Diprospan (Betamethasone) suspension for injection

Instructions for Diprospan (Betamethasone) suspension for injection

English product name
Diprospan®

Release form
susp. d/injc. 2 mg+5 mg/1 ml: amp. 1 or 5 pcs

Description:

The injection suspension is transparent, colorless or yellowish, slightly viscous, containing easily suspended particles of white or almost white, free from foreign impurities; A persistent white or yellowish suspension is formed during the shaking.

1 ml
betamethasone sodium phosphate 2.63 mg,
This corresponds to the content of betamethasone 2 mg
betamethasone dipropionate 6.43 mg,
This corresponds to the content of betamethasone 5 mg

Auxiliary substances:

• dihydrate sodium hydrophosphate - 2.51 mg,
• chloride sodium - 5 mg,
• dehydrate edetate - 0.1 mg,
• polyoxyethylene sorbitanmonooleate (polysorbate 80) - 0.5 mg,
• benzyl alcohol - 9 mg,
• methylparahydroxybenzoate - 1.3 mg, propyl parahydroxybenzoate - 0.2 mg,
• sodium carmellose - 5 mg,
• macrogol (polyethylene glycol) - 20 mg,
• chlorohydrogen acid - q.s.,
• water d/i - q.s. up to 1 ml.

ATC codes
H02AB01 Betamethasone

Clinical-pharmacological groups / Group affiliation
GCS for injection - combination of depot and fast form

Active substance
betamethasone dinatria phosphate
betamethasone dipropionate

Pharmacotherapy group:

Glucocorticosteroid

Storage Conditions
The drug should be stored in a place inaccessible to children, protected from light at a temperature not higher than 25 ° C; do not freeze.

Best before date
The shelf life is two years. Do not apply after expiry date.

Pharmacological effect:

GKS. It has a high glucocorticoid and low mineralocorticoid activity. The preparation has an anti-inflammatory, anti-allergic and immunosuppressive effect, and also has a pronounced and varied effect on various types of metabolism.

Testimony:

• Treatment of conditions and diseases in which GCS therapy allows to achieve an adequate clinical effect
• (it must be taken into account that in some diseases GCS therapy is additional and does not replace the standard therapy):
• diseases of the musculoskeletal system and soft tissues,
  including rheumatoid arthritis, osteoarthrosis, bursitis, ankylosing
• spondyloarthritis,
• epicondylitis,
• radiculitis, 
• coccigodinia, 
• scialgia, 
• lumbago, 
• curvaceous cyst, 
• exostasis, 
• fasciitis, 
• diseases of the foot;
• allergic diseases,
• including bronchial asthma, 
• hay fever (pollinosis), 
• allergic bronchitis, 
• seasonal or year-round rhinitis, 
• drug allergy, 
• whey disease, 
• reactions to insect bites;
• dermatological diseases, 
• including atopic dermatitis, 
• monoid eczema, 
• neurodermites, 
• contact dermatitis, 
• pronounced photodermatitis, 
• urticaria, red flat lychee, 
• insulin lipodystrophy,
•  lipodystrophy, 
• anterior lupus erythematosus, 
• psoriasis, 
• keloid scars, 
• common bubble, 
• herpetic dermatitis, 
• cystic acne;
• systemic connective tissue diseases, 
• including systemic lupus erythematosus, 
• scleroderma, 
• dermatomyositis, 
• nodular periarteritis;
• haemoblastosis (palliative leukemia and lymphoma therapy in adults, acute leukemia in children);
• primary or secondary adrenal cortex insufficiency (with mandatory simultaneous application of mineralocorticoids);
• other diseases and pathological conditions requiring therapy of systemic GCS (adrenal syndrome,
•  ulcerative colitis, 
• regional ileitis, 
• malabsorption syndrome, 
• lesions of the mucous membranes of the eye when it is necessary to introduce the preparation into the conjunctival bag,
• pathological changes of blood when it is necessary to use GCS, nephrotic syndrome).

Method of use, course and dosage:

Diprospan® is used for in/m, intra-articular, near-articular, intrabursal, intracutaneous, intra-tissue and intrauterine administration.
The small size of the crystals of betamethasone dipropionate allows the use of needles of a small diameter (up to 26 calibers) for injection and insertion directly into the lesion site.
The preparation is not intended for administration in/in and out/to.
Injections of Diprospan® should be carried out in strict compliance with the rules of aseptics.
The dosing regime and the method of administration are set individually, depending on the indications, the severity of the disease and the patient's reaction.
In most cases, the initial dose of Diprospan® is one to two ml. The introduction is repeated as necessary, depending on the patient's condition.

B/m introduction
Diprospan® should be injected deep into/m, while selecting large muscles and avoiding entering other tissues (to prevent tissue atrophy).
For severe conditions requiring emergency treatment, the initial dose is 2 ml.
In various dermatological diseases, as a rule, 1 ml of Diprospan® suspension is sufficient.
In case of respiratory system diseases, the drug begins to work within a few hours after the injection of suspension. For bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis, significant improvement is achieved after 1-2 ml of Diprospan®.
For acute and chronic bursitis, the initial dose for in/m administration is 1-2 ml of suspension. If necessary, several repeated injections are carried out.
If a satisfactory clinical response does not occur after a certain time interval, Diprospan® should be discontinued and another therapy should be prescribed.

Use in liver disorders
Use with caution in liver cirrhosis.

Terms of Sale
The drug is prescription.

Use in children
Children with Diprospan® (especially long-term) should be carefully monitored for possible stunting and secondary adrenal cortex failure.

• Nosology (ICD codes)
• C82
• Follicular [nodular] non-Hodgkin lymphoma
• C83
• Nefollicular lymphoma
• C91.0
• Acute lymphoblastic leukemia [ALL]
• C92.0
• Acute myeloblast leukemia [AML]
• E25
• Adrenal gland disorders
• E27.1
• Primary adrenal cortex insufficiency
• E27.4
• Other and unspecified insufficiency of adrenal cortex
• E88.1
• Lipodystrophy not classified in other categories
• H10.1
• Acute atopic (allergic) conjunctivitis
• H10.2
• Other acute conjunctivitis
• H10.4
• Chronic conjunctivitis
• J30.1
• Allergic rhinitis caused by plant pollen
• J30.3
• Other allergic rhinitis (year-round allergic rhinitis)
• J44
• Other chronic obstructive pulmonary disease
• J45
• Asthma
• K50
• Crohn's disease [regional enteritis]
• K51
• Ulcerative colitis
• K90
• Intestinal absorption disorders
• L10
• Bubble [pemfigure]
• L13.0
• Dermatitis herpetiforma
• L20.8
• Other atopic dermatitis (neurodermatitis, eczema)
• L23
• Allergic contact dermatitis
• L24
• Simple Irritable [irritant] Contact Dermatitis
• L28.0
• Simple chronic lychee (limited neurodermatitis)
• L30.0
• Monetoid eczema
• L40
• Psoriasis
• L43
• Lishay red flat
• L50
• Urticaria
• L56.2
• Photo Contact Dermatitis [berloque dermatitis]
• L63
• Alopecia
• L70
• Ugri
• L91.0
• Hypertrophic scar
• L93.0
• Red lupus erythematosus
• M05
• Seropositive rheumatoid arthritis
• M15
• Polyarthrosis
• M30
• Nodular polyarteritis and related conditions
• M32
• Systemic lupus erythematosus
• M33
• Dermatopolimiosite
• M34
• Systemic sclerosis
• M43.6
• Krivosheya
• M45
• Ankylosing spondylitis
• M53.3
• Cross-coccygeal violations not classified in other headings (including coccigodinia)
• M54.1
• Radikulopathy
• M54.3
• Ishias
• M54.4
• Lumbago with Sciatica
• M65
• Synovitis and tenosinovites
• M70
• Soft tissue diseases related to load, overload and pressure
• M71
• Other bursopathy
• M72
• Fibroplastic disorders
• M77
• Other Entesopathy (epicondylitis)
• N00
• Acute jade syndrome
• N03
• Chronic nephritic syndrome
• N04
• Nephrotic syndrome
• T80.6
• Other whey reactions
• T88.7
• Pathological reaction to a drug or medicines unspecified
• Z51.5
• Palliative care