Hydrocodone/ibuprof 7.5-200mg Tb
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 Nonsteroidal Anti-inflammatory Drug (NSAID) combination
Pharmacologic Class
Opioid agonist; Cyclooxygenase (COX) inhibitor
Pregnancy Category
Category C (1st/2nd trimester), Category D (3rd trimester)
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 a strong opioid pain medicine, and ibuprofen, which is a common anti-inflammatory drug. It is used to treat moderate to severe pain. Hydrocodone works in your brain to change how your body feels and responds to pain. Ibuprofen works by reducing substances in the body that cause pain, fever, and inflammation.
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.
Important Warnings
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 prescribed dose or take it more frequently or for a longer period than recommended, as this may increase the risk of severe side effects.
Interactions and Precautions
Before taking this medication with other strong pain medications or using a pain patch, consult your doctor.
If your pain worsens, you become more sensitive to pain, or experience new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Long-term or high-dose use of opioid medications like this one may lead to tolerance, where the medication becomes less effective. If this occurs, consult your doctor. Do not take more than the prescribed dose.
Regular use of opioid medications may also lead to dependence. If you need to reduce the dose or stop taking the medication, consult your doctor to avoid withdrawal or other severe problems.
Monitoring and Follow-up
Regularly have your blood work and other lab tests checked as directed by your doctor.
High blood pressure has been associated with medications like this one. Have your blood pressure checked as recommended 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, use this medication with caution and consult your doctor, as you may be more susceptible to side effects.
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine your risk.
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 the medication at room temperature in a dry place, away from the bathroom.
Keep the medication in a secure location, out of reach of children and pets, and inaccessible to others. A locked box or area may be helpful.
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 advised 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 frequently than recommended 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.
Important Warnings
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 prescribed dose or take it more frequently or for a longer period than recommended, as this may increase the risk of severe side effects.
Interactions and Precautions
Before taking this medication with other strong pain medications or using a pain patch, consult your doctor.
If your pain worsens, you become more sensitive to pain, or experience new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Long-term or high-dose use of opioid medications like this one may lead to tolerance, where the medication becomes less effective. If this occurs, consult your doctor. Do not take more than the prescribed dose.
Regular use of opioid medications may also lead to dependence. If you need to reduce the dose or stop taking the medication, consult your doctor to avoid withdrawal or other severe problems.
Monitoring and Follow-up
Regularly have your blood work and other lab tests checked as directed by your doctor.
High blood pressure has been associated with medications like this one. Have your blood pressure checked as recommended 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, use this medication with caution and consult your doctor, as you may be more susceptible to side effects.
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine your risk.
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 the medication at room temperature in a dry place, away from the bathroom.
Keep the medication in a secure location, out of reach of children and pets, and inaccessible to others. A locked box or area may be helpful.
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 advised 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 frequently than recommended 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 addiction, overdose, or serious side effects.
- Store this medication securely to prevent accidental ingestion by children or others.
- Stay hydrated to help prevent constipation, a common side effect of hydrocodone.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 tablet (7.5 mg hydrocodone / 200 mg ibuprofen) orally every 4 to 6 hours as needed for pain
Dose Range:
1 - 5 mg
Condition-Specific Dosing:
Maximum daily dose:
5 tablets (37.5 mg hydrocodone / 1000 mg ibuprofen) in 24 hours
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 dose reduction and extended dosing intervals, especially for ibuprofen component. Monitor renal function closely.
Severe:
Contraindicated for ibuprofen component; significant dose reduction and extended intervals for hydrocodone component. Avoid use if possible.
Dialysis:
Not recommended due to ibuprofen component; hydrocodone is minimally dialyzable.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function
Moderate:
Use with caution; consider dose reduction and extended dosing intervals for both components. Monitor liver function closely.
Severe:
Significant dose reduction and extended intervals for both components. Avoid use if possible.
Pharmacology
Mechanism of Action
Hydrocodone acts as an opioid agonist, primarily 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 cyclooxygenase (COX-1 and COX-2) enzymes, thereby decreasing prostaglandin synthesis, which mediates inflammation, pain, and fever.
Pharmacokinetics
Absorption:
Bioavailability:
Hydrocodone: ~60-70%; Ibuprofen: ~80-90%
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 (highly variable)
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); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; GASTROINTESTINAL RISK; CARDIOVASCULAR THROMBOTIC EVENTS.
Hydrocodone: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; CYP3A4 Interaction; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants.
Ibuprofen: Cardiovascular Thrombotic Events (NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery); Gastrointestinal Risk (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).
Hydrocodone: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; CYP3A4 Interaction; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants.
Ibuprofen: Cardiovascular Thrombotic Events (NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery); Gastrointestinal Risk (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).
Side Effects
Urgent 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 or seek immediate 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.
Kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
High or low blood pressure: severe headache, dizziness, fainting, or changes in vision.
High potassium levels: abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, numbness or tingling, or shortness of breath.
Low blood sugar: dizziness, headache, drowsiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
Respiratory issues: difficulty breathing, 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 difficulties during sleep).
Weakness on one side of the body, speech or thinking difficulties, balance changes, drooping on one side of the face, or blurred vision.
Fever, chills, sore throat, unexplained bruising or bleeding, or extreme 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. 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 or seek medical attention if they bother you or persist:
Anxiety.
Dizziness, drowsiness, fatigue, or weakness.
Dry mouth.
Excessive sweating.
Nervousness or excitability.
Constipation, diarrhea, stomach pain, nausea, 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 or seek immediate 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.
Kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
High or low blood pressure: severe headache, dizziness, fainting, or changes in vision.
High potassium levels: abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, numbness or tingling, or shortness of breath.
Low blood sugar: dizziness, headache, drowsiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
Respiratory issues: difficulty breathing, 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 difficulties during sleep).
Weakness on one side of the body, speech or thinking difficulties, balance changes, drooping on one side of the face, or blurred vision.
Fever, chills, sore throat, unexplained bruising or bleeding, or extreme 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. 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 or seek medical attention if they bother you or persist:
Anxiety.
Dizziness, drowsiness, fatigue, or weakness.
Dry mouth.
Excessive sweating.
Nervousness or excitability.
Constipation, diarrhea, stomach pain, nausea, 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:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Severe dizziness or lightheadedness
- Confusion
- Cold, clammy skin
- Pinpoint pupils
- Severe stomach pain
- Black, tarry stools or blood in vomit (signs of stomach bleeding)
- Unusual bruising or bleeding
- Swelling of the face, lips, tongue, or throat (allergic reaction)
- Chest pain, shortness of breath, weakness on one side of the body, or slurred speech (signs of heart attack or stroke)
- Decreased urination or swelling in the legs (signs of kidney problems)
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.
Presence of any 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 or recent use of:
+ Other NSAIDs.
+ Salicylate drugs, such as aspirin.
+ Pemetrexed.
+ Certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
+ Drugs for depression or Parkinson's disease in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause very high blood pressure.
Fertility issues or ongoing fertility checks.
Pregnancy, planned pregnancy, or pregnancy during treatment. 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.
Presence of any 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 or recent use of:
+ Other NSAIDs.
+ Salicylate drugs, such as aspirin.
+ Pemetrexed.
+ Certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
+ Drugs for depression or Parkinson's disease in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause very high blood pressure.
Fertility issues or ongoing fertility checks.
Pregnancy, planned pregnancy, or pregnancy during treatment. 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 in some cases. Monitor for signs of liver problems, 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 problem called aseptic meningitis. Seek medical attention immediately 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 for heart failure, and death may be higher. Discuss these risks with your doctor. Additionally, people taking medications like this one after a recent heart attack may be at increased risk of heart attack and heart-related death.
Serotonin Syndrome: Combining this medication with certain other medications can lead to a severe and potentially 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 decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, consult your doctor.
Adrenal Gland Problems: Taking opioid medications 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 immediately.
Severe Skin Reactions: This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can be fatal and may also affect internal 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 immediately.
