Colistimethate sodium for injection and inhalation        (Colistin Leaflet)

Each Injection contains:
Composition:
Colistin Colistimethate sodium injection
Colistin 1 MIU
Each vial contains:
1 Million International Units (1 MIU) Colistimethate Sodium

DOSAGE:
Powder for solution for injection, infusion and inhalation

Mode of Action:
Colistimethate sodium is a cyclic polypeptide antibiotic derived from Bacillus polymyxa var. colistinus and belongs to the polymyxin group. The polymyxin antibiotics are cationic surface-active agents that work by damaging the cell membrane. The resulting physiological effects are lethal to the bacterium. Polymyxins are selective for Gramnegative bacteria that have a hydrophobic outer membrane.

Microbiology
Commonly susceptible species
Acinetobacter species*
Citrobacter species
Escherichia coli
Haemophilus influenzae
Pseudomonas aeruginosa
Species for which acquired resistance may be a problem
Enterobacter species
Klebsiella species
Inherently resistant organisms
Brucella species
Burkholderia cepacia and related species
Neisseria species
Proteus species
Providencia species
Serratia species
Anaerobes
All Gram-positive organisms
*In vitro results may not correlate with clinical responses in the case of Acinetobacter species.
When 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.

Cross-resistance
Cross-resistance between colistimethate sodium and polymyxin B would be expected. Since the mechanism of action of the polymyxins is different from that of other antibiotics, resistance to colistin and polymyxin by the above mechanism alone would not be expected to result in resistance to other drug classes.


DOSAGE AND METHOD OF ADMINISTRATION
Systemic Treatment
Colistin can be given as a 50 mL intravenous infusion over a period of 30 minutes. Patients with a totally implantable venous access device (TIVAD) in place may tolerate a bolus injection of up to 2 million units in 10 mL given over a minimum of 5 minutes (see Reconstitution for Parenetral Administration). The dose is determined by the severity and type of infection and the age, weight and renal function of the patient. Should clinical or bacteriological response be slow the dose may be increased as indicated by the patient's condition. A minimum of 5 days treatment is generally recommended. For the treatment of respiratory exacerbations in cystic fibrosis patients, treatment should be continued for up to 12 days.


CONTRAINDICATIONS
Colistin is contraindicated in patients with known hypersensitivity to colistimethate sodium (colistin) or to polymyxin B and in patients with myasthenia gravis.

WARNINGS AND PRECAUTIONS
Use with extreme caution in patients with porphyria. Nephrotoxicity or neurotoxicity may occur if the recommended parenteral dose isexceeded. Use with caution in renal impairment (see DOSAGE AND METHOD OF ADMINISTRATION) as colistimethate sodium is renally excreted. It is advisable to assess baseline renal function and to monitor during treatment. Serum colistimethate sodium concentrations should be monitored. Bronchospasm may occur on inhalation of antibiotics. This may be prevented or treated with appropriate use of beta2-agonists. If troublesome, treatment should be withdrawn.

PACKAGING INFORMATION
Colistin 1,2,3,4,4.5, & 5  MIU is available in vial of 10 mL

Drug Interactions
Concomitant use of colistimethate sodium with other medicinal products of neurotoxic and/or nephrotoxic potential should be avoided. These include the aminoglycoside antibiotics such as gentamicin, amikacin, netilmicin and tobramycin. There may be an increased risk of nephrotoxicity if given concomitantly with cephalosporin antibiotics. Neuromuscular blocking drugs and ether should be used with extreme caution in patients receiving colistimethate sodium. Renal Impairment Use with caution in renal impairment as colistimethate sodium is renally excreted and please refer under DOSAGE AND METHOD OF ADMINISTRATION.

Pregnancy
There are no adequate data on the use of colistimethate sodium in pregnant women. Single dose studies in human pregnancy show that colistimethate sodium crosses the placental barrier and hence should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Lactation
Colistimethate sodium is secreted in breast milk. Colistimethate sodium should be administered to breastfeeding women only when clearly needed.
Paediatric Use
Please refer under PHARMACOKINETICS AND DOSAGE AND METHOD OF
ADMINISTRATION.
Geriatric Use
Elderly patients are more likely to have decreased renal function, hence care should be
taken in dose selection and it may be useful to monitor renal function.

