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Dexamethasone Sodium Phosphate Injection Medicine Adrenocortical Steroid Anti Inflammatory Drugs

Categories Injection Medicine
Brand Name: Unipharma
Model Number: 4mg/ml
Certification: GMP,ISO9001
Place of Origin: CHINA
MOQ: 50000 boxes
Price: USD0.36-USD0.38/box
Payment Terms: L/C, D/A, D/P, T/T, Western Union
Supply Ability: 1000,000 boxes/Month
Delivery Time: 30 days
Packaging Details: 10 ampoules/box,10 box/strip,200 strips/carton
Characteristic: odorless or has a slight odor of alcohol, is exceedingly hygroscopic, and is freely soluble in water.
Composition: 4 mg/mL
Route of administration: sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration
Clinical Pharmacology: antiinflammatory
Package: 10 ampoules/box,10 box/strip,200 strips/carton
Contraindications: Systemic fungal infections.
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    Dexamethasone Sodium Phosphate Injection Medicine Adrenocortical Steroid Anti Inflammatory Drugs

    Dexamethasone sodium phosphate injection 4mg/ml water-soluble synthetic adrenocortical steroid anti-inflammatory drug


    Compostion:


    Each mL of the injection contains the following components:

    Dexamethasone Sodium Phosphate

    (equivalent to 4 mg of Dexamethasone Phosphate)...4.37 mg

    Sodium Sulfite.............................................................1 mg

    Benzyl Alcohol.............................................................10 mg

    Sodium Citrate.............................................................for isotonicity

    Water for Injection........................................................q.s.

    pH adjusted between 7.5 and 10.5 with Citric Acid and/or Sodium Hydroxide.


    molecular weightchemical name
    516.419- fluoro-11b,17,21-trihydroxy-16a-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate) disodium salt

    Clinical Pharmacology


    Dexamethasone Sodium Phosphate Injection, USP has a rapid onset but short duration of action when compared with less soluble preparations. Because of this, it is suitable for the treatment of acute disorders responsive to adrenocortical steroid therapy. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, including dexamethasone, are primarily used for their potent antiinflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.


    Contraindications


    Systemic fungal infections. (See WARNINGS regarding amphotericin B)
    Hypersensitivity to any component of this product, including sulfites (see WARNINGS).


    Overdosage


    Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic.
    The oral LD50 of dexamethasone in female mice was 6.5 g/kg. The intravenous LD50 of dexamethasone sodium phosphate in female mice was 794 mg/kg.


    Dosage and Administration


    Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL -- For intravenous, intramuscular, intra-articular, intralesional, and soft tissue injection.

    Dexamethasone Sodium Phosphate Injection, USP can be given directly from the vial, or it can be added to Sodium Chloride Injection or Dextrose Injection and administered by intravenous drip.

    Solutions used for intravenous administration or further dilution of this product should be preservative-free when used in the neonate, especially the premature infant.

    When it is mixed with an infusion solution, sterile precautions should be observed. Since infusion solutions generally do not contain preservatives, mixtures should be used within 24 hours.

    DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.


    Intravenous and Intramuscular Injection


    The initial dosage of Dexamethasone sodium phosphate injection varies from 0.5 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.5 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient's response is satisfactory. If a satisfactory clinical response does not occur after a reasonable period of time, discontinue Dexamethasone Sodium Phosphate Injection, USP and transfer the patient to other therapy.

    After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response. Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily. If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually. When the intravenous route of administration is used, dosage usually should be the same as the oral dosage. In certain overwhelming, acute, life-threatening situations, however, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. The slower rate of absorption by intramuscular administration should be recognized.


    Adverse reactions


    Fluid and electrolyte disturbancesMusculoskeletalGastrointestinalDermatologicNeurologicEndocrine
    Sodium retention
    Fluid retention
    Congestive heart failure in susceptible patients
    Potassium loss
    Hypokalemic alkalosis
    Hypertension
    Muscle weakness
    Steroid myopathy
    Loss of muscle mass
    Osteoporosis
    Vertebral compression fractures
    Aseptic necrosis of femoral and humeral heads
    Pathologic fracture of long bones Tendon rupture
    Peptic ulcer with possible subsequent perforation and hemorrhage
    Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease
    Pancreatitis
    Abdominal distention
    Ulcerative esophagitis
    Impaired wound healing
    Thin fragile skin
    Petechiae and ecchymoses
    Erythema
    Increased sweating
    May suppress reactions to skin tests
    Burning or tingling, especially in the perineal area (after I.V. injection)
    Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema
    Convulsions
    Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
    Vertigo
    Headache
    Psychic disturbances
    Menstrual irregularitiesDevelopment of cushingoid state
    Suppression of growth in children
    Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness
    Decreased carbohydrate tolerance
    Manifestations of latent diabetes mellitus
    Increased requirements for insulin or oral hypoglycemic agents in diabetics
    Hirsutism


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