TACROLIMUS capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

TACROLIMUS (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J)

Доступна з:

Cardinal Health 107, LLC

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)], liver transplants [see Clinical Studies (14.2)], heart transplant [see Clinical Studies (14.3)], or lung transplant [see Clinical Studies (14.4)] in combination with other immunosuppressants. Additional pediatric use information is approved for Astellas Pharma US, Inc.'s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. Tacrolimus injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see Adverse Reactions (6)] . Pregnancy Exposure Registry There is a pregnancy registry that monitors p

Огляд продуктів:

Strength 1 mg (containing the  equivalent of 1 mg  anhydrous tacrolimus) Shape/Colour Oblong/opaque green Imprint on capsule cap  and body "SAL" on the cap and "721" on the body Carton of 100 Capsules (10 capsules per blister card x 10) NDC 0904-7097-61 Note: Tacrolimus capsules, USP are not filled to maximum capsule capacity. Capsule contains labeled amount. Store and Dispense Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Tacrolimus can cause fetal harm. Tacrolimus capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Tacrolimus capsules. If such contact occurs, wash the skin thoroughly with soap and water; if ocular contact occurs, rinse eyes with water. In case a spill occurs, wipe the surface with a wet paper towel. Follow applicable special handling and disposal procedures1 .

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

TACROLIMUS- TACROLIMUS CAPSULE
CARDINAL HEALTH 107, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TACROLIMUS CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TACROLIMUS CAPSULES.
TACROLIMUS CAPSULES, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1994
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK FOR DEVELOPING SERIOUS INFECTIONS AND MALIGNANCIES WITH
TACROLIMUS
CAPSULES OR OTHER IMMUNOSUPPRESSANTS THAT MAY LEAD TO HOSPITALIZATION
OR DEATH. (5.1,
5.2)
RECENT MAJOR CHANGES
Indications and Usage (1.1) 7/2021
Dosage and Administration (2.2, 2.3) 7/2021
Warnings and Precautions (5.11) 12/2020
INDICATIONS AND USAGE
Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant
indicated for the prophylaxis of organ
rejection in adult patients receiving allogeneic liver, kidney, heart
or lung transplants, and pediatric
patients receiving allogeneic liver transplants in combination with
other immunosuppressants. (1.1) (1)
DOSAGE AND ADMINISTRATION
ADULT
(2)
Patient Population
(2)
Initial Oral Dosage (formulation)
(2)
Whole Blood Trough Concentration
Range
(2)
Kidney Transplant
(2)
With azathioprine
(2)
0.2 mg/kg/day capsules, divided in
two doses, every 12 hours
(2)
Month 1-3: 7-20 ng/mL
Month 4-12: 5-15 ng/mL
(2)
With MMF/IL-2 receptor
antagonist
(2)
0.1 mg/kg/day capsules, divided in
two doses, every 12 hours
(2)
Month 1-12: 4-11 ng/mL
(2)
Liver Transplant
(2)
With
corticosteroids only
(2)
0.1-0.15 mg/kg/day capsules, divided
in two doses, every 12 hours
(2)
Month 1-12: 5-20 ng/mL
(2)
Heart Transplant
(2)
With azathioprine or
MMF
(2)
0.075 mg/kg/day capsules, divided in
two doses, every
12 hours
(2)
Month 1-3: 10-20 ng/mL
Month ≥ 4: 5-15 ng/mL
(2)
Lung Tranplant
(2)
With azathioprine or MMF
(2)
0.075 mg/kg/day capsules, divided in
two doses, every 12 hours
(2)
Month 1-3: 10-15 ng/mL
Month 4-12: 8-12 ng/mL
(2)
PEDIATRIC
1
MMF = Mycophenolate mofetil
1. Patie