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Antihistamines & Antiallergics

Stadexmin

 

Pack size:

Box of 1 bottle 500 tablets.

 

Composition:

Each tablet contains betamethas 0.25 mg

and dexchlorpheniramine maleate 2.0 mg.

 

Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place.

Protect from light. Do not store above 30oC.



 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Treatment of difficult cases of respiratory, dermatologic and ocular allergies, as well as ocular inflammatory disorders, where adjunctive systemic corticosteroid therapy is indicated.
     
  • Orally administered.
     
  • Dose should be individualized and adjusted according to the specific disease being treated, its severity and the response of the patient.
  • Adults and children >12 years:
    Recommended initial dose: 1-2 tablets 4 times daily, after meals and at bedtime. Do not exceed 8 tablets daily.
    In younger children, adjust dose according to severity of the condition and response of the patient rather than by age or body weight.
  • Children 6-12 years:
    Recommended dose: ½ tablet 3 times daily. If an additional daily dose is required, it should be taken preferably at bedtime. Do not exceed 4 tablets daily.


Or as prescribed by physicians.

 

  • Patients with known hypersensitivity to any ingredient of the drug.
  • Children under 6 years.
  • Newborn and premature infants.
  • Patients receiving monoamine oxidase (MAO) inhibitors therapy.
  • Patients with systemic fungal infections.
  • Gastro-duodenal ulcer.
  • Narrow-angle glaucoma.
  • Prostatic hypertrophy or bladder neck obstruction.

     

Betamethasone

  • Adverse effects of betamethasone are associated with dose and duration of therapy. As other corticosteroids, adverse effects include fluid and electrolyte, musculoskeletal, gastrointestinal, dermatological, neurological, endocrine, ophthalmic and metabolic disorders.

Common

  • Sodium retention and fluid retention; increased excretion of potassium.
  • Menstrual irregularities, Cushing's syndrome, growth retardation in children, decreased glucose tolerance, manifestations of latent diabetes mellitus.
  • Muscle atrophy, muscle weakness, osteoporosis, pathologic fracture of bone, particularly vertebral fractures, aseptic necrosis of femoral heads.

Uncommon

  • Gastroduodenal ulcer, gastrointestinal perforation and bleeding, acute pancreatitis.
  • Euphoria, insomnia, excitement.
  • Glaucoma and cataract.

Rare

  • Acne, haemorrhage, ecchymoses, hirsutism, delayed scar healing.


Dexchlorpheniramine maleate

Common

  • Drowsiness, sedation.
  • Dry mouth.

Rare

  • Vertigo.
  • Nausea.

     

Betamethasone

  • Systemic corticosteroids should be used with great caution in the presence of congestive heart failure, recent myocardial infarction, or hypertension, in patients with diabetes mellitus, epilepsy, glaucoma, hypothyroidism, hepatic failure, osteoporosis, peptic ulceration, psychoses or severe affective disorders, and renal impairment. Children may be at increased risk of some adverse effects; in addition, corticosteroids may cause growth retardation. The elderly too may be at greater risk from adverse effects.
  • Corticosteroids are usually contra-indicated in the presence of acute infections uncontrolled by appropriate antimicrobial therapy. Patients already receiving corticosteroids are more susceptible to infection, the symptoms of which, moreover, may be masked until an advanced stage has been reached. Patients with active or doubtfully quiescent tuberculosis should not be given corticosteroids except, very rarely, as adjuncts to treatment with antitubercular drugs. Patients with quiescent tuberculosis should be observed closely and should receive chemoprophylaxis if corticosteroid therapy is prolonged.
  • The risks of chickenpox and probably of severe herpes zoster are increased in non-immune patients receiving therapeutic doses of systemic corticosteroids, and patients should avoid close personal contact with either infection. Passive immunisation is recommended for non-immune patients who do come into contact with chickenpox. Similar precautions apply to measles. Live vaccines should not be given to patients receiving high-dose systemic corticosteroid therapy nor for at least 3 months afterwards; killed vaccines or toxoids may be given although the response may be attenuated.
  • During prolonged courses of corticosteroid therapy, patients should be examined regularly. Sodium intake may need to be reduced and calcium and potassium supplements may be necessary.

Dexchlorpheniramine maleate

  • Should be used with care in conditions such as angle-closure glaucoma, urinary retention, prostatic hyperplasia, or pyloroduodenal obstruction due to its anticholinergic adverse effects.
  • Effect of the sedating dexchlorpheniramine maleate increases with alcohol and concurrent use of other sedatives.
  • Dexchlorpheniramine maleate can cause drowsiness, dizziness and psychomotor impairment in some patients, and can have seriously effects on ability to drive and use machines. Should be avoided when driving and controlling machine.
  • Should be used with caution in the elderly (> 60 years) because they are increasing sensitive to anticholinergic adverse effects.

The use of Stadexmin during pregnancy, in nursing mothers or in women of childbearing age requires that the possible benefits of the drug be weighed against potential hazards to mother and fetus or infant. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Attention is drawn, particularly among drivers and machine operators, the risk of drowsiness attached to the use of this medicine, especially in early treatment. This is accentuated by taking alcoholic beverages or medicines containing alcohol.

 

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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