Composition
Active ingredient:
diclofenac 50 mg;
Auxiliary substances:
1,2-propylene glycol,
aerosil,
vitepsol
Pharmacological action
Diclofenac – analgesic, antiplatelet, antipyretic, anti-inflammatory.
It blocks cyclooxygenase, reduces the synthesis of PG and thromboxanes, and suppresses the exudative and proliferative phases of inflammation.
Reduces the amount of serotonin, histamine and bradykinin, increases the threshold of sensitivity of pain receptors: reduces the concentration of PG in the thermoregulatory center of the hypothalamus, increases heat transfer.
Pharmacokinetics
It is well absorbed in the gastrointestinal tract, in plasma it is almost completely bound by blood proteins (66-99%). It quickly penetrates into the tissues and synovial fluid, where it persists for 4-6 hours longer than in the blood. T1/2 — 1,1–2 h. It is metabolized in the liver. It is excreted in the urine (65%) and bile (35%).
Indications
Rheumatoid arthritis, ankylosing spondylitis, deforming osteoarthritis, periarticular inflammation, post-traumatic inflammatory and painful conditions of soft tissues and joints, tendovaginitis, neuritis, synovitis, acute muscle pain, neuralgia, back pain and toothache.
Use during pregnancy and lactation
Use during pregnancy and lactation is possible in cases where the potential benefit to the mother exceeds the potential risk to the fetus or newborn.
Contraindications
Hypersensitivity, peptic ulcer of the stomach and duodenum, bronchial asthma, cardiovascular insufficiency, arterial hypertension, liver and kidney diseases, children and adolescents (up to 12 years), pregnancy, lactation (you should stop breastfeeding).
Side effects
From the digestive system: Â nausea, vomiting, epigastric pain, anorexia, flatulence, constipation, gastritis up to erosive with bleeding, increased transaminase activity, drug-induced hepatitis, pancreatitis.
From the urinary system: Â interstitial nephritis.
From the central nervous system: Â headache, dizziness, disorientation, agitation, insomnia, irritability, fatigue, aseptic meningitis.
Respiratory system disorders: Â bronchospasm.
From the hematopoietic system: Â anemia, thrombocytopenia, leukopenia, agranulocytosis.
Dermatological reactions: Â exanthema, erythema, eczema, hyperemia, erythroderma, photosensitization.
Allergic reactions: Â erythema multiforme, Lyell’s syndrome, Stevens-Johnson syndrome, anaphylactic reactions, including shock.
Local reactions: Â at the injection site, burning, infiltrate formation, and adipose tissue necrosis are possible.
Other services: Â fluid retention in the body, edema, increased blood pressure.
Interaction
Concomitant use of Diclofenac with digoxin, phenytoin or lithium preparations may increase the plasma concentrations of these drugs; with diuretics and antihypertensive agents, the effect of these drugs may decrease; with potassium-sparing diuretics, hyperkalemia may develop; with acetysalicylic acid, a decrease in the concentration of diclofenac in blood plasma and an increased risk of side effects.
Diclofenac may increase the toxic effect of cyclosporine on the kidneys.
Diclofenac can cause hypo – or hyperglycemia, so when used concomitantly with hypoglycemic agents, monitoring of blood glucose concentration is required.
When using methotrexate for 24 hours before or after taking Diclofenac, it is possible to increase the concentration of methotrexate and increase its toxic effect.
When used concomitantly with anticoagulants, regular monitoring of blood clotting parameters is necessary.
How to take, course of use and dosage
Rectally. For adults: Â 100 mg 1 time a day,50 mg 2 times a day or 25 mg 3-4 times a day.
The maximum daily dose is 150 mg.
Children over 12 years of age: 50 mg 1-2 times a day or 25 mg 2-3 times a day.
Special instructions
Avoid contact with the ointment (gel). Apply Diclofenac to damaged skin, open wounds, eyes and mucous membranes.
The use of Diclofenac in the form of an ointment is possible only as prescribed by a doctor in the following cases: a history of peptic ulcer of the stomach and duodenum; liver and kidney function disorders; severe hematopoietic disorders; bronchial asthma, rhinitis, nasal mucosal polyps; a history of allergic reactions. Caution should be exercised when using the drug concomitantly with other NSAIDs.
Use in pediatrics
If it is necessary to use the drug in the form of an ointment in children under 6 years of age, a doctor’s supervision is required.
Influence on the ability to drive a car and manage mechanisms
Due to the fact that when using the drug in high doses, side effects such as dizziness and fatigue may develop, in some cases the ability to drive a car or other moving objects is impaired. These phenomena are amplified when taking alcohol at the same time.
Form of production
Rectal suppositories
Storage conditions
Store in a dry place protected from light at a temperature of not more than 25 C. Keep out of reach of children.
Shelf
life is 2 years.
Active ingredient
Diclofenac
Conditions of release from pharmacies
By prescription
Dosage form
rectal suppositories
Description
Pregnant women in the first and second trimester as prescribed by a doctor, For adults, For adults as prescribed by a doctor, For Children as prescribed by a doctor, For children over 6 years of age
Indications
Osteoarthritis, Adnexitis, Migraine, Arthritis, Rheumatoid Arthritis, Gout, Sciatica, Bursitis, Tendon Inflammation, Lumbago, Swelling after injuries and operations, Periarthritis, Osteoarthritis
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Side effects of Diclofenac Altfarm, rectal suppositories 50mg, 10pcs.
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