Ammonium Chloride/ Theophylline/ β-Hydroxyethyl Theophylline/ Diphenylpyraline

Registered South African indications:

• Cough

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

Ammonium Chloride
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Severe renal impairment
• Severe hepatic impairment
• Metabolic alkalosis 

Cautions

• Pregnancy
• Breastfeeding
• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• Respiratory insufficiency

Theophylline
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Concomitant use with ephedrine in children
• Acute porphyria
• Children (tab)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Cardiac arrhythmia
• Acute myocardial infarction
• Congestive cardiac failure
• Peptic ulcer disease
• Hyperthyroidism
• Severe hypertension
• Chronic alcoholism
• Chronic lung disease
• Acute febrile illnesses

B-Hydroxyethyl Theophylline
Contraindications

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

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Peptic ulcer disease
• Cardiac disease
• Benign prostatic hypertrophy 
• Glaucoma 

Diphenylpyraline
Contraindications

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

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Closed angle glaucoma
• Prostatic hypertrophy
• Cardiac disease

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

Cough

Ammonium Chloride/ Theophylline/ B-Hydroxyethyl Theophylline/ Diphenylpyraline
360/50/5/4 (mg/15ml)

• Oral (syr): 15ml, 8hrly

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Take with meals

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

Cough

Ammonium Chloride/ Theophylline/ B-Hydroxyethyl Theophylline/ Diphenylpyraline
360/50/5/4 (mg/15ml)

• Younger than 1 year: Not established for use
• Between 1-5 years: 5ml, 8hrly
• Between 6-12 years: 10ml, 8hrly
• Older than 12 years: See adult dosage

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Take with meals

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

Pregnancy

• FDA Pregnancy Category Not Rated (NR) (B-Hydroxyethyl Theophylline, Diphenylpyraline)

Breastfeeding

• Caution (Ammonium Chloride, Theophylline, B-Hydroxyethyl Theophylline, Diphenylpyraline)

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended (Ammonium Chloride) 
• Severe: Contraindicated (Ammonium Chloride)

Hepatic Impairment

• Mild to moderate: Caution; no dose adjustment recommended (Ammonium Chloride) 
• Severe: Contraindicated (Ammonium Chloride)

Elderly

• Caution; dosage adjustment recommended (Theophylline)

Drugs in Sport

• Permitted - No warning

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

Ammonium Chloride
Central Nervous System Disorders

• Coma
• Confusion
• Seizures
• Fever  

Gastrointestinal Disorders

• Gastrointestinal discomfort
• Nausea and vomiting

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 

Skin and Subcutaneous Tissue Disorders

• Rash
• Maculo-papular rash
• Erythema
• Pruritus
• Urticaria
• Exfoliative dermatitis

Sensory Disorders

• Visual disturbances

Others

• High doses may cause hyperthermia and extreme thirst 

B-Hydroxyethyl Theophylline
Central Nervous System Disorders

• Insomnia
• Irritability

Cardiovascular Disorders

• Tachycardia
• Palpitations

Gastrointestinal Disorders

• Abdominal pain
• Diarrhoea
• Nausea and vomiting

Diphenylpyraline
Central Nervous System Disorders

• Drowsiness
• Sedation
• Seizures

Gastrointestinal Disorders

• Dryness of secretions

Immune, Blood and Lymphatic System Disorders

• Agranulocytosis
• Haemolytic anaemia

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

Ammonium Chloride

• Potassium sparing diuretics

Theophylline

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

B-Hydroxyethyl Theophylline

• Central nervous system depressants 
• Warfarin
• Sulphonylureas

Diphenylpyraline

• Central nervous system depressants 
• Anticholinergic agents
• Warfarin
• Sulphonylureas

None routine

Ammonium chloride
Ammonium chloride is used as an expectorant. It causes irritation of the bronchial mucosa, which results in the production of excess respiratory tract fluid. This allows for easier mucus expulsion due to its decreased viscosity. 

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 predominently as a bronchodilator and vasodilator. 

B-Hydroxyethyl Theophylline 
B-Hydroxyethyl Theophylline is N-7 substituted theophylline derivative which acts similar to other xanthines. The bronchodilating action of xanthines is thought to result from the competitive inhibition of phosphodiesterase, which is the enzyme responsible for the breakdown cyclic AMP in smooth muscle cells. 

Diphenylpyraline
Diphenylpyraline is an antihistamine, which produces therapeutic anti-allergic effects by binding to histamine H1-receptors. 

COMBINATION PREPARATIONS

Ammonium Chloride/ Theophylline/ B-Hydroxyethyl Theophylline/ Diphenylpyraline

Syrup (per 15ml) 360mg/50mg/5mg/4mg

• Theophen Comp (Pharmacare)