ROMACALM 15
Suppositories

No steroidal Anti-inflammatory drugs

  • Chemical Composition

    Meloxicam 15 mg /1 suppository

  • Packing

    10Suppositories

  • Medical Id

    SU-04

  • License Number

    85/2003

  • License date

    5/5/2003

Mechanism Of Action Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. The mechanism of action like that of other NSAIDS may be related to prostaglandin synthetase inhibition. Meloxicam is a Cyclo-oxygenase-2 (COX-2) inhibitor with a 75-fold selectivity for COX-2 relative to COX-1 in recombinant human enzymes.
INDICATIONS Romacalm is used in the management of rheumatoid arthritis, for the short-term symptomatic treatment of acute exacerbation of osteoarthritis, and for the symptomatic treatment of ankylosing spondylitis.
CONTRAINDICATIONS Romacalm is contraindicated in patients with hypersensitivity to drug, and in those with history of asthma or allergic-type reactions after taking aspirin or other NSAIDs.
Side EFFECTS The most frequently reported side effects include headache, fatigue, dizziness, diarrhea, stomach pain, colitis, nausea, and upper respiratory tract infection. More serious side effects include anemia, thrombocytopenia, neutopenia, angioedema, arrhythmias, palpitations, tachycardia, hypertension, skin rash, and difficulty breathing.
WARNINGS Romacalm should be avoided in patients with renal failure, unless receiving dialysis, in severe hepatic failure, and in bleeding disorders. Reumacalm suppositories should be avoided in patients with a history of procitis, haemorrhoides, or rectal bleeding.
DRUG INTERACTIONS Meloxicam, like some other NSAIDs, may diminish the antihypertensive effect of ACE inhibitors. Meloxicam can increase the effect of anti-coagulants. NSAIDs can reduce sodium excretion associated with diuretics, leading to sodium retention. Meloxicam also increases lithium levels and decreased clearance. Therefore the plasma lithium levels should be monitored during concomitant therapy with lithium salts. Meloxicam may increase prothrombin time (PT) or international normalized ratio (INR); concomitant use with warfarin increases risk of bleeding complications. Meloxicam should not be taken with any other NSAIDs. Drug \ Clinical Laboratory Test Interactions: Meloxicam may cause elevations in liver tests. It may also cause elevated blood creatinine levels.
Pregnancy And lactations Romacalm is also contraindicated during pregnancy and lactation.
Dosage And Administration -For the treatment of rheumatoid arthritis: one suppository of Romacalm -15 daily. -For the treatment of osteoarthritis: one tablet or one suppository of Romacalm -7.5 daily, increased if necessary to one tablet or one suppository of Romacalm --15 daily. -For the treatment of ankylosing sponylitis one suppository of Romacalm -15 daily. A dose of 7.5 mg daily is recommended for long-term treatment in the elderly and for dialysis patients also.
OVERDOSE It has been shown that cholestyramine accelerates Meloxicam elimination, therefore it may be used in case of overdose
Storage Conditions Store it in a cool and dry place below 25ْ C.