Diphenhydramine Hydrochloride

Registered South African indications:

• Relief of cough and its congestive symptoms and for treatment of hay fever and other allergic conditions affecting the upper respiratory tract (syr)
• Alleviation of temporary insomnia (cap)

Registered South African contraindications

Syrup

• Hypersensitivity to the active ingredient or any of its excipients
• Diphenhydramine hydrochloride should not be used with monoamine oxidase inhibitors or within 14 days of stopping monoamine oxidase inhibitor treatment
• Acute asthmatic attacks
• Renal impairment
• Hepatic impairment
• Not be used in children below 6 years of age

Capsule

• Epilepsy
• Pregnancy
• Breastfeeding
• Not to be taken by children under the age of twelve years

South African recommendations

Considerations related to syrup dosage form

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Glaucoma 
• Urinary retention
• Prostatic hypertrophy
• Cardiovascular disease

Central nervous system and psychomotor effects

• Diphenhydramine hydrochloride may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant medicines
• In infants and children, it may act as a cerebral stimulant, with symptoms including insomnia, nervousness, tachycardia, tremors and convulsions
• Large doses may precipitate fits in epileptics
• Deepening coma, extrapyramidal effects and photosensitisation of the skin may occur
• Elderly patients are more susceptible to central nervous system depressant and hypotensive effects

Coadministration with other diphenhydramine containing products

• Do not use with any other product containing diphenhydramine, including topical applications

Effect on skin tests

• The positive results of skin tests may be suppressed

Respiratory considerations

• Diphenhydramine hydrochloride should be used with care in respiratory conditions including emphysema, chronic bronchitis, or acute or chronic bronchial asthma
• Diphenhydramine hydrochloride should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician

Excipient warnings

• Diphenhydramine hydrochloride contains sucrose and glucose; patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine
• This medicine contains sodium benzoate, which may increase neonatal jaundice following an increase in bilirubinaemia, potentially developing into kernicterus

Considerations related to capsule dosage form

Caution in the following patient groups

• Renal impairment
• Hepatic impairment
• Elderly

Continuation of condition

• If the condition persists for more than 10 days, a doctor should be consulted

Central nervous system (CNS) depressants

• The use of diphenhydramine hydrochloride leads to drowsiness, which is aggravated by the simultaneous intake of alcohol and other CNS depressants

Excipient warnings

• Diphenhydramine hydrochloride capsule contains lactose and fructose; patients with rare hereditary conditions of galactose intolerance (e.g., galactosaemia), Lapp lactase deficiency, glucose-galactose malabsorption, or fructose intolerance should not take this medicine

Effects on ability to drive and use machines (cap, syr)

• Diphenhydramine hydrochloride capsule and syrup may cause drowsiness, dizziness or blurred vision. Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights as impaired decision making could lead to accidents

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

South African registered indications and dosages

Alleviation of temporary insomnia

• Oral (cap): 50-100mg, at night 20 min before retiring

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Diphenhydramine hydrochloride capsules are intended for occasional use. They are not to be used on successive nights or over periods exceeding several days

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

South African registered indications and dosages

Relief of cough and its congestive symptoms and for treatment of hay fever and other allergic conditions affecting the upper respiratory tract

Younger than 6 years

• Not recommended (see Contraindications)

Between 6-12 years

• Oral (syr): 14mg (10ml), 3hrly; Max: 4 doses/24hrs should not be exceeded

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Shake the bottle before use

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Should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician

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Capsules are not to be taken by children under the age of twelve years (see Contraindications)

Pregnancy

South African recommendations

Syrup

• Caution
• Safety has not been established
• Diphenhydramine crosses the placenta

Capsule

• Contraindicated
• Safety and/or efficacy has not been established

Breastfeeding

South African recommendations

Syrup

• Caution
• Safety has not been established
• Diphenhydramine is excreted into breastmilk

Capsule

• Contraindicated
• Safety and/or efficacy has not been established

Fertility

South African recommendations

• No information available

South African recommendations

Syrup

• Contraindicated

Capsule

• Caution; no information available

South African recommendations

Syrup

• Contraindicated

Capsule

• Caution; no information available

South African recommendations

Syrup

• Caution
  Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects

Capsule

• Caution; no information available

Blood and the lymphatic system disorders

Less frequent

• Thrombocytopenia

Frequency unknown

• Agranulocytosis
• Leucopenia
• Haemolytic anaemia

Immune System Disorders

Frequency unknown

• Allergic reactions
• Anaphylaxis

Endocrine Disorders

Less frequent

• Epigastric pain

Metabolism and Nutrition Disorders

Less frequent

• Anorexia
• Increased appetite

Psychiatric Disorders

Less frequent

• Euphoria
• Confusional state
• Irritability
• Hallucination
• Nervousness

Nervous System Disorders

Frequent

• Sedation

Less frequent

• Headache
• Agitation
• Abnormal coordination
• Convulsion
• Dizziness
• Insomnia
• Paraesthesia
• Somnolence
• Tremor

