Voltaren - instructions for use, analogs, reviews and release forms (tablets and suppositories 25 mg, 50 mg and 100 mg retard, gel 1% Emulgel, injections in ampoules) for the treatment of inflammation in adults, children and pregnancy

In this article, you can read the instructions for using the drug Voltaren. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Voltaren in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Voltaren analogues with existing structural analogues. Use for the treatment of inflammatory and degenerative diseases of the musculoskeletal system in adults, children, as well as during pregnancy and lactation.

Voltaren - Non-steroidal anti-inflammatory drug. Voltaren contains Diclofenac sodium (the active substance of the drug), a substance of non-steroidal structure, which has a pronounced anti-inflammatory, analgesic and antipyretic effect.

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

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 rest and movement pain, morning stiffness and swelling of the joints, as well as an improvement in the functional state.

In post-traumatic and post-operative inflammatory phenomena, Voltaren quickly reduces pain (arising both at rest and during movement), reduces inflammatory edema and swelling of the postoperative wound.

When Voltaren was used in tablets and suppositories, a pronounced analgesic effect of the drug was noted with moderate and severe pain of non-rheumatic origin.When applying the drug in the form of a solution for intravenous administration, the effect of the drug occurs in 1-15 minutes. It was also found that Voltaren is able to reduce pain and reduce blood loss in primary dysmenorrhea.

In addition, Voltaren facilitates migraine attacks (when used in suppositories).

Pharmacokinetics

After ingestion of tablets coated with enteric-coated shell, diclofenac is completely absorbed from the intestine. Although absorption is rapid, its onset may be delayed due to the presence of an enteric-soluble coating in the tablet. The degree of absorption is directly proportional to the dose. In the case of taking Voltaren Tablets during or after meals, passing it through the stomach slows down (compared with the reception on an empty stomach), but the amount of absorbable diclofenac does not change. After repeated administration of the drug, pharmacokinetics do not change. When observing the recommended dosage regimen of the drug, cumulation is not noted.

Absorption of Voltaren from rectal suppositories begins quickly, although the rate of its absorption is lower in comparison with the same index for oral administration of tablets,coated with enteric coating. With repeated injections of the drug in the form of suppositories, pharmacokinetic parameters do not change. Provided that the recommended dosage regimen of the drug cumulation is not noted.

After intramuscular introduction of Voltaren in a dose of 75 mg, his absorption begins immediately. The degree of absorption is directly proportional to the dose. With subsequent administration of the drug, pharmacokinetic parameters do not change. Provided that the recommended intervals between injections of the drug cumulation is not noted.

About 60% of the dose is excreted in the urine in the form of glucuronic conjugates of unchanged active substance, as well as in the form of metabolites, most of which are also glucuronic conjugates. Unchanged, less than 1% of diclofenac is excreted. The rest of the dose is excreted as metabolites with bile.

After taking the drug inside the differences in absorption, metabolism or excretion of the drug, associated with the age of patients, is not noted. In children, diclofenac concentrations in blood plasma when taking equivalent doses of the drug (mg / kg body weight) are similar to those in adults.

Indications

• inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, ankylosing spondylitis, spondyloarthritis, osteoarthritis, juvenile rheumatoid arthritis (for enteric coated tablets, 25 mg and 50 mg or rectal 25 mg suppositories);
• inflammatory and degenerative forms of rheumatic diseases: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis (for a solution for intravenous administration);
• spine diseases accompanied by pain syndrome;
• rheumatic diseases of extraarticular soft tissues;
• acute attack of gout (for tablets covered with enteric-coated shell and solution for intravenous administration);
• renal colic (for solution for intravenous administration);
• biliary colic (for solution for intravenous administration);
• post-traumatic and postoperative pain syndromes, accompanied by inflammation and edema;
• gynecological diseases accompanied by pain syndrome and inflammation (eg, primary algodismenorea, adnexitis);
• as an additional remedy for severe infectious and inflammatory diseases of the ear, throat and nose, which occur with severe pain syndrome, for example,at a pharyngitis, a tonsillitis, an otitis (with exception of tablets of the prolonged action). 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;
• migraine attacks (for suppositories);
• severe migraine attacks (for a solution for the / m administration).

Intramuscular injection of the drug is particularly preferred at the onset of exacerbations of inflammatory and degenerative diseases with high inflammation activity and pain conditions caused by inflammation of non-rheumatic genesis.

Forms of release

The tablets covered with a cover, soluble in an intestine of 25 mg and 50 mg (Rapid).

Tablets, coated with a shell, prolonged action of 100 mg (retard).

Candles for rectal administration 25 mg, 50 mg and 100 mg.

Solution for intramuscular injection (injections in ampoules for injection) 25 mg / ml.

Gel for external use 1% Voltaren Emulgel.

Eye drops 0.1% Voltaren Ophtha.

Voltaren Akti (tablets of Diclofenac potassium).

Forms of release in the form of an ointment does not exist, perhaps it is a fake or other drug based on Diclofenac.

Instructions for use and dosage

Intestinal-coated tablets

Tablets should be swallowed whole, washed down with liquid, preferably before meals.

