Revmoksikam of the tab. of 15 mg No. 20

Pharmacological properties

Pharmacodynamics. to revmoksika is npvp a class of enoliyevy acid, having anti-inflammatory, analgeziruyushchy and antipyretic effect.

Meloksikam showed high anti-inflammatory activity in all standard models of inflammation. As well as for other NPVP, its exact mechanism of action remains to unknown. However there is the general mechanism of action for all NPVP (including meloksika): oppression of biosynthesis of prostaglandins which are inflammation mediators.

Pharmacokinetics. Absorption. Meloksikam is well absorbed from a GIT at oral administration, the absolute bioavailability of medicament is 90%. After single use of a meloksikam of the C _max in blood plasma it is reached during 5–6 h

At reusable dosing the stable concentration are reached for the 3-5th day. Dosing of 1 times a day results in average concentration in blood plasma with rather small fluctuations of peaks: within 0.4-1 mkg/ml for 7.5 mg and 0.8-2 mkg/ml for 15 mg according to (the C _min and the C _max in a stable state respectively). Average concentration of a meloksikam in blood plasma in a stable state are reached during 5–6 h. Simultaneous consumption of food or use of inorganic antacids does not influence medicament absorption.

Distribution. Meloksikam very strongly contacts proteins of blood plasma, mainly albumine (99%). Meloksikam gets into synovial fluid where its concentration is twice lower, than in blood plasma. Distribution volume low, on average 11 l after in oil or in/in introductions, also shows individual deviations within 7–20%. Distribution volume after use of repeated oral doses of a meloksikam (7.5-15 mg) is 16 l with deviation coefficient ranging from 11 up to 32%.

Biotransformation. Meloksikam is subject to extensive biotransformation in a liver.

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In urine identified 4 various metabolites of a meloksikam which are pharmakodinamichesk inactive. The main metabolite, 5 -karboksimeloksikam (60% of a dose), is formed by oxidation of an intermediate metabolite 5 -hydroksimetilmeloksikama which is also allocated, but to a lesser extent (9% of a dose). According to the researches in vitro it is supposed that CYP 2C9 plays an important role in the course of metabolism whereas isoenzymes of CYP 3A4 play a smaller role. The activity of peroxidase at patients, perhaps, is responsible for two other metabolites, components of 16 and 4% of the appointed dose respectively.

Elimination. Removal of a meloksikam happens generally in the form of metabolites in equal parts to urine and a stake. Less than 5% of a daily dose are allocated in not changed view with a stake, the insignificant quantity is distinguished with urine. T _½ makes 13–25 h depending on a route of administration (peroral, in oil or in / c). The plasma clearance is about 7-12 ml/min. after a single oral dose, in/in or rectal use.

Linearity of a dose. Meloksikam shows linear pharmacokinetics within a therapeutic dose of 7.5-15 mg after oral and administration in oil.

Special groups of patients. Patients with a liver/renal failure. The liver and renal failure of easy and moderate degree significantly does not influence pharmacokinetics of a meloksikam. Patients with moderate degree of a renal failure had much higher general clearance. Weaker communication with proteins of blood plasma was noted at patients with an end-stage a renal failure. At an end-stage of a renal failure the increase in volume of distribution can lead to increase in concentration of a free meloksikam. It is not necessary to exceed a daily dose of 7.5 mg (see USE).

Patients of advanced age. At patients of male advanced age the average pharmacokinetic parameters are similar to parameters at male young volunteers. Patients of advanced age have an AUC and T _{½ value} above the corresponding indicators at young volunteers of both sexes. The average clearance of blood plasma in an equilibrium state at patients of advanced age was slightly lower, than at young volunteers.

Indication

Short-term symptomatic treatment of a bad attack of a pseudorheumatism and ankylosing spondylitis at impossibility of oral and rectal administration of drug.

Use

to Apply

orally.

General daily amount of medicine should be applied one-time, washing down with water or other liquid, during meal.

Side reactions can be minimized by use of the smallest effective dose during the smallest duration of treatment necessary for control of symptoms (see. Special INSTRUCTIONS). It is necessary to estimate periodically need of the patient for reduction of expressiveness of symptoms and the response to treatment.

Exacerbation of an osteoarthritis: 7.5 mg/days. If it is necessary, the dose can be raised to 15 mg/days

Pseudorheumatism ankylosing a spondylitis: 15 mg/days

See. Special categories of patients given below.

Depending on therapeutic effect a dose can be lowered to 7.5 mg/days

NOT to EXCEED the DOSE of 15 mg/days!

Special categories of patients.

Patients of advanced age and patients with the increased risk of development of side reactions. The recommended dose for long-term treatment of a pseudorheumatism and an ankylosing spondylitis for patients of advanced age makes 7.5 mg/days

to Patients with the increased risk of development of side reactions should begin 7.5 mg/days with a dose (see. Special INSTRUCTIONS).

Renal failure. At the patients with a heavy renal failure who are on dialysis, the dose should not exceed 7.5 mg/days. The dose decline is not required to patients with a slight and average renal failure (namely — to patients with clearance of creatinine of 25 ml/min.) (concerning patients with a heavy renal failure without use of dialysis see CONTRAINDICATIONS).

Liver failure. With a slight and average liver failure of a dose decline it is not required to patients (concerning patients with a heavy liver failure see CONTRAINDICATIONS).

Contraindication

Known hypersensitivity to active ingredient, other components of medicament or active agents with similar action, such, as npvp, acetylsalicylic acid. revmoksika cannot appoint to patients with symptoms oh, the nasal polyps, a Quincke's disease or small tortoiseshell connected with intake of acetylsalicylic acid or others npvp (reactions of cross hypersensitivity are possible); disturbances of a hemostasis or simultaneous use with anticoagulants (risk of emergence in oil of a hematoma); the gastrointestinal bleeding or perforation connected with the previous therapy npvp in the anamnesis; an active or recurrent round ulcer / bleeding in the anamnesis (2 or more separate confirmed cases of an ulcer or bleeding); gastrointestinal bleeding, the had recently hemorrhagic stroke and other bleedings; heavy heart failure; heavy liver failure; renal failure resistant to dialysis; perioperatsionny pain at aortocoronary shunting.

Side effects

Given researches and epidemiological data allow to assume

that use of some npvp (especially in high doses and at long-term treatment) can be connected with small increase in risk of the vascular trombotichesky phenomena (such as myocardial infarction or stroke) (see special instructions).

from digestive system: dyspepsia, nausea, vomiting, abdominal pain, constipations, diarrhea, meteorism, eructation, esophagitis, gastritis, gastroduodenal ulcer, concealed or macroscopic gastrointestinal hemorrhage, stomatitis, gastrointestinal perforation, colitis. Gastrointestinal bleeding, an ulcer or perforation can be heavy or lethal, especially at patients of advanced age (see. Special INSTRUCTIONS).

from a gepatobiliariy system: temporary disturbance of indicators of function of a liver (for example increase in level of transaminases or bilirubin), hepatitis, jaundice, liver failure.

from the system of blood: anemia, changes of indicators of blood test (including change of quantity of leukocytes), a leukopenia, thrombocytopenia. It was reported about very exceptional cases of an agranulocytosis (see. Separate serious and/or frequent side reactions).

from the immune system: allergic reactions, including anaphylactoid/anaphylactic reactions, including an acute anaphylaxis.

from skin: a Quincke's disease, an itching, rash, a small tortoiseshell, reactions of photosensitivity, a multiformny erythema, Stephens's syndrome — Johnson, a toxic epidermal necrolysis, bullous dermatitis, exfoliative dermatitis.

from a respiratory system: emergence of attacks OH at persons with an allergy to acetylsalicylic acid or to other NPVP, respiratory infections, cough.

from mentality: change of mood, nightmares, confusion of consciousness, disorientation, insomnia.

from nervous system: dizziness, headache, drowsiness.

from a cardiovascular system: increase in the ABP, inflows, hypostases, feeling of strong heartbeat. It was reported about the heart failure connected with use of NPVP.

from an urinogenital system: OPN, in particular patients with factors have a delay of sodium and water, a hyperpotassemia, changes of indicators of function of kidneys (increase in levels of creatinine and/or urea) of risk, infections of urinary tract, disturbance of frequency of urination.

from an organ of sight: conjunctivitis, visual disturbances, including illegibility of sight.

from an organ of hearing and a vestibular mechanism: dizziness, a ring in ears.

from the musculoskeletal system: the arthralgia, a dorsodynia, symptoms connected with joints.

General disorders and local reactions: hardening in the place of an injection, pain in the place of an injection, hypostasis, including hypostasis of the lower extremities, grippopodobny symptoms.

Separate serious and/or frequent side reactions. It was reported about very exceptional cases of an agranulocytosis at the patients accepting to meloksika and other potentially miyelotoksichny medicines (see INTERACTIONS).

Side reactions which were not associated with medicament use, but which are characteristic of other connections of a class. An organic lesion of kidneys which probably leads to OPN: it was reported about very exceptional cases of interstitial nephrite, acute tubular necrosis, a nephrotic syndrome and papillary necrosis (see. Special INSTRUCTIONS).

Special instructions

Side reactions can be minimized by use of the smallest effective dose during the shortest time of the treatment necessary for control of symptoms (see use and information on gastrointestinal and cardiovascular risks below).

Recommended maximum daily dose cannot be exceeded in case of insufficient therapeutic effect, it is also not necessary to apply in addition NPVP as it can increase toxicity whereas therapeutic advantages are not proved. It is necessary to avoid simultaneous use of a meloksikam with NPVP, including selection TsOG-2 inhibitors.

Meloksikam should not apply

to treatment of the patients needing simplification of an acute pain.

in the absence of improvement after several days clinical advantages of treatment should be estimated repeatedly.

Should pay attention to an esophagitis, gastritis and/or a round ulcer in the anamnesis for the purpose of ensuring their full treatment prior to therapy meloksikamy. It is necessary to carry out regular monitoring because of possible recuring at the patients treated meloksikamy and patients with such cases in the anamnesis.

Gastrointestinal disturbances. As well as at use of other NPVP, potentially lethal gastrointestinal bleeding, an ulcer or perforation can arise in the course of treatment, irrespective of existence of the previous symptoms or serious gastrointestinal diseases in the anamnesis at any time.

Risk of gastrointestinal bleeding, ulcer or perforation is higher than

at increase in a dose of NPVP at patients with the ulcer in the anamnesis which is especially complicated by bleeding or perforation (see CONTRAINDICATIONS), and at patients of advanced age. Such patients should begin treatment with the smallest effective dose. To such patients can be reasonable to accept combination therapy with protective medicines (such as mizoprostol or inhibitors of a proton pomp). It also concerns patients for whom the combined reception of a low dose of acetylsalicylic acid or other medicines increasing gastrointestinal risks is necessary (see information given below and INTERACTIONS).

to Patients with gastrointestinal toxicity in the anamnesis, especially to patients of advanced age, it is necessary to report about all unusual abdominal symptoms (especially gastrointestinal bleedings), mainly at the initial stages of treatment. It is necessary to show care concerning patients who at the same time accept the medicines increasing risk of an ulcer or bleeding, such as heparin, anticoagulants, for example warfarin, or other NPVP, including acetylsalicylic acid in anti-inflammatory doses (single dose of 1 g or a daily dose of 3 g) (see INTERACTIONS), receive radical therapy, or in geriatric practice.

