Brexin Chiesi drugs reduce symptoms caused by osteoarthritis (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Piroxicam
Ingredient Gout, osteoarthritis, closed abdominal trauma, upper respiratory tract infections, joint spondylitis, arthritis, rheumatoid arthritis

Ingredient

Composition information	Content
Piroxicam	20mg

Uses

indications

Brexinic drugs are indicated to reduce symptoms caused by osteoarthritis (including osteoarthritis), rheumatoid arthritis or joint spondylitis.

Pharmacokological

Piroxicam, belonging to the n-isocyclic-carboxyamide benzothiazine group, is the first drug of the Oxicam group, a new NSAID subgroup. Piroxicam has anti -inflammatory, analgesic, cooling effect, similar to other nonsteroidal anti -inflammatory drugs. Animal studies show that Piroxicam affects the movement of cells to the inflamed area. Like other NSAIDs, Piroxicam affects prostaglandin synthesis through Cyclo-Oxygenase inhibitors. Unlike Indomethacin, Piroxicam is a recovery prostaglandin inhibitor. In a study on 8 patients with progressive rheumatoid arthritis, Piroxicam (20 mg/day for 15 days) significantly reduces the function of polygamy white blood cells (PMN), the creation of peripheral blood anion and epidemic, as well as the concentration of PMN and PMN-ELASTASE in epidemics. The modulation of the activity of PMN creates anti -inflammatory effects of Piroxicam.

Brexin is a new form of preparation of piroxicam, in which the main active ingredient is complex with beta-cyclodextrin.

beta-cyclodextrin is an oligosaccharide, derived from common starch hydrolysis with enzymes. Due to the characteristics of the chemical structure, Beta-Cyclodextrin can produce cage complexes with many different drugs, so it can improve some of the characteristics of the drug such as solubility, stability and bioavailability.

piroxicam-balla-cyclodextrin is very good in water and absorbs much faster than Piroxicam when used oral and rectal. Increasing solubility will help the drug quickly achieve high concentrations in the blood and the peak concentration will be achieved earlier, clinically anti -inflammatory effects of the drug will appear earlier and more efficient.

is still the same as with Piroxicam, half -life eliminates the prolonged plasma of Brexin remain the same, so the preparation still needs to be used once a day.

With appropriate pharmacokinetic and pharmacokinetic properties, Brexin is suitable for the treatment of inflammatory and/or rheumatism causing pain, which greatly affects the whole situation and the ability to perform common activities of the patient, and need to be active and fast treatment.

In the test of the mouse legs with Carrageenin, Brexin has faster anti -inflammatory effect than Piroxicam; In the first hours after actual use, Brexin is more efficient than Piroxicam 2 - 3 times including oral or rectal lines.

Oral pain relief effects are evaluated on mice by mice that causes pain with phenylquinone; 5 minutes after drinking, 99% of the maximum inhibitory effect of Brexin and 78% of Piroxicam. The effect of both drugs remains stable for about 2 hours after drinking.

Brexin and piroxicam treatment index value is calculated by comparing anti -inflammatory effects, evaluated on rats by testing rat edema with Carrageenin and the effect of stomach irritation, on the same experimental animal.

Brexin uses oral orally with a 2.65 times higher treatment index than oral piroxicam; Brexin's treatment index is 2.31 times higher than oral Brexin.

Brexin has been shown to cause less adverse effects on the gastrointestinal tract of the person through 3 double blind clinical trials, with control, assessing blood loss through the part by the radioactive marking method of 51CR red blood cells. In these studies, the drug use time is 28 days. Two of the three studies have shown blood loss through the use due to significantly less brexinic use until the end of 4 weeks of treatment, the remaining research also shows the same trend.

In another study, comparing the effects of Brexin's stomach, regular piroxicam, indomethacin and placebo after using 14 days; The difference in the risk of the stomach (Max GPD) is also evaluated. Brexin causes less risk to the stomach than piroxicam or indomethacin at this index and has the corresponding relationship between Max GPD and endoscopic evaluation damage. In short, Brexin has a better pharmacotic activity index compared to the toxicity on the gastrointestinal tract better than normal piroxicam.

pharmacokinetics

After drinking or placing Brexin rectum, only the activity (piroxicam) is absorbed.

