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

LOCAL USE

These are those of local corticosteroid therapy, when the affection justifies a strong local concentration. Any local injection prescription must take account of the infectious danger, in particular the risk of promoting bacterial proliferation.

This product is indicated in the conditions:

Skin: keloid scars
ENT: intra-sinus irrigation in sinusitis subacute or chronic justifying drainage.
Rheumatologic:
- intra-articular injections: inflammatory arthritis, severe arthritis
- periarticular injections: tendonitis, bursitis
- soft tissue injections: talalgia, carpal tunnel syndrome, Dupuytren’s disease

PRESENTATION (S) AVAILABLE FOR DIPROSTENE

1 pre-filled syringe (s) of 1 ml glass with needle (s)

FEATURE	DESCRIPTION
Pharmaceutical class	systemic corticosteroids
Active substance (s)	for 1 ml of suspension for injection: betamethasone (disodium phosphate) (2.63 mg), betamethasone dipropionate (6.43 mg)
General medicine	no
Pharmaceutical form	suspension for injection
Route (s) of administration	endosinus, intra-articular, intralesional, intramuscular, periarticular
Social security reimbursement rate	65%
Laboratory (s)	MSD FRANCE
Conditions of issue	available by simple prescription

Diprostene Dosage

The dose to use is determined by your doctor, depending on your weight and the disease being treated.
It is strictly individual.

Diprostene Contraindications

INTRAMUSCULAR USE

Never use DIPROSTENE, suspension for injection in a pre-filled syringe in the following cases:

in premature and term newborns, due to the presence of benzyl alcohol,
most infections,
certain evolving viral diseases (viral hepatitis, herpes, chickenpox, shingles),
certain untreated mental disorders,
vaccination with live vaccines,
allergy to one of the constituents,
coagulation disorders, anticoagulant therapy in progress.

This medication SHOULD NOT GENERALLY BE USED, unless your doctor advises otherwise, in combination with medications which may cause certain heart rhythm disturbances.

LOCAL USE

Never use DIPROSTENE, suspension for injection in a pre-filled syringe in the following cases:

infections,
allergy to one of the constituents,
coagulation disorders, current anticoagulant treatment,
in premature and term newborns, due to the presence of benzyl alcohol.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

How To Take Diprostene ?

Method and route of administration

INTRAMUSCULAR INJECTABLE OR LOCAL INJECTION.
Do not inject into the tendons.

Duration of treatment

It is determined by your doctor.

how does Diprostene work?

Pharmacotherapeutic group: corticosteroids for systemic use, not associated, ATC code: H02AB01 .

Physiological glucocorticoids (cortisone and hydrocortisone) are essential metabolic hormones.
Synthetic corticosteroids, including betamethasone, are used primarily for their anti-inflammatory effect.
In high doses, they decrease the immune response. Their metabolic and sodium retention effect is less than that of hydrocortisone.

How To Store Diprostene ?

Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C and protected from light.
After opening: the product should be used immediately.
Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

Diprostene injection side effects

Like all medicines, DIPROSTENE, suspension for injection in a pre-filled syringe can cause side effects, although not everybody gets them.

INTRAMUSCULAR USE

This essential drug is most often well tolerated when following the recommendations and especially the diet. However, depending on the dose and duration of treatment, it can cause more or less bothersome effects. The most frequently encountered are:

swelling and redness of the face, weight gain,
appearance of bruises,
increased blood pressure, heart damage (congestive heart failure),
excitement, sleep disturbances, euphoria, behavioral disturbances, confusion, convulsions, depressive state on stopping treatment,
bone fragility (osteoporosis, fractures),
modification of certain biological parameters (salt, sugar, potassium) which may require a diet or additional treatment as well as an increase in blood pH.

Other much rarer effects have been observed:

risk of disturbances in the secretion of the adrenal gland,
growth disorder in children,
period disorders,
weakness of muscles
hiccups, stomach or intestinal ulcers, gastrointestinal perforations and bleeding, inflammation of the pancreas,
skin disorders: acne, small red spots (purpura), significant hair growth, delayed healing,
certain forms of glaucoma (increased pressure inside the eye) and cataracts (clouding of the lens).

