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Dosage: Adults and children 16 years of age and over: The maximum single dose of ULTRACET is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. The lowest effective dose should be used for the shortest period of time.
Adults and adolescents (12 years and older): ULTRACET is not approved for use in patients below 12 years old.
Paediatric population: The safety and efficacy of ULTRACET has not been studied in the paediatric population. Therefore, use of ULTRACET is not recommended in patients under 12 years of age.
Treatment withdrawal: Do not stop use of ULTRACET abruptly. Withdrawal symptoms may be relieved by tapering the medication (see Treatment withdrawal under Precautions).
Special populations: Children below 16 years of age: The use of ULTRACET is contraindicated in children below 12 years of age (see Contraindications).
The safety and effectiveness of ULTRACET in children aged 12 to below 16 years of age has not been established (see Contraindications and Use in Children: Other risk factors for life-threatening respiratory depression in children).
Elderly (65 years of age and older): No overall differences with regard to safety or pharmacokinetics were noted between subjects ≥65 years of age and younger subjects. However, 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.
Renal impairment: In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of ULTRACET be increased not to exceed 2 tablets every 12 hours.
Hepatic impairment: The use of ULTRACET in patients with severe hepatic impairment is not recommended.
Administration: ULTRACET tablets are for oral administration.
ULTRACET can be administered without regard to food.
