Instructions Olfen-75 solution for injection ampoule 2 ml No. 5
Composition
active ingredients: diclofenac sodium, lidocaine hydrochloride monohydrate;
1 ampoule (2 ml) contains: diclofenac sodium 75 mg and lidocaine hydrochloride monohydrate 20 mg;
Excipients: disodium edetate, acetylcysteine, propylene glycol, polyethylene glycol 400, sodium hydroxide, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent, practically colorless to slightly yellow solution.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs.
ATX code M01A B55.
Pharmacological properties
Pharmacodynamics
The drug Olfen®-75 contains diclofenac sodium salt - a non-steroidal active substance with pronounced antirheumatic, anti-inflammatory, analgesic and antipyretic properties. Inhibition of the biosynthesis of prostaglandins, which play a significant role in the occurrence of inflammation, pain and fever, is considered to be the main mechanism of its action. In rheumatic diseases, the anti-inflammatory and analgesic properties of the drug cause a clinical response, which is characterized by a pronounced disappearance of signs and symptoms (pain at rest and during movement, morning stiffness and swelling of the joints), as well as a noticeable improvement in motor function.
In post-traumatic/post-operative conditions with inflammation, diclofenac sodium provides rapid relief of sudden pain and pain on movement, and reduces swelling caused by inflammation and wounds. When used simultaneously with opioids for the treatment of postoperative pain, diclofenac sodium significantly reduces the need for them. The drug Olfen®-75 exhibits a pronounced analgesic effect in moderate to severe pain of non-rheumatic origin 15–30 minutes after administration, it can be used for the initial therapy of inflammatory and degenerative rheumatic diseases, as well as for the treatment of pain caused by non-rheumatic inflammation.
Pharmacokinetics
Absorption. After intramuscular administration of 75 mg of diclofenac, the maximum concentration in the blood plasma, which is on average 2.5 μg/ml, is reached after 20 minutes. The therapeutic concentration of the drug Olfen®-75 in the blood plasma is 0.7–2.0 μg/ml. Repeated administration of the drug does not cause any changes in the kidneys. Pharmacokinetic properties do not change after repeated administration. When the recommended intervals between administrations are observed, no accumulation of the drug in the body was observed.
Distribution. 99.7% of diclofenac binds to serum proteins, mainly albumin (99.4%). The apparent volume of distribution of diclofenac sodium is 0.12–0.17 l/kg. The drug Olfen®-75 penetrates into the synovial fluid, where the maximum concentration is determined 2–4 hours after reaching the peak concentration in the blood plasma. At the same time, the half-life from the synovial fluid is 3–6 hours. Due to this, even 4–6 hours after administration of the drug, the concentration of the active substance in the synovial fluid is higher than in the blood plasma and remains higher for 12 hours.
Metabolism: Approximately half of the total amount of the administered active substance undergoes first-pass metabolism. As a result, the area under the concentration-time curve (AUC) after oral or rectal administration of the drug is approximately half the AUC observed after parenteral administration of an equivalent dose of the drug.
Biotransformation of diclofenac occurs by glucuronidation and methoxylation with the formation of several phenolic metabolites, two of which are pharmacologically active, but to a lesser extent than diclofenac sodium itself.
Elimination: Diclofenac sodium is eliminated from plasma at a systemic clearance rate of
263 ± 56 ml/min (mean ± standard deviation). The terminal half-life in plasma is 1–2 hours. Approximately 60% of the administered dose is excreted by the kidneys as metabolites and less than 1% as unchanged drug. The remaining part of the administered dose is excreted in the bile as metabolized form and then in the feces.
Linearity/non-linearity: Plasma concentration shows a linear relationship with dose.
Pharmacokinetics in certain patient groups. No significant differences in the absorption, metabolism and elimination of the drug were observed in elderly patients. In patients with impaired renal function after the use of the usual dose of the drug, no increase in the amount of unchanged active substance was observed. If creatinine clearance was less than 10 ml/min, the theoretical level of metabolites in the blood plasma at steady state was approximately 4 times higher than in healthy volunteers. Despite this, the metabolites were ultimately eliminated with bile. In cases of impaired liver function (chronic hepatitis, compensated cirrhosis), the pharmacokinetics and metabolism of the drug do not differ from those in patients with normal liver function.
