PYXIME SUSP

PYXIME Cefixime for Oral Suspension USP 100 mg / 5ml

Compositon of Pyxime [Cefixime]:

Each 5 ml (After Reconstitution) contains

Cefixime USP ( As Trihydrate )

Eq. To Anhydrous Cefixime …………….. 100mg.

Excipients……………………………………….Q.S.

Colour : Erythrosine.

Pharmacological Properties :

Pyxime [Cefixime] is a broad spectrum semi-synthetic third generation cephalosporin for oral administration. The bactericidal action results from inhibition of cell wall synthesis. Pyxime [Cefixime] is highly beta-lactamase stable, which makes it effective against many organisms resistant to penicillin’s and cephalosporins.

Indications of Pyxime [Cefixime] :

Pyxime [Cefixime] is active against the following gram-positive and gram-negative organisms: Streptococcus pneumonia, streptococcus pyogenes, Streptococcus agalactiae, haemophilus influenzae, haemophilus parainfluenzae, moraxella (branhamella) catarrhalis, Escherichia coil, proteus mirabilis, proteus vulgaris, Neisseria gonorrhea, klebsiella pneumonia, klebsiella oxytoca, pasteurella multocida, providencia species, shigella species, citrobacter diversus, serratia marcescens. Pyxime [Cefixime] is indicated in the treatment of the following infections:

• Pharyngitis, tonsillitis and sinusitis.
• Acute bronchitis and acute exacerbation of chronic bronchitis.
• Otitis media.
• Uncomplicated urinary tract infection
• Uncomplicated cervical or urethral gonorrhea.

Dosage and administration of Pyxime [Cefixime]:

• 400 mg daily, this may be given as 400 mg once daily or 200 mg every 12 hours.
• For the treatment of uncomplicated urethral or cervical gonococcal infections.
• 400mg as single dose is recommended.
• Usual pediatric dose: 8mg/kg/day of suspension. This may be given as single dose or in two divided doses as 4mg/kg/12 hours.

The following table shows children dose :

Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.

Dosage in renal impairment :

n case of renal impairment, the dosage should be adjusted according to the creatinine clearance.lf the creatinine clearance more than or equals 60 ml/min. he standard dose of 400 mg can be given, if it ranges from 21-60 ml/min, 75% of the standard dose can be given and in cases where it is less than 20m1/min. Half the standard dose can be given.

Contraindications :

Pyxime [Cefixime] Is contraindicated in patients who had previous hypersensitivity reactions to any of cephalosporins antibiotics

Adverse Effects :

Pyxime [Cefixime] has mild and transient side effects such as diarrhea, nausea, vomiting, abdominal pain. Skin rashes, urticaria and transient elevation in liver enzymes.

Some of these adverse effects may occur :

Hypersensitivity reaction:

• Anaphylactic/Anaphylactoid Reactions
• Angioedema
• Facial Edema
• Hepatic:
• Hepatitis
• Jaundice -Renal:
• Acute Renal Failure
• Central nervous system
• Seizures
• Hemic and lymphatic systems:
• neutropenia

‘Abnormal Laboratory Tests:

• hyperbilirubinemia

Other

• toxic epidermal necrolysis

Warnings and precautions Pyxime [Cefixime]:

As with other antibiotic, prolonged use may result in overgrowth of non-susceptible organisms. Drug interaction with warfarin and anticoagulant may occur.

Overdose :

Although no specific antidote exists, gastric lavage may be indicated.

Use in pregnancy and lactation :

Pregnancy Category B: this drug should be used during pregnancy only if clearly needed.lt is not known whether Pyxime [Cefixime] is excreted in breast milk, yet no problems in humans have reported to date.

Storage :

Store below 30°C. Protect from light and moisture.

Packing :

60ml

HDPE Plastic bottle.

KEEP ALL MEDICINE  S OUT OF REACH OF CHILDREN

Marketed by:

PYXUS PHARMACEUTICALS PVT. LTD.