Xtampza ER

Generic name: oxycodone
Dosage form: extended-release capsules
Drug class: Narcotic analgesics

Medically reviewed by  A Ras MD.

What is Xtampza ER?

Xtampza ER is A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

It is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed by your healthcare provider, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

It is not for use to treat pain that is not around-the-clock.

Description

XTAMPZA ER (oxycodone) extended-release capsules are an opioid agonist for oral use. The capsules contain microspheres formulated with oxycodone base and are supplied in strengths of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), and 36 mg (equivalent to 40 mg oxycodone HCl) capsules. The capsule strengths describe the amount of oxycodone base per capsule. The structural formula for oxycodone is as follows:

• C18H21NO4              
•  MW 315.37 g/mol

The chemical name is 4,5 α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one.

Oxycodone base is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone is present as myristate salt in the XTAMPZA ER formulation.

Each XTAMPZA ER capsule contains either 9, 13.5, 18, 27, or 36 mg of oxycodone (equivalent to 10, 15, 20, 30, or 40 mg of oxycodone HCl, respectively) and the following inactive ingredients: myristic acid, yellow beeswax, carnauba wax, stearoyl polyoxyl-32 glycerides, magnesium stearate, and colloidal silicon dioxide. The capsule shells collectively contain titanium dioxide, hypromellose, and water. Additionally, the 9 mg and 18 mg strength capsule shells contain yellow iron oxide, the 13.5 and 36 mg strength capsule shells contain red iron oxide, and the 27 mg strength capsule shells contain black iron oxide.

Mechanism of Action

Oxycodone is a full opioid agonist and is relatively selective for the mu 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 to analgesia for 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. In addition, when oxycodone binds to mu-opioid receptors, it results in positive subjective effects, such as drug liking, euphoria, and high.

What is the most important information I should know about Xtampza ER?

• Get emergency help right away if you take too much Xtampza ER (overdose). When you first start taking Xtampza ER, when your dose is changed, or if you take too much (overdose), serious life-threatening breathing problems that can lead to death may occur.
• Taking Xtampza ER 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 Xtampza ER. They could die from taking it. Selling or giving away Xtampza ER is against the law.
• Store Xtampza ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Who should not take Xtampza ER?

Do not take Xtampza ER 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 Xtampza ER?

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

• head injury, seizures
• problems urinating
• liver, kidney, thyroid problems
• 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 Xtampza ER 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 Xtampza ER. It may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Xtampza ER with certain other medicines can cause serious side effects that could lead to death.

How should I take Xtampza ER?

When taking Xtampza ER:

• Do not change your dose. Take Xtampza ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• If you cannot swallow Xtampza ER capsules, see the detailed Instructions for Use that come with Xtampza ER.
• Always take Xtampza ER capsules with approximately the same amount of food to ensure enough medicine is absorbed.
• Swallow Xtampza ER whole. Do not snort, or inject Xtampza ER because this may cause you to overdose and die.
• The contents of the Xtampza ER capsules may be sprinkled on soft food, sprinkled into a cup and then put directly into the mouth, or given through a nasogastric or gastrostomy tube.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking Xtampza ER without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused Xtampza ER by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

What should I avoid while taking Xtampza ER?

While taking Xtampza ER do not:

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

What are the possible side effects of Xtampza ER?

The possible side effects of Xtampza ER are:

• 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, mental changes such as confusion.

These are not all the possible side effects of Xtampza ER. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Xtampza ER?

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Dispense in tight, light-resistant container, with child-resistant closure.

Store Xtampza ER securely and dispose of properly

What are the ingredients in Xtampza ER?

Active ingredients: oxycodone

Inactive ingredients:

9mg and 18mg: myristic acid, yellow wax, carnauba wax, peg-32 stearate, magnesium stearate, silicon dioxide, hypromellose unspecified, titanium dioxide, water, ferric oxide yellow

13.5mg and 36mg: myristic acid, yellow wax, carnauba wax, peg-32 stearate, magnesium stearate, silicon dioxide, hypromellose unspecified, titanium dioxide, water, ferric oxide red

27mg: myristic acid, yellow wax, carnauba wax, peg-32 stearate, magnesium stearate, silicon dioxide, hypromellose unspecified, titanium dioxide, water, ferrosoferric oxide

Label

PRINCIPAL DISPLAY PANEL – 9 MG CAPSULE BOTTLE LABEL

• NDC 24510-110-10
• Xtampza® ER
• (oxycodone)
  EXTENDED-RELEASE
  CAPSULES
  CII
• 9 mg
• Each capsule contains Oxycodone 9 mg
  (Equivalent to 10 mg Oxycodone Hydrochloride)
• 100 Capsules
  Rx Only
• Always take with food. Taking on an empty
  stomach can decrease drug absorption.
• Attention Dispenser: Accompanying Medication
  Guide must be provided to the patient upon dispensing.

SRC: NLM .