LOCAL USE

Local risks: infection, lesion, inflammation and calcifications of the joint,
Repeated injections may cause symptoms of hypercorticism (weight gain, swelling) and unbalance diabetes, high blood pressure,
Headaches and hot flashes can occur. They usually go away within a day or two,
Weakening of the skin,
Local and general allergic reactions.

If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Diprostene Interactions

SYSTEMIC USE

Not recommended associations

Medicines giving torsades de pointes: astemizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine.

Use substances which do not have the disadvantage of causing torsades de pointes in the event of hypokalaemia.

CYP3A inhibitors:

Co-administration of CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side effects. The combination should be avoided unless the benefits outweigh the increased risk of systemic side effects from corticosteroids; in this case, patients should be monitored for possible systemic side effects of corticosteroids.

Combinations subject to precautions for use

Acetylsalicylic acid by system and by extrapolation from other salicylates

Decrease in salicylemia during treatment with corticosteroids and risk of salicylate overdose after stopping it, by increased elimination of salicylates by corticosteroids. Adjust the doses of salicylates during the combination and after stopping treatment with corticosteroids.

Antiarrhythmics giving torsades de pointes: amiodarone, brétylium, disopyramide, quinidines, sotalol.

Hypokalaemia is a contributing factor as is bradycardia and a pre-existing long QT space.
Prevent hypokalaemia, correct it if necessary; monitor the QT space. In case of torsade, do not administer antiarrhythmic (electrosystolic training).

Oral anticoagulants

Possible impact of corticosteroid therapy on the metabolism of the oral anticoagulant and on that of coagulation factors.
Haemorrhagic risk specific to corticosteroid therapy (digestive mucosa, vascular fragility) at high doses or in prolonged treatment longer than 10 days.
When the association is justified, strengthen monitoring: biological control on the 8th day, then every 15 days during corticosteroid therapy and after stopping it.

Other hypokalaemic drugs: hypokalaemic diuretics alone or in combination, stimulant laxatives, amphotericin B IV

Increased risk of hypokalaemia by additive effect.
Monitor serum potassium, correct it if necessary, especially in the case of digitalis therapy.

Digital

Hypokalaemia promoting the toxic effects of digitalis.
Monitor serum potassium, correct it if necessary and possibly ECG.

Heparin parenterally

Aggravation by heparin of the hemorrhagic risk specific to corticosteroid therapy (digestive mucosa, vascular fragility) at high doses or in prolonged treatment longer than 10 days.
The association must be justified, strengthen surveillance.

Enzyme inducers: carbamazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampicin

Decrease in plasma levels and the efficacy of corticosteroids by increasing their hepatic metabolism. The consequences are particularly important in Addisonians and in cases of transplantation.
Clinical and biological monitoring, adjustment of the dosage of corticosteroids during the combination and after stopping the enzyme inducer.

Insulin, metformin, sulfonylureas

Elevation of blood sugar with sometimes ketosis (decrease in tolerance to carbohydrates by corticosteroids).
Warn the patient and reinforce blood and urine self-monitoring, especially at the start of treatment. If necessary, adjust the dosage of the antidiabetic medication during treatment with corticosteroids and after stopping it.

Isoniazid (described for prednisolone)

Decreased plasma levels of isoniazid. Mechanism invoked: increased hepatic metabolism of isoniazid and decrease in that of glucocorticoids.
Clinical and biological monitoring.

Associations to take into account

Antihypertensives

Decreased antihypertensive effect (hydrosodium retention of corticosteroids).

Interferon alpha

Risk of inhibition of the action of interferon.

Live attenuated vaccines

Risk of generalized, possibly fatal disease. This risk is increased in subjects already immunocompromised by the underlying disease.
Use an inactivated vaccine when it exists (poliomyelitis).

LOCAL USE

The risks of interactions of glucocorticoids with other drugs are exceptional by local injection under the usual circumstances of use. These risks should be considered in the event of multiple injections (several locations) or repeated in the short term.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Effects on ability to Drive and use machines

This specialty contains an active ingredient that can induce a positive reaction to the tests performed during doping controls.

