Hydrocodone-Acetaminophen

What is hydrocodone-acetaminophen? (Vicodin)

Hydrocodone-acetaminophen relieves pain. People use it when other nonopioid pain medications don't work well enough or if they can’t tolerate them.

Acetaminophen relieves pain and reduces fever in patients. However, acetaminophen may cause other side effects, including liver damage, when taken in more significant amounts.

Hydrocodone is a painkiller known as a narcotic analgesic. It relieves severe pain by acting on the central nervous system. It can also stop or prevent coughs by working on the respiratory tract. If you use hydrocodone for an extended period, you may develop a dependency on it.

However, if you suffer from chronic pain, you shouldn't let the fear of becoming dependent on narcotics stop you from taking your prescription. If you follow your doctor’s instructions closely, it’s unlikely that you’ll become addicted to hydrocodone-acetaminophen.

You may experience withdrawal symptoms if you abruptly discontinue your treatment. However, you can usually prevent severe withdrawal symptoms by slowly decreasing the dosage over some time before stopping completely.

This drug is only accessible under a restricted distribution system called Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy).

How do you take hydrocodone-acetaminophen?

Take this drug precisely as instructed by your healthcare provider. Don't take too much of it, don't take it more often, and don’t take it for longer than your doctor prescribed.

If you take too much for a prolonged period, you may become addicted or cause an overdose.

Taking large amounts of hydrocodone-acetaminophen (Vicodin) can cause liver damage.

You need to understand the rules of the REMS program¹ to avoid addiction and mis­using hydrocodone-acetaminophen. A medication guide will accompany this drug. Follow the instructions carefully. Ask your doctor if you have any questions.

Hydrocodone-acetaminophen is available as both an oral tablet and oral liquid formulation:

• Hydrocodone bitartrate (5mg) / Acetaminophen (300mg) 

• Hydrocodone bitartrate (5mg) / Acetaminophen (325mg)

• Hydrocodone bitartrate (7.5mg) / Acetaminophen (300mg)

• Hydrocodone bitartrate (7.5mg) / Acetaminophen (325mg)

• Hydrocodone bitartrate (10mg) / Acetaminophen (300mg)

• Hydrocodone bitartrate (10mg) / Acetaminophen (325mg)

• Hydrocodone bitartrate (7.5mg) / Acetaminophen (325mg) per 15ml oral solution

A dosing regimen for pain management

• Use the lowest effective dose. Your doctor will adjust your prescription according to the severity of the pain, your body’s response, and your previous analgesic experience.

• Your doctor must continually evaluate the quantity required to maintain adequate pain control and minimize adverse effects.

• The usual adult dosage of hydrocodone (5mg) and acetaminophen (300/325mg) is one or more tablets every four to six hours as needed. Your total daily dosage shouldn't exceed eight tablets.

• The usual adult dose of solution (7.5mg/325mg per 15ml) for initial oral solution treatment is one tablespoonful (15ml). The total daily dosage for adults is no more than six tablespoonfuls.

• If you develop a physical dependency on opioid drugs, abrupt discontinuation of these medications may cause severe withdrawal symptoms, uncontrolled chronic pain, and suicidal tendencies. Only stop this medication under close monitoring by your physician.

If you have liver problems

Liver Disease: Symptoms, Causes, Prevention & Treatment

The manufacturer's label doesn’t recommend dosage adjustment for patients with liver problems. It's advisable to initiate therapy at the lowest dose with continuous observation.

In cases of moderate or severe liver disease, you may not be a candidate for this medication. Your physician will help determine the best drug and dose for you.

If you have kidney problems

What You Need To Know About Kidney Disease

The manufacturer's label doesn’t recommend dosage adjustment for patients with kidney problems. However, your body eliminates 26% of hydrocodone and 85% of acetaminophen in the urine², so use them with caution. Your physician will recommend dosing based on your medical conditions and lab work.

Pediatric patients

The dose for pediatric patients is adjusted based on the desired analgesic effect. When considering acetaminophen for pain relief, it is essential to include the maximum daily dose of acetaminophen from other sources, including prescription and over-the-counter (OTC) products.

The daily dose of acetaminophen should not exceed 2g (2,000mg) to minimize liver toxicity.

Your child’s pediatrician will determine the proper dosing based on weight and any other medical conditions.

Older adults

For safety and efficacy, older adults should start the initial dose at the lowest effective dose and closely monitor for side effects.

Seeing results

Hydrocodone-acetaminophen tablets must pass through the digestive tract before they work. Your body quickly absorbs acetaminophen, which begins to take effect in about 30 minutes.

The hydrocodone component is slow-acting but begins to alleviate pain approximately 30-60 minutes after ingestion. The pain-relieving effects typically last between four and six hours.

Potential side effects of hydrocodone-acetaminophen

Acetaminophen-hydrocodone may make you feel drowsy, dizzy, or lightheaded. Don't drive or use machinery until you know how your body reacts to the medication.

This drug can also have other side effects:

Common side effects

The more common side effects of acetaminophen-hydrocodone include:

• Feeling dizzy or lightheaded

• Constipation

• Nausea

• Drowsiness or sleepiness

• Vomiting

Serious side effects

Talk to your healthcare provider if you have any severe side effects. Call 911 if your condition feels life-threatening or if you have a medical emergency. Serious side effects and symptoms can include the following:

• Skin rash

• Swelling of your face, throat, and mouth

• Trouble breathing

• Drug dependence

• Liver problems: Symptoms include yellowing of the skin and eyes (jaundice), abdominal bloating and pain, loss of appetite, and nausea

Long-term use of hydrocodone-acetaminophen

Long-term use can lead to dependence. Stopping the medication abruptly after long-term use may cause withdrawal symptoms;

• Dilated pupils

• Flu-like symptoms

• Runny nose

• Sweating

• Flushed face

Seek medical help if any of these symptoms occur.

Missed doses

You usually take this medication when needed. However, if your doctor has prescribed a regular dosing schedule, take the missed dose whenever you remember it.

Before taking your next dose:

• Wait at least four hours after taking your last dose of the tablet or solution

• At least twelve hours after taking your last extended-release pill

Skip the missed dose if it is almost time for your next dose. Instead, continue your regular dosing schedule as usual. Don't take two doses to make up for one that you missed.

Overdoses

An overdose occurs when you take more than the usual or prescribed amount of this medication. It can happen accidentally or intentionally.

An overdose is an emergency, and you should seek urgent medical care if you suspect symptoms of an overdose. If naloxone is available, administer it immediately.

Symptoms of overdose:

• Change in consciousness or extreme drowsiness

• A sudden decrease in the amount of urine or bloody or cloudy urine

• Chest pain or discomfort

• Slow or irregular heartbeat

• Coughing that sometimes produces a frothy pink sputum

• Pale or blue lips, fingernails, or skin

• A general feeling of discomfort or illness

• Increased sweating

• Lightheadedness, dizziness, or fainting

• Difficult, irregular, fast, slow, or shallow breathing

• Decreased muscle tone or movement

• Decreased awareness or responsiveness

• Cold and clammy skin

• Swelling in the legs and ankles

• Unpleasant breath odor

You can call the US Poison Control Center at 1-800-222-1222 for assistance if you have no symptoms but think you’ve overdosed.

What to discuss with your doctor before taking hydrocodone-acetaminophen

• Any allergies you have and what signs you had when they occurred

• All medication you’re taking, including prescription, over-the-counter drugs, supplements, and any herbal products

• Any personal medical history of asthma, gastrointestinal, or kidney problems

• If you’re taking buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

• If you've taken any prescription drugs for depression or Parkinson's disease in the past 14 days, as you may develop high blood pressure. These medications include isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline.

Stopping hydrocodone-acetaminophen

Hydrocodone withdrawal is just like any other form of opioid withdrawal. It's not easy. Everyone experiences withdrawal differently. You will likely experience physical and psychological symptoms, but your personal experience will depend on several factors, such as:

• Your dose 

• How long you've been using opioids or other painkillers

• Whether you're mixing hydrocodone with other drugs, such as morphine, oxycodone, alcohol, or benzodiazepines

• Any history of substance abuse

• Your mental and physical health

If you've been taking low doses of hydrocodone as prescribed by your doctor, you should experience relatively mild withdrawal symptoms. However, withdrawal can be highly uncomfortable if you're a long-term opioid user. For most people, withdrawal symptoms start about 8-24 hours after their final dose.

If you're taking extended-release opioids, you may experience slower withdrawal symptoms than if you were taking immediate-release opioids.

Common hydrocodone withdrawal symptoms

• Sleeping problems

• Stomach cramping or diarrhea

• Flu-like feeling

• Sweating

• Runny nose

• Headache

• Chills

• Muscle, bone, and joint aches and pain

• Nausea or vomiting

• Teary eyes

• Tremors

• Anxiety or restlessness 

• Goosebumps

• Heart pounding

• Agitation

• Skin-crawling

If you're looking for a better idea about how mild symptoms compare with intense ones, take a look at the clinical opioid withdrawal scale (COWS)³. Clinicians use this tool to identify the different withdrawal stages. For example, sweating can include any number of things, from feeling flushed to sweat pouring down your face.

After acute withdrawal, some individuals experience protracted withdrawal, also known as post-acute withdrawal syndrome (PAWS). Withdrawal symptoms are usually mild and primarily psychological, so you won't experience any physical illness.

Instead, you might experience waves of depression or bouts of insomnia. Some people experience protracted withdrawal, but others don't. Those who do can expect withdrawal symptoms to appear on and off during the first six months.

Hydrocodone-acetaminophen and pregnancy

Taking opioid painkillers during pregnancy can cause problems for you and your baby. Ideally, you shouldn’t take them. The potential risks include:

• Neonatal abstinence syndrome (NAS): This causes withdrawal in newborns. Symptoms include irritability, tremors, seizures, vomiting, diarrhea, fever, and poor appetite

• Neural tube defects: Congenital disabilities of the brain, spine, or spinal cord

• Congenital heart disease: Problems with the structure of a baby's heart

• Gastroschisis: A congenital malformation of a baby's abdominal wall, where the intestines protrude from the abdomen through a hole beside the umbilicus (belly button)

• Miscarriage or stillbirth

• Preterm delivery: Birth before 37 weeks

• Low birth weight, leading to stunted growth

Some women need to use opioid pain medication while they're pregnant. If your doctor recommends taking opioid drugs during pregnancy, you should discuss the risks and benefits.

If both of you conclude that you should take opioid painkillers, you can work together to minimize the risks.

Some of the ways you could do this include:

• Taking them for the least amount of time possible

• Taking the lowest dose of medicine that will help you

• Going to all your prenatal appointments

• Following your provider's instructions carefully when taking the medications

• Contacting your doctor immediately if you experience any side effects

If I take opioids and get pregnant, what should I do?

Contact your doctor if you're taking opioid painkillers and get pregnant. Never stop taking opioids on your own. If you suddenly stop using opioids, it could cause serious health problems for you or your baby. Stopping opioids during pregnancy may be worse than taking them.

Breastfeeding

There are no adequate human studies on women to determine whether this medication is safe during breastfeeding. Therefore, before taking this medication while breastfeeding, weigh the potential benefits against the possible risks and discuss this in detail with your doctor.

Interactions with other drugs

Acetaminophen-hydrocodone pills can interact with other medications or supplements you may be taking. An interaction is when one substance alters the effects of another. It may harm you or prevent the drug from doing its job.

Tell your doctor about any medicines, vitamins, or supplements you're taking. Your doctor should carefully manage all of your medications. Finally, ask your doctor or pharmacist for advice if you want to know if this drug interacts with anything else.

Below are examples of drugs that can interact with acetaminophen-hydrocodone.

Medications that cause drowsiness

Taking certain medications with acetaminophen-hydrocodone increases your risks of drowsiness, tiredness, dizziness, and reduced physical and cognitive function.

If you need to take one of these drugs with an acetaminophen-hydromorphone combination, reduce the dosage of either drug with the prescribing physician's approval.

Examples of these drugs include:

• Other opioids (narcotics)

• Antihistamines

• Antipsychotics

• Benzodiazepines

Medications that increase serotonin

Taking this drug with other drugs that raise your serotonin levels can cause severe problems. Serotonin syndrome is a potentially fatal condition.

If you're taking one of these medications, tell your doctor:

• Certain antidepressants

• Certain drugs for migraine

• Certain drugs for nausea

• Tramadol

• Linezolid

Drugs that inhibit the activities of certain enzymes in the livers

If you take this drug with other medications that inhibit the activity or function of certain liver enzymes, you may experience an increased level of hydrocodone and more side effects. These include breathing problems or drowsiness.

Examples of these drugs are:

• Protease inhibitors for HIV⁴

• Erythromycin

• Ketoconazole

Taking this medicine with drugs that raise the activity of certain liver enzymes can lower the amount of hydrocodone or acetaminophen in your body. As a result, you may need a larger dose of this medication to control your pain. Only your physician should change your dosage.

Examples of these drugs include:

• Rifampin

• Carbamazepine

• Phenytoin

Allergy information

Tell your doctor if you've ever experienced an unusual or allergic reaction to this medicine. Inform them of any other allergies, such as allergies to foods, dyes, preservatives, or animals.

Read the labels carefully for non-prescription products.

This medicine may cause an allergic reaction (anaphylaxis), which can be life-threatening.

Symptoms include:

• Breathing difficulties

• Rash

• Itching/swelling (especially of the face, tongue, and throat)

• Severe dizziness

• Faster heartbeat

If you’re having an allergic reaction, seek emergency medical care.

Clinical trial history

According to research⁵, oral hydrocodone-acetaminophen did not provide significantly better pain relief than oral codeine-acetamino­phen. There were no clinical differences between the two groups regarding side effects or patient satisfaction.

Codeine-acetaminophen may be a reasonable substitute for hydrocodone-acetaminophen.

These findings need to be validated independently in similar and other acute painful conditions.

Tips and advice for taking hydrocodone-acetaminophen

• Do not drink alcohol while taking hydromorphone-acetaminophen.

• Taking it with food or milk may prevent stomach upset

• If you feel light-headed, dizzy, and nauseous, lying down might help.

• Hydrocodone-acetaminophen can cause constipa­tion. Drinking lots of water, eating fiber, and exercising can help.

• Don't combine hydrocodone-acetaminophen with other medications that contain acetaminophen. Ask your pharmacist to check if you're taking too much acetaminophen if you aren't sure.

• This drug might make you feel dizzy or sleepy. Don't drive or operate heavy machinery until you know whether hydrocodone-acetaminophen is safe for you.

• Don't stop taking opioids abruptly if you've been taking them for some time. You may need to cut back gradually over several days or weeks with your doctor’s supervision.