Research on healthy volunteers shows that at the equivalent dose (20 mg of piroxicam), the maximum concentration of piroxicam in plasma is much earlier when using Brexin (oral use: within 30 - 60 minutes, compared to about 2 hours of regular piroxicam, rectal lines: within 2 hours compared to 6 - 7 hours of regular Piroxicam).

Essence parameters, KEL and T1/2 are not different from Piroxicam often because complexes with beta-cyclodextrin only affects the absorption kinetics rather than excreting.

The active ingredient is excreted through the kidney for 72 hours after taking the drug of both Brexin and Piroxicam preparations are usually about 10% of the dose.

After drinking a complex, beta-cyclodextrin in non-metabolic form is not detected in plasma or urine. Beta-Cyclodextrin is metabolized in the colon by the intestinal bacterial system into non-branched dextrins, maltose and glucose.

Before taking Brexin Chiesi drugs reduce symptoms caused by osteoarthritis (2 blisters x 10 tablets)

How to use

Should use Brexin 1 time/day.

Oral tablets: If the patient is prescribed half a dose, to split the tablet in half, leave the tablet on the flat surface, groove on the top. Gently press with your thumb, the pill will be broken in two equal parts.

Dosage

Piroxicam prescription should be indicated by a doctor who has experience in the diagnosis and treatment of patients with arthritis or osteoarthritis.

The maximum recommended dose per day is 20mg of piroxicam.

Unwanted effects can be reduced by using the minimum doses that work in the shortest time necessary to control symptoms. Treatment benefits and drug tolerance should be reviewed within 14 days. If the continued treatment is considered necessary, this should be considered regularly. The use of Piroxicam is associated with increased risk of gastrointestinal complications, so the use of therapy in combination with stomach protection drugs (such as Misoprostol or Proton pump inhibitors) should be considered, especially for elderly patients.

Elderly: Daily dose reduction may be reasonable; The right dose must be accurately indicated by the doctor.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Symptoms

Symptoms of overdose are headaches, drowsiness, dizziness and fainting. In the case of overdose, it is necessary to treat support and treat symptoms. Drinking activated carbon can help reduce the absorption of piroxicam-byclodextrin.

Handling

Although no research has been conducted so far, the hemolytic refinement is not to remove Piroxicam, due to a strong drug associated with plasma proteins.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Brexin, you may experience unwanted effects (ADR).

Clinical and epidemiological studies show that the use of NSAIDs (especially in high doses and long -term treatments) can slightly increase the risk of arterial thrombosis (e.g. myocardial infarction and stroke) (see special and cautious warnings when used). Reports on ADR are often encountered in the digestive tract. Stomach ulcers may occur, puncture or gastrointestinal bleeding, sometimes fatal, especially in the elderly (see the special and cautious warning part). Symptoms of nausea, vomiting, diarrhea, flatulence, constipation, indigestion, mouth ulcers, abdominal pain, black stools, vomiting blood, severe inflammation of colitis or Crohn's disease (see special and cautious warning) have been reported related to the use of NSAIDs.

Common, ADR> 1/100

Blood disorders and lymph: Anemia.

Nervous system disorders: headache. Itching.

Nervous system disorders: dizziness, drowsiness.

eye disorders: blurred vision.

Hemorrhagic and lymphatic disorders: ischemia, hemolytic anemia, thrombocytopenia, leukemia, eosinophilia, reducing 3 lines of peripheral blood cells. Urology: Nephritis nephritis, kidney disease, kidney syndrome, renal failure.

Skin disorders and subcutaneous organization: Serious adverse reactions on the skin (Scars): Stevens Johnson syndrome (SJS) and poisoned epidermal necrosis (Ten) have been reported (see special and cautious warnings when used)

Unknown frequency:

Metabolic and nutritious disorders: Keeping water. Orange. Hemoglobin decreases, hematocrit decreases. The likelihood of causing congested heart failure in elderly patients or people with damaged heart function should be noted.

The risk of cardiovascular thrombosis (see more warning and caution).

Clinical and epidemiological tests show that the use of some NSAIDs (especially in high doses and long -term treatment) may slightly increase the risk of arterial thrombosis (eg myocardial or dull infarction).

Instructions on how to handle ADR

Please inform the doctor or pharmacist about all the unwanted effects of the drug stated or any side effects of the drug that has not been mentioned here.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Brexinic medicine is contraindicated in the following cases:

There is a history of stomach ulcer, bleeding or puncture of the gastrointestinal tract. Cox-2 and acetylsalicylic acid with analgesic dose. weight) When using piroxicam, with other NSAIDs and other drugs. Heavy.

