Proceeding from the visible surface towards the surface attached to the skin, there are four consecutive layers: 1) a backing layer of pigmented polyester and aluminum film; 2) a drug reservoir of clonidine, mineral oil, polyisobutylene, and colloidal silicon dioxide; 3) a microporous polypropylene membrane that controls the rate of delivery of clonidine from the system to the skin surface; 4) an adhesive formulation of clonidine, mineral oil, polyisobutylene, and colloidal silicon dioxide. Prior to use, a protective slit release liner of polyester that covers the adhesive layer is removed.
Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance; at a 45 tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance.
clonidine tts 2 patch
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Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated.
Following intravenous administration clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine has a total clearance of 177 mL/min and a renal clearance of 102 mL/min. The apparent volume of distribution (Vz) of clonidine is 197 L (2.9 L/kg). Clonidine crosses the placental barrier. It has been shown to cross the blood brain barrier in rats.
The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine.
Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.
Patients should be instructed to consult their physicians promptly about the possible need to remove the patch if they observe moderate to severe localized erythema and/or vesicle formation at the site of application or generalized skin rash.
Fertility of male and female rats was unaffected by clonidine doses as high as 150 µg/kg (approximately 3 times the MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 µg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m2 basis).
Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of CATAPRES (clonidine hydrochloride) produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 µg/kg).
Adverse Events Associated with Oral CATAPRES Therapy: Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving CATAPRES (clonidine hydrochloride, USP) tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.
Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because the CATAPRES-TTS PATCH contains aluminum, it is recommended to remove the system before undergoing an MRI.
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.
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.
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 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.
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.
Peel off the backing from the patch and apply the patch to a clean, dry, and hairless area of the skin on the upper outer arm or upper chest. Press the patch firmly in place for about 10 seconds to make sure it stays on. Do not apply the patch on oily, broken, or irritated skin. Avoid applying the patch to areas of the skin where it might be easily rubbed off (such as on skin folds). Use this medication as directed by your doctor. The patch is usually worn for 1 week and then replaced. Follow the dosing schedule carefully. Wash your hands after handling the patch.
When replacing your patch, make sure to apply the new patch to a different area. Fold the old patch in half with the sticky side together and throw away in the trash away from children and pets. Do not flush the patch down the toilet.
Use this medication regularly to get the most benefit from it. To help you remember, change the patch on the same day each week. It may help to mark your calendar with a reminder. Keep using this medication even if you feel well. Most people with high blood pressure do not feel sick.
Do not stop using this medication without consulting your doctor. You may experience symptoms such as nervousness, agitation, shaking, and headache. A rapid rise in blood pressure may also occur if the drug is suddenly stopped. The risk is greater if you have used this drug for a long time or in high doses, or if you are also taking a beta blocker (such as atenolol). There have also been rare reports of severe, possibly fatal reactions (such as stroke) from stopping this drug too quickly. It is important that you do not run out of clonidine patches or miss any doses. To prevent any reactions while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Precautions Before using clonidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Some products have ingredients that could raise your blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen). Does CATAPRES-TTS 2 Patch, Transdermal Weekly interact with other drugs you are taking? Enter your medication into the WebMD interaction checker Check Interaction Overdose This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness/drowsiness, fainting, slow/irregular heartbeat, slow/shallow breathing, seizures. Notes Do not share this medication with others. 2ff7e9595c
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