peak concentration of plasma is within 30 to 60 minutes after drinking with the dose of treatment.
Distribution
Paracetamol is distributed quickly and evenly in most body tissues. About 25% Paracetamol in the blood combined with plasma protein.
Elimination
The half -life of paracetamol plasma is 1.25 - 3 hours, which can last for toxic doses or in patients with liver damage.After the treatment dose, 90 to 100%of urine can be seen on the first day, mainly after the liver combination with glucuronic acid (about 60%), sulfuric acid (about 35%) or cysteine (about 3%); It also detects a small amount of hydroxyl and acetyl metabolites. Children are less likely to glucuro than drugs than adults.
paracetamol is n-hydroxylation by cytochrom P450 to create N-acetyl-Benzoquinonimin, an intermediate reaction. This metabolic substance normally reacts with sulfhydryl groups in glutathion and thus deducted activity.
However, if taking high doses of paracetamol, this metabolic is formed in sufficient amount to exhaust the glutathion of the liver; In that situation, its reaction to the sulfhydryl group of liver protein increases, which can lead to liver damage.
Before taking Doucetz Mega We Care medicine treats painful to severe pain (3 blisters x 10 tablets)
How to use
orally orally use.
Dosage
Adults and children over 16 years old:
Maximum dose of 1-2 capsules every 4 - 6 hours, when necessary to reduce pain can be up to up to 8 tablets/day.
Children under 16:
Safety and efficiency have not been established.
Elderly:
In general, there is no difference in safety or pharmacokinetics among objects> 65 years old and young people.
Although half -life of tramadol increased by 17% after drinking in volunteers over 75 years old, the usual dosage could be used. In patients over 75 years old, due to tramadol, the minimum distance between doses should not be shorter than 6 hours.
kidney failure:
Because of tramadol, the use of Duocetz is not recommended in patients with severe renal impairment (creatinine clearance
Hepatic failure:
Do not use in patients with severe liver failure. In case of average liver failure, it is advisable to consider extending the distance between the doses.
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?
Expression:
Duocetz is a multi -component combination. Clinical manifestations of overdose medication may be signs or symptoms of tramadol poisoning, paracetamol or both.
Symptoms of overdose due to tramadol:
In principle, poisoning with tramadol, the same symptoms as when poisoning of other central -acting painkillers (opium). Special symptoms include: pupils, vomiting, cardiovascular collapse, consciousness disorders leading to coma, convulsions and respiratory inhibitors leading to respiratory extraction.
Symptoms of paracetamol overdose:
Paracetamol overdose is a special concern in young children. The symptoms of paracetamol overdose in the first 24 hours are pale, nausea, vomiting, anorexia and abdominal pain. Liver damage may appear after 12 - 48 hours after drinking. Abnormalities of glucose metabolism and metabolic acidosis may occur.
In case of severe poisoning, liver failure can progress to brainstorming, coma and death. Acute renal failure with acute renal necrosis may develop even in the absence of serious liver damage. Arrhythmic and pancreatitis have also been reported.
Liver damage can occur in adults that have used 7.5 - 10g paracetamol or more. This is due to the excess of a toxic metabolite (usually detoxified with glutathion when using the dose of paracetamol treatment), which can accumulate toxic to the liver.
Management:
Emergency treatment:
Perform liver tests at the beginning (overdose) and repeat every 24 hours. There is often an increase in liver enzymes (ASAT, ALAT) and return to normal after one or two weeks.
Take supportive measures such as maintenance of tracheal ventilation and cardiovascular maintenance; use Naloxon to treat respiratory inhibitors; Can control well with diazepam.
Specific antidote for paracetamol, NAC, should be used orally or intravenously, as soon as possible, if possible, within 8 hours after overdose.
What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.
Side Effects
When using the drug, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Uncommon, 1/1000 Mental disorders: depression, hallucinations, nightmares, memory loss. Cardiovascular disorders: hypertension, chest drum, tachycardia, arrhythmia. Rare, 1/10000 Mental disorders: Drug dependence. Marketing surveillance: Common, ADR> 1/100 Uncommon, 1/1000 Skin disorders and skin -dependent parts: Skin reaction (rash, urticaria). Rare, 1/10000 Very rare and unknown frequency Although it is not observed in clinical trials, the appearance of unwanted effects related to the use of tramadol or paracetamol cannot be excluded: tramadol: Hypotension posture, slow heart rate, collapse (tramadol). Tramadol monitoring monitoring after circulation on the market shows that it rarely changes the effects of warfarin, including increasing blood clotting time. rarely Develing asthma although the causal relationship has not been established. Symptoms of the drug stop reaction, similar to the association they quit may include: agitation, anxiety, stress, insomnia, hyperactivity, tremor and digestive symptoms. If the sudden use of tramadol is stopped, the symptoms of stopping drugs are very rare, including: panic, serious anxiety, hallucinations, abnormalities, tinnitus and other abnormal central neurological symptoms. paracetamol: Paracetamol's side effects are very rare but hypersensitivity reactions like skin rash may occur. There have been reports on hematopoietic disorders including platelets and leukopenia, but not necessarily related to paracetamol. There have been a few reports that paracetamol can reduce blood prothombin when used with Warfarin -like compounds. In other studies, prothrombin time does not change. Very rare skin reaction. Instructions on how to handle ADR Notice immediately to the doctor the unwanted effects encountered when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
contraindicated drugs in the following cases:
Precautions when using
The risk of seizures
Scratches have been reported in patients with tramadol used in recommended doses. The market report indicates that the risk of convulsions increases with tramadol dose on the recommended dose. Simultaneous use of tramadol increases the risk of convulsions in patients using:
Other opioids.
