DOXYLAMINE Drug Interactions: What You Need to Know

7.

Drug Interactions

Severe drowsiness can occur when used in combination with alcohol or other sedating medications. (7)

7.1 Drug Interactions Use of doxylamine succinate and pyridoxine hydrochloride 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 doxylamine succinate and pyridoxine hydrochloride is not recommended.

7.2 Drug-Food Interactions A food-effect study demonstrated that the delay in the onset of action of doxylamine succinate and pyridoxine hydrochloride may be further delayed, and a reduction in absorption may occur when tablets are taken with food <span class="opacity-50 text-xs">[see Dosage and Administration (2), Clinical Pharmacology (12.3)]</span> . Therefore, doxylamine succinate and pyridoxine hydrochloride should be taken on an empty stomach with a glass of water <span class="opacity-50 text-xs">[see Dosage and Administration (2)]</span>.

7.3 False Positive Urine Tests for Methadone, Opiates and PCP False positive drug screens for methadone, opiates, and PCP can occur with doxylamine succinate/pyridoxine hydrochloride use. Confirmatory tests, such as Gas Chromatography Mass Spectrometry (GC-MS), should be used to confirm the identity of the substance in the event of a positive immunoassay result.

7.1 Drug Interactions Use of doxylamine succinate and pyridoxine hydrochloride 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 doxylamine succinate and pyridoxine hydrochloride is not recommended.

7.2 Drug-Food Interactions A food-effect study demonstrated that the delay in the onset of action of doxylamine succinate and pyridoxine hydrochloride may be further delayed, and a reduction in absorption may occur when tablets are taken with food <span class="opacity-50 text-xs">[see Dosage and Administration (2), Clinical Pharmacology (12.3)]</span> . Therefore, doxylamine succinate and pyridoxine hydrochloride should be taken on an empty stomach with a glass of water <span class="opacity-50 text-xs">[see Dosage and Administration (2)]</span>.

7.3 False Positive Urine Tests for Methadone, Opiates and PCP False positive drug screens for methadone, opiates, and PCP can occur with doxylamine succinate/pyridoxine hydrochloride use. Confirmatory tests, such as Gas Chromatography Mass Spectrometry (GC-MS), should be used to confirm the identity of the substance in the event of a positive immunoassay result.

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are contraindicated in women with any of the following conditions:

• Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation
• Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets [see Drug Interactions (7.1) ] .
• Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation. ( 4 )
• Monoamine oxidase (MAO) inhibitors. ( 4 , 7 )

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 asthma, 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. Women should 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 their healthcare provider. Doxylamine succinate and pyridoxine hydrochloride 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 <span class="opacity-50 text-xs">[see Drug Interactions (7.1)]</span> .

5.2 Concomitant Medical Conditions Doxylamine succinate and pyridoxine hydrochloride has anticholinergic properties and, therefore, should be used with caution in women with: asthma, 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 <span class="opacity-50 text-xs">[see Drug Interactions (7.3)]</span>.

5.1 Activities Requiring Mental Alertness Doxylamine succinate and pyridoxine hydrochloride 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 until cleared to do so by their healthcare provider. Doxylamine succinate and pyridoxine hydrochloride 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 <span class="opacity-50 text-xs">[see Drug Interactions (7.1)]</span> .

5.2 Concomitant Medical Conditions Doxylamine succinate and pyridoxine hydrochloride has anticholinergic properties and, therefore, should be used with caution in women with: asthma, 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 <span class="opacity-50 text-xs">[see Drug Interactions (7.3)]</span>.