Piroxicam

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Piroxicam: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Piroxicam

ATX code: M02AA07

Active ingredient: piroxicam

Producer: OZON, LLC (Russia), Obolenskoe - pharmaceutical company, CJSC (Russia), Sopharma, JSC (Bulgaria), VERTEX, JSC (Russia), Production of medicines (Russia), Lekhim-Kharkov, JSC (Ukraine), Khimfarmzavod Krasnaya star (Ukraine)

Description and photo update: 2019-09-09

Prices in pharmacies: from 24 rubles.

Buy

Piroxicam is a non-steroidal anti-inflammatory drug (NSAID), analgesic, antipyretic and suppressing the development of the inflammatory process.

Release form and composition

Film-coated tablets (20 pcs. In blister strip packs, 1 pack in a cardboard box);
Capsules: No. 3, gelatinous solid; dosage 0.01 g - white body and blue cap, dosage 0.02 g - cream body and orange cap; the contents of the capsule are creamy-white to white powder, the formation of a cylindrical shape is allowed, easily disintegrating when touched (10 pcs. in blisters of PVC / aluminum foil, 2 blisters in a cardboard box);
Rectal suppositories: bullet-shaped, greenish-yellow in color, marbling is allowed (5 pcs. In a blister, 2 blisters in a cardboard box);
Gel for external use 0.5% and 1%: transparent, from greenish-yellow to light yellow, with the smell of ethanol, air bubbles and opalescence are allowed (30, 50 or 100 g in aluminum tubes, 1 tube in cardboard box).

Each pack also contains instructions for the use of Piroxicam.

Composition of 1 tablet:

Active ingredient: piroxicam - 0.01 or 0.02 g;
Auxiliary components: disubstituted calcium phosphate, magnesium stearate, sodium lauryl sulfate, starch, hydroxypropyl cellulose.

Composition of 1 capsule:

Active ingredient: piroxicam - 0.01 or 0.02 g;
Auxiliary components: wheat starch, microcrystalline cellulose, glycine, talc, colloidal silicon dioxide, magnesium stearate;
Capsule shell: titanium dioxide, gelatin, indigo carmine Fd & C Blue 2 (dosage 0.01 g), iron oxide yellow and Sunset yellow (dosage 0.02 g).

Composition of 1 suppository:

Active ingredient: piroxicam - 0.02 g;
Auxiliary components: polyethylene oxide 400, polyethylene oxide 1500.

Composition of 1 g of gel:

Active ingredient: piroxicam - 0.005 or 0.01 g;
Auxiliary components: propylene glycol, triethanolamine (trolamine), ethyl alcohol 95% (ethanol 95%), carbomer, methyl parahydroxybenzoate (nipagin, methylparaben), purified water - up to 1 g.

Pharmacological properties

Pharmacodynamics

Piroxicam is a non-steroidal anti-inflammatory drug from the oxicam group. It has analgesic, anti-inflammatory and antipyretic effects.

The mechanism of action of piroxicam is based on the inhibition of prostaglandin synthesis due to inhibition of cyclooxygenase activity.

Thanks to the use of the drug, pain is relieved. Piroxicam relieves or weakens the severity of the inflammatory process and pain in the joints at rest and during movement, helps to reduce morning stiffness and swelling of the joints, increase the range of motion.

The analgesic effect develops within 30 minutes after taking Piroxicam inside. Anti-inflammatory properties appear by the end of the first week of therapy. The duration of action after a single oral dose is 24 hours.

Pharmacokinetics

Pills and capsules

Piroxicam after oral administration is well absorbed from the gastrointestinal tract. C _max (maximum concentration of a substance) in plasma is reached in 3-5 hours. C _max after a single dose of piracetam at a dose of 20 mg is 1.5–2 μg / ml, with a regular intake of the same dose - 3–8 μg / ml. In the case of taking Piroxicam with food, the absorption rate slows down, but without affecting the absorption volume. Bioavailability is about 100%. Equilibrium concentration is reached within 7-12 days.

Binds to blood plasma proteins at a level of 98%. V _d (volume of distribution) ranges from 0.12 to 0.14 l / kg. Penetrates into the synovial fluid in the range of 40-50%, with breast milk from 1 to 3%.

Metabolism occurs in the liver by conjugation and hydrolysis to form inactive metabolites.

Excretion is carried out in the form of conjugates mainly with urine (2/3 of the dose taken) and in small quantities with feces. About 5% is excreted unchanged. T _1/2 (half-life) - from 36 to 45 hours. T _1/2 in patients with liver disease may be lengthened.

Rectal suppositories

Piroxicam is well absorbed in the intestines. C _max in blood plasma is reached 3-5 hours after application.

