Amelotex injections instructions for use
Amelotex as a solution for intramuscular injection refers to the pharmacological group of non-steroidal anti-inflammatory drugs. The active substance of this medication, meloxicam, is a selective inhibitor of the COX-2 enzyme, thereby reducing the production of prostaglandins (inflammatory mediators), the severity of inflammation and the intensity of pain. Amelotex in injections is used mainly in the complex therapy of various inflammatory diseases of the musculoskeletal system.
Form of issue and composition
Solution for intramuscular injection Amelotex is available in transparent ampoules of 1.5 ml in several types of packaging:
- 3 ampoules - are contained in 1 circuit cell pack.
- 5 ampoules in 1 contour squamous packaging.
- 6 ampoules - 2 contoured cell packs of 3 ampoules each.
- 10 ampoules - 2 contour cell packs of 5 ampoules each.
- 20 ampoules - 4 contour cell packs of 5 ampoules each.
In 1 ml of the solution for intramuscular injection contains 10 mg meloxicam, respectively in 1 ampoule - 15 mg. Also in 1 ampoule contains auxiliary substances:
- Meglumine - 9.375 mg.
- Glycofurfural 150 mg.
- Poloxamer 75 mg.
- Sodium chloride 4.5 mg.
- Glycerol 7.5 mg.
- Sodium hydroxide solution 1M - up to pH 8.2-8.9.
- Water for injection - up to a volume of 1.5 ml.
Packing with a different number of ampoules in the package makes it possible to conveniently choose the package for the course of treatment.
The main active substance of the solution for intramuscular injections is meloxicam, which belongs to the pharmacological group of non-steroidal 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 tissues during an inflammatory reaction. They have a number of effects:
- Irritating sensitive nerve endings - the emergence of a feeling of pain in the area of the inflammatory process.
- Increase the permeability of the walls of the vessels of the microcirculatory bed - while the intercellular substance of the tissues leaves the liquid part of the blood (plasma) with the development of edema.
- Reduce the intensity of outflow of blood with its stagnation in the inflammatory process due to narrowing of venous vessels (hyperemia).
In the body, there are several subspecies of prostaglandins. Some of them do not take part in the inflammation process, they are localized to the stomach and perform a protective function against the mucous membrane - prevent the development of erosions and ulcers under the action of hydrochloric acid of gastric juice. The production of such physiologically necessary prostaglandins catalyzes the enzyme cycloxygenase 1 (COX-1). Prostaglandins, which are mediators of inflammation, are synthesized with the help of COX-2. A large number of preparations of the group of non-steroidal anti-inflammatory drugs block the enzymes of COX-1 and COX-2, which leads to a high risk of ulcerative disease of the stomach and duodenum during their application. 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 mucosa of the stomach and duodenum. The anti-inflammatory effect of the active substance of the solution for injection is manifested in a decrease in the intensity of pain, the severity of edema of the tissues and their hyperemia.
The therapeutic concentration in the blood of meloxicam is reached after 15-20 minutes after intramuscular injection of Amelotex injection solution. It practically all (99%) binds to the proteins of the blood plasma and spreads through the body. The greatest amount is stored in the connective tissue. Meloksikam penetrates through the blood-brain barrier (from the blood, it can enter the tissues of the brain, spinal cord and spinal fluid). Also, the active substance of the drug flows freely through the placenta into the fetus during pregnancy and into breast milk during lactation. Half-life (the time during which 50% of the active substance of the drug is excreted from the body) for meloxicam is 10-12 hours. Meloksikam is processed in the liver to intermediate decay products, which are excreted mostly by the kidneys. Partly they can be excreted through the intestine, where I come from the liver with bile.
Indications for use
Since meloxicam is well accumulated 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 pathological structures of the motor apparatus, which are accompanied by an inflammatory process. These include:
- Rheumatoid arthritis - inflammation of the joints due to a malfunction of the immune system, which produces autoantibodies that affect the tissues of the joints.
- Osteoarthritis is a degenerative-dystrophic pathology of the joints with the destruction of their cartilaginous tissue and the development of the inflammatory reaction.
- Ankylosing spondylitis (Bechterew's disease) is an autoimmune pathology accompanied by inflammation of the entire vertebral structure with a significant decrease in its mobility and pain.
- Arthritis - inflammation of joint tissues of various etiologies (bacterial infection, local hypothermia).
Application of the solution for intramuscular injection Amelotex in these diseases is a component of symptomatic therapy, which allows to reduce the intensity of pain syndrome and other inflammatory manifestations. The preparation does not influence the elimination of the cause of inflammation.
