Diclofenac-Teva solution for injectioan 75mg/3ml 5pcs — Made in Germany — Free Delivery

(Diclofenac-Teva)

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Description Diclofenac-Teva solution for injectioan 75mg/3ml 5pcs — Made in Germany — Free Delivery

Pharmacological properties

Pharmacodynamics. Diclofenac-Teva is a non-steroidal preparation with pronounced analgesic / anti-inflammatory properties, inhibits cog. diclofenac sodium in vitro at concentrations equivalent to those achieved in humans does not inhibit the biosynthesis of proteoglycans in cartilage tissue in humans. If the preparation is used to relieve postoperative pain concurrently with opioids, it significantly reduces the need for opioids.

Pharmacokinetics. Absorption. After the introduction of 75 mg of diclofenac by intramuscular injection, absorption begins immediately, and the average Cmax in blood plasma, which is ≈2.558 ± 0.968 μg / ml (2.5 μg / ml = 8 μmol / L), is reached after about 20 minutes. The volume of absorption is linearly proportional to the dose.

In the case when 75 mg of diclofenac is administered by intravenous infusion for 2 hours, the average Cmax in blood plasma is approximately 1.875 ± 0.436 μg / ml (1.9 μg / ml = 5.9 μmol / L). A shorter infusion time leads to a higher Cmax in blood plasma, while longer infusions lead to a concentration plateau proportional to the infusion rate after 3-4 hours. In contrast to the corresponding results of oral administration, in the case of using the preparation in the form of suppositories or in / m of administration, the concentration in the blood plasma decreases rapidly immediately after reaching the maximum levels.

Bioavailability. AUC after i / m or i / v administration is approximately double that after oral or rectal administration, because this route avoids first pass metabolism through the liver.

Distribution. 99.7% of diclofenac binds to proteins, mainly albumin (99.4%).

Diclofenac penetrates into the synovial fluid, where Cmax is established 2-4 hours after reaching the peak value in blood plasma. The expected T1 / 2 from the synovial fluid is 3-6 hours. 2 hours after reaching Cmax in the blood plasma, the concentration of diclofenac in the synovial fluid exceeds that in the blood plasma and remains higher for 12 hours.

Diclofenac was detected at a low concentration (100 ng / ml) in breast milk in one woman who was breastfeeding. The estimated amount of the preparation that enters the infant's body with breast milk is equivalent to 0.03 mg / kg / day.

Metabolism. Diclofenac biotransformation occurs partly by glucuronization of an intact molecule, but mainly by single and multiple hydroxylation and methoxylation, which leads to the formation of several phenolic metabolites, most of which are converted to the glucuronide conjugate. Two of these phenolic metabolites are biologically active, but their effect is much less pronounced than that of diclofenac.

Excretion. The total systemic plasma clearance of diclofenac is 263 ± 56 ml / min (mean ± SD). The final T1 / 2 from blood plasma reaches 1-2 hours. Four metabolites, including two active ones, also have a short T1 / 2 from blood plasma - 1-3 hours.

Approximately 60% of the administered dose is excreted in the urine as a glucuronide conjugate of an intact molecule and as metabolites, most of which are also converted to glucuronide conjugates. Less than 1% is excreted as unchanged substance. The remainder of the dose is eliminated in the form of metabolites in the feces.

Special patient groups. Elderly patients. There were no differences in absorption, metabolism or excretion of the preparation depending on the patient's age, except that in 5 elderly patients, a 15-minute intravenous infusion led to a plasma concentration of 50% higher than that in young healthy volunteers ...

Patients with impaired renal function. In patients with impaired renal function, if the usual dosage regimen is observed, accumulation of the unchanged active substance can not be expected, based on the kinetics of the preparation after a single use. Assuming a creatinine clearance of 10 ml / min, the levels of hydroxymetabolites in the blood plasma are approximately 4 times higher than in healthy volunteers. However, metabolites are finally excreted in the bile.

Patients with liver disease. In patients with chronic hepatitis or compensated liver cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.

Indications

With i / m introduction:

inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain syndrome, extra-articular rheumatism;
acute attacks of gout;
renal and hepatic colic;
pain and swelling after injuries and operations;
severe migraine attacks.
In the form of intravenous infusion: treatment or prevention of postoperative pain.

