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IBUDONE

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Overview

What is IBUDONE?

Each IBUDONE 5 mg/200 mg tablet contains:

Hydrocodone Bitartrate, USP ........................ 5 mg

Ibuprofen, USP .......................................... 200 mg

Each IBUDONE 10 mg/200 mg tablet contains:

Hydrocodone Bitartrate, USP ...................... 10 mg

Ibuprofen, USP .......................................... 200 mg

IBUDONE (hydrocodone bitartrate and ibuprofen tablets) is supplied in a fixed combination tablet form for oral administration. IBUDONE combines the opioid agonist, hydrocodone bitartrate, with the nonsteroidal anti- inflammatory (NSAID) agent, ibuprofen.

Hydrocodone bitartrate is a semisynthetic opioid agonist. Its chemical name is: 4,5 α-epoxy-3- methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its chemical formula is: CHNO CHO 2½HO, and the molecular weight is 494.50. Its structural formula is:

Ibuprofen is a nonsteroidal anti-inflammatory agent [non-selective COX inhibitor] with analgesic and antipyretic properties. Its chemical name is: (±)-2-(-isobutylphenyl) propionic acid. Its chemical formula is: CHO, and the molecular weight is: 206.29. Its structural formula is:



What does IBUDONE look like?



What are the available doses of IBUDONE?

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What should I talk to my health care provider before I take IBUDONE?

Sorry No records found

How should I use IBUDONE?

IBUDONE tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Carefully consider the potential benefits and risks of IBUDONE and other treatment options before deciding to use IBUDONE. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals .

Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse .

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with IBUDONE and adjust the dosage accordingly .

After observing the response to initial therapy with IBUDONE, the dose and frequency should be adjusted to suit an individual patient's needs.


What interacts with IBUDONE?


  • IBUDONE is contraindicated in patients with:

    • Significant respiratory depression .
    • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment .
    • Known or suspected gastrointestinal obstruction, including paralytic ileus .
    • Known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to hydrocodone, ibuprofen, or any components of the drug product . Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.
    • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients .
    • In the setting of coronary artery bypass graft (CABG) surgery .



What are the warnings of IBUDONE?

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Hydrocodone Component

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Prolonged use of IBUDONE during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .

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Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

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IBUDONE may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) . Monitor these patients for signs of hypotension after initiating or titrating the dosage of IBUDONE. In patients with circulatory shock, IBUDONE may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of IBUDONE in patients with circulatory shock.

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The hydrocodone in IBUDONE may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during IBUDONE therapy.

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IBUDONE may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of IBUDONE and know how they will react to the medication .

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Ibuprofen Component

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A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, IBUDONE is contraindicated in patients with this form of aspirin sensitivity . When IBUDONE is used in patients with pre-existing asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.

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NSAIDs, including ibuprofen, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of IBUDONE at the first appearance of skin rash or any other sign of hypersensitivity. IBUDONE is contraindicated in patients with previous serious skin reactions to NSAIDs .

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Ibuprofen may cause premature closure of the fetal ductus arteriosus. Avoid use of NSAID- containing products, including IBUDONE, in pregnant women starting at 30 weeks of gestation (third trimester) .

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Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy as found in IBUDONE. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease. If signs or symptoms of meningitis develop in a patient on IBUDONE, the possibility of its being related to ibuprofen should be considered.


What are the precautions of IBUDONE?

Masking of Inflammation and Fever

The pharmacological activity of IBUDONE in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

Ophthalmological Effects

Blurred or diminished vision, scotomata, and changes in color vision have been reported with oral ibuprofen. Discontinue ibuprofen if a patient develops such complaints, and refer the patient for an ophthalmologic examination that includes central visual fields and color vision testing.

Information for Patients

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Disposal of Unused IBUDONE

Advise the patient to read the FDA-approved patient labeling () that accompanies each prescription dispensed. Patients, families, or their caregivers should be informed of the following information before initiating therapy with IBUDONE and periodically during the course of ongoing therapy.

Laboratory Monitoring

Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients with a CBC and a chemistry profile periodically .

Drug Interactions



Carcinogenicity, Mutagenicity, Impairment of Fertility



Pregnancy



Nursing Mothers



Pediatric Use

The safety and effectiveness of IBUDONE in pediatric patients below the age of 16 have not been established.

Geriatric Use

In controlled clinical trials there was no difference in tolerability between patients
Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of IBUDONE slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression .

Both hydrocodone and ibuprofen are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Hepatic Impairment

Patients with hepatic impairment may have higher hydrocodone plasma concentrations than those with normal function. In patients with severe hepatic impairment, use a low initial dose. Monitor these patients closely for adverse events such as respiratory depression, sedation, and hypotension.

Renal Impairment

Patients with renal impairment may have higher hydrocodone plasma concentrations than those with normal function. Use a low initial dose in patients with renal impairment and monitor closely for adverse events such as respiratory depression, sedation, and hypotension.


What are the side effects of IBUDONE?

The following adverse reactions are described below and elsewhere in the labeling including the section.

Clinical Trials 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 practice.

IBUDONE 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 . 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 IBUDONE 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 IBUDONE, 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.

