Tempalgin during pregnancy and breastfeeding

We depend on the emotional sphere more than we think. Severe stress and experiences in the body are reflected by changes in the production of neurotransmitters and changes in the functions of the body's autonomous systems, which is reflected in the occurrence of pain. Pain of neurological origin most often manifests itself as migraine or migraine-like headache, and significantly disrupts the quality of life of patients. Actually, the subjective sensations are such that they make you think about poison - remember Pontius Pilate? Treatment for chronic migraine consists mainly of:

• in eliminating individual triggering factors, such as strong odors, bright light, stress;
• preventing headache attacks with specific anti-migraine drugs;
• relief of acute symptoms.

Combination analgesics are widely used for the relief of severe headaches and the initial treatment of patients with mild to moderate migraine symptoms.

Comparison of the effectiveness of Tempalgin and Pentalgin

The effectiveness of Tempalgin is quite similar to Pentalgin - this means that the ability of the drug substance to provide the maximum possible effect is similar.
For example, if the therapeutic effect of Tempalgin is more pronounced, then using Pentalgin even in large doses will not achieve this effect.

Also, the speed of therapy - an indicator of the speed of therapeutic action - is approximately the same for Tempalgin and Pentalgin. And bioavailability, that is, the amount of a drug reaching its site of action in the body, is similar. The higher the bioavailability, the less it will be lost during absorption and use by the body.

What is the difference?

There are contraindications, consult a specialist

Tablets with a characteristic green color are Tempalgin, which over time became a household name and practically a second name for painkillers. Includes:

1. "Analgin" - metamizole sodium, 500 mg, an analgesic with antipyretic and weak antispasmodic effects of the pyrazolone series. It has a strong analgesic effect, its main drawback is the ability to cause agranulocytosis - a decrease in the level of leukocytes, which is why Metamizole has been banned for use in the USA, Japan and the Schengen countries since approximately the late 70s of the last century. Currently, data on its inhibitory effect on hematopoiesis are considered significantly exaggerated, but it is worth limiting the frequency and dose of analgin.
2. Tempidone, international name Triacetonamine-4-toluene sulfonate 20 mg, is an antidepressant with a pronounced sedative and anti-anxiety effect. In this combination, it is not only an auxiliary component that enhances and prolongs the analginic effect of analgin by 2-3 times, but also has a positive effect due to its influence on the neurotransmitter serotonin, which plays a pathogenetic role in migraine.

Analysis of indications for use:

• Headache, migraine, peripheral pain of a psychosomatic nature (neuralgia, myalgia, arthralgia, dysmenorrhea) are logically placed in first place;
• for pain caused by spasm of smooth muscles (renal, hepatic colic) - recommended in combination with an antispasmodic;
• surgical pain;
• fever due to ARVI.

20 tab.

Comparison of the safety of Tempalgin and Pentalgin

The safety of a drug includes many factors.

At the same time, it is higher for Pentalgin than for Tempalgin. It is important where the drug is metabolized: drugs are excreted from the body either unchanged or in the form of products of their biochemical transformations. Metabolism occurs spontaneously, but most often involves major organs such as the liver, kidneys, lungs, skin, brain and others. When assessing the metabolism of Pentalgin, as well as Tempalgin, we look at which organ is the metabolizing organ and how critical the effect on it is.

The risk-benefit ratio is when the prescription of a drug is undesirable, but justified under certain conditions and circumstances, with the obligatory observance of caution in use. At the same time, Pentalgin has fewer risks when used than Tempalgin.

Also, when calculating safety, it is taken into account whether only allergic reactions occur or possible dysfunction of the main organs. In other matters, as well as the reversibility of the consequences of using Pentalgin and Tempalgin.

