Silenam
Silenam Uses, Dosage, Side Effects, Food Interaction and all others data.
Silenam Hydrochloride is a preparation of Silenam. It is a fourth generation broad-spectrum cephalosporin antibiotic. Silenam acts by inhibition of bacterial cell wall synthesis. It is highly resistant to hydrolysis by most beta-lactamases and exhibits rapid penetration into gram-negative bacterial cells.
Silenam has been shown to be active against most strains of the following microorganisms:
Gram-Positive Microorganisms:
Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Viridans group streptococci, Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus hominis, Streptococcus agalactiae.
Gram-Negative Microorganisms:
Enterobacter, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Acinetobacter calcoaceticus, Citrobacter diversus, Citrobacter freundii, Enterobacter spp., Haemophilus influenzae (including beta-lactamase producing strains), Haemophilus parainfluenzae, Hafnia alvei, Klebsiella oxytoca, Moraxella catarrhalis (including beta-lactamase producing strains), Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens, Neisseria meningitidis.
Anaerobes:
Trade Name | Silenam |
Availability | Prescription only |
Generic | Cefepime |
Cefepime Other Names | Cefepima, Cefepime, Cefepimum |
Related Drugs | amoxicillin, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin, Augmentin |
Weight | 1gm |
Type | Injection |
Formula | C19H24N6O5S2 |
Weight | Average: 480.561 Monoisotopic: 480.124959288 |
Protein binding | The serum protein binding of cefepime is approximately 20% and is independent of its concentration in serum. |
Groups | Approved, Investigational |
Therapeutic Class | Fourth generation Cephalosporins |
Manufacturer | Healthcare Formulations Pvt Limited |
Available Country | India, Nigeria |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Silenam Hydrochloride is used for the treatment of the following infections:
• Pneumonia (moderate to severe)
• Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis)
• Uncomplicated Skin and Skin Structure Infections
• Complicated Intra-abdominal Infections
• Empiric Therapy for Febrile Neutropenic Patients.
Silenam is also used to associated treatment for these conditions: Bacterial Infections, Complicated Intra-Abdominal Infections, Complicated Urinary Tract Infection, Febrile Neutropenia, Meningitis, Bacterial, Pyelonephritis, Severe Pneumonia, Uncomplicated Urinary Tract Infections, Moderate Pneumonia, Uncomplicated skin and subcutaneous tissue bacterial infections
How Silenam works
Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).
Dosage
Silenam dosage
Recommended dosage schedule for adults with normal renal function
Type of Infection Dose Frequency Duration (Days)
Moderate to severe Pneumonia 1-2 g IV q12h 10
Empiric Therapy for Febrile Neutropenic Patients 2 g IV q8h 7
Mild to moderate Uncomplicated or Complicated Urinary 0.5-1 g IV/IM q12h 7-10
Tract Infections (including pyelonephritis)
Severe Uncomplicated or Complicated Urinary 2 g IV q12h 10
Tract Infections (including pyelonephritis)
Moderate to severe Uncomplicated Skin and Skin Structure 2 g IV q12h 10
Infections
Complicated Intra-abdominal Infections 2 g IV q12h 7-10
Pediatric Patients (2 months up to 16 years)
The maximum dose for pediatric patients should not exceed the recommended adult dose.
Type of Infection Pediatric patients up to 40 kg in weight
Dose Frequency Duration
(Days)
Uncomplicated and Complicated Urinary Tract Infections 50 mg/kg q12h 7-10
(including pyelonephritis)
Uncomplicated Skin and Skin Structure Infections 50 mg/kg q12h 10
Pneumonia 50 mg/kg q12h 10
Febrile Neutropenic Patients 50 mg/kg q8h 7
Impaired Hepatic Function - No adjustment is necessary for patients with impaired hepatic function.
