Decilone/Decilone Forte

Decilone/Decilone Forte

dexamethasone

Manufacturer:

Asian Antibiotics

Distributor:

Westmont
Full Prescribing Info
Contents
Dexamethasone.
Action
Pharmacologic Classification: Corticosteroid.
Pharmacology: Dexamethasone (Decilone) is a superior anti-inflammatory and anti-allergic agent which is more potent than other corticosteroids currently used.
Solution for injection: Dexamethasone is a highly potent and long-acting glucocorticoid with negligible sodium-retaining properties. It has powerful anti-inflammatory and immunosuppressive effects.
Pharmacokinetics: Bioavailability: On equal-weight basis, dexamethasone (in Decilone) is six times more potent than triamcinolone or 6-methylprednisolone, six to eight times more potent than prednisone and prednisolone, 25 to 30 times more than hydrocortisone, and about 35 times more than cortisone. It is especially useful in those patients who have become refractory or have developed untoward reactions to other corticosteroids.
Decilone provides the distinct advantage of a greatly enhanced anti-inflammatory activity at a much lower dosage that is virtually devoid of sodium-retaining effect.
Solution for Injection: Intravenous dexamethasone sodium phosphate is converted to dexamethasone rapidly and quantitatively. Pharmacokinetic parameters were not dose dependent when given to healthy subjects in 1.5 mg and 15 mg doses and to cancer patients in 40-200 mg doses.
Dexamethasone's peak plasma concentration is reached within 5 minutes after intravenous administration of dexamethasone phosphate.
Dexamethasone's plasma half-life is shortened in chronic renal failure and simultaneous use of other drugs, e.g., rifampicin, phenobarbital, and phenytoin. Phenytoin decreases the oral bioavailability of dexamethasone by over 50%; plasma half-life is shortened and mean plasma clearance is increased to approximately three times the normal.
Metabolic clearance is reduced and plasma half-life is prolonged in patients with liver disease. Dexamethasone is cleared more rapidly from the circulation of the fetus and neonate than in the mother.
Up to 77% of dexamethasone is bound to plasma proteins. Percentage binding of dexamethasone, unlike that of cortisol, remains practically unchanged with increasing steroid concentrations.
Indications/Uses
Dexamethasone (Decilone) is indicated for the effective management of various inflammatory and allergic conditions which respond to corticosteroid therapy, such as: skin diseases, collagen diseases, blood dyscrasias, certain neoplastic diseases, and adrenocortical insufficiency.
Solution for Injection: By Intravenous (IV) or Intramuscular (IM) Injection When Oral Therapy Is Not Feasible: Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone is the first choice; synthetic analogs like dexamethasone may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).
Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used).
Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.
Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.
Congenital adrenal hyperplasia.
Nonsuppurative thyroiditis.
Hypercalcemia associated with cancer.
Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis.
Synovitis of osteoarthritis.
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
Ankylosing spondylitis.
Acute and subacute bursitis.
Acute nonspecific tenosynovitis.
Acute gouty arthritis.
Psoriatic arthritis.
Epicondylitis.
Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus.
Acute rheumatic carditis.
Dermatologic Diseases: Pemphigus.
Bullous dermatitis herpetiformis.
Severe erythema multiforme (Stevens-Johnson syndrome).
Exfoliative dermatitis.
Mycosis fungoides.
Severe seborrheic dermatitis.
Severe psoriasis.
Allergic States: Control of severe incapacitating allergic conditions intractable to adequate trials of conventional treatment in adults and children with: Bronchial asthma.
Seasonal or perennial allergic rhinitis.
Contact dermatitis.
Atopic dermatitis.
Serum sickness.
Drug hypersensitivity reactions.
Urticarial transfusion reactions.
Acute noninfectious laryngeal edema (epinephrine is the drug of first choice).
Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: Herpes zoster ophthalmicus.
Iritis, iridocyclitis.
Chorioretinitis.
Diffuse posterior uveitis and choroiditis.
Optic neuritis.
Sympathetic ophthalmis.
Anterior segment inflammation.
Allergic conjunctivitis.
Keratitis.
Allergic corneal marginal ulcers.
Respiratory Diseases: Symptomatic sarcoidosis.
Berylliosis.
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.
Loeffler's syndrome not manageable by other means.
Aspiration pneumonitis.
Hematologic Diseases: Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated).
Secondary thrombocytopenia in adults.
Acquired (autoimmune) hemolytic anemia.
Erythroblastopenia (red blood cell anemia).
Congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases: For palliative management of leukemias and lymphomas in adults.
Edematous States: To induce diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type, or that due to lupus erythematosus.
Gastrointestinal Diseases: To tide the patient over a critical period of the disease in: Ulcerative colitis.
Regional enteritis.
Other Uses: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement.
Diagnostic testing of adrenocortical hyperfunction.
Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.
By Intra-Articular Or Soft Tissue Injection: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Synovitis of osteoarthritis.
Rheumatoid arthritis.
Acute and subacute bursitis.
Acute gouty arthritis.
Epicondylitis.
Acute nonspecific tenosynovitis.
Post-traumatic osteoarthritis.
By Intralesional Injection: Keloids.
Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, lichen simplex chronicus (neurodermatitis).
Discoid lupus erythematosus.
Necrobiosis lipoidica diabeticorum.
Alopecia areata.
May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
Dosage/Direction for Use
Decilone 500 mcg Tablet: The dosage must be adjusted to the individual requirements depending upon the severity of the condition, anticipated duration of therapy, tolerance to the steroid, and according to the response obtained. The total daily dosage should be divided into 3 or 4 equal amounts.
Initial Suppressive Dosage: For initial suppressive therapy, a practical distinction between doses could be made in accordance with the form of a particular disorder.
Chronic Nonfatal Forms (e.g. rheumatoid arthritis, chronic bronchial asthma): 0.5 to 1 mg (1 to 2 tablets) daily.
Chronic Potentially Fatal Forms (e.g. disseminated lupus erythematosus, pemphigus, sarcoidosis): 2 to 4.5 mg (4 to 9 tablets) daily.
Acute Nonfatal Forms (e.g. seasonal allergies, dermatological and self-limited ocular disorders): 2 to 3 mg (4 to 6 tablets) daily.
Acute Potentially Fatal Forms (e.g. acute rheumatic fever, severe allergic reactions): 4 to 10 mg (8 to 20 tablets) daily.
Acute Leukemia, Nephrotic Syndrome, Acute Pemphigus: 10 to 15 mg (20 to 30 tablets) daily.
Maintenance Dosage: As soon as the symptoms have subsided, dosage should be gradually reduced to the minimum amount (usually 1 tablet daily) capable of producing adequate relief of symptoms.
Decilone Solution for Injection: Individualize Dexamethasone route of administration and dosage based on the condition being treated and the response of the patient.
All dosage of injectable dexamethasone is expressed as mg Dexamethasone sodium phosphate.
Dexamethasone sodium phosphate injection may be administered through the following routes: Intramuscular or Intravenous injection, Intravenous infusion, Intra-articular injection, Intrasynovial injection, Intralesional injection, Soft tissue injection.
Intravenous (IV) and Intramuscular (IM) Injection: Initial Dosage: May vary from 0.5 to 9 mg dexamethasone sodium phosphate per day depending on the disease being treated.
Maintain or adjust initial dose until satisfactory patient response is achieved.
Discontinue dexamethasone injection and transfer the patient to other therapy if there is no satisfactory response after a reasonable period of treatment.
Determine proper maintenance dose by decreasing the initial dosage in small amounts to the lowest dosage that maintains adequate clinical response.
Monitor patients closely for signs that indicate dosage adjustment is needed such as remissions or exacerbations of the disease and stress (i.e., surgery, infection, trauma).
Withdraw dexamethasone gradually if treatment is to be stopped after more than a few days.
Dosage of dexamethasone administered intravenously should usually be the same as the oral dosage. However, in overwhelming, acute, life-threatening situations, increases in the usual dosage may be justified and may be in multiples of the oral dosages.
Note that absorption through intramuscular administration may be slower than intravenous administration.
Use in Shock: Usual Dose (Any of the following regimens is usually recommended): High-Dose: 1-6 mg dexamethasone sodium phosphate/kg body weight as single IV injection or 40 mg dexamethasone sodium phosphate IV injection repeated every 2-6 hours as needed.
20 mg dexamethasone sodium phosphate IV injection followed by continuous IV infusion of 3 mg dexamethasone sodium phosphate/kg body weight/day.
