To whom and when is tempalgin indicated? Drug interactions with the drug tempalgin
Tempalgin is a medicine that many people resort to when pain occurs. It is sold in pharmacies; you do not need to provide a prescription to purchase it. The drug is available in tablets, in packages of 10, 20 and 100 pieces; one blister contains 10 biconvex green pills. You can learn more about its use and dosage by reading the information below.
What are Tempalgin tablets for?
According to the instructions, it is a non-narcotic analgesic, which is endowed with antipyretic and analgesic properties. The drug is used to treat pain that occurs if it is mild or moderate in nature.
These include headaches, unpleasant pain caused by dental procedures or ordinary toothache, as well as neuralgia, myalgia or arthralgia. In addition to them, the medicine can be used:
- At high body temperature;
- Patients with increased nervous excitability;
- For inflammation and infectious diseases;
- In combination with other drugs during antispasmodic therapy to eliminate hepatic, renal and intestinal colic, in which mild pain of visceral origin is observed;
- For postoperative pain.
Tempalgin is able to eliminate the described sensations for a long time.
For toothache
The drug should be taken after talking with the dentist, otherwise taking it may interfere with subsequent diagnosis. Doctors may recommend taking this drug half an hour before the start of dental treatment, as well as the same time after the medical intervention.
Tempalgin can help the patient not only overcome the pain threshold, but also have a tranquilizing effect on his nervous system and prevent fears before the procedure.
For headaches
It can have several origins:
- During menopause or menstruation;
- For viral and infectious diseases;
- After taking potent medications for a long time;
- For migraines;
- As a result of overstrain of cerebral vessels or their expansion;
- With high intracranial pressure;
- After stopping drinking drinks containing coffee;
- Changes in the brain;
- For arterial hypertension.
With blood pressure
It is better not to take this medicine, as it can cause both a decrease and an increase in blood pressure. This refers to its side effects, which can sometimes be observed with an overdose of Tempalgin.
Side effects may include tachycardia, headaches, or heaviness in the heart area. Such symptoms are unsafe; if they occur, you should immediately call a doctor or go to see him.
During menstruation
The medicine prevents the pain that often accompanies PMS. The drug has an analgesic effect, and also eliminates tearfulness and nervousness, which usually arise against the background of hormonal imbalance, which sometimes appears these days. In parallel with this drug, it is often suggested to use antispasmodic drugs.
Tempalgin, instructions for use
The drug is prescribed by a doctor, but there are cases when a person has already taken it and knows about its dosage, then if pain occurs that is not systemic in nature, the medicine can be used independently.
Composition of Tempalgin
According to the instructions, this medication has two active ingredients:
- Tempidon. It can relieve feelings of anxiety, fear and restlessness, while reducing motor functions and reducing blood pressure.
- Metamizole sodium. An effective analgesic that not only eliminates pain, but also relieves inflammation.
One pill contains 500 mg of Metamizole sodium and 20 mg of Tempidone. In addition to them, it contains additional substances: microcrystalline cellulose, wheat starch, talc, magnesium stearate and povidone K 25.
The film coating is Opadry II 85 F21526 green.
The effectiveness of the product is achieved by an optimally balanced combination of its two active components. Tempidone prolongs the effect of the anesthetic substance - metamizole, and its effect becomes noticeable after 20-30 minutes after administration. The calming effect can last up to three hours.
Application and dosage
It is better to take the tablets after meals; they do not need to be chewed; after swallowing, the tablet is washed down with plenty of water.
Approximate dose of medication for different ages:
- For adults. The usual dosage is 1 tablet twice a day, a single dose of medicine should not exceed one pill, in extreme cases it can be two tablets. When visiting a dentist, take the tablet half an hour before medical intervention.
- For patients over 65 years of age, a single dose does not exceed 2 pills; the duration of use should not be long.
- Children who have reached the age of 12. The maximum dosage and amount of medication per day is 1 tablet.
Tempalgin should be taken with caution by those who have problems with the liver; they may only partially eliminate metamizole metabolites, and if there is serious liver damage, they should be treated with Tempalgin, using half of its recommended dosage.
Clients with impaired renal function should take only half the dose of the drug, since the active substance is eliminated through them.
Consequences of overdose
You should strictly adhere to the treatment regimen established by the doctor; with an increased dose of the medication, the following symptoms may occur: tachycardia, oliguria, dyspeptic disorders, feeling tired and lethargic, nausea, often accompanied by vomiting, convulsions, loss of consciousness and arterial hypotension.
If one of these symptoms is present, then you need to perform a gastric lavage; perhaps you can limit yourself to taking sorbents or saline solutions. In advanced cases, symptomatic therapy or hemodialysis is used.
Side effects
Tempalgin, like any medication, causes several deviations in human functioning, manifested in different body systems:
- Nervous: dizziness and headache, rare, but hallucinations still occur;
- Digestive: hyperbilirubinemia, jaundice, dry mouth, burning sensation in the epigastric region;
- Respiratory: shortness of breath and bronchospasm;
- Hematopoiesis: agranulocytosis, leukopenia and thrombocytopenia;
- Cardiovascular: fluctuations in blood pressure readings, cyanosis and tachycardia;
- Urinary: proteinuria, nephritis, oliguria, red staining of urine.
