Meloxicam solution for injection 10mg / ml 1.5ml amp piece 3

Description

Composition
Active substance:
1 ml of solution contains: meloxicam 10.00 mg / ml.
Product form:
A solution for intramuscular injection of 10 mg / ml.
Contraindications
Hypersensitivity (including NSAIDs to other groups), a combination of asthma, recurrent nasal polyposis and paranasal sinuses and the intolerance of acetylsalicylic acid (ASA) drugs and pyrazolone series; gastric ulcer and duodenum 12 (exacerbation), severe hepatic failure, chronic renal failure (CRF) in patients not undergoing dialysis (creatinine clearance (CC) of less than 30 ml / min), active gastrointestinal bleeding; progressive renal disease, severe liver failure or active liver disease, condition after coronary bypass surgery, confirmed by hyperkalemia, inflammatory bowel disease, children’s age (15 years), pregnancy, lactation.
Carefully
Advanced age, coronary artery disease (CAD), chronic heart failure (CHF) cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, CC less than 60 ml / min, ulcerative lesions of the gastrointestinal tract in history, presence of infection H. pylori, long-term use of NSAIDs, alcoholism, severe somatic diseases, simultaneous reception of oral glucocorticoid means (GCS) (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including klopidog relational), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).
Indications
Rheumatoid arthritis; osteoarthritis; Ankylosing spondylitis (Bechterew’s disease) and other inflammatory and degenerative diseases of the joints, accompanied by pain syndrome. It is intended for symptomatic therapy, reduce pain and inflammation at the time of use; on the progression of the disease is not affected.
Interaction with other drugs
When concomitantly with other NSAIDs increases the risk of gastrointestinal ulcers and gastrointestinal bleeding.
With simultaneous use of NSAIDs with lithium therapy increases the concentration of lithium ions in the plasma due to lower renal excretion of lithium. If necessary, such a combination therapy is recommended to monitor the level of lithium ion in plasma at the start of treatment at dose selection and cancellation of meloxicam.
Meloxicam reduces the effectiveness of an intrauterine contraceptive device (IUD), antihypertensive drugs. Indirect anticoagulants, ticlopidine, heparin, thrombolytics increase risk of bleeding. Methotrexate increases the mielodepressivnoe action; Diuretics increase the risk of renal dysfunction; Cyclosporin enhances the nephrotoxicity; cholestyramine accelerates the elimination. Myelotoxic drugs increase the expression gematotoksichnosti drug.
Overdose
Symptoms: impaired consciousness, bleeding from the gastrointestinal tract, acute renal failure.
Treatment: No specific antidote; Symptomatic therapy.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug.
Pharmacodynamics:
Nonsteroidal antiinflammatory drugs (NSAIDs), anti-inflammatory, antipyretic, analgesic action. It refers to the class of oxicams; enolievoy acid derivative. The mechanism of action – inhibition of prostaglandin synthesis (Pg) through selective suppression of cyclooxygenase enzyme activity 2 (TSOG2). When administered in high doses and long-term use of individual peculiarities of body TSOG2 selectivity decreases. Inhibits synthesis area Pg in inflammation to a greater extent than in the gastric mucosa and kidney, which is associated with relatively selective inhibition TSOG2. Less common causes erosive-ulcerous disease of the gastrointestinal tract (GIT).
Pharmacokinetics:
Meloxicam is completely absorbed following intramuscular administration. Relative bioavailability compared to oral bioavailability is almost 100%. After intramuscular administration at a dose of 5 mg of the maximum concentration in blood was 1.62 g / ml and is attained within about 60 minutes.
Meloxicam binds well to plasma proteins, particularly albumin (99%). Penetrates into the synovial fluid. in the synovial fluid concentration is about 50% of plasma concentrations. The volume of distribution – an average of 11 liters. Interindividual deviation is 30-40%.
