Amelotex tabs 15mg #20

Amelotex instruction

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Composition

One Amelotex tablet contains:
    active substance - meloxicam - 7.5 mg or 15 mg depending on the dosage;
    auxiliary substances - MCC - 57.6 / 55.8 mg; lactose monohydrate-76.92 / 71.22 mg; sodium citrate -18 mg; crospovidone-10.8 mg; povidone-5.4 mg; colloidal silicon dioxide-1.44 mg; magnesium stearate -2.34 mg.

Form of issue

Amelotex tablets biconvex, round, with a notch from one side, light yellow or light yellow-greenish color, may have a slight roughness. Ten such tablets are in a cellular contour pack, one or two such packages in a cardboard bundle.

pharmachologic effect

The drug has analgesic, antipyretic and anti-inflammatory effect.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Meloxicam refers to non-steroidal anti-inflammatory drugs that have analgesic, antipyretic and anti-inflammatory effects.
The anti-inflammatory effect is associated with inhibition of the activity of cyclooxygenase-2, which participates in the synthesis of prostaglandins in the inflammatory focus. To a lesser extent, the drug has an effect on cyclooxygenase-1, also involved in the biosynthesis of prostaglandin, which protects the mucosa of the digestive tract and contributes to the regulation of blood flow in the kidneys.
Meloksikam belongs to the group of oxycam; chemically - derived enolic acid.

Pharmacokinetics

With intramuscular injection, the drug binds to plasma proteins by 98%. It penetrates through all the tissue barriers and penetrates into the joint fluid. The concentration in the joint fluid reaches 50% of the maximum concentration in the plasma.
It is excreted through the kidneys and intestines equally in the form of metabolites. In the original form, up to 5% of the daily dose of the drug is excreted through the intestine, with almost no toxicity in the urine unchanged. The half-life is 15-19 hours. Plasma clearance - 8 ml / min. The clearance of the drug is slower in patients older than 50 years. Renal or hepatic insufficiency of moderate severity has no effect on the pharmacokinetics of the drug.
Pills. The medicine is quickly absorbed from the intestine, the absolute bioavailability is 89%. Admission together with food does not alter adsorption. When using the drug orally in doses of 15 and 7.5 mg, its concentration in the blood is proportional. Meloksikam is completely metabolized in the liver, as a result, up to four inert derivatives can be formed. The main metabolite, 5-carboxymelloxicam, is formed from the oxidation of 5-hydroxymethylmeloxicam. Peroxidase is involved in the production of the other two derivatives.

Indications for the use of Amelotex

    rheumatoid arthritis;
    osteoarthritis;
    ankylosing spondylitis;
    degenerative and inflammatory diseases of the joints, with concomitant pain syndrome (solution for intramuscular injection).
Amelotex is intended for symptomatic treatment, easing of pain and inflammation during use, it does not influence the development of the disease.

Contraindications

Amelotex has the following contraindications:
    allergy to any of the components of the drug;
    heart failure in the stage of decompensation;
    period of recovery after aortocoronary bypass surgery;
    combination (complete or incomplete) of recurrent polyposis of paranasal sinuses and nose, bronchial asthma and hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs;
    erosive and ulcerative changes in the mucosa of the duodenum or stomach, gastrointestinal bleeding;
    cerebrovascular bleeding;
    severe hepatic impairment;
    bowel diseases of an inflammatory nature (eg, ulcerative colitis);
    severe renal failure, another kidney pathology;
    lactation period;
    pregnancy;
    deficiency of lactose, lactose intolerance or glucose-galactose malabsorption syndrome (tablets);
    age less than 15 years.
Use with caution: to reduce the risk of side effects, the lowest effective dose should be taken with the shortest course for ischemic heart disease, congestive heart failure, cerebrovascular disease, diabetes, hyperlipidemia, smoking, peripheral arterial pathology, creatinine clearance less than 60 ml / min , ulcerative lesions of the digestive system in history, in old age, the presence of Helicobacter pylori, with long-term use of other non-steroidal anti-inflammatory drugs x drugs, alcohol abuse, concomitant therapy drugs listed below: anticoagulants, antiplatelet agents, oral glucocorticosteroid agents, selective serotonin reuptake inhibitors (fluoxetine, citalopram and others).

