ULTRAM Coated tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Janssen Pharmaceuticals, Inc.

Λέξεις κλειδιά

50458-659

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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

ULTRAM is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, ...

2. Dosage and Administration

2.1 Important Dosage and Administration Instructions Do not use ULTRAM concomitantly with other tramadol-containing products. Do not administer ULTRAM at a dose exceeding 400 mg per day. Use the lowest ...

3. Dosage Forms and Strengths

ULTRAM (tramadol hydrochloride) 50 mg tablets are white, capsule-shaped, coated, with a functional score. The tablets are imprinted ULTRAM on one side and 06 59 on the scored side.

4. Contraindications

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

5. Warnings and Precautions

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

6. Adverse Reactions

The following serious adverse reactions are described, 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 ULTRAM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

Table 2. Clinically Significant Drug Interactions with ULTRAM: Inhibitors of CYP2D6 Clinical Impact: The concomitant use of ULTRAM and CYP2D6 inhibitors may result in an increase in the ...

8. Use in Specific Populations

8.6 Renal and Hepatic Impairment Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than ...

8.1. Pregnancy

Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with ULTRAM in pregnant women are insufficient to inform a drug-associated ...

8.2. Lactation

Risk Summary ULTRAM 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 ULTRAM 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

A total of 455 elderly (65 years of age or older) subjects were exposed to ULTRAM in controlled clinical trials. Of those, 145 subjects were 75 years of age and older. In studies including geriatric patients, ...

9.1. Controlled Substance

ULTRAM (tramadol hydrochloride) contain tramadol, a Schedule IV controlled substance.

9.2. Abuse

ULTRAM contains tramadol, a substance with a high potential for abuse similar to other opioids. ULTRAM 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 drugs to maintain a defined effect such as analgesia (in the absence of disease ...

10. Overdosage

Clinical Presentation Acute overdosage with ULTRAM can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, ...

11. Description

ULTRAM (tramadol hydrochloride) tablets, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis2[(dimethylamino)methyl]1(3-methoxyphenyl) cyclohexanol hydrochloride. ...

12.1. Mechanism of Action

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

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

The analgesic activity of ULTRAM is due to both parent drug and the M1 metabolite [see Clinical Pharmacology (12.1,12.2)]. Tramadol is administered as a racemate and both the [-] and [+] forms ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in an NMRI mouse carcinogenicity study, particularly in aged mice. Mice ...

14. Clinical Studies

ULTRAM has been given in single oral doses of 50, 75 and 100 mg to patients with pain following surgical procedures and pain following oral surgery (extraction of impacted molars). In single-dose models ...

16.1. How Supplied

ULTRAM (tramadol hydrochloride) 50 mg tablets are white, capsule-shaped, coated, with a functional score. The tablets are imprinted ULTRAM on one side and 06 59 on the scored side. Bottle of 100 tablets: ...

16.2. Storage and Handling

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

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 ...