Tramadol HCl (Newdorphin) 50 mg/ml (100 mg/2 ml) Solution for Injection Opioid Analgesic

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1 Korea United Pharm. Inc. Tramadol HCl (Newdorphin) Opioid Analgesic Manufactured by: KOREA UNITED PHARM. INC. 153 Budong-Ri, Seo-Myeon, Yeongki-Kun Chungnam, Korea Imported/Distributed by: MACROPHARMA CORPORATION #1 Julia Vargas Avenue, Ortigas Home Depot, Brgy. Ugong, Pasig City, Philippines

2 GENERIC NAME TRAMADOL HCl IUPAC NAME (±)-trans-2-dimethylaminomethyl-1-(3-methoxyphenyl)cyclohexanol hydrochloride CHEMICAL STRUCTURE PHARMACOLOGICAL CLASSIFICATION Opioid Analgesic STRENGTH /DOSAGE FORM (IM/IV) PRODUCT DESCRIPTION Clear, colorless solution in colorless ampoule INDICATIONS Tramadol is indicated for the management of moderate to moderately severe acute or chronic pain (several cancers), and pain after medical examination and surgery. 2 P a g e

3 DOSAGE AND ADMINISTRATION The recommended dosage of tramadol hydrochloride is mg given once daily, intravenously or intramuscularly, if necessary, the administration is repeated every 4 hours to 6 hours. The dosage should not exceed up to 400 mg per day. Dosage requirements vary according to the patient's age and symptom. Administration in children. The pediatric use of tramadol is not recommended because safety and efficacy in children and infants have not been established. In the UK, tramadol hydrochloride is licensed for the management of moderate to severe pain in children 12 years of age and older; usual adult doses may be given. However, in some other European countries it is licensed in younger children although the age range permitted can vary: for example, in France, a usual dose in those aged 3 years and over is 1 to 2 mg/kg orally, which may be repeated 3 or 4 times daily, whereas in Germany, similar doses are permitted in children as young as 1 year old. Tramadol has also been given parenterally to children in doses similar to those used orally. 1 Administration in hepatic or renal impairment. A dosage interval of 12 hours is recommended for tramadol usage in severe hepatic impairment. The dosage interval should also be increased to 12 hours in patients with a creatinine clearance (CC) less than 30 ml/minute; in the USA licensed product information suggests that the maximum oral dose should not exceed 200 mg daily in these patients. Tramadol should not be given to patients with more severe renal impairment (CC less than 10 ml/minute). 1 3 P a g e

4 CONTRAINDICATIONS The drug is contraindicated in the following patients. Acute alcoholic patients Patients intoxicated with central nervous systemic drugs such as sleeping pills, sedatives, or psychotropic drugs Patients with severe respiratory depression (light respiratory depression may occur) Patients at risk for stupor with head injury, intracranial pathology Patients taking MAO inhibitors Pregnant women and nursing mothers Patients who have a history of hypersensitivity to the drug or opium PRECAUTIONS Tramadol should be used with caution in patients with renal or hepatic impairment and should be avoided if renal impairment is severe. Removal by haemodialysis is reported to be minimal at 7%. Tramadol should be used with care in patients with a history of epilepsy or those susceptible to seizures. 1 Precautions in administration Injection site around the nerve should be avoided, and must be changed right and left alternately. If the patient feels pain and backflow of bloods occur when a needle is injected, the injection site should be changed. The drug should not be mixed with barbiturate derivatives upon administration as it may cause precipitation. 4 P a g e

5 USE IN PREGNANCY AND LACTATION Animal studies and in vitro studies have demonstrated mutagenesis, carcinogenesis, impairment of fertility; the drug therefore should not be prescribed to pregnant women or who are suspected to be pregnant. Tramadol hydrochloride is excreted during lactation; it should not be used in nursing mothers. USE IN THE ELDERLY In the elderly, 75 years or older, the dose of over 300 mg daily should not be administered because maximum serum concentrations may be slightly elevated. DEPENDENCE AND WITHDRAWAL Tramadol may have lower potential for producing dependence than morphine. A WHO expert committee1 considered in 2003 that the available information on tramadol was not sufficient to warrant international control. Studies in animals indicated that tramadol produced little tolerance, had mild withdrawal symptoms, and a lower abuse potential than codeine and pentazocine. Subsequently, when reviewed in 2006, the committee2 considered that, despite an increase in its use, tramadol continued to show a low level of abuse and concluded that there was not sufficient evidence to justify a further review. 1 Nevertheless, there have been reports of dependence and abuse, particularly in opioiddependent persons, and of withdrawal symptoms. In October 1996, the UK CSM9 commented that since June 1994 they had received reports of drug dependence in 5 patients and withdrawal symptoms associated with tramadol in 28 patients, which corresponded to a reporting rate of about 1 in Doses in excess of the recommended maximum of 400 mg daily had been taken by 5 of the patients. The duration of treatment before onset of these effects ranged from 10 to 409 days 5 P a g e

