What is Diprofos injection used for?

Diprophos 1 ml - suspension for injection

Merck Sharp & Dohme Gesellschaft mbH

Standard drug Human
Date of approval06.04.1979
Submission statusDelivery through a (public) pharmacy
Prescription StatusSingle-dose medicinal products based on a doctor's prescription
Pharmacological groupCorticosteroids for systemic use, pure

All information

Brief information

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Merck Sharp & Dohme Gesellschaft mbH

What is it and what is it used for?

Betamethasone, the active substance in Diprophos Suspension, belongs to a group of medicines called corticoids. Corticoids are used in many inflammatory and allergic processes because of their anti-inflammatory effects. Diprophos is given to treat rheumatic diseases.

What do you need to consider before use?

If any of the items on this list apply to you, you should not be given Diprophos.

How is it used?

Diprophos will be given to you by your doctor. Your doctor will adjust the dosage to best suit your needs.

How should it be stored?

Do not store above 25 ° C. Do not freeze. Store in the original package in order to protect from light. Keep this medicine out of the sight and reach of children.

What is it and what is it used for?

The active substance in Diprophos Suspension, betamethasone, belongs to a group of medicines called corticoids (cortisone derivatives). Corticoids are used in many inflammatory and allergic processes because of their anti-inflammatory effects. Cortisones are endogenous substances that are produced in the adrenal cortex and are an important part of various processes in our body. This also includes the regulation of inflammatory processes.

Diprophos Suspension is indicated for all diseases that respond to systemic (affecting the whole body) or local, topical corticosteroid therapy, when oral (treatment with tablets) or local treatment is not possible or inadequate. If necessary, this treatment can be carried out in addition to the basic therapy.

Diprophos Suspension is indicated for:

  • Rheumatic diseases, such as rheumatic fever (especially with rheumatic inflammation of the heart), chronic inflammation of 5 or more joints (chronic polyarthritis), diseases of the joints caused by wear and tear (degenerative) and non-infectious diseases, bursitis, lumbago-like (lumbago-like) Complaints and others.
  • Malignant (neoplastic) diseases: for the soothing treatment of malignant diseases of the white blood cells (leukemia) and lymph nodes (lymphoma) in adults; in acute leukemia in children.
  • Allergic diseases such as bronchial asthma, hay fever, drug allergies, contact allergies.
  • Skin diseases such as bladder addiction (pemphigus vulgaris), severe greasy, scaly skin inflammation (seborrheic dermatitis), neurodermatitis, various types of skin lichen, circular hair loss (alopecia) and others.
  • Collagen disorders: during worsening or as maintenance treatment in certain cases of systemic lupus erythematosus (an immune system disorder that can affect any organ in the body).
  • Diseases of the gastrointestinal tract: critical phases of ulcerative colitis (large intestinal ulcers) and regional intestinal inflammation.
  • Respiratory diseases such as inflammatory changes in the lungs and lymph nodes (Boeck's disease), aspiration pneumonia (a special form of pneumonia), chronic spastic bronchitis (a special form of bronchitis), and others.
  • Blood disorders: acquired anemia (autoimmune anemia).
  • Eye diseases: Inflammation and diseases of the anterior and posterior segment caused by disorders of the immune system such as optic nerve inflammation, iris, ciliary body and retinal inflammation. Ocular herpes.
  • Hormonal disorders: replacement treatments for adrenal weakness.

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What do you need to consider before use?

Diprophos Suspension must not be used

  • if you are allergic to betamethasone dipropionate, betamethasone disodium phosphate or any of the other ingredients of this medicine (listed in section 6).
  • with internal fungal diseases.
  • for stomach and intestinal ulcers.
  • with severe bone loss (osteoporosis).
  • if you have severe muscle diseases (except myasthenia gravis).
  • with viral diseases, e.g. chickenpox, ocular herpes, shingles.
  • for polio (poliomyelitis).
  • with chronic active inflammation of the liver (hepatitis).
  • for lymph node swelling after tuberculosis vaccination (BCG).
  • in glaucoma (narrow and wide-angle glaucoma).
  • in children under 6 years of age.
  • Caution in patients with blood coagulation disorders, e.g. due to defective blood platelets (idiopathic thrombopenic purpura): Diprophos suspension must not be administered intramuscularly (injected into the muscle).
  • about 8 weeks before and up to 2 weeks after vaccination.
  • in the case of mental illness only in emergencies.
  • in the case of infections in the area of ​​application.
  • Injections into a joint should not be given in the following diseases:
    • Bacterial infection of the joint
    • Infections within or in the immediate vicinity of the joint to be treated
    • Tendon tear
    • Instability of the joint to be treated
    • Calcifications around the joint (periarticular calcification)
    • Syphilis disease of a joint (Charcot's joint)
    • Tendency to bleed (drug or spontaneous)

Children and adolescents

The parenteral administration of depot corticoids is contraindicated in children under 6 years of age. Between the ages of 6 and 14, use is only indicated in life-threatening circumstances.

Warnings and Precautions

Talk to your doctor or pharmacist before you are given Diprophos Suspension.

  • The drug must not be administered intravenously (into the veins)!
  • Serious neurological events, some fatal, have been reported with injections into the spinal canal (epidural). Specifically, these reported events include spinal cord infarction, partial paraplegia in which both legs are affected (paraplegia), partial paraplegia in which both arms and legs are affected (quadriplegia), damage to the visual cortex in the brain (cortical blindness), and stroke, but are not limited to the named. These serious neurological events have been reported with and without the use of fluoroscopy to look at how the body works (fluoroscopy). The safety and efficacy of administration of corticosteroids into the spinal canal (epidural injection) have not been established and corticosteroids are not approved for this use.
  • If you are known to have allergic reactions to corticosteroids, appropriate precautions should be taken.
  • Report the first signs of side effects, in particular stomach upset, full moon face, weight gain, skin changes or a worsening of your general condition to your doctor immediately.
  • Tell your doctor if you are pregnant or breastfeeding.
  • Before starting corticosteroid therapy, a detailed examination is necessary, in particular gastric and duodenal ulcers must be ruled out.
  • To prevent ulcers in the digestive tract, your doctor will prescribe acid-inhibiting preparations that protect the mucous membranes.
  • More frequent medical check-ups are necessary for longer-term treatment.
  • The food should be rich in potassium (especially rich in bananas and dried fruits), protein and vitamins, but low in fats, carbohydrates (flour, sugar) and table salt.
  • You should not be vaccinated against chickenpox during treatment with Diprophos Suspension. No other vaccinations (immunizations) should be given to patients receiving particularly high doses of corticoids.
  • Contact with people who have chickenpox or measles should be avoided while using this medicine. If there is contact with sick people, medical advice should be obtained.
  • Careful use in myasthenia gravis (special muscle disease) and high blood pressure.
  • Corticoids should not be injected into infected tissue, directly into tendons, or into the intervertebral spaces.
  • Do not use the medicine on the face and do not inject into the subcutaneous fatty tissue.
  • If you have a local or internal infection (caused by bacteria, viruses or fungi) treatment with Diprophos Suspension alone is not indicated, but it can be used with sufficient caution in connection with therapy against bacteria, viruses or fungi.
  • Betamethasone, like other corticoids, can mask diabetes (diabetes mellitus).
  • Corticoid treatment can increase the risk of developing tuberculosis (TB) in patients with “dormant” (latent) TB. Your doctor will recommend more frequent checkups in this case.
  • Corticoids can increase the motility and the number of sperm cells.
  • More recent study data indicate that after repeated administration of corticoids after the rupture of the bladder there is a significantly higher risk of neonatal blood poisoning (early onset sepsis).
  • If you have an underactive thyroid or cirrhosis, the effects of corticosteroids may be increased.
  • If you experience blurred vision or other visual disturbances, contact your doctor.
  • Diprophos Suspension may only be used for the following underlying diseases if they are treated accordingly at the same time:
  • Diabetes
  • tuberculosis
  • acute and chronic bacterial infections and amoebic infections
  • high blood pressure
  • Risk of vessel occlusion
  • Heart and kidney weakness
  • acute and chronic kidney disease

Using Diprophos Suspension with other medicines

Tell your doctor or pharmacist if you are taking / using, have recently taken / used, or intend to take / use any other medicines, including medicines that can be obtained without a prescription.