Warnings and Precautions

Special warnings

This medicine should be taken under strict medical supervision.

INTRAMUSCULAR USE

BEFORE TREATMENT

Tell your doctor in the event of recent vaccination, in the event of digestive ulcer, diseases of the colon, recent surgery on the intestine, diabetes, high blood pressure, infection (especially history of tuberculosis) , liver failure, kidney failure, osteoporosis and myasthenia gravis (muscle disease with muscle fatigue).
Tell your doctor if you are staying in the tropics, subtropics or southern Europe, due to the risk of parasitic disease.

DURING AND AFTER TREATMENT

Avoid contact with people with chickenpox or measles.
Tell your doctor if pain or fever develops after the injection.
Repeated injections risk causing symptoms of hypercorticism (weight gain, swelling, hypertension …) and unbalance diabetes, mental disorders or severe hypertension.

LOCAL USE

In the absence of data concerning the risk of calcification, it is preferable to avoid the administration of a corticosteroid intra-disc.
Notify your doctor in the event of recent vaccination and evolving viral diseases (viral hepatitis, herpes, chickenpox, shingles).
This medicine should be taken under strict medical supervision.
Tell your doctor if pain or fever develops after the injection.
Repeated injections risk causing symptoms of hypercorticism (weight gain, swelling, hypertension …) and unbalance diabetes, mental disorders or severe hypertension.

Precautions for use

In the event of long-term treatment with corticosteroids, your doctor may advise you to follow a diet, in particular low in sodium salt, rapid sugars and high in protein.

Related to excipients

This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and may cause allergic reactions with hives and difficulty breathing.
This medicine contains 9 mg / ml of benzyl alcohol. It can cause toxic reactions and allergic reactions in infants and children up to 3 years old.
This medicine contains 5 mg of sodium per pre-filled syringe. The sodium level is less than 1 mmol per pre-filled syringe, that is to say “sodium-free”.

PREGNANCY & BREAST-FEEDING & FERTILITY

`Pregnancy`

Systemic use:

In animals, experimentation shows a variable teratogenic effect depending on the species.
In humans, there is a placental transfer. However, epidemiological studies have found no teratogenic risk taking steroids during the 1 st quarter.
In chronic diseases requiring treatment throughout pregnancy, a slight delay in intrauterine growth is possible. Neonatal adrenal insufficiency has been observed exceptionally after high dose corticosteroid therapy.
It is justified to observe a period of clinical (weight, diuresis) and biological monitoring of the newborn.
Accordingly, corticosteroids may be prescribed during pregnancy, if needed.

Local use:

The risk of systemic corticosteroids should be considered in the event of multiple injections (several locations) or repeated short term: with systemic corticosteroids, a slight delay in intrauterine growth is possible.
Neonatal adrenal insufficiency has been observed exceptionally after high dose corticosteroid therapy.

`Feeding with milk`

Systemic use:

In case of treatment in large doses and chronically, breast-feeding is not recommended.

Local use:

In case of treatment in large doses, breast-feeding is not recommended.

What happens if I overdose from Diprostene ?

Not applicable.
Not applicable.
Not applicable.
Not applicable.

What should I do if I miss a dose?

Not applicable.
Not applicable.
Not applicable.
Not applicable.

What happens if you stop taking Diprostene ?

Not applicable.
Not applicable.
Not applicable.
Not applicable.

What is Forms and Composition ?

SHAPES and PRESENTATIONS

Suspension for injection: Box of 1 pre-filled syringe of 1 ml + 2 sterile needles in an individual case (50 8/10 and 25 5/10).

COMPOSITION

	p syringe
Betamethasone (DCI)	5 mg
(as dipropionate: 6.43 mg / ml)
Betamethasone (DCI)	2 mg
(as disodium phosphate: 2.63 mg / ml)

Excipients: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), benzyl alcohol, sodium edetate, anhydrous sodium hydrogen phosphate, sodium chloride, polysorbate 80, sodium carmellose, macrogol 4000, concentrated hydrochloric acid, water ppi.
Excipients with known effect: benzyl alcohol (9 mg / ml); sodium (5 mg / ml); Methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

Betamethasone