Alka-Seltzer effervescent pills №10

Alka-Seltzer

INN or grouping name

Acetylsalicylic acid + [Citric acid + Sodium bicarbonate].

Dosage form

Effervescent tablets.

Composition

1 pill contains

Active ingredients: acetylsalicylic acid - 324 mg, sodium bicarbonate dried (87.5% sodium bicarbonate, 12.5% ​​sodium carbonate) - 1625 mg, citric acid - 965 mg.

Excipients: Povidone 25 2 mg, dimethicone / silicate * 1 mg, doss sodium benzoate ** 0.1 mg, sodium saccharinate 2 mg, lemon flavor 1.95 mg, lime flavor 1.95 mg.

* a mixture of dimethicone and Calcium silicate in a ratio of 70:30.

** a mixture of sodium dusate and sodium benzoate in a ratio of 85:15.

Round, flat pills of white color, on one side “ALKA SELTZER” engraving in a convex circle protruding around the perimeter. The reverse side has a chamfer.

Combination analgesic (NSAIDs + antacid).

Pharmacology

Combined medication, the action of which is due to its active ingredients.

Acetylsalicylic acid It has analgesic, antipyretic anti-inflammatory effect, which is caused by inhibition of cyclooxygenase enzymes involved in the synthesis of prostaglandins.Acetylsalicylic acid inhibits platelet aggregation, blocking the synthesis of thromboxane A2.

Sodium bicarbonate neutralizes free hydrochloric acid in the stomach, which reduces the irritant effect of the drug.

Lemon acid promotes more rapid absorption of the drug.

Pharmacokinetics

After oral administration, ASA is quickly completely absorbed from the gastrointestinal tract. During the period of absorption and immediately after it, the ASC is converted into the main active metabolite - salicylic acid. ASA reaches its maximum plasma concentration in 10–20 minutes, and salicylic acid in 0.3–2 hours.

About 80% of ASA and salicylic acid binds to plasma proteins and is rapidly distributed in tissues. Salicylic acid is metabolized in the liver with the formation of metabolites - salicilurate, salicylovofenol glucuronide, salicylacyl glucuronide, gentisic and gentisuric acids. It is excreted into breast milk and passes through the placenta.

Elimination of salicylic acid is dose-dependent. The half-life varies from 2-

3 hours when taking the drug in low doses up to about 15 hours when using high doses. Salicylic acid and its metabolites are excreted mainly by the kidneys.

Indications and usage

Symptomatic treatment of pain syndrome of mild and moderate severity: headache (including after alcohol consumption), toothache, sore throat, pain in the back and muscles, pain in the joints, pain during menstruation.

Increased body temperature for colds and other infectious and inflammatory diseases (in adults and children over 15 years).

Contraindications

Hypersensitivity to Acetylsalicylic acid and other NSAIDs or other components of the drug.

Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase).

Hemorrhagic diathesis.

The combined use of Methotrexate at a dose of 15 mg per week or more.

A complete and incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including a history).

Pregnancy (I and III trimester), breastfeeding period.

The drug is not prescribed to children under 15 with acute respiratory infections caused by viral infections, due to the risk of Reye's syndrome

(encephalopathy and acute fatty liver with acute development of liver failure).

Carefully

With concomitant therapy with anticoagulants, gout, gastric ulcer and / or duodenal ulcer (in history), including chronic or recurrent peptic ulcer disease, or episodes of Gastrointestinal bleeding; renal and / or hepatic failure, glucose-6-phosphate dehydrogenase deficiency, heart failure, pregnancy II trimester.

Dosage and administration

The drug is intended for adults and children over 15 years.

Inside, take a single dose of 1-3 pills (the interval between doses should be 4-8 hours).The maximum daily dose should not exceed 9 pills (3 g).

Method of application: to dissolve previously 1-3 pills in 1 glass (200 ml) of water.

The duration of treatment (without consulting a doctor) should not exceed 5 days when prescribed as an anesthetic and more than 3 days as an antipyretic.

Adverse reactions

From the gastrointestinal tract: abdominal pain, heartburn, nausea, vomiting, overt (vomiting blood, tarry stools) or hidden signs of gastrointestinal bleeding that can lead to iron deficiency anemia, erosive and ulcerative lesions (including perforations) of the gastrointestinal tract, isolated cases - abnormal liver function (increased activity of "liver" transaminases).

