Palladone

Palladone is a prescription medication used to relieve pain. Palladone belongs to a group of drugs called narcotic analgesics. These work by changing the way that the brain and nervous system respond to pain.

This medication comes in extended release tablets and are taken once a day. 

Do not chew, divide, dissolve, break or open Palladone tablets. Swallow tablets whole with water. 

Common side effects of Palladone constipation, nausea, and vomiting.

Palladone can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Palladone affects you.

Palladone is a prescription medication used to relieve constant (around the clock) pain that is moderate to severe and expected to last for weeks or longer. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take Palladone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Palladone dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• what pain medication you where taking and the dose you were on

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; AND NEONATAL OPIOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse

Hydromorphone hydrochloride extended-release tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing hydromorphone hydrochloride extended-release tablets, and monitor all patients regularly for the development of these behaviors or conditions.

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of hydromorphone hydrochloride extended-release tablets. Monitor for respiratory depression, especially during initiation of hydromorphone hydrochloride extended-release tablets or following a dose increase. Instruct patients to swallow hydromorphone hydrochloride extended-release tablets whole; crushing, chewing, or dissolving hydromorphone hydrochloride extended-release tablets can cause rapid release and absorption of a potentially fatal dose of hydromorphone.

Accidental Ingestion

Accidental ingestion of even one dose of hydromorphone hydrochloride extended-release tablets, especially by children, can result in a fatal overdose of hydromorphone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of hydromorphone hydrochloride extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Serious side effects have been reported with Palladone including the following:

• Rash
• Hives
• Swelling of the eyes, face, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs
• Difficulty breathing or swallowing
• Hoarseness
• Seizures
• Chest pain
• Extreme drowsiness
• Fainting

Palladone can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Palladone affects you.

Do not suddenly stop taking Palladone.

Do not take Palladone if you:

• are allergic to Palladone or to any of its ingredients
• have respiratory depression
• have acute, severe, or uncontrolled asthma

Palladone extended release tablets may only be used in patients who are opioid-tolerant.

Serious side effects have been reported with Palladone. See the “Palladone Precautions” section.

Common side effects of Palladone include the following:

• Constipation
• Nausea
• Vomiting
• Nervousness
• Dizziness
• Drowsiness
• Itching
• Dry mouth
• Sweating
• Weakness
• Headache
• Difficulty sleeping

This is not a complete list of Palladone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Buprenorphine (Buprenex, Butrans, in Suboxone)
• Butorphanol (Stadol)
• Ipratropium (Atrovent)
• Medications for glaucoma, irritable bowel disease, Parkinson's disease, ulcers, and urinary problems
• Pentazocine (Talwin)

Also tell your doctor or pharmacist if you are taking any of the following medications or have stopped taking them within the past 2 weeks:

• Isocarboxazid (Marplan)
• Phenelzine (Nardil)
• Selegiline (Eldepryl, Emsam, Zelapar)
• Tranylcypromine (Parnate)

This is not a complete list of Palladone drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Palladone falls into category C. There are no well-controlled studies that have been done in pregnant women. Palladone should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Palladone has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Palladone, a choice should be made whether to stop nursing or to stop use of this medication. 

Hydromorphone has the potential for addiction, abuse, and misuse. Use this medication only as prescribed.

Seek immediate medical attention if you have difficulty breathing.

Do not abruptly discontinue using extended release hydrocodone. Discuss a tapering regimen with your health care provider before you stop taking extended release hydrocodone.