"The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.
Diclegis is a delayed-release tablet intended for women who have"...
The following adverse reactions are discussed elsewhere in the labeling:
- Somnolence [see WARNINGS AND PRECAUTIONS]
- Falls or other accidents resulting from the effect of the combined use of DICLEGIS with CNS depressants including alcohol [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
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 trials of another drug and may not reflect the rates observed in clinical practice.
The safety and efficacy of DICLEGIS were compared to placebo in a double-blind, randomized, multi-center trial in 261 women with nausea and vomiting of pregnancy. The mean gestational age at enrollment was 9.3 weeks, range 7 to 14 weeks gestation [see Clinical Studies]. Adverse reactions for DICLEGIS that occurred at an incidence ≥ 5 percent and exceeded the incidence for placebo are summarized in Table 1.
Table 1: Number (Percent) of Subjects with ≥ 5
Percent Adverse Reactions in a 15-Day Placebo- Controlled Study of DICLEGIS
(Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and
at a Higher Incidence with DIGLEGIS than Placebo are Shown)
(N = 133)
(n = 128)
|Somnolence||19 (14.3%)||15 (11.7%)|
The following adverse events, listed alphabetically, have been identified during post-approval use of the combination of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. 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.
Ear and labyrinth disorders: vertigo
Eye disorders: vision blurred, visual disturbances
Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, diarrhea
General disorders and administration site conditions: chest discomfort, fatigue, irritability, malaise
Immune system disorders: hypersensitivity
Psychiatric disorders: anxiety, disorientation, insomnia, nightmares
Renal and urinary disorders: dysuria, urinary retention
Read the Diclegis (doxylamine succinate and pyridoxine hydrochloride delayed-release tablets) Side Effects Center for a complete guide to possible side effects
Use of DICLEGIS is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with DICLEGIS is not recommended.
A food-effect study demonstrated that the delay in the onset of action of DICLEGIS may be further delayed, and a reduction in absorption may occur when tablets are taken with food [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Therefore, DICLEGIS should be taken on an empty stomach with a glass of water [see DOSAGE AND ADMINISTRATION].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/11/2013
Additional Diclegis Information
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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