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F-Corten

Composition:
Each 2 ml contains:-
Dexamethasone sodium phosphate             8 mg

Properties:
Dexamethasone is a corticosteroid with mainly glucocorticoid activity with minimum mineralocorticoid activity. It has potent anti-inflammatory and antiallergic activity.
It also possesses immunosuppressant action and it protects the body against stress.
Dexamethasone sodium phosphate has a rapid onset but short duration of action.

Pharmacokinetics:
Dexamethasone is rapidly absorbed from the gastrointestinal tract. Its biological half-life is about 190 minutes. Binding to plasma proteins is less than for most other corticosteroids. Up to 65% of the dose is excreted in urine.

Indications & usage:
- Endocrine disorders such as: Primary or secondary adrenocortical insufficiency in conjunction with mineralolcorticoids.
- Rheumatic disorders: As Post-traumatic osteoarthritis, rheumatoid arthritis, acute gouty arthritis, psoriatic arthritis and ankylosing spondylitis.
- Collagen diseases: During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus, acute rheumatic carditis.
- Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in bronchial asthma, serum sickness, contact dermatitis, seasonal or perennial allergic dermatitis and drug hypersensitivity reactions.
- Dermatologic diseases such as: Pemphigus, severe erythema multiforme, exfoliative dermatitis, severe psoriasis and seborrheic dermatitis.
- Ophthalmic diseases such as: Herpes zoster ophthalmicus, keratitis and allergic conjunctivitis.
- Palliative management of leukemias and lymphomas in adults, Acute leukemia of childhood.


Contraindications:
Systemic fungal infections and hypersensitivity to any component of this medication.

Side effects:
Some of the following side effects may occur in some cases:
Fluid and electrolyte disturbances, muscle weakness, osteoporosis, gastrointestinal disturbances, headache, posterior subcapsular cataracts and impaired wound healing, menstrual irregularities, hirsutism, increase insulin & oral hypoglycemic requirements for diabetics.  

Drug ineractions:
- Phenytoin, phenobarbital, ephedrine and rifampin may enhance the metabolic clearance of F-corten.
- When F-corten is concomitantly administered with potassium depleting diuretics, patients should be observed closely for development of hypokalemia.

Warnings & precautions:
-    Appropriate precautionary measures should be taken prior to administration especially when the patient has a history of allergy to any drug.
-    Drug induced secondary adrenocortical insufficiency may result from too rapid withdrawal of F-Corten and may be minimized by gradual reduction of dosage.
-    F-Corten may mask some signs of infection and new infections may appear during their use.
-    Prolonged use of F-Corten may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
-    Patients who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals.
-    The drug may aggrevate psychotic disorders.
-    F-Corten contains sodium bisulfite that may cause allergic type reactions including anaphylactic symptoms and asthmatic episodes in certain susceptible people.
Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
-    In patients on corticosteroid therapy subjected to any unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
-    Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained. However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g. for Addison´s disease.
- Following prolonged therapy, withdrawal of F-corten may result in fever, myalgia, arthralgia and malaise.
- There is an enhanced effect of F-corten in pateints with hypothyroidism and in those with cirrhosis.
- F-corten should be used cautiously in non-specific ulcerative colitis and ocular herpes simplex.
- Psychic derangements may appear when F-corten is used.
- Prothrombin time should be checked frequently.
- It is important to use the least dose.

Pregnancy:
Use of F-corten in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighed against the possible hazards to the mother and embryo or fetus.

Lactation:
Mothers taking F-corten should be advised not to nurse.

Dosage and administration:
Intravenous, intramuscular injection:
The initial dose varies from 0.5 – 9 mg/day according to the disease and the response of the patient.
In less severe diseases doses lower than 0.5 mg may suffice, while in severe diseases doses higher than 9 mg may be required.
The drug should be withdrawn gradually.

Intra-articular, intralesional and soft tissue injection:
- Dosage and frequency of injection varies depending on the condition and the site of injection.
- 0.2 – 6 mg, the frequency ranges from once every three to five days to once every two to three weeks.

Therapeutic category: corticosteroids

Legal category: Prescription only medicine (POM).

Package:
Box containing 3, 6 & 100 ampoules, each containing 2 ml.

Storage:
Store at a temperature below 30 C°, protect from light.

 

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.