Dolcet Mini Special Precautions

Administer drug with care to the following patients: Patients who receive morphine concomitantly or continuously (as mild morphine antagonism was recognized in the animal study, withdrawal symptoms may occur).
Patients who receive CNS inhibitors, such as opiates, anesthetics, somnifacients, phenothiazine, tranquilizers and sedatives.
Patients with biliary tract diseases (high dosage resulted in contracting oddi sphincter was in the animal study).
Patients with hepatic disorders (sometimes active serum GOT and GPT counts showed to increase in the animal study).
Patients with renal impairment.
Alcohol-consuming patients.
Patients with hypersensitivity to opium.
Epilepsy patients or any patients who can have convulsion.
Patients who have altered consciousness caused by shock state and unknown cause.
General Cautions: Do not exceed a recommended dose to administer, and do not use other tramadol or paracetamol concomitantly.
This drug contains tramadol as an active ingredient. A portion of the analgesic effect of this drug is attributable to the binding of the active ingredient, tramadol, to the mu-opioid receptor. Upon repeated administration of opioids, tolerance, physical dependence, and psychological dependence may develop, even at recommended dosages. Assess each patient's risk for opioid dependence and abuse prior to prescribing this drug and monitor all patients receiving this drug for development of these behaviors. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). This should not be used in opioid-dependent patients. Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Patients who have potential drug abuse should be observed carefully and be administered for short-term. Tramadol is not appropriate for alternative drug for opioid-dependent patients, and opioid-acting drugs or withdrawal symptoms of morphine cannot be inhibited. In case of combined use with opioid agonist-antagonist (nalbuphine, buprenorphine and pentazocine), as there are risks of reduced analgesic effect and incidence of withdrawal symptom due to competitive block, a combined use is not recommended.
In case administration of this drug is discontinued unexpectedly, withdrawal symptoms (e.g. anxiety, diaphoresis, insomnia, spasticity, ache, nausea, agitans, diarrhea, upper respiratory syndrome, piloerection, excitement, nervousness, hyperkinesis, and gastrointestinal symptoms) may occur. Panic attack, severe anxiety, hallucination, sensory anomaly, tinnitus, and abnormal CNS reactions were also reported very rarely. From the clinical experience, withdrawal symptoms can be alleviated when reducing dose to discontinue.
In patients who were administered with tramadol, allergic reactions (e.g., urticaria, rash, bronchospasm, toxic skin necrosis and Stevens-Johnson syndrome, etc.) including serious and rarely fatal anaphylactic reaction are reported. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive this drug. Advise patients to seek immediate medical attention if they experience any symptoms of hypersensitivity reaction.
In case of administering tramadol to patients who have possibility of seizure or who received other drugs that decrease seizure threshold, particularly selective serotonin reabsorption inhibitors, tricyclic antidepressants, anti-psychotics, centrally-acting analgesics or local anesthetics, convulsion has been reported. Epilepsy patients who are controlled with medications or patients who have possibility of epilepsy must use this drug only when necessary.
Excessive administration of paracetamol to chronic alcoholics may increase hepatotoxicity. It is not recommended to administer this drug to patients with hepatic impairment.
Pharmacokinetic and tolerability of this drug was not tested in patients with hepatic failure. Tramadol and paracetamol are mainly metabolized in the liver. It is not recommended to use this drug to patients with severe hepatic failure.
Complex of tramadol and paracetamol was not studied in patients with renal failure. From the experience of using tramadol, excretion of tramadol and active metabolome M1 and excretory rate may decrease in patients with renal function failure. For patients with less than 30 mL/min of creatinine clearance, do not exceed 4 tablets for every 12 hours of administration interval.
In case tramadol is administered for long-term, the possibility of dependency cannot be excluded completely, so it is recommended to adjust a dosing period or to have withdrawal period temporarily.
When enflurane is used with tramadol during usual anesthesia as nitric oxide in one study, the case of weakening anesthesia during operation was reported to increase. Until additional information is available, use of tramadol should be avoided during low level of anesthesia.
Use caution when administering this drug in patients taking SSRIs. Concomitant use of tramadol with SSRI's increases the risk of adverse events, including seizures and serotonin syndrome.
Life-threatening respiratory depression and death have occurred in children who received tramadol. Tramadol and codeine are subject to variability in metabolism based upon CYP2D6 genotype, which can lead to an increased exposure to an active metabolite. Based upon post-marketing reports with tramadol or with codeine, children younger than 12 years of age may be more susceptible to the respiratory depressant effects of tramadol. Furthermore, children with obstructive sleep apnea who are treated with opioids post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to their respiratory depressant effect. Risk of life-threatening respiratory depression and death is as follows: This drug is contraindicated for children younger than 12 years of age.
This drug is contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy.
Avoid the use of this drug in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol unless the benefits outweigh the risks. Risk factors include conditions associated with hypoventilation such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.
As with adults, when prescribing opioids for adolescents, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of opioid overdose.
Tramadol is subject to the same polymorphic metabolism as codeine, with ultra-rapid metabolizers of CYP2D6 substrates being potentially exposed to high levels of morphine in breast milk because the mother was an ultra-rapid metabolizer of codeine. A baby nursing from an ultra-rapid metabolizer mother taking this drug could potentially be exposed to high levels of M1, and experience life-threatening respiratory depression.
Opioid analgesics may occasionally cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy. Symptoms of acute or chronic adrenal insufficiency may include e.g. severe abdominal pain, nausea and vomiting, low blood pressure, extreme fatigue, decreased appetite, and weight loss.
Impact on driving and machine control: Tramadol may cause sleepiness or vertigo, and this may be enhanced by alcohol or other CNS inhibitors. As it affects agility, caution should be used for any actions of potential risk, such as driving or machinery operating. Use in Children: Life-threatening respiratory depression and death have occurred in children who received tramadol. In some of the reported cases, these events followed tonsillectomy and/or adenoidectomy, and one of the children had evidence of being an ultra-rapid metabolizer of tramadol (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6). Children with sleep apnea may be particularly sensitive to the respiratory depressant effects of tramadol. The risk of life-threatening respiratory depression and death is as follows: This drug is contraindicated for all children younger than age 12 years of age.
This drug is contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy.
Avoid the use of this drug in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol unless the benefits outweigh the risks. Risk factors include conditions associated with hypoventilation such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.
Use in the Elderly: Since decreased hepatic, renal, and cardiac functions and accompanying diseases concomitantly and various drug therapies may occur frequently, this drug should be administered with caution to elderly patients.