Description and Composition of Biophin Plus
Biophin Plus is cephalosporin antibiotics that is used in the treatment of various bacterial infections. Details of this is obtainable under uses or indications. It contains ceftriaxone and Sulbactam as its active pharmaceutical ingredient. In addition, there are other inactive ingredients called excipients in sufficient quantities that it has as well.
Uses or Indications of Biophin Plus
This section answers the question: what is Biophin Plus used to treat?
Ceftriaxone Sulbactam Injection is used for the treatment, control, prevention, and improvement of the following diseases conditions and symptoms:
- Bacterial Infections
- Intraabdominal infections
- Gynecological infections
- Skin or soft tissue infections
- Surgical infections
- Surgical site infections
- Lyme disease
How Biophin Plus Works
This section discusses the mechanism of action of Biophin Plus.
Ceftriaxone works by inhibiting the mucopeptide synthesis in the bacterial cell wall. This is done by selective and irreversible binding of Ceftriaxone to transpeptidases, also called transamidases, which are penicillin-binding proteins (PBPs) that catalyze the cross-linking of the peptidoglycan polymers forming the bacterial cell wall. Sulbactam in the other hand protects Ceftriaxone from being deactivated by beta lactamase enzyme. It achieves this by irreversibly binding to the enzyme. Sulbactam broadens Ceftriaxone’s spectrum of activity to be used against beta lactamase enzyme producing bacteria.
Warnings and Precautions
This section addresses what you need to know before you are given Ceftriaxone & Sulbactam for Injection.
Before using this drug, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery. etc.). Some health conditions may make you more susceptible to the side effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition
persists or worsens. Important counseling points are listed below.
- Do not drive or operate heavy machinery
- Pregnant, planning to get pregnant or breastfeeding
- Regularly check your urine for sugar level
Contraindications of Biophin Plus
This section addresses when Biophin Plus should not be be used.
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.
Carcinogenesis, Mutagenesis and Impairment of Fertility
This section shows whether Biophin Plus causes cancer, mutations or impairs fertility.
Considering the maximum duration of treatment and the class of the compound, carcinogenic studies with Ceftriaxone in animals have not been performed. The maximum duration of animal toxicity studies was 6 months.
Genetic toxicological tests included the Ames test, a micronucleus test and a test for chromosomal aberrations in human lymphocytes cultured in vitro with Ceftriaxone. Ceftriaxone showed no potential mutagenic activity in these studies.
Impairment of fertility
Ceftriaxone produced no impairment in fertility when given intravenously to rats at approximately 20 times the recommended dose of 2 gm/day
Pregnancy: Can Biophin Plus be used during Pregnancy?
Teratogenic effects: Biophin Plus is in Pregnancy category B. Reproductive studies have been performed in mice and rats at daily doses upto 586 mg/kg/day upto 20 times the usual human dose and no evidence of embryo toxicity, fetotoxicity or teratogenicity. In primates no teratogenicity or embryogenicity was demonstrated at a dose approximately 3 times the human dose.
There are however no well controlled studies in pregnant women. Because animal reproductive studies are not alway predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Should Biophin Plus be Used by Nursing Mothers?
Low concentrations of Ceftriaxone are excreted in human milk. No risk to nursing infants have been reported but should be exercised when ceftriaxone-sulbactam is administered to nursing women.
Ceftriaxone-Sulbactam should not be administered to hyperbilirubinemic neonates, especially premature.
Dosage of Biophin Plus
What is the dose of Ceftriaxone Sulbactam?
The recommended adult dosage is 1.5 g to 3 g per day. This 1.5 to 3 g range represents the total of Ceftriaxone content plus the sulbactam content and corresponds to a range of 1 g Ceftriaxone /0.5g sulbactam to 2 g Ceftriaxone/1 g sulbactam respectively. The total dose of sulbactam should not exceed 4 grams per day.
Neonates, infants and children up to 12 years:
The following dosage schedules are recommended for once daily administration. Neonates (up to 14 days): 20 to 50 mg/kg bodyweight 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 or more, the usual adult dosage should be used. Intravenous doses of NLT 50 mg/kg bodyweight should be given by infusion over at least 30 minutes.
Side Effects of Biophin Plus
The following is a list of possible side effects that may occur from all constituting ingredients of Ceftriaxone Sulbactam injection. This is not a comprehensive list. These side effects are possible, but do not always occur. Some of the side effects may be rare but serious. Consult your doctor if you observe any of the following side effects, especially if they not go resolve after some time.
- Pain at site of injection
- Inflammation of a vein caused by a blood clots
- Itching of skin
How to Store Biophin Plus
This section answers how Ceftriaxone Sulbactam should be stored safely.
Your doctor or pharmacist is responsible for storing Ceftriaxone & Sulbactam for injection. They are also responsible for disposing of any unused Ceftriaxone & Sulbactam for injection correctly. Keep out of the reach and sight of children. Do not use Ceftriaxone & Sulbactam for Injection after the expiry date printed on the pack. Store in a temperature not exceeding 30°C, protected from light and moisture.
Chemical Structure of Ceftriaxone
Chemical Structure of Sulbactam
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