DICLEGIS doxylamine succinate and pyridoxine hydrochloride 10 mg; 10 mg Tablet, Delayed Release, 100-count
Other active recalls for Doxylamine Succinate And Pyridoxine Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antihistamine class.
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🏭 Manufacturer & labeler
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🩺 Clinical
The combination of doxylamine and pyridoxine is used to treat nausea and vomiting in pregnant women . Doxylamine is in a class of medications called antihistamines. It works by blocking the action of certain natural substances in the body that may contribute to nausea and vomiting. Pyridoxine (vitamin B6) is a vitamin. A lack of pyridoxine in the body may also be a factor in causing nausea and vomiting during pregnancy.
Read the full MedlinePlus article ↗- Yes — this is the only FDA-approved oral medication specifically indicated for nausea and vomiting of pregnancy. Multiple large studies, including meta-analyses covering tens of th...
- Is this medication actually safe to take during pregnancy?
- Food can significantly reduce how much of the pyridoxine (vitamin B6) component your body actually absorbs — in some studies by around 50%. It also delays when the medication start...
- Why do I have to take it on an empty stomach?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
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A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
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Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
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Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
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A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII C2E1CI501T
Magnesium trisilicate is a mineral compound that acts as an antacid and absorbent in medicines. It helps neutralize stomach acid and can absorb moisture and gases, making it useful in tablets and powders.
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A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
25 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.671 | $167.14 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $2.28 | $227.88 / 100 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Doxylamine succinate and pyridoxine hydrochloride 10 mg/1; 10 mg 00591-2132-01 | Actavis | 100 tablets | $1.145 | AB | Availability likely | save 31% |
| Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mg 49884-0186-01 | Par | 100 tablets | $1.145 | AB | Availability likely | save 31% |
| Doxylamine succinate and Pyridoxine hydrochloride 10 mg/1; 10 mg 69452-0206-20 | Bionpharma | 100 tablets | $1.145 | AB | Availability likely | save 31% |
| Doxylamine succinate and pyridoxine hydrochloride 10 mg/1; 10 mg 70505-0100-10 | Analog | 100 tablets | $1.145 | AB | Availability likely | save 31% |
| Diclegis 10 mg/1; 10 mgthis 55494-0100-10 | Duchesnay | 100 tablets | $1.671 | AB | Availability likely | — |
| Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mg 63629-2184-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mg 72162-1485-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 55494-0100-10 You're viewing this | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) | $1.67 / ea | $167.14 | 2013-05-15 | Active |
| 55494-0100-99 | 12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99) | — | — | 2014-03-28 | Active |
You're viewing the largest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 55494-0100-10?
What is the difference between NDC 55494-0100-10 and NDC 55494-0100-99?
What NDC number is used to bill for this package of DICLEGIS doxylamine succinate and pyridoxine hydrochloride 10 mg; 10 mg Tablet, Delayed Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 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. DICLEGIS is a fixed dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Take two tablets daily at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime) as described in the full prescribing information. ( 2 )
2.1Dosage Information 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 [ see Clinical Pharmacology (12.3) ]. 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 ▾
3 DOSAGE FORMS AND STRENGTHS DICLEGIS delayed-release tablets are white, round, film coated tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. The tablets are imprinted with the pink image of a pregnant woman on one side. Delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS DICLEGIS is 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 DICLEGIS [ 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 )
⚠️ 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 DICLEGIS 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: DICLEGIS may interfere with urine screening for methadone, opiates and PCP ( 5.3 )
5.1Activities 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 (7.1) ] .
5.2Concomitant Medical Conditions DICLEGIS has 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.
5.3Interference 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 )].
🤒 Adverse Reactions ▾
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 DICLEGIS with CNS depressants including alcohol [see Warnings and Precautions ( 5.1 ) ] The most common adverse reaction with DICLEGIS (≥5 percent and exceeding the rate in placebo) is somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Duchesnay Inc. at 1-855-722-7734 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 (14) ] .
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 DICLEGIS than Placebo are Shown) Diclegis (N = 133) Placebo (n = 128) Somnolence 19 (14.3%) 15 (11.7%)
6.2Postmarketing 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
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Severe drowsiness can occur when used in combination with alcohol or other sedating medications. ( 7 )
7.1Drug Interactions 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.
7.2Drug-Food Interactions 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 (2) , Clinical Pharmacology (12.3) ] . Therefore, DICLEGIS should be taken on an empty stomach with a glass of water [ see Dosage and Administration (2 )].
7.3False 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.
7.1Drug Interactions 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS DICLEGIS is intended for use in pregnant women. ( 8.1 )
8.1Pregnancy Risk Summary DICLEGIS is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Maternal risks are discussed throughout the labeling. No increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women.
In the U.S. general population, the estimated background risks for major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data Human Data The combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many epidemiological studies (cohort, case control and meta-analyses) designed to detect possible teratogenicity. A meta-analysis of 16 cohort and 11 case-control studies published between 1963 and 1991 reported no increased risk for malformations from first trimester exposures to doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride.
A second meta-analysis of 12 cohort and 5 case-control studies published between 1963 and 1985 reported no statistically significant relationships between fetal abnormalities and the first trimester use of the combination doxylamine succinate and pyridoxine hydrochloride with or without dicyclomine hydrochloride.
8.2Lactation 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 sedationhave 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 the sedative effects of DICLEGIS resulting in worsening of their apnea or respiratory 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.
8.4Pediatric Use The safety and effectiveness of DICLEGIS in children under 18 years of age have not been established. Fatalities have been reported from doxylamine overdose in children. The overdose cases have been characterized by coma, grand mal seizures and cardiorespiratory arrest.
Children appear to be at a high risk for cardiorespiratory arrest. A toxic dose for children of more than 1.8 mg/kg has been reported. A 3 year old child 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.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary DICLEGIS is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Maternal risks are discussed throughout the labeling. No increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women.
In the U.S. general population, the estimated background risks for major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data Human Data The combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many epidemiological studies (cohort, case control and meta-analyses) designed to detect possible teratogenicity. A meta-analysis of 16 cohort and 11 case-control studies published between 1963 and 1991 reported no increased risk for malformations from first trimester exposures to doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride.
A second meta-analysis of 12 cohort and 5 case-control studies published between 1963 and 1985 reported no statistically significant relationships between fetal abnormalities and the first trimester use of the combination doxylamine succinate and pyridoxine hydrochloride with or without dicyclomine hydrochloride.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of DICLEGIS in children under 18 years of age have not been established. Fatalities have been reported from doxylamine overdose in children. The overdose cases have been characterized by coma, grand mal seizures and cardiorespiratory arrest.
Children appear to be at a high risk for cardiorespiratory arrest. A toxic dose for children of more than 1.8 mg/kg has been reported. A 3 year old child 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 ▾
10 OVERDOSAGE
10.1Signs 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. At toxic doses, doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death.
10.2Management of Overdose If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment. For additional information about overdose treatment, call a poison control center ( 1‑800-222-1222 ).
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of DICLEGIS is unknown.
12.3Pharmacokinetics The pharmacokinetics of DICLEGIS has been characterized in healthy non-pregnant adult women. Pharmacokinetic results for doxylamine and pyridoxine, including its vitamin B6 metabolites, pyridoxal, pyridoxal 5’-phosphate, pyridoxamine and pyridoxamine 5’-phosphate, are summarized in Tables 2 to 5. Absorption A single-dose (two tablets) and multiple-dose (four tablets daily), open-label study was conducted to assess the safety and pharmacokinetic profile of DICLEGIS administered in healthy non-pregnant adult women.
Single-doses (two tablets at bedtime) were administered on Days 1 and 2. Multiple-doses (one tablet in the morning, one tablet in the afternoon and two tablets at bedtime) were administered on Days 3-18. Blood samples for pharmacokinetic analysis were collected pre-and post-dose on Days 2 and 18 as well as pre-dose prior to bedtime dose only (trough) on Days 9, 10, 11, 16, 17, and 18.
