Betafos

Trade Name:

Betafos 1 ampoule 2 ml

Solution for i/m i/a p/a i/l i/d i/b use

Composition

Each 2 ml contains:

Betamethasone dipropionate 12,86 mg eq.to Betamethasone 10 mg

Betamethasone sodium phosphate 4 mg

Properties

Betafos belongs to a group of medicines known as corticosteroids. These medicines help to relieve parts of the body affected by inflammation. They act by reducing swelling, redness, itching and allergic reactions.

Indications

Betafos ampoule is used for the treatment, control, prevention and improvement of the following diseases, conditions and symptoms:

-arthritis, bursitis, sciatica, lumbago or other conditions of the bones or deep tissues;

-allergic conditions, such as asthma, hay fever, bronchitis, drug allergy, insect bites or stings;

Contraindications

Betafos suspension is contraindicated in patients with systemic fungal infections, in those with sensitivity reactions to betamethasone or to other corticosteroids, or to any component of this product.

Dosage and administration

Dosing requirements are variable and must be individualized on the basis of the specific disease, its severity and the response of the patient. The initial dose should be maintained or adjusted until a satisfactory response is observed. If a satisfactory clinical response does not occur after a reasonable period of time, treatment with Betafos suspension should be discontinued and other appropriate therapy initiated.

Systemic administration:

For systemic therapy, treatment is initiated with 1 to 2 ml in most conditions and repeated as necessary. Administration is by deep intramuscular (IM) injection in the gluteal region.

Side effects

Fluid and electrolyte disturbances: sodium retention, potassium loss, hypokalemic alkalosis; fluid retention; congestive heart failure in susceptible patients; hypertension.

Musculoskeletal: muscle weakness, corticosteroid myopathy, loss of muscle mass; 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; joint instability (from repeated intra-articular injections). •Gastrointestinal: peptic ulcer with possible subsequent perforation and hemorrhage; pancreatitis; abdominal distention; ulcerative esophagitis.

Dermatologic: impaired wound healing; skin atrophy; thin fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; suppressed reactions to skin tests; reactions such as allergic dermatitis, urticaria, angioneurotic edema. •Neurologic: convulsions; increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment; vertigo; headache.

Storage

Store at a temperature not exceeding 30°C. Protect from light and freezing.

Package:

Carton box holds a plastic container with 1 vial 2 ml, paper instructions