T _1/2 has significant individual variability within 30–86 hours (on average - 50 hours). About 5% of the substance is excreted unchanged.

A stable concentration in blood plasma is achieved within 7-12 days, the maximum effective concentration - within 14 days after the start of therapy.

Gel for external use

When applied externally, piroxicam penetrates through the skin surface into the underlying tissues of the joints and muscles.

After applying the gel, the balance between the concentrations of the substance in the skin and muscles (or synovial fluid) is achieved in a few hours. When a daily dose of gel is applied over 14 days, which is equivalent to 20 mg of piroxicam for oral administration, the plasma concentration of the active substance in the blood slowly increases and reaches 200 ng / mg on the fourth day. The equilibrium plasma concentration of piroxicam in the blood is 300–400 ng / ml. This is approximately 5% of the concentration that is achieved when piroxicam is administered orally in appropriate dosage forms.

T _1/2 from blood plasma - 79 hours.

Indications for use

Piroxicam tablets, capsules, suppositories are intended for the symptomatic treatment of diseases of the musculoskeletal system: osteoarthritis, rheumatoid arthritis, spondylitis, gout, sciatica, tendovaginitis, bursitis, neuralgia, myalgia, ankylosing spondyloarthritis (ankylosing spondylitis, inflammation of the soft tissues), pain in the spine post-traumatic pain and to reduce pain in primary dysmenorrhea. The drug reduces inflammation and pain, but does not affect the course of the disease.

Gel Piroxicam is used to relieve pain in sports injuries (bruises, sprains, dislocations, damage to muscles and ligaments), ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, chronic juvenile arthritis, tendinitis, tendovaginitis, scapular syndrome.

Contraindications

Capsules

Absolute:

Full or partial combination of bronchial asthma, recurrent polyposis of the mucous membrane of the paranasal or sinuses of the nose and intolerance to acetylsalicylic acid and other NSAIDs (currently and in history);
Active gastrointestinal bleeding, erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, cerebrovascular or other bleeding;
Hemophilia and other blood clotting disorders;
Inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase;
Decompensated heart failure;
Severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia;
Liver failure or any active liver disease;
The period after coronary artery bypass grafting;
Age up to 15 years;
Pregnancy and lactation;
Individual intolerance to the components of the drug, as well as other NSAIDs.

Relative (Piroxicam is prescribed under medical supervision):

Peripheral artery disease;
Cerebrovascular disease, ischemic heart disease, congestive heart failure;
Diabetes;
Renal failure with creatinine clearance of 30-60 ml / min;
Hyperlipidemia / dyslipidemia;
The presence of Helicobacter pylori;
Arterial hypertension;
Bronchial asthma;
Hepatic porphyria;
Postoperative period;
Dehydration;
Frequent alcohol consumption;
Smoking;
Anamnestic data on the development of ulcerative lesions of the gastrointestinal tract;
Prolonged use of NSAIDs;
Severe somatic diseases;
Simultaneous use with anticoagulants, antiplatelet agents, oral glucocorticosteroids, selective serotonin reuptake inhibitors;
Age over 65.

Pills and suppositories

Complicated history of gastrointestinal ulcer, bleeding or perforation;
Active peptic ulcer, inflammatory gastrointestinal disease, or gastrointestinal bleeding;
Complicated history of gastrointestinal disorders that led to bleeding, such as Crohn's disease, ulcerative colitis, diverticulitis, gastrointestinal cancer;
Combined use with other NSAIDs, including selective COX-2 inhibitors and acetylsalicylic acid in analgesic doses;
Complicated history of serious allergic reactions of any type, especially skin reactions such as erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome;
Severe renal / hepatic impairment;
Severe heart failure;
Simultaneous use with anticoagulants;
Complicated history of manifestations of bronchial asthma, rhinitis, urticaria, nasal polyps or Quincke's edema when using acetylsalicylic acid and other NSAIDs;
Hemorrhagic diathesis, changes in the blood picture of unknown etiology (including a burdened history);
Age under 18;
Pregnancy and lactation;
Individual intolerance to the components of Piroxicam (in the form of rapid skin reactions), other NSAIDs and antirheumatic agents.

Elderly patients (over 65 years of age), especially in the presence of impaired liver, kidney or heart function, Piroxicam is prescribed with caution.

Gel for external use

Absolute:

Full or partial combination of bronchial asthma, recurrent polyposis of the mucous membrane of the paranasal or sinuses of the nose and intolerance to acetylsalicylic acid and other NSAIDs (currently and in history);
Violations of the integrity of the skin at the site of the intended application;
Severe renal failure with creatinine clearance less than 30 ml / min;
Age under 14;
III trimester of pregnancy and lactation period;
Individual intolerance to the components of the drug, as well as other NSAIDs.

