Meloflex Rompharm solution 10 mg/ml 1.5 ml amp N 5 buy, description and instructions for use of the medicine, buy Meloflex Rompharm solution 10 mg/ml 1.5 ml amp N 5 order on Apteka-ot-sklada. ru

Meloflex Rompharm solution 10 mg/ml 1.5 ml amp N 5

Active substance

meloxicam

ATX code

M01AC06 (Meloxicam)

Release form, packaging and composition of the drug

Solution for intramuscular administration

yellow with a greenish tint, transparent.

1 ml
meloxicam	10 mg

[PRING] meglumine - 6.25 mg, glycofurfural - 100 mg, poloxamer 188 - 50 mg, glycine - 5 mg, sodium chloride - 3.5 mg, sodium hydroxide solution 1M - pH 8.6-9, water for injection - up to 1 ml.

1.5 ml - colorless glass ampoules with a capacity of 2 ml (3) - contour cell packaging (1) - cardboard packs. 1.5 ml - colorless glass ampoules with a capacity of 2 ml (5) - contour cell packaging (1) - cardboard packs.

Clinical and pharmacological group

NSAIDs

Pharmacotherapeutic group

NSAIDs

pharmachologic effect

Suction and distribution

Plasma protein binding - 99%. Passes through histohematic barriers and penetrates into the synovial fluid. Concentration in synovial fluid is 50% of plasma concentration.

Metabolism and excretion

Metabolized in the liver to inactive metabolites.

Excreted through the intestines and kidneys (in approximately equal parts), unchanged - 5% of the daily dose (through the intestines). T1/2 - 20 hours. Plasma clearance - on average 8 ml/min (decreases in the elderly).

Indications for use

rheumatoid arthritis;
osteoarthritis;
ankylosing spondylitis (Bechterew's disease).

Intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Dosage

The drug is administered deep intramuscularly. IV is contraindicated.

IM administration of the drug is indicated only during the first days of treatment. Subsequently, treatment is continued with oral forms (tablets).

Osteoarthritis in the acute phase:

7.5 mg/day; if the condition does not improve, the dose can be increased to 15 mg/day.

Rheumatoid arthritis, ankylosing spondylitis:

15 mg/day. Depending on the therapeutic effect, the dose can be reduced to 7.5 mg/day. The daily dose of meloxicam should not exceed 15 mg.

In elderly patients

The recommended dose for long-term therapy
of rheumatoid arthritis or ankylosing spondylitis
is 7.5 mg/day. In patients with an increased risk of side effects, therapy should begin with a dose of 7.5 mg/day.

In dialysis patients with severe renal failure

The daily dose of meloxicam should not exceed 7.5 mg.
In patients with mild or moderate renal impairment (creatinine clearance more than 25 ml/min),
there is no need to reduce the dose.

In patients with mild or moderate liver dysfunction

there is no need to reduce the dose of the drug.

Contraindications

a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid and pyrazolone drugs;
peptic ulcer of the stomach and duodenum (in the acute phase);
active gastrointestinal bleeding;
chronic renal failure in patients not undergoing dialysis (creatinine clearance less than 30 ml/min);
progressive kidney disease;
severe liver failure or active liver disease;
condition after coronary artery bypass surgery;
confirmed hyperkalemia;
inflammatory bowel diseases;
children and adolescents up to 18 years of age;
hypersensitivity to the components of the drug;
hypersensitivity to other NSAIDs.

Carefully :

old age, coronary artery disease, chronic heart failure, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (creatinine clearance 30-60 ml/min), history of ulcerative lesions of the gastrointestinal tract, presence of Helicobacter pylori infection, long-term use of NSAIDs, alcoholism, severe somatic diseases, simultaneous use of oral corticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including including citalopram, fluoxetine, paroxetine, sertraline).

Overdose

Increased dose-dependent side effects.

Symptoms:

impaired consciousness, nausea, vomiting, epigastric pain, bleeding from the gastrointestinal tract, acute renal failure, acute liver failure, respiratory arrest, asystole.

Treatment:

symptomatic therapy. Forced diuresis, alkalinization of urine, hemodialysis are ineffective due to the high degree of binding of meloxicam to plasma proteins. There is no specific antidote.

Side effects

Frequency of side effects: often (more than 1%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (less than 0.01%).

From the digestive system:

often - dyspepsia, incl. nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; infrequently - transient increase in the activity of liver transaminases, hyperbilirubinemia, belching, esophagitis, gastroduodenal ulcer, bleeding from the gastrointestinal tract (including hidden), stomatitis; rarely - gastrointestinal perforation, colitis, hepatitis, gastritis.

From the hematopoietic organs:

often - anemia; infrequently - changes in the blood formula, incl. leukopenia, thromocytopenia.

From the skin:

often - itching, skin rash; infrequently - urticaria; rarely - photosensitivity, bullous rashes, erythema multiforme, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the respiratory system:

infrequently - the occurrence of attacks of bronchial asthma in persons allergic to acetylsalicylic acid or other NSAIDs.

