Theophylline/ Mepyramine Maleate/ Codeine

Registered South African indications:

• Cough

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

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Theophylline should be administered with caution to elderly patients and those suffering from cardiac disease and liver disease
• Care should be taken in patients with a history of peptic ulceration
• Codeine phosphate is generally contraindicated in respiratory depression and known instances of allergy to codeine

Cautions

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Renal impairment
• Smokers
• Patients undergoing routine haemodialysis

Impact on alertness and concentration

• May lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants
• Patients should not operate hazardous machinery or drive motor vehicles when under medication

Coadministration with other medicines

• The bronchodilatory and toxic effects of theophylline may be enhanced by sympathomimetics and by administration with other xanthines

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

Cough

Theophylline/ Mepyramine maleate/ Codeine
52.8/15.84/8.45 (mg/15ml)

• Oral (syr): 15ml, 4hrly

Paed. forms avail. in SA and covered in this monograph: syr

Cough

Theophylline/ Mepyramine Maleate/ Codeine
52.8/15.84/8.45 (mg/15ml)

• Younger than 1 year: Oral (syr): 5ml, 4hrly

• Older than 1 year: Oral (syr): 10ml, 4hrly

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Shake bottle before use

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

Pregnancy

• Caution
• As with all medicines, care should be taken when administering this preparation during the first trimester of pregnancy

Breastfeeding

• Caution; no information available

Renal impairment

• Caution; no information available

Hepatic impairment

• Liver disease: Contraindicated

Elderly

• Contraindicated

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

Theophylline
Central Nervous System Disorders

• Headache
• Confusion
• Restlessness
• Hyperventilation
• Vertigo
• Tremor
• Seizures
• Anxiety
• Insomnia
• Mania
• Delirium

Cardiovascular Disorders

• Palpitations
• Tachycardia
• Cardiac arrhythmias
• Hypotension

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain
• Diarrhoea
• Gastro-oesophageal reflux
• Gastrointestinal bleeding

Endocrine and Metabolic Disorders

• Hypokalaemia
• Hypophosphataemia
• Hyponatraemia 
• Extreme thirst 
• Hyperthermia

Skin and Subcutaneous Tissue Disorders

• Maculopapular rash
• Erythema
• Pruritus
• Urticaria
• Exfoliative dermatitis

Sensory Disorders

• Visual disturbances

Mepyramine
Central Nervous System Disorders

• Sedation 
• Drowsiness
• Excitement 
• Euphoria
• Insomnia 
• Nervousness
• Tremor 

Cardiovascular Disorders

• Palpitations
• Hypotension 

Gastrointestinal Disorders

• Nausea and vomiting 
• Anorexia 
• Abdominal discomfort
• Constipation 
• Diarrhoea
• Dry mouth 

Skin and Subcutaneous Tissue Disorders

• Photosensitivity 
• Rash 
• Contact dermatitis 

Immune, Blood and Lymphatic System Disorders

• Agranulocytosis 
• Leucopaenia
• Haemolytic anaemia
• Thrombocytopaenia 

Sensory Disorders

• Blurred vision 

Codeine
Central Nervous System Disorders

• Dizziness
• Drowsiness
• Mood changes
• Euphoria 
• Dysphoria
• Mental depression
• Restlessness
• Confusion
• Headache
• Raised intracranial pressure
• Hallucinations
• Nightmares
• Vertigo

Cardiovascular Disorders

• Tachycardia
• Palpitations
• Bradycardia 
• Postural hypotension
• Facial flushing 
• Hypotension

Respiratory Disorders

• Dyspnoea
• Respiratory depression

Gastrointestinal Disorders

• Nausea and vomiting
• Constipation
• Dry mouth
• Stomach cramps
• Pancreatitis
• Biliary spasm

Genitourinary System Disorders

• Sexual dysfunction
• Erectile dysfunction
• Decreased potency
• Decreased libido
• Difficulty with micturation
• Urinary retention
• Ureteric spasm
• Dysuria

Endocrine and Metabolic Disorders

• Hyperglycaemia
• Anorexia

Musculoskeletal Disorders

• Uncontrolled muscle movements
• Muscle rigidity 

Skin and Subcutaneous Tissue Disorders 

• Skin rashes
• Urticaria
• Pruritus
• Sweating 
• Facial oedema

Immune System Disorders

• Maculopapular rash
• Fever
• Splenomegaly 
• Lymphadenopathy 

Sensory Disorders

• Blurred or double vision or other changes in vision
• Miosis

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

Theophylline

• Xanthine derivatives 
• Beta-2 agonists 
• Steroids 
• Diuretics 
• Allopurinol 
• Cimetidine 
• Influenza vaccine 
• Propranolol 
• Macrolide antibiotics 
• Lithium 
• St John's wort 
• Ketamine 
• Beta blockers 
• Doxapram
• CYP450 inducers 

Mepyramine

• Monoamine oxidase inhibitors 
• Anticholinergic
• Central nervous system depressants 

Codeine

• Alcohol
• Anaesthetics
• Antiarrhythmic agents
• Central nervous system depressants
• Antihistamines
• Domperidone 
• Metoclopramide
• Cimetidine

None routine. Specific cases may require

• Hepatic function
• Respiratory function

Theophylline
Theophylline is a phosphodiesterase inhibitor which results in smooth muscle relaxation, diuresis, cardiac stimulation, cerebral stimulation and skeletal muscle stimulation. Through its ability to bring about smooth muscle relaxation, theophylline acts predominantly as a bronchodilator and vasodilator. 

Mepyramine
Mepyramine reversibly competes for histamine-1 receptors in target tissues, thereby preventing the action of histamine. Mepyramine is a 1st generation antihistamine that has sedative, mild anticholinergic and local anaesthetic activity.

Codeine Phosphate
Codeine is a centrally acting weak analgesic. It exerts its effect through mu opioid receptors. It resembles morphine in its pharmacodynamic actions although much weaker in its effects.

COMBINATION PREPARATIONS

Theophylline/ Mepyramine maleate/ Codeine

Syrup (per 15ml) 52.8mg/ 15.84mg/ 8.45mg

• Adco-Metaxol (Adcock)