Fixinic Dosage

• Dosage of Fixinic in details
• Fixinic interactions
• Fixinic reviews

Dosage of Fixinic in details

Adults

The recommended dose of Fixinic 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 Fixinic 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 Fixinic 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
	Fixinic (Fixinic) for Oral Suspension	Fixinic (Fixinic) 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. Fixinic (Fixinic) 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 Fixinic should be administered for at least 10 days.

Renal Impairment

Fixinic 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	Fixinic (Fixinic) 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

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

• Film-coated tablets provide 400 mg of Fixinic 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 “Fixinic” across one side and “LUPIN” across the other side.
• Capsules provide 400 mg of Fixinic 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 Fixinic as trihydrate. The 100 mg tablet is pink, round tablet, debossed with “Fixinic 100” on one side and “LUPIN” on other side. The 150 mg tablet is pink, round tablet, debossed with “Fixinic 150” on one side and “LUPIN” on other side. The 200 mg tablet is pink, round tablet, debossed with “Fixinic 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 Fixinic 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

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

What other drugs will affect Fixinic?

There may be other drugs that can interact with Fixinic. 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.

Fixinic interactions

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

Probenecid: Concomitant administration of probenecid reportedly increases C_max and AUC of Fixinic 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 Fixinic in healthy adult men may result in a 20-25% decrease in C_max and AUC of Fixinic but did not affect protein-binding, serum t_½ or renal clearance. This effect may not be clinically important since serum concentrations of Fixinic 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 Fixinic 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 Fixinic. It is recommended that other tests based on enzymatic glucose oxidase reactions (eg, Clinistix) be used.

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. FDA/SPL Indexing Data. "XZ7BG04GJX: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

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Information checked by Dr. Sachin Kumar, MD Pharmacology