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Jenloga

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Jenloga

Jenloga Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Jenloga (clonidine hydrochloride) extended release is a central alpha agonist used for hypertension. It is also approved for the treatment of attention deficit hyperactivity disorder (ADHD). It is available in generic form. Common side effects include dry mouth, dizziness, drowsiness, or constipation.

The recommended dose of Jenloga is 1 tablet, twice daily, or as directed by your doctor. Jenloga may interact with alcohol and antidepressants, narcotic pain relievers, barbiturates, and sedatives such as alprazolam (Xanax) and clonazepam (Klonopin). Tell your doctor all medications you take. If you are pregnant, only take Jenloga if the potential benefit outweighs the potential risk to the fetus. Jenloga is excreted into breast milk. Breastfeeding is not recommended while using this drug.

Our Jenloga (clonidine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Jenloga FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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
(N=12)
0.4 mg per day
(N=15)
0.6 mg per day
(N=15)
Total
(N=42)
N % N % N % N %
At least one AR reported 5 42 10 67 12 80 27 64
Dry Mouth 0 0 8 53 8 53 16 38
Fatigue 2 17 4 27 4 27 10 24
Dizziness 0 0 3 20 2 13 5 12
Headache 1 8 1 7 2 13 4 10
Nausea 1 8 1 7 1 7 3 7
Somnolence 0 0 1 7 1 7 2 5
Insomnia 0 0 0 0 2 13 2 5

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.

Dermatoloaical: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.

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.

Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention.

Hematoloaic: Thrombocytopenia.

Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain.

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 entire FDA prescribing information for Jenloga (Clonidine Tablets) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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