Dexamethasone

 

Ingredients

Active Ingredients: Dexamethasone

 

Non-Active Ingredients: lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No.10 (0.5, 4 mg), FD&C Blue No.1(0.75, 1.5 mg), FD&C Green No.3 (4, 6 mg), FD&C Red No.3 (1.5 mg), FD&C Red No.40 (1.5 mg), and FD&C Yellow No.6 (0.5, 4 mg).

 

Indications

Dexamethasone is indicated in the treatment of inflammation and pain associated with asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness, bullous dermatitis, herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), dermatologic diseases, endocrine disorders, regional enteritis, ulcerative colitis, diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid (block or impending block when used with appropriate antituberculous chemotherapy), leukemias and lymphomas, acute exacerbation of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, head injury, ophthalmic diseases, renal diseases, acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), dermatomyositis, polymyositis, and systemic lupus erythematosus.

 

How It Works

Dexamethasone is a potent synthetic member of the glucocorticoid class of steroid drugs. It acts as an anti-inflammatory and immunosuppressant.

 

Dosage

Tablets(0.5 mg)

Dosage requirements are variable and must be individualized on the basis of the disease being treated and the response of the patient. The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated.

 

Multiple sclerosis: 

Daily doses of 30 mg of Dexamethasone per day for a week followed by 4 to 12 mg every other day for one month have been shown to be effective.

 

For palliative management of patients with recurrent or inoperable brain tumors: maintenance therapy with either Dexamethasone Sodium Phosphate injection or tablets in a dosage of 2 mg two or three times daily may be effective. 

 

Shock: 4 to 8 mg intravenously initially, repeat if necessary to a total max dose of 24 mg.

 

Autoimmune diseases and inflammations: long term therapy with 0.5 to 1.5 mg oral per day. Avoid more than 1.5 mg daily, because serious side effects are more frequently encountered with higher doses.

 

Pediatric dosage: The initial dose of Dexamethasone may vary depending on the specific disease being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day).

 

Generally, the lowest possible dose of corticosteroids should be used to control the condition under treatment. 

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Precautions

Dacadron is contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. Existing gastrointestinal ulceration, Cushing's syndrome, severe forms of heart insufficiency, severe hypertension, uncontrolled diabetes mellitus, systemic tuberculosis, severe systemic viral, bacterial, fungal infections, preexisting wide angle glaucoma and osteoporosis. Administration with live viruses is contraindicated in patients receiving immunosuppressive doses of corticosteroids.

 

Average and large doses of corticosteroids can cause elevation of blood pressure, sodium and water retention, and increase excretion of potassium. This happens when Decadron is used in large doses. Dietary salt restriction and potassium supplementation may be necessary. Allcorticosteroids increase calcium excretion. There is a connection between corticosteroids use and left ventricular free wall rupture after a recent myocardial infarction, therefore use caution in these patients during therapy with corticosteroids

 

Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Too rapid withdrawal of corticosteroids may result in adrenocortical insufficiency. Since this may continue for months, hormone therapy should be reinstituted. If the patient is already receiving steroids then the dosage may have to be increased.

 

Patients who are on corticosteroids can easily get Infections caused by any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body.

 

Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by amoeba, candida, cryptococcus, mycobacterium, nocardia, pneumocystis, toxoplasma.

 

Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. The use ofcorticosteroids in active tuberculosis should be restricted to cases of fulminating or disseminated tuberculosis. If corticosteroids are indicated in patients with latent tuberculosis and close monitoring is necessary. Chickenpox and measles can also have a more serious effects and possibly be fatal in pediatric and adult patients on corticosteroids.

 

Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.

 

Since complications of treatment with corticosteroids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy,

As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy.

 

Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation. Be careful when doing physical activities.

 

The adverse effects of corticosteroids in pediatric patients are similar to those in adults.

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

 

Consult a doctor before taking Decadron if you are pregnant or nursing. Decadron may pass into breast milk and caution should be used.

 

Drug Interactions

Consult a doctor before taking Decadron if you are on the following medication:  Aminoglutethimide, Antibiotics, Anticholinesterases, Anticoagulants, Antidiabetics, Antitubercular drugs, Cholestyramine, Cyclosporine, Dexamethasone suppression test (DST), Digitalis glycosides, Ephedrine, Estrogens, including oral contraceptives, Hepatic Enzyme Inducers, Inhibitors and Substrates, Ketoconazole, Nonsteroidal anti-inflammatory agents (NSAIDS), Phenytoin, Thalidomide, Vaccines.

 

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:aprepitant, birth control pills, "blood thinners" (warfarin), bupropion, certain cancer drugs (dasatinib, lapatinib, sunitinib, aldesleukin),caspofungin, (glyburide), digoxin, drugs affecting liver enzymes that remove dexamethasone from your body (such as azole antifungals including ketoconazole, barbiturates including phenobarbital, macrolide antibiotics including erythromycin, rifamycins including rifampin, certain anti-seizure medications including phenytoin, carbamazepine), drugs that may cause potassium loss (amphotericin B, water pills/diuretics such as hydrochlorothiazide), HIV protease inhibitors (indinavir), isoniazid, mifepristone, quinolone antibiotics (levofloxacin), salicylates (salsalate), temsirolimus, thalidomide.

 

Check all prescription and non-prescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that may increase the risk of stomach bleeding.

 

Adverse/Side Effects

Stomach upset, headache, dizziness, menstrual changes, trouble sleeping, increased appetite, or weight gain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

 

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

 

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of infection, fever, persistent sore throat, bone/joint pain, increased thirst/urination, fast/slow/irregular heartbeat, eye pain/pressure, heartburn, black stools, vomit that looks like coffee grounds, puffy face, swelling of the ankles/feet, stomach/abdominal pain, pain/redness/swelling of arms/legs, tiredness, mental/mood changes (depression, mood swings, agitation), unusual hair/skin growth, muscle pain/cramps, weakness, easy bruising/bleeding, slow wound healing, thinning skin, seizures. 

 

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

 

Overdose

In the case of acute overdose, according to the patient’s condition, supportive therapy may include gastric lavage or emesis. In case of overdose call local emergency room or poison control.

 

Storage Instructions

Store at controlled room temperature 20 to 25°C (68 to 77°F). Keep out of the reach of children and pets.

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