metamizole sodium tablet
Indications
Metamizole Sodium Tablet is indicated in adolescents aged 15 years or older and adults for:
1.acute severe pain following trauma or surgery
2.painful colics
3.tumour pain
4.other acute or chronic severe pain, if other therapeutic measures are contraindicated
5.high fever that does not respond to other measures
Dosage and Administration
Usage: Oral
Dosage:
Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to Metamizole Sodium Tablet. It is essential to choose the lowest dose that controls pain and fever.
Body weight / Age | Single dose | Daily maximum dos | |||
kg | age | tablets | mg | tablets | mg |
> 53 | ≥ 15 years | 1-2 | 500-1,000 | 8 | 4,000 |
Precautions & Warning:
1.Agranulocytosis
2.Pancytopenia
3.Anaphylactic/anaphylactoid reactions
4. Severe cutaneous reactions
5. Hypotensive reactions
6. Drug-induced liver injury
7. Renal and hepatic impairment
8. Interference with laboratory tests
Contraindications:
1. Hypersensitivity to the active substance, pyrazolones or pyrazolidines, e.g. medicinal products containing metamizole, propyphenazone, phenazone or phenylbutazone.
2. In patients with known analgesic asthma syndrome or known analgesic intolerance of the urticaria/angioedema type, i.e. patients who react with bronchospasm or other anaphylactoid types of reaction to salicylates, paracetamol or other non-narcotic analgesics, such as diclofenac, ibuprofen, indomethacin or naproxen
3. Disturbances of bone marrow function (e.g. after treatment with cytostatic medicinal products) or haematopoietic disorders
4. Hereditary glucose-6-phosphate dehydrogenase deficiency (risk of haemolysis)
5. Acute intermittent hepatic porphyria (risk of inducing an porphyria attack)
6. Third trimester of pregnancy
7. Children less than 15 years of age.
Adverse Reactions:
1. Blood and lymphatic system disorders: leukopenia;agranulocytosis or thrombocytopenia; aplastic anaemia, pancytopenia, including cases with lethal outcome.Agranulocytosisis typically characterised by inflammatory mucosal changes (e.g. in the mouth, nose, throat and genital and anal region), sore throat, swallowing difficulties, fever and chills. In patients receiving antibiotics, these signs may, however, be minimal.
2. Immune system disorders; anaphylactoid or anaphylactic reactions; analgesics-induced asthma-syndrome; In patients with analgesics asthma syndrome intolerance typically takes the form of asthma attacks. Milder reactions typically take the form of skin and mucosal reactions (e.g. prorates, a burning sensation, redness, urticaria, swelling), dyspnoea and, more rarely, gastrointestinal complaints (e.g.
nausea, dyspepsia, vomiting).
3. Cardiac disorders:Kounis syndrome
4. Vascular disorders:hypotensive reactions during or after administration which may be pharmacological in origin and not accompanied by other signs of anaphylactoid or anaphylactic reaction;Such reactions may lead to a severe fall in blood pressure.
Storage instructions:
This medicinal product does not require any special temperature storage conditions.