Bula do remedy Dexmine

the package insert of the medicine Dexmine. Therapeutic class of the Anti-inflammatory and Antihistamínico. Active principles Betamethasone and Maleate Dexclorfeniramina.

what For?

Dexmine is indicated for the adjuvant treatment of the diseases allergic respiratory tract like: bronchial asthma and severe allergic rhinitis; in the disease-allergic skin rashes, such as atopic dermatitis (eczema), contact dermatitis, drug reactions and diseases of the serum, and in the disorders allergic inflammatory eye, such as: keratitis, iritis, non-granulomatous,
coriorretinite, iridocyclitis, choroiditis, conjunctivitis, and uveitis.

Use adult and children above 2 years and above 6 years – oral Use

Pharmacokinetics

How it works?

Dexmine brings together the anti-inflammatory effect and antiallergic of the betamethasone and the action antihistamine of the maleate dexclorfeniramina.

The combined use of betamethasone and maleate dexclorfeniramina allows the use of lower doses of corticosteroids, with results similar to those obtained with higher doses of steroids alone.

The maleate dexclorfeniramina, allows the effect of anti-histamine for approximately 12 hours.

Dosage

How to use?

The dosage must be individualized and adjusted according to the condition under treatment and the response obtained.

When the symptoms of respiratory allergy are adequately controlled, a withdrawal slow of the association and an isolated treatment with an antihistamine should be considered.

    the

  • Adults:

The recommended starting dose for adults and children over 12 years is 1 to 2 tablets (or two teaspoonfuls of syrup) 3 to 4 times per day after meals and at bedtime.

The dose should not exceed 8 tablets (or 8 tablespoons of syrup) per day.

In children of younger age the dose should be adjusted according to the severity of the disease and the body weight.

    the

  • Children 6 to 12 years:

The recommended dose is ½ tablet (or ½ teaspoon of the syrup) 3 times per day.

If a daily dose additional is required it should be administered, preferably
at bedtime.

The dosage should not exceed 4 tablets or 4 teaspoonfuls of syrup)
day.

    the

  • Children 2 to 6 years:

The initial dose of the product syrup is ¼ to ½ teaspoon, 3 times per day, with dose adjustment according to patient response.

The daily dose should not exceed more than 2 teaspoons.

With the clinical improvement, the dose should be reduced gradually to the minimum level of maintenance and discontinued whenever possible.

Side Effects

What are the evils that can cause me?

In some cases, Dexmine can produce some reactions to unpleasant transient in the majority of the time.

Tell your doctor the appearance of reactions to unpleasant, such as:

gastrointestinal Disorders, dermatological, neurologic, metabolic, psychiatric, or adverse effects general as: hives, skin rash, excessive perspiration, chills, dryness in the mouth and throat.

Contraindications

When should I not use?

Dexmine is contraindicated in patients with infection, systemic fungal infection, in premature infants and newborns, in patients who are receiving therapy with monoamine oxidase inhibitors (Maois), and who demonstrate hypersensitivity to any of the components of your formula or to drugs of similar chemical structure.

Warnings and Precautions

what should I know before using?

Dexmine in pregnancy and breast feeding: tell your doctor immediately if there is suspicion of pregnancy, during or after the use of the medication and if you are breastfeeding.

    the

  • Betamethasone:

there May be adjustments needed posológicos according to the remission or exacerbation of the disease, the individual response of the patient to the treatment or exposure of the patient to the situations of emotional stress or physical, such as: infection, surgery, or trauma.

it May be necessary clinical follow-up during the period of up to one year after the end of prolonged treatment or with high doses.

adrenocortical Insufficiency secondary may arise with the withdrawal very fast corticosteroid, and the risk can be minimized with gradual dose reduction.

The effects of the corticosteroids are increased in patients with hypothyroidism or in patients with cirrhosis.

corticosteroids should be used with caution in patients with herpes simplex of the eye.

corticosteroids may exacerbate instabilities emotional existing or potential trends, and psychotic.

corticosteroids should be used with caution in patients with: ulcerative colitis non-specific if there is likelihood of perforation is imminent, abscess or another infection by pyogenic; diverticulitis; bowel anastomosis recent peptic ulcer, active or latent, renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.

Since the complications of treatment with glicorticóides are dependent on dose and duration of treatment, a decision about the risk/benefit must be taken for each patient.

corticosteroids may mask some symptoms of infection.

The prolonged use of corticosteroid can produce cataract, subcapsular posterior, glaucoma with possible damage to optic nerves, and worsen ocular infection secondary due to fungi or viruses.

With the therapy, corticosteroid, diet with salt restriction and potassium supplementation should be considered.

All corticosteroids increase calcium excretion.

patients under therapy with corticosteroids should not be vaccinated against smallpox.

Other processes of immunization should not be performed in patients who are receiving corticosteroids, especially at high doses.

