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 Ultracet
INTERNATIONAL NON-PROPRIETARY NAMES
Tramadol
Paracetamol
QUALITATIVE AND QUANTITATIVE COMPOSITION
ULTRACET is available as tablets for oral administration containing 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
PHARMACEUTICAL FORM
A light yellow tablet with an off-white core, with debossing as follows: 'T/A' on one
side and 'JANSSEN' on the other side.
CLINICAL PARTICULARS
Therapeutic Indications
ULTRACET is indicated for the management of moderate to severe pain.
Posology and Method of Administration
Oral use.
Tablets must be swallowed whole with a sufficient quantity of liquid. They must not
be broken/chewed.
ULTRACET should under no circumstances be administered for longer than is
strictly necessary. If repeated use or long-term treatment with ULTRACET is
required as a result of the nature and severity of the illness, then careful and regular
monitoring should take place (with breaks in treatment, where possible) to assess
whether continuation of the treatment is necessary.
Adults and Children Over 16 Years
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.
ULTRACET™ can be administered without regard to food.
Pediatric (Children Below 16 Years)
The safety and effectiveness of ULTRACET has not been established in the
pediatric population.
Elderly (Geriatric)
It should he noted that in volunteers >75 years of age, elimination half-life was
increased by 17% following oral administration. In patients >75 years of age the
recommended minimum interval between doses is ≥
6 hours.
Contraindications
ULTRACET should not be administered to patients who have previously
demonstrated hypersensitivity to tramadol paracetamol, any other component of this
product or opioids. It is also contraindicated in cases of acute intoxication with alcohol,
hypnotics, narcotics, centrally acting analgesics, opiods or psychotropic drugs.
ULTRACET should not be administered to patients who are receiving monoamine oxidase inhibitors or within 2 weeks of their withdrawal, patients with severe hepatic
impairment and patients with epilepsy not well controlled by treatment.
Special Warnings and Special Precautions for Use
Seizures
Seizures 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: Selective serotonin reuptake
inhibitors (SSRI antidepressants or anorectics), Tricyclic antidepressants (TCAs), and
other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or Opioids.
Administration of tramadol may enhance the seizure risk in patients taking: MAO
inhibitors, Neuroleptics or Other drugs that reduce the seizure threshold.
Risk of convulsions may also increase in patients with epilepsy, those with a history
of seizures, or in patients with a recognized risk for seizure (such as head trauma,
metabolic disorders, alcohol and drug withdrawal, CNS infections). In tramadol
overdose, naloxone administration may increase the risk of seizure.
Anaphylactoid Reactions
Patients with a history of anaphylactoid reactions to codeine and other opioids may
be at increased risk and therefore should not receive ULTRACET.
Respiratory Depression
Administer ULTRACET cautiously in patients at risk for respiratory depression.
When large doses of tramadol are administered with anesthetic medications or
alcohol, respiratory depression may result. Treat such cases as an overdose. It
naloxone is to be administered, use cautiously because it may precipitate seizures.
Use with CNS Depressants
ULTRACET should be used with caution and in reduced dosages when
administered to patients receiving CNS depressants such as alcohol, opioids,
anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Increased Intracranial Pressure or Head Trauma
ULTRACET should be used with caution in patients with increased intracranial
pressure or head injury.
Physical Dependence and Abuse
Tramadol may induce physical dependence of the morphine-type (µ-opioid).
Tramadol should not be used in opioid-dependent patients. Tramadol has been
shown to reinitiate 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 those patients
with prior history of opioid dependence. The risk in patients with substance abuse
has been observed to be higher
Use with Alcohol
Chronic heavy alcohol abusers may be at increased risk of liver toxicity from
excessive paracetamol use.
Withdrawal
Withdrawal symptoms may occur if
ULTRACET is discontinued abruptly. Panic
attacks, severe anxiety, hallucinations, parathesia, tinnitus, and unusual CNS
symptoms have also been very rarely reported with abrupt discontinuation of
tramadol hydrochloride. Clinical experience suggests that withdrawal symptoms may
be relieved by tapering the medication.
Use with MAO Inhibitors and Serotonin Reuptake Inhibitors
Use ULTRACET with great caution in patients taking monoamine oxidase inhibitors.
Concomitant use of tramadol with MAO inhibitors or SSRI's increases the risk of
adverse events, including seizure and serotonin syndrome diarrhea, tachycardia,
sweating, trembling, confusion, coma).
Use in Renal Disease
ULTRACET has not been studied in patents with impaired renal function. 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. ULTRACET is not
recommended in patents with creatinine clearance of less than 10 mL/min.
Use In Hepatic Disease
The use of ULTRACET in patients with severe hepatic impairment is not recommended.
Precautions General
The recommended dose of ULTRACET should not be exceeded.
ULTRACET should not be co-administered with other tramadol or paracetamol-containing products.
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