Dexalgin granules for oral administration 25mg, No. 10

• Symptomatic treatment of pain syndrome (mild and moderate) of various origins, including musculoskeletal pain, algomenorrhea (painful menstruation), toothache.

• The drug is intended for symptomatic treatment, reducing pain and inflammation at the time of use.

Inside.

The contents of the sachet are dissolved in a glass of water, stirring well until completely dissolved (a translucent yellow solution with a lemon odor is obtained). The prepared solution cannot be stored.

Simultaneous food intake slows down the absorption of dexketoprofen, therefore, in case of acute pain, it is recommended to use the drug at least 15 minutes before a meal.

The recommended dose is 25 mg dexketoprofen (1 sachet of Dexalgin) every 8 hours.

The maximum daily dose is 75 mg.

DexalginЃ is not intended for long-term therapy, the course of treatment should not exceed 3-5 days.

Elderly patients

Elderly patients should take Dexalgin starting at a lower dose (the maximum daily dose is 50 mg). In case of good tolerance, the doses recommended for the general population may be used. Patients in this category have an increased risk of side effects, and therefore, careful monitoring of the patient's condition is recommended.

Patients with hepatic impairment

Patients with mild to moderate hepatic impairment should take Dexalgin0 ^, starting with a lower dose (the maximum daily dose is 50 mg). Careful monitoring of the patient's condition is recommended. The use of the drug Dexalgin in patients with severe hepatic insufficiency is contraindicated.

Patients with renal impairment

Patients with mild renal failure - CKD, stage 2 (GFR 60-89 ml / min / 1.73 m2) should take Dexalgin starting at a lower dose (maximum daily dose is 50 mg). Careful monitoring of the patient's condition is recommended. The use of Dexalgin in patients with CKD stage 3a (GFR 45-59 ml / min / 1.73 m2), stage 36 (GFR 30-44 ml / min / 1.73 m2) and stage 4 (GFR <30 ml / min / 1.73 m), contraindicated.

Active substance

dexketoprofen trometamol - 36.9 mg, which corresponds to the content of dexketoprofen 25 mg

Excipients: ammonium glycyrrhizinate - 2 mg, neohesperidin dihydrochalcone - 1.5 mg, quinoline yellow dye (E104) - 1.2 mg, lemon flavor - 40 mg, sucrose with colloidal silicon dioxide (500: 1) - 2418 mg.

• Hypersensitivity to dexketoprofen, other components of the drug and other NSAIDs;

• complete or incomplete combination of bronchial asthma, acute rhinitis, recurrent polyposis of the nose and paranasal sinuses, urticaria or angioedema and intolerance to acetylsalicylic acid or other NSAIDs (including a history);

• phototoxic and photoallergic reactions when using ketoprofen or fibrates in anamnesis;

• erosive and ulcerative lesions of the gastrointestinal tract in the acute stage;

• a history of gastrointestinal bleeding or perforation, including those associated with previous use of NSAIDs;

• gastrointestinal bleeding;

• other active bleeding (including suspected intracranial hemorrhage);

• chronic or recurrent dyspepsia (manifestations of which may include pain or discomfort in the epigastric region, a feeling of fullness in the stomach after eating, a feeling of early (rapid) satiety);

• inflammatory bowel disease (Crohn's disease, ulcerative colitis);

• hemorrhagic diathesis and other blood clotting disorders;

• severe heart failure (NYHA class III-IV);

• period after coronary artery bypass grafting;

• severe liver failure (10-15 points on the Child-Pugh scale);

• chronic kidney disease (CKD): stage 3a (glomerular filtration rate (GFR) 45-59 ml / min / 1.73 m2), stage 36 (GFR 30-44 ml / min / 1.73 m2) and stage 4 (GFR <30 ml / min / 1.73 m2).

• progressive kidney disease, confirmed hyperkalemia;

• severe dehydration (due to vomiting, diarrhea, or insufficient fluid intake);

• age up to 18 years (due to the lack of data on efficacy and safety);

• pregnancy and the period of breastfeeding;

• deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption.

  Carefully

• Before using the drug, if you have the conditions specified in this section, you should consult your doctor. History of liver disease, hepatic porphyria, CKD stage 2 (GFR 60-89 ml / min / 1.73m), chronic heart failure, arterial hypertension, significant decrease in circulating blood volume (including, after surgery), elderly patients over 65 years of age (including those receiving diuretics, weakened patients and patients with low body weight), bronchial asthma, the simultaneous use of glucocorticosteroids (including prednisolone), anticoagulants (including warfarin) , antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), coronary heart disease (IHD),cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, presence of Helicobacter pylori infection, systemic lupus erythematosus (SLE) and other systemic connective tissue diseases, hematopoietic disorders, long-term use of non-steroidal anti-inflammatory drugs (NSAIDs), osteoporosis, severe , alcoholism, severe somatic diseases.

pharmachologic effect

NSAIDs. It has anti-inflammatory, analgesic and antipyretic effects. The mechanism of action is based on the inhibition of prostaglandin synthesis due to the suppression of COX.

The analgesic effect occurs 30 minutes after administration, the duration of the action is 4-6 hours.

Pharmacokinetics

After taking the drug inside, Cmax of dexketoprofen in humans is achieved on average after 30 minutes (15-60 minutes). Plasma protein binding - 99%. Average Vd - less than 0.25 l / kg. T1 / 2 is 1.65 hours. It is metabolized. It is excreted mainly by the kidneys in the form of metabolites.

Side effect

From the digestive system: heartburn, abdominal pain; rarely - erosive and ulcerative lesions of the gastrointestinal tract.

From the nervous system: headaches, dizziness, nervousness, sleep disturbance, paresthesia.

From the side of the cardiovascular system: palpitations, increased blood pressure.

Allergic reactions: skin rash, bronchospasm.

Others: chills, swelling of the limbs, photosensitivity; rarely - a change in the picture of peripheral blood, renal dysfunction.

Application during pregnancy and lactation

Use during pregnancy and lactation is contraindicated.

Application for violations of liver function

Contraindicated in liver failure. For patients with impaired liver function, the initial dose is no more than 50 mg / day.

Application for impaired renal function

Contraindicated in renal failure. For patients with impaired renal function, the initial dose is no more than 50 mg / day.

Application in children

The drug is contraindicated for use in children and adolescents under the age of 18 years.

Use in elderly patients

Care should be taken when prescribing the drug to elderly patients. For the elderly, the initial dose is no more than 50 mg / day.

special instructions

Care should be taken when prescribing the drug to elderly patients, patients with allergic reactions, with systemic diseases of the connective tissue and patients with impaired hematopoiesis.

Patients should be informed that in the event of side effects, as well as in the absence of a clinical effect within 3-5 days of treatment, it is necessary to inform the attending physician about it.

Special care is required with the simultaneous use of dexketoprofen with phenytoin, sulfonamides and drugs that reduce blood clotting.

Influence on the ability to drive vehicles and mechanisms

Since dexketoprofen can cause a decrease in the ability to concentrate, it should be used with caution in patients engaged in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Drug interactions

With the simultaneous use of dexketoprofen with other NSAIDs, the risk of side effects may increase.

With simultaneous use with lithium preparations, it is possible to increase the concentration of the latter in the blood plasma.

Use dexketoprofen with caution less than 24 hours before the start of use or after the end of methotrexate therapy. the concentration of the latter in blood plasma (and therefore toxicity) may increase.

Some cases of bleeding with the simultaneous use of NSAIDs and anticoagulants are described.