(+977) 4110791, 01-4110761 info@opl.com.np
BACMAX

Generic Name:                    Cefpodoxime Proxetil

Therapeutic Category:     Antibiotics

Pharmacological Class:   Second Generation Cephalosporin

Composition:                      Bacmax RPOS

                                                Each 5 ml of reconstituted suspension contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime Proxetil 50 mg

Presentation:                      Available in 60 ml bottle with a measuring cap

Description

A third-generation cephalosporin, Cefpodoxime Proxetil is a bactericidal agent that inhibits cell wall synthesis. It’s usually active against gram-positive aerobes, such as S. aureus (including penicillinase-producing strains), S. saprophyticus, S. pneumoniae, and S. pyogenes, and gram-negative aerobes, such as E. coli, H. influenzae (including beta-lactamase-producing strains), K. pneumoniae, M.catarrhalis, Neisseria gonorrhoeae (including penicillinase-producing strains), and P. mirabilis.

Mechanism of Action

Cefpodoxime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefpodoxime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.


Indications

  • Lower respiratory tract infections: Acute community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis
  • Upper respiratory tract infections: Acute otitis media, acute maxillary sinusitis, pharyngitis, tonsillitis.
  • Uncomplicated urinary tract infections: Cystitis, Pyuria.
  • Skin and soft tissue infections: Furuncle, cellulitis, subcutaneous abscess, infectious atheroma & periproctal abscess.

Dosage

 Route of administration: Oral

BACMAX RPOS

Adults and Elderly:

Not applicable for this product

Infants (>2 months) and Children (up to 11 years):

The recommended mean dosage for children is 8mg/kg/day, administered in two divided doses at 12-hour intervals.

 

The following table provides dosage regimen for children as per the bodyweight graduations provided on the measuring cap:

Body weight in kgCefpodoxime dose in mg to be used twice dailyCefpodoxime dose in ml to be used twice daily
5202.5
10405
15607.5
208010
2510012.5

 

Direction for Reconstitution

  • Shake the bottle until the powder flows freely.
  • Boil the water and let it cool down at room temperature.
  • Add approximately one half of the total water required for reconstitution. Shake vigorously to suspend powder.
  • Add remaining water up to the mark and shake vigorously.
  • This provides 60 ml of solution.

Note: Store the suspension at 2-80C

     Do not use the suspension for more than 7 days

 

Pharmacokinetics

Absorption: Absorbed via the GI tract. Absorption and mean peak plasma levels increase when drug is given with food.

Distribution: Widely distributed to most tissues and fluids. Adequate data on CSF levels are not available.

Protein binding: 22 to 33% in serum and from 21 to 29% in plasma

Metabolism: De-esterified to its active metabolite, cefpodoxime

Route of elimination: Renal

Half-life: 2.09 to 2.84 hours

Adverse Effects

Common side-effects are:

  • Nausea, vomiting, stomach pain, mild diarrhea, bloating, gas, constipation
  • diaper rash; mild itching or skin rash
  • stiff or tight muscles, back pain, muscle pain
  • headache, tired feeling
  • anxiety, nervousness, feeling restless or hyperactive
  • dizziness, spinning sensation
  • dry mouth, unusual or unpleasant taste in your mouth
  • white patches or sores inside your mouth or on your lips

 Contraindications

BACMAX is contraindicated in the following situations:

  • Hypersensitivity to cefpodoxime or to any of the components of the formulation.
  • Safety of Cefpodoxime is not established in infants under the age of 2 months.

Precautions

  • Bacterial or fungal overgrowth of non-susceptible organisms may occur with prolonged or repeated therapy
  • Use with caution in patients with history of penicillin allergy
  • Use caution in patients with history of beta-lactam allergy, especially IGE mediated reactions, including angioedema, anaphylaxis, urticaria)
  • Some dosage forms may contain the metabolite of benzyl alcohol benzoic acid; large amounts of benzyl alcohol associated with potentially fatal toxicity (gasping syndrome) in neonates; avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates

Drug Interactions

  • Antacids, H2 antagonists, oral anticholinergics may decrease efficacy of Cefpodoxime.
  • It may be potentiated by probenecid.
  • Also, administration of concomitant diuretics, other nephrotoxic drugs must be avoided.
*Terminologies:

Cystitis: An inflammation of the bladder.

Prostatitis: The inflammation (swelling) of the prostate gland.

Plague: An infectious disease caused by the bacterium Yersinia pestis.

Tendinitis: The inflammation of a tendon, most commonly from overuse but also from infection or rheumatic disease.

Myasthenia Gravis: A chronic autoimmune neuromuscular disease that causes weakness in the skeletal muscles, which are responsible for breathing and moving parts of the body, including the arms and legs.