CIPROFLOXACIN 200mg/100ml Infusion

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COMPOSITION :

Ciprofloxacin lactate monohydrate Infusion 200 mg/100 ml, each 100 ml contains : Ciprofloxacin lactate monohydrate equivalent to Ciprofloxacin 200 mg.

 

DESCRIPTIONS :

Ciprofloxacin lactate monohydrate with active ingredient Ciprofloxacin lactate monohydrate (equivalent to Ciprofloxacin) available in 200 mg/100 ml infusion.

 

INDICATIONS :

  • Lower respiratory tract in the treatment of outpatients with pneumonia due to Pneumococcus Ciprofloxacin lactate monohydrate should not be used as a first choice of drug. Ciprofloxacin lactate monohydrate can be regarded as an advisable treatment for pneumonias caused by Klebsiella, Enterobacter, Proteus, Pseudomonas, Haemophilus, Branhamella, Legionella and Staphylococcus.
  • Kidney and/or urinary tract.
  • Genital organs, including gonorrhoea and prostatitis.
  • Abdominal cavity (e.g., bacterial infections of the gastrointestinal tract, biliary tract, peritonitis).
  • Skin and soft tissue.
  • Bones and joints.
  • Sepsis.

Infections or imminent risk of infection (prophylaxis), patients whose immune system has been weakened (e.g., patient on immunosuppressants or in states of neutropenia). Selective intestinal decontamination in immunosuppressed patients.

 

DOSAGE AND ADMINISTRATIONS : 

Single/daily doses for adults (mg Ciprofloxacin)

(2 x daily every 12 hours or 3 x daily every 8 hours)

  • Dosage for respiratory tract infection (according to severity and organism) : 2 x 200 – 400 mg.
  • Dosage for urinary tract infections :
  1. Acute, uncomplicated : 2 x 100 mg.
  2. Cystitis in women (before menopause) : Single dose 100 mg.
  3. Complicated : 2 x 200 mg.
  • Dosage for gonorrhoea :
  1. Extragenital : 2 x 100 mg.
  2. Acute, uncomplicated : Single dose 100 mg.
  • Dosage for other interactions (see indications) : 2 x 200 – 400 mg.
  • Particularly severe, life threatening infections e.g., Streptococcal pneumoniae, recurrent infections in cystic fibrosis, bone and joint infections, septicemia, peritonitis : 3 x 400 mg.

After intravenous administration the treatment can be continued orally.

  • Dosage for impaired kidney and liver function :
  1. Creatinine clearance < 20 ml/minute – serum creatinine > 3 mg/100 ml : Half the normal dose twice daily or the full normal dose once a day.
  2. Impaired kidney function + haemodialysis : Half the normal dose twice daily or the full normal dose once a day, on dialysis days after dialysis.
  3. Impaired liver function : No dosage adjustment required.
  4. Impaired kidney and liver function : Half the normal dose twice daily or the full normal dose once a day, possible check Ciprofloxacin lactate monohydrate serum levels.

Method of administration :

The intravenous infusion is administered over a period of 30 minutes for 100 and 200 mg or 60 minutes for 400 mg.

The infusion solution may be administered simultaneously with or following other infusion solutions. It may also be injected into infusions which are already running. After the bottle has been broached the drug’s stability is limited by microbiological and hygienic factors. The solutions themselves are not sensitive to oxygen and therefore, are still stable after the containers have been opened.

Where their compatibility with other infusion solutions/drugs has not been proven, the infusion solution and diluted infusion solution concentrate should, in principle, be administered separately. Visible sign of incompatibility include precipitation, clouding, discoloration.

Since Ciprofloxacin lactate monohydrate infusion solution is sensitive to light, the bottles should only be taken out of the cardboard packaging immediately before use in daylight, full efficacy is guaranteed for a period of 3 days.

Duration of use :

The duration of treatment depends upon the severity and the clinical course of the illness and on bacteriological results. Treatment should generally be continued for at least 3 days after the temperature has returned to normal and/or the clinical symptoms have disappeared.

