Orthofer - instructions for use, dose, side effects, contraindications

Excipients: milk sugar, sugar, potato starch, low molecular weight polyvinylpyrrolidone, stearic acid, acetylphthalyl cellulose, titanium dioxide, castor oil, Vaseline oil, tropeolin 0.

Description:

Tablets, covered with a film intestinal-soluble coating, from light orange to dark orange, round, biconvex. On the cross-section there are two layers.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Has anti-inflammatory, analgesic, antipyretic and anti-aggregation effect.

Inhibiting cycloxygenases 1 and 2, disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins (Pg) in both the inflammation focus and in healthy tissues, suppresses the exudative and proliferative phases of inflammation.

Pharmacokinetics:

Absorption is fast and complete, food slows down the absorption rate.After oral administration, 50 mg maximum concentration is 1.5 μg / ml, the time to reach the maximum concentration is 2-3 hours.

The concentration in the plasma is linear depending on the amount of the administered dose.

Changes in the pharmacokinetics of diclofenac against the background of repeated administration are not noted. Do not cumulate while observing the recommended interval between meals.

Bioavailability - 50%. The connection with plasma proteins is 95-98% (most of it is associated with albumins). Penetrates into the synovial fluid; The maximum concentration in the synovial fluid is observed 2-4 hours later than in the plasma. The half-life of the synovial fluid is 3-6 h (the concentration of the active substance in the synovial fluid 4-6 hours after the administration of the drug is higher than in the plasma, and remain higher for another 12 h).

Metabolism: 50% of the active substance is metabolized during the "first pass" through the liver. Metabolism occurs as a result of multiple or one-time hydroxylation and conjugation with glucuronic acid. The pharmacological activity of metabolites is lower than that of diclofenac.

Systemic clearance is 260 ml / min.60% of the administered dose is excreted as metabolites through the kidneys; less than 1% is unchanged, the rest of the dose is excreted as metabolites with bile.

Indications:

Inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile and chronic arthritis, ankylosing spondylitis, gouty arthritis), acute gouty arthritis.

Degenerative diseases of the musculoskeletal system (deforming osteoarthritis, osteochondrosis).

Lumbago, sciatica, neuralgia, myalgia.

Diseases of the periarticular tissues (tendovaginitis, bursitis).

Post-traumatic pain syndromes accompanied by inflammation, post-operative pain, migraine, renal colic; primary algodismenorea, adnexitis, proctitis.

Infectious and inflammatory diseases of the ENT organs with severe pain syndrome (pharyngitis, tonsillitis, otitis), residual pneumonia.

Feverish syndrome.

Contraindications:Hypersensitivity (including other NSAIDs), erosive and ulcerative lesions of the gastrointestinal tract (gastrointestinal tract) (in the phase of exacerbation), aspirin asthma, hematopoiesis disorders, pregnancy, children under 6 years old, lactation period.

Carefully:

Induced acute liver porphyria, severe impairment of liver and kidney function, heart failure.

Pregnancy and lactation:Contraindicated.

Dosing and Administration:

Inside, without chewing, during or after a meal, with a small amount of water. Adults - 25-50 mg 2-3 times a day. When the optimal therapeutic effect is achieved, the dose is gradually reduced and switched to maintenance treatment at a dose of 50 mg / day. The maximum daily dose is 150 mg.

For children over 12 years of age, the daily dose to 2 mg / kg of body weight.

With juvenile rheumatoid arthritis, the daily dose can be increased to 3 mg / kg.

Side effects:

From the digestive system: Gastralgia, nausea, vomiting, diarrhea, flatulence, anorexia, increased intensity of hepatic transaminases, gastrointestinal bleeding (hematemesis, melena), hepatitis with jaundice or without jaundice, drug-induced hepatitis, pancreatitis, non-specific colitis with bleeding, exacerbation of ulcerative colitis or illness Crohn's disease, aphthous stomatitis, glossitis, erosive esophagitis, constipation.

From the nervous system: headache, dizziness, fatigue, paresthesia,memory loss, loss of orientation, decreased visual acuity, diplopia, hearing loss, tinnitus, insomnia, irritability, convulsions, depression, anxiety, nightmarish dreams, tremors, psychotic reactions, taste disorders.

From the skin side: alopecia, photosensitivity.

From the urinary system: edema, acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

On the part of the organs of hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, aplastic anemia.

Allergic reactions: bronchospasm, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), allergic purpura, systemic anaphylactic reactions (including shock) skin rash, bullous dermatitis, exudative erythema multiforme, erythroderma, exfoliative dermatitis.

Other: impotence, palpitation, chest pain, increased blood pressure (BP).

Overdose:

Symptoms: dizziness, headache, hyperventilation of the lungs, confusion, in children - myoclonic cramps, nausea, vomiting, abdominal pain, bleeding, dysfunction of the liver and kidneys.

Treatment: gastric lavage, the introduction of activated charcoal, symptomatic therapy aimed at eliminating the increase in blood pressure, violations of kidney function, seizures, irritation of the gastrointestinal tract, respiratory depression. Forced diuresis, hemodialysis are ineffective.

Interaction:

Increases plasma concentrations of digoxin, lithium and cyclosporine.

Against the background of potassium-sparing diuretics, the risk of hyperkalemia increases, against the background of anticoagulants - the risk of bleeding.

Reduces the effects of diuretic, hypotensive and hypnotics.

Increases the likelihood of side effects of NSAIDs and glucocorticoids (gastrointestinal bleeding), toxicity of methotrexate and nephrotoxicity of cyclosporine.

Acetylsalicylic acid reduces the concentration of diclofenac in the blood.

With simultaneous use with oral antidiabetic drugs, both hypo- and hyperglycemia are possible.

Special instructions:

To quickly achieve the desired therapeutic effect take 30 minutes before meals. In other cases, take before, during or after a meal in undiluted form, with plenty of water.

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 people taking diuretics and patients who for any reason have a decrease in the volume of circulating fluid for example, after major surgery). If in such cases appoint diclofenac, recommend as a precautionary measure to monitor kidney function.

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.

Effect on the ability to drive transp. cf. and fur:It is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Intestine-soluble film coated tablets, 25 mg.

Packaging:

10, 15, 20 tablets in a planar cell package, 1,2,3,4,5, or 10 contiguous cell packs in a pack; 20, 30, 40, 50 tablets in a glass jar, a can of polymer, plastic bottle, 1 can, a bottle in a pack.

Storage conditions:

List B. In a dry, protected from light and inaccessible to children place.

Shelf life:3 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N002288 / 02-2003

Date of registration:14.08.2008

Expiration Date:Unlimited

The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia

Manufacturer: & nbsp

BRYNTSALOV-A, CJSC Russia

Information update date: & nbsp12.06.2017

Illustrated instructions

Instructions

Orthofer® (Ortopher®)