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:

Par Pharmaceutical, 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 pregnant women over several decades, based on published literature, including control

Product summary:

Clonidine hydrochloride extended-release tablets are available as following: Bottles of 60…..NDC 10370-257-02 Bottles of 180…..NDC 10370-257-13 Bottles of 500…..NDC 10370-257-05 Bottles of 60…..NDC 10370-302-02 Bottles of 180…..NDC 10370-302-13 Bottles of 500…..NDC 10370-302-05 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
PAR PHARMACEUTICAL, INC.
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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 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 renal failure. Measure heart rate
and blood pressure prior to
initi