Description overdue on 06/06/2014
- Latin name: Arcoxia
- ATC code: M01AH05
- Active substance: Etoricoxib (Etoricoxib)
- Manufacturer: Merck (USA)
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications Arcoxia
- Contraindications
- Side effects
- Instructions for use Arcoxia
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Babies
- With alcohol
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
Arcoxia One tablet contains active substance: etorikoksiba - 30, 60, 90 or 120 mg, depending on the dosage.
Excipients: dibasic calcium phosphate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate .
Cover structure: Opadry White II, carnauba wax.
The composition of the coating film: lactose monohydrate, hypromellose, titanium dioxide, triacetin, Aluminum-based varnish indigokarmina , Iron oxide yellow dye.
Product form
The drug Arcoxia is a film-coated tablets turquoise, lenticular, spherical, with the inscription " ACX 30 "From one side and the inscription" 101 "- The other end.
- Tablets 30 mg are available dosage of 2, 4, 7 or 14 pieces in a blister; 2, 1 or 4 of blisters in a carton box.
- Arcoxia 60 mg tablets are available by 7 pieces in a blister; 1 or 4 of blisters in a carton box.
- Arcoxia 90 mg tablets are also available for 7 pieces in a blister; 1 or 4 of blisters in a carton box.
- Tablets 120 mg dose produced 7 pieces in a blister; 1 blister in a carton box.
Pharmacological action
NSAIDs . Selective blocker cyclooxygenase-2.
Pharmacodynamics and pharmacokinetics
Pharmacodynamics
Etorikoksib - Oral selective blocker Cyclooxygenase-2 .
In clinical trials, the drug Arcoxia dose-dependently blocked cyclooxygenase-2 without suppression COX-1 when used in a dose of less than 150 mg per day. Etoricoxib does not inhibit the production of prostaglandins stomach and does not alter the function Platelet .
Cyclooxygenase regulates the formation prostaglandins . There are two forms of it - Tsiklookigenaza 1 and Tsiklookigenaza-2 . The latter is regarded as the main factor responsible for the production of mediators of pain, fever and inflammation. Tsiklookigenaza-2 It is involved in the mechanisms of ovulation, implantation and obturauii ductus arteriosus , To control the functions of the nervous system and kidney. She also participates in the process of ulcer healing.
Pharmacokinetics
Etorikoksib well absorbed by oral use. Absolute bioavailability It reaches 100%. The maximum drug concentration in the blood one hour after administration of fasting. When taken during food preparation was no significant effect on the absorption rate.
92% etorikoksiba It binds to blood proteins. The drug is extensively metabolised, less than 2% of the dose is excreted in the urine in unchanged form. The man studied metabolites 5 etorikoksiba . The main metabolite is 6-carboxylic acid Formed by oxidation of 6-Hydroxymethyl . These materials are either biologically inactive or weakly active blockers are COX-2 . None of them suppresses COX-1 . 70% of the drug excreted in the urine, about 25% - the faeces. The half-life is 22 hours.
Pharmacokinetics in elderly patients (over 65 years) is identical to that of younger persons and is independent of gender.
Pharmacokinetics the drug in children under 12 years of age has not been studied. Safety and efficiency etorikoksiba in children has not been proved.
Indications Arcoxia
Indications for use of the drug:
- symptomatic treatment rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, accompanied by inflammatory symptoms and pain;
- the treatment of moderate and severe acute postoperative pain after abdominal, gynecological and dental operations;
- Acute gouty arthritis .
The decision on the appointment of the electoral blocker COX-2 It should be made taking into account all the risks for the individual patient.
Contraindications
Arcoxia is contraindicated in:
- at sensitization to the active substance, any other substance in a preparation, or to other NSAIDs ;
- with active ulcer or bleeding from the stomach or intestines;
- during lactation and pregnancy;
- in severe liver damage (blood albumin of less than 25 g / l);
- those with renal creatinine clearance less than 30 ml / min;
- children under 16 years of age;
- individuals with inflammatory bowel disease;
- at Heart Failure congestive;
- patients hypertension Whose blood pressure is consistently greater 140/90 mmHg. Article .;
- at coronary heart disease , Peripheral artery disease and other cardiovascular diseases.
Side effects
The appointment of the drug may cause the following side effects:
- On the part of the central nervous system: at least 10% of cases - dizziness, head pain, weakness; in less than 1% of cases - sleepiness, sleep disturbances, taste disturbance, paresthesia , Anxiety, impaired concentration, hypersensitivity, depression, less than 0.01% of the cases - hallucinations, confusion.
- From the digestive system: in less than 10% of cases - a pain in the upper floor of the abdomen, diarrhea . dyspepsia, nausea, bloating; in less than 1% of cases - belching, bloating, constipation , Increased peristalsis, gastritis , Dry mucous membranes of the mouth, ulcer gastric mucosa or duodenal . esophagitis , Mouth ulcers, vomiting; less than 0.01% of the cases - ulcers of the stomach and intestine with perforation or bleeding.
- Liver: less than 0.01% of the cases - hepatitis .
- From the upper respiratory tract: in less than 1% of cases - conjunctivitis , Ringing in the ears, blurred vision, vertigo .
- From the side of immunity: at least 0.01% of the cases - anaphylactic reactions Including strong pressure drop and shock.
- With the genitourinary system: in less than 1% of cases - proteinuria ; less than 0.01% of the cases - reversible renal failure .