Using tramadol may increase the risk of convulsions in patients in use: Mao inhibitors, neuroleptics, or other drugs that reduce seizures.
The risk of convulsions can also increase in patients with epilepsy, a history of convulsions, or patients at risk of convulsions (such as head injuries, metabolic disorders, drinking alcohol and stopping drugs, central nervous system infections). In the overdose of tramadol, use with naloxon may increase the risk of convulsions.
Risk of suicide
Do not specify the patient for suicide or addiction.
Use carefully for patients to use sedative drugs, antidepressants and excessive alcohol use and people with emotional disorders or depression. For patients with depression or suicide, it is advisable to consider the use of non -addictive painkillers.
The death of tramadol has occurred in patients with a history of emotional disorders or suicide ideas before or a history of sedative, alcohol and drugs that affect the central nervous system.
Serotonin syndrome risks
The development of serotonin syndrome is life -threatening when using tramadol -containing drugs, including Duocetz, especially simultaneously using serotonergic drugs such as SSRIS, SNRIS, TCAS, MAIS, and TRIPTANS, these drugs reduce the metabolism of serotonin (including Maois), and reduce the transformation of tramadol (CYP2D6 and CYP3 inhibitors. A4). This can happen when using the recommended dose.
Serotonin syndrome may include mental changes, status (agitation, hallucinations, coma), instability (tachycardia, unstable blood pressure, hyperthermia), neuromuscular illness (increased reflexes, loss of coordination) and/or digestive symptoms (nausea, vomiting, diarrhea).
Anaphylactic reaction
Anaphylactic reaction rarely death in patients treated with tramadol. Anaphylaxis often occurs after the first dose. Other allergic reactions include itching, urticaria, bronchospasm, angioedema, epidermal necrosis and Stevens Johnson syndrome. Patients with a history of anaphylactic reaction with codeine and other opioids may be at high risk and should not be used.
Respiratory failure
Use carefully in patients at risk of respiratory failure. In these patients, other non -opioid analgesic should be considered. When tramadol is highly used with anesthetic or alcohol, respiratory failure may occur. Respiratory failure should be treated when using overdose. If you use naloxon, you should be used carefully because it can promote seizures.
Interaction with other drugs: Central Neurology (CNS)
Duocetz should be used carefully and reduce the dose when used for patients taking central neurological inhibitors such as alcohol, opium, anesthetic, sleeping pills, phenothiazine, sedative or sedative pills. Tramadol increases the risk of the central nervous system and respiratory failure in these patients.
Interaction with alcohol and drug abuse
Tramadol may have side effects when used in combination with alcohol, other opium, or drugs that cause the central nervous system weakening.
Increased intracranial pressure or head injury
Duocetz should be used cautiously in patients with increased intracranial pressure or head injury. The respiratory inhibiting effects of opioids include carbon dioxid hold and secondary cerebrospinal fluid pressure and may increase significantly in these patients.
In addition, tramadol's pupils (co -pupils) changes can obscure the existence, level, or intracranial disease. Doctors should also pay close attention to the side effects of the drug when evaluating the nerve status in these patients if they are using.used for outpatient patients
Tramadol can reduce mental and physical, need to mean to perform dangerous tasks such as driving or operating machinery. Should warn patients who are using this drug.
used with Mao inhibitors and re -inhibition of Serotonin re -inhibition
Use of Duocetz should be very careful in patients with Monoamine oxidase inhibitors. Animal studies have shown an increase in the amount of death when used in combination with tramadol with Mao inhibitors. Simultaneous use of tramadol with Mao inhibitors or SSRIs increases the risk of side effects, including epilepsy and serotonin syndrome.
used with alcohol
Duocetz should not be used when drinking alcohol. Using Duaetz in patients with liver disease is not recommended.
Using other drugs containing paracetamol
Because paracetamol is toxic to the liver at higher doses than the recommended dose, Duetz should not be used simultaneously with other Paracetamol -containing drugs.