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 in some cases. Monitor for signs of liver problems, 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 problem called aseptic meningitis. Seek medical attention immediately 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 for heart failure, and death may be higher. Discuss these risks with your doctor. Additionally, people taking medications like this one after a recent heart attack may be at increased risk of heart attack and heart-related death.
Serotonin Syndrome: Combining this medication with certain other medications can lead to a severe and potentially 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 decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, consult your doctor.
Adrenal Gland Problems: Taking opioid medications 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 immediately.
Severe Skin Reactions: This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can be fatal and may also affect internal 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 immediately.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Pinpoint pupils
- Cold, clammy skin
- Bluish discoloration of lips or fingernails
- Limp muscles
- Loss of consciousness
- Severe stomach pain or vomiting (due to ibuprofen overdose)
What to Do:
Seek immediate emergency medical attention. Call 911 or Poison Control at 1-800-222-1222. Naloxone may be administered for opioid overdose. Supportive care for ibuprofen overdose.
Drug Interactions
Contraindicated Interactions
- Concurrent use with other NSAIDs (increased GI/renal risk)
- History of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
- Severe uncontrolled heart failure
- Significant respiratory depression (for hydrocodone component)
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (for hydrocodone component)
- Known or suspected paralytic ileus (for hydrocodone component)
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants): Increased risk of respiratory depression, profound sedation, coma, and death.
- Anticoagulants (e.g., warfarin): Increased risk of bleeding (due to ibuprofen).
- Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding (due to ibuprofen).
- SSRIs/SNRIs: Increased risk of bleeding (due to ibuprofen).
- Diuretics (e.g., furosemide, thiazides): Reduced natriuretic effect of diuretics (due to ibuprofen).
- ACE inhibitors/ARBs: Reduced antihypertensive effect and increased risk of renal impairment (due to ibuprofen).
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): Increased hydrocodone plasma concentrations, potentially leading to increased opioid effects.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): Decreased conversion of hydrocodone to hydromorphone, potentially reducing analgesic effect.
- Methotrexate: Increased methotrexate levels and toxicity (due to ibuprofen).
- Lithium: Increased lithium plasma concentrations (due to ibuprofen).
- Corticosteroids: Increased risk of GI ulceration and bleeding (due to ibuprofen).
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased hydrocodone plasma concentrations, potentially leading to reduced efficacy.
- Beta-blockers: Reduced antihypertensive effect (due to ibuprofen).
- Digoxin: Increased digoxin plasma concentrations (due to ibuprofen).
- Pemetrexed: Increased pemetrexed levels and toxicity (due to ibuprofen).
Minor Interactions
- Not specifically categorized as minor for this combination, as most interactions are significant.
Monitoring
Baseline Monitoring
Pain level and characteristics
Rationale: To establish baseline for efficacy assessment.
Timing: Prior to initiation
Respiratory rate and sedation level
Rationale: To assess baseline CNS function and risk of respiratory depression.
Timing: Prior to initiation
Renal function (BUN, creatinine)
Rationale: To assess baseline kidney function, especially important due to ibuprofen component.
Timing: Prior to initiation, especially in patients with risk factors
Liver function (ALT, AST, bilirubin)
Rationale: To assess baseline liver function.
Timing: Prior to initiation, especially in patients with risk factors
Complete Blood Count (CBC)
Rationale: To assess for baseline anemia or other hematologic abnormalities, especially if long-term use is anticipated.
Timing: Prior to initiation, if long-term use is anticipated
Routine Monitoring
Pain level and relief
Frequency: Regularly during therapy, especially after dose adjustments
Target: Acceptable pain control with minimal side effects
Action Threshold: Inadequate pain control or excessive side effects warrant dose adjustment or alternative therapy.
Respiratory rate and sedation level
Frequency: Regularly, especially during initiation and dose escalation
Target: Respiratory rate >10 breaths/min, easily arousable
Action Threshold: Respiratory rate <10 breaths/min, excessive sedation, or difficulty arousing requires immediate intervention (e.g., naloxone, respiratory support).
Signs of GI bleeding (e.g., melena, hematemesis)
Frequency: Daily patient inquiry
Target: Absence of GI bleeding symptoms
Action Threshold: Any signs of GI bleeding require immediate medical evaluation and discontinuation of drug.
