Lofexidine

• It is used to help with the signs of opioid withdrawal.

Use lofexidine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Do not take naltrexone within 2 hours before or 2 hours after lofexidine.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like 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.
• Dizziness or passing out.
• Slow heartbeat.
• A type of abnormal heartbeat (prolonged QT interval) can happen with lofexidine. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

• Store at room temperature.
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• Store in the original container. Do not take out the antimoisture cube or packet.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about lofexidine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01.

Medical Disclaimer

Lofexidine comes as a tablet to take by mouth. It is usually taken with or without food four times a day (5 to 6 hours between each dose) to manage withdrawal symptoms after your last use of an opioid medication. It may be taken for up to 14 days depending on your symptoms and side effects. Take lofexidine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lofexidine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may need to reduce, interrupt, or discontinue your treatment if you experience certain side effects. Talk to your doctor about how you are feeling during your treatment.

Lofexidine helps to reduce the severity of opioid withdrawal symptoms but may not completely prevent them. Do not stop taking lofexidine without talking to your doctor. If you suddenly stop taking lofexidine, your blood pressure may increase or you may experience withdrawal symptoms such as diarrhea, difficulty falling asleep or staying asleep, anxiety, chills, sweating, and leg or arm pain. Your doctor will probably tell you to decrease your dose gradually over 2 to 4 days.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Take the missed dose as soon as you remember it. Then resume taking your next dose (5 to 6 hours later). Do not take a double dose to make up for a missed one.

Take lofexidine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines.

Lofexidine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take lofexidine with or without food.

Do not take oral naltrexone within 2 hours of using lofexidine.

Drink plenty of fluids and avoid becoming overheated during treatment with lofexidine to prevent unwanted effects.

Dosing

The dose of lofexidine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of lofexidine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For opioid withdrawal symptoms:
    • Adults—The usual dose is three 0.18 milligram (mg) tablets taken 4 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 0.72 mg (4 tablets) 4 times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of lofexidine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress while you are using lofexidine to make sure lofexidine is working properly and to check for unwanted effects.

Lofexidine may cause low blood pressure, slow heartbeat, or fainting. Contact your doctor right away if you have any changes to your heart rhythm. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Lofexidine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for anxiety or benzodiazepines, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using lofexidine. Check with your doctor before taking any of the other medicines listed above while you are using lofexidine.

After a period of not using an opioid medicine, you may be more sensitive to its effects and at greater risk of overdosing. Talk to your doctor if you have concerns.

Do not suddenly stop using lofexidine without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of unwanted side effects.

Lofexidine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how lofexidine affects you.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Chest pain or discomfort
• chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• slow or irregular heartbeat
• unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dizziness
• drowsiness
• dry mouth
• relaxed and calm feeling
• sleepiness
• trouble sleeping
• unusual drowsiness

Less common

• Continuing ringing or buzzing or other unexplained noise in the ears
• hearing loss

Incidence not known

• Anxiety
• diarrhea
• increased sweating
• pain the arms or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take lofexidine with or without food.

You may need to take lofexidine for up to 14 days. Your doctor will change your dose or stop this treatment based on your opioid withdrawal symptoms. Follow all dosing instructions very carefully.

Lofexidine may not completely prevent all symptoms of opioid withdrawal, which may include yawning, pounding heartbeats, watery eyes, feeling cold, stomach pain, feeling sick, body aches, muscle tightness, or trouble sleeping.

You may need additional forms of counseling, support, and/or monitoring as you go through opioid withdrawal.

Lofexidine can cause serious side effects on your heart or blood vessels. Call your doctor at once if you have slow heartbeats, severe dizziness, or a light-headed feeling (like you might pass out). If you have these side effects, do not take your next lofexidine dose until you talk with your doctor.

You should not stop using lofexidine suddenly, or you could have a rapid increase in blood pressure and unpleasant symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture- absorbing preservative.

If you start using opioid medication after a long period of not using it, you will be more sensitive to opioid effects. This could increase your risk of overdose and death.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.