Application

The preparation should be used in the lowest effective doses for the shortest possible period, taking into account the purpose of treatment for each individual patient.

Adults. Diclofenac sodium, injection solution, do not apply for 2 days. If necessary, treatment can be continued with tablets or suppositories of diclofenac sodium.

IM injection. To prevent damage to nerve or other tissues at the site of intramuscular injection, the following rules must be observed.

The dose is usually 75 mg (1 ampoule), which is injected deeply into the upper outer quadrant of the gluteus maximus muscle. In severe cases (for example, colic), the daily dose can be increased to two injections of 75 mg, between which an interval of several hours is observed (one injection in each buttock). Alternatively, 75 mg injectable solution can be combined with other dosage forms of diclofenac sodium (eg tablets, suppositories) up to a total maximum daily dose of 150 mg.

In a migraine attack, clinical experience is limited to cases with the initial use of 1 ampoule of 75 mg, the dose is administered as soon as possible after the use of suppositories of 100 mg on the same day (if necessary). The total daily dose should not exceed 175 mg on the 1st day.

There are no available data on the use of diclofenac sodium for the treatment of 1 day migraine attacks.

IV infusion. Immediately before starting the intravenous infusion, diclofenac sodium should be diluted in 100-500 ml of 0.9% sodium chloride solution or 5% glucose solution. Only transparent solutions can be used.

Diclofenac sodium, injection solution, should not be given as an IV bolus injection.

Recommended alternative dosage regimens of Diclofenac sodium, injection solution:

for the treatment of moderate to severe postoperative pain: 75 mg must be administered continuously for 30 minutes to 2 hours; if necessary, the treatment can be repeated after 4–6 hours, but the dose should not exceed 150 mg / day;

for the prevention of postoperative pain: 15 min – 1 h after surgery, a loading dose of 25–50 mg should be administered, after which it is necessary to apply a continuous infusion of ≈5 mg / h up to a maximum daily dose of 150 mg.

Elderly patients. No dose adjustment is required, but due to the possible occurrence of adverse reactions, it is necessary to carefully monitor elderly patients.

The recommended maximum daily dose of diclofenac sodium is 150 mg.

Contraindications

Known hypersensitivity to the active substance or any component of the preparation; a history of bleeding or perforation of the gastrointestinal tract associated with previous NSAID treatment; history of active ulcer / bleeding or recurrent ulcer / bleeding (≥2 separate episodes of diagnosed ulcer or bleeding); iii trimester of pregnancy; like other NSAIDs, diclofenac is also contraindicated in patients in whom the use of ibuprofen, acetylsalicylic acid or other NSAIDs provokes attacks of BA, angioedema, urticaria or acute rhinitis; inflammatory bowel disease (eg Crohn's disease or ulcerative colitis); liver failure; renal failure; congestive heart failure (nyha ii – iv); high risk of postoperative bleeding, blood clotting, hemostasis disorders, hematopoietic disorders or cerebrovascular bleeding; treatment of perioperative pain with coronary artery bypass grafting (or using a heart-lung machine); ischemic heart disease in patients with angina pectoris, myocardial infarction; cerebrovascular diseases in patients who have suffered a stroke or have episodes of transient ischemic attacks; peripheral arterial disease.

In this dosage form, the preparation is contraindicated in children.

For IV use only:

concomitant use of NSAIDs or anticoagulants (including low doses of heparin);

a history of hemorrhagic diathesis, a history of confirmed or suspected cerebrovascular bleeding;

surgical interventions associated with a high risk of bleeding;

History of asthma;

moderate or severe impairment of renal function (plasma creatinine 160 μmol / l);

hypovolemia or dehydration for any reason.

Side effects

Adverse reactions to the preparation are indicated in accordance with the frequency: very often (≥1 / 10); often (from ≥1 / 100 to 1/10); infrequently (from ≥1 / 1000 to 1/100); rarely (from ≥1 / 10,000 to 1/1000); very rare (1/10 000); frequency unknown (cannot be estimated from available data).

The side effects presented below include those associated with the administration of diclofenac sodium in the context of short and long term use.

From the side of the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis.

From the immune system: rarely - hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock); very rarely - angioedema (including facial edema).

Mental disorders: very rarely - disorientation, depression, insomnia, nightmares, irritability, mental disorders.

From the nervous system: often - headache, dizziness; rarely - drowsiness, fatigue; very rarely - paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbance, stroke; the frequency is unknown - confusion, hallucinations, impaired sensitivity, general malaise.

From the side of the organ of vision: very rarely - visual impairment, blurred vision, diplopia; frequency unknown - optic neuritis.

On the part of the hearing organs and the labyrinth: often - vertigo; very rarely - ringing in the ears, hearing impairment.

From the side of the heart: very rarely - palpitations, chest pain, heart failure, myocardial infarction.

From the vascular system: very rarely - hypertension, arterial hypotension, vasculitis.

From the respiratory system, chest and mediastinal organs: rarely - BA (including dyspnea), bronchospasm; very rarely - pneumonitis.

From the digestive system: often - nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia; rarely - gastritis, gastrointestinal bleeding, vomiting with blood impurities, hemorrhagic diarrhea, melena, stomach or intestinal ulcer with or without bleeding or with perforation (sometimes fatal, especially in elderly patients); very rarely - colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, disorders of the esophagus, intestinal membrane strictures, pancreatitis.

On the part of the hepatobiliary system: often - an increase in the level of transaminases, rarely - hepatitis, jaundice, abnormal liver function; very rarely - fulminant hepatitis, hepatonecrosis, liver failure.

On the part of the skin and subcutaneous tissues: often - rash; rarely - urticaria; very rarely - bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity, purpura, allergic purpura, pruritus.

From the side of the kidneys and urinary tract: very rarely - acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and disorders at the injection site: often - reaction at the injection site, pain, induration; rarely - edema, necrosis at the injection site; very rarely - an abscess at the injection site.

On the part of the reproductive system and mammary glands: very rarely - impotence.

Clinical research data and epidemiological data indicate an increased risk of thrombotic complications (for example, myocardial infarction or stroke) associated with the use of diclofenac, in particular in high therapeutic doses (150 mg / day) and with prolonged use.

Special instructions

General recommendations. unwanted effects can be reduced by administering the lowest effective dose for the shortest time possible to control symptoms.

The use of Diclofenac-Teva with systemic NSAIDs, including selective COX-2 inhibitors, should be avoided due to the lack of any synergistic benefits and the possibility of additional side effects.

Care should be taken when prescribing the preparation to elderly patients. In particular, for elderly patients with poor health and for patients with low body weight, it is recommended to use the minimum effective dose.

As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid, may also occur without prior exposure to diclofenac.

Diclofenac sodium, due to its pharmacodynamic properties, can mask the signs and symptoms of infection.

Effects on the digestive system. With the use of all NSAIDs, including diclofenac, cases of gastrointestinal bleeding (vomiting of blood, melena), ulceration or perforation have been reported, which can be fatal and occur at any time during treatment with or without warning symptoms, as well as if there is a history of serious gastrointestinal events. These events usually have more serious consequences in elderly patients. If patients receiving diclofenac experience gastrointestinal bleeding or ulceration, the preparation should be discontinued.

As with all NSAIDs, including diclofenac, close medical supervision is necessary; special caution should be exercised when prescribing diclofenac to patients with symptoms suggestive of gastrointestinal disorders, or with a history of gastric or intestinal ulcers, bleeding or perforation. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, including diclofenac, as well as in patients with a history of ulcers, especially with complications such as bleeding or perforation.

In elderly patients, there is an increased frequency of adverse reactions with the use of NSAIDs, especially such as gastrointestinal bleeding and perforation, which can be fatal.

To reduce the risk of toxic effects on the digestive system in patients with a history of ulcers, especially those with complications such as bleeding or perforation, and in elderly patients, treatment is started and maintained with the minimum effective doses.

For such patients, as well as patients who require the combined use of preparations containing low doses of acetylsalicylic acid or other preparations that are likely to increase the risk of adverse effects on the digestive system, combination therapy with protective preparations should be considered (for example proton pump inhibitors or misoprostol).

Patients with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding). Cautions are also needed for patients receiving combination therapy with preparations that may increase the risk of ulcers or bleeding, such as systemic corticosteroids, anticoagulants (such as warfarin), antithrombotics (such as acetylsalicylic acid), or selective serotonin reuptake inhibitors.