Average duration of treatment :

  • 1 day for acute gonorrhoea.
  • Up to 7 days of infections of the kidneys, urinary tract and abdominal cavity, throughout the entire neutropenic phase in immunocompromised patients.
  • A maximum of 2 months for osteomyelitis.
  • And 7 – 14 days for all other interactions.

Treatment should be carried out for a minimum of 10 days in Streptococcal infections due to the risk of late complications.

Initial intravenous treatment may be replaced by oral therapy with Ciprofloxacin HCl monohydrate after a few days.

 

OVERDOSAGE : 

In the incident of oral overdose, reversible renal toxicity has been reported in some cases. Therefore, apart from routine emergency measures, it is recommended to monitor renal function and to administer Mg2+ or Ca2+ containing antacids which reduce the absorption of Ciprofloxacin.

Only a small amount of Ciprofloxacin (< 10 %) is removed from the body after haemodialysis or peritoneal dialysis.

 

CONTRAINDICATIONS : 

  • Patients with hypersensitivity to Ciprofloxacin or other Quinolone derivatives antibiotic.
  • Ciprofloxacin should not be prescribed to children (under 18 years old), 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 cartilage of an organism which is not fully grown cannot be completely ruled out. 

 

WARNINGS AND PRECAUTIONS :

  • Caution administered in patients with renal impairment.
  • The administered dose should not exceed the recommended dose.
  • Ciprofloxacin should be given carefully in elderly patients.
  • Central nervous system : In case of epilepsy and in patients with history of CNS disorders (e.g., low-threshold of seizure, history of convulsion, lower blood circulation to brain and stroke), Ciprofloxacin should only be given if the benefits greater than the risks, because these patients may suffered central nervous system side effects. In these cases, Ciprofloxacin has to be discontinued and the physician should be informed immediately.
  • Although given according to a doctor prescription, this drug can interfere with the patients response, ability to drive and run the engine. The disorder will be more severe if this drug is taken with alcohol.
  • Skin system : Avoid patients in excessive sunlight exposure or UV-light. If phototoxicity (i.e., sunburn-like skin reactions) occurs, treatment should be discontinued.
  • Severe infections and/or infections due to gram positive or anaerobic bacteria : Ciprofloxacin 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 must be co-administered with other appropriate antibacterial agents.
  • Streptococcus pneumoniae infections : Ciprofloxacin is not recommended for treatment of pneumococcal infections due to inadequate efficacy against Streptococcus pneumoniae.
  • Genital tract infections : Epididymo-orchitis and pelvic inflammatory diseases may be caused by Fluoroquinolone-resistant Neisseria gonorrhoeae. Ciprofloxacin should be co-administered with another appropriate antibacterial agent, unless Ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
  • Cardiac disorders : Ciprofloxacin is associated with cases of QT prolongation. In general, elderly patients may be more susceptible to drugs that affect on the QT interval. Precaution should be taken when using Ciprofloxacin with concomitant drugs that can result in prolongation with the QT interval (e.g., class IA or III antiarrhythmics) or in patients with risk factors for torsade de pointes (e.g., patient with QT prolongation, hypokalemia).
  • Children and adult : As with medicinal products in its class, Ciprofloxacin has been proven to cause arthropathy in weight-bearing joints of immature animals. The analysis of available safety data from Ciprofloxacin use in patients less than 18 years old, the majority of whom had cystic fibrosis, did not disclose any evidence of drug-related cartilage or articular damage. The use of Ciprofloxacin has not been studied for indications other than the treatment of acute pulmonary exacerbation of cystic fibrosis caused by Pseudomonas aeruginosa infection (children 5 – 17 years old), complicated urinary tract infections and pyelonephritis due to Escherichia coli (children 1 – 17 years old) and for the use in inhalational anthrax (post-exposure).
  • Hypersensitivity : Hypersensitivity and allergic reactions may occur in the use of single dose and a physician should be informed immediately. Anaphylactic reactions are very rare and can be life-threatening after the first administration. If this occurs, Ciprofloxacin should be discontinued and medical treatment (e.g., treatment for shock) is required.
  • Gastrointestinal system : In the incident of severe and persistent diarrhea during treatment, a physician must be consulted since this symptom can hide a serious intestinal disease that requires immediate treatment (life-threatening pseudomembranous colitis with fatal outcome). In such cases, the use of Ciprofloxacin must be discontinued and appropriate therapy (e.g., oral Vancomycin 4 x 250 mg/day). Drugs that inhibits peristalsis are contraindicated include aminase, alkaline phosphatase or cholestatic jaundice, especially in patients with liver damage.
  • Local IV site reactions have been reported with the intravenous administration of Ciprofloxacin. These reactions are more frequent if the infusion time is 30 minutes or less. These may appear as local skin reactions which resolve rapidly upon completion of the infusion. Subsequent intravenous administration is not contraindicated unless the reactions recur or worsen.
  • Musculoskeletal system : Ciprofloxacin should not be used in patients with a history of tendon disease/disorder related to Quinolone treatment. Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur within 48 hours after the use of Ciprofloxacin. The risk of tendinopathy may be increased in elderly patients or in patients concomitantly treated with corticosteroid. At any sign of tendinitis (e.g., painful swelling, inflammation), Ciprofloxacin treatment should be discontinued, immediately contact a doctor to consult on a replacement drugs and avoid other activities that use tendons are affected. Ciprofloxacin should be used cautiously in patients with myasthenia gravis.
  • In patients for whom Sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.) the additional Sodium load should be taken into account.
  • Cytochrome P450 : Ciprofloxacin is a moderate inhibitor of the CYP450 1A2 enzymes. Caution when given concomitantly Ciprofloxacin with drugs which are metabolized via the same enzymatic pathway (e.g., Theophylline, Methylxanthines, Caffeine, Duloxetine, Clozapine). Increased plasma concentrations associated with drug-specific side effects may be observed due to inhibition of their metabolic clearance by Ciprofloxacin.
  • Laboratory tests : Ciprofloxacin in vitro potency may interfere with Mycobacterium spp. culture test, thus giving a false negative result.

