Project Description

Diclofenac

natrii film coated tablets 0.025 g – Tabulettar Diclophenac 0.025 obductae

international nonproprietary name

Diclofenac

Ref

BP-0034

Pharmacotherapeutic group

Not narcotic analgesics  (non-steroid anti-inflammatory drugs)

Composition of the preparation

1 film coated tablet contains 25 mg of diclofenac-natrii.

Pharmacological action

Pharmacodynamics

Diclofenac-natrii is a non-steroid anti-inflammatory drug. It exerts an analgesic anti-inflammatory and antipyretic effect. Diclofenac-natrii is an inhibitor of prostaglandins biosynthesis. It inhibits the platelets aggregation. In case of a prolonged appliance it exerts a desensitizing effect.

The preparation reduces pain in a tranquil state and under movements, the morning movements restriction, the joints swelling, improves their functional capacity. In case of inflammatory processes developing after the operations and traumas it reduces both spontaneous pains quickly and pains in movement as well as the inflammatory edema.

Pharmacokinetics

Being introduced orally it is absorbed practically completely. Food intake may inhibit the absorption rate not influencing its completeness. The maximal plasma concentration  is achieved in 1–2 hours. Fixation with the blood proteins is about 99%. About 35% of the diclofenac dose received is eliminated in the form of metabolites with feces, about 65% is metabolized in the liver and is eliminated by kidneys. The half period of elimination from plasma is about 2 hours, from the synovial fluid – 3–6 hours. In case the interval between the injections is kept to the preparation does not accumulate.

Indications 

Rheumatoid arthritis, osteoarthrosis, ankylosing spondilitis, acute gouty attack, lumbar pain, acute muscular and skeletal disturbances and traumas including periarthritis, tendonitis, tenosynovitis, bursitis. Pain and inflammation control in case of orthopedic and other minor surgeries.

special indication

Not established

special warning

Because of reactions possible inhibiting driving and working with machines are not recommended.

Dosage and method of administration

The preparation in prescribed for oral intake to adults in doses of 0.025–0.05 g 2–3 times a day. The therapeutic effect achieved the dose is to 0.025 g 3 times a day. The tablets are swallowed unchewn during meal or immediately after meal. Doses for children are 0.5–2 μg/kg/day (half a tablet – 0.015 g).

overdosage

Symptoms: dizziness, headache, hyperventilation, mental confusion, in children – myoclonic convulsions, nausea, vomiting, abdominal pain, bleedings, hepatic and renal functions disturbances.

Treatment: The stomach washing, activated charcoal introduction, symptomatic therapy for the increased arterial pressure lowering, the renal function disturbances, the convulsions, the gastrointestinal tract irritation, the respiration suppression removing. The forced diuresis and hemodialysis have a low effect.

safety measures

Diclofenac-natrii should be prescribed with care to persons at bleeding risk, having cardiovascular diseases and hepatic and renal functions severe disturbances. In case the treatment is prolonged the blood formula and hepatic function should be controlled regularly, the feces should be tested for occult bleeding.

Side effects

In the beginning of treatment pains in the epigastric area, eructation, vomiting, diarrhea as well as headache and mild dizziness are possible. In some cases dermal allergic reactions may occur.

Contraindications

Increased individual sensitivity to the preparation and other NSADs, hemopoiesis disturbances of unclear etiology, gastric and duodenal ulcers, destructive and inflammatory intestinal diseases at the exacerbation phase, aspirin bronchial asthma, childish age (under 15 years), pregnancy, breastfeeding (should be stopped for the therapy period).

Interactions with other medicinal preparations

The preparation increases the blood levels of lithium, digoxin, indirect anticoagulants, oral anti-diabetic preparations (both hypo- and hyperkalemia are possible), chinolone derivatives. It increases the methotrexate, cyclosporin toxicity, the possibility of glucocorticoids caused side effects development (gastrointestinal bleedings), hyperkalemia risk on the background of diuretics intake, reduces the diuretics effect. The plasma concentration reduces in case of acetyl salicylic acid intake.

The form of release

Tablets, enterosoluble film coated 25 mg.

Diclophenac-natrii tablets: 30, 60 tablets in a pot, 10, 20 tablets in a contour cellular pack, 10 tablets in a contour not cellular pack.

Diclofenac: 10 tablets in a contour cellular pack, 3 contour cellular packs in a cartoon.  Diclofenac is manufactured in cooperation with CTS Chemical Industries, Ltd., Israel.