UNDESIRABLE EFFECTS
Systemic Treatment
The likelihood of adverse events may be related to the age, renal function and
condition of the patient. In cystic fibrosis patients, neurological events have been reported in up to 27% of patients. These are generally mild and resolve during or shortly after treatment. Neurotoxicity may be associated with overdose, failure to reduce the dose in patients with renal insufficiency and concomitant use of either neuromuscular blocking drugs or other drugs with similar neurological effects. Reducing the dose may alleviate symptoms. Effects may include apnoea, transient sensory disturbances (such as facial paraesthesia and vertigo) and, rarely, vasomotor instability, slurred speech, visual disturbances, confusion, or psychosis. Adverse effects on renal function have been reported, usually following use of higher than recommended doses in patients with normal renal function, or failure to reduce the dosage in patients with renal impairment, or during concomitant use of other nephrotoxic drugs. The effects are usually reversible on discontinuation of therapy. In cystic fibrosis patients treated within the recommended dosage limits, nephrotoxicity appears to be rare (less than 1%). In seriously ill, hospitalized, non-cystic fibrosis patients, signs of nephrotoxicity have been reported in approximately 20% of patients. Hypersensitivity reactions, including skin rash and drug fever, have been reported. If these occur, treatment should be withdrawn. Local irritation at the site of injection may occur.

Inhalation Treatment
Inhalation may induce coughing or bronchospasm. Sore throat or mouth has been reported and may be due to Candida albicans infection or hypersensitivity. Skin rash may also indicate hypersensitivity; if this occurs, treatment should be withdrawn.

OVERDOSAGE
Overdose can result in neuromuscular blockade that can lead to muscular weakness, apnoea, and possible respiratory arrest. Overdose can also cause acute renal failure characterized by decreased urine output and increased serum concentrations of BUN and creatinine. There is no specific antidote, so overdose should be managed by supportive treatment. Measures to increase the rate of elimination of colistin, e.g., mannitol diuresis, prolonged haemodialysis or peritoneal dialysis may be tried, but effectiveness is unknown.

INCOMPATIBILITIES
Mixing drugs in infusions, injections and nebulizer solutions involving colistimethate
sodium should be avoided. The addition of other antibiotics such as erythromycin, tetracycline, and cephalothin to solutions of Colistin may lead to precipitation.

STORAGE AND HANDLING INSTRUCTIONS
Before opening:
Do not store above 25°C. Keep the vials in the outer carton.
Reconstituted solutions:

Solutions for infusion or injection
Chemical and physical in-use stability for 28 days at 4oC has been demonstrated. From a microbiological point of view, solutions should be used immediately. If not used immediately in-use storage times and conditions prior to use are the responsibility of the user. They would normally be no longer than 24 hours at 2 to 8°C, unless reconstituted and diluted under controlled and validated aseptic conditions.

Solutions for Nebulization:
Solutions for nebulization have similar in-use stability and should be treated as above. Patients self-treating with nebulized antibiotic should be advised to use solutions immediately after preparation. If this is not possible, solutions should not be stored for longer than 24hrs in a refrigerator.


 

Colistimethate sodium powder for inhalation (Colobreathe) for Pseudomonas aeruginosa lung infection in cystic fibrosis

Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited,  medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.
Information for Health Care Professionals

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited)

Colistin®
Colistimethate sodium
for injection and inhalation
 

Select Language English Russian French German Italian Japanese Korean Portuguese Spanish Greek Dutch Hindi

              
 Print page   Send by mail

GENERIC NAME: COLISTIMETHATE SODIUM
DOSAGE FORM: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
FOR :TREATMENT BY INHALATION OF PSEUDOMONAS AERUGINOSA LUNG INFECTION IN PATIENTS WITH CYSTIC FIBROSIS
Mfg: TAJ PHARMACEUTICALS LIMITED., INDIA

