Doxylamine

Registered South African indications:

• Insomnia

Contraindications

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other antihistamines
• Pregnancy
• Lactation
• Severe cardiovascular disorders
• Acute asthma attack
• Epilepsy
• Concomitant use of monoamine oxidase inhibitors (MAOIs)

Cautions

• Elderly
• Closed angle glaucoma
• Urinary retention
• Prostatic hypertrophy
• Pyloroduodenal obstruction
• Respiratory disease
• Thyroid dysfunction
• Cardiovascular disease
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab

Insomnia

• Oral (tab): 25-50mg, dly at night

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For short term use only

Not established for use in children below 12 years

Pregnancy

South African recommendations

• Contraindicated
• It is known that doxylamine succinate crosses the placenta
• Doxylamine succinate should not be used during pregnancy

Breastfeeding

South African recommendations

• Contraindicated
• Doxylamine succinate should not be used during breastfeeding

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no information available

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Sedation
• Lassitude
• Disorientation
• Dizziness 
• Vertigo
• Incoordination
• Euphoria 
• Depression
• Headache
• Irritability 
• Nightmares
• Insomnia
• Nervousness
• Tachycardia
• Tremors
• Seizures

Cardiovascular Disorders

• Hypotension
• Palpitations
• Tachycardia

Respiratory Disorders

• Tight chest 

Gastrointestinal Disorders

• Dry mouth
• Nausea and vomiting
• Diarrhoea 
• Constipation
• Anorexia 
• Increased appetite 
• Epigastric pain

Genitourinary Disorders

• Difficulty in micturition
• Dysuria
• Urinary retention

Musculoskeletal Disorders

• Muscular weakness

Immune, Blood and Lymphatic System Disorders

• Allergic reactions 
• Agranulocytosis
• Leucopenia 
• Haemolytic anemia 

Sensory Disorders

• Blurred vision
• Diplopia
• Tinnitus

• Central nervous system depressants
• Monoamine oxidase inhibitors
• Anticholinergics
• Benzylpenicilloyl polylysine
• Eluxadoline
• Hyaluronidase
• Levosulpiride
• Potassium chloride
• Potassium citrate
• Secretin
• Glucagon

None routine

Doxylamine is a competitive histamine H1 antagonist. It has sedative and anticholinergic properties.  

Tablet 25mg

• Somnil (Pharmacare)

COMBINATION PREPARATIONS

Dicyclomine/ Doxylamine/ Pyridoxine

Tablet 10mg/10mg/50mg

• Asic (Pharmaceutical Ent) originator

Paracetamol/ Dextromethorphan/ Ephedrine/ Doxylamine

Syrup (per 30ml) 600mg/15mg/9mg/7.5mg

• Vicks Medinite (Procter & Gamble)

Paracetamol/ Caffeine/ Codeine/ Doxylamine

Tablet 450mg/30mg/10mg/5mg

• Abflex-4 (Cipla)
• Acurate (Pharmascript)
• Adco-Paxidal (Adcock)
• Alpha-Dol (Be-tabs)
• Codoxol (Sun Pharma)
• Doxy Co (Gulf)
• Lenapain (Pharmacare)
• Resdol (Adcock)
• Sedapain (Pharmacare)
• Sedinol (Pharmacare)
• Syndol  (Adcock) originator
• Tensopyn (Mirren)

Tablet 450mg/45mg/10mg/5mg

• Adco-dol (Adcock)
• Pynstop (Adcock)

Tablet  450mg/50mg/10mg/5mg

• Betapyn (Adcock)

Tablet  500mg/30mg/10mg/5mg

• Pharmadol (Medicine)

Tablet effervescent 450mg/50mg/10mg/5mg

• Tensopyn Eft (Mirren)

Sodium citrate/ Dextromethorphan/ Doxylamine/ Cetylpyridium

Syrup (per 10ml) 500mg/30mg/6mg/2.5mg

• Cepacol cough linctus (Adcock)