DIPROSPAN (BETAMETHASONE) HYPAK INJECTION
In stock: 626 units
INDICATIONS AND USAGE: DIPROSPAN * Injectable Suspension is indicated for the treatment of acute and chronic disorders that respond to corticosteroids. The corticosteroid hormone therapy is an adjunct and not replace conventional therapy.
q musculoskeletal ailments and soft tissue: rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, radiculitis, coccydynia, sciatica, lumbago, stiff neck, ganglion cyst, exostosis and fasciitis.
q Allergic conditions: chronic bronchial asthma (including adjunctive therapy for status asthmaticus), angioneurotic edema, allergic bronchitis, seasonal or perennial allergic rhinitis, drug reactions, serum sickness, and insect bites.
q dermatological ailments: Atopic dermatitis (nummular eczema), neurodermatitis (lichen simplex circumscribed), contact dermatitis, severe solar dermatitis, urticaria, hypertrophic lichen planus, necrobiosis lipoid of diabetics, alopecia areata, discoid lupus erythematosus, psoriasis, keloids, pemphigus dermatitis herpetiformis and cystic acne.
q Collagen Diseases: Lupus erythematosus, scleroderma, dermatomyositis and periarteritis nodosa.
q Neoplastic Diseases: For palliative management of leukemias and lymphomas in adults and acute leukemia in children.
q Other conditions: adrenogenital syndrome, Ulcerative colitis, regional ileitis, sprue, hoof disorders (bursitis below heloma hard hallus rigidus, bunionette), conditions that require subconjunctival injection, blood dyscrasias that respond to corticosteroids, nephritis and nephrotic syndrome.
The primary or secondary adrenocortical insufficiency may be treated with DIPROSPAN * Suspension for injection, but should be supplemented with mineralocorticosteroides.
DIPROSPAN * Injectable Suspension is recommended for:
q Intramuscular injection in conditions responsive to systemic corticosteroids.
q injection directly into soft tissues, such therapy when indicated.
q intra and periarticular injection in arthritic disorders.
intralesional injections q in various dermatological conditions.
q Local injection in certain inflammatory and cystic disorders of the foot.
Contraindications DIPROSPAN * Suspension for injection is contraindicated in patients with systemic fungal infections in those with sensitivity reactions to betamethasone, other corticosteroids, or any component of this product.
PRECAUTIONS: DIPROSPAN * Suspension for injection is for intravenous or subcutaneous.
It is mandatory to use a strict aseptic technique when administering DIPROSPAN * Suspension for injection.
Suspension for injection containing DIPROSPAN * 2 esters of betamethasone, one of which, betamethasone sodium phosphate, disappears rapidly from the site of injection.
Therefore the potential to cause systemic effects of this soluble portion of DIPROSPAN * Suspension for injection should be taken into account by the physician when using this preparation.
DIPROSPAN * Suspension for injection should be administered intramuscularly with caution to patients with idiopathic thrombocytopenic purpura.
Intramuscular injections of corticosteroids should be administered deeply into large muscle masses to avoid local tissue atrophy.
The intra-articular, intralesional or soft tissue of a corticosteroid may cause systemic effects in addition to local effects.
Avoid corticosteroid injection in a previously infected joint.
Therefore it is necessary to suck all present and analyze joint fluid to exclude a septic process. From a clinical standpoint, these data suggest a septic arthritis: significant increase of pain and local swelling, further restriction of joint mobility and general malaise or fever. If confirmed the diagnosis of sepsis should be instituted appropriate antimicrobial therapy.
Corticosteroids should not be injected into unstable joints, infected areas or intervertebral spaces. Repeated injections in osteoarthritic joints can increase the destruction of the joint. Avoid injecting corticosteroids directly into the substance of tendons because delayed rupture may occur in the tendon.
After intra-articular corticosteroid therapy, the patient should be careful not to overuse the joint in which symptomatic benefit has been obtained.
Because there have been rare cases of anaphylactoid reactions in patients receiving parenteral corticosteroid therapy should be appropriate precautionary measures before administration, especially when the patient has a history of allergy to any drug.
When necessary, the long-term corticosteroid therapy, it must move from parenteral to oral administration, after considering the benefits and potential risks.
When present either a remission or exacerbation of the clinical picture is likely to have to make an adjustment of dosage according to individual patient response to treatment and patient exposure to emotional or physical stress, as in the case of serious infection, surgery or serious trauma.
After stopping a long-term corticosteroid therapy or high doses, it is necessary to closely monitor the patient for a year.
Corticosteroids may mask some signs of infection may develop new infections while in use. When corticosteroids are used, it may be a reduction of the resistance and inability to maintain localized infections.
Prolonged use of corticosteroids may cause posterior subcapsular cataracts (especially in children), glaucoma with possible damage to the optic nerves, and may also promote secondary eye infections caused by fungi or viruses.
Normal and elevated doses of corticosteroids may increase blood pressure, salt and water retention and potassium excretion. Is less likely that these effects occur with the synthetic derivatives except when used in high doses. May be considered dietary salt restriction and potassium supplementation. All corticosteroids increase calcium excretion.
Patients who are receiving corticosteroid treatment should not be vaccinated against smallpox. Should not be undertaken other immunization procedures in patients receiving corticosteroids, especially when high doses are being used, because of possible hazards of neurological complications and there will probably be a lack of antibody response.
However, immunizing procedures can be undertaken in patients receiving corticosteroids as replacement therapy for example in the case of Addison's disease.
It should be noted in patients receiving immunosuppressive doses of corticosteroids to avoid being exposed to measles or chickenpox, if exposed, to consult a doctor. This is especially important in children.
Corticosteroid therapy in patients with active tuberculosis should be restricted to cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management together with appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or positive tuberculin reaction, you need to watch closely as it can occur reactivation of the disease. During prolonged corticosteroid therapy, patients should receive chemoprophylaxis. If used chemoprophylactic rifampin is a program, it should be noted enhancer effect of hepatic metabolic clearance of corticosteroids, may be necessary to adjust the dosage of corticosteroid.
You must use the lowest possible dose of corticosteroid to control the condition being treated, and where necessary reduce the dosage, this reduction should be done gradually.
The withdrawal of corticosteroids too quickly can induce secondary adrenocortical insufficiency, which can be minimized by gradual reduction of dosage. Such relative insufficiency may persist for months after discontinuation of treatment, therefore, upon the occurrence of stress during this period should reinstituted the steroids. If the patient is already receiving corticosteroids may be necessary to increase dosage. As can be impaired secretion of mineralocorticoid should be administered concomitantly salt or mineralocorticosteroide.
The corticosteroid effect is increased in patients with hypothyroidism or cirrhosis.
We recommend the cautious use of corticosteroids in patients with ocular herpes simplex because of possible corneal perforation.
With the steroids may develop psychological disorders. Emotional instability or psychotic tendencies may be aggravated by existing corticosteroids.
Corticosteroids should be used with caution in: nonspecific ulcerative colitis especially when there is a probability of impending perforation, abscess formation or other pyogenic infection. Also care must be taken when used in the presence of diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis.
Since complications of treatment with glucocorticoids are dependent on the dose and duration of treatment, must make a decision based on the risks and benefits for each patient.
As administration of corticosteroids may disrupt the growth rates and inhibit the endogenous production of corticosteroids in infants and children, growth and development of patients receiving prolonged treatment should be monitored carefully.
Corticosteroids may alter motility and sperm count in some patients.
Use in pregnancy and lactation: As there have been no controlled studies of reproduction in humans with corticosteroids, the use of DIPROSPAN * Suspension for injection during pregnancy or in women of childbearing age requires that the potential benefits of the drug estimated on the basis of potential risks to mother and fetus. Infants born to mothers who received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
Because of the potential DIPROSPAN * Suspension for injection to cause unwanted side effects in infants, take a decision on whether to discontinue nursing or the drug, taking into account the importance of the agent to the mother.
ADVERSE REACTIONS: Adverse reactions DIPROSPAN * Suspension for injection, which were the same as reported for other corticosteroids, are related to dosage and duration of treatment.
Typically, such reactions can be reversed or minimized by reducing the dosage, which is generally preferable to the cessation of drug therapy.
