Nemel Cipro Ciprofloxacin hydrochloride Tablets

Nemel Cipro

CIPROFLOXACIN TABLETS B.P. 500mg

 

COMPOSITION

Each film coated tablet contains

Ciprofloxacin hydrochloride B.P 500mg

NEMEL CIPRO is available in 500mg (Cipropfloxacin equivalent) strength.

 

CLINICAL PHARMACOLOGY

Ciprofloxacin given as an oral caplet is rapidly and well absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability is approximately 70% with no substantial loss by first pass metabolism.

 

MICROBIOLOGY

Aerobic Gram-positive bacteria

Enterococcus faecalls (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptive
isolates only), staphylococcus epidermidis (methicillin-susceptible isolates only, Staphylococcus saprophyticus, Streptococcus pneumonea
(penicillin-susceptible isolates only), Streptococcus pyogenes.

Aerobic gram-negative bacteria

Campylobacter jejuni, Proteus Mirabilis, Citrobacter koseri (diversus), proteus vulgaris, Citrobacter freundi, Providencia rettgeri, Enterobacter cloacae, Providencia stuartil, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenza, Salmonella type, Haemophilus parainfluenzae, Serratia marcescens, Klebsiella pneumonia, Shigella boydii, Moraxella catarrhalis, Shigella dysenteriae, Morganella morganii, Shigella flexneri, Neisseria gonorrhoeae, Shigella sonnei.

The following in vitro data are available, but their clinical significance is unknown.

Aerobi Gram-positive bacteria

Staphylococcus haemolyticus (methicillin-susceptible isolates only), Staphylococcus hominis (methicillin-susceptible isolates only), Bacillus anthracis.

Aerobic Gram-negative bacteria

Acinetobacter iwoffi, Pasteurella muttocida, Aeromonas hydrophila, Salmonella enteritidis, Edwardsiella tarda, Vibrio cholera, Enterobacter aerogenes, Vibrio parahaemolyticus, Klebsiella oxytoca, Vibrio vulnificus, Legionella pneumophila, Yersinia enterocolitica.

 

INDICATIONS AND USAGE

Adult Patients

Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri (diversus), Citrobacter treindil, Pseudomonas aeruginosa nethicillin-susceptible, Staphylococcus epidermidis, Staphylococcus saprophyticus, or vancomycin-susceptible, Enterococcus faecalls.

Acute Uncomplicated Cystitis in Females caused by Escherichia coli or Staphylococcus saprophyticus.

Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis.

Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomona aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or penicillin-susceptible Streptococcus pneumoniae.

– Also, Moraxella catarrhalla for the treatment of acute exacerbations of chronic bronchitis.

– Ciprofloxacin is not a drug of first choice in the treatment of presumed or coli, med pneumonia secondary to streptococcus pneumoniae.

Acute Sinusitis caused by Haemophilus influenzae, penicllin-susceptible streptococcus pneumoniae, or Moraxella catarrhalis.

Skin and Skin Structure infections caused by Escherichia coli, Kiebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuarti, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susctptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

Complicated Intra-Abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides tragilis.

Typhoid Fever (Enteric Fever) caused by salmonella typhii.

Uncomplicated Cervical and Urethral Gonorrhea due to Neisseria gonorrhoea.

 

Adult and Pediatric Patients (1 to 17) years age)

Inhalational Anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. If anaerobic organisms suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with Nemel Cipro may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.

 

CONTRAINDICATIONS

Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to Ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components. Concomitant administration with tizanidine is contraindicated.

Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline.

Pregnant Woman: The safety and effectiveness of ciprofloxacin in pregnant and lactating woman have not been established.

Pediatrics: Ciprofloxacin should be used in pediatric patients (less than 18 years of age) only for infections listed in the INDICATIONS AND USAGE section.

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria and itching.

Pseudomembraneous Colitis: Clostridium difficile associated diarrhea (CDA) has been reported with use of nearly all antibacterial agents, including NEMEL CIPRO, and may range from mild diarrhea to fatal colitis. Treatment with antibacterial agenst alters the normal flora of the colon leading to overgrowth of C. difficile.

Peripheral neuropathy: Rare cases of sensory motor axonal polyneuropathy affecting small and/or large axons resulting in parathesis hypoesthesias, dysesthesias and weekness have been reported in patients receiving quinolones.

