Oxycodone hydrochloride and Ibuprofen

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Overview

What is Oxycodone hydrochloride and Ibuprofen?

Each Oxycodone Hydrochloride and Ibuprofen Tablets contain: Oxycodone hydrochloride, USP 5 mg and Ibuprofen, USP 400 mg.

Oxycodone Hydrochloride and Ibuprofen Tablets are supplied in a fixed combination tablet form for oral administration and combines the opioid analgesic agent, oxycodone hydrochloride, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.

Oxycodone hydrochloride, USP is a centrally acting semisynthetic opioid analgesic. Its chemical name is 4,5α- Epoxy-14-hydroxy-3-methoxy-methylmorphinan-6-one hydrochloride. Its molecular formula is CHNO •HCl and molecular weight is 351.82. Its structural formula is:

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

Inactive ingredients in Oxycodone Hydrochloride and Ibuprofen Tablets include: calcium stearate, croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, pregelatinized starch (corn), and stearic acid. The coloring agents consist of hypromellose, lactose monohydrate, polyethylene glycol, synthetic yellow iron oxide, titanium dioxide, and triacetin.

What does Oxycodone hydrochloride and Ibuprofen look like?

What are the available doses of Oxycodone hydrochloride and Ibuprofen?

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What should I talk to my health care provider before I take Oxycodone hydrochloride and Ibuprofen?

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How should I use Oxycodone hydrochloride and Ibuprofen?

Oxycodone Hydrochloride and Ibuprofen Tablets are indicated for the management of short term (no more than 7 days) acute to moderate pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Carefully consider the potential benefits and risks of Oxycodone Hydrochloride and Ibuprofen Tablets and other treatment options before deciding to use Oxycodone Hydrochloride and Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses reserve Oxycodone Hydrochloride and Ibuprofen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

Important Dosage and Administration Instructions

Carefully consider the potential benefits and risks of Oxycodone Hydrochloride and Ibuprofen Tablets and other treatment options before deciding to use. 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 to 72 hours of initiating therapy and following dosage increases with Oxycodone Hydrochloride and Ibuprofen Tablets and adjust the dosage accordingly

Initial Dosage

Initiating Treatment with Oxycodone Hydrochloride and Ibuprofen Tablets

Initiate treatment with Oxycodone Hydrochloride and Ibuprofen Tablets in a dosing range of one 5 mg/400 mg tablet every 6 hours as needed for pain.

Dosage should not exceed four 5 mg/400 mg tablets in a 24-hour period and should not exceed 7 days.

Titration and Maintenance of Therapy

Individually titrate Oxycodone Hydrochloride and Ibuprofen Tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Oxycodone Hydrochloride and Ibuprofen Tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse . Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Oxycodone Hydrochloride and Ibuprofen Tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of Oxycodone Hydrochloride and Ibuprofen Tablets

When a patient who has been taking Oxycodone Hydrochloride and Ibuprofen Tablets regularly and may be physically dependent no longer requires therapy with Oxycodone Hydrochloride and Ibuprofen Tablets, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Oxycodone Hydrochloride and Ibuprofen Tablets in a physically dependent patient

What interacts with Oxycodone hydrochloride and Ibuprofen?

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What are the warnings of Oxycodone hydrochloride and Ibuprofen?

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What are the precautions of Oxycodone hydrochloride and Ibuprofen?

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What are the side effects of Oxycodone hydrochloride and Ibuprofen?

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What should I look out for while using Oxycodone hydrochloride and Ibuprofen?

Oxycodone Hydrochloride and Ibuprofen Tablets are contraindicated in patients with:

Oxycodone component

What might happen if I take too much Oxycodone hydrochloride and Ibuprofen?

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

Clinical Presentation

Oxycodone Component

Acute overdose with Oxycodone Hydrochloride and Ibuprofen Tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Ibuprofen Component

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred . Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare

Treatment of Overdose

In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and 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, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to Oxycodone Hydrochloride and Ibuprofen Tablets overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to Oxycodone Hydrochloride and Ibuprofen Tablets overdose.

Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in Oxycodone Hydrochloride and Ibuprofen Tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdose (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

How should I store and handle Oxycodone hydrochloride and Ibuprofen?

Store at 20° to 25°C (68° to 77°F); see USP controlled room temperature. Protect from light. Do not freeze.Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP. Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50).Dispense in a tight, light-resistant container as defined in the USP.Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled RoomTemperature].Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised – January 201740-9065Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP. Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50).Dispense in a tight, light-resistant container as defined in the USP.Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled RoomTemperature].Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised – January 201740-9065Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP. Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50).Dispense in a tight, light-resistant container as defined in the USP.Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled RoomTemperature].Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised – January 201740-9065Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP. Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50).Dispense in a tight, light-resistant container as defined in the USP.Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled RoomTemperature].Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised – January 201740-9065Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP. Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50).Dispense in a tight, light-resistant container as defined in the USP.Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled RoomTemperature].Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised – January 201740-9065Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP. Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50).Dispense in a tight, light-resistant container as defined in the USP.Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled RoomTemperature].Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised – January 201740-9065Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP. Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50).Dispense in a tight, light-resistant container as defined in the USP.Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled RoomTemperature].Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised – January 201740-9065Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP. Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50).Dispense in a tight, light-resistant container as defined in the USP.Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled RoomTemperature].Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised – January 201740-9065Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP. Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50).Dispense in a tight, light-resistant container as defined in the USP.Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled RoomTemperature].Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised – January 201740-9065

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Effects on the Central Nervous System

Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.

Oxycodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations.

Effects on the Gastrointestinal Tract and Other Smooth Muscle

Oxycodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

Effects on the Cardiovascular System

Oxycodone produces peripheral vasodilation, which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

Effects on the Endocrine System

Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans . They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon.

Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date .

Effects on the Immune System

Opioids have been shown to have a variety of effects on components of the immune system. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.

Concentration–Efficacy Relationships

The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. The minimum effective analgesic concentration of oxyocodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome, and/or the development of analgesic tolerance

Concentration–Adverse Reaction Relationships

There is a relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions

Non-Clinical Toxicology

Oxycodone Hydrochloride and Ibuprofen Tablets are contraindicated in patients with:

Oxycodone component

Inhibitors of CYP3A4 and CYP2D6

The concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of oxycodone hydrochloride and ibuprofen, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone Hydrochloride and Ibuprofen Tablets is achieved

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone hydrochloride and ibuprofen plasma concentration will decrease , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Oxycodone Hydrochloride and Ibuprofen Tablets.

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

Inducers of CYP3A4

The concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of oxycodone hydrochloride , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to Oxycodone Hydrochloride and Ibuprofen Tablets

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone hydrochloride 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 increasing the Oxycodone Hydrochloride and Ibuprofen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Oxycodone Hydrochloride and Ibuprofen Tablets dosage reduction and monitor for signs of respiratory depression.

Benzodiazepines and Other Central Nervous System (CNS) Depressants

Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants such as benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.

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

Serotonergic Drugs

The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome .

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

Monoamine Oxidase Inhibitors (MAOIs)

The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, or linezolid, may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma)

The use of Oxycodone Hydrochloride and Ibuprofen Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

If urgent use of an opioid is necessary, 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.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics

Agonist/antagonist analgesics such as pentazocine, nalbuphine, butorphanol and buprenorphine may reduce the analgesic effect of Oxycodone Hydrochloride and Ibuprofen Tablets and/or precipitate withdrawal symptoms in these patients.

Avoid concomitant use of these drugs.

Muscle Relaxants

Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

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

Anticholinergics

The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

Monitor patients for signs of urinary retention or reduced gastric motility when Oxycodone Hydrochloride and Ibuprofen Tablets are used concomitantly with anticholinergic drugs.

Neuromuscular Blocking Agents

Oxycodone, as well as other opioid analgesics, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Drugs That Interfere With Hemostasis

Ibuprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of ibuprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.

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 Oxycodone Hydrochloride and Ibuprofen Tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding

Aspirin

Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone

Concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding

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

NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).

During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets 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. These effects are usually reversible.

During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and ACE-inhibitors, ARBs, or beta-blockers, in who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function

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

Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.

During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects

Digoxin

The concomitant use of ibuprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and digoxin, monitor serum digoxin levels.

Lithium

NSAIDs have produced elevations in plasma lithium concentration and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. This effect has been attributed to inhibition of renal prostaglandin synthesis.

During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and lithium, monitor patients for signs of lithium toxicity.

Methotrexate

Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).

During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and methotrexate, monitor patients for methotrexate toxicity.

Cyclosporine

Concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and cyclosporine may increase cyclosporine’s nephrotoxicity.

During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and cyclosporine, monitor patients for signs of worsening renal function.

NSAIDs and Salicylates

Concomitant use of ibuprofen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy

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

Pemetrexed

Concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).

During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets 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.

Oxycodone Hydrochloride and Ibuprofen Tablets 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 Oxycodone Hydrochloride and Ibuprofen Tablets and know how they will react to the medication

The following adverse reactions are discussed in greater detail in other sections:

Clinical Trials Experience

Listed below are the adverse event incidence rates from single dose analgesia trials in which a total of 2,437 patients received either oxycodone hydrochloride and ibuprofen combination product, ibuprofen (400 mg), oxycodone hydrochloride (5 mg), or placebo. Adverse event information is also provided from an additional 334 patients who were exposed to oxycodone hydrochloride and ibuprofen combination product 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 that were reported by at least 1% of patients taking oxycodone hydrochloride 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 oxycodone hydrochloride and ibuprofen treated patients in studies not listed above include the following:

Body as Whole:

Cardiovascular System:

Digestive System:

Hemic and Lymphatic System:

Metabolic and Nutritional Disorders:

Nervous System:

Respiratory System:

Urogenital System:

Adverse events that occurred in the study in at least 2% of patients treated with oxycodone hydrochloride and ibuprofen include the following:

Body as Whole:

Cardiovascular System:

Digestive System:

Nervous System:

Adverse events that occurred in less than 2% of and at least two oxycodone hydrochloride and ibuprofen treated patients in the study not listed previously include the following:

Body as Whole:

Cardiovascular System:

Hemic and Lymphatic System:

Metabolic and Nutritional Disorders:

Musculoskeletal System:

Nervous System:

Skin and Appendages:

Special Senses:

Urogenital System:

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Oxycodone Hydrochloride and Ibuprofen Tablets. 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.

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

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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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Review

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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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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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