Hydromorphone Hydrochloride

Dosage Forms And Strengths

Each 1 mL pre-filled syringe contains 0.5 mg/0.5 mL, 1 mg/mL, 2 mg/mL, or 4 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution.

Each 1 mL pre-filled syringe contains 10 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution.

Storage And Handling

DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless pre-filled syringes. Each 1 mL pre-filled syringe of sterile, aqueous solution contains 0.5 mg, 1 mg, 2 mg, or 4 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION contains no added preservative and is supplied as follows:

0.5 mg/0.5mL in a 1mL pre-filled disposable syringe, NDC 76045-009-05
1 mg/mL in a 1mL pre-filled disposable syringe, NDC 76045-009-10
2mg/mL in a 1mL pre-filled disposable syringe, NDC 76045-010-10
4mg/mL in a 1mL pre-filled disposable syringe, NDC 76045-011-10

Available in a carton of twenty-four (24) syringes for each strength.

DILAUDID-HP INJECTION (hydromorphone hydrochloride) is supplied in clear pre-filled syringes with a dark grey plunger rod. Each 1 mL pre-filled syringe of sterile aqueous solution contains 10 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID-HP INJECTION contains no added preservative and is supplied as follows:

10mg/mL in a 1mL pre-filled disposable syringe, NDC 76045-012-10

Available in a carton of twenty-four (24) syringes.

PROTECT FROM LIGHT.

Protect from light until time of use. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Access to drugs with a potential for abuse such as DILAUDID INJECTION and DILAUDID-HP INJECTION presents an occupational hazard for addiction in the health care industry. Routine procedures for handling controlled substances developed to protect the public may not be adequate to protect health care workers. Implementation of more effective accounting procedures and measures to restrict access to drugs of this class (appropriate to the practice setting) may minimize the risk of self-administration by health care providers.

Distributed by: Fresenius Kabi, Lake Zurich, IL 60047. Revised: Feb 2017

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications, [see DRUG INTERACTIONS].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see ADVERSE REACTIONS].

Healthcare professionals can telephone Fresenius Kabi USA, LLC at 1-800-551-7176 for information or to report adverse events on this product.

Instructions For Use

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if color is darker than pale yellow, if it is discolored in any other way or if it contains a precipitate.

CAUTION: Certain glass syringes may malfunction, break or clog when connected to some Needleless Luer Access Devices (NLADs) and needles. This syringe has a larger internal syringe tip and an external collar (luer collar). The external collar must remain attached to the syringe. Data show that the syringe achieves acceptable connections with the BD Eclipse™ Needle and the Terumo SurGuard2™ Safety Needle and with the following non-center post NLADs: Alaris SMARTSITE™, B-Braun ULTRASITE™, BD-Q SYTE™, Maximum MAX PLUS™, and B-Braun SAFSITE™. The data also show acceptable connections are achieved to the center post ICU Medical CLAVE.. However, spontaneous disconnection of this glass syringe from needles and NLADs with leakage of drug product may occur. Assure that the needle or NLAD is securely attached before beginning the injection. Visually inspect the glass syringe-needle or glass syringe .NLAD connection before and during drug administration. Do not remove the clear plastic wrap around the external collar. (See Figure 1)

Figure 1

1. Inspect the outer packaging (blister pack) by verifying:
   • blister integrity
   • drug name
   • drug strength
   • dose volume
   • route of administration
   • expiry date to be sure that the drug has not expired
   • sterile field applicability
   Do not use if package has been damaged.
2. Peel open the paper (top web) of the outer packaging that displays the product information to access the syringe. Do not pop syringe through. (See Figure 2)
3. Bend the plastic part of the outer packaging (thermoform) so as to present the plunger rod for syringe removal. Once the syringe is removed, if applicable, discard the StabilOxR CANISTER contained at the end of the blister pack.

Figure 2


4. Perform visual inspection on the syringe by verifying:
   • absence of syringe damage
   • absence of external particles
   • absence of internal particles
   • proper drug color
   • expiration date to be sure that the drug has not expired
   • drug name
   • drug strength
   • dose volume
   • route of administration
   • integrity of the plastic wrap around the external collar
5. Do not remove plastic wrap around the external collar. Push plunger rod slightly to break the stopper loose while tip cap is still on.
6. Do not remove plastic wrap around the external collar. Remove tip cap by twisting it off. (See Figure 3)

Figure 3


7. Discard the tip cap.
8. Expel air bubble.
9. Adjust dose into sterile material (if applicable).
10. Connect the syringe to appropriate injection connection depending on route of administration. Before injection, ensure that the syringe is securely attached to the needle or NLAD.
11. Depress plunger rod to deliver medication. Ensure that pressure is maintained on the plunger rod during the entire administration.
12. Remove syringe from NLAD (if applicable) and discard into appropriate receptacle. If delivering the medication with a needle, to prevent needle stick injuries, do not recap needle.

