Exalgo

Exalgo (hydromorphone HCl) Extended Release Tablets is a narcotic pain reliever (opiate analgesic) used to help relieve moderate to severe ongoing pain (such as due to cancer). Common side effects of Exalgo include:

• nausea,
• vomiting,
• constipation,
• diarrhea,
• stomach pain,
• lightheadedness,
• dizziness,
• drowsiness,
• blurred vision,
• double vision,
• flushing (warmth, redness, or tingly feeling),
• dry mouth,
• sweating,
• itching,
• sleep problems (insomnia), or
• strange dreams.

Tell your doctor if you have serious side effects of Exalgo including:

• mental/mood changes (such as agitation, hallucinations, confusion),
• severe stomach or abdominal pain, or
• difficulty urinating.

The dose of Exalgo is taken once daily, with food. Patients will be monitored when starting this drug. Exalgo may interact with medications for pain, narcotic antagonists, other products that may also affect breathing or cause drowsiness such as alcohol, allergy or cough-and-cold products, anti-seizure drugs, medicines for sleep or anxiety, muscle relaxants, narcotics, or psychiatric medicines. Tell your doctor all medications and supplements you use. During pregnancy, Exalgo should be used only if prescribed. Tell your doctor if you are pregnant or if you plan to become pregnant. Thus drug may increase the risk of birth defects if used during the first two months of pregnancy. Using it near the expected delivery date may harm the fetus. Tell the doctor right away if you notice symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Exalgo (hydromorphone HCl) Extended Release Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Exalgo Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• confusion, feelings of extreme happiness or sadness;
• severe weakness or drowsiness;
• a light-headed feeling, like you might pass out;
• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

• drowsiness, tiredness;
• dizziness;
• headache; or
• constipation, nausea, vomiting, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Exalgo (Hydromorphone Hydrochloride Extended Release Tablets)

 

Exalgo Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

• 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 Benzodiazepine 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

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

EXALGO was administered to a total of 2,524 patients in 15 controlled and uncontrolled clinical studies. Of these, 423 patients were exposed to EXALGO for greater than 6 months and 141 exposed for greater than one year.

The most common adverse reactions leading to study discontinuation were nausea, vomiting, constipation, somnolence, and dizziness. The most common treatment-related serious adverse reactions from controlled and uncontrolled chronic pain studies were drug withdrawal syndrome, overdose, confusional state, and constipation.

The overall incidence of adverse reactions in patients greater than 65 years of age was higher, with a greater than 5% difference in rates for constipation and nausea when compared with younger patients.

The overall incidence of adverse reactions in female patients was higher, with a greater than 5% difference in rates for nausea, vomiting, constipation and somnolence when compared with male patients.

A 12-week double-blind, placebo-controlled, randomized withdrawal study was conducted in opioid tolerant patients with moderate to severe low back pain [see Clinical Studies]. A total of 447 patients were enrolled into the open-label titration phase with 268 patients randomized into the double-blind treatment phase. The adverse reactions that were reported in at least 2% of the patients are contained in Table 2.

Table 2. Number (%) of Patients with Adverse Reactions Reported in ≥ 2% of Patients with Moderate to Severe Low Back Pain During the Open-Label Titration Phase or Double-Blind Treatment Phase by Preferred Term

Preferred Term	Open-Label Titration Phase	Double-Blind Treatment Phase
	EXALGO (N=447)	EXALGO (N=134)	Placebo (N=134)
Constipation	69 (15)	10 (7)	5 (4)
Nausea	53 (12)	12 (9)	10 (7)
Somnolence	39 (9)	1 (1)	0 (0)
Headache	35 (8)	7 (5)	10 (7)
Vomiting	29 (6)	8 (6)	6 (4)
Pruritus	21 (5)	1 (1)	0 (0)
Dizziness	17 (4)	3 (2)	2 (1)
Insomnia	13 (3)	7 (5)	5 (4)
Dry Mouth	13 (3)	2 (1)	0 (0)
Edema Peripheral	13 (3)	3 (2)	1 (1)
Hyperhidrosis	13 (3)	2 (1)	2 (1)
Anorexia/Decreased Appetite	10 (2)	2 (1)	0 (0)
Arthralgia	9 (2)	8 (6)	3 (2)
Abdominal Pain	9 (2)	4 (3)	3 (2)
Muscle Spasms	5 (1)	3 (2)	1 (1)
Weight Decreased	3 (1)	4 (3)	3 (2)

The adverse reactions that were reported in at least 2% of the total treated patients (N=2,474) in the 14 chronic clinical trials are contained in Table 3.

Table 3.
Number (%) of Patients with Adverse Reactions Reported in ≥ 2% of Patients with Chronic Pain Receiving EXALGO in 14 Clinical Studies by Preferred Term

Preferred Term	All Patients (N=2,474)
Constipation	765 (31)
Nausea	684 (28)
Vomiting	337 (14)
Somnolence	367 (15)
Headache	308 (12)
Asthenia/Fatigue	272 (11)
Dizziness	262 (11)
Diarrhea	201 (8)
Pruritus	193 (8)
Insomnia	161 (7)
Hyperhidrosis	143 (6)
Edema Peripheral	135 (5)
Anorexia/Decreased Appetite	139 (6)
Dry Mouth	121 (5)
Abdominal Pain	115 (5)
Anxiety	95 (4)
Back Pain	95 (4)
Dyspepsia*	88 (4)
Depression	81 (3)
Dyspnea	76 (3)
Muscle Spasms	74 (3)
Arthralgia	72 (3)
Rash	64 (3)
Pain in Extremity	63 (3)
Pain	58 (2)
Drug Withdrawal Syndrome	55 (2)
Pyrexia	52 (2)
Fall	51 (2)
Chest pain	51 (2)
* Reflux esophagitis, gastroesophageal reflux disease and Barrett’s esophagus were grouped and reported with dyspepsia

The following Adverse Reactions occurred in patients with an overall frequency of < 2% and are listed in descending order within each System Organ Class:

Cardiac disorders: palpitations, tachycardia, bradycardia, extrasystoles

Ear and labyrinth disorders: vertigo, tinnitus

Endocrine disorders: hypogonadism

Eye disorders: vision blurred, diplopia, dry eye, miosis

Gastrointestinal disorders: flatulence, dysphagia, hematochezia, abdominal distension, hemorrhoids, abnormal feces, intestinal obstruction, eructation, diverticulum, gastrointestinal motility disorder, large intestine perforation, anal fissure, bezoar, duodenitis, ileus, impaired gastric emptying, painful defecation

General disorders and administration site conditions: chills, malaise, feeling abnormal, feeling of body temperature change, feeling jittery, hangover, gait disturbance, feeling drunk, body temperature decreased

Infections and infestations: gastroenteritis, diverticulitis

Injury, poisoning and procedural complications: contusion, overdose

Investigations: weight decreased, hepatic enzyme increased, blood potassium decreased, blood amylase increased, blood testosterone decreased

Metabolism and nutrition disorders: dehydration, fluid retention, increased appetite, hyperuricemia

Musculoskeletal and connective tissue disorders: myalgia

Nervous system disorders: tremor, sedation, hypoesthesia, paresthesia, disturbance in attention, memory impairment, dysarthria, syncope, balance disorder, dysgeusia, depressed level of consciousness, coordination abnormal, hyperesthesia, myoclonus, dyskinesia, crying, hyperreflexia, encephalopathy, cognitive disorder, convulsion, psychomotor hyperactivity

Psychiatric disorders: confusional state, nervousness, restlessness, abnormal dreams, mood altered, hallucination, panic attack, euphoric mood, paranoia, dysphoria, listless, suicide ideation, libido decreased, aggression

Renal and urinary disorders: dysuria, urinary retention, urinary frequency, urinary hesitation, micturition disorder

Reproductive system and breast disorders: erectile dysfunction, sexual dysfunction

Respiratory, thoracic and mediastinal disorders: rhinorrhea, respiratory distress, hypoxia, bronchospasm, sneezing, hyperventilation, respiratory depression

Skin and subcutaneous tissue disorders: erythema

Vascular disorders: flushing, hypertension, hypotension

Postmarketing Experience

The following adverse reactions have been identified during post approval use of hydromorphone. Because these reactions are 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.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs [see DRUG INTERACTIONS].

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use [see WARNINGS AND PRECAUTIONS].

Anaphylaxis: Anaphylactic reaction has been reported with ingredients contained in EXALGO [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

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

Read the entire FDA prescribing information for Exalgo (Hydromorphone Hydrochloride Extended Release Tablets)