Ciprofloxacin Tablets USP 750mg Taj Pharma

  1. Name of the medicinal product

Ciprofloxacin Tablets USP 250mg Taj Pharma
Ciprofloxacin Tablets USP 500mg Taj Pharma
Ciprofloxacin Tablets USP 750mg Taj Pharma

  1. Qualitative and quantitative composition

a) Ciprofloxacin Tablets USP 250mg Taj Pharma
Each film-coated tablet contains:
Ciprofloxacin hydrochloride USP
Equivalent to Ciprofloxacin USP 250mg
Excipients: Q.S.

b) Ciprofloxacin Tablets USP 500mg Taj Pharma
Each film-coated tablet contains:
Ciprofloxacin hydrochloride USP
Equivalent to Ciprofloxacin USP 500mg
Excipients: Q.S.

c) Ciprofloxacin Tablets USP 750mg Taj Pharma
Each film-coated tablet contains:
Ciprofloxacin hydrochloride USP
Equivalent to Ciprofloxacin USP 750mg
Excipients: Q.S.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film-coated tablet.

White to off white, round shaped  film coated tablets

  1. Clinical particulars
  • Therapeutic indications

Ciprofloxacin Taj Pharma film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to Ciprofloxacin Taj Pharma before commencing therapy.

Adults

  • Lower respiratory tract infections due to Gram-negative bacteria
  • pneumonia
  • broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
  • Chronic suppurative otitis media
  • Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria
  • Acute pyelonephritis
  • Complicated urinary tract infections
  • Bacterial prostatitis
  • Genital tract infections
  • gonococcal urethritis and cervicitis due to susceptible Neisseria gonorrhoeae
  • epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae
  • pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae
  • Intra-abdominal infections
  • Infections of the skin and soft tissue caused by Gram-negative bacteria
  • Infections of the bones and joints
  • Inhalation anthrax (post-exposure prophylaxis and curative treatment)

Ciprofloxacin Taj Pharma may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

In exacerbations of chronic obstructive pulmonary disease Ciprofloxacin Taj Pharma should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

In uncomplicated acute cystitis Ciprofloxacin Taj Pharma should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

Children and adolescents

  • Broncho-pulmonary infections due to Pseudomonas aeruginosain patients with cystic fibrosis
  • Complicated urinary tract infections and acute pyelonephritis
  • Inhalation anthrax (post-exposure prophylaxis and curative treatment)

Ciprofloxacin Taj Pharma may also be used to treat severe infections in children and adolescents when this is considered to be necessary.

Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

  • Posology and method of administration

Posology

The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to Ciprofloxacin Taj Pharma of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.

The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.

Treatment of infections due to certain bacteria (e.g. Pseudomonas aeruginosaAcinetobacter or Staphylococci) may require higher Ciprofloxacin Taj Pharma doses and co-administration with other appropriate antibacterial agents.

Treatment of some infections (e.g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.

Adults

Indications Daily dose inmg Total duration of treatment (potentially including initial parenteral treatment with Ciprofloxacin Taj Pharma)
Infections of the lower respiratory tract 500mg twice daily to 750mg twice daily 7 to 14 days
Infections of the upper respiratory tract Acute exacerbation of chronic sinusitis 500mg twice daily to 750mg twice daily 7 to 14 days
Chronic suppurative otitis media 500mg twice daily to 750mg twice daily 7 to 14 days
Malignant external otitis 750mg twice daily 28 days up to 3 months
Urinary tract infections (see section 4.4) Uncomplicated cystitis 250mg twice daily to 500mg twice daily 3 days
In pre-menopausal women, 500mg single dose may be used
Complicated cystitis, Uncomplicated pyelonephritis 500mg twice daily 7 days
Complicated pyelonephritis 500mg twice daily to 750mg twice daily at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)
Prostatitis 500mg twice daily to 750mg twice daily 2 to 4 weeks (acute) to 4 to 6 weeks (chronic)
Genital tract infections Gonococcal uretritis and cervicitis 500mg as a single dose 1 day (single dose)
Epididymo-orchitis and pelvic inflammatory diseases 500mg twice daily to 750mg twice daily at least 14 days
Infections of the gastro-intestinal tract and intra-abdominal infections Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea 500mg twice daily 1 day
Diarrhoea caused by Shigella dysenteriae type 1 500mg twice daily 5 days
Diarrhoea caused by Vibrio cholerae 500mg twice daily 3 days
Typhoid fever 500mg twice daily 7 days
Intra-abdominal infections due to Gram-negative bacteria 500mg twice daily to 750mg twice daily 5 to 14 days
Infections of the skin and soft tissue 500mg twice daily to 750mg twice daily 7 to 14 days
Bone and joint infections 500mg twice daily to 750mg twice daily max. of 3 months
Neutropenic patients with fever that is suspected to be due to a bacterial infection. Ciprofloxacin Taj Pharma should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance. 500mg twice daily to 750mg twice daily Therapy should be continued over the entire period of neutropenia
Prophylaxis of invasive infections due to Neisseria meningitides 500mg as a single dose 1 day (single dose)
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.

Drug administration should begin as soon as possible after suspected or confirmed exposure.

500mg twice daily 60 days from the confirmation of Bacillus anthracis exposure

Paediatric population

Indications Daily dose inmg Total duration of treatment (potentially including initial parenteral treatment with Ciprofloxacin Taj Pharma)
Cystic fibrosis 20mg/kg body weight twice daily with a maximum of 750mg per dose. 10 to 14 days
Complicated urinary tract infections and pyelonephritis 10mg/kg body weight twice daily to 20mg/kg body weight twice daily with a maximum of 750mg per dose. 10 to 21 days
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure. 10mg/kg body weight twice daily to 15mg/kg body weight twice daily with a maximum of 500mg per dose. 60 days from the confirmation of Bacillus anthracis exposure
Other severe infections 20mg/kg body weight twice daily with a maximum of 750mg per dose. According to the type of infections

Elderly patients

Elderly patients should receive a dose selected according to the severity of the infection and the patient’s creatinine clearance.