 

DRUG INTERACTIONS : 

  • Class IA or III antiarrhythmics :

Cation when using Ciprofloxacin together with class IA or III antiarrhythmics as Ciprofloxacin may have an additive effect on the QT interval.

  • Chelation formation :

The simultaneous administration of Ciprofloxacin (oral) and multivalent cation-containing drug and mineral supplements (e.g., Calcium, Magnesium, Aluminium, Iron), polymeric phosphate binders (e.g., sevelamer, lanthanum carbonate), Sucralfate or Antacids and highly buffered drugs (e.g., Didanosine tablets) containing Magnesium, Aluminium or Calcium reduce the absorption of Ciprofloxacin. Consequently, Ciprofloxacin 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 receptors blockers.

  • Administration with food :

The concurrent administration of dairy products or mineral-fortified drinks (e.g., milk, yoghurt, Calcium-fortified orange juice) and Ciprofloxacin should be avoided because absorption of Ciprofloxacin may be reduced. Calcium as part of a meal does not significantly affect absorption.

  • Probenecid :

Probenecid interferes with renal secretion of Ciprofloxacin. Co-administration of Probenecid and Ciprofloxacin may increases the Ciprofloxacin serum concentrations.

  • Metoclopramide :

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

  • Omeprazole :

Concomitant administration of Ciprofloxacin and Omeprazole caused a slight reduction of Cmax and AUC of Ciprofloxacin.

  • Tizanidine :

There was an increase in Tizanidine serum concentrations when given concomitantly with Ciprofloxacin. Associated with the increases serum concentrations was a potentiated hypotensive  and sedative effect. Tizanidine should not be administered together with Ciprofloxacin.

  • Theophylline :

Concurrent administration of Ciprofloxacin and Theophylline may increase serum Theophylline concentration, which can cause side effects of Theophylline. In very rare cases, these side effects can be life threatening or fatal. If the use of this combination is unavoidable, the serum Theophylline concentration should be monitored and the Theophylline dose can be reduced.

  • Xanthine derivatives :

Concurrent administration of Ciprofloxacin and Caffeine or Pentoxifylline (Oxpentifylline) containing products, raised serum concentrations of Xanthine derivatives.

  • Methotrexate :

Concurrent administration of Methotrexate and Ciprofloxacin may inhibit renal tubular transport and thus potentially leading to increased plasma levels of Methotrexate. This state might increase the risk of Methotrexate associated toxic reactions. Therefore, patients who received treatment with Methotrexate should be carefully monitored when administered together with Ciprofloxacin treatment.

  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) :

Non-clinical studies have shown that high doses of Quinolone (gyrase inhibitors) with very high doses are combined with NSAIDs (other than salicylic acid) may cause seizures.

  • Cyclosporin :

The transient increase in the concentration of serum creatinine was seen while in concurrent administration of Ciprofloxacin and Cyclosporin. In this case, serum creatinine concentrations should be monitored frequently (twice a week).

  • Vitamin K antagonists :

Concurrent administration of Ciprofloxacin and Vitamin K antagonists may increase the anticoagulant effects. The INR (international normalized ratio) should be monitored frequently during and shortly after co-administration of Ciprofloxacin with a Vitamin K antagonists (e.g., Warfarin, Acenocoumarol, Phenprocoumon or Fluindione).

  • Glibenclamide :

In particular cases, concurrent administration of Ciprofloxacin and Glibenclamide may increase Glibenclamide effects (hypoglycemia).

  • 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, similar effects can be expected upon concomitant administration.

  • Ropinirole :

Concurrent administration of Ropinirole and Ciprofloxacin resulting in an increase of Cmax and AUC of Ropinirole by 60% and 84%, respectively. Monitoring Ropinirole-related side effects dose adjustment as appropriate is recommended during and shortly after co-administration with Ciprofloxacin.

  • Lidocaine :

Concurrent administration of Ciprofloxacin and Lidocaine will reduces clearance of intravenous Lidocaine by 22%. Although Lidocaine treatment was well tolerated, a possible interaction with Ciprofloxacin may cause adverse reactions.

  • Clozapine :

After concomitant administration of 250 mg Ciprofloxacin with Clozapine for 7 days, serum concentrations of Clozapine and N-desmethylclozapine were increased by 29% and 31%. Clinical surveillance and appropriate adjustment of Clozapine dosage during and shortly after co-administration with Ciprofloxacin are advised. 

  • Sildenafil :

Cmax and AUC of Sildenafil were increased approximately two-fold in healthy subjects after an oral dose of 50 mg given concomitantly with 500 mg Ciprofloxacin. Therefore, caution should be used prescribing Ciprofloxacin concomitantly with Sildenafil and taking into a consideration the risks and the benefits.

  • Phenytoin :

Altered (decreased or increased) serum levels of Phenytoin were observed in patients receiving Ciprofloxacin and Phenytoin simultaneously. To avoid the loss of seizure control associated with decreased Phenytoin levels and to prevent Phenytoin overdose-related adverse effects when Ciprofloxacin is discontinued in patients receiving both agents, monitoring of Phenytoin therapy, including Phenytoin serum concentration measurements, is recommended during and shortly after co-administration of Ciprofloxacin with Phenytoin.

  • Oral antidiabetic agents :

Hypoglycaemia has been reported when Ciprofloxacin and oral antidiabetic agents, mainly Sulfonylureas (e.g., Glibenclamide, Glimepiride), where co-administered, presumably by intensifying the action of the oral antidiabetic agent.

  • Pregnancy : 

Ciprofloxacin should not be used in pregnant women.

  • Lactating women :

Ciprofloxacin is excreted in breast milk. Ciprofloxacin should not be used in lactating women.

  • Effects on ability to drive and use machines :

Ciprofloxacin may result in an impairment of the patient’s ability to drive or operate machinery due to CNS reactions. This disorders would be worse if taken with alcohol. 

