Can You Take Hydrocodone and Ibuprofen at the Same Time
Physicians Total Care, Inc.
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS7.v mg/200 mg
Full PRESCRIBING Data: CONTENTS*
- HYDROCODONE BITARTRATE AND IBUPROFEN DESCRIPTION
- CLINICAL PHARMACOLOGY
- Hydrocodone component
- Ibuprofen component
- Pharmacokinetics
- CLINICAL STUDIES
- HYDROCODONE BITARTRATE AND IBUPROFEN INDICATIONS AND USAGE
- HYDROCODONE BITARTRATE AND IBUPROFEN CONTRAINDICATIONS
- WARNINGS
- CARDIOVASCULAR EFFECTS
- Hypertension
- Congestive Heart Failure and Edema
- Misuse Abuse and Diversion of Opioids
- Respiratory Depression
- Caput Injury and Increased Intracranial Pressure
- Acute Intestinal Conditions
- Gastrointestinal (GI) Furnishings - Take chances of GI Ulceration, Bleeding and Perforation
- Renal Effects
- Advanced Renal Disease
- Anaphylactoid Reactions
- Skin Reactions
- Pregnancy
- PRECAUTIONS
- General
- Special Risk Patients
- Coughing Reflex
- Hepatic Effects
- Hematological Effects
- Pre-existing Asthma
- Hygienic Meningitis
- Data for Patients
- Laboratory Tests
- Drug Interactions
- Carcinogenicity, Mutagenicity, and Impairment of Fertility
- Pregnancy: Pregnancy Category C.
- Labor and Delivery
- Nursing Mothers
- Pediatric Use
- Geriatric Use
- HYDROCODONE BITARTRATE AND IBUPROFEN Adverse REACTIONS
- DRUG Abuse AND DEPENDENCE
- Misuse Abuse and Diversion of Opioids
- OVERDOSAGE
- Signs and Symptoms
- Treatment
- HYDROCODONE BITARTRATE AND IBUPROFEN DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- Storage
- Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- PRINCIPAL Display PANEL
FULL PRESCRIBING INFORMATION
CS-3
Rx Simply
HYDROCODONE BITARTRATE AND IBUPROFEN Description
Each hydrocodone bitartrate and ibuprofen tablet contains:
Hydrocodone Bitartrate, USP vii.five mg
Ibuprofen, USP 200 mg
Hydrocodone bitartrate and ibuprofen is supplied in a fixed combination tablet class for oral administration. Hydrocodone bitartrate and ibuprofen combines the opioid analgesic amanuensis, hydrocodone bitartrate, with the nonsteroidal anti-inflammatory (NSAID) amanuensis, ibuprofen.
Hydrocodone bitartrate is a semisynthetic and centrally acting opioid analgesic. Its chemic proper noun is:4,5 (a)-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (one:i) hydrate (2:5). Its chemic formula is: C18H21NO3•C4H6O6•21/2H2O, and the molecular weight is 494.50. Its structural formula is:
Hydrocodone Bitartrate Structural Formula Ibuprofen 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 chemical formula is: C13H18O2, and the molecular weight is: 206.29. Its structural formula is: Ibuprofen Structural Formula
Inactive ingredients in hydrocodone bitartrate and ibuprofen tablets include: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910 3cP, hypromellose 2910 6cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 8000, polydextrose, pregelatinized starch, titanium dioxide and triacetin.
CLINICAL PHARMACOLOGY
Hydrocodone component
Hydrocodone is a semisynthetic opioid analgesic and antitussive with multiple deportment qualitatively similar to those of codeine. About of these involve the central nervous system and smooth muscle. The precise mechanism of activeness of hydrocodone and other opioids is not known, although it is believed to relate to the being of opiate receptors in the central nervous system. In addition to analgesia, opioids may produce drowsiness, changes in mood, and mental clouding.
Ibuprofen component
Ibuprofen is a non-steroidal anti-inflammatory agent that possesses analgesic and antipyretic activities. Its way of activeness, like that of other NSAIDs, is not completely understood, but may exist related to inhibition of cyclooxygenase action and prostaglandin synthesis. Ibuprofen is a peripherally acting analgesic. Ibuprofen does not have any known effects on opiate receptors.
Pharmacokinetics
Absorption
After oral dosing with the hydrocodone bitartrate and ibuprofen tablet, a top hydrocodone plasma level of 27 ng/mL is achieved at ane.7 hours, and a peak ibuprofen plasma level of thirty mcg/mL is achieved at ane.eight hours. The result of food on the absorption of either component from the hydrocodone bitartrate and ibuprofen tablet has not been established.
