Doxylamine succinate and pyridoxine hydrochloride

*Pill not to scale
Bioequivalent
Diclegis®
Active ingredient
Doxylamine succinate and pyridoxine hydrochloride
Indication
Indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
NDC:
70505-100-10
Strength:
10mg/10mg
Dosage Form:
Delayed-release tablets
Route of Administration:
Oral administration
Package Size:
100 tablets
Color:
White
Shape:
Round, Film coated tablet
Imprint:
Pink image of a pregnant women on one side
Therapeutic Equivalence:
AB
Therapeutic Class:
Antihistamine plus Vitamin B6
Food Constraint:
Certified Kosher, Kosher for Passover and Halal

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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.

LIMITATIONS OF USE

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.

IMPORTANT SAFETY INFORMATION

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are intended for use in pregnant women.

Do not take doxylamine succinate and pyridoxine hydrochloride delayed-release tablets if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. Please refer to the Patient Information leaflet for the complete list of ingredients. You should also not take doxylamine succinate and pyridoxine hydrochloride delayed-release tablets in combination with medicines called monoamine oxidase inhibitors (MAOIs) (Marplan, Nardil, Emsam, Eldepryl, Zelapar, and Parnate), as these medicines can intensify and prolong the adverse central nervous system (CNS) effects of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets.

The absorption and action of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets may be impacted when tablets are taken with food. Therefore, you should take doxylamine succinate and pyridoxine hydrochloride delayed-release tablets on an empty stomach with a glass of water.

The most common side effect of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is drowsiness. Do not drive, operate heavy machinery, or do other activities that need your full attention unless your healthcare provider says that you may do so.

Do not drink alcohol, or take other CNS depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. Severe drowsiness can happen or become worse causing falls or accidents.

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets may cause an incorrect positive result for urine drug screening tests for methadone, opiates and PCP.

These are not all the possible side effects of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. Call your doctor for medical advice about side effects.

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets should be used with caution in women who have certain medical conditions, such as asthma, eye problems called increased intraocular pressure or narrow angle glaucoma, stomach problems called stenosing peptic ulcer or pyloroduodenal obstruction, a bladder problem called urinary bladder-neck obstruction, or who are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed, so that he/she can assess if doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are right for you. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets can pass into your breast milk and may harm your baby. You should not breastfeed while using doxylamine succinate and pyridoxine hydrochloride delayed-release tablets.

It is not known if doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are safe and effective in children under 18 years of age.

Due to the delayed-release properties of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, signs of overdose may not appear right away. If you take too much doxylamine succinate and pyridoxine hydrochloride (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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets and 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.

Keep doxylamine succinate and pyridoxine hydrochloride delayed-release tablets and all medicines out of the reach of children. Carefully read the storage instruction as detailed in the doxylamine succinate and pyridoxine hydrochloride delayed-release tablets Patient Information leaflet. Analog Pharma encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication and important safety information

INDICATION

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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..

LIMITATIONS OF USE

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.

IMPORTANT SAFETY INFORMATION

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are intended for use in pregnant women.

Indication and important safety information

INDICATION

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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.

LIMITATIONS OF USE

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.