 

ADVERSE REACTIONS : 

  • Gastrointestinal disorder :
  1. Common : Nausea, diarrhea.
  2. Uncommon : Vomiting, gastrointestinal and abdominal pain, dyspepsia, flatulence.
  3. Very rare : Pancreatitis.
  • Nervous system disorder :
  1. Uncommon : Headache, dizziness, sleep disorder, taste disorder.
  2. Rare : Par- and dis-aethesia, hypoaethesia, tremors, seizures, vertigo.
  3. Very rare : Migraine, disturbed coordination, smell disorder, hyperesthesia, intracranial hypertension.
  4. Frequency unknown : Peripheral neuropathy and polyneuropathy.
  • Renal and urinary tract disorder :
  1. Uncommon : Renal impairment.
  2. Rare : Renal failure, haematuria, crystalluria, nephritis tubulointerstitial.
  • Cardiovascular system disorder :
  1. Rare : Tachycardia, palpitation, atrial flutter, ectopic ventricular, syncope, hypertension, angina pectoris, myocardial infarction, cardiopulmonary arrest, cerebral thrombosis, hot flushes, migraine and collapse.
  • Infections and infestations :
  1. Uncommon : Mycotic superinfections.
  2. Rare : Antibiotic-associated colitis (very rarely with possible fatal outcome).
  • Blood and lymphatic system disorders :
  1. Uncommon : Eosinophilia.
  2. Rare : Leucopenia, anaemia, neutropenia, leukocytosis, thrombocytopenia, thrombocytaemia.
  3. Very rare : Haemolytic anaemia, agranulocytosis, pancytopenia (life-threatening), bone marrow depression (life-threatening).
  • Immune system disorders :
  1. Rare : Allergic reaction, allergic oedema/angioedema.
  2. Very rare : Anaphylactic reaction, Anaphylactic shock (life-threatening), serum sickness-like reaction.
  • Metabolism and nutrition disorder :
  1. Uncommon : Anorexia.
  2. Rare : Hyperglycemia.
  • Psychiatric disorders :
  1. Uncommon : Psychomotor hyperactivity/agitation.
  2. Rare : Confusion and disorentiation, anxiety reaction, abnormal dreams, depression, hallucinations.
  3. Very rare : Psychotic reactions.
  • Eye disorders :
  1. Rare : Visual disturbances. 
  2. Very rare : Visual colour distortions.
  • Ear and labyrinth disorders :
  1. Rare : Tinnitus, hearing loss, hearing impaired.
  • Vascular disorders :
  1. Rare : Vasodilatation, hypotension, syncope.
  2. Very rare : Vasculitis.
  • Respiratory, thoracic and mediastinal disorders :
  1. Rare : Dyspnoea (including asthmatic condition).
  • Hepatobiliary disorders :
  1. Uncommon : Increase in transaminases, increased bilirubin.
  2. Rare : Hepatic impairment, jaundice, hepatitis (non infective).
  3. Very rare : Liver necrosis (very rarely progressing to life-threatening hepatic failure).
  • Skin and Subscutaneous tissue disorders :
  1. Uncommon : Rash, pruritus, urticaria.
  2. Rare : Photosensitivity reactions, unspecific blistering.
  3. Very rare : Petechiae, erythema multiforme, erythema nodosum, Stevens-Johnson syndrome (life-threatening), toxic epidermal necrolysis (life-threatening).
  • Musculoskeletal, connective tissue and bone disorders :
  1. Uncommon : Arthralgia.
  2. Rare : Myalgia, arthritis, increased muscle tone and cramping.
  3. Very rare : Muscular weakness, tendonitis, tendon rupture (especially Achilles tendon), exacerbation of myasthenia gravis symptoms.

From the cases have been reported, the risk of tendonitis side effects not immediately disappear even though the use of Ciprofloxacin was stopped. Adverse effects in tendon can occur until several months after treatment is stopped.

  • Common disorders :
  1. Uncommon : Non significant pain, feeling unwell, fever.
  2. Rare : Edema sweating (hyperhidrosis).
  3. Very rare : Gait disorder.
  • Investigations :
  1. Uncommon : Increased alkaline phosphatase in blood.
  2. Rare : Abnormal prothrombin concentration, increased amylase.

 

PRESENTATION : 

Ciprofloxacin lactate monohydrate Infusion 200 mg/100 ml Bottle @ 100 ml                

Reg. No. GKL1002342049A1

 

STORAGE :

STORE BELOW 30ºC, PROTECT FROM LIGHT 

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

BERNOFARM

Sidoarjo – Indonesia

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