Fluid and electrolyte disturbances: sodium retention, potassium loss, hypokalemic alkalosis, fluid retention, congestive heart failure and hypertension in susceptible patients.
Musculoskeletal: muscle weakness, myopathy corticosteroid, muscle loss, aggravation of myasthenic symptoms in myasthenia gravis, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, tendon rupture and instability of the joint (intra-articular injections repeated).
Gastrointestinal: peptic ulcers with possible subsequent perforation and hemorrhage, pancreatitis, abdominal distension, with or without esophagitis, esophageal ulcers.
Skin: Impairment of wound healing, skin atrophy, fragile and thin skin, petechiae and ecchymoses, facial erythema, increased sweating, depressed 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 state "cushingoid" intrauterine fetal growth depression or during childhood, poor adrenal and pituitary secondary response, particularly in times of stress, as in trauma, surgery or serious illness, reduced carbohydrate tolerance, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetic patients.
Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.
Metabolic: negative nitrogen balance due to protein catabolism.
Psychiatric: euphoria, mood changes, including severe depression to frank psychotic manifestations, personality change and insomnia.
Other: anaphylactoid or hypersensitivity reactions and reactions or similar hypotensive shock.
Other adverse reactions related to parenteral corticosteroid therapy include rare instances of blindness associated with intralesional therapy around the face and head, hyperpigmentation or hypopigmentation, subcutaneous and cutaneous atrophy, sterile abscess, inflammation after injection (following intra-articular use) and arthropathy Charcot type.
Drug Interactions and Laboratory:
Drug Interactions: Concurrent use of phenobarbital, phenytoin, rifampin or ephedrine may enhance the metabolism of corticosteroids, reducing their therapeutic effects.
Patients receiving a corticosteroid and an estrogen should be observed to determine the presence of excessive corticosteroid effects.
Concurrent use of corticosteroids with diuretics may accentuate potassium depleting hypokalemia. Concurrent use of corticosteroids with cardiac glycosides may increase the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Corticosteroids may promote potassium depletion caused by amphotericin B. In all patients taking any of these combination therapies, determinations of serum electrolytes, especially potassium levels should be monitored closely.
Concurrent use of corticosteroids with coumarin-type anticoagulants may increase or decrease the anticoagulant effects and you may need a dosage adjustment.
The combined effects of steroids or nonsteroidal anti-inflammatory glucocorticosteroid alcohol can lead to an increase in the frequency or severity of gastrointestinal ulcers.
Corticosteroids may reduce blood levels of salicylate. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia cases.
When corticosteroids are administered to diabetic patients may need to adjust the dosage of antidiabetic drug.
Concomitant treatment with glucocorticoids may inhibit the response to somatotropin.
Laboratory Test Interactions: Corticosteroids may affect the nitroblue tetrazolium test for bacterial infections and give false negative results.
DOSAGE AND ADMINISTRATION: The dosage requirements are variable and must be individualized based on the specific disease, its severity and patient response.
The initial dose should be maintained or adjusted until a satisfactory response observed. If a satisfactory clinical response occurred after a reasonable period, treatment with DIPROSPAN * Suspension for injection should be discontinued and appropriate therapy instituted another.
Systemic administration: For systemic treatment, the administration is initiated with 1 to 2 ml in the case of most conditions and repeated as necessary. The injection is intramuscular (IM) deep in the gluteal region. The dosage and frequency of administration depend on the severity of the condition of the patient and the therapeutic response. Initially, in the case of severe illness such as lupus erythematosus or status asthmaticus, you can apply an injection of 2 ml, while further action needed to save the patient's life.
A wide variety of dermatological conditions respond effectively to an IM injection 1 ml of DIPROSPAN * Suspension for injection, which can be repeated in accordance with clinical response.
In the respiratory tract disorders, onset of relief of symptoms usually occurs within hours of an injection administered IM of DIPROSPAN * Suspension for injection. In cases of bronchial asthma, allergic bronchitis and allergic rhinitis has been achieved effective control of symptoms with administration of 1 to 2 ml.
In the treatment of acute or chronic bursitis excellent results were achieved with an IM injection 1 to 2 ml of DIPROSPAN * Suspension for injection, repeated as necessary.
