Hydrocodone/ibuprofen 10-200mg Tab
WARNING: This drug has an opioid drug in it. Opioid drugs can put you at risk for drug use disorder. Misuse or abuse of this drug can lead to overdose and death. If you have questions, talk with your doctor.This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing.Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life- threatening if not treated. @ COMMON USES: It is used to manage pain when non- opioid pain drugs do not treat your pain well enough or you cannot take them.
Drug Class
Opioid analgesic and NSAID combination
Pharmacologic Class
Opioid agonist (hydrocodone), Nonsteroidal anti-inflammatory drug (ibuprofen)
Pregnancy Category
Category D
FDA Approved
Jan 1997
DEA Schedule
Schedule II
Overview
What is this medicine?
This medication is a combination of two pain relievers: hydrocodone, which is an opioid, and ibuprofen, which is an anti-inflammatory drug. It is used for short-term relief of moderate to severe pain.
How to Use This Medicine
Taking Your Medication Safely
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food.
Important Safety Precautions
Do not inject or snort this medication, as this can lead to severe side effects, including trouble breathing and death from overdose.
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Do not exceed the dose or frequency prescribed by your doctor. Taking more than recommended can increase the risk of severe side effects.
Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
Monitoring Your Condition
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may need higher doses to achieve the same effect. This is known as tolerance. Consult your doctor if the medication stops working well. Do not take more than prescribed.
Potential Risks and Interactions
Long-term or regular use of opioid medications like this one can lead to dependence. Stopping the medication abruptly or reducing the dose can increase the risk of withdrawal or other severe problems. Consult your doctor before making any changes to your dosage.
Inform your doctor if you experience increased pain, mood changes, thoughts of suicide, or other adverse effects.
Regular blood work and lab tests are necessary to monitor your condition. Follow your doctor's instructions for scheduling these tests.
High blood pressure has been associated with medications like this one. Have your blood pressure checked as directed by your doctor.
If you are taking aspirin to prevent a heart attack, discuss this with your doctor.
If you smoke, have asthma, or are 65 or older, consult your doctor about potential risks and interactions.
Seizure Risk and Bleeding
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.
You may be more prone to bleeding while taking this medication. Be cautious, avoid injury, and use a soft toothbrush and electric razor.
Storage and Disposal
Store this medication at room temperature in a dry place, away from bathrooms and out of reach of children and pets.
Keep this medication in a secure, locked location to prevent unauthorized access.
Dispose of unused or expired medication according to your pharmacist's instructions. Do not flush it down the toilet or pour it down the drain unless advised to do so. Check with your pharmacist about potential drug take-back programs in your area.
Missed Doses
If you take this medication regularly, take a missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or extra doses.
* If you take this medication as needed, do not take it more frequently than prescribed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food.
Important Safety Precautions
Do not inject or snort this medication, as this can lead to severe side effects, including trouble breathing and death from overdose.
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Do not exceed the dose or frequency prescribed by your doctor. Taking more than recommended can increase the risk of severe side effects.
Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
Monitoring Your Condition
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may need higher doses to achieve the same effect. This is known as tolerance. Consult your doctor if the medication stops working well. Do not take more than prescribed.
Potential Risks and Interactions
Long-term or regular use of opioid medications like this one can lead to dependence. Stopping the medication abruptly or reducing the dose can increase the risk of withdrawal or other severe problems. Consult your doctor before making any changes to your dosage.
Inform your doctor if you experience increased pain, mood changes, thoughts of suicide, or other adverse effects.
Regular blood work and lab tests are necessary to monitor your condition. Follow your doctor's instructions for scheduling these tests.
High blood pressure has been associated with medications like this one. Have your blood pressure checked as directed by your doctor.
If you are taking aspirin to prevent a heart attack, discuss this with your doctor.
If you smoke, have asthma, or are 65 or older, consult your doctor about potential risks and interactions.
Seizure Risk and Bleeding
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.
You may be more prone to bleeding while taking this medication. Be cautious, avoid injury, and use a soft toothbrush and electric razor.
