RIVASTIGMINE patch

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

RIVASTIGMINE (UNII: PKI06M3IW0) (RIVASTIGMINE - UNII:PKI06M3IW0)

Inapatikana kutoka:

Amneal Pharmaceuticals LLC

Njia ya uendeshaji:

TRANSDERMAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Rivastigmine transdermal system is indicated for the treatment of dementia of the Alzheimer’s type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. Rivastigmine transdermal system is indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PDD). Rivastigmine transdermal system is contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation [see Description (11)] . - previous history of application site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis [see Warnings and Precautions (5.3)] . Isolated cases of generalized skin reactions have been described in postmarketing experience [see Adverse Reactions (6.2)] . Risk Summary There are no adequate data on the developmental risks associated with the use of rivastigmine transdermal system in pregnant women. In animals, no adverse effects on embryo-fetal development were observed at oral doses 2-4 times the maximum recommended human dose (MRHD) (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Animal Data Oral administration of rivastigmine to pregnant rats and rabbits throughout organogenesis produced no adverse effects on embryo-fetal development up to the highest dose tested (2.3 mg/kg/day), which is 2 and 4 times, respectively, the MRHD of 12 mg per day on a body surface area (mg/m2 ) basis. Risk Summary There are no data on the presence of rivastigmine in human milk, the effects on the breastfed infant, or the effects of rivastigmine on milk production. Rivastigmine and its metabolites are excreted in rat milk following oral administration of rivastigmine; levels of rivastigmine plus metabolites in rat milk are approximately 2 times that in maternal plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for rivastigmine and any potential adverse effects on the breastfed infant from rivastigmine or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. The use of rivastigmine transdermal system in pediatric patients (below 18 years of age) is not recommended. Of the total number of patients in clinical studies of rivastigmine transdermal system, 88% were 65 years and over, while 55% were 75 years. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Increased exposure to rivastigmine was observed in patients with mild or moderate hepatic impairment with oral rivastigmine. Patients with mild or moderate hepatic impairment may be able to only tolerate lower doses [see Dosage and Administration (2.2),  Clinical Pharmacology (12.3)] . No data are available on the use of rivastigmine in patients with severe hepatic impairment. Because rivastigmine blood levels vary with weight, careful titration and monitoring should be performed in patients with low or high body weights [see Dosage and Administration (2.2),  Clinical Pharmacology (12.3) ] . Rivastigmine (riv” a stig’ meen) Transdermal System You will need the following supplies (See Figure A): Rivastigmine transdermal system is supplied in cartons containing 30 patches (see Figure A) Figure A - Rivastigmine transdermal system is a thin, light pink colored, plastic patch that sticks to the skin. Each rivastigmine transdermal system is sealed in a pouch that protects it until you are ready to put it on (See Figure A). - Only 1 rivastigmine transdermal system should be worn at a time. Do not apply more than 1 rivastigmine transdermal system at a time to the body. - Do not open the pouch or remove the rivastigmine transdermal system until you are ready to apply it. Using rivastigmine transdermal system : Step 1. Choose an area to apply the rivastigmine transdermal system (See Figure B). - Instructions for Caregivers: Apply rivastigmine transdermal system to the upper or lower back if it is likely that the patient will remove it. If this is not a concern, the rivastigmine transdermal system can be applied instead to the upper arm or chest. Do not apply the rivastigmine transdermal system to areas where it can be rubbed off by tight clothing or belts. - Only apply the rivastigmine transdermal system to healthy skin that is clean, dry, hairless, and free of redness, irritation, burns or cuts. Figure B The diagram represents areas on the body where rivastigmine transdermal system may be applied. Only 1 patch should be worn at a time. Do not apply multiple patches to the body. Step 2. Remove the rivastigmine transdermal system from the pouch (See Figure C). Carefully cut the pouch along the dotted line to open and remove the rivastigmine transdermal system. Save the pouch for later use. Figure C - Do not cut or fold the rivastigmine transdermal system itself. Step 3. Remove 1 side of the adhesive liner (See Figure D). - A protective liner covers the sticky (adhesive) side of the rivastigmine transdermal system. Peel off 1 side of the protective cover. Do not touch the sticky part of the rivastigmine transdermal system with your fingers. Figure D Step 4. Apply the rivastigmine transdermal system to your skin (See Figure E). -  Apply the sticky (adhesive) side of the rivastigmine transdermal system to your chosen area of skin and then peel off the other side of the protective cover. Figure E - Press down on the rivastigmine transdermal system firmly for 30 seconds to make sure that the edges stick to your skin (See Figure F). Figure F Step 5. Wash your hands with soap and water right away. Note: - If your rivastigmine transdermal system falls off, select a new area, and repeat Steps 2 to 5 to apply a new rivastigmine transdermal system. - Be sure to replace the new rivastigmine transdermal system the next day at the same time as usual. Removing your rivastigmine transdermal system : Step 6. Remove the rivastigmine transdermal system from the skin (See Figure G). - Gently pull on 1 edge of the rivastigmine transdermal system to remove it from your skin. Figure G Throwing away the used rivastigmine transdermal system : Step 7. Throw away the used rivastigmine transdermal system (See Figure H). - Fold the used rivastigmine transdermal system in half (with the sticky sides together) and put it back into the pouch that you saved. Figure H - Throw away the used rivastigmine transdermal system safely and out of the reach of children and pets. - Some medicine stays in the patch for 24 hours after you use it and should be folded together (sticky side together) and safely thrown away. Do not try to re-use rivastigmine transdermal systems. Step 8. Wash your hands with soap and water right away. - After you remove the rivastigmine transdermal system, if any adhesive remains on your skin, you can use soap and water or an oil-based substance (such as baby oil) to remove the adhesive. Alcohol or other dissolving liquids (such as nail polish remover) should not be used. This Instructions for Use have been approved by the U.S. Food and Drug Administration. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ  08807 Rev. 12-2018-01

