Description
Latin name
Tempalgin
Release form
film-coated tablets.
Packaging
20 pcs.
Pharmacological action
Tempalgin – a combined analgesic-antipyretic.
It has analgesic, antipyretic, mild anti-inflammatory and sedative effects.
The composition of the drug includes a non-opioid analgesic metamizole sodium and anxiolytic (tranquilizer) tempidone.
Indications
moderate or mild pain (including headache, migraine, toothache, neuralgia, radicular syndrome, myalgia, arthralgia, algomenorrhea), especially in patients with increased nervous irritability
mild (viscer including renal, hepatic, intestinal colic) in combination with antispasmodic therapy
pain after surgical and diagnostic interventions (as an adjuvant)
fever in colds and other infectious and inflammatory diseases.
Contraindications
hypersensitivity to the drug,
severe renal / hepatic failure,
chronic heart failure,
arterial hypotension (blood pressure lower than 100 mmHg),
inhibition of hematopoiesis (granulocytopenia, leukopenia, agranulocytosis, cytostatic or infectious neutropenia),
glucose-6-phosphate deficiency, aspredehyde, children’s age (up to 14 years).
With caution is prescribed for kidney diseases (pyelonephritis, glomerulonephritis, including a history), moderate / severe liver / renal failure, with bronchial asthma, a predisposition to the development of arterial hypotension, and prolonged alcohol abuse.
Use during pregnancy and lactation
The drug is contraindicated in pregnancy.
Do not use the drug during lactation, because both components are excreted in breast milk.
Composition
1 coated tablet contains:
Active ingredients: metamizole sodium 500 mg triacetonamine 4-toluenesulfonate (tempidone) 20 mg.
Excipients: wheat starch, microcrystalline cellulose, talc, magnesium stearate, crospovidone (Kollidon K25), titanium dioxide, polyethylene glycol 400, castor oil, glycerol, dibutyl phthalate, euradite L acetone 12.5, green dye.
Dosage and administration of
Inside, after meals, washed down with water.
Dose depends on the severity of pain and individual sensitivity to the drug.
Adults: usual dose – 1 tablet. 1-3 times a day. The maximum single dose should not exceed 1 table. The maximum daily dose is 4 tablets.
For dental procedures: 1 tab. 30 minutes before the intervention.
Children over 15 years: 1 tab. in a day. The maximum daily dose is 2 tablets.
Special patient groups
Patients older than 65 years. Usually, a dose reduction is not required. In patients with age-related renal and hepatic impairment, Tempalgin treatment should be short-lived. The maximum daily dose is 2 tablets.
Impaired liver function. In patients with impaired liver function, an increase in T1 / 2 metabolites of metamizole sodium is possible. In patients with moderate or severe liver damage, treatment is recommended 1/2 of the recommended dose for adults (maximum daily dose – 2 tablets).
Impaired renal function. Metamizole sodium and its metabolites are excreted by the kidneys. In patients with impaired renal function, Tempalgin ® should be treated using 1/2 of the recommended adult dose (maximum daily dose is 2 tablets).
Duration of treatment
Treatment with Tempalgin ® should not last more than 3-5 days. Its use more over a long period of time or in higher doses is possible only after consultation with a doctor.
Drug Interaction
Tempalgin enhances the effects of ethanol.
Co-administration of Tempalgin with chlorpromazine or other phenothiazine derivatives may lead to marked hyperthermia.
Sedatives and tranquilizers enhance the analgesic effect of the drug.
With the simultaneous use of thiamazole and cytostatics increase the risk of leukopenia.
Concomitant use of metamizole sodium with cyclosporine decreases the latter’s plasma concentration.
Metamizole sodium, ousting oral hypoglycemic drugs, indirect anticoagulants, ACS and indomethacin from the protein bond increases their action.
When used concurrently, barbiturates, phenylbutazone and other inducers of microsomal liver enzymes attenuate the action of sodium metamizole.
Co-administration of metamizole sodium with other non-opioid analgesics, tricyclic antidepressants, oral contraceptives, allopurinol can lead to mutual enhancement of toxic effects.
Codeine, histamine H 2 receptor blockers and propranolol delay the excretion of metamizole sodium and enhance its action.
Overdose
Symptoms: nausea, vomiting, epigastric pain, oliguria, tachycardia, decreased blood pressure, shortness of breath, tinnitus, drowsiness, impaired consciousness, convulsions.
Treatment: gastric lavage, appointment of salt laxatives and activated carbon in severe cases – hemodialysis, forced diuresis, symptomatic therapy, in the development of convulsive syndrome – in / in the introduction of diazepam and high-speed barbiturates.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Expiration
4 years.
Active ingredient
Metamizole sodium, Pithophenone, Tryatsetonamyn-4-toluenesulfonate
pharmacy terms and conditions without a prescription
dosage form
dosage form
tablets
Sofarma Bolgaria
