Hydrocodone/ibuprofen 5-200mg 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; Nonsteroidal anti-inflammatory drug (NSAID), COX inhibitor
Pregnancy Category
Category D
FDA Approved
Aug 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 a non-steroidal anti-inflammatory drug (NSAID). It is used to treat moderate to severe pain. The hydrocodone works in your brain to change how your body feels and responds to pain, while ibuprofen reduces pain, inflammation, and fever.
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 the medication by mouth only, with or without food. If it causes stomach upset, take it with food. Never inject or snort this medication, as this can lead to severe side effects, including trouble breathing and death from overdose.
Important Warnings and Precautions
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, as this 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.
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. If the medication stops working well, consult your doctor; do not take more than prescribed.
Long-term or regular use of opioid medications like this one can lead to dependence. Suddenly stopping or reducing the dose can increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose or stopping the medication, and follow their instructions. Report any increased pain, mood changes, thoughts of suicide, or other adverse effects to your doctor.
Monitoring and Maintenance
Have your blood work and other lab tests done as directed by your doctor. This medication can cause high blood pressure, so have your blood pressure checked regularly. If you are taking aspirin to prevent a heart attack, discuss this with your doctor. Smokers and individuals with asthma should also consult their doctor, as they may be more sensitive to this medication.
Seizures can occur in some individuals, including those with a history of seizures. Discuss your risk with your doctor. This medication can also increase the risk of bleeding, so be cautious and avoid injury. Use a soft toothbrush and an electric razor to minimize the risk of bleeding. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Storage and Disposal
Store the medication at room temperature in a dry place, away from the bathroom. Keep it in a safe location, out of reach of children and pets, and consider using a locked box or area. Dispose of unused or expired medication according to the instructions of your pharmacist. Do not flush it down the toilet or pour it down the drain unless instructed to do so. Check with your pharmacist for 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 often than prescribed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication by mouth only, with or without food. If it causes stomach upset, take it with food. Never inject or snort this medication, as this can lead to severe side effects, including trouble breathing and death from overdose.
Important Warnings and Precautions
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, as this 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.
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. If the medication stops working well, consult your doctor; do not take more than prescribed.
Long-term or regular use of opioid medications like this one can lead to dependence. Suddenly stopping or reducing the dose can increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose or stopping the medication, and follow their instructions. Report any increased pain, mood changes, thoughts of suicide, or other adverse effects to your doctor.
Monitoring and Maintenance
Have your blood work and other lab tests done as directed by your doctor. This medication can cause high blood pressure, so have your blood pressure checked regularly. If you are taking aspirin to prevent a heart attack, discuss this with your doctor. Smokers and individuals with asthma should also consult their doctor, as they may be more sensitive to this medication.
Seizures can occur in some individuals, including those with a history of seizures. Discuss your risk with your doctor. This medication can also increase the risk of bleeding, so be cautious and avoid injury. Use a soft toothbrush and an electric razor to minimize the risk of bleeding. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Storage and Disposal
Store the medication at room temperature in a dry place, away from the bathroom. Keep it in a safe location, out of reach of children and pets, and consider using a locked box or area. Dispose of unused or expired medication according to the instructions of your pharmacist. Do not flush it down the toilet or pour it down the drain unless instructed to do so. Check with your pharmacist for 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 often than prescribed by your doctor.
Lifestyle & Tips
- Do not drink alcohol while taking this medication, as it can increase the risk of serious side effects like extreme drowsiness and breathing problems.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- To reduce stomach upset, take this medication with food or milk.
- Do not take more than the prescribed dose or take it more often than prescribed, as this can lead to overdose, addiction, or serious side effects.
- Store this medication securely away from children and pets, as accidental ingestion can be fatal.
- Do not share this medication with others, as it can be dangerous for them and is against the law.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (hydrocodone 5 mg/ibuprofen 200 mg) every 4 to 6 hours as needed for pain.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
maximumSingleDose:
Two tablets (hydrocodone 10 mg/ibuprofen 400 mg)
maximumDailyDose:
Five tablets (hydrocodone 25 mg/ibuprofen 1000 mg) in a 24-hour period
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (safety and efficacy not established for pediatric patients under 16 years of age)
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor renal function.
Moderate:
Use with caution; consider reduced dose and extended dosing interval. Monitor renal function closely.
Severe:
Contraindicated due to ibuprofen component (risk of renal failure).
Dialysis:
Not recommended; ibuprofen is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
Use with caution; monitor for increased adverse effects.
Moderate:
Use with caution; consider reduced dose and extended dosing interval. Monitor for signs of hepatic toxicity.