When developing gastrointestinal bleeding or ulcer at the patients applying to meloksika should cancel treatment.

NPVP should be taken with caution to patients with gastrointestinal diseases in the anamnesis (ulcer colitis, Crohn's disease) as these states can become aggravated (see. Side EFFECTS).

Disturbance from a liver. Up to 15% of the patients accepting NPVP (including Revmoksikam), can have increase in level of one or more hepatic tests. Such laboratory deviations can progress, can remain invariable or can be temporary. Significant increases in AlAT or AsAT (approximately in 3 and more times is higher than the upper bound of norm) were noted at 1% of patients during the researches with NPVP. Besides, throughout researches with NPVP it was reported about exceptional cases of heavy hepatic reaction, including jaundice and fulminantny hepatitis with a lethal outcome, necrosis of a liver and a liver failure; some of them with a lethal outcome.

Condition of patients with symptoms of an abnormal liver function or with deviations of hepatic tests should be estimated concerning development of symptoms of heavier liver failure during therapy by Revmoksikam. If clinical symptoms demonstrate development of diseases of a liver or system manifestations of a disease (for example an eosinophilia, rash are observed, etc.), in this case Revmoksikam's reception should be stopped.

Cardiovascular disturbances. Patients with AG and/or with stagnant heart failure easy and moderate severity in the anamnesis are recommended to be observed carefully as at therapy of NPVP the delay of liquid and hypostasis were noted.

Patients with risk factors is recommended to be observed carefully in clinical conditions concerning the ABP at the beginning of therapy, especially at the beginning of a course of treatment meloksikamy.

Given researches and epidemiological data allow to assume

that use of some NPVP (especially in high doses and at long-term treatment) is connected with small increase in risk of the vascular trombotichesky phenomena (such as myocardial infarction or stroke). There are not enough data for an exception of such risk at use of a meloksikam.

to Patients with uncontrollable AG, the stagnant heart failure established to an ischemic heart disease, a disease of peripheral arteries and/or cerebrovascular diseases should carry out by

therapy only the meloksikamy ambassador of careful inspection. Similar inspection is necessary prior to long-term treatment of patients with risk factors of cardiovascular diseases (for example with AG, a lipidemia, diabetes, smokers).

NPVP are raised by risk of serious cardiovascular trombotichesky complications, a myocardial infarction and stroke which come to an end with a lethal outcome. Increase in risk is connected with use duration. Patients with cardiovascular diseases or risk factors of cardiovascular diseases have the increased risk of trombotichesky complications.

Disturbance from skin. At use of NPVP in isolated cases serious skin reactions were noted, some of them were lethal, including exfoliative dermatitis, Stephens's syndrome — Johnson and a toxic epidermal necrolysis (see. Side EFFECTS). The highest risk of emergence of such reactions is recorded in an initiation of treatment, at the same time in most cases such reactions appeared within the first month of treatment. At the first appearance of skin rash, damages of a mucous membrane or other signs of hypersensitivity it is necessary to stop use of a meloksikam.

Anaphylactic reactions. As well as at use of other NPVP, anaphylactic reactions can arise at patients without the known reaction on Revmoksikam. Revmoksikam it is not necessary to apply at patients with an aspirinovy triad. This symptomatic complex meets at patients with OH at which rhinitises, with nasal polyps either without those or at which heavy, potentially lethal bronchospasm after use of acetylsalicylic acid or other NPVP was shown were observed. It is necessary to take measures of emergency aid at identification of anaphylactic reaction.

Parameters of a liver and function of kidneys. As well as at treatment the majority of NPVP, described isolated cases of increase in level of transaminases in blood plasma, bilirubin in plasma of blood or other parameters of function of a liver, increase in creatinine in blood plasma and urea nitrogen in blood and also other deviations of laboratory indicators. In most cases these deviations were insignificant and were temporary. At considerable or steady deviations the use of a meloksikam should be stopped and carried out control tests.

Functional renal failure. NPVP owing to oppression of vasodilating influence of renal prostaglandins can induce a functional renal failure by decrease in glomerular filtration. This side effect is dose-dependent. In an initiation of treatment or after increase in a dose the careful observation of a diuresis and function of kidneys at patients with such risk factors is recommended:

• advanced age;
• simultaneous use with APF inhibitors, antagonists of receptors of angiotensin II, diuretics (see INTERACTIONS);
• hypovolemia (any genesis);
• stagnant heart failure;
• renal failure;
• nephrotic syndrome;
• lyupus-nephropathy;
• heavy degree an abnormal liver function (blood plasma albumine in the range from ≥10 to 25 g/l on Chayld's classification — I Drink).

In isolated cases of NPVP can be led to interstitial nephrite, a glomerulonephritis, renal medullary necrosis or a nephrotic syndrome.

Dose of a meloksikam for the patients with an end-stage a renal failure who are on dialysis should not exceed 7.5 mg. Patients with a renal failure of easy and moderate degree cannot reduce a dose (level of clearance of creatinine of 25 ml/min.).

Delay of sodium, potassium and water. NPVP can strengthen a delay of sodium, potassium and water and to affect natriuretic effect of diuretics. Besides, decrease in antihypertensive effect of hypotensive medicines can be observed (see INTERACTIONS). As a result at sensitive patients the hypostasis, heart failure or AG can develop or amplify. Therefore carrying out clinical monitoring is recommended to patients with risk of a delay of sodium, potassium and water (see USE and CONTRAINDICATIONS).

Hyperpotassemia. Diabetes or simultaneous use of the medicines aggravating a kaliyemiya can cause a hyperpotassemia (see INTERACTIONS). In such cases it is necessary to carry out control of level of potassium regularly.

Other cautions and security measures. Side reactions are worse transferred by the patients of advanced age weakened by the patients needing careful observation. As well as at treatment by other NPVP, it is necessary to be careful rather sick advanced age at which depression of function of kidneys, a liver and heart is more probable. Patients of advanced age have higher frequency of emergence of side reactions to NPVP, especially gastrointestinal bleedings and perforation which can be lethal (see USE).

Meloksikam, as well as any other NPVP, can mask symptoms of infectious diseases.

Use of a meloksikam can have negative effect on reproductive function and is not recommended to women who want to become pregnant. Therefore for the women who are going to become pregnant or undergoing inspection concerning infertility there can be reasonable a termination of reception of a meloksikam (see Use during pregnancy and feeding by a breast).

structure of the tablets Revmoksikam on 7.5 mg and 15 mg includes lactose therefore the medicament is not recommended to be taken to patients with rare congenital intolerance of a galactose, deficiency of lactase or disturbance of absorption of glucose or a galactose.

Masking of inflammation and fever. The pharmacological action of Revmoksikam directed to reduction of fever and inflammation can mask symptoms of an infectious disease.

Treatment by corticosteroids. Revmoksikam cannot be probable substitute of corticosteroids at treatment of corticosteroid insufficiency.

Hematologic effects. Anemia can be noted at the patients receiving NPVP, including Revmoksikam. It can be connected with a liquid delay, gastrointestinal bleeding of unknown origin, macroscopic bleeding or incompleteness the described influence on an erythrogenesis. At patients at long-term treatment of NPVP, including Revmoksikam, it is necessary to control the level of hemoglobin or a hematocrit in the presence of anemia symptoms.

NPVP slow down aggregation of thrombocytes and can increase a bleeding time at some patients. Unlike acetylsalicylic acid, their influence on function of thrombocytes quantitatively is less, quickly and reversibly. Patients to whom Revmoksikam is appointed and at whom collateral impacts on the functions of thrombocytes which are shown fibrillation disturbance or to the patients receiving anticoagulants are possible need careful observation.

Use for patients with OH. Patients with OH can have aspirinochuvstvitelny asthma. Intake of acetylsalicylic acid by patients from aspirinochuvstvitelny it is OH associated with a heavy bronchospasm which can be lethal. Due to cross-reaction, including a bronchospasm, between acetylsalicylic acid and other NPVP Revmoksikam the patients sensitive to atsetilsalitsilivy acid should not accept, and it is necessary to apply carefully to patients with OH.

Medicine contains 1 mmol of sodium (23 mg) in an ampoule of 1.5 ml, that is in fact is free from sodium.

Use during pregnancy and feeding by a breast. Pregnancy. Oppression of synthesis of prostaglandins can have negative effect on pregnancy and/or development of an embryo/fruit. Data of epidemiological researches allow to assume increase in risk of an abortion, development of heart diseases and a gastroshizis after use of inhibitors of synthesis of prostaglandins during the early period of pregnancy. Absolute risk of developing heart diseases increased from less than 1% to 1.5%. It is considered that this risk increases with increase in a dose and increase in duration of treatment.

during I and II trimester of pregnancy to meloksika should not be applied, except for emergency.

or during I and II trimester of pregnancy of a dose and treatment duration meloksikamy have to be

For the woman trying to become pregnant minimum.

during the III trimester of pregnancy all inhibitors of synthesis of prostaglandins can create risk for a fruit:

• cardiopulmonary toxicity (with premature closing of an arterial channel and pulmonary hypertensia);
• disturbance of work of kidneys which can develop in a renal failure with oligogidramniony.

Risks in deadlines for pregnancy for mother and the newborn:

extension of a bleeding time, anti-aggregation effect, even is possible

• at very low doses;
• oppression of reductions of a uterus that leads to a delay or delay in childbirth.

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Therefore to meloksika it is contraindicated during the III trimester of pregnancy.

Feeding by a breast. Though there are no specific data on Revmoksikam, NPVP is known that they can get into breast milk. Therefore use is not recommended to the women nursing.

Children. Revmoksikam, mg tablets 7.5 and 15, is contraindicated to children up to 16 years.

Ability to influence speed of response at control of vehicles or work with other mechanisms. There are no special researches about influence of medicament on ability to run vehicles or to work with other mechanisms. However on the basis of a pharmakodinamichesky profile and the observed side reactions it is possible to assume what to meloksika does not influence or has insignificant influence on the specified activity. However to patients at whom dysfunctions of sight were noted including illegibility of sight, dizziness, drowsiness, vertigo or other disturbances of central nervous system, it is recommended to refrain from driving or work with other mechanisms.

Interaction

Pharmakodinamichesky interactions

Other NPVP and acetylsalicylic acid of 3 g/days. The combination with other NPVP is not recommended (see. Special INSTRUCTIONS), including acetylsalicylic acid in anti-inflammatory doses (1 g a single dose or 3 g the general daily dose).

Corticosteroids (for example GKS). Simultaneous use with corticosteroids demands care because of the increased risk of bleeding or appearance of ulcers in a GIT.

Anticoagulants or heparin applied in geriatric practice or in therapeutic doses. Considerably the risk of bleedings owing to oppression of function of thrombocytes and injury of a mucous membrane of a stomach and a duodenum increases. NPVP can enhance effects of anticoagulants, such as warfarin (see. Special INSTRUCTIONS). Simultaneous use of NPVP and anticoagulants or heparin in geriatric practice or in therapeutic doses is not recommended (see. Special INSTRUCTIONS).

care because of the increased risk of bleedings is necessary for

In other cases of use of heparin. Careful control of the international normalized relation is necessary if the impossibility of avoidance of this combination is proved.

Thrombolytic and anti-aggregation medicines. The increased risk of bleedings because of oppression of function of thrombocytes and injury of a mucous membrane of a stomach and a duodenum.

Selective serotonin reuptake inhibitors. The increased risk of gastrointestinal bleeding.

