Artrigan

Meloxicam (Artrigan) is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the symptoms of arthritis, primary dysmenorrhea, fever; and as an analgesic, especially where there is an inflammatory component. It is closely related to piroxicam. In Europe it is marketed under the brand names Movalis, Melox, and Recoxa. In North America it is generally marketed under the brand name Meloxicam (Artrigan). In Latin America, the drug is marketed as Tenaron.

Paracetamol (Artrigan) is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Paracetamol (Artrigan) exists as small alkaline deliquescent crystals with a saline tasteacinol was introduced to medicine as a solvent for uric acid. When taken into the body the drug is partly oxidized and partly eliminated unchanged. Outside the body, piperazine has a remarkable power to dissolve uric acid and producing a soluble urate, but in clinical experience it has not proved equally successfulacinol was first introduced as an anthelmintic in 1953. A large number of piperazine compounds have anthelmintic Paracetamol (Artrigan). Their mode of Paracetamol (Artrigan) is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.

Osteoarthritis (OA)

Meloxicam (Artrigan) is indicated for relief of the signs and symptoms of osteoarthritis in adults.

Rheumatoid Arthritis (RA)

Meloxicam (Artrigan) is indicated for relief of the signs and symptoms of rheumatoid arthritis in adults.

Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

Meloxicam (Artrigan) is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in pediatric patients who weigh greater than or equal to 60 kg.

For systemic use of Paracetamol (Artrigan) Sante Naturelle: prevention and treatment of hypo- and avitaminosis of vitamin C; providing increased need for vitamin C during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

Meloxicam (Artrigan) (Meloxicam (Artrigan)) is a nonsteroidal anti-inflammatory drug (NSAID). Meloxicam (Artrigan) works by reducing hormones that cause inflammation and pain in the body.

Meloxicam (Artrigan) is used to treat pain or inflammation caused by rheumatoid arthritis and osteoarthritis in adults. Meloxicam (Artrigan) is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old.

Meloxicam (Artrigan) may also be used for purposes not listed in this medication guide.

Paracetamol (Artrigan) (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of Paracetamol (Artrigan) of is not known.

Paracetamol (Artrigan) is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. It relieves pain in mild arthritis but has no effect on the underlying inflammation and swelling of the joint.

Paracetamol (Artrigan) may also be used for other purposes not listed in this medication guide.

General Dosing Instructions

Carefully consider the potential benefits and risks of Meloxicam (Artrigan) and other treatment options before deciding to use Meloxicam (Artrigan). Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Meloxicam (Artrigan), adjust the dose to suit an individual patient's needs.

In adults, the maximum recommended daily oral dose of Meloxicam (Artrigan) is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended.

Meloxicam (Artrigan) may be taken without regard to timing of meals.

Osteoarthritis

For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of Meloxicam (Artrigan) is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

Rheumatoid Arthritis

For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of Meloxicam (Artrigan) is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

Juvenile Rheumatoid Arthritis (JRA) Pauciarticular And Polyarticular Course

For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of Meloxicam (Artrigan) is 7.5 mg once daily in children who weigh ≥ 60 kg. There was no additional benefit demonstrated by increasing the dose above 7.5 mg in clinical trials.

Meloxicam (Artrigan) tablets should not be used in children who weigh < 60 kg.

Renal Impairment

The use of Meloxicam (Artrigan) in subjects with severe renal impairment is not recommended.

In patients on hemodialysis, the maximum dosage of Meloxicam (Artrigan) is 7.5 mg per day.

Non-Interchangeability With Other Formulations of Meloxicam (Artrigan)

Meloxicam (Artrigan) Tablets have not shown equivalent systemic exposure to other approved formulations of oral Meloxicam (Artrigan). Therefore, Meloxicam (Artrigan) Tablets are not interchangeable with other formulations of oral Meloxicam (Artrigan) product even if the total milligram strength is the same. Do not substitute similar dose strengths of Meloxicam (Artrigan) Tablets with other formulations of oral Meloxicam (Artrigan) product.

How supplied

Dosage Forms And Strengths

Meloxicam (Artrigan) (Meloxicam (Artrigan)) Tablets

• 7.5 mg: pastel yellow, round, biconvex, uncoated tablet containing Meloxicam (Artrigan) 7.5 mg. Impressed with the Boehringer Ingelheim logo on one side and the letter “M” on the other.
• 15 mg: pastel yellow, oblong, biconvex, uncoated tablet containing Meloxicam (Artrigan) 15 mg. Impressed with the tablet code “15” on one side and the letter “M” on the other.

