VOLTAREN AMPOULES 75MG 3ML

elease form

Solution for intramuscular injection.

Packaging

In 1 ampoule 3 ml of solution. In the package 5 ampoules.

5 pieces

Pharmacology

NSAIDs. Voltaren contains Diclofenac sodium, a nonsteroidal substance that has a pronounced anti-inflammatory, analgesic and antipyretic effect.

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

In vitro, diclofenac sodium at 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 decrease in the severity of such manifestations of diseases as pain at rest and on movement, morning stiffness and swelling of the joints, as well as an improvement in functional status.

In post-traumatic and postoperative inflammatory events, Voltaren quickly relieves pain (arising both at rest and when moving), reduces inflammatory swelling and swelling of a postoperative wound.

Indications

• inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, osteoarthritis;
• abdominal pain, accompanied by pain;
• rheumatic diseases of extra-articular soft tissue;
• acute attack of gout (only for enteric-coated tablets);
• post-traumatic and postoperative pain syndromes accompanied by inflammation and swelling;
• gynecological diseases accompanied by pain and inflammation (for example, primary algomenorrhea, adnexitis);
• as an additional remedy for severe infectious and inflammatory diseases of the ear, nose and throat, occurring with severe pain, for example, pharyngitis, tonsillitis, otitis media (except for retard tablets). The main treatment of the disease is carried out in accordance with generally accepted principles, incl. with the use of etiotropic therapy. Isolated fever is not an indication for the use of the drug

V / m administration of the drug is particularly preferable at the onset of exacerbations of inflammatory and degenerative diseases with a high activity of inflammation and in painful conditions caused by inflammation of non-rheumatic genesis.

Contraindications

• a stomach or intestinal ulcer;
• anamnestic information about attacks of asthma, urticaria, acute rhinitis associated with the use of Acetylsalicylic acid or other NSAIDs, as well as any drugs that suppress the production of prostaglandins;
• proctitis (only for suppositories);
• blood disorders;
• children's age up to 14 years;
• Hypersensitivity to diclofenac and any other ingredients of the drug.

Pregnanacy and breastfeeding

Application Voltarena during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

The drug is prescribed in the minimum effective dose. As in the case of the use of other prostaglandin synthetase inhibitors, these recommendations are especially important in the third trimester of pregnancy (suppression of uterine contractility and premature closure of the arterial duct in the fetus are possible).

The use of Voltaren in the form of a solution for i / m administration during pregnancy is not recommended.

If necessary, the appointment of Voltaren in the form of a solution for the / m introduction during lactation should decide on the termination of breastfeeding.

Special notes

During application Voltarena careful medical observation of patients who have complaints indicating gastrointestinal diseases is necessary; having a history of ulcerative lesions of the stomach or intestines; suffering from ulcerative colitis or Crohn's disease, as well as having impaired liver function.

Against the background of Voltaren's use, Gastrointestinal bleeding may occur (for the first time or again) or develop ulceration / perforation of the gastrointestinal tract, accompanied by or not accompanied by precursor symptoms. More serious consequences of these complications may occur in elderly patients.In those rare cases where these complications develop in patients receiving Voltaren, the drug should be discontinued.

The first use of Voltaren, as well as other NSAIDs, in rare cases may develop allergic reactions, including anaphylactic and anaphylactoid reactions.

Voltaren, due to its pharmacodynamic properties, can mask the manifestations of infectious diseases.

Voltaren, as well as other NSAIDs, can temporarily inhibit platelet aggregation. Therefore, in patients with impaired hemostasis, careful monitoring of relevant laboratory parameters is necessary.

With long-term use of Voltaren, like other NSAIDs, systematic monitoring of the pattern of peripheral blood is shown.

Influence on ability to drive motor transport and control mechanisms:

Patients who develop dizziness or other disorders of the central nervous system, including visual impairment during the use of Voltaren, should not drive a car or operate machinery during the period of use of the drug.

Active ingredient

1 ml of solution contains diclofenac (in the form of sodium salt) - 25 mg (1 ampoule - 75 mg);
Excipients: mannitol, sodium disulfite, benzyl alcohol, propylene glycol, water d / i, sodium hydroxide.