Effects on the liver. When taking the preparationby patients with impaired liver function, careful medical supervision is necessary, since their condition may worsen. As with other NSAIDs, including diclofenac, the level of one or more liver enzymes may be increased. During long-term treatment with Diclofenac-Teva, regular monitoring of liver function is required as a precautionary measure.

If liver dysfunction persists or worsens, if clinical signs or symptoms may be associated with progressive liver disease, or if other manifestations are noted (eg eosinophilia, rash), the use of Diclofenac-Teva should be discontinued.

Diseases such as hepatitis may progress without prodromal symptoms.

Caution is necessary if Diclofenac-Teva is used in patients with hepatic porphyria, due to the likelihood of provoking an attack.

Effects on the kidneys. Since fluid retention and edema have been recorded in the treatment of NSAIDs, including diclofenac, special attention should be paid to patients with impaired cardiac or renal function, a history of hypertension, elderly patients, patients receiving concomitant therapy with diuretics or preparations that significantly affect renal function, and patients with a significant decrease in extracellular fluid volume for any reason, for example, before or after major surgery. In such cases, monitoring of renal function is recommended as a precautionary measure. Discontinuation of therapy usually results in a return to the condition prior to treatment.

Effects on the skin. In connection with the use of NSAIDs, including diclofenac sodium, serious skin reactions (some of them fatal) have been reported extremely rarely, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The highest risk of developing these reactions is observed at the beginning of the course of therapy, in most cases during the first month of treatment. The use of the preparation Diclofenac-Teva should be discontinued at the first appearance of a skin rash, mucosal lesions or any other signs of hypersensitivity.

Systemic lupus erythematosus and mixed connective tissue diseases. Patients with systemic lupus erythematosus and mixed connective tissue diseases may be at increased risk of developing aseptic meningitis.

Cardiovascular and cerebrovascular effects. Prescribing diclofenac to patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidemia, diabetes mellitus, smoking) can only be after a thorough clinical assessment. Since the cardiovascular risks of diclofenac may increase with increasing doses and increasing duration of treatment, it should be used for the shortest possible period and at the lowest effective dose.

The patient's need for diclofenac sodium should be periodically reviewed to reduce the severity of symptoms and the response to therapy should be monitored. Use with caution in patients aged ≥65 years.

For patients with a history of hypertension and / or congestive heart failure of mild to moderate severity, appropriate monitoring and recommendations should be made, since cases of fluid retention and edema have been reported in connection with the use of NSAIDs, including diclofenac.

Clinical studies and epidemiological data indicate that the use of diclofenac, especially in high doses (150 mg / day) for a long time, may be associated with a slight increase in the risk of arterial thrombotic events (for example, myocardial infarction or stroke).

It is not recommended to prescribe diclofenac for patients with uncontrolled hypertension, congestive heart failure, stable coronary artery disease, peripheral arterial disease and / or cerebrovascular disease; if necessary, use is possible only after a careful assessment of the risk / benefit ratio only in a dose of no more than 100 mg / day. A similar assessment should be performed before starting long-term treatment of patients with risk factors for cardiovascular events (eg hypertension, hyperlipidemia, diabetes mellitus and smoking).

Patients should be informed about the possibility of serious cases (chest pain, shortness of breath, weakness, speech impairment) that can occur at any time. In this case, you should immediately consult a doctor.

Influence on hematological parameters. With prolonged use of the preparation, like other NSAIDs, monitoring of the blood test is recommended. Like other NSAIDs, Diclofenac-Teva can temporarily inhibit platelet aggregation. Patients with hemostasis disorders, hemorrhagic diathesis or hematological disorders should be closely monitored.

History of asthma. Patients with AD, seasonal allergic rhinitis, patients with swelling of the nasal mucosa (nasal polyps), COPD, or chronic respiratory tract infections (especially those associated with allergic, rhinitis-like symptoms) are more likely than others to have exacerbation-like NSAID reactions AD (so-called intolerance to analgesics / analgesic asthma), Quincke's edema or urticaria. In this regard, such patients are recommended special precautions (readiness to provide emergency care). This also applies to patients with allergies to other substances, manifested by skin reactions, itching or hives.

