Sandoz® diclofenac

General characteristics. Structure:

Active ingredient: Diclofenac of sodium of 25 mg.
 
Excipients: Lactose, calcium гидрогенфосфат, microcrystallic cellulose, corn starch, glikolit sodium starch, magnesium stearate, colloid silicon dioxide, эудгидрат L 30, triethyl citrate, talc, titanium dioxide, a yellow oxide of iron.

Pharmacological properties:

Pharmacokinetics. Absorption
After intake diclofenac is quickly and completely soaked up from intestines.

Food slows down the absorption speed, however amount of the absorbed substance does not change. The maximum concentration in a blood plasma is defined approximately in 2 hours.
 
Distribution 
About 99% of diclofenac contact serum proteins. Cumulation of drug is not observed.
 
Metabolism 
After intake about 50% of active agent are metabolized at "the first passing" through a liver. Diclofenac is substantially metabolized. Metabolites are inactive, only one of them has activity, but smaller, than diclofenac.
 
Removal
The size of an elimination half-life makes about 1-2 hours. About 60% of the accepted dose are removed in the form of metabolites with kidneys, less than 1% are excreted with urine in not changed look, other part of metabolites is removed with bile.
Non-steroidal anti-inflammatory drug (NPVP). Has the antiinflammatory, analgetic and febrifugal effect caused by oppression of synthesis of prostaglandins.

Indications to use:

Inflammatory diseases of a musculoskeletal system: Pseudorheumatism.
Psoriasis, juvenile chronic arthritis.
Ankylosing spondylitis.
Gouty arthritis (including acute).

Degenerative diseases of a musculoskeletal system: The deforming osteoarthrosis.
Osteochondrosis .

Lumbago.
Sciatica.
Neuralgia.
Mialgiya.
Diseases of extraarticular fabrics: Tendovaginitis.
Bursitis.
Rheumatic defeat of soft tissues.

The posttraumatic pain syndromes which are followed by an inflammation.
Postoperative pains.
Migraine.
Renal or bilious colic .
Primary альгодисменорея.
Adnexitis.
Proctitis.
Infectious and inflammatory diseases of ENT organs with the expressed pain syndrome: Pharyngitis.
Tonsillitis.
Otitis.
Residual phenomena of pneumonia.

Feverish syndrome.

Route of administration and doses:

The dose of diclofenac should be selected individually depending on disease severity.
Adult: it is recommended to accept from 50 to 150 mg of diclofenac a day divided into 2-3 separate receptions. In the absence of other appointments it is recommended to accept as initial therapy on 100-150 mg a day, and at long therapy - on 75-100 mg divided into 2-3 separate receptions.
To children is aged more senior than years: diclofenac appoint 2 mg/kg of body weight in a dose, and the day dose is divided also into several receptions.

Pill should be taken entirely, without chewing and to wash down with water. Administration of drug to food is preferable.

Features of use:

Patients with asthma, hay cold, polyps of a mucous nasal cavity, obstruction of respiratory tracts or with persistent infections of respiratory tracts (especially followed by the phenomena, similar that at hay cold), and also patients with hypersensitivity in relation to non-steroidal anti-inflammatory drugs, at diclofenac use earlier, than other patients, have to be afraid of development of asthmatic attacks (a so-called analgetic intolerantnost / "aspirinovy" asthma), local cutaneous dropsies and mucous membranes (Quincke's edema) and small tortoiseshells. Such patients have to accept diclofenac only at observance of precautionary measures and only on doctor's orders.

At simultaneous use of the means reducing coagulability of blood , or lowering the content of sugar in blood it is necessary to carry out control of parameters of coagulability of blood and a glycemia.

Diclofenac can is passing to slow down aggregation of thrombocytes. Therefore patients with disturbance of indicators of coagulability have to show care.

The concomitant use of diclofenac and drugs of lithium (kaliysberegayushchy diuretics) demands control of the size of concentration of lithium and potassium in blood.

At prolonged use of diclofenac it is necessary to carry out regular control of parameters of a liver, renal function, and also a blood picture.

In case of use of diclofenac before operations, it is necessary to inform of it the attending physician, or the stomatologist.

It is necessary to show extra care at appointment to patients with a heart or renal failure, and also at therapy of the elderly people accepting diuretics and patients at whom for any reason decrease in volume of the circulating blood is observed (for example, after large surgical intervention). If in such cases appoint diclofenac, recommend to control function of kidneys as a precautionary measure.

When performing long therapy it is necessary to carry out the analysis a calla on the occult blood.

Patients at advanced age need careful medical observation.
Influence on ability to driving of motor transport and to control of mechanisms
As at reception of diclofenac by-effects from the central nervous system can take place, such as fatigue and dizziness, disturbance of ability of driving of cars and/or service of cars is in certain cases possible. In this case speed of reactions can also decrease. Therefore it is better to avoid driving of the car, service of the cars and performance of work demanding speed of reaction at reception of diclofenac.

Side effects:

It is necessary to remember that extent of manifestation of by-effects depends on a dose and individual sensitivity.
From the alimentary system
Sometimes - nausea, vomiting , locks, pains in epigastriums, a meteorism.

