Zafil O Dosage
The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet or capsule daily or the 400 mg tablet may be split and given as one half tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The capsule and tablet may be administered without regard to food.
In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.
The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.
Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because Cefixime (Zafil O) for oral suspension is available in three different concentrations (100 mg/5 mL, 200 mg/5 mL, and 500 mg/5 mL).
Table 1: Suggested doses for pediatric patients
|PEDIATRIC DOSAGE CHART |
Doses are suggested for each weight range and rounded for ease of administration
|Cefixime (Zafil O) (cefixime) for |
|Cefixime (Zafil O) (cefixime) Chewable Tablet|
|100 mg/5 mL||200 mg/5 mL||500 mg/5 mL|
|Patient Weight (kg)||Dose/Day (mg)-||Dose/Day (mL)||Dose/Day (mL)||Dose/Day (mL)||Dose|
|5 to 7.5*||50||2.5||--||--||--|
|7.6 to 10*||80||4||2||--||--|
|10.1 to 12.5||100||5||2.5||1||1 tablet of 100 mg|
|12.6 to 20.5||150||7.5||4||1.5||1 tablet of 150 mg|
|20.6 to 28||200||10||5||2||1 tablet of 200 mg|
|28.1 to 33||250||12.5||6||2.5||1 tablet of 100 mg and 1 tablet of 150 mg|
|33.1 to 40||300||15||7.5||3||2 tablets of 150 mg|
|40.1to 45||350||17.5||9||3.5||1 tablet of 150 mg and 1 tablet of 200 mg|
|45.1 or greater||400||20||10||4||2 tablets of 200 mg|
|* The preferred concentrations of oral suspension to use are 100 mg/5 mL or 200 mg/5 mL for pediatric patients in these weight ranges.|
Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. Cefixime (Zafil O) (cefixime) Chewable Tablets must be chewed or crushed before swallowing.
Otitis media should be treated with the chewable tablets or suspension. Clinical trials of otitis media were conducted with the chewable tablets or suspension, and the chewable tablets or suspension results in higher peak blood levels than the tablet when administered at the same dose. Therefore, the tablet or capsule should not be substituted for the chewable tablets or suspension in the treatment of otitis media.
In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.
Cefixime (Zafil O) may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.
Table 2: Doses for Adults with Renal Impairment
|Renal Dysfunction||Cefixime (Zafil O) (cefixime) for |
|Creatinine Clearance (mL/min)||100 mg/5 mL||200 mg/5 mL||500 mg/5 mL||400 mg||200 mg|
|Dose/Day (mL)||Dose/Day (mL)||Dose/Day (mL)||Dose/Day||Dose/Day|
|60 or greater||Normal dose||Normal dose||Normal dose||Normal dose||Normal dose|
|21 to 59 * OR renal hemodialysis*||13||6.5||2.6||Not Appropriate||Not Appropriate|
|20 or less OR continuous peritoneal dialysis||8.6||4.4||1.8||0.5 tablet||1 tablet|
|* The preferred concentrations of oral suspension to use are 200 mg/5 mL or 500 mg/5 mL for patients with this renal dysfunction|
|Strength||Bottle Size||Reconstitution Directions|
|100 mg/5 mL and 200 mg/5 mL||100 mL||To reconstitute, suspend with 68 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.|
|100 mg/5 mL and 200 mg/5 mL||75 mL||To reconstitute, suspend with 51 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.|
|100 mg/5 mL and 200 mg/5 mL||50 mL||To reconstitute, suspend with 34 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.|
|200 mg/5 mL||37.5 mL||To reconstitute, suspend with 26 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.|
|200 mg/5 mL||25 mL||To reconstitute, suspend with 17 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.|
|500 mg/5 mL||20 mL||To reconstitute, suspend with 14 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.|
|500 mg/5 mL||10 mL||To reconstitute, suspend with 8 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.|
After reconstitution, the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.
Cefixime (Zafil O) is available for oral administration in the following dosage forms and strengths:
Cefixime (Zafil O)® 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|
|Cefixime (Zafil O)® (cefixime) 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 “Cefixime (Zafil O)” across one side and “LUPIN” across other side, containing 400 mg of cefixime 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|
|Cefixime (Zafil O)® (cefixime) 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 cefixime 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|
|Cefixime (Zafil O)® (cefixime) Chewable Tablets||100 mg||Pink, round tablet, debossed with “Cefixime (Zafil O) 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 “Cefixime (Zafil O) 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 “Cefixime (Zafil O) 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|
|Cefixime (Zafil O)® (cefixime) 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 cefixime 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 cefixime 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 cefixime as the trihydrate.||Bottle of 10 mL||27437-207-02|
|Bottle of 20 mL||27437-207-03|
Manufactured for: Lupin Pharma Baltimore, Maryland 21202 United States. Manufactured by:Lupin Limited Mandideep 462 046 India. Revised: January 2016
There may be other drugs that can interact with cefixime. 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 taking a new medication without telling your doctor.
