Paracetamol EXTRATAB - Instructions For Use, Price Of Tablets, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Paracetamol EXTRATAB

Paracetamol EXTRATAB: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Paracetamol EXTRATAB

ATX code: N02BE51

Active ingredient: paracetamol (Paracetamol) + ascorbic acid (Ascorbic acid)

Manufacturer: JSC "Pharmaceutical Enterprise" Obolenskoe "(Russia)

Description and photo update: 2019-13-11

Prices in pharmacies: from 75 rubles.

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Paracetamol EXTRATAB is a combined analgesic non-narcotic drug.

Release form and composition

The drug is produced in the form of tablets: oblong with rounded ends, biconvex, with a risk on one side, white or white with a yellow tint; light marbling is possible (5, 6, 7, 10, 12 or 15 pcs. in a blister strip of aluminum foil and polyvinyl chloride film, in a cardboard box of 1, 2, 3, 4 or 5 packages and instructions for use of Paracetamol EXTRATAB).

1 tablet contains:

• active ingredients: paracetamol - 500 mg, ascorbic acid - 150 mg;
• additional components: polyethylene glycol 6000 (macrogol 6000), hydroxypropyl methylcellulose (hypromellose), stearic acid, corn starch.

Pharmacological properties

Pharmacodynamics

Paracetamol EXTRATAB is a combined oral preparation that includes an analgesic non-narcotic agent (paracetamol) and vitamin C (ascorbic acid).

Paracetamol

The active substance has antipyretic and analgesic effects, inhibits cyclooxygenase 1 and 2 (COX-1 and COX-2) mainly in the central nervous system (CNS), affecting the centers of thermoregulation and pain.

Cellular peroxidase enzymes in inflamed tissues neutralize the effect of paracetamol on COX, which leads to an almost complete absence of its anti-inflammatory effect. As a result of the lack of influence on the production of prostaglandins in peripheral tissues, paracetamol is not able to negatively affect water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract (GIT). The likelihood of methemoglobin synthesis is unlikely.

Vitamin C

The main water-soluble antioxidant is not synthesized in the cells of tissues and blood, in the human body and comes only with food. It is a cofactor in a number of hydroxylation and amidation reactions - it supports the transfer of electrons to enzymes, providing them with a reducing equivalent.

Ascorbic acid takes part in the following processes:

• hydroxylation of lysine and proline residues of procollagen with the formation of hydroxylysine and hydroxyproline (post-translational modification of collagen);
• oxidation of folic acid to folinic acid;
• oxidation of lysine side chains in proteins, as a result of which hydroxytrimethyllysine is formed during the synthesis of carnitine;
• metabolism of medicinal substances in liver microsomes;
• hydroxylation of dopamine, leading to the formation of norepinephrine.

This vitamin enhances the activity of amidating enzymes involved in the processing of oxytocin, cholicystokinin and antidiuretic hormone. Plays an important role in adrenal steroidogenesis.

At the tissue level, it is responsible for the synthesis of collagen, proteoglycans and other organic components of the intercellular substance of bones, teeth and capillary endothelium.

Pharmacokinetics

Paracetamol

The active substance of Paracetamol EXTRATAB has a high absorption. The maximum concentration (C _max) of the agent is 5–20 μg / ml, the period required to reach it (T _Cmax) is 0.5–2 hours. It binds to plasma proteins by 15%, passes through the blood-brain barrier (BBB). The volume of distribution (Vd) can vary from 0.8 to 1.36 l / kg body weight. Less than 1% of the dose of the drug taken by a nursing woman is excreted with breast milk. The therapeutically effective plasma concentration of paracetamol is achieved when it is used at a dose of 10–15 mg / kg.

