Ortophenum

Ortophenum – the non-steroidal anti-inflammatory drug (NPVS) derivative of phenylacetic acid with the expressed analgeziruyushchy, antiinflammatory and moderate febrifugal action.

Form of release and structure

Dosage forms:

• The tablets covered with a kishechnorastvorimy cover (in a blister strip packaging: on 10 pieces, in a cardboard pack 3 packagings, on 15 pieces, in a cardboard pack 2 packagings);
• Solution for intramuscular introduction (in oil) (on 3 ml in ampoules, in planimetric packaging of 5 ampoules, in a cardboard pack 1 or 2 packagings);
• Ointment for external use of 2% (on 20, 30 or 50 g in aluminum tubas, in a cardboard pack 1 tuba);
• Gel for external use of 5%: with a yellow shade or colourless transparent weight with a characteristic smell of ethanol, existence of vials of air and opalescence is possible (on 30 or 50 g in aluminum tubas, in a cardboard pack 1 tuba).

Active ingredient of Ortophenum – sodium diclofenac:

• 1 tablet: 0,025 g;
• 1 ml of solution: 0,025 g;
• 1 g of ointment: 0,02 g;
• 1 g of gel: 0,05 g.

Auxiliary components of gel: propylene glycol, ethanol of 95%, the gietelloza, water purified.

Indications to use

• Chronic and degenerative pathologies of a musculoskeletal system of an inflammatory etiology (osteoarthrosis, osteochondrosis, periartropatiya);
• Joint syndrome: gout, ankylosing spondylitis, pseudorheumatism, osteoarthritis;
• Inflammation of a musculoskeletal system and soft tissues at stretching and bruises;
• Neuralgia, backbone pains, arthralgia, mialgiya;
• Inflammation and pain syndrome after surgeries and injuries;
• Pains at gout;
• Migraine;
• Algodismenorey;
• Pain syndrome at a proctitis, an adnexitis;
• Bilious and renal gripes;
• Pain syndrome at infectious and inflammatory otorhinolaryngological diseases.

Contraindications

• Aggravation of erosive cankers of the digestive tract (DT);
• Aspirinovy triad;
• Disturbances of process of a hemopoiesis of unspecified genesis;
• Age up to 6 years;
• Hypersensitivity to components of drug and other NPVS.

With extra care patients should apply Ortophenum with the instruction in the anamnesis on diseases of kidneys, a liver, the GIT sore with the dispeptic phenomena, bronchial asthma, heart failure, arterial hypertension, during the period after carrying out extensive surgeries, at advanced age.

During pregnancy and breastfeeding use is possible only on doctor's orders in special cases if the expected advantage for mother exceeds potential threat for a fruit or the child.

Route of administration and dosage

The dosage form of drug, dose and the period of use are appointed by the doctor on the basis of clinical indications.

Tablets are intended for intake.

The recommended dosing:

• Adults: on 1-2 tablets 2-3 times a day, the daily dose should not exceed 6 tablets;
• Children of 6 years are also more senior: the daily dose is defined at the rate of 0,002 g on 1 kg of weight of the child.

For stopping of the expressed pain syndrome at treatment of acute or chronic pathologies introduction of Ortophenum in oil in a dose of 0,075 g is shown.

Gel and ointment apply outwardly, applying with a thin layer on painful body parts. Frequency rate of procedures 3-4 times a day on 2-4 g of drug.

Side effects

The tablets covered with a kishechnorastvorimy cover, solution for introduction (in oil)

• Alimentary system: unpleasant feelings and pain in epigastriums, nausea, vomiting, a lock, diarrhea, a meteorism, anorexia; in some cases – erosion, bleedings, cankers and perforation of a GIT; seldom – an abnormal liver function;
• System of a hemopoiesis: seldom – anemia, thrombocytopenia, a leukopenia, an agranulocytosis;
• Nervous system: dizziness, excitement, headache, sleeplessness, feeling of fatigue, irritability; seldom – paresthesias, a diplopia, a sight rasplyvchivost, a sonitus, spasms, a tremor, a depression, mental disturbances;
• Urinary system: seldom – a renal failure; perhaps – hypostases (at patients with predisposition);
• Allergic reactions: skin itch, rash;
• Dermatological reactions: seldom – a hair loss;
• Local reactions: at introduction in oil burning in the place of an injection is possible; in some cases – formation of abscess and/or infiltrate, a necrosis of fatty tissue.

Ointment for external use of 2%, gel for external use of 5%

• Seldom: burning, itch, rash, reddening;
• Perhaps: at long use and/or drawing on extensive body parts – emergence of system side effects against the background of resorptive effect of diclofenac.

Special instructions

Purpose of diclofenac is shown to patients with allergic reactions to sulfites and NPVS in the anamnesis only in urgent cases with obligatory systematic control of a picture of peripheral blood, function of kidneys and a liver.

During use of tablets and solution it is impossible to take alcohol.

It is contraindicated to apply cream and gel on sites with the broken integrity of an integument.

It is necessary to avoid hit of drug in eyes or on mucous membranes of a body.

During treatment by tablets and solution the speed of psychomotor reactions therefore the patient is recommended to be managed with care vehicles and mechanisms can decrease.

Medicinal interaction

At simultaneous use of Ortophenum:

• Anti-hypertensive medicines – can weaken the therapeutic effect;
• Glucocorticosteroids – increase risk of development of side effects from system of digestion;
• Diuretics – reduce the action;
• Kaliysberegayushchy diuretics – promote increase in level of potassium concentration in blood;
• Hypoglycemic drugs – development of a hyperglycemia or hypoglycemia in patients with a diabetes mellitus is possible;
• Acetylsalicylic acid – reduces concentration of diclofenac in a blood plasma;
• Warfarin – in some cases can lead to developing of bleedings;
• Colestyraminum, колестипол – reduce absorption of diclofenac from a GIT;
• The methotrexate – can increase toxicity because of increase in the concentration in a blood plasma;
• Digoxin, lithium, Phenytoinum – is possible growth of their concentration in a blood plasma;
• Cyclosporine – increases the nephrotoxicity;
• Rifampicin – can reduce concentration of diclofenac in a blood plasma;
• Pentazocine – causes risk of development of a big convulsive attack;
• Tseftriakson – raises the excretion with bile;
• Morphine – increases risk of respiratory depression and development of other side effects of a metabolite of morphine.

The risk of emergence at sick spasms increases at Ortophenum combination to antibacterial agents of a hinolonovy row.

The drug combination with other NPVS increases risk of emergence of undesirable effects.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C, tablets and solution – in the dark place, to protect tablets from moisture.

Period of validity – 2 years.