Products

Dexaglobe Ampoules

Betamethasone Dipropionate
& Betamethasone Sod. Phosphate 

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Active ingredient

Each 1 ml contains:
• Betamethasone Dipropionate 6.43 mg (eq. to 5 mg Betamethasone).
• Betamethasone Sodium Phosphate 2.63 mg (Eq. to 2 mg Betamethasone).
 

Indications

Dexaglobe is indicated for systemic and local treatment of acute and chronic corticosteroid responsive disorders, especially in the following conditions:
• Musculoskeletal and soft tissue conditions:
As an adjunctive therapy of short term during the acute attacks or exacerbation of the following diseases: osteoarthritis, rheumatoid arthritis (special cases may require a lower maintenance dose), bursitis, ankylosing spondylitis, epicondylitis, radiculitis, Coccydynia, sciatica, lumbago, stiff neck , synovial cysts, exostosis, fascitis.
• Collagen diseases. 
During exacerbation or as maintenance therapy in some cases of systemic lupus erythematosus, scleroderma, dermatomyositis, polyarteritis nodosa.
• Allergic Conditions
- As adjunctive therapy in asthmatic conditions and hypersensitivity reactions to drugs or insect stings.
- In severe allergic conditions unresponding to conventional methods, in particular acute attacks and exacerbations of
the following diseases: chronic bronchial asthma, seasonal or perennial allergic rhinitis, severe allergic bronchitis, severe angioedema, serum sickness, atopic dermatitis, neurodermatitis, contact dermatitis, urticaria, severe solar exanthema.                                   
• Dermatological Disorders
Atopic dermatitis , neurodermatitis , necrobiosis lipoidica diabeticorum , alopecia areata,discoid lupus erythematous , psoriasis , keloids , pemphigus , dermatitis herpetiformis , urticarial,Hypertrophic lichen planus, necrobiosis lipoidica diabeticorum, alopecia areata, discoid lupus erythematosus, psoriasis, keloids, pemphigus, dermatitis herpetiformis, cystic acne.                     
• Neoplastic Diseases
For palliative treatment of leukemia and lymphomas in adults and acute leukemia of children.

Dosage and Administration

Dosing requirements are variable and must be individualized on the basis of the specific disease, the severity of the condition and the response of the patient.
The initial dose should be maintained or adjusted until a satisfactory response is observed. If a satisfactory clinical response does not occur after a reasonable period of time treatment with Dexaglobe , suspension should be discontinued and other appropriate therapy initiated.
• Systemic administration: 
- Treatment is initiated with 1 to 2 ml in most conditions and repeated as necessary. 
- Administration is by deep intramuscular (IM) injection in the gluteal region: Dosage and frequency of administration will depend on the severity of the patient’s condition and the therapeutic response. 
- In a severe illness such as lupus erythematous or status asthmatics which has been resolved by appropriate life –saving procedures, 2 ml might be required initially. 
- A wide variety of dermatological conditions responds to IM injections of corticosteroids: An IM injection of 1 ml, repeated according to the response of the condition, has been found to be effective. 
- In respiratory tract disorders, onset of relief of symptoms has occurred within a few hours after IM injection of Dexaglobe suspension: Effective control of symptoms with 1-2 ml is obtained in bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis. 
- In the treatment of the acute or chronic bursitis, excellent results are obtained with 1 to 2 ml of Dexaglobe suspension, repeated as necessary.
• Local administration:
- Concomitant use of local anesthetics is rarely necessary.
If coadministration of a local anesthetic is desired, Dexaglobe suspension may be mixed (in the syringe) with 1% or 2% procaine hydrochloride or lidocaine, using formulations which do not contains parabens. Similar local anesthetics mat be also used. Anesthetics containing methyl paraben, propyl paraben, phenol, etc. should be avoided.
- The required dose of Dexaglobe suspension is first withdrawn into the syringe, the local anesthetics is then drawn in and the syringe is shaken briefly.
- In acute subdeltoid, subacromial, olecranon and prepatellar brutitis, an intrabursal injection of 1 to 2 ml of Dexaglobe suspension may relieve pain and restore full range of movement within a few hours. Chronic bursitis may be treated with reduce dosage once acute symptoms are controlled. In acute tenosynovitis, tendinitis, and peritendinitis, one injection of Dexaglobe suspension should alleviate the condition.
- In chronic forms of these conditions, it may be necessary to repeat the injections as the patient’s condition requires, following 0.5 to 2 ml intra-articular administration of Dexaglobe suspension 
Relief of pain, soreness and stiffness associated with rheumatoid arthritis and osteoarthiritis may be experienced within two to four hours. Duration of relief, which varies widely in both diseases, is four or more weeks in the majority of cases.
- An intra-articular injection of Dexaglobe suspension is well tolerated in the joint and periarticular tissue. Recommended doses for intra-articular injection are large joints (knee, hip, shoulder) 1-2 ml, medium joints (elbow, wrist, ankle) 0.5-1 ml, small joints (foot, hand, chest) 0.25-0.5 ml.
- Dermatologic conditions may respond to intralesional administration of Dexaglobe suspension. Response of some lesions not treated directly may be due to slight systemic effect of the drug. In intralesional treatment, an intradermal dosage of 0.2 ml / cm2 of Dexaglobe suspension evenly injected with a tuberculin syringe and 26-guage needle is recommended. The total amount of Dexaglobe suspension injected at all sites each week should not exceed 1 ml Dexaglobe suspension may be used effectively in disorders of the foot that are responsive to corticosteroids. Bursitis under Heloma durum may be controlled with two successive injections of 0.25 ml each.
- In some conditions such as Hallux rigidus, varus of 5th toe and acute gouty arthritis, onset of relief may be rapid. A tuberculin syringe with a 25- guage needle is suitable for most injections recommended doses at intervals of approximately one week: bursitis under heloma durum or molle 0.25-0.5 ml , bursitis under calcaneal spur  0.5 ml , bursitis over hallux rigidus 0.5 ml , bursitis over varus of the 5th toe  0.5 ml , synovial cyst 0.25 – 0.5 ml , morton’s neuralgia (metatarsalgia )  0.25-0.5 ml , tenosynovitis  0.5 ml , periosititis of cuboid  0.5 ml,  acute gouty arthritis , 0.5 -1 ml. After favourable 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.

Contraindication

As with other corticosteroid, Dexaglobe suspension is contraindicated in patients with:
• Systemic fungal infections.
• Hypersensitivity to betamethasone dipropionate, betamethasone sodium phosphate, other corticosteroid, or to any component of this product. 
• Dexaglobe suspension is not to be administered intramuscularly to patients with idiopathic thrombocytopenic purpura.