Distribution
Ibuprofen is highly protein-jump (99%) like most other non-steroidal anti-inflammatory agents. Although the extent of protein bounden of hydrocodone in human plasma has not been definitely determined, structural similarities to related opioid analgesics suggest that hydrocodone is not extensively protein bound. As virtually agents in the 5-band morphinan group of semi-synthetic opioids demark plasma protein to a similar degree (range nineteen% [hydromorphone] to 45% [oxycodone]), hydrocodone is expected to fall within this range.
Metabolism
Hydrocodone exhibits a complex pattern of metabolism, including O-demethylation, N -demethylation, and 6-keto reduction to the corresponding 6-α-and 6-β-hydroxy metabolites. Hydromorphone, a strong opioid, is formed from the O-demethylation of hydrocodone and contributes to the total analgesic effect of hydrocodone. The O-and N-demethylation processes are mediated past separate P-450 isoenzymes: CYP2D6 and CYP3A4, respectively.
Ibuprofen is present in this production every bit a racemate, and post-obit assimilation information technology undergoes interconversion in the plasma from the R-isomer to the S-isomer. Both the R- and Southward- isomers are metabolized to ii master metabolites: (+)-ii-four'-(2hydroxy-ii-methyl-propyl) phenyl propionic acid and (+)-2-iv'-(2carboxypropyl) phenyl propionic acrid, both of which broadcast in the plasma at low levels relative to the parent.
Elimination
Hydrocodone and its metabolites are eliminated primarily in the kidneys, with a hateful plasma one-half-life of 4.5 hours. Ibuprofen is excreted in the urine, fifty% to 60% as metabolites and approximately xv% equally unchanged drug and conjugate. The plasma one-half-life is 2.2 hours.
Special Populations
No pregnant pharmacokinetic differences based on age or gender have been demonstrated. The pharmacokinetics of hydrocodone and ibuprofen from hydrocodone bitartrate and ibuprofen tablets has non been evaluated in children.
Renal Impairment
The consequence of renal insufficiency on the pharmacokinetics of the hydrocodone bitartrate and ibuprofen tablet dosage form has non been determined.
CLINICAL STUDIES
In single-dose studies of postal service surgical hurting (abdominal, gynecological, orthopedic), 940 patients were studied at doses of one or two tablets. Hydrocodone bitartrate and ibuprofen tablets produced greater efficacy than placebo and each of its individual components given at the same dose. No advantage was demonstrated for the two-tablet dose.
HYDROCODONE BITARTRATE AND IBUPROFEN INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options earlier deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the everyman constructive dose for the shortest duration consistent with individual patient treatment goals (encounter WARNINGS ). Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term (mostly less than ten days) direction of acute pain. Hydrocodone bitartrate and ibuprofen tablets are not indicated for the treatment of such weather as osteoarthritis or rheumatoid arthritis.
HYDROCODONE BITARTRATE AND IBUPROFEN CONTRAINDICATIONS
Hydrocodone bitartrate and ibuprofen tablets is contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. Patients known to be hypersensitive to other opioids may showroom cross-sensitivity to hydrocodone.
Hydrocodone bitartrate and ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (meet WARNINGS - Anaphylactoid Reactions, and PRECAUTIONS - Preexisting Asthma ).
Hydrocodone bitartrate and ibuprofen tablets is contraindicated for the handling of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
WARNINGS
CARDIOVASCULAR EFFECTS
Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of upwards to three years elapsing have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a like take chances. Patients with known CV disease or risk factors for CV disease may exist at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, fifty-fifty in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to accept if they occur.
There is no consequent evidence that concurrent utilise of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID employ. The concurrent utilise of aspirin and an NSAID does increase the risk of serious GI events (run into GI WARNINGS ).
Two big, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days post-obit CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS ).
Hypertension
NSAID-containing products, including hydrocodone bitartrate and ibuprofen tablets, can pb to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have dumb response to these therapies when taking NSAIDs. NSAID-containing products, including hydrocodone bitartrate and ibuprofen tablets, should be used with caution in patients with hypertension. Claret pressure level (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Congestive Heart Failure and Edema
Fluid memory and edema accept been observed in some patients taking NSAIDs. Hydrocodone bitartrate and ibuprofen tablets should be used with caution in patients with fluid retention or eye failure.
Misuse Abuse and Diversion of Opioids
Hydrocodone bitartrate and ibuprofen tablets comprise hydrocodone an opioid agonist, and is a Schedule 3 controlled substance. Opioid agonists accept the potential for being driveling and are sought past abusers and people with addiction disorders, and are subject to diversion.
