Monowel

Monowel

cefoxitin

Manufacturer:

Biolab

Distributor:

Cathay Drug
Full Prescribing Info
Contents
Cefoxitin sodium.
Description
Each vial contains 1.05 g Cefoxitin sodium equivalent to 1 g Cefoxitin.
Action
Pharmacology: Cefoxitin is a beta-lactam antibiotic derived from the chemical modification of cephamycin C (a naturally occurring antibiotic substance produced by Streptomyces lactamdurans, a novel filamentous bacterium). Cefoxitin is a bactericidal broad-spectrum, semi-synthetic antibiotic for parenteral administration. This new class of beta-lactam antibiotics, the cephamycins, are characterized by a 7-alphamethoxy-beta-lactam. The methoxy group is responsible for the property of resistance to degradation by bacterial beta-lactamases (penicillinases and cephalosporinases).
Side chains, attached by chemical modification of the basic cephamycin nucleus, determine some of the specific antibacterial actions and other properties. Cefoxitin has a broad spectrum antibacterial activity against gram-positive and gram-negative pathogens, both aerobic and anaerobic. Cefoxitin inhibits bacterial cell wall synthesis and is bactericidal. The unique molecular structure of Cefoxitin gives a particularly high degree of resistance to beta-lactamases, a major mechanism of bacterial resistance to penicillins and cephalosporins. A high percentage of gram-negative rods which are beta-lactamase producing and resistant to penicillins or other cephalosporins are susceptible to Cefoxitin. In addition, a high percentage of penicillinase-producing, penicillin-resistant gram-positive and gram-negative cocci are susceptible to Cefoxitin.
Indications/Uses
TREATMENT: Cefoxitin sodium (Monowel) is indicated for the treatment of the following infections due to susceptible organisms: Peritonitis and other intra-abdominal and intrapelvic infections; Gynecological infections; Septicemia; Endocarditis; Urinary tract infection, including uncomplicated gonorrhea; Respiratory tract infections; Bone and joint infections; Skin and soft tissue infections.
Cefoxitin sodium (Monowel) is a broad-spectrum bactericidal antibiotic indicated for the treatment of infections caused by susceptible strains of gram-positive and gram-negative pathogens both aerobic and anaerobic. Cefoxitin sodium (Monowel) has been clinically effective not only in infections due to antibiotic sensitive organisms, but also in infections due to organisms resistant to one or more of the following antibacterial agents: penicillin, ampicillin, carbenicillin, tetracyclines, erythromycin, chloramphenicol, other cephalosporins, kanamycin, gentamycin, tobramycin and sulfamethoxazole-trimethoprim. Many gram-negative pathogens are resistant to penicillins and cephalosporin through the action of the beta-lactamases which are produced by these pathogens. Cefoxitin sodium (Monowel) is remarkably stable in the presence of these bacterial beta-lactamases, both penicillinases and cephalosporinases. Hence, the clinical efficacy of Cefoxitin sodium (Monowel) extends to many infections caused by such pathogens, of which the following are of particular clinical importance: E. coli; Klebsiella; Proteus mirabilis; Proteus, indole positive (which include the organisms now called Morganella morganii and Proteus vulgaris); Serratia marcescens; Providencia (including Providencia rettgeri) and the anaerobic Bacteroides fragilis. Cefoxitin sodium (Monowel) is indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. The majority of these mixed infections are associated with contamination by fecal flora as well as flora originating from the vagina, skin and mouth. In these mixed infections, Bacteroides fragilis is the most commonly encountered anaerobic pathogen and is usually resistant to aminoglycosides, cephalosporins, and virtually all penicillins. However, Bacteroides fragilis is usually susceptible to Cefoxitin sodium (Monowel). Cefoxitin sodium (Monowel) is indicated for adjunctive therapy in the surgical treatment of infections, including abscesses, infection complicating hollow viscous perforations, cutaneous infections and infections of serous surfaces, whether caused by aerobes, mixed aerobes and anaerobes, or anaerobes.
PROPHYLAXIS: Cefoxitin sodium (Monowel) is indicated for the prevention of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated, potentially contaminated, or where the occurrence of postoperative infection could be especially serious.
Dosage/Direction for Use
Cefoxitin sodium (Monowel) may be administered intravenously or intramuscularly. (See INTRAVENOUS ADMINISTRATION and INTRAMUSCULAR ADMINISTRATION in the following text). Dosage and route of administration should be determined by severity of infections, susceptibility of the causative organism and condition of the patient. Therapy may be started while awaiting the results of susceptibility testing.
TREATMENT DOSAGE: ADULTS: Usual adult dose: 1 g or 2 g of Cefoxitin sodium (Monowel) every 8 hours (see Table 1).

Click on icon to see table/diagram/image

Adults with renal insufficiency: An initial loading dose of 1 g to 2 g may be given. After a loading dose, the recommendations on Maintenance Dose in Adults with Reduced Renal Function, may be used as a guide.
Patients undergoing hemodialysis: The loading dose of 1-2 g should be given after each hemodialysis, and the maintenance dose should be given as indicated in the table on Maintenance Dose in Adults with Reduced Renal Function. (See Table 2.)

Click on icon to see table/diagram/image

Uncomplicated urinary tract infection: In uncomplicated urinary tract infection due to susceptible organisms, 1 g intramuscularly twice a day has been shown effective.
Uncomplicated gonorrhea: For single dose therapy of uncomplicated gonorrhea, including those caused by penicillinase-producing strains, the recommended dose is 2 g of Cefoxitin sodium (Monowel) intramuscularly given 1 g of probenecid by mouth at the same time or up to 1 hour before.
Neonates (Including Premature Infants), Infants and Children: (See Table 3.)

