Composition, form of production and packaging
The tablets covered with a film cover of light pink color, round biconcave; On a cross-section - white or almost white color.
1 tab.
diclofenac potassium 25 mg
10 pieces. - blisters (1) of PVC / PVDH film and aluminum foil - packs of cardboard.
10 pieces. - blisters (2) made of PVC / PVDH film and aluminum foil - packs cardboard.
10 pieces. - blisters (3) made of PVC / PVDH film and aluminum foil - packs cardboard.
10 pieces. - blisters (4) of PVC / PVDH film and aluminum foil - packs of cardboard.
20 pcs. - blisters (1) of PVC / PVDH film and aluminum foil - packs of cardboard.
20 pcs. - blisters (2) made of PVC / PVDH film and aluminum foil - packs cardboard.
20 pcs. - blisters (3) made of PVC / PVDH film and aluminum foil - packs cardboard.
20 pcs. - blisters (4) of PVC / PVDH film and aluminum foil - packs of cardboard.
The tablets covered with a film cover of light pink color, round biconcave; On a cross-section - white or almost white color.
1 tab.
diclofenac potassium 50 mg
10 pieces. - blisters (1) of PVC / PVDH film and aluminum foil - packs of cardboard.
10 pieces. - blisters (2) made of PVC / PVDH film and aluminum foil - packs cardboard.
10 pieces. - blisters (3) made of PVC / PVDH film and aluminum foil - packs cardboard.
10 pieces. - blisters (4) of PVC / PVDH film and aluminum foil - packs of cardboard.
20 pcs. - blisters (1) of PVC / PVDH film and aluminum foil - packs of cardboard.
20 pcs. - blisters (2) made of PVC / PVDH film and aluminum foil - packs cardboard.
20 pcs. - blisters (3) made of PVC / PVDH film and aluminum foil - packs cardboard.
20 pcs. - blisters (4) of PVC / PVDH film and aluminum foil - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
NSAID, a derivative of phenylacetic acid. Has a pronounced anti-inflammatory, analgesic and antipyretic effect. The mechanism of action is based on the inhibition of the synthesis of prostaglandins (which play a major role in the pathogenesis of inflammation, pain and fever) by inhibiting the enzyme cyclooxygenase (COX). In traumatic and postoperative conditions, the drug quickly reduces the severity of the pain syndrome (including pain during movement), as well as swelling of the tissues due to inflammation and trauma.
With primary dysmenorrhea, the drug weakens the pain and reduces the intensity of bleeding. The drug may temporarily inhibit platelet aggregation.
PHARMACOKINETICS
After oral administration, diclofenac potassium is rapidly absorbed from the digestive tract. C max in blood plasma is reached after 40 minutes.
V d is 550 ml / kg. Diclofenac potassium penetrates into the synovial fluid, excreted in breast milk. Metabolized with the formation of inactive metabolites (glucuronic and sulfate conjugates).
More than 50% of the dose is excreted in the urine during the first 4 hours. With bile, 30-35% of the dose in the form of metabolites is excreted.
INDICATIONS
For rapid relief of pain syndrome and short-term therapy of the following acute conditions:
- pain syndrome and inflammation after trauma and surgical interventions;
- Primary and secondary algodismenorea;
- adnexitis;
- Pain in the spine;
- Arthralgia;
- as part of a combination therapy of infectious and inflammatory diseases of ENT organs with severe pain syndrome;
- headache.
DOSING MODE
Inside. The dose is set individually, depending on the severity of the pain syndrome. In order to quickly achieve the desired therapeutic effect, the drug is taken 30 minutes before meals. In other cases, take before, during or after eating, without chewing, squeezed with enough water.
Adults prescribe in a daily dose of 75-150 mg, divided into 2-3 doses. For adolescents over 14 years of age, the daily dose is 75-100 mg in 2-3 doses.
