Buy Opana Online Uses & Side Effects With Risk Prevention

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Description

Generic Name

Oxymorphone hydrochloride

Active Ingredient

Oxymorphone hydrochloride

Chemical Name

Oxymorphone hydrochloride is chemically described as 4,5α-epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride.

Oxymorphone hydrochloride is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. It is a semisynthetic opioid derived from morphine and has a molecular weight of about 337.80.

Medication Classification

Oxymorphone is an opioid analgesic (a narcotic pain reliever) and a full opioid agonist. It works by binding to opioid receptors in the central nervous system to change how the body senses and responds to pain.

Oxymorphone is a Schedule II (CII) controlled substance under U.S. federal law.

Indications

• Immediate-release tablets and injection are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
• Extended-release tablets (Opana ER) were indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment in patients for whom alternative treatments were inadequate. This product was withdrawn from the U.S. market in 2017 and is no longer marketed.

Dosage Forms and Available Strengths

• Dosage Forms:
• • Immediate-release oral tablets
  • Extended-release oral tablets (withdrawn from the U.S. market in 2017)
  • Injection (solution for intravenous, intramuscular, or subcutaneous use)
• Routes of Administration: Oral, intravenous, intramuscular, and subcutaneous
• Common Strengths:
• • Immediate-release tablets: 5 mg and 10 mg
  • Extended-release tablets (formerly marketed): 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg
  • Injection: 1 mg/mL

Inactive Ingredients

Inactive ingredients vary by dosage form and manufacturer. Immediate-release tablets may contain lactose, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, and colorants. Injectable forms may contain sodium citrate, citric acid, and sodium chloride. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

Dosage & Administration

Important: Take or use oxymorphone exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Your provider will set your dose based on your pain, your prior opioid use, and your overall health. Do not change your dose on your own.

How to Take or Use Oxymorphone

• Immediate-release tablets: Take the tablet on an empty stomach, at least 1 hour before or 2 hours after eating. Swallow the tablet with water.
• Extended-release tablets (when previously available): These were to be swallowed whole. They were never to be crushed, chewed, broken, or dissolved, as this could release a fatal dose all at once. This product is no longer marketed in the U.S.
• Injection: This form is given by a trained healthcare professional in a medical setting.

General Dosing Principles

• Dosing is individualized based on the severity of pain, your response, and whether you are opioid-tolerant.
• Extended-release oxymorphone was only for patients who were already opioid-tolerant. Using such products in patients who are not opioid-tolerant can cause fatal respiratory depression.
• Your provider will select the exact dose, strength, and schedule for your situation.

Food Considerations

Oxymorphone should be taken on an empty stomach, at least 1 hour before or 2 hours after eating. Food, especially a high-fat meal, can significantly increase blood levels and raise the risk of serious side effects. Avoid alcohol entirely while taking oxymorphone, as the combination can be fatal.

Missed Dose Instructions

• If oxymorphone is taken on a schedule and you miss a dose, take it as soon as you remember.
• If it is close to the time for your next dose, skip the missed dose and continue your regular schedule.
• Do not take two doses at once to make up for a missed dose.
• If oxymorphone is prescribed only as needed, take it only when you have pain, following your provider's directions.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Store injectable products according to the specific product labeling.
• Keep out of the reach of children. Accidental use by a child can be fatal.

Disposal

Because oxymorphone is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, the FDA recommends flushing certain opioid products, including oxymorphone, down the toilet to prevent accidental exposure. Follow the disposal instructions on your product label or ask your pharmacist. Accidental exposure, especially in children, can cause serious harm or death.

Special Instructions

Children: The safety and effectiveness of oxymorphone have not been established in pediatric patients. It is not recommended for use in children. Keep the medication where children cannot reach it. Accidental ingestion by a child can cause fatal respiratory depression. If a child swallows this medication, seek emergency care immediately.

Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of oxymorphone, including sedation, confusion, dizziness, constipation, and breathing problems. A provider may start at a lower dose and monitor closely, given the higher risk of falls and possible reduced liver, kidney, or lung function.

Patients with Liver or Kidney Problems: Use with caution. Oxymorphone is contraindicated in patients with moderate or severe liver problems. A lower starting dose may be needed for patients with mild liver problems or kidney problems, since impaired organ function can increase drug levels and prolong effects.

