Hydroco/apap 2.5-325mg Tablets

Hydrocodone is a semisynthetic opioid analgesic that acts as a full agonist at mu-opioid receptors in the central nervous system (CNS), producing analgesia, sedation, and respiratory depression. Acetaminophen is a non-opioid analgesic and antipyretic, believed to act primarily through central inhibition of prostaglandin synthesis (possibly via COX-3 or other mechanisms) and modulation of serotonergic descending pain pathways.

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, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Clammy skin
Excessive sweating
Confusion
Difficulty walking
Severe constipation or stomach pain, which may indicate a severe bowel problem
Hearing loss or changes in hearing
Chest pain or pressure
Abnormal heartbeat (fast or slow)
Breathing difficulties, including:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Mood changes
Difficulty urinating
Changes in urine output
Vision changes
Seizures
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, which may be life-threatening
Signs of serotonin syndrome, a potentially life-threatening condition, including:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Abnormal heartbeat (fast or irregular)
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach or vomiting
+ Severe headache

Other Possible Side Effects

While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following potential side effects:

Constipation
Upset stomach or vomiting
Stomach pain or heartburn
Dizziness
Drowsiness
Fatigue
Weakness
Headache

If you experience any of these side effects or any other symptoms that concern you or do not go away, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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. Be sure to describe the allergic reaction you experienced, including any symptoms.
Certain health conditions, such as:
+ Lung or breathing problems, including asthma, difficulty breathing, or sleep apnea
+ High levels of carbon dioxide in the blood
+ Stomach or bowel blockage or narrowing
Other medications you are taking, including:
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Any medications for depression or Parkinson's disease taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as these can cause very high blood pressure)
All your prescription and over-the-counter medications, natural products, vitamins, and health problems. This is not an exhaustive list, and it is crucial to discuss all your medications and health conditions with your doctor to ensure safe use.

Remember to consult your doctor and pharmacist before starting, stopping, or changing the dose of any medication to guarantee safe use and minimize potential interactions.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Avoid driving and performing tasks 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 and exercise caution when climbing stairs.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses are required to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose. Additionally, regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor to avoid withdrawal or other severe problems. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.

Interactions with Other Substances
Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal consequences. Also, avoid taking other products that contain acetaminophen, as excessive acetaminophen consumption can cause liver damage. Carefully review labels and follow the directions exactly. Do not take more than 4,000 mg of acetaminophen per day, unless specifically instructed by your doctor. Certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe amount of acetaminophen for you, consult your doctor or pharmacist. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.

Liver Problems
Monitor for signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes. If you experience any of these symptoms, contact your doctor promptly.

Hormonal Effects
Long-term use of opioid medications like this one can lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation difficulties, inform your doctor.

Adrenal Gland Problems
Taking an opioid medication like this one can rarely cause a severe adrenal gland problem. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.

Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.

Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) (within 14 days)
• Other acetaminophen-containing products (risk of overdose)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) in patients who are also CYP2D6 poor metabolizers (risk of increased hydrocodone exposure)

• CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tricyclic antidepressants, skeletal muscle relaxants): Increased risk of respiratory depression, profound sedation, coma, and death.
• CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): Increased hydrocodone plasma concentrations, leading to increased opioid effects.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased hydrocodone plasma concentrations, leading to reduced efficacy and potential withdrawal.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Increased risk of serotonin syndrome.
• Anticholinergic drugs (e.g., atropine, scopolamine): Increased risk of urinary retention and severe constipation/paralytic ileus.
• Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.

• Antihypertensives: May cause additive hypotensive effects.
• P-glycoprotein inhibitors: May increase hydrocodone absorption.
• Naloxone, Naltrexone: May precipitate opioid withdrawal.
• Warfarin: Acetaminophen may enhance the anticoagulant effect of warfarin with chronic high doses.

• Metoclopramide: May antagonize the effect of opioids on gastrointestinal motility.

• Respiratory depression (slow, shallow breathing)
• Excessive sedation or somnolence
• Dizziness, lightheadedness
• Nausea, vomiting
• Constipation
• Pruritus (itching)
• Signs of liver damage (yellowing of skin/eyes, dark urine, severe fatigue, abdominal pain, loss of appetite)
• Signs of opioid withdrawal (if abruptly discontinued after chronic use): restlessness, lacrimation, rhinorrhea, yawning, sweating, chills, myalgia, pupillary dilation, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, increased blood pressure, respiratory rate, or heart rate.

Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS).

Hydrocodone and acetaminophen are excreted into breast milk. Use is generally not recommended due to potential for serious adverse reactions in the breastfed infant, including sedation, respiratory depression, and withdrawal symptoms. If use is unavoidable, monitor the infant closely.

Contraindicated in children under 6 years of age due to risk of fatal respiratory depression. Use in older children and adolescents requires extreme caution, individualized dosing, and close monitoring due to variability in CYP2D6 metabolism and increased sensitivity to opioids. Generally, non-opioid alternatives should be considered first.

Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor closely for CNS and respiratory depression. Increased risk of falls.

• Always counsel patients on the risks of addiction, abuse, and misuse, and the importance of safe storage and disposal.
• Emphasize the maximum daily dose of acetaminophen (3000 mg or 4000 mg depending on label) and caution against taking other acetaminophen-containing products.
• Warn patients about the dangers of combining with alcohol or other CNS depressants.
• Monitor for respiratory depression, especially during initiation or dose escalation, and educate patients/caregivers on signs to watch for.
• Consider prescribing naloxone for patients at high risk of overdose (e.g., history of overdose, concomitant benzodiazepine use, higher doses).
• For chronic pain, explore non-opioid and non-pharmacological pain management strategies before initiating or continuing opioid therapy.
• Taper slowly when discontinuing after prolonged use to avoid withdrawal symptoms.

• NSAIDs (e.g., ibuprofen, naproxen, celecoxib)
• Acetaminophen (single agent)
• Tramadol (single agent)
• Tapentadol
• Non-pharmacological therapies (e.g., physical therapy, acupuncture, massage, cognitive behavioral therapy, exercise)

If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it 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. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using 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 seeking help, be prepared to provide information about what was taken, the quantity, and the time of the incident.