PACKAGING INFORMATION
Colistin 1,2,3,4,4.5, & 5 MIU
is available in vial of 10 mL

COLISTIMETHATE FOR INJECTION IS INDICATED FOR THE TREATMENT OF ACUTE OR CHRONIC INFECTIONS DUE TO SENSITIVE STRAINS OF CERTAIN GRAM-NEGATIVE BACILLI. IT IS PARTICULARLY INDICATED WHEN THE INFECTION IS CAUSED BY SENSITIVE STRAINS OF PSEUDOMONAS AERUGINOSA. THIS ANTIBIOTIC IS NOT INDICATED FOR INFECTIONS DUE TO PROTEUS OR NEISSERIA. COLISTIMETHATE FOR INJECTION HAS PROVEN CLINICALLY EFFECTIVE IN TREATMENT OF INFECTIONS DUE TO THE FOLLOWING GRAM-NEGATIVE ORGANISMS: ENTEROBACTER AEROGENES, ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, AND PSEUDOMONAS AERUGINOSA.
COLISTIMETHATE FOR INJECTION MAY BE USED TO INITIATE THERAPY IN SERIOUS INFECTIONS THAT ARE SUSPECTED TO BE DUE TO GRAM-NEGATIVE ORGANISMS AND IN THE TREATMENT OF INFECTIONS DUE TO SUSCEPTIBLE GRAM-NEGATIVE PATHOGENIC BACILLI.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Colistimethate for injection and other antibacterial drugs, Colistimethate for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy

CONTRAINDICATIONS
THE USE OF COLISTIMETHATE FOR INJECTION IS CONTRAINDICATED FOR PATIENTS WITH A HISTORY OF SENSITIVITY TO THE DRUG OR ANY OF ITS COMPONENTS.
WARNINGS
MAXIMUM DAILY DOSE CALCULATED FROM COLISTIN BASE ACTIVITY SHOULD NOT EXCEED 5 MG/KG/DAY WITH NORMAL RENAL FUNCTION.
TRANSIENT NEUROLOGICAL DISTURBANCES MAY OCCUR. THESE INCLUDE CIRCUMORAL PARESTHESIA OR NUMBNESS, TINGLING OR FORMICATION OF THE EXTREMITIES, GENERALIZED PRURITUS, VERTIGO, DIZZINESS, AND SLURRING OF SPEECH. FOR THESE REASONS, PATIENTS SHOULD BE WARNED NOT TO DRIVE VEHICLES OR USE HAZARDOUS MACHINERY WHILE ON THERAPY. REDUCTION OF DOSAGE MAY ALLEVIATE SYMPTOMS. THERAPY NEED NOT BE DISCONTINUED, BUT SUCH PATIENTS SHOULD BE OBSERVED WITH PARTICULAR CARE.
NEPHROTOXICITY CAN OCCUR AND IS PROBABLY A DOSE-DEPENDENT EFFECT OF COLISTIMETHATE SODIUM. THESE MANIFESTATIONS OF NEPHROTOXICITY ARE REVERSIBLE FOLLOWING DISCONTINUATION OF THE ANTIBIOTIC.
OVERDOSAGE CAN RESULT IN RENAL INSUFFICIENCY, MUSCLE WEAKNESS, AND APNEA (SEE OVERDOSAGE SECTION). SEE PRECAUTIONS, DRUG INTERACTIONS SUBSECTION FOR USE CONCOMITANTLY WITH OTHER ANTIBIOTICS AND CURARIFORM DRUGS.

Respiratory arrest has been reported following intramuscular administration of Colistimethate sodium. Impaired renal function increases the possibility of apnea and neuromuscular blockade following administration of Colistimethate sodium. Therefore, it is important to follow recommended dosing guidelines. See DOSAGE AND ADMINISTRATION section for use in renal impairment.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Colistimethate for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.