Dilaudid HP 10MG

Dilaudid HP 10MG (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid agonist.

DILAUDID Tablets are supplied in 2 mg, 4 mg, and 8 mg tablets for oral administration. The tablet strengths describe the amount of hydromorphone hydrochloride in each tablet.

DILAUDID Oral Solution is supplied as 5mg/5 mL (1 mg/mL) viscous liquid.

The chemical name is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular Weight is 321.80.

safety information

Instruct patients to obtain a calibrated measuring cup/syringe for administering DILAUDID Oral Solution to ensure that the dose is measured and administered accurately.

Do not use household teaspoons or tablespoons to measure DILAUDID Oral Solution, as using aWARNINGS AND PRECAUTIONS].

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
• Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS].

Dilaudid Oral Solution

Initiate treatment with DILAUDID Oral Solution in a dosing range of one-half (2.5 mL) to two teaspoonsful (10 mL), 2.5 mg to 10 mg, every 3 to 6 hours as needed for pain.

Dilaudid Tablets

Initiate treatment with DILAUDID Tablets in a dosing range of 2 mg to 4 mg, orally, every 4 to 6 hours.

Dosage Modifications In Patients With Hepatic Impairment

Initiate treatment with one-fourth to one-half the usual DILAUDID starting dose depending on the degree of impairment [see Use In Specific Populations, and CLINICAL PHARMACOLOGY].

Dosage Modifications In Patients With Renal Impairment

Initiate treatment with one-fourth to one-half the usual DILAUDID starting dose depending on the degree of impairment [see Use In Specific Populations, and CLINICAL PHARMACOLOGY].

Titration And Maintenance Of Therapy

Individually titrate DILAUDID Oral Solution or DILAUDID Tablets to a dose that provides adequate analgesia and minimizes adverse reactions. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

side effect

• Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
• Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
• Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
• Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
• Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
• Severe Hypotension [see WARNINGS AND PRECAUTIONS]
• Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]
• Withdrawal [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Serious adverse reactions associated with DILAUDID include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.

The most common adverse effects are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. These effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.

Less Frequently Observed Adverse Reactions

Cardiac disorders: tachycardia, bradycardia, palpitations

Eye disorders: vision blurred, diplopia, miosis, visual impairment

Gastrointestinal disorders: constipation, ileus, diarrhea, abdominal pain

General disorders and administration site conditions: weakness, feeling abnormal, chills

Hepatobiliary disorders: biliary colic

Metabolism and nutrition disorders: decreased appetite

Musculoskeletal and connective tissue disorders: muscle rigidity

Nervous system disorders: headache, tremor, paraesthesia, nystagmus, increased intracranial pressure, syncope, taste alteration, involuntary muscle contractions, presyncope

Psychiatric disorders: agitation, mood altered, nervousness, anxiety, depression, hallucination, disorientation, insomnia, abnormal dreams

Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effects

Respiratory, thoracic, and mediastinal disorders: bronchospasm, laryngospasm

Skin and subcutaneous tissue disorders: urticaria, rash, hyperhidrosis

Vascular disorders: flushing, hypotension, hypertension

Postmarketing Experience

Confusional state, convulsions, drowsiness, dyskinesia, dyspnea, erectile dysfunction, fatigue, hepatic enzymes increased, hyperalgesia, hypersensitivity reaction, lethargy, myoclonus, oropharyngeal swelling, peripheral edema, and somnolence.