Medicinal Products

DEXAMETHASONE MYLAN 20 mg / 5 ml 4 mg / 1 mL

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Dexamethasone
laboratory: Mylan

Injectable solution
Box of 10 ampoules of 5 ml
All forms

Indication

SYSTEMIC USE :
The indications are:
- those of the general corticotherapy per os when the parenteral route is necessary in case of impossibility of the oral route (vomiting, gastric suction, disorders of consciousness);
- conditions requiring a rapid therapeutic effect:
. allergic:
severe angioedema in addition to antihistamines,
anaphylactic shock in addition to adrenaline.
. infectious:
severe typhoid fever, especially with mental confusion, shock, coma,
Stridulous laryngitis (subglottic laryngitis) in children.
. neurological:
cerebral edema (tumors, Toxoplasma abscess ...).
. ENT:
laryngeal dyspnea.
LOCAL USE :
These are those of local corticosteroid therapy, when the condition justifies a high local concentration. Any local injection prescription must be aware of the danger of infection, particularly the risk of promoting bacterial growth.
This product is indicated in the conditions:
- dermatological:
keloid scars,
- rheumatologic:
. Periarticular injections: tendinitis, bursitis,
. Soft tissue injections: talalgia, carpal tunnel syndrome, Dupuytren's disease.

Dosage DEXAMETHASONE MYLAN 20 mg / 5 ml 4 mg / 1 mL Solution for injection Box of 10 ampoules of 5 ml

- This specialty is not suitable for inhaled administration by nebulizer.
- Anti-inflammatory equivalence (equipotence) for 5 mg prednisone: 0.75 mg dexamethasone.
SYSTEMIC USE :
INJECTIONS IV OR IM.
- The dosage varies according to the diagnosis, the severity of the condition, the prognosis, the patient's response and the tolerance to the treatment.
- This solution can be diluted in a solution of sodium chloride or glucose.
- When combined with an infusion solution, the mixture should be used within 24 hours.
- The initial dosage may vary from 2 to 20 mg / day, depending on the type of disease to be treated.
- The range of parenteral dosage is usually 1/3 to 1/2 of the oral doses given every 12 hours.
IN CASE OF CEREBRAL EDEMA:
- First 10 mg (2.5 ml) IV and then 4 mg (1 ml) IM, every 6 hours until regression of the symptomatology of cerebral edema. A therapeutic result is usually obtained in 12 to 24 hours.
- High doses are recommended for intensive short-term treatment in the case of acute cerebral edema that endangers the patient's life.
RECOMMENDED DOSAGE SCHEME WITH HIGH DOSES IN CEREBRAL EDEMA ROUTE IV:
- Adults:
. Initial dosage: 50 mg.
. D1 to D3: 8 mg / 2 h.
. D4: 4 mg / 2 h.
. D5 to D8: 4 mg / 4 h.
Then decrease by 4 mg / day.
- Children (> 35 kg):
. Initial dosage: 25 mg.
. D1 to D3: 4 mg / 2 h.
. D4: 4 mg / 4 h.
. D5 to D8: 4 mg / 6 h.
Then decrease by 2 mg / day.
- Children (<35 kg):
. Initial dosage: 20 mg.
. D1 to D3: 4 mg / 3 h.
. D4: 4 mg / 6 h.
. D5 to D8: 2 mg / 6 h.
Then decrease by 1 mg / day.
LOCAL USE :
- As an indication, examples of single doses usually used:
. Bursae: 0.5-0.75 ml = 2-3 mg.
. Tendinous sheaths: 0.1-0.25 ml = 0.4-1 mg.
. Soft tissue infiltration: 0.5-1.5 ml = 2-6 mg.
- The frequency of injections varies from one every 3 to 5 days, to one every 2 to 3 weeks.

Against indications

CONTRAINDICATED:
SYSTEMIC USE :
This drug is usually contraindicated in the following situations: (There is, however, no absolute contraindication for life-threatening corticosteroid therapy):
- Hyper-sensitivity to one of the compounds,
- any infectious condition excluding specified indications (see indications section),
- certain viruses in evolution (in particular hepatitis, herpes, varicella, herpes zoster),
psychotic states not yet controlled by a treatment,
- live vaccines,
- coagulation disorders, anticoagulant treatment in case of intramuscular injection (contraindication related to the IM administration route).
LOCAL USE :
- This medicine is contraindicated in the following situations:
. Hyper-sensitivity to one of the compounds,
. local or general infection, or suspicion of infection,
. Severe coagulation disorders, ongoing anticoagulant therapy.
- Do not inject in intratendinous.
NOT RECOMMENDED :
SYSTEMIC USE :
- This drug is generally not recommended in combination with non-antiarrhythmic drugs, giving torsades de pointes (see section interactions: astemizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine).
- Breast-feeding: In the case of treatment at high doses and chronically, breastfeeding is not recommended.
LOCAL USE :
- In the absence of data concerning the risk of calcification, it is preferable to avoid the administration of an intradiscal corticosteroid.
- Breast-feeding: in the case of treatment at large doses, breast-feeding is not recommended.

Side effects Dexamethasone Mylan 20 MG / 5 ML

Due to the presence of sulfites and parahydroxybenzoates : risk of allergic reactions, including anaphylactic reactions, urticaria, bronchospasm, contact eczema.
SYSTEMIC USE :
Rare cases of anaphylactic reactions have been reported in patients treated with parenteral corticosteroids (see section 4.4). Cardiac arrhythmias have also been described related to intravenous administration.
Other effects:
- Hydro-electrolytic disorders: hypokalemia, metabolic alkalosis, water-soluble retention, arterial hypertension, congestive heart failure.
- Endocrine and metabolic disorders: iatrogenic Cushing's syndrome, inertia of ACTH secretion, sometimes permanent adrenocortical atrophy, decrease in glucose tolerance, revelation of latent diabetes, stunting of growth in children, menstrual irregularities.
- Musculoskeletal disorders: Muscular atrophy preceded by muscle weakness (increased protein catabolism), osteoporosis, pathological fractures, particularly vertebral compression, aseptic osteonecrosis of the femoral heads.
Some cases of tendon ruptures have been described in an exceptional way, in particular in co-prescription with fluoroquinolones.
- Digestive disorders: hiccups, peptic ulcers, ulceration of the small bowel, perforations and digestive haemorrhages, acute pancreatitis have been reported, especially in children.
- Skin disorders: acne, purpura, bruising, hypertrichosis, delayed healing.
- Neuropsychic disorders:
. frequently: euphoria, insomnia, excitement.
. rarely: manic-looking access, confusional or confuso-oniric states, convulsions.
. depressive state upon discontinuation of treatment.
- Eye disorders: some forms of glaucoma and cataracts.
- Hypertrophic cardiomyopathy in children of low birth weight.
LOCAL USE :
The systemic adverse effects of glucocorticoids have a low risk of occurrence after local administration, given the low blood levels but the risk of hypercorticism (retention of water and sodium, imbalance of diabetes and hypertension ...) increases with dose and frequency of injections.
- risk of local infection (depending on the injection site): arthritis, ...
- localized atrophy of muscle, subcutaneous and cutaneous tissues. Risk of tendon rupture when injected into the tendons,
- acute arthritis with microcrystals (with microcrystalline suspension) of early onset,
- local calcifications,
- local and general allergic reactions,
- flush: headaches and flushing may occur. They usually disappear in a day or two,
- hiccups,
- hypertrophic cardiomyopathy in children of low birth weight.

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