Allergic reactions may occur in the form of urticaria, rash and itching, anaphylactic shock, erythema multiforme and epidermal necrolysis.
Contraindications
The drug should not be used in the following cases:
- If you are intolerant to its components;
- Heart failure;
- Impaired kidney and liver function;
- Arterial hypotension;
- "Aspirin triad";
- Children under 14 years of age;
- Glucose-6-phosphate dehydrogenase deficiency.
Tempalgin during pregnancy
In the initial stages, it should not be used so as not to harm the baby; because of this, it is also contraindicated in the last six weeks of gestation. The rest of the time during pregnancy, the drug can be taken under the supervision of a doctor.
When feeding a newborn, Tempalgin should not be used to treat any pain, as it is excreted in breast milk and can pass on to the baby.
Interaction of Tempalgin with drugs
It may be prescribed in combination with other drugs, with which it may behave differently. Here are the most common combinations and their interactions.
| Medicine | Tempalgin |
| Phenothiazine | may cause exacerbation of hypertension |
| Ethanol | the medicine increases its effect |
| Thiamazole and Cytostatics | the risk of leukopenia increases |
| Phenylbutazone and barbiturates | reduce the effectiveness of the main drug |
| Sedatives and tranquilizers | enhance the effect of Tempalgin on the body |
| Cyclosporine | reduces its percentage in plasma |
| X-ray contrast drugs, penicillin and colloid blood substitutes | cannot be used together |
| Hypoglycemic drugs, indomethacin, indirect anticoagulants and corticosteroids | Tempalgin enhances their activity |
| Contraceptive hormonal drugs, analgesics and allopurinol | Lead to toxicity in the body |
Features of use
Treatment should not be accompanied by drinking alcoholic beverages. When using Tempalgin for a week, you need to monitor the condition of the liver and the overall blood picture.
Tempalgin belongs to the group of non-narcotic painkillers. This drug is characterized by a pronounced anti-inflammatory and analgesic effect. In addition, Tempalgin has a sedative and antipyretic effect. The medicine helps eliminate pain of various origins. Tempalgin helps well with neuralgia and myalgia, headaches, toothaches, renal and hepatic colic, febrile conditions characteristic of viral or colds. Helps eliminate post-traumatic and post-operative pain.1. Pharmacological action
An anesthetic drug with antipyretic and mild sedative and anti-inflammatory effects.2. indications for use
- Elevated temperature during infectious diseases or inflammatory processes;
- Pain syndrome of moderate and moderate severity of various origins.
3. Method of application
- Recommended dosage of Tempalgin: one tablet 1-3 times a day. In the absence of the desired therapeutic effect, it is possible to take another tablet of the drug;
- Maximum single dose: two tablets;
- Maximum daily dose: 6 tablets;
- Duration of treatment: does not exceed 5 days.
Any change in the dosage of Tempalgin or the duration of its use should only be done with the permission of the attending physician.
Features of application:
- Long-term use should be accompanied by mandatory monitoring of the blood picture;
- While using Tempalgin, patients should refrain from activities related to the speed of reaction, control of complex mechanisms and vehicles of various categories.
4. Side effects
- Disorders of the hematopoietic system (increased level of agranulocytes, decreased level of platelets, decreased level of leukocytes);
- Nervous system disorders (hallucinations, headaches, dizziness);
- Various allergic reactions (Stevens-Johnson syndrome, skin rashes, Lyell's syndrome, bronchospasm, itchy skin);
- Disorders of the urinary system (various disorders of the kidneys);
- Cardiovascular system disorders (blue skin, changes in blood pressure, heart rhythm disturbances).
5. Contraindications
- Patients under 14 years of age;
- Severe liver dysfunction;
- Simultaneous use of Tempalgin with radiopaque agents;
- Individual intolerance to the drug and its components;
- Inhibition of hematopoietic processes;
- Reduced blood pressure;
- Simultaneous use of Tempalgin with colloidal blood substitutes;
- Hypersensitivity to Tempalgin and its components;
- Chronic functional heart failure;
- Simultaneous use of alcoholic beverages;
- Pregnancy and lactation;
- Simultaneous use of Tempalgin with Penicillin;
- Aspirin asthma;
- The use of Tempalgin to relieve acute abdominal pain of unknown origin;
- Deficiency of the enzyme glucose-6-phosphate dehydrogenase;
- Severe renal failure.
6. During pregnancy and lactation
Use of Tempalgin at any stage of pregnancy strictly contraindicated.The use of Tempalgin during breastfeeding is possible only in exceptional cases and after complete cessation of breastfeeding during treatment.
