Piroxicam Capsules USP 20mg Taj Pharma

  1. Name of the medicinal product

Piroxicam Capsules USP 10mg Taj Pharma
Piroxicam Capsules USP 20mg Taj Pharma

  1. Qualitative and quantitative composition

a) Piroxicam Capsules USP 10mg Taj Pharma
Each capsule contains:
Piroxicam Tablets USP 10mg
Excipients: Q.S.

b) Piroxicam Capsules USP 20mg Taj Pharma
Each capsule contains:
Piroxicam Tablets USP 20mg
Excipients: Q.S.

  1. Pharmaceutical form

Capsules for oral administration.

  1. Clinical particulars
    • Therapeutic indications

Piroxicam is indicated for symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis.

Due to its safety profile (see sections 4.2, 4.3 and 4.4), Piroxicam is not a first line option should an NSAID be indicated. The decision to prescribe Piroxicam should be based on an assessment of the individual patient’s overall risks (see sections 4.3 and 4.4).

  • Posology and method of administration

The prescription of Piroxicam should be initiated by physicians with experience in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases.
The maximum recommended daily dose is 20 mg.
Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. The benefit and tolerability of treatment should be reviewed within 14 days. If continued treatment is considered necessary, this should be accompanied by frequent review.
Given that piroxicam has been shown to be associated with an increased risk of gastrointestinal complications, the need for possible combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients.

Use in the elderly
Elderly, frail or debilitated patients may tolerate side-effects less well and such patients should be carefully supervised. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function.

For oral administration. To be taken preferably with or after food.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

  • Contraindications

History of gastro-intestinal ulceration, bleeding or perforation.
Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn’s disease, gastrointestinal cancers or diverticulitis.

Patients with active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding.
Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and acetylsalicylic acid at analgesic doses.
Concomitant use with anticoagulants.
History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Hypersensitivity to the active substance or the excipients, previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications.

Patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, nasal polyps, angioedema or urticaria.

Severe heart failure.
During the last trimester of pregnancy.

  • Special warnings and precautions for use

Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).

The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events.

Gastrointestinal (GI) Effects, Risk of GI Ulceration, Bleeding, and Perforation
NSAIDs, including piroxicam, can cause serious gastrointestinal events including bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.

NSAID exposures of both short and long duration have an increased risk of serious GI event. Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.
Patients with significant risk factors for serious GI events should be treated with piroxicam only after careful consideration (see sections 4.3 and below).

The possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered (see section 4.2).
Serious GI Complications
Identification of at-risk subjects

The risk for developing serious GI complications increases with age. Age over 70 years is associated with high risk of complications. The administration to patients over 80 years should be avoided.

Patients taking concomitant oral corticosteroids, selective serotonin reuptake inhibitors (SSRIs) or anti-platelet agents such as low-dose acetylsalicylic acid are at increased risk of serious GI complications (see below and section 4.5). As with other NSAIDs, the use of piroxicam in combination with protective agents (e.g. misoprostol or proton pump inhibitors) must be considered for these at-risk patients.

Patients and physicians should remain alerted for signs and symptoms of GI ulceration and/or bleeding during piroxicam treatment. Patients should be asked to report any new or unusual abdominal symptom during treatment. If a gastrointestinal complication is suspected during treatment, piroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered.

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with piroxicam after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for Piroxicam.

Piroxicam should be used with caution in patients with a history of bronchial asthma (see also section 4.3).

Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered piroxicam with caution as they may have abnormally high plasma levels due to reduced metabolic clearance (see section 5.2).

Skin reactions
Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the use of piroxicam.

Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment.

If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, piroxicam treatment should be discontinued. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis.

