Hydromorphone rectal

Generic Name: hydromorphone (rectal) (hye dro MOR fone)

Brand Names: Dilaudid

What is hydromorphone rectal?

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

Hydromorphone rectal is used to treat moderate to severe pain.

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

What is the most important information I should know about hydromorphone rectal?

Do not use hydromorphone with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. You may have withdrawal symptoms when you stop using this medication after using it over a long period of time. Do not stop using hydromorphone suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. 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. 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.

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

Do not take hydromorphone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for using the rectal suppository. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

What should I discuss with my healthcare provider before using hydromorphone rectal?

Do not use this medication if you are allergic to hydromorphone, or if you have breathing problems such as an asthma attack.

Before using hydromorphone, tell your doctor if you are allergic to any drugs, or if you have:

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  asthma, COPD, sleep apnea, or other breathing disorders;

  
  


• liver disease;


• kidney disease;


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  underactive thyroid;

  
  


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  curvature of the spine;

  
  


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  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


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  low blood pressure;

  
  


• 
  

  gallbladder disease;

  
  


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  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  enlarged prostate, urination problems;

  
  


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  mental illness; or

  
  


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  a history of drug or alcohol addiction.

  
  

If you have any of these conditions, you may not be able to use hydromorphone, or you may need a dosage adjustment or special tests during treatment.

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. FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydromorphone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to anyone younger than 18 years old. Older adults may be more sensitive to the effects of this medicine.

How should I use hydromorphone rectal?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Never use more hydromorphone than is prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not take hydromorphone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for using the rectal suppository. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down after inserting it and hold in the suppository for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are using hydromorphone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using hydromorphone. You may need to stop using the medicine for a short time.

You may have withdrawal symptoms when you stop using this medication after using it over a long period of time. Withdrawal symptoms include feeling restless or irritable, blurred vision, runny nose, watery eyes, yawning, sweating, tingly feeling under your skin, sleep problems, weakness, muscle spasms, severe back or stomach pain, muscle cramps, hot and cold flashes, nausea, vomiting, diarrhea, weight loss, and fast heart rate. Do not stop using hydromorphone suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store the suppositories in the refrigerator and do not allow them to freeze.

What happens if I miss a dose?

Since hydromorphone is sometimes used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Try to use the medicine at a time when you can lie down afterward and hold the medicine in. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of hydromorphone can be fatal.

Symptoms of a hydromorphone overdose may include extreme drowsiness, muscle weakness, confusion, cold and clammy skin, pinpoint pupils, shallow breathing, slow heart rate, fainting, or coma.

What should I avoid while using hydromorphone rectal?

Do not drink alcohol while you are using hydromorphone. Dangerous side effects or death can occur when alcohol is combined with hydromorphone. Check the label of any other medicines you take to be sure they do not contain alcohol.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by hydromorphone, which could result in extreme drowsiness or coma.

Do not use hydromorphone if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you use hydromorphone before the MAO inhibitor has cleared from your body. 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.

Hydromorphone rectal side effects

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:

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  shallow breathing, slow heartbeat;

  
  


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  seizure (convulsions);

  
  


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  cold, clammy skin;

  
  


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  confusion;

  
  


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  severe weakness or dizziness; or

  
  


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  feeling light-headed, fainting.

  
  

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

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  constipation;

  
  


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  warmth, tingling, or redness under your skin;

  
  


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  nausea, vomiting, diarrhea, loss of appetite;

  
  


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  dizziness, headache;

  
  


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  dry mouth;

  
  


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  sweating;

  
  


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  itching; or

  
  


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  sleep problems (insomnia).

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Hydromorphone Dosing Information

Usual Adult Dose for Pain:

Doses should be titrated to appropriate analgesic effects while minimizing adverse effects. When changing routes of administration, it should be noted that oral doses are less than one-half as effective as parenteral doses. Oral doses may be only one fifth as effective as parenteral doses.

Oral: Initial: Opiate-naive: 1 to 2 mg/dose every 3 to 4 hours as needed; patients with prior opiate exposure may tolerate higher initial doses
Usual dose: 2 to 4 mg/dose; oral doses up to 8 mg have been used

Note: The American Pain Society recommends an initial oral dose of 4 to 8 mg for severe pain in adults.

Chronic pain: Oral: Patients taking opioids chronically may become tolerant and require doses higher than the usual dosage range to maintain the desired effect. Tolerance can be managed by appropriate dose titration. There is no optimal or maximal dose for hydromorphone in chronic pain. The appropriate dose is one that relieves pain throughout its dosing interval without causing unmanageable side effects.

