Doclac gel 5% 50g

Active ingredient and dosage form

Solution for i / m administration transparent, slightly colored, with a faint smell of benzyl alcohol.
1 ml of solution contains 25 mg of Diclofenac sodium, 1 ampoule (3 ml) - 75 mg;
Excipients: benzyl alcohol, water for injection;
in ampoules of 3 ml, 5 or 10 ampoules in a carton box.

Coated tablets: 1 pill contains diclofenac sodium 25 or 50 mg;
10, 20, 30, 50 or 100 pcs. packaged.

Tablets retard: 1 pill contains diclofenac sodium 75 or 150 mg;
20, 30, 50, 100 pcs. packaged.

Rectal suppositories: 1 suppository contains diclofenac - 25, 50 or 100 mg
Excipients: 1,2-propylene glycol, aerosil, witepsol);
10 pieces. packaged.

Ointment 1% white or almost white in color, with a weak peculiar smell.
1 g ointment contains 10 mg of diclofenac sodium
Excipients - polyethylene oxide-400, polyethylene oxide-4000, 1,2-propylene glycol, nipagin, nipazol;
30 or 40 in aluminum tubes, 1 tube in a carton box.

Gel 1%: 1 g of gel contains 10 mg of diclofenac sodium;
in tubes of 40, 60 g, in a cardboard bundle 1 tube.

Gel 5%: 1 g of gel contains Diclofenac sodium 50 mg;
in tubes of 50 and 100 g

Mechanism of action

Nonsteroidal anti-inflammatory agent (NSAIDs). It has anti-inflammatory, analgesic and antipyretic effects. Inhibits the COX enzyme in the cascade of arachidonic acid metabolism and violates the biosynthesis of prostaglandins.
When applied externally, it has anti-inflammatory and analgesic effects. Reduces and relieves pain at the site of application of the ointment (including pain in the joints at rest and when moving), reduces morning stiffness and swelling of the joints. Contributes to increased range of motion.

With i / m administration, the peak plasma concentration is reached in 10-20 minutes, 99% of the administered drug is bound to blood proteins. Diclofenac penetrates well into the tissue and synovial fluid, the peak of the concentration of diclofenac in which is observed 4 hours after administration. 35% of diclofenac is excreted in the form of metabolites, 65% is metabolized in the liver and excreted in the form of inactive derivatives through the kidneys. The elimination half-life from plasma is 2 hours, from synovial fluid 4-6 hours.

When applied topically, it is partially absorbed through the skin, bioavailability - 6%. Communication with plasma proteins - 99.7%. Excreted by the kidneys. In patients with polyarthritis who receive local therapy (in the area of ​​the inflamed joint), the concentration in synovial fluid is higher than the concentration in plasma.

With rectal administration, the time to reach Cmax is 30 minutes. Plasma concentration is linearly dependent on the magnitude of the dose administered. Changes in the pharmacokinetics of diclofenac against the background of repeated administration is not observed.

Indications and usage

 
Inflammatory and inflammatory-activated degenerative forms of rheumatism:
- chronic polyarthritis;
- ankylosing spondylitis (ankylosing spondylitis);
- arthrosis;
- spondyloarthrosis;
- neuritis and neuralgia, such as cervical syndrome, lumbago (backache), sciatica;
- Acute gout attacks.
Rheumatic lesions of soft tissue.
Painful swelling or inflammation after injuries or surgery.
Non-rheumatic inflammatory pain conditions.
Ointment, gel 
- inflammatory and degenerative diseases of the joints (osteochondrosis, osteoarthritis, periarthropathy);
- rheumatism of soft tissues;
- traumatic bruises;
- sprains, muscles and tendons;
- inflammatory swelling of soft tissues;
- arthralgia and myalgia caused by severe physical exertion.

Note: the use of injection solution is indicated if it is necessary to achieve a quick effect, or it is impossible to receive candles.

Contraindications

 
- Pathological changes in the blood picture of unclear genesis;
- gastric ulcer and duodenal ulcer;
- destructive-inflammatory bowel disease in the acute phase;
- pregnancy;
- the period of lactation (breastfeeding should be abandoned);
- children and adolescents up to 12 years (in / m introduction, supp.);
- children's age up to 6 years (tablets, ointment);
- hypersensitivity to Acetylsalicylic acid or other NSAIDs (including the "aspirin triad");
- Hypersensitivity to diclofenac and other components of the drug;
- inflammation of the rectum - proctitis (suppositories)

Taking Diclofenac is possible only under the strict supervision of a physician after careful evaluation of the benefit / risk ratio. under the following conditions: congenital hematopoietic disorder (induced porphyria); systemic lupus erythematosus and other systemic diseases of connective tissue; the presence of complaints on the function of the gastrointestinal tract, or in case of suspected gastric or duodenal ulcer, as well as erosive and ulcerative lesions (ulcerative colitis, Crohn's disease); in patients with previous kidney disease and / or severe liver dysfunction; with severe hypertension and / or heart failure; in elderly patients; immediately after surgery.

With great care and only under the direct supervision of a physician can you use Diclofenac in patients with bronchial asthma, allergic rhinitis, polyps of the nasal mucosa, as well as in chronic obstructive respiratory diseases and chronic infections of the respiratory tract due to the risk of an asthma attack, angioedema or urticaria.

Dosage and administration

Solution for i / m administration
Diclofenac is administered at the beginning of treatment once a / m at a dose of 75 mg (1 ampoule) or maximum 150 mg (2 ampoules) per day only for adults and only in those cases when it is necessary to obtain a particularly rapid therapeutic effect.
Usually, injections are prescribed for 1-5 days.
If it is necessary to continue therapy, they switch to the administration of diclofenac in the form of tablets, capsules, and the use of suppositories.
V / m injection can be combined with the use of the drug orally or rectally, while the maximum daily dose should not exceed 150 mg.

Pills
Adults are recommended to take from 50 to 150 mg of diclofenac per day, divided into 2-3 separate doses.
In the absence of other prescriptions, it is recommended to take 100–150 mg per day as initial therapy, and 75–100 mg divided by 2-3 separate doses for long-term therapy.
Children over 6 years old Diclofenac is prescribed in a dose of 2 mg / kg of body weight, and the daily dose is also divided into several doses.

Suppositories
Rectally. Adults: 100 mg once a day, 50 mg 2 times a day, or 25 mg 3-4 times a day.
The maximum daily dose is 150 mg.
Children over 12 years old: 50 mg 1-2 times a day or 25 mg 2-3 times a day.

Ointment, gel in a dose of 2-4 g, apply a thin layer on the skin over the inflammation and rub it slightly, the frequency of application is 2-3 times / day.
The maximum daily dose of ointment should not exceed 8 g.
The course of treatment is not more than 14 days. The need for a more prolonged use of the drug is determined by the doctor.

Adverse reactions

Side effects depend on individual sensitivity, the magnitude of the applied dose and the duration of treatment.
Gastrointestinal: nausea, vomiting, epigastric pain, anorexia, flatulence, constipation, gastritis up to erosive with bleeding, increased transaminase activity, drug-induced hepatitis, pancreatitis.
Urogenital: interstitial nephritis.
From the side of the central nervous system: headache, dizziness, disorientation, agitation, insomnia, irritability, fatigue, aseptic meningitis .
On the part of the respiratory system: bronchospasm.
From the hemopoietic system: anemia, thrombocytopenia, leukopenia, agranulocytosis.
Dermatological reactions: exanthema, erythema, eczema, hyperemia, erythroderma, photosensitization.
Allergic reactions: erythema multiforme, Lyell's syndrome, Stevens-Johnson syndrome, Anaphylactic reactions , including shock.
Local reactions: burning at the injection site, formation of infiltrate, necrosis of adipose tissue.
Other: fluid retention, edema, increased blood pressure.
For external use
At the site of application of the ointment, a skin rash, burning, redness are possible. With prolonged external use of the drug may develop systemic side effects of the digestive system, central nervous system, respiratory system, as well as allergic reactions.

The drug is contraindicated for use during pregnancy and lactation.

Diclofenac ointment (gel) on the damaged surface of the skin, open wounds, eyes and mucous membranes should be avoided.
The use of Diclofenac in the form of an ointment is possible only on prescription in the following cases: a history of gastric ulcer and duodenal ulcer; abnormal liver and kidney function; severe violations of the hematopoietic system;bronchial asthma, rhinitis, polyps of the nasal mucosa; allergic reactions in history.
With caution, use the drug simultaneously with other NSAIDs.
Use in pediatrics
If necessary, use the drug in the form of ointment in children under 6 years old required medical supervision.
Influence on ability to driving of the car and control of mechanisms
Due to the fact that the use of the drug in high doses may develop such side effects as dizziness and fatigue, in some cases the ability to drive a car or other moving objects is impaired. These phenomena are intensified while taking alcohol.

Symptoms: the clinical picture is determined by disorders of the central nervous system (headache, dizziness, irritability, hyperventilation with increased convulsive readiness, in children - myoclonic convulsions) and disorders of the digestive system (abdominal pain, nausea, vomiting; bleeding from the gastrointestinal tract and / or abnormal liver function); possible impaired renal function.
Treatment: symptomatic therapy, careful monitoring of the patient's condition. The specific antidote is not known.

With the simultaneous use of the drug Diclofenac with Digoxin , phenytoin or lithium preparations, it is possible to increase the plasma concentrations of these drugs; with diuretics and antihypertensivesmeans - perhaps reducing the action of these drugs; with potassium-sparing diuretics, hyperkalemia may develop; with acetisalicylic acid - a decrease in the concentration of diclofenac in the blood plasma and an increase in the risk of side effects.
Diclofenac may enhance the toxic effects of cyclosporine on the kidneys.
Diclofenc may cause hypo-or hyperglycemia, therefore, when used simultaneously with hypoglycemic agents, it is necessary to control the concentration of glucose in the blood.
When using Methotrexate for 24 hours before or after taking Diclofenac, it is possible to increase the concentration of methotrexate and enhance its toxic effect.
With simultaneous use with anticoagulants requires regular monitoring of blood coagulation.

List B. Store in a dry, dark place at a temperature not exceeding 25 C. Store in a place inaccessible to children.
Ointment: in a dry place at a temperature of 8 to 15 ° C. Freezing is not allowed.

drug is indicated on the package.