SPL MEDGUIDE
Oxycodone Hydrochloride (ox-ee-CO-dohn) Oral Solution, CII
Oxycodone Hydrochloride Oral Solution is:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
- An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about Oxycodone Hydrochloride Oral Solution:
- Get emergency help right away if you take too much Oxycodone Hydrochloride Oral Solution (overdose) . When you first start taking Oxycodone Hydrochloride Oral Solution, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
- Taking Oxycodone Hydrochloride Oral Solution with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- Never give anyone else your Oxycodone Hydrochloride Oral Solution. They could die from taking it. Store Oxycodone Hydrochloride Oral Solution away from children and in a safe place to prevent stealing or abuse. Selling or giving away Oxycodone Hydrochloride Oral Solution is against the law.
Do not take Oxycodone Hydrochloride Oral Solution if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
- an allergy to oxycodone or any of the other ingredients in Oxycodone Hydrochloride Oral Solution.
Before taking Oxycodone Hydrochloride Oral Solution, tell your healthcare provider if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. Prolonged use of Oxycodone Hydrochloride Oral Solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- breastfeeding. Oxycodone Hydrochloride Oral Solution passes into breast milk and may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Oxycodone Hydrochloride Oral Solution with certain other medicines can cause serious side effects that could lead to death.
When taking Oxycodone Hydrochloride Oral Solution:
- Do not change your dose. Take Oxycodone Hydrochloride Oral Solution exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- See the detailed Instructions for Use for information about how to take Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL).
- Always use the enclosed calibrated measuring cup that comes with Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL and the enclosed calibrated oral syringe that comes with Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL) to correctly measure your dose. Never use a household teaspoon or tablespoon to measure Oxycodone Hydrochloride Oral Solution.
- Take your prescribed dose every 4 to 6 hours. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
- Call your healthcare provider if the dose you are taking does not control your pain.
- If you have been taking Oxycodone Hydrochloride Oral Solution regularly, do not stop taking Oxycodone Hydrochloride Oral Solution without talking to your healthcare provider.
- After you stop taking Oxycodone Hydrochloride Oral Solution, destroy the unused solution by flushing down the toilet.
While taking Oxycodone Hydrochloride Oral Solution DO NOT:
- Drive or operate heavy machinery, until you know how Oxycodone Hydrochloride Oral Solution affects you. Oxycodone Hydrochloride Oral Solution can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Oxycodone Hydrochloride Oral Solution may cause you to overdose and die.
What are the possible side effects of Oxycodone Hydrochloride Oral Solution:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of Oxycodone Hydrochloride Oral Solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
This Medication Guide has been approved by the U.S. Food and Drug Administration.
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
20101 N.E 16 th PLACE
MIAMI, FL 33179
Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL) Oral Syringe
Important information about measuring Oxycodone Hydrochloride Oral Solution
- Always use the oral syringe provided with your Oxycodone Hydrochloride Oral Solution to make sure you measure the right amount.
- Measure the dose of medicine from the widest part of the plunger. Do not measure from the narrow tip. See Figure 1.
Step 1. Insert the tip of the oral syringe into the medicine bottle.
Step 2. Pull back the plunger to the line that matches the dose prescribed by your healthcare provider.
Step 3. Remove the oral syringe from the medicine bottle.
Step 4. Take your medicine by slowly pushing the plunger until the oral syringe is empty
FIGURE 1
