Indication
(Tramadol hydrochloride/Paracetamol) is indicated for the short-term (five days or less) management of acute pain & to treat moderate to severe pain.
Dosage & Administration
Tablet can be administered without regard to food.
For the management of pain
The recommended dose is 1 or 2 tablets every 4 to 6 h as needed for pain relief (max, 8 tablets/day).
In Renal function impairment
In patients with creatinin clearance less than 30 mL/min, it is recommended that the dosing interval be increased not to exceed 2 tablets every 12 h.
Precautions
- This combination may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
- This combination should not be taken with alcohol containing beverages.
- The patient should be instructed not to take this combination in combination with other tramadol or paracetamolcontaining products, including over-the-counter preparations.
- This combination should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
Special Populations
Use in Pregnancy & Lactation
Pregnancy Category C. There are no well controlled studies in pregnant women. This combination preparation should be used during pregnancy only if the potential benefits justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mother because its safety in infants and newborns has not been studied.
Children
Safety and efficacy have not been established in pediatric patients below 16 years of age.
Elderly
This combination showed no significant changes in pharmacokinetics of tramadol and paracetamol in elderly
patients with normal renal and hepatic function.
Use in Renal diseases
Renal impairment results in decreased rate and extent of excretion of tramadol and its active metabolite. Adjust dosage in patients with creatinin clearance less than 30 ml/min.
Use in Hepatic diseases
The pharmacokinetics and tolerability of this combination in patients with impaired hepatic function has not been studied. Since tramadol and paracetamol are both extensively metabolized by the liver, the use of this combination in patients with hepatic impairment is not recommended.