Eye Disorders

Less frequent

• Blurred vision

Ear and Labyrinth Disorders

Less frequent

• Tinnitus

Cardiac Disorders

Less frequent

• Palpitations
• Tachycardia

Vascular Disorders

Less frequent

• Hypotension

Respiratory, Thoracic and Mediastinal Disorders

Less frequent

• Tightness of the chest
• Dry throat
• Nasal dryness

Gastrointestinal Disorders

Less frequent

• Nausea
• Vomiting
• Diarrhoea
• Constipation
• Dryness of the mouth

Skin and Subcutaneous Tissue Disorders

Less frequent

• Rash
• Pruritus
• Urticaria

Musculoskeletal, Connective Tissue and Bone Disorders

Less frequent

• Muscular weakness

Renal and Urinary Disorders

Less frequent

• Difficulty in micturition
• Dysuria
• Urinary retention

General Disorders and Administration Site Conditions

Less frequent

• Asthenia

• Atropine
• Tricyclic antidepressants
• Monoamine oxidase inhibitors (MAOIs)
• Ototoxic agents
• Aminoglycoside antibiotics
• Central nervous system depressants
• Barbiturates
• Hypnotics
• Narcotic analgesics
• Sedatives
• Tranquillisers

Other interactions

• Alcohol

None routine

Diphenhydramine hydrochloride is an antihistaminic and, by its atropine like action, relieves cough.

Tablet 25mg

• Sleepeze-PM (GlaxoSmithKline)

Capsule 50mg

• Betasleep (Adcock)

Syrup 5mg (per 5ml)

• Benylin Paediatric Syrup

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)

Ammonium/ Citric acid/ Theophylline/ Diphenhydramine/ Menthol

Syrup (per 10ml) 273.86mg/ 113.83mg/ 56.32mg/ 28.15mg/ 2.28mg

• Adco-Diatussin (Adcock)

Ammonium Chloride/ Etofylline/ Diphenhydramine

Syrup (per 15ml) 410.5mg/105.5mg/42.2mg

• Dilinct ( Adcock)

Ammonium chloride/ Theophylline/ Diphenhydramine hcl/ Hydroxyethyl theophylline/ Citric acid

Syrup (per 5ml) 120mg/16,667mg/6.667mg/1.667mg/50mg

• Alcophyllex (Adcock) originator

Ammonium/ Citric acid/ Diphenhydramine

Syrup (per 5ml) 50mg/50mg/12mg

• Histodor (Pharmacare)

Syrup  (per 5ml) 137mg/57mg/14.07mg

• Broncleer children (Adcock)

Syrup (per 5ml) 135mg/55mg/14.1mg

• Clear cough syrup (Be-Tabs)

Syrup (per 5ml) 136mg/56mg/14mg

• Amcough (Innovata)
• Betalin (Be-Tabs)
• Medilyn (Medpro)

Syrup (per 5ml) 137mg/57mg/14.1mg

• DPH (Adcock)

Ammonium chloride/ Diphenhydramine

Syrup (per 5ml) 125mg/12.5mg

• Benylin Original (Johnson & Johnson) originator
• Expectalin (Johnson & Johnson) originator

Ammonium/ Diphenhydramine/ Codeine

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

• Benylin with Codeine (Johnson & Johnson) originator
• Expectalin with Codeine (Johnson & Johnson) originator

Syrup (per 5ml) 100mg/12mg/7.5mg

• Flutex Co Linctus (Aspen)

Glyceryl guaiacolate/ Diphenhydramine/ Pholcodeine

Syrup (per 5ml) 100mg/15mg/8mg

• Folcofen (Alliance) originator

Diphenhydramine/ Sodium citrate/ Ammonium chloride

Syrup (per 5ml) 14mg/56mg/136mg

• Bencough expectorant (Medicine Dev)

Paracetamol/ Pseudoephedrine/ Diphenhydramine

Liquid (per 20ml) 1000mg/45mg/25mg

• Benylin Four Flu (Johnson & Johnson)

Tablet 500mg/22.5mg/12.5mg

• Benylin Four Flu (Johnson & Johnson)

Paracetamol/ Ascorbic acid/ Diphenhydramine/ Phenylephrine

Capsule 400mg/50mg/10mg/5mg

• Fluend (Akacia)

Paracetamol/ Caffeine/ Codeine/ Diphenhydramine

Tablet 400mg/50mg/10mg/5mg

• Lenadol (Pharmacare)
• Propain (Adcock)
• Tensolve (Pharmacare)

Diphenhydramine/ Mepyramine maleate

Cream (per 5g) 50mg/50mg

• Histodor (Pharmacare)

Calamine/ Zinc/ Diphenhydramine/ Phenol

Lotion (per ml) 150mg/50mg/10mg/4mg

• Adco-Biohist (Adcock)