Etamsylate Solution for Injection 250mg/2ml in Prefilled Syringe
- NAME OF THE MEDICINAL PRODUCT
Etamsylate Solution for Injection 250mg/2ml in Prefilled Syringe Taj Pharma.
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Etamsylate Solution for Injection 250mg/2ml in Prefilled Syringe
Active ingredient is:
Etamsylate 125mg/ml. (250mg per 2 ml Prefilled Syringe).
Excipients: Each 2ml ampoule also contains 0.8mg of sodium metabisulphite (E223) For a full list of excipients, see section 6.1
- PHARMACEUTICAL FORM
Solution for injection in Prefilled Syringe.
A clear, colourless, aqueous solution for injection (pH 6.2 to 6.8).
- CLINICAL PARTICULARS
Etamsylate injection is indicated in neonates.
Etamsylate injection is used clinically for the prophylaxis and treatment of periventricular haemorrhage (bleeding into the brain immediately adjacent to cerebralventricles) in low birth weight infants (< 1.5 Kg).
Posology and method of administration
The normal dosage is 12.5mg/kg body weight given by intravenous or intramuscular route within an hour of birth and every six hours for the first 4 days of life.
Clinical studies have not been performed in patients presenting hepatic or renal impairment. Consequently, caution is required when administering Etamsylate injection to these patients.
Use in patients with a known hypersensitivity to etamsylate or to any of the excipients. Acute porphyria
Bronchial asthma, confirmed hypersensitivity to sulphites.
Special warnings and precautions for use
Etamsylate injection is intended for neonatal use only.
If the infant develops a fever then treatment should be discontinued.
Due to the risk of a fall in blood pressure during parenteral administration, caution is required in patients presenting unstable pressure or hypotension (see section 4.8 “undesirable effects”).
Etamsylate injection solution contains sodium metabisulphite as antioxidant, which may cause allergic reactions, nausea
and diarrhoea in susceptible patients.
The allergic reactions may go as far as anaphylactic shock and cause life threatening
asthma attacks. The prevalence in the population is not known but is probably low. However, hypersensitivity to sulphites is observed more frequently in patient with asthma than in those without asthma (see section 4.3 “Contraindications”). If a hypersensitivity reaction occurs, the administration of Etamsylate injection solution must be stopped immediately.
Interaction with other medicinal products and other forms of interaction
Etamsylate injection is incompatible with solutions of sodium bicarbonate and compound sodium lactate. When Etamsylate injection is mixed with saline it should be used immediately.
Thiamine (vitamin B1) is inactivated by the sulphite contained in Etamsylate injection. If a dextran infusion is required, Etamsylate must be injected first.
Fertility, pregnancy and lactation
Clinical use is not relevant for this indication.
There are no clinical data available concerning use in pregnant women.
Animal experiments have not revealed any direct or indirect toxicity affecting pregnancy, embryonic development, foetal development and/or post-natal development.
Caution is required if used during pregnancy.
In the absence of data concerning passage into breast milk, breast-feeding is inadvisable during treatment. Alternatively, the treatment should be stopped if breast-feeding is continued.
Effects on ability to drive and use machines
Not applicable in this population.
In adults, Etamsylate injection has no effect upon driving capacity and managing of machines.
In infants no major side-effects have been reported.
In adults, the following side effects were described. These side effects are classified according to the MedDRA convention by system organ class and by frequency as follows:
Very common (≤1/10) Common (≤1/100 to <1/10)
Uncommon (≤1/1 000 to <1/100) Rare (≤1/10 000 to <1/1 000)
Very rare (<1/10 000), not known (cannot be estimated from the available data)
Common: nausea, diarrhoea, abdominal discomfort.
Skin and subcutaneous tissue disorders
General disorders and administration site conditions
Common: asthenia Very rare: fever.
Nervous system disorders
Very rare: thromboembolism, hypotension.
Blood and lymphatic system disorders
Very rare: agranulocytosis, neutropenia, thrombocytopenia
Musculoskeletal and connective tissue disorders
Immune system disorders
Very rare: hypersensitivity
These reactions are generally reversible when stopping treatment course.
In case of skin reactions or fever, the treatment must be stopped and the treating physician informed as this may constitute hypersensitivity reactions.
There is no experience of overdosage with Etamsylate .
In the event of any overdose, start symptomatic treatment.
- PHARMACOLOGICAL PROPERTIES
Other systemic haemostatics.
Etamsylate is a non-hormonal agent which reduces capillary exudation and blood loss. Etamsylate does not affect the normal coagulation mechanism since administration is without effect on prothrombin times, fibrinolysis, platelet count or function.
Etamsylate is thought to act by increasing capillary vascular wall resistance and platelet adhesiveness; in the presence of a vascular lesion, it inhibits the biosynthesis and action of those prostaglandins which cause platelet disaggregation, vasodilation and increased capillary permeability. Etamsylate does not have a vasoconstricting action.
Following intravenous administration maximum blood levels of etamsylate are achieved in 2-3 minutes, while after intramuscular injection, maximum blood levels of etamsylate are achieved after about one hour. Etamsylate is excreted unchanged, largely by the urinary route.
Preclinical safety data
No further information is available.
- PHARMACEUTICAL PARTICULARS
List of excipients
Sodium metabisulphite, Sodium hydrogen carbonate (for pH adjustment) Water for injections
Etamsylate injection is incompatible with solutions of sodium bicarbonate and compound sodium lactate.
Unopened: 3 years
Once opened: from a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are responsibility of the user and would normally not be longer than 24 hours at 2 to 8 oC, unless dilution has taken place in controlled and validated aseptic conditions
Special precautions for storage
Store below 25°C. Keep the ampoule in the outer carton.
Nature and contents of container
2 ml clear, Type I glass Prefilled Syringes containing a colourless, sterile, aqueous solution. Outer cartons containing Prefilled Syringes.
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
Discard if solution is colored.
For single use only, any remaining solution should be discarded.
- Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST