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Uses

Acute Pain

A strong analgesic used in the relief of moderate to severe pain.

Usually, temporary relief of moderate to severe pain such as that associated with acute and some chronic medical disorders including renal or biliary colic, acute trauma, postoperative pain, and cancer.

Used to provide analgesia during diagnostic and orthopedic procedures.

Highly concentrated 10-mg/mL injection is used for relief of moderate to severe pain in opiate-tolerant patients requiring large doses for adequate pain relief; smaller volume may be injected IM or sub-Q, and discomfort of larger volumes avoided.

IV route (including patient-controlled administration) is preferred for administration of opiate agonists after major surgery since repeated IM injections may cause pain and trauma.

Consider around-the-clock dosing of analgesics in the initial stages of acute pain to avoid wide swings in pain and sedation often associated with as-needed dosing regimens.

Chronic Pain

For relief of malignant (cancer) pain and chronic nonmalignant pain.

In the management of severe, chronic pain associated with a terminal illness such as cancer, the principal goal of analgesic therapy is to make the patient relatively pain-free while maintaining as good a quality of life as possible.

Analgesic therapy must be individualized and titrated according to patient response and tolerance.

Although consideration of the dependence potential of opiate agonists has often limited their effective use by many clinicians in terminally ill patients with severe, chronic pain, such consideration is irrelevant in the context of terminal illness.

As tolerance to initial dosage develops, larger doses may be given as necessary.

Alternative analgesic adjuncts such as tricyclic antidepressants or anticonvulsants also should be considered in the treatment of chronic nonmalignant pain (e.g., neurogenic pain).

During prolonged use, especially when opiate agonists are self-administered, precautions should be taken to prevent unnecessary increases in dosage.

Cough

Control of persistent, nonproductive cough.

Dosage and Administration

Administration

Administer orally, rectally, or by sub-Q, IM, or slow IV injection or infusion.

Oral Administration

Use highly potent 8-mg tablets only after careful evaluation of the clinical situation.

IV Administration

For solution and drug compatibility, see Compatibility under Stability.

Administer by direct IV injection or IV infusion. Also administered IV via a controlled-delivery device for patient-controlled analgesia (PCA).

Reconstitution

Add 25 mL of sterile water for injection to lyophilized powder in the 250-mg vial to provide 10-mg/mL solution.

Dilution

For IV infusion, use 10-mg/mL injection (from the 50-mg ampul, 500-mg single-use vial, or 250-mg vial) for preparation of IV infusion solutions.

If the 500-mg single-use (10-mg/mL) vial is used, remove container seal and rubber stopper in a laminar flow hood or equivalent clean air compounding area; do not penetrate with a syringe.

Withdraw appropriate amount and then discard any unused portion in an appropriate manner.

Rate of Administration

If rapid onset and shorter duration of analgesia are required, may give IV at slow rate (over at least 2–3 minutes), with special attention to the possibility of respiratory depression and hypotension.

Experience with IV administration of the highly concentrated 10-mg/mL injection is limited; if administered IV, inject slowly over at least 2–3 minutes.

IV injection for PCA: self-administered intermittently as needed (“prn”) via controlled-delivery device, with usual lockout intervals (minimum time between self-administered doses programmed into device) of 6–12 minutes.

IM Administration

IM injection is discouraged for any analgesic (e.g., the injection itself is painful, delayed onset).

Use 10-mg/mL injection only in patients tolerant to and receiving high dosages of opiates; do not use when low doses are required.

Use 10-mg/mL injection only when required volume can be accurately measured.

Sub-Q Administration

Use 10-mg/mL injection only in patients tolerant to and receiving high dosages of opiate agonists; do not use when low doses are required.

Use 10-mg/mL injection only when required volume can be accurately measured.

Inject 10-mg/mL injection sub-Q with a short 30-gauge needle to minimize local adverse reactions.

Dosage

Available as hydromorphone hydrochloride; dosage expressed in terms of the salt.

Give the smallest effective dose as infrequently as possible to minimize the development of tolerance and physical dependence.

Reduce dosage in poor-risk patients, in pediatric or geriatric patients, and in patients receiving other CNS depressants.

In patients who are tolerant to opiate agonists and who require high dosages (e.g., patients with severe chronic pain associated with cancer), individualize dosage of highly potent preparations based on response and tolerance.

Avoid abrupt withdrawal from relatively high dosages (e.g., in chronic pain patients) since precipitation of severe abstinence syndrome is likely.

Pediatric Patients

Pain

Oral

Children 6–12 years of age: 0.03–0.08 mg/kg every 4–6 hours as needed.†

Children >12 years of age: 1–4 mg every 4–6 hours as needed.†

IV, IM, or Sub-Q

Children 6–12 years of age: 0.015 mg/kg every 4–6 hours as needed.†

Children >12 years of age: 1–4 mg every 4–6 hours as needed.†

Cough

Oral

Children 6–12 years of age: 0.5 mg every 3–4 hours.†

Children >12 years of age: 1 mg every 3–4 hours.†

Adults

Pain

Oral

Usually, 2 mg every 4–6 hours as necessary.

For severe pain, 4 mg (or more) every 3–6 hours as indicated and tolerated.

IV or IM

1.5–2 mg every 3–6 hours as necessary.

For severe pain, 3–4 mg every 4–6 hours may be given.

Pain associated with terminal cancer: individual doses of 1–14 mg.

Sub-Q

2 mg every 4–6 hours as necessary.

For severe pain, 3–4 mg every 4–6 hours.

Pain associated with terminal cancer: individual doses of 1–14 mg; occasionally, individual 30-mg doses (60 mg total) in opiate-tolerant patients.

Rectal

Suppository: 3 mg every 6–8 hours as necessary.

Cough

Oral

Usually, 1 mg every 3–4 hours.

Special Populations

Geriatric and Debilitated Patients

Select dosage with caution, and use lower than usual initial dosages.