ULTRACET - Acetaminophen & Tramadol Hydrochloride Tablets USP
NAME OF THE MEDICINAL PRODUCT: ULTRACET
International Non-Proprietary Names:
Tramadol (INN) / Tramadol (USAN)
Paracetamol (INN) / Acetaminophen (USAN)
QUALITATWE AND QUANTITATIVE COMPOSITIONS
ULTRACET is available as tablets for oral administration containing 37.5 / 18.75 mg tramadol hydrochloride and 325/162.5 mg Acetaminophen
PHARMACEUTICAL FORM
ULTRACET is available as a light yellow, film-coated, biconvex, capsule shaped tablet.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
ULTRACET is indicated for the management of moderate to severe pain.
POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise prescribed, ULTRACET should be administered as follows:
ADULTS AND CHILDREN OVER 16 YEARS
The suggested maximum single dose of ULTRACET is 1 to 2 tablets every 4 to 6 hours, as needed for pain relief, up to a per day maximum equivalent to 300 mg tramadol hydrochloride and 2.6 g acetaminophen
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 populations.
ELDERLY (GERIATRIC)
No Overall differences with regard to safety or pharrnacokinetics were noted between subjects >65 years of age and younger subjects.
CONTRAINDICATIONS
ULTRACET should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, and any other component of this product or opioids. It is also contraindicated in cases of acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs.
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.
ANAPHYLACTOID REACTIONS
Patients with a history or anaphylactoid reactions to codeine and other opiods may be at increased risk and therefore should net 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. If naloxone is to be administered, use cautiously because it may precipitate seizures.
NAME OF THE MEDICINAL PRODUCT: ULTRACET
International Non-Proprietary Names:
Tramadol (INN) / Tramadol (USAN)
Paracetamol (INN) / Acetaminophen (USAN)
QUALITATWE AND QUANTITATIVE COMPOSITIONS
ULTRACET is available as tablets for oral administration containing 37.5 / 18.75 mg tramadol hydrochloride and 325/162.5 mg Acetaminophen
PHARMACEUTICAL FORM
ULTRACET is available as a light yellow, film-coated, biconvex, capsule shaped tablet.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
ULTRACET is indicated for the management of moderate to severe pain.
POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise prescribed, ULTRACET should be administered as follows:
ADULTS AND CHILDREN OVER 16 YEARS
The suggested maximum single dose of ULTRACET is 1 to 2 tablets every 4 to 6 hours, as needed for pain relief, up to a per day maximum equivalent to 300 mg tramadol hydrochloride and 2.6 g acetaminophen
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 populations.
ELDERLY (GERIATRIC)
No Overall differences with regard to safety or pharrnacokinetics were noted between subjects >65 years of age and younger subjects.
CONTRAINDICATIONS
ULTRACET should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, and any other component of this product or opioids. It is also contraindicated in cases of acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs.
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.
ANAPHYLACTOID REACTIONS
Patients with a history or anaphylactoid reactions to codeine and other opiods may be at increased risk and therefore should net 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. If naloxone is to be administered, use cautiously because it may precipitate seizures.
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