Nimid Forte 100mg 100 tablets — Made in India — Free Delivery
(Nimid Forte)
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Description Nimid Forte 100mg 100 tablets — Made in India — Free Delivery
Pharmacological properties
Pharmacodynamic parameters. Nimid forte is a combination of the muscle relaxant tizanidine and npvp nimesulide.
A nitrobenzene derivative - a member of the methanesulfonanilide group, nimesulide inhibits the COX-mediated conversion of arachidonic acid into a precursor of prostaglandins, prostacyclin and thromboxane A2. Nimesulide exhibits both analgesic and antipyretic and anti-inflammatory effects mediated by the action of COX-2, but has little effect on platelet function or loss of gastric cytoprotection associated with COX-1 activity. The therapeutic effect of nimesulide is the result of a complex of its effects targeting a number of key inflammatory mediators, such as prostaglandins, free radicals, proteolytic enzymes and histamine.
Tizanidine, an imidazoline derivative, is a centrally acting α2-adrenergic receptor agonist. Tizanidine inhibits the release of excitatory amino acids such as glutamate and aspartate in the neurons of the spinal cord and enhances presynaptic inhibition of motor neurons with the greatest effect in the polysynaptic spinal tract, which leads to a decrease in muscle tone and resistance to passive movements. It also reduces the frequency of muscle spasms and myoclonus, and increases the strength of active muscle contractions. It is likely that α2-adrenergic receptor-mediated inhibition of interneuronal activity underlies the additional antinociceptive and anticonvulsant activity of tizanidine. The affinity (to a lesser extent) for α1-adrenergic receptors may explain the moderate and transient effect of tizanidine on the cardiovascular system.
Pharmacokinetic parameters. Nimesulide has a rapid onset of action and has a high absorption rate after oral administration (Cmax in blood plasma is reached after 2-3 hours). Nimesulide is tightly bound to blood plasma proteins (up to 97.5%) and has a moderately small volume of distribution. However, it is rapidly distributed in the synovial fluid.
Nimesulide is metabolized in oxidation reactions through the cytochrome P450 system of the liver (mainly CYP 2C9), mainly into 4-hydroxy metabolite (4-OH-NME), which has similar pharmacological properties to the parent preparation.
Elimination is progressive, T½ is 2–5 hours for the parent preparation and 3–9 hours for its main metabolite, 4-OH-NME.
It is excreted in the form of metabolites by the kidneys (about 50% of the administered dose) and with feces (about 29%). In an unchanged state, 1–3% of the dose is excreted. Changes in pharmacokinetic parameters in elderly patients are not observed.
Tizanidine is rapidly absorbed. Cmax in blood plasma is reached 1 hour after application. Bioavailability is 20–34%, binding to blood plasma proteins is 30%.
T1 / 2 - 2.5 h, linear pharmacokinetics. The equilibrium concentration of tizanidine is reached within 24–48 hours after administration; with repeated administration, no noticeable changes in the pharmacokinetic profile were revealed.
Tizanidine during the first passage is extensively metabolized in the liver by the cytochrome 450 CYP 1A2 system to inactive metabolites. 70% of the dose is excreted in the urine, 20% in the feces; about 2.7% - unchanged.
In patients with severe renal impairment, the Cmax in the blood plasma doubles, and the final T1 / 2 - up to approximately 14 hours (6-fold increase in the AUC values).
An increase in the content of the preparation in the blood is possible in patients with hepatic insufficiency.
Indications
Acute pain due to spasm of striated muscles; ankylosing spondylitis; vertebroalgia.
Application
Use the lowest dose necessary to control symptoms for a minimum period of time (no more than 15 days) only after a rigorous weighted risk-benefit analysis. stop taking after the onset of the analgesic effect.
Adults take 1 tablet in the morning and in the evening (daily dose - 2 tablets) after meals, per os, drink plenty of water.
No dose adjustment is required in elderly patients or with mild to moderate renal impairment.
Contraindications
Hypersensitivity to the active substance of the preparation or its other constituents; hypersensitivity reactions (urticaria, bronchospasm, rhinitis) to acetylsalicylic acid or other NSAIDs; toxic liver damage caused by the use of nimesulide; a stomach or duodenal ulcer (acute phase), recurrent ulcers or bleeding in the digestive tract; intracerebral hemorrhage or other pathology with concomitant hemorrhage; severe disorders of the coagulation system; severe heart failure; severe liver or kidney failure; fever and flu-like manifestations; the assumption of an acute surgical disease; combined use with fluvoxamine and ciprofloxacin;
preparation and alcohol addiction;
childhood.
