Palladone Hydromorphone


Palladone Hydromorphone


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What is Palladone Hydromorphone?

Palladone hydromorphone HCl extended-release Capsules are inicated for the
management of persistent, moderate to severe pain in patients requiring continuous,
around-the-clock analgesia with a high potency opioid for an extended period of time
(weeks to months) or longer. Palladone™ Capsules should only be used in patients
who are already receiving opioid therapy, who have demonstrated opioid tolerance,
and who require a minimum total daily dose of opiate medication equivalent to 12
mg of oral hydromorphone. Patients considered opioid tolerant are those who are
taking at least 60 mg oral morphine/day, or at least 30 mg of oral oxycodone/day, or
at least 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid,
for a week or longer. Palladone Capsules should be administered once every 24
Appropriate patients for treatment with Palladone Capsules include patients who
require high doses of potent opioids on an around-the-clock basis to improve pain
control and patients who have difficulty attaining adequate analgesia with
immediate-release opioid formulations.

Precautions while using Palladone

It is very important that your doctor check your progress while you are using Palladone Hydromorphone. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Do not use Palladone Hydromorphone if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid , linezolid , phenelzine, selegiline, tranylcypromine within the past 14 days.

Palladone Hydromorphone will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Palladone Hydromorphone may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Palladone Hydromorphone may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

If you have been using Palladone Hydromorphone regularly for several weeks or more, do not change your dose or suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely, or to take another narcotic for a while, to lessen the chance of withdrawal side effects (eg, abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping).

Do not take too much of this Palladone Hydromorphone. This can be life-threatening. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

Using Palladone Hydromorphone while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Uses for Palladone

Palladone hydromorphone  oral liquid and tablets are used to relieve pain. The hydromorphone extended-release capsules and Hydromorphone

Hydromorphone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

Palladone Hydromorphone is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

 Side effects of Palladone Hydromorphone

Along with its needed effects, Palladone Hydromorphone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  • Agitation
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody, black, or tarry stools
  • blurred vision
  • changes in behavior
  • chest pain or discomfort
  • decreased urination
  • dry mouth
  • fast, pounding, slow, or irregular heartbeat
  • lightheadedness, dizziness, or fainting
  • mood or mental changes
  • rapid breathing
  • severe stomach pain, cramping, or burning
  • stiff neck
  • sunken eyes
  • thoughts of killing oneself
  • trouble breathing
  • unusual tiredness
  • vomiting of material that looks like coffee grounds, severe and continuing
  • wrinkled skin

Incidence not known

  • Bluish lips or skin
  • change in the ability to see colors, especially blue or yellow
  • cold, clammy skin
  • confusion
  • constricted, pinpoint, or small pupils (black part of the eye)
  • cough
  • decrease in frequency of urination or urine amount
  • deep or fast breathing with dizziness
  • difficulty in passing urine (dribbling)
  • dizziness
  • fast or weak pulse
  • headache
  • hives or welts, itching, skin rash
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • noisy breathing
  • overactive reflexes
  • painful urination
  • pale or blue lips, fingernails, or skin
  • poor coordination
  • restlessness
  • sweating
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • trouble sleeping

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Additional information


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