Description overdue on 06/10/2014
- Latin name: Amelotex
- ATC code: M01AC06
- Active substance: Meloxicam (Meloxicam)
- Manufacturer: PharmFirma Sotex, JSC (Russia)
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications Amelotex
- Contraindications
- Side effects
- Instructions for use Amelotex
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Babies
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
One ampoule contains Amelotex:
- active ingredient - meloxicam - 15 mg;
- excipients - glikofurfurola - 150 mg; meglumine - 9, 375 mg; glycerol - 7. 5 mg; poloxamer - 75 mg; sodium chloride - 4, 5 mg; sodium hydroxide - To pH 8, 2-8, 9; water - up to 1, 5 ml.
One tablet contains Amelotex:
- active ingredient - meloxicam - 7, 5 mg or 15 mg per dosage depending;
- excipients - 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 silica -1, 44 mg; magnesium stearate 2, 34 mg.
Product form
Injections Amelotex in the form of a solution for intramuscular injection is a clear liquid yellow-green color from colorless glass ampoules:
- Three such vials in Valium planimetric package, one or two such packages in a carton box;
- five vials of Valium planimetric in packaging; one, two or four such packing in a cardboard package.
Tablets Amelotex biconvex, round, scored from one side, light yellow or light yellow-green color, there may be a light roughness. Ten of these tablets Valium planimetric package, one or two such packages in a carton box.
Pharmacological action
The drug has analgesic, antipyretic and inflammatory action .
Pharmacodynamics and pharmacokinetics
Pharmacodynamics
Meloxicam refers to NSAIDs That have analgesic, antipyretic and anti-inflammatory action.
Anti-inflammatory effects associated with inhibition of activity Cyclooxygenase-2 Involved in the synthesis of prostaglandins in inflammatory foci. To a lesser extent the drug has an effect on cyclooxygenase-1 Also involved in the biosynthesis prostaglandin Protecting the lining of the digestive tract and contributing to the regulation of blood flow in the kidney.
Meloxicam It refers to the group oxycam ; chemically - derived enolievoy acid.
Pharmacokinetics
Intramuscular injection of the drug binds to plasma proteins by 98%. It penetrates all tissue barriers and penetrates into the joint fluid. The concentration in the synovial fluid reaches 50% of the maximum plasma concentration.
Excreted through the kidneys and intestines equally as metabolites. In its original form through the intestine stands up to 5% of the daily dose of the drug in the urine in unchanged form meloxicam almost no output. The half-life of 15-19 hours. Plasma clearance - 8 ml / min. Clearance the drug is slowed in patients older than 50 years. Renal or hepatic failure moderately severe effect on the pharmacokinetics of the drug has not.
Pills. The drug is rapidly absorbed from the intestine, the absolute bioavailability - 89%. Reception, together with the food does not change adsorption. When using the drug orally in doses of 15 and 7, 5 mg of blood levels are proportional. Meloxicam completely metabolized in the liver, resulting in up to four may be formed of inert derivatives. The main metabolite, 5-karboksimeloksikam formed by oxidation 5 gidroksimetilmeloksikama . The production of the other two derivatives is involved peroxidase .
Indications Amelotex
Indications Amelotex:
- rheumatoid arthritis ;
- osteoarthritis ;
- ankylosing spondylitis ;
- degenerative and inflammatory diseases of the joints, with accompanying pain (solution for intramuscular injection).
Amelotex for symptomatic treatment, relief of pain and inflammation during use, on the development of the disease is not affected.
Contraindications
Amelotex has the following contraindications:
- allergy any of the components of the formulation;
- heart failure decompensated;
- convalescence after coronary artery bypass grafting ;
- mix (complete or incomplete) recurrent polyposis paranasal sinuses and nose, asthma and hypersensitivity to acetylsalicylic acid E and other NSAIDs ;
- erosive and ulcerative changes in the mucosa of the stomach or duodenum, gastrointestinal bleeding;
- cerebrovascular bleeding;
- severe hepatic insufficiency ;
- inflammatory bowel disease (e.g. ulcerative colitis );
- severe renal insufficiency And one renal failure;
- lactation;
- pregnancy;
- deficit lactose Intolerance lactose or syndrome galactose malabsorption glucose (pills);
- age less than 15 years.
C care to apply: to reduce the risk of side effects should be the minimum effective dose in the most short-course coronary heart disease . Heart Failure congestive, cerebrovascular diseases, diabetes . hyperlipidemia, smoking, peripheral arterial disease, creatinine clearance less than 60 ml / min, ulcerative lesions of the digestive system in history, in old age, the presence of Helicobacter pylori , Chronic administration of other NSAIDs, alcohol abuse, concomitant therapy with drugs listed below: anticoagulants, antiplatelet agents, Oral glucocorticosteroid agents, selective serotonin reuptake inhibitor ( fluoxetine . citalopram and others).
