Voltaren
Use during pregnancy and breastfeeding
There is insufficient data on the safety of diclofenac in pregnant women.
Therefore, Voltaren® should be prescribed in the first and second trimesters of pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Voltaren®, like other inhibitors of prostaglandin synthesis, is contraindicated in the last 3 months of pregnancy (possible suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus). Despite the fact that the drug Voltaren®, like other NSAIDs, passes into breast milk in small quantities, the drug should not be prescribed to nursing women to prevent undesirable effects on the child. If it is necessary for a nursing woman to use the drug, stop breastfeeding.
Since Voltaren®, like other NSAIDs, can have a negative effect on fertility, women planning pregnancy are not recommended to take the drug.
For patients undergoing examination and treatment for infertility, the drug should be discontinued.
Use for liver dysfunction
During the period of use of the drug Voltaren®, an increase in the activity of one or more liver enzymes may be observed; with long-term therapy with the drug, monitoring of liver function is indicated as a precautionary measure. If liver dysfunction persists and progresses or signs of liver disease or other symptoms (for example, eosinophilia, rash, etc.) occur, the drug should be discontinued. It should be borne in mind that hepatitis during the use of the drug Voltaren® can develop without prodromal phenomena.
Use for renal impairment
During therapy with Voltaren®, it is recommended to monitor renal function in patients with hypertension, impaired cardiac or renal function, the elderly, patients receiving diuretics or other drugs that affect renal function, as well as in patients with a significant decrease in the volume of circulating blood plasma of any etiology, for example, during the period before and after major surgical interventions. After discontinuation of drug therapy, normalization of renal function indicators to pre-baseline values is usually observed.
Use in children
The drug in this dosage should not be used in children and adolescents under 18 years of age.
special instructions
Gastrointestinal tract damage:
When using diclofenac, phenomena such as bleeding or ulceration/perforation of the gastrointestinal tract, in some cases with fatal outcome, were observed. These events may occur at any time when using drugs in patients with or without previous symptoms and a history of serious gastrointestinal diseases. In older patients, such complications can have serious consequences. If bleeding or gastrointestinal ulceration develops in patients receiving Voltaren®, the drug should be discontinued. To reduce the risk of toxic development of gastrointestinal complications, as well as in patients receiving therapy with low doses of acetylsalicylic acid (Aspirin) or other drugs that can increase the risk of gastrointestinal damage, gastroprotectors (for example, proton pump inhibitors or misoprostol) should be taken. Patients with a history of gastrointestinal lesions, especially the elderly, should report all symptoms of the digestive system to the doctor.
Patients with bronchial asthma
Exacerbation of asthma (NSAID intolerance/NSAID-induced asthma), angioedema and urticaria are most often observed in patients suffering from bronchial asthma, seasonal allergic rhinitis, nasal polyps, COPD or chronic infectious diseases of the respiratory tract (especially those associated with allergic rhinitis-like symptoms). In this group of patients, as well as in patients with allergies to other drugs (rash, itching or urticaria), special caution should be observed when using the drug Voltaren® (preparedness for resuscitation measures).
Skin reactions
Serious dermatological reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in some cases fatal, have been reported very rarely with the use of diclofenac. The highest risk and incidence of severe dermatological reactions were observed in the first month of treatment with diclofenac. If patients receiving Voltaren® develop the first signs of skin rash, damage to the mucous membranes or other symptoms of hypersensitivity, the drug should be discontinued. In rare cases, in patients who are not allergic to diclofenac, anaphylactic/anaphylactoid reactions may develop when using Voltaren®.
Effects on the liver
Since during the period of use of the drug Voltaren® there may be an increase in the activity of one or more liver enzymes, during long-term therapy with the drug, monitoring of liver function is indicated as a precaution. If liver dysfunction persists and progresses or signs of liver disease or other symptoms (for example, eosinophilia, rash, etc.) occur, the drug should be discontinued. It should be borne in mind that hepatitis during the use of the drug Voltaren® can develop without prodromal phenomena.
