Compound Betamethasone Injection

This product is a compound preparation of soluble betamethasone ester and slightly soluble betamethasone ester, which can play a strong anti-inflammatory, anti-rheumatic and anti-allergic role in the treatment of diseases that respond to corticosteroids. Soluble betamethasone sodium phosphate is quickly absorbed after injection and takes effect quickly. After injection, slightly soluble betamethasone dipropionate becomes a reservoir for slow absorption, which continues to work and thus controls symptoms for a long time. The crystals of betamethasone dipropionate are tiny and can be administered intradermally and intralesionally through fine needles (as thin as 26-gauge needles). Glucocorticoid drugs such as betamethasone can cause a variety of significant metabolic reactions and change the body's immune response to various stimuli. Betamethasone has high glucocorticoid activity and mild mineralocorticoid activity.

This product is a compound preparation, and its components are: 5 mg of betamethasone dipropionate (calculated as betamethasone) and 2 mg of betamethasone sodium phosphate (calculated as betamethasone) per 1 ml. Excipients are disodium hydrogen phosphate, sodium chloride, disodium edetate, polysorbate 80, 1% benzyl alcohol (antibacterial agent), 0.15% methylparaben (antibacterial agent), sodium carboxymethylcellulose, polyethylene glycol 4000, phosphoric acid and water for injection.

This product is a white suspension.

This product is suitable for the treatment of acute and chronic diseases that are sensitive to corticosteroids. Corticosteroid therapy is an adjunct to conventional therapy and cannot replace conventional therapy. Musculoskeletal and soft tissue diseases: rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, radiculitis, coccygeal pain, sciatica, low back pain, torticollis, ganglion cyst, exostosis, fasciitis. Allergic diseases: chronic bronchial asthma (including adjunctive treatment of status asthmaticus), hay fever, angioedema, allergic tracheitis, seasonal or perennial allergic rhinitis, drug reactions, serum sickness, insect bites. Skin diseases: atopic dermatitis (coin-shaped eczema), neurodermatitis (localized simple lichen), contact dermatitis, severe solar dermatitis, urticaria, hypertrophic lichen planus, diabetic lipid progressive necrosis, alopecia areata, discoid lupus erythematosus, psoriasis, keloid, pemphigus, herpetic dermatitis, cystic acne. Collagen diseases: disseminated lupus erythematosus, scleroderma, dermatomyositis, nodular perivascular inflammation. Tumors: palliative treatment of adult leukemia and lymphoma, acute leukemia in children. Other diseases: adrenal gland syndrome, ulcerative colitis, segmental ileitis, stomatitis diarrhea, foot diseases (bursitis under the hard corn, hallux rigidus, inversion of the little toe), diseases requiring subconjunctival injection, cachexia, nephritis and nephrotic syndrome that are effective with corticosteroids. This product can treat primary or secondary adrenal insufficiency, but mineralocorticoids should be appropriately supplemented. This product is recommended for: (1) intramuscular injection to treat diseases that respond to systemic corticosteroids; (2) direct injection into the soft tissue of patients with indications; (3) intra-articular and peri-articular injection to treat arthritis; (4) intralesional injection to treat various skin diseases; and (5) local injection to treat certain inflammatory and cystic diseases of the foot.

