NIFIN 100

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NIFIN 100 TABS

COMPOSITION:

Cefpodoxime (as cefpodoxime proxetil) ............................................................................100 mg

Excipients q.s...................................................................................................................... 1 tablet

(Sodium starch glycolate, pregelatinized starch, aerosil, sodium lauryl sulfate, croscarmellose sodium, ludipress, talc, magnesium stearate, HPMC 606, HPMC 615, PEG 6000, titanium dioxide, red ferric oxide).

DOSAGE FORM: Film coated tablet.

PRESENTATION: Box of 2 blisters x 10 tablets.

PHARMACODYNAMICS:

Nifin 100 Tabs contains cefpodoxime which is classified as a third generation cephalosporin. Cefpodoxime is stable in the presence of beta-lactamases produced by Gram-positive and Gram-negative bacteria. Cefpodoxime is active against Gram-positive cocci e.g., Streptococcus pneumoniae, Staphylococcus, and Gram-negative bacteria e.g., E.coli, Klebsiella, Proteus mirabilis and Citrobacter.

PHARMACOKINETICS:

Cefpodoxime is absorbed through the gastrointestinal tract. Bioavailability of cefpodoxime is about 50% and is increased in the presence of food. The elimination half-life of cefpodoxime is 2.1 - 2.8 hours in patients with normal renal function and 3.5 - 9.8 hours in patients with renal impairment. Cefpodoxime is excreted unchanged in the urine. No biotransformation occurs in the liver and kidney.  Approximately 40% cefpodoxime is bound plasma protein.

INDICATIONS:

Treatment of mild to moderate lower respiratory tract infections, including acute community acquired pneumonia caused by susceptible Streptococcus pneumoniae or Haemophilus influenzae (including beta-lactamase-producing strains) and acute exacerbation of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae or M. catarrhalis (non-beta-lactamase-producing strains only).

Substitute for penicillin in the treatment of mild to moderate upper respiratory tract infections (including pharyngitis, tonsillitis, etc.) caused by susceptible Streptococcus pyogenes.

Treatment of acute otitis media caused by S. pneumoniae, H. influenza (including beta-lactamase-producing strains) or B. catarrhalis.

Treatment of mild to moderate urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.

Treatment of acute gonorrhea caused by nonpenicillinase or penicillinase-producing strains of Neisseria gonorrhoeae.

Treatment of skin infections caused by Staphylococcus aureus (including penicillinase-producing strains) or susceptible strains of Streptococcus pyogenes.

CONTRAINDICATIONS:

Cefpodoxime is contraindicated in patients with a known allergy to cephalosporins and porphyria. Previous history of severe hypersensitivity reaction (anaphylaxis) to penicillins or other beta-lactam antibiotics.

Children aged under 15 days.

PRECAUTIONS:

Patients who are hypersensitive to penicillins or suffered from renal insufficiency.

Cefpodoxime should not be used in the treatment of atypical pneumonia caused by organisms such as Legionella, Mycoplasma and Chlamydia. Cefpodoxime is not recommended for the treatment of pneumonia due to S. pneumonia.

Cefpodoxime should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis. As with other antibiotics, prolonged use of cefpodoxime may result in the overgrowth of non-susceptible organisms (Candida and Clostridium difficile). Pseudo-membranous colitis has been reported with the use of cefpodoxime proxetil.

PREGNANCY AND LACTATION:

Cautions should be taken in pregnant women and nursing mothers.

There are no data from the use of cefpodoxime in pregnant women; however, cefpodoxime should be used during pregnancy only if clearly needed.

Low concentrations of cefpodoxime are excreted into breast milk; but it may affect breast-fed infants such as: intestinal flora disorder, direct impact on infant body, misleading result of antibio-gramme.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

Dizziness has been reported during treatment with cefpodoxime. It should not be taken during driving or using machines.

INTERACTIONS:

Histamine H2-antagonists and antacids reduce the bioavailability of cefpodoxime. Probenecid reduces the excretion of cephalosporins. Cephalosporins potentially enhance the anticoagulant effect of coumarin and reduce the contraceptive effect of estrogen.

ADVERSE EFFECTS:

Common: Nausea, vomiting, diarrhea, abdominal pain. Headache. Rash, urticaria, pruritus.

Uncommon: Serum sickness-like reactions. Erythema multiforme. Disordered hepatic enzyme, hepatitis, and temporary obstructive jaundice.

Rare: Eosinophilia, blood disorders. Reversible interstitial nephritis. Excitement, sleeping trouble, hypertonia, and dizziness.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

No found. Supportive measures are almost indicated to remove cefpodoxime from the body. Symptomatic treatment is practiced as other cephalosporins.

DOSAGE & ADMINISTRATION:

The drug should be taken after a meal.

Adults and children aged more than 13 years:

Pharyngitis, tonsillitis, mild to moderate urinary tract infections: 100 mg (1 tablet) twice daily every 12 hours for 5 - 10 days.

Otitis media, chronic bronchitis, mild to moderate acute pneumonia: 200 mg (2 tablets) twice daily every 12 hours for 10 - 14 days.

Skin infection: 400 mg (4 tablets) twice daily every 12 hours for 7 - 14 days.

Gonorrhea: a single dose of 200 mg (2 tablets).

Children:

Treatment of acute otitis media, children aged from 5 months to 12 years: 5 mg/kg (maximum 200 mg) twice daily in 10 days. Or 10 mg/kg (maximum 400 mg) once daily for 10 days.

Treatment of bronchitis, mild to moderate tonsillitis, children aged from 5 months to 12 years: 5 mg/kg (maximum100 mg) twice daily for 5 - 10 days. 

Treatment of other infections:

Children aged from 15 days to 6 months: 8 mg/kg/day in 2 divided doses.

Children aged from 6 months to 2 years: 40 mg twice daily.

Children aged from 3 - 8 years: 80 mg twice daily.

Children aged more than 9 years: 100 mg twice daily.

Patients with renal impairment: 

Creatinine clearance less than 30 ml/min; to the patients with non-haemodialysis: indicated as usual dose, taking every 24 hours; to patients with haemodialysis: indicated as usual dose, taking 3 times/ week.

Or as directed by the physician.

Read the directions carefully before use.

Consult the physician for more information.

This drug is for prescription only.

Shelf-life: 24 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

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