Universal reference book for medicines
Product name: OXICAMOX (OXICAMOX)

Active substance: meloxicam

Type: NSAIDs

Manufacturer: SANDOZ (Slovenia) manufactured by CIPLA (India)
Composition, form of production and packaging
Tablets
from light yellow to light yellow with a weak greenish shade of color, round, flat, with risk on one side and bevel.

1 tab.

meloxicam 7.5 mg

Auxiliary substances: corn starch - 22 mg, pregelatinized starch - 9.5 mg, silicon dioxide colloidal anhydrous - 0.8 mg, sodium citrate dihydrate - 10 mg, lactose monohydrate - 43 mg, microcrystalline cellulose - 66.4 mg, magnesium stearate - 0.8 mg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (5) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
Tablets from light yellow to light yellow with a weak greenish shade of color, round, flat, with risk on one side and bevel.

1 tab.

meloxicam 15 mg

Auxiliary substances: corn starch - 44 mg, pregelatinized starch - 19 mg, silicon dioxide anhydrous - 1.6 mg, sodium citrate dihydrate - 20 mg, lactose monohydrate - 86 mg, cellulose microcrystalline - 132.8 mg, magnesium stearate - 1.6 mg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (5) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

NSAIDs that have analgesic, anti-inflammatory and antipyretic effects.
The mechanism of pronounced anti-inflammatory effect of meloxicam is associated with selective inhibition of the enzyme COX-2, which participates in the biosynthesis of prostaglandins in the inflammatory region.
Ex vivo found that meloxicam (in doses of 7.5 mg and 15 mg) inhibited COX-2 more actively, exerting a greater inhibitory effect on the production of prostaglandin E2 (a reaction controlled by COX-2) than on the production of thromboxane involved in blood coagulation (reaction controlled by COX-1).
These effects depended on the size of the dose. Ex vivo showed that meloxicam at recommended doses did not affect platelet aggregation and bleeding time, in contrast to indomethacin, diclofenac, ibuprofen and naproxen, which significantly inhibited platelet aggregation and increased bleeding time. When administered in high doses, prolonged use and individual characteristics of COX-2, the selectivity decreases. Suppresses the synthesis of prostaglandins in the inflammation region to a greater extent than in the gastric mucosa or kidneys, which is associated with a relatively selective inhibition of COX-2. Less often causes erosive and ulcerative lesions of the gastrointestinal tract. To a lesser extent, meloxicam acts on COX-1, which is involved in the synthesis of prostaglandins protecting the gastrointestinal mucosa and taking part in the regulation of blood flow in the kidneys.
PHARMACOKINETICS

Suction

Meloksikam is well absorbed from the digestive tract, when ingested bioavailability is 89%, eating does not affect absorption.
Equilibrium concentration in the plasma is achieved 3-5 days from the start of the drug. When ingestion C max in the plasma is achieved after 5-6 hours. Does not cumulate.
Distribution

The binding with plasma proteins is more than 99%.
The range of differences between maximal and basal concentrations of meloxicam when taken 1 time / day is relatively small and lies in the range 0.4-1 μg / ml for a dose of 7.5 mg and 0.8-2 μg / ml for a dose of 15 mg (the values ​​of C min and Cmax ). Meloksikam penetrates through the histogematic barriers, the concentration in the synovial fluid reaches 50% of the C max drug in the plasma.
Metabolism

Almost completely metabolized in the liver with the formation of four pharmacologically inactive derivatives.
The main metabolite, 5'-carboxymeloxicam (60% of the dose value), is formed by oxidation of the intermediate metabolite, 5'-hydroxycarboxymeloxicam, which is also excreted, but to a lesser extent (9% of the dose value).In vitro studies have shown that the isozyme CYP2C9 plays an important role in this metabolic transformation, the CYP3A4 isoenzyme plays an additional role. In the formation of the other two metabolites (which constitute, respectively, 16% and 4% of the dose), peroxidase takes part, the activity of which probably varies individually.
Excretion

It is excreted through the intestines and kidneys in equal proportions, mainly in the form of metabolites.
5% of the daily dose is excreted unchanged through the intestine, in the urine in unchanged form the drug is detected only in trace amounts. T 1/2 meloxicam 15-20 h.
Plasma clearance is an average of 8 ml / min (decreases in old age).
V d is low, and averages 11 liters.
Pharmacokinetics in special clinical cases

Hepatic and renal failure of mild to moderate severity does not significantly affect the pharmacokinetic parameters of meloxicam.
With a severe degree of kidney failure due to a decrease in the elimination of the drug, the daily dose should not exceed 7.5 mg.
INDICATIONS

Symptomatic therapy of the following diseases:

osteoarthritis;

- acute and chronic rheumatoid arthritis;

ankylosing spondylitis;

- gout and other inflammatory and degenerative joint diseases accompanied by pain syndrome.

DOSING MODE

The drug is taken orally during meals at a daily dose of 7.5-15 mg.
The drug should be taken during or after a meal, washed down with water or milk (the volume of the liquid is not less than 100 ml). The recommended daily dose is 7.5 mg; the maximum -15 mg. In elderly patients and patients with severe renal failure who are on hemodialysis, the daily dose should not exceed 7.5 mg. With moderate renal failure (QC more than 25 ml / min), as well as with moderate hepatic insufficiency, dose adjustment is not required.
SIDE EFFECT

The frequency of occurrence of side effects is characterized as often (? 1/10), infrequently (? 1/1000, <1/10), rarely (? 1/1000).

From the digestive system: often - dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea;
infrequent - gastrointestinal hemorrhages (including hidden ones), peptic ulcers, gastroduodenal ulcer, esophagitis, stomatitis, transient increase in hepatic transaminase activity, hyperbilirubinemia, belching; rarely - perforation of the gastrointestinal tract, gastritis, colitis, hepatitis.
From the side of the central nervous system: often - dizziness, headache;
infrequently - a noise in the ears, drowsiness; rarely - confusion, disorientation, insomnia, emotional lability.
On the part of the organs of hematopoiesis: often - anemia;
infrequently - a change in the blood formula, leukocytopenia, thrombocytopenia; rarely - agranulocytosis.
Allergic reactions: rarely - angioedema, anaphylactoid / anaphylactic reactions.

From the cardiovascular system: often - peripheral edema;
infrequently - increased blood pressure, a feeling of palpitations, "hot flashes" of blood to the skin of the face.
From the respiratory system: rarely - bronchospasm.

From the skin: often - itching, skin rash;
infrequently - hives; rarely - bullous rashes, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity.
From the sense organs: rarely - conjunctivitis, visual impairment, incl.
blurred vision.
From the side of the urinary system: infrequently - hypercreatininaemia and / or increased urea in the blood serum, sodium and water retention, hyperkalemia;
rarely acute renal failure in patients at increased risk; connection with the reception of meloxicam is not established - interstitial nephritis, albuminuria, hematuria.
CONTRAINDICATIONS

- lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in anamnesis);

- erosive and ulcerative changes in the mucous membrane of the stomach or duodenum;

- gastrointestinal, cerebrovascular and other bleeding, incl.
in the history (or suspicion of bleeding);
- Inflammatory bowel disease (ulcerative colitis, Crohn's disease);

- severe hepatic impairment or active liver disease;

- chronic renal failure in patients not undergoing dialysis (QC less than 30 ml / min), progressive kidney disease, incl.
confirmed hyperkalemia;
- condition after aortocoronary shunting;

Decompensated heart failure;

- Pregnancy;

- the period of breastfeeding;

- Children's age (up to 15 years);

- hypersensitivity to meloxicam or any other component of the drug and other NSAIDs.

With caution: IHD, cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure with QC 30-60 ml / min.

Anamnestic data on the development of gastric ulcerative lesions, the presence of Helicobacter pylori infection, advanced age, prolonged use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with anticoagulants (eg, warfarin), antiplatelet agents (acetylsalicylic acid, clopidogrel), oral GCS (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).

To reduce the risk of developing adverse events, the minimum effective dose should be used as short a course as possible.

PREGNANCY AND LACTATION

In the first and second trimesters of pregnancy, the prescription of the drug is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.If it is necessary to prescribe the drug for lactation, it is necessary to resolve the issue of stopping breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in chronic renal failure in patients not subject to dialysis (creatinine clearance less than 30 ml / min), with progressive kidney disease, including confirmed hyperkalemia.

With caution: chronic renal failure with creatinine clearance of 30-60 ml / min.

In patients with severe renal failure who are on hemodialysis, the daily dose should not exceed 7.5 mg.
With moderate renal failure (creatinine clearance more than 25 ml / min) dose adjustment is not required.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe hepatic insufficiency or active liver disease.

APPLICATION FOR CHILDREN

Contraindicated for children under 15 years.