7. Interaction with other drugs
Simultaneous use of Tempalgin:- and medicines that contain ethyl alcohol or alcoholic beverages, an increase in the effect of ethyl alcohol is observed;
- with sedatives or tranquilizers leads to an increase in the analgesic effect of Tempalgin;
- with Cyclosporine leads to a decrease in the plasma concentration of the latter;
- with drugs that have an analgesic effect, contraceptive drugs in the form of tablets, tricyclic antidepressants and Allopurinol, a mutual increase in toxic effect on the body is observed;
- with Chlorpromazine there is a marked increase in body temperature;
- with Thiamazole and antitumor drugs leads to a decrease in the level of leukocytes;
- with drugs that reduce blood clotting (indirect action), Indomethacin, drugs that reduce blood glucose levels (in tablet form) and drugs of adrenal hormones, there is an increase in the therapeutic effect of the latter;
- with drugs that have a blocking effect on histamine receptors, Propanolol and Codeine, an increase in the therapeutic effect of Tempalgin is noted;
- with Phenylbutazone, barbiturates and drugs that reduce the activity of liver enzymes, leads to a weakening of the therapeutic effect of Tempalgin.
8. Overdose
- Cardiovascular system disorders (low blood pressure, heart rhythm disturbances);
- Nervous system disorders (confusion, seizures, drowsiness);
- Respiratory system disorders (shortness of breath);
- Digestive system disorders (functional kidney failure, abdominal pain, vomiting, functional liver failure).
9. Release form
Tablets - 20 or 100 pcs.10. Storage conditions
Tempalgin is stored in a dry, dark place.11. Composition
1 tablet:
- metamizole sodium - 500 mg;
- triacetonamine-4-toluene sulfonate (tempidone) - 20 mg;
Excipients: wheat starch, microcrystalline cellulose, talc, magnesium stearate, crospovidone (kollidon K25), titanium dioxide, polyethylene glycol 400, castor oil, glycerol, dibutyl phthalate, eudragit L acetone 12.5, green dye.
12. Conditions for dispensing from pharmacies
The drug is available without a prescription.Found a mistake? Select it and press Ctrl + Enter
* Instructions for medical use of the drug Tempalgin are published in free translation. THERE ARE CONTRAINDICATIONS. BEFORE USE, YOU MUST CONSULT WITH A SPECIALIST
To suppress the inflammatory process, reduce the severity of pain and maintain body temperature, doctors prescribe the drug Tempalgin. The medicine is inexpensive, and is characterized by a systemic effect on the body. The instructions for use of Tempalgin provide a complete description of the drug, but before starting treatment you need to consult a doctor.
Composition and release form
Tempalgin is a representative of the pharmacological group of nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine is produced in the form of round green tablets with a shiny surface, coated with an enteric coating. The drug is packaged in blisters (10 pcs.), 1 package contains 2, 10 or 30 blisters, instructions for use. Chemical composition of Tempalgin tablets:
| Active components | Excipients |
| metamizole sodium (500 mg) | crospovidone |
| tempidone (20 mg) | Magnesium stearate |
| castor oil |
|
| microcrystalline cellulose |
|
| methyl methacrylate copolymer |
|
| wheat starch |
|
| titanium dioxide |
|
| polyethylene glycol |
|
| glycerol |
|
| macrogoal |
|
| dibutyl phthalate |
|
| green dye |
|
| Eudragit L acetone |
How the drug works
Tempalgin tablets have antipyretic, analgesic, anxiolytic, and anti-inflammatory properties. According to the instructions, they provide a therapeutic effect 15 minutes after taking a single dose. The therapeutic effect is formed by the active ingredients of the drug:
- Metamizole sodium, being a non-opiate pain reliever, reduces the intensity of moderate pain.
- Tempdion calms the nervous system, reduces emotional arousal, and weakens the inflammatory process.
After consuming a single dose, the active ingredients of Tempalgin are productively absorbed from the intestinal lumen and evenly distributed throughout the tissues. The metabolic process takes place in the liver. Inactive metabolites are excreted by the kidneys - with urine, in small concentrations through the intestines unchanged. The therapeutic effect is temporary, the tablets do not cure the disease, but help stop the acute stage.
What are Tempalgin tablets for?
The medication is prescribed for pain of different localization and etiology. This is a good opportunity to provide a long-lasting analgesic effect. For example, Tempalgin helps very well with toothache, and it also stops moderate migraine attacks. The detailed instructions for use of the medication provide a complete list of indications:
- pain of visceral origin;
- renal and intestinal colic (in combination with antispasmodics);
- neuralgia (inflammatory process of peripheral nerves);
- osteochondrosis with severe radicular syndrome;
- arthralgia (joint pain);
- myalgia (muscle soreness);
- algodismenorrhea (premenstrual syndrome);
- intoxication of the body of infectious and non-infectious nature (as part of complex treatment).
According to the instructions, this medication is often used before invasive diagnostic or surgical interventions. The purpose of this pharmaceutical prescription is to reduce the severity of pain during instrumental examination or during surgery. The therapeutic effect is noticeable with increased nervous excitability.