With primary dysmenorrhea, the initial daily dose is 50-100 mg, the average daily dose is 50-150 mg, the maximum daily dose is 200 mg.
For elderly patients , especially for the depleted and weakened, the use of the drug in the lowest effective dose is recommended.
The drug Tabuk-Di should be taken no more than 5 days to relieve pain without consulting a doctor. If the pain persists during the specified time, you should immediately call your doctor.
SIDE EFFECT
Very frequent -> 10%; frequent -> 1% and <10%; not frequent -> 0.1% and <1%; rare -> 0.01% and <0.1%; very rare - <0.01%.
From the digestive system: often - epigastric pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased activity of aminotransferases; rarely gastritis, proctitis, gastrointestinal bleeding (vomiting with blood, melena, diarrhea with blood impurity), gastrointestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, liver dysfunction; very rarely - stomatitis, glossitis, esophagitis, nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease, constipation, pancreatitis, fulminant hepatitis.
From the nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - a violation of sensitivity, including paresthesia, memory disorders, tremors, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis, disorientation, depression, insomnia, nightmares, irritability, mental disorders.
From the senses: often - vertigo; very rarely - visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, a violation of taste sensations.
From the urinary system: very rarely - acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.
From the hematopoiesis: very rarely - thrombocytopenia, leukopenia, hemolytic and aplastic anemia, agranulocytosis.
Allergic reactions: rarely - anaphylactic / anaphylactoid reactions, including marked decrease in blood pressure and shock; very rarely - angioedema (including face).
From the cardiovascular system: very rarely - palpitations, chest pain, increased blood pressure, vasculitis, myocardial infarction.
On the part of the respiratory system: rarely - bronchial asthma (including dyspnea); very rarely - pneumonia.
On the part of the skin: often - skin rash; rarely - hives; very rarely - bullous eruptions, eczema, incl. multiform and Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, itching, hair loss, photosensitivity, purpura, incl. allergic.
CONTRAINDICATIONS
- complete or incomplete combination of bronchial asthma;
- recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in the anamnesis);
- erosive and ulcerative lesions of the stomach and duodenum;
- active gastrointestinal hemorrhage;
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis);
- severe hepatic and cardiac failure;
- period after aortocoronary shunting;
- severe renal failure (creatinine clearance less than 30 ml / min);
progressive kidney disease;
active liver disease;
- confirmed hyperkalemia;
- pregnancy (III trimester);
- lactation period;
- children's age till 15 years;
- hereditary lactose intolerance;
- violation of absorption of glucose-galactose;
- Insufficiency of lactase;
- Hypersensitivity (including to other NSAIDs).
With caution
Peptic ulcer and duodenal ulcer, ulcerative colitis, illness, history, history of liver disease, hepatic porphyria, chronic hepatic insufficiency, chronic heart failure, arterial hypertension, significant decrease in the volume of circulating blood (including after extensive surgery ), elderly patients (including those receiving diuretics, weakened patients and with low body weight), bronchial asthma, simultaneous reception of GCS (including prednisolone), anticoagulants (including warf arina), antiaggregants (including ascorbic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), coronary heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, diseases of peripheral arteries, smoking, chronic renal failure (creatinine clearance 30-60 ml / min), presence of Helicobacter pylori infection, prolonged use of NSAIDs, alcoholism, severe physical illnesses.
PREGNANCY AND LACTATION
Clinical studies to study the effect of diclofenac during pregnancy have not been conducted. Therefore, in the I and II trimesters of pregnancy, the drug is prescribed only if the potential benefit to the mother's health exceeds the risk to the fetus. The use of diclofenac is contraindicated in the third trimester of pregnancy because of possible atony of the uterus and / or premature closure of the ductus arteriosus (ductus arteriosus).
Diclofenac penetrates into breast milk in small amounts, so it is not recommended to use when breastfeeding to prevent unwanted side effects in the child.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated:
- severe renal failure (creatinine clearance less than 30 ml / min);
progressive kidney disease.