Click on icon to see table/diagram/image

In severe infections, the total daily dosage may be increased to 200 mg/Kg, but not to exceed 12 g per day. Cefoxitin sodium (Monowel) is not recommended for the therapy of meningitis. If meningitis is suspected, an appropriate antibiotic should be used. In children with renal insufficiency the dose frequency should be reduced as indicated for adults. (See Warnings.)
PROPHYLACTIC DOSE: For prophylactic use in surgery the following doses are recommended: General Surgery: Adults: 2 g administered intramuscularly or intravenously 1/2 to 1 hours before initial incision; then 2 g every 6 hours. Ordinarily, prophylactic therapy does not extend beyond 24 hours.
Neonates, infants and children: In case of infants and children, 30-40 mg/Kg doses may be given at times designated previously. However, in neonates 30-40 mg/Kg doses may be given one half to 1 hour prior to surgery has been effective. For prolonged or heavily contaminated procedures, additional 2 g doses may be given at 6 hours intervals. Ordinarily, prophylactic therapy does not extend beyond 24 hours (see Warnings).
Obstetric-Gynecologic: For patients undergoing caesarean section a single 2 g dose should be administered intravenously as soon as the umbilical cord is clamped. For prophylactic use in gynecologic surgical procedure a single 2 g dose administered intravenously or intramuscularly one-half to one hour prior to surgery has been effective. For prolonged or heavily contaminated procedures, additional 2 g doses may be given at 6 hours intervals. Ordinarily, prophylactic therapy does not extend beyond 24 hours.
Administration: INTRAVENOUS ADMINISTRATION: The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
For intermittent intravenous administration, a solution containing 1 g or 2 g in 10 ml of Sterile Water for Injection can be injected over a period of 3 to 5 minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing cefoxitin sodium, it is advisable to temporarily discontinue administration of any other solutions at the same site.
For the administration of higher doses by continuous intravenous infusion, a solution of cefoxitin sodium be added to an intravenous bottle containing 5% Dextrose Injection, 0.9% Sodium Chloride Injection, 5% Dextrose and 0.9% Sodium Chloride Injection or 5% Dextrose Injection with 0.02% sodium bicarbonate solution. Butterfly or scalp vein type needles are preferred for this type of infusion.
INTRAMUSCULAR ADMINISTRATION ONLY: Reconstitute Cefoxitin sodium (Monowel) 1 g with 2 mL Sterile Water for Injection, or 0.5% or 1% lidocaine HCl (without epinephrine) solution. Cefoxitin sodium (Monowel) is given by deep injection into a large muscle mass.
Avoid injection into a blood vessel. Note: Some patients may be hypersensitive to lidocaine.
Contraindications
Cefoxitin sodium (Monowel) is contraindicated in persons who have shown hypersensitivity to cefoxitin. In the absence of clinical experience, Cefoxitin sodium (Monowel) should not be administered to patients who have shown hypersensitivity to cephalosporins.
Warnings
Solutions containing preservatives should not be used for injection of for flushing catheters in treating neonates. Benzyl alcohol as preservative in Bacteriostatic Water for Injection and Bacteriostatic Sodium Chloride in Injection has been associated with toxicity with neonates. Data are unavailable on the toxicity of other preservatives in this age group. Therefore, any diluent used with Cefoxitin sodium (Monowel) in the treatment of neonates should be free of any preservatives.
Special Precautions
The total daily dosage should be reduce when Cefoxitin sodium (Monowel) is administered to patients with transient persistent reduction of urinary output due to renal insufficiency (see Dosage & Administration) because high and prolonged serum antibiotic concentrations can occur from usual doses. There are no controlled studies in pregnant women. Use of the drug during pregnancy requires that anticipated benefits be weighed against possible risks. Cefoxitin is excreted in human milk, and consequently caution should be exercised when administered in nursing mother.
Adverse Reactions
The most common were local reactions following intravenous injection. Allergic reactions namely phlebitis and inflammation at the site of injection and gastrointestinal reactions namely nausea and vomiting.
Caution For Usage
Preparation of Solution: For intravenous use, 1 g should be constituted with at least 10 mL of Sterile Water for Injection, and 2 g with 10 or 20 mL. 1 g or 2 g of cefoxitin sodium for infusion may be constituted with 50 or 100 mL of 0.9% Sodium Chloride Injection, 5% or 10% Dextrose Injection, or any of the solutions listed under Compatibility and Stability.
Compatibility and Stability: The compatibility and stability of Cefoxitin sodium (Monowel) in solution with the following frequently used intravenous infusion fluids and injectable additives have been established: 0.9% Sodium Chloride Injection, 5% or 10% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose Injection with 0.02% Sodium bicarbonate solution, 5% Dextrose Injection with 0.2% or 0.45% saline solution, Lactated Ringer's Injection, 5% Dextrose in Lactated Ringer's Injection, 5% or 10% Invert sugar in water, 10% Invert sugar in saline solution, 5% Sodium Bicarbonate Injection, M/6 Sodium Lactate solution, Insulin in normal saline
Insulin in 10% invert sugar, Heparin, 100 units/ml and 0.1 unit/ml, Mannitol 2.5% and 5%, Mannitol 10%.
Cefoxitin sodium (Monowel) has been shown chemically and visually compatible with aminoglycosides such as amikacin, gentamycin, kanamycin and tobramycin when admixed in 200 mL of 0.9% Sodium Chloride or 5% Dextrose in Water.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
After reconstitution with Sterile Water for Injection or 1% Lidocaine HCl, the solution of Cefoxitin sodium (Monowel) maintains satisfactory potency for 24 hours at room temperature or for 7 days in refrigerator.
MIMS Class
ATC Classification
J01DC01 - cefoxitin ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj (vial) 1 g x 1's.
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