Lortab

Lortab contains a combination of acetaminophen and hydrocodone. Hydrocodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen, also called Tylenol, is a less potent pain reliever that increases the effects of hydrocodone.

Lortab is used to treat severe and persistent pain that requires an opioid pain reliever and that cannot be adequately treated with other options, including immediate-release opioid medications. The brand Lortab has been discontinued, but generic acetaminophen and hydrocodone tablets are still available.

Limitations of use for opioids

• Lortab contains an opioid analgesic; it carries the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, Therefore, it should only be used in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
• Lortab is not indicated as an as-needed (prn) pain relief.

Lortab is a Schedule II (CII) controlled substance, meaning it has a high potential for abuse, with a risk of psychological or physical dependence, but has a currently accepted medical use.

Take Lortab exactly as prescribed. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain, if your pain gets worse, if you feel more sensitive to pain, or if you have new pain. Do not take more medicine without first talking to your doctor.

Hydrocodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Lortab is against the law.

Measure liquid Lortab with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you need surgery or medical tests, tell the doctor ahead of time that you are using Lortab. You may need to stop using the medicine for a short time.

Do not stop using Lortab suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse, and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor.

Hydrocodone can slow or stop your breathing. Never use Lortab in larger amounts, or for longer than prescribed. Narcotic pain medicine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Do not use Lortab if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Stop taking Lortab and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Pain medications containing acetaminophen with hydrocodone are now required to have boxed warnings due to the serious and life-threatening risks from their use. A boxed warning is the strongest safety-related warning issued by the FDA.

Addiction, misuse, and overdose

This medicine contains an opioid, which exposes patients to the risks of opioid addiction. Some people may misuse it, abuse it, or take too much, which can lead to overdose or death. Your healthcare provider should check your risk before prescribing it and monitor you while you are taking it.

Serious breathing problems

This medicine can cause slow or stopped breathing, which can be life-threatening or fatal. This risk is highest when starting the medicine or after the dose is increased. Taking it exactly as prescribed is very important.

Accidental swallowing

Even one dose can be deadly if swallowed by accident, especially by a child. Keep this medicine stored safely and out of reach.

Dangerous interactions with alcohol or other sedating medicines

Taking hydrocodone/acetaminophen with opioids, benzodiazepines (such as medicines for anxiety or sleep), gabapentinoids (gabapentin or pregabalin), alcohol, or other drugs that make you sleepy can cause:

• extreme drowsiness
• slowed breathing
• coma
• death

These combinations should only be used when other treatment options are not enough.

Risk during pregnancy

If taken for a long time during pregnancy, this medicine can cause opioid withdrawal in a newborn baby after birth. This can be serious and may be life-threatening without proper treatment.

Safe use education

Healthcare providers are encouraged to teach patients and caregivers about the serious risks of this medicine, how to use it safely, and why it is important to read the Medication Guide each time it is prescribed.

Drug interactions

Some medicines can change how hydrocodone works in your body. This can raise the amount of hydrocodone in your bloodstream and increase the risk of serious side effects, including dangerous breathing problems or extreme sleepiness. Your provider may need to monitor you closely if you take certain other medicines with it.

Liver damage risk

This medicine also contains acetaminophen, which can cause serious liver damage if too much is taken. In some cases, this has led to liver transplant or death. The risk is higher if you take:

• more than 4,000 mg of acetaminophen in one day
• more than one medicine that contains acetaminophen

Always check labels carefully to make sure you are not taking multiple products with acetaminophen.

You should not use Lortab if you are allergic to acetaminophen (Tylenol) or hydrocodone, if you have severe asthma, trouble breathing, or other lung problems, if you have a bowel blockage or narrowing of the stomach or intestines, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use Lortab if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Some medicines can interact with hydrocodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or the prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure Lortab is safe for you, tell your doctor if you have:

• liver disease, cirrhosis, or if you drink more than 3 alcoholic beverages per day;
• a history of alcoholism or drug addiction;
• diarrhea, inflammatory bowel disease, bowel obstruction, severe constipation;
• kidney disease;
• low blood pressure, or if you are dehydrated;
• a history of head injury, brain tumor, or stroke;
• asthma, COPD, sleep apnea, or other breathing disorders; or
• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Lortab is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

If you use narcotic medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby. If you breastfeed, carefully observe your infant for increased sleepiness (more than usual), breathing difficulties, or limpness, and seek immediate medical care if you notice these signs.

Get emergency medical help if you have signs of an allergic reaction to Lortab: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Lortab and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Call your doctor at once if you have:

• shallow breathing, slow heartbeat;
• a light-headed feeling, like you might pass out;
• confusion, unusual thoughts or behavior;
• seizure (convulsions);
• easy bruising or bleeding;
• infertility, missed menstrual periods;
• impotence, sexual problems, loss of interest in sex;
• liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Lortab side effects include:

• drowsiness, headache;
• upset stomach, constipation;
• blurred vision; or
• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Since Lortab is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and hydrocodone can be fatal. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Lortab will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen, which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications - opioid pain medicine or prescription cough medicine;
• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or
• drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen and hydrocodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.