Index
- Introduction: what is it?
- Dosage: how is it used and how does it work?
- Warnings and Precautions
- Interactions and side effects
- Pregnancy and breastfeeding
- Notes (validity, storage conditions)
Questions and answers
Introduction: what is it?
Tachipirina is a drug with an excellent antipyretic (lowers fever) and analgesic (reduces pain) effect . This makes Tachipirina considered a first-line treatment for pain relief, being the first choice in the treatment of chronic pain. For this purpose it can also be associated with codeine in case of acute pain (to treat more severe forms of pain, for example postoperative pain) and persistent chronic pain and alternating it in case of mild to moderate acute pain. Tachipirina is also a valid aspirin substitute for the treatment of fever and pain, especially in patients in whom aspirin is contraindicated (peptic ulcer, blood clotting disorders, children, drug hypersensitivity).
In particular, tachipirina as an antipyretic is used for the symptomatic treatment of febrile diseases such as influenza , also in association with salicylates, antihistamines, caffeine, sympathomimetics and barbiturates,in exanthematous diseases , acute diseases of the respiratory tract, colds and more. As an analgesic it is indicated in the symptomatic treatment of mild and moderate pain of various origins, in acute otitis media, in dysmenorrhea (painful menstruation), in headache, in neuralgia, for post-surgery pain and in case of pain from knee osteoarthritis. and hip.
The active ingredient is paracetamol , which has analgesic and antipyretic effects similar to those of aspirin, but with very weak anti-inflammatory effects and without the antiplatelet effect on platelets.
Tachipirina is sold in different pharmaceutical forms and different strengths:
- Tablets and effervescent
tablets White, scored, round, biconvex tablet with a central score line. The tablets may contain 500 mg or 1000 mg of the active ingredient (paracetamol). - Granules for oral or effervescent solution.
White to slightly yellow granules. The granules may contain 125 mg, 500 mg or 1000 mg of paracetamol. - Oral drops
Clear syrupy orange solution containing 100 mg of paracetamol / ml of solution. - Suppositories
White to cream colored suppositories. Suppositories can contain 62.5 mg, 125 mg, 250 mg, 500 mg or 1000 mg of paracetamol. - Syrup
Solution of clear, colorless or slightly yellow syrupy consistency, of 120 mg paracetamol / 5 ml sugar-free syrup. - Solution for infusion: 1 ml contains 10 mg of paracetamol. One 50 ml bag contains 500 mg of paracetamol. One 100 ml bag contains 1000 mg of paracetamol. Tachipirine solution for infusion is indicated for the short-term treatment of pain of moderate intensity, especially following surgery and for the short-term treatment of fever, when intravenous administration is clinically warranted by the urgent need to treat pain or hyperthermia and / or when other routes of administration are impossible to practice. The 100 ml bag is reserved for adults, adolescents and children weighing more than 33 kg. The 50 ml bag is reserved for infants born at term, infancy, children who start walking and children weighing less than 33 kg.
Tachipirina, in the lower-dose pharmaceutical forms, not exceeding 500 mg, is considered an SOP drug – non-prescription but non-prescription medicines. In the case of 1000 mg tachipirina, a medical prescription is required to buy it at the pharmacy.
See the directions for taking this drug in patients infected with COVID-19 coronavirus:
Taking NSAIDs and COVID-19 coronaviruses
Dosage: how is it used and how does it work?
Tachipirina is a good substitute for aspirin , especially in patients with stomach problems or on anticoagulant therapy; it has analgesic and antipyretic properties comparable to those of aspirin, but the anti-inflammatory effects are rather scarce. Paracetamol is a good pain reliever, therefore it can give relief in all conditions in which there is a form of medium-mild pain, for example in case of headache. Paracetamol is also widely used in the composition of drugs for colds, in combination with other medicines (often decongestants); the main use in these cases is to relieve fever and widespread pain, but it can also give benefits to sore throats (although we must remember that paracetamol has no anti-inflammatory effect).
Paracetamol does not affect uric acid levels and does not alter the aggregation of platelets. Unlike aspirin, it does not antagonize the effects of uricosuric substances and can be taken in combination with probenecid in the treatment of gout (use caution, see chapter “interactions”). When given alone, Tachipirina is not suitable for treating inflammatory conditions such as rheumatoid arthritis, but it can be used as a pain reliever in addition to anti-inflammatory therapy .