Side effects
Associated with nimesulide
- Eosinophilia, anemia, decreased platelet count (≤150⋅109 / l), decreased content of all blood corpuscles, purpura;
- rash, pruritus, hyperhidrosis, dermatitis, erythema, Quincke's edema, facial edema, urticaria, blistering, Lyell's syndrome, Stevens-Johnson's, erythema polymorphism;
- hypersensitivity; anaphylactic reactions;
- increased heart rate 90 beats / min, hemorrhages, blood pressure lability, hot flushes, hypertension, myocardial infarction, heart failure;
- swelling, weakness, malaise, decreased body temperature;
- dizziness, cephalalgia, hypersomnia, encephalopathy / Reye's syndrome;
- blurriness, visual disturbances;
- feeling of fear, nervousness, fearful dreams;
- dyspnea, BA, bronchospasm;
- cholestasis, hepatitis, including fulminant, increased activity of liver enzymes;
- vomiting, nausea, diarrhea, constipation, flatulence, gastritis, stomatitis, dyspepsia, abdominal pain, melena, hemorrhage in the digestive tract, duodenal / stomach ulcer and perforation, hematemesis, exacerbation of Crohn's disease and colitis;
- difficulty, urinary retention, hematuria, renal failure, decreased urine output, interstitial nephritis;
- an increase in the level of potassium in the blood.
Associated with tizanidine
- Decreased platelet count (≤150⋅109 / L), petechiae or hematoma;
- anaphylactic reactions, hypersensitivity;
- hepatitis, jaundice, increased activity of transaminases in blood plasma, deterioration of liver function;
- blurred vision, paresthesia, drowsiness, confusion and loss of consciousness, fainting, vertigo, dizziness, nervousness, agitation;
- depression, hallucinations, sleep disorders, insomnia;
- tremor, muscle weakness, spasms, muscle pain, dorsalgia;
- increased heart rate, decreased blood pressure (90/60 mm Hg), decreased heart rate (40 beats / min), lengthening of the Q – T segment;
- decreased appetite, nausea, vomiting, xerostomia, gastrointestinal disorders and pain, stool disorders;
- flu-like condition, weakness, increased fatigue, asthenia, withdrawal syndrome;
- alopecia, itching, rashes, urticaria.
Special instructions
For nimesulide
The lowest dose needed to control symptoms should be used in the shortest period of time.
If there is no effect (a decrease in the intensity of the manifestations of pathology), the therapy is completed.
Do not use in combination with hepatotoxic agents and ethanol.
The use of NSAIDs in the infectious process of microbial etiology can mask the associated fever. Therapy with nimesulide is completed if the patient develops a fever or flu-like symptoms, as well as if an ulcer or bleeding from the digestive tract occurs.
In the event of symptoms of liver damage, preparation therapy is completed without renewal. For such patients, nimesulide should not be prescribed again.
Use with caution in patients with ulcerative colitis or Crohn's disease (possibly exacerbation). It is also likely that exacerbations of Crohn's disease and other gastrointestinal pathologies will develop when combined with antiplatelet, anticoagulant preparations, and oral contraceptives.
Do not use in combination with other pain relievers and NSAIDs.
The likelihood of an ulcer, hemorrhage or perforation of the digestive tract increases in parallel with an increase in the dose of NSAIDs in patients with a history of this pathology and in elderly patients. In this group of patients, therapy should be started at the lowest dose necessary to control symptoms.
These patients and patients who simultaneously receive acetylsalicylic acid for cardioprophylaxis or other preparations that increase the likelihood of developing gastrointestinal complications need additional protection with proton pump inhibitors or misoprostol.
Caution is required in patients receiving GCS, selective serotonin reuptake inhibitors, acetylsalicylic acid or anticoagulants, as well as in patients (primarily elderly) with toxic damage to the digestive tract.
It is necessary to monitor the condition of patients with heart failure and / or hypertension, patients with excessive accumulation of fluid in the body or edema associated with the use of NSAIDs.
A number of NSAIDs (mainly with prolonged use and high doses) are associated with a low likelihood of developing arterial thrombosis. There is little information about nimesulide on this matter.
Before using nimesulide, a thorough analysis of the condition of patients with risk factors for cardiovascular pathology (smoking, hypertension, elevated blood lipids, diabetes mellitus) is required, as well as in patients with coronary artery disease, acute heart failure, uncontrolled hypertension, pathology of peripheral arteries and / or cerebral vessels ...
In view of the likelihood of a decrease in renal function in patients with impaired renal function or with heart failure, it is necessary to carefully prescribe the preparation in this category of patients with discontinuation of therapy if the condition worsens.
Due to the likelihood of bleeding and perforation of the digestive tract, disorders of renal, hepatic or cardiac functions, careful monitoring of the condition of elderly patients is necessary.
It is used with caution in patients with hemorrhagic diathesis.
It is not a substitute for acetylsalicylic acid for the prevention of cardiovascular pathology.
The likelihood of developing Lyell and Stevens-Johnson syndrome, as well as exfoliative dermatitis, is increased in patients with these reactions that occurred within a month during the previous course of therapy.
In case of allergic reactions, including skin rashes and mucosal lesions, immediate withdrawal of the preparation is required.
The use of nimesulide is not recommended in patients who are planning a pregnancy, as well as in the I and II trimester of pregnancy. In such cases, use the minimum dose and duration of therapy.
Women who find it difficult to get pregnant or those who are being tested for infertility are not recommended to prescribe the preparation Nimid Forte.
The doctor should be notified if the patient becomes pregnant while taking nimesulide.
You should not drive vehicles or other mechanisms in case of taking the preparation.
For tizanidine
Do not use in combination with CYP 1A2 inhibitors.