Hydrocodone bitartrate and ibuprofen tablets tin be driveling in a fashion similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and ibuprofen tablets in situations where the physician or chemist is concerned virtually an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE ).
Respiratory Depression
At high doses or in opioid-sensitive patients, hydrocodone may produce dose-related respiratory depression past interim directly on the brain stem respiratory centers. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.
Head Injury and Increased Intracranial Force per unit area
The respiratory depressant effects of opioids and their chapters to elevate cerebrospinal fluid force per unit area may exist markedly exaggerated in the presence of caput injury, intracranial lesions or a pre-existing increment in intracranial pressure level. Furthermore, opioids produce agin reactions, which may obscure the clinical course of patients with head injuries.
Astute Abdominal Weather condition
The administration of opioids may obscure the diagnosis or clinical grade of patients with astute intestinal conditions.
Gastrointestinal (GI) Effects - Hazard of GI Ulceration, Bleeding and Perforation
NSAIDs, including hydrocodone bitartrate and ibuprofen tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, haemorrhage, ulceration, and perforation of the tum, modest intestine, or large intestine, which can be fatal. These serious adverse events can occur at whatsoever time, with or without alarm symptoms, in patients treated with NSAIDs. Just 1 in five patients who develops a serious upper GI adverse upshot on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused past NSAIDs occur in approximately i% of patients treated for 3-6 months, and in about 2-four% of patients treated for one year. These trends go on with longer elapsing of utilise, increasing the likelihood of developing a serious GI event at some fourth dimension during the course of therapy. Notwithstanding, even short-term therapy is not without risk.
NSAIDs should exist prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer affliction and/or gastrointestinal haemorrhage who use NSAIDs have a greater than 10-fold increased take chances for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the gamble for GI haemorrhage in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health condition. Near spontaneous reports of fatal GI events are in elderly or devitalized patients and therefore, special intendance should exist taken in treating this population.
To minimize the potential risk for an adverse GI result in patients treated with an NSAID, the lowest constructive dose should be used for the shortest possible elapsing. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse issue is suspected. This should include discontinuation of the NSAID until a serious GI agin effect is ruled out. For high-gamble patients, alternate therapies that do not involve NSAIDs should be considered.
Renal Effects
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory part in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may crusade a dose-dependent reduction in prostaglandin germination and, secondarily, in renal claret flow, which may precipitate overt renal decompensation. Patients at greatest chance of this reaction are those with dumb renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is commonly followed by recovery to the pretreatment country.
Advanced Renal Disease
No information is bachelor from controlled clinical studies regarding the employ of hydrocodone bitartrate and ibuprofen tablets in patients with advanced renal illness. Therefore, handling with hydrocodone bitartrate and ibuprofen tablets is not recommended in patients with avant-garde renal disease. If hydrocodone bitartrate and ibuprofen tablets therapy must exist initiated, close monitoring of the patient'southward renal function is advisable.
Anaphylactoid Reactions
Every bit with other NSAID-containing products, anaphylactoid reactions may occur in patients without known prior exposure to hydrocodone bitartrate and ibuprofen tablets. Hydrocodone bitartrate and ibuprofen tablets should non exist given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm afterwards taking aspirin or other NSAIDs. Fatal reactions to NSAIDs have been reported in such patients (see CONTRAINDICATIONS and PRECAUTIONS - Pre-existing Asthma ). Emergency assistance should exist sought in cases where an anaphylactoid reaction occurs.
Peel Reactions
Products containing NSAIDs, including hydrocodone bitartrate and ibuprofen tablets, can cause serious peel 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. Patients should be informed nearly the signs and symptoms of serious peel manifestations and use of the drug should be discontinued at the first advent of skin rash or whatsoever other sign of hypersensitivity.
Pregnancy
As with other NSAID-containing products, hydrocodone bitartrate and ibuprofen tablets should be avoided in tardily pregnancy because it may cause premature closure of the ductus arteriosus.
PRECAUTIONS
General
Hydrocodone bitartrate and ibuprofen tablets cannot exist expected to substitute for corticosteroids or to care for corticosteroid insufficiency. Precipitous discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of hydrocodone bitartrate and ibuprofen tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Special Hazard Patients
Every bit with any opioid analgesic agent, hydrocodone bitartrate and ibuprofen tablets should be used with circumspection in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's affliction, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.
Cough Reflex
Hydrocodone suppresses the cough reflex; as with opioids, caution should exist exercised when hydrocodone bitartrate and ibuprofen tablets are used postoperatively and in patients with pulmonary disease.
