If you think there has been an overdose, call your poison control center or get medical care right away. Keep bottle tightly closed and protect from moisture.
The drug is used to treat nausea and vomiting associated with pregnancy. You may report side effects to FDA at 1-800-FDA-1088.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. 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. Maternal risks are discussed throughout the labeling. 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.
It is best to take this medicine on an empty stomach.
All rights reserved. Single-doses (two tablets at bedtime) were administered on Days 1 and 2.
The combination may result in severe drowsiness leading to falls or accidents Doxylamine succinate and pyridoxine hydrochloride 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.There have been reports of false positive urine screening tests for methadone, opiates, and PCP with doxylamine succinate/pyridoxine hydrochloride use The following adverse reactions are discussed elsewhere in the labeling: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.
Your list will be saved and can be edited at any time.The above information is provided for general This medicine comes with a patient information insert.
Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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.Doxylamine succinate and pyridoxine hydrochloride is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. advice about side effects. Excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. There was a 0.7 (95% confidence interval 0.2 to 1.2 with p-value 0.006) mean decrease (improvement in nausea and vomiting symptoms) from baseline in PUQE score at Day 15 with doxylamine succinate and pyridoxine hydrochloride compared to placebo (see Table 6).
Baseline was defined as the PUQE score completed at the enrollment visit.Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg are supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister.
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 as a daily prescription and not on an as needed basis.
Do not give doxylamine succinate and pyridoxine hydrochloride delayed-release tablets to other people, even if they have the same symptoms that you have. Do not remove desiccant canister from bottle.See FDA-approved patient labeling (Patient Information)Inform women to avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using doxylamine succinate and pyridoxine hydrochloride until cleared to do so.Inform women of the importance of not taking doxylamine succinate and pyridoxine hydrochloride 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.Inform women that use of doxylamine succinate and pyridoxine hydrochloride may result in false positive urine drug screening for methadone, opiates and PCP.Drowsiness is a common side effect when taking doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, but can also be severe: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. Do not use doxylamine succinate and pyridoxine hydrochloride delayed-release tablets for a condition for which it was not prescribed. Follow your doctor's orders or the directions on the label.