B

ody as a Whole

Cardiovascular

Central Nervous System

Digestive

Metabolic and Nutritional Disorders

Respiratory

Skin and Appendages

Special Senses

Urogenital

Incidence less than 1%

Body as a Whole

Cardiovascular

C

e

ntral Nervous System

Digestive

Me

tabolic and Nutritional

M

usculoskeletal

Respiratory

Skin and Appendages

Special Senses

Urogenital

Postmarketing Experience

The following adverse reactions have been identified during post approval use of hydrocodone. 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.

S

er

otonin syndrome:

Adrenal insufficiency:

Anaphylaxis:

Androgen deficiency:

(see )

  • Addiction, Abuse, and Misuse
  • Life-Threatening Respiratory Depression
  • Neonatal Opioid Withdrawal Syndrome
  • Interactions with Cytochrome P450 3A4 Inhibitors and Inducers
  • Interactions with Benzodiazepines or Other CNS Depressants
  • Adrenal Insufficiency
  • Severe Hypotension
  • Seizures
  • Withdrawal
  • Cardiovascular Thrombotic Events
  • Gastrointestinal Bleeding, Ulceration, and Perforation
  • Hepatotoxicity
  • Hypertension
  • Heart Failure and Edema
  • Renal Toxicity and Hyperkalemia
  • Anaphylactic Reactions
  • Exacerbation of Asthma Related to Aspirin Sensitivity
  • Serious Skin Reactions
  • Premature Closure of Fetal Ductus Arteriosus
  • Hematologic Toxicity
  • Aseptic Meningitis



What should I look out for while using IBUDONE?

IBUDONE is contraindicated in patients with:


What might happen if I take too much IBUDONE?

Following an acute overdosage, toxicity may result from hydrocodone and/or ibuprofen.


How should I store and handle IBUDONE?

Handling and DisposalAzacitidine for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. Handling and DisposalAzacitidine for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. IBUDONE (hydrocodone bitartrate and ibuprofen tablets) 5 mg/200 mg are available as:White, film-coated, oval shaped, scored tablets, debossed "3584" on one side and debossed "V" on the reverse side, in bottles of 100 (NDC 50991-578-01).IBUDONE (hydrocodone bitartrate and ibuprofen tablets) 10 mg/200 mg are available as:Purple, film-coated, oval shaped, scored tablets, debossed "3586" on one side and debossed "V" on the reverse side in bottles of 100 (NDC 50991-579-01).IBUDONE (hydrocodone bitartrate and ibuprofen tablets) 5 mg/200 mg are available as:White, film-coated, oval shaped, scored tablets, debossed "3584" on one side and debossed "V" on the reverse side, in bottles of 100 (NDC 50991-578-01).IBUDONE (hydrocodone bitartrate and ibuprofen tablets) 10 mg/200 mg are available as:Purple, film-coated, oval shaped, scored tablets, debossed "3586" on one side and debossed "V" on the reverse side in bottles of 100 (NDC 50991-579-01).


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Clinical Information

Chemical Structure

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Clinical Pharmacology

H

y

d

r

ocodone Component

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

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buprofen Component

The mechanism of action, like that of other NSAIDs, is not completely understood, but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Ibuprofen is a potent inhibitor of prostaglandin synthesis in vitro. Ibuprofen concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because ibuprofen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Non-Clinical Toxicology
IBUDONE is contraindicated in patients with:







After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to IBUDONE.

If concomitant use is necessary, consider dosage reduction of IBUDONE until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider a dosage increase of IBUDONE until stable drug effects are achieved. Monitor for signs of opioid withdrawal.









After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

If concomitant use is necessary, consider a dosage increase of IBUDONE until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider IBUDONE dosage reduction and monitor for signs of respiratory depression.







Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation .









If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue IBUDONE if serotonin syndrome is suspected.

Monoamine Oxidase Inhibitors (MAOIs)

If urgent use of an opioid is necessary with MAOIs such as phenelzine, tranylcypromine, linezolid, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.

The use of IBUDONE is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics

Avoid concomitant use of these drugs.

Muscle Relaxants

Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of IBUDONE and/or the muscle relaxant as necessary.

Anticholinergics

Monitor patients for signs of urinary retention or reduced gastric motility when IBUDONE is used concomitantly with anticholinergic drugs.

Drugs That Interfere With Hemostasis

Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.

Monitor patients with concomitant use of IBUDONE with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding .





Concomitant use of IBUDONE and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding .

ACE-Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers

During concomitant use of IBUDONE and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. Monitor for signs of worsening renal function . These effects are usually reversible.

When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.

Diuretics

During concomitant use of IBUDONE with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects .

Digoxin

During concomitant use of IBUDONE and digoxin, monitor serum digoxin levels.





During concomitant use of IBUDONE and lithium, monitor patients for signs of lithium toxicity.

Methotrexate

During concomitant use of IBUDONE and methotrexate, monitor patients for methotrexate toxicity.









During concomitant use of IBUDONE and cyclosporine, monitor patients for signs of worsening renal function.





The concomitant use of ibuprofen with other NSAIDs or salicylates is not recommended.

Pemetrexed

During concomitant use of IBUDONE and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.

NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.

In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.

The pharmacological activity of IBUDONE in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

The following adverse reactions are described below and elsewhere in the labeling including the section.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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