APPLICATION IN ELDERLY PATIENTS

Take with caution in old age.

In elderly patients, the daily dose should not exceed 7.5 mg.

SPECIAL INSTRUCTIONS

During long-term treatment, control of the peripheral blood picture, electrolyte balance, coagulation system and functional state of the liver and kidneys is necessary.When using the drug, an increase in the concentration of hepatic enzymes and urea in the blood serum can be observed.
These changes are weak and are transitory. In case of strongly pronounced changes, the drug should be withdrawn.
Care should be taken when using the drug in patients who have a history of peptic ulcer and duodenal ulcer, as well as in patients who are on anticoagulant therapy.
In such patients, the risk of erosive and ulcerative gastrointestinal lesions is increased.
When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a blood test with determination of hemoglobin, hematocrit, analysis of feces for latent blood is shown.

To prevent the development of gastropathy is recommended to combine with protective drugs, for example, misoprostol or proton pump inhibitors.

Long-term use of Oksikamox in patients with uncontrolled high blood pressure, heart failure, concomitant IHD, peripheral arterial occlusive lesions and / or cerebrovascular diseases, risk factors for cardiovascular disease (eg, high blood pressure, hyperlipidemia, diabetes, smoking) after a thorough examination.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

Patients taking both diuretics and meloxicam should take a sufficient amount of fluid.

In patients with mild to moderate renal impairment (QC greater than 30 mL / min), dosage adjustment is not required.

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

If allergic reactions (itching, skin rash, urticaria, photosensitization) occur during treatment, you should contact your doctor to resolve the issue of stopping the drug.In patients with an increased risk of developing side effects, treatment starts with a dose of 7.5 mg.

In patients with dehydration of various etiologies, chronic heart failure, cirrhosis, nephrotic syndrome, taking diuretics, with clinically pronounced renal disease, daily diuresis and renal function should be monitored.

The use of meloxicam, as well as other drugs that block the synthesis of prostaglandins, can affect fertility, so it is not recommended for women planning to become pregnant.

During the period of treatment, ethanol is not recommended.

Special precautions for the destruction of unused medicinal product

There is no need for special precautions when destroying an unused Oksikamox.

Impact on the ability to manage motor transport and other mechanisms

Special studies on the effect of the drug on the ability to drive vehicles and mechanisms have not been carried out, nevertheless, care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: dizziness, nausea, vomiting, pain in the epigastric region.
There may be bleeding from the gastrointestinal tract, acute renal failure, acute liver failure, respiratory arrest, asystole.
Treatment: gastric lavage no later than 6 hours after admission, forced diuresis, symptomatic therapy.
There is no specific antidote. Hemodialysis is ineffective.
DRUG INTERACTION

The combined use of meloxicam and other NSAIDs or acetylsalicylic acid is not recommended, as the risk of ulceration of the gastrointestinal tract and bleeding may increase.

The combined use of meloxicam with lithium preparations may lead to an increase in the concentration of these drugs in the serum.

NSAIDs can reduce the effect of diuretics and antihypertensive drugs.
In patients with impaired renal function (eg, dehydrated or elderly patients), the simultaneous administration of ACE inhibitors or angiotensin II receptor antagonists with cyclooxygenase inhibitory drugs can lead to further impairment of renal function, including the possible development of acute renal failure, which in most cases is reversible.
With the combined use of meloxicam and glucocorticoids, selective serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline), the risk of ulcers of the gastrointestinal tract and serious gastrointestinal bleeding increases.

The combined use of meloxicam with methotrexate may lead to an increase in serum concentration in the serum and an increase in its toxic effect (the risk of anemia and leukopenia, it is recommended that a general blood test be performed periodically).

The risk of nephrotoxic effects associated with the administration of cyclosporine, preparations of gold, increases when combined with meloxicam.
When combined, the hepatotoxicity of cyclosporine also increases.
When combined with meloxicam and anticoagulants (warfarin) or thrombolytic agents (alteplase, streptokinase, urokinase), the risk of bleeding increases.

Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication.

Inhibitors of microsomal oxidation reduce the risk of hepatotoxic effects of meloxicam.

With simultaneous use with intrauterine contraceptives, the effectiveness of the latter may be reduced.

Caffeine enhances the analgesic effect of meloxicam.

Colesteramine lowers the absorption of meloxicam.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Keep out of the reach of children, dry, protected from light, at a temperature of no higher than 25 ° C.
Shelf life - 2.5 years. Do not use after the expiration date printed on the package.
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