Abrupt withdrawal of the preparation is not recommended (due to a possible increase in heart rate and blood pressure, the development of a stroke). The dose should be reduced slowly.
In severe renal impairment, you should start with 2 mg once a day with a gradual increase in the dose by small values, taking into account the tolerability and effectiveness of treatment.
Since the development of liver dysfunction associated with tizanidine is possible (in rare cases at a dose of 12 mg / day), they should be monitored in patients with manifestations of liver failure. In the case of a prolonged 3-fold or more increase in the activity of ALT or ASAT, it is necessary to stop taking the preparation Nimid Forte.
A decrease in blood pressure (90 mm Hg) is possible up to loss of consciousness or cardiovascular collapse (including as a result of combined use with CYP 1A2 inhibitors and / or antihypertensive preparations).
Caution is required in the combined use of agents that lengthen the Q – T interval.
Caution is required in patients with heart failure and / or ischemic heart disease. At an early stage of treatment in this category of patients, regular ECG monitoring is required.
Recommended to be taken with caution in elderly patients.
Should not be taken by children and adolescents.
A careful weighted analysis of the risks and benefits of taking the preparation in patients with myasthenia gravis is required.
Due to the small amount of information regarding the use of tizanidine during pregnancy, the preparation is not recommended for this category of patients (administration is possible if the potential benefit to the mother outweighs the possible risk to the fetus).
Interactions
Related to nimesulide
The likelihood of developing hemorrhages or ulcers in the digestive tract increases when used with antiplatelet preparations, selective serotonin reuptake inhibitors and GCS (the latter also increase the likelihood of developing ulcers in the digestive tract).
The combination with acetylsalicylic acid or warfarin is not used in cases of severe blood clotting disorders. In other cases, these combinations are not recommended, but if their use is inevitable, careful monitoring of the parameters of the coagulation system is required.
A decrease in the activity of diuretics and other antihypertensive preparations is possible. When combined with ACE inhibitors, angiotensin II antagonists in patients with impaired renal function (including the elderly or with dehydration), further deterioration of renal function and the occurrence of acute renal failure (usually reversible) are possible. Adequate fluid intake by the patient and scrupulous monitoring of renal function are essential.
The combined intake reduces the diuretic activity of furosemide, its effects on the excretion of sodium and potassium (to a lesser extent). Caution is required in patients with renal or hepatic impairment.
The combined use of lithium preparations requires monitoring of its content in the blood plasma (with its increase, accordingly, the toxicity increases due to a decrease in clearance).
There are no clinically significant interactions with cimetidine and antacids, warfarin, theophylline, glibenclamide, digoxin,
The combined use of the preparation with CYP 2C9 substrates increases their content in blood plasma.
Plasma levels (and toxic effects) of methotrexate may increase when using nimesulide for 1 day before or after taking methotrexate.
When combined with nimesulide, it is possible to increase the nephrotoxicity of cyclosporine.
Valproic and salicylic acids, as well as tolbutamide, displace bound nimesulide in vitro, but this phenomenon is not observed when the preparation is used in a clinical setting.
Tizanidine related
When combined with CYP 1A2 inhibitors, an increase in the blood content of tizanidine is possible (and, accordingly, the development of manifestations of an overdose, including an extension of the Q – T interval).
When used in combination with inducers of CYP 1A2, it is possible to reduce the content of tizanidine in the blood (and, accordingly, its therapeutic effect).
Do not use with ciprofloxacin and fluvoxamine, α2-adrenergic agonists.
Should not be combined with oral contraceptives, propafenone, amiodarone, mexiletine, ticlopidine, cimetidine, rofecoxib, norfloxacin, pefloxacin, enoxacin.
When combined with antihypertensive and diuretics, a decrease in blood pressure (90/60 mm Hg) and heart rate (60 beats / min) is possible. With a sharp withdrawal of the preparation against the background of the use of such preparations, an increase in blood pressure and heart rate, stroke in rare cases is possible.
It is possible to reduce the concentration (and, accordingly, the therapeutic effect) by 50% when taken in combination with rifampicin. It is not recommended to use in combination for an extended period (or carefully adjust the dose if necessary).
Tobacco smoking is associated with a decrease in systemic exposure to tizanidine.
With the combined use of baclofen or benzodiazepine, psychotropic, narcotic, analgesic, antihistamines with tizanidine, their effect, as well as the hypnotic effect of tizanidine, may be enhanced.
Do not combine with the use of alcoholic beverages.
Overdose
Manifested by hypersomnia, lethargy, nausea, vomiting, epigastralgia, possible hemorrhages in the alimentary tract, ag, opn, acute liver failure, miosis, decreased blood pressure (90/60 mm Hg), dizziness, respiratory depression, lengthening of the q – t interval , anxiety, anaphylactoid reactions, and coma.
There is no specific antidote. Treatment is symptomatic. In a 4-hour period after taking a high dose of the preparation , gastric lavage and intake of activated charcoal are performed. Hemodialysis has no effect. Meticulous monitoring of hepatic and renal functions is required.
Storage conditions
At a temperature of ≤25 ° C in the original packaging.
Tags: Nimid
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