Amelotex, 10 mg/ml 1.5 ml 10 pcs

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drugs.

ATX code: M01AC06

Pharmacological properties

Pharmacodynamics

Nonsteroidal anti-inflammatory drug, has anti-inflammatory, antipyretic, analgesic effects.

Selectively inhibits the enzymatic activity of cyclooxygenase-2. Suppresses the synthesis
of prostaglandins in the area of inflammation to a greater extent than in the gastric mucosa
or kidneys. Less often causes erosive and ulcerative lesions of the gastrointestinal tract.
It belongs to the class of oxycams; a derivative of enolic acid.

Pharmacokinetics

The binding to plasma proteins is 99%. Passes through the histohematic barriers, penetrates into
synovial fluid. Concentration in synovial fluid reaches 50% of the maximum concentration in plasma. Less than 5% of the daily dose is excreted unchanged through the intestines, only trace amounts of the drug are found unchanged in
the urine. The half-life (T
1/2) of meloxicam is 15-20 hours. Plasma clearance averages 8 ml/min. The drug clearance is decreased in elderly patients. Distribution volume is low and averages 11 l.

Hepatic or renal insufficiency of moderate severity has no significant effect on the pharmacokinetics of meloxicam.

Indications

rheumatoid arthritis;
osteoarthritis;
ankylosing spondylitis (ankylosing spondylitis);
inflammatory and degenerative diseases of the joints, accompanied by pain
syndrome.

Pharmacological effect

Pharmacotherapeutic group: non-steroidal anti-inflammatory drugs.

ATX code: M01AC06

Pharmacological properties

Pharmacodynamics

Non-steroidal anti-inflammatory drug, has anti-inflammatory, antipyretic properties.
lowering, analgesic effect.

Selectively inhibits the enzymatic activity of cyclooxygenase-2. Suppresses synthesis
prostaglandins in the area of ​​inflammation to a greater extent than in the gastric mucosa
or kidneys. Less commonly causes erosive and ulcerative lesions of the gastrointestinal tract.
Belongs to the class of oxicams; enolic acid derivative.

Pharmacokinetics

Communication with plasma proteins – 99%. Passes through histohematic barriers, penetrates
synovial fluid. Concentration in synovial fluid reaches 50% of the maximum
low concentration in plasma.

It is excreted equally through the intestines and kidneys, mainly in the form of metabolites.
Less than 5% of the daily dose is excreted unchanged through the intestines, in
In urine, unchanged drug is found only in trace amounts. Period
The half-life (T1/2) of meloxicam is 15-20 hours. Plasma clearance is
average 8 ml/min. In elderly people, drug clearance is reduced. Distribution volume
leniya is low and averages 11 liters.

Liver or kidney failure of moderate severity with significant impact
does not affect the pharmacokinetics of meloxicam.

Special instructions

If peptic ulcers or gastrointestinal bleeding occur, the development
side effects on the skin and mucous membranes, the drug should be discontinued. U
patients with a decrease in circulating blood volume and reduced glomerular filtration
tion (dehydration, chronic heart failure, surgery)
the appearance of clinically pronounced chronic renal failure is possible, which
paradise is completely reversible after discontinuation of the drug (in such patients, at the beginning of treatment,
monitor daily diuresis and renal function). With a persistent and significant increase
transaminases and changes in other indicators of liver function, the drug should be discontinued
and carry out control tests. In patients with an increased risk of side effects from treatment,
treatment starts with a dose of 7.5 mg. In end-stage chronic renal failure in
for patients on dialysis, the dose should not exceed 7.5 mg/day. During the treatment period
It is necessary to be careful when driving vehicles and engaging in other potential activities.
socially hazardous activities that require increased concentration and attention
speed of psychomotor reactions (with the appearance of dizziness and drowsiness).

Active ingredient

Meloxicam

Composition

1 ampoule (1.5 ml) contains meloxicam as an active substance – 15 mg
excipients: meglumine, glycofurfural, poloxamer 188, sodium chloride, glycerol, sodium hydroxide solution 1 M, water for injection.