Cardiac glycosides (used to treat
Heart failure)
Strengthening the effect through
Potassium deficiency.
Saluretics (dehydrating agents)
Amphotericin B (used to treat
Fungal diseases)
Additional potassium excretion.
oral anti-diabetic drugs (used to treat
Diabetes)
Blood sugar lowering is decreased.
Coumarin derivatives (used in patients for
Blood thinning used)
Blood-thinning effect is weakened.
Barbiturates, hydantoins, rifampicin,
Ephedrine (a sleeping pill, used to treat tuberculosis,
Active ingredient with decongestant
Effect)
Effect of Diprophos Suspension will
reduced.
Estrogens (sex hormones)Effect of Diprophos Suspension will
reinforced.
aspirinThere is an increased risk of bleeding
and ulcers in the gastrointestinal tract and that
Risk of decreased effectiveness of
Aspirin.
NSAIDs (non-steroidal anti-inflammatory
Medicines, e.g. many pain relievers and
Anti-inflammatory drugs)
The risk of bleeding in the gastrointestinal tract increases
by taking
nonsteroidal anti-inflammatory drugs and
Anti-inflammatory drugs (NSAIDs) increased.
ACE inhibitors (used to treat
High blood pressure)
With simultaneous administration of ACE inhibitors
can reduce the risk of
Changes in the blood count may be increased.
Chloroquine, hydrochloroquine, mefloquine (for
Treatment of malaria)
Increased risk of
Muscle weakness (myopathies) and
Heart failure (cardiomyopathies).
Ciclosporin (used to suppress
Immune system)
The effects of both ciclosporin and
of Diprophos suspension is used at the same time
Application increased.
Isoniazid (used to treat tuberculosis
(Tbc))
Corticoids reduce the effects of isoniazid.
Growth hormonesA weakening or prevention of the
Effect of growth hormones is possible.
Ketoconazole (used to treat
Fungal diseases)
The effect of ketoconazole is increased.
Bupropion (smoking cessation drug and
Antidepressant)
It may increase your risk of
Seizures are coming.
Methotrexate (used to suppress
Immune system)
Increased effect of Diprophos Suspension, the mechanism is unknown.
Protirelin (used to diagnose
Thyroid disorders)
It can lead to incorrect results.
AntibioticsMacrolide antibiotics can reduce excretion
of corticoids significantly delay.
Some medicines, including some
Medicines for HIV: ritonavir, cobicistat
You can see the effects of Diprophos
step up and your doctor may react
carefully monitor if you do this
Taking medication.

Vaccinations

The effectiveness of all vaccines can be reduced by the simultaneous use of Diprophos Suspension (8 weeks before to 2 weeks after active immunization). The formation of protective antibodies can also be completely absent.

Pregnancy, breastfeeding and fertility

Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or breast-feeding, or if you suspect you may be pregnant, as large amounts of benzyl alcohol can build up in your body and cause side effects ( so-called "metabolic acidosis").

If you are pregnant your doctor will decide whether you can use Diprophos Suspension. In principle, cortisone-containing drugs should not be used in the first three months of pregnancy.

As it is not known whether corticoids are excreted in breast milk, breast-feeding should not be used during treatment. Consult your doctor before starting breastfeeding again.

Driving and using machines

Diprophos Suspension has no influence on the ability to drive or use machines.

Diprophos suspension contains 9 mg / ml benzyl alcohol.

Benzyl alcohol can cause allergic reactions.

If you have liver or kidney disease, ask your doctor or pharmacist for advice, as large amounts of benzyl alcohol can build up in your body and cause side effects (called 'metabolic acidosis').

Diprophos suspension contains methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate. These can cause allergic reactions, including late reactions and, in rare cases, cramping of the airways (bronchospasm).

Diprophos suspension contains sodium, but less than 1 mmol sodium (23 mg) per ampoule, i.e. H. it is almost "sodium free". The sodium content per ml corresponds to an amount of 8.4 mg table salt (NaCl).

The use of this medicinal product (Diprophos Suspension) can lead to positive results in doping tests.

How is it used?

Diprophos Suspension can be administered intramuscularly (into the muscle), intraarticularly (into the joints), intradermally (into the skin), intralesional (into the affected area) or by local infiltration (injection into the tissue). It must not be administered intravenously (in veins).

The doctor decides on the dosage. Corticoids should only be used for as long and only in as low a dose as is absolutely necessary to achieve and maintain the desired therapeutic effect.

Use in children and adolescents

In children under 6 years of age, the injection of depot corticoids is contraindicated. Between the ages of 6 and 14, use is only indicated in life-threatening circumstances.

The doctor will determine the dose individually for your child.

Use in the elderly

Your doctor will determine the dose for you individually. Due to the increased risk of osteoporosis, it is only used with a special risk-benefit assessment.

If you have been given more Diprophos Suspension than intended

In the event of an overdose, your doctor will give you appropriate treatment.

If you forget to use Diprophos Suspension

See your doctor as soon as possible for the forgotten syringe and then go back to your normal treatment plan.

If you stop using Diprophos Suspension

Long-term use must not be suddenly discontinued. Your doctor will gradually reduce the dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are the possible side effects?

Like all medicines, this medicine can have side effects, although not for everyone
must occur.


Even if not all of these side effects have to occur, a doctor could be required in individual cases
Treatment may be required.


With long-term treatment and / or high dosage, the following diseases can occur:
Frequency not known (frequency not based on available data
assessable):


Hormonal diseases
Menstrual disorders, impotence, increased hair growth, growth retardation in fetuses and
in children, pseudo-Cushing's syndrome (full moon face, bull neck, weight gain,
High blood pressure, blue-red stripes on the skin [striae] and punctiform skin bleeding [petechiae]),
Decrease in the function or atrophy of the adrenal cortex, secondary
Inresponsibility of the adrenal cortex and the pituitary gland, especially under stress and with
Trauma, surgery or illness, decreased carbohydrate tolerance, manifestation
a "sleeping" (latent) diabetes, worsening of an existing one
Diabetes, steroid diabetes (diabetes caused by steroids), increased need for
Insulin or tablets for diabetics.


Metabolism and nutrition disorders
Increased retention of sodium and water in the body, increased potassium excretion with
Potassium deficiency and disturbance of the acid-base balance, congestive heart failure in sensitive people
Patients (congestive heart failure with reduced pumping capacity of the heart: associated with this
is too little blood ejection from the heart and a backlog of blood), high blood pressure, increased
Blood sugar and sugar in the urine, increased protein breakdown e.g. breakdown of muscles.


Psychiatric illness
Euphoria (high mood), mood swings, severe depression up to
mental disorders (psychoses), changes in personality, insomnia.


Nervous system disorders
Convulsions, symptoms of a brain tumor usually occurring after treatment such as exacerbation
intracranial pressure and papillary edema without the presence of a tumor (pseudotumor cerebri),
Headache, dizziness.

Eye diseases
Cataract, green star (glaucoma), protrusion of the eyeball (exophthalmos),
Increase in pressure in the eye, blurred vision.

Diseases of the gastrointestinal tract
Gastrointestinal complaints, hiccups, activation and development of gastric and gastric disorders
Duodenal ulcer with possible breakthrough and bleeding,
Inflammation of the pancreas (pancreatitis), drum belly, ulcer inflammation of the
Esophagus (ulcerative esophagitis). Alcoholism favors the development of one
Inflammation of the pancreas and colon ulcers favor the development of a breakthrough.

Skin and subcutaneous tissue disorders
Delayed wound and bone healing, thin skin (skin atrophy), punctiform (petechiae,
Purpura) and extensive (ecchymosis) bleeding of the skin and mucous membranes, inflammatory
Redness (erythema) of the face, increased sweating, suppressed reactions to skin tests,
Breakdown of fatty tissue, striped reddening of the skin (Striae rubrae), increased storage of
Pigments, symptoms similar to acne (steroid acne) and miliaria (blistering), allergic
Skin inflammation (dermatitis), hives (urticaria), angioneurotic edema, vesicle-like
Inflammation of the skin (papules) on the face with a gap around the lips
(perioral dermatitis), inflammation of the hair follicle (folliculitis) and increased hair growth.

Vascular disease
Inflammation of the vessel walls (necrotic angiitis), increased risk of vascular occlusion
(Risk of thrombosis), chronic rheumatism promotes the development of vascular inflammation
(Vasculitis), spider veins (telangiectasia).

General disorders and administration site conditions
Hypersensitivity reactions (anaphylactic and anaphylactoid reactions) such as burning sensation,
Itching, skin irritation, dry skin, redness, blistering of the skin and cardiovascular
Reactions (shock-like states, drop in blood pressure), feeling of heat, especially after injection into
Arteries.

Infections and parasitic diseases
There can be unwanted effects like infection and exacerbation of existing ones
Infections (e.g. tuberculosis, fungal infections, infections by bacteria or viruses) occur.

Musculoskeletal, connective tissue and bone diseases
Muscle weakness due to loss of muscle mass (corticosteroid myopathy), bone loss
(Osteoporosis) with increased risk of bone fractures, worsening of symptoms
Myasthenia gravis. In rare cases, inflammation and death of bone tissue occurs
in the area of ​​the long tubular bones (upper arm, thigh), joint instabilities, tendon rupture.

Additional side effects associated with corticosteroid injections
include rare incidents of blindness associated with intralesional therapy (injection
in the affected area) around the mouth and head, hyperpigmentation or hypopigmentation
(Change in pigmentation), subcutaneous or cutaneous tissue atrophy (thinning of the
Tissue), sterile abscess, flare-up after injection (after intra-articular application) and
charcot-like arthropathy (pronounced joint wear).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. this is also valid
for side effects not listed in this leaflet.
You can also report side effects directly
Federal Office for Safety in Health Care,
Traisengasse 5, 1200 Vienna,
AUSTRIA
Fax: +43 (0) 50 555 36207
http://www.basg.gv.at/
Show.


By reporting side effects you can help provide more information about the
Safety of this drug will be provided.

How should it be stored?

Do not store above 25 ° C. Do not freeze.

Store in the original package in order to protect from light. Keep this medicine out of the sight and reach of children.

You can use this medicine according to the instructions on the carton according to “Us. Do not use until “stated expiry date. The expiry date refers to the last day of the month indicated.

Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.

additional Information

What Diprophos Suspension contains

  • The active ingredients are: 5 mg / ml betamethasone (as dipropionate) and 2 mg / ml betamethasone (as disodium phosphate).
  • The other ingredients are: benzyl alcohol, methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, disodium hydrogen phosphate dihydrate, sodium chloride, disodium edetate, polysorbate 80, sodium carboxymethyl cellulose, polyethylene glycol, hydrochloric acid for pH adjustment and water for injections (see section 2 for information on Sodium content).

What Diprophos suspension looks like and contents of the pack

Diprophos Suspension is a clear, colorless liquid with white suspendable microcrystals and a pH of 6.5 to 7.5.

Diprophos Suspension is offered in 1 ml ampoules of 1 and 5 pieces.

Marketing Authorization Holder and Manufacturer

Pharmaceutic entrepreneur:

Merck Sharp & Dohme Ges.m.b.H., Vienna

Email: [email protected]

Manufacturer:

Schering-Plow Labo NV

Industrial park 30

B-2220 Heist-op-den-Berg, Belgium

Z.Nr .: 16.460

This leaflet was last revised in September 2018.

The following information is intended for healthcare professionals only:

The injection suspension is drawn up in the required amount after shaking the ampoule. Local anesthetics containing vasoconstrictors and preservatives such as methyl or propyl 4-hydroxybenzoate should not be used.

Influence on examination methods:

  • Skin reactions to allergy tests can be suppressed.
  • Corticoids can falsely simulate a positive reaction in the blue tetrazolium test used to detect systemic bacterial infections.

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