clonidine - Medications

Catapres‑TTS ® (clonidine transdermal system) is a transdermal system 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 Catapres‑TTS ® is a multi-layered film, 0.2 mm thick, containing clonidine as the active agent. The system areas are 3.5 cm 2 (Catapres‑TTS ® ‑1), 7.0 cm 2 (Catapres‑TTS ® ‑2) and 10.5 cm 2 (Catapres‑TTS ® ‑3) and the amount of drug released is directly proportional to the area (see Release Rate Concept ). The composition per unit area is the same for all three doses. 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. Cross Section of the System: cross-section-table Release Rate Concept Catapres‑TTS ® (clonidine transdermal system) is programmed to release clonidine at an approximately constant rate for 7 days. The energy for drug release is derived from the concentration gradient existing between a saturated solution of drug in the system and the much lower concentration prevailing in the skin. Clonidine flows in the direction of the lower concentration at a constant rate, limited by the rate‑controlling membrane, so long as a saturated solution is maintained in the drug reservoir. Following system application to intact skin, clonidine in the adhesive layer saturates the skin site below the system. Clonidine from the drug reservoir then begins to flow through the rate‑controlling membrane and the adhesive layer of the system into the systemic circulation via the capillaries beneath the skin. Therapeutic plasma clonidine levels are achieved 2 to 3 days after initial application of Catapres‑TTS ® . The 3.5, 7.0, and 10.5 cm 2 systems deliver 0.1, 0.2, and 0.3 mg of clonidine per day, respectively. To ensure constant release of drug for 7 days, the total drug content of the system is higher than the total amount of drug delivered. Application of a new system to a fresh skin site at weekly intervals continuously maintains therapeutic plasma concentrations of clonidine. If the Catapres‑TTS ® is removed and not replaced with a new system, therapeutic plasma clonidine levels will persist for about 8 hours and then decline slowly over several days. Over this time period, blood pressure returns gradually to pretreatment levels. catapres-tts-structure

Clonidine transdermal system, USP is a transdermal system 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-[(2,6-Dichlorophenyl)imino]imidazolidine and has the following chemical structure: Meets USP Drug Release Test 3. System Structure and Components Clonidine transdermal system is a multi-layered film, 0.25 mm thick, containing clonidine as the active agent. The system areas are 3.33 cm 2 (0.1 mg/day), 6.67 cm 2 (0.2 mg/day), and 10.0 cm 2 (0.3 mg/day) and the amount of drug released is directly proportional to the area (see DESCRIPTION: Release Rate Concept ). The composition per unit area is the same for all three doses. Proceeding from the visible surface towards the surface attached to the skin, there are three consecutive layers: 1) a backing layer of pigmented polyethylene and polyester film, 2) a solid matrix reservoir of clonidine, mineral oil, polyisobutylene, and colloidal silicon dioxide, 3) 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 formulation layer is removed. Clonidine transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These pieces of protective film are removed and discarded at the time of use. Cross Section of the System: Clonidine Cross Section Release Rate Concept Clonidine transdermal system is programmed to release clonidine at an approximately constant rate for 7 days. The energy for drug release is derived from the concentration gradient existing between the patch and the much lower concentration prevailing in the skin. Clonidine flows in the direction of the lower concentration at a constant rate. Following system application to intact skin, clonidine in the adhesive formulation layer saturates the skin site below the system. Clonidine from the patch then begins to flow into the systemic circulation via the capillaries beneath the skin. Therapeutic plasma clonidine levels are achieved 2 to 3 days after initial application of clonidine transdermal system. The 3.33, 6.67, and 10.0 cm 2 systems deliver 0.1, 0.2, and 0.3 mg of clonidine per day, respectively. To ensure constant release of drug for 7 days, the total drug content of the system is higher than the total amount of drug delivered. Application of a new system to a fresh skin site at weekly intervals continuously maintains therapeutic plasma concentrations of clonidine. If the clonidine transdermal system is removed and not replaced with a new system, therapeutic plasma clonidine levels will persist for about 8 hours and then decline slowly over several days. Over this time period, blood pressure returns gradually to pretreatment levels. Clonidine Structural Formula

Clonidine transdermal system USP provides continuous systemic delivery of clonidine USP for 7 days at an approximately constant rate. Clonidine USP 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: C 9 H 9 Cl 2 N 3 M.W. 230.10 Chemical Structure System Structure and Components Clonidine transdermal system USP is a multi-layered film, 0.2 mm thick, containing clonidine USP as the active agent. The system areas are 4.33 cm 2 (clonidine USP 0.1 mg per day), 8.67 cm 2 (clonidine USP 0.2 mg per day) and 13 cm 2 (clonidine USP 0.3 mg per day) and the amount of drug released is directly proportional to the area (see Release Rate Concept ). The composition per unit area is the same for all three doses. The inactive ingredients are: aluminum, colloidal silicon dioxide, ethylene vinyl acetate copolymer, light mineral oil, microporous polypropylene membrane, pigmented polyethylene polyester film, polyisobutylene and silicon coated polyester film. Proceeding from the visible surface towards the surface attached to the skin, there are four consecutive layers: 1) a backing layer of polyester film; 2) a drug reservoir; 3) a microporous polypropylene membrane that controls the rate of delivery of clonidine USP from the system to the skin surface; 4) an adhesive formulation. Prior to use, a protective slit release liner of silicone coated polyester film that covers the adhesive layer is removed. Cross Section of the System: Figure Release Rate Concept Clonidine transdermal system USP is programmed to release clonidine USP at an approximately constant rate for 7 days. The energy for drug release is derived from the concentration gradient existing between a saturated solution of drug in the system and the much lower concentration prevailing in the skin. Clonidine USP flows in the direction of the lower concentration at a constant rate, limited by the rate-controlling membrane, so long as a saturated solution is maintained in the drug reservoir. Following system application to intact skin, clonidine USP in the adhesive layer saturates the skin site below the system. Clonidine USP from the drug reservoir then begins to flow through the rate-controlling membrane and the adhesive layer of the system into the systemic circulation via the capillaries beneath the skin. Therapeutic plasma clonidine USP levels are achieved 2 to 3 days after initial application of clonidine transdermal system USP. The 4.33, 8.67 and 13 cm 2 systems deliver 0.1, 0.2, and 0.3 mg of clonidine USP per day, respectively. To ensure constant release of drug for 7 days, the total drug content of the system is higher than the total amount of drug delivered. Application of a new system to a fresh skin site at weekly intervals continuously maintains therapeutic plasma concentrations of clonidine USP. If the clonidine transdermal system USP is removed and not replaced with a new system, therapeutic plasma clonidine USP levels will persist for about 8 hours and then decline slowly over several days. Over this time period, blood pressure returns gradually to pretreatment levels.

Clonidine transdermal system USP provides continuous systemic delivery of clonidine USP for 7 days at an approximately constant rate. Clonidine USP 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: C 9 H 9 Cl 2 N 3 M.W. 230.10 System Structure and Components Clonidine transdermal system USP is a multi-layered film, 0.2 mm thick, containing clonidine USP as the active agent. The system areas are 4.33 cm 2 (clonidine USP 0.1 mg per day), 8.67 cm 2 (clonidine USP 0.2 mg per day) and 13 cm 2 (clonidine USP 0.3 mg per day) and the amount of drug released is directly proportional to the area (see Release Rate Concept ). The composition per unit area is the same for all three doses. The inactive ingredients are: aluminum, colloidal silicon dioxide, ethylene vinyl acetate copolymer, light mineral oil, microporous polypropylene membrane, pigmented polyethylene polyester film, polyisobutylene and silicon coated polyester film. Proceeding from the visible surface towards the surface attached to the skin, there are four consecutive layers: 1) a backing layer of polyester film; 2) a drug reservoir; 3) a microporous polypropylene membrane that controls the rate of delivery of clonidine USP from the system to the skin surface; 4) an adhesive formulation. Prior to use, a protective slit release liner of silicone coated polyester film that covers the adhesive layer is removed. Cross Section of the System: Release Rate Concept Clonidine transdermal system USP is programmed to release clonidine USP at an approximately constant rate for 7 days. The energy for drug release is derived from the concentration gradient existing between a saturated solution of drug in the system and the much lower concentration prevailing in the skin. Clonidine USP flows in the direction of the lower concentration at a constant rate, limited by the rate-controlling membrane, so long as a saturated solution is maintained in the drug reservoir. Following system application to intact skin, clonidine USP in the adhesive layer saturates the skin site below the system. Clonidine USP from the drug reservoir then begins to flow through the rate-controlling membrane and the adhesive layer of the system into the systemic circulation via the capillaries beneath the skin. Therapeutic plasma clonidine USP levels are achieved 2 to 3 days after initial application of clonidine transdermal system USP. The 4.33, 8.67 and 13 cm 2 systems deliver 0.1, 0.2, and 0.3 mg of clonidine USP per day, respectively. To ensure constant release of drug for 7 days, the total drug content of the system is higher than the total amount of drug delivered. Application of a new system to a fresh skin site at weekly intervals continuously maintains therapeutic plasma concentrations of clonidine USP. If the clonidine transdermal system USP is removed and not replaced with a new system, therapeutic plasma clonidine USP levels will persist for about 8 hours and then decline slowly over several days. Over this time period, blood pressure returns gradually to pretreatment levels.

