KAPVAY- 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:

Concordia Pharmaceuticals Inc.

INN (International Name):

CLONIDINE HYDROCHLORIDE

Composition:

CLONIDINE HYDROCHLORIDE 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KAPVAY® (clonidine hydrochloride) extended-release is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)] . KAPVAY is 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 KAPVAY, 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 controlled trials, a retrospective cohort study and case reports, have not iden

Product summary:

KAPVAY extended-release tablets are round, white, non-scored, standard convex with debossing "651" on one side. NDC 59212-658-60 and NDC 59212-658-13 - 0.1 mg tablets supplied in a carton containing one bottle of 60 tablets. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

New Drug Application

Summary of Product characteristics

KAPVAY - CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE
CONCORDIA PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KAPVAY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KAPVAY.
KAPVAY® (CLONIDINE HYDROCHLORIDE) EXTENDED-RELEASE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
KAPVAY is 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 dose increases, and periodically
while on therapy. Avoid concomitant use
of drugs with additive effects unless clinically indi