Patients with renal and hepatic impairment

Recommended starting and maintenance doses for patients with impaired renal function:

Creatinine Clearance [mL/min/1.73 m2] Serum Creatinine [μmol/L] Oral Dose [mg]
> 60 < 124 See Usual Dosage.
30-60 124 to 168 250-500mg every 12 h
<30 > 169 250-500mg every 24 h
Patients on haemodialysis > 169 250-500mg every 24 h (after dialysis)
Patients on peritoneal dialysis > 169 250-500mg every 24 h

In patients with impaired liver function no dose adjustment is required.

Dosing in children with impaired renal and/or hepatic function has not been studied.

Method of administration

Tablets are to be swallowed unchewed with fluid. They can be taken independent of mealtimes. If taken on an empty stomach, the active substance is absorbed more rapidly. Ciprofloxacin Taj Pharma tablets should not be taken with dairy products (e.g. milk, yoghurt) or mineral-fortified fruit-juice (e.g. calcium-fortified orange juice) (see section 4.5).

In severe cases or if the patient is unable to take tablets (e.g. patients on enteral nutrition), it is recommended to commence therapy with intravenous Ciprofloxacin Taj Pharma until a switch to oral administration is possible.

  • Contraindications
  • Hypersensitivity to the active substance, to other quinolones or to any of the excipients listed in section 6.1.
  • Concomitant administration of Ciprofloxacin Taj Pharma and tizanidine (see section 4.5).
  • Special warnings and precautions for use

The use of Ciprofloxacin Taj Pharma should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment of these patients with Ciprofloxacin Taj Pharma should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).

Prolonged, disabling and potentially irreversible serious adverse drug reactions

Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors. Ciprofloxacin Taj Pharma should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.

Severe infections and mixed infections with Gram-positive and anaerobic pathogens

Ciprofloxacin Taj Pharma monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens. In such infections Ciprofloxacin Taj Pharma must be co-administered with other appropriate antibacterial agents.

Streptococcal Infections (including Streptococcus pneumoniae)

Ciprofloxacin Taj Pharma is not recommended for the treatment of streptococcal infections due to inadequate efficacy.

Genital tract infections

Gonococcal uretritis, cervicitis, epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates.

Therefore, Ciprofloxacin Taj Pharma should be adminstered for the treatment of gonococcal uretritis or cervicitis only if Ciprofloxacin Taj Pharma-resistant Neisseria gonorrhoeae can be excluded.

For epididymo-orchitis and pelvic inflammatory diseases, empirical Ciprofloxacin Taj Pharma should only be considered in combination with another appropriate antibacterial agent (e.g. a cephalosporin) unless Ciprofloxacin Taj Pharma resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.

Urinary tract infections

Resistance to fluoroquinolones of Escherichia coli – the most common pathogen involved in urinary tract infections – varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to quinolones.

The single dose of Ciprofloxacin Taj Pharma that may be used in uncomplicated cystitis in pre-menopausal women is expected to be associated with lower efficacy than the longer treatment duration. This is all the more to be taken into account as regards the increasing resistance level of Escherichia coli to quinolones.

Intra-abdominal infections

There are limited data on the efficacy of Ciprofloxacin Taj Pharma in the treatment of post-surgical intra-abdominal infections.

Travellers’ diarrhoea

The choice of Ciprofloxacin Taj Pharma should take into account information on resistance to Ciprofloxacin Taj Pharma in relevant pathogens in the countries visited.

Infections of the bones and joints

Ciprofloxacin Taj Pharma should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.

Inhalational anthrax

Use in humans is based on in-vitro susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.

Paediatric population

The use of Ciprofloxacin Taj Pharma in children and adolescents should follow available official guidance. Ciprofloxacin Taj Pharma treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.

Ciprofloxacin Taj Pharma has been shown to cause arthropathy in weight-bearing joints of immature animals. Safety data from a randomised double-blind study on Ciprofloxacin Taj Pharma use in children (Ciprofloxacin Taj Pharma: n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years) revealed an incidence of suspected drug-related arthropathy (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%. Respectively, an incidence of drug-related arthropathy by 1-year follow-up was 9.0% and 5.7%. The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups. Treatment should be initiated only after a careful benefit/risk evaluation, due to possible adverse events related to joints and/or surrounding tissue (see section 4.8)..

Broncho-pulmonary infections in cystic fibrosis

Clinical trials have included children and adolescents aged 5-17 years. More limited experience is available in treating children between 1 and 5 years of age.

Complicated urinary tract infections and pyelonephritis

Ciprofloxacin Taj Pharma treatment of urinary tract infections should be considered when other treatments cannot be used, and should be based on the results of the microbiological documentation.

Clinical trials have included children and adolescents aged 1-17 years.

Other specific severe infections

Other severe infections in accordance with official guidance, or after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a Ciprofloxacin Taj Pharma use.

The use of Ciprofloxacin Taj Pharma for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited. Consequently, caution is advised when treating patients with these infections.

Hypersensitivity

Hypersensitivity and allergic reactions, including anaphylaxis and anaphylactoid reactions, may occur following a single dose (see section 4.8) and may be life-threatening. If such reaction occurs, Ciprofloxacin Taj Pharma should be discontinued and an adequate medical treatment is required.

Musculoskeletal System

Ciprofloxacin Taj Pharma should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment. Nevertheless, in very rare instances, after microbiological documentation of the causative organism and evaluation of the risk/benefit balance, Ciprofloxacin Taj Pharma may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where the microbiological data may justify the use of Ciprofloxacin Taj Pharma.

Tendinitis and tendon rupture

Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided.

At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with Ciprofloxacin Taj Pharma should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.Ciprofloxacin Taj Pharma should be used with caution in patients with myasthenia gravis, because symptoms can be exacerbated (see section 4.8).

Vision disorders

If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.

Photosensitivity

Ciprofloxacin Taj Pharma has been shown to cause photosensitivity reactions. Patients taking Ciprofloxacin Taj Pharma should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment (see section 4.8).

Central Nervous System

Ciprofloxacin Taj Pharma like other quinolones are known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported. Ciprofloxacin Taj Pharma should be used with caution in patients with CNS disorders which may be predisposed to seizure. If seizures occur Ciprofloxacin Taj Pharma should be discontinued (see section 4.8). Psychiatric reactions may occur even after the first administration of Ciprofloxacin Taj Pharma. In rare cases, depression or psychosis can progress to suicidal ideations/thoughts culminating in attempted suicide or completed suicide. In the occurrence of such cases, Ciprofloxacin Taj Pharma should be discontinued.

Peripheral neuropathy

Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with Ciprofloxacin Taj Pharma should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition (see section 4.8).

Cardiac disorders

Caution should be taken when using fluoroquinolones, including Ciprofloxacin Taj Pharma, in patients with known risk factors for prolongation of the QT interval such as, for example:

  • congenital long QT syndrome
  • concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics)
  • uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia)
  • cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)

Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including Ciprofloxacin Taj Pharma, in these populations. (See section 4.2 Elderly patients, section 4.5, section 4.8, section 4.9).

Dysglycaemia

As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or with insulin. Cases of hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).

Gastrointestinal System

The occurrence of severe and persistent diarrhoea during or after treatment (including several weeks after treatment) may indicate an antibiotic-associated colitis (life-threatening with possible fatal outcome), requiring immediate treatment (see section 4.8). In such cases, Ciprofloxacin Taj Pharma should immediately be discontinued, and an appropriate therapy initiated. Anti-peristaltic drugs are contraindicated in this situation.

Renal and urinary system

Crystalluria related to the use of Ciprofloxacin Taj Pharma has been reported (see section 4.8). Patients receiving Ciprofloxacin Taj Pharma should be well hydrated and excessive alkalinity of the urine should be avoided.

Impaired renal function

Since Ciprofloxacin Taj Pharma is largely excreted unchanged via renal pathway dose adjustment is needed in patients with impaired renal function as described in section 4.2 to avoid an increase in adverse drug reactions due to accumulation of Ciprofloxacin Taj Pharma.

Hepatobiliary system

Cases of hepatic necrosis and life-threatening hepatic failure have been reported with Ciprofloxacin Taj Pharma (see section 4.8). In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued.

Glucose-6-phosphate dehydrogenase deficiency

Haemolytic reactions have been reported with Ciprofloxacin Taj Pharma in patients with glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin Taj Pharma should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk. In this case, potential occurrence of haemolysis should be monitored.

Resistance

During or following a course of treatment with Ciprofloxacin Taj Pharma bacteria that demonstrate resistance to Ciprofloxacin Taj Pharma may be isolated, with or without a clinically apparent superinfection. There may be a particular risk of selecting for Ciprofloxacin Taj Pharma-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.

Cytochrome P450

Ciprofloxacin Taj Pharma inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine). Co-administration of Ciprofloxacin Taj Pharma and tizanidine is contra-indicated. Therefore, patients taking these substances concomitantly with Ciprofloxacin Taj Pharma should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e.g. of theophylline) may be necessary (see section 4.5).

Methotrexate

The concomitant use of Ciprofloxacin Taj Pharma with methotrexate is not recommended (see section 4.5).

Interaction with tests

The in-vitro activity of Ciprofloxacin Taj Pharma against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking Ciprofloxacin Taj Pharma.

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 (e.g. 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.

Sodium

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

Interaction with other medicinal products and other forms of interaction

Effects of other products on Ciprofloxacin Taj Pharma:

Drugs known to prolong QT interval

Ciprofloxacin Taj Pharma, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section 4.4).

Chelation Complex Formation

The simultaneous administration of Ciprofloxacin Taj Pharma (oral) and multivalent cation-containing drugs and mineral supplements (e.g. calcium, magnesium, aluminium, iron), polymeric phosphate binders (e.g. sevelamer or lanthanum carbonate), sucralfate or antacids, and highly buffered drugs (e.g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of Ciprofloxacin Taj Pharma. Consequently, Ciprofloxacin Taj Pharma should be administered either 1-2 hours before or at least 4 hours after these preparations. The restriction does not apply to antacids belonging to the class of H2 receptor blockers.

Food and Dairy Products

Dietary calcium as part of a meal does not significantly affect absorption. However, the concurrent administration of dairy products or mineral-fortified drinks alone (e.g. milk, yoghurt, calcium-fortified orange juice) with Ciprofloxacin Taj Pharma should be avoided because absorption of Ciprofloxacin Taj Pharma may be reduced.

Probenecid

Probenecid interferes with renal secretion of Ciprofloxacin Taj Pharma. Co-administration of probenecid and Ciprofloxacin Taj Pharma increases Ciprofloxacin Taj Pharma serum concentrations.

Metoclopramide

Metoclopramide accelerates the absorption of Ciprofloxacin Taj Pharma (oral) resulting in a shorter time to reach maximum plasma concentrations. No effect was seen on the bioavailability of Ciprofloxacin Taj Pharma.

Omeprazole

Concomitant administration of Ciprofloxacin Taj Pharma and omeprazole containing medicinal products results in a slight reduction of Cmax and AUC of Ciprofloxacin Taj Pharma.

Effects of Ciprofloxacin Taj Pharma on other medicinal products:

Agomelatine

In clinical studies, it was demonstrated that fluvoxamine, as a strong inhibitor of the CYP450 1A2 isoenzyme, markedly inhibits the metabolism of agomelatine resulting in a 60-fold increase of agomelatine exposure. Although no clinical data are available for a possible interaction with Ciprofloxacin Taj Pharma, a moderate inhibitor of CYP450 1A2, similar effects can be expected upon concomitant administration (see ‘Cytochrome P450’ in section 4.4).

Tizanidine

Tizanidine must not be administered together with Ciprofloxacin Taj Pharma (see section 4.3). In a clinical study with healthy subjects, there was an increase in serum tizanidine concentration (Cmax increase: 7-fold, range: 4 to 21-fold; AUC increase: 10-fold, range: 6 to 24-fold) when given concomitantly with Ciprofloxacin Taj Pharma. Increased serum tizanidine concentration is associated with a potentiated hypotensive and sedative effect.

Methotrexate

Renal tubular transport of methotrexate may be inhibited by concomitant administration of Ciprofloxacin Taj Pharma, potentially leading to increased plasma levels of methotrexate and increased risk of methotrexate-associated toxic reactions. The concomitant use is not recommended (see section 4.4).

Theophylline

Concurrent administration of Ciprofloxacin Taj Pharma and theophylline can cause an undesirable increase in serum theophylline concentration. This can lead to theophylline-induced side effects that may rarely be life threatening or fatal. During the combination, serum theophylline concentrations should be checked and the theophylline dose reduced as necessary (see section 4.4).