Caregivers: Give the medication exactly as prescribed. Watch for excessive sleepiness, slowed or shallow breathing, confusion, or trouble waking the patient, and seek emergency care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking oxymorphone suddenly after prolonged use. Abrupt discontinuation can cause opioid withdrawal symptoms.
• If you and your provider decide to stop treatment, the dose should be reduced gradually using a plan set by your provider.
• Withdrawal symptoms may include restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle aches, widened pupils, irritability, anxiety, backache, joint pain, weakness, stomach cramps, trouble sleeping, nausea, loss of appetite, vomiting, diarrhea, and a rapid heartbeat.
• Tell your provider if withdrawal symptoms occur so the taper can be adjusted.

Overdose Warning

An overdose of oxymorphone can be serious and may be fatal, especially when combined with benzodiazepines, alcohol, or other CNS depressants. Symptoms of overdose may include:

• Slowed, shallow, or stopped breathing
• Extreme drowsiness or difficulty staying awake
• Loss of consciousness or coma
• Limp or weak muscles
• Cold, clammy skin
• Pinpoint pupils
• Slow heartbeat or low blood pressure

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. Naloxone may be used to reverse an opioid overdose. Because of oxymorphone's potency, repeated doses of naloxone may be needed, and the patient should be watched closely even after the first dose.

Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking oxymorphone and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Respiratory depression: Slow, shallow, or stopped breathing; extreme sleepiness; or difficulty waking. This risk is highest when starting treatment, after a dose increase, or when combined with other CNS depressants.
• Serotonin syndrome: Agitation, hallucinations, fast heartbeat, fever, excessive sweating, shivering, shaking, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea, especially when taken with certain other medicines.
• Adrenal insufficiency: Ongoing nausea, vomiting, loss of appetite, dizziness, or severe weakness.
• Severe allergic reactions: Rash, hives, swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing.
• Severe low blood pressure: Dizziness, lightheadedness, or fainting, especially when standing up.
• Seizures
• Severe constipation or bowel obstruction: Ongoing constipation, stomach pain, or inability to have a bowel movement.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Constipation
• Nausea or vomiting
• Drowsiness or sleepiness
• Dizziness or lightheadedness
• Sweating
• Dry mouth
• Itching
• Headache

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

Warnings & Precautions

FDA Boxed Warning: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; and Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

• Addiction, abuse, and misuse: Oxymorphone exposes users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing and monitor throughout treatment.
• Life-threatening respiratory depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially when starting treatment and after dose increases.
• Accidental ingestion: Accidental ingestion of even one dose, especially by children, can result in fatal overdose. Store securely and out of reach.
• Neonatal opioid withdrawal syndrome (NOWS): Prolonged use during pregnancy can result in NOWS, which may be life-threatening if not recognized and treated.
• Risks from concomitant use with benzodiazepines or other CNS depressants: Combining oxymorphone with these substances may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with no alternative options, and limit the dose and duration.

Additional Note on Extended-Release Withdrawal: Concerns about abuse of Opana ER, including serious infections and blood disorders linked to injecting the reformulated tablets, led the FDA to request its removal from the U.S. market in 2017. This history highlights the significant abuse potential of oxymorphone products.

Conditions to Disclose to Your Healthcare Provider

Before taking oxymorphone, tell your healthcare provider if you have or have had any of the following:

• Breathing problems, such as asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea
• Liver or kidney problems
• A head injury, brain tumor, or a condition causing increased pressure in the brain
• Adrenal gland problems, such as Addison's disease
• Low blood pressure or fainting spells
• Enlarged prostate or urination problems
• Gallbladder, pancreas, or thyroid problems
• Seizures or a seizure disorder
• Mental health conditions, including depression
• Stomach or bowel problems, such as blockage or ongoing constipation
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take or use oxymorphone if you:

• Have significant respiratory depression
• Have acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
• Have a known or suspected gastrointestinal obstruction, including paralytic ileus
• Have moderate or severe liver problems
• Have a known hypersensitivity to oxymorphone or any component of the formulation
• Are not opioid-tolerant (for extended-release products)

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Key interactions include:

• Benzodiazepines and other CNS depressants: Combined use increases the risk of profound sedation, respiratory depression, coma, and death. This includes sedatives, tranquilizers, muscle relaxants, sleep medications, other opioids, and alcohol.
• Alcohol: Drinking alcohol or taking products that contain alcohol can dangerously increase oxymorphone levels in the blood, raising the risk of fatal overdose. Avoid alcohol entirely.
• Serotonergic drugs: Combined use with certain antidepressants (such as SSRIs, SNRIs, and tricyclics) or other serotonergic medicines may increase the risk of serotonin syndrome.
• Monoamine oxidase inhibitors (MAOIs): May increase the effects of oxymorphone. Use within 14 days of an MAOI is not recommended.
• Mixed agonist/antagonist and partial agonist opioids: Drugs such as buprenorphine, nalbuphine, or pentazocine may reduce the pain-relieving effect and may trigger withdrawal.
• Anticholinergic drugs: May increase the risk of severe constipation, urinary retention, or bowel obstruction.
• Diuretics: Oxymorphone may reduce their effectiveness.

