Biography

🌐 Visit My Official Shop 🌐

No Prescription Needed ! Tap Here and Place Your Order Now

Don’t Delay! 🎉 Order Medicine + Flat 25% Today!👈💊🚚

Description

Generic Name

Hydrocodone bitartrate and acetaminophen

Active Ingredients

• Hydrocodone bitartrate – a semisynthetic opioid analgesic
• Acetaminophen – a non-opioid pain reliever and fever reducer

Chemical Name and Composition

Hydrocodone bitartrate is chemically described as 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It is a fine, white crystalline powder that is soluble in water. It is a semisynthetic opioid derived from codeine and thebaine.

Acetaminophen is chemically described as N-acetyl-p-aminophenol. It is a white, odorless, crystalline powder that is slightly soluble in water. It has a molecular weight of about 151.16.

Vicodin combines these two ingredients in each tablet. Hydrocodone acts on the central nervous system to relieve pain, while acetaminophen adds to the pain-relieving effect and can reduce fever.

Medication Classification

Vicodin is a combination opioid analgesic.

• Hydrocodone is a mu-opioid receptor agonist. It binds to opioid receptors in the brain and spinal cord to change how the body senses and responds to pain.
• Acetaminophen works through a separate pathway to relieve pain and reduce fever, adding to the effect of hydrocodone.

Vicodin is a Schedule II (CII) controlled substance under U.S. federal law.

Indication

Vicodin is indicated for the relief of moderate to moderately severe pain in adults. Because of the risks of addiction, abuse, and misuse, it should be reserved for use in patients for whom alternative treatment options, such as non-opioid pain relievers, are inadequate or not tolerated.

Dosage Form and Available Strengths

• Dosage Form: Oral tablets
• Route of Administration: Oral
• Common Strengths (hydrocodone bitartrate / acetaminophen per tablet):
• • 5 mg / 300 mg
  • 7.5 mg / 300 mg
  • 10 mg / 300 mg

Formulations and strengths may vary by manufacturer and brand. To reduce the risk of liver injury, the FDA limits acetaminophen to 325 mg per dosage unit in these combination products. Confirm the exact strengths on your product label.

Inactive Ingredients

Inactive ingredients vary by strength and manufacturer. Vicodin tablets may contain croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and colorants that differ by tablet strength. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

---

Dosage & Administration

Important: Take Vicodin exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Your provider will set your dose based on your pain, your prior opioid use, and your overall health. Do not change your dose on your own.

How to Take Vicodin

• Swallow the tablet with water.
• Vicodin is usually taken every 4 to 6 hours as needed for pain, following your provider's directions.
• Do not take more than prescribed, and do not take it more often than directed.
• Never take more than one product that contains acetaminophen at the same time. Taking too much acetaminophen can cause serious liver damage.

General Dosing Principles

• Dosing is individualized based on the severity of your pain, your response, and your prior opioid experience.
• Total daily acetaminophen from all sources should not exceed the limit set by your provider, generally no more than 4,000 mg (4 grams) per day for most adults. Your provider may set a lower limit.
• Do not increase your dose or take it more often without talking to your provider.

Food Considerations

Vicodin may be taken with or without food. Taking it with food may help reduce stomach upset. Avoid alcohol entirely while taking Vicodin. Combining alcohol with hydrocodone can cause dangerous slowed breathing, and combining alcohol with acetaminophen increases the risk of liver damage.

Missed Dose Instructions

• Vicodin is often taken only when you have pain, so a missed dose may not be a concern. Take it when needed, following your provider's directions.
• If you take it on a schedule and miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue your regular schedule.
• Do not take two doses at once to make up for a missed dose.
• If you are unsure what to do, contact your healthcare provider or pharmacist.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Keep out of the reach of children. Accidental use by a child can be fatal.

Disposal

Because Vicodin is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, the FDA recommends flushing certain opioid products, including hydrocodone-containing products, down the toilet to prevent accidental exposure. Follow the disposal instructions on your product label or ask your pharmacist. Accidental exposure, especially in children, can cause serious harm or death.