Pregnant and lactating women.

Caution when used

Unwanted effects can be reduced by the minimum dosage that works in the shortest time necessary to control symptoms. Clinical benefits and tolerances should be periodically evaluated and should be discontinued as soon as the skin reaction first appears for the first time or complications of the gastrointestinal tract related to NSAIDs.

Effects on the gastrointestinal tract, the risk of gastrointestinal ulcer, bleeding and puncture of the digestive tract

NSAIDS, including Piroxicam, can cause serious digestive complications including bleeding, ulcers, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious side effects can occur at any time, have or have no warning symptoms, in patients treated with NSAIDs.

Patients who use NSAID in a short time and long term are at risk of increasing serious gastrointestinal complications. Evidence from observation studies shows that Piroxicam may be at high risk of stomach toxicity, like other NSAIDs. Patients with significant risk factors for serious digestive complications should only be treated with Piroxicam after careful consideration (see the contraindications and below). Consider coordination with gastric protection agents (such as Misoprostol or Proton -Ppi pump inhibitors) (see the dose and usage).

Serious digestive complications

Determine the risk of

The risk of serious digestive complications increases with age. Over 70 years of high risk of complications. It is necessary to avoid taking medicine for patients over 80 years old. Patients with concurrent oral corticosteroids, Serotonin (SSRIs) or platelita acetylsalicylic anti -alleges inhibitors such as acetylsalicylic acid are at high risk of serious digestive complications (see the lower part and drug interactions). Like other NSAID drugs, the use of Piroxicam in combination with protective drugs (such as Misoprostol or Proton pump inhibitors) must be considered for patients at risk.

Patients and doctors should be alert with signs and symptoms of ulcer and/or hemorrhage during piroxicam treatment. Patients should be required to report any abdominal abdominal symptoms or abnormalities during treatment. If there is suspicion of gastrointestinal complications during treatment, piroxicam should be stopped immediately and consider further clinical and treatment.

Cardiovascular and cerebrovascular disorders

Patients with hypertension and/or heart failure should be properly monitored and advised, because the condition of holding salt and edema has been reported when combined with NSAID treatment therapy.

Patients with uncontrolled arterial hypertension, congestive heart failure, ischemic heart disease, peripheral artery disease, and/or cerebrovascular disease should only be treated with piroxicam after careful consideration.

It is necessary to consider before starting long -term treatment in patients with cardiovascular risk factors (for example: arterial hypertension, hyperglycemia, diabetes, smoking).

Heart thrombosis

NSAIDs, not aspirin, use systemic sugar, can increase the risk of cardiovascular thrombosis, including myocardial and diverse infarction, which can lead to death. This risk can appear early in the first few weeks of taking the drug and can increase over time. The risk of cardiovascular thrombosis is recorded mainly at high doses.

Doctors need to periodically evaluate the appearance of cardiovascular events, even if the patient has no previous cardiovascular symptoms. Patients need to be warned of symptoms of serious cardiovascular events and need to see a doctor as soon as they appear.

To minimize the risk of adverse events, the lowest daily daily dose is needed in the shortest possible time.

Renal function impairment

Note in the case of renal failure (see the contraindications). There is a risk of kidney disease in dehydration patients.

Skin reaction

Life-threatening skin reactions (Stevens-Johnson syndrome (SJS) and poisoned epidermal necrosis (Ten) have been reported when using piroxicam.

Patients need to be notified of signs and symptoms as well as closely monitor the skin reactions. The highest risk of SJS or tennis in the first week of treatment.

If there are symptoms or signs of SJS or ten (for example, progressive leather rash often accompanied by water balls or mucosal lesions) appear, piroxicam should be stopped.

SJS and Ten's treatment for the best results if diagnosed early and immediately stop any suspected drug. Early medication for better prognosis.

If the patient has appeared SJS or ten when using Piroxicam, absolutely must not reuse Piroxicam in this patient.

Other

Due to the interaction with the metabolism of arachidonic acid, the drug can cause bronchospasm and may cause shock and other allergic reactions in asthma patients or a history of a patient.