Local Administration: Concomitant use of local anesthetic is rarely necessary. If desired co-administer a local anesthetic, DIPROSPAN * injectable suspension can be mixed (in the syringe is not in the vial) with procaine hydrochloride 1 or 2% lidocaine or using formulations containing no parabens.
Local anesthetics can also be used like. Anesthetics containing methyl paraben, propylparaben, phenol, etc.. should be avoided.
The dosage of DIPROSPAN * Injectable Suspension is first withdrawn from the vial into the syringe. Then take the local anesthetic and the syringe is gently agitated.
In cases of acute bursitis subdeltoide, subacromial, olecranon and prepatellar, intrabursal injection of 1 to 2 ml of DIPROSPAN * Suspension for injection can relieve pain and restore full motion in a few hours. Chronic bursitis may be treated with reduced dosage once the acute symptoms have been controlled.
In tenosynovitis, tendinitis and tendinopathy acute injection DIPROSPAN * Suspension for injection should relieve the condition. In chronic forms of these disorders can be repeated as needed injecting the patient.
After two to four hours after intraarticular administration of 0.5 to 2 ml of DIPROSPAN * Suspension for injection, you may feel relief from pain, sensitivity and stiffness associated with rheumatoid arthritis and osteoarthritis. The duration of relief, which varies widely in both diseases is 4 or more weeks in most cases.
An intraarticular injection of DIPROSPAN * Suspension for injection is better tolerated in the joint and periarticular tissues. The 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 DIPROSPAN * Suspension for injection. The response of some untreated lesions may be due directly to a mild systemic effect of the drug. In intralesional treatment is recommended intradermal dose of 0.2 ml/cm2 of DIPROSPAN * Suspension for injection, evenly injected with a tuberculin syringe and a 26 gauge needle. The total amount of DIPROSPAN * Injectable suspension injected at all sites per week must not exceed 1 ml.
DIPROSPAN * Suspension for injection can be effectively used in foot disorders that respond to corticosteroid treatment. Bursitis hard heloma below can be controlled with 2 successive injections of 0.25 ml each. In some disorders such as hallus rigidus, bunionette and acute gouty arthritis, onset of relief can be fast. For most suitable injections is a tuberculin syringe with a 25 gauge needle.
Recommended doses at intervals of about a week: Bursitis under heloma drive or mola, from 0.25 to 0.5 ml; bursitis below the heel spur, 0.5 ml; bursitis on hallus rigidus, 0.5 ml; bursitis on bunionette, 0.5 ml; synovial cyst, 0.25 to 0.5 ml; neuralgia Morton (metatarsalgia), 0.25 to 0.5 ml, tenosynovitis, 0.5 ml; periostitis of cuboid, 0.5 ml, acute gouty arthritis, 0.5 to 1 ml.
After a favorable response is observed, you must determine the appropriate dose and maintenance dose is reduced initial drug in small quantities at appropriate intervals to reach the lowest dose that maintains an adequate clinical response.
The patient's exposure to situations that cause stress, not related to the disease being treated, you may need an increased dosage of DIPROSPAN * Suspension for injection. If the drug is to be suspended after prolonged treatment, the dosage should be gradually reduced.
Symptoms: It is expected that acute overdosage with glucocorticosteroids, including betamethasone, leading to a potentially fatal. Except with more extreme dosages, it is unlikely that a few days of excessive administration of glucocorticoids cause harmful results if there are no specific contraindications, as in the case of patients with diabetes mellitus, glaucoma or active peptic ulcer, or patients taking drugs such as digitalis, coumarin-type anticoagulants or diuretics, potassium depleting.
Treatment: Complications arising from the metabolic effects of corticosteroids or the effects of basic or concomitant diseases, or which are the result of drug interactions should be treated appropriately. Maintain an adequate fluid intake and monitor serum electrolytes and urine, with special attention to the balance of sodium and potassium. Electrolyte imbalance treated where necessary.
Name of medicine: Diprospan HYPAK
Comparable patent medicine: Diprospan
Active ingredient: Betamethasone
Presentation: Solution for injection
Extended-release tablets: No
Box with a disposable sterile syringe with needle
Made in: Mexico