Special Instructions

Children: Vicodin is not for use in children. Safety and effectiveness in pediatric patients have not been established, and opioids carry a serious risk of fatal breathing problems in children. Keep the medication where children cannot reach it. Accidental ingestion by a child can cause fatal respiratory depression. If a child swallows this medication, seek emergency care immediately.

Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of Vicodin, including sedation, confusion, dizziness, constipation, and breathing problems. A provider may start at a lower dose and monitor closely, given the higher risk of falls and possible reduced liver, kidney, or lung function.

Patients with Liver Problems: Use with caution. Because Vicodin contains acetaminophen, which is processed by the liver, impaired liver function raises the risk of liver injury. Tell your provider about any liver disease. A lower dose or a different medication may be needed.

Patients with Kidney Problems: Use with caution. Reduced kidney function can affect how the body clears the medication. Your provider may adjust your dose and monitor you more closely.

Caregivers: Give the medication exactly as prescribed. Watch for excessive sleepiness, slowed or shallow breathing, confusion, or trouble waking the patient, and seek emergency care right away if these occur. Also watch for signs of liver problems, such as yellowing of the skin or eyes. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking Vicodin suddenly after prolonged use. Abrupt discontinuation can cause opioid withdrawal symptoms.
• If you and your provider decide to stop treatment, the dose should be reduced gradually using a plan set by your provider.
• Withdrawal symptoms may include restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle aches, widened pupils, irritability, anxiety, backache, joint pain, weakness, stomach cramps, trouble sleeping, nausea, loss of appetite, vomiting, and diarrhea.
• Tell your provider if withdrawal symptoms occur so the taper can be adjusted.

Overdose Warning

An overdose of Vicodin can be serious and may be fatal. It carries two distinct dangers: opioid overdose from hydrocodone and liver injury from acetaminophen. The risk is highest when combined with benzodiazepines, alcohol, or other CNS depressants.

Symptoms of hydrocodone (opioid) overdose may include:

• Slowed, shallow, or stopped breathing
• Extreme drowsiness or difficulty staying awake
• Loss of consciousness or coma
• Limp or weak muscles
• Cold, clammy skin
• Pinpoint pupils
• Slow heartbeat or low blood pressure

Symptoms of acetaminophen overdose may develop over hours to days and may include:

• Nausea, vomiting, loss of appetite
• Sweating
• Pain in the upper right side of the stomach
• Yellowing of the skin or eyes (jaundice)
• Dark urine
• Confusion or unusual tiredness

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. Naloxone may be used to reverse the opioid effects, and repeated doses may be needed. A medicine called acetylcysteine may be used to help prevent liver damage from acetaminophen if given early. Seek care right away, even if you feel well, because liver damage can appear later.

---

Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking Vicodin and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Respiratory depression: Slow, shallow, or stopped breathing; extreme sleepiness; or difficulty waking. This risk is highest when starting treatment, after a dose increase, or when combined with other CNS depressants.
• Liver damage (from acetaminophen): Nausea, vomiting, loss of appetite, sweating, pain in the upper right side of the stomach, yellowing of the skin or eyes, dark urine, or unusual tiredness. Liver injury can be severe and, in some cases, fatal.
• Severe skin reactions: A serious rash with blistering, peeling skin, or reddening, which may signal reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis. These can occur with acetaminophen and can be life-threatening.
• Severe allergic reactions (including anaphylaxis): Rash, hives, swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing.
• Adrenal insufficiency: Ongoing nausea, vomiting, loss of appetite, dizziness, or severe weakness.
• Serotonin syndrome: Agitation, hallucinations, fast heartbeat, fever, sweating, shivering, muscle stiffness, twitching, or loss of coordination, especially when taken with certain other medicines.
• Severe low blood pressure: Dizziness, lightheadedness, or fainting, especially when standing up.
• Severe constipation or bowel obstruction: Ongoing constipation, stomach pain, or inability to have a bowel movement.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Drowsiness or sleepiness
• Dizziness or lightheadedness
• Nausea or vomiting
• Constipation
• Dry mouth
• Feeling anxious or having mood changes
• Itching
• Headache

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

---

Warnings & Precautions

FDA Boxed Warning: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants; and Hepatotoxicity

