Voltaren, rectal suppositories 50mg, 10pcs

Composition

1 suppository contains:

Active ingredients:

diclofenac (in the form of sodium salt) – 50 mg.

Auxiliary substances:  

solid fat – up to 2 g

Pharmacological action

Voltaren is a nonsteroidal anti-inflammatory drug (NSAID). It has a pronounced analgesic, anti-inflammatory and antipyretic effect.

The main mechanism of action of diclofenac, established in the experimental conditions, is considered to be inhibition of prostaglandin biosynthesis. Prostaglandins play an important role in the genesis of inflammation, pain, and fever.

In vitro, diclofenac sodium in concentrations equivalent to those achieved in the treatment of patients does not inhibit the biosynthesis of cartilage proteoglycans. In rheumatic diseases, the anti-inflammatory and analgesic properties of Voltaren provide a clinical effect characterized by a significant reduction in the severity of such manifestations of diseases as pain at rest and during movement, morning stiffness and joint swelling, as well as an improvement in functional condition.

Indications

inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, osteoarthritis; – diseases of spine, accompanied by pain syndrome; – extra-articular rheumatic diseases of soft tissues; – post-traumatic and postoperative pain syndromes, accompanied by inflammation and swelling; gynecological diseases, accompanied by pain syndrome and inflammation (e. g., primary algomenorrhea, adnexitis); – as an additional tool in severe infectious and inflammatory diseases of the ear, nose and throat, accompanied with severe pain syndrome, for example, pharyngitis, tonsillitis, otitis media. The main treatment of the disease is carried out in accordance with generally accepted principles, including the use of etiotropic therapy. Isolated fever is not an indication for the use of the drug; – migraine attacks.

Contraindications

-proctitis (only for suppositories); – hematopoiesis disorders – – children under 14 years of age; – hypersensitivity to diclofenac and any other ingredients of the drug.

The drug is not recommended for use in the third trimester of pregnancy (possible suppression of uterine contractility and premature closure of the arterial duct in the fetus).

Side effects

When assessing the frequency of occurrence of various adverse reactions, the following gradations were used: often – >10%, sometimes – > > 1-10%, rarely – > > 0.001-1%, in some cases

-From the digestive system:  sometimes – epigastric pain, nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia; rarely – gastrointestinal bleeding (vomiting of blood, melena, diarrhea with blood admixture), stomach and intestinal ulcers, accompanied or not accompanied by bleeding or perforation; in some cases-aphthous stomatitis, glossitis, esophageal damage, the appearance of diaphragmatic strictures in the intestines disorders of the distal colon, such as non – specific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn’s disease, constipation, pancreatitis; sometimes – increased levels of aminotransferases in the blood serum; rarely – hepatitis, accompanied or not accompanied by jaundice; in some cases – lightning-fast hepatitis.

From the central nervous system and peripheral nervous system:  sometimes-headache, dizziness; rarely-drowsiness; in some cases-sensitivity disorders, including paresthesia, memory disorders, disorientation, insomnia, irritability, convulsions, depression, anxiety, nightmares, tremors, psychotic reactions, aseptic meningitis.

From the side of the senses:  in some cases-visual disturbances (blurred vision, diplopia), hearing disorders, tinnitus, taste disorders.

From the cardiovascular system:  in some cases-palpitations, chest pain, increased blood pressure, worsening congestive heart failure.

Dermatological reactions:  sometimes-skin rashes; rarely-urticaria; in some cases-bullous rashes, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell’s syndrome (acute toxic epidermal necrolysis), erythroderma (exfoliative dermatitis), hair loss, photosensitivity reactions; purpura, including allergic.

From the urinary system:  rarely-edema; in some cases-acute renal failure, hematuria, proteinuria, interstitial nephritis; nephrotic syndrome; papillary necrosis.

From the hematopoietic system:  in some cases – thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.

Hypersensitivity reactions:  rarely-bronchospasm, systemic anaphylactic / anaphylactoid reactions, including hypotension; in some cases-vasculitis, pneumonitis.

Interaction

Voltaren can be administered together with oral hypoglycemic drugs and the effectiveness of the latter does not change. However, there are separate reports of the development of both hypoglycemia and hyperglycemia in such cases, which made it necessary to change the dose of hypoglycemic drugs against the background of the use of Voltaren.

Caution should be exercised when using NSAIDs less than 24 hours before the start of use or after the end of methotrexate therapy, as its level in the blood (and, consequently, toxicity) may increase.