Contraindications

hypersensitivity to the active substance or auxiliary components;
contraindicated in the period after coronary artery bypass grafting;
uncompensated heart failure;
complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and
paranasal sinuses and intolerance to acetylsalicylic acid and other nonsteroidal
ny anti-inflammatory drugs (including in the anamnesis);

– erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal tract
pre-intestinal bleeding;

inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
cerebrovascular bleeding or other bleeding;
severe liver failure or active liver disease;
severe renal failure in patients not undergoing dialysis (clearance
creatinine less than 30 ml/min), progressive kidney diseases, incl. confirmed
hyperkalemia;
pregnancy, breastfeeding period;
children under 15 years of age.

With caution

To reduce the risk of adverse events, you should use minimal
an effective dose of the minimum possible short course for:

coronary heart disease, cerebrovascular diseases, congestive heart disease
insufficiency, dyslipidemia/hyperlipidemia, diabetes mellitus, peri-
spherical arteries, smoking, creatinine clearance less than 60 ml/min, anamnestic
data on the development of ulcerative lesions of the gastrointestinal tract, in the presence of infection
tions of Helicobacter pylori, in old age, with long-term use of nonsteroidal drugs
anti-inflammatory drugs, frequent alcohol consumption, severe somatic
diseases, concomitant therapy with the following drugs: anticoagulants (for example,
warfarin), antiplatelet agents (eg acetylsalicylic acid, clopidogrel), oral
glucocorticosteroids (for example prednisolone), selective reuptake inhibitors
serotonin (eg citalopram, fluoxetine, paroxetine, sertraline).

Side Effects

From the digestive system: nausea, vomiting, belching, abdominal pain, constipation or
diarrhea, flatulence, increased activity of “liver” transaminases, hyperbilirubinemia,
stomatitis, erosive and ulcerative lesions of the gastrointestinal tract, esophagitis, gastritis,
colitis, perforation of the gastrointestinal tract, gastrointestinal bleeding
(hidden or obvious), hepatitis.

From the nervous system: dizziness, vertigo, headache, tinnitus, confusion.
loss of consciousness, drowsiness, disorientation, emotional lability.

From the respiratory system: bronchospasm.

From the hematopoietic organs: anemia, leukopenia, thrombocytopenia.

From the cardiovascular system: peripheral edema, increased arterial
pressure, “rushes” of blood to the skin of the face and upper chest, palpitations.

From the urinary system: edema, hypercreatininemia, increased concentration
urea levels in blood serum. In rare cases – acute renal failure,
interstitial nephritis, albuminuria, hematuria.

From the senses: conjunctivitis, visual impairment, incl. blurred vision.

From the skin: itching, skin rash, urticaria, photosensitivity, bullous
rashes, erythema multiforme, toxic epidermal necrolysis.

Allergic reactions: angioedema, anaphylactoid, anaphylactic reactions
tions.

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

Interaction

When used simultaneously with other non-steroidal anti-inflammatory drugs,
ratami increases the risk of developing ulcerative lesions of the gastrointestinal tract and
gastrointestinal bleeding.
Increases plasma lithium concentration; reduces the effectiveness of intrauterine devices
contraceptives, antihypertensive drugs.
Indirect anticoagulants, ticlopidine, heparin, thrombolytics increase the risk of bleeding;
methotrexate enhances the myelosuppressive effect; diuretics increase the risk of developing
renal dysfunction; cyclosporine enhances the nephrotoxic effect; cholestira-
min accelerates elimination. Myelotoxic drugs increase symptoms
hematotoxicity of the drug.

Overdose

Symptoms: increased side effects.
Treatment: symptomatic. There are no specific antidotes or antagonists.

Storage conditions

List B. In a place protected from light at a temperature of 8 to 25 ° C. Do not store in the refrigerator.
Keep out of the reach of children.

Shelf life

4 years. Do not use after expiration date.

Manufacturer

PharmFirma Sotex, Russia