Storage And Handling

Meloxicam (Artrigan) is available as a pastel yellow, round, biconvex, uncoated tablet containing Meloxicam (Artrigan) 7.5 mg or as a pastel yellow, oblong, biconvex, uncoated tablet containing Meloxicam (Artrigan) 15 mg. The 7.5 mg tablet is impressed with the Boehringer Ingelheim logo on one side, and on the other side, the letter “M”. The 15 mg tablet is impressed with the tablet code “15” on one side and the letter “M” on the other.

Meloxicam (Artrigan) (Meloxicam (Artrigan)) tablets 7.5 mg: NDC 0597-0029-01; Bottles of 100

Meloxicam (Artrigan) (Meloxicam (Artrigan)) tablets 15 mg: NDC 0597-0030-01; Bottles of 100

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep Meloxicam (Artrigan) tablets in a dry place.

Dispense tablets in a tight container.

Keep this and all medications out of the reach of children.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Revised: May 2016

Usual Adult Paracetamol (Artrigan) Dose for Fever:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Artrigan) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Adult Paracetamol (Artrigan) Dose for Pain:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Artrigan) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Pediatric Dose for Fever:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Usual Pediatric Dose for Pain:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

See also:
What is the most important information I should know about Meloxicam (Artrigan)?

Known hypersensitivity to Meloxicam (Artrigan) or any excipient of Meloxicam (Artrigan). There is a potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs).

Meloxicam (Artrigan) should not be given to patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of acetylsalicylic acid or other NSAIDs. Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Active or recent gastrointestinal ulceration or perforation. Active inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Severe hepatic insufficiency. Nondialysed severe renal insufficiency.

Overt gastrointestinal bleeding, recent cerebrovascular bleeding or established systemic bleeding disorders.

Severe uncontrolled heart failure.

In case of rare hereditary conditions that may be incompatible with an excipients of Meloxicam (Artrigan).

Use in pregnancy & lactation: Meloxicam (Artrigan) is contraindicated during pregnancy.

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the embryo-foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastrochisis after use of a prostaglandin-synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from <1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In preclinical studies, administration of a prostaglandin-synthesis inhibitor has been shown to result in increase pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in preclinical studies given a prostaglandin-synthesis inhibitor during the organogenetic period.

During the 3rd trimester of pregnancy, all prostaglandin-synthesis inhibitors may expose the foetus to: Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydramniosis; the mother and the neonate, at the end of pregnancy, to possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labour.

While no specific experience exists for Meloxicam (Artrigan), NSAIDs are known to pass into mother's milk.

Administration therefore is contraindicated in women who are breastfeeding.

See also:
What is the most important information I should know about Paracetamol (Artrigan)?

Paracetamol (Artrigan) should not be used in patients who have previously exhibited hypersensitivity to aspirin and/or nonsteroidal antiinflammatory agents. Paracetamol (Artrigan) should not be given to patients with a recent history of gastrointestinal bleeding or in patients with bleeding disorders (e.g., hemophilia).

Use Meloxicam (Artrigan) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Meloxicam (Artrigan) comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Meloxicam (Artrigan) refilled.
• Take Meloxicam (Artrigan) by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers).
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Shake gently before each use.
• Take Meloxicam (Artrigan) with a full glass of water (8 oz/240 mL) as directed by your doctor.
• If you take cholestyramine, ask your doctor or pharmacist how to take it with Meloxicam (Artrigan).
• If you miss a dose of Meloxicam (Artrigan), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Meloxicam (Artrigan).

Use Paracetamol (Artrigan) exactly as directed on the label, or as prescribed by your doctor.

Do not use more of this medication than is recommended. An overdose of Paracetamol (Artrigan) can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more Paracetamol (Artrigan) could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking Paracetamol (Artrigan) and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of Paracetamol (Artrigan). Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

Measure the liquid form of Paracetamol (Artrigan) with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The Paracetamol (Artrigan) chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the Paracetamol (Artrigan) disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the Paracetamol (Artrigan) effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Do not take a Paracetamol (Artrigan) rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.

Try to empty your bowel and bladder just before using the Paracetamol (Artrigan) suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.

Stop using Paracetamol (Artrigan) and call your doctor if:

• you still have a fever after 3 days of use;

• you still have pain after 7 days of use (or 5 days if treating a child);

• you have a skin rash, ongoing headache, or any redness or swelling; or

• if your symptoms get worse, or if you have any new symptoms.

Urine glucose tests may produce false results while you are taking Paracetamol (Artrigan). Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

Store Paracetamol (Artrigan) at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.

Use: Labeled Indications

IV:

Pain: Management of moderate to severe pain in adults, alone or in combination with non-nonsteroidal anti-inflammatory drug analgesics.

Limitation of use: Because of delayed onset of analgesia, Meloxicam (Artrigan) (injection) alone is not recommended for use when rapid onset of analgesia is required

Oral:

Osteoarthritis: Relief of the signs and symptoms of osteoarthritis (OA); management of OA pain.