Side effects
From the digestive system: more than 1% of cases - dyspepsia , Including nausea, abdominal pain, diarrhea ; 0, 1-1% in sluchaev- hyperbilirubinemia, a temporary increase hepatic transaminases . gastroduodenal ulcer . esophagitis , Bleeding from the digestive tract, stomatitis ; less than 0, 1% - perforation, hepatitis . colitis . gastritis .
Skin: more than 1% of cases - pruritus, rash; 0, 1-1% of cases - hives ; less than 0, 1% - bullous rash, photosensitivity, Stevens-Johnson syndrome .
From the hematopoietic system: more than 1% of cases - reduced hemoglobin; 0, 1-1% of cases - leukopenia, thrombocytopenia .
With the respiratory system: Less than 0, 1% - bronchospasm .
From the nervous system: more than 1% of cases - dizziness, headache; 0, 1-1% of cases - vertigo , Drowsiness; less than 0, 1% - disorientation, confusion.
Since the cardiovascular system: more than 1% of cases - swelling; 0, 1-1% - high blood pressure . heartbeat , Redness of the face.
With the genitourinary system: 0, 1-1% of cases - hypercreatininemia ; less than 0, 1% - renal failure .
From the upper respiratory tract: less than 0, 1% - blurred vision, conjunctivitis .
From the immunity Less than 0, 1% - angioedema . anaphylactic reactions .
Instructions for use Amelotex
Instructions for use Amelotex (injections for intramuscular injection)
Intramuscular - 7, 5-15 mg per day. If the kidney function ( creatinine clearance & gt; 25 ml / min) and liver at steady state dose correction is not performed. The initial dose in patients with an increased risk of side effects - 7 5 mg per day.
The maximum daily dose of medication Amelotex - 15 mg.
Instructions on pills Amelotex
Taken orally once a day with meals.
- With rheumatoid arthritis 15 mg per day. Depending on the therapeutic effect of the dosage can be reduced to 7, 5 mg per day.
- With osteoarthritis 7 and 5 mg per day. The dose may be increased to 15 mg per day for inefficiency.
- With ankylosing spondylitis 15 mg per day.
The maximum daily dose - 15 mg.
In patients with an increased risk of side effects, severe renal insufficiency Passing hemodialysis dose should not be more than 7, 5 mg per day.
Overdose
Symptoms of overdose include nausea, abdominal pain, vomiting, hepatic failure , Bleeding from the digestive tract, renal failure, sleep apnea, asystole .
Treatment of overdose: a unique antidote to Amelotex not; you must perform gastric lavage, then welcome Activated Carbon , Symptomatic treatment. Kolestiramin activates drug excretion from the body. Hemodialysis and forced diuresis ineffective.
Cooperation
At simultaneous reception:
- from Abciximab, aspirin, warfarin, heparin, Dalteporinom Nart increased risk of bleeding;
- from Acebutolol, hydrochlorothiazide, captopril, lisinopril, moexipril, perindopril, timolol attenuated hypotensive effect ;
- with others NSAIDs dramatically increases the risk of severe side effects.
Terms of sale
Throughout available on medical prescription.
Storage conditions
Keep away from children. Store in a dark, dry place at a temperature of 25 degrees.
Shelf life
Three years.
Cautions
Be careful when taking the drug by persons who have suffered in the past duodenal ulcer and stomach As well as those passing on anticoagulant therapy . These people increase the risk of ulcerative erosive complications.
You should also monitor the functional state when using the drug elderly people with chronic cardiac insufficiency . cirrhosis liver.
For people undergoing hemodialysis Daily dose to be not higher than 7, 5 mg.
If persistent increase transaminases and other violations of liver function is recommended to carry out drug control tests and cancel the drug.
Makers together meloxicam and diuretics Must consume sufficient liquid.
If, during any therapy Amelotex allergic reactions , You must stop using the drug.
Application meloxicam and other means of blocking the biosynthesis prostaglandins May affect the fertility , Therefore intake of these funds is not recommended for women who are planning a pregnancy.
It is recommended to give up driving and occupation, requiring concentration, for the duration of treatment, as it may cause dizziness and headaches.
Analogs Amelotex
Lornoxicam
Teksamen
Artrozan
Movalis
Meloxicam
Ksefokam
Revmoksikam
Analogs Amelotex fairly common and well known: Artrozan, Matara, meloxicam Meloxicam Pfizer, Movalis, Movasin, Oksikamoks .
Babies
The drug is banned for use to persons under 15 years of age.
During pregnancy and lactation
The drug is banned for pregnant. nursing mothers and women planning pregnancy.
Reviews Amelotex
Reviews Amelotex tablets, as well as reviews injections Amelotex extremely ambiguous.
Along with reports of excellent analgesic effect found negative assessment of the drug because of side effects or lack of efficacy (due to individual resistance).
Price Amelotex
In Russia, the price Amelotex 15 mg (20 tablets) is 120-133 rubles, and 3 vials of 10 mg of the drug will cost 290-330 rubles. In Ukraine, the drug in tablets of 15 mg (20 pieces) can be bought for 75-86 hryvnia, the price shots Amelotex (3 ampoules) - 170-175 hryvnia.
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