Tergocin IM/IV Injection

Teicoplanin is a glycopeptide-antibiotic produced by Actinoplanes teichomyceticus. It is presented as a sterile, pyrogen-free ivory white powder for reconstitution with water for injection. It is freely soluble in water and on reconstitution gives a clear solution. Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a site different from that affected by beta-lactams. Peptidoglycan synthesis is blocked by specific binding to D-alanyl-D-alanine residues.

Teicoplanin can be given intravenously (as a bolus injection or infusion) or intramuscularly. The intravenous injection may be administered either as a bolus over 3 to 5 minutes or as a 30-minute infusion. Only the infusion method should be used in neonates. It should be given once daily after one or more loading doses. The dosage of Teicoplanin should be adapted on the severity of the infection and patient’s response to treatment.

In adults (Normal kidney function):

• On the first day, a dose of 6 mg/kg (generally 400 mg) intravenously is recommended. On the following days, the dose may be 6 mg/kg/day (generally 400 mg) intravenously or 3 mg/kg/day (generally 200 mg) intravenously or intramuscularly as a single daily dose. The highest dose and the intravenous route are recommended for serious infections.
• In potentially fatal infections, treatment should be started with 6 mg/kg (usually 400 mg) twice daily for 1 to 4 days (loading dose) and continued with 6 mg/kg/day intravenously on the following days (maintenance dose).

In adults and elderly (Kidney failure): In patients with kidney failure, the dosage should be adjusted from the 4th day of treatment as follows:

• In moderate kidney failure (creatinine clearance between 40 and 60 ml/min), the daily dose of Teicoplanin should be halved or given on alternate days.
• In severe kidney failure (creatinine clearance less than 40 ml/min) and in hemodialysis patients, the daily dose of Teicoplanin should be reduced to a third, or given every 3 days.
• If creatinine clearance is equal to or less than 20 ml/min, treatment with Teicoplanin may be given only if monitoring of drug levels in the blood can be guaranteed.

In children (Normal kidney function):

• In Children (2 months to 12 years): Treatment should be started at a dose of 10 mg/kg every 12 hours for a total of 3 doses and then continued at a dose of 6-10 mg/kg/day, the highest dose being used for the most serious infections or for children with neutropenia.
• In neonates (up to 2 months): Treatment should be started at a dose of 16 mg/kg on the first day, followed by maintenance doses of 8 mg/kg/day by slow intravenous infusion (lasting approximately 30 minutes).

In children (Kidney failure): As like adults, dosage adjustment is recommended. Measuring Teicoplanin levels in the blood may be useful to make treatment as effective as possible.

Clostridium difficile infection associated diarrhea: The recommended dose is 100-200 mg administered twice a day for 7 to 14 days. Giving Teicoplanin along with another suitable bactericidal antibiotic is recommended for infections requiring maximum bactericidal activity or in situations where the presence of Gram-negative bacteria cannot be ruled out (empirical treatment of fever in patients with neutropenia). In most patients, this medicine can be seen to have an effect 48 to 72 hours after the start of treatment. However, the total duration of treatment is determined based on the type and severity of the infection and the patient’s response to treatment. In endocarditis and osteomyelitis, a period of at least 3 weeks is recommended.

Due to potential for increased adverse effects, Tergocin should be administered with caution in patients receiving concurrent nephrotoxic or ototoxic drugs, such as Aminoglycosides, Amphotericin B, Cyclosporion and Frusemide.

Teicoplanin is contraindicated in patients with known Hypersensitivity to the drug.

Local reaction: Erythema, injection site abscess when given intramuscularly.
Allergic reaction: Rash, pruritus, fever, shivering, anaphylactic reactions.
Gastrointestinal reactions: Nausea, vomiting, diarrhea.
CNS reactions: Physical weakness, dizziness, headache.
Hearing reactions: Ringing in the ears, balance disorders.

Pregnancy Category B3. Teicoplanin should not be used during confirmed or presumed pregnancy or during lactation unless the potential benefits outweigh possible risks.

Tergocin should be administered with caution in patients known to be hypersensitive to Vancomycin since cross-hypersensitivity may occur.

Glycopeptide

Inject slowly the 3 ml of water from the ampoule into the 200 mg or 400 mg powder vial containing Tergocin active ingredient. Rotate the vial gently between hands until all the powder is dissolved to avoid foaming. If foam is developed, allow the solution to stand for approximately 15 minutes so that the foam disappears. Only clear and yellowish solutions should be used.

Tergocin can be administered in the following infusion solutions:

• Sodium chloride 9 mg/ml (0.9%) solution
• Ringer solution
• Ringer-lactate solution
• 5% dextrose solution
• 10% dextrose solution
• 0.18% sodium chloride and 4% glucose solution
• 0.45% sodium chloride and 5% glucose solution

Store at a temperature not exceeding 30°C in a dry place. Protect from light. The reconstituted solution should be used immediately, or stored under refrigeration (2 to 8° C) for 24 hours maximum.