ROXICET Tablet / Oral solution (2016)

Βιβλιογραφική αναφορά

Συγγραφείς

West-Ward Pharmaceuticals Corp

Λέξεις κλειδιά

0054-4650 0054-3686 0054-8650 0054-8648

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BOXED WARNING SECTION

Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the ...

1. Description

Each tablet for oral administration contains: Oxycodone Hydrochloride USP: 5 mg+ (+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen: 325 mg Each 5 mL of oral solution for ...

2. Clinical Pharmacology

Central Nervous System Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings ...

3. Indications and Usage

ROXICET is indicated for the relief of moderate to moderately severe pain.

4. Contraindications

ROXICET should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. Oxycodone is contraindicated in any situation where opioids ...

5. Warnings

Misuse, Abuse and Diversion of Opioids Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. ...

6. Precautions

Acute Abdominal Conditions The administration of ROXICET (Oxycodone and Acetaminophen) or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions. ROXICET ...

6.1. General

Opioid analgesics should be used with caution when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, ...

6.2. Information for Patients

The following information should be provided to patients receiving ROXICET by their physician, nurse, pharmacist, or caregiver: Patients should be aware that ROXICET contains oxycodone, which is a morphine-like ...

6.3. Laboratory Tests

Although oxycodone may cross-react with some drug urine tests, no available studies were found which determined the duration of detectability of oxycodone in urine drug screens. However, based on pharmacokinetic ...

6.4. Drug Interactions

Drug/Drug Interactions with Oxycodone Opioid analgesics may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression. Patients ...

6.5. Drug/Laboratory Test Interactions

Depending on the sensitivity/specificity and the test methodology, the individual components of ROXICET (Oxycodone and Acetaminophen) may cross-react with assays used in the preliminary detection of cocaine ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Animal studies to evaluate the carcinogenic potential of oxycodone and acetaminophen have not been performed. Mutagenesis The combination of oxycodone and acetaminophen has not been evaluated ...

6.7. Pregnancy

Category C. Animal reproductive studies have not been conducted with ROXICET. It is also not known whether ROXICET can cause fetal harm when administered to a pregnant woman or can affect reproductive ...

6.8. Labor and Delivery

ROXICET is not recommended for use in women during and immediately prior to labor and delivery due to its potential effects on respiratory function in the newborn.

6.9. Nursing Mothers

Ordinarily, nursing should not be undertaken while a patient is receiving ROXICET because of the possibility of sedation and/or respiratory depression in the infant. Oxycodone is excreted in breast milk ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

Special precaution should be given when determining the dosing amount and frequency of ROXICET for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population when ...

7. Adverse Reactions

Serious adverse reactions that may be associated with ROXICET use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see OVERDOSAGE). The most frequently ...

8. Drug Abuse and Dependence

ROXICET is a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused ...

9. Overdosage

Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen. Signs and Symptoms Toxicity from oxycodone poisoning includes the opioid triad of: pinpoint pupils, ...

10. Dosage and Administration

Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain ...

11. How supplied

ROXICET Tablets, Oxycodone and Acetaminophen Tablets USP (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg). White, round, s cored tablets (Identified 54 543). NDC 0054-8650-24: Unit dose, 25 tablets ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container, as defined in the USP/NF. ROXICET Oral Solution, Oxycodone ...