Directions for use and dosage
Tempalgin is intended for oral use. According to the instructions, the tablets must be swallowed whole, not chewed first, and washed down with plenty of water. It is better to take a single dose after a meal, otherwise irritation of the mucous membrane of the digestive canal may occur. Daily doses depend on the severity of the pain syndrome and are 1 table. 1–3 times per day. The maximum single dosage is no more than 2 tablets, daily dosage is 6 tablets.
Tempalgin during menstruation
According to the instructions, Tempalgin tablets are allowed to be used for painful menstruation (algodismenorrhea). The recommended (safe) dosage depends on the age of the patient in a particular clinical case. For example, girls over 15 years old are prescribed no more than 2 tablets. per day. Adult women are allowed to take up to 3 tablets. per day. The course of treatment is 3–5 days. For algodismenorrhea, No-shpa is additionally recommended.
Tempalgin for headaches
When migraine attacks become more frequent, the doctor recommends Tempalgin as a reliable pain reliever. The patient is prescribed to drink 1 tablet. three times a day. If the medicine at this dosage does not help stop an acute attack, you can take a second tablet. The maximum daily dose is 6 tablets. The course of treatment lasts 5 days, after which you need to seek advice.
For toothache
When a tooth hurts, you need to drink 1 tablet. Tempalgina. If the pain has not subsided after 15 minutes, you are allowed to take a second tablet. Daily dosage – no more than 6 tablets, divided into 3 daily doses. It is recommended to continue treatment for no more than 5 days. If there is no positive dynamics, you need to consult a specialist on the 3rd day.
Special instructions
According to the instructions for use, Tempalgin tablets are contraindicated for children under 14 years of age. For this category of patients, it is necessary to select an analogue with a mild, gentle effect. The instructions contain other, equally important instructions:
- If the medication is used for a long time (more than 7 days), careful monitoring of peripheral blood parameters, the functional state of the liver, and kidneys is necessary.
- If you are experiencing acute abdominal pain, you should refrain from taking such a pharmaceutical drug until the etiology of the pathological process is clarified.
- Metamizole sodium provokes agranulocytosis (decrease in granulocytes in the blood), accompanied by the development of stomatitis, vaginitis, sore throat of unknown etiology, proctitis. In such clinical pictures, immediate discontinuation of this drug is required.
- Since Tempdion in its chemical composition provides a sedative effect, during the period of treatment with Tempalgin it is necessary to temporarily stop driving and not engage in work associated with increased concentration.
- The course of treatment is 5 days. Afterwards, on the recommendation of the attending physician, it is necessary to alternate painkillers, otherwise the so-called “addictive effect” develops.
Tempalgin during pregnancy
When carrying a fetus, the medication is prohibited for use. Both active substances penetrate the placental barrier and cause severe intrauterine pathologies. It is necessary to refuse such treatment throughout the entire period of pregnancy, otherwise you can harm the health of the unborn baby. Tempalgin is also contraindicated during lactation, since both components are excreted in breast milk. When treating young mothers with this medication, the question arises of temporarily stopping breastfeeding and transferring the baby to artificial formula.
Drug interactions
Tempalgin is often prescribed as part of complex therapy. For such clinical cases, the detailed instructions for use contain information about drug interactions:
- In combination with Chlorpromazine or other phenothiazine derivatives, symptoms of severe hyperthermia develop.
- When used together with sedatives and tranquilizers, the analgesic effect of Tempalgin is enhanced.
- In combination with Allopurinol, tricyclic antidepressants, non-opioid analgesics, and oral contraceptives, toxic effects of the selected drug therapy occur.
- Thiamazole and cytostatics, when used simultaneously with Tempalgin, increase the risk of developing leukopenia.
- Metamizole sodium in combination with GCS, indirect anticoagulants and Indomethacin increases the therapeutic effect of the latter.
- In combination with Cyclosporine, the concentration of the immunosuppressant in the blood plasma decreases, and when used simultaneously with Phenylbutazone and other inducers of microsomal liver enzymes, barbiturates, the effect of Tempalgin is weakened.
- Combination with penicillin, radiopaque agents, and colloidal blood substitutes is prohibited.
- Histamine H2 receptor blockers, Codeine and Propranolol slow down the elimination of the active substances of the drug and enhance the therapeutic effect.
Tempalgin and alcohol
The instructions for use state that combining this analgesic with alcoholic beverages is strictly contraindicated. If this rule is violated, an excessive depressive effect on the brain leads to serious complications with the patient’s health. Visual and auditory hallucinations appear, and the normal functioning of the central nervous system (CNS) organs is disrupted.
Side effects
After the start of conservative treatment, the patient's condition may deteriorate sharply. The detailed instructions describe side effects that apply to many internal organs and systems:
- from the gastrointestinal tract: dry mouth, jaundice, increased bilirubin, cholestasis, burning sensation in the chest, pain in the epigastric region;
- from the cardiovascular system: decrease in blood pressure (arterial hypotension), tachycardia, increased heart rate, impaired outflow of venous blood;
- from the central nervous system: migraine attacks, dizziness, auditory and visual hallucinations, emotional instability, drowsiness, tendency to depression;
- from the urinary system: red urine, decreased renal function, oliguria, anuria, proteinuria;
- from the hematopoietic organs: thrombocytopenia, neutropenia, leukopenia, agranulocytosis;
- from the skin: swelling of soft tissues, urticaria, cyanosis (yellowing of the skin and mucous membranes), angioedema, bronchospasm, anaphylactic shock, exudative erythema.
