TYLENOL WITH CODEINE Tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

A-S Medication Solutions

Λέξεις κλειδιά

50090-0006

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

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

1. Description

TYLENOL with Codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic ...

2. Clinical Pharmacology

Mechanism of Action Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic properties of codeine have been speculated ...

3. Indications and Usage

TYLENOL with Codeine (acetaminophen and codeine phosphate) tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments ...

4. Contraindications

TYLENOL with Codeine is contraindicated for: All children younger than 12 years of age (see WARNINGS). Post-operative management in children younger than 18 years of age following tonsillectomy and/or ...

5. Warnings

Addiction, Abuse, and Misuse TYLENOL with Codeine contains codeine. Codeine in combination with acetaminophen, is a Schedule III controlled substance. As an opioid, TYLENOL with Codeine tablets expose ...

6. Precautions

Risks of Driving and Operating Machinery TYLENOL with Codeine tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. ...

6.2. Information for Patients

Information for Patients/Caregivers Advise the patient to read the FDA-approved patient labeling (Medication Guide). Addiction, Abuse and Misuse Inform patients that the use of TYLENOL with Codeine tablets, ...

6.4. Drug Interactions

CYP2D6 Inhibitors Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of TYLENOL with Codeine and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase ...

6.5. Drug/Laboratory Test Interactions

Codeine may increase serum amylase levels. Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term studies to evaluate the carcinogenic potential of the combination of codeine and acetaminophen have not been conducted. Two-year carcinogenicity studies have been conducted in ...

6.7. Pregnancy

Teratogenic Effects Codeine A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses ...

6.8. Labor and Delivery

Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory ...

6.9. Nursing Mothers

Codeine and its active metabolite, morphine, are present in human milk. There are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed ...

6.10. Pediatric Use

The safety and effectiveness of TYLENOL with Codeine in pediatric patients below the age of 18 have not been established. Life-threatening respiratory depression and death have occurred in children who ...

6.11. Geriatric Use

Elderly patients (aged 65 years or older) may have increased sensitivity to TYLENOL with Codeine tablets. In general, use caution when selecting a dosage for an elderly patient, usually starting at the ...

7. Adverse Reactions

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse (see WARNINGS) Life-Threatening Respiratory Depression (see WARNINGS) ...

8. Drug Abuse and Dependence

Controlled Substance TYLENOL with Codeine tablets contain codeine. Codeine in combination with acetaminophen, is a Schedule III controlled substance. Abuse TYLENOL with Codeine tablets contain codeine, ...

9. Overdosage

Following an acute overdosage, toxicity may result from codeine or acetaminophen. Clinical Presentation Codeine Acute overdosage with codeine can be manifested by respiratory depression, somnolence progressing ...

10. Dosage and Administration

Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Initiate the dosing regimen ...

11. How Supplied

Product: 50090-0006 NDC: 50090-0006-2 20 TABLET in a BOTTLE Manufactured by: Janssen Ortho LLC, Gurabo, Puerto Rico 00778 Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560