From the side of the central nervous system:

often - dizziness, headache; uncommon - vertigo, tinnitus, drowsiness; rarely - confusion, disorientation, emotional lability.

From the cardiovascular system:

often - peripheral edema; infrequently - increased blood pressure, palpitations, flushes of blood to the skin of the face.

From the urinary system:

uncommon - hypercreatininemia and/or increased urea concentration in the blood serum; rarely - acute renal failure; The connection with taking meloxicam has not been established - interstitial nephritis, albuminuria, hematuria.

From the senses:

rarely - conjunctivitis, visual impairment, incl. blurred visual perception.

Allergic reactions:

rarely - angioedema, anaphylactoid/anaphylactic reactions.

Overdose

Pharmacodynamic interaction

The simultaneous use of several NSAIDs (including salicylates) may increase the risk of developing erosive and ulcerative lesions of the gastrointestinal tract due to a synergistic effect, therefore the use of meloxicam with other NSAIDs is not recommended.

When using meloxicam with diuretics, the patient must drink sufficient fluids, and regular medical monitoring of renal function is required before and during treatment.

Combined use with indirect anticoagulants increases the risk of bleeding due to inhibition of platelet function and damage to the mucous membrane of the stomach and intestines. Therefore, combined use with NSAIDs and indirect anticoagulants is not recommended.

With the combined use of thrombolytic and antithrombotic drugs with meloxicam, an increased risk of bleeding is possible (periodic monitoring of blood coagulation parameters is necessary).

Concomitant use with ACE inhibitors and other antihypertensive drugs in elderly patients with symptoms of dehydration can provoke the development of acute renal failure. In addition, combined use with meloxicam may reduce their hypotensive effect.

Meloxicam enhances the nephrotoxic effect of cyclosporine.

Meloxicam may reduce the effectiveness of contraceptives.

Pharmacokinetic interaction

NSAIDs may increase serum lithium concentrations to toxic levels (decreased renal excretion of lithium). Therefore, the simultaneous use of meloxicam with lithium preparations is not recommended. If their combined use is necessary, the lithium content in the blood serum should be carefully monitored before, during and after the end of the course of therapy with meloxicam and lithium preparations.

When used simultaneously with methotrexate, the negative effect on the hematopoietic system increases (the risk of developing anemia and leukopenia). Periodic monitoring of the hemogram is necessary.

Cholestyramine accelerates the elimination of meloxicam, increasing the clearance of meloxicam by 50%, reducing its T1/2 by 13±3 hours. This interaction is of clinical significance.

When taken simultaneously with antacids, cimetidine and digoxin, no significant clinical interaction is observed.

NSAIDs reduce the effectiveness of contraceptive intrauterine devices.

When using meloxicam together with drugs that have a known ability to inhibit CYP2C9 and/or CYP3A4 (or are metabolized by these enzymes), the possibility of pharmacokinetic interaction should be taken into account. The possibility of interaction of meloxicam with oral hypoglycemic agents cannot be excluded.

When meloxicam is used simultaneously with selective serotonin reuptake inhibitors, the risk of gastrointestinal bleeding increases.

Storage conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C. Shelf life: 4 years.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Special Instructions

Caution should be exercised when treating patients with a history of gastrointestinal diseases. Patients experiencing gastrointestinal symptoms should be monitored regularly. If ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding occur, Meloflex Rompharm should be discontinued.

As with the use of other NSAIDs, gastrointestinal bleeding, ulcers and perforations, potentially life-threatening to the patient, can occur during treatment at any time, both in the presence of warning symptoms or a history of serious gastrointestinal complications, and in the absence these signs. The consequences of these complications are generally more serious in older people.

Particular attention should be paid to patients reporting the development of adverse events from the skin and mucous membranes. In such cases, discontinuation of the use of Meloflex Rompharm should be considered.

In patients with reduced blood volume and reduced glomerular filtration (dehydration, chronic heart failure, liver cirrhosis, nephrotic syndrome, clinically significant kidney disease, taking diuretics, dehydration after major surgery), clinically pronounced chronic renal failure may occur, which is completely reversible after discontinuation of the drug (in such patients, daily diuresis and renal function should be monitored at the beginning of treatment).

If there is a persistent and significant increase in transaminases and changes in other indicators of liver function, the drug should be discontinued and control tests performed.

In patients with an increased risk of side effects, treatment begins with a dose of 7.5 mg. In end-stage chronic renal failure in patients on dialysis, the dose should not exceed 7.5 mg/day.

Impact on the ability to drive vehicles and operate machinery

There is no data on the negative effect of the drug on the ability to drive vehicles or operate machinery. If there are disorders of the central nervous system (decreased visual acuity, increased fatigue, dizziness or other disorders), these types of activities are contraindicated.