Tempalgin overdose
According to the instructions for use, if daily doses are systematically exceeded, signs of tachycardia occur, vomiting attacks become more frequent, and blood pressure drops. Other symptoms of an overdose of Tempalgin are shortness of breath, abdominal pain, drowsiness, muscle cramps, and tinnitus. The patient is prescribed urgent gastric lavage and oral administration of enterosorbents. Forced diuresis to cleanse the blood and hemodialysis are mandatory. Further treatment, as recommended by a doctor, is symptomatic.
Contraindications
According to the instructions for use, not everyone is allowed to use the product. Medical contraindications:
- arterial hypotension;
- “aspirin” asthma;
- liver and kidney failure;
- deficiency of the enzyme glucose-6-phosphate dehydrogenase;
- chronic heart failure;
- periods of pregnancy, lactation;
- inhibition of hematopoiesis in the red bone marrow;
- intolerance to the active ingredients of Tempalgin.
The instructions contain relative medical contraindications. In such clinical pictures, the medication is taken with extreme caution.
Manufacturer: SOPHARMA JSC
Anatomical-therapeutic-chemical classification: Metamizole sodium
Registration number: No. RK-LS-5No. 020109
Registration date: 25.06.2018 - 25.06.2023
Instructions
- Russian
Trade name
Tempalgin ® M
International nonproprietary name
Metamizole sodium
Dosage form
Tablets 500 mg
Compound
One tablet contains:
active substance - metamizole sodium 500 mg,
excipients: wheat starch, microcrystalline cellulose (type 101), povidone K 25, talc, magnesium stearate.
Description
Tablets are round in shape, with a flat surface, white or almost white in color, with a score line on one side.
Pharmacotherapeutic group
Analgesics. Other analgesics-antipyretics. Pyrazolones. Metamizole sodium.
ATX code N02BB02
Pharmacological properties
Pharmacokinetics
Suction. After oral administration, metamizole is hydrolyzed in the gastrointestinal tract. The active metabolites are 4-methyl-amino-antipyrine (MAA) and 4-amino-antipyrine (AA). MAA is characterized by rapid and complete resorption. Maximum plasma concentration is achieved within 1-2 hours. The bioavailability of MAA is approximately 90%. Food does not affect the pharmacokinetics of metamizole.
Distribution. Binds 50-60% to plasma proteins. Penetrates the blood-brain and placental barrier. Volume of distribution is approximately 0.7 l/kg.
Metabolism. Metamizole undergoes intense biotransformation in the gastrointestinal tract and liver. Its main metabolite, 4-methyl-amino-antipyrine, is metabolized in the liver to other metabolites, including 4-amino-antipyrine (AA), which is pharmacologically active.
Excretion. It is excreted in the urine in the form of metabolites, and only 3% of the excreted amount of metamizole is unchanged.
Patients with hepatic impairment: The half-life of the active metabolite of MAA in patients with hepatic impairment is prolonged by approximately three times. These patients are recommended to be treated with lower doses of metamizole.
Patients with renal impairment: Patients with impaired renal function have a reduced rate of elimination of some metabolites. These patients are recommended to be treated with lower doses of metamizole.
Pharmacodynamics
Metamizole sodium is an analgesic from the pyrazolone group with pronounced analgesic and antipyretic effects. It has a weaker anti-inflammatory activity, as well as a weak antispasmodic effect. The main mechanism of its action is to inhibit the synthesis of prostaglandins by inhibiting cyclooxygenase. Stimulates the release of beta-endorphins, reduces the level of endogenous pyrogens and acts directly on the thermoregulatory center in the hypothalamus.
Indications for use
To relieve pain of mild to moderate intensity of various origins
Febrile syndrome resistant to other therapy.
Directions for use and doses
Dosage
The dose depends on the intensity of pain or the degree of fever and on individual sensitivity to metamizole.
Adults and teenagers over 15 years of age (>53 kg weight)
250-500 mg 2-3 times a day.
The maximum single dose is 1 g. The maximum daily dose is 2 g.
Patients over 65 years of age
Usually no dose reduction is required. In patients with age-related impairment of renal and hepatic function, treatment should be carried out using ½ the recommended adult dose for a short period of time (see section "Pharmacokinetics").
Patients with impairedwe eatfunctionsand liver
In these patients, the half-life of metamizole metabolites may increase (see section “Pharmacokinetics”). In patients with moderate to severe liver damage, treatment with ½ the recommended adult dose is recommended.
Patients with impairedwe eatfunctionsand kidneys
Metamizole and its metabolites are excreted by the kidneys (see section “Pharmacokinetics”). In patients with impaired renal function, treatment with metamizole should be ½ the recommended adult dose.
