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Cefpodoxime Proxetil & Dicloxacillin {ER} Tablet
Packing:- 10 x 10 (Alu- Alu)
Indications:- Lower respiratory tract infections like Pneumonia, Bronchitis,
Lung abcess

  • Tablet Presentation
    Each Film Coated Tablets Contains:
    Cefpodoxime Proxetil IP - 200 mg
    Dicloxacillin {ER} IP - 500 mg


    Cefpodoxime Proxetil is (6R,7R)-7-{[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyimino-acetyl]amino} -3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid an oral third generation cephalosporin antibiotic. It is commonly used to treat acute otitis media, pharyngitis and sinusitis.
    Dicloxacillin Sodium is (2S,5R,6R)-6-{[3-(2,6-dichlorophenyl)-5-methyl- oxazole-4 carbonyl]amino}-3,3- dimethyl-7-oxo-4-thia- 1-azabicyclo [3.2.0] heptane-2-carboxylic acid a narrow-spectrum beta- lactum antibiotic of the penicillin class. It is commonly used in Pneumonia, septic arthritis and throat infections.

    Indications

    Cefpodoxime Proxetil:
    ⇛Acute otitis media
    ⇛ Pharyngitis and/or tonsillitis
    ⇛ Community-acquired pneumonia
    ⇛ Acute bacterial exacerbation of chronic bronchitis
    ⇛ Acute, uncomplicated urethral and cervical gonorrhea
    ⇛ Acute, uncomplicated ano-rectal infections in women
    ⇛ Uncomplicated skin and skin structure infections
    ⇛ Acute maxillary sinusitis
    ⇛ Uncomplicated urinary tract infections (cystitis).

    Dicloxacillin Sodium:
    ⇛ Staphylococcal skin infections and cellulitis – including impetigo, otitis externa, folliculitis, boils, carbuncles, and mastitis.
    ⇛ Pneumonia (adjunct)
    ⇛ Osteomyelitis, septic arthritis, throat infections, streptococcus
    ⇛ Septicaemia
    ⇛ Empirical treatment for endocarditis
    ⇛ Surgical prophylaxis.

    Rationale of Combination

    Product Description:
    ⇛ Reduction in the frequency of the dosing.
    ⇛ Increase in the effectiveness of drug by localization at the site of action.
    ⇛ Uniform drug delivery.
    ⇛ Release of one or more drugs continuously in a predetermined pattern for a fixed period time, either systemically or to a specified target organ.

    Pharmacology

    Cefpodoxime Proxetil:
    Mechanism of Action:
    The bactericidal activity of cefpodoxime results from its inhibition of cell wall synthesis. The active metabolite of cefpodoxime binds preferentially to penicillin binding protein 3, which inhibits production of peptidoglycan, the primary constituent of bacterial cell walls. Cefpodoxime proxetil is a prodrug that is absorbed from the gastrointestinal tract and de- esterified to its active metabolite, cefpodoxime.

    Pharmacokinetics:
    Absorption: Following oral administration of 100 mg of cefpodoxime proxetil to fasting subjects, approximately 50% of the administered cefpodoxime dose was absorbed systemically.
    Protein Binding: 22 to 33% in serum and from 21 to 29% in plasma.
    Elimination: Over the recommended dosing range (100 to 400 mg), approximately 29 to 33% of the administered cefpodoxime dose was excreted unchanged in the urine in 12 hours.
    Half Life: 2.09 to 2.84 hours.

    Dicloxacillin Sodium:
    Mechanism of Action:
    Dicloxacillin exerts a bactericidal action against penicillin-susceptible microorganisms during the state of active multiplication. All penicillins inhibit the biosynthesis of the bacterial cell wall. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, dicloxacillin 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 dicloxacillin interferes with an autolysin inhibitor.

    Pharmacokinetics:
    Absorption: Absorption of the isoxazolyl penicillins after oral administration is rapid but incomplete: peak blood levels are achieved in 1-1.5 hours. Oral absorption of dicloxacillin is delayed when the drugs are administered after meals.
    Protein Binding: Binds to serum protein, mainly albumin.
    Elimination: Dicloxacillin sodium is rapidly excreted as unchanged drug in the urine by glomerular filtration and active tubular secretion.
    Half Life: The elimination half-life for dicloxacillin is about 0.7 hour.

    Adverse Effects

    Cefpodoxime Proxetil:
    ⇛ Upset stomach
    ⇛ Diarrhea
    ⇛ Vomiting
    ⇛ Mild skin rash

    Dicloxacillin Sodium:
    ⇛ Nausea, vomiting, stomach pain
    ⇛ Vaginal itching or discharge
    ⇛ Headache
    ⇛ Swollen, black, or "hairy" tongue; or
    ⇛ Thrush (white patches or inside your mouth or throat)

    Contraindications

    ⇛ Hypersensitivity reactions to cefpodoxime, other cephalosporins, penicillins, or other drugs.
    ⇛ If cefpodoxime is to be administered to penicillin sensitive patients, caution should be exercised because cross hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.

    Do not use the medication id you have:
    ⇛ Asthma
    ⇛ Liver disease
    ⇛ Kidney disease
    ⇛ A bleeding or blood clotting disorder
    ⇛ A history of diarrhea caused by taking antibiotics or
    ⇛ A history of any type of allergy
    ⇛ Tell your doctor if you are pregnant or plan to become pregnant during treatment.
    ⇛ Dicloxacillin can make birth control pills less effective, which may result in pregnancy.
    Before taking dicloxacillin, tell your doctor if you use birth control pills.
    ⇛ Dicloxacillin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    Drug Interactions

    Cefpodoxime Proxetil:
    Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels by 24% to 42% and the extent of absorption by 27% to 32%, respectively. The rate of absorption is not altered by these concomitant medications. Oral anti-cholinergics (e.g., propantheline) delay peak plasma levels (47% increase in Tmax), but do not affect the extent of absorption (AUC).
    Probenecid: As with other beta-lactam antibiotics, renal excretion of cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC and 20% increase in peak cefpodoxime plasma levels.
    Nephrotoxic Drugs: Although nephrotoxicity has not been noted when cefpodoxime proxetil was given alone, close monitoring of renal function is advised when cefpodoxime proxetil is administered concomitantly with compounds of known nephrotoxic potential.
    Drug/Laboratory Test Interactions: Cephalosporins, including cefpodoxime proxetil, are known to occasionally induce a positive direct Coombs' test.
    TAKE CEFPODOXIME TABLETS WITH FOOD.

    Dicloxacillin Sodium:
    Before taking dicloxacillin, tell your doctor if you are using any of the following drugs:
    Methotrexate
    Probenecid
    Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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