Orthofen - instructions for use, doses, side effects, contraindications

Excipients: benzyl benzoate (benzyl benzoate medical) - 6.0 g; polysorbate-80 - 1.0 g; methyl parahydroxybenzoate (methylparaben, nipagine) 0.08 g; propyl parahydroxybenzoate (propylparaben, nipazole) 0.02 g; carbomer (carbomer 940) 0.75 g; trolamine (triethanolamine thermostable) - 0.40 g; purified water - up to 100.0 g.

Description:

Homogeneous ointment white or white with a gray or creamy hue of color with a weak specific odor.

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

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Non-steroidal anti-inflammatory drug for external use. Diclofenac has a pronounced analgesic and anti-inflammatory effect. Indiscriminately inhibiting cyclooxygenase types 1 and 2 (COX-1 and COX-2), disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.

Diclofenac is used to eliminate pain syndrome and reduce puffiness associated with the inflammatory process.

Pharmacokinetics:With the recommended method of applying the drug, systemic absorption of diclofenac is not more than 6%. The connection with plasma proteins is 99.7%. It is excreted by the kidneys. Diclofenac mainly distributed and retained deep in the tissues defeated by inflammation. When applying the drug on the affected joint, the concentration of diclofenac in the synovial fluid is higher than in the blood plasma.

Indications:

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of application, the progression of the disease is not affected.

- Post-traumatic inflammation of soft tissues and joints, for example, as a result of sprains and bruises;

- rheumatic diseases of soft tissues (tendonitis, bursitis, periarticular tissue damage):

- pain and swelling associated with diseases of the muscles and joints of rheumatoid arthritis, osteoarthritis, radiculitis, lumbago, sciatica, muscle pain and rheumatic rheumatic origin).

Contraindications:

- Hypersensitivity to diclofenac or any of the components that make up the drug;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history);

- pregnancy (III trimester);

- the period of breastfeeding;

- age up to 12 years;

- violation of the integrity of the skin in the intended site of application.

Carefully:Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe impairment of liver and kidney function, chronic heart failure, blood clotting disorders (including hemophilia, prolonged bleeding time, a tendency to bleeding), advanced age, bronchial asthma, pregnancy (I and II trimester).

Pregnancy and lactation:The use of the drug during the first and second trimester of pregnancy is recommended only on the prescription of the doctor, comparing the benefits for the mother and the risk to the fetus. The drug is contraindicated in the third trimester of pregnancy in connection with the possibility of lowering the tone of the uterus and / or premature closure of the arterial duct of the fetus.Due to the lack of data on the penetration of diclofenac into breast milk, the drug is not recommended for use during breastfeeding.

Dosing and Administration:

For external use only. Adults and children over 12 years of age, the drug is applied 2 times a day (every 12 hours, preferably in the morning and in the evening), lightly rubbing into the skin. The required amount of the drug depends on the size of the painful area. A single dose of the drug - 2-4 g (in volume comparable to the size of a cherry or hazel, respectively), which is enough to handle the area of 400-800 cm2. If the hands are not a zone of pain localization, then after applying the drug they must be washed, the maximum daily dose of the drug is 8 g.

The duration of treatment depends on the indications and the effect observed. The drug should not be changed more than 14 days with post-traumatic inflammations and rheumatic diseases of soft tissues without a doctor's recommendation. If after 7 days of application the therapeutic effect is not observed or the condition worsens, you should consult a doctor.

Side effects:

Classification of the incidence of adverse events according to the recommendations of the World Health Organization (WHO):

very often> 1/10;

often from> 1/100 to <1/10;

infrequently from> 1/1000 to <1/100;

rarely from> 1/10000 to <1/1000;

very rarely <1/10000, including individual messages;

the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

From the immune system:

very rarely - generalized skin rash, allergic reactions (hives, hypersensitivity: angioedema).

From the respiratory and thoracic and mediastinal organs:

very rarely - attacks of suffocation, bronchospastic reactions.

From the skin:

often - erythema, dermatitis, including contact dermatitis (symptoms: eczema, itching, fromSkin, skin, papules, vesicles, peeling);

rarely bullous dermatitis;

very rarely - the reaction of photosensitization, pustular eruptions.

Overdose:

Symptoms

Due to low systemic absorption in external applications, an overdose is unlikely. With accidental ingestion, it is possible to develop systemic adverse reactions.

Treatment

In case of accidental ingestion - gastric lavage (only within an hour after a random intake), induction of vomiting, reception of activated charcoal, symptomatic therapy.Dialysis and forced diuresis are not effective due to the high degree of binding of diclofenac to plasma proteins (about 99%).

Interaction:Diclofenac can enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs has not been described.

Special instructions:The drug should be applied only to intact skin, avoiding getting on open wounds. Do not allow the drug to enter the mouth, eyes and mucous membranes. After applying the drug, a bandage bandage is allowed, but no airtight occlusive dressings should be applied. Avoid excessive exposure to sunlight on the area of application. If side effects occur, discontinue use and consult a doctor.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and mechanisms.

Form release / dosage:

Ointment for external use 2%.

Packaging:

30 g or 50 g in an aluminum tube. One tube together with instructions for use in a pack of cardboard.

Storage conditions:At a temperature of no higher than 25 ° C.Keep out of the reach of children.

Shelf life:

2 years 6 months Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-002245/07

Date of registration:17.08.2007 / 14.08.2015

Expiration Date:Unlimited

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp12.06.2017

Illustrated instructions

Instructions

Orthophene (Ortophen)