Blood pressure and fluid retention/edema
Frequency: Periodically, especially in patients with cardiovascular risk factors
Target: Stable blood pressure, no new or worsening edema
Action Threshold: Significant increase in blood pressure or new/worsening edema requires evaluation and potential discontinuation.
Renal function (BUN, creatinine)
Frequency: Periodically (e.g., every 3-6 months) for chronic use, or more frequently in at-risk patients
Target: Within normal limits or stable from baseline
Action Threshold: Significant increase in BUN/creatinine requires dose adjustment or discontinuation.
Liver function (ALT, AST)
Frequency: Periodically (e.g., every 3-6 months) for chronic use, or more frequently in at-risk patients
Target: Within normal limits or stable from baseline
Action Threshold: Significant increase in liver enzymes requires dose adjustment or discontinuation.
Symptom Monitoring
- Drowsiness
- Dizziness
- Nausea
- Vomiting
- Constipation
- Abdominal pain
- Heartburn
- Black, tarry stools (melena)
- Coffee-ground vomit (hematemesis)
- Unusual bruising or bleeding
- Swelling of hands or feet (edema)
- Shortness of breath
- Rash
- Itching
- Difficulty breathing or swallowing
- Signs of addiction or misuse (e.g., drug-seeking behavior, escalating doses)
Special Patient Groups
Pregnancy
Generally not recommended, especially in the third trimester due to risks to the fetus. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Category C. Limited human data, but potential for congenital malformations with opioid exposure. Ibuprofen: Animal studies show adverse effects, human data limited.
Second Trimester:
Category C. Similar risks as first trimester. Ibuprofen: Avoid prolonged use.
Third Trimester:
Category D. Hydrocodone: Risk of neonatal opioid withdrawal syndrome. Ibuprofen: Risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension, and renal dysfunction in the fetus. Avoid use.
Lactation
Use with caution. Both hydrocodone and ibuprofen are excreted in breast milk. Monitor the infant for signs of sedation, respiratory depression, or feeding difficulties.
Infant Risk:
Hydrocodone: L3 (moderate risk, monitor infant for drowsiness, breathing problems, feeding difficulties). Ibuprofen: L2 (safer, generally considered compatible with breastfeeding at usual doses, but monitor for GI upset).
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 16 years of age. Not recommended due to the risks associated with opioid use in children and the potential for serious adverse effects.
Geriatric Use
Use with caution, generally starting at the lower end of the dosing range. Elderly patients are at increased risk for respiratory depression, CNS effects, and gastrointestinal/renal adverse events associated with both hydrocodone and ibuprofen. Monitor renal and hepatic function closely.
Clinical Information
Clinical Pearls
- This combination offers both opioid and NSAID mechanisms for pain relief, which can be synergistic for certain types of pain.
- Due to the hydrocodone component, this medication carries significant risks of addiction, abuse, and respiratory depression. Prescribe for the shortest duration and lowest effective dose.
- The ibuprofen component adds risks of GI bleeding/ulceration and cardiovascular thrombotic events. Assess patient's risk factors for these before prescribing.
- Counsel patients extensively on the risks of concomitant use with alcohol or other CNS depressants.
- Educate patients on signs of overdose and the importance of secure storage to prevent accidental ingestion.
- Consider alternative therapies for chronic pain to minimize long-term opioid and NSAID exposure.
Alternative Therapies
- Single-agent NSAIDs (e.g., ibuprofen, naproxen, celecoxib)
- Single-agent opioids (e.g., hydrocodone, oxycodone, morphine)
- Acetaminophen
- Non-pharmacological pain management (e.g., physical therapy, acupuncture, massage)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
Cost & Coverage
Average Cost:
Varies widely, typically $15-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 (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, do not share your medication with others, and never take someone else's medication.
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 you refill your prescription. 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 used as an emergency treatment. 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, how much, and when it happened, 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 you refill your prescription. 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 used as an emergency treatment. 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, how much, and when it happened, to ensure prompt and effective treatment.