Relative (Piroxicam is prescribed under medical supervision):

Exacerbation of hepatic porphyria;
Exacerbation of erosive and ulcerative diseases of the gastrointestinal tract, including peptic ulcer of the stomach and duodenum, Crohn's disease, ulcerative colitis;
Severe liver failure or active liver disease;
Confirmed hyperkalemia;
Progressive kidney disease;
Chronic heart failure;
Bronchial asthma;
Condition after coronary artery bypass grafting;
Combined use with other NSAIDs;
Blood coagulation disorders, including hemophilia, bleeding tendency, prolonged bleeding time, hemorrhagic diathesis;
Elderly age;
I – II trimesters of pregnancy.

Piroxicam, instructions for use: method and dosage

Piroxicam is not a first choice drug due to its safety profile, therefore, the primary prescription of the drug should be carried out by a physician experienced in the diagnostic assessment and treatment of inflammatory or degenerative rheumatic diseases.

With the simultaneous use of various forms of Piroxicam (tablets, capsules, gel, suppositories) or other drugs based on piroxicam, its total dose should not exceed 0.04 g per day.

Pills and capsules

Piroxicam capsules and tablets are intended for oral use and should be taken with meals.

The duration of the course of therapy and the dosage of the drug are determined by the attending physician.

Unless otherwise prescribed, the recommended dosing regimen, depending on the condition / disease, is as follows:

Diseases of the musculoskeletal system and / or joints (osteoarthritis, rheumatoid arthritis, spondylitis): 0.01-0.02 g per day once or in 2 doses; if necessary, the daily dose can be temporarily increased to 0.03 g (once or in several doses) or reduced to 0.01 g;
Acute diseases of the musculoskeletal system: the first 2 days - 0.04 g per day (once or in several doses), then for 1-2 weeks - 0.02 g per day;
Acute gout attack: 0.04 g per day for 3-5 days;
Dysmenorrhea (with the appearance of the first symptoms): the first 2 days - 0.04 g per day (once or in several doses), in the next 1-3 days - 0.02 g per day for 1 dose;
Post-traumatic pain: initial dose - 0.02 g 1 time per day; it is allowed, if necessary, to increase the dose in the first 2 days up to 0.04 g (once or in several doses).

If the recommended daily doses are exceeded, the likelihood of side effects increases.

For adults, the maximum daily dose of Piroxicam is 0.04 g.

Rectal suppositories

Suppositories Piroxicam is used rectally after a cleansing enema; it is recommended to moisten the suppository with water before administration.

The recommended dosage regimen is 1 pc. Once a day. The duration of the course is determined by the attending physician, taking into account the course and severity of the disease, the achieved therapeutic effect and the general tactics of treatment.

The maximum recommended daily dose is 0.02 g (1 suppository).

The effect of the use and tolerance of Piroxicam should be assessed every 2 weeks. When long-term therapy is needed, this assessment should be done more frequently. It has been proven that the use of piroxicam increases the risk of gastrointestinal complications, therefore, it is necessary to carefully weigh the need for combination therapy with gastroprotective drugs (misoprostol or proton pump inhibitors), especially in elderly patients.

Before using the suppository, it is required to tear off 1 pc from the blister pack. in the primary package along the perforation line, then pull the edges of the film in different directions and, tearing it apart, release the suppository from the primary package.

Gel for external use

Piroxicam gel is intended for external use.

A column of gel 5-10 mm long is applied to the skin over the painful area 3-4 times a day and rubbed gently.

The duration of therapy, depending on the severity of symptoms, is on average:

Tendinitis, tendovaginitis and shoulder scapular syndrome - 2 weeks;
Sports injuries - 1-2 weeks.

The maximum duration of therapy is 2 weeks.

