Bextasol sodium phosphate and Bextasol acetate combination injection provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, lung or breathing problems, blood or bone marrow problems, eye or vision problems, lupus, serious skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Bextasol sodium phosphate and Bextasol acetate combination is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.
Bextasol sodium phosphate and Bextasol acetate is to be given only by or under the direct supervision of your doctor.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Bextasol 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.
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 and insect bites.
Neoplastic Diseases: 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, digiti quinti varus), affections requiring subconjunctival injection, corticosteroid-responsive blood dyscrasias, nephritis and nephrotic syndrome.
Primary or secondary adrenocortical insufficiency may be treated with Bextasol Suspension but should be supplemented with mineralocorticosteroids, if applicable.
Bextasol Suspension is recommended for intramuscular injection in conditions responsive to systemic corticosteroids; injection directly into the affected soft tissues where indicated; intra-articular and periarticular injection in arthritides; intralesional injection in various dermatologic conditions; and local injection in certain inflammatory and cystic disorders of the foot.
How should I use Bextasol?
Use Bextasol solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Bextasol solution by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Use the dropper that comes with Bextasol solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
If Bextasol solution needs to be stopped (or if a different medicine is added to therapy) by your doctor, this will be done gradually. The risk of side effects may be increased if Bextasol solution is suddenly stopped.
If you miss a dose of Bextasol solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Bextasol solution.
Uses of Bextasol in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions
Endocrine disorders: Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Note: Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance
Gastrointestinal diseases: During acute episodes in regional enteritis and ulcerative colitis
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia
Neoplastic diseases: Palliative management of leukemias and lymphomas
Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Note: Treatment guidelines recommend the use of high-dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014).
Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids
Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis
Rheumatic disorders: Adjunctive therapy for short-term administration in acute gout flares; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy
Intra-articular or soft tissue administration:
Adjunctive therapy for short-term administration in acute gout flares, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis
Treatment of alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum
Off Label Uses
Accelerate fetal lung maturation
According to systematic reviews of randomized controlled trials using Bextasol or dexamethasone, evidence supports the use of a single course of antenatal corticosteroids to accelerate fetal lung maturation in women at risk for preterm delivery, with no clear advantages found regarding use of one corticosteroid over another.
Each gram of Bextasol (Bextasol*) Cream* contains: 640 mcg Bextasol dipropionate (equivalent to 500 mcg Bextasol).
Each gram of Bextasol (Bextasol*) Ointment* contains: 640 mcg Bextasol dipropionate (equivalent to 500 mcg Bextasol).
Bextasol (Bextasol*) Cream and Ointment contain Bextasol dipropionate, a synthetic corticosteroid with anti-inflammatory activity to be administered topically.
Bextasol dipropionate is a white to creamy white odorless crystalline powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. It has a molecular weight of 504.16 and the empirical formula C28H37FO7; a chemical name of 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione,17,21-dipropionate.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Pod-Care 100C: Bextasol sodium phosphate 3 mg and Bextasol acetate 3 mg per 1 mL [contains benzalkonium chloride, disodium edta]
ReadySharp Bextasol: Bextasol sodium phosphate 3 mg and Bextasol acetate 3 mg per 1 mL [contains benzalkonium chloride, disodium edta]
Bextasol Soluspan: Bextasol sodium phosphate 3 mg and Bextasol acetate 3 mg per 1 mL (5 mL) [contains benzalkonium chloride, edetate disodium]
Generic: Bextasol sodium phosphate 3 mg and Bextasol acetate 3 mg per 1 mL (5 mL)
Note: Dosages expressed as combined amount of Bextasol sodium phosphate and Bextasol acetate; 1 mg is equivalent to Bextasol sodium phosphate 0.5 mg and Bextasol acetate 0.5 mg.
Usual dosage range: IM: Initial: 0.25 to 9 mg/day (based on severity of disease and patient response).
Antenatal fetal maturation (off-label use): IM: 12 mg every 24 hours for a total of 2 doses (ACOG 171 2016). A single course of Bextasol is recommended for women between 24 and 34 weeks of gestation, including those with ruptured membranes or multiple gestations, who are at risk of delivering within 7 days. A single course may be appropriate in some women beginning at 23 weeks gestation or late preterm (between 34 0/7 weeks and 36 6/7 weeks gestation). A single repeat course may be considered in some women with pregnancies less than 34 weeks gestation at risk for delivery within 7 days and who had a course of antenatal corticosteroids >14 days prior (ACOG 171 2016; ACOG 713 2017, ACOG 188 2018).
Bursitis (other than of foot): Intra-articular: 3 to 6 mg (0.5 to 1 mL) for one dose; additional injections may be required for acute exacerbations or chronic conditions; generally, injections should be separated by a minimum of 4 to 6 weeks and limited to ≤4 injections per year. If symptoms are not improved after 1 or 2 injections, additional injections are unlikely to provide benefit (Cardone 2002); following resolution of acute episodes, reduced doses may be warranted for chronic conditions.
Dermatologic conditions: Intradermal: 1.2 mg/cm displayed a good or excellent response (Chowdri, 1994). Another trial (n=25, age range: 7 weeks to 2 years) used lower doses of 3 to 12 mg (in combination with triamcinolone); 16 patients experienced a marked response (Kushner, 1985).
Concurrent use of phenobarbital, phenytoin, rifampin 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 effects.
Concurrent use of corticosteroids 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.
Concurrent use of corticosteroids with coumarin-type anticoagulants may increase or decrease the anticoagulant effects, 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 salicylate 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. Doses of Bextasol in excess of 300-450 mcg (0.3-0.45 mg)/m2 of body surface per day should be avoided during administration of somatotropin.
Laboratory Tests: Corticosteroids may affect the nitro-blue tetrazolium test for bacterial infection and produce false-negative results.
In addition to its needed effects, some unwanted effects may be caused by Bextasol topical (the active ingredient contained in Bextasol). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Bextasol topical:
Burning, itching, or stinging at the application site
thinning of the hair
Incidence not known:
Blistering, burning, crusting, dryness, or flaking of the skin
itching, scaling, severe redness, soreness, or swelling of the skin
redness and scaling around the mouth
thinning of the skin with easy bruising, especially when used on where the skin folds together (e.g. between the fingers)
Minor Side Effects
Some of the side effects that can occur with Bextasol topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Acne or pimples
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
Incidence not known:
Burning and itching of the skin with pinhead-sized red blisters
burning, itching, and pain in hairy areas, or pus at the root of the hair
increased hair growth on the forehead, back, arms, and legs
lightening of normal skin color
lightening of treated areas of dark skin
reddish purple lines on the arms, face, legs, trunk, or groin
You should not use this medication if you are allergic to Bextasol, or if you have a fungal infection anywhere in your body.
Before taking Bextasol, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.
Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.
Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
Do not receive a "live" vaccine while you are taking Bextasol. Vaccines may not work as well while you are taking a steroid.
Do not stop using Bextasol suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.
DailyMed. "BETAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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