6 (average 3 months). Withdrawal symptoms reported were typically those of opioid withdrawal in general. A more recent report from the Swedish Medical Products Agency stated that between 1996 to 2005 they had received 71 reports of withdrawal symptoms associated with tramadol; treatment duration ranged from 1 week to over 3 years at daily doses of between 50 mg to 2 g. 1 OVERDOSAGE In a multicentre case series, 126 cases of tramadol toxicity were reported between October 1995 and August 1996; of these, 87 involved exposure to tramadol alone. Common symptoms included lethargy, nausea, tachycardia, and agitation; seizures were also noted. Respiratory depression was seen in only 2 patients. The inhibitory effects of tramadol on monoamine reuptake, rather than its opioid effects, was considered to result in much of its toxicity. A similar pattern of toxicity has also been seen in a more recent report. In 190 tramadol-only exposures reported between January 1999 and July 2001, the main symptoms of overdosage were CNS depression, nausea and vomiting, tachycardia, and seizures. Again, the incidence of respiratory depression was rare, with only 1 case reported. 1 ADVERSE REACTIONS Seizure: The administration over the usual dosage may increase seizure occurring; however, the usual dosage has been reported to cause seizure. The drug may increase possibility of seizure occurring in the patients under therapy of the following drugs. Tricyclic antidepressant and other tricyclic agents (cyclobenzaprine, prometazine, etc.) Selective serotonin re-absorption inhibitor (SSRI antidepressant or anorexigenic agent) MAO inhibitors 6 P a g e

7 Neuroleptic Other seizure minimum decreasing agent The possibility of seizure may increase in patients with epilepsy, patients with a history of seizure, patients with a potential risk of seizure (the patients with head injury, metabolic disorder and alcoholic and abstinence patients, patients with infections of central nervous system) In overdosage of the drug, naloxone administration may increase the risk of convulsions. Hypersensitivity: In case of symptom of hypersensitivity such as shock, the administration should be discontinued. Respiratory: Occasionally, respiratory depression may occur. Therefore, in this case, artificial respiration or the administration of dimorpholamine is effective. Cardiovascular: Palpitations, B.P. depression, arrhythmia, face pallor, myocardial ischemia may occur occasionally. The drug can affect cardiovascular system infrequently. Central Nervous System: Drowsiness, sleep, migraine, excitation, tremor, and tinnitus, numbness of hands, apprehension, abatement, fatigue, diaphoresis, dizziness, disesthesia, dysuria, xerostomia, and dipsia may occur occasionally. Gastrointestinal: Nausea, vomiting, abdominal distention, and gurgle may occur. Genitourinary system: Ischuria, oliguria, menopausal syndrome, dysuria, and emmeniopathy may occur. Skin: Urticaria, vesicle, Stevens-Johnson syndrome may occur. Dependence: There has been little evidence of dependence in animal studies. However, dose increase or consecutive administration should be considered before administration. Others: Occasionally, flush, heat, chill, feeling of cool, urticaria, irritation of injection site may occur. 7 P a g e

8 DRUG INTERACTIONS Carbamazepine is reported to diminish the analgesic activity of tramadol by reducing serum concentrations. The risk of seizures is increased if tramadol is used with other drugs that have the potential to lower the seizure threshold. Tramadol inhibits reuptake of noradrenaline and serotonin and enhances serotonin release and there is the possibility that it may interact with other drugs that enhance monoaminergic neurotransmission including lithium, tricyclic antidepressants, and SSRIs; it should not be given to patients receiving MAOIs or within 14 days of their discontinuation. Metabolism of tramadol is mediated by the cytochrome P450 isoenzyme CYP2D6. Use with specific inhibitors of this enzyme, such as quinidine, may increase concentrations of tramadol and lower concentrations of its active metabolite but the clinical consequences of this effect are unclear. Anticoagulants. There have been reports of enhanced anticoagulant activity in patients given tramadol with warfarin33,34 including 2 deaths from haemorrhagic stroke,34 and also with phenprocoumon,35 although a randomised, double-blind, placebocontrolled study in 19 patients failed to find evidence of an interaction between phenprocoumon and tramadol. 1 Antidepressants. A possible case of serotonin syndrome has been reported with tramadol and sertraline,. There have also been occasional reports of the syndrome in patients given tramadol with citalopram, fluoxetine, or paroxetine. 1 5-HT3-receptor antagonists. The pre-operative use of ondansetron has been noted to reduce the postoperative analgesic efficacy of tramadol. In one study, the cumulative dose of tramadol was up to 35% greater in those patients who also received ondansetron compared to those who received no antiemetic. In addition there was no difference in the incidence of postoperative nausea and vomiting between the two groups. 1 8 P a g e

