"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)./"...
The following serious adverse reactions are discussed in detail elsewhere in the labeling:
Jenloga (clonidine tablets) Clinical Trials Experience
Table 1 displays the most common treatment-emergent adverse reactions (ARs) reported by more than one patient in the mild to moderate hypertension study. The incidence of ARs progressively increased with increasing doses and was notably less in the 0.2 mg per day treatment group compared with the 0.4 mg per day and 0.6 mg per day treatments groups. The majority of ARs were mild. ARs of moderate severity occurred in 6 patients and included two reports each of insomnia and dry mouth. One patient (0.4 mg per day group) experienced symptomatic sinus bradycardia two weeks after initiating study drug. This event was the only severe AR, the only serious AR, and the only AR that led to discontinuation of study drug. Because the number of subjects is small and the duration of exposure short, no inferences regarding differences in adverse events between Jenloga (clonidine tablets) and other clonidine formulations is warranted.
Table 1: Incidence of Treatment-Emergent Adverse Reactions
by Dosing Group Reported by at least Two Patients in the Safety Population
|Adverse Reaction||Treatment Group|
| 0.2 mg per day
| 0.4 mg per day
| 0.6 mg per day
|At least one AR reported||5||42||10||67||12||80||27||64|
Experience with Immediate-Release Clonidine
Most adverse reactions are mild and tend to diminish with continued therapy. The most frequent (which also appear to be dose-related) are dry mouth (approximately 40%),; drowsiness (approximately 33%),; dizziness (approximately 16%),; constipation and sedation (approximately 10% each).
The following less frequent adverse reactions have also been reported in patients receiving immediate-release clonidine, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.
Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs' test and increased sensitivity to alcohol.
Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud's phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis.
Central Nervous System (CMS): Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares.
Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting.
Musculoskeletal: Leg cramps and muscle or joint pain.
Oro-otolarvngeal: Dryness of the nasal mucosa.
Qphthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes.
Read the Jenloga (clonidine tablets) Side Effects Center for a complete guide to possible side effects
No drug interaction studies have been conducted with Jenloga (clonidine tablets) . The following have been reported with other oral formulations of clonidine.
Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates, or other sedating drugs.
In patients taking clonidine and a tricyclic antidepressant concomitantly, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose.
Drugs Known to Affect Sinus Node Function or AV Nodal Conduction
Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.This 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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