Promethazine

Registered South African indications:

• Allergic disorders and anaphylactic reactions
• Sensitisation reactions to various medicines or other substances

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Coma or central nervous system depression
• Children younger than 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 and adolescents with signs and symptoms of Reye's syndrome
• Intestinal obstruction
• Raised intracranial pressure
• Prolonged use more than 7 days
• Sodium controlled diet (syr)
• Coadministration with ototoxic agents
• Galactose intolerance
• Total lactase deficiency
• Fructose intolerance (syr)
• Glucose-galactose malabsorption
• May impair ability to drive and operate machinery

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

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

• Oral (tab): Initial: 10mg, 12hrly; Max: 20mg, 8hrly, as needed, OR 25mg, 12-24hrly; Max: 50mg/24hrs 
• Oral (syr): Initial: 10mg, 12hrly; Max: 20mg, 8hrly, as needed

---

If daytime relief is needed, use 8hrly dose. If requiring a larger dosage, take as a single dose at night

---

Nausea and vomiting
Motion sickness

• Oral (syr, tab): 20-25mg, 6-8hrly, as needed, starting the night before the journey

Insomnia - Short-term treatment

• Oral (syr, tab): 20-50mg, dly at night

---

May impair ability to drive and operate machinery for up to 12 hours

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

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

• Younger than 2 years: Contraindicated
• Between 2-5 years: Oral (syr): 5-15mg, dly OR 5mg, 12hrly; Max: 15mg/24hrs  
• Between 5-10 years: Oral (syr, tab): 10-25mg, dly OR 5-10mg, 12hrly; Max: 20-25mg/24hrs 
• Older than 10 years: See adult dosage

Nausea and vomiting
Motion sickness

• Younger than 2 years: Contraindicated
• Between 2-5 years: Oral (syr): 5mg, 6-8hrly, as needed, starting the night before the journey
• Between 5-10 years: Oral (syr, tab): 10mg, 6-8hrly, as needed, starting the night before the journey
• Older than 10 years: See adult dosage

Sedation - Short-term treatment

• Younger than 2 years: Contraindicated
• Between 2-5 years: Oral (syr): 15-20mg, dly at night
• Between 5-10 years: Oral (syr, tab): 20-25mg, dly at night
• Older than 10 years: See adult dosage

Pregnancy 

• Caution
• 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
• Confusion
• Paradoxical hyperexcitability
• Extrapyramidal side effects
• Tic-like movements of head and face
• Restless legs syndrome

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

• Urticaria
• Rash
• Pruritis
• Photosensitivity reactions

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis
• Haemolytic anaemia
• Blood dyscrasias

Sensory Disorders

• Blurred vision

• Anticholinergic agents
• Tricyclic antidepressants
• Central nervous system depressants
• Sedatives
• Hypnotics
• Monoamine oxidase inhibitors

Other interactions

• Alcohol

None routine 

Additional observations

• Mental status
• CNS effects

Tablet 10mg, syrup - EML (Primary)

Tablet 25mg - Non-EML 

---

Interference with test results

• Promethazine hydrochloride may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results
• Promethazine hydrochloride 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. 

Tablet 10mg

• Phenergan (Sanofi)

Tablet 25mg

• Phenergan (Sanofi)

Syrup (per 5ml) 5mg

• Brunazine (Trinity) originator
• Lenazine (Pharmacare)
• Prohist (Be-Tabs)

Also available in the following forms: Injection and cream.

COMBINATION PREPARATIONS

Paracetamol/ Promethazine/ Codeine

Syrup (per 5ml) 120mg/6.5mg/5mg

• Adco-Kiddipayne (Adcock Ingram)
• Ban Pain A/F (Pharmacare)
• Dynapayne Syrup (Thebe)
• Goldgesic Syrup (Medicine Dev)
• Infapain Forte (Alliance) originator
• Lentogesic (Adcock Ingram)
• Medipyn (Caps Pharma)
• Painagon (Be-Tabs)
• Pynmed Syrup (Cipla)
• Salterpyn Syrup (Adcock Ingram)
• Stopayne Syrup (Adcock Ingram)

Paracetamol/ Promethazine/ Codeine

Syrup (per 5ml) 120mg/7mg/5mg

• Tenston Syrup (Adcock Ingram)

Promethazine/ Codeine/ Ephedrine

Syrup (per 5ml) 3.6mg/9mg/7.2mg

• Dequa-Coff (Pharmacare)
• Lenazine Forte (Pharmacare)

Syrup (per 5ml) 3mg/9.2mg/7mg

• Brunacod (Trinity) originator

Promethazine/ Pholcodine

Syrup (per 5ml) 1.5mg/1.5mg

• Tixylix (Pharmacare)

Promethazine/ Ephedrine

Syrup (per 5ml) 3.6mg/7.2mg

• Phensedyl Cough Linctus (Sanofi)

Paracetamol/ Promethazine/ Codeine/ Pseudoephedrine

Syrup (per 5ml) 120mg/6.5mg/5mg/25mg

• Colcaps (Adcock Ingram)