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Kalcep 200 Tablets

NAFDAC Reg. No. C4-1659 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Kalcep 200 Tablets
NAFDAC number
C4-1659
Active ingredient
Cefpodoxime (Cefpodoxime Proxetil)
Strength
200 mg
Form
Tablet
Pack size
1 x 10 (in Alu-Alu pack)
Manufacturer
Not listed
Applicant (holder)
Pushkal Pharmaceutical Limited
Approved
29 Mar 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
28 Mar 2026
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Kalcep 200 Tablets is on the NAFDAC register with an active registration (C4-1659). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Kalcep 200 Tablets is used for

From the official U.S. FDA label for cefpodoxime (cefpodoxime proxetil), the active ingredient registered with NAFDAC.

What it is used for

Cefpodoxime proxetil 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 DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilusinfluenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains). …

Possible side effects

Clinical Trials Film-coated Tablets (Multiple dose) In clinical trials using multiple doses of cefpodoxime proxetil film-coated tablets, 4696 patients were treated with the recommended dosages of cefpodoxime (100 to 400 mg Q 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. One-hundred twenty-nine (2.7%) patients discontinued medication due to adverse events thought possibly or probably related to drug toxicity. Ninety-three (52%) of the 178 patients who discontinued therapy (whether thought related to drug therapy or not) did so because of gastrointestinal disturbances, nausea, vomiting, or diarrhea. …

Do not use if

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

Warnings

BEFORE THERAPY WITH CEFPODOXIME PROXETIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS 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. IF AN ALLERGIC REACTION TO CEFPODOXIME PROXETIL OCCURS, DISCONTINUE THE DRUG. …

Pregnancy & breastfeeding

Pregnancy Teratogenic Effects Pregnancy Category B Cefpodoxime proxetil was neither teratogenic nor embryocidal when administered to rats during organogenesis at doses up to 100 mg/kg/day (2 times the human dose based on mg/m2) or to rabbits at doses up to 30 mg/kg/day (1 to 2 times the human dose based on mg/m2). There are, however, no adequate and well-controlled studies of cefpodoxime proxetil use in pregnant women. …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Kalcep 200 Tablets

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Kalcep 200 Tablets

What is in Kalcep 200 Tablets?

Kalcep 200 Tablets contains Cefpodoxime (Cefpodoxime Proxetil) (200 mg), as tablet, according to its NAFDAC registration record.

Is Kalcep 200 Tablets registered with NAFDAC?

Yes. Kalcep 200 Tablets is listed on the NAFDAC register under registration number C4-1659, and its registration is active as of 27 October 2026.

Has Kalcep 200 Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Kalcep 200 Tablets in our automatically synced alert list.

How can I check that my pack of Kalcep 200 Tablets is genuine?

Run a free authenticity scan with the NAFDAC number C4-1659, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Kalcep 200 Tablets used for?

Cefpodoxime proxetil 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 DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media caused by Strep (Summarised from the official U.S. FDA label for cefpodoxime (cefpodoxime proxetil). Always follow your doctor or pharmacist.)

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