Hepatic Effects
Borderline elevations of one or more liver enzymes may occur in upward to fifteen% of patients taking NSAIDs including ibuprofen equally found in hydrocodone bitartrate and ibuprofen tablets. These laboratory abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. Notable elevations of SGPT (ALT) or SGOT (AST) (approximately iii or more times the upper limit of normal) have been reported in approximately ane% of patients in clinical trials with NSAIDS. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.
A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver examination has occurred, should be evaluated for prove of the evolution of more than severe hepatic reactions while on hydrocodone bitartrate and ibuprofen tablets therapy. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.thou., eosinophilia, rash, etc.), hydrocodone bitartrate and ibuprofen tablets should be discontinued.
Hematological Effects
Anemia is sometimes seen in patients receiving NSAIDs including ibuprofen every bit found in hydrocodone bitartrate and ibuprofen tablets. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs including ibuprofen, should have their hemoglobin or hematocrit checked if they exhibit whatever signs or symptoms of anemia.
NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their issue on platelet function is quantitatively less, of shorter elapsing, and reversible. Patients receiving hydrocodone bitartrate and ibuprofen tablets who may be adversely afflicted by alterations in platelet part, such as those with coagulation disorders or patients receiving anticoagulants, should exist carefully monitored.
Pre-existing Asthma
Patients with asthma may have aspirin-sensitive asthma. The utilize of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which may be fatal. Since cantankerous-reactivity betwixt aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, hydrocodone bitartrate and ibuprofen tablets should not be administered to patients with this class of aspirin sensitivity and should exist used with circumspection in patients with pre-existing asthma.
Aseptic Meningitis
Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy as institute in hydrocodone bitartrate and ibuprofen tablets. Although it is probably more than probable to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not accept an underlying chronic illness. If signs or symptoms of meningitis develop in a patient on hydrocodone bitartrate and ibuprofen tablets, the possibility of its being related to ibuprofen should be considered.
Information for Patients
Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should as well be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.
- Hydrocodone bitartrate and ibuprofen tablets (hydrocodone bitartrate seven.v mg and ibuprofen 200 mg), like other opioid-containing analgesics, may impair mental and/or physical abilities required for the performance of potentially chancy tasks such as driving a car or operating machinery; patients should be cautioned accordingly.
- Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should exist avoided.
- Hydrocodone bitartrate and ibuprofen tablets can be driveling in a manner similar to other opioid agonists, legal or illicit. Hydrocodone bitartrate and ibuprofen tablets may be habit-forming. Patients should take the drug merely for every bit long every bit it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
- Hydrocodone bitartrate and ibuprofen tablets, similar other NSAID-containing products, may cause serious CV side furnishings, such as MI or stroke, which may issue in hospitalization and fifty-fifty death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of breast pain, shortness of breath, weakness, slurring of oral communication, and should inquire for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (meet WARNINGS, Cardiovascular Furnishings ).
- Hydrocodone bitartrate and ibuprofen tablets, like other NSAID-containing products, can cause GI discomfort and serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even expiry. Although serious GI tract ulcerations and haemorrhage can occur without alert symptoms, patients should be warning for the signs and symptoms of ulcerations and bleeding, and should ask for medical communication when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS, Gastrointestinal Furnishings: Risk of Ulceration, Haemorrhage, and Perforation ).
- Hydrocodone bitartrate and ibuprofen tablets, similar other NSAID-containing products, can cause serious peel side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and fifty-fifty expiry. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such equally itching, and should inquire for medical advice when observing any indicative signs or symptoms. Patients should exist brash to end the drug immediately if they develop whatever type of rash and contact their physicians as soon equally possible.
- Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.
- Patients should exist informed of the warning signs and symptoms of hepatotoxicity (e.one thousand., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
- Patients should be informed of the signs of an anaphylactoid reaction (e.thousand., difficulty breathing, swelling of the face or pharynx). If these occur, patients should be instructed to seek immediate emergency help (come across WARNINGS ).
- In late pregnancy, as with other NSAIDs, hydrocodone bitartrate and ibuprofen tablets should exist avoided considering it may cause premature closure of the ductus arteriosus.
- Patients should be instructed to report whatsoever signs of blurred vision or other centre symptoms.
Laboratory Tests
Considering serious GI tract ulcerations and bleeding can occur without alert symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (eastward.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, hydrocodone bitartrate and ibuprofen tablets should be discontinued.
Drug Interactions
ACE-inhibitors
Reports propose that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking hydrocodone bitartrate and ibuprofen tablets concomitantly with ACE-inhibitors.