The metabolic transformation of the agent occurs in the liver in three main ways: conjugation with sulfates, conjugation with glucuronides, oxidation by microsomal hepatic enzymes. During the last process, toxic intermediate metabolic products are formed, which are subsequently conjugated with glutathione, and then with cysteine and mercapturic acid. For this pathway of biotransformation, the main isoenzyme of cytochrome P ₄₅₀ is the isoenzyme CYP2E1, and the secondary isozymes are CYP1A2 and CYP3A4. With a lack of glutathione, these metabolites can lead to damage and necrosis of hepatocytes. Additional pathways of drug metabolism include the processes of hydroxylation to 3-hydroxyparacetamol and methoxylation to 3-methoxyparacetamol, subsequently conjugated with sulfates or glucuronides.

In newborns (including premature babies) and young children, sulfation dominates, in adults - glucuronidation. Conjugated metabolites of paracetamol (sulfates, glucuronides, conjugates with glutathione) are characterized by weak pharmacological (including toxic) activity.

The half-life of the active substance (T _1/2) is 1–4 hours. Paracetamol is excreted by the kidneys in the form of metabolites, mainly conjugates, and only 3% is unchanged. In elderly patients, the clearance of the drug decreases and T _1/2 increases.

Vitamin C

Plasma content of ascorbic acid is normally about 10–20 μg / ml. The active substance binds to plasma proteins by 25%. Intensively penetrates into platelets and leukocytes, and then into all tissues; the highest level of content is observed in leukocytes, glandular organs, liver and lens of the eye; passes through the placenta. In platelets and leukocytes, a higher concentration of ascorbic acid is recorded, compared with the concentration in erythrocytes and in plasma.

In deficient conditions, the content of vitamin C in leukocytes decreases later and more slowly, and is considered a better criterion for assessing deficiency than its content in plasma. It is metabolized mainly in the liver with the formation of deoxyascorbic acid, then oxaloacetate (oxaloacetic acid) and ascorbate-2-sulfate. The drug is excreted unchanged and in the form of metabolites with feces, urine, sweat, and also with breast milk.

When using high doses, the rate of excretion increases dramatically. Ethanol consumption and smoking cause the accelerated destruction of ascorbic acid (conversion into inactive metabolites), rapidly decreasing its reserves in the body. Vitamin C is eliminated by hemodialysis.

Indications for use

• infectious and inflammatory diseases, such as acute respiratory viral infections (ARVI), including influenza - as an antipyretic agent;
• mild and moderate pain syndrome (headache, toothache), non-inflammatory origin, with neuralgia, pain in muscles and joints, algodismenorrhea - as an anesthetic.

Contraindications

Absolute:

• gastrointestinal bleeding;
• erosive and ulcerative lesions of the gastrointestinal tract (during an exacerbation);
• deficiency of glucose-6-phosphate dehydrogenase;
• severe diseases of the kidneys, liver (renal and / or liver failure);
• pregnancy (I – III trimesters), lactation period;
• age up to 6 years.

Relative (Paracetamol EXTRATAB should be used with extreme caution):

• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);
• erosive and ulcerative diseases of the gastrointestinal tract (in history);
• blood diseases (leukopenia, thrombocytopenia, agranulocytosis), thalassemia, sideroblastic anemia;
• bronchial asthma;
• hyperoxaluria, urolithiasis;
• hemochromatosis;
• alcoholism.

Paracetamol EXTRATAB, instructions for use: method and dosage

Paracetamol EXTRATAB tablets are taken orally.

Adults and adolescents over 12 years of age (weighing more than 50 kg) are recommended to take 1 tablet 3-4 times a day with an interval of 4-8 hours, children 6-12 years old - ½ tablet.

The maximum daily dose in children should not exceed 2 tablets, the maximum duration of treatment is 3 days.

Adults should not use Paracetamol EXTRATAB as an antipyretic agent for more than 3 days, as an anesthetic for more than 5 days.

Side effects

Paracetamol in the composition of the drug Paracetamol EXTRATAB can cause the following negative side reactions:

• hematopoietic organs and lymphatic system: extremely rare - anemia, leukopenia;
• immune system: rarely - itchy skin, rash, urticaria, angioedema;
• digestive system: rarely - nausea; extremely rarely - diarrhea, vomiting, pain in the epigastric region, increased activity of liver enzymes, jaundice, pancreatitis;
• other reactions: weakness.

