Ethifix Uses

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What is Ethifix?

Ethifix is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, Ethifix will not work for colds, flu, or other virus infections.

Ethifix is available only with your doctor's prescription.

Ethifix indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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To reduce the development of drug resistant bacteria and maintain the effectiveness of Ethifix (Ethifix) and other antibacterial drugs, Ethifix should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Ethifix (Ethifix) is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria:

Uncomplicated Urinary Tract Infections

Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.

Otitis Media

Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.)

Note: For patients with otitis media caused by Streptococcus pneumoniae, overall response was approximately 10% lower for Ethifix than for the comparator.

Pharyngitis And Tonsillitis

Pharyngitis and Tonsillitis caused by Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Ethifix is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of Ethifix in the subsequent prevention of rheumatic fever is not available.)

Acute Exacerbations Of Chronic Bronchitis

Acute Exacerbations of Chronic Bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.

Uncomplicated Gonorrhea (cervical/urethral)

Uncomplicated Gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).

How should I use Ethifix?

Use Ethifix chewable tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Ethifix chewable tablets.

Uses of Ethifix in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Treatment of uncomplicated urinary tract infections (due to Escherichia coli and Proteus mirabilis), otitis media (due to Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes), pharyngitis and tonsillitis (due to Streptococcus pyogenes), acute exacerbations of chronic bronchitis (due to Streptococcus pneumoniae and Haemophilus influenzae); uncomplicated cervical/urethral gonorrhea (due to N. gonorrhoeae [penicillinase- and nonpenicillinase-producing])

Note: Due to concerns of resistance, the CDC no longer recommends use of Ethifix as a first-line regimen in the treatment of uncomplicated gonorrhea in the US; ceftriaxone is the preferred cephalosporin in combination with azithromycin (CDC 2012; CDC [Workowski 2015]).

Off Label Uses

Gonococcal infection, expedited partner therapy

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, Ethifix in combination with azithromycin is an effective and recommended treatment of gonorrhea only in the following circumstances: Heterosexual partners with gonorrhea if health department partner-management strategies are impractical/unavailable and there is concern by the provider for the prompt evaluation and treatment of the partner; medication may be delivered to partner by patient, collaborating pharmacy, or disease investigation specialist as permitted by law; written materials to educate partners about their exposure to gonorrhea, importance of therapy, and when to seek clinical evaluation for adverse reactions/complications must also be provided with the medication.

Gonococcal, uncomplicated infection of the rectum

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, Ethifix, in combination with azithromycin, may be used as an alternative agent to ceftriaxone (in combination with azithromycin) for the treatment of uncomplicated gonococcal infections of the rectum only if ceftriaxone is unavailable.

Rhinosinusitis, acute bacterial

Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults, Ethifix (among other cephalosporins) is effective and recommended alternative agent (in combination with clindamycin) for the treatment of ABRS.

Clinical experience suggests the utility of Ethifix (in combination with clindamycin) for the treatment of ABRS. Additional trials may be necessary to further define the role of Ethifix for this condition.

Ethifix description

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Ethifix, an antibiotic, is a 3rd-generation cephalosporin like ceftriaxone and cefotaxime. Ethifix is highly stable in the presence of β-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of β-lactamases may be susceptible to Ethifix. The antibacterial effect of Ethifix results from inhibition of mucopeptide synthesis in the bacterial cell wall.

Ethifix dosage

Adults

The recommended dose of Ethifix 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 Ethifix should be administered for at least 10 days.

Pediatric Patients (6 months or older)

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 Ethifix 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

Ethifix (Ethifix) for

Oral Suspension

Ethifix (Ethifix) 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. Ethifix (Ethifix) 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 Ethifix should be administered for at least 10 days.

Renal Impairment

Ethifix 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 Ethifix (Ethifix) for

Oral Suspension

Tablet Chewable Tablet
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

Reconstitution Directions For

Oral Suspension

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.

How supplied

Dosage Forms And Strengths

Ethifix is available for oral administration in the following dosage forms and strengths:

Storage And Handling

Ethifix® 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
Ethifix® (Ethifix) 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 “Ethifix” across one side and “LUPIN” across other side, containing 400 mg of Ethifix 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
Ethifix® (Ethifix) 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 Ethifix 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
Ethifix® (Ethifix) Chewable Tablets 100 mg Pink, round tablet, debossed with “Ethifix 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 “Ethifix 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 “Ethifix 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
Ethifix® (Ethifix) 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 Ethifix 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 Ethifix 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 Ethifix 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

Ethifix interactions

See also:
What other drugs will affect Ethifix?

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Carbamazepine: Elevated carbamazepine levels have been reported when administered concomitantly with Ethifix. 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 Ethifix and nifedipine increases oral bioavailability of Ethifix as a result of higher Cmax and AUC.