If the patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be re-started in this patient at any time.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Evidence from observational studies suggests that piroxicam may be associated with a higher risk of serious skin reaction than other non-oxicam NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Piroxicam should be used with caution in patients with renal, hepatic and cardiac impairment. In rare cases, non-steroidal anti-inflammatory drugs may cause interstitial nephritis, glomerulitis, papillary necrosis and the nephrotic syndrome. Such agents inhibit the synthesis of the prostaglandin which plays a supportive role in the maintenance of renal perfusion in patients whose renal blood flow and blood volume are decreased. In these patients, administration of a non-steroidal anti-inflammatory drug may precipitate overt renal decompensation, which is typically followed by recovery to pre-treatment state upon discontinuation of non-steroidal anti-inflammatory therapy. Patients at greatest risk of such a reaction are with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease; such patients should be carefully monitored whilst receiving NSAID therapy. Because of reports of adverse eye findings with non-steroidal anti-inflammatory drugs, it is recommended that patients who develop visual complaints during treatment with Piroxicam have ophthalmic evaluation.

Impaired female fertility

The use of Piroxicam may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Piroxicam should be considered.

  • Interaction with other medicinal products and other forms of interaction

Antacids: Concomitant administration of antacids had no effect on piroxicam plasma levels.

Anticoagulants: NSAIDs, including piroxicam, may enhance the effects of anticoagulants, such as warfarin. Therefore the use of piroxicam with concomitant anticoagulant such as warfarin should be avoided (see section 4.3).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs)increased risk of gastrointestinal bleeding (see section 4.4).

Aspirin and other Non-Steroidal Anti-Inflammatory Drugs: Piroxicam, like other non-steroidal anti-inflammatory drugs decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.

As with other NSAIDs, the use of piroxicam together with acetylsalicylic acid or concomitant use with other NSAIDs, including other piroxicam formulations, must be avoided, since data are inadequate to show that combinations produce greater improvement that that achieved with piroxicam alone; moreover, the potential for adverse reactions is enhanced (see section 4.4). Human studies have shown that concomitant use of piroxicam and acetylsalicylic acid reduces the plasma piroxicam concentration to about 80% of the usual value.

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Ciclosporin, Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are given with ciclosporin or tacrolimus.

Cimetidine: Results of two separate studies indicate a slight but significant increase in absorption of piroxicam following cimetidine administration but no significant changes in elimination rate constants or half-life. The small increase in absorption is unlikely to be clinically significant.

Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Digoxin, Digitoxin: Concurrent therapy with Piroxicam and digoxin, or Piroxicam and digitoxin, did not affect the plasma levels of either drug.

Diuretics: Non-steroidal anti-inflammatory drugs may cause sodium, potassium and fluid retention and may interfere with the natriuretic action of diuretic agents. These properties should be kept in mind when treating patients with compromised cardiac function or hypertension since they may be responsible for the worsening of those conditions.

Highly protein-bound drugs: Piroxicam is highly protein-bound and therefore might be expected to displace other protein-bound drugs. The physician should closely monitor patients for change when administering Piroxicam to patients on highly protein-bound drugs.

Lithium: Non-steroidal anti-inflammatory drugs, including Piroxicam, have been reported to increase steady state plasma lithium levels. It is recommended that these levels are monitored when initiating, adjusting and discontinuing Piroxicam.

Piroxicam, like other non-steroidal anti-inflammatory drugs, may interact with the following drugs / classes of therapeutic agents:
Antihypertensives -antagonism of the hypotensive effect
Methotrexate – Reduced excretion of methotrexate, possibly leading to acute toxicity
Quinolone antibiotics – possible increased risk of convulsions
Mifepristone – NSAIDs could interfere with mifepristone-mediated termination of pregnancy

  • Fertility,pregnancy and lactation

Fertility: Based on the mechanism of action, the use of NSAIDs, including Piroxicam, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including Piroxicam, should be considered.

Pregnancy: Although no teratogenic effects were seen in animal testing, the safety of Piroxicam during pregnancy or during lactation has not yet been established. Piroxicam inhibits prostaglandin synthesis and release through a reversible inhibition of the cyclo-oxygenase enzyme. This effect, as with other non-steroidal anti-inflammatory drugs, has been associated with an increased incidence of dystocia and delayed parturition in pregnant animals when drug administration was continued in late pregnancy. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see section 4.3).

Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.

Lactation: A study indicates that piroxicam appears in the breast milk at about 1% to 3% of the maternal plasma concentrations. No accumulation of piroxicam occurred in milk relative to that in plasma during treatment for up to 52 days. Piroxicam is not recommended for use in nursing mothers as clinical safety has not been established.

  • Effects on ability to drive and use machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

  • Undesirable effects

 

System Organ Class Very Common

≥1/10

Common

≥1/100 to <1/10

Uncommon

≥1/1000 to <1/100

Rare

≥1/10 000 to <1 000

Very Rare

<1/10000

Not Known

(cannot be estimated from available data)

Blood and lymphatic system disorders Anaemia

Eosinophilia

Leucopenia

Thrombo-cytopenia

Aplastic anaemia

Haemolytic anaemia

Immune system disorders Anaphylaxis

Serum sickness

Metabolism and nutrition disorders Anorexia

Hyperglycaemia

Hypoglycaemia Fluid retention
Psychiatric disorders Depression

Dream abnormalities

Hallucinations

Insomnia

Mental confusion

Mood alterations

Nervousness

Nervous system disorders Dizziness

Headache

Somnolence

Vertigo

Paresthesia
Eye disorders Blurred vision Eye irritations

Swollen eyes

Ear and labyrinth disorders Tinnitus Hearing impairment
Cardiac disorders Palpitations Cardiac failure

Arterial thrombotic events

Vascular disorders Vasculitis

Hypertension

Respiratory, thoracic and mediastinal disorders Bronchospasm

Dyspnoea

Epistaxis

Gastrointestinal disorders Abdominal discomfort

Abdominal pain

Constipation

Diarrhoea

Epigastric distress

Flatulence

Nausea

Vomiting Indigestion

Stomatitis Gastritis

Gastrointestinal bleeding (including hematemesis and melena)

Pancreatitis

Perforation

Ulceration

Hepatobiliary disorders Fatal hepatitis

Jaundice

Renal and urinary disorders Interstitial nephritis

Nephrotic syndrome

Renal failure

Renal papillary necrosis

Skin and subcutaneous tissue disorders Pruritis

Skin rash

Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (see section 4.4) Alopecia

Angioedema

Dermatitis exfoliative

Erythema multiforme

Non-thrombocytopenic purpura (Henoch-Schoenlein)

Onycholysis

Photoallergic reactions

Urticaria

Vesiculo bullous reactions

Reproductive system and breast disorders Female fertility decreased
General disorders and administration site conditions Oedema (mainly of the ankle) Malaise
Investigations Increased serum transaminase levels

Weight increase

Positive ANA

Weight decrease

Decreases in hemoglobin and hematocrit unassociated with obvious gastro-intestinal bleeding

Gastrointestinal: These are the most commonly encountered side-effects but in most instances do not interfere with the course of therapy.

Objective evaluations of gastric mucosa appearances and intestinal blood loss show that 20mg/day of Piroxicam administered either in single or divided doses is significantly less irritating to the gastrointestinal tract than aspirin.

Some epidemiological studies have suggested that piroxicam is associated with higher risk of gastrointestinal adverse reactions compared with some NSAIDs, but this has not been confirmed in all studies. Administration of doses exceeding 20mg daily (of more than several days duration) carries an increased risk of gastrointestinal side effects, but they may also occur with lower doses (see Section 4.2).

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. The possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should therefore be borne in mind.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Liver function: Changes in various liver function parameters have been observed. Although such reactions are rare, if abnormal liver function tests persist or worsen, if clinical symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g.eosinophilia, rash etc.), Piroxicam should be discontinued.

Other: Routine ophthalmoscopy and slit-lamp examination have revealed no evidence of ocular changes.

