Pronunciation:

GWAHN-fa-seen

Brand Names:

• Intuniv
• Tenex

Dosage Forms:

• Tablet
• Tablet, Extended Release

Classifications:

Therapeutic—

Antihypertensive

Pharmacologic—

Alpha-2 Adrenergic Agonist

Uses of This Medicine:

Guanfacine is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Guanfacine works by controlling the nerve impulses along certain nerve pathways. As a result, it relaxes the blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

Guanfacine extended-release tablets are also used alone or together with other medicines to treat attention deficit hyperactivity disorder (ADHD) in children and teenagers. It works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of guanfacine tablets in children younger than 12 years of age. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of guanfacine extended-release tablets in children 6 years of age and older. Safety and efficacy have not been established in children younger than 6 years of age.

Older adults—

Appropriate studies on the relationship of age to the effects of guanfacine tablets have not been performed. No geriatric-specific problems have been documented to date, although the starting dose of guanfacine tablets is usually lower in elderly patients due to the higher risk of certain side effects.

Appropriate studies have not been performed on the relationship of age to the effects of guanfacine extended-release tablets in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Conivaptan
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Iobenguane I 131
• Mavacamten
• Netupitant
• Omaveloxolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Yohimbine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bradycardia (slow heart rate), history of or
• Dehydration or
• Depression or
• Heart attack, recent or
• Heart block, history of or
• Heart or blood vessel disease, history of or
• Heart rhythm problems (eg, sinus node dysfunction, atrioventricular block) or
• Hypotension (low blood pressure), history of or
• Kidney failure or
• Stroke, history of or
• Syncope (fainting), history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine 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 medicine should come with patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are using this medicine for high blood pressure:

• Take your daily dose of guanfacine at bedtime. If you are taking more than one dose per day, take your last dose at bedtime. Taking it this way will help lessen daytime drowsiness.
• In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.
• Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.
• Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to use it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Swallow the extended-release tablet whole with water, milk, or other liquids. Do not crush, break, or chew it.

You should not take the extended-release tablets with high fat meals.

Dosing—

The dose of this medicine 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 this medicine. 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 (extended-release tablets):
  • For attention deficit hyperactivity disorder (ADHD):
    • Adults and children 6 years of age and older—At first, 1 milligram (mg) once a day, either in the morning or evening, at the same time each day. Your doctor may slowly adjust your dose as needed and tolerated. However, the dose is usually not more than 4 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—At first, 1 milligram (mg) once a day, at bedtime. Your doctor may slowly increase your dose up to 3 mg per day, as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, 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.

If you missed taking guanfacine extended-release tablets for 2 or more days in a row, check with your doctor. If your body suddenly goes without this medicine, some unwanted effects may occur. If you have any questions about this, check with your doctor.

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.

Precautions While Using This Medicine:

Your doctor should check you or your child's progress at regular visits to make sure this medicine is working properly and to decide if you or your child should continue to take it.

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you or your child are using it. If you notice any change to you or your child's recommended blood pressure or heart rate, call your doctor right away. If you have questions about this, talk to your doctor.

Do not suddenly stop taking this medicine without checking first with your doctor. Stopping this medicine suddenly may increase your blood pressure and heart rate (rebound hypertension). Your doctor may want you to slowly reduce the amount you or your child are taking before stopping it completely.

Make sure that you have enough guanfacine on hand to last through the weekends, holidays, and vacations. You should not miss any doses. You may want to ask your doctor for another written prescription for guanfacine to carry in your wallet or purse. You can then have it filled if you run out when you are away from home.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine.

Guanfacine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you or your child are using this medicine.

Guanfacine may cause some people to become dizzy, drowsy, faint, lightheaded, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Also, standing up slowly when getting up from a lying or sitting position may also help.

This medicine may worsen heart rhythm problems (eg, sinus node dysfunction, atrioventricular block), especially in patients who are taking other medicines. Talk to your doctor if you have concerns.

Guanfacine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your physician or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

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 (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

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

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

sweating

unusual tiredness or weakness

Less common

Chest pain or discomfort

cough

difficulty with breathing

fast, slow, pounding, or irregular heartbeat

increased need to urinate

lightheadedness, dizziness, or fainting

mental depression

noisy breathing

passing urine more often

tightness in the chest

Incidence not known

Agitation

back pain

cracks in the skin

drowsiness

fast, pounding, or irregular pulse

feeling of constant movement of self or surroundings

fever

headache

irritability

loss of consciousness

loss of heat from the body

mood or mental changes

numbness or tingling in the arms, legs, or face

red, swollen skin

scaly skin

seeing or hearing things that are not there

seizures

sensation of spinning

stiff neck

swelling

vomiting

weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Dizziness (extreme) or faintness

unusual tiredness or weakness (severe)

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

Constipation

dizziness

dryness of the mouth

nausea

sleepiness or unusual drowsiness

unusual dullness or feeling of sluggishness

upper abdominal or stomach pain

weight gain

Less common

Belching

decreased appetite

decreased sexual ability

dry, itching, or burning eyes

heartburn

indigestion

lack or loss of strength

paleness of the skin

stomach discomfort, upset, or pain

trouble with sleeping

Incidence not known

Change in taste

decreased interest in sexual intercourse

difficulty in moving

general feeling of discomfort or illness

hair loss, thinning of hair

inability to have or keep an erection

joint pain or swelling

leg cramp or pain

loss in sexual ability, desire, drive, or performance

muscle ache, cramp, pain, or stiffness

seeing or hearing things that are not there

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Anxiety or tenseness

increased salivation

nervousness or restlessness

shaking or trembling of the hands and fingers

stomach cramps

sweating

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.