From the side of the central nervous system: dizziness, tinnitus (usually are signs of overdose).

From the hemopoietic system: increased risk of bleeding, which is a consequence of the influence of acetylsalicylic acid on platelet aggregation.

Allergic reactions: skin rash, Anaphylactic reactions, bronchospasm, angioedema.

When these symptoms appear, it is recommended to stop taking the drug and immediately contact your doctor.

Overdosage

Symptoms

Overdose moderate severity: nausea, vomiting, tinnitus, hearing loss, headache, dizziness, and confusion.These symptoms disappear when the dose is lowered.

Severe overdose: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, respiratory failure, severe hypoglycemia.

Treatment: hospitalization, lavage, taking Activated carbon, monitoring acid-base balance, alkaline diuresis in order to get urine pH between 7.5-8 (forced alkaline diuresis is considered achieved if the concentration of salicylates in the plasma is more than 500 mg / l (3, 6 mmol / l) in adults or 300 mg / l (2.2 mmol / l) in children), hemodialysis, fluid loss, symptomatic therapy.

Interaction with other drugs

Combined application:

with methotrexate at a dose of 15 mg per week or more: hemolytic cytotoxicity of methotrexate increases (the renal clearance of methotrexate decreases and methotrexate is replaced by salicylates due to blood plasma proteins);

with anticoagulants, such as Heparin : increases the risk of bleeding due to inhibition of platelet function, damage to the mucous membrane of the gastrointestinal tract, the displacement of anticoagulants (oral) from the connection with plasma proteins;

with other nonsteroidal anti-inflammatory drugs, as well as with large doses of salicylates (3 g per day or more): as a result of synergistic interaction, increases the risk of gastric and duodenal ulcers and bleeding from the gastrointestinal tract;

with uricosuric drugs, for example, benzbromarone: reduces urikozurichesky effect;

with Digoxin : digoxin concentration increases due to decreased renal excretion;

with hypoglycemic drugs such as insulin : hypoglycemic effect of hypoglycic drugs is increased due to the hypoglycemic action of acetylsalicylic acid;

with drugs of the thrombolytic group: the risk of bleeding increases;

with diuretics: reduced glomerular filtration due to reduced prostaglandin synthesis;

with systemic glucocorticosteroids, excluding Hydrocortisone, used as replacement therapy for Addison's disease: the use of glucocorticosteroids reduces the concentration of salicylates in the blood by increasing the excretion of the latter;

with angiotensin converting enzyme inhibitors: at a dose of 3 g per day and more, glomerular filtration decreases due to inhibition of the action of prostaglandins and, as a result, the antihypertensive effect is reduced;

with valproic acid: toxicity of valproic acid increases;

with ethanol: the risk of damaging effects on the mucous membrane of the gastrointestinal tract increases and the bleeding time increases.

Acetylsalicylic acid can cause bronchospasm, an attack of bronchial asthma, or other hypersensitivity reactions. Risk factors are the presence of asthma, nasal polyps, fever, chronic broncho-pulmonary diseases, history of allergies (allergic rhinitis, skin rashes).

Acetylsalicylic acid may increase the tendency to bleeding, which is associated with its inhibitory effect on platelet aggregation. This should be considered when surgical interventions are necessary, including small interventions such as tooth extraction. Before surgery, to reduce bleeding during the operation and in the postoperative period, the drug should be discontinued for 5-7 days and notified to the doctor.

Children can not prescribe drugs containing acetylsalicylic acid, because in the case of viral infection increases the risk of Reye's syndrome. Symptoms of Reye’s syndrome are prolonged vomiting, acute encephalopathy, and enlarged liver.

If necessary, the use of the drug during lactation breastfeeding should be discontinued.

Acetylsalicylic acid reduces the excretion of uric acid from the body, which can cause an acute attack of gout in predisposed patients.

One effervescent pill Alka-Seltzer contains 477 mg of sodium, which should be considered in a diet with controlled sodium intake.

The effect of taking the drug on driving a vehicle and other mechanisms has not been revealed.

Influence on ability to steer the car and moving mechanisms

Does not affect.

Effervescent pills 324 mg + 965 mg + 1625 mg. 2 pills effervescent in a strip of paper, laminated aluminum foil; on 1, 3, 5, 6 or 10 strips together with the application instruction in a cardboard pack.

At a temperature not higher than 25 ° С.

Keep out of the reach of children.

3 years. Do not use after expiration date.

Alka-seltzer