Amelotex, tablets 7.5 mg 20 pcs.

Amelotex is a non-steroidal anti-inflammatory drug with anti-inflammatory, antipyretic and analgesic effects.

Indications

Arthritis, Osteoarthritis, Osteochondrosis, Arthrosis, Rheumatoid Arthritis, Lumbago, Pain, Radiculitis, Sciatica, PeriarthritisRheumatoid Arthritis; Osteoarthritis; Ankylosing Spondylitis (Behterew’s disease).

Active ingredient

Meloxicam

Composition

One tablet contains as the active ingredient meloxicam – 7.5 mg.

How to take, the dosage

The drug is taken orally with meals once a day.

The recommended dosing regimen:

• Rheumatoid arthritis: 15 mg per day. Depending on the therapeutic effect, the dose may be reduced to 7.5 mg per day.
• Osteoarthritis: 7.5 mg per day. If ineffective, the dose may be increased to 15 mg daily.
• Ankylosing spondyloarthritis: 15 mg daily.

The maximum daily dose should not exceed 15 mg.

In patients at increased risk of side effects, and in patients with significant renal impairment who are on hemodialysis, the dose should not exceed 7.5 mg daily.

Interaction

Concomitant use with other nonsteroidal anti-inflammatory drugs (as well as with acetylsalicylic acid) increases the risk of erosive ulcerative lesions and bleeding from the gastrointestinal tract.

In concomitant use with hypotensive drugs, the effectiveness of the latter may be reduced.

Simultaneous use with lithium preparations may lead to cumulation of lithium and increase its toxic effects (it is recommended to control the lithium concentration in the blood).

In concomitant use with methotrexate there is an increased side effect of the latter on the hematopoietic system (risk of anemia and leukopenia, periodic control of total blood count is indicated).

Concomitant use with diuretics and with cyclosporine increases the risk of renal failure.

Concomitant use with intrauterine contraceptives may decrease the effectiveness of the latter.

In concomitant use with anticoagulants (heparin, ticlopidine, warfarin), as well as with thrombolytic drugs (streptokinase, fibrinolysin) the risk of bleeding increases (periodic monitoring of blood clotting is necessary).

In concomitant use with colestiramine, as a result of binding of meloxicam, its excretion through the gastrointestinal tract is increased.

Concomitant use with selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

Special Instructions

Caution should be exercised when using the drug in patients with a history of peptic ulcer disease and duodenal ulcer, as well as in patients on anticoagulant therapy. These patients have an increased risk of gastrointestinal ulcer-erosive diseases.

Perhaps caution should be exercised and renal function parameters should be monitored when using the drug in elderly patients, patients with chronic heart failure with circulatory insufficiency, patients with cirrhosis of the liver, and patients with hypovolemia due to surgical interventions.

In patients with renal insufficiency, if creatinine clearance is greater than 30 ml/min, no dosing adjustment is necessary. In patients on hemodialysis, the dosage of the drug should not exceed 7.5 mg/day.

In case of persistent and significant elevation of transaminases and changes in other liver function parameters, the drug should be discontinued and control tests should be performed.

Patients taking diuretics and meloxicam at the same time should take plenty of fluids.

If allergic reactions (itching, skin rash, urticaria, photosensitization) occurred during treatment, the drug should be stopped.

Meloxicam, as well as other non-steroidal anti-inflammatory drugs, can mask the symptoms of infectious diseases.

The use of meloxicam, as well as other drugs that block the synthesis of prostaglandins, may affect fertility, so it is not recommended for women planning to become pregnant.

The effect on the ability to drive:

The use of the drug may cause adverse effects in the form of headache and dizziness, drowsiness. It is necessary to refrain from driving vehicles and operating machines and mechanisms requiring concentration.

Contraindications

• Contraindicated in the period after coronary artery bypass surgery;
• decompensated heart failure;
erosive-ulcerative changes of mucous coat of stomach or duodenum, active gastrointestinal bleeding;
• inflammatory bowel disease (non-specific ulcerative colitis, Crohn’s disease);
• Cerebrovascular bleeding or other bleeding;
• explicit hepatic insufficiency or active liver disease;
• explicit renal insufficiency in patients not undergoing dialysis (creatinine clearance less than 30 mL/min), advanced renal disease including.
• pregnancy, breastfeeding
• hypersensitivity to the active substance or excipients
• children under 15 years of age.

Due to the presence of lactose in the preparation patients with rare hereditary diseases, such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take the preparation.
With caution:
To reduce the risk of adverse events, the lowest effective dose should be used for the shortest possible course at:
coronary heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, creatinine clearance less than 60 ml/min, history of gastrointestinal ulcers, in the presence of Helicobacter pylori infection, the elderly, long-term use of nonsteroidal anti-inflammatory drugs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (e.g., warfarin), antiaggregants (e.g., acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (e.g., prednisolone), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline).

Side effects

Gastrointestinal tract: more than 1% – dyspepsia, including nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; 0.1-1% – transient increase in “liver” transaminases activity, hyperbilirubinemia, belching, esophagitis, gastroduodenal ulcer, bleeding from the gastrointestinal tract (including hidden).including latent), stomatitis; less than 0.1% – gastrointestinal perforation, colitis, hepatitis, gastritis.

Hematopoietic organs: more than 1% – anemia; 0.1-1% – changes of blood count, including leukopenia, thrombocytopenia.

The skin: more than 1% – itching, skin rash; 0,1-1% – urticaria; less than 0,1% – photosensitization, bullous rash, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis.

Respiratory system disorders: less than 0.1% – bronchospasm.

Nervous system disorders: more than 1% – dizziness, headache; 0.1-1% – vertigo, tinnitus, drowsiness; less than 0.1% – confusion, disorientation, emotional lability.

Cardiovascular system: more than 1% – peripheral edema; 0.1-1% – increase of blood pressure, palpitation, “rushes” of blood to the face.

Urinary system: 0.1-1% – hypercreatininemia and/or increased serum urea; less than 0.1% – acute renal failure; relationship with meloxicam administration is not determined – interstitial nephritis, albuminuria, hematuria.

Sensory system disorders: less than 0.1% – conjunctivitis, visual impairment, including blurred vision.

Allergic reactions: less than 0.1% – angioedema, anaphylactoid/anaphylactic reactions.

Overdose

Symptoms: impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, liver failure, respiratory arrest, asystole.

Treatment: there is no specific antidote; in case of overdose of the drug, gastric lavage, administration of activated charcoal (within the next hour), symptomatic therapy should be carried out. Colestiramine accelerates excretion of the drug from the body. Forced diuresis, hemodialysis are ineffective due to high binding of the drug to blood proteins.

Pregnancy use

It is contraindicated in pregnancy and lactation.

Similarities

Movalis, Meloxicam, Amelotex, Movasin, Arthrosan, Meloxicam-Teva, Meloxicam DS, Meloxicam Stada, Petcam Tabs, Meloxidil, Elox-SOLofar