Amelotex injections instructions for use
The drug Amelothex in the form of a solution for intramuscular administration belongs to the pharmacological group of drugs of nonsteroidal anti-inflammatory drugs. The active ingredient of this drug - meloxicam, is a selective inhibitor of the enzyme COX-2, thereby reducing the production of prostaglandins (mediators of the inflammatory response), the severity of inflammation and the intensity of pain. Amelotex injections is used mainly in the treatment of various inflammatory diseases of the musculoskeletal system.
Release form and composition
Solution for intramuscular injections Amelotex is produced in 1.5 ml clear ampoules in several types of packaging:
- 3 ampoules - contained in 1 blister cell packaging.
- 5 ampoules - in 1 blister pack.
- 6 ampoules - 2 blister cell packs of 3 ampoules.
- 10 ampoules - 2 blister packs of 5 ampoules.
- 20 ampoules - 4 blister packs of 5 ampoules each.
1 ml of solution for intramuscular injections contains 10 mg of meloxicam, respectively, in 1 ampoule - 15 mg. Also in 1 ampoule contains excipients:
- Meglumin - 9.375 mg.
- Glycofurfural - 150 mg.
- Poloxamer - 75 mg.
- Sodium chloride - 4.5 mg.
- Glycerol - 7.5 mg.
- Sodium hydroxide solution 1M - to pH 8.2-8.9.
- Water for injection - up to a volume of 1.5 ml.
Packaging with a different number of ampoules in a package allows convenient selection of packaging for a course of treatment.
The main active ingredient of the solution for intramuscular injections is meloxicam, which belongs to the pharmacological group of nonsteroidal anti-inflammatory drugs. This substance is active against the enzyme cycloxygenase 2 (COX-2), which catalyzes the synthesis of prostaglandins. Prostaglandins are biologically active compounds that are formed in the tissues during an inflammatory reaction. They have a number of effects:
- Sensitive nerve endings irritate - the emergence of a feeling of pain in the area of the inflammatory process.
- Increase the permeability of the walls of blood vessels of the microcirculatory bed - while the liquid part of the blood (plasma) enters the intercellular substance of the tissues with the development of edema.
- Reduce the intensity of the outflow of blood with its stagnation in the area of the inflammatory process due to the narrowing of the venous vessels (hyperemia).
In the body, there are several subspecies of prostaglandins. Some of them do not take part in the process of inflammation, they are localized in the stomach and perform a protective function against the mucous membrane - they prevent the development of erosions and ulcers under the action of hydrochloric acid of gastric juice. The production of such physiologically necessary prostaglandins is catalyzed by the enzyme cycloxygenase 1 (COX-1). Prostaglandins, which are mediators of inflammation, are synthesized using COX-2. A large number of drugs in the group of nonsteroidal anti-inflammatory drugs are blocked by COX-1 and COX-2 enzymes, which leads to a high risk of developing gastric ulcer and duodenal ulcer during their use. Due to its selectivity, meloxicam blocks only COX-2, due to which it has a pronounced anti-inflammatory effect and has a minimal damaging effect on the mucous membrane of the stomach and duodenum. The anti-inflammatory effect of the active ingredient of the injection solution is manifested in a decrease in the intensity of pain, severity of tissue swelling and their hyperemia.
The therapeutic concentration of meloxicam in the blood is reached already 15-20 minutes after the intramuscular injection of Amelotex injection. It almost all (99%) binds to plasma proteins and spreads through the body. Its greatest amount is stored in the connective tissue. Meloxicam penetrates the blood-brain barrier (from the blood it can get into the tissues of the brain, spinal cord and spinal fluid). Also, the active ingredient of the drug freely passes through the placenta into the fetus during pregnancy and into breast milk during lactation. The half-life (the time during which 50% of the active ingredient of the drug is excreted from the body) for meloxicam is 10-12 hours. Meloxicam is processed in the liver to intermediate decay products, which are derived to a greater extent by the kidneys. In part, they can be excreted through the intestines, where I enter from the liver with bile.
Indications for use
Since meloxicam accumulates well in a therapeutic dose in the tissues of the organs of the musculoskeletal system, the solution for intramuscular injections of Amelotex is indicated for various pathologies of the structures of the musculoskeletal system, which are accompanied by an inflammatory process. These include:
- Rheumatoid arthritis is inflammation of the joints due to the impaired functioning of the immune system, which produces autoantibodies affecting the tissues of the joints.
- Osteoarthritis is a degenerative-dystrophic pathology of the joints with the destruction of their cartilage tissue and the development of an inflammatory reaction.
- Ankylosing spondyloarthritis (ankylosing spondylitis) is an autoimmune pathology, accompanied by inflammation of the structures of the entire spine with a significant decrease in its mobility and pain.
- Arthritis is an inflammation of the tissues of the joints of various etiologies (bacterial infection, local hypothermia).
Application of the solution for intramuscular injections Amelotex in these diseases is a component of symptomatic therapy, which allows to reduce the intensity of pain syndrome and other inflammatory manifestations. The drug does not affect the elimination of the cause of inflammation.
