What is clonidine?

Clonidine lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels to relax and your heart to beat more slowly and easily.

Clonidine (Catapres tablet/patch, Javadin) is used to treat hypertension (high blood pressure).

The Kapvay brand is an extended-release tablet used to treat attention deficit hyperactivity disorder (ADHD).

Onyda XR is an extended-release oral suspension used to treat ADHD in children 6 years and older.

Clonidine is sometimes given with other medications. Clonidine is also available as a transdermal patch worn on the skin. Do not use two forms of this medicine at the same time.

Warnings

Before you take clonidine, tell your doctor if you have heart disease or severe coronary artery disease, a heart rhythm disorder, slow heartbeats, low blood pressure, a history of heart attack or stroke, kidney disease, or if you have ever had an allergic reaction to a Catapres TTS transdermal skin patch.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not take this medicine if you are allergic to clonidine.

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

• heart disease or severe coronary artery disease;
• a heart rhythm disorder, slow heartbeats;
• high or low blood pressure, or a history of fainting spells;
• a heart attack or stroke;
• pheochromocytoma (tumor of the adrenal gland);
• kidney disease; or
• if you have ever had an allergic reaction to a Catapres TTS transdermal skin patch.

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

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of clonidine on the baby.

Clonidine may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

If you are breastfeeding, tell your doctor if you notice somnolence, tiredness, rapid breathing, and poor feeding in the nursing baby.

Catapres is not approved for use by anyone younger than 18 years old. Do not give Kapvay to a child younger than 6 years old.

How should I take clonidine?

Take clonidine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Clonidine is usually taken in the morning and at bedtime. If you take different doses of this medicine at each dosing time, it may be best to take the larger dose at bedtime.

Clonidine may be taken with or without food.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Javadin oral solution is for adults with hypertension and can be taken with or without food.

Tell your doctor if you have a planned surgery.

You may have withdrawal symptoms if you stop using this medicine suddenly. Ask your doctor before stopping the medicine.

Call your doctor if you are sick with vomiting. This is especially important for a child taking clonidine.

If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Clonidine Adult Dose for Hypertension

Oral Tablets:

• Initial dose: 0.1 mg orally 2 times a day (morning and bedtime)
• Titration: Increments of 0.1 mg orally per day may be made at weekly intervals to desired response
• Maintenance dose: 0.2 to 0.6 mg orally per day in divided doses
• Maximum dose: 2.4 mg orally per day in divided doses

Comments:
Taking the larger portion of the oral daily dose at bedtime may minimize the transient adjustment effects of dry mouth and drowsiness

Transdermal patches:

• Initial dose: 0.1 mg/24 hr patch applied every 7 days
• Maintenance dose: If, after 1 to 2 weeks, the desired reduction in blood pressure is not achieved, increase the dosage by adding another 0.1 mg/24 hr patch or changing to a larger system
• Maximum dose: Doses above two 0.3 mg/24 hr patches applied every 7 days is usually not associated with additional efficacy

Comments:
-The transdermal patch should be applied to a hairless area of intact skin on the upper outer arm or chest.
-Each new patch should be applied on a different skin site from the previous location.
-If the patch loosens during 7-day wearing, the adhesive cover should be applied directly over the system to ensure good adhesion.
-There have been rare reports of the need for patch changes prior to 7 days to maintain blood pressure control.
-When substituting patches for the oral formulation or for other antihypertensive drugs, physicians should be aware that the antihypertensive effect of the patches may not commence until 2 to 3 days after initial application; therefore, gradual reduction of prior drug dosage is advised. Some or all previous antihypertensive treatment may have to be continued, particularly in patients with more severe forms of hypertension.
Use: For hypertension, alone or in combination with other antihypertensive agents

Javadin Oral Solution:

• Initial dose: 0.1 mg orally twice daily with or without food (morning and bedtime).
• Titrate in increments of 0.1 mg per day at weekly intervals if necessary until the desired response is achieved.
• Usual maintenance dose: 0.2 mg-0.6 mg per day, given in divided doses.

Comments: Store at 20°C to 25°C (68°F to 77°F). Discard unused portion 60 days after first opening. 

