Oxaydo

What is Oxaydo?

Oxaydo is a strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short term (acute) and long term (chronic) 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.

This is 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.

Description

OXAYDO (oxycodone HCl) 5 mg and 7.5 mg tablets are an immediate-release opioid agonist intended for oral administration only.

Chemically, oxycodone HCl is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one HCl, a white, odorless crystalline powder. Oxycodone HCl is soluble in water (1 g in 6 to 7 mL). The molecular weight of oxycodone HCl is 351.82. The molecular formula for oxycodone HCl is C18H21NO4•HCl, and the structure is:

The inactive ingredients in OXAYDO include: colloidal silicon dioxide NF; crospovidone NF; magnesium stearate NF; microcrystalline cellulose NF; polyethylene oxide NF; and sodium lauryl sulfate NF.

The tablets are round, convex, white and debossed with the strength (5 or 7.5) on one side and the letter “O” on the other side.

Mechanism of Action

Oxycodone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

What is the most important information I should know about Oxaydo?

• Get emergency help right away if you take too much Oxaydo (overdose). When you first start taking Oxaydo, 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 Oxaydo 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 Oxaydo. They could die from taking it. Store Oxaydo away from children and in a safe place to prevent stealing or abuse. Selling or giving away Oxaydo is against the law.

Who should not take Oxaydo?

Do not take Oxaydo if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

What should I tell my healthcare provider before taking Oxaydo?

Before taking Oxaydo, tell your healthcare provider if you have a history of:

• head injury, seizures
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.
• liver, kidney, thyroid problems
• pancreas or gallbladder problems

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of Oxaydo during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Not recommended during treatment with Oxaydo. It may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Oxaydo with certain other medicines can cause serious side effects that could lead to death.

How should I take Oxaydo?

When taking Oxaydo:

• Do not change your dose. Take Oxaydo exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose exactly as instructed by your healthcare provider. Your healthcare provider may adjust the dose until it is right for you. 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 Oxaydo regularly, do not stop taking OXAYDO without talking to your healthcare provider.
• After you stop taking Oxaydo, destroy the unused tablets by flushing them down the toilet.

What should I avoid while taking Oxaydo?

While taking Oxaydo DO NOT:

• Drive or operate heavy machinery, until you know how Oxaydo affects you. Oxaydo 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 Oxaydo may cause you to overdose and die.

What are the possible side effects of Oxaydo?

The possible side effects of Oxaydo:

• 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 Oxaydo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are the ingredients in Oxaydo?

Active ingredient: oxycodone hydrochloride

Label

• PRINCIPAL DISPLAY PANEL – NDC 69344-113-11 – 5 MG 100-COUNT BOTTLE LABEL

   

  

• PRINCIPAL DISPLAY PANEL – NDC 69344-213-11 – 7.5 MG 100-COUNT BOTTLE LABEL

   

  

  SRC: NLM .