Allergex Mepyramine Cream
Clinical Summary
Quick overview from the medicine insert
Indication
Relief of symptoms associated with allergic conditions such as hay fever, urticaria, and insect bites.
Dosage (summary)
Apply a thin layer of cream to the affected area 2-3 times daily, or as directed by a healthcare professional.
Onset of Action / Duration
Onset of action typically occurs within 30 minutes, with a duration of effect lasting up to 6 hours.
Special Populations
- Elderly patients
- Patients with liver impairment
- Patients with renal impairment
Pregnancy & Breastfeeding
Use with caution during pregnancy and lactation; consult a healthcare professional before use.
Key Drug Interactions
- May enhance the sedative effects of alcohol and other CNS depressants.
- Use with caution in combination with other antihistamines.
Contraindications
- Hypersensitivity to mepyramine maleate or any other component of the formulation.
- Patients with narrow-angle glaucoma.
- Patients with prostatic hypertrophy.
Common side effects
- Local skin reactions (e.g., redness, itching, burning).
- Drowsiness.
- Dry mouth.
Counselling Points
- Advise patients to avoid applying to broken skin or open wounds.
- Instruct patients to wash hands after application to avoid accidental contact with eyes.
- Caution patients about potential drowsiness; advise against driving or operating heavy machinery until they know how the medication affects them.
Serious warnings
- Not for use in children under 2 years of age.
- Use with caution in patients with cardiovascular disease.
Important Disclaimer
The Allergex Mepyramine Cream professional information leaflet below is the property of Adcock Ingram and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
ALLERGEX MEPYRAMINE CREAM is indicated for the treatment of allergic and pruritic conditions such as, urticaria, allergic dermatoses, itching pruritis, atopic dermatitis, contact dermatitis and insect bites.
4.2 Posology and method of administration
Apply to the affected area two or three times daily for up to three days. For external use only. Method of administration: Topical
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients. Should not be used for acute vesicular and exudative dermatoses. Mepyramine is contra-indicated in premature infants or neonates. Use with occlusive dressings. Use on broken skin and in patients hypersensitive to mepyramine.
4.4 Special warnings and precautions for use
Repeated application of ALLERGEX MEPYRAMINE CREAM for periods longer than a few days is not recommended and treatment should be discontinued immediately if skin sensitization occurs.
4.5 Interaction with other medicinal products and other forms of interaction
No significant interactions described.
4.6 Fertility, pregnancy and lactation
Safety in pregnancy and lactation has not been established.
4.7 Effects on ability to drive and use machines
May theoretically be extensively absorbed through the skin when applied over large areas and cause somnolence and mild disorientation.
4.8 Undesirable effects
Tabulated list of adverse reactions presented in system organ class
System organ class Undesirable effects
- Skin and subcutaneous tissue disorders Local application of antihistamines causes a risk of skin sensitisation with eczematous eruptions.
- General disorders and administrative site conditions Systemic side effects have been reported after topical application of antihistamines to large areas of the skin.
- Nervous system disorders Somnolence and mild disorientation
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/publications/Index/8 May also report to Adcock Ingram Limited using the following email: [email protected]
4.9 Overdose
If accidentally ingested, the stomach should be emptied by aspiration. Emetics should not be used. Other treatment is symptomatic and supportive.
