Doxylamine Pyridoxine Brand Name– BONJESTA | Diclegis
What is Doxylamine Pyridoxine
Doxylamine Pyridoxine is a combination drug product indicated for the treatment of pregnancy-induced nausea/vomiting in women who do not respond to conservative management (i.e., diet and lifestyle modifications).
Doxylamine is a sedating antihistamine (H-1 receptor antagonist) of the ethanolamine class; pyridoxine is also known as vitamin B6. The efficacy and safety of doxylamine pyridoxine were evaluated in controlled clinical trials. Study subjects (n = 261) were at least 18 years of age and were in their 7 to 14th week of pregnancy.
Women were randomized to receive 2 weeks of active treatment or placebo. Women taking doxylamine pyridoxine experienced greater improvement in nausea and vomiting compared with those taking placebo.
Epidemiological studies have shown no increase risk of teratogenicity with combined use of doxylamine and pyridoxine.
Clinical evaluation of doxylamine; pyridoxine was limited to pregnancy within 14 weeks, therefore it is important to reassess continued need for therapy as pregnancy progresses.
Doxylamine may cause marked drowsiness or sleepiness.
Therefore, women taking doxylamine; pyridoxine should avoid using this product when engaging in activities requiring mental alertness, such as driving or operating heavy machinery, until cleared to do so by their health care provider.
Diclegis delayed-release tablets were FDA-approved in April 2013.
Bonjesta extended-release tablets were FDA-approved in November 2016.
Indications
- pregnancy-induced nausea/vomiting
For the treatment of pregnancy-induced nausea/vomiting that is unresponsive to conservative management
Side Effects
- abdominal pain
- anxiety
- asthenia
- blurred vision
- confusion
- constipation
- diarrhea
- dizziness
- drowsiness
- dysarthria
- dyspnea
- dysuria
- fatigue
- headache
- hyperhidrosis
- hypertension
- hypotension
- insomnia
- irritability
- maculopapular rash
- malaise
- migraine
- myasthenia
- mydriasis
- nightmares
- palpitations
- paresthesias
- pruritus
- rash
- restlessness
- sinus tachycardia
- urinary retention
- vertigo
- weakness
- xerophthalmia
- xerostomia
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- anticholinergic medications
- asthma
- bladder obstruction
- breast-feeding
- closed-angle glaucoma
- contact lenses
- driving or operating machinery
- ethanol ingestion
- GI obstruction
- hepatic disease
- ileus
- increased intraocular pressure
- laboratory test interference
- MAOI therapy
- peptic ulcer disease
- pregnancy
- urinary retention
- urinary tract obstruction
Interactions
- Acetaminophen; Butalbital
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine; Dihydrocodeine
- Acetaminophen; Codeine
- Acetaminophen; Dichloralphenazone; Isometheptene
- Acetaminophen; Hydrocodone
- Acetaminophen; Oxycodone
- Acetaminophen; Pentazocine
- Acetaminophen; Propoxyphene
- Acetaminophen; Tramadol
- Aldesleukin, IL-2
- Alfentanil
- Alosetron
- Amantadine
- Ambenonium Chloride
- Amobarbital
- Amoxapine
- Amphetamine
- Amphetamine; Dextroamphetamine
- Amphetamine; Dextroamphetamine Salts
- Anticholinergics
- Apomorphine
- Apraclonidine
- Aripiprazole
- Asenapine
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Aspirin, ASA; Caffeine; Dihydrocodeine
- Aspirin, ASA; Caffeine; Orphenadrine
- Aspirin, ASA; Carisoprodol
- Aspirin, ASA; Carisoprodol; Codeine
- Aspirin, ASA; Oxycodone
- Atropine; Difenoxin
- Atropine; Diphenoxylate
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Azelastine
- Azelastine; Fluticasone
- Baclofen
- Barbiturates
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Belladonna; Opium
- Benzhydrocodone; Acetaminophen
- Benzodiazepines
- Benzphetamine
- Brompheniramine; Carbetapentane; Phenylephrine
- Brompheniramine; Guaifenesin; Hydrocodone
- Brompheniramine; Hydrocodone; Pseudoephedrine
