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.
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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.
- 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.
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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.
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Do not drink alcohol. Using alcohol with Oxycodone Hydrochloride Oral Solution may increase your risk of dangerous side effects, including death.
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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?
Oxycodone Hydrochloride Oral Solution is in a group of drugs called narcotic pain relievers.
Oxycodone Hydrochloride Oral Solution is only for adults who have moderate to severe pain.
- Oxycodone Hydrochloride Oral Solution is a prescription medicine that is used to manage moderate to severe pain that is expected to last a short period of time (acute), and pain that continues around-the-clock and is expected to last for a long period of time (chronic).
- Oxycodone Hydrochloride Oral Solution is a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs.
- Prevent theft, misuse or abuse. Keep Oxycodone Hydrochloride Oral Solution in a safe place to keep it from being stolen. Oxycodone Hydrochloride Oral Solution can be a target for people who misuse or abuse prescription medicines or street drugs.
- Never give Oxycodone Hydrochloride Oral Solution to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.
- Selling or giving away this medicine is against the law.
- It is not known if Oxycodone Hydrochloride Oral Solution is safe and effective in children under age 18 years of age.
- Oxycodone Hydrochloride 100 mg per 5 mL (20 mg per mL) Oral Solution is only for adults with moderate to severe pain who are already using an opioid narcotic pain medicine and have been using this medicine continuously for several weeks or longer.
Who should not take Oxycodone Hydrochloride Oral Solution?
Do not take Oxycodone Hydrochloride Oral Solution if you:
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are allergic to oxycodone, oxycodone salts, or any of the ingredients in Oxycodone Hydrochloride Oral Solution. See the end of this Medication Guide for a complete list of ingredients in Oxycodone Hydrochloride Oral Solution.
- are having breathing problems and there is no emergency medical equipment nearby
- are having an asthma attack or have severe asthma, trouble breathing, or lung problems
- have a bowel blockage called paralytic ileus
What should I tell my healthcare provider before taking Oxycodone Hydrochloride Oral Solution?
Before taking Oxycodone Hydrochloride Oral Solution, tell your healthcare provider if you:
- have trouble breathing or lung problems
- have had a head injury
- have liver or kidney problems
- have adrenal gland problems, such as Addison’s disease
- have severe scoliosis that affects your breathing
- have thyroid problems
- have problems urinating or enlargement of your prostate
- have or had convulsions or seizures
- have a past or present drinking problems or alcoholism
- have hallucinations (seeing or hearing things that are not really there) or other severe mental problems
- have constipation or other bowel problems
- have problems with your pancreas or gallbladder
- have past or present substance abuse or drug addiction
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if Oxycodone Hydrochloride Oral Solution will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
If you take Oxycodone Hydrochloride Oral Solution regularly before your baby is born, your newborn baby may have signs of withdrawal because their body has become used to the medicine. Signs of withdrawal in a newborn baby can include:
- irritability
- being very active
- problems sleeping
- high pitched cry
- shaking (tremors)
- vomiting
- diarrhea or more stools than normal
- weight loss
If you are taking Oxycodone Hydrochloride Oral Solution right before your baby is born, your baby could have breathing problems.
- If you are breast-feeding or plan to breastfeed, some Oxycodone Hydrochloride Oral Solution passes into your breast milk. A nursing baby could become very sleepy or have difficulty breathing or feeding well. If you stop breastfeeding, your baby may have withdrawal symptoms. See the list of withdrawal symptoms above. You and your healthcare provider should decide if you will take Oxycodone Hydrochloride Oral Solution or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Sometimes the doses of medicines that you take with Oxycodone Hydrochloride Oral Solution may need to be changed if used together. Be especially careful about taking other medicines that make you sleepy such as:
- sleeping pills
- other pain medicines
- anti-nausea medicines
- tranquilizers
- muscle relaxants
- antihistamines
- anti-anxiety medicines
- anti-depressants
- monoamine oxidase inhibitors (MAOIs)
- anticholinergic medicines
Ask your healthcare provider if you are not sure if your medicine is one listed above.
What should I avoid while taking Oxycodone Hydrochloride Oral Solution?
- You should not drink alcohol while using Oxycodone Hydrochloride Oral Solution. Drinking alcohol with Oxycodone Hydrochloride Oral Solution may increase your risk of having dangerous side effects or death.
- Do not drive, operate heavy machinery, or do other dangerous activities, especially when you start taking Oxycodone Hydrochloride Oral Solution and when your dose is changed, until you know how Oxycodone Hydrochloride Oral Solution affects you. Oxycodone can make you sleepy. Ask your healthcare provider to tell you when it is okay to do these activities.
What are the possible side effects of Oxycodone Hydrochloride Oral Solution?
Oxycodone Hydrochloride Oral Solution can cause serious side effects, including:
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See “What is the most important information I should know about Oxycodone Hydrochloride Oral Solution?”
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Oxycodone can cause serious breathing problems that can become life-threatening, especially if Oxycodone Hydrochloride Oral Solution is used the wrong way. Call your healthcare provider or get help right away if:
- your breathing slows down
- you have shallow breathing (little chest movement with breathing)
- you feel faint, dizzy, confused, or
- you have any other unusual symptoms
These can be symptoms that you have taken too much Oxycodone Hydrochloride Oral Solution (overdose) or the dose is too high for you.
These symptoms may lead to serious problems or death if not treated right away.
- Oxycodone Hydrochloride Oral Solution can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lose blood or take certain other medicines.
- Oxycodone can cause physical dependence. Do not stop taking Oxycodone or any other opioid without talking to your healthcare provider about how to slowly stop your medicine. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction. Tell your healthcare provider if you have any of these symptoms of withdrawal while slowly stopping Oxycodone:
- feel restless
- tearing eyes
- sweating
- chills or hair on your arms “stand up”
- muscle aches, backache
- dilated pupils of your eyes
- feel irritable or anxious
- trouble sleeping
- runny nose
- yawning
- nausea, loss of appetite, vomiting, diarrhea,
stomach-area (abdominal) cramps
- increase in your blood pressure, breathing
faster, or your heart beats faster
- There is a chance of abuse or addiction with Oxycodone Hydrochloride Oral Solution. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.
- Seizures. Oxycodone Hydrochloride Oral Solution may cause seizures or make seizures that you already have worse.
Call your healthcare provider if you have any of the symptoms listed above.
Common side effects of Oxycodone Hydrochloride Oral Solution include:
- nausea
- constipation
- vomiting
- headache
- itchiness
- trouble sleeping
- dizziness
- weakness
- drowsiness
- sweating
- lightheadedness
Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including Oxycodone Hydrochloride Oral Solution. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Oxycodone Hydrochloride Oral Solution.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Oxycodone Hydrochloride Oral Solution. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Oxycodone Hydrochloride Oral Solution?
- Store Oxycodone Hydrochloride Oral Solution in a dry area at room temperature 59°F to 86°F (15°C to 30°C)
- Protect Oxycodone Hydrochloride Oral Solution from moisture and light.
- After you stop taking Oxycodone, flush the unused oral solution down the toilet.
Keep Oxycodone Hydrochloride Oral Solution out of the reach of children. Accidental overdose by a child is a medical emergency and can lead to death.
General information about Oxycodone Hydrochloride Oral Solution
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Oxycodone Hydrochloride Oral Solution for a condition for which it was not prescribed.
Do not give your Oxycodone Hydrochloride Oral Solution to other people, even if they have the same symptoms you have. Selling or giving away Oxycodone Hydrochloride Oral Solution may harm others, may cause death, and is against the law.
This Medication Guide summarizes the most important information about Oxycodone Hydrochloride Oral Solution. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Oxycodone Hydrochloride Oral Solution that is written for healthcare professionals.
For more information about Oxycodone Hydrochloride Oral Solution, call Novel Laboratories, Inc. at 1-866-403-7592.
What are the ingredients in Oxycodone Hydrochloride Oral Solution?
Active ingredient: oxycodone hydrochloride
Inactive ingredients: 100 mg per 5 mL contains citric acid anhydrous, D&C Yellow #10, natural/artificial mixed berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, and sorbitol solution.
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
PI9206000102
Rev. 02/2015
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Patient Instructions for Use
Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL) Oral Syringe
Important information about measuring Oxycodone Hydrochloride Oral Solution
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Always use the oral syringe provided with your Oxycodone Hydrochloride Oral Solution to make sure you measure the right amount.
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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
Novel Laboratories, Inc.