Durafos 2 ml 1 ampoule

Durafos 2 ml 1 ampoule

Composition:

Each 2 ml contains:

Active ingredients:

Betamethasone dipropionate (micronized) 12.86 mg (equivalent to Betamethasone 10 mg)

Betamethasone sodium phosphate 5.26 mg (equivalent to Betamethasone 4 mg)

Inactive ingredients:

Methyl paraben, propyl paraben, benzyl alcohol, edetate disodium, sodium chloride, disodium hydrogen phosphate dihydrate, polysorbate 80, carboxymethylcellulose sodium, polyethylene glycol, sodium hydroxide, hydrochloric acid, water for injections.

Description:

DURAFOS is a powerful anti-inflammatory and anti-allergic corticosteroid formulation used to quickly relieve pain, swelling, and stiffness in joints, soft tissues, and skin, as well as to manage severe allergic reactions and autoimmune disorders. It contains two forms of betamethasone:

-Betamethasone sodium phosphate acts rapidly to reduce acute symptoms.

-Betamethasone dipropionate provides long-lasting effects, controlling inflammation for several days or even weeks after a single injection.

Thanks to the fine particle size, the suspension can be injected deeply into muscles or directly into inflamed joints or tissues to deliver targeted, effective relief with a single dose. DURAFOS is especially useful when fast and prolonged control of inflammation is required.

Indications for Use:

DURAFOS is indicated for systemic and local treatment of corticosteroid-responsive disorders, including:

Musculoskeletal and soft tissue conditions: Osteoarthritis, rheumatoid arthritis, bursitis, ankylosing spondylitis, etc.

Collagen diseases: Systemic lupus erythematosus, scleroderma, etc.

Allergic conditions: Asthma, allergic rhinitis, angioedema, atopic dermatitis, urticaria, etc.

Dermatological disorders: Psoriasis, alopecia areata, lupus erythematosus, etc.

Neoplastic diseases: Palliative care in leukemia and lymphomas.

Other conditions: Adrenogenital syndrome, ulcerative colitis, nephrotic syndrome, etc.

Dosage and Method of Administration:

Dosage must be individualized.

Systemic use: Deep IM injection of 1–2 ml in the gluteal region; may be repeated as needed.

Contraindications:

Hypersensitivity to betamethasone esters or excipients

Systemic fungal infections

IM use in patients with idiopathic thrombocytopenic purpura

Precautions:

-Not for IV or subcutaneous injection

-Use cautiously in patients with gastrointestinal ulcers, hypertension, renal or hepatic impairment, psychiatric disorders, glaucoma, epilepsy, postmenopausal women, and the elderly

-Benzyl alcohol content contraindicates use in neonates, infants, pregnant or breastfeeding women

-Emergency treatment should be available due to rare risk of anaphylaxis

Side Effects:

Short-term use: Minimal risk

Long-term/high-dose use:

Metabolic: Cushing's syndrome, fluid retention, hypokalemia

Musculoskeletal: Osteoporosis, myopathy, fractures

GI: Nausea, ulcers, bleeding

Dermatologic: Skin atrophy, striae, hyperpigmentation

Psychiatric: Mood swings, insomnia, depression

Others: Local tissue damage with repeated injections

Pregnancy and Breastfeeding:

Do not use in pregnant or nursing women. Benzyl alcohol may cause serious adverse effects in pediatric patients.

Storage Conditions:

Store at a temperature not exceeding 30°C. Do not freeze. Keep out of reach of children.

Packaging:

The carton box contains 1 ampoule and a package insert. Ampoule, 2 ml.