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doxylamine succinate and pyridoxine hydrochloride

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Overview

What is DICLEGIS?

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 CHNO • CHO 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 CHNO • 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.



What does DICLEGIS look like?



What are the available doses of DICLEGIS?

Delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. ()

What should I talk to my health care provider before I take DICLEGIS?

Pregnancy Category A. DICLEGIS is intended for use in pregnant women. ()

How should I use DICLEGIS?

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.


What interacts with DICLEGIS?

Sorry No Records found


What are the warnings of DICLEGIS?

Sorry No Records found


What are the precautions of DICLEGIS?

Sorry No Records found


What are the side effects of DICLEGIS?

Sorry No records found


What should I look out for while using DICLEGIS?

DICLEGIS is contraindicated in women with any of the following conditions:


What might happen if I take too much DICLEGIS?


How should I store and handle DICLEGIS?

Store at 20 to 25C (68 to 77F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg are packaged in a carton of three pouches (NDC 0378-7280-53) and a carton of five pouches (NDC 0378-7280-98); each pouch contains a blister pack of 21 tablets. Each blister pack contains 21 white to off-white , round, flat-faced, unscored tablet debossed with on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg are packaged in a carton of three pouches (NDC 0378-7280-53) and a carton of five pouches (NDC 0378-7280-98); each pouch contains a blister pack of 21 tablets. Each blister pack contains 21 white to off-white , round, flat-faced, unscored tablet debossed with on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism of action of DICLEGIS is unknown.

Non-Clinical Toxicology
DICLEGIS is contraindicated in women with any of the following conditions:

Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when metronidazole vaginal gel is prescribed for patients on this type of anticoagulant therapy.

In patients stabilized on relatively high doses of lithium, short-term oral metronidazole therapy has been associated with elevation of serum lithium levels and, in a few cases, signs of lithium toxicity.

Use of cimetidine with oral metronidazole may prolong the half-life and decrease plasma clearance of metronidazole.

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 .

The following adverse reactions are discussed elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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