Other xanthine derivatives

On concurrent administration of Ciprofloxacin Taj Pharma and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.

Phenytoin

Simultaneous administration of Ciprofloxacin Taj Pharma and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.

Cyclosporin

A transient rise in the concentration of serum creatinine was observed when Ciprofloxacin Taj Pharma and cyclosporin containing medicinal products were administered simultaneously. Therefore, it is frequently (twice a week) necessary to control the serum creatinine concentrations in these patients.

Vitamin K antagonists

Simultaneous administration of Ciprofloxacin Taj Pharma with a vitamin K antagonist may augment its anti-coagulant effects. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of Ciprofloxacin Taj Pharmato the increase in INR (international normalised ratio) is difficult to assess. The INR should be monitored frequently during and shortly after co-administration of Ciprofloxacin Taj Pharma with a vitamin K antagonist (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione).

Duloxetine

In clinical studies, it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in an increase of AUC and Cmax of duloxetine. Although no clinical data are available on a possible interaction with Ciprofloxacin Taj Pharma, similar effects can be expected upon concomitant administration (see section 4.4).

Ropinirole

It was shown in a clinical study that concomitant use of ropinirole with Ciprofloxacin Taj Pharma, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively. Monitoring of ropinirole-related side effects and dose adjustment as appropriate is recommended during and shortly after co-administration with Ciprofloxacin Taj Pharma (see section 4.4).

Lidocaine

It was demonstrated in healthy subjects that concomitant use of lidocaine containing medicinal products with Ciprofloxacin Taj Pharma, a moderate inhibitor of CYP450 1A2 isozyme, reduces clearance of intravenous lidocaine by 22%. Although lidocaine treatment was well tolerated, a possible interaction with Ciprofloxacin Taj Pharma associated with side effects may occur upon concomitant administration.

Clozapine

Following concomitant administration of 250mg Ciprofloxacin Taj Pharma with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after coadministration with Ciprofloxacin Taj Pharma are advised (see section 4.4).

Sildenafil

Cmax and AUC of sildenafil were increased approximately twofold in healthy subjects after an oral dose of 50mg given concomitantly with 500mg Ciprofloxacin Taj Pharma. Therefore, caution should be used prescribing Ciprofloxacin Taj Pharma concomitantly with sildenafil taking into consideration the risks and the benefits.

Zolpidem

Co-administration of Ciprofloxacin Taj Pharma may increase blood levels of zolpidem, concurrent use is not recommended.

Pregnancy and lactation

Pregnancy

The data that are available on administration of Ciprofloxacin Taj Pharma to pregnant women indicates no malformative or feto/neonatal toxicity of Ciprofloxacin Taj Pharma. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism / foetus (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Ciprofloxacin Taj Pharma during pregnancy.

Breast-feeding

Ciprofloxacin Taj Pharma is excreted in breast milk. Due to the potential risk of articular damage, Ciprofloxacin Taj Pharma should not be used during breast-feeding.

Effects on ability to drive and use machines

Due to its neurological effects, Ciprofloxacin Taj Pharma may affect reaction time. Thus, the ability to drive or to operate machinery may be impaired.

Undesirable effects

The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.

ADRs derived from clinical studies and post-marketing surveillance with Ciprofloxacin Taj Pharma (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below. The frequency analysis takes into account data from both oral and intravenous administration of Ciprofloxacin Taj Pharma.

System Organ Class Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1 000 to < 1/100 Rare ≥ 1/10 000 to < 1/1 000 Very Rare < 1/10 000` Frequency not known (cannot be estimated from available data)
Infections and Infestations Mycotic superinfections
Blood and Lymphatic System Disorders Eosinophilia Leukopenia

Anaemia

Neutropenia

Leukocytosis

Thrombocytopenia

Thrombocytaemia

Haemolytic anaemia

Agranulocytosis

Pancytopenia (lifethreatening)

Bone marrow depression (life threatening)

Immune System Disorders Allergic reaction

Allergic oedema / angiooedema

Anaphylactic reaction

Anaphylactic shock (lifethreatening) (see section 4.4)

Serum sickness like reaction

Endocrine disorders Syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
Metabolism and Nutrition Disorders Decreased appetite Hyperglycaemia

Hypoglycaemia

Hypoglycaemic coma (see section 4.4)

Psychiatric Disorders* Psychomotor hyperactivity / agitation Confusion and disorientation

Anxiety reaction

Abnormal dreams

Depression(potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

Hallucinations

Psychotic reactions (potentially culminating in suicidal ideations/ thoughts or suicide attempts and completed suicide) (see section 4.4) Mania, incl. hypomania
Nervous System Disorders* Headache

Dizziness

Sleep disorders

Taste disorders

Par- and Dysaesthesia

Hypoaesthesia

Tremor

Seizures (including status epilepticus see section 4.4)

Vertigo

Migraine

Disturbed coordination

Gait disturbance

Olfactory nerve disorders

Intracranial hypertension and pseudotumor cerebri

Peripheral neuropathy and polyneuropathy (see section 4.4)
Eye Disorders* Visual disturbances(e.g. diplopia) Visual colour distortions
Ear and Labyrinth Disorders* Tinnitus,

Hearing loss / Hearing impaired

Cardiac Disorders Tachycardia Ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation),

ECG QT prolonged (see sections 4.4 and 4.9)

Vascular Disorders Vasodilatation

Hypotension

Syncope

Vasculitis
Respiratory, Thoracic and Mediastinal Disorders Dyspnoea (including asthmatic condition)
Gastrointest inal Disorders Nausea

Diarrhoea

Vomiting

Gastrointestinal and abdominal pains,

Dyspepsia

Flatulence

Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4) Pancreatitis
Hepatobiliary Disorders Increase in transaminases

Increased bilirubin

Hepatic impairment

Cholestatic icterus

Hepatitis

Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
Skin and Subcutaneous Tissue Disorders Rash,

Pruritus

Urticaria

Photosensitivity reactions (see section 4.4) Petechiae

Erythema multiforme

Erythema nodosum

Stevens- Johnson Syndrome (potentially lifethreatening)

Toxic epidermal necrolysis (potentially life- threatening)

Acute generalised exanthematous pustulosis (AGEP), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Musculoskeletal and Connective Tissue Disorders* Musculoskeletal pain (e.g. extremity pain, back pain, chest pain),

Arthralgia

Myalgia,

Arthritis

Increased muscle tone and cramping

Muscular weakness

Tendinitis

Tendon rupture (predominantly Achilles tendon) (see section 4.4)

Exacerbation of symptoms of myasthenia gravis (see section 4.4)

Renal and Urinary Disorders Renal impairment Renal failure

Haematuria

Crystalluria (see section 4.4)

Tubulointerstitial nephritis

General Disorders and Administration Site Conditions* Asthenia

Fever

Oedema,

Sweating (hyperhidrosis)

Investigations Increase in blood alkaline phosphatase Increased amylase International normalized ratio increased (in patients treated with Vitamin K antagonists)

*Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see Section 4.4).

