Ziftum 500/250 Tablets
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Ziftum
Cefuroxime Axetil Tablets USP 500mg
COMPOSITION:
Each film coated tablet contains:
Cefuroxime Axetil USP equivalent to
Ceturoxime…..500 mg
Excipients……q.S.
Colour: Titanium Dioxide BP
Cefuroxime Axetil Tablets USP 250mg
COMPOSITION:
Each film coated tablet contains:
Cefuroxime Axetil USP equivalent to
Cefuroxime……250 mg
Excipients…..q.s.
Colour: Titanium Dioxide BP
PHARMACOLOGICAL CLASSIFICATION:
Antibacterial agent.
PHARMACOLOGICAL ACTION:
Cefuroxime Axetil owes its in vivo bacterial activity to the parent compound cefuroxime. All cephalosporins (B-lactam antibiotics) inhibit cell wall production and are selective inhibitors of peptidoglycan synthesis. The initial step in drug action consists of binding of the drug to cell receptors called Penicillin-Binding Proteins. After a -lactam antibiotic has bound to these receptors, the transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked. Bacterial lysis is the end result.
INDICATIONS:
ZIFTUM –
For Adolescents and Adults having age of 13 years and older
- Pharyngitis / Tonsillitis
- Acute Bacterial Exacerbations of Chronic Bronchitis
- Secondary Bacterial Infections of Acute Bronchitis
- Uncomplicated Skin and Skin-structure Infections
- Uncomplicated Urinary Tract Infections
- Uncomplicated Gonorrhea
- Early Lyme Disease
Pediatric Patients (who can swallow tablets whole)
- Acute Otitis Media
- Acute Bacterial Maxillary Sinusitis
DOSAGE: ZIFTUM
| Population/ Infection | Dosage | duration (days) |
| Adolescents and Adults (13 years and older) | ||
| Pharyngitis / Tonsiitis | 250 mg b.i.d.
|
10 |
| Acute Bacterial Maxillary Sinusitis | 250 mg b.i.d. | 10 |
| Acute Bacterial Exacerbations of Chronic Bronchitis | 250 or 500 mg b.i.d | 10* |
| Secondary Bacterial Infections of Acute Bronchitis | 250 or 500 mg b.i.d. | 5-10 |
| Uncomplicated Skin and Skin-structure Infections | 250 or 500 mg b.i.d. | 10 |
| Uncomplicated Urinary Tract Infections | 250 mg b.i.d. | 7-10 |
| Uncomplicated Gonorrhea | 1,000 mg once | single dose |
| Early Lyme Disease | 500 mg b.i.d. | 20 |
| Pediatric Patients (who can swallow tablets whole) | ||
| Acute Otitis Media | 250 mg b.i.d. | 10 |
| Acute Bacterial Maxillary Sinusitis | 250 mg b.i.d. | 10 |
| *The safety and effectiveness of cefuroxime administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established. | ||
CONTRAINDICATIONS:
- Hypersensitivity to cefuroxime, other cephalosporins or to any of the excipients.
- Previous immediate and /or severe hypersensitivity reaction to penicillin or to any other type of beta-lactammedicinal products.
WARNINGS AND SPECIAL PRECAUTIONS:
Cefuroxime Axetil should be given with caution to patients with a history of kidney disease, such as kidney failure (renal failure), an allergy to cephalosporin or penicillin antibiotics, any other allergies, including to foods, dyes or preservatives.
SIDE EFFECTS:
Cefuroxime is generally well tolerated and side effects are usually transient. Cefuroxime, if ingested with food, is both better absorbed and less likely to cause its most common side effects of diarrhea, nausea, vomiting, headaches/migraines, dizziness and abdominal pain. Although there is a widely quoted cross-allergy risk of 10% between cephalosporins and penicillin, recent assessments have shown no increased risk for cross-allergy for cefuroxime and several other 2nd generation or later. cephalosporins.
Other side effects of Cefuroxime may include seizures, signs of an allergic reaction, such as: an unexplained rash, hives, Itching, unexplained swelling (especially of the lips, mouth or throat), wheezing or other breathing problems.
DRUG INTERACTION:
Probenecid reduces renal clearance of cefuroxime, may show nephrotoxicity with aminoglycoside and furosemide. Other drug interactions may include with oral contraceptives, antacids like famotidine, cimetiidne, ranitidine and Omeprazole, Blood thinner like warfarin.
FERTILITY, PREGNANCY & LACTATION:
Pregnancy:
There are limited data from the use of cefuroxime in pregnant women. Studies in animals have shown no harmful effects on pregnancy, embryonal or foetal development, parturition or postnatal development. Cefuroxime axetil should be prescribed to pregnant women only if the benefit outweighs the risk.
Breast Feeding:
Cefuroxime is excreted in human milk in small quantities. Adverse effects at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded. Breast feeding might have to be discontinued due to these effects. The possibility of sensitisation should be taken into account. Cefuroxime should only be used during breast feeding after benefit/risk assessment by the physician in charge.
Fertility:
There are no data on the effects of cefuroxime axetil on fertility in humans. Reproductive studies in animals have shown no effects on fertility.
OVERDOSAGE AND TREATMENT:
Overdose of cephalosporins may cause cerebral irritancy leading to convulsions. In case of overdose cefuroxime serum levels can be reduced by haemodialysis and peritoneal dialysis.
STORAGE:
Store below 30°C. Protect from light.
Keep medicine out of reach of children.
PRESENTATION:
1×6 tablets Alu-Alu blister Pack.
Updated on 9/Feb/2024