"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
NOTE: This extended-release formulation of clonidine hydrochloride is also approved for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications under the trade name KAPVAY.
DOSAGE AND ADMINISTRATION
Jenloga (clonidine tablets) is an extended-release tablet formulation of clonidine hydrochloride. While it is dosed twice a day, the same as the immediate-release clonidine formulation, it is not to be used interchangeably with the immediate-release formulation. Substitution may necessitate further dose adjustment based upon tolerability or blood pressure response.
Jenloga (clonidine tablets) tablets must be swallowed whole and never crushed, cut or chewed.
Adjust the dose of Jenloga (clonidine tablets) according to the patient's individual blood pressure response. Initiate treatment with one 0.1 mg tablet at bedtime. Increase the dose in increments of 0.1 mg per day at weekly intervals, if necessary, until the desired response is achieved. Total daily doses above 0.1 mg per day should be divided and taken at morning and bedtime. For example, a daily dose of 0.2 mg should be taken as 0.1 mg in the morning and 0.1 mg at bedtime or a daily dose of 0.4 mg taken as 0.2 mg in the morning and 0.2 mg at bedtime. If morning and bedtime doses are not equal, the bedtime dose should be the larger of the two.
Jenloga (clonidine tablets) was studied at doses of 0.2 to 0.6 mg per day, with little or no therapeutic benefit seen for the 0.6 mg dose over the 0.4 mg dose [see Clinical Studies]. Doses of Jenloga (clonidine tablets) higher than 0.6 mg per day (0.3 mg twice daily) were not evaluated in clinical trials and are not recommended.
Dosing in Renal Impairment
Start at 0.1 mg per day and uptitrate slowly. Monitor patients carefully to prevent excessive blood pressure lowering or bradycardia. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental Jenloga (clonidine tablets) following dialysis.
Dosage Forms And Strengths
Jenloga (clonidine tablets) is available as 0.1 mg tablets (white, round, standard convex with "651" debossed on one side), or 0.2 mg tablets (white, oval, standard convex with "652" debossed on one side). Jenloga (clonidine tablets) tablets must be swallowed whole and never crushed, cut or chewed.
Jenloga (clonidine tablets) 0.1 mg tablets are white, round, standard convex with "651" debossed on one side, supplied as:
- bottles containing 60 (NDC 59630-651 -60)
- bottles containing 180 tablets (NDC 59630-651-18).
Jenloga (clonidine tablets) 0.2 mg tablets are white, oval, standard convex with "652" debossed on one side, supplied as:
- bottles containing 60 (NDC 59630-652-60)
- bottles containing 180 tablets (NDC 59630-652-18).
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
Manufactured by: Patheon Inc. 2100 Syntex Court, Mississauga, Ontario, Canada L5N 7K9. Revised: 09/2010This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/25/2010
Additional Jenloga Information
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