Country: United States
Language: English
Source: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)
Safecor Health, LLC
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE 20 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Oxycodone hydrochloride oral solution 100 mg/5 mL (20 mg/mL ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. Oxycodone hydrochloride oral solution 100 mg/5 mL (20 mg/mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. Oxycodone hydrochloride is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. Oxycodone hydrochloride is contraindicated in any patient who has or is suspected of having paralytic ileus. Oxycodone hydrochloride is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. Oxycodone hydrochloride is contraindicated in patients with known
Oxycodone Hydrochloride Oral Solution Oxycodone Hydrochloride Oral Solution 20 mg/mL is a yellow solution available in one strength as follows: Supplied as an individual overwrapped and flagged calibrated oral syringe: Syringes of 0.5 mL containing 0.25 mL (5 mg) NDC 48433-347-47 Syringes of 1 mL containing 0.5 mL (10 mg) NDC 48433-347-55 Storage Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F). PROTECT from MOISTURE and LIGHT. Handling All opioids, including oxycodone hydrochloride, are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly. DEA Order Form Required
New Drug Application Authorized Generic
OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride solution Safecor Health, LLC ---------- Medication Guide Oxycodone Hydrochloride (ox-ee-CO-dohn) CII Oral Solution IMPORTANT: Keep Oxycodone Hydrochloride Oral Solution in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes Oxycodone Hydrochloride Oral Solution, get emergency help right away. Read the Medication Guide that comes with Oxycodone Hydrochloride Oral Solution before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about Oxycodone Hydrochloride Oral Solution? Oxycodone Hydrochloride Oral solution can cause serious side effects, including, death. 1. Take Oxycodone Hydrochloride Oral Solution exactly as prescribed by your healthcare provider. If you take the wrong dose or strength of Oxycodone Hydrochloride Oral Solution, you could overdose and die. 2. It is especially important when you take Oxycodone Hydrochloride Oral Solution that you know exactly what dose and strength to take, and the right way to measure your medicine. Your healthcare provider or pharmacist should show you the right way to measure your medicine. 3. Oral Syringe. Always use the oral syringe provided with Oxycodone Hydrochloride Oral Solution, 100 mg per 5 mL (20 mg per mL) to help make sure you measure the right amount. 4. Do not drink alcohol. Using alcohol with Oxycodone Hydrochloride Oral Solution may increase your risk of dangerous side effects, including death. 5. Opioid Tolerance. Do not take oxycodone Hydrochloride Oral Solution, 100 mg per 5 mL (20 mg per mL), unless you are "opioid tolerant." Opioid tolerant means that you take another opioid medicine for your constant (around the clock) pain and your body is used to it. What is Oxycodone Hydrochloride Oral Solution? Oxy Read the complete document
OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION SAFECOR HEALTH, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OXYCODONE HYDROCHLORIDE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE ORAL SOLUTION CII INITIAL U.S. APPROVAL: 1950 WARNING: RISK OF MEDICATION ERRORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ OXYCODONE HYDROCHLORIDE ORAL SOLUTION, 100 MG/5 ML (20 MG/ML) IS AVAILABLE IN ONE CONCENTRATION, AS 20 MG OXYCODONE HYDROCHLORIDE PER ML OF SOLUTION. THE 100 MG/5 ML (20 MG/ML) CONCENTRATION IS INDICATED FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. TAKE CARE TO AVOID DOSING ERRORS DUE TO CONFUSION BETWEEN BETWEEN MG AND ML, AND OTHER OXYCODONE SOLUTIONS WITH DIFFERENT CONCENTRATIONS, WHICH COULD RESULT IN ACCIDENTAL OVERDOSE AND DEATH. (5.1) KEEP OXYCODONE HYDROCHLORIDE ORAL SOLUTION OUT OF THE REACH OF CHILDREN. INDICATIONS AND USAGE Oxycodone Hydrochloride 20 mg per mL solution is an opioid agonist indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. (1) DOSAGE AND ADMINISTRATION Oxycodone Hydrochloride Oral Solution: 5 to 15 mg every 4 to 6 hours as needed. (2.2) DOSAGE FORMS AND STRENGTHS Oral Solution 100 mg/5 mL (20 mg/mL): Each mL contains 20 mg of oxycodone hydrochloride. (3) CONTRAINDICATIONS Respiratory depression in the absence of resuscitative equipment. (4) Paralytic ileus. (4) Acute or severe bronchial asthma or hypercarbia. (4) Known hypersensitivity to oxycodone. (4) WARNINGS AND PRECAUTIONS Risk of Medication Errors: Use caution when prescribing, dispensing, and administering to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. (5.1) Respiratory depression: Increased risk in elderly, debilitated patients, those suffering from conditions accompanied by hypoxia, hyperc Read the complete document