2010/09/17

Alka-seltzer

Composition, structure and packing

Effervescent tablets are white, round, flat, one side engraved "ALKA SELTZER" a presenter on the perimeter of a convex disc; reverse side has a chamfer.

1 tab. acetylsalicylic acid 324 mg
citric acid 965 mg
sodium bicarbonate 1,625 g

Excipients: povidone 25, siloxane / silicate, sodium benzoate Doss, sodium saccharinato, flavor, lemon lime flavor.

Clinico-pharmacological group

NSAIDs combined composition.

Pharmacological action

Combination drug whose action is due to its constituent active components.

Acetylsalicylic acid 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 by blocking the synthesis of thromboxane A2.

Sodium carbonate neutralizes free hydrochloric acid in the stomach, which reduces the irritating effect of the drug.

Citric acid promotes more rapid absorption of the drug.

Indications for use of the drug

Symptomatic treatment of pain:
headache (including after excessive alcohol consumption);
toothache;
sore throat;
back pain and muscle;
joint pain;
pain during menstruation.

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

Dosage regimen

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

Inside, adults and children over 15 years take 1 tablet up to 6 times when the strong pain and high temperature - 2-3 tablets, maximum daily dose should not exceed 9 tablets

Usage: Dissolve a pill / tablet in a glass (200 ml) of water.

The interval between doses of the drug should be at least 4 hours regular adherence of the drug to avoid a sharp rise in temperature and decrease the intensity of pain.

Duration of treatment (without consulting a doctor) must not exceed 5 days when administered as an analgesic, and more than 3 days - as a febrifuge.

Side effect
On the part of the digestive system: stomach pain, heartburn, nausea, vomiting, obvious (vomiting blood, tarry stools), or hidden signs of gastrointestinal bleeding, which can lead to iron deficiency anemia, erosive and ulcerative lesions (including those with perforation), gastrointestinal tract, in rare cases - violations of liver function (increased hepatic transaminases).
From the side of the central nervous system: dizziness, tinnitus (usually a sign of overdose).
On the part of the hemopoietic system: an increased risk of bleeding, due to the effects of aspirin on platelet aggregation.

Allergic reactions: skin rash, anaphylactic reactions, bronchospasm, edema Quincke. When these symptoms should stop taking the drug and immediately contact your doctor.

Contraindications to the use of the drug
Hypersensitivity to aspirin and other NSAIDs, or other components of the drug;
erosive-ulcerative lesions GIT (exacerbation);
bleeding diathesis;
combined use of methotrexate in doses of 15 mg per week or more;
asthma, caused by intake of salicylates or other NSAIDs;
pregnancy (I and III trimester);
breastfeeding.

The drug is not indicated for children under 15 years of age with acute respiratory diseases caused by viral infections, because of the risk of developing Reye syndrome (encephalopathy and acute fatty liver with development of acute liver failure).

Precautions: If concomitant therapy with anticoagulants, gout, gastric ulcers and / or duodenal ulcer (history), including chronic or recurrent course of ulcer disease, or episodes of gastrointestinal bleeding, kidney and / or liver failure, deficiency of glucose-6- phosphate.

Pregnancy and lactation

The drug is contraindicated in pregnancy (I and III trimesters).

If necessary, use during lactation breastfeeding should be discontinued.

Application for violations of liver function

Precautions: hepatic impairment.

Application for violations of renal function

Precautions: renal impairment.

Cautions

Acetylsalicylic acid may induce bronchospasm, bronchial asthma or other hypersensitivity reactions.

Risk factors are the presence of bronchial asthma, nasal polyps, fever, chronic broncho-pulmonary diseases, a history of allergy (allergic rhinitis, skin rash).

Acetylsalicylic acid can increase the propensity for bleeding, which is associated with its inhibitory effect on platelet aggregation. This should be considered when necessary surgeries, including small interfering as tooth extraction. Before surgery to reduce bleeding during surgery and the postoperative period should stop taking the drug for 5-7 days and notify the physician.

Children should not be prescribed drugs containing acetylsalicylic acid, as in the case of viral infection and increased risk of Reye syndrome. Symptoms of Reye syndrome are prolonged vomiting, acute encephalopathy, liver enlargement.

In the treatment of vascular diseases daily dose of aspirin is between 75 to 300 mg.

Acetylsalicylic acid reduces the excretion of uric acid from the organism that can cause an acute attack of gout in predisposed patients.

One effervescent tablet of Alka-Zelttsera contains 445 mg of sodium, which should be considered when diet, with controlled sodium intake.

Effects on ability to drive vehicles and management mechanisms

There were no effect of the drug to control a motor vehicle and other mechanisms.

Overdose

Symptoms: overdose of moderate severity: nausea, vomiting, tinnitus, hearing loss, headache, dizziness and confusion. These symptoms are at lower dose. Severe overdose: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, respiratory failure, marked hypoglycemia.

Treatment: hospitalization, lavage, activated charcoal method, monitoring the acid-alkaline balance, alkaline diuresis in order to achieve the level of urine pH between 7.5-8 (forced alkaline diuresis is achieved if the concentration of salicylate in plasma is more than 500 mg / l ( 3.6 mmol / l) in adults or 300 mg / L (2.2 mmol / l) in children), hemodialysis, loss of fluid, symptomatic therapy.

Drug Interactions

Joint application:
with methotrexate 15 mg per week or more: increased hemolytic cytotoxicity of methotrexate (decreased renal clearance of methotrexate and methotrexate replaced salicylates in relation to blood plasma proteins);
with anticoagulants such as heparin: increased risk of bleeding due to inhibition of platelet function, damage to the gastrointestinal mucosa, displacement of anticoagulants (oral) in relation to blood plasma proteins;
with other NSAIDs, as well as with large doses of salicylates (3 g per day or more): as a result of synergies and increased risk of ulcers and bleeding;
with urikozuratami such benzbromaron: reduces urikozurichesky effect;
with digoxin: the concentration of digoxin increased due to the reduction of renal excretion;
with antidiabetic drugs, such as insulin: increased hypoglycemic effect of antidiabetic agents due to hypoglycemic action of acetylsalicylic acid;
with thrombolytic therapy group: the risk of bleeding increases;
with diuretics at a dose of 3 mg per day and more: reduced glomerular filtration due to the reduction of synthesis of prostaglandins;
with systemic GCS, excluding hydrocortisone, used as replacement therapy in Addison's disease: the application of GCS reduced the level of salicylates in the blood by increasing the excretion of the latter;
with ACE inhibitors: a dose of 3 grams per day or more reduced glomerular filtration due to inhibition of prostaglandins and hence reduces the antihypertensive effect;
with valproic acid: increased toxicity of valproic acid;
with ethanol: increases the risk of damaging effect on the gastrointestinal mucosa and increases bleeding time.

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The drug is approved for use as a non-prescription medicines.

Terms and Conditions of storage

At temperatures below 25 ° C, the reach of children.

Shelf life - 3 years. Do not use a later date on the package.