The posology varies according to the age and weight of the patient. For the dosage to be taken it is recommended to carefully follow the instructions in the information leaflet. In children up to 10 years of age it is essential to respect the posology defined on the basis of body weight and not on the basis of age, which is approximate and indicated only for information. If the age of the child does not correspond to the weight shown in the tables provided with the information leaflet, always refer to the body weight for the choice of dosage.
In children weighing up to 7.2 kg it is recommended to use the formulation in drops, between 7.2 and 11 kg it is possible to use drops or syrup as the dosage per weight range is identical, between 12 and 32 kg it is recommended to use the syrup.
Tachipirina solution should be administered as an intravenous infusion over 15 minutes, diluted in 0.9% sodium chloride solution (physiological saline) or in 5% glucose solution up to one tenth of the total volume. The use of Tachipirina 1000 mg is reserved for adults and children over 15 years of age. In adults, the maximum oral dose is 3 g and rectally 4 g of paracetamol per day .
The doctor must assess the actual need for treatments that last for more than 3 consecutive days.
Paracetamol can also be taken on an empty stomach, as it generally does not cause gastric problems since, unlike traditional anti-inflammatory drugs (NSAIDs), it does not have a direct gastrological action when it reaches the stomach. In addition, it has a different mechanism of action from classic anti-inflammatory drugs and therefore does not manifest even an indirect gastrological action. In any case, in subjects at risk or in case of gastrointestinal side effects (nausea, heartburn, etc.) it is preferable to administer it on a full stomach.
Absorption of paracetamol from the oral route is complete and rapid and its rate is correlated to the rate of gastric emptying. Maximum plasma concentrations are reached between 30 and 60 minutes after ingestion. Paracetamol is evenly distributed in all tissues.
Paracetamol reduces the synthesis of prostaglandins by acting as a non-selective inhibitor of the enzyme cyclo-oxygenase (COX-1, an enzyme present in almost all our cells and which synthesizes prostaglandins, important endogenous compounds that are used to transport information locally in our body) by blocking the peroxidic site of the enzyme and therefore has a different action from that of other non-steroidal anti-inflammatory drugs (NSAIDs and aspirin). The presence of high concentrations of peroxides, typical of sites where there is inflammation, reduces the COX inhibition activity of paracetamol in inflamed areas, particularly at the peripheral level. The analgesic effect is due to a direct action of paracetamol at the level ofCentral Nervous System , probably mediated by the opioid and serotonergic system, as well as by an inhibition of the synthesis of prostaglandins at a central level by acting on a third form of the enzyme cyclo-oxygenase (COX-3), expressed in the brain, which could represent the predominant target of paracetamol and other drugs with marked antifebrile characteristics. This appears to raise the threshold of sensation to pain stimuli, leading to an analgesic effect against pain for various causes. Furthermore, paracetamol has a marked antipyretic activity, always acting centrally on the body temperature regulation centers.
Elimination occurs essentially via the urine . 90% of the ingested dose iseliminated by the kidneys in 24 hours , mainly as glucuronide (from 60 to 80%) and as sulfur conjugates (from 20 to 30%). Less than 5% is eliminated unchanged. The elimination half-life is approximately 2 hours. The analgesic action of Tachipirina “solution for infusion” begins 5-10 minutes after the start of administration. The peak of the analgesic effect is generally obtained in 1 hour and the duration of this effect usually varies from 4 to 6 hours . Tachipirine solution for infusion reduces fever within 30 minutes of starting administration with a duration of antipyretic effect of at least 6 hours.
Warnings and Precautions
RISK OF DOSING ERRORS
Be careful to avoid dosing errors due to possible confusion between milligrams (mg) and milliliters (ml). This could cause accidental overdose and death.
Tachipirina should be used with caution in subjects with hypersensitivity to paracetamol or to any of the excipients contained in the pharmaceutical forms in use.
- Tachipirina tablets contain: sodium (to be taken into consideration in people with reduced kidney function or who follow a low sodium diet).
