CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE- clonidine hydrochloride tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

CLONIDINE HYDROCHLORIDE

Composition:

CLONIDINE HYDROCHLORIDE 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including clonidine hydrochloride extended-release tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. Risk Summary Prolonged experience with clonidine in p

Product summary:

Clonidine hydrochloride extended-release tablets are available as following: Bottles of 60…..NDC 60429-431-60 Store at 20°to 25°C (68°to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE- CLONIDINE
HYDROCHLORIDE TABLET, EXTENDED RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. 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 and 0.2 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 r