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PROMETHAZINE HYDROCHLORIDE is a brand name for Promethazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: As symptomatic treatment of allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drug or foreign proteins. As an antiemetic For short term use: - Treatment of insomnia in adults - As a paediatric sedative
Verbatim from this product's MHRA label. Tap a section to expand.
3).
As an antihistamine in allergy:
Children 6-10 years 25 mg as a single dose*. Maximum daily dose 25 mg. Children over 10 years and adults (including elderly) 25 mg as a single dose*. Increasing to a maximum of 25 mg twice a day as required. *Single doses are best taken at night.
As an antiemetic:
Children 6-10 years The use of Promethazine liquid is recommended. Children over 10 years and adults (including elderly) 25 mg to be taken the night before the journey. To be repeated after 6-8 hours as required. As a paediatric sedative for short term use and for short term treatment of insomnia in adults: Children 6-10 years 25 mg as a single night-time dose.
Children over 10 years and adults (including elderly) 25 or 50 mg as a single night-time dose. Method of administration For oral use.
The following CIOMS frequency raiting is used:
Very common (≥1/10); commom (≥1/100 to 1/10); uncommon (≥1/1,000 to 1/100); rare (≥1/10,00 to 1/1,000); vary rare (<1/10,000), not known (cannot be estimated from the available data).
Immune System disorders Not known:
Allergic reactions, including urticaria, angioedema, and anaphylactic reactions have been reported.
Skin and subcutaneous tissue disorders Not known:
Rash, Photosensitive skin reactions have been reported.
Nervous system disorders Very common:
Sedation or Somnolence Not known: Dizziness, headaches, extrapyramidal effects including restless legs syndrome, muscle spasms and tic-like movements of the head and face.
Not known:
Dystonia, including oculogyric crisis, usually transitory are commoner in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases.
Not known:
Anticholinergic effects such as ileus paralytic, risk of urinary retention, dry mouth, constipation, accommodation disorder, neuroleptic malignant syndrome, psychomotor hyperactivity. The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.
Not known: children less than 6 years of age also experienced psychomotor hyperactivity.
Psychiatric disorders Not known:
Agitation, confusional state, anxiety, hallucinations, aggression.
Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with Promethazine use. 8). Promethazine should be avoided in patients with liver or renal dysfunction, parkinson’s disease, hypothyroidism, cardiac failure, pheochromocytoma, myasthenia gravis, or prostate hypertrophy, or in patients with a history of narrow angle glaucoma or agranulocytosis.
Caution must be exercised when using H1-antihistamines such as Promethazine due to the risk of sedation. 5). Promethazine should not be used for longer than 7 days without seeking medical advice. Caution should be used in patients with: • asthma, bronchitis or bronchiectasis.
Promethazine may thicken or dry lung secretions and impair expectoration, • severe coronary artery disease, • narrow angle glaucoma, • epilepsy, • hepatic or renal insufficiency, • bladder neck or pyloroduodenal obstruction. g. salicylates.
It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting. QT interval As phenothiazines can prolong the QT interval, caution is advised in treated patients with pronounced bradycardia, cardiovascular disease, with a hereditary form of prolongation of the QT interval and concomitant use with other products leading to QT prolongation.
QT Prolongation Phenothiazine derivatives may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). e. drug induced) QT prolongation.
8). 8). 8). The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye's Syndrome. Excipient(s) with known effect This medicine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
1. Promethazine should not be used in patients in coma or suffering from CNS depression of any cause. Promethazine is contraindicated for use in children less than 6 years of age because of the potential for fatal respiratory depression.
Promethazine should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Promethazine in United Kingdom.
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Not known:
Infants (newborn and premature) are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmare and disorientation. Not known: children less than 6 years of age also experienced aggression and hallucination.
4), nasal congestion Hepatobiliary disorders Not known Jaundice, cholestatic Blood and lymphatic system disorders Not known: Blood dyscrasias including haemolytic anaemia rarely occur. Agranulocytosis, leukopenia, eosinophilia, thrombocytopenia (including thrombocytopenia purpura).
General and administration site conditions Not known:
Tiredness Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 5). Phenothiazines may be additive with, or may potentiate the action of, other CNS depressants such as opiates or other analgesics, barbiturates or other sedatives, general anesthetics, or alcohol.
8) and requires immediate hematological investigation. All patients should be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count.
Treatment should be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the blood count.