Rapten Retard (diclofenac sodium) tablets 100 mg. №20

Description

Rapten Retard (diclofenac sodium) tablets 100 mg. №20

Composition

active substance: diclofenac;

1 tablet contains: diclofenac sodium 100 mg;

auxiliary substances: sucrose, cetyl alcohol, magnesium stearate, talc, povidone K-25, colloidal anhydrous silicon dioxide;

shell: hypromellose, talc, titanium dioxide (E 171), macrogol 6000, polysorbate 80, yellow sunset (E 110), cochineal red (E 124), brown dye (yellow sunset (E 110), azorubin (E 122), diamond black (E 151)).

Medicinal form

Tablets covered with a film shell, prolonged action.

Main physicochemical properties: pink, round, biconvex tablets covered with a film cover.

Pharmacotherapeutic group

Means affecting the musculoskeletal system. Nonsteroidal anti-inflammatory drugs. Acetic acid derivatives and related compounds.
ATX code M01A B05.

Pharmacological properties 

Rapten Retard is a non-steroidal drug with antirheumatic, anti-inflammatory, analgesic and antipyretic effects. The main mechanism of action of diclofenac is to slow down the biosynthesis of prostaglandin by inhibiting the isoenzymes of cyclooxygenase: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). Prostaglandins play an important role in the appearance of inflammation, pain and fever. Diclofenac sodium in vitro does not inhibit proteoglycan biosynthesis in cartilage tissue at concentrations equivalent to those achieved in humans.

The anti-inflammatory and analgesic effects of diclofenac in rheumatic diseases are reflected in a marked reduction in pain at rest and in motion, morning immobility, general edema and improved performance. Diclofenac quickly soothes spontaneous pain and pain when moving, reduces inflammatory edema and swelling of wounds in post-traumatic and postoperative inflammation. Diclofenac has an analgesic effect in moderate and severe pain of non-rheumatic origin, relieves pain during the first painful menstruation and reduces the duration of bleeding.

Rapten Retard is specially designed for patients with a clinical picture in which a dose of diclofenac 100 mg / day is adequate. A single daily dose is adequate for long-term treatment because it increases patient fitness and reduces the possibility of error in dose titration.

Indication 

Pain relief and reduction of inflammation to varying degrees in various conditions, including:

• joint pathology: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute gout attacks;
• acute musculoskeletal diseases such as periarthritis (eg, scapular periarthritis), tendinitis, tendovaginitis, bursitis;
• other pathological conditions caused by injuries, including fractures, low back pain, sprains, dislocations, orthopedic, dental and other minor surgical interventions.

Contraindication:

• Diclofenac, like other NSAIDs, is contraindicated in patients who develop bronchial asthma, angioneurotic edema, urticaria, urticaria or other urticaria in response to ibuprofen, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (NSAIDs). symptoms.
• Acute gastric or intestinal ulcer; gastrointestinal bleeding or perforation, gastrointestinal bleeding or history of perforation after NSAID use, acute or recurrent gastric or intestinal ulcer in the anamnesis.
• Inflammatory bowel disease (eg, Crohn’s disease or ulcerative colitis).
• Hepatic failure.
• Renal failure.
• Congestive heart failure (NYHA II-IV).
• Ischemic heart disease in patients with angina, myocardial infarction.
• Cerebrovascular disease in patients who have suffered a stroke or have episodes of transient ischemic attacks.
• Diseases of peripheral arteries.
• Treatment of perioperative pain during coronary artery bypass grafting (or use of an artificial circulation device).

Method of application and dosage

Adults should be prescribed 1 tablet (100 mg) once a day. The tablets should be taken before meals, without chewing, washed down with water. If the symptoms become more intense at night or in the morning, it is recommended to take 100 mg tablets of Rapten Retard in the evening.

In general, it is recommended to select the dose individually. The drug should be used in the lowest effective doses for the shortest period of time, taking into account the objectives of treatment in each individual patient.

The maximum daily dose is 200 mg.
Dose determination for elderly patients.

Although the pharmacokinetic characteristics of diclofenac did not lead to clinically significant changes in elderly patients, all NSAIDs should be used with caution in this group of patients as they are prone to adverse reactions. The lowest effective dose of diclofenac is recommended for the elderly or the underweight. Long-term use of NSAIDs is not recommended for the elderly. Regular monitoring of patients during the course of therapy is recommended. And in the event that there is no improvement or unwanted side effects, the drug should be discontinued.

Children

Do not use Rapten Retard in pediatric practice.

Overdose

Symptoms. There is no typical clinical picture of diclofenac overdose. Overdose can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, agitation, coma, drowsiness, tinnitus, convulsions. Acute renal failure and liver damage are possible in case of severe intoxication.

Treatment. Treatment of acute NSAID poisoning, including diclofenac, is maintenance and symptomatic therapy. This applies to the treatment of such manifestations as hypotension, renal failure, convulsions, gastrointestinal disorders, respiratory depression. Specific treatments such as forced diuresis, dialysis, or hemoperfusion are unlikely to be effective in eliminating NSAIDs, including diclofenac, because the active substances in these drugs are highly bound to blood proteins and undergo extensive metabolism. After the use of potentially toxic doses, activated charcoal can be used, and after the use of potentially life-threatening doses – gastric decontamination (eg, vomiting, gastric lavage).

Side effects:

• From the hematopoietic and lymphatic systems: Thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia) and agranulocytosis.
• On the part of the immune system: Hypersensitivity reactions, including asthma, systemic anaphylactic and anaphylactoid reactions (including hypotension and shock); angioneurotic edema (including facial edema).
• From the psyche: Disorientation, depression, insomnia, nightmares, irritability, psychotic disorders; confusion, hallucinations.
• From the nervous system: Headache, dizziness; drowsiness; paresthesia, memory disorders, convulsions, restlessness, anxiety and fear, trembling of the hands (tremor), aseptic meningitis, sensitivity disorders, taste disturbances, cerebrovascular disorders; optic neuritis.
• From sight: Visual disturbances (diplopia, blurred vision).
• From the hearing and balance control center: Dizziness; tinnitus, hearing disorders.
• From the cardiovascular system: Frequent heartbeat, chest pain, heart failure, myocardial infarction; hypertension, vasculitis; arterial hypotension; impotence.
• Respiratory, thoracic and mediastinal disorders: Asthma (including dyspnea); pneumonitis.
• From the gastrointestinal tract: Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence and anorexia; gastritis, gastrointestinal bleeding, hematemesis, melena (tar-like feces), gastric and intestinal ulcers, accompanied or not accompanied by bleeding or perforation (sometimes fatal, especially in the elderly); colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn’s disease), constipation, stomatitis, glossitis, esophageal disorders, diaphragmatic intestinal strictures, pancreatitis; stomatitis (including ulcerative stomatitis).
• From the hepatobiliary system: Increased levels of transaminases; hepatitis, jaundice, liver disorders; fulminant (transient) hepatitis; liver necrosis, liver failure.
• From the skin and subcutaneous tissue: Rash, urticaria; bullous rash, eczema, erythema (redness), polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, allergic purpura.
• From the urinary system: Acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, medullary necrosis of the kidney.
• General disorders: Edema; fatigue; general malaise.

Clinical trials and epidemiological data suggest an increased risk of thrombotic complications (eg myocardial infarction or stroke) associated with diclofenac, particularly at high therapeutic doses (150 mg daily) and with long-term use.