Indication
− inflammatory or 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, inflammation and swelling after injuries and surgeries;
− severe migraine attacks.
Contraindication
Hypersensitivity to the active substances or to any other components of the medicinal product;
increased individual sensitivity to lidocaine or other amide local anesthetics;
history of seizures caused by the use of lidocaine;
porphyria;
myasthenia gravis;
anticoagulant therapy;
history of gastrointestinal bleeding or perforation associated with previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs);
active peptic ulcer/bleeding or history of recurrent peptic ulcer/bleeding (two or more separate episodes of established ulceration or bleeding);
active gastric and/or duodenal ulcer, gastrointestinal bleeding or perforation;
like other NSAIDs, diclofenac is also contraindicated in patients in whom the use of ibuprofen, acetylsalicylic acid or other NSAIDs provokes attacks of bronchial asthma, bronchospasm, angioedema, urticaria, acute rhinitis, nasal polyps or allergy-like symptoms;
inflammatory bowel diseases (such as Crohn's disease or ulcerative colitis);
liver failure (class C on the Child-Pugh scale);
renal failure (glomerular filtration rate (GFR) < 15 ml/min/1.73 m2);
congestive heart failure [II–IV functional class according to the NYHA (New York Heart Association) classification];
ischemic heart disease in patients with angina pectoris or previous myocardial infarction;
cerebrovascular disease in patients who have had a stroke or have episodes of transient ischemic attacks;
peripheral artery disease;
contraindicated for the treatment of perioperative pain during coronary artery bypass grafting (or when using a cardiopulmonary bypass machine);
severe disorders of the cardiac conduction system, atrioventricular block II and III degree, sick sinus syndrome, Adams-Stokes syndrome,
Wolff-Parkinson-White syndrome, complete transverse heart block, bradycardia, cardiogenic or hypovolemic shock, severe hypotension;
high risk of postoperative bleeding, blood clotting disorders, incomplete hemostasis, hematopoiesis disorders, or cerebrovascular bleeding.
Interaction with other medicinal products and other types of interactions
The following interactions of the drug Olfen®-75 and/or other dosage forms of diclofenac may occur.
Diclofenac may increase plasma concentrations of lithium and digoxin when used concomitantly. Monitoring of serum lithium and digoxin levels is recommended.
Concomitant use of diclofenac sodium with diuretics or antihypertensive drugs (e.g. β-blockers, angiotensin-converting enzyme [ACE] inhibitors) may lead to a reduction in the antihypertensive effect. Such combinations should be used with caution, and blood pressure should be closely monitored in these patients, especially in the elderly. Patients should be adequately hydrated. It is recommended to monitor renal function at the beginning of concomitant therapy and regularly thereafter, especially in the case of diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity.
Drugs causing hyperkalemia: Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may be associated with increases in serum potassium, therefore patients should be monitored more frequently.
Concomitant administration of diclofenac and other systemic NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, or corticosteroids increases the risk of gastrointestinal bleeding or ulceration. The simultaneous use of two or more NSAIDs should be avoided.
Caution is advised when diclofenac sodium is taken with anticoagulants and antiplatelet agents, as their combined use increases the risk of bleeding. Although there is no evidence of an effect of diclofenac on the action of anticoagulants, there have been isolated reports of a risk of hemorrhagic complications in patients taking diclofenac and anticoagulants simultaneously. Therefore, close monitoring of patients taking diclofenac and anticoagulants is recommended, and, if necessary, adjustment of the anticoagulant dosage. Like other NSAIDs, diclofenac in high doses can reversibly inhibit platelet aggregation.
Antidiabetic drugs. It has been established that diclofenac sodium can be administered together with oral hypoglycemic drugs without affecting their clinical effects. However, there are isolated reports of hypoglycemic and hyperglycemic reactions after the administration of diclofenac sodium, which required a change in the dose of hypoglycemic drugs. In this regard, it is recommended to monitor blood glucose levels during such combined therapy. There have also been isolated reports of metabolic acidosis in the case of simultaneous use of diclofenac and metformin, especially in patients with pre-existing renal impairment.