Paediatric population

The incidence of arthropathy (arthralgia, arthritis), mentioned above, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16 g has been reported to cause acute renal failure.

Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria. Reversible renal toxicity has been reported.

Apart from routine emergency measures, e.g. ventricular emptying followed by medical carbon it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria. Patients should be kept well hydrated. Calcium or magnesium containing antacids may theoretically reduce the absorption of Ciprofloxacin Taj Pharma in overdoses.

Only a small quantity of Ciprofloxacin Taj Pharma (<10%) is eliminated by haemodialysis or peritoneal dialysis.

In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.

  1. Pharmacological properties

Pharmacodynamic properties

Pharmacotherapeutic group: Fluoroquinolones,

Mechanism of action:

As a fluoroquinolone antibacterial agent, the bactericidal action of Ciprofloxacin Taj Pharma results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.

Pharmacokinetic /Pharmacodynamic relationship:

Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of Ciprofloxacin Taj Pharma for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.

Mechanism of resistance:

In-vitro resistance to Ciprofloxacin Taj Pharma can be acquired through a stepwise process by target site mutations in both DNA gyrase and topoisomerase IV. The degree of cross-resistance between Ciprofloxacin Taj Pharma and other fluoroquinolones that results is variable. Single mutations may not result in clinical resistance, but multiple mutations generally result in clinical resistance to many or all active substances within the class.

Impermeability and/or active substance efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance. All in-vitro mechanisms of resistance are commonly observed in clinical isolates. Resistance mechanisms that inactivate other antibiotics such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may affect susceptibility to Ciprofloxacin Taj Pharma. Plasmid-mediated resistance encoded by qnr-genes has been reported.

Spectrum of antibacterial activity:

Breakpoints separate susceptible strains from strains with intermediate susceptibility and the latter from resistant strains:

EUCAST Recommendations

Microorganisms Susceptible Resistant
Enterobacteriaceae S ≤ 0.5mg/L R > 1mg/ L
Pseudomonas spp. S ≤ 0.5mg/L R > 1mg/ L
Acinetobacter spp. S ≤ 1mg/L R > 1mg/ L
Staphylococcus spp.1 S ≤ 1mg/L R >1mg/L
Haemophilus influenzae and Moraxella catarrhalis S ≤ 0.5mg/L R > 0.5mg/L
Neisseria gonorrhoeae S ≤0.03mg/L R > 0.06mg/L
Neisseria meningitidis S ≤0.03mg/L R > 0.06mg/L
Non-species-related breakpoints* S ≤0.5mg/L R > 1mg/ L

1 Staphylococcus spp. – breakpoints for Ciprofloxacin Taj Pharma relate to high dose therapy.

* Non-species-related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species. They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended.

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Groupings of relevant species according to Ciprofloxacin Taj Pharma susceptibility (for Streptococcus species see section 4.4)

COMMONLY SUSCEPTIBLE SPECIES
Aerobic Gram-positive micro-organisms

Bacillus anthracis (1)

Aerobic Gram-negative micro-organisms

Aeromonas spp.

Brucella spp.

Citrobacter koseri

Francisella tularensis

Haemophilus ducreyi

Haemophilus influenzae*

Legionella spp.

Moraxella catarrhalis*

Neisseria meningitidis

Pasteurella spp.

Salmonella spp.*

Shigella spp.*

Vibrio spp.

Yersinia pestis

Anaerobic micro-organisms

Mobiluncus

Other micro-organisms

Chlamydia trachomatis ($)

Chlamydia pneumoniae ($)

Mycoplasma hominis ($)

Mycoplasma pneumoniae ($)

SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM
Aerobic Gram-positive micro-organisms

Enterococcus faecalis ($)

Staphylococcus spp. *(2)

Aerobic Gram-negative micro-organisms

Acinetobacter baumannii+

Burkholderia cepacia+*

Campylobacter spp.+*

Citrobacter freundii*

Enterobacter aerogenes

Enterobacter cloacae*

Escherichia coli*

Klebsiella oxytoca

Klebsiella pneumoniae*

Morganella morganii*

Neisseria gonorrhoeae*

Proteus mirabilis*

Proteus vulgaris*

Providencia spp.

Pseudomonas aeruginosa*

Pseudomonas fluorescens

Serratia marcescens*

Anaerobic micro-organisms

Peptostreptococcus spp.

Propionibacterium acnes

INHERENTLY RESISTANT ORGANISMS
Aerobic Gram-positive micro-organisms

Actinomyces

Enteroccus faecium

Listeria monocytogenes

Aerobic Gram-negative micro-organisms

Stenotrophomonas maltophilia

Anaerobic micro-organisms

Excepted as listed above

Other micro-organisms

Mycoplasma genitalium

Ureaplasma urealitycum

* Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications

+ Resistance rate ≥ 50% in one or more EU countries

($): Natural intermediate susceptibility in the absence of acquired mechanism of resistance

(1): Studies have been conducted in experimental animal infections due to inhalations of Bacillus anthracis spores; these studies reveal that antibiotics starting early after exposition avoid the occurrence of the disease if the treatment is made up to the decrease of the number of spores in the organism under the infective dose. The recommended use in human subjects is based primarily on in-vitro susceptibility and on animal experimental data together with limited human data. Two-month treatment duration in adults with oral Ciprofloxacin Taj Pharma given at the following dose, 500mg bid, is considered as effective to prevent anthrax infection in humans. The treating physician should refer to national and/or international consensus documents regarding treatment of anthrax.

(2): Methicillin-resistant S. aureus very commonly express co-resistance to fluoroquinolones. The rate of resistance to methicillin is around 20 to 50% among all staphylococcal species and is usually higher in nosocomial isolates.

Pharmacokinetic properties

Absorption

Following oral administration of single doses of 250mg, 500mg, and 750mg of Ciprofloxacin Taj Pharma tablets, Ciprofloxacin Taj Pharma is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later.

Single doses of 100-750mg produced dose-dependent maximum serum concentrations (Cmax) between 0.56 and 3.7mg/L. Serum concentrations increase proportionately with doses up to 1000mg.

The absolute bioavailability is approximately 70-80%.

A 500mg oral dose given every 12 hours has been shown to produce an area under the serum concentration-time curve (AUC) equivalent to that produced by an intravenous infusion of 400mg Ciprofloxacin Taj Pharma given over 60 minutes every 12 hours.

Distribution

Protein binding of Ciprofloxacin Taj Pharma is low (20-30%). Ciprofloxacin Taj Pharma is present in plasma largely in a non-ionised form and has a large steady state distribution volume of 2-3 L/kg body weight. Ciprofloxacin Taj Pharma reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflamed lesions (cantharides blister fluid), and the urogenital tract (urine, prostate, endometrium) where total concentrations exceeding those of plasma concentrations are reached.

Biotransformation

Low concentrations of four metabolites have been reported, which were identified as: desethyleneCiprofloxacin Taj Pharma (M 1), sulphoCiprofloxacin Taj Pharma (M 2), oxoCiprofloxacin Taj Pharma (M 3) and formylCiprofloxacin Taj Pharma (M 4). The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.

Ciprofloxacin Taj Pharma is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.

Elimination

Ciprofloxacin Taj Pharma is largely excreted unchanged both renally and, to a smaller extent, faecally. The serum elimination half-life in subjects with normal renal function is approximately 4-7 hours.

Excretion of Ciprofloxacin Taj Pharma (% of dose)
Oral Administration
Urine Faeces
Ciprofloxacin Taj Pharma 44.7 25.0
Metabolites (M1-M4) 11.3 7.5

Renal clearance is between 180-300 mL/kg/h and the total body clearance is between 480-600 mL/kg/h. Ciprofloxacin Taj Pharma undergoes both glomerular filtration and tubular secretion. Severely impaired renal function leads to increased half lives of Ciprofloxacin Taj Pharma of up to 12 h.

Non-renal clearance of Ciprofloxacin Taj Pharma is mainly due to active trans-intestinal secretion and metabolism. 1% of the dose is excreted via the biliary route. Ciprofloxacin Taj Pharma is present in the bile in high concentrations.

Paediatric patients

The pharmacokinetic data in paediatric patients are limited.

In a study in children Cmax and AUC were not age-dependent (above one year of age). No notable increase in Cmax and AUC upon multiple dosing (10mg/kg three times daily) was observed.

In 10 children with severe sepsis Cmax was 6.1mg/L (range 4.6-8.3mg/L) after a 1-hour intravenous infusion of 10mg/kg in children aged less than 1 year compared to 7.2mg/L (range 4.7-11.8mg/L) for children between 1 and 5 years of age. The AUC values were 17.4mg*h/L (range 11.8-32.0mg*h/L) and 16.5mg*h/L (range 11.0-23.8mg*h/L) in the respective age groups.

These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of paediatric patients with various infections, the predicted mean half-life in children is approx. 4-5 hours and the bioavailability of the oral suspension ranges from 50 to 80%.

Preclinical safety data

Non-clinical data reveal no special hazards for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential, or toxicity to reproduction.

Like a number of other quinolones, Ciprofloxacin Taj Pharma is phototoxic in animals at clinically relevant exposure levels. Data on photomutagenicity/photocarcinogenicity show a weak photomutagenic or phototumorigenic effect of Ciprofloxacin Taj Pharma in-vitro and in animal experiments. This effect was comparable to that of other gyrase inhibitors.

Articular tolerability:

As reported for other gyrase inhibitors, Ciprofloxacin Taj Pharma causes damage to the large weight-bearing joints in immature animals. The extent of the cartilage damage varies according to age, species and dose; the damage can be reduced by taking the weight off the joints. Studies with mature animals (rat, dog) revealed no evidence of cartilage lesions. In a study in young beagle dogs, Ciprofloxacin Taj Pharma caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.

  1. Pharmaceutical particulars

List of excipients

Tablet core:

Cellulose microcrystalline, Sodium starch glycolate (Type A), Povidone (K 30), Silica, colloidal anhydrous, Magnesium stearate

Film coating:

Hypromellose, Titanium dioxide, Macrogol 400

Incompatibilities

Not applicable.

Shelf life

4 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Ciprofloxacin Taj Pharma film-coated tablets are available in PVC/PVdC-Aluminum foil blister pack.

Pack sizes: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100 and 500 film-coated tablets

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

Ciprofloxacin Taj Pharma Tablets USP 750mg Taj Pharma

Package leaflet: Information for the user

(Ciprofloxacin Taj Pharma hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet

  1. What Ciprofloxacin Taj Pharma is and what it is used for
  2. What you need to know before you take Ciprofloxacin Taj Pharma
  3. How to take Ciprofloxacin Taj Pharma
  4. Possible side effects
  5. How to store Ciprofloxacin Taj Pharma
  6. Contents of the pack and other information

1. What Ciprofloxacin Taj Pharma is and what it is used for

Ciprofloxacin Taj Pharma is an antibiotic belonging to the fluoroquinolone family. The active substance is Ciprofloxacin Taj Pharma. Ciprofloxacin Taj Pharma works by killing bacteria that cause infections. It only works with specific strains of bacteria.

Adults

Ciprofloxacin Taj Pharma is used in adults to treat the following bacterial infections:

  • respiratory tract infections
  • long lasting sinus infections
  • complicated urinary tract infections
  • inflammation of kidney
  • inflammation of prostate gland due to bacterial infection
  • genital tract infections in men and women
  • intra-abdominal infections
  • skin and soft tissue infections
  • bone and joint infections
  • anthrax inhalation exposure

Ciprofloxacin Taj Pharma may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection.

If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin Taj Pharma.

Children and adolescents

Ciprofloxacin Taj Pharma is used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections:

  • lung and bronchial infections in children and adolescents suffering from cystic fibrosis
  • complicated urinary tract infections, including infections that have reached the kidneys (acute pyelonephritis)
  • anthrax inhalation exposure

Ciprofloxacin Taj Pharma may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.