Piroxicam, like other NSAIDs, reduces platelet aggregation and prolongs blood flow time, which must be noted when blood tests and caution are prudent when the patient is treated simultaneously with platelet aggregation inhibitors.

Tablets contain lactose monohydrate. Patients with rare genetic problems such as galactose intolerance, congenital lactase deficiency or glucose and galactose intolerance should not use this product.

The ability to drive and operate machinery

piroxicam-3-cyclodextrin may change alertness, leading to driving or performing activities that require fast reflexes (such as machinery) can be affected.

Pregnancy

Reproduction

The use of Piroxicam-B-Cyclodextrin may reduce the fertility of women and are not recommended in women intending to become pregnant. In women who are difficult to conceive or are checking for fertility, it is advisable to consider stopping the use of piroxicam.

Pregnant women

Prostaglandin synthesis inhibitors may have harmful effects during pregnancy and/or embryo/fetal development. Epidemic studies show the risk of miscarriage, cardiovascular deformities and congenital abdominal walls (gastroschisis) after taking prostaglandin synthesis inhibitors at the beginning of pregnancy. The absolute risk of cardiovascular defects increased from less than 1% to about 1.5%. This risk is thought to increase in dosage and treatment time.

Animal studies have shown toxicity on the reproductive system. Piroxicam is not used in the first three months or 3 months of pregnancy unless it is really necessary. If you have to use piroxicam for women who are expecting children or in the first three months or 3 months in the middle of pregnancy, should be used in low doses and the shorter treatment time as possible.

If used in the last three months of pregnancy, Prostaglandin synthetic inhibitor causes the following effects as follows:

toxicity on the heart (with early closing of the arteriosclerotic and pulmonary turbocharger).

Renal dysfunction, which can lead to renal failure and amniotic fluid.

For mothers and babies:

Prolonged bleeding time, may occur even when the dose is very low.

Inhibit the reaction, thus slow or prolong labor.

Therefore Piroxicam is not used in the last three months of pregnancy (see the contraindication section).

Breastfeeding period

Data shows Piroxicam concentration in breast milk ranges from 1% to 3% of the maternal plasma piroxicam concentration. Piroxicam-B-Cyclodextrin is not recommended for women who breastfeed for clinical safety in infants.

Drug interaction

as well as other NSAIDs, should avoid using piroxicam along with acetylsalicylic acid or simultaneous use with other NSAID drugs, including other piroxicam formulas, because the data is not enough to indicate that these combinations are more effective than using only piroxicam; Moreover, the likelihood of adverse reactions increases (see the special warning and caution when used).

Human studies have shown simultaneous use of piroxicam and acetylsalicylic acid reducing plasma piroxicam concentration to about 80% of the usual value (see the contraindications).

corticosteroids: Increasing the risk of stomach ulcers or bleeding (see the special and cautious warning part when used).

Anticoagulants: NSAIDS, including Piroxicam, can increase the effects of anti -dynamic drugs, such as warfarin. Therefore, avoid using piroxicam with anticoagulant drugs like warfarin (see the contraindications).

Anti -plateletic drugs and reabsorption inhibitors choose Loc Serotonin (SSRIs): increases the risk of gastrointestinal bleeding (see special and cautious warnings when used).

Lithium: NSAIDS drugs including Piroxicam have been reported to increase plasma lithium levels in a stable state and need to be monitored when starting to use drugs, dose adjustments or stop treatment with piroxicam-byclodextrin.

Diuretics, enzyme inhibitors, Angiotensin II receptor antagonists: NSAIDs may lose diuretic effect, by preventing prostaglandin synthesis. Treatment combined with enzyme inhibitors and NSAIDs in patients with renal function may increase the risk of more impaired renal function and kidney failure. Patients need to be rehydrated. Kidney function should be monitored at the beginning of treatment. Moreover, NSAIDs can reduce the lowering effect of the enzyme inhibitors.

ciclosporin and tarolimus: may increase the risk of kidney toxicity when using NSAIDs along with ciclosporin or tacrolimus. Piroxicam can reduce the effectiveness of diuretics and antihypertensive drugs. In the case of simultaneous use with drugs containing potassium, or diuretics holding potassium, there is a risk of increased blood potassium concentration (hyperkalemia).

When encountering any of the above cases, notify the doctor immediately.

Do not drink alcohol during treatment with Brexin.

Storage

Store at temperatures below 30 ° C.

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