Saturday, September 14, 2013


MOBITIL 150225116511 Ampoules for I.M. Injection
Anti-inflammatory, Anti-rheumatic, Analgesic
Each ampoule (1.5 ml) contains 15mg melosicam.
4-hydrosy-2-melhyl-N-(5-methyl-2-thiazotyl(-21-l-1 ,2-benzothiazine-3-carbosamide-1 ,1-dioxide.
MOSITIL is a new potent nonsteroidal anti-inflammatory drug, belonging to the enolic acid group. It acts through the preferential inhibition of cyclo-osygenase-2 (COX-2(. with potantially high anti-inflammatory and analgesic actions.
Nonsteroidal anti-intammatory drugs (NSAIDs) are potent anti-inflammatory agents that act through the inhibition of the cyclo-osygenase (CCX) enzyme and the subsequent inhibition of prostaglandin synthesis at the site of intammstion. Recently two isotorms of the CCX enzyme have benn identified;
1- COX-l ,which is constitutively (naturally) expressed in many cells and tissues including the gastric macosa, — where the inhibition of COX-1 is responsibleforthe toxicity associateowith the clinically active NSAIOa.
2- COX-2, which is induced by the proinflammatory cytokines at the site of inflammation, where the anti-
inflammatory properties of NSAIOs are caused by the inhibition of inducible COX-2.
MOBITIL preferentially/nhibits COX-2 enzyme. PHARMACOKINETICS: Absorption: is complete after intramuscular administration.
-Plasma protein binding: 99%.
- Steady state plasma concentration:Achievedwithin 3-S days with a 15mg single daily dose.
Metabolism: Melosicam is extensively metabolized in the liver, with only traces of the drug appearing unchanged in the urine and feces. The main metabotites are formed by hydrosylation and further osidation of the methyl group of the thiazolyl moiety.
Excretion: Melosicam is escreted through both renal and hepatic pathways. The excretion of a single dose is complete inS days.
- Elimination half life (1%): 17-20 hours.
- Total plasma clearance (CL): 0.42-0.45 liter/hoar.
The pharmscokinstic parameters of melosicam are linear over the dose range of 7.5-30mg
Neither moderate hepatic insufficiency nor moderate renal dysfunction has any mievant effects on the
pharmacokinetics of melosicam. In terminal renal failure, the volume of distribution is increased and s daily dose
of 7.5mg must not be exceeded.
INDICATIONS: * Symptomatic treatment ot acute exacerbations of inflammatory and degenerative rheumatic disesses, such as
rheumatoid srthritis, osteosrthritis, and ankylosing spondylitis.
* Post-traumatic end post-operative pain, inflammation and swelling.
• Painful syndromes of the vertebret column.
* Painful and/or inflammatoryconditions in gynecology such as primary dysmenorrhea or ednesitis.
* Painful and/or inflammetory conditions in dentistry.
CONTRAINDICATIONSAND PRECAUTIONS: * Hypersensitivity to theosicam group of NSAIDs.
- Use with caution in patients known to be hypersensitive to other NSAIDs or aspirin as there is a probability for cross sensitivity.
•Active peptic ulcer.
* Severe hepetic insufficiescy.
* Severe, non-dialyzed rensi insufficiency.
* Pregnancy and breast-feeding.
ADVERSE REACTIONS: The following adverse reactionswere infrequently reported:
* CNS: Headache, drowsiness, tinnitus.
* OtT: Dyspepsia, nausea, flatulence, diarrhea orconstipation.
* Cardiovascular: Peripheral edema.
• Dsrmatological: Pruritus, skin rash.
DOSAGE ANDADMtNISTRATION: • One 15 mg injection once e day. The injections must be administered slowly by deep intramuscular injeclios in the upper outer quadrant of the buttock. Is case of repeated administration, it is recommended to alternate teft end right side. In case of hip prosthesis, the injection should be performed on the otherside.
* In dialysis patientswith severe renal failure: the dose should not euceed 7.5mg per day (halt an 1.5 ml ampoule(
HOW SUPPLIED: Bos containing three 1.5 mI-ampoules of 15mg melosicam.
OTHER DOSAGE FORMS AVAILABLE: MOBiTiLTablets: Box containing 10 tablets of either 7.5mg or 15mg metovicam.
MOtttTtLSuppositorres: Ens containing S suppositories ott 5mg melosicam.
Keep out of reach of children.
To be used under medical supervision.
PRODUCT OF: Medicat Union Pharmaceaficals,
Abu-Sultan, Ismailia, Egypt. 

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