INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ZYDUS-MELOXICAM 7,5 mg (tablets)
ZYDUS-MELOXICAM 15 mg (tablets)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ZYDUS-MELOXICAM 7,5 mg (tablets)
ZYDUS-MELOXICAM 15 mg (tablets)

COMPOSITION:
Each ZYDUS-MELOXICAM 7,5 mg tablet contains 7,5 mg
meloxicam.
Each ZYDUS-MELOXICAM 15 mg tablet contains 15 mg meloxicam.

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics (anti-inflammatory agents)

PHARMACOLOGICAL ACTION:
Meloxicam, an oxicam (enolic acid) derivative, is a non-steroidal anti-inflammatory compound (NSAID) with analgesic, antipyretic and anti-inflammatory activities. The action of meloxicam is related to inhibition of the enzyme cyclo-oxygenase (COX), resulting in the decreased formation of prostaglandins (mediators of inflammation) and thromboxanes. A selective COX-2 inhibitory (anti-inflammatory effect) in vitro in relation to COX-1 has been demonstrated. Inhibition of COX-1 (gastrointestinal, renal and platelet effects) in vivo occurs. It is suggested that the extent of inhibition of COX-1 in vivo is a function of dose and inter-individual variability of meloxicam concentrations.
Pharmacokinetics:
The extent of absorption after oral administration is 89% and concomitant administration with food does not affect absorption. Meloxicam is 99% protein bound and has an elimination half-life of 15-20 hours. Meloxicam is extensively metabolised in the liver (mainly by oxidation) and less than 5% of the daily dose is excreted unchanged in the faeces and urine.

INDICATIONS:
ZYDUS-MELOXICAM
is indicated for the symptomatic treatment of:
Rheumatoid arthritis
Painful osteoarthritis
Ankylosing spondylitis
Episodes of acute sciatica

CONTRA-INDICATIONS:
Hypersensitivity to ZYDUS-MELOXICAM or to any components of the formulation.
Patients in whom attacks of asthma, urticaria, nasal polyps or acute rhinitis are precipitated by acetylsalicylic acid/ aspirin or by other non-steroidal anti-inflammatory agents.
Active peptic ulcer disease
Severe hepatic impairment
Sever non dialysed renal impairment
Pregnancy (see PREGNANCY AND LACTATION)

WARNINGS:
Children under the age of 18 years- Safety and efficacy have not been established.
ZYDUS-MELOXICAM should be used with caution in patients with: -
Gastrointestinal bleeding
Hepatic impairment –Increases risk of renal decompensation.
Renal impairment – Increases risk of renal decompensation.
Congestive heart failure – Increases risk of renal decompensation.

INTERACTIONS:
Acetylsalicylic acid/ Aspirin and other NSAIDS –May result in an increase in gastric ulceration and/ or bleeding.
Warfarin and other anticoagulants –Increase the risk of bleeding complications.
Lithium – May result in an increase in plasma lithium concentrations. Monitor lithium plasma concentrations carefully when therapy with ZYDUS-MELOXICAM is initiated or withdrawn.
Methotrexate –May result in increased haematological toxicity due to methotrexate toxicity.
Angiotension-converting enzyme (ACE) inhibitors and other anti-hypersensitivity agents –May result in a decrease in antihypertensive effects and an increased risk of renal failure.
Cholestyramine - May result in a reduced therapeutic effect of ZYDUS-MELOXICAM.
Ciclosporin –Increases the risk of nephrotoxicity
Alcohol - Simultaneous intake may increase the risk of bleeding
Diuretics –May result in renal impairment if the patient is dehydrated (see Precautions).
Intrauterine device –NSAIDS may decrease the efficacy of intrauterine devices.

PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy and lactation has not been established. The use of ZYDUS-MELOXICAM during the third trimester is not recommended because of possible adverse effects on the foetus, such as premature closure of the ductus arteriosus, which may lead to persistent pulmonary hypertension in the newborn. See CONTRA-INDICATIONS.

