Codeine Phosphate/ Diphenhydramine Hydrochloride/ Ammonium Chloride/ Sodium Citrate

Registered South African indications: 

• Alleviation of cough

Registered South African contraindications

8.33/13.33/130/54.166 (mg/5ml)
10/12.5/125/50 (mg/5ml)

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Renal impairment
• Hepatic impairment
• Patients with respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract
• Acute alcoholism
• Head injuries
• Conditions in which intracranial pressure is raised
• During an attack of bronchial asthma
• Heart failure secondary to chronic lung disease
• Children under 2 years of age (10/12.5/125/50 (mg/5ml))

2.5/7/68.5/28 (mg/5ml)
5/14/137/56 (mg/5ml)

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Children under 2 years of age

Codeine Phosphate

• Patients with respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion
• Acute alcoholism
• Head injuries
• Conditions in which intracranial pressure is raised
• During an attack of bronchial asthma
• Heart failure secondary to chronic lung disease
• Patients receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment

Diphenhydramine Hydrochloride

• Acute porphyria
• Premature infants or neonates
• Epileptics as large doses they may precipitate fits

Ammonium Chloride

• Renal impairment
• Hepatic impairment
• Advanced arteriosclerosis
• Dehydration

Sodium Citrate

• Patients with metabolic or respiratory alkalosis, hypocalcaemia, or hypochlorhydria should not take bicarbonate-containing salts

South African recommendations

8.33/13.33/130/54.166 (mg/5ml)
10/12.5/125/50 (mg/5ml)

Drowsiness and impaired concentration

• This medicine may cause drowsiness and reduced concentration, worsened by simultaneous intake of alcohol or other CNS depressants
• Patients should avoid hazardous tasks where a lapse in concentration could lead to accidents

Codeine Phosphate

Risk of dependence and addiction

• Overdosing or long-term, continuous use can lead to dependence and addiction

Administer cautiously to patients with:

• Hypothyroidism
• Adrenocortical insufficiency
• Impaired liver function
• Prostatic hypertrophy
• Shock
• Use carefully in patients with inflammatory or obstructive bowel disorders

Dosage considerations

• Dosage should be lower for elderly and debilitated patients

Severe side effects at high doses

• Large doses can cause respiratory depression, hypotension, circulatory failure, deepening coma, and, in children, convulsions

Dependence risk

• Prolonged use of high doses of codeine can lead to morphine-type dependence

Diphenhydramine Hydrochloride

Risks for epileptics

• High doses may induce seizures in individuals with epilepsy

Should be used carefully in conditions sensitive to atropine-like effects

• Glaucoma
• Prostatic hypertrophy

Sodium Citrate

Use cautiously in patients with:

• Cardiac failure
• Hypertension
• Impaired renal function
• Peripheral and pulmonary oedema
• Toxaemia of pregnancy

2.5/7/68.5/28 (mg/5ml)
5/14/137/56 (mg/5ml)

Pregnancy

• Should not be used during pregnancy

Breastfeeding

• Should not be used during lactation

Impacts on drowsiness and concentration

• The medicine may cause drowsiness and impaired concentration, especially when taken with alcohol or CNS depressants

Codeine Phosphate

Use cautiously or in reduced doses for patients with

• Hypothyroidism
• Adrenocortical insufficiency
• Impaired renal or liver function
• Prostatic hypertrophy
• Myasthenia gravis
• Shock
• Inflammatory or obstructive bowel disorders

Dosage considerations

• Dosage should be lower for elderly and debilitated patients

Dependence risk

• Prolonged use of high doses of codeine can lead to morphine-type dependence

Diphenhydramine Hydrochloride

Use with caution in patients with

• Epilepsy
• Severe cardiovascular disorders
• Closed angle glaucoma
• Urinary retention
• Prostatic hypertrophy
• Pyloroduodenal obstruction

Sodium Citrate

Use cautiously in patients with

• Congestive heart failure
• Hypertension
• Renal dysfunction
• Liver cirrhosis
• Pre-eclampsia
• Peripheral or pulmonary oedema
• Patients receiving corticosteroids

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

South African registered indications and dosages

Alleviation of cough

Codeine Phosphate/ Diphenhydramine Hydrochloride/ Ammonium Chloride/ Sodium Citrate
2.5/7/68.5/28 (mg/5ml)
5/14/137/56 (mg/5ml)

• Oral (syr): 10ml, 4hrly

8.33/13.33/130/54.166 (mg/5ml)
10/12.5/125/50 (mg/5ml)

• Oral (syr): 5-10ml, 4hrly

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Codeine component (10/12.5/125/50 (mg/5ml)): A maximum daily dose not exceeding 80 milligrams, exceeding the prescribed dose, together with prolonged and continuous use of this medication may lead to dependence and addiction

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

South African registered indications and dosages

Alleviation of cough

Codeine Phosphate/ Diphenhydramine Hydrochloride/ Ammonium Chloride/ Sodium Citrate
8.33/13.33/130/54.166 (mg/5ml)

• Younger than 1 year: No information available
• Between 1-6 years: Oral (syr): 2.5ml, 4hrly
• Between 6-12 years: Oral (syr): 5ml, 4hrly
• Older than 12 years: See adult dosage

2.5/7/68.5/28 (mg/5ml)
5/14/137/56 (mg/5ml)
10/12.5/125/50 (mg/5ml)

• Younger than 2 years: Contraindicated
• Between 2-6 years: Oral (syr): 2.5ml, 4hrly
• Between 6-12 years: Oral (syr): 5ml, 4hrly
• Older than 12 years: See adult dosage

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Codeine component (10/12.5/125/50 (mg/5ml)): A maximum daily dose not exceeding 80 milligrams, exceeding the prescribed dose, together with prolonged and continuous use of this medication may lead to dependence and addiction

Pregnancy

South African recommendations

• Caution; not recommended
• Sodium citrate should be used with caution in toxaemia of pregnancy
• Should not be used during pregnancy

Breastfeeding

South African recommendations

• Caution; not recommended
• Should not be used during lactation

Fertility

South African recommendations

• No information available

South African recommendations

• Contraindicated

South African recommendations

• Contraindicated

South African recommendations

• Caution; dose adjustment recommended
  The dosage should be reduced in elderly and debilitated patients

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

Codeine Phosphate

Gastrointestinal Disorders

• Vomiting
• Constipation

Central Nervous System Disorders

• Drowsiness
• Confusion
• Vertigo

Autonomic Nervous System Disorders

• Dry mouth
• Sweating
• Facial flushing

Cardiovascular Disorders

• Bradycardia
• Palpitations
• Orthostatic hypotension
• Circulatory failure (larger doses)

Respiratory Disorders

• Respiratory depression (larger doses)

Renal and Urinary Disorders

• Difficulty in micturition
• Ureteric or biliary spasm

Neurological Disorders

• Raised intracranial pressure
• Deepening coma (larger doses)
• Convulsions (in children)

Other Effects

• Hypothermia
• Restlessness
• Changes in mood
• Miosis

Diphenhydramine Hydrochloride

Central Nervous System Disorders

• Sedation, varying from slight drowsiness to deep sleep
• Inability to concentrate
• Lassitude
• Dizziness
• Muscular weakness
• Incoordination
• Headache
• Elation or depression
• Irritability
• Nightmares
• Anorexia
• Tingling, heaviness, and weakness of the hands
• Symptoms of cerebral stimulation
• Insomnia
• Nervousness
• Tachycardia
• Tremors
• Muscle twitching
• Convulsions

Cardiovascular Disorders

• Hypotension

Respiratory Disorders

• Tightness of the chest

Gastrointestinal Disorders

• Nausea
• Vomiting
• Diarrhoea or constipation
• Epigastric pain
• Dryness of the mouth

Renal and Urinary Disorders

• Difficulty in micturition

Sensory Disorders

• Blurred vision
• Tinnitus

Ammonium Chloride

Gastrointestinal Disorders

• Nausea
• Vomiting

Hydration and Exocrine Disorders

• Thirst

Neurological Disorders

• Headache
• Progressive drowsiness

Respiratory Disorders

• Hyperventilation

Metabolic Disorders

• Profound acidosis
• Hypokalaemia

Sodium Citrate

Electrolyte Imbalance Disorders

• Hypernatraemia

Neurological Disorders

• Restlessness
• Weakness
• Dizziness
• Headache
• Delirium

Hydration and Exocrine Disorders

• Thirst
• Reduced salivation and tear production

Cardiovascular Disorders

• Hypotension
• Tachycardia

Respiratory Disorders

• Hyperpnoea
• Respiratory arrest

Renal Disorders

• Oliguria

Dermatological Disorders

• Flushing of the skin

Other Disorders

• Swollen tongue
• Pyrexia

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

Codeine Phosphate

• Monoamine oxidase inhibitors
• Alcohol
• Anaesthetics
• Hypnotics
• Sedatives
• Phenothiazines

Diphenhydramine Hydrochloride

• Central nervous system depressants
• Alcohol
• Barbiturates
• Hypnotics
• Narcotic analgesics
• Sedatives
• Tranquilizers
• Anticholinergic agents
• Atropine
• Tricyclic antidepressants

None routine. Specific cases may require

• Renal function
• Hepatic function
• Respiratory function
• Electrolytes

Acts as a cough suppressant, as an expectorant in the relief of cough, aids in drying up excess mucous secretions.

Codeine Phosphate
Codeine has an analgesic and antitussive action and is frequently used to allay an irritating unproductive cough.

Diphenhydramine Hydrochloride
Diphenhydramine has the properties and uses of antihistamine drugs in general. It has sedative, anti-emetic, anticholinergic, local anaesthetic and mild spasmolytic properties.

Ammonium Chloride
Ammonium chloride is used as an expectorant.

COMBINATION PREPARATIONS

Ammonium/ Citric Acid/ Diphenhydramine/ Codeine

Syrup (per 5ml) 68,5mg/28mg/7mg/2.5mg

• Tussitot (Adcock)

Syrup (per 5ml) 125mg/50mg/12.5mg/10mg

• Broncleer with codeine (Adcock)