Ascorbic acid in the composition of Paracetamol EXTRATAB tablets can cause the following negative side reactions:

• immune system: skin flushing, skin rash;
• laboratory parameters: hypokalemia, glucosuria, hyperprothrombinemia, thrombocytosis, erythropenia, neutrophilic leukocytosis.

Overdose

Symptoms of an overdose caused by paracetamol may include: during the first 24 hours - pallor of the skin, nausea, vomiting, abdominal pain, anorexia, metabolic acidosis, impaired glucose metabolism; 12–48 hours later, signs of liver dysfunction.

With severe intoxication, disorders such as arrhythmia, pancreatitis, liver failure with progressive encephalopathy, coma and death are possible; acute renal failure with tubular necrosis (including without severe liver damage). In adults, the hepatotoxic effect is found when the drug is taken at a dose of 10 g or more. In rare cases, liver failure occurs with lightning speed and can be complicated by renal failure (tubular necrosis).

For 8-9 hours after overdose, it is recommended to administer SH-group donors and precursors of glutathione synthesis - methionine, for 8 hours - acetylcysteine. Depending on the level of paracetamol in the blood, as well as on the period after administration, additional therapeutic measures may be required (subsequent administration of methionine, intravenous injections of acetylcysteine).

Symptoms of an overdose caused by ascorbic acid may include: flatulence, irritation of the gastrointestinal mucosa, nausea, diarrhea, abdominal pain of a spastic nature, irritability, insomnia, hypoglycemia, urinary frequency, nephrolithiasis.

Treatment is symptomatic; forced diuresis is indicated.

special instructions

It is impossible to use Paracetamol EXTRATAB in doses exceeding the recommended ones. In the case of hyperthermia lasting more than 3 days, and pain syndrome noted for more than 5 days, a specialist consultation is necessary.

If the course of therapy lasts more than 5 days, monitoring of liver function and peripheral blood picture is required.

It should be borne in mind that while taking Paracetamol EXTRATAB, laboratory tests for the quantitative determination of plasma glucose and uric acid concentrations are distorted.

In order to avoid liver damage by toxic substances, paracetamol treatment cannot be combined with the intake of ethanol-containing drinks, as well as prescribe to persons who abuse alcohol.

There is evidence indicating that the frequent use of medicines containing paracetamol causes an aggravation of the symptoms of bronchial asthma.

Influence on the ability to drive vehicles and complex mechanisms

There are no data on the effect of Paracetamol EXTRATAB on the ability to drive a car and use other complex equipment.

Application during pregnancy and lactation

There are no data confirming the efficacy / safety of using the combination of paracetamol + ascorbic acid in pregnant and lactating women. As a consequence, it is impossible to assess the likely balance of risk and benefit.

Treatment with Paracetamol EXTRATAB during pregnancy and lactation is contraindicated.

Pediatric use

In pediatric practice, the drug is recommended for children 6 years of age and older.

With impaired renal function

In patients with severe kidney disease (renal failure), the use of Paracetamol EXTRATAB is contraindicated.

For violations of liver function

For patients with severe liver disease (liver failure), drug therapy is contraindicated.

Drug interactions

Before the simultaneous use of Paracetamol EXTRATAB with other drugs, you should consult your doctor.

Interaction reactions that are possible when combining paracetamol with other medicinal substances / agents:

• uricosuric drugs: their effectiveness decreases;
• coumarin derivatives, including warfarin: against the background of prolonged and regular use of paracetamol, the effect of these agents is potentiated and the threat of bleeding is aggravated;
• cholestyramine: absorption of paracetamol decreases and its effectiveness is weakened;
• chloramphenicol: it is possible to increase T _{1/2 of} this substance up to 5 times;
• nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid, metamizole sodium, ibuprofen): the threat of renal papillary necrosis and analgesic nephropathy, end-stage renal failure increases;
• domperidone, metoclopramide: increase the absorption of paracetamol;
• ethanol: exacerbates the hepatotoxicity of paracetamol, exacerbating the risk of developing acute pancreatitis;
• salicylamide: increases T _{1/2 of} paracetamol, which causes its accumulation, provoking the intensive formation of its toxic metabolites;
• diflunisal: the level of paracetamol in plasma increases by 50%, the threat of hepatotoxicity is aggravated;
• phenylbutazone, rifampicin, barbiturates, ethanol, phenytoin, tricyclic antidepressants and other inducers of microsomal liver enzymes: increase the production of hydroxylated active metabolites, which can cause the development of severe intoxications, including with small overdoses;
• other non-narcotic analgesics, drugs containing paracetamol: it is not recommended to use them simultaneously with EXTRATAB Paracetamol.