Usual Pediatric Dose for Attention Deficit Disorder

Kapvay Extended-release tablets:
6 years and older:
-Initial dose: 0.1 mg orally at bedtime
-Titration: Increase in 0.1 mg/day increments every 7 days until desired response; doses should be administered twice daily (either split equally or with the higher split dosage given at bedtime)
-Maximum dose: 0.4 mg/day in 2 divided doses

Comments:
-May be taken with or without food.
-If a dose is missed, that dose should be skipped and take the next dose as scheduled.
-Tablets should be swallowed whole, and not crushed, chewed, or broken to avoid increasing the rate of drug release.
-When discontinuing therapy, taper daily dose by no more than 0.1 mg every 3 to 7 days.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

Onyda XR Extended-release oral suspension
–Children 6 years and older.
-Initial Onyda XR dose: 0.1 mg orally once daily at bedtime with or without food. Dosage may be increased in increments of 0.1 mg per day at weekly intervals.
-Maximum recommended dosage: 0.4 mg once daily at bedtime.
-Comments: Do not substitute Onyda XR for other clonidine products on a mg-per-mg basis because of differing pharmacokinetic profiles.
-When discontinuing: Taper the dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include feeling cold, irritable, weak, drowsy, or light-headed, or having weak reflexes, pinpoint pupils, slow heartbeats, shallow breathing, or a seizure.

What should I avoid while taking clonidine?

Avoid drinking alcohol. It may increase certain side effects of clonidine.

Avoid driving or hazardous activity until you know how clonidine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Clonidine side effects

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

Call your doctor at once if you have:

• severe chest pain, shortness of breath, irregular heartbeats;
• a very slow heart rate; or
• a light-headed feeling, like you might pass out.

Common clonidine side effects may include:

• drowsiness, dizziness;
• feeling tired or irritable;
• dry mouth;
• constipation, loss of appetite; or
• sleep problems (insomnia), nightmares.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect clonidine?

Using clonidine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• other heart or blood pressure medications;
• an antidepressant; or
• any other medicine that contains clonidine.

This list is not complete. Other drugs may interact with clonidine, including prescription and over-the-counter medicines, vitamins, and herbal products. 

What is guanfacine?

Guanfacine is used to treat high blood pressure (hypertension). It is sometimes given with other blood pressure medications.

The Intuniv brand of guanfacine is used to treat attention deficit hyperactivity disorder (ADHD).

Guanfacine may also be used for purposes not listed in this medication guide.

Guanfacine side effects

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

Guanfacine may cause serious side effects. Call your doctor at once if you have:

• anxiety, nervousness;
• hallucinations (especially in children);
• severe drowsiness;
• slow heartbeats; or
• a light-headed feeling, like you might pass out;

If you stop taking guanfacine, tell your doctor if you have headaches, confusion, rapid heartbeats, tremors, increased blood pressure, or if you feel nervous or agitated. If left untreated, these symptoms could lead to very high blood pressure, vision problems, or seizures.

Common side effects of guanfacine may include:

• dizziness, drowsiness;
• low blood pressure, slow heartbeats;
• feeling tired or irritable;
• trouble sleeping;
• dry mouth; or
• stomach pain, nausea, constipation.

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 .

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

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

Intuniv is not approved for use by anyone younger than 6 years old. Guanfacine is not approved for use by anyone younger than 12 years old.

Tell your doctor if you have ever had:

• heart problems, coronary artery disease (clogged arteries);
• a heart rhythm disorder;
• a heart attack or stroke;
• high or low blood pressure;
• liver disease; or
• kidney disease.

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

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks.

How should I take guanfacine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Avoid taking guanfacine with high-fat foods, or your body could absorb the medicine too quickly.

Take Intuniv with a full glass of water, milk, or other liquid.

Take Guanfacine at bedtime to ease drowsiness.

Swallow the Intuniv tablet whole and do not crush, chew, or break it.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Intuniv doses are based on weight in children, and any changes may affect your child’s dose.

You should not stop using guanfacine suddenly. Stopping suddenly can raise your blood pressure and cause unpleasant symptoms.

Call your doctor if you are sick with vomiting and cannot take your medicine as usual.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

Your doctor will need to check your progress on a regular basis. Your blood pressure and heart rate may also need to be checked.

If you have high blood pressure, keep using guanfacine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture, heat, and light.

Guanfacine dosing information

Usual Adult Dose for Hypertension:

Initial dose: 1 mg orally once a day at bedtime; may increase to 2 mg once a day if satisfactory result not achieved after 3 to 4 weeks.

Comments: Adverse reactions increase significantly with doses above 3 mg/day.

