Atracente Tablets

Adult dose

For children aged 12 and older and adults: The dosage should be adjusted based on the level of pain and therapeutic response. A starting dose of 2 tablets is recommended, followed by a minimum interval of 6 hours for subsequent doses, ensuring not to exceed 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Do not administer this medication for longer than necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to assess the need for ongoing administration of this medication. Elderly Administer the usual adult dosage. However, for elderly patients over 75 years old, tramadol has an increased half-life of 17% when given orally, so doses should be administered at intervals of at least 6 hours. Renal Impairment For patients with moderate renal impairment (creatinine clearance 10-30 ml/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance less than 10 ml/min), administration is not recommended. Tramadol is removed very slowly during dialysis, so there is no need for redosing after dialysis to maintain analgesic effect. Hepatic Impairment For patients with moderate hepatic impairment, consider extending the dosing interval. For severe hepatic impairment, this medication should not be administered.

Child dose

For children aged 12 and older and adults: The dosage should be adjusted based on the level of pain and therapeutic response. A starting dose of 2 tablets is recommended, followed by a minimum interval of 6 hours for subsequent doses, with a maximum of 8 tablets per day.

This medication may cause liver damage in individuals who regularly consume more than three drinks per day, and therefore should be discussed with a doctor or pharmacist. If a rash or hypersensitivity reaction appears during the use of this medication, it should be stopped immediately and a doctor consulted. The active ingredient tramadol may increase the risk of seizures if taken in excess of the recommended dose, and using it in conjunction with certain antidepressants or other central nervous system drugs can also increase seizure risk. Rarely, patients taking this medication may experience life-threatening anaphylaxis; if allergic symptoms occur, medical personnel should be notified immediately. There is a risk of respiratory depression in patients with acute and severe bronchial asthma, so it should be administered in a monitored environment. Taking this medication with alcohol or benzodiazepines may lead to severe side effects such as profound sedation or respiratory depression; thus, co-administration should be avoided. Patients with elevated intracranial pressure or head injury may experience worsening symptoms when taking this medication, requiring careful monitoring. The tramadol component can cause physical and psychological dependence, so long-term usage should be monitored closely for signs of dependency. The acetaminophen component can cause liver damage in cases of overdose, so care should be taken not to exceed a total daily dose of 4,000 mg, and patients with impaired liver function should consult with a doctor before taking this medication. Especially in ultra-rapid metabolizers of CYP2D6, the plasma concentration of the active metabolite may increase, heightening the risk of respiratory depression; thus, dosage adjustment and careful monitoring are necessary. This medication should not be administered to children under 12 years old, or to those under 18 years post-tonsillectomy and adenoidectomy. Adolescents aged 12 to 18 should also avoid administration if there are risk factors present. Patients with symptoms of sleep apnea or hypoxemia may experience worsening symptoms after taking this medication, so ongoing assessment is required, and dosage may need to be reduced or stopped if necessary. This medication may cause hyponatremia; thus, elderly patients or those with risk factors should be closely monitored for signs of hyponatremia. Patients with hypersensitivity to any component of this medication, severe respiratory depression, significant liver, kidney, or heart dysfunction, pregnant or breastfeeding women, and those taking certain medications should not take this medication. This medication may cause drowsiness or dizziness, requiring caution when driving or operating machinery. In cases of overdose, serious side effects such as respiratory depression, seizures, or liver damage can occur, necessitating immediate emergency treatment, including the potential administration of an antidote. The use of this medication in conjunction with other narcotic analgesics or central nervous system depressants should be approached with caution, and if discontinuation is necessary, gradual tapering is recommended. Potential side effects of this medication include nausea, vomiting, constipation, headache, dizziness, drowsiness, nausea, vomiting, constipation, dry mouth, diarrhea, dyspepsia, abdominal pain, discomfort, flatulence, pruritus, sweating, rash, fatigue, flushing, hypoglycemia, anxiety, nervousness, emotional instability, euphoria, decreased libido, sleep disturbances, confusion, disorientation, agitation, abnormal dreams, drug abuse, hallucinations, withdrawal syndrome, migraine, drowsiness, sensory loss, tremors, and sensory disturbances; if any unusual symptoms occur, a doctor should be consulted.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, risk of liver damage with daily consumption of alcohol exceeding three drinks, acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), seizures, life-threatening anaphylactic reactions, risk of life-threatening respiratory depression, severe respiratory depression condition, severe symptoms due to increased intracranial pressure, severe liver dysfunction.

Mild side effects

• Decreased appetite
• insomnia
• depression
• dizziness
• headache
• drowsiness
• nausea
• vomiting
• constipation
• dry mouth

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. Additionally, it is important to store it at room temperature below 25°C to maintain the drug's effectiveness and safety.

Appearance

Pale yellow to yellow oblong film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle