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Pyridoxine

R06A - Antihistamines for systemic use ATC R06AE55 Small molecule approved 1982 Oral Parenteral Natural product

JFDA label: Vominore tablet

Mechanism of Action

12.1 Mechanism of Action The mechanism of action of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is unknown.

Indications

Approved

  • Anemia — anemia
  • Diabetes Mellitus, Type 2 — type 2 diabetes mellitus
  • Kidney Failure, Chronic — chronic kidney disease
  • Osteoporosis — osteoporosis
  • Postoperative Nausea and Vomiting — Nausea and vomiting

Off-label

  • Alzheimer Disease
  • Atherosclerosis
  • Attention Deficit Disorder with Hyperactivity
  • Colorectal Neoplasms
  • Epilepsy
  • Fatty Liver, Alcoholic
  • HIV Infections
  • Hand-Foot Syndrome
  • Heart Diseases
  • Heart Failure
  • Hepatitis, Alcoholic
  • Lymphoma
  • Movement Disorders
  • Multiple Myeloma
  • Myocardial Infarction
  • Myocardial Ischemia
  • Non-alcoholic Fatty Liver Disease
  • Psychotic Disorders
  • Spasms, Infantile
  • Tuberculosis
  • Tuberculosis, Pulmonary
  • Vomiting

Contraindications

Source: openFDA

  • 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 delayed-release tablets [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 ) Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Nervous system disorders (4)

Not Known Headache · Neuropathy peripheral · Paraesthesia · Somnolence

Gastrointestinal disorders (1)

Not Known Nausea

Dosing

Source: openFDA

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 tablets whole. Do not crush, chew, or split doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. Take as a daily prescription and not on an as needed basis. Reassess the woman for continued need for doxylamine succinate and pyridoxine hydrochloride delayed-release tablets as her pregnancy progresses.

Warnings & Precautions

Source: openFDA

Warnings & Precautions

Activities requiring mental alertness: Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using doxylamine succinate and pyridoxine hydrochloride delayed-release tablets until cleared to do so by a healthcare provider ( 5.1 ) Central nervous system (CNS) depressants: Concurrent use with alcohol or other CNS depressants is not recommended ( 5.1 ) Anticholinergic actions: Use with caution in patients with increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction ( 5.2 ) Interference with urine drug screen: doxylamine succinate and pyridoxine hydrochloride delayed-release tablets may interfere with urine screening for methadone, opiates and PCP ( 5.3 )

Activities Requiring Mental Alertness Doxylamine succinate and pyridox

Activities Requiring Mental Alertness Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets until cleared to do so by their healthcare provider. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 [see Drug Interactions (7.1) ] .

Concomitant Medical Conditions Doxylamine succinate and pyridoxine hyd

Concomitant Medical Conditions Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have anticholinergic properties and, therefore, should be used with caution in women with: increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction.

Interference with Urine Screen for Methadone, Opiates and Phencyclidin

Interference with Urine Screen for Methadone, Opiates and Phencyclidine Phosphate (PCP) There have been reports of false positive urine screening tests for methadone, opiates, and PCP with doxylamine succinate/pyridoxine hydrochloride use [see Drug Interactions ( 7.3 )].

Pregnancy & Lactation

Pregnancy

FDA category A

Safe

First-line pharmacological treatment for NVP. Often combined with doxylamine. 10–25 mg TDS. Safe throughout pregnancy

Lactation

Compatible Hale L1

Higher doses of 100 to 200 mg daily used to prevent or treat some B 6 -responsive diseases have not been studied during lactation but would not be ex

Chemistry & Properties

2D structure
FormulaC8H11NO3
Molecular weight169.18 g/mol
IUPAC name4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol
CAS65-23-6
PubChem CID1054
InChIKeyLXNHXLLTXMVWPM-UHFFFAOYSA-N
logP0.08 (XLogP -0.8)
Polar surface area73.58 Ų
H-bond acceptors / donors4 / 3
Drug-likeness (QED)0.59
Lipinski violations0
SMILESCc1ncc(CO)c(CO)c1O

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrantNo

Enzyme interactions

EnzymeRoleDetail
CYP2D6Substrate —
CYP3A4Substrate —

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)P-gp (Inhibitor)P-gp (Substrate)

Drug–drug interactions (13, DDInter)

Interacting drugSeverityManagement
Altretamine moderate
Levodopa moderate
Phenobarbital moderate
Phenytoin moderate
Amobarbital minor
Butabarbital minor
Butalbital minor
Methohexital minor
Methylphenobarbital minor
Pentobarbital minor
Primidone minor
Secobarbital minor
Thiopental minor

Registered Products (13)

BrandForm / strengthPackAgentCitizen (JOD)
Poly-B-Bion Ampoule 1 mg, 100 mg, 100 mg 3 amp pack varies شركة مستودع ادوية جرينلاند 1.120
Vominore tablet Tablet 50 mg, 25 mg 20 tab pack varies THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY/JORDAN 1.890
Neurorubine Forte Tablet 1 mg, 50 mg, 200 mg 20 tab Khoury Drug Store 2.050
Nervovit tablet Tablet 200 mcg, 200 mg, 200 mg 20 tab UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN 2.110
BECOZYM FORTE TAB Tablet 50 mg, 25 mg, 0.15 mg, 0.01 mg, 10 mg, 15 mg, 15 mg 20 tab The Jordan Drugstore Co 2.270
Neurorubine Amp Ampoule 1 mg/3 ml, 100.00 mg/3 ml, 100.00 mg/3 ml 3 ml Khoury Drug Store 2.300
B Complete Ampoules Ampoule 1 mg, 100 mg, 100 mg 5 amp Hikma Pharmaceuticals Co.Ltd/Jordan 3.070
B-YOSEF Ampoule 100 mcg, 100 mg, 100 mg 10 amp moon light drugs store 4.420
Pronatal Tablet 0.6 mg, 2.6 mcg, 18 mg, 0.03 mg, 2 mg, 85 mg, 15 mg, 0.06 mg, 150 mg, 0.03 mg, 0.2 mg, 0.05 mg, 11 mg, 1.9 mg, 27 mg, 1 mg, 53 mg, 1.4 mg, 200 IU, 1.4 mg 30 tab THE ARAB DRUG STORE P.S.C 5.570
Elevit Pronatal film-coated tablets Film-Coated Tablet 0.80 mg, 4.00 mcg, 19.00 mg, 10.00 mg, 200 mcg, 100.00 mg, 1080 mcg, 12.5 mcg, 125.00 mg, 7.50 mg, 2.60 mg, 60.00 mg, 1.00 mg, 125 mg, 1.00 mg, 1.80 mg, 100.00 mg, 1.60 mg, 15.00 mg 30 tab The Jordan Drugstore Co 8.330
Medivitan injection Powder for Injection 1.05 mg, 1 mg, 5 mg 8 amp Karmel Drug Store 11.770
Poly-B-Bion Ampoule 1 mg, 100 mg, 100 mg 100 amp pack varies شركة مستودع ادوية جرينلاند 31.730
Vominore tablet Tablet 50 mg, 25 mg 1000 tab pack varies THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY/JORDAN 80.330