ULTRACET Coated tablet (2022)

Βιβλιογραφική αναφορά

Συγγραφείς

Janssen Pharmaceuticals, Inc.

Λέξεις κλειδιά

50458-650

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BOXED WARNING SECTION

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK ...

1. Indications and Usage

ULTRACET tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use ULTRACET tablets are ...

2. Dosage and Administration

2.1 Important Dosage and Administration Instructions ULTRACET is not approved for use for more than 5 days. Do not exceed the recommended dose of ULTRACET. Do not co-administer ULTRACET with other tramadol ...

3. Dosage Forms and Strengths

ULTRACET tablets each contain 37.5 mg of tramadol hydrochloride and 325 mg of acetaminophen. The tablets are light yellow, coated, capsule-shaped, and debossed with O-M on one side and 650 on the other. ...

4. Contraindications

ULTRACET is contraindicated for: all children younger than 12 years of age [see Warnings and Precautions (5.4)] post-operative management in children younger than 18 years of age following tonsillectomy ...

5. Warnings and Precautions

5.1 Addiction, Abuse and Misuse ULTRACET contains tramadol, a Schedule IV controlled substance. As an opioid, ULTRACET exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and ...

6. Adverse Reactions

The following serious adverse reactions are discussed, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of tramadol-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is ...

7. Drug Interactions

Table 2 includes clinically significant interactions with ULTRACET. Table 2. Clinically Significant Drug Interactions with ULTRACET: Inhibitors of CYP2D6 Clinical Impact: The ...

8. Use in Specific Populations

8.8 Sex Tramadol clearance was 20% higher in female subjects compared to males in four Phase 1 studies of ULTRACET in 50 male and 34 female healthy subjects. The clinical significance of this difference ...

8.1. Pregnancy

Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5)]. Available data with ULTRACET in pregnant women ...

8.2. Lactation

Risk Summary ULTRACET is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Tramadol ...

8.3. Females and Males of Reproductive Potential

Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions ...

8.4. Pediatric Use

The safety and effectiveness of ULTRACET in pediatric patients have not been established. Life-threatening respiratory depression and death have occurred in children who received tramadol [see Warnings ...

8.5. Geriatric Use

Elderly patients (65 years of age or older) may have increased sensitivity to tramadol. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing ...

8.6. Hepatic Impairment

The pharmacokinetics and tolerability of ULTRACET in patients with impaired hepatic function have not been studied. Based on information using tramadol immediate-release tablets in subjects with advanced ...

8.7. Renal Impairment

The pharmacokinetics and tolerability of ULTRACET in patients with renal impairment has not been studied. Based on studies using tramadol extended-release tablets, the excretion of tramadol and metabolite ...

9.1. Controlled Substance

ULTRACET contains tramadol, a Schedule IV controlled substance.

9.2. Abuse

ULTRACET contains tramadol, a substance with a high potential for abuse similar to other opioids and can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions ...

9.3. Dependence

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of ...

10. Overdosage

Clinical Presentation ULTRACET is a combination drug. The clinical presentation of overdose may include the signs and symptoms of tramadol toxicity, acetaminophen toxicity or both. The initial symptoms ...

11. Description

ULTRACET (tramadol hydrochloride/acetaminophen) Tablets combines two analgesics, tramadol hydrochloride and opioid agonist, and acetaminophen. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl] ...

12. Clinical Pharmacology

The following information is based on studies of tramadol alone or acetaminophen alone, except where otherwise noted.

12.1. Mechanism of Action

ULTRACET contains tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re-uptake, and acetaminophen. Although the mode of action of tramadol is not completely understood, the analgesic ...

12.2. Pharmacodynamics

Effects on the Central Nervous System Tramadol produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness ...

12.3. Pharmacokinetics

Tramadol is administered as a racemate and both the [-] and [+] forms of both tramadol and M1 are detected in the circulation. Absorption The absolute bioavailability of tramadol from ULTRACET tablets ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no animal or laboratory studies on the combination product (tramadol and acetaminophen) to evaluate carcinogenesis, mutagenesis, or impairment of fertility. Data on the individual components ...

14. Clinical Studies

14.1 Single-Dose Studies for Treatment of Acute Pain In single-dose studies in acute pain, two tablets of ULTRACET administered to patients with pain following oral surgical procedures provided greater ...

16.1. How Supplied

ULTRACET (tramadol hydrochloride/acetaminophen) tablets containing 37.5 mg tramadol hydrochloride and 325 mg acetaminophen are light yellow, coated, capsule-shaped tablets debossed with O-M on one side ...

16.2. Storage and Handling

Dispense in a tight container. Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Store ULTRACET securely and dispose of properly [see Patient ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store ...