IV: Initial: Opiate-naive: 0.2 to 0.6 mg/dose every 2 to 4 hours as needed; patients with prior opiate exposure may tolerate higher initial doses.

Patient-controlled analgesia (PCA):
All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Doses, lockouts, and limits should be adjusted based on required loading dose, age, state of health, and presence of opioid tolerance. The lower end of dosing range should be used for opioid-naive patients. Assess patient and pain control at regular intervals and adjust settings if needed.
Usual concentration: 0.2 mg/mL
Demand dose: Usual initial: 0.1 to 0.2 mg; usual range: 0.05 to 0.4 mg
Lockout interval: Usual initial: 6 minutes; usual range: 5 to 10 minutes

IM, subcutaneous:
Note: IM use may result in variable absorption and a lag time to peak effect.
Initial: Opiate-naive: 0.8 to 1 mg every 4 to 6 hours as needed; patients with prior opioid exposure may require higher initial doses; usual dosage range: 1 to 2 mg every 3 to 6 hours as needed.

Rectal: 3 mg (1 suppository) every 4 to 8 hours as needed.

IV: Critically ill adult patients: 0.7 to 2 mg (based on 70 kg patient) every 1 to 2 hours as needed. More frequent dosing may be needed (e.g., mechanically ventilated patients).
IV continuous infusion: Usual dosage range: 0.5 to 1 mg/hour (based on 70 kg patient) or 7 to 15 mcg/kg/hour

Epidural:
Bolus dose: 0.8 to 1.5 mg
Infusion concentration: 0.05 to 0.075 mg/mL
Infusion rate: 0.04 to 0.4 mg/hour
Demand dose: 0.15 mg
Lockout interval: 30 minutes

Hydromorphone extended release tablets:
Hydromorphone extended release tablets are indicated for opioid tolerant patients only. Patient must not be started on hydromorphone extended release tablets as their first opioid.

Hydromorphone extended release tablets should be swallowed whole and should not be broken, crushed, dissolved, or chewed before swallowing. The tablets are to be administered every 24 hours with or without food.

The dose range of hydromorphone extended release tablets studied in clinical trials is 8 mg to 64 mg.

Patients receiving oral immediate-release hydromorphone may be converted to hydromorphone extended release tablets by administering a starting dose equivalent to the patient's total daily oral hydromorphone dose, taken once daily. The dose of hydromorphone extended release tablets can be titrated every 3 to 4 days until adequate pain relief with tolerable side effects has been achieved.

It is critical to accurately initiate the dosing regimen individually for each patient. Overestimating the hydromorphone extended release tablets dose when converting patients from another opioid medication can result in fatal overdose with the first dose. In the selection of the initial dose of hydromorphone extended release tablets, the following should be noted:
-the daily dose, potency, and specific characteristics of the opioid the patient has been taking previously;
-the reliability of the relative potency estimate used to calculate the equivalent hydromorphone dose needed;
-the patient's degree of opioid tolerance;
-the age, general condition, and medical status of the patient;
-concurrent non-opioid analgesics and other medications, such as those with central nervous system activity;
-the type and severity of the patient's pain;
-the balance between pain control and adverse effects;
-risk factors for abuse, addiction, or diversion, including a prior history of abuse, addiction, or diversion.

Dosing recommendations, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Conversion from Oral Opioids to hydromorphone extended release tablets:
For conversion from other opioids to hydromorphone extended release tablets, physicians and other healthcare professionals are advised to refer to published relative potency data, keeping in mind that conversion ratios are only approximate. In general, therapy with hydromorphone extended release tablets should be started by administering 50% of the calculated total daily dose of hydromorphone extended release tablets every 24 hours. The initial dose of hydromorphone extended release tablets can be titrated until adequate pain relief with tolerable side effects has been achieved.

Conversion from transdermal fentanyl to hydromorphone extended release tablets:
Eighteen hours following the removal of the transdermal fentanyl patch, hydromorphone extended release tablets treatment can be initiated. For each 25 mcg/hr fentanyl transdermal dose the equianalgesic dose of hydromorphone extended release tablets is 12 mg every 24 hours. An appropriate starting dose of hydromorphone extended release tablets is 50% of the calculated total daily dose every 24 hours.

Individualization of Dosage:
Once therapy is initiated, assess pain relief and other opioid adverse reactions frequently.

Titrate patients to adequate analgesia with dose increases not more often than every 3 to 4 days, in order to attain steady-state plasma concentrations of hydromorphone at each dose.

As a guideline, consider dosage increases of 25% to 50% of the current daily dose of hydromorphone extended release tablets for each titration step.

