Stadexmin

Rx

Indications

• Symptomatic treatment of seasonal and perennial allergic rhinitis after failure of antihistamine alone or associated with local corticosteroids.
• Symptomatic treatment of short duration (maximum 10 days) acute hives.

Dosage

• Adult and children over 12 years old: 3 or 4 tablets per a day.
• Children from 6 to 12 years old: 1 tablet, morning and evening.
  The lowest effective dosage should always be sought, which can be lowered to 1 tablet every 2 days.
• The usual duration of treatment for acute urticaria will not exceed 10 days; therefore, when stopping treatment need not gradually reduce the dose.

Usage

• Orally administered.

• Hypersensitivity to any of the ingredients.

Due to the presence of betamethasone:

• Any infectious condition,
• Certain evolving virus diseases (in particular hepatitis, herpes, chickenpox, shingles);
• Psychotic states not yet controlled by treatment;
• Taking live vaccines;

Due to the presence of dexchlorphenilamine maleate:

• Risk of narrow-angle glaucoma;
• Risk of urinary retention linked to urethro-prostatic disorders;
• Children under 6 years old;
• Breast-feeding;
• In combination with non-antiarrhythmic drugs, giving torsades de pointes;

Common

Betamethasone

• Adverse effects are especially to be feared in large doses or during prolonged treatment over several months;
• Hypokalaemia, metabolic alkalosis, hydrosodium retention, arterial hypertension, congestive heart failure;
• Latrogenic Cushing’s syndrome, inertia of ACTH secretion, sometimes definitive adrenocortical atrophy, decrease in glucose tolerance, growth arrest in children, menstrual irregularities;
• Muscle atrophy preceded by muscle weakness (increased protein catabolism), osteoporosis, pathological fractures in particular vertebral compression, aseptic osteonecrosis of the femoral heads;
• Euphoria, sleeplessness, excitement.

Dexchlorpheniramine maleate

• Sedation or drowsiness
• Dryness of the mucous membranes, constipation, accommodation disorders, mydriasis, heart palpitations, risk of urinary retention.
• Orthostatic hypotension.

• This medicine is not suitable for treatment of chronic urticatia.
• In paitents with peptic ulcer, corticosteroid therapy is not contraindicated if an anti-ulcer treatment is associated. In the event of ulcerative history, corticosteroid therapy may be prescribed, with clinical monitoring and if necessary after fibroscopy.
• Corticosteroids therapy can promote the occurrence of various infectious complications due in particular to bacteria, yeasts and parasites. The occurrence of malignant anguillulosis is a significant risk.
• All subjects coming from an endemic area (tropical, subtropical, southern Europe) must have a parasitological examination and systematic eradication treatment before corticosteroid therapy.
• The signs of progressive infection may be masked by corticosteroid therapy.
• It is important, before starting treatment, to rule out any possibility of visceral focus, in particular tuberculosis, and to monitor the appearance of infectious pathologies during treatment.
• In the case of anamnesis tuberculosis, prophylactic anti-tuberculosis treatment is necessary if there are significant radiological sequelae and if it is not possible to ensure that a well managed 6 months treatment with rifampicin has been given.
• The use of corticosteroids requires particularly adapted surveillance, especially in the elderly and in case of ulcerative colitis (risk of perforation), recent intestinal anastomosis, renal failure, liver failure, osteoporosis, myasthenia gravis.
• When treatment with Stadexmin is necessary, it is not contraindicated in patients with diabetes and arterial hypertension, but treatment can lead to imbalance. Their management should be reassessed.
• Hydrosodium retention is usual when treatment with Stadexmin, partly responsible for a possible rise in blood pressure. The sodium intake will be moderate in the daily diet.
• Patients should avoid contact with individuals with chickenpox or measles, due to the risk of immunosuppression.
• Betamethasone can induce a positive reaction to tests performed during doping controls.
• The drug should be used with cautions in elderly patients presenting: Greater sensitivity to postural hypotension, dizziness and sedation; chronic constipation (risk of paralytic ileus); possible prostatic hypertrophy, patients in case offliver failure and/or kidney severe.
• The intake of alcoholic beverages or medicines containing alcohol during Stadexmin administration is not recommended.
• Visual disturbances may appear during systemic or local corticosteroid therapy (especially nasal, inhaled and intraocular). In the event of blurred vision or the appearance of any other visual symptom appearing during corticosteroid therapy, an ophthalmological examination is required to check for visual disturbances, in particular cataracts, glaucoma, or more lesion. Rare such as central serous chorioretinopathy, described with the administration of corticosteroids by systemic or local route.
• Stadexmin contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Stadexmin contains the azo colouring agents e.g., sunset yellow and ponceau 4R, which may cause allergic reactions.
• The drug can be prescribed if necessary during pregnancy, especially in the third trimester, limited to occasional use. If the administration of this drug took place at the end of pregnancy, it seems justified to observe a period of monitoring of the neurological and digestive functions of the infants.
• Taking Stadexmin during breastfeeding is not recommended.
• Attention is drawn, particularly in drivers and machine operators, the risk of drowsiness associated to the use of this medicine, especially at the start of treatment. This phenomenon is accentuated by taking alcoholic beverages or medicines containing alcohol.