Hydromorphone

Dosage Modifications in Patients with Renal Impairment Initiate treatment with one-fourth to one-half the usual hydromorphone hydrochloride tablets starting dose depending on the degree of impairment [see Use in Specific Populations , Clinical Pharmacology ].

Dosage Modifications in Patients with Hepatic Impairment Initiate treatment with one-fourth to one-half the usual hydromorphone hydrochloride tablets starting dose depending on the degree of impairment [see Use in Specific Populations , Clinical Pharmacology ] .

Important Dosage and Administration Instructions Hydromorphone hydrochloride tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions].

Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of hydromorphone hydrochloride tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic.

Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions].

Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with hydromorphone hydrochloride tablets. Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions ( 2.1 , 5 )]. Initiate treatment with hydromorphone hydrochloride tablets in a dosing range of 2 mg to 4 mg, orally, every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia.

Titrate the dose based upon the individual patient’s response to their initial dose of hydromorphone hydrochloride tablets [see Dosage and Administration, Warnings and Precautions].