Patients in the doses of immunosuppressive corticosteroids should be warned to avoid contact with people with chickenpox or measles, and if you occur to exposure, seek medical guidance. This recommendation is particularly important for children.

The therapy with corticosteroid, in active tuberculosis should be restricted to cases of tuberculosis, disseminated or fulminating, in which the corticosteroid is used in conjunction with a regime of anti-tuberculosis appropriate.

If corticosteroids are indicated patients with latent tuberculosis, it will be necessary to close clinical observation. During prolonged therapy with corticosteroids patients should receive chemoprophylaxis.

The growth and development of children of low age, under prolonged therapy with corticosteroid, should be monitored with caution, because administration of corticosteroids can interfere with the rate of the normal growth and suppress the endogenous production of corticosteroids in these patients.

The steroid therapy can alter the mobility and number of sperm.

    the

  • Maleate dexclorfeniramina:

Should be used with caution in patients with narrow-angle glaucoma, peptic ulcer estenosante, obstruction of pylorus-duodenal, prostatic hypertrophy or obstruction of the cervix the bladder, cardiovascular diseases, including among which hypertension, in patients with elevated intraocular pressure or hyperthyroidism.

patients should be cautioned regarding the risk of driving a motor vehicle or operate machinery, since it can occur drowsiness, due to the presence of the anti-histamine.

antihistamines may cause: sedation, dizziness and hypotension in patients over 60 years of age.

The safety and efficacy of the product are not yet established in children below 2 years of age.

Drug Interactions

    the

  • Betamethasone:

The concomitant use of phenobarbital, phenytoin, rifampin or ephedrine may enhance the metabolism of corticosteroids, reducing their therapeutic effects.

The patients who are receiving corticosteroids and estrogens must be observed regarding the effects of excessive use.

The concomitant use of corticosteroid with diuretics depletores potassium can aggravate the hypokalemia.

The concomitant use of corticosteroids with glycosides heart may increase the possibility of arrhythmias or toxicity of the associated digital to hypokalaemia.

corticosteroids may increase the potassium depletion caused by amphotericin B.

In all patients who are receiving any of the combination therapies, the determinations of serum electrolyte, particularly potassium levels, should be monitored.

The concomitant use of corticosteroids with anticoagulants of the type cumarínico can increase or decrease the effects of anticoagulants, possibly requiring adjustment in dosage.

The combined effects of drugs anti-inflammatory non-steroids, or alcohol with glucocorticoids may result in an increase in the occurrence or severity of ulceration to the gastrointestinal.

corticosteroids may decrease the concentrations of salicylate in blood.

The aspirin should be used cautiously in conjunction with corticosteroids in hipoprotrombinemia.

Adjustments in the dosages of the drugs hypoglycaemic may be necessary when corticosteroids are administered to diabetic patients.

concomitant Therapy with glicorticóide can inhibit the response to somatotropin.

    the

  • Maleate dexclorfeniramina:

MAO inhibitors (oxidase) and shrinks intensificam the effects of antihistamines and alcohol, tricyclic antidepressants, barbiturates and other Central Nervous System depressants can potentiate the sedative effect of the dexclorfeniramina.

The action of oral anticoagulants can be reduced by antihistamines.

Overdose

what to do if someone use a larger amount than is recommended?

Dexmine association is a drug and, therefore, the toxicity of each of its components should be considered.

The toxicity of an excessive dose single product is the result particularly of the dexclorfeniramina.

The lethal dose for an estimated maleate dexclorfeniramina is 2.5 to 5.0 mg/Kg.

A single dose of excessive corticosteroid, in general, does not produce acute symptoms.

The effects of hypercortisolism only occur with the repeated administration of high doses.

The reactions of superdose of antihistamines may vary from Central Nervous System depression to your stimulation.

Dryness of the mouth, pupils dilated and fixed, fever, facial flushing and gastrointestinal symptoms may occur.

In the child, the stimulation occurs in a dominant fashion, can also cause hallucinations, incoordination and seizures tonic-clonic.

In adults, a cycle consisting of depression with dullness and coma, and a phase of excitement leading to convulsions, may occur.

Treatment:

In the case of a superdose acute corticosteroid gastric emptying can help.

to Maintain an adequate fluid intake and monitor electrolytes in serum and urine, with particular attention to the balance of sodium and potassium.

Treat the electrolyte imbalance if necessary.

In the superdose anti-histamines, the treatment is essentially symptomatic and supportive.

Should induce êmese through the ingestion of a glass of water or milk; stimulating the reflex of vomiting.If this does not occur, gastric lavage with isotonic saline solution is indicated. Should not be used stimulants.

Vasopressores can be used for the treatment of hypotension.

The seizures are treated with a depressant short-acting, such as thiopental.

The dialysis has not been considered useful.