Promethazine

Registered South African indications:

• Disorders known to respond to antihistamine therapy
• Anaphylactic or anaphylactoid reactions
• Motion sickness
• Nausea and vomiting
• Preoperative and postoperative use
• Parkinsonian symptoms (larger doses)

Contraindications 

South African recommendations

• Hypersensitivity to the active ingredient or any of its excipients
• Cross sensitivity to other antihistamines
• Children <2 years
• Acute asthma attacks
• Comatose patients
• Pre-existing central nervous system depression
• Pre-existing bone marrow depression
• Pre-existing liver disorders
• Pre-existing phaeochromocytoma
• Pre-existing Reye’s Syndrome
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use
• Coadministration with anticholinergic agents

Recommendations in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Coma
• Central nervous system depression of any cause
• Children <2 years
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Asthma
• Bronchitis
• Bronchiectasis
• Severe coronary artery disease
• Narrow-angle glaucoma
• Epilepsy  
• Bladder neck obstruction
• Pyloro-duodenal obstruction
• Children with signs and symptoms of Reye's syndrome
• Coadministration with ototoxic agents
• Hypertension
• Suspected cases of intestinal obstruction or raised intracranial pressure
• May impair ability to drive and operate machinery

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

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Disorders known to respond to antihistamine therapy
- Seasonal rhinitis (hay fever)
- Rhinoconjunctivitis (allergic conjunctivitis)
- Perennial allergic conjunctivitis
- Vasomotor rhinitis
- Conjunctivitis
- Pruritus
- Urticaria
- Angioedema
- Dermatographism
- Urticarial transfusion reactions
Anaphylactic or anaphylactoid reactions (Additional agent required)

• IV/IM: 25mg; Repeat after 2hrs if needed

Motion sickness
- Prophylaxis and treatment of nausea, vomiting, dizziness and vertigo associated with motion sickness

• IV/IM: 25mg, 12hrly as needed

Nausea and vomiting
- Associated with anaesthesia and surgery

• IV/IM: Initial: 25mg; Maintenance: 10-25mg, 4-6hrly as needed

Preoperative and postoperative use
- For hypnotic and sedative effects

• IV/IM: 25-50mg, at night OR pre- or post-surgically

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Administered by slow intravenous injection or injected into the tubing of a freely running infusion in a concentration of not more than 25mg/ml, although it is usually diluted to 2.5mg/ml. The rate of infusion should not exceed 25mg per min

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Indications and dosages registered in other jurisdictions

Allergic conditions of the upper respiratory tract and skin
- Allergic rhinitis
- Urticaria
Anaphylactic reactions to drugs and foreign proteins
Sedation and treatment of insomnia
Adjunct in preoperative sedation in surgery and obstetrics

• IV/IM: 25-50mg; Max: 100mg/24hrs 

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Administered by deep intramuscular injection, or, in emergency, by slow intravenous injection after dilution of the 2.5% solution to 10 times its volume with water for injections immediately before use

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

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Disorders known to respond to antihistamine therapy
- Seasonal rhinitis (hay fever)
- Rhinoconjunctivitis (allergic conjunctivitis)
- Perennial allergic conjunctivitis
- Vasomotor rhinitis
- Conjunctivitis
- Pruritus
- Urticaria
- Angioedema
- Dermatographism
- Urticarial transfusion reactions
Anaphylactic or anaphylactoid reactions (Additional agent required)

Younger than 2 years

• Contraindicated

Older than 2 years

• IM: 0.125mg/kg body mass, 4-6hrly OR 0.5mg/kg body mass, at bedtime as needed OR 6.25-12.5mg, 8hrly as needed OR 25mg at bedtime as needed

Nausea and vomiting
- Associated with anaesthesia and surgery

Younger than 2 years

• Contraindicated

Older than 2 years

• IM/IV: 0.25-0.5mg/kg, 4-6hrly as needed OR 10-25mg, 4-6hrly as needed

Motion sickness
- Prophylaxis and treatment of nausea, vomiting, dizziness and vertigo associated with motion sickness

Younger than 2 years

• Contraindicated

Older than 2 years

• IM/IV: 0.5mg/kg, 12hrly as needed OR 10-25mg, 12hrly as needed

Preoperative and postoperative use
- For hypnotic and sedative effects

Younger than 2 years

• Contraindicated

Older than 2 years

• IM/IV: 0.5-1mg/kg, as needed OR 10-25mg, as needed

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Administered by slow intravenous injection or injected into the tubing of a freely running infusion in a concentration of not more than 25mg/ml, although it is usually diluted to 2.5mg/ml. The rate of infusion should not exceed 25mg per min

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Indications and dosages registered in other jurisdictions

Allergic conditions of the upper respiratory tract and skin
- Allergic rhinitis
- Urticaria
Anaphylactic reactions to drugs and foreign proteins
Sedation

Younger than 2 years

• Contraindicated

Between 5-10 years

• IM (deep): 6.25-12.5mg

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Administered by deep intramuscular injection, after dilution of the 2.5% solution to 10 times its volume with water for injections immediately before use

Pregnancy 

• Caution; not recommended
• Promethazine should not be used during pregnancy unless the physician considers it essential. The use of promethazine is not recommended in the 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate

Breastfeeding

• Caution; not recommended
• Available evidence suggests that the amount excreted in milk is insignificant. However, there are risks of neonatal irritability and excitement

Renal Impairment 

• Caution; no dose adjustment recommended

Hepatic Impairment 

• Caution; no dose adjustment recommended

Elderly 

• Caution; no dose adjustment recommended
  The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Drowsiness
• Dizziness
• Restlessness
• Headaches
• Nightmares
• Tiredness
• Disorientation
• Paradoxical hyperexcitability in children
• Confusion
• Tic-like movements of the head and face
• Extrapyramidal effects

Cardiovascular Disorders

• Palpitations
• Hypotension
• Arrhythmias

Gastrointestinal Disorders

• Dry mouth
• Anorexia
• Gastric irritation

Hepatobiliary Disorders

• Jaundice

Genitourinary Disorders

• Urinary retention

Musculoskeletal Disorders

• Muscle spasms

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Urticaria
• Photosensitive skin reactions

Immune, Blood and Lymphatic System Disorders

• Blood dyscrasias
• Haemolytic anaemia
• Allergic reactions
• Anaphylaxis

Sensory Disorders

• Blurred vision

• Anticholinergic agents
• Tricyclic antidepressants  
• Sedative
• Hypnotics
• Central nervous system depressants
• Antihypertensive agents
• Anticonvulsant agents
• Monoamine oxidase inhibitors

Other interactions

• Alcohol

None routine

Additional observations

• Mental status
• CNS effects
• Signs and symptoms of tissue injury at injection site

Interference with test results

• Promethazine hydrochloride may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results
• Promethazine hydrocloride should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false-negative results

Ototoxicity

• Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates

Promethazine, a phenothiazine derivative, is a long-acting antihistamine with anti-emetic central sedative and anti-cholinergic properties.

Injection (per ml) 25mg

• Promethazine HCL-Fresenius (Fresenius Kabi)
• Phenergan (Sanofi)

Injection (per 2ml) 50mg

• Promethazine HCL-Fresenius (Fresenius Kabi)

Also available in the following forms: Table, syrup and cream.