Mesipol (Meloxicam) 10mg/ml 1.5ml 3 vials, 10mg/ml 1.5ml 5 vials,

Composition: 

1 ml contains:

Active substance: Meloxicam — 10 mg.

Excipients: meglumin, glicotrol, poloxamer 188, sodium chloride,

glycine, sodium hydroxide, water for injection.

Description:

Clear solution yellow or greenish-yellow color with characteristic odor.

Pharmacological properties

Pharmacodynamics

Meloxicam is a nonsteroidal anti-inflammatory drug that has

analgesic, anti-inflammatory and antipyretic activity.

anti-inflammatory effects associated with inhibition of enzyme activity

cyclooxygenase 1-2 (COX-2) involved in the biosynthesis of prostaglandins in the field

inflammations. To a lesser extent meloxicam acts on cyclooxygenase-1 (COX-1),

involved in the synthesis of prostaglandin, protects the mucous membranes of the gastrointestinal tract and is involved in the regulation of blood flow to the kidneys.

Indications for use

• Symptomatic treatment of rheumatoid arthritis,
• Symptomatic treatment of osteoarthritis,
• Symptomatic treatment of ankylosing spondylitis (Bechterew’s disease),
• Symptomatic treatment of other inflammatory and degenerative diseases
• joints, accompanied by pain syndrome.

Contraindications

• hypersensitivity to the active substance or auxiliary components,
• full or partial combination of bronchial asthma, recurrent polyposis
• of the nose and paranasal sinuses and intolerance of acetylsalicylic acid and
• other NSAIDs (including history), erosive-ulcerative changes of the gastric mucosa or 12 duodenal ulcer, active gastrointestinal bleeding,
• inflammatory bowel disease (nonspecific ulcerative colitis, disease
• Krone), is contraindicated in the period following the CABG,
• decompensated heart failure, cerebrovascular bleeding or other bleeding, severe hepatic insufficiency or active liver disease, severe renal failure in patients not undergoing dialysis (creatinine clearance less than 30 ml/min.),
• progressive renal diseases including confirmed hyperkalemia,
• pregnancy, breastfeeding, children up to age 18 years.

With caution: advanced age, ischemic heart disease, congestive heart failure, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery disease, Smoking, creatinine clearance less than 60 ml/min, ulcerative lesions of the gastrointestinal tract in the anamnesis, presence of infection Helicobacter pуlory, prolonged use of NSAIDs, frequent use of alcohol, serious somatic diseases, simultaneous administration of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective inhibitors of reverse takeover serotonin (including citalopram, fluoxetine, paroxetine, sertraline).

Method of application and doses

Intramuscular injection is indicated only for the first 2-3 days. In further treatment continues with the use of oral forms (tablets).

The recommended dose is 7 5 mg or 15 mg once a day, depending on the intensity of pain and the severity of the inflammatory process.

The drug is administered by deep intramuscular injection.

Given the possible incompatibility, the contents of the vials Masipa® should not be

mix IN the SAME syringe with other drugs.

In patients with increased risk of adverse reactions and renal

failure, on hemodialysis’ dose should not exceed 7, 5 mg per day.

The drug should not be administered intravenously.

The maximum daily dose of meloxicam is 15 mg.

Combined use. The total daily dose of the drug Masipa®, used in the form of tablets, suppositories, suspensions for oral administration and injection should not exceed 15 mg.

Side effect

From the digestive system: more 1% — neuralgia, nausea, vomiting,

abdominal pain, constipation, flatulence, diarrhoea, 0, 1-1% of a transient increase of

activity of “liver” transaminases, hyperbilirubinemia, eructation, esophagitis, erosive ulcerative lesions of the gastrointestinal tract, hidden or obvious gastrointestinal bleeding, stomatitis, less than 0, 1%- perforation of the digestive tract, colitis, hepatitis, gastritis.

With the hematopoietic system: more 1% — anemia, 0, 1-1% – change formula

blood, including leukopenia, thrombocytopenia.

With the skin: more the 1% – itching, skin rash, 0, 1-1% — hives, less than 0, 1% — photosensitivity, bullous eruptions, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis.