9 CLINICAL PHARMACOLOGY Mechanism of Action: Tramadol, a centrally acting analgesic structurally related to codeine and morphine, consists of two enantiomers, both of which contribute to analgesic activity via different mechanisms. (+)-Tramadol and the metabolite (+)-Odesmethyl-tramadol (M1) are agonists of the µ. opioid receptor. (+)-Tramadol inhibits serotonin reuptake and ( )-tramadol inhibits norepinephrine reuptake, enhancing inhibitory effects on pain transmission in the spinal cord. The complementary and synergistic actions of the two enantiomers improve the analgesic efficacy and tolerability profile of the racemate. 3 Pharmacokinetics: Tramadol is readily absorbed after oral doses but is subject to some first-pass metabolism. Mean absolute bioavailability is about 70 to 75% after oral use and 100% after intramuscular injection. Plasma protein binding is about 20%. Tramadol is metabolised by N and O-demethylation via the cytochrome P450 isoenzymes CYP3A4 and CYP2D6 and glucuronidation or sulfation in the liver. The metabolite O-desmethyltramadol is pharmacologically active. Tramadol is excreted mainly in the urine, predominantly as metabolites. Tramadol is widely distributed, crosses the placenta, and appears in small amounts in breast milk. The elimination half-life is about 6 hours. 1 CLINICAL TRIALS Tramadol: a review of its use in perioperative pain Tramadol is a synthetic, centrally acting analgesic agent with 2 distinct, synergistic mechanisms of action, acting as both a weak opioid agonist and an inhibitor of monoamine neurotransmitter reuptake. The 2 enantiomers of racemic tramadol function in a complementary manner to enhance the analgesic efficacy and improve the tolerability profile of tramadol. 9 P a g e

10 In several comparative, well designed studies, oral and parenteral tramadol effectively relieved moderate to severe postoperative pain associated with surgery. Its overall analgesic efficacy was similar to that of morphine or alfentanil and superior to that of pentazocine. Tramadol provided effective analgesia in children and in adults for both inpatient and day surgery. Tramadol was generally well tolerated in clinical trials. The most common adverse events (incidence of 1.6 to 6.1%) were nausea, dizziness, drowsiness, sweating, vomiting and dry mouth. Importantly, unlike other opioids, tramadol has no clinically relevant effects on respiratory or cardiovascular parameters at recommended doses in adults or children. Tramadol also has a low potential for abuse or dependence. Conclusions: The efficacy of tramadol for the management of moderate to severe postoperative pain has been demonstrated in both inpatients and day surgery patients. Most importantly, unlike other opioids, tramadol has no clinically relevant effects on respiratory or cardiovascular parameters. Tramadol may prove particularly useful in patients with poor cardiopulmonary function, including the elderly, the obese and smokers, in patients with impaired hepatic or renal function, and in patients in whom nonsteroidal anti-inflammatory drugs are not recommended or need to be used with caution. Parenteral or oral tramadol has proved to be an effective and well tolerated analgesic agent in the perioperative setting. 4 Tramadol Infusion for Postthoracotomy Pain Relief: A Placebo-Controlled Comparison with Epidural Morphine Wecompared continuous IV tramadol as an alternative to neuraxial or systemic opioids for the management of postthoracotomy pain in a prospective, randomized, double-blinded, controlled study. General anesthesia was supplemented by thoracic epidural analgesia with 0.25% bupivacaine. At rib approximation, patients received one of the following: IV tramadol (150-mg bolus followed by infusion, total P a g e

11 mg/24 h, n _ 29), epidural morphine (2 mg, then 0.2 mg/h, n _ 30), or patientcontrolled analgesia (PCA) morphine only (n_ 30). All patients received PCA morphine and rescue morphine as necessary postoperatively. For the first 24 h, pain and sedation scores and respiratory, cardiovascular, and side effect measures were monitored. There was no significant difference in pain scores and PCA morphine use between tramadol and epidural morphine. Pain scores at rest and on coughing were lower in the Tramadol and Epidural Morphine groups than in the PCA Morphine group at various time points over the first 12 h. The Tramadol and Epidural Morphine groups used significantly less hourly PCA morphine than the PCA Morphine group at specific time points in the first 10 h. Vital capacities in the Tramadol group were significantly closer to baseline values at the 20-h point than in the PCA Morphine group. We conclude that an intraoperative bolus of tramadol followed by an infusion was as effective as epidural morphine and avoided the necessity of placing a thoracic epidural catheter. 11 P a g e

12 STORAGE Store at temperatures not exceeding 30ºC. CAUTION Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription. AVAILABILITY In 1 ml & 2 ml clear and colorless glass ampoule; Box of 10 s REFERENCES 1. Martindale: The Complete Drug Reference 36 th Edition 2. Tramadol HCl (Newdorphin) 50 mg/ml (100 mg/2 ml) Solution for Injection, Product Literature 3. Grond, S., Sablotzki, A. Clinical Pharmacology of Tramadol Clinical Pharmacokinetics 2004: 43-13: Scott L, Perry CM. Tramadol: a review of its use in perioperative pain Drugs 2000: 60: Bloch, MB, et al, Tramadol Infusion for Postthoracotomy Pain Relief: A Placebo Controlled Comparison with Epidural Morphine, Anesth Analg 2002; 94: Revision Date: 30-Sep P a g e

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