Contraindications for use
Meloksikam in the solution for intramuscular injections Amelotex can have a negative effect on the body under various pathological and physiological conditions, which are a contraindication to the 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 until the development of asthmatic status.
- The combination of bronchial asthma, recurring (with frequent exacerbations) polyposis of the nasal cavity, paranasal sinuses and intolerance of acetylsalicylic acid (as well as other representatives of the group of nonsteroidal anti-inflammatory drugs) in the past.
- Allergic reactions to meloxicam or excipients - they can manifest as skin changes (rash, itching, urticaria ), angioedema, edema ( Quincke's edema ) and anaphylactic shock (an 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 (complication of peptic ulcer of the stomach or duodenum), bleeding of any other localization.
- Insufficient functional activity of the liver.
- Acute or chronic renal failure.
- Inflammatory nonspecific pathology of the intestine (ulcerative colitis, Crohn's disease).
- Pregnancy at any time, the period of breastfeeding and children under 15 years.
Before the first use of the drug, it is necessary to pay attention to possible contraindications. In case the doctor prescribes the Amelotex administration, he first ascertains the absence of contraindications to its use.
Dosing and Administration
The drug Amelotex is administered intramuscularly. Its dosage is determined by the type of inflammatory pathology and the severity of its course, which is manifested by a different intensity of pain. Usually the initial dosage is 7.5 mg per day (1/2 ampoules), if necessary, increase it to 15 mg per day. The drug is administered once a day at the same time, the intramuscular injection is performed in compliance with the rules of aseptic and antiseptic to prevent infection. Do not administer the drug into the hematoma, subcutaneous hemorrhage. The average course of treatment is 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:
- The digestive system - nausea, sometimes vomiting, belching of the air, abdominal pain, unstable stool (constipation or diarrhea), bloating or gastrointestinal bleeding. Possible esophagitis, gastritis or enteritis.
- Liver and bile ducts - increase of 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 organs - bronchospasm (narrowing of the lumen of the bronchi).
- Hemopoiesis is anemia (decrease in the number of erythrocytes and hemoglobin level), thrombocytopenia (decrease in the number of platelets), and leukopenia (decrease in the number of leukocytes).
- Cardiovascular system - development of peripheral edema, palpitation, blood flow to the upper half of the trunk and face, increasing systemic blood pressure.
- Urinary system - increased levels of uric acid, urea, creatine in the blood, swelling of the tissues, there can rarely be a development of acute renal failure.
- Skin - the appearance of rash and itching, increased reaction to light (photosensitivity), allergic urticaria.
- Eyes - decreased visual acuity, conjunctivitis .
- Allergic reactions - depending on the severity of the sensitization of the body, they can vary from skin rash and itching to the development of anaphylactic shock.
Typically, these side effects can develop with prolonged use of the drug, more than 5 days. In the place of intramuscular injection of Amelotex, reactions in the form of burning and redness of the skin are possible. In case of side effects, the drug is stopped.
Before starting the solution for intramuscular injections of Amelotex, you should carefully study the instructions and make sure there are no contraindications. It is worth paying attention to special instructions:
- Excluded the introduction of the drug to pregnant women, nursing women and children under 15 years.
- Elderly, the dose of the drug is reduced.
- With special care and constant clinical and laboratory control, the drug is prescribed for people with pathology of liver, kidney and peptic ulcer of the stomach or duodenum.
- The simultaneous use of Amelotec with other drugs can increase their activity (other representatives of non-steroidal anti-inflammatory drugs) or reduce it (antihypertensive drugs). Therefore, it is absolutely necessary to consult a doctor.
- In view of the possible development of drowsiness, the drug is undesirable to use for people whose activity is associated with increased concentration of attention and requires a rapid psychomotor reaction.
If you have any doubts or questions, you should consult your doctor. In pharmacies, the solution for intramuscular injection Amelotex is dispensed by prescription.
Exceeding the permissible dose of the drug may lead to the development of any one or more side effects. There is no specific antidote, symptomatic therapy is used to improve the condition.
Terms and conditions of storage
Shelf life - 2 years. Keep out of reach of children and dark places at temperatures from +8 to +25 ° C.
Analogues of injections Amelotex
Analogues of the solution for injection Amelotex include Revmoxicam, Meloxicam, Movalis.
Prices for Amelotex
Amelotex solution for intramuscular injection 10 mg / ml, 3 pcs. - from 314 rubles.