Effects on the kidneys
During therapy with Voltaren®, it is recommended to monitor renal function in patients with hypertension, impaired cardiac or renal function, the elderly, patients receiving diuretics or other drugs that affect renal function, as well as in patients with a significant decrease in the volume of circulating blood plasma of any etiology , for example, in the period before and after major surgical interventions. After discontinuation of drug therapy, normalization of renal function indicators to pre-baseline values is usually observed.
Effects on the cardiovascular system
NSAID therapy, incl. Diclofenac, particularly long-term and high-dose therapy, may be associated with a small increase in the risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke).
In patients with diseases of the cardiovascular system and a high risk of developing diseases of the cardiovascular system (for example, with arterial hypertension, hyperlipidemia, diabetes mellitus, smokers), the drug should be used with extreme caution, at the lowest effective dose for the shortest possible duration of treatment, since the risk of thrombotic complications increases with increasing dose and duration of treatment. With long-term therapy (more than 4 weeks), the daily dose of diclofenac in such patients should not exceed 100 mg. The effectiveness of treatment and the patient's need for symptomatic therapy should be periodically assessed, especially in cases where its duration is more than 4 weeks. When the first symptoms of thrombotic disorders appear (for example, chest pain, feeling short of breath, weakness, speech impairment), the patient should immediately seek medical help.
Impact on the hematopoietic system
Voltaren® may temporarily inhibit platelet aggregation. Therefore, in patients with hemostasis disorders, it is necessary to carefully monitor relevant laboratory parameters. With long-term use of the drug Voltaren®, it is recommended to conduct regular clinical tests of peripheral blood.
Masking signs of an infectious process
The anti-inflammatory effect of the drug Voltaren® may complicate the diagnosis of infectious processes.
Use simultaneously with other NSAIDs
Voltaren® should not be used concomitantly with NSAIDs, including selective COX-2 inhibitors, due to the risk of increased adverse events.
Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions (driving vehicles, working with moving mechanisms, etc.)
Patients who experience visual disturbances, dizziness, drowsiness, vertigo or other central nervous system disorders while using the drug Voltaren® should not drive vehicles or operate machinery.
Voltaren®
Enteric-coated tablets
The tablets should be swallowed whole with liquid, preferably before meals.
For adults
The recommended initial 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 daily dose should be divided into several doses. If it is necessary to treat night pain or morning stiffness, in addition to taking the drug during the day, Voltaren® is prescribed in the form of suppositories before bedtime; in this case, the total daily dose should not exceed 150 mg.
With primary dysmenorrhea
the daily dose is selected individually; usually it is 50-150 mg. The initial dose should be 50-100 mg; if necessary, over several menstrual cycles it can be increased to 150 mg/day. The drug should be started when the first symptoms appear. Depending on the dynamics of clinical symptoms, treatment can be continued for several days.
Children weighing ≥ 25 kg
the drug is prescribed at 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 can be increased to a maximum of 3 mg/kg (in several doses).
Use enteric-coated tablets, 50 mg in children
Not recommended.
Extended-release film-coated tablets
The tablets should be swallowed whole, preferably with meals.
For adults
The recommended initial dose is 100 mg (1 tablet of prolonged action)/day. The same dose is used in relatively mild cases of the disease, as well as for long-term therapy. In cases where the symptoms of the disease are most pronounced at night or in the morning, it is advisable to take extended-release tablets at night.
Long-acting tablets should not be given to children
.
Rectal suppositories
For adults
The recommended initial 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. Frequency of application - 2-3 times. To relieve night pain or morning stiffness, Voltaren® is prescribed in suppositories before bedtime, in addition to taking the drug in tablet form during the day; in this case, the total daily dose should not exceed 150 mg.
With primary dysmenorrhea
the daily dose is selected individually; usually it is 50-150 mg. The initial dose should be 50-100 mg; if necessary, over 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.
During 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 subsequent days, the daily dose of the drug should not exceed 150 mg (in several administrations).
Children weighing ≥ 25 kg
the drug is prescribed at a dose of 0.5-2 mg/kg body weight/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 increased to a maximum of 3 mg/kg (in several administrations).
Use suppositories 50 mg and 100 mg in children
Not recommended.
Solution for intramuscular administration
Voltaren® is administered by deep injection into the gluteal muscle. Voltaren injections should not be used for more than 2 days in a row. If necessary, treatment can be continued with Voltaren in the form of tablets or rectal suppositories.