Like other preparations that suppress the activity of prostaglandin synthetase, diclofenac sodium can provoke the development of bronchospasm in patients with asthma or in patients with a history of asthma.

Fertility in women. The use of the preparation Diclofenac-Teva can lead to impaired fertility in women and is not recommended for women who seek to become pregnant. Consideration should be given to discontinuing the preparation in women who may have difficulty conceiving or undergoing screening for infertility.

IM injection. The instructions for injection must be strictly followed to prevent adverse events at the injection site, which can lead to muscle weakness, muscle paralysis, hypesthesia and necrosis at the injection site.

Children. Diclofenac in the form of an injection solution should not be administered to premature babies or newborns. The use of benzyl alcohol can lead to toxic and anaphylactoid reactions in children under 3 years of age.

Pregnancy. In the first and second trimester of pregnancy, the preparation Diclofenac-Teva can be prescribed only if the expected benefit to the mother exceeds the potential risk to the fetus, only in the minimum effective dose. The duration of treatment should be as short as possible.

Like other NSAIDs, the preparation is contraindicated in the third trimester of pregnancy (possibly suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus).

Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Epidemiological data indicate an increased risk of miscarriage and / or the risk of developing heart defects and gastroschisis after using an inhibitor of prostaglandin synthesis in early pregnancy. The absolute risk of cardiovascular disease rises from less than 1% to about 1.5%.

It is possible that the risk increases with the dose and duration of treatment. It has been shown that in animals the administration of an inhibitor of prostaglandin synthesis leads to an increase in pre- and post-implantation loss and mortality of the embryo / fetus.

In addition, in animals that received an inhibitor of prostaglandin synthesis during the period of organogenesis, an increased frequency of various malformations was recorded, including those of the cardiovascular system. If Diclofenac-Teva is used in women seeking to become pregnant, or in the first trimester of pregnancy, the dose of the preparation should be as low as possible, and the duration of treatment should be as short as possible.

During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can affect the fetus as follows:

cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

impaired renal function, which can progress to renal failure with oligohydroamnion.

The effect of diclofenac on the mother and newborn, as well as at the end of pregnancy:

possible prolongation of bleeding time, antiplatelet effect, which can be observed even at very low doses;

inhibition of uterine contractions, which leads to a delay or lengthening of labor.

Thus, the preparation is contraindicated in the third trimester of pregnancy.

Breastfeeding period. Like other NSAIDs, diclofenac is excreted in breast milk in small amounts. Thus, in order to avoid undesirable effects on the infant, the preparation should not be used during breastfeeding.

Fertility Like other NSAIDs, diclofenac sodium can affect a woman's fertility. The preparation is not recommended for women planning to become pregnant. Women with problems with conception or undergoing tests for infertility should stop using the preparation.

Children. Not intended for use in children.

The ability to influence the reaction rate when driving or working with other mechanisms. Patients who, during treatment with Diclofenac-Teva, experience visual impairment, dizziness, vertigo, drowsiness or other disorders of the central nervous system, should refrain from driving vehicles and working with other mechanisms.

Interactions

Such interactions between the diclofenac-teva preparation and / or other diclofenac preparations may be observed.

Lithium. If used simultaneously, diclofenac can increase the concentration of lithium in the blood plasma. Monitoring of plasma lithium levels is recommended.

Digoxin. If used simultaneously, diclofenac can increase the concentration of digoxin in the blood plasma. Monitoring of plasma digoxin levels is recommended.

Diuretics and antihypertensive preparations. The simultaneous use of diclofenac, like other NSAIDs, with diuretics and antihypertensive agents (for example, β-adrenergic receptor blockers, ACE inhibitors) can lead to a decrease in their antihypertensive effect by inhibiting the synthesis of vasodilating prostaglandins. Therefore, this combination is used with caution, and patients, especially the elderly, should be closely monitored for blood pressure.

Patients should receive adequate hydration, and monitoring of renal function after initiation of concomitant therapy and on a regular basis after it is also recommended, especially with regard to diuretics and ACE inhibitors, due to an increased risk of nephrotoxicity.

Preparations that cause hyperkalemia. Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may be associated with an increase in plasma potassium levels, so patients should be monitored more frequently.