Tempalgin tablets p/o 500mg/20mg No. 10x1

Name

Tempalgin tablet p/o 500 mg/20 mg in blister pack. in pack No. 10x1

Description

Round, biconvex, film-coated tablets, green in color, odorless.

pharmachologic effect

Tempalgin is a combination drug that contains the active substances metamizole sodium and triacetonamine-4-toluene sulfonate. It has a pronounced and long-lasting analgesic effect due to the non-narcotic analgesic metamizole sodium, which suppresses the synthesis of prostaglandins. Triacetonamine-4-toluene sulfonate reduces motor agitation and has a calming effect.

Indications for use

• Acute pain after injury or surgery
• Colic
• Pain due to tumor diseases
• Other acute or chronic severe pain when other therapeutic measures are contraindicated or ineffective
• High temperature that cannot be controlled by other means.

Contraindications

• In case of hypersensitivity to metamizole and other pyrazolone derivatives or pyrizalidin (including patients who have developed agranulocytosis after using these substances) or any other ingredients of analgin.
• In patients with a history of aspirin asthma or analgesic intolerance syndrome (urticaria, angioedema), in patients with bronchospasm or other forms of anaphylactoid reactions to salicylates, paracetamol or other non-narcotic analgesics such as diclofenac, ibuprofen, indomethacin and naproxen).
• In case of impaired bone marrow function (for example, after treatment with cytostatics) or diseases of the hematopoietic system.
• Hereditary hemolytic anemia associated with deficiency of glucose-6-phosphate dehydrogenase.
• Patients with systolic blood pressure below 100 mm Hg.
• In acute intermittent porphyria (risk of an attack of porphyria).
• In the last trimester of pregnancy.
• During breastfeeding.
• If acute surgical pathology is suspected.
• Children under 15 years of age.

special instructions

Use extreme caution when using Tempalgin contains the pyrazolone derivative metamizole and has a rare but life-threatening risk of shock and agranulocytosis. Patients with atopic bronchial asthma and hay fever have an increased risk of developing hypersensitivity reactions. Patients with anaphylactoid reactions to metamizole are most vulnerable to the entire group of non-narcotic analgesics. Patients with anaphylactoid reactions or other immunologically mediated reactions (eg, agranulocytosis) may react in the same way to other pyrazolones and pyrazolidines. When using the drug, agranulocytosis may develop. Therefore, if an unmotivated increase in temperature, chills, sore throat, difficulty swallowing, stomatitis, as well as inflammation of the external genitalia and anus is detected, immediate discontinuation of the drug is necessary. When choosing a route of administration, it is important to remember that parenteral administration of analgin is associated with an increased risk of anaphylactic or anaphylactoid reactions. The risk of potentially severe anaphylactoid reactions to analgin increases significantly in patients with:

• asthma syndrome on analgesics or angioedema on non-narcotic analgesics;
• bronchial asthma, especially with concomitant rhinosinusitis and nasal polyps;
• chronic urticaria;
• intolerance to dyes (for example, tartrazine) and preservatives (for example, benzoates);
• alcohol intolerance. These patients may react to alcoholic beverages even in small quantities with symptoms such as sneezing, watery eyes, and severe facial flushing. Such alcohol intolerance may be a sign of previously diagnosed asthma to analgesics.

When prescribed to patients with acute cardiovascular pathology, careful monitoring of hemodynamics is necessary. Use with caution in patients with blood pressure levels below 100 mmHg. Art., with myocardial infarction, multiple trauma, with anamnestic indications of liver and kidney diseases (pyelonephritis, glomerulonephritis), during treatment with cytostatics, with chronic alcoholism, a burdened allergic history, blood diseases. Analgin can lead to hypotensive reactions. These reactions may be dose dependent. These reactions usually occur with parenteral rather than enteral administration. The risk of developing such reactions increases:

• with rapid intravenous administration;
• in patients with previous hypotension, dehydration or dehydration, unstable blood pressure, or incipient circulatory failure (for example, in patients with multiple traumas or a heart attack);
• in patients with high fever.