When performing an IM injection, in order to avoid damage to the nerve or other tissues, it is recommended to inject the drug deep IM into 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, colic)
as an exception, 2 injections of 75 mg each can be given, several hours apart (the second injection should be given in the opposite gluteal region). Alternatively, one injection of the drug per day (75 mg) can be combined with other dosage forms of Voltaren (tablets, rectal suppositories), and the total daily dose should not exceed 150 mg.
For migraine attacks
the best result is achieved if Voltaren® is administered as early as possible after the onset of the 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.
VOLTAREN solution for intramuscular administration 25 mg/ml amp. 3ml No.5
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, damage to the esophagus, the occurrence of diaphragm-like strictures in the intestine, disorders of the distal colon, such as nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease, constipation, pancreatitis, fulminant 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, tremor, psychotic reactions, aseptic meningitis. From the senses: In some cases - visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, disturbances in taste. From the cardiovascular system: In some cases - a feeling of 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 - swelling. 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. Local reactions: Induration, pain. In some cases - abscesses, necrosis. The listed side effects were observed, incl. when using doses of the drug and duration of treatment that differ from those recommended.
Instructions for use VOLTAREN®
During treatment with Voltaren, gastrointestinal bleeding may occur at any time or a gastrointestinal ulcer may develop, sometimes complicated by perforation; Moreover, there are not always symptoms that are harbingers of these complications or an indication in the anamnesis of ulcerative lesions. More serious consequences of these complications may occur in older patients. In those rare cases where these complications develop in patients receiving Voltaren, the drug should be discontinued.
In a patient who has not previously received Voltaren, during treatment with the drug, as well as during therapy with other NSAIDs, allergic reactions, including anaphylactic and anaphylactoid reactions, may in rare cases develop.
Voltaren, due to its pharmacodynamic properties, can mask complaints and symptoms characteristic of infectious and inflammatory diseases.
It is possible to develop hypersensitivity reactions to sodium metabisulfite, which is part of the injection solution.
During the use of Voltaren, careful medical monitoring is necessary for patients with symptoms of gastrointestinal diseases and a history of ulcerative lesions of the stomach or intestines; those suffering from ulcerative colitis or Crohn's disease, as well as those with impaired liver function.
During the use of Voltaren, as well as other NSAIDs, the level of one or more liver enzymes may increase. Therefore, during long-term therapy with Voltaren, regular liver function testing is indicated as a precaution. If abnormalities in liver function parameters persist or worsen, or if complaints or symptoms indicating liver disease develop, as well as if other side effects occur (including eosinophilia, rash), Voltaren should be discontinued. It must be borne in mind that hepatitis during the use of Voltaren can occur without prodromal phenomena.
Caution is necessary when prescribing Voltaren to patients with hepatic porphyria, because the drug can provoke attacks of porphyria.
Since prostaglandins play an important role in maintaining renal blood flow, special caution is required when treating patients with impaired cardiac or renal function, elderly patients, patients receiving diuretics, as well as patients who have a significant decrease in blood volume of any etiology, for example, during before and after major surgical interventions. In these cases, during the use of Voltaren, regular monitoring of renal function is recommended as a precautionary measure. Discontinuation of the drug usually results in renal function returning to baseline levels.
With long-term use of Voltaren, like other NSAIDs, systematic monitoring of peripheral blood patterns is indicated.
Voltaren, like other NSAIDs, may temporarily inhibit platelet aggregation. Therefore, in patients with hemostasis disorders, careful monitoring of relevant laboratory parameters is necessary.
Taking into account general medical provisions, caution when using Voltaren is also necessary in elderly patients. This is especially true in frail or low-weight elderly people; they are recommended to prescribe the drug at the minimum effective dose.
Particular caution should be observed when administering Voltaren intramuscularly to patients with bronchial asthma (due to the risk of increasing the severity of symptoms of the disease), as well as to patients with allergic rhinitis (including seasonal) and polyps of the nasal mucosa.
Impact on the ability to drive vehicles and operate machinery
Patients who experience dizziness or other unpleasant sensations from the central nervous system, including visual disturbances, while using Voltaren, should not drive a car or operate machinery.