- Tachipirina effervescent granules contains: sodium, aspartame (it is a source of phenylalanine and may be harmful in case of phenylketonuria due to the risk linked to the accumulation of the amino acid phenylalanine), maltitol (use with caution in patients with rare hereditary problems of intolerance to fructose).
- Tachipirina syrup without sugar contains: sodium, sorbitol (patients with rare hereditary problems of fructose intolerance, should not take this medicine), methyl parahydroxybenzoate (can cause allergic reactions even delayed).
- Tachipirina syrup contains : sucrose (patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency, should not take this medicine. To be taken into consideration in people with diabetes mellitus), methyl parahydroxybenzoate, sodium.
- Tachipirina drops, solution contains : sorbitol, propylene glycol (can cause symptoms similar to those caused by alcohol).
Tachipirina is contraindicated in patients with severe haemolytic anemia or severe hepatocellular insufficiency (these contraindications do not refer to the 500mg oral formulations). In rare cases of allergic reactions, administration should be discontinued and appropriate treatment instituted.
In case of jaundice in children under three months of age, the single dose should be reduced. Use with caution in case of chronic alcoholism , excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (causing low hepatic glutathione reserves), dehydration, hypovolemia. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (includingGilbert’s syndrome ), severe hepatic insufficiency (Child-Pugh grade> 9), acute hepatitis, concomitantly treated with drugs that impair liver function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anemia.
High doses or prolonged intakes of the product can cause alterations in the kidney and blood, even serious , therefore the administration in subjects with renal insufficiency must be carried out only if actually necessary and under direct medical supervision. In case of prolonged use it is advisable to monitor the liver and kidney function and the blood count.
During treatment with Tachipirina, before taking any other drug, check that it does not contain the same active ingredient, as if paracetamol is taken in high doses, serious adverse reactions can occur.
Instruct the patient to contact the doctor before associating any other medication.
Tachipirina does not affect the ability to drive or use machines.
The pharmacokinetics and metabolism of paracetamol are not modified in elderly subjects. No dosage adjustment is required in this population.
The pharmacokinetic parameters of paracetamol observed in infancy and children are similar to those observed in adults, with the exception of the plasma half-life which is slightly shorter (1.5-2 hours) than in adults. In infants, the plasma half-life is longer than in infants, approximately 3.5 hours. Significantly less excretion of glucuroconjugates and greater excretion of sulfur conjugates is observed in infants, infants and children up to 10 years compared to adults.
In case of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between dosing should be at least 8 hours.
Interactions and side effects
Paracetamol is normally well tolerated. Therapeutic doses have no clinically relevant effects on the cardiovascular and respiratory systems, on platelets or on coagulation. Undesirable effects in the gastrointestinal tract are less frequent than with therapeutic doses of NSAIDs. Occasionally, skin rashes and other allergic reactions may develop, which in some cases can be severe and be accompanied by fever and mucosal lesions.
The most serious acute side effect is life-threatening hepatic necrosis. Paracetamol is mainly metabolised in the liver. There are two main metabolic pathways: conjugation with glucuronic acid and sulfo-conjugation. The latter route is rapidly saturable at doses that exceed therapeutic doses. A small fraction (less than 4%) is catalyzed by cytochrome P450 (in particular CYP2E1) and leads to the formation of a reactive intermediate, N-acetyl-p-benzoquinoneimine, which, under normal conditions of use, is rapidly detoxified. from glutathione and eliminated in the urine after conjugation with cysteine and mercapturic acid. On the contrary, during severe intoxications (overdose), the quantity of this toxic metabolite is such as to saturate the detoxification systems with consequent accumulation of the metabolite, leading to dysfunction of the liver enzyme systems and metabolic disorders. In adults, hepatotoxicity can occur after ingestion of a single dose of 10-15 g (150-250 mg / kg body weight) of paracetamol; doses of 20-25 g are potentially fatal. Conditions that lead to induction (stimulation of activity) of the CYP2E1 enzyme, such as high alcohol consumption, or a depletion of glutathione levels, as a result of prolonged fasting or malnutrition, increase the chance of liver damage, including in the presence of therapeutic dosages of paracetamol (only in very rare cases).
