Medicinal Products

DIPROSTENE 7 mg / mL

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Betamethasone, Betamethasone
laboratory: Schering-Plow

Injectable suspension
Box of 1 pre-filled syringe of 1 mL
All forms

Indication

SYSTEMIC USE

Seasonal allergic rhinitis after failure of other therapies (general antihistamine, intranasal corticosteroid, or short-course oral corticosteroid).

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: keloids scars

· ENT: intra-sinus irrigation in subacute or chronic sinusitis justifying drainage.

· Rheumatologic:

o intra-articular injections: inflammatory arthritis, osteoarthritis

o Periarticular injections: tendonitis, bursitis

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

Dosage DIPROSTENE 7 mg / mL Suspension for injection Box of 1 1 mL pre-filled syringe

This specialty is not suitable for administration by inhaled fogger.

Anti-inflammatory equivalence (equipotence) for 5 mg prednisone: 0.75 mg betamethasone.

SYSTEMIC USE

INTRAMUSCULAR PATH

Seasonal allergic rhinitis after failure of other therapies (general antihistamine, intranasal corticosteroid or oral corticosteroid in short course). 1 injection of 1 ml during the allergic period.

To renew once.

LOCAL USE

The usual dosage is 1/4 to 2 ml depending on the size and seat of the injection.

The injection should not be too superficial because of the risk of subcutaneous atrophy. The injection will be repeated only in case of reappearance or persistence of symptoms.

Against indications

SYSTEMIC USE

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

· Because of the presence of benzyl alcohol, this drug is contraindicated in premature infants and term newborns,

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

· Some developing viruses (including hepatitis, herpes, chickenpox, shingles),

· Psychotic states not yet controlled by a treatment,

· Hyper-sensitivity to one of the compounds,

· Disorders of coagulation, anticoagulant treatment in progress in case of intramuscular injection or local use,

· Live vaccines.

This drug is generally not recommended in combination with non-anti-arrhythmic 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,

· Due to the presence of benzyl alcohol, this drug is contraindicated in premature infants and term newborns.

Diprostene side effects

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, ACTH secretion inertia, sometimes permanent adrenocortical atrophy, decreased glucose tolerance, development of latent diabetes, stunting 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.

· 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.

LOCAL USE

Systemic adverse effects of glucocorticoids have a low risk of occurrence after local administration, given low blood levels but the risk of hypercorticism (retention of water and sodium, imbalance of diabetes and high blood pressure ...) 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 go away in a day or two.

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