Ultracet Dosage/Direction for Use

ULTRACET should only be used in patients for whom alternative treatment options are ineffective or not tolerated (e.g., non-opioid analgesics).
ULTRACET must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving ULTRACET can lead to dangerous adverse events including death (see Precautions).
For acute pain, it is recommended that ULTRACET be used for a maximum of 7 days at the lowest dose that provides adequate pain relief.
All doses of opioids carry an inherent risk of fatal or non-fatal adverse events. This risk is increased with higher doses. For the management of chronic non-cancer, non-palliative pain, it is recommended that a maximum daily dosage of 300 mg (50 morphine milligram equivalent) of ULTRACET not be exceeded. Each patient should be assessed for their risk prior to prescribing ULTRACET, as the likelihood of experiencing serious adverse events can depend upon the type of opioid, duration of treatment, level of pain as well as the patient's own level of tolerance. In addition, the level of pain should be assessed routinely to confirm the most appropriate dose and the need for further use of ULTRACET (see Recommended Dose and Dosage Adjustment as follows).
Dosing Considerations: ULTRACET (tramadol hydrochloride and paracetamol) tablets should only be used during post-operative period in patients that can take oral medications (see Peri-Operative Considerations under Precautions).
ULTRACET is not indicated for rectal administration.
Do not co-administer ULTRACET tablets with other paracetamol- or tramadol-containing products.
ULTRACET may be taken with or without food.
The maximum recommended dose of ULTRACET should not be exceeded. The lowest effective dose should be used for the shortest period of time consistent with individual patient treatment goals.
Tramadol is converted to the active M1 metabolite by CYP2D6, hence its safety and efficacy is controlled by CYP2D6 activity, which has a high degree of variability in humans (see Pharmacology: Pharmacokinetics: Special Populations and Conditions: Race under Actions). Levels of CYP2D6 activity have been associated with outcomes from tramadol administration that range from an absence of effect to responses with the potential of serious medical consequences (see Respiratory under Precautions; Overview under Interactions).
Recommended Dose and Dosage Adjustment: Adults: For the management of pain, the recommended dose of ULTRACET is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
Patients with Hepatic Impairment: ULTRACET is contraindicated in patients with severe hepatic impairment (see Contraindications).
Patients with Renal Impairment: ULTRACET is contraindicated in patients with severe renal impairment (see Contraindications).
Dose Titration: Dose titration is the key to success with opioid analgesic therapy. Proper optimization of doses scaled to the relief of the individual's pain should aim at administration of the lowest dose which will achieve the overall treatment goal of satisfactory pain relief with acceptable side effects.
Dosage adjustments should be based on the patient's clinical response.
Geriatrics: Respiratory depression has occurred in the elderly following administration of large initial doses of opioids to patients who were not opioid-tolerant or when opioids were co-administered with other agents that can depress respiration. ULTRACET should be initiated at a low dose and slowly titrated to effect (see Precautions; Pharmacology under Actions).
Pediatric Use: The safety and effectiveness of ULTRACET has not been studied in the pediatric population. Therefore, use of ULTRACET is not recommended in patients under 18 years of age.
Use with Non-Opioid Medications: If a non-opioid analgesic is being provided, it may be continued. If the non-opioid is discontinued, consideration should be given to increasing the opioid dose to compensate for the non-opioid analgesic. ULTRACET can be safely used concomitantly with usual doses of other non-opioid analgesics.
Management of Patients Requiring Rescue Medication: If ULTRACET is used as rescue medication in conjunction with extended-release tramadol tablets, the total daily dose of tramadol should not exceed 300 mg (8 tablets). Fentanyl products should not be used as rescue medication in patients taking ULTRACET.
Adjustment or Reduction of Dosage: Physical dependence with or without psychological dependence tends to occur with chronic administration of opioids, including ULTRACET. Withdrawal (abstinence) symptoms may occur following abrupt discontinuation of therapy. These symptoms may include body aches, diarrhea, gooseflesh, loss of appetite, nausea, nervousness or restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, tachycardia, trouble with sleeping, unusual increase in sweating, palpitations, unexplained fever, weakness and yawning. Do not stop use of ULTRACET abruptly (see Dependence/Tolerance under Precautions).
Following successful relief of moderate to severe pain, periodic attempts to reduce the opioid dose should be made. Smaller doses or complete discontinuation may become feasible due to a change in the patient's condition or mental state. Patients on prolonged therapy should be withdrawn gradually from the drug if it is no longer required for pain control. In patients who are appropriately treated with opioid analgesics and who undergo gradual withdrawal for the drug, these symptoms are usually mild (see Precautions). Tapering should be carried out under medical supervision.
Patient should be informed that reducing and/or discontinuing opioids decreases their tolerance to these drugs. If treatment needs to be re-initiated, the patient must start at the lowest dose and titrate up to avoid overdose.
Missed Dose: If the patient forgets to take one or more doses, they should take their next dose at the next scheduled time and in the normal amount.