Interaction reactions that can occur with the combined use of ascorbic acid with other medicinal substances / preparations:

• heparin and indirect anticoagulants: the effectiveness of these drugs decreases;
• benzylpenicillin and tetracyclines: the content of these drugs in the blood increases;
• disulfiram: the interaction of this substance and ethanol is blocked against the background of long-term use of ascorbic acid in large doses;
• ethinylestradiol (including as part of oral contraceptives): its bioavailability increases when combined with ascorbic acid in a daily dose of 1 g;
• iron preparations: their absorption in the intestine improves (ferric iron is converted to ferrous);
• deferoxamine: this combination may increase the elimination of iron;
• oral contraceptives, acetylsalicylic acid, alkaline drinks, fresh juices: absorption and assimilation of ascorbic acid decreases;
• acetylsalicylic acid: the elimination of this substance decreases and the excretion of ascorbic acid in the urine increases;
• drugs of the quinoline series, salicylates, calcium chloride, glucocorticosteroids (GCS): against the background of prolonged use, reserves of ascorbic acid are depleted;
• short-acting salicylates and sulfonamides: the risk of crystalluria increases;
• drugs with an alkaline reaction (including alkaloids): the excretion of these drugs increases;
• oral contraceptives: their content in the blood decreases;
• isoprenaline: the chronotropic effect of this substance decreases;
• primidone, barbiturates: enhance renal elimination of ascorbic acid;
• mexiletine: its renal elimination increases when combined with ascorbic acid in high doses;
• antipsychotics (neuroleptics) - phenothiazine derivatives: the therapeutic effect of these drugs is weakened;
• tricyclic antidepressants, amphetamine: reduced tubular reabsorption of these drugs.

Analogs

Paracetamol EXTRATAB analogues are: Grippostad, Daleron S, Apap C Plus, Daleron C junior, Paracetamol Extra, FluZiOZ, Paracetamol-S-Hemofarm, etc.

Terms and conditions of storage

Store in a place protected from moisture and light, out of reach of children, at a temperature not exceeding 25 ° C

Shelf life is 2 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Paracetamol EXTRATAB

The reviews on Paracetamol EXTRATAB found on specialized sites are quite diverse. Many patients consider the drug to be more powerful than standard Paracetamol, and its analgesic and antipyretic effects are stronger. The drug is effective for the symptoms of colds and acute respiratory viral infections, eliminates moderate muscle pain, pain syndrome with neuralgia, relieves headache and toothache.

Another group of patients believes that the effect of the drug is no different from the effect of the cheaper non-combined Paracetamol. In some cases, it is noted that Paracetamol EXTRATAB relieves high fever, but does not help in the treatment of pain. There are also complaints about the development of side effects, most often in the form of nausea and allergic reactions.

Price for Paracetamol EXTRATAB in pharmacies

The price of Paracetamol EXTRATAB tablets (500 mg + 150 mg) can be for 10 pcs. in the package - 65 rubles, for 20 pcs. in the package - 90 rubles.

Paracetamol EXTRATAB: prices in online pharmacies

Drug name Price Pharmacy

Paracetamol Extratab 500 mg + 150 mg tablets 10 pcs. RUB 75 Buy

Paracetamol extratab tab. 500mg + 150mg n10 82 RUB Buy

Paracetamol Ekstratab 500 mg + 150 mg tablets 20 pcs. RUB 88 Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!