Doxynus-B6 Uses

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What is Doxynus-B6?

Doxynus-B6 is a delayed-release tablet containing a combination of Doxynus-B6. Doxylamine (Doxynus-B6) is an antihistamine that reduces the effects of natural chemical histamine in the body.

Pyridoxine (Doxynus-B6) is a form of vitamin B (B6).

Doxynus-B6 is used to treat nausea and vomiting during pregnancy, sometimes called morning sickness.

Doxynus-B6 may also be used for purposes not listed in this medication guide.

Doxynus-B6 indications

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Doxynus-B6 is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Limitations of Use

Doxynus-B6 has not been studied in women with hyperemesis gravidarum.

How should I use Doxynus-B6?

Use Doxynus-B6 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Doxynus-B6.

Doxynus-B6 dosage

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Doxynus-B6 Dosage

Generic name: Doxylamine (Doxynus-B6) SUCCINATE 10mg, Pyridoxine (Doxynus-B6) HYDROCHLORIDE 10mg

Dosage form: tablet, delayed release

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Dosage Information

Initially, take two Doxynus-B6 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. Swallow tablets whole. Do not crush, chew, or split Doxynus-B6 tablets.

Take as a daily prescription and not on an as needed basis. Reassess the woman for continued need for Doxynus-B6 as her pregnancy progresses.

More about Doxynus-B6 (Doxylamine (Doxynus-B6) / Pyridoxine (Doxynus-B6))

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Doxynus-B6 interactions

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What other drugs will affect Doxynus-B6?

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Drug Interactions

Use of Doxynus-B6 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 Doxynus-B6 is not recommended.

Drug-Food Interactions

A food-effect study demonstrated that the delay in the onset of action of Doxynus-B6 may be further delayed, and a reduction in absorption may occur when tablets are taken with food. Therefore, Doxynus-B6 should be taken on an empty stomach with a glass of water.

Doxynus-B6 side effects

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What are the possible side effects of Doxynus-B6?

The following adverse reactions are discussed elsewhere in the labeling:
Somnolence
Falls or other accidents resulting from the effect of the combined use of Doxynus-B6 with CNS depressants including alcohol

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 Doxynus-B6 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. Adverse reactions for Doxynus-B6 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 Doxynus-B6 (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence with Doxynus-B6 than Placebo are Shown)

Doxynus-B6

(N = 133)

Placebo

(n = 128)

Somnolence

19 (14.3%)

15 (11.7%)

Postmarketing Experience

The following adverse events, listed alphabetically, have been identified during post-approval use of the combination of 10 mg Doxylamine (Doxynus-B6) succinate and 10 mg Pyridoxine (Doxynus-B6) 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

Doxynus-B6 contraindications

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What is the most important information I should know about Doxynus-B6?

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Doxynus-B6 is contraindicated in women with any of the following conditions:

Known hypersensitivity to Doxylamine (Doxynus-B6) succinate, other ethanolamine derivative antihistamines, Pyridoxine (Doxynus-B6) hydrochloride or any inactive ingredient in the formulation
Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of Doxynus-B6.

Active ingredient matches for Doxynus-B6:

Doxylamine/Pyridoxine

Doxylamine succinate/folic acid/vitamin B6 in India.


Unit description / dosage (Manufacturer)Price, USD
Doxynus-B6 Doxylamine succinate 10 mg, vitamin B6 10 mg, folic acid2.5 mg. TAB / 10$ 0.42
DOXYNUS-B6 tab 10's (Cronus)$ 0.42

List of Doxynus-B6 substitutes (brand and generic names):

DOXYNIL tab 15's (Impact)
Doxyrid-B6 Doxylamine succinate 10 mg, pyridoxine 10 mg. TAB / 10 (Biocin)$ 0.36
DOXYRID-B6 tab 10's (Biocin)$ 0.36
Doxytar Doxylamine succinate 10 mg, pyridoxine hydrochloride 10mg, folic acid 2.5 mg TAB / 10 (Altar)$ 0.39
DOXYTAR tab 10's (Altar)$ 0.39
DPF Doxylamine succinate 10 mg, Pyridoxine 10 mg, Folic acid2.5 mg. TAB / 200 (Corona Remedies Pvt Ltd)$ 6.02
200's (Corona Remedies Pvt Ltd)$ 6.02
DPF 10+10+2.5 Tablet (Corona Remedies Pvt Ltd)$ 0.03
DPF tab 10's (Corona Remedies Pvt Ltd)$ 0.30
DPF-OD Doxylamine succinate 20 mg, Pyridoxine hydrochloride 20mg, Folic acid 5 mg. TAB / 10 (Corona (Pioneer))$ 0.54
10's (Corona (Pioneer))$ 0.54
DPF-OD tab 10's (Corona (Pioneer))$ 0.63
EMNETIC-OD tab 10's (Emcure)$ 0.52
Eudox Plus Doxylamine succinate 10 mg, vitamin B6 10 mg, folic acid2.5 mg. TAB / 10 (Alpic (Eucrasia))$ 0.42
EUDOX PLUS tab 10's (Alpic (Eucrasia))$ 0.42
Feel Good Doxylamine Succinate 10mg, Pyridoxine HCI 10mg TAB / 10 (Zee Laboratories Ltd)$ 0.29
10's (Zee Laboratories Ltd)$ 0.29
Feel Good 100 gm Powder (Zee Laboratories Ltd)$ 0.01
Feel Good 10+10 Tablet (Zee Laboratories Ltd)$ 0.03
FEEL GOOD tab 10's (Zee Laboratories Ltd)$ 0.29
Feel Good -HR Doxylamine Succinate 10mg, Pyridoxine HCI 10mg, FolicAcid 5mg TAB / 10$ 0.41
Freshta -DS Doxylamine Succinate 20mg, Pyridoxine 20mg TAB / 10
10's (Sienna)
Freshta-DS Doxylamine Succinate 20mg, Pyridoxine 20mg TAB / 10 (Sienna)
FRESHTA-DS tab 10's (Sienna)
Freshta-DS Doxylamine Succinate 20mg, Pyridoxine 20mg TAB / 10 (Sienna)
Genis Doxylamine Succinate 10mg, Pyridoxine 10mg TAB / 10 (Triton (Corolla))
10's (Triton (Corolla))
GENIS tab 10's (Triton (Corolla))$ 0.24
10's (Akesiss Pharma Pvt Ltd)$ 0.59
Gooday Doxylamine Succinate 20mg, Pyridoxine HCl 20mg TAB / 10 (Akesiss Pharma Pvt Ltd)$ 0.59
Gooday 20+20 Tablet (Akesiss Pharma Pvt Ltd)$ 0.06
GOODAY 20 MG/20 MG TABLET 1 strip / 10 tablets each (Akesiss Pharma Pvt Ltd)$ 0.64
GOODAY tab 10's (Akesiss Pharma Pvt Ltd)$ 0.69
Gooday Doxylamine Succinate 20mg, Pyridoxine HCl 20mg TAB / 10 (Akesiss Pharma Pvt Ltd)$ 0.59
Gooday 20 mg/20 mg Tablet (Akesiss Pharma Pvt Ltd)$ 0.07
Goodmorn Doxylamine Succinate 10mg, Pyridoxine HCI 10mg TAB / 10 (DWD Pharmaceuticals Ltd.)$ 0.31
10's (DWD Pharmaceuticals Ltd.)$ 0.36

References

  1. DailyMed. "ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. PubChem. "folic acid". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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