Severe:
Contraindicated due to ibuprofen component (risk of hepatic failure) and hydrocodone (impaired 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 exerts its analgesic, anti-inflammatory, and antipyretic effects primarily through the inhibition of prostaglandin synthesis by reversibly inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes.
Pharmacokinetics
Absorption:
Bioavailability:
Hydrocodone: ~60-70% (oral); Ibuprofen: ~80-90% (oral)
Tmax:
Hydrocodone: ~1.3 hours; Ibuprofen: ~1-2 hours
FoodEffect:
Food may delay Tmax for both components but does not significantly affect the extent of absorption.
Distribution:
Vd:
Hydrocodone: ~2.2-4.0 L/kg; Ibuprofen: ~0.1-0.2 L/kg
ProteinBinding:
Hydrocodone: ~20-50%; Ibuprofen: >99% (primarily to albumin)
CnssPenetration:
Yes (both components cross the blood-brain barrier)
Elimination:
HalfLife:
Hydrocodone: ~3.8 hours; Ibuprofen: ~1.8-2.5 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Hydrocodone: <10%; Ibuprofen: <1%
Pharmacodynamics
OnsetOfAction:
Hydrocodone: ~10-30 minutes; Ibuprofen: ~30-60 minutes
PeakEffect:
Hydrocodone: ~1 hour; Ibuprofen: ~1-2 hours
DurationOfAction:
Hydrocodone: ~4-6 hours; Ibuprofen: ~4-6 hours
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; GASTROINTESTINAL ADVERSE EVENTS; CARDIOVASCULAR THROMBOTIC 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 regularly for the development of these behaviors and conditions.
REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
Accidental Ingestion: Accidental ingestion 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 that appropriate treatment will be available.
CYP3A4 Interaction: Concomitant use with CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can result in a fatal overdose of hydrocodone.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing 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.
Gastrointestinal Adverse Events: NSAIDs cause an increased risk of serious gastrointestinal 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 regularly for the development of these behaviors and conditions.
REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
Accidental Ingestion: Accidental ingestion 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 that appropriate treatment will be available.
CYP3A4 Interaction: Concomitant use with CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can result in a fatal overdose of hydrocodone.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing 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.
Gastrointestinal Adverse Events: NSAIDs cause an increased risk of serious gastrointestinal 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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, 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: inability to urinate, changes in urine output, blood in the urine, or significant weight gain
Signs of high or low blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, numbness or tingling, or shortness of breath
Signs of low blood sugar: dizziness, headache, drowsiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating
Breathing difficulties, slow or shallow breathing
Severe constipation or stomach pain, which 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, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Fever, chills, sore throat, unexplained bruising or bleeding, or excessive fatigue
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Anxiety
Dizziness, drowsiness, fatigue, 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, 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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, 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: inability to urinate, changes in urine output, blood in the urine, or significant weight gain
Signs of high or low blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, numbness or tingling, or shortness of breath
Signs of low blood sugar: dizziness, headache, drowsiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating
Breathing difficulties, slow or shallow breathing
Severe constipation or stomach pain, which 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, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Fever, chills, sore throat, unexplained bruising or bleeding, or excessive fatigue
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Anxiety
Dizziness, drowsiness, fatigue, 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, 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:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Severe dizziness or lightheadedness
- Confusion
- Bluish lips or fingernails
- Severe stomach pain
- Black, tarry, or bloody stools
- Vomit that looks like coffee grounds
- Unusual bruising or bleeding
- Swelling of the face, lips, tongue, or throat
- Difficulty urinating or changes in the amount of urine
- Yellowing of the skin or eyes (jaundice)
- Signs of an allergic reaction (rash, itching, hives)
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 conditions and situations to ensure safe treatment:
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.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
Existing health problems, including:
+ Lung or breathing issues, such as asthma, breathing difficulties, 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.
Current medications, including:
+ Other NSAIDs.
+ Salicylate drugs, such as aspirin.
+ Pemetrexed.
+ Certain drugs, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain depression or Parkinson's disease medications in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure.
Fertility issues or ongoing fertility evaluation.
* Pregnancy, planned pregnancy, or suspected pregnancy. 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 under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe treatment. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
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.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
Existing health problems, including:
+ Lung or breathing issues, such as asthma, breathing difficulties, 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.
Current medications, including:
+ Other NSAIDs.
+ Salicylate drugs, such as aspirin.
+ Pemetrexed.
+ Certain drugs, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain depression or Parkinson's disease medications in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure.
Fertility issues or ongoing fertility evaluation.
* Pregnancy, planned pregnancy, or suspected pregnancy. 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 under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe treatment. Never start, stop, or change the dose of any medication without consulting your doctor.