Cases of bleeding and perforation, erosive cankers of a mucous membrane of a GIT, nonspecific hemorrhagic colitis , exacerbation of ulcer colitis, increase in activity of hepatic transaminases in blood, hepatitis are noted.

Diarrhea, anorexia, fulminant hepatitis, pancreatitis, aphthous stomatitis, glossitis, erosive esophagitis.
 
From a nervous system
Headache, paresthesias, depression, psychotic reactions, aseptic meningitis.
 
Dermatological reactions
In rare instances — skin rash, an erythema, a small tortoiseshell, a photosensitization.
 
From sense bodys
Decrease in visual acuity, diplopia, scotoma, decrease in hearing, sonitus, disturbance of flavoring feelings.
 
From an urinary system
Seldom - a hamaturia, a proteinuria, a nephrotic syndrome, an acute renal failure, an oliguria, an anury, intersticial nephrite.
 
From urinogenital system
Vaginal bleeding, plentiful periods, blood in urine , cystitis.
 
From bodies of a hemopoiesis
Aplastic anemia, hemolitic anemia, leukopenia, thrombocytopenia, agranulocytosis.
 
Allergic reactions
Small tortoiseshell, attacks of bronchial asthma, anaphylactoid reactions (including ~ an arterial hypertension), a multiformny exudative erythema, a malignant exudative erythema (Stephens-Johnson's syndrome), system anaphylactic reactions (including shock), a Quincke's disease.
 
Others 
Hypostases, heartbeat, stethalgia, increase in the ABP.

Very seldom - disturbance of a rhythm.

Decrease in the ABP is characteristic of an acute anaphylaxis.

Interaction with other medicines:

At a concomitant use of diclofenac and digoxin (for increase in force of cordial reductions), Phenytoinum (for treatment of convulsive attacks) or a lity (for treatment intellectually - physical disturbances) increase in plasma level of these means is possible.

Diclofenac can weaken effect of diuretics and antihypertensives.

The concomitant use of diclofenac and kaliysberegayushchy diuretics can lead to increase in level of potassium in plasma . Diclofenac in combination with glucocorticoids or other non-steroidal anti-inflammatory drugs results in risk of development of by-effects from digestive tract.

Reception of diclofenac within 24 hours before reception of a methotrexate can lead to increase in concentration of a methotrexate and increase in number of the undesirable phenomena.

So far during a clinical use interaction between diclofenac and the means braking coagulability of blood was not revealed. However, at their combined use it is recommended to carry out control of parameters of coagulability.

Non-steroidal anti-inflammatory drugs (diclofenac) can increase renal toxicity of cyclosporine.

There are single messages on influence of diclofenac on sugar level what demands correction of doses of anti-diabetic drugs. Therefore at simultaneous use of these means it is recommended to control sugar level in blood.

It is necessary to remember that the specified interactions can take place and at short reception of medicines.

Alcohol, drugs of potassium and corticotropin increase the frequency of development of side effects from digestive tract.

The risk of development of side effects from kidneys increases in a combination with acetaminophen.

Heparin and trombolitik provoke development of NPVP-gastropathies.

Tsefamandol , цефаперазон, цефотетан, valproic acid provoke a prothrombinopenia and increase risk of development of bleedings and ulcerations from a GIT.

Contraindications:

- Hypersensitivity in relation to diclofenac and to drug components.
- Aspirinovy asthma.
- Disturbances of a hemopoiesis of not clear etiology.
- Stomach ulcer and 12-perstny gut.

With care:
- Inborn disturbance of a hemopoiesis (the induced porphyrias).
- Existence of complaints to function of digestive tract or suspicion of stomach ulcer or a 12-perstny gut, and also at intestinal inflammations (colitis, a disease Krone).
- Arterial hypertension.
- Heart failure.
- Renal failure.
- Heavy abnormal liver functions.
- Right after serious surgical interventions.
- Existence of some autoimmune diseases (a lupus erythematosus and mixed collagenoses).
- Anemia.

Use at pregnancy and feeding by a breast

If during prolonged use of diclofenac pregnancy approach was established, it is necessary to report about it to the attending physician.

In the first and second trimester of pregnancy reception of diclofenac is possible only after consultation with the attending physician. In the last 3 months of pregnancy it is impossible to accept diclofenac in connection with existence of high risk of complications at mother and the child.

Diclofenac and its metabolites in insignificant quantities pass into maternal milk. As so far it is not known of harming the baby at short-term use of diclofenac. As a rule, it is not necessary to cancel feeding by a breast for this period. If use of drug in high doses and is necessary for a long time, it is necessary to consider a question of cancellation of chest feeding.

Overdose:

 Symptoms: disturbances of the central character, such as headache, dizziness, oglushennost and loss of consciousness , at children can develop myoclonic spasms, and also abdominal pains, nausea and vomiting. Further gastrointestinal bleedings, and also abnormal liver functions and kidneys are possible.

Treatment: the specific antidote is not revealed. At suspicion on overdose by diclofenac it is necessary to inform of it the attending physician who depending on severity of poisoning will undertake necessary actions.

Storage conditions:

To store in the dry place at a temperature not above 25 °C. Period of validity: 5 years. To store in places unavailable to children. Not to use after expiry date.

Issue conditions:

According to the recipe

Packaging:

In the blister of 10 tablets. In packaging 3 blisters.