CLONIDINE HYDROCHLORIDE- clonidine hydrochloride tablet, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02)

Sẵn có từ:

Bluepharma - Industria Farmaceutica, S.A.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)] . Clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, and angioedema [see Adverse Reactions (6)] . 8.1 Pregnancy Pregnancy Category C: Risk Summary There are no adequate or well-controlled studies with clonidine hydrochloride in pregnant women. In animal embryofetal studies, increased resorptions were seen in rats and mice administered oral clonidine hydrochloride from implantation through organogenesis at 10 and 5 times, respectively, the maximum recommended human dose (MRHD). No embryotoxic or teratogenic effects were seen in rabbits administered oral clonidine hydrochloride during organogenesis at doses up to 3 times the MRHD. Clonidine hydrochl

Tóm tắt sản phẩm:

Clonidine hydrochloride extended-release tablet 0.1 mg is a white to off-white round, biconvex tablets with debossing: “U” on one side and “77” on the other side and supplied as follows. Bottles of 60 tablets with child-resistant closure, NDC 0832-0777-60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Keep clonidine hydrochloride extended-release tablets and all medicines out of the reach of children.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLONIDINE HYDROCHLORIDE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLONIDINE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
(1)
(1)
(1)
Clonidine hydrochloride is a centrally acting alpha2-adrenergic
agonist indicated for the treatment of attention deficit
hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy
to stimulant medications. (1) (1)
DOSAGE AND ADMINISTRATION
Start with one 0.1 mg tablet at bedtime for one week. Increase daily
dosage in increments of 0.1 mg/day at weekly
intervals until the desired response is achieved. Take twice a day,
with either an equal or higher split dosage being
given at bedtime, as depicted below (2.2)
TOTAL DAILY DOSE (2)MORNING DOSE (2)BEDTIME DOSE (2)
0.1 mg/day (2)
(2)
0.1 mg (2)
0.2 mg/day (2)
0.1 mg (2)
0.1 mg (2)
0.3 mg/day (2)
0.1 mg (2)
0.2 mg (2)
0.4 mg/day (2)
0.2 mg (2)
0.2 mg (2)
Do not crush, chew or break tablet before swallowing. (2.1)
Do not substitute for other clonidine products on a mg-per-mg basis,
because of differing pharmacokinetic profiles. (2.1)
When discontinuing, taper the dose in decrements of no more than 0.1
mg every 3 to 7 days to avoid rebound
hypertension. (2.3)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 0.1 mg not scored. (3) (3)
CONTRAINDICATIONS
History of a hypersensitivity reaction to clonidine. Reactions have
included generalized rash, urticaria, angioedema. (4) (4)
WARNINGS AND PRECAUTIONS
Hypotension/bradycardia/syncope: Titrate slowly and monitor vital
signs frequently in patients at risk for hypotension,
heart block, bradycardia, syncope, cardiovascular disease, vascular
disease, cerebrovascular dis