For adults, the recommended initial dose is 100-150 mg per day. In relatively mild cases of the disease, as well as for long-term therapy, 75-100 mg per day is sufficient. The daily dose should be divided into several receptions. If necessary, to work on night pain or morning stiffness, in addition to taking the drug during the day, Voltaren is prescribed as a suppository before bedtime; while the total daily dose should not exceed 150 mg.

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

Children with a body weight of more than 25 kg prescribe the drug in a dose at the rate of 0.5-2 mg / kg body weight per day (in 2-3 divided doses, depending on the severity of the disease). For the treatment of rheumatoid arthritis, the daily dose can be maximally increased to 3 mg / kg (in several doses).

Use tablets coated with enteric-coated shell, 50 mg in children is not recommended.

The tablets of the prolonged action covered with a cover

Tablets should be swallowed whole, preferably with food.

For adults, the recommended initial dose is 100 mg (1 tablet of prolonged action) per day. The same dose is used in relatively mild cases of the disease, as well as for long-term therapy. In those cases where the symptoms of the disease are most pronounced at night or in the morning, prolonged-release tablets should be taken at night.

Do not administer prolonged-action tablets to children.

Rectal Candles

For adults, the recommended initial dose is 100-150 mg per day. In relatively mild cases of the disease, as well as for long-term therapy, 75-100 mg per day is sufficient. Multiplicity of application - 2-3 times. To alleviate night pain or morning stiffness, Voltaren is prescribed in suppositories before bedtime, in addition to using the drug in the form of tablets during the day; while the total daily dose should not exceed 150 mg.

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

With a migraine attack, the initial dose is 100 mg. The drug is prescribed for the first symptoms of an approaching attack. If necessary, on the same day, Voltaren can additionally be used in suppositories in 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 administrations).

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

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

Solution for intramuscular injection

Voltaren is injected by deep injection into the gluteus muscle.Do not use Voltaren's injections for more than 2 consecutive days. If necessary, treatment can be continued with Voltaren in the form of tablets or rectal suppositories.

When conducting an injection in order to avoid damage to the nerve or other tissues, it is recommended to inject the drug deep in the / m in the upper outer quadrant of the gluteal region.

The dose is usually 75 mg (the contents of 1 ampoule) once a day.

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

In migraine attacks, the best result is achieved if Voltaren is administered as early as possible after the onset of an attack, IM at a dose of 75 mg, followed by the use of suppositories at a dose of up to 100 mg on the same day, if required. The total daily dose should not exceed 175 mg on the first day.

Gel

The drug is used externally.

Adults and children over 12 years of age, the drug is applied to the skin 3-4 times a day and lightly rubbed. The required amount of the drug depends on the size of the painful area. A single dose of the drug is 2-4 g (which is comparable in volume to the size of a cherry or walnut, respectively). After applying the product, the hands should be washed.

The duration of treatment depends on the indications and effectiveness of therapy (to enhance the effect, the gel can be used together with other Voltaren dosage forms). After 2 weeks from the beginning of therapy it is recommended to evaluate the feasibility of further use of the drug.

Side effect

• pain in the epigastric region;
• nausea, vomiting;
• diarrhea;
• cramps in the abdomen;
• dyspepsia;
• flatulence;
• anorexia;
• gastrointestinal bleeding (vomiting of blood, melena, diarrhea with an admixture of blood);
• ulcers of the stomach and intestines, accompanied or not accompanied by bleeding or perforation;
• aphthous stomatitis;
• glossitis;
• damage to the esophagus;
• nonspecific hemorrhagic colitis;
• exacerbation of ulcerative colitis or Crohn's disease;
• constipation;
• headache;
• dizziness;
• drowsiness;
• sensitivity disorders, including paresthesia;
• memory disorders;
• insomnia;
• irritability;
• convulsions;
• depression;
• feeling of anxiety;
• visual impairment (blurred vision, diplopia);
• hearing impairment;
• noise in ears;
• violation of taste;
• pain in the chest;
• increased blood pressure;
• skin rash;
• hives;
• eczema;
• erythema multiforme;
• hair loss;
• edema;
• hematuria (blood in the urine);
• Thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis;
• bronchospasm;
• systemic anaphylactic / anaphylactoid reactions, including arterial hypotension;
• abscesses, necrosis (with intramuscular injection).

Contraindications

• an ulcer of the stomach or intestines;
• history of asthma attacks, hives, 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);
• children and adolescents under 18 years (for solution for intravenous administration);
• hypersensitivity to diclofenac and any other ingredients of the drug.

Solution for the / m introduction is not prescribed during pregnancy.

Application in pregnancy and lactation

The use of Voltaren in pregnancy is only possible when the expected benefit to the mother exceeds the potential risk to the fetus. The drug is prescribed in the minimum effective dose. As with other prostaglandin synthetase inhibitors, these recommendations are especially important in the 3rd trimester of pregnancy (possibly suppressing the contractility of the uterus and premature closure of the arterial duct in the fetus).

The use of Voltaren in the form of a solution for intramuscular injection during pregnancy is not recommended.

When Voltaren is ingested at a dose of 50 mg every 8 hours, diclofenac penetrates into breast milk, but in so small a quantity that there is no reason to expect any undesirable phenomena in the infant breastfed.

If it is necessary to prescribe Voltaren in the form of a solution for intravenous administration during lactation, the question of stopping breastfeeding should be resolved.

special instructions

During the application of Voltaren, careful medical supervision of those patients who have complaints indicating GI disease is necessary; who have information in the history of ulcerative lesions of the stomach or intestines;suffering from ulcerative colitis or Crohn's disease, as well as those with impaired liver function.

During the application of Voltaren, as well as other NSAIDs, the level of one or more liver enzymes may increase. Therefore, with prolonged therapy Voltaren as a precautionary measure shows control of liver function. If violations from the functional indicators of the liver persist or worsen, or if there are clinical manifestations of liver disease or other symptoms (including eosinophilia, rash), Voltaren should be discarded. It should be borne in mind that hepatitis against the background of the use of Voltaren may occur without prodromal phenomena.

Caution is necessary for the appointment of Voltaren with a patient with hepatic porphyria; the drug can provoke porphyria attacks.

Because prostaglandins play an important role in maintaining renal blood flow, particular caution is required in patients with impaired cardiac or renal function, patients receiving diuretics, and patients who have a significant decrease in the volume of blood plasma circulating any etiology, for example, in the period up to and after massive surgical interventions.In these cases, during the application of Voltaren, monitoring of renal function is recommended as a precautionary measure. Discontinuation of the drug usually leads to the restoration of kidney function to the baseline level.

Caution should be exercised when using Voltaren in elderly patients. This is especially true in weakened or low-weight elderly people; they are recommended to prescribe the drug at the lowest effective dose.

Particular care should be taken with the introduction of Voltaren in patients with bronchial asthma, because of the risk of increasing the severity of the symptoms of the disease.

On the background of the application of Voltaren at any time, gastrointestinal bleeding may occur (for the first time or repeatedly) or ulceration / perforation of the gastrointestinal tract, accompanied or not accompanied by symptoms-precursors. More serious consequences of these complications can be observed in elderly patients. In those rare cases in which patients who receive Voltaren develop these complications, the drug should be withdrawn.

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

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

Voltaren, as well as other NSAIDs, may temporarily inhibit platelet aggregation. Therefore, patients with hemostasis disorders need careful monitoring of relevant laboratory parameters.

With prolonged use of Voltaren, as well as other NSAIDs, a systematic control of the picture of peripheral blood is shown.

Impact on the ability to drive vehicles and manage mechanisms

Patients who, with Voltaren's onset, experience dizziness or other abnormalities from the CNS, including visual impairment, should not drive or operate machinery during the period of application.

Drug Interactions

Voltaren can increase the concentration of lithium and Digoxin in the plasma with simultaneous application 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).

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

Although the clinical studies have not established the influence of Voltaren on the effect of anticoagulants, there are some reports of an increased risk of bleeding in cases of their joint application. It is recommended to closely monitor patients receiving these drugs at the same time.

Voltaren may be prescribed in association with oral hypoglycemic agents, and the efficacy of the latter is not affected. However, some reports of development in such cases as hypoglycemia and hyperglycemia are known, which necessitated a change in the dose of hypoglycemic drugs against the background of Voltaren.

Caution should be exercised when using NSAIDs less than 24 hours before the application or after the end of Methotrexate therapy. its concentration in the blood (and, consequently, toxicity) may increase.

The effect of NSAIDs on the activity of prostaglandins in the kidneys can enhance the nephrotoxicity of cyclosporine.

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

Pharmaceutical interaction

Do not mix Voltaren solution contained in ampoules with solutions of other drugs for injection.

Analogs of the drug Voltaren

Structural analogs for the active substance:

• Artrex;
• Beliefed;
• Voltaren Akti;
• Voltaren Ophtha;
• Voltaren Rapid;
• Voltaren Emulgel;
• Diklak Lipogel;
• Diklak;
• Diklobene;
• Dicluberl;
• Diqlovit;
• Diklogen;
• Diclomax;
• Diclomelan;
• Diclonac;
• Diclonate;
• Dicloran;
• Diclorium;
• Diclofen;
• Diclofenac;
• Diclofenac bufus;
• Diclofenac of potassium;
• Diclofenac sodium;
• Diclofenac retard;
• Diclofenac Sandoz;
• Diclofenac Stade;
• Diclofenac-AKOS;
• Diclofenac-Acry;
• Diclofenac-Altpharm;
• Diclofenac-ratopharm;
• Diclofenac-UBF;
• Diclofenac-FPO;
• Diclofenac-Eskom;
• Diclofenaclong;
• Diclofenacol;
• Diphene;
• Dorosan;
• Naklof;
• Naklofen;
• Sodium diclofenac;
• Orthophene;
• Orthofer;
• Orthoflex;
• Revmavek;
• Remetan;
• Sanfinak;
• SwissSet;
• Feloran;
• Flotac.

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