Usual Pediatric Dose for Attention Deficit Disorder:

6 YEARS TO LESS THAN 18 YEARS:
Initial dose: 1 mg orally once a day, either in the morning or evening, at approximately the same time each day; may adjust in increments of no more than 1 mg/week.

Recommended target dose: 0.05 to 0.12 mg/kg/day (total daily dose between 1 and 7 mg) once a day, depending on clinical response and tolerability

Maximum dose: 6 to 12 years: Doses above 4 mg/day have not been evaluated; 13 to 17 years: Doses above 7 mg/day have not been evaluated.

Comments: Attention Deficit Hyperactivity Disorder (ADHD) may require treatment for an extended period of time; healthcare providers should periodically reevaluate treatment and adjust dose as needed.

Use: Treatment of ADHD as monotherapy and as adjunctive therapy to stimulant medications.

Usual Pediatric Dose for Hypertension:

12 YEARS OR OLDER:
Initial dose: 1 mg orally once a day at bedtime; may increase to 2 mg once a day if satisfactory result not achieved after 3 to 4 weeks.

Comments: Adverse reactions increase significantly with doses above 3 mg/day.

What happens if I miss a dose?

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

Call your doctor for instructions if you miss more than 2 doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include severe drowsiness, slow heart rate, and feeling like you might pass out.

What should I avoid while taking guanfacine?

Avoid driving or hazardous activity until you know how guanfacine will affect you. Your reactions could be impaired.

Drinking alcohol can increase certain side effects of guanfacine.

What other drugs will affect guanfacine?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Using guanfacine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your other medicines. Some may affect guanfacine, especially:

• ketoconazole;
• a barbiturate, such as phenobarbital;
• blood pressure medications;
• medicine to treat mental illness; or
• a sedative, such as Valium or Xanax.

What is Intuniv?

Intuniv reduces nerve impulses in your heart and blood vessels. Intuniv works by relaxing blood vessels, which lowers blood pressure and improves blood flow.

Intuniv is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD) in children who are at least 6 years old.

Intuniv is a long acting tablet that is taken once daily, normally in the morning, at approximately the same time each day.

The Tenex brand of guanfacine is used to treat high blood pressure (hypertension). It is sometimes given with other blood pressure medications.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Avoid becoming overheated or dehydrated during excercise and in hot weather. Avoid drinking alcohol.

Tell your doctor if you regularly use other medicines that make you sleepy. They can add to sleepiness caused by Intuniv.

Before taking this medicine

You should not use Intuniv if you are allergic to guanfacine.

Intuniv is not approved for use by anyone younger than 6 years old.

Tell your doctor if you have ever had:

• heart problems, coronary artery disease (clogged arteries);
• a heart rhythm disorder;
• a heart attack or stroke;
• high or low blood pressure;
• liver disease; or
• kidney disease.

It is not known whether Intuniv 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 a baby while you are using this medicine. Ask your doctor about any risks.

How should I take Intuniv?

Take Intuniv exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Avoid taking Intuniv with high-fat foods, or your body could absorb the medicine too quickly.

Take Intuniv at bedtime to ease drowsiness.

Take Intuniv with a full glass of water, milk, or other liquid.

Swallow the Intuniv tablet whole and do not crush, chew, or break it.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Guanfacine doses are based on weight in children, and any changes may affect your child’s dose.

You should not stop using Intuniv suddenly. Stopping suddenly can raise your blood pressure and cause unpleasant symptoms.

Call your doctor if you are sick with vomiting and cannot take your medicine as usual.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

Your doctor will need to check your progress on a regular basis. Your blood pressure and heart rate may also need to be checked.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Pediatric Dose for Attention Deficit Disorder:

6 YEARS TO LESS THAN 18 YEARS:
Initial dose: 1 mg orally once a day, either in the morning or evening, at approximately the same time each day; may adjust in increments of no more than 1 mg/week.

Recommended target dose: 0.05 to 0.12 mg/kg/day (total daily dose between 1 and 7 mg) once a day, depending on clinical response and tolerability

Maximum dose: 6 to 12 years: Doses above 4 mg/day have not been evaluated; 13 to 17 years: Doses above 7 mg/day have not been evaluated.

Comments: Attention Deficit Hyperactivity Disorder (ADHD) may require treatment for an extended period of time; healthcare providers should periodically reevaluate treatment and adjust dose as needed.

Use: Treatment of ADHD as monotherapy and as adjunctive therapy to stimulant medications.