Anticholinergics
The concurrent use of anticholinergics with hydrocodone preparations may produce paralytic ileus.
Antidepressants
The utilise of Monoamine Oxidase Inhibitors (MAOIs) or tricyclic antidepressants with hydrocodone bitartrate and ibuprofen tablets may increment the issue of either the anti-depressant or hydrocodone.
MAOIs take been reported to intensify the effects of at to the lowest degree ane opioid drug causing feet, confusion and pregnant depression of respiration or coma. The use of hydrocodone is not recommended for patients taking MAOIs or within 14 days of stopping such handling.
Aspirin
When hydrocodone bitartrate and ibuprofen tablets are administered with aspirin, the protein bounden of aspirin is reduced, although the clearance of free hydrocodone bitartrate and ibuprofen tablets is not altered. The clinical significance of this interaction is non known; however, as with other NSAID-containing products, concomitant administration of hydrocodone bitartrate and ibuprofen tablets and aspirin is not generally recommended because of the potential of increased agin effects.
CNS Depressants
Patients receiving other opioids, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and ibuprofen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of 1 or both agents should be reduced.
Diuretics
Ibuprofen has been shown to reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with hydrocodone bitartrate and ibuprofen tablets the patient should exist observed closely for signs of renal failure (come across WARNINGS-Renal Effects ), too as efficacy.
Lithium
Ibuprofen has been shown to elevate plasma lithium concentration and reduce renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. This issue has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when hydrocodone bitartrate and ibuprofen tablets and lithium are administered concurrently, patients should exist observed for signs of lithium toxicity.
Methotrexate
Ibuprofen, also equally other NSAIDs, has been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that ibuprofen could enhance the toxicity of methotrexate. Caution should be used when hydrocodone bitartrate and ibuprofen tablets are administered concomitantly with methotrexate.
Mixed Agonist/Antagonist Opioid Analgesics
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesics such as hydrocodone. In this state of affairs, mixed agonist/adversary analgesics may reduce the analgesic upshot of hydrocodone and/or may precipitate withdrawal symptoms in these patients.
Neuromuscular Blocking Agents
Hydrocodone, also equally other opioid analgesics, may enhance the neuromuscular blocking action of skeletal musculus relaxants and produce an increased caste of respiratory depression.
Warfarin
The effects of warfarin and NSAIDs on GI haemorrhage are synergistic, such that users of both drugs together have a run a risk of serious GI haemorrhage higher than users of either drug alone.
Carcinogenicity, Mutagenicity, and Damage of Fertility
The carcinogenic and mutagenic potential of hydrocodone bitartrate and ibuprofen tablets has non been investigated. The power of hydrocodone bitartrate and ibuprofen tablets to impair fertility has not been assessed.
Pregnancy: Pregnancy Category C.
Teratogenic Furnishings
Reproductive studies conducted in rats and rabbits accept not demonstrated evidence of developmental abnormalities. Hydrocodone bitartrate and ibuprofen tablets, administered to rabbits at 95 mg/kg (five.72 and 1.ix times the maximum clinical dose based on trunk weight and surface area, respectively), a maternally toxic dose, resulted in an increase in the percentage of litters and fetuses with any major abnormality and an increase in the number of litters and fetuses with one or more nonossified metacarpals (a minor aberration). Hydrocodone bitartrate and ibuprofen tablets, administered to rats at 166 mg/kg (10.0 and 1.66 times the maximum clinical dose based on torso weight and surface surface area, respectively), a maternally toxic dose, did not result in any reproductive toxicity. However, animate being reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Hydrocodone bitartrate and ibuprofen tablets should exist used during pregnancy only if the potential benefit justifies the potential chance to the fetus.
Nonteratogenic Effects
Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular organization (closure of the ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided. Babies born to mothers who have been taking opioids regularly prior to commitment will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory charge per unit, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.
Labor and Commitment
Equally with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia and delayed parturition occurred in rats. Administration of hydrocodone bitartrate and ibuprofen tablets is not recommended during labor and commitment. The furnishings of hydrocodone bitartrate and ibuprofen tablets on labor and delivery in pregnant women are unknown.
Nursing Mothers
It is not known whether hydrocodone is excreted in human milk. In limited studies, an analysis capable of detecting i mcg/mL did not demonstrate ibuprofen in the milk of lactating mothers. Nevertheless, considering of the limited nature of the studies, and because of the potential for serious adverse reactions in nursing infants from hydrocodone bitartrate and ibuprofen tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Employ
The safety and effectiveness of hydrocodone bitartrate and ibuprofen tablets in pediatric patients below the age of 16 accept not been established.