Central Nervous System: Quinolones, including Ciprofloxacin, may also cause central nervous system (CNS) events, including nervousness, agitation, insomnia, anxiety, nightmares or paranoia, renal impairment, alteration of the dosage regimen is necessary for patients with impairment of renal function.

Nursing Mother: Ciprofloxacin is excreted in juman milk.

Pediatric Use: Ciprofloxacin, like other quinolones, cause athropathy and histological changes in weight-bearing joints of juvenile animal resulting lameness.

Adverse Reaction: Like all medicines, Nemel Cipro can cause side effects, although not everybody gets them. If any of the effects gets serious, if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Common side effects, diarrhea, joint pains in children.

Uncommon side effects, fungal super infections, a high concentration of eosinophils, loss of appetite (anorexia), hyperactivity or agitation, headache, dizziness, steeping problems, or taste disorders, vomiting, abdominal pain, digestive problems such as stomach upset (Indigestion/heartburn) increased amount of certain substances in the blood (transaminases and or bilirubin), rash, itching or hives, joint pain in adults, poor kidney function, pains in your muscles and bones, feeling unwell (asthenia), or fever, increase in blood alkaline phosphatase (a certain substance in the blood).

 

OVERDOSE

In the event of acute overdose, reversible renal toxicity has been reported in some cases.

The stomach should be emptied by induction, vomiting or by gastric lavage. The patient should be carefully observed and given supportive treatment, including monitoring of renal function and administration of magnesium, aluminum, or calcium containing antacids which can reduce the absorption of Ciprofloxacin. Adequate hydration must be maintained. Only a small amount of Ciprofloxacin (<10%) is removed from the body after hemodialysis or peritoneal dialysis.

 

DOSAGE AND ADMINISTRATION

ADULT DOSAGE GUIDELINES

Infection Severity Dose Frequency Usual Duration
Urinary tract Acute Uncomplicated
Mild/Moderate
Severe/ Complicated
250mg
250mg
500mg
q12h       q12h
q12h
5days 7 to
14 days
7 to 14 days
Chronic Bacteria Prostatis Mild/Moderate 500mg q12h 24 days
Lower Respiratory Tract Mild/Moderate Severe/Complicated 500mg
750mg
q12h       q12h 7 to 14days
7 to 14days
Acute Sinusitis Mild/Moderate 500mg q12h 10days
Skin and Skin Structure Mild/Moderate Severe/Complicated 500mg
750mg
q12h
q12h
7 to 14 days 7 to 14 days
Bone and Joint Mild/Moderate Severe/Complicated 500mg
750mg
q12h
q12h
4 to 6 weeks
4 to 6 weeks
Intra-Abdominal Complicated 500mg q12h 7 to 14 days
lnfectious Diarrhea Mild/Moderate
Structure
500mg q17h 5 to 7 days
Typhoid Fever Mild/Moderate 500mg q12h 10 days
Urethral and Cervical Gonococcal infections Uncomplicated 200mg q12h       q12h Single dose

 

PEDIATRIC DOSAGE GUIDELINES

Infection Route of Administration Dose (mg/kg) Frequency Total Duration
Complicated
Urinary Tract of
Pyelonephritis
(patient from 1 to 7 years of age)
Intravenous 6 to 10mg/kg (maximum 400mg per dose; not to be exceeded even in patients weighing >51kg) Every 12 hours 10 – 21 days
Oral 10mg/kg
(maximum
400mg
12 hours
per dose)
Every 12 hours
Inhalational
Anthrax (post-
Exposure)
Intravenous 10mg/kg
maximum
400mg
12 hours
per dose)
Every 12 hours 60 days
Oral 15mg/kg
(maximum 500mg
per dose)
Every 12 hours

 

How supplied

Nemel Cipro 500 is available as a white coloured capsule shaped film-coated tablet engraved with ‘Nemel’ on one side and ‘plain’ on other side, available in blister packs of 10 tablets.

 

Storage

Store NEMEL CIPRO in a cool & dry place.

Protect from direct sun light.

 

Keep NEMEL CIPRO and all medicines out of the reach of children.

 

Manufactured by

NEMEL PHARMACEUTICAL NIG. LTD

Head Office: Plot 35, Enugu Industrial Layout, Enugu, Nigeria.

Branch Office: 4A/4B, Medical Road Phase VI, Trans-Ekulu, Enugu.

nemelpharm@gmail.com

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