- From the respiratory system: in less than 1% of cases - shortness of breath, cough, epistaxis; less than 0.01% of the cases - bronchospasm .
- Cardio-vascular system: in less than 10% of cases - palpitations, increased blood pressure; in less than 1% of cases - the cerebral circulation, tides . Atrial fibrillation , ECG changes; less than 0.01% of the cases - hypertensive crisis .
- Infections: In less than 1% of cases - gastroenteritis , Urinary tract infections, respiratory tract.
- Skin and subcutaneous tissue: less than 10% of cases - ecchymosis ; in less than 1% of cases - swelling of the face, itching, rash; less than 0.0% of the 1 - Stevens-Johnson syndrome . hives . Lyell's syndrome .
- Metabolic disorders: less than 10% of cases - swelling; in less than 1% of cases - changes in appetite.
- From the musculoskeletal tract: in less than 1% of cases - arthralgia . convulsions . myalgia .
- Other: often - flu-like symptoms ; rarely - pain in the chest.
- Changes in clinical analysis: less than 10% of cases - increased transaminases; less than 1% - decrease hematocrit Increase in activity creatine, hyperkalemia, lowering hemoglobin, thrombocytopenia, leukopenia, increase creatinine serum uric acid; less than 0.01% of the cases - an increase in sodium in the blood.
Instructions for use Arcoxia
Instructions for use Arcoxia required to take this medication by mouth, without taking into account food intake. After swallowing pills Arcoxia drink water.
- With osteoarthritis : The recommended dose - 60 or 30 mg once a day.
- Ankylosing spondylitis and rheumatoid arthritis : Arcoxia 90mg tablet taken once a day.
- Acute gouty arthritis : In acute dose of 120 mg once a day. Duration of drug Arcoxia 120 mg not to exceed 8 days.
We recommend using the minimum effective dose of the shortest possible path.
Overdose
During the tests no reported overdose Arcoxia.
If the state of overdose still developed, may cause harmful symptoms of the stomach and intestines, kidneys and cardiovascular system. Treatment - symptomatic. Etorikoksib not released during hemodialysis.
Cooperation
Lithium. Nonsteroidal anti-inflammatory agents and inhibit the excretion lithium urine, increasing its level in blood.
Methotrexate. When using etorikoksiba and Methotrexate should be monitored for the strengthening of the toxic effect of the latter.
Oral contraceptives . Joint reception Oral contraceptives can delay their removal, and as a result increase the frequency of side effects ( thromboembolism veins).
Digoxin . Etorikoksib It enhances the toxic effects Digoxin .
Rifampicin . Simultaneous use etorikoksiba and rifampicin It leads to a decrease in blood etorikoksiba content of 65%.
Antacids . Do not have a significant effect on pharmacokinetics etorikoksiba .
Terms of sale
Throughout released strictly on prescription.
Storage conditions
Store at temperatures below 30 degrees. Keep away from children.
Shelf life
Three years. Do not use after the expiration date.
Cautions
Admission Arcoxia requires constant monitoring of blood pressure. All patients in the appointment of the drug necessary to carry out monitoring of blood pressure during the first 14 days of treatment. It is also recommended to regularly monitor indicators of kidney and liver.
In the case of increasing the level of liver enzymes three times more compared to the normal level of the drug should be abolished.
Given the emergence of an increased risk of side effects due to the increase in the duration of admission is necessary to regularly assess the need to extend the use of Arcoxia and the ability to reduce the dose.
It is forbidden to use the drug with other NSAIDs .
The shell of the drug contains lactose in a small amount - this should be taken into account in the appointment of patients with Arcoxia lactose intolerance .
During treatment, you need to be very careful when driving and occupation of potentially hazardous activities requiring concentration of attention and speed of psychomotor reactions. Persons with a history marked by episodes of dizziness, weakness, should refrain from such activities.
Analogs of Arcoxia
Celebrex
Ranseleks
The only analogue containing etoricoxib Arcoxia is Eksinef (Spain / Netherlands). The drugs have a similar structure and effects of the active substance: Denebola . RAYZON . Ranseleks . Celebrex and others. Price counterparts in most cases below the price Arcoxia.
Babies
The drug is banned for use in children under 16 years.
Compatible with alcohol
It should abandon admission alcohol for a period of treatment.
During pregnancy and lactation
Application etorikoksiba and other inhibitors COX-2 not recommended for pregnant women, women planning pregnancy and breastfeeding.
If a woman becomes pregnant during treatment, the drug should be abolished.
Application in the last trimester of pregnancy can lead to suppression of uterine contractions and early closing ductus arteriosus .
Women who used etoricoxib Should not breast-feed.
Comments about Arcoxia
Medical portals and forums abound reviews on Arcoxia. In general, reviews of physicians and patients about these tablets are the same: almost 100% efficiency in the use of the drug and is sufficiently high number of reports of adverse events. Also, many complain about the relatively high cost of the drug.
Price Arcoxia
In Russia, the tablet dose of 120 mg (7 pieces) will cost 530-600 rubles, the price Arcoxia 90 mg (7 pieces) - 380-410 rubles, the price Arcoxia 60 mg (7 pieces) - 300-330 rubles. Buy 7 tablets of this product in Ukraine will cost an average of 121 hryvnia per 120 mg, 114 hryvnia for 90 mg and 88 mg in 60 hryvnia.
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