Geriatric Utilize
In controlled clinical trials there was no difference in tolerability between patients < 65 years of age and those ≥ 65, apart from an increased trend of the elderly to develop constipation. However, because the elderly may exist more than sensitive to the renal and gastrointestinal effects of nonsteroidal anti-inflammatory agents as well as possible increased risk of respiratory depression with opioids, actress caution and reduced dosages should be used when treating the elderly with hydrocodone bitartrate and ibuprofen tablets.
HYDROCODONE BITARTRATE AND IBUPROFEN Adverse REACTIONS
Hydrocodone bitartrate and ibuprofen tablets were administered to approximately 300 hurting patients in a prophylactic 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 beneath are from approximately 150 patients who were in a group that received one tablet of hydrocodone bitartrate and ibuprofen an boilerplate of 3 to iv times daily. The overall incidence rates of adverse experiences in the trials were fairly similar for this patient grouping and those who received the comparison handling, acetaminophen 600 mg with codeine sixty mg.
The post-obit lists agin events that occurred with an incidence of i% or greater in clinical trials of hydrocodone bitartrate and ibuprofen tablets, without regard to the causal human relationship of the events to the drug. To distinguish dissimilar rates of occurrence in clinical studies, the adverse events are listed as follows:
proper noun of adverse result = less than 3%
adverse events marked with an asterisk * = three% to ix%
agin event rates over 9% are in parentheses.
Trunk 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 rima oris*; Dyspepsia (12%); Flatulence*; Gastritis; Melena; Oral cavity ulcers; Nausea (21%); Thirst; Airsickness*.
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 oral communication; Tremor, Vertigo.
Digestive
Chalky stool; "Clenching teeth"; Dysphagia; Esophageal spasm; Esophagitis; Gastroenteritis; Glossitis; Liver enzyme acme.
Metabolic and Nutritional
Weight decrease.
Musculoskeletal
Arthralgia; Myalgia.
Respiratory
Asthma; Bronchitis; Hoarseness; Increased cough; Pulmonary congestion; Pneumonia; Shallow animate; Sinusitis.
Skin and Appendages
Rash; Urticaria.
Special Senses
Altered vision; Bad gustatory modality; Dry eyes.
Urogenital
Cystitis; Glycosuria; Impotence; Urinary incontinence; Urinary retention.
DRUG Abuse AND DEPENDENCE
Misuse Abuse and Diversion of Opioids
Hydrocodone bitartrate and ibuprofen tablets contain hydrocodone, an opioid agonist, and is a Schedule Iii controlled substance. Hydrocodone bitartrate and ibuprofen, and other opioids used in analgesia tin can be abused and are discipline to criminal diversion.
Habit is a primary, chronic, neurobiologic illness, with genetic, psychosocial, and ecology factors influencing its evolution and manifestations. Information technology is characterized by behaviors that include i or more than of the following: impaired control over drug use, compulsive utilise, 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 cease 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 data for other treating physician(s). "Dr. shopping" to obtain boosted prescriptions is common amid drug abusers and people suffering from untreated addiction.
Corruption and addiction are separate and distinct from physical dependence and tolerance. Physical dependence normally assumes clinically pregnant dimensions but after several weeks of continued opioid use, although a mild degree of physical dependence may develop later on a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the aforementioned caste of analgesia, is manifested initially by a shortened duration of analgesic event, and subsequently past decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should exist aware that corruption of opioids can occur in the absenteeism of true habit and is characterized by misuse for not-medical purposes, often in combination with other psychoactive substances. Hydrocodone bitartrate and ibuprofen tablets, like other opioids, may be diverted for not-medical use. Record-keeping of prescribing data, 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.
OVERDOSAGE
Post-obit an acute overdosage, toxicity may result from hydrocodone and/or ibuprofen.
Signs and Symptoms
Hydrocodone component
Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis) extreme somnolence progressing to stupor or blackout, skeletal muscle flaccidity, common cold and clammy pare, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory plummet, cardiac arrest and death may occur.
Ibuprofen component
Symptoms include gastrointestinal irritation with erosion and hemorrhage or perforation, kidney impairment, liver damage, center harm, hemolytic anemia, agranulocytosis, thrombocytopenia, aplastic anemia, and meningitis. Other symptoms may include headache, dizziness, tinnitus, defoliation, blurred vision, mental disturbances, skin rash, stomatitis, edema, reduced retinal sensitivity, corneal deposits, and hyperkalemia.
