Clonidine (transdermal route)


    Brand Name

    US Brand Name

    Catapres-TTS-1

    Catapres-TTS-2

    Catapres-TTS-3


    Description

    Clonidine transdermal 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.

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

    This product is available in the following dosage forms:

    • Patch, Extended Release

    Before Using

    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.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of clonidine transdermal in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    No information is available on the relationship of age to the effects of clonidine transdermal 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 transdermal.

    Breastfeeding

    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.

    Drug Interactions

    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
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amlodipine
    • Amoxapine
    • Amphetamine
    • Aranidipine
    • Atenolol
    • Bepridil
    • Betaxolol
    • Bevantolol
    • Bisoprolol
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Ceritinib
    • Cilnidipine
    • Clevidipine
    • Clomipramine
    • Crizotinib
    • Desipramine
    • Dextroamphetamine
    • Dibenzepin
    • Digoxin
    • Dilevalol
    • Diltiazem
    • Dothiepin
    • Doxepin
    • Esmolol
    • Felodipine
    • Imipramine
    • Iobenguane I 131
    • Isradipine
    • Labetalol
    • Lercanidipine
    • Levobunolol
    • Lisdexamfetamine
    • Lofepramine
    • Macimorelin

    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

    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:

    • Heart attack, recent or
    • Heart or blood vessel disease or
    • Heart rhythm problems or
    • Stroke—Use with caution. May cause side effects to become worse.
    • Irritated or scraped skin—Effects may be increased because more medicine is absorbed in the body.
    • Kidney disease—Effects may be increased because of slower removal from the body.

    Proper Use

    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 patients 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. You must continue to take 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.

    To use the skin patch:

    • Use this medicine exactly as directed by your doctor. It will work only if applied correctly. This medicine usually comes with patient instructions. Read them carefully before applying the patch.
    • Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.
    • Do not try to trim or cut the adhesive patch to adjust the dosage. Check with your doctor if you think the medicine is not working as it should.
    • Gently wash the area of skin where you will apply the patch with soap and water. Rinse the skin completely and dry with a clean, dry tissue.
    • Apply the patch right away after removing it from the pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
    • Apply the patch to a clean, dry, and intact skin area on your upper, outer arm or upper chest. Choose an area with little or no hair that is free of scars, cuts, or irritation. Avoid putting the patch on skin areas where it could be rubbed off by tight clothing.
    • Press the patch firmly in place with your fingertips to make sure that the edges stick well.
    • The patch should stay in place during showering, bathing, or swimming for a full 7 days. If the patch becomes loose, press the edges against the skin and cover the patch with one of the white adhesive covers that are included in the package. Apply a new patch if the first one becomes too loose or falls off.
    • It is best to apply each patch to a different area of the skin to prevent skin irritation.

    To help you remember to use your medicine, try to apply the patch at the same time and on the same day of the week.

    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 transdermal dosage form (patch):
      • For high blood pressure:
        • Adults—One patch applied once every 7 days. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

    If you miss changing the transdermal patch for 2 or more days, 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.

    Storage

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

    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.

    After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.


    Precautions

    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 using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using 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 transdermal 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.

    You may have some skin redness, a rash, itching, or blistering at the place where you wear the patch. If this irritation is severe or does not go away, call your doctor. Do not remove the patch unless your doctor tells you to.

    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.

    Before having a magnetic resonance imaging (MRI) scan, tell the doctor in charge that you are using this medicine. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.

    Clonidine transdermal may cause some people to become drowsy or less alert than they are normally. This is more likely to happen when you begin to use it or when you increase the amount of medicine you are using. 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.

    Clonidine transdermal 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.

    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 use 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 using clonidine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for a long time.

    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.


    Side Effects

    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

    • Itching or redness of the skin

    Incidence not known

    • Blistering, burning, crusting, dryness, or flaking of the skin
    • blurred vision
    • chest pain or discomfort
    • darkening of the skin
    • decreased urine output
    • dilated neck veins
    • dizziness
    • extreme fatigue
    • fainting
    • fast, slow, pounding, or irregular heartbeat or pulse
    • fever
    • general feeling of discomfort or illness
    • inability to speak
    • irregular breathing
    • itching, scaling, severe redness, soreness, or swelling of the skin
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • lightheadedness, dizziness, or fainting
    • paleness or cold feeling in the fingertips and toes
    • seizures
    • severe or sudden headache
    • shortness of breath
    • slurred speech
    • swelling of the face, fingers, feet, or lower legs
    • temporary blindness
    • tightness in the chest
    • tingling or pain in the fingers or toes when exposed to cold
    • troubled breathing
    • unusual tiredness or weakness
    • weakness in the arm or leg on one side of the body, sudden and severe
    • weight gain
    • wheezing

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

    Symptoms of overdose

    • Bluish lips or skin
    • change in consciousness
    • clumsiness
    • confusion
    • constricted, pinpoint, or small pupils (black part of the eye)
    • depression
    • difficult or troubled breathing
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • drowsiness
    • headache
    • irregular, fast or slow, or shallow breathing
    • irritability
    • lack of coordination
    • loss of consciousness
    • low body temperature
    • muscle aches or weakness
    • nervousness
    • not breathing
    • pale or blue lips, fingernails, or skin
    • pounding in the ears
    • shivering
    • sleepiness
    • sweating
    • weak or feeble pulse

    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:

    Incidence not known

    • Anxiety
    • burning or dryness of the eyes
    • confusion as to time, place, or person
    • decreased interest in sexual intercourse
    • dry mouth
    • hair loss
    • hives or welts
    • holding false beliefs that cannot be changed by fact
    • hyperventilation
    • inability to have or keep an erection
    • itching skin
    • leg cramps
    • loss in sexual ability, desire, drive, or performance
    • loss of appetite
    • muscle or joint pain
    • raised red swellings on the skin, lips, tongue, or in the throat
    • redness of the skin
    • restlessness
    • seeing, hearing, or feeling things that are not there
    • shaking
    • skin rash
    • swelling of the breasts or breast soreness in both females and males
    • thinning of the hair
    • trouble sleeping
    • unusual excitement, nervousness, or restlessness
    • vivid dreams or nightmares
    • weight loss

    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.






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