Diclofenac may inhibit the renal tubular clearance of methotrexate, leading to increased methotrexate levels. Caution is advised when NSAIDs, including diclofenac, are administered less than 24 hours before methotrexate treatment, as this may increase the blood concentration of methotrexate and increase its toxicity. Serious toxicity has been reported when methotrexate and NSAIDs, including diclofenac, were administered within 24 hours of each other. This interaction is mediated by accumulation of methotrexate as a result of impaired renal excretion in the presence of NSAIDs.
Diclofenac, like other NSAIDs, may increase the nephrotoxicity of cyclosporine and tacrolimus through its effects on renal prostaglandins. Therefore, it should be used at lower doses than in patients not receiving cyclosporine and tacrolimus.
There have been isolated reports of convulsions, possibly resulting from the concomitant use of quinolone antibiotics and NSAIDs. Convulsions may occur in patients with or without a history of epilepsy or seizures. Therefore, caution should be exercised when considering the use of quinolones in patients already receiving NSAIDs.
When using phenytoin concomitantly with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to the expected increase in phenytoin exposure.
Colestipol and cholestyramine may delay or reduce the absorption of diclofenac, therefore it is recommended to administer diclofenac at least 1 hour before or 4-6 hours after colestipol/cholestyramine.
Concomitant use of cardiac glycosides and NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma glycoside levels.
NSAIDs should not be used for 8–12 days after mifepristone administration, as NSAIDs may reduce its effect.
Caution is advised when co-administering diclofenac with CYP2C9 inducers (e.g. rifampicin). This may lead to a significant reduction in plasma concentrations and exposure to diclofenac.
It is recommended to prescribe diclofenac with caution simultaneously with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole), as this may lead to a significant increase in peak plasma concentrations and enhanced effects of diclofenac due to inhibition of its metabolism.
Alcohol. The use of NSAIDs and the simultaneous use of alcohol may increase the side effects of the active substance, especially from the gastrointestinal tract or central nervous system (CNS).
Interactions related to the lidocaine hydrochloride monohydrate content may also occur.
When using lidocaine in combination with antiarrhythmics, β-blockers or calcium antagonists, the additive inhibitory effect on atrioventricular conduction, intraventricular conduction and force of contraction should be considered.
β-blockers, propranolol and others, as well as cimetidine, peptidine, bupivacaine, quinidine, disopyramide, amitriptyline, nortriptyline, chlorpromazine, imipramine increase the level of lidocaine in the blood serum, reducing its hepatic metabolism.
In case of intoxication with cardiac glycosides and digitalis glycosides, lidocaine may increase the severity of atrioventricular (AV) block. Lidocaine weakens the cardiotonic effect of cardiac glycosides.
When used simultaneously with antiarrhythmic drugs (amiodarone, verapamil, quinidine, etc.) or anticonvulsants (hydantoin derivatives) and phenytoin, the cardiodepressive effect of lidocaine is enhanced. When used simultaneously with sedatives and hypnotics, anesthetics (hexobarbital, thiopental sodium intravenously), the inhibitory effect on the central nervous system may be enhanced.
When used simultaneously with procainamide, delusions and hallucinations are possible. Lidocaine may enhance the effect of drugs that cause blockade of neuromuscular transmission, since the latter reduce the conductivity of nerve impulses. Ethanol enhances the depressant effect of lidocaine on respiration.
Norepinephrine, mexiletine – increases the toxicity of lidocaine (decreases the clearance of lidocaine). Isadrin and glucagon – increases the clearance of lidocaine. Midazolam moderately increases the concentration of lidocaine in the blood.
Narcotic analgesics (e.g. morphine) – when used in combination with lidocaine, the analgesic effect of narcotic analgesics is enhanced, but respiratory depression is also increased. Prenylamine – the risk of developing torsades de pointes increases. Propafenone – the duration and severity of CNS side effects may increase. Rifampicin – the concentration of lidocaine in the blood may decrease.
Polymyxin B – respiratory function should be monitored. Vasoconstrictors (epinephrine, methoxamine, phenylephrine) – when used in combination with lidocaine, they help slow down the absorption of lidocaine and prolong the effect of the latter. Guanadrel, guanethidine, mecamylamine, trimetaphan – when used in combination for spinal and epidural anesthesia, the risk of severe hypotension and bradycardia increases. Acetazolamide, thiazide and loop diuretics – when used in combination with lidocaine, they cause hypokalemia and reduce the effect of the latter. Anticoagulants (including ardeparin, dalteparin, danaparoid, enoxaparin, heparin, warfarin and others) – when used in combination with lidocaine, they increase the risk of bleeding.
Application features
General recommendations: Gastrointestinal ulceration, bleeding, or perforation may occur during treatment with NSAIDs, selective or nonselective COX-2 inhibitors, with or without warning symptoms or a history of serious gastrointestinal events. Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Diclofenac sodium, like other NSAIDs, increases the risk of serious cardiovascular thrombotic events, myocardial infarction and stroke. Placebo-controlled studies have shown an increased risk of thrombotic cardiovascular and cerebrovascular complications with the use of certain selective COX-2 inhibitors. A direct correlation of this risk with the selectivity of individual NSAIDs for COX-1/COX-2 has not yet been established. Due to the lack of comparative clinical trial data on long-term treatment with maximum doses of diclofenac, such an increased risk cannot be excluded. In the absence of such data, a careful risk-benefit assessment should be carried out before using diclofenac in patients with clinically confirmed ischemic heart disease, cerebrovascular pathology, obliterating atherosclerosis of the peripheral arteries or significant risk factors (e.g. arterial hypertension, hyperlipidemia, diabetes mellitus, smoking). Diclofenac should be used only after a careful analysis of the possible risks and benefits of such treatment. Given this risk, the lowest effective dose should be administered for the shortest possible duration of treatment.
The renal effects of NSAIDs include fluid retention with oedema and/or hypertension. Therefore, diclofenac should be used with particular caution in patients with impaired cardiac function and other conditions predisposing to fluid retention. Caution should also be exercised in patients taking concomitant diuretics or ACE inhibitors or in patients prone to hypovolaemia.
The effects are generally more severe in the elderly. Caution should be exercised when prescribing the drug to the elderly. In particular, the lowest effective dose is recommended for elderly patients with frailty and for patients with low body mass index.
The use of Olfen®-75 with systemic NSAIDs, including selective COX-2 inhibitors, should be avoided due to the lack of any synergistic benefit and the risk of additional side effects.
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, are possible with diclofenac. Hypersensitivity reactions may also progress to Kounis syndrome, a severe allergic reaction that may cause myocardial infarction. Symptoms of this reaction include chest pain associated with an allergic reaction to diclofenac.
Nonsteroidal anti-inflammatory drugs, due to their pharmacodynamic properties, may mask the signs and symptoms of infection. Prolonged use of analgesics may cause headaches that cannot be treated by increasing the dose of these drugs.
When using NSAIDs in elderly patients, adverse reactions occur more often, especially gastrointestinal bleeding and perforation, which can be fatal. To reduce the risk of gastrointestinal disorders in patients with a history of ulcer, especially complicated by bleeding or perforation, as well as in elderly patients, patients in poor health or with low body weight, the drug should be used in the minimum effective dose for the shortest possible period of time. In such patients, as well as in patients who regularly take low doses of acetylsalicylic acid / aspirin or other drugs that increase the risk of adverse effects on the gastrointestinal tract, it is advisable to prescribe combination therapy with agents that have a protective effect on the gastric mucosa (for example, proton pump inhibitors or misoprostol).
Patients with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is also required in patients receiving concomitant medications that increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants (e.g. warfarin), antithrombotic agents (e.g. acetylsalicylic acid), or SSRIs.
The use of NSAIDs, including diclofenac, increases the risk of gastrointestinal anastomotic leakage - careful medical supervision and caution are necessary when using diclofenac after gastrointestinal surgery.