Treatment
Main attention should exist given to the re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. Naloxone, a narcotic adversary, can opposite respiratory low and blackout associated with opioid overdose or unusual sensitivity to opioids, including hydrocodone. Therefore, an advisable dose of naloxone hydrochloride should be administered intravenously with simultaneous efforts at respiratory resuscitation. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should exist administered every bit needed to maintain adequate respiration. Supportive measures should exist employed as indicated. Gastric emptying may exist useful in removing unabsorbed drug. In cases where consciousness is impaired it may exist inadvisable to perform gastric lavage. If gastric lavage is performed, lilliputian drug will likely exist recovered if more than an hour has elapsed since ingestion. Ibuprofen is acidic and is excreted in the urine; therefore, it may exist benign to administer alkali and induce diuresis. In add-on to supportive measures the use of oral activated charcoal may aid to reduce the absorption and reabsorption of ibuprofen. Dialysis is non probable to be effective for removal of ibuprofen because it is very highly bound to plasma proteins.
HYDROCODONE BITARTRATE AND IBUPROFEN DOSAGE AND Administration
Advisedly consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with private patient treatment goals (run into WARNINGS ).
After observing the response to initial therapy with hydrocodone bitartrate and ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient'due south needs.
For the curt-term (generally less than ten days) management of acute hurting, the recommended dose of hydrocodone bitartrate and ibuprofen tablets is one tablet every 4 to 6 hours, as necessary. Dosage should non exceed 5 tablets in a 24-hour menstruum. It should exist kept in mind that tolerance to hydrocodone can develop with continued utilise and that the incidence of untoward effects is dose related.
The everyman effective dose or the longest dosing interval should be sought for each patient (see WARNINGS ), especially in the elderly. After observing the initial response to therapy with hydrocodone bitartrate and ibuprofen tablets, the dose and frequency of dosing should be adjusted to suit the individual patient need, without exceeding the total daily dose recommended.
HOW SUPPLIED
Hydrocodone bitartrate and ibuprofen tablets are available as:
White, film-coated circular tablets debossed with "
524" on one side and manifestly on the other side.
| Bottles of 20 | NDC 54868-4976-1 |
| Bottles of 30 | NDC 54868-4976-0 |
| Bottles of 40 | NDC 54868-4976-three |
| Bottles of 60 | NDC 54868-4976-v |
| Bottles of xc | NDC 54868-4976-7 |
| Bottles of 100 | NDC 54868-4976-four |
| Bottles of 120 | NDC 54868-4976-two |
| Bottles of 180 | NDC 54868-4976-6 |
Storage
Store at 20° to 25°C (68° - 77°F) [See USP Controlled Room Temperature.]
Dispense in a tight, light-resistant container.
A Schedule CS-III Controlled Substance.
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)
What is the most important data I should know about medicines chosen Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines may increment the chance of a centre assail or stroke that can atomic number 82 to death. This chance increases:
- with longer apply of NSAID medicines
- in people who take heart disease
NSAID medicines should never be used right before or afterwards a centre surgery called a "coronary artery bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at whatever time during handling. Ulcers and bleeding:
- can happen without warning symptoms
- may cause death
The take a chance of a person getting an ulcer or haemorrhage increases with:
- taking medicines called "corticosteroids" and "anticoagulants"
- longer use
- smoking
- drinking booze
- older age
- having poor wellness
NSAID medicines should only exist used:
- exactly as prescribed
- at the lowest dose possible for your treatment
- for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to care for hurting and redness, swelling, and heat (inflammation) from medical atmospheric condition such as:
• different types of arthritis
• menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not have an NSAID medicine:
- if you lot had an asthma attack, hives, or other allergic reaction with aspirin or whatsoever other NSAID medicine
- for pain right before or after heart featherbed surgery
Tell your healthcare provider:
- virtually all your medical conditions.
- well-nigh all of the medicines you take. NSAIDs and another medicines tin interact with each other and cause serious side effects. Go on a list of your medicines to show to your healthcare provider and pharmacist.
- if yous are meaning. NSAID medicines should not exist used by pregnant women late in their pregnancy.
- if you are breastfeeding. Talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
| Serious side effects include: | Other side furnishings include: |
|
|
Become emergency help right abroad if you take any of the post-obit symptoms:
|
|
Terminate your NSAID medicine and call your healthcare provider correct abroad if you have any of the following symptoms:
|
|
These are not all the side furnishings with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your physician for medical advice nearly side effects. Yous may study side effects to FDA at 1-800-FDA-1088.
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Aspirin is an NSAID medicine only it does not increase the take chances of a heart attack. Aspirin tin cause haemorrhage in the brain, stomach, and intestines. Aspirin can likewise cause ulcers in the stomach and intestines.