These patients require careful evaluation and close monitoring. Preventive measures (such as circulatory stabilization) may be necessary to reduce the risk of hypotensive reactions. In exceptional cases, analgin can be used in patients in whom a decrease in blood pressure is unacceptable, for example, with severe coronary heart disease or corresponding stenosis of the cerebral arteries. Use is possible only after careful monitoring of hemodynamic parameters. Patients with renal or hepatic insufficiency should take analgin only after a careful assessment of the benefits, risks and necessary precautions. It is necessary to consult with the patient before administering analgin. In patients with an increased risk of anaphylactic reactions, analgin can be used only after a thorough analysis of the possible risks in relation to the expected benefits. When taking analgin in such cases, the patient should be carefully monitored to ensure medical care and emergency preparedness. Important information about some of the components included in the composition The drug contains wheat starch, which is acceptable for people with celiac disease. Patients with a wheat allergy (other than celiac disease) should not use this drug.

Use of other drugs

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including those taken without a prescription. Treatment may be affected by the simultaneous use of drugs that suppress the central nervous system, painkillers, anti-inflammatory drugs, contraceptive drugs, coumarin anticoagulants (reduce blood clotting), chlorpromazine (for the treatment of mental illnesses), chloramphenicol (an antibiotic), cyclosporine (used for tumor diseases ), sleeping pills.

Use with food and beverages

It is preferable to take the tablets after meals with plenty of water. During treatment with Tempalgin, drinking alcohol is not recommended, as the side effects of the drug may increase.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before using any medicine. Pregnancy It is not recommended to use Tempalgin during pregnancy. Breastfeeding The use of the drug during breastfeeding is undesirable. If treatment with the drug is required, breastfeeding should be discontinued.

Driving vehicles and working with machinery

When using Tempalgin, do not drive vehicles or operate machinery, as this drug reduces the ability to concentrate and slows down conditioned reflexes.

Mode of application

The dosage depends on the intensity of pain or fever and individual sensitivity to metamizole. In principle, the minimum dose that successfully controls pain and/or fever should be selected. It usually takes 30 to 60 minutes after oral administration before the effect occurs. Adults and adolescents aged 15 years (> 53 kg) up to 1000 mg of metamizole per dose (2 tablets). In case of insufficient effect, it is possible to increase the single dose depending on the maximum daily dose - up to 4 times a day (exceeding the daily dose is not permissible). Elderly In elderly patients, the dose should be reduced since the elimination of metabolites may be delayed. General condition and decreased creatinine clearance In patients with reduced status and decreased creatinine clearance, the dose should be reduced, since the elimination of metamizole metabolic products may be prolonged. Kidney and liver function With impaired renal and liver function, the rate of elimination is reduced; multiple doses and high doses should be avoided. Dose adjustment is usually not required. Route of Administration The route of administration is based on the desired therapeutic effect and the patient's condition. In many cases, oral administration is sufficient to provide satisfactory effect (other dosage forms of metamizole are available for intravenous or intramuscular administration to achieve rapid effect, but, usually, parenteral administration of the drug is associated with a higher risk of anaphylactic or anaphylactoid reactions). The tablets should be swallowed whole with plenty of liquid (for example, 1 glass of water). Duration of treatment The duration of treatment depends on the type and severity of the disease and is determined by the doctor. Long-term treatment with metamizole requires regular monitoring of blood counts, including counting of differentiated leukocytes. If you take more than the required dose of the drug, you may experience: nausea, dizziness, abdominal pain, weakness to the point of loss of consciousness, severely low blood pressure to the point of shock (loss of consciousness with low blood pressure), and abnormal heart rhythms . If some of these symptoms appear, you should immediately stop using the drug and consult your doctor! If you miss a dose of Tempalgin If you miss one dose, take it as soon as possible. If it is near time for your next dose, take it as usual. Do not take a double dose to make up for a missed dose. Continue to use the medicine according to the directions in this leaflet. If you have any additional questions about using this medicine, ask your doctor or pharmacist.

