(Ciprofloxacin hydrochloride)
1- INDICATIONS AND USAGE
Cipromega should be reserved for use in patients who have no other treatment options for uncomplicated urinary tract infections (UTI).
Fluoroquinolones should not be used in the following indications:
- To treat infections that might get better without treatment or are not severe (such as throat infections).
- To treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
- For preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder).
- To treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.
Cipromega is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below
Uncomplicated Urinary Tract Infections (Acute Cystitis)
Cipromega is indicated for the treatment of uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus
Because fluoroquinolones, including Cipromega, have been associated with serious adverse reactions and for some patients uncomplicated UTI (acute cystitis) is self-limiting, reserve Cipromega for treatment of uncomplicated UTIs (acute cystitis) in patients who have no alternative treatment options.
Complicated Urinary Tract Infections, and Acute Uncomplicated Pyelonephritis
Cipromega is indicated for the treatment of complicated urinary tract infections (CUTI) caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis. Proteus mirabilis, or Pseudomonas aeruginosa and acute uncomplicated pyelonephritis (AUP) caused by Escherichia coli.
Limitations of Use
The safety and efficacy of Cipromega in treating infections other than urinary tract infections has not been demonstrated.
Cipromega is not indicated for pediatric patients.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cipromega and other antibacterial drugs. Cipromega should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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 Cipromega may be initiated before results of these tests are known, once results become available appropriate therapy should be continued.
As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
2- DOSAGE AND ADMINISTRATION
Dosage
Ciprofloxacin extended release tablets and ciprofloxacin immediate-release tablets are not interchangeable. Cipromega should be administered orally once daily (Table 1).
Table 1: Dosage Guidelines
| Indication | Dose | Frequency | Usual Duration |
| Uncomplicated Urinary Tract Infection (Acute Cystitis) | 500 mg | every 24 hours | 3 days |
| complicated Urinary Tract Infection and Acute uncomplicated pyelonephritis | 1000 mg | every 24 hours | 7-14 days |
Patients whose therapy is started with Ciprofloxacin IV for UTIs may be switched to Ciprofloxacin extended release tablets when clinically indicated at the discretion of the physician.
Administration
Cipromega tablets should be taken whole and not split, crushed, or chewed.
Cipromega should be administered at least 2 hours before or 6 hours after antacids containing magnesium or aluminum, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) as well as sucralfate, Didanosine chewable/buffered tablets or pediatric powder, other highly buffered drugs, metal cations such as iron, and multivitamin preparations with zinc.
Concomitant administration of Cipromega with dairy products (like milk or yogurt) or with calcium-fortified products alone should be avoided since decreased absorption is possible. A 2-hour window between substantial calcium intake (greater than 800 mg) and dosing with Cipromega is recommended.
Adequate hydration of patients receiving Cipromega should be maintained to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Impaired Renal Function
In patients with chronic UTI and acute uncomplicated pyelonephritis with a creatinine clearance of ≤ 30 mL/min, the dose of Ciprofloxacin extended release tablets should be reduced from 1000 mg to 500 mg daily. The use of Ciprofloxacin 1000 mg XR tablets is not recommended in this patient population.
For patients on hemodialysis or peritoneal dialysis, administer Ciprofloxacin extended release tablets after the dialysis procedure is completed (maximum dose should be Ciprofloxacin 500 mg XR every 24 hours). The use of Ciprofloxacin 1000 mg XR is not recommended in this patient population.
For patients on continuous ambulatory peritoneal dialysis (CAPD), the maximum dose should be 500 mg every 24 hours.
3-DOSAGE FORMS AND STRENGTHS
1000 mg white to off white oblong film coated tablet Contains Ciprofloxacin Hydrochloride 1164 mg equivalent to Ciprofloxacin 1000 mg.
500 mg white to off white oblong film coated tablet Contains Ciprofloxacin Hydrochloride 582 mg equivalent to Ciprofloxacin 500 mg.