Meloxicam is metabolized almost completely inert to 4 pharmacological metabolites. The main metabolite, 5-karboksimeloksikam (60% of dose), formed by oxidation of an intermediate metabolite of 5-gidroksimetilmeloksikama. In vitro studies have shown that this metabolic transformation plays an important role of CYP2C9 isoenzyme, additional important isoenzyme CYP3A4. The formation of two other metabolites (components 16 and 4% of the dose) participates peroxidase activity which can be individually varied.
Excretion of meloxicam, preferably in the form of metabolites is done in the same amount of urine and feces. In an unmodified form with the faeces derived at least 5% of the daily dose. In the urine as unchanged drug is detected only in trace amounts. The average half-life of about 20 hours Plasma clearance -. An average of 8 ml / min.
Meloxicam exhibits linear pharmacokinetics in doses of 7.5-15 mg when administered intramuscularly.
Conditions of supply of pharmacies
On prescription.
side effects
From the digestive system: more than 1% – indigestion, including nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; 0.1-1% – transient increase in activity of “liver” transaminases, hyperbilirubinemia, regurgitation, esophagitis, gastroduodenal ulcer, bleeding from the gastrointestinal tract (including hidden), stomatitis; less than 0.1% – perforation of the gastrointestinal tract, colitis, hepatitis, gastritis.
From the side of hematopoiesis: more than 1% – anemia; 0.1-1% – changes in blood counts, including leukopenia, thrombocytopenia.
For the skin: more than 1% – itching, skin rash; 0.1-1% – urticaria; less than 0.1% – photosensitivity, bullous eruptions, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis.
Respiratory system: less than 0.1% – bronchospasm.
From the nervous system: more than 1% – dizziness, headache; 0.1-1% -vertigo, tinnitus, drowsiness; less than 0.1% – confusion, disorientation, emotional lability.
Cardio – vascular system: more than 1% – peripheral edema; 0.1-1% -increase in blood pressure (BP), heart rate, “tides” of blood to the skin.
From the urinary system: 0.1-1% – hypercreatininemia and / or an increase in urea in blood serum; less than 0.1% – acute renal failure; connection with the intake of meloxicam is not installed – interstitial nephritis, albuminuria, hematuria.
From the senses: less than 0.1% – conjunctivitis, visual disturbances, including blurred vision.
Allergic reactions: less than 0.1% – angioedema, anaphylactoid / anaphylactic reactions.
special instructions
In the event of peptic ulcer or gastrointestinal bleeding, development of the side effects of the skin and mucous membranes of the drug should be discontinued.
Patients with a reduced volume of circulating blood (CBV) and reduced glomerular filtration (dehydration, chronic heart failure, liver cirrhosis, nephrotic syndrome, symptomatic kidney disease, diuretics, dehydration after major surgical operations) may cause clinically significant CRF, which is fully reversible after withdrawal preparation (in these patients at the beginning of the treatment should be monitored daily diuresis and renal function). When persistent and substantial increase in transaminases and changes in other liver function tests drug should be discontinued and conduct control tests. In patients with an increased risk of side effects, treatment is initiated with a dose of 7.5 mg. In end-stage renal failure patients on dialysis, the dose should not exceed 7.5 mg / day. During treatment, care must be taken when driving and other lesson. Potentially hazardous activities that require high concentration and psychomotor speed reactions (If dizziness and drowsiness). To reduce the risk of adverse effects on the gastrointestinal tract should be used minimally effective dose of the lowest possible short course.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Intramuscular administration of Meloxicam is expedient for the first 2-3 days of treatment. In the future, should go to the reception of the drug inside.
Meloxicam recommended dose for injection is 7.5 mg or 15 mg / day. depending on the intensity of pain and the severity of the inflammatory process. The maximum recommended daily dose should not exceed 15 mg.
In patients with chronic severe renal insufficiency, hemodialysis, Meloxicam dose should not exceed 7.5 mg / day.
Given that the dosage regimen for children and adolescents under the age of 15 years is not installed, Meloxicam is assigned only to adults and adolescents over 15 years.
Meloxicam be administered by deep intramuscular injection. Should not be used intravenously.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist