Patients should be cautioned against interruption of clonidine transdermal system therapy without their physician's advice. 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 who wear contact lenses should be cautioned that treatment with clonidine transdermal system may cause dryness of eyes. If a patient experiences isolated, mild localized skin irritation before completing 7 days of use, the system may be removed and replaced with a new system applied to a fresh skin site.
If the system should begin to loosen from the skin after application, the patient should be instructed to place the adhesive cover directly over the system to ensure adhesion during its 7-day use. Used clonidine transdermal system patches contain a substantial amount of their initial drug content which may be harmful to infants and children if accidentally applied or ingested.
After use, clonidine transdermal system should be folded in half with the adhesive sides together and discarded away from children's reach. Instructions for use, storage and disposal of the system are provided at the end of this prescribing information.
These instructions are also included in each box of clonidine transdermal system. Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances e.
Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats see 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. 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. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged.
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. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose MRDHD of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. 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.
As clonidine is excreted in human milk, caution should be exercised when clonidine transdermal system is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials. Clinical t rial e xperience w ith Clonidine Transdermal System.
Most systemic adverse effects during clonidine transdermal system therapy have been mild and have tended to diminish with continued therapy. In the above mentioned 3-month controlled clinical trial, as well as other uncontrolled clinical trials, the most frequent adverse reactions were dermatological and are described below. Allergic contact sensitization to clonidine transdermal system was observed in 5 patients.
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.
Analysis of skin reaction data showed that the risk of having to discontinue clonidine transdermal system treatment because of contact dermatitis was greatest between treatment weeks 6 and 26, although sensitivity may develop either earlier or later in treatment.
In a large-scale clinical acceptability and safety study by physicians in a total of patients, other allergic reactions were recorded for which a causal relationship to clonidine transdermal system was not established: maculopapular rash 10 cases ; urticaria 2 cases ; and angioedema of the face 2 cases , which also affected the tongue in one of the patients. The following adverse reactions have been identified during post-approval use of clonidine transdermal system.
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 clonidine transdermal 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. Ophthalmological : Blurred vision; burning of the eyes and dryness of the eyes. Adverse Events Associated with Or al C lonidine Th erapy: 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 patients; drowsiness, about 33 in ; dizziness, about 16 in ; constipation and sedation, each about 10 in The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride, USP tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.
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.
Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of the eyes. Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis.
The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0. If symptoms of poisoning occur following dermal exposure, remove all clonidine transdermal systems.
After their removal, the plasma clonidine levels will persist for about 8 hours, then decline slowly over a period of several days. Rare cases of clonidine transdermal system poisoning due to accidental or deliberate mouthing or ingestion of the patch have been reported, many of them involving children. There is no specific antidote for clonidine overdosage. Ipecac syrup-induced vomiting and gastric lavage would not be expected to remove significant amounts of clonidine following dermal exposure.
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. Talk with your doctor if this medication stops working well such as your blood pressure readings remain high or increase. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of:. This drug may make you dizzy or drowsy. Alcohol or marijuana cannabis can make you more dizzy or drowsy. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose MRDHD of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits.
Increased resorptions were not associated with treatment at the same time or at higher dose levels up to 3 times the oral MRDHD when the dams were treated on gestation days No adequate well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: As clonidine is excreted in human milk, caution should be exercised when Clonidine Transdermal System is administered to a nursing woman. 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.
Because the Clonidine Transdermal Patch contains aluminum, it is recommended to remove the system before undergoing an MRI. Clinical trial experience with transdermal systems containing clonidine: Most systemic adverse effects during transdermal system therapy containing clonidine have been mild and have tended to diminish with continued therapy. In the above mentioned 3-month controlled clinical trial, as well as other uncontrolled clinical trials, the most frequent adverse reactions were dermatological and are described below.
Allergic contact sensitization to clonidine transdermal therapy was observed in 5 patients. 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. Analysis of skin reaction data showed that the risk of having to discontinue clonidine transdermal treatment because of contact dermatitis was greatest between treatment weeks 6 and 26, although sensitivity may develop either earlier or later in treatment.
In a large-scale clinical acceptability and safety study by physicians in a total of patients, other allergic reactions were recorded for which a causal relationship to clonidine transdermal treatment was not established: maculopapular rash 10 cases ; urticaria 2 cases ; and angioedema of the face 2 cases , which also affected the tongue in one of the patients. Marketing Experience with transdermal systems containing clonidine: Other adverse effects reported since the drug has been marketed are listed below by body system.
In this setting, an incidence or causal relationship cannot always be accurately determined. However, none of the events listed below occurred in a frequency greater than 0. Body as a Whole: Fever; malaise; weakness; and pallor, and withdrawal syndrome. Cardiovascular: Congestive heart failure; cerebrovascular accident; electrocardiographic abnormalities i. DermatologicaI: Angioneurotic edema; localized or generalized rash; hives; urticaria; contact dermatitis; pruritus; alopecia; and localized hypo or hyperpigmentation.
Genitourinary: Difficult micturition; loss of libido; and decreased sexual activity. Ophthalmological: Blurred vision; burning of the eyes and dryness of the eyes. Adverse Events Associated with Oral Clonidine 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 patients; drowsiness, about 33 in ; dizziness, about 16 in ; constipation and sedation, each about 10 in The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride USP, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.
Body as a Whole: Weakness, about 10 in patients; fatigue, about 4 in ; headache and withdrawal syndrome each about 1 in Also reported were pallor; a weakly positive Coombs' test; increased sensitivity to alcohol; and fever. Cardiovascular: Orthostatic symptoms, about 3 in patients; palpitations and tachycardia, and bradycardia, each about 5 in Syncope, Raynaud's phenomenon, congestive heart failure, and electrocardiographic abnormalities i.
Rare cases of sinus bradycardia and AV block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Nervousness and agitation, about 3 in patients; mental depression, about 1 in and insomnia, about 5 in Other behavioral changes, vivid dreams or nightmares, restlessness, anxiety, visual and auditory hallucinations and delirium have rarely been reported.
Dermatological: Rash, about 1 in patients; pruritus, about 7 in ; hives, angioneurotic edema and urticaria, about 5 in ; alopecia, about 2 in Gastrointestinal: Nausea and vomiting, about 5 in patients; anorexia and malaise: each about 1 in ; mild transient abnormalities in liver function tests, about 1 in ; hepatitis, parotitis, constipation, pseudo-obstruction, and abdominal pain, rarely.
Genitourinary: Decreased sexual activity, impotence and loss of libido, about 3 in patients; nocturia, about 1 in ; difficulty in micturition, about 2 in ; urinary retention, about 1 in Metabolic: Weight gain, about 1 in patients; gynecomastia, about 1 in ; transient elevation of blood glucose or serum creatine phosphokinase, rarely. Musculoskeletal: Muscle or joint pain, about 6 in and leg cramps, about 3 in Ophthalmological: Dryness of the eyes, burning of the eyes and blurred vision were reported.
Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis.
The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure.
As little as 0. If symptoms of poisoning occur following dermal exposure, remove all Clonidine Transdermal Systems. After their removal, the plasma clonidine levels will persist for about 8 hours, then decline slowly over a period of several days. Rare cases of clonidine transdermal system poisoning due to accidental or deliberate mouthing or ingestion of the patch have been reported, many of them involving children. There is no specific antidote for clonidine overdosage. Ipecac syrup-induced vomiting and gastric lavage would not be expected to remove significant amounts of clonidine following dermal exposure.
Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine.
The largest overdose reported to date, involved a year-old male who ingested mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semi-coma, and premature ventricular contractions.
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