4- CONTRAINDICATIONS
1. Quinolones should not generally be used in patients aged less than 18 years, pregnant women or breast feeding mothers unless benefits outweigh the risks
2. Hypersensitivity: Cipromega is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components
3. Tizanidine: Concomitant administration with tizanidine is contraindicated.
4. History of tendon disorders related to fluoroquinolone administration
5-WARNINGS AND PRECAUTIONS
Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (eg. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis. giant cell arteritis, Behcet’s disease, hypertension, known atherosclerosis). In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects
Fluoroquinolones, including Cipromega have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting Cipromega. Patients of any age or without pre-existing risk
factors have experienced these adverse reactions.
Discontinue Cipromega immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including Cipromega, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Tendinitis and Tendon Rupture
Fluoroquinolones, including Cipromega, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and also been reported in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons.
Tendinitis and tendon rupture can occur within hours or days of starting Cipromega, or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.
Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.
Discontinue Cipromega immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon.
Avoid fluoroquinolones, including Cipromega, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.
Peripheral Neuropathy
Fluoroquinolones, including Cipromega, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including Cipromega.
Symptoms may occur soon after initiation of Cipromega and may be irreversible in some patients.
Discontinue Cipromega immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations isensations including light touch, pain, temperature, position sense and vibratory sensation and/or motor strength in order to minimize the development of an irreversible condition.
Avoid fluoroquinolones, including Cipromega, in patients who have previously experienced peripheral neuropathy.
Central Nervous System Effects
Psychiatric Adverse Reactions: Fluoroquinolones, including Cipromega, have been associated with an increased risk of psychiatric adverse reactions, including toxic psychosis, psychotic reactions progressing to suicidal ideations/thoughts, hallucinations, or paranoia, depression, or self-injurious behavior such as attempted or completed suicide, anxiety, agitation, or nervousness, confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment.
These reactions may occur following the first dose. Advise patients receiving Cipromega to inform their healthcare provider immediately if these reactions occur, discontinue the drug, and institute appropriate care.
Central Nervous System Adverse Reactions: Fluoroquinolones, including Cipromega, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (psoudotumor celebri), dizziness, and tremors.
Cipromega, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported.
As with all fluoroquinolones, use Cipromega with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (for example, certain drug therapy, renal dysfunction).
If seizures occur, discontinue Cipromega and institute appropriate care.
Exacerbation of Myasthenia Gravis
Fluoroquinolones, including Cipromega, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis.
Avoid Cipromega in patients with known history of myasthenia gravis.
6-Adverse Reactions
The following events occurred with ciprofloxacin XR tablet: nausea, headache, dizziness, diarrhea, vomiting, vaginal moniliasis & dyspepsia.
Table: Medically Important Adverse Reactions That Occurred With Ciprofloxacin XR Tablets
| System Organ Class | Adverse Reactions |
| Body as a Whole | Abdominal pain, Asthenia, Malaise |
| Cardiovascular | Bradycardia, Migraine, Syncope |
| Central Nervous System | Abnormal dreams, Convuisive seizures (including status epilepticus), Depersonalization, Depression (potentially culminating in self-injurious behavior such as suicidal ideations thoughts and attempted or completed suicide), Hypertonia, Incoordination, Insomnia, Somnolence, Tremor, Vertigo |
| Gastrointestinal | Constipation, Dry mouth, Flatulence, Thirst |
| Hepatobiliary Disorders | Liver function tests abnormal |
| Investigations | Prothrombin decrease |
| Metabolic | Hyperglycemia , Hypoglycemia |
| Psychiatric Disorders | Anorexia |
| Skin/Hypersensitivity | Dry skin, Maculopapular rash, Photosensitivity/phototoxicity reactions, Pruritus, Rash, Skin disorder, Urtic arial, Vesiculobullous rash |
| Special Senses | Diplopia, Taste perversion |
| Urogenital | Dysmenorrhea, Hematuna, Kidney function abnormal, Vaginitis |
For more information about: Ciprofloxacin 1000 mg Extended Release Film Coated Tablets – view the leaflet by clicking the link here.
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ATC code: J01MA02