Clonidine extended-release tablets are available for oral administration in two dose strengths: 0.17 mg and 0.26 mg. The 0.17 mg and 0.26 mg tablets are equivalent to 0.2 mg and 0.3 mg of immediate-release clonidine hydrochloride, respectively. Clonidine hydrochloride, a centrally active alpha-adrenergic agonist, is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2.6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: C 9 H 9 C l2 N 3 ·HCl Mol. Wt. 266.56 Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol. The inactive ingredients are: crospovidone, dental-type silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl acetate, povidone, sodium polystyrene sulfonate, triacetin. The 0.17 mg tablet also contains hypromellose, polyethylene glycol, and titanium dioxide. The 0.26 mg tablet also contains D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, fractionated coconut oil, maltodextrin, polydextrose, talc, and titanium dioxide. molecularstructure

Clonidine extended-release tablets are available for oral administration in two dose strengths: 0.17 mg and 0.26 mg. The 0.17 mg and 0.26 mg tablets are equivalent to 0.2 mg and 0.3 mg of immediate-release clonidine hydrochloride, respectively. Clonidine hydrochloride, a centrally active alpha-adrenergic agonist, is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2.6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: C 9 H 9 C l2 N 3 ·HCl Mol. Wt. 266.56 Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol. The inactive ingredients are: crospovidone, dental-type silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl acetate, povidone, sodium polystyrene sulfonate, triacetin. The 0.17 mg tablet also contains hypromellose, polyethylene glycol, and titanium dioxide. The 0.26 mg tablet also contains D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, fractionated coconut oil, maltodextrin, polydextrose, talc, and titanium dioxide. molecularstructure

