Home Products Syrup

Dexamethasone "Syrup"


Composition:
Each 100 ml contains:
Dexamethasone micronized 10 mg         

Pharmacological properties:
Dexamethasone is a synthetic adrenocortical steroid which is readily absorbed from the gastrointestinal tract. Dexamethasone is primarily used for its potent anti-inflammatory effect in disorders of many organ systems.
Generally glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.
It has little or no effect on sodium and water retention. The drug reduces hyperemia by diminishing the capillary permeability, local oedema formation, leucocytosis and cellular infiltration.

Indications & Usage:
1.    Endocrine disorders such as:- Congenital adrenal hyperplasia, non supportive thyroiditis & hypercalcemia associated with cancer.
2.    Adjunctive therapy for short-term administration in Psoriatic arthritis, acute gouty arthritis, post-traumatic osteoarthritis & rheumatoid arthritis. (selected cases may require low-maintenance therapy)
3.    During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus and acute rheumatic carditis.     
4.    Exfoliative dermatitis, severe Psoriasis & severe seborrheic dermatitis.
5.    Allergic rhinitis, Bronchial asthma & drug hypersensitivity reactions.
6.    Severe acute and chronic allergic and inflammatory processes of the eye.
7.    Hematologic disorders: such as, Acquired (autoimmune) hemolytic anemia, Erythroblastopenia.
8.    Palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.
9.    To induce remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
10.  Cerebral edema associated with primary or metastatic brain tumour, craniotomy or head injury.

Contraindications:

Dexamethasone syrup is contraindicated in case of:
1.    Systemic fungal infections.
2.    Hypersensitivity to dexamethasone.
3.    In patients with peptic ulcer, osteoporosis, psychosis and should be used with great caution in presence of congestive heart failure.
4.    In the presence of acute bacterial infection, herpes zoster, herpes simplex, ulceration of the eye and other viral infections.

Side effects:
Some of the following side effects may occur in some cases:
- Fluid & electrolyte disturbances (sodium & fluid retention, potassium loss).
- Hypertension.
- Muscle weakness
- Osteoporosis.
- Weight gain may occur.
- Gastrointestinal:
  Abdominal distension, peptic ulcer, perforation, and hemorrhage.
- Dermatologic:
  May suppress reaction to skin tests, erythema, thin fragile skin, other cutaneous reactions such as allergic dermatitis, urticaria, angioneurotic edema.
- Neurologic:
  Vertigo, headache.
- Endocrine:
  Manifestations of latent diabetes mellitus.
  Increased requirements of insulin or oral hypoglycemic agents in diabetics.
  Hirsutism.
- Ophthalmic:
  Glaucoma, exophthalmos.

Warnings & Precautions:

•    Corticosteroids may mask some signs of infection.
•    Patients who are on drugs which suppress the immune system (i.e dexamethasone) are more susceptible to infections than healthy individuals.    
•    Prolonged use of corticosteroids may produce cataracts and glaucoma.
•    All corticosteroids increase calcium excretion.
•    Large doses of dexamethasone can cause elevation of blood pressure, salt and water retention.
•    The use of dexamethasone tablets in active tuberculosis should be restricted to cases of fulminating or disseminated tuberculosis, while in patients with latent tuberculosis close observation is necessary as activation of the disease may occur.
•    Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroids withdrawal syndrome including fever, myalgia, arthralgia & malaise & it can be minimized by gradual reduction of dosage.
•    Psychic derangements may appear when corticosteroids are used ranging from euphoria, insomnia, mood swings to severe depression.
•    There is an enhanced effect of corticosteroids in patients with hypothyroidism & in those with cirrhosis.
•    Corticosteroids should be used cautiously in patients with ocular herpes simplex, non specific ulcerative colitis, perforation, abscess, renal insufficiency, hypertension & myasthenia gravis.

Pregnancy:
Use of corticosteroids in pregnancy or in women of child bearing potential requires that the anticipated benefits be weighed against the possible hazards to the mother & fetus.
Lactation:
Mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.

Overdosage:

Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available. Treatment is supportive & symptomatic.

Dosage & Administration:

Dosage requirements are variable & must be individualized on the basis of the disease & the response of the patient.
- The initial dosage in less severe diseases: doses lower than 0.75 mg may suffice.
- The initial dosage in severe diseases: doses higher than 9 mg may be required.
- The initial dosage should be maintained or adjusted until the patient's response is satisfactory.
- After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response.

N.B.
If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually.

Therapeutic category: Synthetic corticosteroid.

Legal category:
POM.

Storage: Protect from light, at a temperature below 30º C.

Package: Bottle of 100 ml.
 

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.