Carbamazepine: Elevated carbamazepine levels have been reported when administered concomitantly with cefixime. Drug monitoring when these drugs are given together is advised.
Chloramphenicol: In vitro and in vivo antagonism have been noted between cephalosporins and chloramphenicol against a variety of gram-positive and gram-negative bacteria; therefore, it is recommended that combined therapy with chloramphenicol and a cephalosporin be avoided, particularly when bactericidal activity is considered important.
Nifedipine: Concomitant administration of cefixime and nifedipine increases oral bioavailability of cefixime as a result of higher Cmax and AUC.
Probenecid: Concomitant administration of probenecid reportedly increases Cmax and AUC of cefixime and decreases renal clearance and volume of distribution of the drug.
Salicylates: Concomitant administration of 650 mg oral dose of aspirin and a 400 mg oral dose of cefixime in healthy adult men may result in a 20-25% decrease in Cmax and AUC of cefixime but did not affect protein-binding, serum t½ or renal clearance. This effect may not be clinically important since serum concentrations of cefixime remained higher than the MIC values reported for most susceptible organisms. However, some clinicians state that this effect may be clinically important in certain infections.
Warfarin and other Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is given concomitantly.
Interference with Laboratory Tests: Nitroprusside Test: A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide.
Coombs' Test: A false-positive Coombs' test has been reported during treatment with other cephalosporin antibiotics; therefore, it should be recognized that a positive Coombs' test may be due to the drug, eg, Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition or in hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed.
Clinitest, Benedict's Solution, Fehling's Solution: A false-positive reaction for glucose in the urine using Clinitest, Benedict's solution, or Fehling's solution may result when done during therapy with cefixime. It is recommended that other tests based on enzymatic glucose oxidase reactions (eg, Clinistix) be used.
The usual dose of Ofloxacin (Zafil O)® (ofloxacin tablets) Tablets is 200 mg to 400 mg orally every 12 h as described in the following dosing chart. These recommendations apply to patients with normal renal function (i.e., creatinine clearance > 50 mL/min). For patients with altered renal function (i.e., creatinine clearance < 50 mL/min), see the Patients with Impaired Renal Function Subsection.
|Infection†||Unit Dose||Frequency||Duration||Daily Dose|
|Acute Bacterial Exacerbation of Chronic Bronchitis||400 mg||q12h||10 days||800 mg|
|Comm. Acquired Pneumonia||400 mg||q12h||10 days||800 mg|
|Uncomplicated Skin and Skin Structure Infections||400 mg||q12h||10 days||800 mg|
|Acute, Uncomplicated Urethral and Cervical Gonorrhea||400 mg||single dose||1 day||400 mg|
|Nongonococcal Cervicitis/Urethritis due to C. trachomatis||300 mg||q12h||7 days||600 mg|
|Mixed Infection of the urethra and cervix due to C. trachomatis and N. gonorrhoeae||300 mg||q12h||7 days||600 mg|
|Acute Pelvic Inflammatory Disease||400 mg||q12h||10-14 days||800 mg|
|Uncomplicated Cystitis due to E. coli or K. pneumoniae||200 mg||q12h||3 days||400 mg|
|Uncomplicated Cystitis due to other approved pathogens||200 mg||q12h||7 days||400 mg|
|Complicated UTI's||200 mg||q12h||10 days||400 mg|
|Prostatitis due to E.Coli||300 mg||q12h||6 weeks||600 mg|
|† DUE TO THE DESIGNATED PATHOGENS|
Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; or multivitamins containing zinc; or Videx® (didanosine) should not be taken within the two-hour period before or within the two-hour period after taking ofloxacin.
Patients with Impaired Renal Function: Dosage should be adjusted for patients with a creatinine clearance < 50 mL/min. After a normal initial dose, dosage should be adjusted as follows:
|Creatinine Clearance||Maintenance Dose||Frequency|
|20-50 mL/min||the usual recommended unit dose||q24h|
|< 20 mL/min||½ the usual recommended unit dose||q24h|
When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.
|Men:||Creatinine Clearance (mL/min) =||(140 – age) x (actual body wt in kg)|
|72 x (serum creatinine)|
Women: 0.85 x the value calculated for men
The serum creatinine should represent a steady-state of renal function.
