Hydromorphone Suppository

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use suppository rectally.
• Wash your hands before and after use.
• If suppository is soft, chill in a refrigerator or run cold water over it.
• Lie down on your side.
• Take foil off the rectal suppository and put in, pointed end first. Do not handle too much.
• Wet suppository before putting in rectum.

What do I do if I miss a dose?

• If you take hydromorphone suppository on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time hydromorphone suppository is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take hydromorphone suppository or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to hydromorphone suppository. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Hydromorphone hydrochloride is a Schedule II opioid. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, hydromorphone hydrochloride should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydromorphone hydrochloride is used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, usually assumes clinically significant proportions only after several weeks of continued opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.

Signs and Symptoms:

Serious overdosage with hydromorphone hydrochloride is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, particularly the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur.

Treatment:

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids, including hydromorphone hydrochloride. Therefore, naloxone hydrochloride should be administered as described under Adverse Reactions (see Respiratory Depression) in conjunction with ventilatory assistance.

Since the duration of action of hydromorphone hydrochloride may exceed that of the antagonist, the patient should be kept under continued surveillance; repeated doses of the antagonist may be required to maintain adequate respiration. An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.

Rx Only

NDC 0574-7224-06

HYDROmorphone Hydrochloride 3 mg Suppositories

CII

Warning: May be habit forming

UNIT DOSE

FOR RECTAL USE ONLY

6 Suppositories