DIPROBETASON (Ampoule)
Betamethasone Dipropionate
Betamethasone Sodium Phosphate

DESCRIPTION:
DIPROBETASON suspension is a sterile injectable suspension of Betamethasone dipropionate and Betamethasone sodium phosphate, each ml of DIPROBETASON
Suspension contains Betamethasone dipropionate equivalent to 5 mg Betamethasone and Betamethasone sodium phosphate equivalent to 2 mg Betamethasone in sterile buffered and preserved vehicle.
ACTIONS:
DIPROBETASON suspension is combination of soluble Betamethasone sodium phosphate and very slightly soluble Betamethasone dipropionate that provides potent anti-inflammatory, antirheumatic and antiallergic effects in the treatment of corticosteroid-responsive disorders.
INDICATIONS AND USAGE:
DIPROBETASON suspension is indicated for the treatment of acute and chronic corticosteroid-responsive disorders, corticosteroid hormone therapy is an adjunct to, and not a replacement for conventional therapy.
Musculoskeletal and soft tissue conditions: Rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, radiculitis, sciatica, lumbago, torticollis, ganglion cyst, fasciitis.
Allergic conditions: Chronic bronchial asthma (including adjunctive therapy for status asthmaticus), hay fever, angioneurotic edema, allergic bronchitis, seasonal or perennial allergic rhinitis, drug reactions, serum sickness, insect bites.
Dermatologic conditions: Atopic dermatitis (nummular eczema), neurodermatitis (circumscribed lichen simplex), contact dermatitis, severe solar dermatitis, urticaria, discoid lupus erythematosus, psoriasis, keloids, pemphigus, dermatitis herpetiformis, cystic acne.
Collagen diseases: Disseminated lupus erythematosus, scleroderma, dermatomyositis, periarteritis nodose.
Neoplastic diseases: For palliative management of leukemias and lymphomas in adults, acute leukemia of childhood.
Other Conditions: Adrenogenital syndrome, ulcerative colitis, regional ileitis, sprue. Podiatric conditions: (Bursitis under heloma durum, hallux rigidus, digitus quintet varus), affections requiring subconjunctival injection, corticosteroid-responsive blood dyscrasias, nephritis and nephrotic syndrome.
Primary or secondary adrenocortical insufficiency may be treated with DIPROBETASON suspension but should be supplement with mineralocorticoids, if applicable.
DIPROBETASON suspension is recommended for:
1- Intramuscular injection in conditions responsive to systemic corticosteroids.
2- Injection directly into the affected soft tissues where indicated.
3- Intra-articular and periarticular injection in arthritides.
4- Intralesional injection in various dermatologic conditions.
5- Local injection in certain inflammatory and cystic disorders of the foot.
DOSAGE & ADMINISTRATION:
Dosing requirements are variable and must be individualized on the basis of the specific disease, its severity and the response of the patient.
1.Systemic administration: For systemic therapy, treatment is initiated with 1 to 2 ml in most conditions and repeated as necessary.
2 ml might be required initially in a severe illness, such as lupus erythematosus or status asthmaticus which has been resolved by appropriate life-saving procedures.
In respiratory tract disorders, onset of relief from symptoms has occurred within a few hours after IM injection.
A wide variety of dermatologic conditions respond effectively to an I.M. injection of 1 ml DIPROBETASON suspension, repeated according to the response of the condition.
In the treatment of acute or chronic bursitis, excellent results are obtained with 1 to 2 ml I.M. injection of DIPROBETASON suspension, repeated as necessary.
2.Local Administration: Concomitant use of a local anesthetic is rarely necessary.
DIPROBETASON suspension may be mixed with 1% or 2% lidocaine hydrochloride or similar local anesthetics may also be used. Using formulations which do not contain parabens, methylparaben, propylparaben, phenol, etc.
The required dose of DIPROBETASON suspension is first withdrawn from the vial into the syringe, the local anesthetic is then drawn in, and the syringe is shaken briefly.
In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, an intrabursal injection of 1 to 2 ml of DIPROBETASON Suspension may relieve pain and restore full range of movement within a few hours.
In acute tenosynovitis, tendinitis, and peritendinitis, one injection of DIPROBETASON suspension should alleviate the condition.
Following 0.5 to 2 ml intra-articular administration of DIPROBETASON suspension, relief from pain, soreness, and stiffness associated with rheumatoid arthritis and osteoarthritis may be experienced, within two to four hours, during the relief time, which varies widely in both diseases, is four or more weeks in the majority of cases.
An intra-articular injection of DIPROBETASON suspension is well tolerated in the joint and periarticular tissues. Recommended doses for intra-articular injection are: Large joints (knee, hip, shoulder) 1 to 2 ml, medium joints (elbow, wrist, ankle), 0.5 to 1 ml, small joints (foot, hand, chest), 0.25 to 0.5 ml.
Dermatologic conditions may respond to intralesional administration of DIPROBETASON suspension, response of some lesions not treated directly may be due to a slight systemic effect of the drug.
In intralesional treatment, an intradermal dosage of 0.2 ml/cm2 of DIPROBETASON suspension evenly injected with a tuberculin syringe and 26-gauge needle is recommended. The total amount of DIPROBETASON suspension injected at all sites each week should not exceed 1 ml.
DIPROBETASON suspension may be used effectively in disorders of the foot that are responsive to corticosteroid therapy.
Bursitis under heloma durum may be controlled with two successive injections of 0.25 ml each.
In some conditions, such as hallux rigidus, digitus quintet varus and acute gouty arthritis, onset of relief may be rapid.
Exposure of the patient to stressful situations unrelated to the existing disease may necessary to increase the dosage of DIPROBETASON suspension. If the drug is discontinued, long-term therapy dose should be decreased gradually.
DRUG & LABORATORY TEST INTERACTIONS:
Drug interactions: concurrent use of Phenobarbital, phenytoin, rifampicin or ephedrine may enhance the metabolism of corticosteroids, reducing their therapeutic effects.
Patients receiving both a corticosteroid and an estrogen should be observed for excessive corticosteroid effect.
Concurrent use of corticosteroid with potassium-depleting diuretics may enhance hypokalemia. Concurrent use of corticosteroids with cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Corticosteroids may enhance the potassium depletion caused by amphotericin B. In all patients taking any of these drug therapy combinations, serum electrolyte determinations, particularly potassium levels, should be monitored closely.
Patients receiving both a corticosteroids and an estrogen should be observed for excessive corticosteroid effect.
Concurrent use of corticosteroids with coumarin-type anticoagulants may increase or decrease the anticoagulant effect, possibly requiring adjustment in dosage.
Combined effects of nonsteroidal anti-inflammatory drugs or alcohol with glucocorticosteroids may result in an increased occurrence or increased severity of gastrointestinal ulceration.
Corticosteroids may decrease blood salicylates concentrations. Acetylsalicylic acid should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
Dosage adjustments of an antidiabetic drug may be necessary when corticosteroids are given to diabetics.
Concomitant glucocorticosteroid therapy may inhibit the response to somatotropin.
ADVERSE REACTIONS:
Adverse reactions to DIPROBETASON suspension, which have been the same as those reported for other corticosteroids, is related both to dose and duration of therapy. Usually these reactions can be reversed or minimized by a reduction in dosage, this is generally preferable to withdrawal of drug treatment.
Fluid and electrolyte disturbances: Sodium retention, potassium loss, hypokalemia alkalosis, fluid retention, congestive heart failure in susceptible patients and hypertension.
Musculoskeletal: Muscle weakness, corticosteroid myopathy, loss of muscle mass, aggravation of myasthenia symptoms in myasthenia gravis, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, tendon rupture, joint instability (from repeated intra-articular injections).
Gastrointestinal: Peptic ulcer with possible subsequent perforation and hemorrhage, pancreatitis, abdominal distention and ulcerative esophagitis.
Dermatologic: Impaired wound healing, skin atrophy, thin fragile skin, petechia and ecchymoses, facial erythema, increased sweating, suppressed reactions to skin tests, reactions such as allergic dermatitis, urticaria and angioneurotic edema.
Neurological: Convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo and headache.
Endocrine: Menstrual irregularities, development of cushingoid state, suppression of fetal intrauterine or childhood growth, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, (as trauma, surgery or illness), decreased carbohydrate tolerance, manifestation of latent diabetes mellitus, increased requirements of insulin or oral hypoglycemic agents in diabetics.
Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma and exophthalmos.
Metabolic: Negative nitrogen balance due to protein catabolism.
Psychiatric: Euphoria, mood swings, severe depression to frank psychotic manifestations, personality changes and insomnia.
Other: Anaphylactoid or hypersensitivity and hypotensive or shock-like reactions.
The following additional adverse reactions are related to parenteral corticosteroid therapy: rare instances of blindness associated with intralesional therapy around the face and head; hyperpigmentation or hypopigmentation; subcutaneous and cutaneous atrophy; sterile abscess; post-injection flare (following intra-articular use); charcotlike arthropathy.
CONTRAINDICATIONS:
DIPROBETASON suspension is contraindicated in patients with systemic fungal infections, in those with sensitivity reactions to betamethasone or to other corticosteroid, or any component of this product.
PRECAUTIONS:
DIPROBETASON suspension is not for intravenous or subcutaneous use.
Strict aseptic technique is mandatory in the use of DIPROBETASON suspension.
DIPROBETASON suspension contains two betamethasone esters, one of which, betamethasone sodium phosphate, disappears rapidly from the injection site, the potential for systemic effect produced by this soluble portion of DIPROBETASON suspension should therefore be taken into accounts by the physician when using this preparation.
DIPROBETASON injection should be administered intramuscularly with caution to patients with idiopathic thrombocytopenic purpura.
I.M. injections of corticosteroids should be given deep into large muscle masses to avoid local tissue atrophy.
Soft tissue, intralesional and intra-articular administration of corticosteroid may produce systemic as well as local effects.
Corticosteroids should not be injected into unstable joints, infected areas or intervertebral space, repeated injections into joints of osteoarthritis may increase joint destruction. Avoid injecting corticosteroids directly into the substance of tendons because delayed appearance of tendon rupture has resulted.
While on corticosteroid therapy patients should be not vaccinated against smallpox, other immunization procedures should not be undertaken in patients receiving corticosteroids, especially high doses, because of possible hazards of neurological complications and lack of antibody response.
However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy. e.g. for Addison disease.
Corticosteroid therapy in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management in conjunction with an appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary since reactivation of the disease may occur, during prolonged corticosteroid therapy, patients should receive chemoprophylaxis.
If rifampin is used in a chemoprophylactic program, its enhancing effect on metabolic hepatic clearance of corticosteroids should be considered, adjustment in corticosteroid dosage may be required.
The lowest possible dose of corticosteroid should be used to control the condition under treatment, when dosage reduction is possible, it should be gradual.
USAGE DURING PREGNANCY & LACTATION:
The use of DIPROBETASON suspension during pregnancy or in women of child-bearing age requires that the possible benefits of the drug be weighed against potential hazards to mother and fetus born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
Because of the potential for unwanted adverse effects from DIPROBETASON suspension in nursing mothers, a decision should be made whether to discontinue nursing or to discontinue therapy, taking into account importance of the drug to the mother.
OVERDOSAGE TREATMENT:
Complications resulting from the metabolic effects of the corticosteroid or from deleterious effects of the basic or concomitant illnesses or resulting from drug interactions should be handled as appropriate.
Maintain adequate fluid intake and monitor electrolytes in serum and urine, with particular attention to sodium and potassium balance. Treat electrolyte imbalance if necessary.
HOW SUPPLIED
DIPROBETASON injection, 2 ml ampoule
STORAGE
Shake well before using.
Store between (2-25) C. Protect from light.
Protect from freezing.