Voltaren rectal suppositories 50mg, No. 10

• inflammatory and degenerative diseases of the musculoskeletal system;

• rheumatoid arthritis;

• juvenile chronic arthritis;

• ankylosing spondylitis;

• spondyloarthropathy;

• arthrosis;

• bursitis;

• tenosynovitis;

• gouty arthritis;

• spinal pathologies accompanied by active pain syndrome;

• ossalgia;

• neuralgia;

• myalgia;

• arthralgia;

• radiculitis;

• lumbago;

• rheumatic diseases of extra-articular soft tissues;

• post-traumatic pain syndrome;

• postoperative pain syndrome accompanied by inflammation;

• algodismenorrhea;

• migraine attacks;

• infectious and inflammatory pathologies of ENT organs, accompanied by intense pain syndrome.

Isolated fever is not an indication for the use of the drug.

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

The dose is selected individually, it is recommended to use the drug in the minimum effective dose, if possible with the shortest possible treatment period.

If possible, empty the intestines.

Wash your hands with soap and water and rinse them under running water.

Lie on one side, gently insert the suppository into the anus and gently push it into the rectum about 3 centimeters.

Lie down for about 10 minutes, which is enough to completely dissolve the medicine.

The standard treatment regimen involves a week of therapy. With advanced inflammatory diseases, the course can be increased to 12-14 days. If after this period there is no improvement, a comprehensive diagnosis is performed and another drug is prescribed.

Active ingredient: diclofenac sodium 50 mg;

Excipients: solid fat - up to 1 g.

Contraindications:

• ulcerative lesions of the stomach and intestines;

• attacks of bronchial asthma;

• hives;

• acute rhinitis;

• intolerance to acetylsalicylic acid;

• the use of suppositories at a dose of 50 mg is not recommended for children under 14 years of age; in a dose of 100mg for children under 18 years of age.

• hypersensitivity to the active ingredient;

• third trimester of pregnancy.

With extreme caution, the drug can be prescribed to persons with suspected gastrointestinal tract diseases and a history of Helicobacter pylori infection. The drug is used with caution in ulcerative colitis, Crohn's disease and liver dysfunction.

In patients receiving drugs that increase the risk of gastrointestinal bleeding, including systemic glucocorticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors. Used with caution in patients with mild to moderate liver damage. The drug can be used in persons with renal porphyria. The drug is not prescribed for patients with chronic obstructive pulmonary disease.

The drug Voltaren is produced in the form of suppositories for rectal use. The drug belongs to the group of anti-inflammatory compounds. The action of the remedy is aimed at eliminating pain, reducing fever and thinning the blood.

Description:

Rectal suppositories are white or almost white in color with a slightly pronounced yellow tint. The elements are bullet-shaped with a smooth surface. The drug has a mild odor.

Composition:

Active ingredient: diclofenac sodium 50 mg;

Excipients: solid fat - up to 1 g.

pharmachologic effect

NSAIDs, a derivative of phenylacetic acid. It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme of the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play an important role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system).

In vitro, at concentrations equivalent to those achieved in the treatment of patients, does not inhibit the biosynthesis of proteoglycans in cartilage tissue.

In rheumatic diseases, it reduces joint pain at rest and during movement, as well as morning stiffness and swelling of the joints, and helps to increase the range of motion. Reduces post-traumatic and postoperative pain and inflammatory edema.

In case of post-traumatic and postoperative inflammatory events, it quickly relieves pain (arising both at rest and during movement), reduces inflammatory edema and edema of a postoperative wound.

Suppresses platelet aggregation. With prolonged use, it has a desensitizing effect.

Pharmacokinetics

After oral administration, it is absorbed from the gastrointestinal tract. Food intake slows down the rate of absorption, while the degree of absorption does not change. About 50% of the active substance is metabolized during the 'first pass' through the liver. With rectal administration, absorption is slower. The time to reach Cmax in plasma after oral administration is 2-4 hours, depending on the dosage form used, after rectal

introduction - 1 hour, intramuscular injection - 20 minutes. The concentration of the active substance in the plasma is linearly dependent on the size of the applied dose.

