País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
Clonidine (UNII: MN3L5RMN02) (Clonidine - UNII:MN3L5RMN02)
Physicians Total Care, Inc.
Clonidine
Clonidine 0.1 mg in 1 d
TRANSDERMAL
PRESCRIPTION DRUG
Clonidine Transdermal System is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents. Clonidine Transdermal System should not be used in patients with known hypersensitivity to clonidine or to any other component of the transdermal system.
Clonidine Transdermal Systems 0.1 mg, Clonidine Transdermal Systems 0.2 mg, and Clonidine Transdermal Systems 0.3 mg are supplied as 4 pouched systems and 4 adhesive covers per carton.
Abbreviated New Drug Application
CLONIDINE - CLONIDINE PATCH Physicians Total Care, Inc. ---------- (Read the following instructions carefully before using this medication. If you have any questions, please consult with your doctor). General Information Clonidine Transdermal System is a tan colored, oval shaped adhesive PATCH containing an active blood- pressure-lowering medication. It is designed to deliver the drug into the body through the skin smoothly and consistently for one full week. Normal exposure to water, as in showering, bathing, and swimming, should not affect the PATCH. Figure 1: The optional white, oval shaped, ADHESIVE COVER should be applied directly over the PATCH, should the PATCH begin to separate from the skin. The ADHESIVE COVER ensures that the PATCH sticks to the skin. The Clonidine Transdermal System PATCH must be replaced with a new one on a fresh skin site if the one in use significantly loosens or falls off. 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. How to Apply the Clonidine Transdermal System PATCH 1. Apply the tan colored, oval shaped Clonidine Transdermal System PATCH once a week, preferably at a convenient time on the same day of the week (i.e., prior to bedtime on Tuesday of week one; prior to bedtime on Tuesday of week two, etc.). Figure 2: 2. Select a hairless area such as on the upper, outer arm or upper chest. The area chosen should be free of cuts, abrasions, irritation, scars or calluses and should not be shaved before applying the Clonidine Transdermal System PATCH. Do not place the Clonidine Transdermal System PATCH on skin folds or under tight undergarments, since premature loosening may occur. 3. Wash hands with soap and water and thoroughly dry them. 4. Clean the area chosen with soap and water. Rinse and wipe dry with a clean, dry tissue. 5. Select the pouch labele Llegiu el document complet
CLONIDINE - CLONIDINE PATCH PHYSICIANS TOTAL CARE, INC. ---------- CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE) CLONIDINE TRANSDERMAL SYSTEM 0.1 MG/DAY CLONIDINE TRANSDERMAL SYSTEM 0.2 MG/DAY CLONIDINE TRANSDERMAL SYSTEM 0.3 MG/DAY CLONIDINE TRANSDERMAL SYSTEM FORMULATED TO DELIVER _IN VIVO _0.1, 0.2, OR 0.3 MG CLONIDINE PER DAY, FOR ONE WEEK. RX ONLY PRESCRIBING INFORMATION DESCRIPTION Clonidine Transdermal System is a transdermal system (patch) providing continuous systemic delivery of clonidine for 7 days at an approximately constant rate. Clonidine is a centrally acting alpha-agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2, 6-dichloro-N-2- imidazolidinylidenebenzenamine and has the following chemical structure: SYSTEM STRUCTURE AND COMPONENTS: Clonidine Transdermal System is a multi-laminate patch, 0.3 mm thick, containing clonidine as the active agent. The patch surface areas are 10.8 cm (Clonidine Transdermal System 0.1 mg/day), 21.6 cm (Clonidine Transdermal System 0.2 mg/day), and 32.4 cm (Clonidine Transdermal System 0.3 mg/day). The composition per unit area is the same for all three doses. Proceeding from the outer printed backing layer towards the surface applied to the skin, the system comprises: 1) a backing layer of polyethylene/aluminum/polyester film; 2) a drug reservoir layer of clonidine, isopropyl palmitate, and amine-compatible silicone adhesive; 3) an ethylene vinyl acetate (EVA) membrane that controls the rate of clonidine delivery from the system to the skin; 4) an amine- compatible silicone adhesive layer (ADHESIVE LAYER B); 5) an acrylate adhesive layer (ADHESIVE LAYER C) that attaches to the skin; and 6) a protective release liner of siliconized polyester that is removed prior to use. Cross-sectional view of the Clonidine Transdermal System. Not to scale. 2 2 2 RELEASE RATE CONCEPT: Clonidine Transdermal System is designed to deliver clonidine through the skin at an approximately constant rate for 7 days. Saturated clonidine in the reservoir layer provide Llegiu el document complet