Saturday, September 7, 2013

Mifoxin

Mifoxin
.w..
Mifoxin Tablets 250 & 500 mg (film Coated Tablets) 
Bread Spectrum Antibiotic 
Composition: 
Each tablet contains 
Ciproflcxacin (as HCI monohydrata) 250 & 500 mg. 
Properties: 
Mifosin ( ciproflosacin) is a potent antibacterial agent of flouroquinolones,agroup of synthetic anlibacterials related to nalidixic acid but has greater systemic antibacterialactivity and having a broader spectrum. 
Mifosin is active against gram -vs bacilli sod cocci including pseudomonas, kiabsiella serratia, E. coil, shigella, sslmonetla entsrobactsr, neisseria, campylobscter, nstnrotoxigenic E. coli, haemophilua influsszas, hanmophilus parainfluenres, proteus mirabilis, proteus vulgaris, staphlococcus aureus including pencillinass producing and non producing strains and msthicitlin resistant strains) . It is moderately active against most strains of strnptococci including s. fuecalis, mycobacterium tuberculosis and clamydia trachometis. It is less active against most anaerobic bacteria. 
Mechanism of action: 
Mifosin is bactericidal and acts by inhibiting the A subunit of DNA gyrasa, a type 11 topoisomerase essential for ATP depending coiling and supercoiling of bacterial DNA. 
Absorption: 
Mifosin is well absorbed from gastrointestinal tract after oral administration , it has bioavailsbility of approximately 70%. 
Dtal 
It is distributed throughout,all body tissues and fluids. Tissue concentration ascends that of serum concentration specially in the kidneys , liver, gait bladder, lungs, gynaecological tissue and proslatic tissues, It is also distributed to saliva, nasal secretions, aqueous humor, sputum skin blister fluid, lymph, peritoneel fluid, bile, prostatic secretions and broast milk, It is also distributed through skin, fat, muscles, bones and cartilage as well as cnrnbrospinal fluid. It can crossestha placenta. 
Biotranaformatlon: 
Mainly hepetic through 4 metaboliles which account for approximately 15% of an oral dose, found in urine metebolites and are active but activity is less than the unchanged ciproflosacin which is about 
50% 
Elimination: 
- renal : approximately 50% is excreted unchanged in urine glomaruler filtration and active tubular secretion, excretion is virtually complete within 24 hours. 
- Bilisry & faecal : small amounts are excreted in bile and about 20% ix excreted in faeces within 5 days. 
- Dialysis : haumodialysix or peritoneal dialysis removes only avery smell amount, less than 10% Half life: -. 
Normal renal function is about 4 houm, with impaired renal functions it is slightly prolonged for about flto 8 hours. 
Serum, btla and urine concentrations: 
Time to peak serum concentration in fasting is about 1 to 2 hours, normally with food intake it ix about 2 hours, mean peak serum concentration afar an oral dose of 250 rag is 1.2 to 1.42 mcg)ml, after 500 mg ix 2.4 to 2.flmcglml and after 750 rag is 3.4 to 4.3 mcglml during the first 2 hours after the administration of a 250 rag dose. 
Indications & Usage: 
- respiratory tract infections : pneumoniae due to kiebsiella, haamophilus, proteus, B-coli, enterobacter, 
pseudomonas, pneumococci and staphylococci. 
Acute end chronic bronchitis and bronchopneumonis. 
- skin and soft tissue infection. - Genital infections including proxtatitis and cerercitis. 
- Bone infactiona. - E.N.T. infection. 
- Gastrointestinal infections including that of the biliary tract, diarrhea sad ealmonellosis. 
- Supticemia. - Peritonitis. 
- Pre and post operative as a prophylactic. 
Contra-Indications: 
- patients known to be hypersensitive to quinolones and nalidixic acid.. 
- Not to be administered to subjects under the age of 18 year. 
- Pregnancy and breast faeing. 
- Nnpatic function impairment, renal impairment and C.N.S. disorders. 
Side Effects: 
A few isolated cases reporting C.N.S. stimulation, crystalluria, hypersensitivity reactions in the form of skin rash, itching or swelling of face and neck have occurred. Photosensitivity and visual disturbances may occur during treatment. Patients may exhibit some dizziness, headache, diarrhea, nausea, vomiting and an unpleasant lasts. Sleep troubles am rare and do not necessitate the discontinuation of treatment but should be attended by a physician. 
Drug Interactions: 
- urinary alkalizers may increase the incidence of cryatalluria. 
- Aluminium and magnesium anti—acids as well as sucralfete may interfere with the absorption of 
ciprofloxacin. 
- Ciprofioxacin causes a delay in the hapatic metabolism of theophyllina and caffeine. 
- Probnncid decreanex the tubular secretion of ciprofloxacin. 
Dosage and Administration: 
Doses are administered on an empty stomach and tablets are swallowed together with a glass of 
water. 
- Bone, respiratory tract and skin infections : 500-750 rag b.i.d.for 14 days. 
- G.l.T. infections :500mg bi.d.fcr 5-7 days. 
- Urogenital infections : 250-500 mg b.i.d.for 1-14 days. 
- Gonococcal infections: 250-500 mg ax a single dose. 
- Other systemic infections :250-500mg b.i.d.for 10 days. 
- Usual adult prescribing limit dose is 1.5gm daily. 
Adequate fluid intake should be considered during the course of treatment. 
In renal failure or in impaired renal function , dosage intervals should be adjusted according to the 
following: 
Crestinine C.ml/min Dose 
50 ml! mm Adult dose 
30 - 50 ml I mm 250-500 mgb.id. 
5-29 ml! rain 250-500mg every 18 hours 
Flsemodialysis 250-500 mg every 24 hours 
Packing: 
- Boxes of 10 tablets of each of Mifoain 250 & 500 mg. 
(lledicament is a product which affects your health, and flu cuesumptien contrary is ixsimctons is dangemuu’?j 
- Fofum sticily em dance’s pmssipaan, the method dose sod the instoctono ultra phamraciai wtro sales the medbe,roaot Il-The doctor and the pharmacist am enpertu is medicine. fl’s benefits and risks. 
jJ-Du salty puursef iniermpt the period of h’eulmenl prescribed for you. 
- Do sot repeat the same prescriptes wichnul consutixg poor doctor. 
medirameni out of children reach Councli of Arab Health Miointem and Usion of Arsti Phanoaxixtu
MISR CO. FOR PHARM. IND S.A.E.