If ceftriaxone is not available, alternative cephalosporins for uncomplicated anorectal and urogenital infection include oral Cef-3 or other single-dose injectable regimens (ceftizoxime 500 mg IM, cefoxitin 2 g IM administered with probenecid 1 g orally, or cefotaxime 500 mg IM). Although oral therapy avoids the cost and inconvenience of injections and decreases the risk of accidental needlestick injuries to medical personnel who may be treating a population at high risk of HIV infection, 89 the recommended 400 mg oral dose of Cef-3 does not provide as high or as sustained a bactericidal level as that provided by the ceftriaxone 250 mg IM. In published clinical trials, Cef-3 400 mg orally cured 98% of uncomplicated anorectal and urogenital infections, but only 92% of pharyngeal infections.
As part of dual therapy, doxycycline should be given instead of azithromycin only if a contraindication to azithromycin (e.g., known immunoglobulin E–mediated allergy) exists, considering that gonococcal strains in the US with elevated MICs to Cef-3 are also likely to be tetracycline resistant but not macrolide resistant. 38
A clinical trial of dual treatment of uncomplicated urogenital gonorrhea demonstrated that single doses of oral gemifloxacin 320 mg plus oral azithromycin 2 g were associated with cure rates of >99%, and dual treatment with single doses of intramuscular gentamicin 240 mg plus oral azithromycin 2 g cured 100% of cases. This trial was not powered to provide reliable estimates of the efficacy of these regimens for treatment of rectal or pharyngeal infection, but both regimens cured the few extragenital infections among study participants. Either of these regimens could be considered as alternative treatment options in the presence of cephalosporin allergy. However, gastrointestinal adverse events can limit their use: approximately 8% of patients treated with gemifloxacin plus azithromycin and 3% of patients treated with gentamicin plus azithromycin vomited within 1 hour of medication administration, thus necessitating retreatment with ceftriaxone and azithromycin. 90
None of the other injectable cephalosporins offers any advantage over ceftriaxone for urogenital infection, and efficacy for pharyngeal infection is less certain. Other oral cephalosporins are similarly not recommended because of inferior efficacy and less favorable pharmacodynamics. Although cefpodoxime 400 mg orally, cefpodoxime proxetil 200 mg orally, and cefuroxime axetil 1 g orally all meet minimum efficacy criteria for alternative regimens for urogenital infections, efficacy in treating pharyngeal infections is unsatisfactory (estimated to be 70%, 79%, and 57%, respectively), and concerns exist about the pharmacodynamics of both the lower dose of cefpodoxime and the 1-g dose of cefuroxime axetil. 38
Spectinomycin in a single 2-g dose IM may possibly be useful in persons who cannot tolerate cephalosporins (estimated efficacy 98% for uncomplicated urogenital and anorectal infections), but the drug is relatively expensive, must be injected, is not effective against pharyngeal gonococcal infection (estimated efficacy 52%) or incubating syphilis, and is not available currently in the US. 38,91,92
Monotherapy with azithromycin 2 g orally as a single dose has been demonstrated to be 99% effective against uncomplicated urogenital gonorrhea. 93 However, monotherapy is no longer recommended because of concerns over the ease with which N. gonorrhoeae can develop resistance to macrolides and because several studies documented azithromycin treatment failures. The high rate of gastrointestinal symptoms associated with the 2-g dose also limits its usefulness. Azithromycin 1 g orally, the dose used for gonorrhea dual therapy, is not an appropriate alternative for monotherapy of gonococcal infection. 88
What are some other side effects of Cef-3 Capsules and Tablets?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
How to store Cef-3
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
- If you have been given liqu >
Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.
This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
If you buy any medicines, check with a pharmacist that they are safe to take with your other medicines.
If you are having an operation or any dental treatment, tell the person carrying out the treatment which medicines you are taking.
Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.
If you have any questions about this medicine ask your pharmacist.
How to take Cef-3
- Before you start taking Cef-3, read the manufacturer's printed information leaflet from ins >
Generic Name: Cef-3 (sef IX eem)Brand Name: Suprax
Medically reviewed by Drugs.com on Mar 29, 2019 – Written by Cerner Multum
What is the dosage for Cef-3?
The recommended adult dose for otitis media, tonsillitis, pharyngitis, and urinary tract infections is 400 mg once daily or divided and given as 200 mg every 12 hours. Pediatric patients (6 months and older) have a recommended dose of 8 mg/kg/day once daily or in two doses of 4/mg/kg every 12 hours.
Dosage Forms And Strengths
SUPRAX is available for oral administration in the following dosage forms and strengths:
- Film-coated tablets provide 400 mg of Cef-3 as trihydrate. These are white to off-white, film-coated, capsule shaped tablets with beveled edges and a divided score line on each side. The tablet is debossed with “SUPRAX” across one side and “LUPIN” across the other side.
- Capsules provide 400 mg of Cef-3 as trihydrate. These are size “00EL” capsules with pink opaque cap and pink opaque body with “LU” on the cap and “U43” on the body in black ink. Capsules contain white to yellowish white granular powder.
- Chewable tablets provide either 100 mg or 150 mg or 200 mg of Cef-3 as trihydrate. The 100 mg tablet is pink, round tablet, debossed with “SUPRAX 100” on one side and “LUPIN” on other side. The 150 mg tablet is pink, round tablet, debossed with “SUPRAX 150” on one side and “LUPIN” on other side. The 200 mg tablet is pink, round tablet, debossed with “SUPRAX 200” on one side and “LUPIN” on other side.
- Powder for oral suspension, when reconstituted, provides either 100 mg/5 mL or 200 mg/5 mL or 500 mg/5 mL of Cef-3 as trihydrate. For 100 mg/5 mL and 200 mg/5 mL, the powder has an off white to pale yellow color and is strawberry flavored. For 500 mg/5 mL, the powder has an off white to cream color and is strawberry flavored.
Storage And Handling
SUPRAX ® is available for oral administration in following dosage forms, strengths and packages listed in the table below:
Dosage Form Strength Description Package Size NDC Code Storage SUPRAX ® (Cef-3) tablets USP 400 mg White to off-white, film-coated, capsule shaped tablets with beveled edges and a divided score line on each side, debossed with “SUPRAX” across one side and “LUPIN” across other side, containing 400 mg of Cef-3 as the trihydrate. Bottles of 10 tablets 27437-201-10 Store at 20 to 25°C (68 to 77°F) . Bottle of 50 tablets 27437-201-08 Bottle of 100 tablets 27437-201-01 SUPRAX ® (Cef-3) capsules 400 mg Size “00EL” capsules with pink opaque cap and pink opaque body, imprinted with “LU” on cap and “U43” on body in black ink, containing white to yellowish white granular powder containing 400 mg of Cef-3 as the trihydrate. Bottle of 50 capsules 27437-208-08 Store at 20 to 25°C (68 to 77°F) . Unit Dose Package of 10 (1 blister of 10 capsules) 27437-208-11 SUPRAX ® (Cef-3) chewable tablets 100 mg Pink, round tablet, debossed with “SUPRAX 100” on one side and “LUPIN” on other side. Bottles of 10 tablets 27437-203-10 Store at 20 to 25°C (68 to 77°F) . Bottle of 50 tablets 27437-203-08 Unit Dose Package of 10 (1 blister of 10 tablets) 27437-203-11 150 mg Pink, round tablet, debossed with “SUPRAX 150” on one side and “LUPIN” on other side. Bottles of 10 tablets 27437-204-10 Bottle of 50 tablets 27437-204-08 Unit Dose Package of 10 (1 blister of 10 tablets) 27437-204-11 200 mg Pink, round tablet, debossed with “SUPRAX 200” on one side and “LUPIN” on other side. Bottles of 10 tablets 27437-205-10 Bottle of 50 tablets 27437-205-08 Unit Dose Package of 10 (1 blister of 10 tablets) 27437-205-11 SUPRAX ® (Cef-3) for oral suspension USP 100 mg/5 mL Off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 100 mg of Cef-3 as the trihydrate. Bottle of 50 mL 68180-202-03 Prior to reconstitution: Store drug powder at 20 to 25°C (68 to 77°F) .
