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 • Piroxicam general information

      • Active – active substance / start: piroxicam

      • piroxicam

Feldene Piroxicam 10, 20 mg
Most popular brand: Feldene
Active ingredient: Piroxicam
Available dosage forms: 10, 20 mg
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Piroxicam general information

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Active – active substance / start: piroxicam

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piroxicam – a non-steroidal anti-inflammatory agent – has anti-inflammatory, analgesic and antipyretic effect. Antirheumatic drugs. It is used for pain syndrome (neuralgia, myalgia, sports injuries, sprains, dislocations, contusions, post-operative pain), articular syndrome and rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, osteoarthritis, ankylosing spondylitis, polymyositis and dermatomiazit, tendonitis, tenosynovitis, systemic lupus erythematosus , osteoarthritis), dysmenorrhea.

Active – active substance:
piroxicam / Piroxicam.

Dosage Forms:
The capsules.
Tablets.
rectal suppositories.
The solution for injection.
gel.
Cream.
Maze.

piroxicam

Properties / Action:
piroxicam – a non-steroidal anti-inflammatory agent, belongs to the group of oxicams. Piroxicam has anti-inflammatory, analgesic and antipyretic effect. Antirheumatic drugs.
The mechanism of action is associated with inhibition of the synthesis of prostaglandins from arachidonic acid. Piroxicam under in vitro and in vivo to effectively inhibit the cyclooxygenase (COX), and, thus, the synthesis of prostaglandins, prostacyclin and thromboxane.
When piroxicam applications in in vivo conditions was observed again decline prostanoids in urine, gastric mucosa, and synovial fluid. In animal experiments there are also some other mechanisms, such as the dismutation of some free radicals derived from molecular oxygen, effect on soluble neurotransmitters inflammation, limited cross-lysosomal membrane, increasing cyclic adenozinmono – phosphate and inhibition of platelet aggregation. Piroxicam also inhibits platelet aggregation secondary stage. Effect on the function decline seen polymorphic nuclei chemotaxis formation of superoxides and proteases. There is also an impact on the synthesis of connective tissue macromolecules. It inhibits platelet aggregation.
It is used in various diseases of supporting – motor apparatus, inflammatory and degenerative origin.
piroxicam weakens or eliminates the pain of moderate intensity, reduces the severity of inflammation, with articular syndrome weakens or suppresses inflammation and pain at rest and during movement, reduces morning stiffness of the joints, increases range of motion.
In the systemic application reduces the pain. The analgesic effect occurs within 30 minutes after ingestion. Anti-inflammatory effect manifested by the end of the first week of treatment. After a single dose of the drug efficacy persists for days.
When an external application provides a local anti-inflammatory, analgesic and anti-edema effect, reduces or relieves inflammation and pain in muscles and joints at rest and during movement, reduces morning stiffness and swelling of joints, increases range of motion. When applied externally marked a pronounced effect, in this case the plasma is determined by the low level of the drug.
In experimental studies using non-specific screening system was not found mutagenic potential of piroxicam.

Pharmacokinetics:
Once inside the piroxicam is well absorbed from the gastrointestinal tract. Cmax in plasma attained within 3 -. 5 h Binding to plasma proteins is 99%. Piroxicam crosses the placental barrier, excreted in breast milk. It is metabolized in the liver by hydrolysis and conjugation. Piroxicam is excreted unchanged (5%) in the form of metabolites that are displayed in the kidneys and in small amounts in the faeces. T1 / 2 is about 50 hours. In patients with liver T1 / 2 can be increased.
Half-life prolonged, so drug is given only once a day.
When the local therapy piroxicam very well penetrates through the skin into the underlying tissues, fascia, tendons, joint capsule and articular fluid. The effective concentration of tissue in the patient is achieved within 20 minutes. The concentration in the systemic circulation is thus very low (in patients receiving an equivalent dose inward absorption of the active substance is 5%). These mechanisms is eliminated most undesired reactions accompanying the oral or parenteral therapy piroxicam.

Indications:
prescribe piroxicam in the treatment of painful and swollen syndrome with inflammatory and degenerative rheumatic diseases, pain syndromes and traumatic inflammatory diseases of the joints and spine:
Pain

  • pain in the spine;
  • neuralgia;
  • myalgia;
  • traumatic inflammation of soft tissue and musculoskeletal – musculoskeletal system (sports injuries, strains, sprains, bruises, as well as pain caused by overexertion and swelling in the joints, tendons and muscles);
  • postoperative pain.
    Articular syndrome and rheumatic diseases:
  • rheumatoid arthritis, juvenile rheumatoid arthritis;
  • psoriatic arthritis;
  • osteoarthritis;
  • Ankylosing spondylitis (ankylosing spondylitis);
  • extra-articular rheumatism;
  • dermatomiazit polymyositis and polymyalgia rheumatica;
  • frozen shoulder;
  • plechekistevoy syndrome;
  • epicondylitis;
  • tendinitis;
  • tenosynovitis;
  • aggravation of gout (gouty arthropathy);
  • systemic lupus erythematosus;
  • osteoarthritis peripheric joints.
    Other indications:
  • dysmenorrhea in patients older than 12 years;
  • acute infectious – inflammatory diseases of the upper respiratory tract.

    Dosage and administration:
    Inside or rectally:
    Inside administered in a dose of 10 to 30 mg 1 time per day, during or immediately after a meal. Rectal
    – 20 – 40 mg of 1 – 2 times a day.
    The maximum daily dose for adults – 40 mg.
    Post-operative and post-traumatic pain syndrome: 20 mg 1 time a day (if necessary – 40 mg / day in 1 – 2 admission).
    In acute inflammatory and degenerative – dystrophic diseases of supporting – motor apparatus, accompanied by severe pain, and diseases of the joints in the first 2 – 6 days – 40 mg / day. (In one or multiple doses), the next 7 – 14 days – 20 mg / day. The initial dose should be gradually reduced to the minimum effective dose – 10 – 20 mg per day.
    In acute gout initial dose – 40 mg 1 time per day in the first 2 days, then 40 mg 1 time per day, or 20 mg 2 times a day for 4 – 7 days. the drug is not recommended for long-term treatment of gout.
    In rheumatoid arthritis, ankylosing spondylitis administered in an initial dose of 20 mg 1 time / day. Maintenance dose – 20 mg / day .; in some cases, may decrease to a maintenance dose of 10 mg / day. or an increase of up to 30 mg / day. (In one or more doses).
    The recommended dosage should not exceed, as a possible increased side-effects is not in direct correlation with an increase in the therapeutic effect.
    Intramuscular:
    In acute exacerbation of chronic conditions or process the drug can be administered in / m at a dose of 20 – 40 mg 1 time per day. Injection was carried out for 1 – 2 days. After the relief of acute process of switching to maintenance therapy with oral forms (tablets, capsules, etc..).
    Outer:
    gel, cream, ointment is applied to intact skin in the painful area (affected joint or limb) 3 – 4 times a day for 1 g (which, roughly, It corresponds to the size of a hazelnut) and rub gently. The interval between the individual doses should not be shorter than 4 h. Occlusive dressings do not impose. The duration of treatment depends on the severity of symptoms and the nature of the damage, on average from 4 to 14 days. If the condition does not improve within 2 – weeks, you should see a doctor. Cases of overdose with topical application of piroxicam were observed.

    Overdose:
    Symptoms: drowsiness, blurred vision, at very high doses – loss of consciousness, coma.
    Treatment: gastric lavage, activated charcoal. antacids (to reduce absorption), symptomatic therapy.
    When applied topically overdose is unlikely.

    Contraindications:

  • Hypersensitivity to piroxicam or one of the components of the drug (including allergic to salicylates or other nonsteroidal anti-inflammatory drugs);
  • “aspirin triad” (a history of bronchial asthma caused by NSAIDs);
  • gastric ulcer and duodenal ulcer in the acute phase;
  • expressed human liver and / or kidney disease, disorders of porphyrin metabolism;
  • hemorrhagic diathesis, changes in the blood picture of unknown origin (including history);
  • Simultaneous anticoagulation therapy;
  • proctitis, inflammatory changes or bleeding in the rectum (for the use of candles);
  • Children under 6 years of age (not recommended for use in children under the age of 14 years);
  • Pregnancy, lactation (breastfeeding).

    Use during pregnancy and lactation:
    piroxicam is contraindicated for use in the III trimester of pregnancy.
    If you want to use in I and II trimesters of pregnancy should be related to the expected benefit to the mother and the potential risk to the fetus, due to the lack of reliable clinical data supporting the safety of piroxicam in this period. In experimental studies, similarly as in the use of other NSAIDs, the risk was identified pathological delivery, delayed deliveries and premature closure of the ductus arteriosus. During pregnancy should be administered only under strict medical supervision with careful justification of the application.
    Piroxicam is excreted in breast milk. If necessary, use during lactation should decide the issue of termination of breastfeeding.
    Forms for external use are not recommended for use in the treatment of pregnant women and women breast-fed – the lack of experience.
    Restrictions apply:
    Heart failure and other diseases, accompanied by edema, hypertension.