Duration of treatment
Treatment with metamizole should not last more than 3-5 days. Its use for a longer period of time or in higher doses than indicated is possible only after consultation with your doctor.
Side effects
Side effects are classified by frequency. MedDRA frequency is defined as follows: very common (>1/10), common (>1/100 to<1/10), нечастые (>1/1 000 to<1/100), редкие (>1/10,000 to< 1/1 000), очень редкие (<1/10 000), с неизвестной частотой (на основании существующих данных нельзя сделать оценку).
Uncommon:
Exanthema
Palpitations, tachycardia, cyanosis, cardiac arrhythmia, arterial hypotension
Rarely:
Proteinuria, oliguria, anuria, polyuria, interstitial nephritis, red coloration of urine (due to the metabolite - rubazonic acid)
Leukopenia
Paresthesia, tinnitus, blurred vision, tremor, depression
Maculopapular rash, anaphylactic or anaphylactoid reactions.
Such reactions may occur during or immediately after administration, but may also appear after several hours. They usually occur mainly within the first hour after application.
Milder reactions are manifested by typical reactions from the skin and mucous membrane (for example, itching, burning, redness, urticaria, swelling), dyspnea and, rarely, complaints from the gastrointestinal tract. Such milder reactions can develop into more severe forms with generalized urticaria, severe angioedema (including laryngeal edema), severe bronchospasm, cardiac arrhythmias, decreased blood pressure (sometimes with a previous increase in blood pressure).
For this reason, if skin reactions occur, the use of metamizole should be stopped immediately.
Very rarely:
- asthmatic attack (in patients with analgesic asthma); Stevens-Johnson or Lyell syndrome; anaphylactic shock
Agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia.
The risk of agranulocytosis cannot be predicted. Agranulocytosis may also occur in patients who have used metamizole in the past without side effects. The risk of agranulocytosis increases with long-term use (more than 1 week) of metamizole.
With unknown frequency:
Nausea, vomiting, anorexia, abdominal pain and discomfort, in rare cases ulceration and bleeding.
If any of the side effects become serious, the drug should be stopped immediately. The patient should notify the doctor or pharmacist if he notices other side effects not described in this leaflet.
Contraindications
Hypersensitivity to metamizole or any of the excipients
Hypersensitivity to other pyrazolone derivatives (including in patients with a history of agranulocytosis, after previous use of such substances)
Acute hepatic porphyria
Glucose-6-phosphate dehydrogenase deficiency (threat of hemolysis)
Severe liver and/or kidney diseases
Bone marrow dysfunction (for example, after treatment with cytostatics) or diseases of the hematopoietic system (aplastic anemia, agranulocytosis, leukopenia), infectious neutropenia
Bronchospasm, bronchial asthma, urticaria, acute rhinitis associated with the use of NSAIDs
Pregnancy and lactation
Children under 15 years of age.
Drug interactions
Coumarin anticoagulants. With simultaneous use, metamizole may reduce the activity of coumarin anticoagulants as a result of enzyme induction.
Chlorpromazine and other phenothiazine derivatives . When used simultaneously with metamizole, there is a risk of severe hypothermia.
Cyclosporine. Metamizole reduces plasma levels of cyclosporine when used concomitantly.
Chloramphenicol and other myelotoxic drugs. There is an increased risk of bone marrow suppression when used concomitantly with metamizole.
Inducers of microsomal enzymes (barbiturates, glutethimide, phenylbutazone) can weaken the effect of metamizole.
CNS depressants (benzodiazepines, neuroleptics, opiates) when combined with metamizole enhance its analgesic effect.
When used simultaneously with other analgesics, antipyretics and NSAIDs, mutual enhancement of toxic effects is possible.
The effect of tricyclic antidepressants (psychophorin, amitriptyline), oral contraceptives drugs, analgesics, allopurinol and alcohol are potentiated when used simultaneously with metamizole.
Pyrazolone derivatives are known to interact with captopril, lithium, methotrexate and triamterene, as well as alter the effectiveness of antihypertensive drugs and diuretics. The extent to which metamizole leads to these interactions is not known.
With simultaneous use, the effect of oral hypoglycemic drugs and glucocorticosteroids is enhanced due to their displacement from connection with blood proteins under the influence of metamizole.
Radiocontrast agents, colloidal blood substitutes and penicillin should not be used during treatment with metamizole.
Special instructions
Treatment with metamizole is carried out only for a short period of time or in cases where the expected benefit outweighs the risk of side effects, or there is no other alternative treatment.
There is a small but life-threatening risk of anaphylactic shock and agranulocytosis when using metamizole (see section "Side effects"). The development of agranulocytosis is not dose dependent and cannot be predicted. May occur after the first dose or after repeated use. Typical signs of agranulocytosis are fever, sore throat, painful swallowing, inflammation of the mucous membranes of the mouth, nose, pharynx, anorectal and genital area. If there is a sudden deterioration in the general condition and signs of agranulocytosis appear, treatment with metamizole should be stopped and a complete blood count should be performed.
Patients with a history of anaphylactoid reactions as a result of the use of metamizole have an increased risk of developing such reactions when using other pyrazolones and other non-narcotic analgesics.
The risk of anaphylactoid reactions when using metamizole is significantly higher in patients with:
syndrome of analgesic asthma or analgesic idiosyncrasy such as urticaria - angioedema;
bronchial asthma, especially with concomitant rhinosinusitis and nasal polyps;
chronic urticaria;
idiosyncrasy to dyes (for example, tartrazine), preservatives (for example, benzoates);
alcohol intolerance. Such patients react to minimal intake of alcoholic beverages with symptoms such as sneezing, watery eyes, and severe blurred vision. Such alcohol intolerance may be a sign of undiagnosed analgesic asthma syndrome.
Metamizole can provoke hypotensive reactions (see section "Side effects"). These reactions are dose-dependent and are observed primarily with parenteral administration. Despite this, treatment with metamizole in tablet form should be carried out with extreme caution in patients with hypotension, volume deficiency or dehydration, or unstable circulation.
It should be used with caution in patients with hepatic or renal damage (see sections “Pharmacokinetics” and “Method of administration”).
With longer-term use of metamizole, it is necessary to monitor a general blood count, including the leukocyte count.
The wheat starch in the tablets may contain only traces of gluten and is considered safe for people with celiac disease.
Pregnancy and periodlactation
Pregnancy
No controlled clinical studies have been conducted in pregnant women and there are no observational data on use in this group. Despite the fact that metamizole is a weak inhibitor of prostaglandin synthesis, there is a possibility of premature closure of the ductus botallus, as well as perinatal complications as a result of decreased platelet aggregation in the fetus and mother. Treatment with the drug is contraindicated in pregnant women.
Lactation period
Metamizole metabolites are excreted in breast milk. If treatment with the drug is necessary, breastfeeding should be discontinued.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms
When taking high doses of Tempalgin®, I am advised to drive or operate machines that require active attention, as the drug may have an adverse effect on attention and impair reactions in unexpected situations.
Overdose
Symptoms: nausea, vomiting, abdominal pain, hypothermia, possible development of severe shock, acute renal and liver failure, clonic-tonic convulsions, coma.
Treatment: Symptomatic treatment is used depending on the patient’s condition: forced diuresis, respiratory resuscitation, antishock agents, and rehydration are performed. There is no specific antidote.
Release form and packaging
In this medical article you can familiarize yourself with the drug Tempalgin. The instructions for use will explain in what cases the tablets can be taken, what the medicine helps with, what are the indications for use, contraindications and side effects. The annotation presents the forms of release of the drug and its composition.
In the article, doctors and consumers can only leave real reviews about Tempalgin, from which one can find out whether the medicine has helped in the treatment of headaches and toothaches in adults and children, for which it is also prescribed. The instructions list analogues of Tempalgin, prices of the drug in pharmacies, as well as its use during pregnancy.
Non-narcotic analgesic combination medicine - Tempalgin. The instructions for use indicate that the tablets have an antipyretic effect.
Release form and composition
Tempalgin tablets are green, round in shape, and have a biconvex shiny surface. They are covered with an enteric coating. The drug contains several main active ingredients, their content in one tablet is:
- Tempidone (triacetonamine 4-toluene sulfonate) – 20 mg.
- Metamizole – 500 mg.
Tempalgin tablets are packaged in blister packs of 10 pieces. A cardboard pack contains 2 or 10 blisters, as well as instructions for use of the drug.
Pharmacological action
The drug contains metamizole sodium and triacetonamide 4-toluenesulfonate, as well as wheat starch, talc, magnesium stearate, Avicel RN 101. Tempalgin has an analgesic effect, as well as antipyretic and mild anti-inflammatory and mild tranquilizing effects. Due to its effectiveness and availability, today it is one of the most popular analgesics.
Indications for use
What does Tempalgin help with? Main indications for the use of tablets:
- visceral pain manifestations, for example, renal, intestinal, and hepatic colic;
- various pain syndromes - neuralgia, headache and toothache, migraines, myalgia;
- reduction of mild pain syndromes after examinations and operations.
Instructions for use
Tempalgin tablets are taken orally, without chewing, with a sufficient amount of liquid, during or after meals. Adults are prescribed 1 tablet 1-3 times a day; if the effectiveness is insufficient, you can take 1 more tablet.
The maximum single dose is 2 tablets, the maximum daily dose is 6 tablets. Duration of administration is no more than 5 days. Increasing the daily dose or increasing the duration of treatment is possible only under the supervision of a physician.
Contraindications
There are a number of contraindications for the use of Tempalgin tablets, which include some pathological or physiological conditions of the patient’s body:
- Pregnancy at any stage, as well as the period of breastfeeding (lactation).
- Pathological inhibition of hematopoietic processes in the red bone marrow, accompanied by a decrease in the number of leukocytes (leukopenia), granulocytes (agranulocytosis), neutrophils (neutropenia) in the blood.
