Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: Somnolence [see Warnings and Precautions (5.1) ] Falls or other accidents resulting from the effect of the combined use of doxylamine succinate and pyridoxine hydrochloride with CNS depressants including alcohol [see Warnings and Precautions (5.1) ] The most common adverse reaction with doxylamine succinate and pyridoxine hydrochloride (≥ 5 percent and exceeding the rate in placebo) is somnolence.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc.
at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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 doxylamine succinate and pyridoxine hydrochloride 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 weeks to 14 weeks gestation [see Clinical Studies (14) ] .
Adverse reactions for doxylamine succinate and pyridoxine hydrochloride that occurred at an incidence ≥ 5 percent and exceeded the incidence for placebo are summarized in Table
Table 1: Number (Percent) of Subjects with ≥ 5 Percent Adverse Reactions in a 15‑Day Placebo-Controlled Study of Doxylamine Succinate and Pyridoxine Hydrochloride (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence with Doxylamine Succinate and Pyridoxine Hydrochloride than Placebo are Shown) Doxylamine Succinate and Pyridoxine Hydrochloride (N = 133) Placebo (n = 128) Somnolence 19 (14.3%) 15 (11.7%) 6.2 Postmarketing Experience 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 .
Cardiac disorders : dyspnea, palpitation, tachycardia 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 Nervous system disorders : dizziness, headache, migraines, paresthesia, psychomotor hyperactivity Psychiatric disorders : anxiety, disorientation, insomnia, nightmares Renal and urinary disorders : dysuria, urinary retention Skin and subcutaneous tissue disorders : hyperhidrosis, pruritus, rash, rash maculo-papular
5 WARNINGS AND PRECAUTIONS Activities requiring mental alertness: Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using doxylamine succinate and pyridoxine hydrochloride until cleared to do so by a healthcare provider.
( 5.1 ) Central nervous system (CNS) depressants: Concurrent use with alcohol or other CNS depressants is not recommended.
( 5.1 ) Anticholinergic actions: Use with caution in patients with increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction.
( 5.2 ) Interference with urine drug screen: Doxylamine succinate and pyridoxine hydrochloride may interfere with urine screening for methadone, opiates and PCP.
( 5.3 ) 5.1 Activities Requiring Mental Alertness Doxylamine succinate and pyridoxine hydrochloride may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine.
Like all medications, Doxylamine Succinate And Pyridoxine Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: