Betafos

Composition: Sterile aqueous suspension contains a combination of:
+    Betamethasone Sodium Phosphate equivalent to 2mg Betamethasone.
+    Betamethasone Dipropionate equivalent to 5mg Betamethasone.  

Properties: Pharmacological Properties:
+    Betafos® is a sterile aqueous suspension contains a combination of soluble and very slightly soluble Betamethasone esters. Both together provide potent rapid and prolonged anti-inflammatory, anti-rheumatic and anti-allergic effects.
+    Rapid therapeutic activity is achieved by the soluble ester Betamethasone Sodium Phosphate which is quickly absorbed after injection.
+    Sustained activity is provided by Betamethasone Dipropionate which is only slightly soluble and slowly absorbed thereby controlling symptoms over a prolonged period.
+    Betafos® Betamethasone enjoys both: Longer half-life and higher potency (20 times) compared to cortisol (hydrocortisone).
+    Betafos® Betamethasone has no significant sodium or water retaining effect.

Pharmacokinetic Properties:
+    Corticosteroids are, in general, rapidly distributed to all body tissues. They cross the placenta with variable degrees and distributed in small amounts into breast milk.
+    Betafos® Betamethasone, being a synthetic corticosteroid, is less extensively bound to plasma proteins compared to cortisol (hydrocortisone).
+    It is metabolized mainly in the liver and excreted in urine.

Indications: Allergic States:
+    Control of various incapacitating allergic conditions intractable to conventional treatment, in serum sickness and allergic reactions to drugs or insect bites.

Contra-Indictions: -    Systemic fungal infections.
-    In subjects with hypersensitivity reactions to Betamethasone or other corticosteroids.

Adverse Effects:The same as for other corticosteroids:
-    Abdominal distention, nausea, vomiting, increased appetite, weight gain, pancreatitis, ulcerative esophagitis or peptic ulcer.
-    Impaired wound healing, erythema, hirsutism, increased sweating, suppression of skin test reactions, hyper-pigmentation or hypo-pigmentation, subcutaneous and cutaneous atrophy or sterile abscess in site of injection.
-    Increased intracranial pressure with papilledema, posterior subcapsular cataract, increased intraocular pressure (glaucoma), vertigo or headache.
-    Euphoria, insomnia, mood swings from severe depression to frank psychotic manifestations, personality changes or convulsions.
-    Menstrual irregularities, development of cushingoid state, suppression of fetal intrauterine or childhood growth, secondary adrenocortical and pituitary unresponsiveness particularly in times of stress (e.g. trauma, surgery or illness) and negative nitrogen balance due to protein catabolism.
-    Decreased carbohydrate tolerance, hyperglycemia, manifestations of latent diabetes mellitus, and increased requirements of insulin or oral hypoglycemic agents in diabetics.
-    Rare instances of blindness associated with intra-lesional therapy around the head.
-    Joint instability may result from repeated intra-articular injections.

Dosage & Administration: Betafos® is recommended for:
Intramuscular Injection.

Local Injection:
Intra-articular and peri-articular injection.
Intra-lesional injection in various dermatologic and inflammatory conditions.
-    Dosing requirements are variable and must be individualized according to condition's severity and the response of the patient.
-    If a satisfactory clinical response does not occur after a reasonable period of time, Betafos® therapy should be discontinued and other appropriate therapy initiated.
-    If the drug is to be discontinued after long term therapy the dose should be decreased gradually.

For Systemic Administration:
-    Treatment is initiated with 1-2ml, injected deeply intramuscular in the gluteal region, and repeated as necessary. In severe illness 2ml might be required initially.
-    A wide variety of dermatologic conditions respond to an I.M. injection of 1ml of Betafos® Suspension, to be repeated as necessary.
-    In respiratory tract disorders, effective control of symptoms is obtained in bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis with a dose of 1-2ml I.M. injection of Betafos®.  Symptoms relief is started within few hours.  
-    In the treatment of acute or chronic bursitis, excellent results are obtained with 1-2ml I.M. injection of Betafos®.  Dose can be repeated as necessary.

For Local Administration:
-    Concomitant use of local anesthetic is rarely necessary.
-    If co-administration of a local anesthetic is desired. Betafos® may be mixed in the syringe, not in the ampoule, with 1 or 2% procaine hydrochloride or lidocaine using formulations which do not contain parabens.
-    The required dose of Betafos® Suspension is first withdrawn from the ampoule into the syringe. The local anesthetic is then drawn in, and the syringe is shaken briefly before administration.
-    In acute subdeltoid, subacromial, olecranon and prepatellar bursitis an intra-bursal injection of 1-2ml of Betafos® Suspension may relieve pain and restore full range of movement within few hours.
-    Chronic bursitis may be treated with reduced dosage once acute symptoms are controlled.
-    In acute tenosynovitis, tendinitis and peritendinitis, one injection of Betafos® Suspension should alleviate the condition.
-    In chronic forms of these conditions, it may be necessary to repeat the injection as the patient's condition requires.
?    After intra-articular administration of Betafos® Suspension in rheumatoid and osteoarthritis, relief of pain, soreness and stiffness may be experienced within 2-4 hours, with a period of relief in the majority of cases reaches up to 4 or more weeks.
-    Recommended dose for intra-articular injection varies according to the size of the joint:
•    Large joints (such as knee, hip and shoulder): 1-2ml.
•    Medium joints (such as elbow, wrist and ankle): 0.5-1ml.
•    Small joints (such as foot, hand joints): 0.25-0.5 ml.
-    In Intra-lesional treatment of dermatologic conditions, an intra-dermal dosage of 0.2ml/cm2 of Betafos® evenly injected with a tuberculin syringe and a 26 gauge needle is recommended.
-    The total amount of Betafos® Suspension injected at all sites each week should not exceed 1ml.
-    Recommended doses at intervals of one week in bursitis under calccaneal spur is 0.5ml.  In synovial cyst is 0.25-0.5ml.  In tenosynovitis, periosteitis of cuboid is 0.5ml and in acute gouty arthritis is 0.5-1ml.
-    After favorable response is obtained the proper maintenance dosage should be determined by decreasing the initial dose in small decrements at appropriate time intervals until the lowest dose which will maintain an adequate clinical response is determined.

N.B.: The small crystal size of Betamethasone dipropionate permits the use of a fine gauge needle up to 26 gauges for intra-dermal and intra-lesional administration.

How supplied: 2ml ampoule in packs, each of one ampoule.

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