Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets

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
(dye-CLEE-gis)
(doxylamine succinate and pyridoxine hydrochloride) Delayed-release Tablets

What is DICLEGIS?

• DICLEGIS is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.
• It is not known if DICLEGIS is safe and effective in children under 18 years of age.

Who should not take DICLEGIS?

Do not take DICLEGIS if you:

• are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in DICLEGIS. See the end of this leaflet for a complete list of ingredients in DICLEGIS.
• take monoamine oxidase inhibitors (MAOIs) (Marplan, Nardil, Emsam, Eldepryl, Zelapar, Parnate)

Before taking DICLEGIS, tell your healthcare provider about all of your medical conditions, including;

• if you are breastfeeding or plan to breastfeed. DICLEGIS can pass into your breast milk and may harm your baby. You should not breastfeed while using DICLEGIS.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements.

How should I take DICLEGIS?

• Talk to your healthcare provider about how much DICLEGIS to take and when to take it.
• Take DICLEGIS everyday as prescribed by your healthcare provider. Do not stop taking DICLEGIS without talking to your healthcare provider first.
• See the following schedule for the usual way you should start taking DICLEGIS:
• Day 1- Take 2 tablets, by mouth at bedtime.
• Day 2- Take 2 tablets at bedtime. If your nausea and vomiting is better or controlled on Day 2, continue to take 2 tablets every night at bedtime. This will be your usual dose unless your healthcare provider tells you otherwise.
• Day 3- If you still had nausea and vomiting on Day 2, take 3 tablets on Day 3 (1 tablet in the morning and 2 tablets at bedtime).
• Day 4- If your nausea and vomiting was better or controlled on Day 3, continue to take 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime). If you still had nausea and vomiting on Day 3, start taking 4 tablets each day (1 tablet in the morning, 1 tablet in the afternoon, and 2 tablets at bedtime).
• Do not take more than 4 tablets (1 in the morning, 1 in the mid-afternoon, and 2 at bedtime) in 1 day.
• Take DICLEGIS on an empty stomach with a glass of water.
• Take DICLEGIS tablets whole. Do not crush, chew, or break DICLEGIS tablets before swallowing. If you cannot swallow DICLEGIS tablets whole, tell your healthcare provider.
• If you take too much DICLEGIS (overdose), you may have the following symptoms: restlessness, dry mouth, the pupils of your eyes become larger (dilated), sleepiness, dizziness, confusion, fast heart rate, seizures, muscle pain or weakness, and sudden and severe kidney problems. If you have these symptoms and they are severe, they may lead to death. Stop taking DICLEGIS, call your healthcare provider or go to the nearest hospital emergency room right away. For more information about overdose treatment, call your poison control center at 1-800-222-1222.

What are the possible side effects of DICLEGIS?

DICLEGIS may cause serious side effects, including drowsiness.

• Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so.
• Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take DICLEGIS. Severe drowsiness can happen or become worse causing falls or accidents.

These are not all the possible side effects of DICLEGIS.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA -1088.

How should I store DICLEGIS?

• Store DICLEGIS between 68°F to 77°F (20°C to 25°C).
• Keep DICLEGIS tablets dry, in a tightly closed container, and out of the light.
• Safely throw away medicine that is out of date or no longer needed.

Keep DICLEGIS and all medicines out of the reach of children.

General information about the safe and effective use of DICLEGIS

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about DICLEGIS that is written for health professionals. Do not use DICLEGIS for a condition for which it was not prescribed. Do not give DICLEGIS to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in DICLEGIS?

Active ingredient: doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6)

Inactive ingredients: 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 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

The following adverse reactions are discussed elsewhere in the labeling:

• Somnolence [see WARNINGS AND PRECAUTIONS]
• Falls or other accidents resulting from the effect of the combined use of 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 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]. 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 DIGLEGIS than Placebo are Shown)

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

Read the entire FDA prescribing information for Diclegis (Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets)