Cepsafe

Uses

(Cepsafe) is used for the treatment of the following infections when caused by susceptible organisms:

The upper and lower respiratory tract infections: pharyngitis, sinusitis, otitis media, tonsillitis, laryngo-tracheo-bronchitis, acute and chronic bronchitis, lobar and chronic bronchopneumonia.

Urinary tract infections: cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.

Surgical prophylaxis: Surgical procedures associated with high risk of disastrous consequences of infections. Procef is also of value where postoperative infections would be disastrous and where patients have a reduced host resistance to bacterial infection. Protection is best ensured by achieving adequate local tissue concentrations at the time when contaminations are likely to occur. Thus, Procef should be administered immediately prior to surgery and continued during the postoperative period.

Cepsafe is also used to associated treatment for these conditions: Bacterial Sepsis, Bloodstream Infections, Osteomyelitis, Peritonitis, Respiratory Tract Infections (RTI), Septic Arthritis, Skin and Soft Tissue Infections, Urogenital infection bacterial

How Cepsafe works

Cepsafe is a first generation cephalosporin antibiotic with a spectrum of activity similar to Cefalexin. Cepsafe, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that Cepsafe interferes with an autolysin inhibitor.

Dosage

Cepsafe dosage

(Cepsafe) may be given regardless of meal.

Adults

Oral: The usual dose is 1-2 gm daily in 2 to 4 divided doses. In severe and chronic infection, the dose can be increased upto 4 gm daily which should be given in equally divided doses.

In skin and skin structure infections and respiratory tract infections: Usual dose is 250 mg every 6 hours or 500 mg every 12 hours.

In Lobar pneumonia: Usual dose is 500 mg every 6 hours or 1g every 12 hours.

In uncomplicated urinary tract infections: Usual dose is 500 mg every 12 hours. In more serious urinary tract infections including prostatitis, 500 mg every 6 hours or 1 g every 12 hours may be administered.

Injection: The usual dose is 2-4 g daily in four equally divided doses by deep intramuscular or intravenous route. Dose may be increased to 8 gm daily in severe infections e.g. septicaemia and endocarditis.

Surgical prophylaxis: 1-2 gm immediately prior to surgery, by intramuscular or intravenous injection over 3-5 minutes. Subsequent parenteral or oral doses can be administered as appropriate.

Children

Oral: The usual dose is 25-50 mg/kg/day total, given in 2 or 4 equally divided doses. For otitis media daily dose from 75-100 mg/kg body wt. in divided doses every 6 to 12 hours are recommended. Dose may be increased up to 4 g/day depending on the severity of the infection.

Injection: 50-100 mg/kg/day total, given in 4 equally divided doses.

(200-300 mg/kg/day may be required in more severe infections)

Elderly

There are no specific dosage recommendations or precautions for use in the elderly except as with other drugs to monitor those patients with impaired renal or hepatic functions.

Dosage in renal impairment

A modified dosage schedule is necessary in patients with decreased renal function. Each patient should be considered individually. The following modified dosage schedule is recommended as a guideline, based on creatinine clearance. In adults, the initial loading dose is 750 mg of Cepsafe and the maintenance dose is 500 mg at the following intervals:

Powder for Suspension: For the suspension, shake the bottle well before adding water. Then add 60 ml of boiled and cooled water (with the help of the provided cup) to thebottle. Then continue shaking the bottle gently until the powder is mixed properly. Shake the bottle well before each use.

Paediatric Drops: Shake the bottle well before adding water. Then add 10 ml (or with the help of provided spoon) of boiled and cooled water. Then continuously shake the bottle well until the powder is mixed properly. Shake the bottle well before each use.

500 mg Intramuscular Injection: Add 2.0 ml of water for injection to 500 mg vial and shake.

500 mg Intravenous Injection: Add 5.0 ml of water for injection to 500 mg vial and shake. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

1 gm Intramuscular Injection: Add 4.0 ml of water for injection to 1 gm vial and shake.

1 gm Intravenous Injection: Add 10.0 ml of water for injection to 1 gm vial and shake. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Side Effects

Rarely Cepsafe may induce a hypersensitivity reaction and gastrointestinal disturbances which include nausea, vomiting, diarrhoea, glossitis, heartburn, dizziness, abdominal pain, candidial overgrowth, vaginitis, skin rashes, urticaria, joint pain and oedema. As with other cephalosporin mild transient eosinophilia, leucopenia, neutropenia and rarely positive direct coombs test and pseudomembraneous colitis have been reported.

Precaution

There is evidence of partial cross-allergenicity between penicillins and cephalosporins. Therefore Cepsafe should be used with caution in patients with known hypersensitivity to penicillins.

Interaction

Increased risk of nephrotoxicity with loop diuretics. Decreased renal clearance with probenecid.

Food Interaction

• Take with or without food.

Elimination Route

Over 90 percent of the drug is excreted unchanged in the urine within six hours.

Pregnancy & Breastfeeding use

No teratogenicity has been demonstrated in animals, but safety in pregnancy has not been established. Cepsafe is excreted in the breast milk and should be used with caution in lactating mothers.

Contraindication

Patients with known hypersensitivity to the cephalosporin antibiotics.

Special Warning

Directions for reconstitution:

Cepsafe powder for suspension : Add 70 ml (14 measuring spoonful) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake the bottle well after each addition of water until all the powder is in suspension.

Cepsafe fort powder for suspension :Add 55 ml (with the help of supplied measuring cup) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake the bottle well after each addition of water until all the powder is in suspension.

Cepsafe powder for paediatric drops :Add 10 ml (2 measuring spoonful) of boiled and cooled water to the bottle and shake vigorously.

Note: Shake both the suspension and paediatric drops bottle well before each use. Keep the bottle tightly closed.

Cepsafe 250 IM/IV Injection :

Intramuscular injection : Add 1.2 ml of supplied water for injection BP to the vial and shake.

Intravenous injection : Add 5 ml of supplied water for injection BP to the vial and shake. The solution should be slowly injected directly into a vein over a 3 to 5 minute period.

Cepsafe 500 IM/IV Injection:

Intramuscular injection : Add 2 ml of supplied water for injection BP to the vial and shake.

Intravenous injection : Add 5 ml of supplied water for injection BP to the vial and shake. The solution should be slowly injected directly into a vein over a 3 to 5 minute period.

Cepsafe 1 gm IM/IV Injection:

Intramuscular injection : Add 4 ml of supplied water for injection BP to the vial and shake.

Intravenous injection : Add 10 ml of supplied water for injection BP to the vial and shake. The solution should be slowly injected directly into a vein over a 3 to 5 minute period.

Pharmaceutical precaution

Cepsafe capsule, powder for suspension, powder for paediatric drops and vial (for injection) should be kept in a cool and dry place, away from light. The reconstituted suspension should be used within 7 days if kept at room temperature or within 14 days if refrigerated. The reconstituted Cepsafe injection solution should be used within 2 hours if kept at room temperature or within 12 hours if kept in refrigerator (2-8°C).

Interaction with other Medicine

The cephalosporins are potentially nephrotoxic (particularly Cefaloridine) and may enhance the nephrotoxicity of aminoglycoside antibiotics such as Gentamycin and Tobramycin. One should be cautious about the use of any cephalosporin with Frusemide and Ethacrynic acid.

Storage Condition

Cephradine capsule should be kept below 30° C. Cephradine dry powder for suspension should be kept below 25° C & powder vial for injection should be kept below 25° C.

The reconstituted suspension, forte suspension and paediatric drops should be used within 7 days of preparation if kept at room temperature or within 14 days if kept in a refrigerator.

The Cephradine solution should be protected from bright or direct sunlight. All strengths of reconstituted products should be used immediately.

The reconstituted Cephradine injection solution should be used within 2 hours of preparation if kept at room temperature or within 12 hours when refrigerated at 2° to 8° C.

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