Tempalgin (Metamizole sodium, Tempidon)
International generic name
Drug form and composition
Film-coated tablets. Each film-coated tablet contains: 500 mg Metamizole sodium;
20 mg Tempidon.
Mild to moderate pain of variable origin: headache; migrene; toothache; neuralgia;
neuritis; plexitis; lumbalgia; myalgia and myositis; trauma; postsurgery interventions
and dental procedures; dysmenorrhoea; burning; premedication in the dental practice.
Dosage and administration
In adults, Tempalgin is used orally in dose of 1 - 2 tablets 3 - 4 times daily.
In children over 10 years, the drug is administered in dose of 1 tablet 2 - 3 times
daily. The treatment course duration should not exceed 5 to 7 days.
Hypersensitivity to tempidon, metamizole and other pyrazolone drugs; acute hepatic
porphyria and inborn deficiency of glucose-6-phosphate dehydrogenase; aplastic anemia,
leucopenia and agranulocytosis; severe kidney and liver diseases; pregnancy; children
younger than of 10 years.
Special warnings and precautions
The drug is used cautiously in patients suffering from liver or kidney diseases.
After more prolonged treatment with Tempalgin regular checks of blood count are
necessary. In patients suffering from bronchial asthma, pollinosis, Quincke’s edema,
chronic airway infections or showing hypersensitivity to analgesic and nonsteroidal
anti-inflammatory agents, as well as to other drugs or foods, there is a risk of
allergic reactions and asthmatic attacks. During lactation the drug should be avoided,
because both active ingredients are eliminated in the breast milk. Tempidon decreases
the attention concentration and slows the reflexes. Because of this it should be
used cautiously in car drivers and in people working with machines.
Because of the inhibition of hepatic enzyme systems metabolising drugs, Metamizole
effect is potentiated by tricyclic antidepressants (psychophorin, amitriptyline),
oral contraceptive agents, and allopurinol. Due to this its biotransformation is
slower, and the toxicity is greater. Barbiturates and phenylbutazone are liver enzyme
inductors, and they decrease the strength and duration of the metamizole pharmacodynamic
effect. Metamizole lowers the plasma cyclosporin levels. Chloramphenicol increases
the myelotoxic action of metamizole (additive effect). Alcohol augments the action
of both components. Tempidon potentiates the activity of the hypnotic agents, general
anesthetics, and narcotic and nonnarcotic analgesics.
Itching, skin rash, urticaria, Stevens-Johnson’s syndrome, Layell’s syndrome, angioedema,
vasomotor disturbances; asthmatic attack, allergic shock; nausea, vomiting, abdominal
pain and discomfort, ulcers and bleeding in rare cases. In susceptible patients,
agranulocytosis, leucopenia, aplastic anemia, retention of water and electrolytes
The combined product Tempalgin exerts analgesic and antipyretic action and moderate
anti-inflammatory activity. The analgesic effect is stronger and longer than that
of metamizole, and it influences the psychic pain component. Metamizole exerts its
pharmacodynamic effects by inhibition of the prostaglandin synthesis and formation
of endogenous pyrogens. The other component, Tempidon, possesses a strong anxiolytic
activity and eliminates the state of fear and anxiety.
20 or 300 film-coated tablets.
|Manufacturer Sopharma AD: