DIPROMET (amp)
-
Chemical Name:
Betamethasone (Dipropionate)-Betamethasone (Sodium Phosphate) -
Therapeutic Category:
Anti-inflammatory drugs -
Pharmacologic Category:
Corticosteroid -
Pharmaceutical Form:
Ampoule -
Composition:
Betamethasone Dipropionate 10mg-Betamethasone Sodium Phosphate 4mg/2ml
DIPROMET
Suspension for Injection (Ampoule)
Betamethasone (dipropionate) & betamethasone (disodium phosphate)
1-COMPOSITION:
DIPROMET- suspension for injection: Each 2ml contains betamethasone dipropionate 12.86mg/ml (equivalent to 10mg of betamethasone) and betamethasone disodium phosphate 5.26 mg/ml (equivalent to 4mg of betamethasone).
Excipients:
Sodium Chloride, Mono Basic Sodium Phosphate, Di Basic Sodium Phosphate, Methyl Paraben Sodium, Propyl Paraben Sodium, Di Sodium Edetate, Polyethylene Glycol-3350, Propylene Glycol, Benzyl Alcohol, Tween 80, Water for Injection.
2-PROPERTIES:
This product belongs to a group of medicines known as “corticosteroids”. These medicines help to relieve parts of the body affected by inflammation. They act by reducing swelling, redness, itching, and allergic reaction. They are used to treat certain problems.
3-INDICATIONS:
This product is used in case of inflammation conditions require systemic corticosteroids treatment, particularly:
- Arthritis, bursitis, sciatica, lumbago, or other conditions of bones or deep tissues.
- Allergic conditions, such as asthma, hay fever, bronchitis, drug allergy, insect bites, or stings.
- Skin conditions, such as inflammation, itching, Urticaria, hair loss, psoriasis, scars, or cystic acne.
- Other problems diagnosed by your doctor
4-CONTRAINDICATIONS:
- If you are allergic to active substances or to one of the ingredients contains in this medicine.
- If you are allergic to other corticosteroids.
- If you have a fungal infection-please tell your doctor before taking This product. Your doctor may want to treat the infection before you take Neo Phos Asia.
5-WARNINGS & PRECAUTIONS:
Patient should be aware in the following cases:
- Diabetes mellitus.
- thyroid problems.
- having liver problems.
- having epilepsy or convulsions.
- having eye problems.
- having a viral or bacterial infection .
- having kidney problems.
- having stomach or intestine problems.
- having hypertension or heart problems.
- having muscle weakness or loss of calcium.
- having a history of psychiatric illness.
-needing a vaccination.
Serious neurological event, some of which resulted in death, have been reported in cases of epidural injection of corticosteroids. The specific events reported include, among others, infraction of the spinal cord, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurological events have been reported with and without the use of fluoroscopy. The safety and efficacy of epidural corticosteroid administration have not been established, and corticosteroids are not approved for this type of use.
Children and adolescents
Since corticosteroids can upset the growth of babies and children, it is important that the doctor closely monitors their growth and development in cases of prolonged treatment.
6-DRUGS INTERACTIONS:
These drugs may interact with betamethasone:
- Anti-epileptic medicines,
- Antibiotics,
- Hormonal medicines,
- Medicines for heart or blood problems, such as diuretics.
- Alcohol.
7-PREGNANCY and LACTATION:
This is because it is not known if this productis safe to use while pregnant or breast-feeding.
If corticosteroids are used as treatment during pregnancy, both the mother and the child must be followed carefully during the delivery and after the birth.
8-DRIVING and USING MACHINERY:
Generally, this product will not affect capacity for reaction or coordination. If high doses or prolonged treatments are administrated, however, some patients may experience an exaggerated feeling of well-being (euphoria), become sleepy or develop vision disorders, which could affect their ability to drive a vehicle.
This productcontains benzyl alcohol (9mg/ml) - this can cause harmful and allergic reactions in babies and children under 3 years old. Do not give premature or full-term newborn babies.
This productcontains methyl para-hydroxybenzoate (E218) and propyl para-hydroxybenzoate (E216) – these can cause allergic reactions (possibly delayed) and in rare case breathing problems.
9-DOSAGE and ADMINISTRATION:
This product is a suspension for injection. It should be shaken before use. The injection is generally performed by your doctor or a healthcare professional. Your doctor will decide on the dose based on your needs
The injection can be given by the intramuscular, intraarticular, periarticuar, intralesional, intradermal, and intrabursal routes. It can also be injected into soft tissue.
This productcannot be used for intravenous or subcutaneous administration.
This productshould not be suddenly stopped. The dose must be reduced slowly by the doctor.
10-POSSIBLE SIDE EFFECTS:
The side effects associated with corticosteroids, including this product, depend on the dose and the length of the treatment.
The following side effects during treatment with this product:
- Changes to your heart rate, increase in blood pressure.
- Muscle weakness, muscle pain, loss of calcium.
-Water retention.
- Thinning of the skin, bruising, redness of the face, wounds healing more slowly, sensitivity reactions, increased sweating, Urticaria.
- Certain conditions of the stomach or intestine, such a ulcers, hiccups.
- Convulsions, exaggerated feeling of well-being(euphoria), difficulty sleeping(insomnia), vertigo, headaches, mood changes, serious depression, hyperirritability, psychotic reaction, particularly in patients with history of psychiatric conditions.
- Eye conditions, such as cataract, glaucoma, or protrusion of the eye ball out of its usual place.
- Moon face (swelling of the face), acne, disorders of menstruation and libido, increased need for insulin or oral anti-diabetic medicines in diabetic patients, appearance of symptoms of latent diabetes.
- Slowing of growth of the fetus or of the child.
- Weight gain.
- Inhibition of the skin tests.
- Masking the symptoms of an infection, activation of the latent infection.
- Reduced resistance to infections, particularly those due to mycobacteria, tuberculosis, Candida albicans and viruses.
11-PACKAGING:
DIPROMET – Injectable Suspension: Carton package of one ampoule of 2 ml.
12-STORAGE CONDITIONS:
Store DIPROMET – Injectable Suspension at temperature below 25°C. Protect from light and freezing.
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