Rheumatoid arthritis (orally disintegrating tablet [ODT], tablet, and suspension only): Relief of signs and symptoms of rheumatoid arthritis (RA); relief of the signs and symptoms of pauciarticular or polyarticular course juvenile RA in patients ≥2 years of age (suspension) and in patients weighing ≥60 kg (ODT, tablet).

Off Label Uses

Gout, acute flares

Data from a single-blind, randomized, controlled trial supports the efficacy of Meloxicam (Artrigan) in the treatment of acute gout flares.

Based on the 2012 American College of Rheumatology guidelines for management of gout, NSAIDS are effective and recommended agents in the treatment of acute gout flares.

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How to use Paracetamol (Artrigan)

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

There are many brands and forms of acetaminophen available. Read the dosing instructions carefully for each product because the amount of acetaminophen may be different between products. Do not take more acetaminophen than recommended.

If you are giving acetaminophen to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.

For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.

For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

See also:
What other drugs will affect Meloxicam (Artrigan)?

ACE inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors.

Aspirin

Concomitant administration of aspirin (1000 mg TID) to healthy volunteers tended to increase the AUC (10%) and C_max (24%) of Meloxicam (Artrigan). The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Meloxicam (Artrigan) and aspirin is not generally recommended because of the potential for increased adverse effects. Concomitant administration of low-dose aspirin with Meloxicam (Artrigan) may result in an increased rate of GI ulceration or other complications, compared to use of Meloxicam (Artrigan) alone. Meloxicam (Artrigan) is not a substitute for aspirin for cardiovascular prophylaxis.

Cholestyramine

Pretreatment for four days with cholestyramine significantly increased the clearance of Meloxicam (Artrigan) by 50%. This resulted in a decrease in t_1/2, from 19.2 hours to 12.5 hours, and a 35% reduction in AUC. This suggests the existence of a recirculation pathway for Meloxicam (Artrigan) in the gastrointestinal tract. The clinical relevance of this interaction has not been established.

Cimetidine

Concomitant administration of 200 mg cimetidine QID did not alter the single-dose pharmacokinetics of 30 mg Meloxicam (Artrigan).

Digoxin

Co Meloxicam (Artrigan) 15 mg once daily for 7 days did not alter the plasma concentration profile of digoxin after b-acetyldigoxin administration for 7 days at clinical doses. In vitro testing found no protein binding drug interaction between digoxin and Meloxicam (Artrigan).

Furosemide

Clinical studies, as well as post-marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazide diuretics in some patients. This effect has been attributed to inhibition of renal prostaglandin synthesis. Studies with furosemide agents and Meloxicam (Artrigan) have not demonstrated a reduction in natriuretic effect. Furosemide single and multiple dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of Meloxicam (Artrigan). Nevertheless, during concomitant therapy with furosemide and Meloxicam (Artrigan), patients should be observed closely for signs of declining renal function, as well as to assure diuretic efficacy.

Lithium

In clinical trials, NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. In a study conducted in healthy subjects, mean pre-dose lithium concentration and AUC were increased by 21% in subjects receiving lithium doses ranging from 804 to 1072 mg BID with Meloxicam (Artrigan) 15 mg QD as compared to subjects receiving lithium alone. These effects have been attributed to inhibition of renal prostaglandin synthesis by Meloxicam (Artrigan). Patients on lithium treatment should be closely monitored when Meloxicam (Artrigan) is introduced or withdrawn.

Methotrexate

A study in 13 rheumatoid arthritis (RA) patients evaluated the effects of multiple doses of Meloxicam (Artrigan) on the pharmacokinetics of methotrexate taken once weekly. Co Meloxicam (Artrigan) did not have a significant effect on the pharmacokinetics of single doses of methotrexate. In vitro, methotrexate did not displace Meloxicam (Artrigan) from its human serum binding sites.

Warfarin

Anticoagulant activity should be monitored, particularly in the first few days after initiating or changing Meloxicam (Artrigan) therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding. The effect of Meloxicam (Artrigan) on the anticoagulant effect of warfarin was studied in a group of healthy subjects receiving daily doses of warfarin that produced an INR (International Normalized Ratio) between 1.2 and 1.8. In these subjects, Meloxicam (Artrigan) did not alter warfarin pharmacokinetics and the average anticoagulant effect of warfarin as determined by prothrombin time. However, one subject showed an increase in INR from 1.5 to 2.1. Caution should be used when administering Meloxicam (Artrigan) with warfarin since patients on warfarin may experience changes in INR and an increased risk of bleeding complications when a new medication is introduced.

See also:
What other drugs will affect Paracetamol (Artrigan)?

