Generic Name
(Paracetamol & Tramadol Hydrochloride)Therapeutic Class: Analgesic, Anti Inflammatory (Non-steroidal Anti-inflammatory Drugs (NSAIDs))
Indications:
Paracetamol & Tramadol Hydrochloride tablet is indicated for the management of moderate to moderately severe pain in adults.
Paracetamol & Tramadol Hydrochloride tablet is also indicated for the short-term (five days or less) management of acute pain.
Presentation:
Paracetamol & Tramadol Hydrochloride Tablet: Each film-coated tablet contains Paracetamol BP 325 mg & Tramadol hydrochloride BP 37.5 mg.
Paracetamol & Tramadol Hydrochloride tablet is indicated for the management of moderate to moderately severe pain in adults.
Paracetamol & Tramadol Hydrochloride tablet is also indicated for the short-term (five days or less) management of acute pain.
Presentation:
Paracetamol & Tramadol Hydrochloride Tablet: Each film-coated tablet contains Paracetamol BP 325 mg & Tramadol hydrochloride BP 37.5 mg.
Description:
Paracetamol is a non-opiate, non-salicylate analgesic. Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to m-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin.
Opioid activity is due to both the low-affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to m-opioid receptors.
As with some other opioid analgesics, Tramadol has been shown to inhibit the reuptake of norepinephrine and serotonin in vitro. These mechanisms may contribute independently to the overall analgesic profile of Tramadol.
Dosage & Administration:
Paracetamol & Tramadol Hydrochloride tablet can be administered without regard to food.
For the management of moderate to moderately severe pain, the recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
In case of short-term (five days or less) management of acute pain, the recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
Pediatric & geriatric use: The safety and effectiveness of this combination preparation has not been studied in the pediatric population. 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.
Use in renal disease: This combination preparation has not been studied in patients with impaired renal function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.
Use in hepatic disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.
Side Effects:
The following adverse reactions may happen to this therapy: asthenia, fatigue, hot flushes, dizziness, headache, tremor, abdominal pain, constipation, diarrhoea, dyspepsia, dry mouth, nausea, vomiting, anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence pruritus, rash, increased sweating etc.
Precautions:
This combination preparation may impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
This combination preparation should not be taken with alcohol-containing beverages.
The patient should be instructed not to take this combination preparation in combination with other Tramadol or Paracetamol-containing products, including over-the-counter preparations.
This combination preparation should be used with caution when taking medications such as tranquillizers, hypnotics or other opiate containing analgesics.
Use in Pregnancy & Lactation:
Pregnancy Category C
There are no adequate and well-controlled studies on pregnant women. This combination preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
Storage:
Store in a cool and dry place. Do not freeze.
Paracetamol is a non-opiate, non-salicylate analgesic. Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to m-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin.
Opioid activity is due to both the low-affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to m-opioid receptors.
As with some other opioid analgesics, Tramadol has been shown to inhibit the reuptake of norepinephrine and serotonin in vitro. These mechanisms may contribute independently to the overall analgesic profile of Tramadol.
Dosage & Administration:
Paracetamol & Tramadol Hydrochloride tablet can be administered without regard to food.
For the management of moderate to moderately severe pain, the recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
In case of short-term (five days or less) management of acute pain, the recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
Pediatric & geriatric use: The safety and effectiveness of this combination preparation has not been studied in the pediatric population. 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.
Use in renal disease: This combination preparation has not been studied in patients with impaired renal function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.
Use in hepatic disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.
Side Effects:
The following adverse reactions may happen to this therapy: asthenia, fatigue, hot flushes, dizziness, headache, tremor, abdominal pain, constipation, diarrhoea, dyspepsia, dry mouth, nausea, vomiting, anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence pruritus, rash, increased sweating etc.
Precautions:
This combination preparation may impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
This combination preparation should not be taken with alcohol-containing beverages.
The patient should be instructed not to take this combination preparation in combination with other Tramadol or Paracetamol-containing products, including over-the-counter preparations.
This combination preparation should be used with caution when taking medications such as tranquillizers, hypnotics or other opiate containing analgesics.
Use in Pregnancy & Lactation:
Pregnancy Category C
There are no adequate and well-controlled studies on pregnant women. This combination preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
Storage:
Store in a cool and dry place. Do not freeze.
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