Symptoms may appear during the first 2 days of overdose,while clinical indications of hepatic damage can occur within 2-4 days, with right subcostal pain, jaundice, hepatomegaly and coagulopathy. You can also have kidney failure. The increase in liver enzymes reaches its peak 72-96 hours after ingestion.
Administration of activated charcoal , if within 4 hours of ingestion, reduces the absorption of paracetamol by 50-90% and should be administered if it is suspected that the ingested dose exceeds 7.5 g. Administration of N-acetyl-cysteine is indicated in patients at risk of liver damage. Liver failure could cause hypoglycemia, so blood sugar should be monitored carefully.
The oral absorption of paracetamol depends on the rate of gastric emptying. Therefore, concomitant administration of drugs that slow (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or increase in bioavailability (amount and rate at which the active substance becomes available for its therapeutic action) of the product. Concomitant
administration of cholestyramine reduces the absorption of paracetamol. The simultaneous intake of paracetamol and chloramphenicol can induce an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. Probenecid causes an approximately two-fold reduction in paracetamol clearance by inhibiting its conjugation with glucuronic acid. In case of concomitant treatment with probenecid, a dose reduction of paracetamol should be considered. Salicylamide may prolong the elimination half-life of paracetamol.
Concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants may induce slight variations in the INR values . In these cases, more frequent monitoring of INR values should be performed during concomitant use and after its discontinuation.
Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as phenobarbital, carbamazepine). The same is true in cases of alcoholism and in patients treated with zidovudine.
The administration of paracetamol can interfere with the determination of uricaemia (by the phosphotungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method).
Pregnancy and breastfeeding
Although clinical studies in pregnant or lactating patients have not shown particular contraindications to the use of paracetamol , nor caused undesirable effects affecting the mother or child, it is recommended to administer the product only in cases of actual need and only under direct supervision. check by your doctor or gynecologist. Paracetamol does not appear to have a negative effect on the reclosure of the fetal arterial duct, as observed with some NSAIDs.
In paracetamol can pass into breast milk, but in lower quantities than those normally used in pediatric medicine. In general, use during breastfeeding does not involve particular contraindications or dangers, although the preventive opinion of the pediatrician is always recommended.
Notes (validity, storage conditions)
- Effervescent tablets and tablets: they are valid for 4 years. No particular storage conditions are required. The half tablet after its division can be stored for 24 hours in the original packaging.
- Suppositories: from 62.5 mg: 3 years. Suppositories of 125 mg, 250 mg, 500 mg, 1000 mg: 5 years. Store at a temperature not exceeding 25 ° C.
- Syrup: 2 years. The validity after first opening the syrup is 1 year.
- Oral drops: 4 years. The validity after first opening the drops is 1 year.
- Effervescent granules: 3 years. Store at a temperature below 30 ° C.
- Solution for infusion: 18 months. Do not store above 25 ° C. Do not refrigerate or freeze. Keep the bags in the outer carton to protect the medicine from light. Tachipirina solution for infusion must not be mixed with other medicinal products. The solution should be visually inspected and should not be used in the presence of opalescence, visible particles or precipitates. It must not be reused. Unused solution should be discarded.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
Questions and answers
WHAT IS THE DIFFERENCE BETWEEN TACHIPIRINA AND PARACETAMOL?
Tachipirina is a medicinal product whose active ingredient is paracetamol. There are also other pharmaceutical forms based on paracetamol alone or in association with other active ingredients, such as codeine or vitamin C.
IS IT POSSIBLE TO TAKE TACHIPIRINA AND PARACETAMOL TOGETHER?
Tachipirina contains paracetamol as its active ingredient, and therefore it is inadvisable to take tachipirina and other drugs containing paracetamol to avoid a dangerous overdose of paracetamol.
DOES TACHIPIRINA CONTAIN PARACETAMOL?
Tachipirina contains paracetamol as an active ingredient at different dosages depending on the different pharmaceutical forms used.
DIFFERENCE BETWEEN TACHIPIRINA, PARACETAMOL AND IBUPROFEN
Tachipirina and paracetamol are drugs based on the same active ingredient, paracetamol, and have an antipyretic and analgesic action, and both lower fever and reduce pain, while they have no anti-inflammatory effect. Ibuprofen, on the other hand, is a synthetic analgesic-anti-inflammatory drug, also endowed with a marked antipyretic activity.
