PARCEDOX Film Coated Caplet

Tramadol 3.75 mg + Paracetamol 325 mg

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COMPOSITION :

Parcedox® Film coated caplet, each film coated caplet contains : Paracetamol 325 mg and Tramadol HCl 37.5 mg.

 

DESCRIPTIONS :

Parcedox® contains Paracetamol and Tramadol HCl as active ingredient is available in film coated caplet.

 

INDICATIONS :

Parcedox® is indicated for short term treatment of acute pain.

 

DOSAGE AND ADMINISTRATIONS :

Unless otherwise prescribed, Parcedox®  should be administered as follows :

  • Adults and children over 16 years

The maximum single dose of Parcedox® is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. Parcedox® can be administered without regard to food.

  • Pediatric (children below 16 years)

The safety and effectiveness of Parcedox® has not been established in the pediatric population.

  • Elderly (geriatric)

No overall differences with regard to safety or pharmacokinetics were noted between patients ≥ 65 years of age and younger patients.

 

OVERDOSAGE :

  • The clinical presentation of overdose may include the signs and symptoms of Tramadol toxicity, Paracetamol toxicity or both. The initial symptoms seen within the first 24 hours following an Paracetamol overdose the include gastrointestinal iritability, anorexia, nausea, vomiting, malaise, pallor and diaphoresis.
  • Tramadol

Serious potential consequences of overdosage of the Tramadol component are respiratory depression, lethargy, coma, seizure, cardiac arrest and death.

  • Paracetamol

Paracetamol overdosage may cause hapatic toxicity in some patients, early symptoms following a potentially hepatotoxic overdosage may include gastrointestinal iritability, anorexia, nausea, vomiting, malaise, pallor and diaphoresis. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post ingestion.

  • Treatment

A single or multiple overdose with Tramadol HCl/Paracetamol may be a potentially lethal polydrug with overdose and appopriate expert consulation, if avaliable, is recommended.

While Naloxone will reverse some, but not all, symptoms caused by overdosage with Tramadol, the risk of seizure is also increased with Naloxone administration. Based on experience with Tramadol, hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.

In treating an overdosage of Paracetamol-Tramadol HCl, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. Measure should be taken to reduce drug absorption. Vomiting should be induced mechanically or with syrup of Ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1g/kg) should follow gastric emptying. The first dose should be accompanied by an appopriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolamic in etiology and should respon to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endo-tracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary, to provide assisted respiration.

In adult and pediatric patients, any individual presenting with an unknown amount of Paracetamol ingested or with a questionable or unreliable history about the time of ingestion should have a plasma Paracetamol level drawn and be treated with Acetylcystein. If an assay cannot be obtained and the estimated Paracetamol ingestion exceeds 7.5 – 10 grams for adults and adolescents or 150 mg/kg for children, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy.

 

CONTRAINDICATIONS :

  • Paracetamol-Tramadol HCl should note be administered to patients who have previously demonstrated hypersensitivity to Tramadol, Paracetamol, any other component of this product or Opioids.
  • Paracetamol-Tramadol HCl contraindicated in any situation where Opioids are contraindicated, including acute intoxication with the following : Alcohol, hypnotic, narcotics, centrally acting analgesics, Opioids or psycotropic drugs.

 

WARNINGS AND PRECAUTIONS :

Warnings

  • Seizure risk

Seizure have been reported in patients receiving Tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of Tramadol above the recommended range. Concomitant use of Tramadol increases the seizure risk in patients taking :

    1. Selective serotonin reuptake inhibitor (SSRI antidepressants or anorectics),
    2. Tricyclic antidepressants (TCAs) and other tricyclic compounds (e.g., Cyclobenzaprine, Promethazine etc.) or other Opioids.

Administration of Tramadol may enhance the seizure risk in patients taking : MAO inhibitor, neuroleptics or other drugs that reduce the seizure threshold.

Risk of convulsions may also increase in patients with epilepsy, those with a history of seizure or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal or CNS infection). In Tramadol overdose, Naloxone administration may increase the risk of seizure.

  • Anaphylactoid reactions

Serious and rarely fatal anaphylactic reactions have been reported in patients receiving therapy with Tramadol. When these events do occur it is often following in the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Steven-Johnson syndrome. Patients with a history of anaphylactoid reactions to Codeine and other Opioids may be at increased risk and therefore should not receive Paracetamol-Tramadol HCl.

  • Respiratory depression

Administer Paracetamol-Tramadol HCl cautiously in patients at risk for respiratory depression. In these patients, alternative non-Opioid analgesics should be considered. When large doses of Tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If Naloxone is to be administered, use cautiously because it may precipitate seizures.

