Monowel

Description

The Cathay Drug Co., Inc.

PRODUCT DESCRIPTION

White to off-white, granules, or powder, having a slight characteristic odor

 

FORMULATION

Each vial contains Cefoxitin sodium, USP …………… 1 g

equivalent to Cefoxitin.

 

 

PHARMACOLOGY

Cefoxitin is a beta-lactam 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.

 

 

PHARMACOKINETICS

Cefoxitin is widely distributed in the body tissues and fluids including ascetic, pleural and synovial fluid. The drug diffuses poorly into cerebrospinal fluid following IM or IV administration, even when the meninges are inflamed. It crosses the placenta, and fetal serum concentrations may be equal to maternal serum concentrations. Small amounts of the drug are distributed into breast milk. Relatively high concentrations are achieved in bile.

The serum half-life of Cefoxitin sodium (Monowel) is 0.7 – 1.1 hours in adults with normal renal function. However, serum concentrations of the drug are higher and the serum half-life is longer in patients with renal impairment. Approximately 2% or less of a dose of Cefoxitin sodium (Monowel) is metabolized to descarbamyl Cefoxitin sodium (Monowel) which is microbiologically inactive. This drug is rapidly excreted in urine by both glomerular filtration and tubular secretion. In adults with normal renal function, approximately 85% of a single IM or IV dose of cefoxitin is excreted unchanged in the urine within 6 hours. Cefoxitin sodium (Monowel) is removed by hemodialysis, but not by peritoneal dialysis

 

INDICATIONS

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 organ isms, 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 cephalosporins 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; P. 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 post-operative infection could be especially serious.

 

DOSAGE AND ADMINISTRATION

Cefoxitin sodium (Monowel) may be administered intravenously or intramuscularly. Dosage and route of administration should be determined by severity of infections, susceptibility of the causative organism and condition of the patient. Therapy should 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

USUAL ADULT DOSE

Type of infection	Dose	Frequency	Total Daily Dosage
Uncomplicated	1g	Every 8 hours (occasionally every 6 hours)	3 g (4 g)
Moderately severe or severe	2 g	Every 8 hours (occasionally every 6 hours)	6 g (8 g)
Infections generally needing antibiotics in higher dose	3 g (2 g)	Every 6 hours (occasionally every 4 hours)	12 g

 

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 on the table on below.

MAINTENANCE DOSE IN ADULTS WITH REDUCED RENAL FUNCTION

Renal function	CrCl (mL/min)	Dose	Frequency
Mild impairment	50 – 30	1 – 2 g	Every 8 – 12 hrs
Moderate impairment	29 – 10	1 – 2g	Every 12 – 24 hours
Severe impairment	9 – 5	0.5 – 1 g	Every 12 – 24 hours
Essentially no function	< 5	0.5 – 1 g	Every 24 –  48 hours

 

Uncomplicated urinary tract infection

In uncomplicated urinary tract infection due to susceptible organisms, 1 g intramuscularly twice a day has been shown effective.

 

Uncomplicated gonorrhoea

For single dose therapy of uncomplicated gonorrhoea, including those caused by penicillinase-producing strains, the recommended dose is 2 g cefoxitin sodium intramuscularly given with 1 g of probenecid by mouth at the same time or up to 1 hour before.

Neonates (including premature infants), infants and children

USUAL PEDIATRIC DOSE

Age group	Dose	Frequency
Premature infants with body weights above 1500 g	20 – 40 mg/kg	Every 12 hours
Neonates 0 – 1 week of age 1 – 4 week of age	20 – 40 mg/kg 20 – 40 mg/kg	Every 12 hours Every 8 hours
Infants	20 – 40 mg/kg	Every 6 hours or Every 8 hours
Children	20 – 40 mg/kg	Every 6 hours or Every 8 hours

 

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 with 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.

 

PROPHYLACTIC DOSE

For prophylactic use in surgery the following doses are recommended:

GENERAL SURGERY

Adults

2 g administered intramuscularly or intravenously ½ to 1 hour before initial incision: then 2 g every 6 hours. Ordinarily, prophylactic therapy does not exceed 24 hours.

Neonates, infants and children

In case of infants and children, 30 – 40 mg/kg doses may be given at times designated above. However, in neonates 30 – 40 mg/kg doses may be given one half to 1 hour before the initial incision and the second and third dose may be given every 8 – 12 hours.

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 gynaecologic surgical procedure a single 2 g dose is 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 hour intervals. Ordinarily, prophylactic therapy does not extend beyond 24 hours.

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 compatible solutions listed below.

 

ADMINISTRATION

INTRAVENOUS ADMINISTRATION

The intravenous route is preferable for patients with bacteremia, bacterial septicaemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions such 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 may be added to an intravenous bottle containing 5% Dextrose Injection, 0.9% Sodium Chloride Solution, 5% Dextrose and 0.9%  Sodium Chloride Solution 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 in patients who have shown hypersensitivity to cephalosporins.

 

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, gentamicin, kanamycin and tobramycin when admixed in 200 mL of 0.9% Sodium Chloride or 5% Dextrose in Water.

 

WARNINGS FOR NEONATES

Solutions containing preservatives should not be used for injection or for flushing catheters in treating neonates. Benzyl alcohol as preservative in Bacteriostatic Water for Injection and Bacteriostatic Sodium Chloride Injection has been associated with toxicity in 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 preservative.

 

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 a refrigerator.

AVAILABILITY

Cefoxitin sodium (Monowel) 1g Sterile Powder for Injection IM/IV x 1 vial

CAUTION

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription

 

Manufacturer

Biolab Co., Ltd.

625 Soi 7A Bangpoo Industrial Estate, Sukhumvit Road

Moo 4, Prakasa, Muang, Samutprakarn 10280, Thailand

 

Marketing Authorization Holder

The Cathay Drug Co., Inc.

2/F Vernida I Condominium 120 Amorsolo St. Legaspi Village Makati City

 

Date of revision: July 2019