Dilaudid-HP

DRUG DESCRIPTION

DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid analgesic. The chemical name of DILAUDID is 4,5?-epoxy-3-hydroxy-17- methylmorphinan-6-one hydochloride. The structural formula is:

DILAUDID® (hydromorphone hydrochloride)Structural Formula Illustration

C17H19NO3•HCl       321.80

DILAUDID INJECTION is available as a sterile, aqueous solution in COLORLESS ampules for parenteral administration. Each 1 mL ampule contains 1 mg, 2 mg, or 4 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH between 3.5 and 5.5.

DILAUDID-HP INJECTION is available as a sterile, aqueous solution in AMBER ampules and in AMBER, single-dose vials for intravenous, subcutaneous, or intramuscular administration. Each ampule and single-dose vial contains 10 mg/mL of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH of between 3.5 and 5.5. The single dose vials are capped with stoppers containing natural rubber latex.

DILAUDID-HP INJECTION is also available as sterile, lyophilized powder in an AMBER, single-dose vial for reconstitution for intravenous, subcutaneous, or intramuscular administration. Each single dose vial contains 250 mg sterile, lyophilized hydromorphone HCl with either hydrochloric acid or sodium hydroxide added to adjust the pH. Each vial is to be reconstituted with 25 mL of Sterile Water for Injection USP to provide a solution containing 10 mg/mL with a pH between 4.5 and 6.5. The single dose vials are capped with stoppers containing natural rubber latex.

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

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...

Read All Potential Side Effects and See Pictures of Dilaudid-HP »

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

Before using hydromorphone, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications; or if you have any other allergies. This product may contain inactive ingredients, 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: abdominal problems (such as chronic constipation, ileus), brain disorders (such as brain injury, tumor, increased intracranial pressure, seizures), diarrhea due to infection (such as Clostridium difficile), breathing problems (such as emphysema, chronic bronchitis, asthma, sleep apnea), heart problems (such as irregular heartbeat, heart failure, low blood pressure), disease of the...

Read All Potential Precautions of Dilaudid-HP »


Dilaudid-HP Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Pain, redness, or swelling at the injection site may also occur. 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. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To lower your 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: severe stomach/abdominal pain, fainting, mental/mood changes (such as agitation, hallucinations, confusion), seizures, change in amount of urine/difficulty urinating.

Seek immediate medical attention if any of these rare but serious side effects occur: severe drowsiness/difficulty waking up, slow/shallow/irregular breathing, fast/slow/irregular heartbeat.

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 using hydromorphone, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications; or if you have any other allergies. This product may contain inactive ingredients, 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: abdominal problems (such as chronic constipation, ileus), brain disorders (such as brain injury, tumor, increased intracranial pressure, seizures), diarrhea due to infection (such as Clostridium difficile), breathing problems (such as emphysema, chronic bronchitis, asthma, sleep apnea), heart problems (such as irregular heartbeat, heart failure, low blood pressure), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as depression, psychosis), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, adrenal gland problem (such as Addison's disease), difficulty urinating (such as due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).

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 the use of alcohol and certain other medications that cause drowsiness (see also Drug Interactions section).

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

Caution is advised when using this drug in older adults because they may be more sensitive to its effects, especially slow/shallow breathing, urination problems, and drowsiness.

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 possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have breathing problems or withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This medication may pass into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.


Dilaudid-HP Patient Information Including Side Effects

Brand Names: Dilaudid, Dilaudid-HP

Generic Name: hydromorphone (injection) (Pronunciation: hy dro MOR fone)

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

What is hydromorphone injection (Dilaudid-HP)?

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

Hydromorphone injection is used to treat moderate to severe pain.

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

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

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:

  • constipation;
  • warmth, tingling, or redness under your skin;
  • nausea, vomiting, diarrhea, loss of appetite;
  • dizziness, headache;
  • pain or tenderness where the injection was given;
  • dry mouth;
  • sweating;
  • itching; or
  • sleep problems (insomnia).

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 injection (Dilaudid-HP)?

Hydromorphone may be habit-forming and should be used only by the person it was prescribed for. Hydromorphone injection should never be shared with another person, especially someone who has a history of drug abuse or addiction.

Do not drink alcohol while you are receiving hydromorhphone. 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.

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 hydmorphone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

You should not receive hydromorphone injection unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

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