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. If you have pre-existing heart failure, your risk of heart attack, hospitalization, and death may be higher. Discuss these risks with your doctor. Additionally, people taking this medication after a recent heart attack may be at increased risk of heart attack and death.
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 issues, irregular menstrual periods, or ejaculation problems, consult your doctor.
Adrenal Gland Problems: Taking an opioid medication like this one can lead to a rare but severe adrenal gland problem. 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. These reactions can be life-threatening and may affect other organs. 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 trouble breathing, 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. If you have pre-existing heart failure, your risk of heart attack, hospitalization, and death may be higher. Discuss these risks with your doctor. Additionally, people taking this medication after a recent heart attack may be at increased risk of heart attack and death.
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 issues, irregular menstrual periods, or ejaculation problems, consult your doctor.
Adrenal Gland Problems: Taking an opioid medication like this one can lead to a rare but severe adrenal gland problem. 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. These reactions can be life-threatening and may affect other organs. 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 trouble breathing, seek medical help right away.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness, unresponsiveness, or coma
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Low blood pressure
- Slowed heart rate
- Severe stomach pain
- Nausea, vomiting
- Kidney failure
What to Do:
Seek immediate emergency medical attention. Call 911 or the Poison Control Center at 1-800-222-1222. Naloxone (Narcan) may be administered for opioid overdose. Supportive care for respiratory and cardiovascular function will be provided. Gastric lavage or activated charcoal may be considered if ingestion was recent.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (within 14 days of hydrocodone)
- Coronary Artery Bypass Graft (CABG) surgery (peri-operative use of ibuprofen)
- Other NSAIDs (increased risk of GI and renal adverse effects)
- Aspirin (high-dose, increased risk of GI bleeding)
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids) - increased risk of respiratory depression, profound sedation, coma, and death.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir) - increased hydrocodone plasma concentrations, leading to increased opioid effects.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - decreased hydrocodone plasma concentrations, leading to reduced opioid efficacy.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - decreased conversion of hydrocodone to hydromorphone, potentially reducing analgesic effect.
- Anticoagulants (e.g., warfarin) - increased risk of bleeding due to ibuprofen.
- Antiplatelet agents (e.g., clopidogrel) - increased risk of bleeding due to ibuprofen.
- SSRIs/SNRIs (e.g., sertraline, venlafaxine) - increased risk of bleeding (due to ibuprofen) and serotonin syndrome (with hydrocodone).
- Diuretics (e.g., furosemide, hydrochlorothiazide) - reduced natriuretic effect of diuretics due to ibuprofen.
- ACE inhibitors/ARBs (e.g., lisinopril, valsartan) - 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 plasma concentrations and toxicity due to ibuprofen.
- Cyclosporine - increased nephrotoxicity due to ibuprofen.
- Corticosteroids - increased risk of GI ulceration and bleeding due to ibuprofen.
Moderate Interactions
- Beta-blockers - reduced antihypertensive effect due to ibuprofen.
- Digoxin - increased digoxin plasma concentrations due to ibuprofen.
- Pemetrexed - increased pemetrexed toxicity due to ibuprofen.
- Sulfonylureas - altered blood glucose control due to ibuprofen.
- Zidovudine - increased hematologic toxicity due to ibuprofen.
Minor Interactions
- Herbal supplements with anticoagulant/antiplatelet properties (e.g., ginkgo, garlic, ginger) - theoretical increased bleeding risk with ibuprofen.
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy
Vital signs (respiratory rate, heart rate, blood pressure)
Rationale: To establish baseline and identify potential risks for respiratory depression or cardiovascular effects.
Timing: Prior to initiation of therapy
Renal function (BUN, serum creatinine, eGFR)
Rationale: To assess baseline kidney function due to ibuprofen's renal effects.
Timing: Prior to initiation of therapy
Hepatic function (ALT, AST, bilirubin)
Rationale: To assess baseline liver function due to metabolism of both drugs and potential for hepatic toxicity.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess for baseline anemia or other hematologic abnormalities, as NSAIDs can affect platelet function and rarely cause blood dyscrasias.
Timing: Prior to initiation of therapy
Gastrointestinal history (ulcers, bleeding)
Rationale: To assess risk for GI adverse events with ibuprofen.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain level and efficacy
Frequency: Regularly during therapy, especially after dose adjustments
Target: Acceptable pain relief with minimal side effects
Action Threshold: Inadequate pain control or excessive side effects warrant dose adjustment or alternative therapy.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose escalation
Target: >12 breaths/min, unlabored
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., somnolence, cyanosis) require immediate intervention.
Sedation level (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation and dose escalation
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Difficult to arouse, somnolent, or unresponsive requires immediate intervention.
Signs of GI bleeding (e.g., melena, hematemesis, severe abdominal pain)
Frequency: Periodically, and with any new GI symptoms
Target: Absence of bleeding signs
Action Threshold: Presence of signs requires immediate medical evaluation and discontinuation.
Renal function (BUN, serum creatinine, eGFR)
Frequency: Periodically, especially in patients with risk factors for renal impairment (e.g., elderly, heart failure, diuretic use)
Target: Within patient's baseline range
Action Threshold: Significant increase in creatinine or decrease in eGFR warrants dose adjustment or discontinuation.
Blood pressure
Frequency: Periodically, especially in patients with hypertension or cardiovascular risk factors
Target: Within patient's target range
Action Threshold: Significant increase in BP warrants evaluation and management.
Signs of fluid retention/edema
Frequency: Periodically
Target: Absence of new or worsening edema
Action Threshold: Significant edema warrants evaluation.
Symptom Monitoring
- Drowsiness
- Dizziness
- Nausea
- Vomiting
- Constipation
- Abdominal pain
- Heartburn
- Indigestion
- Dark or tarry stools
- Unusual bruising or bleeding
- Swelling of hands or feet
- Shortness of breath
- Changes in urination
- Yellowing of skin or eyes
Special Patient Groups
Pregnancy
Contraindicated in late pregnancy (third trimester) due to risk of premature closure of the fetal ductus arteriosus from ibuprofen and potential for neonatal opioid withdrawal syndrome from hydrocodone. Use in early pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Hydrocodone: Potential for congenital malformations (limited data). Ibuprofen: Limited data on risk, but generally avoided unless clearly needed.
Second Trimester:
Hydrocodone: Risk of neonatal opioid withdrawal syndrome with prolonged use. Ibuprofen: Avoid unless clearly needed; potential for oligohydramnios/renal dysfunction in fetus.
Third Trimester:
Hydrocodone: Risk of neonatal opioid withdrawal syndrome, respiratory depression in neonate. Ibuprofen: Contraindicated due to risk of premature closure of fetal ductus arteriosus and persistent pulmonary hypertension of the newborn. May also inhibit labor.
Lactation
Not recommended. Hydrocodone and its active metabolite (hydromorphone) are excreted into breast milk and can cause serious adverse reactions in breastfed infants, including respiratory depression and sedation. Ibuprofen is excreted in breast milk in small amounts and is generally considered compatible with breastfeeding, but the combination with hydrocodone increases risk.
Infant Risk:
High risk for hydrocodone (sedation, respiratory depression, poor feeding, withdrawal symptoms). Low risk for ibuprofen alone, but the combination makes it high risk.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 16 years of age. Use is generally not recommended due to the risks associated with opioid use in this population and the lack of specific dosing guidelines.
Geriatric Use
Elderly patients are at increased risk for adverse reactions, including respiratory depression, sedation, and gastrointestinal bleeding/ulceration, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects, especially renal function and CNS effects.
Clinical Information
Clinical Pearls
- This combination product carries significant risks due to both the opioid (hydrocodone) and NSAID (ibuprofen) components. Prescribe only when the benefits outweigh the risks and alternative therapies are inadequate.
- Educate patients thoroughly on the risks of addiction, abuse, misuse, respiratory depression, and accidental ingestion, as well as the NSAID-related cardiovascular and gastrointestinal risks.
- Always assess for concomitant use of other CNS depressants, including alcohol and benzodiazepines, which significantly increase the risk of respiratory depression and death.
- Monitor patients closely for signs of respiratory depression, especially during initiation or dose escalation. Have naloxone readily available if appropriate.
- Advise patients to take with food or milk to minimize GI upset and to report any signs of GI bleeding immediately.
- Avoid use in patients with severe renal or hepatic impairment, or in the peri-operative setting of CABG surgery.
- Consider the patient's overall cardiovascular risk profile before prescribing, as NSAIDs can increase the risk of thrombotic events.
- Due to the Schedule II classification, strict prescribing regulations apply (e.g., no refills, specific prescription requirements).
Alternative Therapies
- Non-opioid analgesics (e.g., acetaminophen, other NSAIDs like naproxen, celecoxib)
- Other opioid analgesics (e.g., morphine, oxycodone, hydromorphone)
- Topical analgesics (e.g., lidocaine patches, capsaicin cream)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants, SNRIs)
- Non-pharmacological therapies (e.g., physical therapy, acupuncture, massage, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1-3 (generic), Tier 3-4 (brand, if available)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential 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 for clarification.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, 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 right away. When reporting the incident, be prepared to provide the necessary information, including 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, which provides crucial information about its safe use. It is essential 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 for clarification.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, 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 right away. When reporting the incident, be prepared to provide the necessary information, including what was taken, the quantity, and the time of the incident, to ensure prompt and effective treatment.