Hepatic effects. Patients with impaired liver function should be closely monitored when diclofenac sodium is prescribed, as their condition may worsen. During treatment with NSAIDs, including diclofenac, one or more liver enzymes may increase. Such changes have been observed very commonly (approximately 15% of patients) with diclofenac in clinical trials, but have rarely been accompanied by clinical symptoms. In most cases, the increase in these values remains within the normal range. Moderate increases in these values above normal (≥ 3 to < 8 × ULN [upper limit of normal]) were common (2.5%), while the frequency of significant increases in these enzyme levels (≥ 8 × ULN) was approximately 1%. In 0.5% of patients, in addition to increases in liver enzymes, clinically manifest liver damage (eosinophilia, rash) developed. The increased enzyme concentrations were generally reversible after discontinuation of the drug.
If liver function abnormalities persist or worsen during treatment with the drug, if clinical signs or symptoms of liver disease (e.g. hepatitis) or other manifestations (e.g. eosinophilia, rash) occur, diclofenac sodium should be discontinued. Diseases such as hepatitis may occur without prodromal symptoms. The drug should be used with caution.
Olfen®-75 in patients with hepatic porphyria due to the possibility of provoking an attack.
Renal effects: Due to the importance of prostaglandins in maintaining renal blood flow, prolonged use of high doses of NSAIDs, including diclofenac, commonly (1–10%) results in fluid retention, edema, and hypertension.
Particular 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 drugs that significantly affect renal function, and patients with a significant decrease in extracellular fluid volume for any reason, e.g. before or after major surgery. In such cases, monitoring of renal function is recommended. Discontinuation of therapy usually leads to a return to the state that existed before treatment. In general, frequent and regular use of analgesics, especially combinations of several analgesics, can lead to persistent renal damage, accompanied by the risk of developing renal failure ("analgesic nephropathy").
Effects on the skin and subcutaneous tissue. Very rarely, severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, sometimes fatal, may occur in association with the use of NSAIDs. Patients are at greatest risk of these reactions at the beginning of treatment, and in most cases these reactions occur within the first month of treatment. At the first signs of skin rash, mucosal lesions or any other signs of hypersensitivity, Olfen®-75 should be discontinued. Like other NSAIDs, diclofenac may rarely cause allergic reactions, including anaphylactic/anaphylactoid reactions, in patients who have not previously taken it.
Patients with systemic lupus erythematosus and mixed connective tissue disease
are at increased risk of aseptic meningitis.
As a rule, diclofenac is not recommended for patients with cardiovascular disease (heart failure, ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If diclofenac is necessary for patients with cardiovascular disease or uncontrolled hypertension or in the presence of significant risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), the risks/benefits should be carefully weighed and only prescribed in doses up to 100 mg per day for a course of treatment of more than 4 weeks.
Since the cardiovascular risks of diclofenac increase with increasing dose and duration of treatment, it should be used for the shortest possible period and at the lowest effective dose. The patient's need for diclofenac should be periodically reviewed for symptom relief and response to therapy, especially when treatment is continued for more than 4 weeks. Use with caution in patients over 65 years of age.
For patients with a history of hypertension and/or mild to moderate congestive heart failure, appropriate monitoring and advice is necessary, as fluid retention and oedema have been reported in association with the use of NSAIDs, including diclofenac. Clinical trial data and epidemiological data suggest that the use of diclofenac, particularly at high doses (150 mg/day) and for long periods, is associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Diclofenac is not recommended for use in patients with uncontrolled hypertension, congestive heart failure, stable ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. If necessary, use should only be considered after careful risk-benefit assessment and only at a dose not exceeding 100 mg/day. A similar assessment should be made before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking).
Patients should be informed of the signs and symptoms of serious arterial thromboembolic events (e.g. chest pain, shortness of breath, weakness, speech disorders), which may occur without warning symptoms. In this case, a doctor should be consulted immediately. If the patient has congestive heart failure
(NYHA functional class II–IV) the drug is contraindicated.
Effects on hematological parameters. Since NSAIDs can temporarily inhibit platelet aggregation, with prolonged use of diclofenac sodium, as with other NSAIDs, it is recommended to monitor hematological parameters. Patients with impaired hemostasis, hemorrhagic diathesis or hematological abnormalities require close monitoring.