Does not cumulate. Plasma protein binding is 99.7% (mainly albumin). Penetrates into synovial fluid, Cmax is reached 2-4 hours later than in plasma.

It is largely metabolized to form several metabolites, among which two are pharmacologically active, but to a lesser extent than diclofenac.

The systemic clearance of the active substance is approximately 263 ml / min. T1 / 2 from plasma is 1-2 hours, from synovial fluid - 3-6 hours. Approximately 60% of the dose is excreted as metabolites by the kidneys, less than 1% is excreted in the urine unchanged, the rest is excreted as metabolites in the bile.

Indications:

• inflammatory and degenerative diseases of the musculoskeletal system;

• rheumatoid arthritis;

• juvenile chronic arthritis;

• ankylosing spondylitis;

• spondyloarthropathy;

• arthrosis;

• bursitis;

• tenosynovitis;

• gouty arthritis;

• spinal pathologies accompanied by active pain syndrome;

• ossalgia;

• neuralgia;

• myalgia;

• arthralgia;

• radiculitis;

• lumbago;

• rheumatic diseases of extra-articular soft tissues;

• post-traumatic pain syndrome;

• postoperative pain syndrome accompanied by inflammation;

• algodismenorrhea;

• migraine attacks;

• infectious and inflammatory pathologies of ENT organs, accompanied by intense pain syndrome.

Isolated fever is not an indication for the use of the drug.

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

Contraindications:

• ulcerative lesions of the stomach and intestines;

• attacks of bronchial asthma;

• hives;

• acute rhinitis;

• intolerance to acetylsalicylic acid;

• the use of suppositories at a dose of 50 mg is not recommended for children under 14 years of age; in a dose of 100mg for children under 18 years of age.

• hypersensitivity to the active ingredient;

• third trimester of pregnancy.

With extreme caution, the drug can be prescribed to persons with suspected gastrointestinal tract diseases and a history of Helicobacter pylori infection. The drug is used with caution in ulcerative colitis, Crohn's disease and liver dysfunction.

In patients receiving drugs that increase the risk of gastrointestinal bleeding, including systemic glucocorticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors. Used with caution in patients with mild to moderate liver damage. The drug can be used in persons with renal porphyria. The drug is not prescribed for patients with chronic obstructive pulmonary disease.

Dosage

The dose is selected individually, it is recommended to use the drug in the minimum effective dose, if possible with the shortest possible treatment period.

If possible, empty the intestines.

Wash your hands with soap and water and rinse them under running water.

Lie on one side, gently insert the suppository into the anus and gently push it into the rectum about 3 centimeters.

Lie down for about 10 minutes, which is enough to completely dissolve the medicine.

The standard treatment regimen involves a week of therapy. With advanced inflammatory diseases, the course can be increased to 12-14 days. If after this period there is no improvement, a comprehensive diagnosis is performed and another drug is prescribed.

Children aged 1 year and older

The drug is prescribed in a dose of 0.5-2 mg / kg body weight / day (in 2-3 doses, depending on the severity of the disease). For the treatment of rheumatoid arthritis, the daily dose may be increased to a maximum of 3 mg / kg (in divided doses). The maximum daily dose is 150 mg.

Pregnancy and lactation

There is insufficient data on the safety of using diclofenac in pregnant women. Therefore, the appointment in the I and II trimesters of pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Diclofenac (like other inhibitors of prostaglandin synthesis) is contraindicated in the third trimester of pregnancy (suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus is possible).

Despite the fact that diclofenac is excreted in breast milk in small quantities, use during lactation (breastfeeding) is not recommended. If necessary, use during lactation, breastfeeding should be discontinued.

Since diclofenac (like other NSAIDs) can have a negative effect on fertility, it is not recommended for women planning pregnancy.

For patients undergoing examination and treatment for infertility, the drug should be canceled.

Storage conditions:

Store at a temperature not exceeding 30 ? C, out of the reach of children.

Dispensing the drug: by prescription

Expiration date: 3 years