Because of the important role of prostaglandins in maintaining renal blood flow, caution should be exercised in appointing patients with cardiac or renal insufficiency, and also in the treatment of elderly patients taking diuretics and patients who for any reason have a decrease in circulating blood volume (in including after extensive surgery). If in such cases diclofenac is prescribed, it is recommended to monitor the kidney function as a precautionary measure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated with active liver disease and severe hepatic insufficiency.
In patients with hepatic insufficiency (chronic hepatitis, compensated cirrhosis), the kinetics and metabolism do not differ from similar processes in patients with normal liver function.
APPLICATION FOR CHILDREN
Contraindicated for children under 15 years.
APPLICATION IN ELDERLY PATIENTS
For elderly patients , especially for the depleted and weakened, the use of the drug in the lowest effective dose is recommended.
SPECIAL INSTRUCTIONS
Because of the important role of prostaglandins in maintaining renal blood flow, caution should be exercised in appointing patients with cardiac or renal insufficiency, and also in the treatment of elderly patients taking diuretics and patients who for any reason have a decrease in circulating blood volume (in including after extensive surgery). If in such cases diclofenac is prescribed, it is recommended to monitor the kidney function as a precautionary measure.
In patients with hepatic insufficiency (chronic hepatitis, compensated cirrhosis), the kinetics and metabolism do not differ from similar processes in patients with normal liver function.
When performing long-term therapy, it is necessary to monitor liver function, the picture of peripheral blood, the analysis of feces for latent blood.
In connection with the negative effect on fertility, women who want to become pregnant, the drug is not recommended. In patients with infertility (including those undergoing examination) it is recommended to cancel the drug.
To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, it is possible to reduce the speed of mental and motor reactions, so it is necessary to refrain from driving and doing other potentially dangerous activities that require increased attention and speed of psychomotor reactions.
OVERDOSE
Symptoms: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, convulsions, with a significant overdose-acute renal failure, hepatotoxic effect.
Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at eliminating blood pressure increase, renal dysfunction, seizures, gastrointestinal irritation, respiratory depression. Forced diuresis, hemodialysis are ineffective (due to the significant connection with proteins and intensive metabolism).
DRUG INTERACTION
Increases the concentration in the blood plasma digoxin, methotrexate, lithium and cyclosporine.
Reduces the effect of diuretics, against the background of potassium-sparing diuretics increases the risk of hyperkalemia; against the background of anticoagulants, antiaggregant and thrombolytic drugs (alteplase, streptokinase, urokinase) increases the risk of bleeding.
Reduces the effect of hypotensive and hypnotic drugs.
Increases the likelihood of side effects of other NSAIDs and GCS (gastrointestinal bleeding), toxicity of methotrexate and nephrotoxicity of cyclosporine.
Acetylsalicylic acid reduces the concentration of diclofenac in the blood.
Simultaneous use with paracetamol increases the risk of developing nephrotoxic effects of diclofenac.
Reduces the effect of hypoglycemic drugs.
Cefamandol, cefoperazone, cefotetan, valproic acid and plikamycin increase the incidence of hypoprothrombinemia.
Cyclosporine and gold preparations increase the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity.
Selective serotonin reuptake inhibitors increase the risk of developing gastrointestinal bleeding.
Simultaneous administration with ethanol, colchicine, corticotropin and preparations of St. John's wort increases the risk of developing gastrointestinal bleeding.
Medicines that cause photosensitivity, increase the sensitizing effect of diclofenac to UV irradiation.
Drugs that block tubular secretion, increase the concentration in the blood plasma diclofenac, thereby increasing its effectiveness and toxicity.
Antibacterial drugs from the quinolone group - the risk of seizures.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The preparation should be stored in a dry, dark place at a temperature of 15 В° C to 30 В° C. Keep out of the reach of children.
Shelf life - 3 years. Do not use after the expiration date.
