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warnings and cautions
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 delayed-release tablets 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 delayed-release tablets may interfere with urine screening for methadone, opiates and PCP ( 5.3 ) 5.1 Activities Requiring Mental Alertness Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using doxylamine succinate and pyridoxine hydrochloride delayed-release tablets until cleared to do so by their healthcare provider. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets use is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol. The combination may result in severe drowsiness leading to falls or accidents [ see Drug Interactions (7.1) ] . 5.2 Concomitant Medical Conditions Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have anticholinergic properties and, therefore, should be used with caution in women with: increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction. 5.3 Interference with Urine Screen for Methadone, Opiates and Phencyclidine Phosphate (PCP) There have been reports of false positive urine screening tests for methadone, opiates, and PCP with doxylamine succinate/pyridoxine hydrochloride use [see Drug Interactions (7.3)].
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 delayed-release tablets with CNS depressants including alcohol [ see Warnings and Precautions (5.1) ] The most common adverse reaction with doxylamine succinate and pyridoxine hydrochloride delayed-release tablets (≥5 percent and exceeding the rate in placebo) is somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Analog Pharma Inc. at 1-844-884-5505 or medicalinfo@analogpharma.com 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 delayed-release tablets 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 (14) ] . Adverse reactions for doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence with Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets than Placebo are Shown) Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets (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