Exalgo

What is Exalgo?

• Exalgo (Hydromorphone hydrochloride)is an opioid agonist used to treat moderate to severe pain.

Hydromorphone

Hydromorphone skeletal2

Hydromorphone molecule ball

What are the uses of this medicine?

• Exalgo prescription pain medicine that contains an opioid (narcotic) that is used to treat moderate to severe around-the-clock pain, in people who are already regularly using opioid pain medicine.

Limitations of Use:

• As an as-needed (prn) analgesic
• For pain that is mild or not expected to persist for an extended period of time
• For acute pain
• For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time

• EXALGO is only for patients in whom tolerance to an opioid of comparable potency is established.

How does this medicine work?

• Hydromorphone, a semi-synthetic morphine derivative, is a hydrogenated ketone of morphine.
• Hydromorphone is principally an agonist of mu-receptors, showing a weak affinity for k-receptors.
• Comparing relative binding affinity for mu- and k-opioid receptors, hydromorphone binds more specifically to mu-receptors than structurally related morphine.
• As an opioid agonist, the principle therapeutic action of hydromorphone is analgesia.
• The precise mechanism of action of opioid analgesics is not known but the effects are thought to be mediated through opioid-specific receptors located predominantly in the central nervous system (CNS).
• Interaction with the mu-opioid receptor subtype is believed to be responsible for most of hydromorphone’s clinical effects.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

What drug interactions can this medicine cause?

• Avoid use of EXALGO with central nervous system depressants such as hypnotics, sedatives, general anesthetics, antipsychotics and alcohol, due to the increased risk of respiratory depression, hypotension and profound sedation or coma.
• Avoid the use of agonist/antagonist analgesics in patients receiving EXALGO.
• EXALGO is not recommended for use in patients who have received MAOIs within 14 days.
• Monitor patients for signs of urinary retention or reduced gastric motility when EXALGO is used concurrently with anticholinergic drugs.

Is this medicine FDA approved?

• Initial U.S. Approval: 1984

How should this medicine be used?

Recommended dosage:

• Individualize dosing based on patient’s prior analgesic treatment experience, and titrate as needed to provide adequate analgesia and minimize adverse reactions.
• EXALGO is administered at a frequency of once daily (every 24 hours), approximately the same time every day, with or without food.
• To avoid medication errors, prescribers and pharmacists must be aware that hydromorphone is available as both immediate-release 8 mg tablets and extended-release 8 mg tablets.

Administration:

• Do not change your dose. Take EXALGO exactly as prescribed by your healthcare provider.
• Take your prescribed dose at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, do not take EXALGO. Take your next dose at your usual time the next day.
• Swallow EXALGO whole. Do not cut, break, chew, crush, dissolve, or inject EXALGO.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking EXALGO without talking to your healthcare provider.
• EXALGO is contained in a hard tablet shell that you may see in your bowel movement; this is normal.
• After you stop taking EXALGO, flush any unused tablets down the toilet.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As EXALGO (hydromorphone HCl) Extended-Release Tablets: 8 mg, 12 mg, 16 mg, 32 mg

This medicine is available in fallowing brand namesː EXALGO ;Dilaudid

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation
• nausea
• sleepiness
• vomiting
• tiredness
• headache
• dizziness

What special precautions should I follow?

• Do not Drive or operate heavy machinery, until you know how EXALGO affects you. EXALGO can make you sleepy, dizzy, or lightheaded.
• Do not Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
• Monitor closely because of increased risk of respiratory depression in elderly, cachectic, and debilitated patients, and patients with chronic pulmonary disease
• Hypotension, profound sedation, coma, or respiratory depression may result if EXALGO is used concomitantly with other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). If EXALGO therapy is to be initiated in a patient taking a CNS depressant, start with a lower EXALGO dose than usual and monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant.
• EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance. Hydromorphone can be abused in a manner similar to other opioid agonists, legal or illicit.
• Respiratory depression is the primary risk of EXALGO. Avoid use of EXALGO in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention.
• Accidental ingestion of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.
• EXALGO is contraindicated in patients with paralytic ileus. Avoid the use of EXALGO in patients with other GI obstruction.
• EXALGO contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
• Avoid the use of mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including EXALGO. When discontinuing EXALGO, gradually taper the dose . Do not abruptly discontinue EXALGO.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• respiratory depression
• somnolence progressing to stupor or coma
• skeletal muscle flaccidity
• cold and clammy skin
• constricted pupils
• pulmonary edema
• bradycardia
• hypotension
• death
• hypoxia

Treatment of overdosage:

• In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation if needed.
• Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated.
• Cardiac arrest or arrhythmias will require advanced life support techniques.
• The opioid antagonists, such as naloxone and naltrexone, are specific antidotes to respiratory depression resulting from opioid overdose.
• EXALGO will continue to release hydromorphone adding to the hydromorphone load for up to 24 hours after administration, necessitating prolonged monitoring for at least 24 to 48 hours beyond the overdose.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• Hydromorphone crosses the placenta.
• EXALGO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of EXALGO in patients 17 years of age and younger have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• HYDROMORPHONE HYDROCHLORIDE

Inactive ingredients:

• BUTYLATED HYDROXYTOLUENE
• CELLULOSE ACETATE
• FERROSOFERRIC OXIDE
• FERRIC OXIDE RED
• HYPROMELLOSE 2910
• ANHYDROUS LACTOSE
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• POLYETHYLENE GLYCOLS
• POVIDONES
• SODIUM CHLORIDE
• TITANIUM DIOXIDE
• TRIACETIN

Who manufactures and distributes this medicine?

• Distributed by:

Mallinckrodt Brand Pharmaceuticals, Inc. Hazelwood, MO USA

• Distributed by:

Physicians Total Care, Inc. Tulsa, Oklahoma

What should I know about storage and disposal of this medication?

• Store at 25ºC (77ºF); excursions permitted to 15° to 30°C (59° to 86°F).

• Dailymed label info on Exalgo
• FDA Exalgo

Exalgo Resources
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