Description and Composition of Roxytal
Roxytal is a fluoroquinolone antibiotic that contains Ciprofloxacin Hydrochloride as its active pharmaceutical ingredient. It also contains other inactive ingredients called excipients in sufficient quantities. Ciprofloxacin is an extremely
broad spectrum antimicrobial agent and acts by inhibiting a subunit
of DNA gyrase which is essential in the reproduction of bacterial DNA. It comes in different dosage forms and strength. Available dosage forms of ciprofloxacin include tablets, infusions, eye/ear drops, ointments, oral suspension, etc.
Indications and Uses of Roxytal
- Roxytal is indicated for the treatment of single or mixed infections caused by two or more susceptible organisms.
- Becauses antibacterial concentrations of Ciprofloxacin are obtained in serum and body tissues as well as in the urine following administration by mouth, Ciprofloxacin has been suggested for use in the treatment of a wide range of infections caused by susceptible organisms including infections of the urinary, respiratory and gastrointestinal tracts, gonorrhoea and septicaemia.
- The extensive tissue penetration of Ciprofloxacin combined with its enhanced antibacterial activity (including antipseudomonal activity), enables Ciprofloxacin to be used alone (pending sensitivity results) or in
combination with an Aminoglycoside or with beta-lactam antibiotics for instance when severe neutropenia is present or with an antibiotic
active against anaerobes where the presence of Bacteroides fragilis
Ciprofloxacin is indicated for the treatment of the following infections
caused by sensitive bacteria :
Severe systemic infections
e.g. septicaemia, bacteraemia,
peritonitis, infections in immunosuppressed patients with haematological or solid tumors and in patients in intensive care unit
with specific problems such as infected burns.
Respiratory tract infections
Lobar and bronchopneumonia, acute, and chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis, empyema.
Urinary tract infections
Uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis.
Skin and soft tissue infections
e.g. infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas, infected burns.
e.g. enteric fever, infective diarrhoea.
Infection of the biliary tract
e.g. cholangitis, cholecystitis, empyema
of the gall bladder.
e.g. peritonitis, intra abdominal abscesses.
Bone and joint infections
e.g. osteomyelitis, septic arthritis.
e.g. salpingitis, endometritis, pelvic inflammatory diseases.
Eye, ear, nose and throat infections
e.g. otitis media, sinusitis, mastoiditis, tonsillitis.
This includes urethral, rectal and pharyngeal gonorrhoea caused by beta-lactamase producing organisms or organisms moderately sensitive to penicillin.
Dosage and Administration of Roxytal
General dosage recommendations : The dosage of Roxytal
is determined by:
- severity and type of infection,
- sensitivity of the causative organism(s) and
- Patient data including the age, weight and renal function
The dosage range for adults is 100-750 mg twice daily. That is 12 hourly.
In infections of the lower and upper urinary tract (depending on severity)
250-500 mg twice daily.
In respiratory tract infections
250-750 mg twice daily for both upper and lower respiratory tract infections, depending on severity.
For the treatment of known Streptococcus pneumonia infection
the recommended dosage is 750 mg twice daily.
A single dose of 250 or 500 mg. This is however not drug of choice in this.
In adults with pseudomonal infections of the lower
respiratory tract, the normal dose is 750 mg twice daily.
As the pharmacokinetics of Ciprofloxacin remain unchanged in patients with cystic fibrosis, the low body weight of these patients would be fallen into consideration when determining dosage.
Dose of ciprofloxacin sustained release tablet 1000mg
uncomplicated urinary tract infection (acute cystitis), the recommended dose is one tablet of 1000mg SR once daily for three days.
Dosage for Ear/Eye Roxytal Drops
- The recommended dosage is 2 drops into the affected eye(s) every 15 minutes for the first 6 hours and then 2 drops into the affected eye every 30 minutes for the remainder of the first day.
- On the second day, instill 2 drops in the affected eye(s) hourly.
- On the third through the fourteenth day, place 2 drops in the affected eye(s) every 4 hours.
- Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
The recommended dosage is 1 or 2 drops instilled into the conjunctival sac of the affected eye(s) every 2 hours while awake for 2 days and 1 or 2 drops every 4 hours while awake for the next 5 days
Instill 2-3 drops in affected ear(s) 3-4 times a day and at night
Impaired renal function
Dosage adjustment is not usually required except in patients with severe renal impairment (serum creatinine >265 micro mol/l or creatinine clearance <20 ml/minute). If adjustment is necessary, this may be achieved by reducing the total daily dose by half, although monitoring of drug serum levels provide the most reliable basis for dose adjustment.
Although higher Ciprofloxacin serum levels are found in the
elderly, no adjustment of dosage is necessary.
The dosage should be 10-30 mg/kg/day depending upon
the severity of infections, administered in two divided doses.
Duration of treatment with Roxytal
The duration of treatment depends upon:
- severity of infection,
- clinical response and
- bacteriological findings.
For acute infections, the usual treatment period is 5 to 10 days with
Contraindication of Roxytal
Roxytal is contraindicated in patients who have shown hypersensitivity to Ciprofloxacin or other quinolones.
Warning and Precautions
Roxytal should be used with caution in patients with a history of convulsive disorders. Crystalluria related to the use of Ciprofloxacin
has been observed only rarely. Patients receiving Ciprofloxacin
should be well hydrated and excessive alkalinity of the urine should
Drug Interactions with Roxytal
- Concurrent administration of Roxytal with theophylline may
lead to elevated plasma concentrations of theophylline and
prolongation of its elimination half-life. This may result in increased risk of theophylline related adverse reactions. If concomitant use cannot be avoided, plasma levels of theophylline should be monitored and dosage adjustments made as appropriate.
- Antacids containing magnesium hydroxide or aluminium hydroxide
may interfere with the absorption of Ciprofloxacin resulting in serum
and urine levels lower than desired, concurrent administration of
these agents with Ciprofloxacin should be avoided.
- Probenecid interferes with renal tubular secretion of Ciprofloxacin and produces an increase in the level of Ciprofloxacin in the serum. This should be considered if patients are receiving both drugs concomitantly.
As with other broad spectrum antibiotics prolonged use of Ciprofloxacin may
result in overgrowth of nonsusceptible organism. Repeated evaluation of the patient’s condition and microbial susceptibility testing is essential. If superinfection occurs during therapy,
appropriate measures should be taken.
Information for Patients taking Roxytal
- Patients should be advised that Roxytal may be taken with or
without meals. The preferred time of dosing is two hours after a meal.
- Patients should also be advised to drink fluids liberally and not take
antacids containing magnesium or aluminium concomitantly or within
two hours after dosing.
- Ciprofloxacin may cause dizziness and light-headedness, therefore patients should know how they react to this
drug before they operate an automobile or machinery or engage in
activities requiring mental alertness or coordination.
Use of Roxytal in Pregnancy and Lactation
Reproduction studies performed in mice, rats and rabbits using parenteral and oral administration did not reveal any evidence of teratogenicity, impairment of fertility or impairment of pre/post natal
development. However as with other quinolones, Ciprofloxacin has
been shown to cause arthropathy in immature animals and therefore
its use during pregnancy is not recommended. Studies in rats have
indicated that Ciprofloxacin is secreted in milk, administration to
nursing mothers is thus not recommended.
Overdosage of Roxytal
No information on Roxytal overdose is available. Routine measures such as gastric lavage should be performed as soon as possible after ingestion of ciprofloxacin tablets or suspension. Serum levels of
Ciprofloxacin are reduced by dialysis.
Side Effects of Roxytal
- Gastrointestinal disturbances e.g. nausea, diarrhoea, vomiting, dyspepsia, abdominal pain.
- Disturbance of the central nervous
system e.g. dizziness, headache, tiredness, confusion, convulsions.
- Hypersensitivity reactions e.g. skin rashes, pruritus and possible
- The following other reactions have also been reported, joint pain, mild photosensitivity and transient increase in liver enzymes (particularly in patients with previous liver damage)
serum bilirubin, urea or creatinine levels.