NOTES:

• All steps must be done sequentially
• Do not autoclave syringe
• Do not use this product on a sterile field
• Do not introduce any other fluid into the syringe at any time
• This product is for single dose only

For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Hydromorphone may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take hydromorphone in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how hydromorphone will affect you.

Do not stop using hydromorphone suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using hydromorphone.

Since hydromorphone is used on an as needed basis, you are not likely to miss a dose. Do not use extra medicine to make up the missed dose.

Extended-release hydromorphone is not for use on an as-needed basis for pain.

Your pharmacist can provide more information about hydromorphone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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The following serious adverse reactions are described, or described in greater detail, in other sections:

• 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 and 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]

The following adverse reactions associated with the use of hydromorphone were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serious adverse reactions associated with DILAUDID INJECTION and DILAUDID-HP INJECTION 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, injection site urticaria, fatigue, injection site reactions, peripheral edema

Hepatobiliary disorders: biliary colic

Immune system disorders: anaphylactic reactions, hypersensitivity reactions

Investigations: hepatic enzymes increased

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, convulsion, drowsiness, dyskinesia, hyperalgesia, lethargy, myoclonus, somnolence

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

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

Reproductive system and breast disorders: erectile dysfunction

Respiratory, thoracic, and mediastinal disorders: bronchospasm, laryngospasm, dyspnea, oropharyngeal swelling

Skin and subcutaneous tissue disorders: injection site pain, urticaria, rash, hyperhidrosis

Vascular disorders: flushing, hypotension, hypertension

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis has been reported with ingredients contained in DILAUDID INJECTION and DILAUDID-HP INJECTION.

Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Dilaudid (Hydromorphone Hydrochloride)

• Bronchitis (Acute)
• Chronic Pain
• Hay Fever (Allergic Rhinitis)
• Pain Management
• Sinus Infection (Sinusitis)

• Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.238 239 246 f

• Importance of informing patients that hydromorphone should not be combined with alcohol or other CNS depressants (e.g., sleep medications, tranquilizers).238 239 246

• Importance of informing patients that this is a drug of potential abuse and should also be protected from theft.238 239 246 Risk of severe or fatal respiratory depression if misused or if used in individuals for whom drug was not prescribed.238 246

• Importance of informing patients to keep the drug in a secure location and out of the reach of children.238 246

• Importance of informing patients that hydromorphone dosage should not be adjusted without consulting with a clinician.238 246 Importance of not abruptly discontinuing hydromorphone following prolonged opiate therapy.238 246

• Importance of informing clinician of any breakthrough pain or adverse effects (e.g., constipation) that occur during therapy, so that therapy may be adjusted based on individual patient requirements.238 246

• Potential risk of serotonin syndrome with concurrent use of hydromorphone and other serotonergic agents.400 Importance of immediately contacting clinician if manifestations of serotonin syndrome (e.g., agitation, hallucinations, tachycardia, labile BP, fever, excessive sweating, shivering, shaking, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea) develop.400

• Potential risk of adrenal insufficiency.400 Importance of contacting clinician if manifestations of adrenal insufficiency (e.g., nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, hypotension) develop.400

• Potential for severe constipation to occur.246 Importance of considering use of appropriate laxative therapy upon initiation of therapy for chronic pain.246

• Possible risk (although causality not established) of hypogonadism or androgen deficiency with long-term opiate agonist or partial agonist use.400 Importance of informing clinician if decreased libido, impotence, erectile dysfunction, amenorrhea, or infertility occurs.400

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.238 239 246 f

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.238 239 246 a

• Importance of informing patients of other important precautionary information. (See Cautions.)

Hydromorphone Extended-release Tablets

• Medication guide must be dispensed with every prescription for the extended-release tablets.247 Importance of patients reading the medication guide before initiating therapy and each time the extended-release tablets are dispensed.246

• Importance of not breaking, crushing, chewing, or dissolving extended-release tablets; potentially fatal overdose can occur.246

• Importance of using extended-release tablets exactly as prescribed and only if opiate tolerant.246 If hydromorphone therapy has been interrupted for 3 or more days, importance of contacting clinician prior to reinitiating treatment.246

• Risk of GI obstruction in patients with preexisting severe narrowing of GI tract.246 Importance of informing clinician of prior GI surgeries and GI conditions that may cause narrowing.246 Importance of promptly reporting symptoms of GI obstruction (e.g., abdominal pain or distension, severe constipation, vomiting).246

• Importance of informing patients that shell of extended-release tablet is nonabsorbable and may be passed in the stool.246

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Subject to control under the Federal Controlled Substances Act of 1970 as schedule II (C-II) drugs.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name