Meloxicam as part of the solution for intramuscular injections Amelotex can have a negative effect on the body in its various pathological and physiological conditions, which are contraindicated for use:
- Individual hypersensitivity to meloxicam or other components of the drug.
- Bronchial asthma - meloxicam (like all other drugs of this pharmacological group) can provoke a severe attack of the disease up to the development of asthmatic status.
- A combination of bronchial asthma, recurrent (with frequent exacerbations) of nasal polyposis, paranasal sinuses, and intolerance to acetylsalicylic acid (also other representatives of the nonsteroidal anti-inflammatory drugs) in the past.
- Allergic reactions to meloxicam or excipients - they can manifest skin changes (rash, itching, urticaria ), angioedema ( angioedema ) and anaphylactic shock (extremely severe allergic reaction with the development of multiple organ failure).
- Decompensated acute or chronic heart failure with severe circulatory disorders.
- Bleeding from the gastrointestinal tract (a complication of gastric ulcer or duodenal ulcer), bleeding any other localization.
- Insufficient functional activity of the liver.
- Acute or chronic renal failure.
- Inflammatory nonspecific bowel disease (ulcerative colitis, Crohn's disease).
- Pregnancy on any term, the period of feeding by a breast and children's age up to 15 years.
Before the first use of the drug, it is necessary to pay attention to possible contraindications. If the doctor prescribes the introduction of Amelotex, he first finds out the absence of contraindications to its use.
Dosing and Administration
The drug Amelotex is injected intramuscularly. Its dosage is determined by the type of inflammatory pathology and the severity of its course, which is manifested by different intensity of pain. Typically, the initial dosage is 7.5 mg per day (1/2 ampoule), if necessary, it is increased to 15 mg per day. The drug is administered 1 time per day at the same time, the introduction of intramuscular, performed in compliance with the rules of asepsis and antiseptics to prevent infection. The introduction of the drug in the area of hematomas, subcutaneous hemorrhage is not allowed. The course of treatment averages 5 days, if necessary, the doctor can extend it up to 10 days.
The use of Amelotex can lead to a number of negative side effects from various body systems:
- Digestive system - nausea, sometimes vomiting, belching with air, abdominal pain, unstable stools (constipation or diarrhea), bloating or gastrointestinal bleeding. Esophagitis, gastritis, or enteritis is possible.
- Liver and biliary tract - increased enzymes (ALT, AST), indicating damage to liver cells, increased bilirubin levels, hepatitis.
- Central nervous system - headache, dizziness, tinnitus, drowsiness, disorientation in time or space, emotional instability.
- Respiratory - bronchospasm (narrowing of the lumen of the bronchi).
- Hematopoiesis - anemia (decrease in the number of red blood cells and hemoglobin level), thrombocytopenia (decrease in the number of platelets), leukopenia (decrease in the number of white blood cells).
- Cardiovascular system - the development of peripheral edema, palpitations, rush of blood to the upper half of the body and face, increased systemic arterial pressure.
- Urinary system - an increase in the level of uric acid, urea, creatine in the blood, tissue edema, rarely can the development of acute renal failure.
- Skin - the appearance of rash and itching, increased reaction to light (photosensitization), allergic urticaria.
- Eyes - reduced visual acuity, conjunctivitis .
- Allergic reactions - depending on the degree of sensitization of the body, they can vary from rash and itching of the skin to the development of anaphylactic shock.
Typically, these side effects may develop with prolonged use of the drug, more than 5 days. In the place of intramuscular injection of Amelotex possible reactions in the form of burning and redness of the skin. In the case of side effects, the drug is discontinued.
Before using the solution for intramuscular injections of Amelotex it is necessary to carefully study the instructions and make sure there are no contraindications. It is worth paying attention to the special instructions:
- The introduction of the drug to pregnant women, nursing women and children under 15 years of age is excluded.
- Older people reduce the dose of the drug.
- With extreme caution and constant clinical and laboratory control, the drug is prescribed to people with pathology of the liver, kidneys, and peptic ulcer of the stomach or duodenum.
- The simultaneous use of Amelotex with other drugs can increase their activity (other representatives of nonsteroidal anti-inflammatory drugs) or reduce it (antihypertensive drugs). Therefore, it is imperative to consult a doctor.
- Due to the possible development of drowsiness, the drug is undesirable to apply to people whose activities are associated with increased concentration of attention and requires a quick psychomotor reaction.
If you have any doubts or questions, you should consult with your doctor. In pharmacies, the solution for intramuscular injection of Amelotex is released by prescription.
Exceeding the permissible dose of the drug can lead to the development of any one or more side effects. There is no specific antidote, symptomatic therapy is carried out to improve the condition.
Terms and conditions of storage
Shelf life - 2 years. Keep out of reach of children and in a dark place at a temperature of +8 to + 25 ° C.
Analogues of injections Amelotex
Analogues of solution for injection Amelotex include Revmoksikam, Meloksikam, Movalis.
Amelotex solution for intramuscular injection of 10 mg / ml, 3 pcs. - from 314 rubles.