Probenecid: Concomitant administration of probenecid reportedly increases Cmax and AUC of Ethifix 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 Ethifix in healthy adult men may result in a 20-25% decrease in Cmax and AUC of Ethifix but did not affect protein-binding, serum t½ or renal clearance. This effect may not be clinically important since serum concentrations of Ethifix 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 Ethifix 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 Ethifix. It is recommended that other tests based on enzymatic glucose oxidase reactions (eg, Clinistix) be used.

Ethifix side effects

See also:
What are the possible side effects of Ethifix?

Applies to Ethifix: oral capsule, oral powder for suspension, oral tablet, oral tablet chewable

As well as its needed effects, Ethifix (the active ingredient contained in Ethifix) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Ethifix, check with your doctor immediately:

More common:

Less common: Incidence not known:

Minor Side Effects

Some Ethifix side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:

Ethifix contraindications

See also:
What is the most important information I should know about Ethifix?

Do not take this medication if you are allergic to Ethifix, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin).

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ethifix will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Active ingredient matches for Ethifix:

Cefixime in Indonesia.


Unit description / dosage (Manufacturer)Price, USD
Ethifix 100 mg x 10's$ 55.80

List of Ethifix substitutes (brand and generic names):

ETRI O 100MG TABLET 1 strip / 10 tablets each (Lincoln Pharmaceuticals Ltd)$ 1.06
ETRI O 200MG TABLET 1 strip / 10 tablets each (Lincoln Pharmaceuticals Ltd)$ 1.92
ETRI O 50MG TABLET 1 strip / 10 tablets each (Lincoln Pharmaceuticals Ltd)$ 0.60
Etri O 200mg Tablet (Lincoln Pharmaceuticals Ltd)$ 0.19
Etri O 50mg Tablet (Lincoln Pharmaceuticals Ltd)$ 0.06
Euphoric 100 mg x 2 Blister x 10 Tablet
Euphoric 200 mg x 2 Blister x 10 Tablet
Eurfix 100 mg/5 mL x 1 Bottle chöùa boät pha 50 mL hoãn dòch
Eurox 200mg TAB / 10 (Health Guard)$ 28.57
200 mg x 10's (Health Guard)$ 28.57
EUROX tab 200 mg x 10's (Health Guard)$ 2.84
Euvixim 50 mg x 12 Packs x 1, 5 g
Euvixim 100 mg x 12 Packs x 1, 5 g
Euvixim 100 mg x 2 Blister x 10 Tablet
Euvixim 100 mg x 1 Bottle 100 Tablet
Euvixim 200 mg x 2 Blister x 10 Tablet
Euvixim 200 mg x 1 Bottle 100 Tablet
EVACEF O Capsule/ Tablet / 200mg / 6 units (Neon Laboratories)$ 2.38
EVACEF O Capsule/ Tablet / 100mg / 10 units (Neon Laboratories)$ 2.06
Evacef O 100mg TAB / 10$ 2.06
Evacef O 200mg TAB / 10$ 2.38
Evacef O 100mg TAB / 10$ 2.06
Evacef O 200mg TAB / 10$ 2.38
100 mg x 10's (Neon Labs)$ 2.06
200 mg x 10's (Neon Labs)$ 2.38
EVACEF-O tab 100 mg x 10's (Neon Labs)$ 2.06
EVACEF-O tab 200 mg x 10's (Neon Labs)$ 2.38
Evapan 100mg TAB / 10 (Eva Biotech)
Evapan 200mg TAB / 10 (Eva Biotech)$ 1.43
Evapan 50mg DRY-SYR / 30ml (Eva Biotech)$ 0.94
100 mg x 10's (Eva Biotech)
200 mg x 10's (Eva Biotech)$ 1.43
50 mg x 30ml (Eva Biotech)$ 0.94
EVAPAN tab 100 mg x 10's (Eva Biotech)
EVAPAN tab 200 mg x 10's (Eva Biotech)$ 1.43
EVAPAN dry syr 50 mg x 30ml (Eva Biotech)$ 0.94
Evofix 400 mg x 2 Blister x 5 Tablet
EXCEF 100MG TABLET 1 strip / 4 tablets each (Ind Swift Laboratories Ltd)$ 0.82
EXCEF 200MG TABLET 1 strip / 4 tablets each (Ind Swift Laboratories Ltd)$ 1.62
EXCEF 50MG TABLET 1 strip / 4 tablets each (Ind Swift Laboratories Ltd)$ 0.44
Excef 100mg Tablet (Ind Swift Laboratories Ltd)$ 0.20

References

  1. DailyMed. "CEFIXIME: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "CEFIXIME". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "CEFIXIME". http://www.drugbank.ca/drugs/DB00671 (accessed September 17, 2018).

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