The excretion of ofloxacin may be reduced in patients with severe liver function disorders (e.g., cirrhosis with or without ascites). A maximum dose of 400 mg of ofloxacin per day should therefore not be exceeded.
Ofloxacin (Zafil O)® (ofloxacin tablets) Tablets are supplied as 200 mg light yellow, 300 mg white, and 400 mg pale gold oval, straight-edged, coated tablets. Each tablet is distinguished by an imprint of “Ofloxacin (Zafil O) (ofloxacin) ” and the appropriate strength. Ofloxacin (Zafil O)® (ofloxacin) Tablets are packaged in bottles in the following configurations:
200 mg tablets - bottles of 50 (NDC 0062 - 1540-02)
300 mg tablets - bottles of 50 (NDC 0062 - 1541-02)
400 mg tablets - bottles of 100 (NDC 0062 - 1542-01)
Ofloxacin (Zafil O)® (ofloxacin) Tablets should be stored in well-closed containers. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Keep out of the reach of children.
Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ USA 08869. Issued January 2011
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ofloxacin, especially:
a diuretic or "water pill";
heart rhythm medication--amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol, and others;
medicine to treat depression or mental illness--amitriptylline, clomipramine, clozapine, desipramine, duloxetine, iloperidone, imipramine, nortriptyline, ziprasidone, and others; or
NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete. Other drugs may interact with ofloxacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Drugs Known to Prolong QT Interval: Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (eg, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Prolongation of bleeding time has been reported during concomitant administration of ofloxacin and anticoagulants.
There may be a further lowering of the cerebral seizure threshold when quinolones are given concurrently with other drugs which lower the seizure threshold eg, theophylline. However, ofloxacin is not thought to cause a pharmacokinetic interaction with theophylline, unlike some other fluoroquinolones.
Further lowering of the cerebral seizure threshold may also occur with certain nonsteroidal anti-inflammatory drugs.
In case of convulsive seizures, treatment with ofloxacin should be discontinued.
Ofloxacin may cause a slight increase in serum concentrations of glibenclamide administered concurrently; patients treated with this combination should be closely monitored.
Vitamin K Antagonists: Coagulation tests should be monitored in patients treated with vitamin K antagonists because of a possible increase in the effect of coumarin derivatives.
Cimetidine: Cimetidine has demonstrated interference with the elimination of some quinolones. This interference has resulted in significant increases in t½ and AUC of some quinolones. The potential for interaction between ofloxacin and cimetidine has not been reported.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): The concomitant administration of a NSAID with a quinolone, including ofloxacin, may increasethe risk of CNS stimulation and convulsive seizures.
Probenecid: The concomitant use of probenecid with certain other quinolones has been reported to affect renal tubular secretion. The effect of probenecid on the elimination of ofloxacin has not been reported.
Theophylline: Steady-state theophylline levels may increase when ofloxacin and theophylline are administered concurrently. As with other quinolones, concomitant administration of ofloxacin may prolong the t½ of theophylline, elevate serum theophylline levels and increase the risk of theophylline-related adverse reactions.
Theophylline levels should be closely monitored and theophylline dosage adjustments made, if appropriate, when ofloxacin is co-administered. Adverse reactions (including seizures) may occur with or without an elevation in the serum theophylline level.
Warfarin: Some quinolones have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. Therefore, if a quinolone antimicrobial is administered concomitantly with warfarin or its derivatives, the prothrombin time or other suitable coagulation test should be closely monitored.
Antidiabetic Agents (eg, Insulin, Glyburide/Glibenclamide): Since disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concurrently with quinolones and an antidiabetic agent, careful monitoring of blood glucose is recommended when these agents are used concomitantly.
Cyclosporine: Elevated serum levels of cyclosporine have been reported with concomitant use of cyclosporine with some other quinolones. The potential for interaction between ofloxacin and cyclosporine has not been reported.
Drugs Metabolized by Cytochrome P450 (CYP450) Enzymes: Most quinolone antimicrobial drugs inhibit CYP450 enzyme activity. This may result in a prolonged t½ for some drugs that are also metabolized by this system (eg, cyclosporine, theophylline/methylxanthines, warfarin) when co-administered with quinolones. The extent of this inhibition varies among different quinolones.
Interactions with Laboratory Tests: Some quinolones, including ofloxacin, may produce false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.
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Information checked by Dr. Sachin Kumar, MD Pharmacology