Diuretics, APF inhibitors and antagonists of receptors of angiotensin II. NPVP can reduce effect of diuretics and other antihypertensive medicines. At some patients with a renal failure (for example at patients with dehydration or at patients of advanced age with a renal failure) simultaneous use of APF inhibitors or antagonists of receptors of angiotensin II and medicines, the oppressing COG, can lead to further deterioration in function of kidneys, including possible OPN which usually is reversible. Therefore the combination should be applied with care, especially at patients of advanced age. Patients need to receive adequate amount of liquid and also at them it is necessary to control function of kidneys after the beginning of the combined therapy and further (see. Special INSTRUCTIONS).

Other antihypertensive medicines (for example blockers of β-adrenoceptors). As well as at use of medicines stated below, decrease in antihypertensive effect of blockers of β-adrenoceptors can develop (owing to oppression of prostaglandins with vasodilating effect).

Inhibitors of a kaltsinevrin (for example cyclosporine, takrolimus). Nephrotoxicity of inhibitors of a kaltsinevrin can amplify NPVP by mediation of effects of renal prostaglandins. During treatment it is necessary to control function of kidneys. It is recommended to control carefully function of kidneys, especially at patients of advanced age.

Intrauterine contraceptives. Earlier it was reported about decrease in efficiency of intrauterine contraceptives at use of NPVP, but it demands further confirmation.

Pharmacokinetic interaction: influence of a meloksikam on pharmacokinetics of other medicines

Lities. There are data on NPVP increasing concentration of lithium in blood plasma (by decrease in renal excretion of lithium) which can reach toxic values. The concomitant use of medicaments of lithium and NPVP is not recommended (see. Special INSTRUCTIONS). If combination therapy is necessary, it is necessary to control carefully lithium level in blood plasma in an initiation of treatment, at selection of a dose and the termination of treatment meloksikamy.

Methotrexate. NPVP can reduce tubular secretion of a methotrexate, thereby increasing concentration it in blood plasma. For this reason it is not recommended to apply combined NPVP to the patients accepting a high dose of a methotrexate (15 mg/week) (see. Special INSTRUCTIONS). The risk of interaction of NPVP and methotrexate should be considered also at the patients accepting a low dose of a methotrexate including patients with a renal failure. In case the combined treatment is required, it is necessary to control indicators of blood and function of kidneys. It is necessary to be careful if reception of NPVP and methotrexate lasts 3 days in a row as methotrexate level in blood plasma can raise and enhance toxicity. Though the methotrexate pharmacokinetics (15 mg/week) did not undergo influence of the accompanying treatment meloksikamy, it is necessary to consider that the hematologic toxicity of a methotrexate can increase at treatment of NPVP (see above and also SIDE EFFECTS).

Pharmacokinetic interaction: influence of other medicines on pharmacokinetics of a meloksikam

Holestiramin accelerates removal of a meloksikam by disturbance of intra hepatic circulation therefore the clearance of a meloksikam increases by 50%, and T _½ decreases to 13±3 h. This interaction is clinically significant.

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did not reveal clinically significant pharmacokinetic interaction at a concomitant use with antacids, Cimetidinum and digoxin.

Overdose

Symptoms of acute overdose npvp are usually limited to a lethargy, drowsiness, nausea, vomiting and epigastric pain which in general are reversible at maintenance therapy. there can be gastrointestinal bleeding. the serious poisoning can bring to ag, an acute renal failure, liver dysfunction, respiratory depression, a coma, spasms, cardiovascular insufficiency and cardiac arrest. it was reported about anaphylactoid reactions at therapeutic use npvp that it can also be noted at overdose.

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At overdose of NPVP to patients recommended the symptomatic and supporting actions. Researches showed the accelerated removal of a meloksikam by means of 4 oral doses of a holestiramin 3 times a day.

Storage conditions

In original packing at a temperature not above 25 °C.