Hiflox-XR Tablet (Extended Release)

Ciprofloxacin is a synthetic quinolone anti-infective agent. Ciprofloxacion has broad spectrum of activity. It is active against most gram negative aerobic bacteria including Enterobacteriaceae and Pseudomonas aeruginosa. Ciprofloxacin is also active against gram-positive aerobic bacteria including penicillinase producing, non penicillinase producing, and methicillin resistant staphylococci, although many strains of streptococci are relatively resistant to the drug. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase needed for the synthesis of bacterial DNA. Following oral administration it is rapidly and well absorbed from the G.I. tract. It is widely distributed into the body tissues and fluids. The half life is about 3.5 hours. About 30% to 50% of an oral dose of Ciprofloxacin is excreted in the urine within 24 hours as unchanged drug and biologically active metabolites.

General dosage recommendations: The dosage of the Ciprofloxacin is determined by the severity and type of infection, the sensitivity of the causative organism(s) and the age, weight and renal function of the patient.

Adults: The dosage range for adults is 100-750 mg twice daily.

In infections of the lower and upper urinary tract (depending on severity): 250-500 mg twice daily.

In respiratory tract infections: 250-500mg twice daily for both upper and lower respiratory tract infections, depending on the severity. For the treatment of known Streptococcus pneumonia infection, the recommended dosage is 750 mg twice daily.

In gonorrhea: A single dose of 250 or 500 mg.

In the majority other infections: 500-750 mg twice daily should be administered.

Cystic fibrosis: 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.

Impaired renal function: Dosage adjustment is not usually required except in patients with several 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.

Elderly: Although higher Ciprofloxacin serum levels are found in the elderly, no adjustment of dosage is necessary.

Adeloscents and children: As with other drugs in its class, Ciprofloxacin has been shown to cause arthropathy in weight bearing joints of immature animals. Although the relevance of this to man is unknown, its use in children, growing children and growing adolescents is not recommended. However, where the benefit of using Ciprofloxacin is considered to outweigh the potential risk, the dosage should be 7.5-15 mg/kg/day depending upon the severity of infection, administered in two divided doses.

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings.

For acute infections: The usual treatment period is 5 to 10 days with Ciprofloxacin tablets. Generally treatment should be continued for three days after the signs and symptoms of the infection have disappeared.

Extended-release tablet:

• In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
• Open flow control clamp to expel air from set.Close clamp.
• Regulate rate of administration with flow control clamp.

Concurrent administration of Hiflox-XR should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Hiflox-XR. Hiflox-XR should not be taken concurrently with milk or other dairy products, since absorption of Hiflox-XR may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Hiflox-XR.

Patients with a history of hypersensitivity to Ciprofloxacin or to other quinolones.

Gastrointestinal disturbances e.g. nausea, diarrhoea, vomiting, dyspepsia, abdominal pain. Disturbances of the central nervous system e.g. headache, dizziness, tiredness, confusion, convulsion & risk of retinal detachment. Hypersensitivity reactions e.g. skin rash (very rarely Stevens-Johnson syndrome and toxic epidermal necrolysis), pruritus and possible systemic reactions. The other less reported reactions are joint pain, mild photosensitivity and transient increase in liver enzymes (particularly in patients with previous liver damage), serum bilirubin, urea or creatinine levels. Risk of hypoglycemia & mental health adverse effects.

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 peri/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.

It should be used with caution in patients with suspected or known CNS disorders such as arteriosclerosis or epilepsy or other factors which predispose to seizures and convulsion.

• Hiflox-XR may be taken with or without meals and to drink fluids liberally.
• Concurrent administration of Hiflox-XR should be avoided with magnesium / aluminium antacids, or sucralfate or with other products containing calcium, iron and zinc. These products may be taken two hours after or six hours before Hiflox-XR.
• Hiflox-XR should not be taken concurrently with milk or yogurt alone, since absorption of Hiflox-XR may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the Hiflox-XR absorption.

Although effective in clinical trials, Hiflox-XR is not a drug of first choice in pediatric population.

Overdose following Hiflox-XR administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.