• Addiction, abuse, and misuse: Vicodin exposes users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing and monitor throughout treatment.
• Life-threatening respiratory depression: Serious, life-threatening, or fatal respiratory depression may occur. The risk is greatest during treatment initiation and after a dose increase. Monitor closely, especially when starting treatment and after dose increases.
• Accidental ingestion: Accidental ingestion of even one dose, especially by children, can result in fatal overdose. Store securely and out of reach.
• Neonatal opioid withdrawal syndrome (NOWS): Prolonged use during pregnancy can result in NOWS, which may be life-threatening if not recognized and treated.
• Risks from concomitant use with benzodiazepines or other CNS depressants: Combining Vicodin with these substances may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with no alternative options, and limit the dose and duration.
• Hepatotoxicity: Acetaminophen has been associated with acute liver failure, sometimes resulting in liver transplant or death. Most cases involved doses above 4,000 mg per day and often more than one acetaminophen-containing product. Do not exceed the recommended acetaminophen limit.

Conditions to Disclose to Your Healthcare Provider

Before taking Vicodin, tell your healthcare provider if you have or have had any of the following:

• Liver problems or a history of liver disease
• Breathing problems, such as asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea
• A head injury, brain tumor, or a condition causing increased pressure in the brain
• Kidney problems
• Adrenal gland problems, such as Addison's disease
• Low blood pressure or fainting spells
• Enlarged prostate or urination problems
• Gallbladder, pancreas, or thyroid problems
• Trouble swallowing, or a narrowing or blockage in your stomach or intestines
• Seizures or a seizure disorder
• Mental health conditions, including depression
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• Regular alcohol use
• Recent use of an MAOI (within the past 14 days)
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take Vicodin if you:

• Have significant respiratory depression
• Have acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
• Have a known or suspected gastrointestinal obstruction, including paralytic ileus
• Have a known hypersensitivity to hydrocodone, acetaminophen, or any component of the formulation. Serious skin reactions and anaphylaxis have been reported.

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Key interactions include:

• Other acetaminophen-containing products: Many prescription and over-the-counter medicines contain acetaminophen, including cold, flu, and pain products. Taking more than one at a time can cause a dangerous acetaminophen overdose and liver damage. Check labels carefully.
• Benzodiazepines and other CNS depressants: Combined use increases the risk of profound sedation, respiratory depression, coma, and death. This includes sedatives, tranquilizers, muscle relaxants, sleep medications, and other opioids.
• Alcohol: Drinking alcohol adds to the sedative effect and raises the risk of liver damage and fatal overdose. Avoid alcohol entirely.
• Monoamine oxidase inhibitors (MAOIs): Combined use, or use within 14 days of an MAOI, may cause serious reactions. Use with caution and talk to your provider before combining.
• Serotonergic drugs: Combined use with certain antidepressants (such as SSRIs, SNRIs, and tricyclics), triptans, or other serotonergic medicines may increase the risk of serotonin syndrome.
• CYP3A4 inhibitors and inducers: Drugs that affect this liver enzyme, such as certain antifungals, macrolide antibiotics, rifampin, or carbamazepine, may change hydrocodone levels and its effects.
• Mixed agonist/antagonist and partial agonist opioids: Drugs such as buprenorphine, nalbuphine, or pentazocine may reduce the pain-relieving effect and may trigger withdrawal.
• Anticholinergic drugs: May increase the risk of severe constipation, urinary retention, or bowel obstruction.
• Warfarin: Regular acetaminophen use may affect blood clotting. Your provider may monitor you more closely.

Monitoring Requirements

Your healthcare provider may monitor:

• Signs of respiratory depression and sedation, especially early in treatment and after dose increases
• Liver function, especially in patients with liver disease or who use alcohol
• Your total daily acetaminophen intake from all sources
• Your pain relief and overall response to treatment
• Your risk for abuse, misuse, and diversion throughout treatment
• Blood pressure, particularly in patients at risk for low blood pressure
• Bowel function, given the risk of constipation
• Signs of withdrawal if the dose is reduced or the medication is stopped

Abuse, Dependence, and Misuse Warnings

Vicodin is a Schedule II controlled substance.

