CLONIDINE HYDROCHLORIDE- clonidine hydrochloride tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

REMEDYREPACK INC.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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)]. Pregnancy Category C: Risk Summary There are no adequate or well-controlled studies with clonidine hydrochloride extended-release tablets 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. Clonidi

Produkt oppsummering:

Clonidine hydrochloride extended-release tablets are white to off white round shaped biconvex tablets, debossed with 'LU' on one side and 'Z55' on other side. NDC 68180-606-06 – 0.1 mg round tablets supplied in bottles containing 30 tablets. NDC 68180-606-07 – 0.1 mg round tablets supplied in bottles containing 60 tablets. NDC 68180-606-09 – 0.1 mg round tablets supplied in bottles containing 90 tablets. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight container.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
REMEDYREPACK INC.
----------
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
Clonidine hydrochloride extended-release tablets are a centrally
acting alpha
-adrenergic agonist indicated for the
treatment of attention deficit hyperactivity disorder (ADHD) as
monotherapy or as adjunctive therapy to stimulant
medications. ( 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
MORNING DOSE
BEDTIME DOSE
0.1 mg/day
0.1 mg
0.2 mg/day
0.1 mg
0.1 mg
0.3 mg/day
0.1 mg
0.2 mg
0.4 mg/day
0.2 mg
0.2 mg
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)
CONTRAINDICATIONS
History of a hypersensitivity reaction to clonidine. Reactions have
included generalized rash, urticaria, angioedema.( 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 disease or chronic renal
failure. Measure heart rate and blood pressure prior to initiation of
therapy, following