- The patient's age is less than 14 years.
- Individual hypersensitivity to any of the components of this medication.
- Chronic heart failure, accompanied by a decrease in myocardial contractility.
- Marked decrease in blood pressure (arterial hypotension).
- Deficiency of the enzyme glucose-6-phosphate dehydrogenase.
- Marked decrease in the functional activity of the kidneys or liver.
- “Aspirin” asthma is a complex of pathological allergic reactions that develop as a result of the entry into the patient’s body of drugs from the pharmacological group of non-steroidal anti-inflammatory drugs. The reaction is often accompanied by an attack of bronchoconstriction (bronchospasm) and clinically resembles bronchial asthma.
The drug is used with caution in patients with concomitant pathology of the kidneys and liver, accompanied by a moderate decrease in their functional activity, bronchial asthma, a predisposition to a decrease in systemic blood pressure, chronic alcoholism. Before starting to use this medicine, it is important to exclude the presence of contraindications.
Side effects
- from the nervous system: dizziness, headache; in some cases – hallucinations;
- from the urinary system: urine stained red;
- from the hematopoietic system: leukopenia, agranulocytosis, thrombocytopenia;
- when taking high doses - functional kidney disorder (interstitial nephritis, anuria, proteinuria, oliguria);
- from the digestive system: rarely - dry mouth, burning sensation in the epigastric region, cholestasis, increased activity of liver enzymes, hyperbilirubinemia, jaundice;
- allergic reactions: bronchospasm, rash, itching, urticaria (including mucous membranes of the nasopharynx and conjunctiva), erythema multiforme (including Stevens-Johnson syndrome), Quincke's edema, toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock;
- from the cardiovascular system: cyanosis, increased or decreased blood pressure, tachycardia.
Children, pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy. The drug should not be used during lactation, because both components are excreted in breast milk.
Tempalgin is contraindicated in children under 14 years of age.
Special instructions
The composition of Tempalgin provides for some restrictions on its use. Its use should not be combined with alcohol consumption. It is necessary to regularly monitor the state of peripheral blood and liver function during long-term use of the drug.
The use of Tempalgin is unacceptable for relieving acute abdominal pain without identifying its causes. Particular caution is required when driving a car during treatment with the drug, as well as during any work that requires significant concentration and high speed of psychomotor reactions.
Drug interactions
The combination of the drug with phenothiazine derivatives causes hyperthermia. In this case, the analgesic effect can be enhanced by tranquilizers and sedatives.
The likelihood of developing leukopenia increases when prescribed with cytostatics or Thiamazole.
This drug can reduce the concentration of Cyclosporine in the plasma, enhance the effectiveness of GCS, hypoglycemic agents, indirect anticoagulants and Indomethacin.
It is also possible to weaken liver enzyme inducers - phenylbutazone or barbiturates. It is possible that mutual enhancement of toxic effects may occur with the simultaneous use of metamizole sodium, NSAIDs, a number of oral contraceptives, Allopurinol and tricyclic antidepressants, while Propranolol, Codeine and H2 receptor blockers can slow down the elimination of this drug.
Analogues of the drug Tempalgin
The analogue, Tempanginol, is determined by its structure.
Analogues of drugs for relieving headaches and migraines include:
- Imigran.
- Nurofen.
- Vinpotropil.
- Brustan.
- Vero Anaprilin.
- Remidon.
- Caffeamine.
- Retafil.
- Analgin.
- Allicor.
- Novo Passit.
- Amylonosar.
- Solpadeine.
- Dimephosphone.
- Picamilon.
- Stugeron.
- Amitriptyline.
- Nurofen forte.
- Ipronal.
- Dilceren.
- MIG 200.
- Histaglobin.
- Cardiomagnyl.
- Topamax.
- Anaprilin.
- Acetaminophen.
- Flamax.
- Coffedon.
- Amigrenin.
- Pentalgin.
- Nobrassite.
- Sumamigrain.
- Upsarin UPSA.
- Nilogrin.
- Paracetamol.
- Grippostad.
- MIG 400.
- Omaron.
- Cinnarizine.
- Burana.
- Efkamon.
- Revalgin.
- Kaffetin.
- Sinusan.
- Ditamin.
- Flucoldex.
- Rudotel.
- Redergin.
- Faspik.
- Nalgesin.
- Lexotan.
- Panadol.
- Obzidan.
- Metovit.
- Kudevita.
- Syncapton.
- Betalok.
- Aspirin-C.
- Novigan.
- Inderal.
- Optinatus.
- Nalgesin forte.
- Naramig.
- Febricet.
- Xanthinol nicotinate.
- Askofen.
- Vasocardin.
- Alisat.
- Contemnol.
- Cefekon.
- Ibufen.
- Nurofen for children.
- Bromazepam Lannacher.
- Aviton.
Vacation conditions and price
The average cost of Tempalgin (tablets No. 20) in Moscow is 115 rubles. Available without a prescription.
The drug should be stored in a dry place, at a temperature not exceeding 25 C. Shelf life – 4 years.