  1. What you need to know before you take Ciprofloxacin Taj Pharma

Do not take Ciprofloxacin Taj Pharma:

  • if you are allergic to Ciprofloxacin Taj Pharma, to other quinolone drugs or to any of the other ingredients of this medicine (listed in section 6).
  • if you are taking tizanidine (see Section 2: Other medicines and Ciprofloxacin Taj Pharma)

Warnings and precautions

Talk to your doctor or pharmacist before taking Ciprofloxacin Taj Pharma.

  • You should not take fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin Taj Pharma, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.
  • if you have ever had kidney problems because your treatment may need to be adjusted
  • if you suffer from epilepsy or other neurological conditions.
  • if you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin Taj Pharma
  • if you are diabetic because you may experience a risk of hypoglycaemia with Ciprofloxacin Taj Pharma.
  • if you have myasthenia gravis (a type of muscle weakness) because symptoms can be exacerbated.
  • if you have heart problems. Caution should be taken when using Ciprofloxacin Taj Pharma, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section 2: Other medicines and Ciprofloxacin Taj Pharma).
  • if you or a member of your family is known to have a deficiency in glucose-6- phosphate dehydrogenase (G6PD), since you may experience a risk of anaemia with Ciprofloxacin Taj Pharma.
  • if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
  • if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
  • if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis).

If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.

For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to Ciprofloxacin Taj Pharma. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

While taking Ciprofloxacin Taj Pharma

Tell your doctor immediately, if any of the following occurs while taking Ciprofloxacin Taj Pharma.

Your doctor will decide whether treatment with Ciprofloxacin Taj Pharma needs to be stopped.

  • Severe, sudden allergic reaction (an anaphylactic reaction/shock, angiooedema). Even with the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop taking Ciprofloxacin Taj Pharma and contact your doctor immediately.
  • Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Ciprofloxacin Taj Pharma therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking

Ciprofloxacin Taj Pharma, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.

  • If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If seizure happens, stop taking Ciprofloxacin Taj Pharma and contact your doctor immediately.
  • You may experience psychiatric reactions the first time you take Ciprofloxacin Taj Pharma. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin Taj Pharma. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, contact your doctor immediately.
  • Hypoglycemia has been reported most often in diabetic patients, predominantly in elderly population. If this happens, contact your doctor immediately.
  • You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/ or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Ciprofloxacin Taj Pharma and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
  • If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
  • Diarrhoea may develop while you are taking antibiotics, including Ciprofloxacin Taj Pharma, or even several weeks after you have stopped taking them. If it becomes severe or persistent or you notice that your stool contains blood or mucus, stop taking Ciprofloxacin Taj Pharma and contact your doctor immediately, as this can be life-threatening.

Do not take medicines that stop or slow down bowel movements.

  • Tell the doctor or laboratory staff that you are taking Ciprofloxacin Taj Pharma if you have to provide a blood or urine sample.
  • If you suffer from kidney problems, tell the doctor because your dose may need to be adjusted.
  • Ciprofloxacin Taj Pharma may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, contact your doctor immediately.
  • Ciprofloxacin Taj Pharma may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
  • Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciprofloxacin Taj Pharma. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.

Prolonged, disabling and potentially irreversible serious side effects Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin Taj Pharma, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Ciprofloxacin Taj Pharma, contact your doctor immediately prior to continuing treatment. You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.

Other medicines and Ciprofloxacin Taj Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Ciprofloxacin Taj Pharma together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: “Do not take Ciprofloxacin Taj Pharma”).

The following medicines are known to interact with Ciprofloxacin Taj Pharma in your body. Taking

Ciprofloxacin Taj Pharma together with these medicines can influence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.

Tell your doctor if you are taking:

  • Vitamin K antagonists (e.g.warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anti-coagulants (to thin the blood)
  • theophylline (for breathing problems)
  • phenytoin ( for epilepsy)
  • probenecid ( for gout)
  • ropinirole ( for Parkinson’s disease)
  • methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
  • tizanidine (for muscle spasticity in multiple sclerosis)
  • olanzapine (an antipsychotic)
  • clozapine (an antipsychotic)
  • metoclopramide (for nausea and vomiting)
  • cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)
  • other medicines that can alter your heart rhythm: medicines that belong to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.
  • zolpidem (for sleep disorders)
  • Ciprofloxacin Taj Pharma may increase the levels of the following medicines in your blood:
  • pentoxifylline (for circulatory disorders)
  • caffeine
  • duloxetine (for depression, diabetic nerve damage or incontinence)
  • lidocaine (for heart conditions or anaesthetic use)
  • sildenafil (e.g. for erectile dysfunction)
  • agomelatine (for depression)
  • Some medicines reduce the effect of Ciprofloxacin Taj Pharma. Tell your doctor if you take or wish to take:
  • antacids
  • omeprazole
  • mineral supplements
  • sucralfate
  • a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
  • medicines or supplements containing calcium, magnesium, aluminium or iron

If these preparations are essential, take Ciprofloxacin Taj Pharma about two hours before or no sooner than four hours after them.

Ciprofloxacin Taj Pharma with food, drink and alcohol

Unless you take Ciprofloxacin Taj Pharma during meals, do not eat or drink any dairy products (such as milk or yoghurt) or drinks with added calcium when you take the tablets, as they may affect the absorption of the active substance.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is preferable to avoid the use of Ciprofloxacin Taj Pharma during pregnancy.

Do not take Ciprofloxacin Taj Pharma during breast feeding because Ciprofloxacin Taj Pharma is excreted in breast milk and can be harmful for your child.

Driving and using machines

Ciprofloxacin Taj Pharma may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprofloxacin Taj Pharma before driving a vehicle or operating machinery. If in doubt, talk to your doctor.

Sodium

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

  1. How to take Ciprofloxacin Taj Pharma

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.

The treatment usually lasts from 5 to 21 days, but may take longer for severe infections.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how many tablets to take and how to take Ciprofloxacin Taj Pharma.

  1. Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste nice.
  2. Do try to take the tablets at around the same time every day.
  3. You can take the tablets at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take Ciprofloxacin Taj Pharma tablets with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-fortified orange juice).

Remember to drink plenty of fluids while you are taking Ciprofloxacin Taj Pharma.

