• VTEM Image Show
  • VTEM Image Show
  • VTEM Image Show
Gloryoxime oral Suspension

(cefpodoximeproxetil) forOral Use Only

-GloryoximeTablets contain cefpodoximeproxetil equivalent to 200 mg

-GloryoximeOral Suspension contains cefpodoximeproxetil equivalent to 50 mg or 100 mg\5ml of cefpodoxime.

Cefpodoxime is an oral third generation cephalosporinantibiotic.It is active against most Gram positive and Gram negative organisms. Notable exceptions include Pseudomonas aeruginosa, Enterococcus, and Bacteroidesfragilis. It is commonly used to treat acute otitis media, pharyngitis, and sinusitis. It also finds use as oral continuation therapy when intravenouscephalosporins (such as ceftriaxone) are necessary for continued treatment.

Cefpodoximeproxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)- l(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2-(2-amino-4- thiazolyl)-2- {(Z)methoxyimino} acetamido]-3- methoxymethyl-8-oxo-5-thia-l-azabicyclo [4.2.0]oct-2-ene-2-carboxylate. Its empirical formula is C21H27N5O9S2 and its structural formula is represented below:

 

The molecular weight of cefpodoximeproxetil is 557,6.

Cefpodoximeproxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoximeproxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied both as film-coated tablets and as flavored granules for oral suspension.

GloryoximeTablets contain cefpodoximeproxetil equivalent to 200 mg of cefpodoxime activity and the other inactive ingredients

Each 5 mL ofGloryoximeOral Suspension contains cefpodoximeproxetil equivalent to 50 mg or 100 mg\5ml of cefpodoxime activity after constitution and the other inactive ingredients.

 

DOSAGE AND ADMINISTRATION

Cefpodoximeproxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see for specific recommendations. Acute otitis mediacaused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilusinfluenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains).

Pharyngitis and/or tonsillitis caused by Streptococcuspyogenes.

. Cefpodoximeproxetil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoximeproxetil for the prophylaxis of subsequent rheumatic fever are not available.

Community-acquired pneumonia caused by S. pneumoniae or H. Influenzae(including beta-lactamase-producing strains).

Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis. Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains of H. influenzae.

Acute, uncomplicated urethral and cervical gonorrhea caused by Neisseriagonorrhoeae (including penicillinase-producing strains).

Acute, uncomplicated ano-rectal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).

NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeae has not been established. Data do not support the use of cefpodoximeproxetil in the treatment of pharyngeal infections due to N. gonorrhoeae in men or women.

Uncomplicated skin and skin structure infections caused by Staphylococcusaureus (including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.

Acute maxillary sinusitis caused by Haemophilusinfluenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.

Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiellapneumoniae, Proteus mirdbilis, or Staphylococcus saprophyticus.

DOSAGE AND ADMINISTRATION

FILM-COATED TABLETS:

Gloryoxime(cefpodoxmineproxetil) Tablets should be administered orally with food to enhance absorption.

The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart:

Adults and Adolescents (age 12 years and older):

Type of Infection

Total Daily Dose

Dose Frequency

Duration

Pharyngitis and/or tonsillitis

200 mg

100 mg Q 12 hours

5 to 10 days

Acute community-acquired pneumonia

400 mg

200 mg Q 12 hours

14 days

Acute bacterial exacerbations of chronic bronchitis

400 mg

200 mg Q 12 hours

10 days

Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)

200 mg

single dose

 

Skin and skin structure

800 mg

400 mg Q 12 hours

7 to 14 days

Acute maxillary sinusitis

400 mg

200 mg Q 12 hours

10 days

Uncomplicated urinary tract infection

200 mg

100 mg Q 12 hours

7 days

 

GRANULES FOR ORAL SUSPENSION:

GLORYOXIME(cefpodoxmineproxetil) Oral Suspension may be given without regard to food. The recommended dosages, durations of treatment, and applicable patient populations are as described in the following chart:

Adults and Adolescents (age 12 years and older):