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic Paracetamol (Artrigan) of Paracetamol (Artrigan).

With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.

With the simultaneous use of anticholinergics may decrease absorption of Paracetamol (Artrigan).

With the simultaneous use of oral contraceptives accelerated excretion of Paracetamol (Artrigan) from the body and may reduce its analgesic Paracetamol (Artrigan).

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Paracetamol (Artrigan).

When Paracetamol (Artrigan) Guardian applied simultaneously with diazepam may decrease excretion of diazepam.

There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with Paracetamol (Artrigan). A case of severe toxic liver injury.

Described cases of toxic effects of Paracetamol (Artrigan), while the use of isoniazid.

When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of Paracetamol (Artrigan), which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of Paracetamol (Artrigan) and phenobarbital.

In applying cholestyramine a period of less than 1 h after administration of Paracetamol (Artrigan) may decrease of its absorption.

At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.

With the simultaneous use of metoclopramide may increase absorption of Paracetamol (Artrigan) and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of Paracetamol (Artrigan), with rifampicin, sulfinpyrazone - may increase clearance of Paracetamol (Artrigan) due to increasing its metabolism in the liver.

At simultaneous application of Paracetamol (Artrigan) Guardian with ethinylestradiol increases absorption of Paracetamol (Artrigan) from the gut.

Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of caffeine increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).

See also:
What are the possible side effects of Meloxicam (Artrigan)?

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events
• GI Bleeding, Ulceration, and Perforation
• Hepatotoxicity
• Hypertension
• Heart Failure and Edema
• Renal Toxicity and Hyperkalemia
• Anaphylactic Reactions
• Serious Skin Reactions
• Hematologic Toxicity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

Osteoarthritis And Rheumatoid Arthritis

The Meloxicam (Artrigan) Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with Meloxicam (Artrigan) 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with Meloxicam (Artrigan) 15 mg/day. Meloxicam (Artrigan) at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo- and/or activecontrolled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or activecontrolled rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across Meloxicam (Artrigan) trials.

A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of Meloxicam (Artrigan) with placebo and with an active control. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of Meloxicam (Artrigan) with placebo.

Table 1a depicts adverse events that occurred in ≥ 2% of the Meloxicam (Artrigan) treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.

Table 1b depicts adverse events that occurred in ≥ 2% of the Meloxicam (Artrigan) treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.

Table 1a : Adverse Events (%) Occurring in ≥ 2% of Meloxicam (Artrigan) Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial

Higher doses of Meloxicam (Artrigan) (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of Meloxicam (Artrigan) should not exceed 15 mg.

Pediatrics

Pauciarticular And Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)

Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to Meloxicam (Artrigan) with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials. These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study. The adverse events observed in these pediatric studies with Meloxicam (Artrigan) were similar in nature to the adult clinical trial experience, although there were differences in frequency. In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia, were more common in the pediatric than in the adult trials. Rash was reported in seven ( < 2%) patients receiving Meloxicam (Artrigan). No unexpected adverse events were identified during the course of the trials. The adverse events did not demonstrate an age or gender-specific subgroup effect.

The following is a list of adverse drug reactions occurring in < 2% of patients receiving Meloxicam (Artrigan) in clinical trials involving approximately 16,200 patients.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Meloxicam (Artrigan). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug. Adverse reactions reported in worldwide post marketing experience or the literature include: acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure; Stevens-Johnson syndrome; toxic epidermal necrolysis, and infertility female.

See also:
What are the possible side effects of Paracetamol (Artrigan)?

Effects due to the presence of acetylsalicylic acid.

Accidents awareness with respiratory or skin reactions (angioedema, urticaria, asthma, anaphylactic shock);

Cross hypersensitivity reactions with NSAIDs and with tartrazine;

At low doses recommended for the use of Paracetamol (Artrigan), side effects of aspirin are generally limited to some irritation of the gastro-intestinal tract.

At higher doses, side effects include gastrointestinal mucosal erosions, gastric ulcer or duodenal ulcer, occult blood loss, melena.

Acetylsalicylic acid may also increase the tendency to bleeding and bleeding time (the lengthening of bleeding continues 4-6 days after stopping the drug).

It may also worsen renal function including cases of pre-existing condition (the long-term use can cause chronic kidney disease).

The signs of salicylic overdose described under.

Effects due to the presence of Paracetamol (Artrigan).

At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of Paracetamol (Artrigan) in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol (Artrigan)) may cause the appearance chronic hepatitis. This justifies the recommendations of caution especially in patients with liver disease prior.

Very rarely, it can produce thrombocytopenia.

The acute liver toxicity in overdose massive (doses greater than 8 g of Paracetamol (Artrigan)) is described in paragraph overdose.