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:

Jubilant Cadista Pharmaceuticals Inc.

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 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 hydr

Product summary:

Clonidine hydrochloride extended-release tablets are white to off-white, round tablets, debossed with “NЧ” on one side and “C” on other side. They are supplied as follows: Bottles of 30’s (Child Resistant)                                              NDC 59746-668-30 Bottles of 60’s (Child Resistant)                                              NDC 59746-668-60 Bottles of 100’s (Child Resistant)                                            NDC 59746-668-01  Bottles of 1000’s (Non Child Resistant)                                  NDC 59746-668-10 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].   Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Jubilant Cadista Pharmaceuticals Inc.
----------
PATIENT INFORMATION
Clonidine Hydrochloride Extended-Release Tablets
(KLOE ni deen)
Read the Patient Information that comes with clonidine hydrochloride
extended-release tablets before you
start taking it and each time you get a refill. There may be new
information. This Patient Information
leaflet does not take the place of talking to your doctor about your
medical condition or treatment.
What are clonidine hydrochloride extended-release tablets?
Clonidine hydrochloride extended-release tablets are prescription
medicine used for the treatment of
Attention-Deficit Hyperactivity Disorder (ADHD). Your doctor may
prescribe clonidine hydrochloride
extended-release tablets alone or together with certain other ADHD
medicines.
•
Clonidine hydrochloride extended-release tablets are not central
nervous system (CNS) stimulant.
•
Clonidine hydrochloride extended-release tablets should be used as
part of a total treatment
program for ADHD that may include counseling or other therapies.
Who should not take clonidine hydrochloride extended-release tablets?
•
Do not take clonidine hydrochloride extended-release tablets if you
are allergic to clonidine in
clonidine hydrochloride extended-release tablets. See the end of this
leaflet for a complete list of
ingredients in clonidine hydrochloride extended-release tablets.
What should I tell my doctor before taking clonidine hydrochloride
extended-release tablets?
Before you take clonidine hydrochloride extended-release tablets, tell
your doctor if you:
•
have kidney problems
•
have low or high blood pressure
•
have a history of passing out (syncope)
•
have heart problems, including history of heart attack
•
have had a stroke or have stroke symptoms
•
had a skin reaction (such as a rash) after taking clonidine in a
transdermal form (skin patch)
•
have any other medical conditions
•
are pregnant or plan to become pregnant. It is not known if

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
JUBILANT CADISTA PHARMACEUTICALS 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 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) (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) (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) (2)
Do not substitute for other clonidine products on a mg-per-mg basis,
because of differing pharmacokinetic profiles. (2.1)
(2)
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) (2)
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 disease or chroni