- Some of these NSAID medicines are sold in lower doses without a prescription (over the counter). Talk to your healthcare provider before using over the counter NSAIDs for more than ten days.
| * Vicoprofen contains the same dose of ibuprofen as over the counter (OTC) NSAIDs, and is usually used for less than 10 days to treat hurting. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. | |
| Generic Name | Tradename |
| Celecoxib | Celebrex |
| Diclofenac | Cataflam, Voltaren, Arthrotec (combined with misoprostol) |
| Diflunisal | Dolobid |
| Etodolac | Lodine, Lodine XL |
| Fenoprofen | Nalfon, Nalfon 200 |
| Flurbiprofen | Ansaid |
| Ibuprofen | Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone) |
| Indomethacin | Indocin, Indocin SR, Indo-Lemmon, Indomethagan |
| Ketoprofen | Oruvail |
| Ketorolac | Toradol |
| Mefenamic Acid | Ponstel |
| Meloxicam | Mobic |
| Nabumetone | Relafen |
| Naproxen | Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole) |
| Oxaprozin | Day pro |
| Piroxicam | Feldene |
| Sulindac | Clinoril |
| Tolmetin | Tolectin, Tolectin DS, Tolectin 600 |
Manufactured by:
Watson Laboratories, Inc.
Corona, CA 92880 USA
Distributed by:
Watson Pharma, Inc.
Rev. engagement: 04/ten
194216
This Medication Guide has been canonical by the U.Southward. Nutrient and Drug Administration.
Relabeling and Repackaging past:
Physicians Total Intendance, Inc.
Tulsa, OK 74146
PRINCIPAL DISPLAY PANEL
Hydrocodone Bitartrate and Ibuprofen Tablets
7.v mg/200 mg
Rx only
HYDROCODONE BITARTRATE AND IBUPROFEN
HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, Picture show COATED
Product Information | |||
|---|---|---|---|
| Product Type | Homo prescription drug characterization | Item Code (Source) | NDC:54868-4976(NDC:62037-524) |
| Route of Administration | ORAL | DEA Schedule | |
Active Ingredient/Active Moiety | ||
|---|---|---|
| Ingredient Proper name | Basis of Strength | Strength |
| HYDROCODONE BITARTRATE HYDROCODONE | vii.5 mg | |
| IBUPROFEN IBUPROFEN | 200 mg | |
Inactive Ingredients | ||
|---|---|---|
| Ingredient Proper noun | Strength | |
| COLLOIDAL SILICON DIOXIDE | ||
| CROSCARMELLOSE SODIUM | ||
| HYPROMELLOSE 2910 (iii MPA.S) | ||
| HYPROMELLOSE 2910 (half dozen MPA.S) | ||
| lactose monohydrate | ||
| MAGNESIUM STEARATE | ||
| cellulose, microcrystalline | ||
| polyethylene glycol 400 | ||
| POLYETHYLENE GLYCOL 8000 | ||
| POLYDEXTROSE | ||
| STARCH, PREGELATINIZED CORN | ||
| titanium dioxide | ||
| triacetin | ||
Product Characteristics | |||
|---|---|---|---|
| Colour | Size | Imprint Code | Shape |
| white (White) | 10 mm | 524 | ROUND |
Packaging | ||||
|---|---|---|---|---|
| # | Item Code | Package Clarification | Marketing First Engagement | Marketing End Date |
| one | NDC:54868-4976-0 | 30 in i Bottle, PLASTIC | ||
| two | NDC:54868-4976-1 | twenty in i BOTTLE, PLASTIC | ||
| iii | NDC:54868-4976-2 | 120 in 1 Bottle, PLASTIC | ||
| 4 | NDC:54868-4976-3 | 40 in i Canteen, PLASTIC | ||
| 5 | NDC:54868-4976-4 | 100 in 1 BOTTLE, PLASTIC | ||
| 6 | NDC:54868-4976-5 | 60 in 1 Bottle, PLASTIC | ||
| 7 | NDC:54868-4976-vi | 180 in one Canteen, PLASTIC | ||
| viii | NDC:54868-4976-seven | xc in 1 Bottle, PLASTIC | ||
Marketing Information | ||||
|---|---|---|---|---|
| Marketing Category | Application Number or Monograph Citation | Marketing Get-go Date | Marketing Stop Appointment | |
| ANDA | ANDA076604 | 2005-07-25 | ||
Source: https://www.drugs-library.com/drugs/hydrocodone-bitartrate-and-ibuprofen-_d86ced85.html
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