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Kapvay 0.1mg Tab 60 by Concordia Pharma

NDC 59630-0658-60 UPC/GTIN No.3-59630-65860-1 Mfg.Part No.65860Concordia Pharmaceuticals IncThis Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).Concordia Pharmaceuticals IncImage 4 of Kapvay 0.1mg Tab 60 by Concordia Pharma

Kapvay 0.1mg Tab 60 by Concordia Pharma

$315.00$289.49

NDC No. 59630-0658-60 UPC/GTIN No. 3-59630-65860-1 MPN 65860 Only Physician,Pharmacy or Licensed Facility can order this Rx Item No. Rx060509 Kapvay 0.1mg Tab 60 by Concordia Pharma Item No. 3060509 NDC No. 59630065860 UPC No. 359630658601 Other Name Kapvay, clonidine hydrochloride tablet Therapeutic Code 240816 Therapeutic Class Central Alpha-Agonists Item Class Non Controlled Rx. Case Qnty: 48 Therapeutic Code 240816 Central Alpha-Agonists Info Adrenergic Alpha2-Agonists [Moa],Central Alpha-2

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KAPVAY- clonidine hydrochloride tablet, extended release
Concordia Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

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)].

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information


KAPVAY is an extended-release tablet to be taken orally with or without food. Swallow tablets whole. Do not crush, chew, or break tablets because this will increase the rate of clonidine release.

Due to the lack of controlled clinical trial data and differing pharmacokinetic profiles, substitution of KAPVAY for other clonidine products on a mg-per-mg basis is not recommended [see Clinical Pharmacology (12.3)].

2.2 Dose Selection
The dose of KAPVAY, administered either as monotherapy or as adjunctive therapy to a psychostimulant, should be individualized according to the therapeutic needs and response of the patient. Dosing should be initiated with one 0.1 mg tablet at bedtime, and the daily dosage should be adjusted in increments of 0.1 mg/day at weekly intervals until the desired response is achieved. Doses should be taken twice a day, with either an equal or higher split dosage being given at bedtime (see Table 1).

Table 1 KAPVAY Dosing Guidance
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
Doses of KAPVAY higher than 0.4 mg/day (0.2 mg twice daily) were not evaluated in clinical trials for ADHD and are not recommended.

When KAPVAY is being added-on to a psychostimulant, the dose of the psychostimulant can be adjusted depending on the patient's response to KAPVAY.

2.3 Discontinuation
When discontinuing KAPVAY, the total daily dose should be tapered in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension [see Warnings and Precautions (5.3)].

2.4 Missed Doses
If patients miss a dose of KAPVAY, they should skip that dose and take the next dose as scheduled. Do not take more than the prescribed total daily amount of KAPVAY in any 24-hour period.

3 DOSAGE FORM S AND STRENGTHS

KAPVAY tablets are available in two strengths, 0.1 mg and 0.2 mg as an extended-release formulation. Both the 0.1 mg and 0.2 mg tablets are white, non-scored, standard convex with debossing on one side. The 0.1 mg tablets are round and the 0.2 mg tablets are oval. KAPVAY tablets must be swallowed whole and never crushed, cut or chewed.

NDC 59630-0658-60 UPC/GTIN No.3-59630-65860-1 Mfg.Part No.65860
Kapvay 0.1mg Tab 60 by Concordia Pharma
NDC 59630-0658-60 UPC/GTIN No.3-59630-65860-1 Mfg.Part No.65860

Concordia Pharmaceuticals Inc

Concordia Pharmaceuticals Inc

This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).
CLONIDINE HCL ORAL TAB ER
This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).