The effect of NSAIDs on the activity of prostaglandins in the kidneys may increase the nephrotoxicity of cyclosporine.

There have been isolated reports of seizures in patients taking concomitant NSAIDs and quinolone antibacterial drugs.

How to take, course of use and dosage

For adults, the recommended starting dose is 100-150 mg / day. In relatively mild cases of the disease, as well as for long-term therapy,75-100 mg/day is sufficient. The frequency of application is 2-3 times. To relieve nighttime pain or morning stiffness, Voltaren is prescribed in suppositories before bedtime, in addition to the use of the drug in tablet form during the day; the total daily dose should not exceed 150 mg.

In primary dysmenorrhea, the daily dose is selected individually; usually it is 50-150 mg. The initial dose should be 50-100 mg; if necessary, for several menstrual cycles, it can be increased to 150 mg / day. Treatment should begin when the first symptoms appear. Depending on the dynamics of clinical symptoms, treatment can be continued for several days.

For a migraine attack, the initial dose is 100 mg. The drug is prescribed at the first symptoms of an approaching attack. If necessary, on the same day, you can additionally apply Voltaren in suppositories at a dose of up to 100 mg. If it is necessary to continue treatment in the following days, the daily dose of the drug should not exceed 150 mg (in several injections).

Children with a body weight of 25 kg or more are prescribed the drug at a dose of 0.5-2 mg / kg of body weight/day (the daily dose, depending on the severity of the manifestations of the disease, should be divided into 2-3 single doses). For the treatment of juvenile rheumatoid arthritis, the daily dose can be increased to a maximum of 3 mg / kg (in several injections).

Use of suppositories 50 mg and 100 mg in children is not recommended.

Special instructions

During the use of Voltaren, careful medical supervision is necessary for those patients who have complaints indicating gastrointestinal diseases; who have a history of ulcerative lesions of the stomach or intestines; who suffer from ulcerative colitis or Crohn’s disease, as well as who have impaired liver function.

During the use of Voltaren, as well as other NSAIDs, the level of one or more liver enzymes may increase. Therefore, monitoring of liver function is indicated as a precautionary measure during long-term therapy with Voltaren. If liver function disorders persist or worsen, or if there are clinical manifestations of liver disease or other symptoms (for example, eosinophilia, rash, etc. ), Voltaren should be discontinued. It should be borne in mind that hepatitis against the background of the use of Voltaren can occur without prodromal phenomena.

Caution is necessary when prescribing Voltaren to patients with hepatic porphyria, as the drug can provoke attacks of porphyria.

Since prostaglandins play an important role in maintaining renal blood flow, special care is required in the treatment of patients with impaired heart or kidney function, patients receiving diuretics, as well as patients who have a significant decrease in the volume of circulating blood plasma of any etiology, for example, in the period before and after massive surgical interventions. In these cases, monitoring of renal function is recommended as a precautionary measure during the use of Voltaren. Discontinuation of the drug usually leads to the restoration of renal function to the initial level. Caution should be exercised when using Voltaren in elderly patients. This is especially true for debilitated or low-weight elderly people; they are recommended to be prescribed the drug at the minimum effective dose.

When Voltaren is used, gastrointestinal bleeding may occur (for the first time or repeatedly) at any time, or ulceration/perforation of the gastrointestinal tract may develop, accompanied or not accompanied by precursor symptoms. More serious consequences of these complications may occur in elderly patients. In those rare cases where patients receiving Voltaren develop these complications, the drug should be discontinued.

When Voltaren is first used, as with other NSAIDs, allergic reactions, including anaphylactic and anaphylactoid reactions, may develop in rare cases. Voltaren, due to its pharmacodynamic properties, can mask the manifestations of infectious diseases. Voltaren, like other NSAIDs, can temporarily inhibit platelet aggregation. Therefore, in patients with hemostatic disorders, careful monitoring of appropriate laboratory parameters is necessary.

With prolonged use of Voltaren, as with other NSAIDs, systematic monitoring of the peripheral blood picture is indicated.

Form of production

Suppositories

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Diclofenac

Conditions of release from pharmacies

By prescription

Dosage form

rectal suppositories

Purpose

For adults as prescribed by a doctor, For pregnant women of the first and second trimester as prescribed by a doctor

Indications

Osteoarthritis, Lumbago, Osteoarthritis and Arthritis, Tendon Inflammation, Sciatica, Rheumatoid Arthritis, Swelling after injuries and operations, Periarthritis, Adnexitis, Gout, Bursitis