The respiratory system: less than 0, 1 % — bronchospasm.

From the Central nervous system: more 1% — dizziness, headache, 0, 1-1% — vertigo, tinnitus, drowsiness, less than About, 1% — confusion,

DISORIENTATE, EMOCIONALNA lability.

From the cardiovascular system with more than 1% and peripheral edema, 0, 1-1% — increase in blood pressure, palpitations, “tides” of blood to the skin.

From the urinary system: 0, 1-1% gipercreatininemia and/or increase of urea in blood serum, less than 0, 1% — acute renal failure, the connection with the reception of meloxicam is not set – interstitial nephritis, albuminuria, hematuria.

From the side of organs of vision: at least 0, 1% — conjunctivitis, visual impairment (including blurred vision.)

Allergic reactions: less than O, 1% – angioneurotic edema, anafilaktoidnye, anaphylactic reaction.

Local reactions: possible burning and pain at the injection site.

Overdose

Symptoms: violation of consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, hepatic failure, respiratory arrest, asystole.

Treatment: the Specific antidote is absent.

Recommended: gastric lavage and symptomatic therapy. In clinical

studies have shown that cholestyramine accelerates the elimination of meloxicam. Haemodialysis ineffective because of the high protein due to blood.

Interaction of meloxicam with other drugs

– While the use of protivovospalitelnoe other non-steroidal drugs (as well as with acetylsalicylic acid) increases the risk of erosivno-yazvennah losses and bleeding of the gastrointestinal tract,

While the use of antihypertensive drugs may decrease the effectiveness of the last,

With the simultaneous use of drugs lithium may develop accumulation

lithium and increase its toxicity (it is recommended to control the concentration of lithium in blood),

While the use of methotrexate increases side effects

latest on the hematopoietic system (the risk of anemia and leukopenia, shows periodic monitoring of complete blood count),

While the use of diuretics increases the risk of developing kidney

failures,

While the use of cyclosporine increases nefrotoksicescoe

effect of meloxicam.

While the use of vnutrimatocny kontraceptivnim means

may decrease the effectiveness of the last,

At simultaneous application with anticoagulants (heparin, tiklopidin, warfarin), and thrombolytic drugs (streptokinase, fibrinolysin)

increases the risk of bleeding (requires periodic monitoring indicators of blood coagulation).

While the use of kolestiraminom, the result of the binding meloxicam, increasing its excretion through the gastrointestinal tract.

While the use of selective inhibitors of reverse takeover of serotonin increases the risk of gastrointestinal bleeding,

Myelotoxic drugs increase the manifestation gematotoksichnosti meloxicam.

Special instruction

Caution must be exercised in applying the drug in patients with a history who have peptic ulcer of stomach and duodenum, and in patients on anticoagulant therapy. These patients are at increased risk of ulcerative and erosive diseases of the gastrointestinal tract.

Use caution and monitor indicators of kidney function when

the use of the drug in elderly patients, patients with chronic

heart failure with symptoms of circulatory failure, 

patients with liver cirrhosis, and in patients with hypovolemia as the result surgery.

In patients with renal failure, if creatinine clearance over 25 ml/min does not require correction of dosing regimen.

In patients on dialysis, the dosage of the drug should not exceed 7, 5 mg/day.

Patients simultaneously receiving diuretics, and meloxicam have take plenty of fluids.

If the treatment process had an allergic reaction (itching, skin rash, urticaria, photosensitivity), you need to stop taking the drug.

Meloxicam, like other NSAIDs, may mask the symptoms of infectious diseases.

Application of meloxicam, like other drugs that block the synthesis

prostaglandins can affect fertility, so it is not recommended for women wishing to get pregnant.

The management of vehicles, maintenance of machines and mechanisms

The use of the drug may cause unwanted effects such as headache and dizziness, drowsiness. Should abandon control

vehicles and service of machines and mechanisms, requiring concentration of attention.

Form release

Solution for intramuscular injection 10 mg/ml

1, 5 ml solution in glass ampoule of the 1st type, with a capacity of 2 ml with encoding

RING green color applied to the surface of the ampoule.

3 or 5 vials, along with instructions for medical use in a cardboard box