Side effects

The adverse effects depend on strength, mode of administration and duration of treatment, age, sex of the patient and the disease being treated.
• For short-term treatment: the risk of adverse effects is minimal. It should be however considered that intestinal bleeding (often caused by stress) can be psychosomatic during treatment with corticosteroids.
• In case of prolonged treatment with high doses i.e. If the Cushing threshold dose (> 1 mg betamethasone per day) is exceeded, the known side effects of corticosteroids occur:
- Fluid and electrolyte imbalance
Sodium and water retention, potassium and calcium depletion, hypokalemic alkalosis, hypophosphatemia ,hypertension, congestive heart failure in susceptible patients.
- Musculoskeletal disorders
Muscle weakness, myoatrophy, Steroid myopathy, osteoporosis (especially in postmenopausal women), aseptic bone necrosis, vertebral compression fractures, and pathological bone fractures.
- Gastrointestinal disorders
Malaise, nausea, gastric ulcer with possible perforation and bleeding, perforation of the small intestine and colon, especially in patients with inflammatory bowel disease, abdominal distension, pancreatitis, ulcerative esophagitis
- Dermatological disorders
Delayed wound healing, petechiae and ecchymoses, excessive sweating, facial flushing and hot flashes (flushing), hypo-or hyperpigmentation, skin atrophy with stretched marks 
intramuscular administration repeatedly (and intra-articular and sub-lesional) betamethasone (or other glucocorticoid) can cause severe local tissue damage (up to atrophy and necrosis).   
- Immunological disorders
Due to negative effect on the number and function of lymphocytes, increased susceptibility to infection, masking of infections, decreased or lack of response to skin testing, activation of latent function susceptibility to infection, masking of infections, decreased or absent response to skin testing, activation of latent infections, opportunistic infections, hypersensitivity reactions, in rare cases up to anaphylactic reactions with hypotension, circulatory collapse and / or bronchospasm. Adverse reactions when applied intralesional and intrasynovial outbreak of joint inflammation charcot arthropathy, infection at the injection site after non sterile injection equipment.
- Neurological Disorders
Convulsions, dizziness, headache, increased intracranial pressure with papillary edema.
- Psychiatric disorders
Euphoria, insomnia, mood changes, personality changes, worsening of affective disorders and psychotic tendency up to manifest psychosis, severe depression.
- Endocrine disorders
Menstrual irregularities , development of cushingoid appearance; stunted growth in children, adrenocortical insufficiency and pituitary side, especially in cases of stress due to trauma, reduced carbohydrate tolerance, manifestations of latent diabetes mellitus.
- Ophthalmological disorders
Posterior subcapsular cataracts,elevated  intraocular pressure, glaucoma, exophthalmos, isolated cases of blindness after intralesional application in the face and head.
- Blood and vascular disorders
Leukocytosis, lymphopenia, eosinopenia, thromboembolism.
- Metabolic disorders
Negative nitrogen balance due to protein catabolism, lipomatosis, weight gain, and increased appetite.
- Others 
Myocardial rupture after acute myocardial infarction.

Drug Interaction

  • Concurrent use of phenobarbital, rifampin, phenytoin or ephedrine may enhance corticosteroid metabolism, thus reducing therapeutic effects.
  • Excessive corticosteroid effects may occur in patients receiving both a corticosteroid and estrogen.
  • Concurrent use of corticosteroids with potassium – depleting diuretics may enhance hypokalemia. Corticosteroid may enhance the potassium depletion caused by amphotericin B.
  • Concurrent use of corticosteroid and cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. 
  • Concurrent use of corticosteroids with coumarin – type anticoagulants may increase or decrease the anticoagulant effects, possibly requiring adjustment in dosage. 
  • Combined effects of non-corticosteroidal anti-inflammatory drugs or alcohol with glucocorticoids may result in an increased occurrence or increased severity of gastrointestinal ulceration.
  • Corticosteroids may decrease blood salicylate concentrations. When corticosteroids are given to diabetes, dosage adjustments of the antidiabetic drug may be necessary. 
  • Concomitant glucocorticoids therapy may inhibit the response to somatotrophin.

Pregnancy and Lactation

Pregnancy, Nursing Mothers & Pediatric use:
• Do not administer injections preserved with benzyl alcohol to premature infants, neonates, infants below 13 years, pregnant women or nursing mothers.
• Benzyl alcohol has been associated with serious adverse events & death, particularly in pediatric patients (it may cause Gasping Syndrome) Injections preservative free should be used in these populations.

Warning and Precaution

  • This product contains benzyl alcohol which is potentially toxic when administered locally to neural tissue.
  • The suspension is NOT for intravenous or subcutaneous use.
  • Complications of corticosteroid therapy are variable according to dosage and duration pf treatment, the benefits and risks should be evaluated for each case individually.
  • The full effectiveness  of betamethasone like all glucocorticoids, is achieved after several hours occurs, the preparation should not be administered in life- threatening situations (e.g., asthmatic disorder , severe allergic reactions) unless another treatment with immediate action is considered.
  • Upon parenteral use of corticosteroids, severe hypersensitivity reactions, such as glottal edema, bronchospasm and anaphylactic shock may in rare cases, particularly in patients with allergic diathesis, e.g.: bronchial asthma or allergy to some medications, therefore we must ensure the availability of emergency treatment (epinephrine, intravenous fluids, resuscitation).
  • In case of acute bronchial asthma, the administration of Dexaglobe is only an adjunctive treatment which does not replace conventional therapy, it is not advisable to administer glucocorticoids in case of respiratory diseases without complications.
  • Corticosteroid therapy may cause psychic disturbances manifested as euphoria, insomnia, and mood changes, severe depression lead to psychological manifestations may occur. Corticosteroids may increase psychic lability or psychotic tendencies that already exist.
  • Caution is advised in:
    Nonspecific ulcerative colitis. With possible threat of perforation, diverticulitis, recent colonic anastomoses, gastric or intestinal ulcer Abscesses, Epilepsy, Narrow or open -angle glaucoma.
    Recent heart attack, severe hypertension, heart failure, Due to the effect of corticosteroids on the electrolyte balance.
    Hypothyroidism and liver cirrhosis, as the effectiveness of glucocorticoids is enhanced.
    Migraine.
    Myasthenia gravis and concurrent administration of cholinesterase inhibitors as the effectiveness of cholinesterase inhibitors is reduced which increases the risk of myasthenic crisis.
    Long-term treatment with combination of glucocorticoids and salicylates because of the increased risk of bleeding  and gastrointestinal ulceration,which may progress to the perforation, any reduction of the dose of  glucocorticoid should be performed with caution  due  to the risk of Salicylate intoxication, simultaneous administration of acetylsalicylic acid in patients with hypoprothrombinemia , tendency to thrombosis.
    Psychiatric history.
    Renal insufficiency.
    In postmenopausal and elderly parenteral therapy with glucocorticoids should only be performed in case of imperative indication and only after carefully balancing the benefits and risks , because of the high risk of osteoporosis.
    Prolonged corticosteroid therapy for more than two weeks can lead to adrenocortical insufficiency by inhibiting the release of ACTH, which up to adrenal atrophy. The adrenal insufficiency can last up to one year or more and poses a risk to patients living in situations of stress and aggression .In patients on corticosteroid therapy subjected to unusual stress (e.g., surgery, severe trauma, and severe infection), it is advisable to add a fast – acting corticosteroid, during and after the stressful event to overcome this situation.
    Upon corticosteroid use, the acute and chronic infections must be controlled by antibiotics or chemotherapeutic agents, corticosteroids may mask the symptoms of an infection.
    The live virus vaccines, including smallpox vaccine, are prohibited during corticosteroid therapy; patients receiving high doses of steroids are particularly at risk of neurological complications and a decline in immune response. 
    In patients with latent tuberculosis or tuberculin reactivity, corticosteroids should be administered if mandatory and the case should be carefully controlled. In case of long term treatment, these patients should receive anti- tuberculosis chemotherapy. In patients with fulminant tuberculosis or military tuberculosis, Dexaglobe should be administered in combination with tuberculostatic therapy appropriately.
    The varicella occurring suring systemic corticosteroid therapy may develop in severity and may be fatal especially in children, they require immediate treatment.
    In patients at risk, prophylactic agent or passive immunological prophylactic agent is indicated due to immunosuppressive effects of corticosteroids other contraindications of long-term corticosteroid therapy are:
    (herpes simplex, herpes zoster, latent amoebiasis, poliomyelitis except bulbo encephalopathic form,lymphoma following BCG vaccination,carcinoma with metastases).
    In children, the long-term treatment with glucocorticoids can lead to growth disturbance and impaired adrenal function, growth and development should therefore be carefully monitored.
    The use of Dexaglobe necessarily requires a strict aseptic injection technique intrasynovial injections can in addition to their local action, also cause systemic effects. Accidental subcutaneous administration may unfortunately expose the patient to risk of reversible atrophy when intra-articular injection of steroids has led to symptomatic improvement, we must then be carefully avoid stressing excessively the joint, as it might otherwise continue to harm. Latent diabetes mellitus can be manifested during corticosteroid therapy, People with Diabetics often require higher doses of insulin.
    Catabolic and anabolic effects of steroids can cause a negative nitrogen balance. An abundant protein intake is necessary.

Package and Storage

Storage:
Store at temperature not exceeding 30°C.
Keep out of reach of Children.
Pack:
Carton box containing 1 ampoule of 2 ml & insert leaflet.

Mother Company

Manufactured by Sunny Pharmaceuticals , Under licence from Marcyrl