BI-PRESTARIUM 10 MG/10 MG

INSTRUCTIONS for medical use of the medicinal product LOXIDOL (LOXIDOL)

Composition

active substance: meloxicam; 1 ampoule (1.5 ml) of the solution contains meloxicam 15 mg; excipients: meglumine, glycofurol, poloxamer 188, glycine, sodium chloride, sodium hydroxide, water for injections.

Pharmaceutical form

Solution for injections.

Main physical and chemical properties

Light-yellow transparent solution.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory and anti-rheumatic drugs. ATC code M01A C06.

Pharmacological properties

Pharmacodynamics

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the enolic acid class, which exhibits anti-inflammatory, analgesic, and antipyretic effects.

Pharmacokinetics

Absorption: After intramuscular administration, meloxicam is completely absorbed. The relative bioavailability compared to oral administration is almost 100%. Therefore, dose adjustment is not required when switching from intramuscular to oral administration.

Distribution: Meloxicam is strongly bound to plasma proteins, mainly albumin (99%). It penetrates into synovial fluid, where its concentration is half that in plasma.

Metabolism: Meloxicam undergoes extensive biotransformation in the liver.

Excretion: Meloxicam is excreted mainly in the form of metabolites in equal parts with urine and feces.

Clinical characteristics

Indications

Short-term symptomatic treatment of acute attacks of rheumatoid arthritis and ankylosing spondylitis, when other routes of administration cannot be used.

Contraindications

Increased sensitivity to the active substance or to other excipients of the medicinal product;

increased sensitivity to active substances with similar action, such as NSAIDs, acetylsalicylic acid;

meloxicam should not be used in patients who have experienced symptoms of asthma, nasal polyps, angioneurotic edema, or urticaria after taking acetylsalicylic acid or other NSAIDs;

gastrointestinal bleeding or perforation associated with previous NSAID therapy in the anamnesis;

active or recurrent peptic ulcer/bleeding in the anamnesis (two or more separate confirmed cases of ulcer or bleeding);

severe liver insufficiency;

severe renal insufficiency (without dialysis use);

gastrointestinal bleeding, cerebrovascular bleeding in the anamnesis, or other coagulation disorders;

hemostasis disorders or concomitant use of anticoagulants (contraindications related to the route of administration);

severe heart failure;

treatment of perioperative pain in coronary artery bypass grafting (CABG);

III trimester of pregnancy (see section "Use during pregnancy or breastfeeding");

patient age under 18 years.

Interaction with other medicinal products and other types of interactions

Pharmacodynamic interactions

Certain medicinal products or therapeutic groups that may contribute to hyperkalemia: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE), angiotensin receptor antagonists (ARA) II, NSAIDs, (low-molecular-weight or unfractionated) heparins, cyclosporine, tacrolimus, and trimethoprim

Pharmacokinetic interactions

Lithium: It has been reported that NSAIDs increase the level of lithium in plasma (due to decreased renal excretion of lithium), which can reach toxic levels.

Methotrexate: NSAIDs may decrease the tubular secretion of methotrexate, thereby increasing its concentration in plasma.

Special warnings and precautions for use

Side effects

Side effects can be minimized by using the smallest effective dose of the medicinal product for the shortest period of time necessary to control the disease.

Effect on the gastrointestinal tract

As with the use of other NSAIDs, potentially life-threatening gastrointestinal bleeding, ulcers, or perforation may occur at any time during treatment, with or without previous symptoms or serious gastrointestinal diseases in the anamnesis.

Effect on the cardiovascular system

During the use of the medicinal product, patients with arterial hypertension and/or congestive heart failure from mild to moderate degree in the anamnesis should be closely monitored, as fluid retention and edema have been observed during NSAID treatment.

Effect on the skin

During the use of meloxicam, life-threatening severe skin lesions have been reported: Stevens-Johnson syndrome and toxic epidermal necrolysis.

Ability to influence the reaction rate when driving vehicles or using other mechanisms

There are no special studies on the effect of meloxicam on the ability to drive vehicles or use other mechanisms.

Method of administration and dosage

Dosage

The medicinal product should be used in a dose of 15 mg once a day (1 injection).

Special patient categories

Elderly patients: The recommended dose of the medicinal product for elderly patients is 7.5 mg per day (half an ampoule of 1.5 ml).

Patients at increased risk of side effects: Patients at increased risk of side effects, such as gastrointestinal diseases in the anamnesis or risk factors for cardiovascular diseases, should start using the medicinal product with a dose of 7.5 mg per day (half an ampoule of 1.5 ml).

Overdose

Symptoms of acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive therapy.

Side effects

Study data and epidemiological data suggest that the use of some NSAIDs (especially in high doses and with prolonged treatment) may be associated with a small increased risk of vascular thrombotic events, such as myocardial infarction or stroke.

From the blood and lymphatic system

uncommon – anemia; rare – deviations of blood test parameters from normal (including changes in leukocyte count), leukopenia, thrombocytopenia.

From the immune system

uncommon – allergic reactions, except anaphylactic or anaphylactoid; frequency unknown – anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, including shock.

Use during pregnancy or breastfeeding

Pregnancy

Suppression of prostaglandin synthesis may negatively affect pregnancy and/or embryo/fetal development.

Breastfeeding period

Although there are no specific data on meloxicam, it is known that NSAIDs can penetrate into breast milk.

Storage conditions

Store at a temperature not exceeding 25 °C in the original packaging and out of reach of children.

Incompatibility

Due to possible incompatibility, the medicinal product should not be mixed with other preparations in the same syringe.

Packaging

1.5 ml of solution in a glass ampoule; 3 ampoules in a contour cell package; 1 contour cell package in a cardboard box.

Release category

By prescription.

Manufacturer

PharmaVision San. ve Tic. A.S./PharmaVision San. ve Tic. A.S.

Manufacturer's location and address

Davutpasa Cad. No:145 Zeytinburnu Istanbul, Turkey/Davutpasa Cad. No:145 Zeytinburnu Istanbul, Turkey.

Applicant

LLC "WORLD MEDICINE", Ukraine/ WORLD MEDICINE, LLC, Ukraine.