Catapres patch 1

Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in patients before, and periodically after, the start of clonidine therapy. In of these patients, the eye examinations were carried out over periods of 24 months or longer. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days.

There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. 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 Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials. Most systemic adverse effects during Catapres-TTS transdermal therapeutic system therapy have been mild and have tended to diminish with continued therapy. Other skin reactions were localized vesiculation 7 patients , hyperpigmentation 5 , edema 3 , excoriation 3 , burning 3 , papules 1 , throbbing 1 , blanching 1 , and a generalized macular rash 1.

In additional clinical experience, contact dermatitis resulting in treatment discontinuation was observed in of patients about 19 in after a mean duration of treatment of 37 weeks. The incidence of contact dermatitis was about 34 in among white women, about 18 in in white men, about 14 in in black women, and approximately 8 in in black men.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: 1 seriousness of the reaction, 2 frequency of reporting, or 3 strength of causal connection to CATAPRES-TTS transdermal therapeutic system.

Body as a Whole: Fever; malaise; weakness; pallor; and withdrawal syndrome. Cardiovascular: Congestive heart failure; cerebrovascular accident; electrocardiographic abnormalities i. Dermatological: Angioneurotic edema; localized or generalized rash; hives; urticaria; contact dermatitis; pruritus; alopecia; and localized hypo or hyper pigmentation.

Genitourinary: Difficult micturition; loss of libido; and decreased sexual activity. Metabolic: Gynecomastia or breast enlargement and weight gain.

Musculoskeletal: Muscle or joint pain; and leg cramps. Ophthalmological: Blurred vision; burning of the eyes and dryness of the eyes. The most frequent which appear to be dose-related are dry mouth, occurring in about 40 of patients; drowsiness, about 33 in ; dizziness, about 16 in ; constipation and sedation, each about 10 in Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome.

Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities i. Cases of sinus bradycardia and AV block have been reported, both with and without the use of concomitant digitalis.

Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations including visual and auditory , insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares.

Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria. Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction including colonic pseudo-obstruction , salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention.

Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. If you have any questions, ask your doctor or pharmacist. 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. If the patch starts to loosen from the skin, you may apply the "adhesive cover" over the patch so that it does not fall off during the 1-week period.

The "adhesive cover" does not contain any medication. 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. When used for a long time, this medication may not work as well and may require different dosing or an additional medication.

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. Dosage must be adjusted according to the degree of impairment, and patients should be carefully monitored.

Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis. See chart below. Read the following instructions carefully before using this medication. If you have any questions, please consult with your doctor. It is designed to deliver the drug into the body through the skin smoothly and consistently for one full week.

During or even after use, a PATCH contains active medication which may be harmful to infants and children if accidentally applied or ingested. After use, fold in half with the sticky sides together. Dispose of carefully out of reach of children. Prescribing Information. Cross Section of the System:.

Pharmacokinetics The plasma half-life of clonidine is Defibrillation or Cardioversion The transdermal clonidine systems should be removed before attempting defibrillation or cardioversion because of the potential for altered electrical conductivity which may increase the risk of arcing, a phenomenon associated with the use of defibrillators.

MRI Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a magnetic resonance imaging scan MRI. Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs.

Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Gastrointestinal: Anorexia and vomiting. Metabolic: Gynecomastia or breast enlargement and weight gain. Musculoskeletal: Muscle or joint pain; and leg cramps. Hematologic: Thrombocytopenia. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa.

Renal Impairment Dosage must be adjusted according to the degree of impairment, and patients should be carefully monitored. Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc.

Select a hairless area such as on the upper, outer arm or upper chest. Wash hands with soap and water and thoroughly dry them.

Clean the area chosen with soap and water. Rinse and wipe dry with a clean, dry tissue. Remove the clear plastic protective backing from the PATCH by gently peeling off one half of the backing at a time as shown in Figure 4. Discard the clear plastic protective backing and wash your hands with soap and water to remove any drug from your hands. Principal Display Panel. Programmed Delivery Clonidine in vivo.

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. 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.

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light. After removing a used patch, fold the patch in half with the sticky sides together.