  • Overdose

In the event of overdosage with Piroxicam, supportive and symptomatic therapy is indicated. Studies indicate that administration of activated charcoal may result in reduced re-absorption of piroxicam, thus reducing the total amount of active drug available.

Although there are no studies to date, haemodialysis is probably not useful in enhancing elimination of piroxicam since the drug is highly protein-bound.

  1. Pharmacological properties
    • Pharmacodynamic properties

Piroxicam is a non-steroidal anti-inflammatory agent which also possesses analgesic and antipyretic properties. Oedema, erythema, tissue proliferation, fever and pain can all be inhibited in laboratory animals by the administration of piroxicam. It is effective regardless of the aetiology of the inflammation. While its mode of action is not fully understood, independent studies in vitro as well as in vivo have shown that piroxicam interacts at several steps in the immune and inflammation responses through:

Inhibition of prostanoid synthesis, including prostaglandins, through a reversible inhibition of the cyclo-oxygenase enzyme.

Inhibition of neutrophil aggregation.
Inhibition of polymorphonuclear cell and monocyte migration to the area of inflammation.
Inhibition of lyosomal enzyme release from stimulated leucocytes.

Reduction of both systemic and synovial fluid rheumatoid factor production in patients with seropositive rheumatoid arthritis.
It is established that piroxicam does not act by pituitary-adrenal axis stimulation. In-vitro studies have not revealed any negative effects on cartilage metabolism.

  • Pharmacokinetic properties

Piroxicam is well absorbed following oral or rectal administration. With food there is a slight delay in the rate but not the extent of absorption following administration. The plasma half-life is approximately 50 hours in man and stable plasma concentrations are maintained throughout the day on once-daily dosage. Continuous treatment with 20mg/day for periods of 1 year produces similar blood levels to those seen once steady state is first achieved.

Drug plasma concentrations are proportional for 10 and 20mg doses and generally peak within 3 to 5 hours after medication. A single 20mg dose generally produces peak piroxicam plasma levels of 1.5 to 2 mcg/ml while maximum plasma concentrations, after repeated daily ingestion of 20mg piroxicam, usually stabilise at 3 to 8 mcg/ml. Most patients approximate steady state plasma levels within 7 to 12 days.

Treatment with a loading dose regimen of 40mg daily for the first 2 days followed by 20mg daily thereafter allows a high percentage (approximately 76%) of steady state levels to be achieved immediately following the second dose. Steady state levels, area under the curves and elimination half-life are similar to that following a 20mg daily dose regimen.

A multiple dose comparative study of the bioavailability of the injectable forms with the oral capsule has shown that after intramuscular administration of piroxicam, plasma levels are significantly higher than those obtained after ingestion of capsules during the 45 minutes following administration the first day, during 30 minutes the second day and 15 minutes the seventh day. Bioequivalence exists between the two dosage forms.

A multiple dose comparative study of the pharmacokinetics and the bioavailability of Piroxicam FDDF with the oral capsule has shown that after once daily administration for 14 days, the mean plasma piroxicam concentration time profiles for capsules and Piroxicam FDDF were nearly superimposable. There were no significant differences between the mean steady state Cmax values, Cmin values, T½, or Tmax values. This study concluded that Piroxicam FDDF (Fast Dissolving Dosage Form) is bioequivalent to the capsule after once daily dosing. Single dose studies have demonstrated bioequivalence as well when the tablet is taken with or without water.

Piroxicam is extensively metabolised and less than 5% of the daily dose is excreted unchanged in urine and faeces. Piroxicam metabolism is predominantly mediated via cytochrome P450 CYP 2C9 in the liver. One important metabolic pathway is hydroxylation of the pyridyl ring of the piroxicam side-chain, followed by conjugation with glucuronic acid and urinary elimination.

Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered piroxicam with caution as they may have abnormally high plasma levels due to reduced metabolic clearance (see section 4.4).

Pharmacogenetics:

CYP2C9 activity is reduced in individuals with genetic polymorphisms, such as the CYP2C9*2 and CYP2C9*3 polymorphisms. Limited data from two published reports showed that subjects with heterozygous CYP2C9*1/*2 (n=9), heterozygous CYP2C9*1/*3 (n=9), and homozygous CYP2C9*3/*3 (n=1) genotypes showed 1.7-, 1.7-, and 5.3-fold higher piroxicam systemic levels, respectively, than the subjects with CYP2C9*1/*1 (n=17, normal metabolizer genotype) following administration of an oral single dose. The mean elimination half life values of piroxicam for subjects with CYP2C9*1/*3 (n=9) and CYP2C9*3/*3 (n=1) genotypes were 1.7- and 8.8-fold higher than subjects with CYP2C9*1/*1 (n=17). It is estimated that the frequency of the homozygous*3/*3 genotype is 0% to 5.7% in various ethnic groups.

  • Preclinical safety data

None stated.

  1. Pharmaceutical particulars
  • List of excipients

Lactose, Corn starch, Vegetable magnesium stearate, Sodium lauryl sulphate, Capsule shell cap (red) contains: Gelatin, Titanium dioxide , Red iron oxide

The body of the capsule shell (blue) contains:
Gelatin, Titanium dioxide , Indigotin

  • Incompatibilities

None stated.

  • Shelf life

36 months.

  • Special precautions for storage

Store below 30°C.

  • Nature and contents of container

Original pack of 30 capsules contained in a white HDPE bottle with a blue round ribbed cap.

6.6 Special precautions for disposal and other handling

No special requirements.
Not all pack sizes may be marketed

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Piroxicam Capsules USP 20mg Taj Pharma

Package Leaflet: Information for the User
Piroxicam

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  1. What Piroxicamis and what it is used for
  2. Before you take Piroxicam
  3. How to take Piroxicam
  4. Possible side effects
  5. How to store Piroxicam
  6. Further information

1. What Piroxicam is and what it is used for

Piroxicam is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This means it will help to relieve pain and reduce swelling affecting joints. Piroxicam is used to relieve some symptoms caused by osteoarthritis (joint disease), rheumatoid arthritis, and ankylosing spondylitis (rheumatism of the spine) such as swelling, stiffness and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it.

Your doctor will only prescribe Piroxicam to you when you have had unsatisfactory relief of symptoms with other NSAIDs.

  1. Before you take Piroxicam
    Do not take Piroxicam
  • If you have previously had or currently have a stomach or intestinal ulcer, bleeding or perforation.
  • If you have, or have previously had disorders of the stomach or intestines such as ulcerative colitis, Crohn’s disease, gastrointestinal cancers or diverticulitis (inflamed or infected pouches/pockets in the colon).
  • If you are taking other NSAIDs such as ibuprofen, celecoxib or acetylsalicylic acid (aspirin), a substance present in many medicines used to relieve pain and lower fever.
  • If you are taking anticoagulants, such as warfarin, to prevent blood clots.
  • Page 1 of 8
  • If you previously had an allergic reaction to piroxicam, (the active ingredient in this medicine) or any of the other ingredients, other NSAIDs or any other medications, especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense reddening of skin, with skin peeling off in scales or layers), Stevens-Johnson syndrome (symptoms are a rash, blistering or peeling of the skin, mouth, eyes or genitals) or toxic epidermal necrolysis (a disease with blistering and peeling of the top layer of skin).
  • If you have severe heart failure.
  • If you are in the last three months of pregnancy.

If any of the above applies to you, tell your doctor immediately and do not take Piroxicam.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of piroxicam, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of piroxicam, you must not be re-started on piroxicam at any time.

If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine.

Take special care with Piroxicam:

Before prescribing Piroxicam (piroxicam), your doctor will assess the benefits this medicine may give you against your risk of developing side effects. Your doctor may need to give you check-ups and will tell you how often you need to be checked during treatment with Piroxicam.

Medicines such as Piroxicam may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment or if you are a smoker. Do not exceed the recommended dose or duration of treatment.

Tell your doctor before you take Piroxicam if you suffer from or have suffered in the past from any of the following conditions:

  • liver disease
  • kidney disease
  • high blood pressure, heart problems or stroke
  • high cholesterol or hardening of the arteries
  • asthma
  • diabetes

If you have or had any other medical problems or any allergies or if you are not sure as to whether you can use Piroxicam tell your doctor before taking this medicine.

You should stop taking Piroxicam immediately and tell your doctor if you have any allergic reaction such as a skin rash, swelling of the face, wheezing or difficulty breathing

Take special care with Piroxicam as like all NSAIDs, Piroxicam can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration and perforation.

You should stop taking Piroxicam immediately and tell your doctor if you have stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements or vomiting blood.

Your doctor may prescribe Piroxicam together with another medicine to protect your stomach and intestines from side effects, particularly if you are over 70 years old, or you are taking other medicines like corticosteroids (medicines given to treat a variety of conditions such as allergies and hormone imbalances), certain medicines for depression called selective serotonin reuptake inhibitors (SSRIs) or low dose acetylsalicylic acid (aspirin) to help prevent heart attacks or stroke. Piroxicam may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Patients over 70 years of age

If you are over 70 years old, your doctor may wish to minimise the length of your treatment and to see you more often while you are taking Piroxicam.
You should not take this medicine if you are over 80 years of age.
Taking other medicines
Tell your doctor about any other medicines you are taking or took recently (in the last week) – even medicines you bought yourself without a prescription. Medicines can sometimes interfere with each other. Your doctor may limit your use of Piroxicam or other medicines, or you may need to take a different medicine.

The following medicines must not be taken with Piroxicam:

  • aspirin or other non-steroidal anti-inflammatory drugs for pain relief
  • anticoagulants such as warfarin to prevent blood clots
  • Tell your doctor before you take Piroxicam if you are taking any of the following medicines:
  • corticosteroids, which are medicines given to treat a variety of conditions such as allergies and hormone imbalances
  • low dose aspirin (75 mg) to help prevent heart attack or stroke
  • certain medicines used to treat heart conditions known as cardiac glycosides, such as digoxin
  • certain medicines for depression such as lithium or selective serotonin re-uptake inhibitors
  • (SSRIs)
  • antihypertensives to treat high blood pressure
  • methotrexate, which can be given to treat various conditions such as cancers, psoriasis and rheumatoid arthritis
  • ciclosporin or tacrolimus, which are given to help prevent rejection of transplanted organs
  • quinolone antibiotics e.g.ciprofloxacin, which are used to treat various infections
  • mifepristone, a medicine used to terminate pregnancy
  • diuretics such as hydrochlorothiazide to treat high blood pressure or kidney problems

Taking Piroxicam with food and drink

Piroxicam should be taken with or after food.

Pregnancy and breast-feeding

If you are pregnant, planning pregnancy or breast-feeding tell your doctor before you take Piroxicam. Do not take Piroxicam if you are in the last three months of pregnancy. It is not usually recommended at other stages of pregnancy, but you may be able to take it if your doctor advises that it is necessary for you.
If you are trying to become pregnant or being investigated for infertility, withdrawal of Piroxicamshould be considered. Piroxicammay increase the risk of miscarriage in early pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machinery

These capsules can cause some people to feel dizzy, drowsy, tired or have problems with their vision.
If you are affected, do not drive or operate machinery.
Important information about some of the ingredients of Piroxicam
Piroxicam contains lactose, a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking Piroxicam.

  1. How to take Piroxicam

Always take Piroxicam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of Piroxicam.
Your doctor will adjust your treatment to the lowest dose that best controls your symptoms. Under no circumstances should you change your dose without first speaking to your doctor.
Swallow your capsules whole with a glass of water. It is best to take your capsules at the same time each day with food or soon after eating.

Adults:
The maximum daily dose of Piroxicam is 20 milligrams taken as one single daily dose.
Elderly:

If you are older than 70 years your doctor may prescribe a lower daily dose and reduce the duration of treatment.
If you feel that the medicine is not very effective, always talk to your doctor. Do not increase the dose.
If you take more Piroxicamthan you should
If you accidentally take too much Piroxicam contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there is any Piroxicam left or not.

If you forget to take Piroxicam

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a missed dose.

If you have any further questions on how to take this product, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop taking Piroxicam if you experience any of the following symptoms after taking this medicine:

  • any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements or vomiting blood
  • sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)
  • a rash, blistering or peeling of the skin, mouth, eyes or genitals
  • yellowing of the skin and the whites of your eyes (jaundice) which may be a sign of hepatitis or other liver problems

Common: may affect up to 1 in 10 people

  • Changes in the red blood cells which may result in unusual bruising or bleeding
  • Changes in the white blood cells which may result in increased risk of infection
  • Anorexia
  • Increase in blood sugar levels
  • Dizziness
  • Headache
  • Vertigo (a spinning sensation)
  • Drowsiness
  • Ringing in ears (tinnitus)
  • Abdominal pain/discomfort
  • Constipation
  • Diarrhoea
  • Wind
  • Feeling sick (nausea)
  • Being sick (vomiting)
  • Indigestion
  • Itching
  • Skin rash
  • Swelling of the feet, hands or other parts of the body (oedema)
  • Weight increase

Uncommon: may affect up to 1 in 100 people

  • Blurred vision
  • Fast or pounding heartbeat
  • Sore mouth and/or lips
  • Decreased/low blood sugar level
  • Rare: may affect up to 1 in 1,000 people
  • Kidney inflammation
  • Kidney failure
  • Kidney damage
  • Change in urine output or appearance
  • Kidney pain or pain in abdomen
  • Very rare: may affect up to 1 in 10,000 people
  • Potentially life-threatening skin rashes including peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) or extensive peeling of the skin (toxic epidermal necrolysis) (see section 2)

Not known: frequency cannot be estimated from the available data

  • Abnormalities in the blood e.g. decreased haemoglobin
  • Fluid retention
  • Sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)
  • Depression
  • Dream abnormalities
  • Hallucinations
  • Changes in sleep patterns
  • Mental confusion
  • Mood alterations
  • Nervousness
  • Pins and needles
  • Eye irritations
  • Swollen eyes
  • Hearing impairment
  • High blood pressure
  • Inflammation of the blood vessels
  • Shortness of breath
  • Constriction of the muscles lining the airways of lungs (bronchial)
  • Nose bleeds
  • Inflammation of the stomach lining (gastritis)
  • Gastrointestinal bleeding including vomiting of blood and black, tarry stools
  • Inflamed pancreas (which may lead to severe pain in the upper abdomen or back)
  • Stomach (peptic) ulcers
  • Upset stomach
  • Hair loss
  • Allergic reaction involving purple spots on the skin, joint pain, abdominal pain and kidney dysfunction (Henoch-Schoenlein purpura)
  • Rashes, blistering, peeling, itching, redness, tenderness, thickening or scaling of skin
  • Loosening or splitting of fingernails
  • Increased sensitivity of the skin to sunlight
  • Decreased fertility
  • Feeling unwell, general aches and pains
  • Weight decrease
  • Yellowing of the skin and the whites of your eyes (jaundice)
  • Inflammation of the liver (hepatitis)
  • Increased risk of heart attack (myocardial infarction)
  • Increased risk of stroke

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

  1. How to store Piroxicam

Keep all medicines out of the reach and sight of children.
Store below 30oC.

Do not use Piroxicam after the expiry date which is stamped on the carton and the bottle label. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

  1. Further information

What Piroxicam contains

The active substance in Piroxicam capsules is piroxicam. Piroxicam comes in two strengths; 10mg or
20mg. The other ingredients are: lactose, corn starch, and vegetable magnesium stearate and sodium lauryl sulphate.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

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Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.