Continue high-dose therapy only until the patient's condition has stabilized. Do not continue high-dose therapy beyond 48-72 hours.
Use in Cerebral Edema: Usual Dose: 10 mg dexamethasone sodium phosphate usually given IV followed by 4 mg dexamethasone sodium phosphate IM every 6 hours.
Response is usually seen within 12-24 hours. Gradually reduce dosage after 2-4 days and gradually discontinue over a period of 5-7 days.
Replace IM administration with oral dexamethasone (1-3 mg thrice a day) whenever possible.
Maintenance dose for relief of symptoms of increased cranial pressure in patients with recurrent or inoperable brain tumors: 2 mg dexamethasone sodium phosphate IM or IV 2 to 3 times/day.
Use in Acute Allergic Disorders: Recommended dose for the management of acute self-limited allergic conditions or acute exacerbations of chronic allergic disorders: 4-8 mg dexamethasone phosphate IM on the first day, followed by oral dexamethasone for the next 6 days.
Intra-articular (IA), Intralesional (IL), and Soft Tissue Injection: When affected joints or areas are limited to one or two sites, intra-articular, intralesional, and soft tissue injection are usually employed.
Usual Dose: 0.2 to 6 mg dexamethasone sodium phosphate.
Dosage of dexamethasone sodium phosphate depends on the degree of inflammation and the size and location of the affected area.
The following table shows the usual single dose of dexamethasone sodium phosphate according to the site of administration: See table.

Click on icon to see table/diagram/image

Dexamethasone sodium phosphate for IA, IL, and soft tissue injection is may be administered from once every 3 to 5 days to once every 2 to 3 weeks.
Decilone Forte (4 mg Tablet): The dosage must be adjusted to the individual requirements depending upon the severity of the condition, anticipated duration of therapy, tolerance to the steroid, and according to the response obtained. The total 48-hour requirement should be given as a single dose at 8 a.m. every other day.
Initial Suppressive Dosage: For initial suppressive therapy, a practical distinction between doses could be made in accordance with the form of a particular disorder.
Chronic Nonfatal Forms (e.g. rheumatoid arthritis, chronic bronchial asthma): 1 - 2 mg (1/4 to 1/2 tablet every other day).
Chronic Potentially Fatal Forms (e.g. disseminated lupus erythematosus, pemphigus, sarcoidosis): 4 - 8 mg (1 to 2 tablets every other day).
Acute Nonfatal Forms (e.g. seasonal allergies, dermatological and self-limited ocular disorders): 4 to 6 mg (1 to 1 1/2 tablet every other day).
Acute Potentially Fatal Forms (e.g. acute rheumatic fever, severe allergic reactions): 8-20 mg (2 to 5 tablets every other day).
Acute Leukemia, Nephrotic Syndrome, Acute Pemphigus: 20 to 30 mg (5 to 7 1/2 tablets every other day).
Maintenance Dosage: As soon as the symptoms have subsided, dosage should be gradually reduced to the minimum amount capable of producing adequate relief of symptoms.
Special Precautions
Dexamethasone (Decilone) is essentially devoid of mineralocorticoid activity.
With large doses, however, the side effects attendant with corticosteroid therapy should be anticipated.
As with other corticosteroids, Dexamethasone (Decilone) should be given with caution in patients who have active, latent or questionably healed tuberculosis, diabetes mellitus, congestive heart failure, infectious diseases, peptic ulcer, fresh intestinal anastomoses, diverticulitis, thrombophlebitis, chronic renal failure, uremia, psychotic tendency, herpes simplex of the eye and in elderly persons.
Solution for Injection: General: Dexamethasone sodium phosphate injection and other steroid formulations should not be autoclaved for sterilization since they are heat sensitive.
Increased corticosteroid dosage is required in patients subjected to stress (e.g., infection, surgery, trauma).
Withdrawal of corticosteroids after prolonged therapy may result in corticosteroid withdrawal syndrome which includes symptoms such as fever, myalgia, arthralgia, and malaise which may occur even in patients without evidence of adrenal insufficiency.
The lowest possible corticosteroid dose should be used to control the condition being treated. Gradual reduction of dosage is recommended whenever possible.
Corticosteroid effects are exaggerated in patients with hypothyroidism and cirrhosis.
Endocrine: Minimize drug-induced secondary adrenocortical insufficiency caused by rapid withdrawal of corticosteroids by gradual reduction of dosage. Since drug-induced adrenocortical insufficiency may persist for months after discontinuation of therapy, reinstitute corticosteroid therapy in any situation of stress occurring during that period. Dosage may have to be increased in patients already receiving corticosteroid therapy. Administer a salt and/or mineralocorticoid concurrently since mineralocorticoid secretion may also be impaired.
Metabolic clearance of corticosteroids may be altered in hypothyroid (decreased clearance) or hyperthyroid (increased clearance) patients. Dosage adjustment based on thyroid status may be necessary for these patients.
Infections: Glucocorticoids suppress the immune system and increase susceptibility to or mask symptoms of infection. Corticosteroids may cause decreased resistance and inability to localize infection. Infections caused by any pathogen including viral, bacterial, fungal, protozoan, or helminthic infections in any location of the body may be associated with corticosteroids alone or in combination with other immunosuppressive agents. These infections may be mild to severe and occurs more frequently with increasing doses of corticosteroids.
Viral Infections: Viral infections such as chicken pox or measles can be more serious or even fatal in non-immune children or adults on corticosteroids. Patients who have not had these diseases, should take particular care to avoid exposure. Prophylaxis with varicella zoster immune globulin (VZIG) may be indicated if exposed to chicken pox, while prophylaxis with immunoglobulin (IG) may be indicated if exposed to measles. Consider treatment with antiviral agents if chicken pox develops.
Special Pathogens: Corticosteroids may cause activation of latent diseases or exacerbation of intercurrent infections due to pathogens including Candida, Mycobacterium, Amoeba, Toxoplasma, Pneumocystis, Cryptococcus, Nocardia, etc.
As corticosteroids may also activate latent amoebiasis, rule out latent or active amoebiasis before initiating corticosteroid therapy in patients who have spent time in the tropics or with unexplained diarrhea.
In patients with known or suspected Strongyloides (threadworm) infestation, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration which is often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Use corticosteroids with great care in these patients.
Do not use corticosteroids in cerebral malaria since it is associated with prolongation of coma and higher incidence of pneumonia and gastrointestinal bleeding.
Tuberculosis: Use dexamethasone in active tuberculosis only in fulminating or disseminated cases in which corticosteroids are used with appropriate antituberculous regimen.
Since reactivity to the disease may occur in patients with latent tuberculosis or tuberculin reactivity, observe these patients closely and administer chemoprophylaxis during prolonged corticosteroid therapy.
Vaccination: Do not administer live or live attenuated vaccines (including small pox vaccine) in patients receiving corticosteroids. Although killed or inactivated vaccines may be administered in patients on corticosteroids, response to such vaccines cannot be predicted.
Patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease, may be immunized.
Ophthalmic: Prolonged use of corticosteroids may cause posterior subcapsular and nuclear cataracts (particularly in children), exopthalmos, or increased intraocular pressure which may result in glaucoma or may occasionally damage the optic nerve. Monitor intraocular pressure if steroid therapy is continued for more than 6 weeks. Development of secondary fungal and viral infections of the eye may be enhanced in patients receiving corticosteroids.
Do not use corticosteroids in active ocular herpes simplex to avoid corneal perforation.
Cardio-Renal: Sodium retention resulting in edema, potassium loss, hypokalemic alkalosis, and hypertension may occur in patients receiving glucocorticoids. Congestive heart failure may occur in susceptible patients. These mineralocorticoid effects occur mostly with average and large doses of hydrocortisone or cortisone and occur less frequently with synthetic corticosteroids such as dexamethasone. However, these effects may occur when synthetic corticosteroids are used in high dosage for prolonged periods. Dietary salt restriction and potassium supplementation may be advised when necessary. All corticosteroids increase calcium excretion which may result to hypocalcemia.
Use corticosteroids with caution in patients with hypertension, congestive heart failure, or renal insufficiency.
Use corticosteroids with caution in patients who have experienced a recent myocardial infarction since corticosteroid use is associated with left ventricular free wall rupture in these patients.