  • Interaction with central nervous system (CNS) depressants

Paracetamol-Tramadol HCl should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, Opioids, anesthetic agents, narcotics, Phenothiazines, tranquilizers or sedative hypnotic. Tramadol increases the risk of CNS and respiratory depression in these patients.

  • Increased intracranial pressure or head trauma

Paracetamol-Tramadol HCl should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of Opioid include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from Tramadol may obscure the existence, extent or course of intracranial pathology. Clinicals should also maintain a high index of suspicion for adverse drug reactions when evaluating altered mental status in these patients if they are receiving Paracetamol-Tramadol HCl.

  • Use in ambulatory patients

Tramadol may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.

  • Use with MAO inhibitors and serotonin re-uptake inhibitors

Use Paracetamol-Tramadol HCl with great caution in patients taking monoamine oxidase inhibitors. Concomitant use of Tramadol with MAO inhibitors or SSRIs increases the risk of adverse event, including seizure and serotonin syndrome.

  • Use with alcohol

Paracetamol-Tramadol HCl should not be used concomitantly with alcohol consumption. The use of Paracetamol-Tramadol HCl in patients with liver disease is not recommended.

  • Use with other Paracetamol-containing products

Due to the potential for Paracetamol hepatotoxicity at doses higher than the recommended dose, Paracetamol-Tramadol HCl should not be used concomitantly with other Paracetamol-containing products.

  • Withdrawal

Withdrawal symptoms may occur if Paracetamol-Tramadol HCl discontinued abruptly. Reported symptoms have included anxiety, sweating, insomnia, rigers, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection and rarely hallucinations. Other symptoms that have been reported less frequently include : Panic attacks, severe anxiety and paresthesias. Withdrawal symptoms may be avoided by tapering Paracetamol-Tramadol HCl at the time of discontinuation.

  • Physical dependence and abuse

Tramadol may induce psychic and physical dependence of the morphine-type (mu-Opioid). Tramadol should not be used in Opioid dependent patients. Tramadol has been shown to reinduce physical dependence in some patients that have been previously dependent on other Opioids. Dependence and abuse including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to the patients with prior history of Opioid dependence.

  • Risk of overdosage

Serious potential consequences of overdosage with Tramadol are central nervous system depression, respiratory depression and death. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of Tramadol alone or in combination with other drugs. In treating an overdosage, primary attention should be given to mountaining adequate ventilation along with general supportive treatment. Serious potential consequences of overdosage with Paracetamol are hepatic (centrilobular) necrosis, leading to hepatic failure and death. Emergency help should be shought immediately and treatment initiated immediately if overdose is suspected, even if symptoms are not apparent.

Precautions

  • General

The recommended dose of Paracetamol-Tramadol HCl should not be exceeded.

Do not co-administer Paracetamol-Tramadol HCl with other Tramadol or Paracetamol-containing products.

  • Pediatric use

The safety and effectiveness of Paracetamol-Tramadol HCl is not clearly known.

  • Geriatric use

In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function; of concomitant disease and multiple drug therapy.

  • Acute abdominal conditions

The administration of Paracetamol-Tramadol HCl may complicate the clinical assessment of patients with acute abdominal conditions.

  • Use in renal disease

Paracetamol-Tramadol HCl use in patients with impaired renal function is not clearly known. Experience with Tramadol suggests that impaired renal function results in a decreased rate and extent of excretion of Tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 ml/minute, it is recommended that the dosing interval of Paracetamol-Tramadol HCl be increased, not to exceed 2 tablets every 12 hours.

  • Use in hepatic disease

Paracetamol-Tramadol HCl use in patients with impaired hepatic function is not clearly known. The use of Paracetamol-Tramadol HCl in patients with hepatic impairment is not recommended.

  • Information for patients
    1. Paracetamol-Tramadol HCl may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
    2. Paracetamol-Tramadol HCl should not be taken with alcohol-containing beverages.
    3. The patient should be instructed not to take Paracetamol-Tramadol HCl in combination with other Tramadol or Paracetamol-containing products, including over-the-counter preparations.
    4. Paracetamol-Tramadol HCl should be used with caution when taking medications such as tranquilizers, hypnotics or other Opiate-containing analgesics.
    5. The patient should be instructured to inform the physician if they are pregnant, think they might become pregnant or are trying to become pregnant.
    6. The patient should understand the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizure, hepatic toxicity and death.

 

PRESENTATION :

Parcedox® Film coated caplet                            Box, 3 strips @ 10 film coated caplets

Reg. No. DKL1702355609A1

 

STORAGE :

STORE BELOW 30°C

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

PT. BERNOFARM

Sidoarjo – Indonesia

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