History of asthma. Patients with bronchial asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease or chronic respiratory tract infections (especially if associated with symptoms resembling allergic rhinitis) are more likely than other patients to experience reactions to NSAIDs such as exacerbation of asthma (so-called analgesic intolerance, leukotriene asthma, aspirin asthma), angioedema or urticaria. Therefore, special precautions (emergency medical attention) are recommended for such patients. This also applies to patients with allergies to other substances, manifested by skin reactions, itching or urticaria.
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac sodium and other NSAIDs can provoke the development of bronchospasm in patients suffering from bronchial asthma or in patients with a history of bronchial asthma.
Female fertility. Olfen®-75 may affect female fertility and is therefore not recommended for women attempting to conceive. Discontinuation of the drug should be considered in women who have difficulty conceiving or in women undergoing investigation for infertility.
Lidocaine. Lidocaine should only be administered by a healthcare professional. Like other lidocaine-containing drugs, Olfen®-75 should be administered with caution to patients with epilepsy, cardiac conduction disorders, and respiratory failure.
Use with caution in patients with moderate heart failure, moderate arterial hypotension, incomplete AV block, 1st degree AV block, intraventricular conduction disorders, moderate liver and kidney dysfunction (creatinine clearance 10 ml/min), respiratory dysfunction, epilepsy, increased seizure readiness, myasthenia gravis, after heart surgery, with genetic predisposition to hyperthermia, debilitated patients and elderly patients, when injecting into an inflamed (infected) area.
During the use of lidocaine, ECG monitoring is mandatory. In case of sinus node dysfunction, prolongation of the PQ interval, QRS widening, or the development of a new arrhythmia, the dose should be reduced or the drug should be discontinued. Before using lidocaine for heart diseases (hypokalemia reduces the effectiveness of lidocaine), it is necessary to normalize the potassium level in the blood.
Other: Due to the presence of propylene glycol, Olfen®-75 may cause symptoms similar to those that occur when drinking alcohol.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially 'sodium-free'.
Use during pregnancy or breastfeeding
Pregnancy: Diclofenac may cause oligohydramnios due to fetal renal dysfunction, and there have been reports of narrowing of the ductus arteriosus.
The use of the drug Olfen®-75, as well as other drugs containing lidocaine hydrochloride monohydrate, is contraindicated during pregnancy.
Breastfeeding. Due to the penetration of NSAIDs into breast milk, diclofenac sodium should not be administered to women who are breastfeeding. If such treatment is absolutely necessary, breastfeeding should be discontinued.
Female fertility. The use of Olfen®-75 may affect female fertility and is therefore not recommended for women attempting to conceive. Discontinuation of the drug should be considered in women who are unable to conceive or in women undergoing infertility evaluation. Based on relevant animal data, impaired male reproductive function cannot be excluded. The relevance of these data for humans has not been established.
Ability to influence reaction speed when driving vehicles or other mechanisms
Patients with visual disturbances, dizziness, drowsiness, lethargy, increased fatigue or other central nervous system disorders should refrain from driving or operating other mechanisms.
Method of administration and doses
The dose is selected individually by the doctor. The drug should be used in the lowest effective doses for the shortest period of time, taking into account the goal of treatment for each individual patient.
Due to the possible occurrence of anaphylactic reactions, up to the development of shock, after the administration of the drug Olfen®-75, the patient should be under supervision for at least 1 hour, and the means necessary for providing emergency medical care should be at hand.
Olfen®-75 is to be administered by intramuscular injection. In order to avoid damage to nerves or other tissues at the injection site (which may lead to muscle weakness, muscle paralysis and decreased sensitivity), the following instructions should be followed. The usual single dose of the drug is the contents of 1 ampoule (i.e. 75 mg of diclofenac sodium), which is administered under aseptic conditions intramuscularly once a day by deep injection into the upper outer quadrant of the gluteal muscle. The solution should be used immediately after opening the ampoule. Any unused solution should be discarded.
In case of severe pain (e.g. colic), as an exception, the drug can be administered 2 times a day with an interval of several hours, necessarily changing the injection site. The combination of parenteral administration of the drug Olfen®-75 with other dosage forms of Olfen® drugs (tablets, capsules, rectal capsules, gel or patch) is permissible provided that the maximum daily dose of diclofenac sodium does not exceed 150 mg.
In the setting of migraine attack, clinical experience is limited to cases with initial use alone.