    Side effects:
    In general, side effects develop during chronic administration at doses greater than 30 mg / day.
    Gastro – intestinal disorders: nausea, anorexia, abdominal pain, flatulence, diarrhea, stomatitis (in rare cases – the formation of gastrointestinal ulcers with possible bleeding, which is an absolute indication for immediate discontinuation of piroxicam).
    Disturbances of liver function (increased activity of enzymes), kidney disease, headache, depression, drowsiness, insomnia, blurred vision, swelling of legs and feet (especially in the lower extremities in patients with heart failure), skin rash, pruritus, angioedema, bronchospasm, in rare cases – anaphylactic reactions, Stevens – Johnson syndrome, Lyell’s syndrome, vasculitis, serum sickness, photosensitivity (photosensitivity reaction).
    Damage to the blood system: anemia (a decrease in hemoglobin and hematocrit), a decrease in platelet aggregation, leukopenia, thrombocytopenia.
    When using candles possible irritation of the rectum, tenesmus, bleeding, bloody stools.
    For external use of the drug in the rare cases of skin redness and itching at the site of application of the drug. Prolonged use may cause local irritation and symptoms of hypersensitivity (contact dermatitis rash, itching). In such cases, stop using the product.

    Special instructions and precautions:
    With care prescribe piroxicam to patients with erosive – ulcerous diseases of the gastrointestinal tract (including bleeding complications) in history, patients with dyspeptic disorders, congestive heart failure of the liver and / or kidney disease, asthma, allergic reactions to aspirin and other NSAIDs in history, blood clotting disorders. Care should be taken when appointing piroxicam elderly and immunocompromised patients, especially in case of violation of cardio – vascular system, kidneys, liver.
    Before use, including local, patients with bronchial asthma, allergic rhinitis, polyps of the nasal mucosa, chronic obstructive airways disease should consult a physician.
    The drug is used for the systematic supervision of a physician. During treatment requires monitoring of the functional state of the liver and peripheral blood picture.
    As the drug reduces platelet aggregation and increases bleeding time, this fact must be considered when determining the bleeding time. Do not appoint simultaneously with oral anticoagulants.
    Not recommended to prescribe piroxicam together with acetylsalicylic acid and other NSAIDs.
    In the period of treatment can not drink alcoholic beverages.
    When applying cutaneous absorption of piroxicam small, its content in the blood plasma is low, so do not be afraid of systemic side effects. Avoid contact with the gel, cream or ointment to the mucous membranes in the eyes. For external use the drug should not be applied to damaged skin and open wounds. When symptoms of local irritation details please discontinue treatment.

    Effect on concentration when driving control mechanisms:
    There is no information about the negative effects of piroxicam drugs for external use (gel, ointment, cream) on the patient’s ability to engage in activities requiring increased attention activity (driving, high altitude operation, operating machinery).

    Drug Interactions:
    piroxicam displaces from its association with blood proteins other drugs. Caution should be used with drugs that strongly bind to plasma proteins (possibly competitive inhibition of binding of other drugs).
    Be wary prescribers simultaneously with indirect anticoagulants, since may increase the anticoagulant action. Anticoagulants increase the risk of bleeding.
    Compared to other NSAIDs and corticosteroids increases the risk ultserogennogo (risk of gastro – intestinal bleeding). piroxicam, acetylsalicylic acid reduces plasma levels of up to 80%.
    piroxicam increases the risk of hyperkalemia in combination with potassium-sparing diuretics and other potassium-containing drugs.
    cimetidine, probenecid and sulfinpyrazone increase the concentration of piroxicam in the blood.
    With the simultaneous use of piroxicam with drugs lithium may increase lithium content in the blood serum.
    Phenobarbital may reduce the concentration of piroxicam in plasma.
    piroxicam increases the concentration of phenytoin.
    piroxicam reduces the effectiveness of antihypertensive drugs, diuretics (due to fluid retention).
    When applying piroxicam 24 hours before or after taking and increases the concentration of the latter in the serum and increases its toxicity.
    When a local application is not described significant interaction with other medicinal products.

    Storage:
    Store in closed containers at a temperature of 10 – 20 ° C, protect from sunlight and frost.
    Keep out of reach of children!
    Do not use the drug after the expiry date stated on the package!
    Holidays from the pharmacy – prescription; for external and local forms – without a prescription.

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