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PHENERGAN ELIXIR 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 for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and 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 Either 10 – 25 mg as a single dose. Or 5 – 10 mg twice a day. Maximum daily dose 25 mg. Children over 10 years and adults (including elderly) Initially 10 mg twice a day. Increasing to a maximum of 20 mg three times a day as required.
As an antiemetic:
Children 6 – 10 years 10 mg to be taken the night before the journey. To be repeated after 6 – 8 hours as required. 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 20 mg or 25 mg as a single night time dose. Children over 10 years and adults (including elderly) 25 mg or 50 mg as a single night time dose.
The use of Phenergan tablets to provide these doses is recommended. Method of administration For oral administration.
The following CIOMS frequency rating is used:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 00 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Immune system disorders Frequency not known:
Allergic reactions, including anaphylactic reaction, urticaria, angioedema.
Skin and subcutaneous tissue disorders Frequency not known:
Rash, photosensitivity reaction.
Nervous system disorders Very common:
Sedation or somnolence Frequency not known: Dizziness, headaches, extrapyramidal effects, restless legs syndrome, muscle spasms and tic-like movements of the head and face.
Frequency 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.
Frequency not known:
Anticholinergic effects such as ileus paralytic, risk of urinary retention, dry mouth, constipation, accommodation disorder. The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine. Frequency Not known: children less than 6 years of age also experienced psychomotor hyperactivity.
Psychiatric disorders Frequency not known:
Agitation, confusional state, anxiety.
Frequency not known:
Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with Phenergan Elixir use. 8). Phenergan Elixir 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 Phenergan Elixir due to the risk of sedation. 5). Phenergan Elixir should not be used for longer than 7 days without seeking medical advice. Caution should be used in patients with: • Asthma, bronchitis or bronchiectasis.
Phenergan may thicken or dry lung secretions and impair expectoration. g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting. 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). Photosensitivity reactions Due to the risk of photosensitivity, exposure to strong sunlight or ultraviolet light should be avoided during or shortly after treatment. 8). The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.
Excipients with known effect Sugar as hydrogenated glucose syrup (maltitol liquid): Patients with rare hereditary problems of fructose intolerance should not take this medicine. If you have diabetes, you should be aware that Phenergan Elixir contains carbohydrates, which the body will convert into small amounts of sugar.
The maximum 25 ml single dose of Phenergan Elixir is equivalent to approximately 5 g of sugar, or one teaspoon of sugar/sugar lump. Taking this amount of Phenergan Elixir is unlikely to affect the control of your diabetes or require you to increase your diabetes medication.
• Phenergan should not be given to patients with a known hypersensitivity to promethazine, other phenothiazines, or to any other ingredients in the formulation of Phenergan Elixir. • Phenergan should not be used in patients in coma or suffering from CNS depression of any cause.
4). • Phenergan 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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Infants, newborns and premature are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation Frequency Not known: children less than 6 years of age also experienced aggression and hallucination.
4), nasal congestion Hepatobiliary disorders Frequency not known: Jaundice cholestatic Blood and lymphatic system disorders Frequency not known: Blood dyscrasias including haemolytic anaemia, agranulocytosis, leukopenia, eosinophilia, thrombocytopenia (including thrombocytopenic purpura).
General disorders and administration site conditions Frequency 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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83% of the WHO recommended daily intake of 2 g sodium for an adult. This should be taken into account if you are on a controlled sodium diet.
Sulphites:
These are preservatives used in Phenergan Elixir, which may rarely cause severe hypersensitivity reaction , characterised by circulatory collapse with CNS depression and bronchospasm in certain susceptible individuals with allergic tendencies.
Benzoic acid:
Phenergan Elixir contains 5mg sodium benzoate in each 5ml dose, which is equivalent to 1mg/ml. Sodium benzoate may increase bilirubinemia in newborn babies (up to 4 weeks old). 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.