Possible side effects

The frequency of possible side effects listed below is determined as follows: very common (> 1/10), common (> 1/100 to 1/1000 to 1/10000

Storage conditions

In the original packaging at a temperature not exceeding 25 °C in a place protected from moisture. Keep out of the reach of children. Medicines should not be disposed of in a sewer or household waste container. Ask your pharmacist how to dispose of unused medications. These measures will contribute to environmental protection.

Best before date

Shelf life: 4 (four) years. Should not be taken after the expiration date marked on the package.

Compound

Each film-coated tablet contains the following active ingredients: metamizole sodium monohydrate 500 mg, triacetonamine-4-toluetsulfonate 20 mg. Excipients: wheat starch, microcrystalline cellulose (type 101), magnesium stearate, talc, povidone K 25. Shell: Opadry II green 85 F21526 (polyvinyl alcohol - partially hydrolyzed, macrogol 3350, talc, titanium dioxide (E 171), aluminum varnish based on quinoline yellow dye (E 104), aluminum varnish FCF based on brilliant blue dye (E 133).

Package

Primary packaging: 10 film-coated tablets are packed in a PVC/aluminum foil blister. Secondary packaging: 1 (one) or 2 (two), or 10 (ten) blisters are packaged together with a consumer leaflet in a cardboard box.

Conditions for dispensing from a pharmacy chain

Over the counter.

Buy Tempalgin tablets p/o 500mg/20mg No. 10x1 in the pharmacy

Price for Tempalgin tablets p/o 500mg/20mg No. 10x1

Instructions for use for Tempalgin tablets p/o 500mg/20mg No. 10x1

Comparison of addiction between Tempalgin and Pentalgin

Like safety, addiction also involves many factors that must be considered when evaluating a drug.

So, the totality of the values ​​of such parameters as “o syndrome” in Tempalgin is quite similar to the similar values ​​in Pentalgin. Withdrawal syndrome is a pathological condition that occurs after the cessation of intake of addictive or dependent substances into the body. And resistance is understood as initial immunity to a drug; in this it differs from addiction, when immunity to a drug develops over a certain period of time. The presence of resistance can only be stated if an attempt has been made to increase the dose of the drug to the maximum possible. At the same time, in Tempalgin the meaning of the “syndrome” is quite small, however, the same as in Pentalgin.

Comparison of side effects of Tempalgin and Pentalgin

Side effects or adverse events are any adverse medical event that occurs in a subject after administration of a drug.

Pentalgin has more adverse effects than Tempalgin. This implies that the frequency of their occurrence is low in Pentalgin and low in Tempalgin. Frequency of manifestation is an indicator of how many cases of an undesirable effect from treatment are possible and registered. The undesirable effect on the body, the strength of influence and the toxic effect of drugs are different: how quickly the body recovers after taking it and whether it recovers at all. When using Pentalgin, the body's ability to recover faster is higher than that of Tempalgin.

Tempalgin during breastfeeding: possible adverse reactions

Tempalgin is strictly contraindicated during breastfeeding, as this drug can pass into breast milk.
The active ingredients of Tempalgin - metamizole (an analgesic and antipyretic) and tempidone (an antidepressant) can have an increased pathological effect on a child who is fed only breast milk, since this group of children is more vulnerable and sensitive. If there is a strong need to use Tempalgin, you should stop breastfeeding while taking the drug.

Since Tempalgin and the active ingredients included in its composition are on the list of contraindicated drugs during lactation, it is recommended to consult your doctor to replace a drug that is approved and safe for breastfeeding.

Sources

• The use of dipyrone during pregnancy and side effects in the perinatal period. /PubMed
• Metamizole (dipyrone, optalgin) during pregnancy, is it safe? Prospective comparative study / PubMed
• First trimester metamizole use - a prospective observational cohort study of pregnancy outcomes / PubMed (English)
• Tempalgin / State register of medicinal products of Ukraine