Lofexidine works by blocking the release of norepinephrine, a hormone similar to adrenaline that contributes to opioid withdrawal symptoms.

Lofexidine is a non-opioid prescription medicine used in adults to help with the symptoms of opioid withdrawal that may happen when you stop taking an opioid suddenly.

Lofexidine will not completely prevent the symptoms of opioid withdrawal, which may include feeling sick, stomach cramps, muscle spasms or twitching, feeling of cold, heart pounding, muscular tension, aches and pains, yawning, runny eyes and sleep problems (insomnia).

Lofexidine will not treat opioid addiction. If you have been diagnosed with opioid addiction, your healthcare provider may prescribe this medicine as part of a complete treatment program for your opioid use disorder.

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 if you feel faint. Do not take another dose of lofexidine until you have talked to your doctor.

Avoid driving and doing other tasks or actions that call for you to be alert until you see how lofexidine affects you.

Avoid becoming overheated or dehydrated, or you could have very low blood pressure. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

You should not stop using lofexidine suddenly. Follow your doctor's instructions about tapering your dose.

High blood pressure, anxiety, arm or leg pain, chills, diarrhea, trouble sleeping, and sweating a lot have happened when this medicine was stopped all of a sudden.

Lofexidine is not used to keep a drug-free state. People who have stopped taking opioid drugs may have more risk of side effects if they take opioid drugs again. This includes a raised chance of overdose and death.

Take lofexidine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take lofexidine with or without food.

You may need to take this medicine 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.

Usual Adult Dose for Opiate Withdrawal:

Initial dose: 0.54 mg orally 4 times a day during period of peak withdrawal
-Dosing should be guided by symptoms and side effects
Frequency of dosing: Every 5 to 6 hours
Maximum single dose: 0.72 mg
Maximum daily dose: 2.88 mg/day
Maximum duration of therapy: 14 days

Comments:
-The period of peak withdrawal symptoms is generally the first 5 to 7 days following last use of opioid.
-Treatment may be continued for up to 14 days with dosing guided by symptoms; lower doses may be appropriate as opioid withdrawal symptoms wane.
-Discontinuation should occur over a 2 to 4-day period to mitigate withdrawal effects of lofexidine (e.g. reducing by 1 tablet per dose every 1 to 2 days).

Use: For the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation.

You should not use lofexidine if you are allergic to it.

To make sure lofexidine is safe for you, tell your doctor if you have ever had:

• slow heartbeats;

• low blood pressure;

• heart problems;

• a heart attack or stroke;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• long QT syndrome (in you or a family member);

• kidney disease; or

• liver disease.

It is not known whether lofexidine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Lofexidine is not approved for use by anyone younger than 18 years old.

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.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) from the bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how lofexidine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated, or you could have very low blood pressure.

Avoid drinking alcohol.

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

Call your doctor at once if you have:

• slow heartbeats;

• severe dizziness or drowsiness; or

• a light-headed feeling, like you might pass out.

Common lofexidine side effects may include:

• low blood pressure;

• dizziness (especially when standing up);

• drowsiness; 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.

Lofexidine can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using lofexidine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using a sedative (such as Valium or Xanax), a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with lofexidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor. Your doctor may order certain lab tests to check your body's response to lofexidine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.