Anticoagulants and antithrombotic agents. It is recommended to take precautions, as the simultaneous administration may increase the risk of bleeding. Although clinical studies do not indicate the effect of diclofenac on the activity of anticoagulants, there are some data on an increased risk of bleeding in patients using simultaneously diclofenac and anticoagulants.

Therefore, to ensure that no changes in anticoagulant dosage are required, careful monitoring of such patients is recommended. Like other NSAIDs, high doses of diclofenac can temporarily suppress platelet aggregation.

Other NSAIDs, including selective COX-2 inhibitors, and GCS. The simultaneous use of diclofenac and other NSAIDs or corticosteroids may increase the risk of gastrointestinal bleeding or ulcers. The simultaneous use of two or more NSAIDs should be avoided.

Selective serotonin reuptake inhibitors. The simultaneous administration of systemic NSAIDs and selective serotonin reuptake inhibitors may increase the risk of gastrointestinal bleeding.

Antidiabetic preparations. Clinical studies have shown that diclofenac can be used together with oral antidiabetic agents without affecting their therapeutic effect. However, there are isolated cases of both hypoglycemic and hyperglycemic effects, requiring a change in the dosage of antidiabetic agents during treatment with diclofenac. In such conditions, monitoring of blood glucose levels is necessary, which is a preventive measure with concomitant therapy.

Methotrexate. Diclofenac can suppress the renal tubular clearance of methotrexate, which leads to an increase in methotrexate levels. When using NSAIDs, including diclofenac, less than 24 hours before treatment with methotrexate, it is recommended to be careful, since the concentration of methotrexate in the blood may increase and the toxicity of this substance may increase. Cases of serious toxicity have been reported when methotrexate and NSAIDs, including diclofenac, were used at intervals within 24 hours. This interaction is mediated due to the accumulation of methotrexate as a result of impaired renal excretion in the presence of NSAIDs.

Cyclosporine. Diclofenac, like other NSAIDs, can increase the nephrotoxicity of cyclosporine due to the effect on renal prostaglandins. Therefore, it should be used at lower doses than for patients not using cyclosporine.

Tacrolimus. When using NSAIDs with tacrolimus, an increased risk of nephrotoxicity is possible, which may be mediated through the renal antiprostaglandin effects of NSAIDs and a calcineurin inhibitor.

Antibacterial quinolones. There are some data on the development of seizures, which may result from the combined use of quinolones and NSAIDs. This can occur in patients with or without a history of epilepsy and seizures. Thus, caution should be exercised when considering the use of quinolones in patients already receiving NSAIDs.

Phenytoin. When using phenytoin simultaneously with diclofenac, it is recommended to monitor the concentration of phenytoin in the blood plasma in connection with the expected increase in phenytoin exposure.

Colestipol and cholestyramine. These preparations may delay or decrease the absorption of diclofenac. Thus, it is recommended to prescribe diclofenac at least 1 hour before or 4–6 hours after the use of colestipol / cholestyramine.

Cardiac glycosides. The simultaneous use of cardiac glycosides and NSAIDs can increase heart failure, reduce the glomerular filtration rate and increase the level of glycosides in the blood plasma.

Mifepristone. NSAIDs should not be used within 8–12 days after using mifepristone, as NSAIDs may reduce its effect.

Potent inhibitors of CYP 2C9. Caution is recommended for the combined administration of diclofenac with potent inhibitors of CYP 2C9 (for example, with voriconazole), which can lead to a significant increase in plasma Cmax and exposure to diclofenac due to inhibition of its metabolism.

Incompatibility. Due to the lack of compatibility studies, this preparation must not be mixed with other preparations.

Overdose

Symptoms the typical clinical symptoms of diclofenac sodium overdose are unknown. in case of overdose, headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, agitation, coma, drowsiness, ringing in the ears, loss of consciousness or convulsions may occur. in case of severe poisoning, opn and liver damage are possible.

Treatment. Within 1 hour after the use of a potentially toxic amount of the preparation inside, the use of activated carbon should be considered. In addition, in adults, gastric lavage should be considered within 1 hour after using a potentially toxic amount of the preparation. For frequent or prolonged convulsions, diazepam should be administered intravenously. Taking into account the clinical condition of the patient, other measures may be indicated. Treatment is symptomatic.

Storage conditions

At a temperature not exceeding 30 ° c.

Store ampoules in a box.

Tags: Diclofenac

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