Side effects

On the part of the digestive system: more than 1% of cases - dyspepsia, including nausea, abdominal pain, diarrhea; 0.1-1% in cases - hyperbilirubinemia, temporary increase in hepatic transaminases, gastroduodenal ulcer, esophagitis, bleeding from the digestive tract, stomatitis; less than in 0.1% of cases - perforation, hepatitis, colitis, gastritis.
From the skin: more in 1% of cases - itching, rash; in 0.1-1% of cases - hives; less than 0.1% of cases - bullous eruptions, photosensitivity, Stevens-Johnson syndrome.
From the hematopoietic system: more than 1% of cases - a decrease in hemoglobin in the blood; in 0.1-1% of cases - leukopenia, thrombocytopenia.
On the part of the respiratory system: less than 0.1% of cases - bronchospasm.
From the nervous system: more than 1% of cases - dizziness, headache; in 0.1-1% of cases - vertigo, drowsiness; less than in 0.1% of cases - disorientation, confusion.
From the cardiovascular system: more than 1% of cases - edema; 0.1-1% - increased blood pressure, palpitations, hyperemia of the face.
On the part of the genitourinary system: in 0.1-1% of cases - hypercreatininaemia; less than 0.1% of cases - renal failure.
From ENT organs: less than 0.1% of cases - visual impairment, conjunctivitis.
On the part of immunity: less than 0.1% of cases - angioedema, anaphylactic reactions.

Instructions for use Amelotex

Are taken orally once a day with meals.
    With rheumatoid arthritis: 15 mg per day. Depending on the therapeutic effect, the dosage can be reduced to 7.5 mg per day.
    With osteoarthritis: 7.5 mg per day. The dose may be increased to 15 mg per day if ineffective.
    With ankylosing spondylitis: 15 mg per day.
The maximum daily dose is 15 mg.
In individuals with an increased risk of side effects, severe renal failure, passing hemodialysis dose should not be more than 7.5 mg per day.

Overdose

Symptoms of an overdose: nausea, abdominal pain, vomiting, liver failure, bleeding from the digestive tract, renal failure, apnea, asystole.
Treatment of an overdose: there is no unique antidote to Amelotex; it is necessary to perform gastric lavage, then reception of activated charcoal, symptomatic treatment. Kolestyramin activates the excretion of the drug from the body. Hemodialysis and forced diuresis are ineffective.

Interaction

With simultaneous reception:
    with Abciximab, Aspirin, Warfarin, Heparin, Dalteporin nartium increases the risk of bleeding;
    with Acebutolol, hydrochlorothiazide, captopril, lisinopril, moexipril, Perindopril, Timolol, the hypotensive effect is weakened;
    with other non-steroidal anti-inflammatory drugs, the risk of serious adverse events increases dramatically.

Storage conditions

Keep away from children. Store in a dark dry place, at a temperature of up to 25 degrees.
Shelf life - three years.

special instructions

Care must be taken when taking the drug by persons who in the past have suffered duodenal ulcers and stomach ulcers, as well as people taking anticoagulant therapy. Such people have increased risk of ulcerative-erosive complications.
It is also necessary to monitor the functional state of the drug when used by elderly people, with chronic heart failure, cirrhosis of the liver.
For people undergoing hemodialysis, the daily dose of the drug should not be above 7.5 mg.
With persistent elevation of transaminases and other violations of liver function, the drug is recommended to conduct control tests and cancel the drug.
Persons taking together meloxicam and diuretics should consume enough fluid.
If allergic reactions occur during Amelotex therapy, stop using the drug.
The use of meloxicam and other drugs that block the biosynthesis of prostaglandins can affect fertility, so taking these drugs is not recommended for women who are planning a pregnancy.
It is recommended to abandon the management of the car and occupations that require concentration of attention, for the duration of treatment with the drug, as it can cause dizziness and headaches.

Children

The drug is banned for use by persons under 15 years of age.

In pregnancy and lactation

The drug is not allowed for pregnant women. breastfeeding and planning pregnancy to women.

Reviews about Amelotex

Reviews about Amelotex in tablets, as well as reviews about Amelotex injections are extremely ambiguous.
Along with reports of an excellent analgesic effect, there are negative evaluations of the drug due to side effects or lack of effect (due to individual resistance).