Ciprogem® Ciprofloxacin Lacquer-coated tablets Broad spectrum antibiotic
Composition, Microbiology, Clinical Pharmacology, Indications, Contraindications, Restriction on use, Side effects, Warning to drivers, Interactions, Dosage, Administration, Warning, Precaution and pack size and Maker of Ciprogem Tablet Medicine for Infections.
1 lacquer-coated tablet contains 582mg ciprofloxacin hydrochloride. H20, corresponding to 500 mg ciprofloxacin.
Ciprogem has a strong antibacterial action against a broad spectrum of bacteria. It prevents transcription by the chromosome (genetic material) of the information needed for the normal metabolism of bacteria. This leads to a rapid decrease in the ability of bacteria to reproduce.
Ciprogem is also characterised by the fact that, as a result of its particular mode of action, it does not generally exhibit parallel resistance to any other antibiotic outside the gyrase inhibitor group.Therefore, Ciprogem is highly effective against bacteria which are resistant for example, to aminoglycosides, penicillins, cephalosporins. tetracyclines and other antibiotics.
The absolute bioavailability of Ciprogem is 70-80%. The maximum blood concentration is reached just 60-90 minutes after ingestion.
Ciprogem is present in high concentrations at the sites of infections, i.e. in the body fluids and tissues.
It only needs to be taken twice daily, in the morning and evening.
Infections caused by pathogens which are sensitive to ciprofloxacin:
— of the respiratory tract. In the treatment of outpatients with pneumonia due to Pneumococcus. Ciprogem should not be used as a first choice of drug. Ciprogem can be regarded as an advisable treatment for pneumonias caused by klebsiella, Enterobacter, Proteus, Pseudomonas, Haemophilus, Branhamella, Lagionella, end Staphylococcus.
— of the middle ear (otitis media), of the paranasal sinuses (sinusitis), especially if these are caused by gramnegative organisms including Pseudomonas or by staphylococcus.
— of the eyes
— of the kidneys and/or urinary tract
— of the reproductive organs, including gonorrhoea
— of the abdominal cavity (e.g. bacterial infections of the gastro-intestinal tract, billiary tract, peritonitis)
— of the skin and soft tissue
— of the bones and joints
Infections, or imminent risk of infection (prophylaxis), in immuno-compromised patients (e.g. those treated with immuno-suppressants, patients with neutropenia).
Administration for selective intestinal decontamination in patients treated with immuno – suppressants Ciprogem has a bactericidal action. As a result of in-vitro investigations, the following pathogens may be regarded as sensitive to ciprogem:
E.Coli, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia, Hafnia, Edwardsiella, Proteus (indole-positive and indole-negative), Providencia, Morganella, Yersina; Vibro, Aeromonas, Plesiomonas, Pasteurella, Haemophilus, Campylobacter, Pseudomonas, Legionella, Neisseria. Moraxella, Branhamella, Acinetobacter, Brucella; Staphylococcus agalactiae, Listeria, Corynebacterium,
The following are sensitive in varying degrees:
Gardnerella, Flavobacterium, Alcaligenes, Streptococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans, Mycoplasma hominis, Mycobacterium tuberculosis and Mycobacterium fortuitum.
The following are generally resistant:
Streptococcus faecium,Ureaplasma urealyticum, Nocardia asteriodes.
Anaerobes, apart from a few exceptions, vary from being moderately sensitive (e.g. Peptococcus, Peptostreptococcus) to resistant (e.g. Bacteroides).
Ciprogem is not active against Treponema pallidum.
Ciprogem should not be used where there is hypersensitivity to ciprofloxacin or to other chemotherapeutic agents of the quinolone group.
Ciprogem should not be prescribed to children, growing adolescents and pregnant or nursing women, as there is no evidence of its safety when used in these groups and, on the basis of results from animal experiments, injury to the articular cartillage of an organism which is not fully grown cannot be completely ruled out. Animal experiments have not shown any evidence of teratogenic effects (malformations).
Restrictions on use
Ciprogem should be used with caution in the elderly. In epileptics and in patients who have suffered from previous CNS – disorders (e.g. lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure or stroke),
Ciprogem should only be used where the benefits of treatment exceed the risks, since these patients are endangered because of possible central-nervous side effects.
The following side-effects have been observed:
— Effects on the gastro – intestinal tract.
Nausea, diarrhoea, vomiting, digestive disorders, abdominal pain, flatulence, anorexia. The doctor should be advised of any severe or persistent diarrhoea occurring during, or after treatment, since these symptoms could conceal a serious intestinal disorder (pseudomembranous colitis) requiring urgent treatment in such cases, Ciprogem should be discontinued and replaced by another appropriate drug (e.g. vancomycin orally, 4 x 250 mg /day). Preparations which inhibit peristalsis are contra-Indicated.
— Effects on the nervous system.
Dizziness, headache, tiredness, insomnia, agitation, trembling; very rarely; peripheral paralgesia, sweating, unsteady gait, convulsion, anxiety states, nightmares, confusion, depression, hallucinations impaired taste and smell, visual disturbances (e.g-double vision, colour vision). In some instances, these reactions occurred after the first administration of Ciprogem already. In these cases Ciprogem has to be discontinued and the doctor should be informed immediately.
— Hypersensitivity reactions
Skin reactions, e.g. Rashes.
— Pruritus, drug fever
(e.g. facial vascular and laryngeal oedema; dyspnoea progressing to life – threatening shock), in these cases Ciprogem has to be discontinued, medical treatment (e.g. treatment for shock) is required.
— Punctate skin haemorrhages (petechiea), blister formation with accompanying haemorrhages (haemorrhagic bullae) and swell nodules (papules) with crust formation showing vascular involvement (vasculitis), Steven-Johnson-syndrome, intestinal nephritis, hepatitis; very rarely major liver disorders including hepatic necrosis.
— Effects on the cardiovascular system
Very rarely; tachycardia hot flushes, migraine, fainting.
Very rarely: joint pains, general feeling of weakness, muscular pains, tendovaginitis, wild photosensitivity, transient impairment in kidney function, including transient kidney failure, tinnitus, transitory impairment of hearing, especially at high frequencies.
— Effects on blood and blood constituents
Eosinophillia, leucocytopenia, leucocytosis, anaemia; very rarely: thrombocytopenia, thrombocytosis, altered prothrombin levels.
— Effect on laboratory values/urine deposits.
There may be a transient rise in the transaminase and alkaline phosphatase levels, or cholestatic jaundice may occur, particularly in patients with previous liver damage; transient increase in serum urea, creatinine and bilirubin levels, hyperglycaemia; in individual cases: crystalluria and haematuria.
Warning to drivers
Even when taken as prescribed, this drug can alter patients’ responsiveness, imparing the ability to drive or operate machinery. This is even more applicable when the drug is taken in conjunction with alcohol.
Drugs which affect the acidity of the stomach (antacids) containing aluminium hydroxide or magnesium hydroxide reduce the uptake (absorption) of Ciprogem. Consequently, Ciprogem should be taken either 1-2 hours before, or at least 4 hours after the antacid. This restriction does not apply to antacids which do not contain aluminum or magnesium hydroxide (e.g. H2– receptor blockers). The simultaneous administration of Ciprogem and theophylline can lead to an unwanted increase in the serum theophylline concentration, thereby producing theophylline – induced side-effects. If the concomitant administration of these two drugs is unavailable, the serum concentration of theophylline should be checked and its dosage reduced accordingly.
Animal experiments have indicated that the combination of very high doses of quinolones (gyrase inhibitors) with certain non-steroidal anti-inflammatory drugs (e.g. fenbufen; but not acetylsalicylic acid) can lead to convulsions.
However, these interactions have not been observed in patients taking Ciprogem.
A transient rise in the concentration of serum creatinine was observed when Ciprogem and Cyclosporin were administered simultaneously. Therefore, it is necessary to control the serum creatinine concentrations in these patients frequently (twice a week).
Unless prescribed otherwise, the following doses are recommended:
Infections of the lower and upper urinary tract 2 x 250 mg/500 mg per day
Complicated infections of the urinary tract (depending on severity) 2 x 500 mg per day
Infections of the respiratory tract y (e.g. Bronchitis) 2 x 500 mg per day
Other infections (cf. indications) 2 x 500mg per day
In particularly severe infections, e.g. recurrent infections in patients with mucoviszidosis, pneumonias, infections of the abdominal cavity, bones and joint caused by Pseudomonas, Staphylococcus or Streptococcus pneumoniae, the daily dosage has to be increased 2 x 750mg (oral) where the patient is not being treated intravenously.
Acute gonorrhoea and acute uncomplicated crystitis in women can be treated with a single dose of 500mg.
Elderly patients should receive as low a dose as possible, taking into account the severity of the illness and the creatinine clearance.
If, due to the severity of the disease or for any other reason, the patient is unable to swallow the lacquer – coated tablets, it is recommended that treatment with intravenous ciprofloxacin be initiated.
Restricted kidney and liver function
1. Restricted kidney function Creatinine clearance <20ml / min – Serum creatinine >3 mg /100 ml: half the normal dose twice daily or the full normal dose once a day.
2. Restricted kidney function + haemodialysis. Dosage as for 1, on dialysis days after dialysis.
3. Restricted liver function – No dosage adjustment required.
4. Restricted kidney and liver function levels. Dosage adjustment as for 1, possibly check Ciprogem serum levels
The tablets should be taken whole with a little fluid. They do not need to be taken at meal times. Absorption of the drug is accelerated if taken on an empty stomach.
The treatment period depends upon the severity and the clinical courses of the illness and bacteriological results. Essentially, treatment should be continued for at least 3 days after the temperature has returned to normal and / or the clinical symptoms have disappeared.
Average treatment period:
1 day for acute gonorrhoea, up to 7 days for infections of the kidneys, urinary tract and abdominal cavity, throughout the entire neutropenic phase in immuno – compromised patients, a maximum of 2 months for osteomyelitis and 7-14 days for all other infections.
Treatment should continue for a maximum of 10 days in streptococcal infections owing to the risk of late complications.
Ciprogem should not be administered after the expiry date.
Keep medicines out of the reach of children.
Presentation and pack size
Packs containing 10 and 50 lacquer – coated tablets.
Gemini Pharmaceuticals Nigeria Ltd.,
Plot 13, Block A, Industrial Estate,
Amuwo-Odofin, Lagos, Nigeria