IV Tandak Injection: Uses, Functions, Composition, Dosage, Indications, Contraindications, Side Effects and Price
TANDAK (Combipack of ceftriaxone with sulbactam for injection with sterilized water for injections BP)
Description : flint glass vial containing white crystalline powder of ceftriaxone with sulbactam for injection along with 10ml FFS ampoule of sterilized water for injections BP.
Pharmaceutical form: powder for injection.
Route of Administration: Intramuscular / Intravenous.
Composition :
Each Tandak 1.5g combipack contain:
Ceftriaxone with sulbactam for injection -1 vial
Each vial contains : ceftriaxone sodium USP equivalent to ceftriaxone anhydrous 1000mg sulbactam sodium USP equi. to sulbactam 500mg
Sterilized water for injections BP 10ml – 1 Ampoule
Each Tandak 375mg combipack contains:
Ceftriaxone with sulbactam for injection – 1 vial
Each vial contains : ceftriaxone sodium USP equi. To ceftriaxone anhydrous 250mg
Sulbactam sodium USP equi. to sulbactam 125 mg
Sterilized water for injections BP 10ml – 1 Ampoule
Clinical pharmacology:
Tandak is an anti- infective, combination of ceftriaxone with sulbactam. Ceftriaxone is a broad spectrum semi- synthetic third – generation cephalosporin with a potent bactericidal activity against a wide range of gram – positive and gram – negative bacteria. Sulbactam is B – lactamase inhibitor.
Indications of tandak :
Tandak is used for the treatment of skin and soft tissue infections, cholecystitis, osteomyelitis, chronic suppurative bacteria otitis media, gonorrhea, chancroid, syphilis, UTI infections, meningitis, nosocomial infection caused by susceptible bacteria.
Dosage and Administration (Directions for use):
Adults
The recommended adult dosage is 1.5g (1 g ceftriaxone as the sodium salt ) to 3 g (2 g ceftriaxone as the sodium salt plus 1g sulbactam as the sodium salt) daily.
This 1.5 to 3 g range represents the total of ceftriaxone content plus the sulbactam content and corresponds to a range of 1g ceftriaxone /0.5 g sulbactam to 2 g ceftriaxone/ 1 g sulbactam.
The total dose of sulbactam should not exceed 4 grams per day.
Pediatrics
Neonates, infants and children up to 12 years:
The following dosage schedules are recommended for once daily administration in children.
Neonates (up to 14 days): 20 to 50 mg/kg body weight once daily. The daily dose should not exceed 50 mg/kg. It is not necessary to differentiate between premature and term infants.
Infants and children (15 days to 12 years) : 20 to 80 mg/kg once daily. For children with body weights of 50 kg or more, the usual adult dosage should be used. Intravenous doses of NLT 50 mg /kg body weight should be given by infusion over at least 30 minutes.
Precautions and warnings :
Before therapy with ceftriaxone instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs.
This product should be given cautiously to penicillin – sensitive patients. Antibiotics should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs.
Serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures.
As with other cephalosporins, anaphylactic reactions with fatal outcome have been reported, even if a patient is not known to be allergic or previously exposed.
Dosage adjustments of tandak should not be necessary in patients with hepatic dysfunction ; however, in patients with both hepatic dysfunction and significant renal disease, caution should be exercised and the ceftriaxone dosage should not exceed 2 gm daily.
Alterations in prothrombin times have occurred rarely in patients treated with ceftriaxone.
Patients with impaired vitamin k synthesis or low vitamin k stores (eg, chronic hepatic disease and malnutrition) may require monitoring of prothrombin time during ceftriaxone or tandak treatment.
Vitamin k administration (10 mg weekly) may be necessary if the prothrombin time prolonged before or during therapy.
Prolonged use of tandak may result in overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If super infection occurs during therapy, appropriate measures should be taken.
Ceftriaxone should be prescribed with caution in individuals with a history of gastrointestinal disease, especially colitis.
Push Tandak slowly when administering it. When given too fast, it can can cause severe vomiting.
Contraindications:
Tandak (Ceftriaxone) injection is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics.
In patients hypersensitive to penicillin, consider the possibility of allergic cross – reactions.
The use of sulbactam is contraindicated in individuals with a history of hypersensitivity reactions to any of the penicillins.
Adverse Reactions / side Effects of tandak :
👉Gastrointestinal complaints : loose stools / diarrhoea, nausea, vomiting, stomatitis, glossitis.
👉Haematological changes : Eosinophilia, haematoma or bleeding, thrombocytopenia, neutropenia, leukopenia, granulocytopenia and haemolytic anaemia.
👉Isolated cases of agranulocytosis (‹500/mm³) have been reported, most of them following total doses of 20 g or more.
👉Exanthema, allergic dermatitis, urticaria, oedema, erythema multiforme may occur.
👉Other side effects of tandak include headache and dizziness, increase in liver enzymes, oliguria, and increase in serum creatinine, mycosis of the genital tract, fever, shivering and anaphylactic or anaphylactoid reactions.
Local: inflammatory reactions in the vein wall may occur after IV administration. These may be minimised by slow ( 2-4 minutes) injection of Tandak. Intramuscular injection without lidocaine solution is painful.
Overdose :
In the case of over dosage, drug concentration would not be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of over dosage should be symptomatic.
Price of Tandak Injection:
A vial of tandak cost about #1,500 naira in Nigeria which is equivalent to $3…Some pharmacies sell wholesale price though.
Packing and presentations :
Combipack 1 x 1.5 g vial of ceftriaxone with sulbactam and 10 ml sterilized water for injections BP.
Combipack 1 x 375 mg vial of ceftriaxone with sulbactam and 10 ml sterilized water for injections BP.
Storage : store below 25°C. Protect from light and moisture.
NAFDAC REG. NO : Tandak 1.5 g – A4 – 8059
NAFDAC NO : Tandak 375 mg – A4 – 8058
Mfg. Lic. No.: G/125
Exported by :
PRIME PHARMACEUTICALS PTV. LTD.
2/3, surya complex, C. G Road, swastilk char Rasta, Navrangpura, Ahmedabad – 380009, Gujarat , India.
Manufactured by:
INTRACIN PHARMACEUTICALS PVT. LTD.
C- 1, B – 53, G. I. D. C. Estate, Nadiad – 387 001, Gujarat, India.
Marketed in Nigeria by:
MARCSON HEALTH CARE LTD.
9, Isawo Road, Agric,
Ikorodu, Lagos, Nigeria.
For the use of a Registered medical practitioner or a hospital or a laboratory only.
KEEP OUT OF REACH OF CHILDREN.
