Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
Clinical Trials Experience
The safety of GELNIQUE was evaluated in 789 patients (389 randomized to GELNIQUE 1 g and 400 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12week clinical efficacy and safety study. A subset of these 789 patients (N=216) participated in the 14-week open-label safety extension that followed the placebo-controlled study. Of 216 patients in the safety extension, 107 were randomized to placebo gel during the double-blind, placebo-controlled 12-week study. In the combined double-blind, placebo-controlled study and the open-label safety extension, a total of 496 patients were exposed to at least one dose of GELNIQUE. Four hundred thirty-one (431) patients received at least 12 weeks of GELNIQUE treatment and 85 patients received 26 weeks of GELNIQUE treatment. The study population primarily consisted of Caucasian women (approximately 90%) with an average age of 59 years who had overactive bladder with urge urinary incontinence.
Table 1 lists adverse reactions that were reported in the randomized, double-blind, placebo-controlled 12-week study in greater than 2% of patients treated with GELNIQUE and at an incidence greater than placebo.
Table 1: Common Adverse Reactions in the Randomized,
Double-blind, Placebo-controlled 12-Week Study ( > 2% and > placebo)
|Adverse Reaction||GELNIQUE 1 gram
|Dry mouth||29 (7.5)||11 (2.8)|
|Urinary tract infection||27 (6.9)||17 (4.3)|
|Application site reactions*||21 (5.4)||4 (1.0)|
|Upper respiratory tract infection||21 (5.4)||20 (5.0)|
|Dizziness||11 (2.8)||4 (1.0)|
|Nasopharyngitis||11 (2.8)||9 (2.3)|
|Fatigue||8 (2.1)||4 (1.0)|
|Gastroenteritis viral||8 (2.1)||7 (1.8)|
|* Includes application site pruritus, dermatitis, papules, anesthesia, erythema, irritation, pain and papules|
Other common adverse reactions that were reported in ≥ 1% of GELNIQUE-treated patients were headache (1.5%), constipation (1.3%), and pruritus (1.3%). Application site pruritus (2.1%) and application site dermatitis (1.8%) were the most commonly reported application site reactions. A majority of adverse reactions were described as mild or moderate in intensity, except for two patients reporting severe headache.
The most common adverse reaction leading to drug discontinuation was application site reaction (0.8% with GELNIQUE versus 0.3% with placebo).
The most common adverse reactions reported during the 14-week open-label extension study were application site reactions (6.0%) and dry mouth (1.9%). The most common reason for premature discontinuation was application site reactions (9 patients or 4.2%). Two of these 9 patients experienced application site reactions of severe intensity (dermatitis, urticaria, and erythema).
The following adverse reactions have been identified during post approval use of GELNIQUE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous System Disorders: dizziness, somnolence, confusion Psychiatric Disorders: hallucinations
Read the Gelnique (oxybutynin chloride 10 % gel) Side Effects Center for a complete guide to possible side effects
No specific drug-drug interaction studies have been performed with GELNIQUE.
The concomitant use of GELNIQUE with other anticholinergic (antimuscarinic) agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, somnolence and other anticholinergic pharmacological effects.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/29/2015
Additional Gelnique Information
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