Dilaudid

DRUG DESCRIPTION

DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid analgesic.

The chemical name of DILAUDID (hydromorphone hydrochloride) is 4,5?-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is:

DILAUDID®
  (hydromorphone hydrochloride) Structural Formula Illustration

Each 5 mL (1 teaspoon) of DILAUDID ORAL LIQUID contains 5 mg of hydromorphone hydrochloride. In addition, other ingredients include purified water, methylparaben, propylparaben, sucrose, and glycerin. DILAUDID (hydromorphone hydrochloride) ORAL LIQUID may contain traces of sodium metabisulfite.

Each DILAUDID 8 mg TABLET contains 8 mg hydromorphone hydrochloride. In addition, the tablets include lactose anhydrous, and magnesium stearate. DILAUDID (hydromorphone hydrochloride) 8 mg TABLET may contain traces of sodium metabisulfite.

What are the possible side effects of hydromorphone (Dilaudid, Dilaudid-5)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such...

Read All Potential Side Effects and See Pictures of Dilaudid »

What are the precautions when taking hydromorphone hydrochloride (Dilaudid)?

Before taking hydromorphone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus),...

Read All Potential Precautions of Dilaudid »


Dilaudid Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or sweating may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Seek immediate medical attention if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking hydromorphone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Liquid products may contain sugar or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, or urinary problems.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of the potential for harm to the unborn baby. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor promptly.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.


Dilaudid Patient Information Including Side Effects

Brand Names: Dilaudid, Dilaudid-5

Generic Name: hydromorphone (oral) (Pronunciation: HYE droe MOR fone)

  • What is hydromorphone (Dilaudid)?
  • What are the possible side effects of hydromorphone (Dilaudid)?
  • What is the most important information I should know about hydromorphone (Dilaudid)?
  • What should I discuss with my healthcare provider before using hydromorphone (Dilaudid)?
  • How should I use hydromorphone (Dilaudid)?
  • What happens if I miss a dose (Dilaudid)?
  • What happens if I overdose (Dilaudid)?
  • What should I avoid while using hydromorphone (Dilaudid)?
  • What other drugs will affect hydromorphone (Dilaudid)?
  • Where can I get more information?

What is hydromorphone (Dilaudid)?

Hydromorphone is in a group of drugs called narcotic pain relievers, also called opioids. It is similar to morphine.

Hydromorphone is used to treat moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain.

Hydromorphone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of hydromorphone (Dilaudid)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

  • nausea, vomiting, constipation, loss of appetite;
  • warmth, tingling, or redness under your skin;
  • dizziness, headache;
  • dry mouth;
  • sweating; or
  • itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about hydromorphone (Dilaudid)?

Hydromorphone may be habit-forming and should be used only by the person it was prescribed for. Hydromorphone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are taking hydromorphone. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take more than your prescribed dose of hydromorphone. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Hydromorphone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not stop using hydromorphone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

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