The required dose varies and must be individualized according to the nature, severity and patient response of the disease. The initial dose should be maintained or adjusted until satisfactory efficacy is achieved. If satisfactory clinical efficacy is not achieved after appropriate treatment, this product should be discontinued and other appropriate treatments should be adopted. Systemic administration: For most diseases, the starting dose for systemic treatment is 1 to 2 ml, which can be repeated if necessary. The method of administration is deep intramuscular injection (IM) in the buttocks. The dose and frequency of administration depend on the severity and efficacy of the disease. For serious diseases such as lupus erythematosus patients who have been relieved by appropriate rescue measures, the initial dose may require 2 ml. A variety of skin diseases are effective after intramuscular injection of 1 ml of this product. Repeated administration can be selected according to the condition. When treating respiratory diseases, symptoms are relieved within a few hours after intramuscular injection of this product. For bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis, injection of 1 to 2 ml of this product can effectively control symptoms. In the treatment of acute or chronic synovial bursitis, intramuscular injection of 1 to 2 ml of this product is extremely effective and can be repeated if necessary. Topical medication: Generally, it is not necessary to use local anesthetics together. If you need to use it together, you can mix this product with 1% or 2% procaine hydrochloride or lidocaine in a syringe (not in a medicine bottle), but you should use a preparation that does not contain paraben preservatives. Similar local anesthetics can also be used, but local anesthetics containing methylparaben, propylparaben and phenol cannot be used. When using, you must first draw an appropriate amount of the suspension injection in the medicine bottle into the syringe, then draw in the local anesthetic and shake it for a while. In the treatment of acute subdeltoid, subacromial, subolecranon and prepatellar synovial bursitis, 1 to 2 ml of this product can relieve pain within a few hours after injection into the bursa, and the activity is not restricted. In the treatment of chronic bursitis, once the acute symptoms are controlled, the dose can be reduced. Acute tenosynovitis, tendinitis and tenosynovitis can be relieved by injecting this product once. In the chronic stage of such diseases, repeated administration may be required depending on the patient's condition. Intra-articular injection of 0.5 to 2 ml of this product can relieve the pain, distress and stiffness associated with rheumatoid arthritis and osteoarthritis within 2 to 4 hours. The duration of relief varies greatly in both diseases, most of which are more than four weeks. The joints and peri-articular tissues are well tolerated when the product is injected intra-articularly. The recommended dose for intra-articular injection is 1 to 2 ml for large joints (knees, hips, shoulders); 0.5 to 1 ml for medium joints (elbows, wrists, ankles); 0.25 to 0.5 ml for small joints (feet, hands, chest). Intralesional injection of this product is effective for skin diseases. Some lesions have shown efficacy without topical medication, which may be due to the mild systemic effect of the drug. The recommended dose for intralesional injection of this product is 0.2 ml/cm2 intradermally, injected with a tuberculin syringe and a 26-gauge needle. The total amount of this product injected in all parts should not exceed 1 ml per week. This product can be effectively used for certain foot diseases that respond to corticosteroids. Each injection of 0.25 ml can control bursitis under hard corns for two consecutive times. For certain diseases such as hallux valgus, inversion of the little toe and acute gouty arthritis, it can quickly relieve symptoms. In most cases, it is suitable for injection with a tuberculin syringe and a 25-gauge needle. The following recommended doses can be used when the interval between doses is about one week: 0.25 to 0.5 ml for bursitis under hard or soft corns; 0.5 ml for bursitis under the calcaneal spur; 0.5 ml for hallux valgus bursitis; 0.5 ml for inversion of the little toe bursitis; 0.25 to 0.5 ml for bursal cysts; 0.25 to 0.5 ml for Morton’s neuralgia (metatarsalgia); 0.5 ml for tenosynovitis; 0.5 ml for cuboid periostitis; and 0.5 to 1 ml for acute gouty arthritis. After achieving good therapeutic effects, the initial dose should be gradually reduced at appropriate time intervals until the dose is gradually reduced to the lowest dose that can fully achieve clinical efficacy, which is used as the maintenance dose. When the patient is in a state of stress that is unrelated to existing diseases, the dose of this product needs to be increased. If the drug needs to be discontinued after long-term treatment, the dose must be gradually reduced.