Bidhaa muhtasari:

Rivastigmine Transdermal System: 4.6 mg/24 hours A 5 cm2 circular patch, consisting of transparent to translucent adhesive layer on light pink colored backing film printed with “Rivastigmine 4.6 mg/24 hours” in red ink, protected by a removable, transparent, overlapping release liner with dimples surrounding the perimeter of the patch. Each patch of 5 cm2 contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. They are available as follows: Carton of 30                NDC 65162-825-34 Rivastigmine Transdermal System: 9.5 mg/24 hours A 10 cm2 circular patch, consisting of transparent to translucent adhesive layer on light pink colored backing film printed with “Rivastigmine 9.5 mg/24 hours” in red ink, protected by a removable, transparent, overlapping release liner with dimples surrounding the perimeter of the patch. Each patch of 10 cm2 contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. They are available as follows: Carton of 30                NDC 65162-826-34 Rivastigmine Transdermal System: 13.3 mg/24 hours A 15 cm2 circular patch, consisting of transparent to translucent adhesive layer on light pink colored backing film printed with “Rivastigmine 13.3 mg/24 hours” in red ink, protected by a removable, transparent, overlapping release liner with dimples surrounding the perimeter of the patch. Each patch of 15 cm2 contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30                NDC 65162-749-34 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

RIVASTIGMINE- RIVASTIGMINE PATCH
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIVASTIGMINE TRANSDERMAL SYSTEM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RIVASTIGMINE TRANSDERMAL SYSTEM.
RIVASTIGMINE TRANSDERMAL SYSTEM
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Rivastigmine transdermal system is an acetylcholinesterase inhibitor
indicated for treatment of:
Mild, moderate, and severe dementia of the Alzheimer’s type (AD).
(1.1)
Mild-to-moderate dementia associated with Parkinson’s disease (PD).
(1.2)
DOSAGE AND ADMINISTRATION
Apply patch on intact skin for a 24-hour period; replace with a new
patch every 24 hours. (2.1, 2.4)
Initial Dose: Initiate treatment with 4.6 mg/24 hours rivastigmine
transdermal system. (2.1)
Dose Titration (2.1):
After a minimum of 4 weeks, if tolerated, increase dose to 9.5 mg/24
hours, which is the minimum effective dose.
Following a minimum additional 4 weeks, may increase dosage to maximum
dosage of 13.3 mg/24 hours.
Mild to Moderate Alzheimer’s Disease and Parkinson’s Disease
Dementia: Rivastigmine transdermal system 9.5 mg/24
hours or 13.3 mg/24 hours once daily. (2.1)
Severe Alzheimer’s Disease: Rivastigmine transdermal system 13.3
mg/24 hours once daily. (2.1)
For treatment interruption longer than 3 days, retitrate dosage
starting at 4.6 mg per 24 hours. (2.1)
Consider dose adjustments in patients with (2.2):
Mild-to-moderate hepatic impairment (8.6)
Low (less than 50 kg) body weight (8.7)
DOSAGE FORMS AND STRENGTHS
Rivastigmine Transdermal System: 4.6 mg/24 hours or 9.5 mg/24 hours or
13.3 mg/24 hours (3)
CONTRAINDICATIONS
Known hypersensitivity to rivastigmine, other carbamate derivatives,
or other components of the formulation. (4)
History of application site reactions with rivastigmine transdermal
patch suggestive of allergic contact dermatitis. (4, 6.2)
WARNINGS AND PRECAUTIONS
Hospitalization and, rarely, death have been reported due to
applicati