Dicyclomine/ Doxylamine/ Pyridoxine

Registered South African indications:

• Nausea and vomiting

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Dicyclomine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Breastfeeding

Cautions

• Renal impairment
• Hepatic impairment
• Elderly
• Glaucoma
• Prostatic hypertrophy
• Reflux oesophagitis secondary to hiatus hernia

Doxylamine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Pregnancy 
• Breastfeeding 
• Epileptics 
• Severe cardiac disease 
• Acute asthma attack 

Cautions

• Hepatic impairment
• Elderly 
• Closed angle glaucoma 
• Urinary retention 
• Prostatic hypertrophy 
• Pyloroduodenal obstruction 
• Cardiac failure 
• Hypertension 
• Oedema 
• Cardiovascular disease 
• May impair ability to drive and operate machinery

Pyridoxine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product

Cautions

• Pregnancy (if doses > recommended daily allowance)
• Prolonged therapy 
• High doses 

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

Control of nausea and vomiting associated with pregnancy

Dicyclomine/ Doxylamine/ Pyridoxine
10/10/50 (mg)

• Oral (tab): 2 tab, dly at night

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1 additional tab can be taken in the morning and in the mid-afternoon in severe cases

Not established for use in children

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• Caution (Dicyclomine)
• Since the risk of teratogenicity cannot be excluded with absolute certainty, the drug should be used during pregnancy only if the benefit outweighs the risk

Breastfeeding

• Contraindicated (Dicyclomine)

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; dose adjustment recommended (Dicyclomine)

Porphyria Information

• Not yet classified (NC) 

Drugs in Sport

• Permitted - No warning 

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Dicyclomine
Central Nervous System Disorders

• Dizziness
• Fatigue
• Sedation

Gastrointestinal Disorders

• Dry mouth
• Constipation
• Anorexia
• Nausea and vomiting

Skin and Subcutaneous Tissue Disorders

• Rash

Sensory Disorders

• Blurred vision

Doxylamine
Central Nervous System Disorders

• Sedation
• Lassitude
• Dizziness 
• Incoordination
• Euphoria 
• Depression
• Headache
• Irritability 
• Nightmares
• Insomnia
• Nervousness
• Tachycardia
• Tremors
• Convulsions
• Epileptiform seizures

Cardiovascular Disorders

• Hypotension

Respiratory Disorders

• Chest tightness

Gastrointestinal Disorders

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

Genitourinary Disorders

• Difficulty in micturition
• Dysuria

Musculoskeletal Disorders

• Muscular weakness

Immune, Blood and Lymphatic System Disorders

• Allergic reactions 
• Agranulocytosis
• Leucopenia 
• Haemolytic anemia 

Sensory Disorders

• Blurred vision
• Tinnitus

Pyridoxine
Central Nervous System Disorders

• Severe peripheral neuritis

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Dicyclomine

• Anticholinergic agents
• Glucagon
• Levosulpiride
• Potassium chloride
• Potassium citrate
• Secretin

Doxylamine

• Central nervous system depressants 
• Monoamine oxidase inhibitors 
• Antimuscarinic agents 
• Ototoxic agents 

Pyridoxine

• Isoniazid 
• Penicillamine 
• Oral contraceptives 
• Levodopa 

None routine

Dicyclomine
Dicycloverine relieves smooth muscle spasm of the gastrointestinal tract. It has antimuscarinic effects on acetylcholine receptors and also has a direct effect on smooth muscle

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

Pyridoxine
Pyridoxine is converted to pyridoxal 5-phosphate in the body. Pyridoxal 5-phosphate is a coenzyme for the synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids and aminolevulinic acid

COMBINATION PREPARATIONS

Dicyclomine/ Doxylamine/ Pyridoxine

Tablet 10mg/10mg/50mg

• Asic (Pharmaceutical Ent) originator