Doxylamine and pyridoxine are absorbed in the gastrointestinal tract, mainly in the jejunum. The C max of doxylamine and pyridoxine are achieved within 7.5 and 5.5 hours, respectively (see Table 2). Table 2 – Single-Dose and Multiple-Dose Pharmacokinetics of DICLEGIS in Healthy Non-Pregnant Adult Women Single Dose Multiple Dose AUC 0-inf C max T max AUC 0-inf C max T max (ng•h/mL) (ng/mL) (h) (ng•h/mL) (ng/mL) (h) Doxylamine 1280.9 ± 369.3 83.3 ± 20.6 7.2 ± 1.9 3721.5 ± 1318.5 168.6 ± 38.5 7.8 ±
1.6Pyridoxine 43.4 ± 16.5 32.6 ± 15.0 5.7 ± 1.5 64.5 ± 36.4 46.1 ± 28.3 5.6 ±
1.3Pyridoxal 211.6 ± 46.1 74.3 ± 21.8 6.5 ± 1.4 1587.2 ± 550.0 210.0 ± 54.4 6.8 ±
1.2Pyridoxal 5`Phosphate 1536.4 ± 721.5 30.0 ± 10.0 11.7 ± 5.3 6099.7 ± 1383.7 84.9 ± 16.9 6.3 ±
6.6Pyridoxamine 4.1 ± 2.7 0.5 ± 0.7 5.9 ± 2.1 2.6 ± 0.8 0.5 ± 0.2 6.6 ±
1.4Pyridoxamine 5'-phosphate 5.2 ± 3.8 0.7 ± 0.5 14.8 ± 6.6 94.5 ± 58.0 2.3 ± 1.7 12.4 ±
11.2Multiple-dose administration of DICLEGIS results in increased concentrations of doxylamine as well as increases in doxylamine C max and AUC 0-last of absorption. The time to reach the maximum concentration is not affected by multiple doses. The mean accumulation index is more than 1.0 suggesting that doxylamine accumulates following multiple dosing (see Table 3).
Although no accumulation was observed for pyridoxine, the mean accumulation index for each metabolite (pyridoxal, pyridoxal 5’-phosphate, and pyridoxamine 5’-phosphate) is more than 1.0 following multiple-dose administration of DICLEGIS. The time to reach the maximum concentration is not affected by multiple doses (see Table 2). Table 3 – Pharmacokinetics of Doxylamine and Pyridoxine Following Single Dose and Multiple Dose Administration of DICLEGIS to Healthy Non-Pregnant Adult Women AUC 0-last (ng•h/mL) AUC 0-inf (ng•h/mL) C max (ng/mL) T max (h) T 1/2el (h) Doxylamine Mean±SD N=18 Single 911.4 ± 205.6 1280.9 ± 369.3 83.3 ± 20.6 7.2 ± 1.9 10.1 ±
2.1Multiple 3661.3 ± 1279.2 3721.5 ± 1318.5 168.6 ± 38.5 7.8 ± 1.6 11.9 ±
3.3Pyridoxine Mean±SD N=18 Single 39.3 ± 16.5 43.4 ± 16.5 32.6 ± 15.0 5.7 ± 1.5 0.5 ±
0.2Multiple 59.3 ± 33.9 64.5 ± 36.4 46.1 ± 28.3 5.6 ± 1.3 0.5 ±
0.1Food Effect The administration of food delays the absorption of both doxylamine and pyridoxine. This delay is associated with a lower peak concentration of doxylamine, but the extent of absorption is not affected (see Table 4). The effect of food on the peak concentration and the extent of absorption of the pyridoxine component is more complex because the pyridoxal, pyridoxamine, pyridoxal 5’-phosphate and pyridoxamine 5’-phosphate metabolites also contribute to the biological activity.
Food significantly reduces the bioavailability of pyridoxine, lowering its C max and AUC by approximately 50% compared to fasting conditions. Similarly, food significantly reduces pyridoxal AUC and reduces its C max by 50% compared to fasting conditions. In contrast, food slightly increases pyridox…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of DICLEGIS is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How supplied DICLEGIS delayed-release tablets are supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each white, round, film-coated, delayed-release tablet contains 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and is imprinted on one side with the pink image of a pregnant woman. DICLEGIS tablets are provided as follows: NDC 55494-100-10 Bottles of 100.
16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.
📋 Description ▾
11 DESCRIPTION DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.
Doxylamine Succinate Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C 17 H 22 N 2 O • C 4 H 6 O 4 and the molecular mass is 388.46.
The structural formula is: Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride.
The empirical formula is C 8 H 11 NO 3 • HCl and the molecular mass is 205.64. The structural formula is: Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether. structure-1 structure-2
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Somnolence and Severe Drowsiness 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.
Interference with urine drug screening Inform women that use of DICLEGIS may result in false positive urine drug screening for methadone, opiates and PCP. DICLEGIS ® is a registered trademark of Duchesnay Inc. U.S.
Patent Nos. 6,340,695 & 7,560,122. Distributed by: Duchesnay USA, Inc.
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