Neuro-Psychiatric: Acute myopathy which occurs most frequently in patients with disorders of neuromuscular transmission such as myasthenia gravis, or in patients receiving therapy with neuromuscular blocking agents such as pancuronium, has been observed with use of high doses of corticosteroids. Acute myopathy, which may result in quadriparesis, is generalized and may involve ocular and respiratory muscles. Elevation of creatine kinase may also be observed. Clinical improvement or recovery may need weeks to years of stopping corticosteroid therapy.
Corticosteroids may lead to mental disturbances including euphoria, mood swings, depression and anxiety, personality changes, and frank psychoses. Corticosteroids may also aggravate emotional instability or psychotic tendencies.
Gastrointestinal: Corticosteroids have been implicated in the development, reactivation, perforation, hemorrhage, and delayed healing of peptic ulcers and should therefore not be used in patients with peptic ulcers except in life-threatening situations.
Use corticosteroids with caution in patients with diverticulitis, recent intestinal anastomoses, or nonspecific ulcerative colitis especially if there is risk of impending perforation, abscess, or other pyogenic infection.
Manifestations of peritoneal irritation following gastrointestinal perforation may not be seen or is minimal in patients receiving corticosteroids.
Musculoskeletal: Manifestations of protein catabolism which may occur during prolonged corticosteroid therapy include muscle wasting, muscle pain or weakness, delayed wound healing, and atrophy of the protein matrix of the bone resulting to osteoporosis, vertebral compression of fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones. These catabolic effects may lead to osteoporosis at any age and inhibition of bone growth in children and adolescents. Since postmenopausal women and geriatric or debilitated patients are especially prone to osteoporosis, special consideration must be given to these patients prior to initiation of corticosteroid therapy.
Intra-articular and Intramuscular Administration: Administration of dexamethasone by intra-articular injection may cause systemic effects apart from its local effects.
Examine any joint fluid present to exclude a septic process. Septic arthritis is characterized by local swelling, further restriction of joint motion, fever, and malaise. Appropriate antimicrobial therapy should be instituted when sepsis is confirmed.
Avoid injecting corticosteroids into an infected site.
Do not inject corticosteroids into unstable joints. Instruct patients not to overuse joints while the inflammatory process remains active even when symptomatic benefits have been obtained.
Joint tissues may be damaged due to frequent intra-articular injection.Recognize that absorption by intramuscular administration is slower.
Adverse Reactions
Excessive mental stimulation, increased appetite, muscle twitching, increase in weight, tachycardia, insomnia and psychic disturbances have been reported.
Solution for Injection: Corticosteroids, given in massive doses intravenously as a "pulse" in emergencies are reasonably free from hazardous long-term consequences. However, continued use of high doses necessary for clinical response in severe illness results in exaggeration of usual corticosteroid problems.
Adverse effects caused by dexamethasone and other corticosteroids include decreased carbohydrate tolerance, development of cushingoid state, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness particularly in times of stress as in trauma, surgery, or illness. These drugs may also cause suppression of growth in children, congestive heart failure in susceptible patients, fluid retention, hypertension, hypokalemic alkalosis, potassium loss, sodium retention, hypertrophic cardiomyopathy in premature infants, and myocardial rupture following recent myocardial infarction.
Musculoskeletal and neurological adverse effects include aseptic necrosis of femoral and humeral heads, loss of muscle mass, muscle weakness, osteoporosis, pathological fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures, convulsions, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after discontinuation of treatment, psychic disorders, vertigo, and cerebral palsy in preterm infants.
Dexamethasone and other corticosteroids may also cause abdominal distention, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large bowel particularly in patients with inflammatory bowel disease, ulcerative esophagitis, facial erythema, increased sweating, impaired wound healing, may suppress reactions to skin tests, petechiae and ecchymoses, thin fragile skin, and other skin reactions such as allergic dermatitis, urticaria, and angioneurotic edema.
Other possible adverse reactions include negative nitrogen balance due to protein catabolism, exopthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, retinopathy of prematurity, increased appetite, malaise, nausea, weight gain, and hiccups.
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, postinjection flare (following intra-articular use), and charcot-like arthropathy.
ATC Classification
H02AB02 - dexamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Decilone: Tab 500 mcg x 100's. Soln for inj (amp) 5 mg/mL x 1 mL x 10's.
Decilone Forte: Tab 4 mg x 100's.
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