If more than two doses of rescue medication are needed within a 24 hour period for two consecutive days, the dose of hydromorphone extended release tablets may need to be titrated upward.

Administer hydromorphone extended release tablets no more frequently than every 24 hours.

During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and the caregiver/family.

Maintenance of Therapy:
During chronic therapy with hydromorphone extended release tablets, assess the continued need for around-the-clock opioid therapy periodically. Continue to assess patients for their clinical risks for opioid abuse, addiction, or diversion particularly with high-dose formulations. If patients need to titrate while on maintenance therapy, follow the same method outlined above to reestablish pain control.

Usual Adult Dose for Cough:

1 mg orally every 3 to 4 hours as needed.

Usual Pediatric Dose for Pain:

Doses should be titrated to appropriate analgesic effects while minimizing adverse effects. When changing routes of administration, it should be noted that oral doses are less than one-half as effective as parenteral doses. Oral doses may be only one fifth as effective as parenteral doses.

Greater than 6 months and greater than 10 kg:
Oral: Usual initial dose: 0.03 mg/kg/dose every 4 hours as needed; usual dose range: 0.03 to 0.06 mg/kg/dose
IV: Usual initial dose: 0.01 mg/kg/dose every 3 to 6 hours as needed
IV continuous infusion: Usual initial dose: 0.003 to 0.005 mg/kg/hour

Children and Adolescents less than 50 kg:
Oral: 0.03 to 0.08 mg/kg/dose every 3 to 4 hours as needed
The American Pain Society recommends an initial oral dose of 0.06 mg/kg for severe pain in children.
IV: 0.015 mg/kg/dose every 3 to 6 hours as needed.
IV continuous infusion: Usual initial dose: 0.003 to 0.005 mg/kg/hour (maximum: 0.2 mg/hour)
IV: Patient-controlled analgesia (PCA): Opiate-naive:
5 to 12 years and less than 50 kg:
PCA has been used in children as young as 5 years of age. However, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.
Usual concentration: 0.2 mg/mL
Demand dose: Usual initial dose: 0.003 to 0.004 mg/kg/dose; usual dose range: 0.003 to 0.005 mg/kg/dose
Lockout: Usual initial: 5 doses/hour
Lockout interval: Range: 6 to 10 minutes
Usual basal rate: up to 0.004 mg/kg/hour

Greater than 50 kg:
Oral: Initial: Opiate-naive: 1 to 2 mg/dose every 3 to 4 hours as needed
Patients with prior opiate exposure may tolerate higher initial doses.

IV: Initial: Opiate-naive: 0.2 to 0.6 mg/dose every 2 to 4 hours as needed.
Patients with prior opiate exposure may tolerate higher initial doses.

Patient-controlled analgesia (PCA):
All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Doses, lockouts, and limits should be adjusted based on required loading dose, age, state of health, and presence of opioid tolerance. The lower end of dosing range should be used for opioid-naive patients. Assess patient and pain control at regular intervals and adjust settings if needed.
Usual concentration: 0.2 mg/mL
Demand dose: Usual initial: 0.1 to 0.2 mg; usual range: 0.05 to 0.4 mg
Lockout interval: Usual initial: 6 minutes; usual range: 5 to 10 minutes
IM, subcutaneous:
Note: IM use may result in variable absorption and a lag time to peak effect.
Initial dose for opiate-naive patients: 0.8 to 1 mg every 4 to 6 hours as needed; patients with prior opioid exposure may require higher initial doses; usual dosage range: 1 to 2 mg every 3 to 6 hours as needed.
Rectal: 3 mg (1 suppository) every 4 to 8 hours as needed.

Usual Pediatric Dose for Cough:

6 to 12 years: 0.5 mg orally every 3 to 4 hours as needed.

Greater than 12 years: 1 mg orally every 3 to 4 hours as needed.

What other drugs will affect hydromorphone rectal?

Do not use hydromorphone with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Before using hydromorphone, tell your doctor if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex). If you are using any of these drugs, you may not be able to use hydromorphone, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect hydromorphone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More hydromorphone resources

• Hydromorphone Side Effects (in more detail)
• Hydromorphone Dosage
• Hydromorphone Use in Pregnancy & Breastfeeding
• Drug Images
• Hydromorphone Drug Interactions
• Hydromorphone Support Group
• 165 Reviews for Hydromorphone - Add your own review/rating

Compare hydromorphone with other medications

• Anesthetic Adjunct
• Cough
• Pain

Where can I get more information?

• Your pharmacist has information about hydromorphone rectal written for health professionals that you may read.

See also: hydromorphone side effects (in more detail)