If you take more Ciprofloxacin Taj Pharma than you should

If you take more than the prescribed dose, get medical help immediately. If possible, take your tablets or the box with you to show the doctor.

If you forget to take Ciprofloxacin Taj Pharma

Take the normal dose as soon as possible and then continue as prescribed. However,if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose.

Be sure to complete your course of treatment.

If you stop taking Ciprofloxacin Taj Pharma

It is important that you finish the course of treatment even if you begin to feel better after a few days. If you stop taking this medicine too soon, your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following section contains the most serious side effects that you can recognize yourself:

Stop taking Ciprofloxacin Taj Pharma and contact your doctor immediately in order to consider another antibiotic treatment if you notice any of the following serious side effects:

Rare (may affect up to 1 in 1,000 people)

  • Seizure (see Section 2: Warnings and precautions)

Very rare (may affect up to 1 in 10,000 people)

  • Severe, sudden allergic reaction with symptoms such as tightness in the chest, feeling dizzy, sick or faint, or experience dizziness when standing up (anaphylactic reaction/shock) (see Section 2: Warnings and precautions)
  • Muscle weakness, inflammation of the tendons which could lead to rupture of the tendon, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Warnings and precautions)
  • A serious life-threatening skin rash, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes and other mucous membranes such as genitals which may progress to widespread blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Not known (frequency cannot be estimated from the available data)

  • Unusual feelings of pain, burning tingling, numbness or muscle weakness in the extremities (neuropathy) (see Section 2: Warnings and precautions)
  • A drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness

(DRESS Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised Exanthematous Pustulosis).

Other side effects which have been observed during treatment with Ciprofloxacin Taj Pharma are listed below by how likely they are:

Common (may affect up to 1 in 10 people):

  • nausea, diarrhoea
  • joint pain and joint inflammation in children

Uncommon (may affect up to 1 in 100 people):

  • fungal superinfections
  • a high concentration of eosinophils, a type of white blood cell
  • decreased appetite (anorexia)
  • hyperactivity or agitation
  • headache, dizziness, sleeping problems, or taste disorders
  • vomiting, abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), or wind
  • increased amounts 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)

Rare (may affect up to 1 in 1,000 people):

  • muscle pain, inflammation of the joints, increased muscle tone and cramping
  • inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Warnings and precautions )
  • changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes)
  • allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema) (see Section 2: Warnings and precautions)
  • increased blood sugar (hyperglycaemia)
  • decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and precautions)
  • confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to thoughts of suicide, suicide attempts, or complete suicide), or hallucinations (see Section 2: Warnings and precautions)
  • pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, or giddiness
  • eyesight problems including double vision (see Section 2: Warnings and precautions)
  • tinnitus, loss of hearing, impaired hearing
  • rapid heartbeat (tachycardia)
  • expansion of blood vessels (vasodilation), low blood pressure, or fainting
  • shortness of breath, including asthmatic symptoms
  • liver disorders, jaundice (cholestatic icterus), or hepatitis
  • sensitivity to light (see Section 2: Warnings and precautions)
  • kidney failure, blood or crystals in the urine, urinary tract inflammation
  • fluid retention or excessive sweating
  • increased levels of the enzyme amylase

Very rare (may affect up to 1 in 10,000 people):

  • a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis ) (see Section 2: Warnings and precautions); a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal
  • allergic reactions called serum sicknesslike reaction (see Section 2: Warnings and precautions)
  • mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see
  • Section 2: Warnings and precautions)
  • migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure and pseudotumor cerebri)
  • visual colour distortions
  • inflammation of the wall of the blood vessels (vasculitis)
  • pancreatitis
  • death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure (see Section 2: Warnings and precautions)
  • small, pin-point bleeding under the skin (petechiae); various skin eruptions or rashes
  • worsening of the symptoms of myasthenia gravis (see Section 2: Warnings and precautions)

Not known (frequency cannot be estimated from the available data)

  • abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called ‘prolongation of QT interval, seen on ECG, electrical activity of the heart)
  • influence on blood clotting (in patients treated with Vitamin K antagonists)
  • Feeling highly excited (mania) or feeling great optimism and overactivity (hypomania).
  • Syndrome associated with impaired water excretion and low levels of sodium (SIADH)

Other side effects include:

  • Increase of your blood sugar levels (hyperglycaemia) or lowering of your blood sugar levels leading to coma (hypoglycaemic coma). This is important for people that have diabetes.

Very rare cases of long lasting ( up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Ciprofloxacin Taj Pharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

  1. Contents of the pack and other information

What Ciprofloxacin Taj Pharma contains

The active substance is Ciprofloxacin Taj Pharma (as hydrochloride).
Each film-coated tablet contains 250mg Ciprofloxacin Taj Pharma (as hydrochloride).
Each film-coated tablet contains 500mg Ciprofloxacin Taj Pharma (as hydrochloride).
Each film-coated tablet contains 750mg Ciprofloxacin Taj Pharma (as hydrochloride).

The other ingredients are:

Tablet core: Cellulose microcrystalline, sodium starch glycolate (Type A), povidone (K 30), silica, colloidal anhydrous, magnesium stearate.

Film coating: Hypromellose, titanium dioxide, macrogol 400.

What Ciprofloxacin Taj Pharma looks like and contents of the pack

Ciprofloxacin Taj Pharma 250mg film-coated tablets

White to off white, round shaped film coated tablets

Ciprofloxacin Taj Pharma 500mg film-coated tablets

White to off white, capsule shaped, film coated tablets

Ciprofloxacin Taj Pharma 750mg film-coated tablets

White to off white, capsule shaped, film coated tablets

Ciprofloxacin Taj Pharma film-coated tablets are available in blister packs.

Pack sizes: 1, 8, 10, 14, 16, 20 and 100 film coated tablets

Not all pack sizes may be marketed

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

Advice/medical education

Antibiotics are used to cure bacterial infections.

They are ineffective against viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness. Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:

  • dosages
  • schedules
  • duration of treatment

Consequently, to preserve the efficacy of this drug:

  1. Use antibiotics only when prescribed.
  2. Strictly follow the prescription.
  3. Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
  4. Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
  5. After completion of treatment, return all unused drugs to your chemist’s shop to ensure they will be disposed of correctly.

 

Related Products

Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.