Dosage and administration

Intramuscularly.

Voltaren administered by deep injection into the gluteus maximus muscle. Do not use Voltarena injections for more than 2 days in a row.If necessary, treatment can be continued by Voltarenum in the form of pills or rectal suppositories.

When conducting intramuscular injections in order to avoid damage to the nerve or other tissues, it is recommended to inject the drug deeply in intramuscular in the upper outer quadrant of the gluteal region.

The dose is usually 75 mg (contents of 1 ampoule) 1 time / day.

In severe cases (for example, with colic) as an exception, 2 injections of 75 mg can be given, with an interval of several hours (the second injection should be carried out in the opposite gluteal region). Alternatively, a single injection of the drug per day (75 mg) can be combined with taking other Voltaren dosage forms (tablets, rectal suppositories), and the total daily dose should not exceed 150 mg.

Adverse effects

When assessing the frequency of occurrence of various adverse reactions used the following gradations:

Often -> 10%.

Sometimes -> 1-10%.

Rarely -> 0.001-1%.

In some cases - <0.001%.

From the digestive system:

Sometimes - pain in the epigastric region, nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia, increased activity of aminotransferases in the blood serum.

Rarely - gastrointestinal bleeding (vomiting blood, melena, diarrhea mixed with blood), stomach and intestinal ulcers, accompanied or not accompanied by bleeding or perforation, hepatitis, accompanied or not accompanied by jaundice.

In some cases - aphthous stomatitis, glossitis, esophageal damage, diaphragm-like strictures in the intestine, distal colon disorders, such as nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn’s disease, constipation, pancreatitis, and fulminant hepatitis.

From the side of 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, tremor, psychotic reactions, aseptic meningitis .

From the senses:

In some cases - visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, taste disturbances.

Since the cardiovascular system:

In some cases - a feeling of heartbeat, chest pain, increased blood pressure, aggravation of congestive heart failure .

Dermatological reactions:

Sometimes - skin rashes.

Rarely - urticaria.

In some cases - bullous rash, 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 - swelling.

In some cases, acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

From the hemopoietic 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.

Local reactions:

Compaction, pain.

In some cases - abscesses, necrosis.

The listed side effects were observed including. with the use of doses of the drug and the duration of treatment, different from the recommended.

Drug interaction

Voltaren may increase the concentration of lithium and Digoxin in plasma with simultaneous use with these drugs.

Voltaren, like other NSAIDs, can reduce the effect of diuretics. The simultaneous use of Voltaren with potassium-sparing diuretics can lead to an increase in the level of potassium in the blood (in the case of such a combination of drugs, this indicator should often be monitored).

Simultaneous use of Voltaren with other NSAIDs may increase the risk of side effects.

Although clinical studies have not established the effect of Voltaren on the effect of anticoagulants, there are some reports of an increased risk of bleeding in cases of their joint use.Careful observation of patients receiving these drugs at the same time is recommended.

Voltaren can be prescribed together with oral hypoglycemic drugs and at the same time the effectiveness of the latter does not change. However, there are individual reports of the development in such cases of both hypoglycemia and hyperglycemia, which necessitated a change in the dose of hypoglycemic drugs during the use of Voltaren.

Caution should be exercised when using NSAIDs less than 24 hours before the start of application or after the end of therapy with Methotrexate, because its blood level (and therefore toxicity) may increase.

The effect of NSAIDs on kidney prostaglandin activity may increase cyclosporine nephrotoxicity.

There are isolated reports of seizures in patients who took both NSAIDs and quinolone antibacterial drugs.

Typical clinical picture characteristic of overdose Voltaren, does not exist.

Symptoms: decrease in blood pressure, renal failure, convulsions, disorders of the gastrointestinal tract and respiratory depression.

Treatment: supportive and symptomatic. It is unlikely that forced diuresis, hemodialysis or hemoperfusion will be useful for removing NSAIDs, becauseThe active substances of these drugs are largely associated with plasma proteins and are extensively metabolized.

Store in a dark place at a temperature not exceeding 30 ° C.