Impaired Renal Function - In patients with impaired renal function (creatinine clearance <60 ml/min), the dose of Silenam should be adjusted. The recommended initial dose of Silenam should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended doses of Silenam in patients with renal insufficiency are presented in the following table:
Creatinine Clearance Recommended Maintenance Schedule
(ml/min)
>60 500 mg q12h 1g q12h 2g q12h 2g q8h
Normal recommended
dosing schedule
30-60 500 mg q24h 1g q24h 2g q24h 2g q12h
11-29 500 mg q24h 500 mg q24h 1g q24h 2g q24h
<11 250 mg q24h 250 mg q24h 500 mg q24h 1g q24h
CAPD 500 mg q48h 1g q48h 2g q48h 2g q48h
Hemodialysis 1g on day 1, then 500 mg q24h thereafter 1g q24h
Preparation of Solutions of Silenam Hydrochloride
Single-dose vial Administration Amount of diluent to be added
500 mg IM 1.3 ml
500 mg IV 5 ml
1 gm IM 2.4 ml
1 gm IV 10 ml
These solutions may be stored up to 24 hours at room temperature or 7 days in a refrigerator.
Silenam Hydrochloride is compatible at concentrations between 1 and 40 mg/ml with the following IV infusion fluids: (1) 0.9% Sodium chloride, (2) 5% and 10% Dextrose.
IV infusion: Add 5 mL, 10 mL, or 10 mL of a compatible IV soln to a vial labeled as containing 500 mg, 1 g, or 2 g, respectively, to provide soln containing approx 100 mg/mL, 100 mg/mL, or 160 mg/mL of the drug, respectively. The appropriate dose of the drug should then be added to a compatible IV soln.
IM inj: Add 1.3 mL or 2.4 mL of an appropriate diluent (e.g. sterile water for inj, NaCl 0.9%) to a vial labeled as containing 500 mg or 1 g respectively, to provide a soln containing approx 280 mg/mL.
Side Effects
Generally Silenam is well tolerated. However, few side-effects including rash, pruritus, urticaria, fever, headache, nausea, vomiting, diarrhea, dizziness, oral moniliasis may occur.
Toxicity
Symptoms of overdose include seizures, encephalopathy, and neuromuscular excitability.
Precaution
In patients with impaired renal function (creatinine clearance <60 ml/min), the dose of Silenam should be adjusted. Silenam should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis.
Interaction
Increased potential for nephrotoxicity and ototoxicity of aminoglycosides. Increased risk of nephrotoxicity with potent diuretics (e.g. furosemide).
Food Interaction
No interactions found.Silenam Drug Interaction
Moderate: furosemide, furosemideUnknown: ciprofloxacin, ciprofloxacin, apixaban, apixaban, sodium chloride, sodium chloride, acetaminophen, acetaminophen, pantoprazole, pantoprazole, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, cholecalciferol, cholecalciferol, ondansetron, ondansetron
Silenam Disease Interaction
Major: colitisModerate: renal dysfunction, dialysis, liver disease, seizure disorders
Volume of Distribution
- 18.0 ±2.0 L
- 0.3 ±0.1 L/kg [Pediatric]
Elimination Route
The absolute bioavailability of cefepime after an IM dose of 50 mg/kg was 82.3 (±15)% in eight patients.
Half Life
2.0 (± 0.3) hours in normal patients. The average half-life in patients requiring hemodialysis was 13.5 (± 2.7) hours and in patients requiring continuous peritoneal dialysis was 19.0 (± 2.0) hours.
Clearance
- 120 mL/min [Healthy adult male receiving a single 30-minute IV infusions of cefepime]
- 3.3 +/-1.0 mL/min/kg [Petriatic patients (2 months – 11 years of age) receiving a single IV dose]
Elimination Route
Elimination of cefepime is principally via renal excretion with an average (±SD) half-life of 2 (±0.3) hours and total body clearance of 120 (±8) mL/min in healthy volunteers. Silenam is excreted in human milk.
