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Vicoprofen

  • Generic Name: hydrocodone and ibuprofen
  • Brand Name: Vicoprofen

Vicoprofen (Hydrocodone and Ibuprofen) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Vicoprofen Side Effects Center

What Is Vicoprofen?

Vicoprofen (hydrocodone and ibuprofen) is a combination of a narcotic pain reliever and a nonsteroidal anti-inflammatory drug (NSAID) used short-term to relieve severe pain. Vicoprofen is not for treating arthritis pain. Vicoprofen is available in generic form.

What Are Side Effects of Vicoprofen?

Common side effects of Vicoprofen include:

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

Dosage for Vicoprofen

The dose of Vicoprofen is adjusted to the individual patient.

What Drugs, Substances, or Supplements Interact with Vicoprofen?

Vicoprofen may adversely interact with antidepressants, MAO inhibitors, aspirin or other NSAIDs, ACE inhibitors, lithium, bronchodilators, diuretics (water pills), corticosteroids, blood thinners, methotrexate, injected narcotic medication, atropine, scopolamine, or bowel or bladder medications. Discuss all medications you are taking with your doctor.

Vicoprofen During Pregnancy or Breastfeeding

During the first 6 months of pregnancy, this medication should be used only when prescribed by a doctor. It is not recommended during the last 3 months of pregnancy due to possible harm to the fetus and interference with normal labor/delivery. Use of this medication near or at the time of delivery may have side effects (such as slow/shallow breathing) on the newborn. Babies born to mothers who have used this medication may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor promptly. Vicoprofen passes into breast milk and may have effects on a nursing infant. Consult your doctor before breastfeeding. Vicoprofen may cause withdrawal reactions. Withdrawal symptoms (restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal, your doctor may reduce your dose gradually. Report any withdrawal reactions to your doctor immediately.

Additional Information

Our Vicoprofen Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Vicoprofen 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.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or 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:

  • weak or shallow breathing, sighing, slow heartbeat, breathing that stops during sleep;
  • swelling, rapid weight gain;
  • a skin rash, no matter how mild;
  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems--loss of appetite, diarrhea, upper stomach pain, tiredness, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
  • low cortisol levels--vomiting, dizziness, worsening tiredness or weakness; or
  • high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

  • dizziness, drowsiness;
  • stomach pain, nausea, vomiting, heartburn, gas;
  • constipation, diarrhea; or
  • headache.

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 Vicoprofen (Hydrocodone and Ibuprofen)

 

Vicoprofen Professional Information

SIDE EFFECTS

VICOPROFEN (hydrocodone and ibuprofen) was administered to approximately 300 pain patients in a safety study that employed dosages and a duration of treatment sufficient to encompass the recommended usage (see DOSAGE AND ADMINISTRATION). Adverse event rates generally increased with increasing daily dose. The event rates reported below are from approximately 150 patients who were in a group that received one tablet of VICOPROFEN (hydrocodone and ibuprofen) an average of three to four times daily. The overall incidence rates of adverse experiences in the trials were fairly similar for this patient group and those who received the comparison treatment, acetaminophen 600 mg with codeine 60 mg.

The following lists adverse events that occurred with an incidence of 1% or greater in clinical trials of VICOPROFEN (hydrocodone and ibuprofen) , without regard to the causal relationship of the events to the drug. To distinguish different rates of occurrence in clinical studies, the adverse events are listed as follows:

name of adverse event = less than 3%

adverse events marked with an asterisk * = 3% to 9%

adverse event rates over 9% are in parentheses.

Body as a Whole

Abdominal pain*; Asthenia*; Fever; Flu syndrome; Headache (27%); Infection*; Pain.

Cardiovascular

Palpitations; Vasodilation.

Central Nervous System

Anxiety*; Confusion; Dizziness (14%); Hypertonia; Insomnia*; Nervousness*; Paresthesia; Somnolence (22%); Thinking abnormalities.

Digestive

Anorexia; Constipation (22%); Diarrhea*; Dry mouth*; Dyspepsia (12%); Flatulence*; Gastritis; Melena; Mouth ulcers; Nausea (21%); Thirst; Vomiting*.

Metabolic and Nutritional Disorders

Edema*.

Respiratory

Dyspnea; Hiccups; Pharyngitis; Rhinitis.

Skin and Appendages

Pruritus*; Sweating*.

Special Senses

Tinnitus.

Urogenital

Urinary frequency.

Incidence less than 1%

Body as a Whole Allergic reaction.

Cardiovascular

Arrhythmia; Hypotension; Tachycardia.

Central Nervous System

Agitation; Abnormal dreams; Decreased libido; Depression; Euphoria; Mood changes; Neuralgia; Slurred speech; Tremor, Vertigo.

Digestive

Chalky stool; “Clenching teeth”; Dysphagia; Esophageal spasm; Esophagitis; Gastroenteritis; Glossitis; Liver enzyme elevation.

Metabolic and Nutritional

Weight decrease.

Musculoskeletal

Arthralgia; Myalgia.

Respiratory

Asthma; Bronchitis; Hoarseness; Increased cough; Pulmonary congestion; Pneumonia; Shallow breathing; Sinusitis.

Skin and Appendages

Rash; Urticaria.

Special Senses

Altered vision; Bad taste; Dry eyes.

Urogenital

Cystitis; Glycosuria; Impotence; Urinary incontinence; Urinary retention.

Drug Abuse and Dependence

Misuse Abuse and Diversion of Opioids

VICOPROFEN (hydrocodone and ibuprofen) contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. VICOPROFEN (hydrocodone 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. VICOPROFEN (hydrocodone 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 Vicoprofen (Hydrocodone and Ibuprofen)

&Copy; Vicoprofen Patient Information is supplied by Cerner Multum, Inc. and Vicoprofen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.