The adverse reactions of this product are similar to those of other corticosteroids, and are related to the dose and course of treatment. They can be eliminated or alleviated by reducing the dose, which is more commonly used. Water and electrolyte disorders: sodium retention, potassium loss, hypokalemic alkalosis, fluid retention, congestive heart failure in susceptible patients, and hypertension. Musculoskeletal: muscle weakness, corticosteroid myopathy, muscle wasting, aggravation of myasthenia gravis symptoms, osteoporosis, vertebral compression fractures, aseptic necrosis of the femoral head and humeral head, pathological fractures of long bones, and joint instability (due to repeated intra-articular injections). Gastrointestinal: peptic ulcer (perforation and bleeding may occur later), pancreatitis, abdominal distension, ulcerative esophagitis. Skin: affects wound healing, skin atrophy, thin and brittle skin, petechiae and ecchymoses, facial erythema, hyperhidrosis, suppressed skin test reactions, allergic dermatitis, urticaria, and angioneurotic edema. Nervous system: convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri), vertigo, headache. Endocrine system: menstrual disorders, Cushing's syndrome-like manifestations, intrauterine development of the fetus or growth inhibition in children; secondary adrenal cortex and pituitary lack of responsiveness, especially in stressful situations such as trauma, surgery or illness; decreased carbohydrate tolerance, manifested as latent diabetes, and increased requirements for insulin or oral hypoglycemic drugs in diabetic patients. Eye: posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos. Metabolic reactions: negative nitrogen balance caused by protein catabolism. Psychiatric symptoms: euphoria, mood swings, severe depression to overt psychosis, personality changes, insomnia. Other: allergic or anaphylactic reactions and hypotension or shock-like reactions. Other adverse reactions associated with corticosteroid injections include blindness, hyperpigmentation or hypopigmentation, subcutaneous and dermal atrophy, sterile abscesses, flushing after intra-articular injection, and Charcot arthritis, which are occasionally associated with intralesional injections of the head and face.

This product is contraindicated in patients with systemic fungal infections, allergies to betamethasone or other corticosteroids, or any of the ingredients in this product.

Precautions for children: This product contains benzyl alcohol and is prohibited for intramuscular injection in children. Precautions for pregnancy and lactation: No controlled human reproductive studies have been conducted on corticosteroids, so this product should only be used for pregnant women or women of childbearing age after weighing the benefits and risks of the drug to the mother and fetus. Infants born to mothers who received large doses of corticosteroids during pregnancy should be carefully observed for signs of adrenal insufficiency. Because this product may have adverse reactions in breastfeeding infants, the importance of the drug to the mother should be considered and a decision should be made to stop the drug or stop breastfeeding. Precautions for the elderly: There is still a lack of research data on the use of drugs in elderly patients.

Concurrent use of phenobarbital, rifampicin, phenytoin, or ephedrine can promote the metabolism of corticosteroids, thereby reducing their efficacy. For patients who use corticosteroids and estrogens at the same time, symptoms of excessive corticosteroid effects should be observed. Concurrent use of corticosteroids and potassium-excreting diuretics can aggravate hypokalemia; concurrent use of corticosteroids and cardiac glycosides may increase the possibility of arrhythmias related to hypokalemia or digitalis poisoning; corticosteroids can promote potassium loss caused by amphotericin B. For patients using any of the above combined medications, serum electrolytes, especially blood potassium concentrations, should be closely monitored. Concurrent use of corticosteroids and coumarin anticoagulants can increase or decrease the anticoagulant effect, so the drug dose may need to be adjusted. The combined effect of nonsteroidal anti-inflammatory drugs or ethanol and corticosteroids can increase the incidence of gastrointestinal ulcers or aggravate ulcers. Corticosteroids can reduce the concentration of blood salicylates. For patients with too little prothrombin, aspirin and corticosteroids should be used with caution. The dosage of antidiabetic medications may need to be adjusted when corticosteroids are used in patients with diabetes. Concurrent glucocorticoid therapy may inhibit the body's response to growth hormone. Drug/Laboratory Test Interactions: Corticosteroids may interfere with the nitroblue tetrazolium test for bacterial infection, resulting in false negative results.

Store at 2-25℃, away from light and freeze.

1ml: betamethasone dipropionate (calculated as betamethasone) 5mg and betamethasone sodium phosphate (calculated as betamethasone) 2mg.

24 months

Chongqing Huapont Pharmaceutical Co., Ltd.

• Founded in:

  2012-06-26

• Address:

  No. 69, Renhe Xingguang Avenue, Yubei District, Chongqing

• Tax NO.:

  915000005992299001

• Registered Funds:

  450 million yuan

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