What is Clonidine ER?

Clonidine is used alone or together with other medicines 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 for heart attacks. These problems may be less likely to occur if the blood pressure is controlled.

Clonidine belongs to the class of medicines called antihypertensives. It works in the brain to change some of the nerve impulses. As a result, the blood vessels relax and blood passes through them more easily, which lowers blood pressure. When the blood pressure is lowered, the amount of blood and oxygen going to the heart is increased.

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 might have to take high blood pressure medicine for the rest of your life.

Kapvay® extended-release tablets is used alone or together with other medicines to treat attention deficit hyperactivity disorder (ADHD). It works 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.

Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes 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. Do not cut, crush, or chew it. You may take the tablet with or without food.

Clonidine extended-release tablets works differently than clonidine immediate-release tablets. Do not switch from the extended-release tablets to the immediate-release tablets unless your doctor tells you to.

For patients using the extended-release oral suspension:

• Shake the bottle well for 5 to 10 seconds before each use.
• Insert the adapter into the neck of the bottle.
• Insert the syringe tip into the adapter and turn the bottle upside down.
• Get the amount of medicine as prescribed by your doctor.
• Place the medicine directly into the mouth.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

This medicine usually comes with patient information leaflet. Read them carefully and make sure you understand them before taking this medicine. If you have any questions, ask your doctor.

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 attention deficit hyperactivity disorder (ADHD):
  • For oral dosage form (extended-release tablets):
    • Teenagers and children 6 years of age and older—At first, 0.1 milligram (mg) once a day, given at bedtime. Your doctor will increase your dose as needed.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
• For high blood pressure:
  • For oral dosage form (extended-release suspension):
    • Adults—At first, 0.17 milligram (mg) or 2 milliliter (mL) once a day, given at bedtime. Your doctor may adjust your dose as needed. The usual dose is 0.17 (2 mL) to 0.52 mg (6 mL) per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • Adults—At first, 0.17 milligram (mg) once a day, given at bedtime. Your doctor may adjust your dose as needed. The usual dose is 0.17 to 0.52 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—0.1 milligram (mg) two times a day, taken in the morning and at bedtime. Your doctor may adjust your dose as needed. The usual dose is 0.2 mg to 0.6 mg per day, divided and given two times a day.
    • Children—Use and dose must be determined by your doctor.

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 miss more than one dose of clonidine tablets, check with your doctor right away. If your body goes without this medicine for too long, your blood pressure may go up to a very high level and cause serious side effects.

If you miss a dose of clonidine extended-release tablets, skip the missed dose and take the next dose as scheduled. Do not double doses.

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.

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:

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.

Appropriate studies have not been performed on the relationship of age to the effects of clonidine in children younger than 18 years of age and Kapvay® extended-release tablets in children younger than 6 years of age. Safety and efficacy have not been established.

No information is available on the relationship of age to the effects of clonidine in geriatric patients. However, elderly patients are more likely to have age-related heart or kidney problems, which may require caution and an adjustment in the dose for patients receiving clonidine.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Nexiclon™ XR extended-release suspension and tablets in the elderly. However, elderly patients are more likely to have age-related heart or kidney problems, which may require an adjustment in the dose for patients receiving this medicine.

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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.

• Acebutolol
• Amitriptyline
• Amoxapine
• Atenolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Carteolol
• Celiprolol
• Clomipramine
• Crizotinib
• Desipramine
• Dilevalol
• Diltiazem
• Dothiepin
• Doxepin
• Esmolol
• Imipramine
• Iobenguane I 131
• Levobunolol
• Lofepramine
• Macimorelin
• Metipranolol
• Metoprolol
• Mirtazapine
• Nadolol
• Nebivolol
• Nortriptyline
• Oxprenolol
• Penbutolol
• Pindolol
• Propranolol
• Protriptyline
• Sotalol
• Tertatolol
• Timolol
• Trimipramine
• Verapamil

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.

• Cyclosporine
• Fluphenazine
• Mepivacaine
• Naloxone
• Yohimbine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 heartbeat) or
• Coronary insufficiency, severe or
• Dehydration or
• Heart attack, recent or
• Heart block or
• Heart or blood vessel disease or
• Heart rhythm problems or
• Hypotension (low blood pressure), history of or
• Kidney disease, severe or
• Stomach or intestinal problems or
• Stroke, history of or
• Syncope (fainting), history of—Use with caution. May cause side effects to become worse.

• Kidney disease—You may require a lower dose.

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Your blood pressure may become worse when the medicine is stopped suddenly, which can cause serious side effects.

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

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. You should avoid over-the-counter [OTC] medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Clonidine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system and may cause drowsiness. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates or medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Clonidine may cause some people to become drowsy or less alert than they are normally. This is more likely to happen when you begin to take it or when you increase the amount of medicine you are taking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

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.

This medicine may cause dryness of the eyes. If you wear contact lenses, this may be a problem for you. Talk to your doctor if you wear contact lenses, and discuss how to treat the dryness.

Dizziness, lightheadedness, or fainting may occur after you take this medicine, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help, but if the problem continues or gets worse, check with your doctor.

The dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking clonidine, be careful to limit the amount of alcohol you drink. Also, use extra care not to become dehydrated or overheated during exercise or hot weather or if you must stand for a long time.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

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