Medicinal Products

DEXAMETHASONE MYLAN 4 mg / 1 mL

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

Injectable solution
Box of 20 ampoules of 1 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 aspiration, disorders of the conscience);

· Conditions requiring a rapid therapeutic effect:
allergic:

o severe angioedema in addition to antihistamines,

o Anaphylactic shock in addition to adrenaline.

Infection:

o severe typhoid fever, especially with mental confusion, shock, coma,

o Stridulous laryngitis (subglottic laryngitis) in children.

neurological:

o cerebral edema (tumors, Toxoplasma abscess.)

ENT :

o 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:

dermatologic:

· Keloid scars

rheumatological:

· Periarticular injections: tendonitis, bursitis

· Soft tissue injections: talalgia, carpal tunnel syndrome, Dupuytren's disease

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

This specialty is not suitable for administration by inhaled fogger.

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 acute life-threatening cerebral edema.

Recommended dosage schedule in high doses in cerebral edema:

Way IV

Initial dosage

J 1 to J 3

J 4

J 5 to J 8

Then decrease

adults

50 mg

8 mg / 2 h

4 mg / 2 h

4 mg / 4 h

4 mg / day

children
(> 35 kg)

25mg

4 mg / 2 h

4 mg / 4 h

4 mg / 6 h

2 mg / day

children
(<35 kg)

20 mg

4 mg / 3 h

4 mg / 6 h

2 mg / 6 h

1 mg / day

LOCAL USE

As an indication, examples of single doses usually used:

in ml

in mg

Bursaries

0.5 - 0.75

2 - 3

Tendinous sheaths

0.1 - 0.25

0.4 - 1

Infiltration of the soft parts

0.5 - 1.5

2 - 6

The frequency of the injections varies from one every 3 to 5 days, to one every 2 to 3 weeks.

Against indications

SYSTEMIC USE

This drug is generally contraindicated in the following situations (there is, however, no absolute contraindication for life-threatening corticosteroid therapy):

· Any infectious condition other than the indications specified (see section Therapeutic indications ),

· Some developing viruses (including hepatitis, herpes, varicella, herpes zoster),

· Psychotic states not yet controlled by a treatment,

· Live vaccines,

· Hyper-sensitivity to one of the compounds,

· Disorders of coagulation, anticoagulant treatment in progress in case of intramuscular injection (contraindication related to the route of administration IM).

This drug is generally not recommended in combination with non-antiarrhythmic drugs, giving torsades de pointes (see section Interactions with other medicinal products and other forms of interaction ).

LOCAL USE

This medicine is contraindicated in the following situations:

· Local or general infection, or suspicion of infection,

· Severe coagulation disorders, ongoing anticoagulant therapy,

· Hyper-sensitivity to one of the compounds.

Side effects Dexamethasone Mylan

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 Warnings and Precautions ). 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 definitive adrenocortical atrophy, decreased glucose tolerance, revelation of latent diabetes, stunted growth in children, menstrual irregularities.

· Musculoskeletal disorders : Muscular atrophy preceded by muscle weakness (increased protein catabolism), osteoporosis, pathological fractures, especially 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 small bowel, perforations and gastrointestinal bleeding, acute pancreatitis have been reported, especially in children.

· Skin disorders: acne, purpura, bruising, hypertrichosis, delayed healing.

· Neuropsychic disorders:

o frequently: euphoria, insomnia, excitement.

o rarely: access of manic pace; confusional or confuso-oniric states, convulsions.

o Depressive state when the treatment is stopped.

· 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 low blood levels but the risk of hypercortisism (retention of water and sodium, imbalance of diabetes and hypertension ...) increases with the 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 low birth weight children.

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