Monitoring Requirements

Your healthcare provider may monitor:

• Signs of respiratory depression and sedation, especially early in treatment and after dose increases
• Your pain relief and overall response to treatment
• Your risk for abuse, misuse, and diversion throughout treatment
• Blood pressure, particularly in patients at risk for low blood pressure
• Bowel function, given the risk of constipation
• Signs of withdrawal if the dose is reduced or the medication is stopped

Abuse, Dependence, and Misuse Warnings

Oxymorphone is a Schedule II controlled substance.

• Oxymorphone is a potent opioid and may be a target for people who abuse prescription medicines or street drugs.
• Physical dependence and tolerance can develop with continued use. Physical dependence is not the same as addiction, but it means you should not stop suddenly.
• Do not increase your dose on your own.
• Do not sell or give away oxymorphone. Doing so may harm others and is against the law.
• Misusing this medication, including injecting or snorting it or taking it in ways other than prescribed, can cause overdose and death. Abuse through injection was a key factor in the 2017 market withdrawal of Opana ER.

Long-Term Use Considerations

• If long-term treatment is needed, your provider should regularly reassess whether it is still appropriate.
• Physical dependence and tolerance are expected with continued use. Any decision to stop treatment should involve a gradual, supervised taper.
• Long-term opioid use may affect hormone levels, leading to symptoms such as low energy, reduced sex drive, or menstrual changes. Tell your provider if these occur.
• Ongoing constipation is common with continued use and may require a management plan from your provider.

Patient Counseling Information

Safe Medication Use

• Take oxymorphone exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Take immediate-release tablets on an empty stomach, at least 1 hour before or 2 hours after eating, since food can dangerously raise drug levels.
• Do not stop taking oxymorphone suddenly after prolonged use. Talk to your healthcare provider about a safe tapering plan.
• Do not share oxymorphone with anyone else. Sharing is dangerous and against the law.
• Keep oxymorphone in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Opioids and CNS depressants: Do not use oxymorphone with other opioids, benzodiazepines, sedatives, or CNS depressants unless directed by your healthcare provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
• Alcohol: Do not drink alcohol while taking oxymorphone. Combining them can dangerously raise drug levels and cause a fatal overdose.
• Driving and machinery: Oxymorphone can make you sleepy or dizzy and can slow your thinking and reaction time. Do not drive or operate heavy machinery until you know how it affects you.
• Naloxone preparedness: Ask your provider about naloxone, a medicine that can reverse an opioid overdose. Make sure family members or caregivers know how to recognize an overdose and use naloxone. Because oxymorphone is potent, more than one dose of naloxone may be needed.
• Pregnancy: Tell your provider right away if you are pregnant or plan to become pregnant, as prolonged use can cause neonatal opioid withdrawal syndrome in your baby.
• Breastfeeding: Oxymorphone can pass into breast milk and may harm a nursing baby. Talk to your provider before breastfeeding while taking oxymorphone.
• Constipation: Ask your provider about ways to prevent or manage constipation while taking oxymorphone.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Have slow, shallow, or stopped breathing, or extreme sleepiness you cannot fight off
• Cannot be easily woken up
• Feel faint, very dizzy, or lightheaded
• Develop signs of serotonin syndrome, such as agitation, hallucinations, fast heartbeat, fever, or muscle stiffness
• Develop signs of adrenal problems, such as ongoing nausea, vomiting, loss of appetite, or severe weakness
• Have a severe allergic reaction, such as swelling of the face or throat, hives, or trouble breathing
• Have a seizure
• Experience withdrawal symptoms such as restlessness, sweating, muscle aches, nausea, or diarrhea after reducing or stopping the medication
• Have severe constipation, stomach pain, or are unable to have a bowel movement
• Have any symptom that concerns you or does not go away