Storage and Disposal
Store this medication at room temperature in a dry place, away from bathrooms and out of reach of children and pets.
Keep this medication in a secure, locked location to prevent unauthorized access.
Dispose of unused or expired medication according to your pharmacist's instructions. Do not flush it down the toilet or pour it down the drain unless advised to do so. Check with your pharmacist about potential drug take-back programs in your area.
Missed Doses
If you take this medication regularly, take a missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or extra doses.
* If you take this medication as needed, do not take it more frequently than prescribed by your doctor.
Lifestyle & Tips
- Do not drink alcohol while taking this medication, as it can increase drowsiness and the risk of serious side effects.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- Take exactly as prescribed; do not take more than the recommended dose or for longer than prescribed.
- Store this medication securely out of reach of children and pets, preferably in a locked cabinet, to prevent accidental ingestion.
- Do not share this medication with anyone else, as it can be dangerous for them.
- Discuss all other medications, supplements, and herbal products you are taking with your doctor to avoid dangerous interactions.
- Do not stop taking this medication suddenly if you have been taking it regularly for a prolonged period, as withdrawal symptoms may occur. Consult your doctor for a plan to safely reduce the dose.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (hydrocodone 10 mg/ibuprofen 200 mg) orally every 4 to 6 hours as needed for pain.
Dose Range:
1 - 5 mg
Condition-Specific Dosing:
maximumDailyDose:
Do not exceed 5 tablets (hydrocodone 50 mg/ibuprofen 1000 mg) in 24 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (safety and efficacy not established; generally not recommended due to opioid component and NSAID risks)
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor renal function.
Moderate:
Use with caution; consider dose reduction and extended dosing interval. Monitor renal function closely.
Severe:
Contraindicated or not recommended due to increased risk of renal failure (ibuprofen component).
Dialysis:
Not recommended; ibuprofen is not significantly removed by dialysis.
Hepatic Impairment:
Mild:
Use with caution; monitor for increased adverse effects.
Moderate:
Use with caution; consider dose reduction and extended dosing interval. Monitor for increased adverse effects.
Severe:
Not recommended due to increased risk of adverse effects and altered drug metabolism.
Pharmacology
Mechanism of Action
Hydrocodone is a semisynthetic opioid analgesic that acts as an agonist at mu-opioid receptors in the central nervous system (CNS), producing analgesia, sedation, and respiratory depression. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis by reversibly inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, thereby exerting analgesic, anti-inflammatory, and antipyretic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (both components are well absorbed)
Tmax:
Hydrocodone: ~1.3 hours; Ibuprofen: ~1-2 hours
FoodEffect:
Food may delay Tmax for ibuprofen but does not significantly affect the extent of absorption. Hydrocodone absorption is not significantly affected by food.
Distribution:
Vd:
Hydrocodone: ~22.8 L/kg; Ibuprofen: ~0.12 L/kg
ProteinBinding:
Hydrocodone: ~20-50%; Ibuprofen: >99%
CnssPenetration:
Hydrocodone: Yes (sufficient for therapeutic effect); Ibuprofen: Limited
Elimination:
HalfLife:
Hydrocodone: ~3.8 hours; Ibuprofen: ~1.8-2.5 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Hydrocodone: Small amount; Ibuprofen: <1%
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes
PeakEffect:
Approximately 1-2 hours
DurationOfAction:
Approximately 4-6 hours
Safety & Warnings
BLACK BOX WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; CARDIOVASCULAR THROMBOTIC EVENTS; GASTROINTESTINAL RISK.
Addiction, Abuse, and Misuse: Hydrocodone/ibuprofen exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing hydrocodone/ibuprofen, and monitor all patients receiving hydrocodone/ibuprofen for development of these behaviors and conditions.
Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone/ibuprofen. Monitor for respiratory depression, especially during initiation of hydrocodone/ibuprofen or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of hydrocodone/ibuprofen, especially by children, can result in a fatal overdose of hydrocodone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of hydrocodone/ibuprofen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure appropriate care will be available.
CYP450 3A4 Interaction: The concomitant use of hydrocodone/ibuprofen with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients receiving hydrocodone/ibuprofen and any CYP3A4 inhibitor or inducer.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, 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 for signs and symptoms of respiratory depression and sedation.
Cardiovascular Thrombotic Events: NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Hydrocodone/ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastric Ulceration, Bleeding, and Perforation: NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Addiction, Abuse, and Misuse: Hydrocodone/ibuprofen exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing hydrocodone/ibuprofen, and monitor all patients receiving hydrocodone/ibuprofen for development of these behaviors and conditions.
Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone/ibuprofen. Monitor for respiratory depression, especially during initiation of hydrocodone/ibuprofen or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of hydrocodone/ibuprofen, especially by children, can result in a fatal overdose of hydrocodone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of hydrocodone/ibuprofen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure appropriate care will be available.
CYP450 3A4 Interaction: The concomitant use of hydrocodone/ibuprofen with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients receiving hydrocodone/ibuprofen and any CYP3A4 inhibitor or inducer.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, 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 for signs and symptoms of respiratory depression and sedation.
Cardiovascular Thrombotic Events: NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Hydrocodone/ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastric Ulceration, Bleeding, and Perforation: NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of high potassium levels, including:
+ Abnormal heartbeat
+ Confusion or weakness
+ Lightheadedness, dizziness, or feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Signs of low blood sugar, such as:
+ Dizziness or headache
+ Feeling sleepy, weak, or shaky
+ Rapid heartbeat or confusion
+ Hunger or sweating
Breathing difficulties, slow breathing, or shallow breathing
Severe constipation or stomach pain (may indicate a serious bowel problem)
Chest pain or pressure
Noisy breathing
Sleep apnea (breathing problems during sleep)
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak
Changes in vision, eye pain, or severe eye irritation
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Shortness of breath, significant weight gain, or swelling in the arms or legs
Seizures
Flu-like symptoms
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Anxiety
Dizziness, drowsiness, tiredness, or weakness
Dry mouth
Excessive sweating
Nervousness or excitability
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Sleep disturbances
Gas
Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of high potassium levels, including:
+ Abnormal heartbeat
+ Confusion or weakness
+ Lightheadedness, dizziness, or feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Signs of low blood sugar, such as:
+ Dizziness or headache
+ Feeling sleepy, weak, or shaky
+ Rapid heartbeat or confusion
+ Hunger or sweating
Breathing difficulties, slow breathing, or shallow breathing
Severe constipation or stomach pain (may indicate a serious bowel problem)
Chest pain or pressure
Noisy breathing
Sleep apnea (breathing problems during sleep)
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak
Changes in vision, eye pain, or severe eye irritation
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Shortness of breath, significant weight gain, or swelling in the arms or legs
Seizures
Flu-like symptoms
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Anxiety
Dizziness, drowsiness, tiredness, or weakness
Dry mouth
Excessive sweating
Nervousness or excitability
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Sleep disturbances
Gas
Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Difficulty breathing or shallow breathing
- Extreme drowsiness or inability to wake up
- Dizziness or lightheadedness when standing up
- Severe stomach pain, black or tarry stools, or vomit that looks like coffee grounds (signs of stomach bleeding)
- Swelling of your face, lips, tongue, or throat (signs of allergic reaction)
- Skin rash, blistering, or peeling
- Unusual bruising or bleeding
- Decreased urination or swelling in your legs/feet (signs of kidney problems)
- Chest pain, shortness of breath, or weakness on one side of the body (signs of heart attack or stroke)
- Yellowing of the skin or eyes (jaundice)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
Certain health conditions, including:
+ Lung or breathing problems, such as asthma, trouble breathing, or sleep apnea
+ High levels of carbon dioxide in the blood
+ Stomach or bowel blockage or narrowing
+ Gastrointestinal (GI) bleeding or kidney problems
+ Heart failure (weak heart) or a recent heart attack
If you are taking any other NSAID, a salicylate drug like aspirin, or pemetrexed.
If you are taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
If you have taken certain medications for depression or Parkinson's disease in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure.