After reconstitution: Store at room temperature or under refrigeration. Keep tightly closed.
Bottle of 75 mL 68180-202-02 Bottle of 100 mL 68180-202-01 200 mg/5 mL Off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 200 mg of Cef-3 as the trihydrate. Bottle of 25 mL 27437-206-05 Bottle of 37.5 mL 27437-206-06 Bottle of 50 mL 27437-206-03 Bottle of 75 mL 27437-206-02 Bottle of 100 mL 27437-206-01 500 mg/5 mL Off white to cream colored powder forming off-white to pale yellow suspension with characteristic fruity odor on constitution. After reconstituted as directed, each mL of reconstituted suspension contains 100 mg of Cef-3 as the trihydrate. Bottle of 10 mL 27437-207-02 Bottle of 20 mL 27437-207-03
Manufactured By: Lupin Limited Mandideep 462 046 India. Revised: March 2018.
Cef-3 side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
severe stomach pain, diarrhea that is watery or bloody;
jaundice (yellowing of the skin or eyes);
pale or yellowed skin, dark colored urine, confusion or weakness;
a seizure (convulsions);
low blood cell counts--sudden weakness or ill feeling, fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed;
kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common side effects may include:
vaginal itching or discharge.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Is Cef-3 safe to take if I'm pregnant or breastfeeding?
Safety in pregnancy has not been established for Cef-3. There are no adequate studies in pregnant women; however, studies in animals suggest no important effects on the fetus.
Safety in nursing mothers has not been established. It is not known if Cef-3 is excreted in breast milk.
Cef-3 is a semisynthetic, cephalosporin antibacterial for oral administration. Chemically, it is (6R,7R)-7--8-oxo-3-vinyl-5-thia-1-azabicyclo oct-2-ene-2-carboxylic acid, 7 2 -(Z)- trihydrate.
Molecular weight = 507.50 as the trihydrate. Chemical Formula is C16H15N5O7S2.3H2O
The structural formula for Cef-3 is:
- Inactive ingredients contained in SUPRAX ® (Cef-3) 400 mg tablets USP are: dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin.
- Inactive ingredients contained in SUPRAX ® (Cef-3) 400 mg capsules are: colloidal silicon dioxide, crospovidone, low substituted hydroxy propyl cellulose, magnesium stearate, and mannitol. The capsule shell contains the following inactive ingredients: ferric oxide black, ferric oxide red, gelatin, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate, and titanium dioxide.
- Inactive ingredients contained in SUPRAX ® (Cef-3) 100 mg or 150 mg or 200 mg chewable tablets are: aspartame, colloidal silicon dioxide, crospovidone, FD&C Red # 40 Aluminium Lake, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, fantasy flavor permaseal, and tutti frutti flavor.
- Inactive ingredients contained in SUPRAX ® (Cef-3) powder for oral suspension USP are: colloidal silicon dioxide, sodium benzoate, strawberry flavor, sucralose (only in 500 mg/5 mL strength), sucrose, and xanthan gum.
Before taking Cef-3
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Cef-3 it is important that your doctor knows:
- If you have ever had an allergic reaction to a medicine. It is particularly important that you tell your doctor if you have had a bad reaction to a penicillin or cephalosporin antibiotic.
- If you have any problems with the way your k >
Important: if you develop an itchy rash, swollen face or mouth, or have difficulty breathing, these can be signs that you are allergic to the antibiotic. Do not take any more Cef-3 and speak with your doctor or go to your local accident and emergency department straightaway.
If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist for further advice.