Hydrocod/acetaminophen 7.5-325/15ml

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 by inhibiting prostaglandin synthesis in the CNS, and possibly through other mechanisms involving serotonergic pathways and nitric oxide.

Urgent Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Signs of low blood sugar: dizziness, headache, feeling sleepy, feeling weak, shaking, fast heartbeat, confusion, hunger, or sweating.
Severe dizziness or fainting.
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 slow or shallow breathing, or noisy breathing.
Sleep apnea (breathing problems during sleep).
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Mood changes.
Difficulty urinating or changes in urine output.
Vision changes.
Seizures.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin reactions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; skin irritation (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
Serotonin syndrome, a potentially life-threatening condition that can occur when taking this medication with certain other drugs. Call your doctor right away if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.

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 do not go away, contact your doctor:

Constipation.
Upset stomach or vomiting.
Stomach pain or heartburn.
Dizziness, sleepiness, tiredness, or weakness.
* Headache.

This list is not exhaustive. If you have questions about side effects or concerns about your symptoms, 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Current or recent use of specific medications, such as:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine
Use of certain depression or Parkinson's disease medications within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
* All your prescription and over-the-counter medications, natural products, and vitamins, as this medication may interact with them.

To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.

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 may be 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 first, as sudden changes may increase the risk of 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 and Contraindications
Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal consequences.

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 instructed to do so 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, including 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 right away.

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

Adrenal Gland Problems
Taking an opioid medication like this one can increase the risk of a rare but severe adrenal gland disorder. 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.

Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Breastfeeding
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 overly sleepy, limp, or has breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) or use within 14 days of MAOI therapy (risk of serotonin syndrome, respiratory depression, coma)
• Severe hepatic impairment (due to acetaminophen component)

• 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, death.
• CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors) - increased hydrocodone plasma concentrations, leading to increased opioid effects.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion) - decreased conversion of hydrocodone to hydromorphone, potentially reducing analgesic effect.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome.
• Mixed agonist/antagonist and partial agonist opioids (e.g., pentazocine, nalbuphine, butorphanol, buprenorphine) - may precipitate opioid withdrawal.
• Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics) - increased risk of urinary retention and severe constipation.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - decreased hydrocodone plasma concentrations, potentially reducing analgesic effect or precipitating withdrawal.
• Diuretics - opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
• Antihypertensives - additive hypotensive effects.
• Drugs that affect gastric emptying (e.g., metoclopramide) - may alter absorption of hydrocodone.

• Not available

• Excessive sedation
• Dizziness
• Nausea and vomiting
• Constipation
• Itching
• Confusion
• Difficulty breathing or shallow breathing
• Signs of liver injury (yellowing of skin/eyes, dark urine, abdominal pain, unusual tiredness)

Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening. Use only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients of the risk of NOWS.

Hydrocodone and its active metabolite (hydromorphone) are present in breast milk and can cause serious adverse reactions in breastfed infants, including sedation, respiratory depression, and death. Acetaminophen is generally considered safe in breastfeeding. Due to the hydrocodone component, use is generally not recommended or should be used with extreme caution and close infant monitoring. If used, observe infant for increased sleepiness, difficulty breathing, or limpness.

Not recommended for children under 6 years of age due to the risk of fatal respiratory depression. For older children, dosing must be carefully calculated based on weight and the specific concentration of the liquid. Close monitoring for respiratory depression and sedation is crucial. Acetaminophen dosing should not exceed 75 mg/kg/day.

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 use an accurate measuring device (e.g., oral syringe) for liquid formulations to ensure precise dosing and avoid accidental overdose, especially in children.
• Educate patients on the serious risks of addiction, abuse, and misuse, and the importance of safe storage and disposal.
• Warn patients about the risk of acetaminophen overdose from combining this product with other acetaminophen-containing medications (prescription or OTC).
• Counsel patients on the signs of respiratory depression and liver toxicity, and when to seek emergency medical attention.
• Opioid-induced constipation is common; proactively recommend a bowel regimen (e.g., stool softener plus stimulant laxative) to prevent severe constipation.
• Be aware of potential drug interactions, especially with other CNS depressants and CYP3A4 inhibitors/inducers.

• Non-opioid analgesics (e.g., NSAIDs like ibuprofen, naproxen)
• Other opioid analgesics (e.g., morphine, hydromorphone, oxycodone)
• Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain)
• Non-pharmacological pain management (e.g., physical therapy, acupuncture, massage, heat/cold therapy)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication.

This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital 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.

In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If 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 disclose what was taken, the quantity, and the time of the overdose.