- Buprenorphine
- Buprenorphine; Naloxone
- Buspirone
- Butabarbital
- Butorphanol
- Cannabidiol
- Capsaicin; Metaxalone
- Carbetapentane; Chlorpheniramine
- Carbetapentane; Chlorpheniramine; Phenylephrine
- Carbetapentane; Diphenhydramine; Phenylephrine
- Carbetapentane; Guaifenesin
- Carbetapentane; Guaifenesin; Phenylephrine
- Carbetapentane; Phenylephrine
- Carbetapentane; Phenylephrine; Pyrilamine
- Carbetapentane; Pseudoephedrine
- Carbetapentane; Pyrilamine
- Carbidopa; Levodopa; Entacapone
- Carbinoxamine; Hydrocodone; Phenylephrine
- Carbinoxamine; Hydrocodone; Pseudoephedrine
- Cariprazine
- Carisoprodol
- Cenobamate
- Cetirizine
- Cetirizine; Pseudoephedrine
- Chlorpheniramine; Codeine
- Chlorpheniramine; Dihydrocodeine; Phenylephrine
- Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
- Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Hydrocodone
- Chlorpheniramine; Hydrocodone; Phenylephrine
- Chlorpheniramine; Hydrocodone; Pseudoephedrine
- Chlorpromazine
- Chlorzoxazone
- Clobazam
- Clozapine
- Codeine
- Codeine; Guaifenesin
- Codeine; Phenylephrine; Promethazine
- Codeine; Promethazine
- COMT inhibitors
- Cyclobenzaprine
- Dantrolene
- Daratumumab; Hyaluronidase
- Desloratadine
- Desloratadine; Pseudoephedrine
- Deutetrabenazine
- Dexmedetomidine
- Dextroamphetamine
- Dextromethorphan; Promethazine
- Dihydrocodeine; Guaifenesin; Pseudoephedrine
- Diphenhydramine; Hydrocodone; Phenylephrine
- Disopyramide
- Donepezil
- Donepezil; Memantine
- Dronabinol
- Droperidol
- Entacapone
- Esketamine
- Eszopiclone
- Ethanol
- Etomidate
- Ezogabine
- Fenfluramine
- Fentanyl
- Flibanserin
- Fluoxetine; Olanzapine
- Fluphenazine
- Fospropofol
- Gabapentin
- Galantamine
- Guaifenesin; Hydrocodone
- Guaifenesin; Hydrocodone; Pseudoephedrine
- Halogenated Anesthetics
- Haloperidol
- Heparin
- Homatropine; Hydrocodone
- Hyaluronidase
- Hyaluronidase, Recombinant; Immune Globulin
- Hydantoins
- Hydrocodone
- Hydrocodone; Ibuprofen
- Hydrocodone; Phenylephrine
- Hydrocodone; Potassium Guaiacolsulfonate
- Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
- Hydrocodone; Pseudoephedrine
- Hydromorphone
- Ibuprofen; Oxycodone
- Iloperidone
- Isocarboxazid
- Ketamine
- Lasmiditan
- Lemborexant
- Levocetirizine
- Levomethadyl
- Levorphanol
- Lithium
- Lofexidine
- Loratadine
- Loratadine; Pseudoephedrine
- Loxapine
- Lumateperone
- Lurasidone
- Magnesium Salts
- Maprotiline
- Meclizine
- Melatonin
- Meperidine
- Meperidine; Promethazine
- Mephobarbital
- Meprobamate
- Metaxalone
- Methadone
- Methamphetamine
- Methocarbamol
- Methohexital
- Metoclopramide
- Metyrapone
- Metyrosine
- Minocycline
- Mirtazapine
- Mitotane
- Molindone
- Monoamine oxidase inhibitors
- Morphine
- Morphine; Naltrexone
- Nabilone
- Nalbuphine
- Nefazodone
- Olanzapine
- Opiate Agonists
- Orphenadrine
- Oxycodone
- Oxymorphone
- Paliperidone
- Papaverine
- Paroxetine
- Pentazocine
- Pentazocine; Naloxone
- Pentobarbital
- Perampanel
- Perphenazine
- Perphenazine; Amitriptyline
- Phenelzine
- Phenobarbital
- Phentermine; Topiramate
- Phenylephrine; Promethazine
- Pimozide
- Pitolisant
- Pramipexole
- Pregabalin
- Primidone
- Procarbazine
- Prochlorperazine
- Promethazine
- Propofol
- Propoxyphene
- Quetiapine
- Ramelteon
- Rasagiline
- Remifentanil
- Risperidone
- Rituximab; Hyaluronidase
- Rivastigmine
- Ropinirole
- Rotigotine
- Safinamide
- Secobarbital
- Selegiline
- Sincalide
- Sodium Iodide
- Sodium Oxybate
- Solifenacin
- Sufentanil
- Suvorexant
- Tacrine
- Tapentadol
- Tasimelteon
- Tetrabenazine
- Thalidomide
- Thiopental
- Thioridazine
- Thiothixene
- Tizanidine
- Tolcapone
- Topiramate
- Tramadol
- Tranylcypromine
- Trastuzumab; Hyaluronidase
- Trazodone
- Tricyclic antidepressants
- Trifluoperazine
- Trimethobenzamide
- Trospium
- Vigabatrin
- Vilazodone
- Zaleplon
- Ziconotide
- Ziprasidone
- Zolpidem