The risk of overdose
Patients using tramadol should be warned not to exceed the recommended dose of the doctor. Tramadol is too high, or alone or in combination with other central neurological inhibitions, including alcohol, which is a cause of drug -related death. Patients should be warned of simultaneous use of tramadol and alcohol -containing drugs because of the serious side effects on the central nervous system.
Because of its combination inhibitor effect, tramadol should be used carefully for patients to use simultaneously use painkillers, sedatives, muscle relaxants, three -round antidepressants, or other central neurological inhibitors. Patients should be notified of the inhibitory effect when combining drugs.
The serious consequence of tramadol overdose is to inhibit the central nervous system, inhibit respiration and death. Some deaths have occurred due to accidentally swallowing a large amount of tramadol or concluding with other drugs. In overdose treatment, attention should be paid to ventilation with supportive treatment.
The serious consequences of paracetamol overdose are liver necrosis, leading to liver failure and death. Must be emergency immediately and start treatment immediately if suspected of overdose, even if the symptoms are not clear.Cet Syndrome
Cowdown syndrome if the sudden stopped. Symptoms include anxiety, sweating, insomnia, tremor, pain, nausea, tremor, diarrhea, upper respiratory symptoms, goosebumps, and rarely hallucinations. Other symptoms have been reported when stopping tramadol and paracetamol include: panic, serious anxiety and paresthesia. Clinical experience shows that the cessation syndrome can be avoided by reducing the dose slowly.
Caution:
Do not overdose recommended. Do not be used with medications containing paracetamol and tramadol.
Children: Safety and effectiveness of Duocetz has not been studied in children.
Elderly: Choosing the dose for elderly patients should be cautious.
In case of acute abdominal pain: Using can complicated the clinical assessment of patients with acute abdominal pain.
Used for patients with renal failure
tramadol and paracetamol have not been studied in patients with renal function. According to experience, the impaired renal function causes a decrease in the proportion and level of excretion of tramadol and its active metabolites (M1). In patients with creatinine clearance below 30ml/min, the recommended dose of the time to use is increased by no more than 2 tablets every 12 hours.
used for patients with liver failure
tramadol hydrochlorid and paracetamol tablets have not been studied in patients with liver function.
The use of Duocetz in patients with liver failure is not recommended.
Doctors need to warn patients on signs of serious skin reactions such as Stevens-Johnson syndrome (SJS), toxic skin necrosis syndrome (Ten) or Lyell syndrome, acute overseas acne syndrome (AGEP).
Information for patients
Patients should be informed that upon can cause convulsions and/or serotonin syndrome when used simultaneously with serotonergic (including SSRT, SNRIS, and Triptans) or drugs that reduce the release of tramadol metabolites.
Duocetz is not used with alcoholic beverages.
Patients need to be instructed to not take or tinketz in combination with drugs containing tramadol or paracetamol.
Duocetz must be used cautiously when used with sedative drugs, sleeping pills or other addictive painkillers.
Patients need to notify the doctor if they are pregnant, think they may be pregnant, or are trying to conceive.
Patients should understand the dosage, the maximum dose in 24 hours and the time between the dose, because exceeding these recommendations can lead to respiratory failure, seizures, liver toxicity and death.
The ability to drive and operate machinery
tramadol can reduce mental and physical, need to mean to perform dangerous tasks such as driving or operating machinery. Should warn patients who are using this drug.
Pregnancy
The teratogenic effect: Group classification c.
There is no complete and controlled research in pregnant women. Duocetz should be used during pregnancy when carefully calculated between effectiveness and the risk of toxic to the fetus.
Duocetz is not used before labor or during labor except for the expected effect is really greater than the risk. Pregnant women if used for long -term tramadol can be addictive and syndrome for babies after birth.
Breastfeeding period
due to tramadol into breast milk and safety for babies and young children after taking the drug that has not been studied, should not take the drug during the breastfeeding period.
Drug interaction
tramadol:
CYP2D6 and CYP3A4 inhibitors
Simultaneously use CYP2D6 and/or CYP3A4 inhibitors such as Quinidin, Fluoxetin, Paroxetin and Amitriptylin (CYP2D6 inhibitors), and ketoconazol and erythromycin (CYP3A4 inhibitors), which can reduce the release of metabolic substances of tramadol, increased risk of serious side effects including serious shrinkage Serotonin.
Serotonergic drugs
There have been reports on serotonin syndrome when combined with tramadol with SSRIs/SNRIS or MAOIS and α2-adrenergic blockers. Caution should be carefully used when used with other drugs with other drugs that affect the serotonin neurotransmitter system, such as SSRIs, Mais, Triptans, Linezolid, Lithium.
If treated simultaneously with a drug that affects the serotonin neurotransmitter, it is necessary to be clinically guaranteed, carefully observing the patient, especially during the first time of treatment and increased dose.
Triptan drug group
Based on the mechanism of tramadol and the risk of serotonin syndrome, caution should be careful when used simultaneously with triptan. If treated at the same time tramadol and paracetamol with triptan, it should be clinically guaranteed, carefully observing the patient, especially in the first time of treatment and dose increases.
carbamazepin
Patients using carbamazepine may significantly reduce tramadol pain effect. Because carbamazepine increases tramadol metabolism and because of the risk of convulsions when combined with tramadol, should not be used simultaneously.
quinidine
tramadol is converted into eyelashes by CYP2D6. Quinidine is an selective inhibitor of isenzym; Therefore, simultaneous use of quinidine and tramadol increases the concentration of tramadol and reduces the concentration of M1. The effect of this interaction is not clear clinically. In in vitro, tramadol does not affect the metabolism of quinidine.
Medications affect tramadol
Puppies interactive in vitro in vitro in liver microsomes show that simultaneous use with CYP2D6 inhibitors such as fluoxetin, paroxetin, and amitriptylin can inhibit the metabolism of tramadol. Use CYP3A4 inhibitors such as ketoconazole and erythromycin, or CYP3A4 induction substances such as rifampin and ST. John’s World with Duocetz can affect the metabolism of tramadol.
The effect of tramadol on other drugs
In Vitro research shows that tramadol does not inhibit CYP3A4 - intermediate metabolism of other drugs when tramadol is used at the same time at the dose of treatment. Tramadol does not stimulate the metabolism in the human body because the maximum concentration in plasma is observed after many doses of oral higher than the expected data of the application.
cimetidine
Simultaneous use has not been studied byetz and cimetidin. Simultaneous use of tramadol and cimetidine does not lead to a significant clinical change in pharmacokinetics of tramadol. Therefore, there is no change in the dosage.
warfarin
tramadol has minor changes on the effect of warfarin, including increasing prothrombin time.
alcohol
Alcohol increases the sedative effect of opioid analgesics. Influence on alertness should be dangerous for people when driving and operating machinery.
Avoid using alcoholic beverages and alcoholic drugs while using this drug.
Opioid antagonists (buprenorphin, nalbuphin, pentazocin)
Reduces analgesic effect by competing in receptors, with the risk of cessation syndrome.
Other opioid derivatives (including cough and replacement therapy), benzodiazepin and barbiturat.
Increased risk of respiratory inhibition can be fatal in case of overdose.
Central nervous system inhibitors, such as opioid derivatives (including cough and alternative therapy), barbiturat, benzodlazepine, anxiety reduced drugs, sedative drugs, anti -sedative drugs, sedative anti -sedative drugs, sedative drugs, central anti -hypertension, thalidomid and bacteric.
These drugs may increase the central inhibition effect. Influence on alertness should be dangerous for people when driving and operating machinery.
Scrambling reducing drugs, such as Bupropion, antidepressants inhibit the reabsorption of serotonin, three -round antidepressants and sedative drugs.
Simultaneous use of tramadol with these drugs may increase the risk of seizures.
In a few studies, the use of anti -vomiting drugs for 5HT3 Ondansetron before or after surgery increases the need for tramadol in patients with pain after surgery.
paracetamol:
Anticoagulant drugs
Long -doses of high -dose Paracetamol increases the anticoagulant effect of COMAARIN and conducting indandion. Research data is still conflicting and also doubted about this interaction, so paracetamol is preferred than salicylate when it is necessary to relieve mild analges or reduce fever for patients using cooumarin or indoplasm.
It is necessary to pay attention to the likelihood of causing serious heat lowering the patient to use simultaneously phenothiazine and cooling (such as paracetamol).
alcohol
Out of alcohol too much and long -term grass increases the risk of Paracetamol's liver toxicity.
Anti -seizure drugs
Anti -convulsions (Phenytoin, Barbiturat, Carbamazepin) cause enzyme induction in the liver microsom, which can increase the toxic liver toxic of paracetamol due to increased drug conversion into toxic substances to the liver. In addition, simultaneous use of isoniazid with paracetamol can also lead to an increase in the risk of toxicity to the liver, but it has not been determined the exact mechanism of this interaction. The risk of paracetamol causes liver toxicity significantly increases in patients with paracetamol doses greater than the recommended dose while taking anti -convulsions; However, patients must restrict self -use of paracetamol while taking anti -convulsions or isoniazid.
Probenecid
Probenecid can reduce paracetamol elimination and increase the half -life period in the plasma of paracetamol.
Isoniazid and anti -tuberculosis drugs
Isoniazid and tuberculosis drugs increase the toxicity of paracetamol for the liver.
Metoclopramid or domperidon increases the absorption rate of paracetamol and cholestyramin, reduces the absorption of paracetamol.
Storage
Storage below 30 ° C. Avoid light and damp.
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