Type of Infection

Total Daily Dose

Dose Frequency

Duration

Pharyngitis and/or tonsillitis

200 mg

100 mg Q 12 hours

5 to 10 days

Acute community-acquired pneumonia

400 mg

200 mg Q 12 hours

14 days

Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)

200 mg

single dose

 

Skin and skin structure

800 mg

400 mg Q 12 hours

7 to 14 days

Acute maxillary sinusitis

400 mg

200 mg Q 12 hours

10 days

Uncomplicated urinary tract infection

200 mg

100 mg Q 12 hours

7 days

 

Infants and Pediatric Patients (age 2 months through 12 years):

Type of Infection

Total Daily Dose

Dose Frequency

Duration

Acute otitis media

10 mg/kg/day
(Max 400 mg/day)

5 mg/kg Q 12 h
(Max 200 mg/dose)

5 days

Pharyngitis and/or tonsillitis

10 mg/kg/day
(Max 200 mg/day)

5 mg/kg/dose Q 12 h
(Max 100 mg/dose)

5 to 10 days

Acute maxillary sinusitis

10 mg/kg/day
(Max 400 mg/day)

5 mg/kg Q 12 hours
(Max 200 mg/dose)

10 days

 

Patients with Renal Dysfunction:

For patients with severe renal impairment (< 30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis.

When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to estimate creatinine clearance (mL/min). For this estimate to be valid, the serum creatinine level should represent a steady state of renal function.

 

 

Males:

Weight (ke) x (140 - age)

(mL/min)

72 x serum creatinine (mg/100 mL)

Females:

0.85 x above value

(mL/min)

 

Patients with Cirrhosis:

Cefpodoxime pharmacokinetics in cirrhotic patients (with or without ascites) are similar to those in healthy subjects. Dose adjustment is not necessary in this population.

Preparation of Suspension:

Constitution Directions For Oral Suspension

Constituted Volume

Final Concentration

Directions

50 mL

50 mg per 5 mL

Suspend in a total of 29 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water.

75 mL

50 mg per 5 mL

Suspend in a total of 44 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water.

100 mL

50 mg per 5 mL

Suspend in a total of 58 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water.

50 mL

100 mg per 5 mL

Suspend in a total of 29 mL of distilled-water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water.

75 mL

100 mg per 5 mL

Suspend in a total of 43 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water.

100 mL

100 mg per 5 mL

Suspend in a total of 57 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water.

 

After mixing, the suspension should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Shake well before using. Keep container tightly closed. The mixture may be used for 14 days. Discard unused portion after 14 days.

Gloryoxime(cefpodoxmineproxetil) Tablets are available in the following strengths:

200 mg divided tablets

Bottles of 50ml 50mg\5ml                    

Store tablets at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Replace cap securely after each opening. Protect unit dose packs from excessive moisture.

Gloryoxime(cefpodoxmineproxetil) Oral Suspension provides the equivalent of 50 mg or 100 mg cefpodoxime per 5 mL suspension (when constituted as directed) and is available in lemon creme flavor in the following sizes:

50 mg/5 mL

100 mg/5 mL

Store unsuspended granules at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Directions for mixing are included on the label. After mixing, suspension should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Shake well before using. Keep container tightly closed. The mixture may be used for 14 days. Discard unused portion after 14 days.

CONTRAINDICATIONS

Cefpodoximeproxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics

SIDE EFFECTS:Diarrhea, nausea/vomiting, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling of the ankles/feet, tiredness, fast/pounding heartbeat, trouble breathing, new signs of infection (e.g., fever, persistent sore throat), dark urine, persistent nausea/vomiting, yellowing eyes/skin, easy bruising/bleeding, change in the amount of urine.

Seek immediate medical attention if any of these rare but very serious side effects occur: vision changes, slurred speech, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

. STORAGE: Store the tablets at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom.

Store the suspension in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light and heat. Do not freeze. Keep the container tightly closed. Throw away any unused medication after 14 days.

Keep all medicines away from children and pets.