DOSAGE AND DIRECTIONS FOR USE:
Safety and efficacy in children under the age of 18 years has not been established.
The tablet should be taken with a glass of water and together with a meal.
The dose of ZYDUS-MELOXICAM in patients with end stage renal disease on haemodialysis should not be greater than 7,5 mg/day. (No dosage reduction is necessary in patients with mild to moderate renal impairment).
Adults:
The maximum daily dose of ZYDUS-MELOXICAM is 15 mg.
Acute sciatica: 7,5 mg once daily. If there is no improvement the dose can be increased to 15 mg a day.
Ankylosing spondylitis: 15 mg once daily
Osteoarthritis: 7,5 mg once daily. Increase to 15 mg if necessary.
Rheumatoid arthritis: 15 mg once daily. Reduce dose if possible (provided therapeutic response is maintained).

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:

Haematological:
Frequent: Anaemia
Less frequent: Thrombocytopenia, neutropenia, eosinophilia, agranulocytosis, leukopenia.
Cardiovascular:
Frequent: Oedema
Less frequent: Palpitations, elevated blood pressure
Neurological:
Frequent: Headache, dizziness, light-headedness
Less frequent: Vertigo, confusion, drowsiness, insomnia, nightmares
Gastrointestinal:
Frequent: Dyspepsia, nausea and vomiting, diarrhoea, flatulence, constipation and abdominal pain.
Less frequent: Gastrointestinal bleeding, perforation or ulceration (generally more serious in the elderly), induction or exacerbation of colitis, gastritis.
Kidney/Genitourinary:
Less frequent: Nephrotic syndrome, glomerulonephritis, interstitial nephritis and papillary necrosis, renal failure
Liver:
Less frequent: Hepatitis
Ocular:
Less frequent: Visual disturbances (such as blurred vision), conjunctivitis
Respiratory:
Less frequent: Bronchospasm (see other)
Skin:
  Frequent: Pruritus, rash
  Less frequent: Flushing, urticaria, stomatitis, photosensitivity, bullous dermatoses, including erythema multiforme and Stevens-Johnson syndrome, toxic epidermal necrolysis
Other:
Less frequent: tinnitus, hypersensitivity reactions including anaphylaxis, angioedema and bronchospasm (especially if patient is aspirin-sensitive and has asthma and/or nasal polyps (ZYDUS-MELOXICAM should be withdrawn immediately.)

Special Precautions:
Patients with a history of gastrointestinal disease should be monitored very carefully while on ZYDUS-MELOXICAM and therapy should be discontinued if any ulceration or bleeding occurs.
Patients should not operate machinery or drive a vehicle if they experience drowsiness, blurred vision or any other central nervous system effect.
Patients who are dehydrated, have heart failure, hepatic or renal dysfunction, taking diuretics or have undergone surgery leading to hypovolaemia, are at particular renal discompensation and renal function should be carefully monitored.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage:
(See SIDE EFFECTS AND SPECIAL PRECAUTIONS)
Treatment of overdosage:
Treatment is symptomatic and supportive as there is no known antidote.
Absorption should be reduced by:
Activate charcoal if patient presents 1 to 2 hours after overdose
Cholestyramine
Gastric lavage if within 1 hour of overdose

IDENTIFICATION:
ZYDUS-MELOXICAM 7,5 mg
tablets: Yellow round, uncoated tablets with flat face and bevelled edges, debossed with the logo “Z” on one side and breakline on the other side. (approx. diameter 6,35 mm).
ZYDUS-MELOXICAM 15 mg tablets: Yellow round, uncoated tablets with flat face and bevelled edges, debossed with the logo “Z” on one side and breakline on the other side. (approx. diameter 7,93 mm).

PRESENTATION:
ZYDUS-MELOXICAM 7,5 mg
tablets:        Aluminium/PVdC blister packs of 3 x 10 strips in an outer carton.
ZYDUS-MELOXICAM 15 mg tablets:        Aluminium/PVdC blister packs of 1 x 10 strips in an outer carton.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
ZYDUS-MELOXICAM 7,5 mg
tablets:        37/3.1/0267
ZYDUS-MELOXICAM 15 mg tablets:         37/3.1/0268

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Zydus Healthcare (Pty) Ltd.
Adrina Building, 1st Floor
32-34 Klinkenberg Road
Van der Hoffpark
Potchefstroom
2531

DATE OF PUBLICATION OF THE PACKAGE INSERT:
9 March 2005

New addition to this site: March 2006
Source: Pharmaceutical Industry

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