Side effects

Tablets, capsules, suppositories

Digestive organs: nausea, vomiting, belching, dry mouth, stomatitis, pain in the epigastric region, loss of appetite, diarrhea or constipation, flatulence, erosive and ulcerative lesions (before perforation) and / or bleeding (in exceptional cases before anemia) of the gastrointestinal tract, increased activity of hepatic enzymes, hepatic failure, increased plasma nitrogen concentration;
Urinary system: renal failure, interstitial nephritis, nephrotic syndrome, nephrosis, proteinuria, erythrocyturia, hyperkalemia, papillary necrosis, glomerulonephritis, increased plasma creatinine and urea concentrations;
Central nervous system: drowsiness, headache, dizziness, tinnitus; less often - insomnia, depression, irritability, paresthesia, lethargy, hallucinations, emotional lability;
Hematopoietic system and hemostasis system: leukopenia, eosinophilia, anemia (including aplastic and hemolytic), decreased hematocrit; rarely - hemorrhages, thrombocytopenia, Shenlein-Henoch disease (thrombocytopenic purpura);
Cardiovascular system: hypertension or hypotension, symptoms of heart failure; rarely - shortness of breath, palpitations;
Allergic reactions: skin rashes, dermatitis with sloughing of the stratum corneum, itching, erythema multiforme, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock, bronchospasm, photosensitis, vibasculitis, angioedema;
Other reactions: hyper- and hypoglycemia, visual impairment, edema of the feet and legs, hyperhidrosis, increase or decrease in body weight.

The most common side effects are from the digestive system; with an increase in the daily dose of piroxicam, the likelihood of these reactions increases.

Symptoms of an overdose with oral forms of the drug are: nausea, vomiting, abdominal pain, blurred vision, drowsiness; in case of taking very large doses - fainting, coma. Therapy of the condition is symptomatic, it is required to flush the stomach with the intake of activated charcoal, antacids are used to slow down absorption. In case of severe poisoning, the patient is hospitalized. There is no specific antidote.

Gel for external use

Local reactions (in the area of application of the gel): redness, inflammation, itching, peeling, contact dermatitis, photosensitivity, eczema;
Systemic reactions (due to the low concentration of piroxicam in the systemic circulation): extremely rarely - abdominal pain, nausea, dyspepsia, gastritis; sometimes shortness of breath; isolated reports - malignant exudative erythema (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell's syndrome);
Hypersensitivity reactions: rhinitis, bronchospasm, urticaria, angioedema.

With the development of any (including local) side effects, the use of Piroxicam should be discontinued.

An overdose with external use of the gel is almost impossible due to the low systemic absorption of piroxicam.

As a result of accidental ingestion of the gel, the following can occur: nausea, vomiting, burning sensation in the mouth, salivation, systemic side reactions (shortness of breath, epigastric pain, headache), interstitial nephritis with impaired renal function and nephrotic syndrome. It is required to wash the stomach and oral cavity, if necessary, to carry out symptomatic therapy. Hemodialysis is ineffective in this case.

Overdose

The main symptoms: blurred vision, drowsiness, vomiting, nausea, epigastric pain, bleeding in the gastrointestinal tract; rarely - acute renal failure, coma, respiratory depression, arterial hypertension; when using large doses - loss of consciousness.

Therapy: gastric lavage with activated charcoal, antacids are prescribed in order to slow down absorption. In case of severe poisoning, hospitalization is indicated.

Symptomatic treatment is carried out. There is no specific antidote.

special instructions

The drug is used only as directed by a doctor for the shortest possible course in the lowest effective dose in order to prevent unwanted side effects. Prolonged use of piroxicam in a daily dose of more than 0.03 g increases the risk of adverse reactions, primarily from the gastrointestinal tract.

The use of several NSAIDs simultaneously increases the risk of side effects, but does not improve the therapeutic effect.

The function of the liver and kidneys, as well as the cellular composition of the blood, needs to be monitored for patients: with impaired gastrointestinal function, after extensive surgical interventions, with bronchial asthma, as well as chronic broncho-obstructive diseases in history, in old age.

Peptic ulcer or gastrointestinal bleeding requires discontinuation of treatment; when piroxicam is absolutely necessary, therapy is continued under medical supervision.

In case of visual impairment, you should consult a specialist.

Since piroxicam affects the tone of the myometrium in women, it is possible to reduce the contraceptive effect of the intrauterine device.

There are currently no recommendations for the use of the drug in childhood and adolescence.

More sensitive, as a rule, to NSAIDs are patients with bronchial asthma, allergic rhinitis, recurrent polyposis of the nose and paranasal sinuses, chronic obstructive pulmonary diseases or chronic pulmonary infections. They may have more frequent attacks of bronchial asthma, there may be urticaria, Quincke's edema.

It is required to exclude the use of alcohol during therapy with piroxicam.

The gel is applied only to intact skin, avoiding contact with open wound surfaces, mucous membranes and eyes. Do not apply an occlusive dressing to the gel-treated area.

Influence on the ability to drive vehicles and complex mechanisms

You should refrain from activities that require the speed of psychomotor reactions and increased concentration of attention.

Application during pregnancy and lactation

Piroxicam in the form of capsules, tablets and suppositories during pregnancy / lactation is not prescribed.