What happens if I miss a dose?

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

Call your doctor for instructions if you miss more than 2 doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include severe drowsiness, slow heart rate, and feeling like you might pass out.

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Drinking alcohol can increase certain side effects of Intuniv.

Intuniv side effects

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

Call your doctor at once if you have:

• anxiety, nervousness;
• hallucinations (especially in children);
• severe drowsiness;
• slow heartbeats; or
• a light-headed feeling, like you might pass out;

If you stop taking Intuniv, tell your doctor if you have headaches, confusion, rapid heartbeats, tremors, increased blood pressure, or if you feel nervous or agitated. If left untreated, these symptoms could lead to very high blood pressure, vision problems, or seizures.

Common Intuniv side effects may include:

• dizziness, drowsiness;
• low blood pressure, slow heartbeats;
• feeling tired or irritable;
• trouble sleeping;
• dry mouth; or
• stomach pain, nausea, constipation.

What is Kapvay?

Kapvay is a prescription medicine supplied as an extended-release tablet and is used to treat attention deficit hyperactivity disorder (ADHD).

Your doctor may prescribe Kapvay alone or together with certain other ADHD medicines.

Kapvay is not a central nervous system (CNS) stimulant.

Kapvay should be used as part of a total treatment program for ADHD that may include counseling or other therapies.

Warnings

Use Kapvay only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before you take Kapvay, tell your doctor if you have heart disease or severe coronary artery disease, a heart rhythm disorder, slow heartbeats, low blood pressure, a history of heart attack or stroke, kidney disease, or if you have ever had an allergic reaction to a clonidine transdermal skin patch (Catapres TTS).

Before taking this medicine

You should not take Kapvay if you are allergic to clonidine.

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

• heart disease or severe coronary artery disease;
• a heart rhythm disorder, slow heartbeats;
• high or low blood pressure, or a history of fainting spells;
• a heart attack or stroke;
• pheochromocytoma (tumor of the adrenal gland);
• kidney disease; or
• if you have ever had an allergic reaction to a clonidine transdermal skin patch (Catapres TTS).

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

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of clonidine on the baby.

Clonidine may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

If you are breastfeeding, tell your doctor if you notice somnolence, tiredness, rapid breathing, and poor feeding in the nursing baby.

Do not give Kapvay to a child younger than 6 years old.

How should I take Kapvay?

Take Kapvay exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Kapvay is usually taken in the morning and at bedtime. If you take different doses of this medicine at each dosing time, it may be best to take the larger dose at bedtime.

Kapvay may be taken with or without food.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Tell your doctor if you have a planned surgery.

You may have withdrawal symptoms if you stop using Kapvay suddenly. Ask your doctor before stopping the medicine.

Call your doctor if you are sick with vomiting. Prolonged illness can make it harder for your body to absorb clonidine, which may lead to withdrawal symptoms. This is especially important for a child taking Kapvay.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Pediatric Dose for Attention Deficit Disorder:

Extended release:
6 years and older:
-Initial dose: 0.1 mg orally at bedtime
-Titration: Increase in 0.1 mg/day increments every 7 days until desired response; doses should be administered twice daily (either split equally or with the higher split dosage given at bedtime)
-Maximum dose: 0.4 mg/day in 2 divided doses

Comments:
-May be taken with or without food.
-If a dose is missed, that dose should be skipped and take the next dose as scheduled.
-Tablets should be swallowed whole, and not crushed, chewed, or broken to avoid increasing the rate of drug release.
-When discontinuing therapy, taper daily dose by no more than 0.1 mg every 3 to 7 days.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include feeling cold, irritable, weak, drowsy, or light-headed, or having weak reflexes, pinpoint pupils, slow heartbeats, shallow breathing, or a seizure.

What should I avoid while taking Kapvay?

Avoid drinking alcohol. It may increase certain side effects of Kapvay.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Kapvay side effects

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

Call your doctor at once if you have:

• severe chest pain, shortness of breath, irregular heartbeats;
• a very slow heart rate; or
• a light-headed feeling, like you might pass out.

Common Kapvay side effects may include:

• drowsiness, dizziness;
• feeling tired or irritable;
• dry mouth;
• constipation, loss of appetite; or
• sleep problems (insomnia), nightmares.

What is lofexidine?

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.

Warnings

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.

Before taking this medicine

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.

How should I take lofexidine?

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.

Dosing information

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.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

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.

Lofexidine side effects

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.