If you are experiencing difficulty getting pregnant or undergoing fertility testing.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This medication may harm an unborn baby if taken at 20 weeks or later in pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. Verify that it is safe to take this medication with all your other medications and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your medication regimen.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
Certain health conditions, including:
+ Lung or breathing problems, such as asthma, trouble breathing, or sleep apnea
+ High levels of carbon dioxide in the blood
+ Stomach or bowel blockage or narrowing
+ Gastrointestinal (GI) bleeding or kidney problems
+ Heart failure (weak heart) or a recent heart attack
If you are taking any other NSAID, a salicylate drug like aspirin, or pemetrexed.
If you are taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
If you have taken certain medications for depression or Parkinson's disease in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure.
If you are experiencing difficulty getting pregnant or undergoing fertility testing.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This medication may harm an unborn baby if taken at 20 weeks or later in pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. Verify that it is safe to take this medication with all your other medications and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your medication regimen.
Precautions & Cautions
Important Warnings and Cautions
To ensure your safety while taking this medication, please be aware of the following important warnings and cautions:
Dizziness and Alertness: Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. Be cautious when climbing stairs.
Alcohol Interaction: Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially life-threatening effects.
Liver Problems: Medications like this one have been associated with liver problems, which can be fatal. Monitor for signs of liver issues, including dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellowing of the skin and eyes. If you experience any of these symptoms, contact your doctor immediately.
Aseptic Meningitis: This medication may increase the risk of a severe brain condition called aseptic meningitis. Seek medical attention right away if you experience symptoms such as headache, fever, chills, severe nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Heart Failure and Heart Attack: The use of medications like this one may increase the risk of heart failure, heart attack, and death, particularly in individuals with pre-existing heart failure. Additionally, people taking this medication after a recent heart attack may be at higher risk of heart attack, hospitalization for heart failure, and death. Discuss these risks with your doctor.
Serotonin Syndrome: Combining this medication with certain other drugs can lead to a life-threatening condition called serotonin syndrome. If you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering, sweating, severe diarrhea, nausea, vomiting, or severe headache, contact your doctor immediately.
Hormonal Effects: Long-term use of opioid medications like this one may lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation issues, consult your doctor.
Adrenal Gland Problems: Taking an opioid medication like this one may cause a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, seek medical attention right away.
Severe Skin Reactions: This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions, which can be fatal. If you experience symptoms such as red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands, seek medical help immediately.
Breastfeeding: If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. If your baby appears extremely sleepy, limp, or has breathing difficulties, seek medical help right away.
To ensure your safety while taking this medication, please be aware of the following important warnings and cautions:
Dizziness and Alertness: Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. Be cautious when climbing stairs.
Alcohol Interaction: Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially life-threatening effects.
Liver Problems: Medications like this one have been associated with liver problems, which can be fatal. Monitor for signs of liver issues, including dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellowing of the skin and eyes. If you experience any of these symptoms, contact your doctor immediately.
Aseptic Meningitis: This medication may increase the risk of a severe brain condition called aseptic meningitis. Seek medical attention right away if you experience symptoms such as headache, fever, chills, severe nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Heart Failure and Heart Attack: The use of medications like this one may increase the risk of heart failure, heart attack, and death, particularly in individuals with pre-existing heart failure. Additionally, people taking this medication after a recent heart attack may be at higher risk of heart attack, hospitalization for heart failure, and death. Discuss these risks with your doctor.
Serotonin Syndrome: Combining this medication with certain other drugs can lead to a life-threatening condition called serotonin syndrome. If you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering, sweating, severe diarrhea, nausea, vomiting, or severe headache, contact your doctor immediately.
Hormonal Effects: Long-term use of opioid medications like this one may lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation issues, consult your doctor.
Adrenal Gland Problems: Taking an opioid medication like this one may cause a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, seek medical attention right away.
Severe Skin Reactions: This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions, which can be fatal. If you experience symptoms such as red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands, seek medical help immediately.
Breastfeeding: If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. If your baby appears extremely sleepy, limp, or has breathing difficulties, seek medical help right away.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Extreme drowsiness or sedation
- Slow, shallow, or stopped breathing
- Cold, clammy skin
- Limp muscles
- Loss of consciousness or unresponsiveness
- Bluish discoloration of lips or fingernails
What to Do:
If you suspect an overdose, seek immediate emergency medical attention. Call 911 or your local emergency number. In the U.S., you can also call the Poison Control Center at 1-800-222-1222. Have naloxone (Narcan) available if prescribed and know how to use it.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (within 14 days of hydrocodone)
- Other NSAIDs (increased GI and renal risk)
- Aspirin (high-dose, antiplatelet effect with ibuprofen)
- Alcohol (increased CNS depression and GI risk)
Major Interactions
- CNS Depressants (e.g., benzodiazepines, other opioids, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants): Increased risk of respiratory depression, profound sedation, coma, and death.
- CYP2D6 Inhibitors (e.g., quinidine, fluoxetine, paroxetine, bupropion): May decrease hydrocodone metabolism to hydromorphone, potentially reducing analgesic effect.
- CYP3A4 Inhibitors (e.g., clarithromycin, ketoconazole, ritonavir): May increase hydrocodone plasma concentrations, leading to increased opioid effects.
- CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease hydrocodone plasma concentrations, leading to reduced opioid effects.
- Anticoagulants (e.g., warfarin): Increased risk of bleeding due to ibuprofen's antiplatelet effect and GI irritation.
- Antiplatelet Agents (e.g., clopidogrel, ticagrelor): Increased risk of bleeding.
- Corticosteroids: Increased risk of GI ulceration and bleeding.
- Diuretics (e.g., furosemide, hydrochlorothiazide): Reduced natriuretic and antihypertensive effects of diuretics due to ibuprofen.
- ACE Inhibitors/ARBs: Reduced antihypertensive effect and increased risk of renal impairment due to ibuprofen.
- Lithium: Increased lithium plasma concentrations and toxicity due to ibuprofen.
- Methotrexate: Increased methotrexate toxicity due to ibuprofen.
- Cyclosporine: Increased nephrotoxicity due to ibuprofen.
- Digoxin: Increased digoxin plasma concentrations due to ibuprofen.
Moderate Interactions
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Increased risk of serotonin syndrome with hydrocodone.
- Sulfonylureas: Increased hypoglycemic effect due to ibuprofen.
Minor Interactions
- Ginkgo Biloba, Garlic, Ginger: May increase bleeding risk with ibuprofen.
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
Rationale: To establish baseline pain level and guide treatment.
Timing: Prior to initiation of therapy
Respiratory rate and depth
Rationale: To assess baseline respiratory status due to opioid risk.
Timing: Prior to initiation of therapy
Renal function (BUN, serum creatinine, GFR)
Rationale: To assess baseline kidney function due to ibuprofen's renal effects.
Timing: Prior to initiation of therapy, especially in patients with risk factors
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline liver function due to hepatic metabolism of both drugs.
Timing: Prior to initiation of therapy, especially in patients with risk factors
Complete Blood Count (CBC)
Rationale: To assess for baseline anemia or bleeding risk, especially if long-term use is considered.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain relief and functional improvement
Frequency: Regularly during therapy (e.g., daily, weekly depending on duration)
Target: Acceptable pain control with minimal adverse effects
Action Threshold: Inadequate pain control or intolerable side effects warrant re-evaluation.
Signs of respiratory depression (rate, depth, sedation level)
Frequency: Regularly, especially during initiation or dose escalation
Target: Normal respiratory rate (12-20 breaths/min), awake and alert
Action Threshold: Respiratory rate <10 breaths/min, excessive sedation, or difficulty arousing requires immediate intervention.
Signs of GI bleeding (e.g., black/tarry stools, severe abdominal pain)
Frequency: Daily patient self-monitoring
Target: Absence of GI bleeding symptoms
Action Threshold: Any signs of GI bleeding require immediate medical attention.
Renal function (BUN, serum creatinine)
Frequency: Periodically, especially with prolonged use or in patients with risk factors (e.g., every 3-6 months)
Target: Within normal limits or stable from baseline
Action Threshold: Significant increase in BUN/creatinine or decrease in GFR warrants dose adjustment or discontinuation.
