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Postmarketing Experience


DICLEGIS® (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use.


BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION. PLEASE SEE FULL PRESCRIBING INFORMATION.


INDICATIONS AND USAGE DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.


Limitations of Use DICLEGIS has not been studied in women with hyperemesis gravidarum.


DOSAGE AND ADMINISTRATION Initially, take two DICLEGIS delayed-release tablets orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking two tablets daily at bedtime. However, if symptoms persist into the afternoon of Day 2, take the usual dose of two tablets at bedtime that night then take three tablets starting on Day 3 (one tablet in the morning and two tablets at bedtime). If these three tablets adequately control symptoms on Day 4, continue taking three tablets daily. Otherwise take four tablets starting on Day 4 (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime).


The maximum recommended dose is four tablets (one in the morning, one in the mid-afternoon and two at bedtime) daily.


Take on an empty stomach with a glass of water. Swallow tablets whole. Do not crush, chew, or split DICLEGIS tablets.


Take as a daily prescription and not on an as needed basis. Reassess the woman for continued need for DICLEGIS as her pregnancy progresses.


DOSAGE FORMS AND STRENGTHS


Delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride.


CONTRAINDICATIONS DICLEGIS is contraindicated in women with any of the following conditions:


antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation


(see Drug Interactions).


WARNINGS AND PRECAUTIONS Activities Requiring Mental Alertness DICLEGIS 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 DICLEGIS until cleared to do so by their healthcare provider.


DICLEGIS 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).


Concomitant Medical Conditions DICLEGIS 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.


Drug Interactions Use of DICLEGIS is contraindicated in women who are taking monoamine oxidase


of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with DICLEGIS is not recommended.


Drug-Food Interactions


may be further delayed and a reduction in absorption may occur when tablets are taken with food. Therefore, DICLEGIS should be taken on an empty stomach with a glass of water (see Dosage and Administration).


ADVERSE REACTIONS


The following adverse reactions are discussed elsewhere in labelling: (see Warnings and Precautions)


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


clinical practice. Somnolence and Severe Drowsiness


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)


Inform women to avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using DICLEGIS until cleared to do so.


Inform women of the importance of not taking DICLEGIS with alcohol or sedating medications, including other antihistamines (present in some cough and cold medications), opiates and sleep aids because somnolence could worsen leading to falls or other accidents.


than Placebo are shown)


DICLEGIS (N = 133)


Somnolence 19 (14.3%)


or medicalinfo@duchesnayusa.com medwatch.


www.fda.gov/


Placebo (n = 128)


Storage and Handling and protect from moisture. Do not remove desiccant canister from bottle.


Distributed by: Duchesnay USA, Inc. Bryn Mawr, PA, 19010 www.Diclegis.com ©2013, Duchesnay Inc. All rights reserved.


hydrochloride with or without dicyclomine hydrochloride. Nursing Mothers


Women should not breastfeed while using DICLEGIS.


The molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected. Excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to


conditions.


Pyridoxine hydrochloride is excreted into breast milk. There have been no reports of adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk.


Pediatric Use been established.


cases have been characterized by coma, grand mal seizures and cardiorespiratory


died 18 hours after ingesting 1,000 mg doxylamine succinate. However, there is no correlation between the amount of doxylamine ingested, the doxylamine plasma level and clinical symptomatology.


OVERDOSAGE Signs and Symptoms of Overdose DICLEGIS is a delayed-release formulation, therefore, signs and symptoms of intoxication may not be apparent immediately.


Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia.


rhabdomyolysis, acute renal failure and death. Management of Overdose


If treatment is needed, it consists of gastric lavage or activated charcoal, whole overdose treatment, call a poison control center (1-800-222-1222).


PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information)


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


USE IN SPECIFIC POPULATIONS


Pregnancy Pregnancy Category A DICLEGIS is intended for use in pregnant women.


The combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many epidemiological studies (cohort, case control and meta-analyses)


11 case-control studies published between 1963 and 1991 reported no increased


2013-0002-01 Apr 2013


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