Application of the gel:

III trimester of pregnancy and the period of breastfeeding: therapy is contraindicated;
I – II trimesters of pregnancy: Piroxicam can be used after assessing the ratio of the expected benefit with the possible risk.

Pediatric use

Contraindication:

Capsules: up to 15 years old;
Tablets and suppositories: up to 18 years old;
Gel for external use: up to 14 years.

With impaired renal function

Capsules

Severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia: therapy is contraindicated;
Renal failure with creatinine clearance of 30-60 ml / min: Piroxicam is prescribed with caution.

Pills and suppositories

In severe renal failure, the use of suppositories and Piroxicam tablets is contraindicated.

Gel for external use

Severe renal failure with creatinine clearance less than 30 ml / min: therapy is contraindicated;
Progressive kidney disease: Piroxicam is prescribed with caution.

For violations of liver function

Capsules

Liver failure or any active liver disease: therapy is contraindicated;
Hepatic porphyria: Piroxicam is used with caution.

Pills and suppositories

In severe hepatic impairment, the use of Piroxicam is contraindicated.

Gel for external use

In case of exacerbation of hepatic porphyria, severe liver failure, or liver disease in the active stage, the drug is prescribed under medical supervision.

Use in the elderly

For elderly patients, Piroxicam is prescribed with caution.

Drug interactions

Tablets, capsules, suppositories

Glucocorticosteroids and / or NSAIDs - the risk of side effects from the gastrointestinal tract (including bleeding) increases;
Phenobarbital - reduces the level of concentration of piroxicam in the blood serum;
Cimetidine, probenecid and sulfinpyrazone - can increase the level of concentration of piroxicam in the blood serum, as a result of which its side effects may increase;
Phenytoin and / or lithium, as well as potassium-sparing diuretics and K ⁺ donors - an increase in the plasma concentration of lithium, phenytoin and potassium is possible;
Diuretics and antihypertensive substances / drugs - piroxicam weakens their effect;
Anticoagulants - blood clotting control is required;
Acetylsalicylic acid - the level of concentration of piroxicam in the blood serum decreases, the likelihood of the formation of erosive and ulcerative lesions of the gastrointestinal tract increases;
Selective serotonin reuptake inhibitors (fluoxetine, citalopram, sertraline, paroxetine) - increase the likelihood of erosive and ulcerative lesions of the gastrointestinal tract;
Methotrexate - it is possible to increase its concentration and increase the toxic effect.

Gel for external use

There was no clinically significant interaction of piroxicam in the form of a gel with other drugs / preparations, but the possibility of an increase in the effect of drugs that cause photosensitization is not excluded.

Analogs

The analogues of Piroxicam are: Aroxicam, Ksefokam, Oxyten, Movalis, Piroxicam, Meloxicam Sopharma, Fedin-20, Finalgel, Aspikam, Lorakam, Melox.

Terms and conditions of storage

Store in a dark, dry place, out of reach of children, at temperatures up to 25 ° C.

Shelf life:

Tablets, capsules - 3 years;
Gel, suppositories - 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Piroxicam

Reviews of Piroxicam in all dosage forms are predominantly positive. Patients recommend it as a fast-acting analgesic and anti-inflammatory agent for diseases of the musculoskeletal system. If the dosage regimen is observed, adverse reactions develop in rare cases. One of the important advantages is the affordable cost of the drug.

Price for Piroxicam in pharmacies

The approximate price for Piroxicam is:

Capsules: 55–91 rubles. (in the package 20 pcs. 10 mg each) or 64–95 rubles. (in the package 20 pcs. 20 mg each);
Gel for external use: 60–65 rubles. (0.5%, in a tube of 30 g), 129–177 rubles. (1%, in a tube of 30 g) or 205-295 rubles. (1%, in a tube of 50 g).

Piroxicam: prices in online pharmacies

Drug name

Price

Pharmacy

Piroxicam 20 mg capsule 20 pcs.

RUB 24

Buy

Piroxicam 10 mg capsule 20 pcs.

RUB 26

Buy

Piroxicam 10 mg capsule 20 pcs.

RUB 49

Buy

Piroxicam 20 mg capsule 20 pcs.

RUB 55

Buy

Piroxicam caps. 10 mg 20 pcs.

RUB 61

Buy

Piroxicam 10 mg capsule 20 pcs.

RUB 61

Buy

Piroxicam 0.5% gel for external use 30 g 1 pc.

RUB 64

Buy

Piroxicam 20 mg capsule 20 pcs.

83 rbl.

Buy

Piroxicam 1% gel for external use 30 g 1 pc.

RUB 100

Buy

Piroxicam 1% gel for external use 50 g 1 pc.

226 r

Buy

See all offers from pharmacies

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!