Mahacef Xl

Uses

Cefixime is used for the following infectious diseases -

Respiratory Tract Infections:

Pneumonia

Sinusitis

Pharyngitis and Tonsillitis

Acute Bronchitis and Acute Exacerbations of Chronic

Bronchitis (AECB)

Otitis Media

Typhoid Fever

Urinary Tract Infections

Uncomplicated gonorrhea (cervical/urethral)

Cloxacillin is used for the treatment of infections caused by Grampositive organisms including infections caused by β-lactamase producing Staphylococci such as :

• Skin and soft tissue infections : Boils, Abscesses, Carbuncles, Furunculosis, Cellulitis, Infected wounds, Infected burns, Otitis media and externa, Protection of skin graft and Skin infections like ulcer, eczema, acne, etc.
• Respiratory tract infections : Pneumonia, Lung abscess, Empyema, Sinusitis, Pharyngitis and Tonsillitis.
• Other infections caused by sensitive organisms : Osteomyelitis, Enteritis, Endocarditis, Urinary tract infection, Meningitis and Septicaemia.

Mahacef Xl is also used to associated treatment for these conditions: Acute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae, Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenzae, Bacterial Sinusitis, Community Acquired Pneumonia (CAP), Gonorrhea of anus, Lyme Disease, Salmonella Infections, Salmonella Typhi Infection, Shigella Infection, Streptococcal Pharyngitis, Streptococcal tonsillitis, Uncomplicated Urinary Tract Infections, Bacterial otitis media, Bacterial rhinosinusitis, Uncomplicated GonorrheaInfection caused by staphylococci, Infections caused by penicillinase-producing staphylococci, Pneumococcal Infection, Streptococcal Infections

How Mahacef Xl works

Like all beta-lactam antibiotics, cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of 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 cefixime interferes with an autolysin inhibitor.

By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, cloxacillin 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 cloxacillin interferes with an autolysin inhibitor.

Dosage

Mahacef Xl dosage

The usual treatment of Cefixime is 7 days. This may be continued for up to 14 days according to the severity of infection.

Cefixime Capsule

Adult and child over 12 years: 200 or 400 mg daily as a single dose or in two divided doses.

Cefixime Suspension

Child over 6 months: 8 mg/kg daily as a single dose or in 2 divided doses

Upper Respiratory Tract Infection (Adult):

• Usual Dose: 250 mg orally every 6 hours for 7 to 14 days, depending on the nature and severity of the infection.
• Maximum dose: 4 g/day.

Upper Respiratory Tract Infection (Pediatric):

• Usual Dose: The safety and efficacy of cloxacillin in children < 1 year have not been established.
• ≥ 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.
• Maximum dose: 4 g/day.

Pneumonia(Adult):

• Usual Dose: 500 mg orally every 6 hours for up to 21 days, depending on the nature and severity of the infection.
• Maximum dose: 4 g/day.

Pneumonia(Pediatric):

• Usual Dose: The safety and efficacy of cloxacillin in children < 1 year have not been established.
• ≥ 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.
• Maximum dose: 4 g/day.

Skin and Structure Infection(Adult):

• Usual Dose: 500 mg orally every 6 hours for 7 days, or until 3 days after acute inflammation resolves, depending on the nature and severity of the infection.
• Maximum dose: 4 g/day.

Skin and Structure Infection (Pediatric):

• Usual Dose: The safety and efficacy of cloxacillin in children < 1 year have not been established.
• ≥ 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.
• Maximum dose: 4 g/day.

Cystitis:

• Usual Adult Dose: 250 mg orally every 6 hours for 3 to 7 days, depending on the nature and severity of the infection. Cloxacillin is rarely indicated for the treatment of cystitis.
• Maximum dose: 4 g/day.

Direction for Reconstitution of Suspension

• To prepare 50 ml suspension, 25 ml boiled and cooled water is required.

• To prepare 40 ml suspension, 20 ml boiled and cooled water is required.

• To prepare 30 ml suspension, 15 ml boiled and cooled water is required.

• To prepare 50 ml DS suspension, 25 ml boiled and cooled water is required.

Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half of the total amount of water and shake well. Add remainder of water, and then shake again.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 14 days.

Side Effects

Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials are mild and self limiting in nature.

Gastro-intestinal disturbance: Diarrhea (if severe diarrhea occurs, Cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported. CNS disturbances: Headache, dizziness.

Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase.

Common side effects are skin rash, transient diarrhoea, nausea, heartburn, pruritus and disturbance of blood electrolyte. Rarely anaphylactic shock.

Toxicity

Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and vomiting.

Oral LD₅₀ in rat and mouse is 5000 mg/kg. Intravenous LD₅₀ in rat is 1660 mg/kg. Symptoms of overdose include wheezing, tightness in the chest, fever, itching, bad cough, blue skin color, fits, and swelling of face, lips, tongue, or throat.

Precaution

Cefixime should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min)

Cloxacillin should be given with caution to patients with known history of allergy.

Interaction

Increased prothrombin time (with or withot bleeding) with anticoagulants (e.g. warfarin). Increased plasma carbamazepine concentrations with concomitant use. Increased bioavailability with nifedipine. Increased serum concentration with probenecid.

May diminish the effect of BCG and typhoid vaccine. May increase risk of methotrexate toxicity. May diminish the therapeutic effect of Na picosulfate. May decrease serum concentrations of mycophenolate. May prolong bleeding time with anticoagulants. Increased serum concentrations with probenecid. Tetracycline may antagonise the bactericidal effect of cloxacillin.

Elimination Route

About 40%-50% absorbed orally whether administered with or without food, however, time to maximal absorption is increased approximately 0.8 hours when administered with food.

Well absorbed from the gastrointestinal tract.

Half Life

3-4 hours (may range up to 9 hours). In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours.

Pregnancy & Breastfeeding use

Pregnancy: Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Lactation: It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

Use in Elderly

No special precautions are necessary. No dosage adjustment is required for elderly

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Contraindication

Patients with known hypersensitivity to cephalosporin antibiotics, children under 6 months.

Cloxacillin should not be given to patients known to be hypersensitive to penicillin.

Special Warning

Use in Children: Safety and effectiveness of cefixime in children aged less than 6 months have not been established. For children younger than 12 years or weighing less than 50 kg, the usual dose is 8 mg/kg/day.

Use in elderly: No special precautions are necessary. Old age is not an indication for dose adjustment.

Dosage in renal impairment:

• Creatinine clearance: 20 ml/min or greater: normal dose
• Creatinine clearance: <20 ml/min or chronic ambulatory peritoneal dialysis
• Haemodialysis: daily dose should not exceed 200 mg.

Acute Overdose

Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Storage Condition

Store in a cool and dry place below 30ºC

Dry powder: Store below 25° C. Reconstituted solution: Store between 2-8° C (stable for 4 days); 23° C (stable for 24 hr).

Innovators Monograph

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