• Hydrocodone is a potent opioid with a high potential for abuse and may be a target for people who abuse prescription medicines or street drugs.
• Physical dependence and tolerance can develop with continued use. Physical dependence is not the same as addiction, but it means you should not stop suddenly.
• Do not increase your dose on your own.
• Do not sell or give away Vicodin. Doing so may harm others and is against the law. Even a single dose can be fatal to someone who is not opioid-tolerant, especially a child.
• Misusing this medication, including crushing, snorting, or injecting it or taking it in ways other than prescribed, can cause overdose and death.

Long-Term Use Considerations

• Vicodin is generally intended for short-term pain relief. If long-term treatment is needed, your provider should regularly reassess whether it is still appropriate.
• Physical dependence and tolerance are expected with continued use. Any decision to stop treatment should involve a gradual, supervised taper.
• Long-term opioid use may affect hormone levels, leading to symptoms such as low energy, reduced sex drive, or menstrual changes. Tell your provider if these occur.
• Long-term or repeated use of acetaminophen raises the risk of liver injury, especially with alcohol use or in people with liver disease.
• Ongoing constipation is common with continued opioid use and may require a management plan from your provider.

---

Patient Counseling Information

Safe Medication Use

• Take Vicodin exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Do not take any other product that contains acetaminophen while taking Vicodin. Check the labels of all your medicines, including over-the-counter cold, flu, and pain products, to avoid taking too much acetaminophen.
• Do not exceed the total daily acetaminophen limit set by your provider, generally no more than 4,000 mg per day for most adults.
• Do not stop taking Vicodin suddenly after prolonged use. Talk to your healthcare provider about a safe tapering plan.
• Do not share Vicodin with anyone else. Sharing is dangerous and against the law.
• Keep Vicodin in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Acetaminophen and your liver: Taking more acetaminophen than recommended can cause serious, sometimes fatal, liver damage. Know how much acetaminophen is in every medicine you take, and do not combine acetaminophen-containing products.
• Benzodiazepines, alcohol, and CNS depressants: Do not use these with Vicodin unless directed by your provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
• Alcohol: Do not drink alcohol while taking Vicodin. Alcohol increases the risk of both liver damage and fatal slowed breathing.
• Driving and machinery: Vicodin can make you sleepy or dizzy and can slow your thinking and reaction time. Do not drive or operate heavy machinery until you know how it affects you.
• Naloxone preparedness: Ask your provider about naloxone, a medicine that can reverse an opioid overdose. Make sure family members or caregivers know how to recognize an overdose and use naloxone.
• Serotonergic medicines and MAOIs: Tell your provider about all antidepressants and other medicines you take. Watch for signs of serotonin syndrome, such as agitation, fast heartbeat, fever, or muscle stiffness.
• Pregnancy: Tell your provider right away if you are pregnant or plan to become pregnant, as prolonged use can cause neonatal opioid withdrawal syndrome in your baby.
• Breastfeeding: Hydrocodone and acetaminophen can pass into breast milk and may cause serious harm to a nursing baby, including breathing problems. Talk to your provider before breastfeeding while taking Vicodin.
• Constipation: Ask your provider about ways to prevent or manage constipation while taking Vicodin.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Have slow, shallow, or stopped breathing, or extreme sleepiness you cannot fight off
• Cannot be easily woken up
• Develop signs of liver problems, such as yellowing skin or eyes, dark urine, upper right stomach pain, nausea, or unusual tiredness
• Develop a skin rash, blistering, or peeling skin
• Have a severe allergic reaction, such as swelling of the face or throat, hives, or trouble breathing
• Develop signs of serotonin syndrome, such as agitation, fast heartbeat, fever, or muscle stiffness
• Develop signs of adrenal problems, such as ongoing nausea, vomiting, loss of appetite, or severe weakness
• Feel faint, very dizzy, or lightheaded
• Have severe constipation, stomach pain, or are unable to have a bowel movement
• Experience withdrawal symptoms such as restlessness, sweating, muscle aches, nausea, or diarrhea after reducing or stopping the medication
• Think you may have taken too much, even if you feel well
• Have any symptom that concerns you or does not go away