Blood pressure
Frequency: Periodically, especially in hypertensive patients
Target: Within target range for patient
Action Threshold: Significant increase in blood pressure warrants re-evaluation of therapy.
Signs of abuse, misuse, or diversion
Frequency: At each clinical encounter
Target: Absence of concerning behaviors
Action Threshold: Any signs warrant further assessment and appropriate intervention.
Symptom Monitoring
- Excessive sedation or drowsiness
- Dizziness or lightheadedness
- Nausea and vomiting
- Constipation
- Difficulty breathing or shallow breathing
- Pinpoint pupils
- Severe stomach pain or discomfort
- Black, tarry stools or blood in vomit (signs of GI bleeding)
- Swelling of hands, ankles, or feet (edema)
- Unusual bruising or bleeding
- Skin rash or itching
- Changes in urination (amount or frequency)
- Signs of allergic reaction (e.g., difficulty breathing, swelling of face/throat, severe rash)
Special Patient Groups
Pregnancy
Category D. Avoid use during pregnancy, especially during the third trimester, due to risks to the fetus. Prolonged use of hydrocodone during pregnancy can lead to neonatal opioid withdrawal syndrome. Ibuprofen use in the third trimester can cause premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension of the newborn.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations with opioid exposure, though data are mixed. NSAID use in early pregnancy may be associated with increased risk of miscarriage.
Second Trimester:
Risk of neonatal opioid withdrawal syndrome with prolonged hydrocodone use. NSAID use generally avoided unless benefits outweigh risks.
Third Trimester:
High risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension of the newborn with ibuprofen. Risk of neonatal opioid withdrawal syndrome with hydrocodone. Avoid use.
Lactation
L3 (Moderately Safe). Hydrocodone and its active metabolite hydromorphone are excreted into breast milk and can cause sedation and respiratory depression in a breastfed infant. Ibuprofen is generally considered safe during lactation (L1) due to low levels in milk and short half-life. Due to the hydrocodone component, caution is advised. Monitor infants for signs of sedation, poor feeding, and respiratory depression.
Infant Risk:
Moderate risk due to hydrocodone. Potential for infant sedation, respiratory depression, and poor feeding. Ibuprofen poses low risk.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not recommended for use in children due to the risks associated with opioid analgesics and NSAIDs in this population.
Geriatric Use
Elderly patients are at increased risk for adverse effects, including respiratory depression, CNS effects (sedation, confusion), and gastrointestinal bleeding/ulceration, and renal impairment. Use with caution, starting with the lowest effective dose and monitoring closely for adverse reactions.
Clinical Information
Clinical Pearls
- This combination product is intended for short-term use only (typically <10 days) due to the risks of opioid dependence/addiction and NSAID-related adverse effects.
- Counsel patients on the serious risks associated with opioid use, including addiction, respiratory depression, and accidental ingestion.
- Emphasize the importance of not exceeding the maximum daily dose due to the combined toxicity of hydrocodone and ibuprofen.
- Advise patients to avoid concomitant use of alcohol, benzodiazepines, or other CNS depressants due to additive respiratory depression and sedation.
- Educate patients on the signs and symptoms of GI bleeding and cardiovascular events, and to seek immediate medical attention if they occur.
- Consider alternative non-opioid or non-NSAID pain management strategies for chronic pain or in patients with contraindications to either component.
- Ensure proper disposal of unused medication to prevent diversion or accidental ingestion.
Alternative Therapies
- Other NSAIDs (e.g., naproxen, celecoxib)
- Acetaminophen
- Other opioid analgesics (e.g., tramadol, morphine, oxycodone)
- Non-pharmacologic pain management (e.g., physical therapy, heat/cold therapy, massage, acupuncture)
- Topical analgesics
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic), Tier 3 or 4 (brand) depending on insurance plan formulary.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care immediately. When seeking help, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure prompt and effective treatment.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care immediately. When seeking help, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure prompt and effective treatment.