Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1
doxylamine succinate and pyridoxine hydrochloride · TABLET, DELAYED RELEASE · Mylan Pharmaceuticals Inc.
Doxylamine Succinate and Pyridoxine Hydrochloride is a tablet, delayed release containing doxylamine succinate and pyridoxine hydrochloride at 10 mg/1, taken oral. Manufactured by Mylan Pharmaceuticals Inc..
Key Facts
- Brand Name
- Doxylamine Succinate and Pyridoxine Hydrochloride
- Generic Name
- doxylamine succinate and pyridoxine hydrochloride
- NDC Code (Product)
0378-4615- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207825
- Marketing Start
- 07/21/2020
Recall History
Teva Pharmaceuticals USA
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets havenot been studied in women with hyperemesis gravidarum. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are a fixed dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B 6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. ( 1 )
Dosage & 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 ) 2.1 Dosage Information Initially, take two doxylamine succinate and pyridoxine hydrochloride 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 tablet…
Contraindications
4 CONTRAINDICATIONS 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 [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 )
Drug Interactions
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 [see Dosage and Administration (2) , Clinical Pharmacology (12.3) ] . Therefore, doxylamine succinate and pyridoxine hydrochloride should be taken on an empty stomach with a glass of water [ see Dosage and Administration (2) ]. 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 …
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 doxylamine succinate and pyridoxine hydrochloride with CNS depressants including alcohol [see Warnings and Precautions (5.1) ] The most common adverse reaction with doxylamine succinate and pyridoxine hydrochloride (≥ 5 percent and exceeding the rate in placebo) is somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 doxylamine succinate and pyridoxine hydrochloride 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 …
Frequently Asked Questions
What is Doxylamine Succinate and Pyridoxine Hydrochloride used for?
Doxylamine Succinate and Pyridoxine Hydrochloride contains doxylamine succinate and pyridoxine hydrochloride. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.
Is Doxylamine Succinate and Pyridoxine Hydrochloride a controlled substance?
Doxylamine Succinate and Pyridoxine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Doxylamine Succinate and Pyridoxine Hydrochloride?
The generic name for Doxylamine Succinate and Pyridoxine Hydrochloride is doxylamine succinate and pyridoxine hydrochloride. There are 5 other brand versions of doxylamine succinate and pyridoxine hydrochloride.
What is the NDC code for Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1?
The NDC (National Drug Code) for Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1 is 0378-4615, listed by Mylan Pharmaceuticals Inc..