Combunox

What Is Combunox?

Combunox (oxycodone hcl and ibuprofen) is a combination narcotic pain reliever and nonsteroidal anti-inflammatory drug (NSAID) used short-term to relieve moderate to severe pain. The brand name Combunox is discontinued, but generic versions may be available.

What Are Side Effects of Combunox?

Common side effects of Combunox (oxycodone hcl and ibuprofen) include:

• nausea,
• vomiting,
• constipation,
• bloating,
• gas,
• diarrhea,
• dizziness,
• drowsiness,
• upset stomach,
• weakness,
• headache,
• blurred vision, or
• dry mouth

Dosage for Combunox

For the management of acute moderate to severe pain, the recommended dose of Combunox is one tablet given orally.

What Drugs, Substances, or Supplements Interact with Combunox?

Combunox may interact with other medicines that make you sleepy (such as cold or allergy medicine, sedatives, other narcotics, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), blood thinners, MAO inhibitors, aspirin or other NSAIDs, heart or blood pressure medications, lithium, bronchodilators, diuretics, steroids, methotrexate, atropine, dimenhydrinate, scopolamine, or bowel or bladder medications. Tell your doctor all medications and supplements you use. Before using Combunox, tell your doctor if you are pregnant or if you plan to become pregnant.

Combunox During Pregnancy or Breastfeeding

During pregnancy, Combunox should be used only if prescribed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the fetus and interference with normal labor/delivery. Tell the doctor if you notice symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Additional Information

Our Combunox (oxycodone hcl and ibuprofen) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Combunox Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg, swelling, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

• weak or shallow breathing, sighing, slow heartbeats, breathing that stops during sleep;
• swelling or rapid weight gain;
• a skin rash, no matter how mild;
• pale skin, feeling light-headed;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• liver problems--loss of appetite, diarrhea, upper stomach pain, tiredness, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes).

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 overweight, malnourished, or debilitated.

Common side effects may include:

• dizziness, drowsiness;
• blurred vision; or
• nausea, vomiting, upset stomach, constipation, diarrhea.

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 Combunox (Oxycodone HCl and Ibuprofen)

 

Combunox Professional Information

SIDE EFFECTS

Listed below are the adverse event incidence rates from single dose analgesia trials in which a total of 2437 patients received either Combunox (oxycodone hcl and ibuprofen) , ibuprofen (400 mg), oxycodone HCl (5 mg), or placebo. Adverse event information is also provided from an additional 334 patients who were exposed to Combunox (oxycodone hcl and ibuprofen) in a multiple dose analgesia trial, without placebo or active component comparison arms, given up to four times daily for up to 7 days.

Adverse Events Which Occurred at a Frequency of ≥ 1% and at a Higher Incidence than in the Placebo Group in Single Dose Studies

	5/400 mg (n=923)	400mg Ibuprofen (n=913)	5mg Oxycodone HCl (n = 286)	Placebo (n=315)
Digestive
Nausea	81 (8.8%)	44 (4.8%)	46 (16.1%)	21 (6.7%)
Vomiting	49 (5.3%)	16 (1.8%)	30 (10.5%)	10 (3.2%)
Flatulence	9 (1.0%)	7 (0.8%)	3 (1.0%)	0
Nervous System
Somnolence	67 (7.3%)	38 (4.2%)	12 (4.2%)	7 (2.2%)
Dizziness	47 (5.1%)	21 (2.3%)	17 (5.9%)	8 (2.5%)
Skin and Appendages
Sweat	15 (1.6%)	7 (0.8%)	4 (1.4%)	1 (0.3%)

Adverse events that were reported by at least 1% of patients taking Combunox (oxycodone hcl and ibuprofen) but were observed at a greater incidence in the placebo treated patients were fever, headache and pruritus.

Adverse events that occurred in less than 1% and in at least two Combunox (oxycodone hcl and ibuprofen) treated patients in Single Dose studies not listed above include the following: Body as Whole: abdominal pain, asthenia, chest pain, enlarged abdomen. Cardiovascular System: hypotension, syncope, tachycardia, vasodilation. Digestive System: constipation, dry mouth, dyspepsia, eructation, ileus. Hemic and Lymphatic System: anemia. Metabolic and Nutritional Disorders: edema. Nervous System: euphoria, insomnia, nervousness. Respiratory System: hypoxia, lung disorder, pharyngitis. Urogenital System: urinary retention.

Adverse events that occurred in the Multiple Dose study in at least 2% of patients treated with Combunox (oxycodone hcl and ibuprofen) include the following: Body as Whole: asthenia (3.3%), fever (3.0%), headache (10.2%). Cardiovascular System: vasodilation (3.0%). Digestive System: constipation (4.5%), diarrhea (2.1%), dyspepsia (2.1%), nausea (25.4%), vomiting (4.5%). Nervous System: dizziness (19.2%), somnolence (17.4%).

Adverse events that occurred in less than 2% of and at least two Combunox (oxycodone hcl and ibuprofen) treated patients in the Multiple Dose study not listed previously include the following: Body as Whole: back pain, chills, infection. Cardiovascular System: thrombophlebitis. Hemic and Lymphatic System: ecchymosis. Metabolic and Nutritional Disorders: hypokalemia. Musculoskeletal System: arthritis. Nervous System: abnormal thinking, anxiety, hyperkinesia, hypertonia. Skin and Appendages: rash. Special Senses: amblyopia, taste perversion. Urogenital System: urinary frequency.

Drug Abuse And Dependence

Combunox (oxycodone hcl and ibuprofen) contains oxycodone, which is a mu-opioid agonist with an abuse liability similar to other opioid agonists and is a Schedule II controlled substance. Combunox (oxycodone hcl and ibuprofen) , and other opioids used in analgesia, can be abused and are subject to criminal diversion.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.

“Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Combunox (oxycodone hcl and ibuprofen) , like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Read the entire FDA prescribing information for Combunox (Oxycodone HCl and Ibuprofen)