Clonidine Transdermal System, USP is a transdermal system 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: Meets USP Drug Release Test 4. The chemical structure for Clonidine. System Structure and Components Clonidine Transdermal System, USP is a multi-layered film, 0.2 mm thick, containing clonidine as the active agent. The system areas are 4.1 cm 2 (0.1 mg per day for one week), 8.2 cm 2 (0.2 mg per day for one week) and 12.3 cm 2 (0.3 mg per day for one week) and the amount of drug released is directly proportional to the area (see Release Rate Concept ). The composition per unit area is the same for all three doses. Proceeding from the visible surface towards the surface attached to the skin, there are four consecutive layers: 1) a backing layer of pigmented polyethylene/aluminum/polyester film; 2) a drug reservoir of clonidine, acrylic adhesive; 3) an ethylene vinyl acetate membrane that controls the rate of delivery of clonidine from the system to the skin surface; 4) an adhesive formulation of clonidine and acrylic adhesive. Prior to use, a translucent to clear secondary protective liner card that rests over the pigmented film is removed; also, a protective release liner of silicone coated polyester film that covers the adhesive layer is removed. Cross Section of the System: Cross Section of the System: Release Rate Concept Clonidine transdermal system is programmed to release clonidine at an approximately constant rate for 7 days. The energy for drug release is derived from the concentration gradient existing between a saturated solution of drug in the system and the much lower concentration prevailing in the skin. Clonidine flows in the direction of the lower concentration at a constant rate, limited by the rate-controlling membrane, so long as a saturated solution is maintained in the drug reservoir. Following system application to intact skin, clonidine in the adhesive layer saturates the skin site below the system. Clonidine from the drug reservoir then begins to flow through the rate-controlling membrane and the adhesive layer of the system into the systemic circulation via the capillaries beneath the skin. Therapeutic plasma clonidine levels are achieved 2 to 3 days after initial application of clonidine transdermal system. The 4.1, 8.2, and 12.3 cm 2 systems deliver 0.1, 0.2, and 0.3 mg of clonidine per day, respectively. To ensure constant release of drug for 7 days, the total drug content of the system is higher than the total amount of drug delivered. Application of a new system to a fresh skin site at weekly intervals continuously maintains therapeutic plasma concentrations of clonidine. If the clonidine transdermal system is removed and not replaced with a new system, therapeutic plasma clonidine levels will persist for about 8 hours and then decline slowly over several days. Over this time period, blood pressure returns gradually to pretreatment levels.

Clonidine Transdermal System, USP provides 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, USP is a multi-layered film, 0.2 mm thick, containing clonidine as the active agent. The system areas are 3.5 cm 2 (Clonidine Transdermal System USP, 0.1 mg/day), 7.0 cm 2 (Clonidine Transdermal System USP, 0.2 mg/day) and 10.5 cm 2 (Clonidine Transdermal System USP, 0.3 mg/day) and the amount of drug released is directly proportional to the area (see Release Rate Concept ). The composition per unit area is the same for all three doses. 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. Cross Section of the System: cross-section-table Release Rate Concept Clonidine Transdermal System, USP, is programmed to release clonidine at an approximately constant rate for 7 days. The energy for drug release is derived from the concentration gradient existing between a saturated solution of drug in the system and the much lower concentration prevailing in the skin. Clonidine flows in the direction of the lower concentration at a constant rate, limited by the rate‑controlling membrane, so long as a saturated solution is maintained in the drug reservoir. Following system application to intact skin, clonidine in the adhesive layer saturates the skin site below the system. Clonidine from the drug reservoir then begins to flow through the rate‑controlling membrane and the adhesive layer of the system into the systemic circulation via the capillaries beneath the skin. Therapeutic plasma clonidine levels are achieved 2 to 3 days after initial application of Clonidine Transdermal System, USP, 0.1 mg/day. The 3.5, 7.0, and 10.5 cm 2 systems deliver 0.1, 0.2, and 0.3 mg of clonidine per day, respectively. To ensure constant release of drug for 7 days, the total drug content of the system is higher than the total amount of drug delivered. Application of a new system to a fresh skin site at weekly intervals continuously maintains therapeutic plasma concentrations of clonidine. If the Clonidine Transdermal System, USP is removed and not replaced with a new system, therapeutic plasma clonidine levels will persist for about 8 hours and then decline slowly over several days. Over this time period, blood pressure returns gradually to pretreatment levels. clonidine structure

NEXICLON XR (clonidine) Extended-Release Tablets are available for oral administration in two dose strengths: 0.17 mg and 0.26 mg. The 0.17 mg and 0.26 mg tablets are equivalent to 0.2 mg and 0.3 mg of immediate-release clonidine hydrochloride, respectively. Clonidine hydrochloride, a centrally active alpha-adrenergic agonist, is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2.6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: C 9 H 9 C l2 N 3 ·HCl Mol. Wt. 266.56 Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol. The inactive ingredients are: crospovidone, dental-type silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl acetate, povidone, sodium polystyrene sulfonate, triacetin. The 0.17 mg tablet also contains hypromellose, polyethylene glycol, and titanium dioxide. The 0.26 mg tablet also contains D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, fractionated coconut oil, maltodextrin, polydextrose, talc, and titanium dioxide. molecularstructure