Guficol

Guficol Uses, Dosage, Side Effects, Food Interaction and all others data.

Each vial contains Guficol Sodium 1 MIU or 34 mg Colistin.Each vial contains Guficol Sodium 2 MIU or 68 mg Colistin.Each vial contains Guficol Sodium 3 MIU or 102 mg Colistin.Each vial contains Guficol Sodium 4.5 MIU or 150 mg Colistin.Guficol sodium is a surface active agent which penetrates into and disrupts the bacterial cell membrane. It has been shown to have bactericidal activity against Aerobic gram-negative microorganisms e.g. Enterobacter aerogenes, E. coli, Klebsiella pneumoniae and PseudomonasGuficol is a surface active agent which penetrates into and disrupts the bacterial cell membrane. Guficol is polycationic and has both hydrophobic and lipophilic moieties. It interacts with the bacterial cytoplasmic membrane, changing its permeability. This effect is bactericidal. There is also evidence that polymyxins enter the cell and precipitate cytoplasmic components, primarily ribosomes.

Guficol is a polymyxin antibiotic agent. Originally, colistimethate sodium was thought to be less toxic than polymyxin B; however, if the drugs are administered at comparable doses, their toxicities may be similar. Polymyxins are cationic polypeptides that disrupt the bacterial cell membrane through a detergentlike mechanism. With the development of less toxic agents, such as extended-spectrum penicillins and cephalosporins, parenteral polymyxin use was largely abandoned, except for the treatment of multidrug-resistant pulmonary infections in patients with cystic fibrosis. More recently, however, the emergence of multidrug-resistant gram-negative bacteria, such as Pseudomonas aeruginosa and Acinetobacter baumannii, and the lack of new antimicrobial agents have led to the revived use of the polymyxins.

Trade Name Guficol
Availability Prescription only
Generic Colistimethate
Colistimethate Other Names Colistin methanesulfonic acid, Colistin sulfomethate, Colistinmethanesulfonic acid
Related Drugs penicillin g potassium, Pfizerpen, Coly Mycin M
Type Vial Injection
Formula C58H105N16O28S5
Weight Average: 1634.87
Monoisotopic: 1633.588775306
Groups Approved, Vet approved
Therapeutic Class Other antibacterial preparation
Manufacturer Gufic Biosciences Ltd
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Guficol
Guficol

Uses

Guficol is used for the treatment of acute or chronic infections caused by sensitive strains of certain gram-negative bacilli. It is particularly used for the infection caused by sensitive strains of Pseudomonas aeruginosa. Guficol is not used for infections due to Proteus or Neisseria. Guficol is very effective in the treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Guficol is also used to associated treatment for these conditions: Bacterial Infections

How Guficol works

Guficol is a surface active agent which penetrates into and disrupts the bacterial cell membrane. Guficol is polycationic and has both hydrophobic and lipophilic moieties. It interacts with the bacterial cytoplasmic membrane, changing its permeability. This effect is bactericidal. There is also evidence that polymyxins enter the cell and precipitate cytoplasmic components, primarily ribosomes.

Dosage

Guficol dosage

Maintenance dose: 9 MIU/day in 2-3 divided doses. In patients who are critically ill, a loading dose of 9 MIU should be administered.

Renal impairment patients: Dose adjustments in renal impairment patients are necessary. Dose reductions are recommended for patients with creatinine clearance < 50 ml/min. Twice daily dosing is recommended.

  • Creatinine clearance <50-30 ml/min: daily dose 5.5-7.5 MIU
  • Creatinine clearance <30-10 ml/min: daily dose 4.5-5.5 MIU
  • Creatinine clearance <10 ml/min: daily dose 3.5 MIU
Haemodialysis (HD) patients:
  • No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
  • HD days: 3 MIU/day (Should be given after the HD session) Twice daily dosing is recommended.
Pediatric population: The dose should be based on lean body weight.
  • Children ≤40 kg: 75,000-150,000 IU/kg/day divided into 3 doses.
  • Children >40 kg: >150,000 IU/kg/day has been reported in children with cystic fibrosis.
Hepatic impairment patients: There are no data in patients with hepatic impairment. Caution is advised when administering colistimethate sodium in these patients.

Direct Intermittent Administration- Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.

Continuous Infusion- Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Guficol for injection to one of the following:

  • 0.9% NaCl
  • 5% dextrose in 0.9% NaCl
  • 5% dextrose in water
  • 5% dextrose in 0.45% NaCl
  • 5% dextrose in 0.225% NaCl
  • Lactated Ringer's solution
There are not sufficient data to recommend usage of Guficol for injection with other drugs or other than the above listed infusion solutions. Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment. The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management. Any infusion solution containing Guficol sodium should be freshly prepared and used for no longer than 24 hours.

Alternative method- As per specialized references for intermittent infusion: Prescribed dose can be diluted in 50-100 ml 0.9% NaCl and administer over 30-60 minutes in IV route.

Side Effects

The following adverse reactions have been reported: gastrointestinal upset, tingling of extremities and tongue, slurred speech, dizziness, vertigo and paresthesia, generalized itching, urticaria and rash, fever, increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance, respiratory distress and apnea, nephrotoxicity and decreased urine output.

Toxicity

Oral LD50 in rats is 5450 mg/kg. Overdosage with colistimethate can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death.

Precaution

Guficol should be used with caution in patient with impaired renal function. When actual renal impairment is present, Guficol may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Guficol should be used with caution in neonates, infants and children.

Interaction

Guficol should not be given with certain antibiotics like- aminoglycosides and polymyxin due to report of interfere with the nerve transmission at the neuromuscular junction. It should not be given with muscle relaxants e.g., tubocurarine and other drugs including ether, succinylcholine, gallamine, decamethonium and sodium citrate. The concomitant use of Sodium Cephalothin and Guficol should be avoided.

Food Interaction

No interactions found.

Guficol Disease Interaction

Major: colitisModerate: renal dysfunction

Elimination Route

Very poor absorption from gastrointestinal tract.

Half Life

2-3 hours following either intravenous or intramuscular administration in adults and in the pediatric population, including premature infants.

Pregnancy & Breastfeeding use

There are no adequate and well-controlled studies about the use of Guficol in pregnant women. Since colistimethate is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Guficol is excreted in human breast milk. Therefore, caution should be exercised when administered to nursing women.

Contraindication

The use of Guficol Sodium Parenteral is contraindicated for patients with a history of sensitivity to the drug or any of its components.

Acute Overdose

Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of B.U.N and creatinine. As in any case of overdose, Guficol Sodium therapy should be discontinued and general supportive measures should be utilized.

Storage Condition

Before reconstitution: Store below 30°C. After reconstitution: Store at 2°C to 8°C (Do not freeze) and use within 24 hours.

Innovators Monograph

You find simplified version here Guficol

Guficol contains Colistimethate see full prescribing information from innovator Guficol Monograph, Guficol MSDS, Guficol FDA label

*** Taking medicines without doctor's advice can cause long-term problems.
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