Pregnancy & Breastfeeding use
Pregnancy: There are no adequate and well-controlled studies of Silenam use in pregnant women. Silenam should be used during pregnancy only if clearly needed.
Lactation: Silenam is excreted in human breast milk in very low concentrations. Caution should be exercised when Silenam is administered to a nursing woman.
Contraindication
Hypersensitivity to cefepime or other cephalosporins.
Acute Overdose
Patients who receive an overdose should be carefully observed and given supportive treatment. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.
Interaction with other Medicine
Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Silenam because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.
Storage Condition
Silenam Hydrochloride should be stored in a cool & dry place and protected from light.
Innovators Monograph
You find simplified version here Silenam
Silenam contains Cefepime see full prescribing information from innovator Silenam Monograph, Silenam MSDS, Silenam FDA label
FAQ
What is Silenam used for?
Silenam is a fourth-generation cephalosporin antibiotic. Silenam has an extended spectrum of activity against Gram-positive and Gram-negative bacteria, with greater activity against both types of organism than third-generation agents. Silenam also used in the treatment of various bacterial infections caused by susceptible bacteria, such as pneumonia, urinary tract infections, and skin infections.
How safe is Silenam?
The safety profile of Silenam is excellent and comparable to that of Silenam and those reported for other cephalosporins.
How does Silenam work?
Silenam works by killing bacteria or preventing their growth.
What are the common side effects of Silenam?
Common side effects of Silenam are include:
- Abdominal or stomach cramps
- back, leg, or stomach pains
- bleeding gums, nosebleeds
- confusion
- convulsions
- dark urine
- difficulty with breathing
- fever, chills
- general body swelling
- headache
- irregular heartbeats
- loss of appetite
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- nausea or vomiting
- numbness and tingling around the mouth, fingertips, or feet
- tremor
- yellowing of the eyes or skin
Is Silenam safe during pregnancy?
Silenam should be used during pregnancy only if clearly needed. The Silenam group is generally considered safe for use during pregnancy, but each drug is slightly different and may have different side effects.
Is Silenam safe during breastfeeding?
Silenam is acceptable in nursing mothers.
Can I drink alcohol with Silenam?
Using alcohol with certain medicines may also cause interactions to occur.
Can I drive after taking Silenam?
Silenam generally does not cause any problems with your ability to drive a car or operate machinery.
When should be best taken of Silenam?
Silenam are supposed to be taken on an empty stomach should be taken about an hour before a meal, or 2 hours after a meal.
How should be taken of Silenam ?
Silenam injection can also be given intramuscularly. It is usually given every 8 or 12 hours for 7 to 10 days. A healthcare provider can teach you how to properly use the medication by yourself.
How long does Silenam take to work?
Silenam takes about six to eight hours for food to pass through your stomach and small intestine.
What is the half-life of Silenam?
The half-life of Silenam was approximately 2.3 hours.
Can Silenam cause kidney failure?
Patients with renal failure who are treated with Silenam has been reported sporadically.
Who should not take Silenam ?
You should not use this Silenam if you are allergic to Silenam or other cephalosporin antibiotic.
What happens if I miss a dose?
Use the Silenam as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.
Can I take Silenam for a long time?
Continue to use this Silenam for the full time prescribed, even if symptoms disappear after a few days. Stopping the Silenam too early may result in a return of the infection.
Is Silenam bad for liver?
Silenam is considered well-tolerated and is associated with few adverse reactions. Although Silenam -induced neurotoxicity and nephrotoxicity have been reported in recent years, there are currently no formal reports of hepatic injury caused by this Silenam.
How long can I take Silenam?
Use this Silenam for the full prescribed length of time, even if your symptoms quickly improve. Some infections must be treated for up to 6 weeks.
Can I overdose on Silenam?
Silenam related neurological toxicity has been associated with overdosing due to severe renal dysfunction.
How often can I take Silenam?
Silenam is usually given every 8 or 12 hours for 7 to 10 days.
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.