Suprax (cefixime) is a cephalosporin antibiotic. It works by fighting bacteria in your body. Suprax is used to treat many different types of infections caused by bacteria. This medicine will not work for viral infections (such as common cold or flu).

Unnecessary or unwanted side effects may occur when taking Suprax. These include:

mild stomach pain, diarrhoea;

headache, tired feeling;

vaginal itching or discharge; or

rash.

If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Suprax and other antibacterial drugs, Suprax should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Pharmacokinetics

TABLE 1 Mean (%CV) Pharmacokinetic Parameters of Cefixime in Healthy Young Adultsa

The pharmacokinetic parameters of cefixime in healthy young adults are summarized in Table 1.

Parameter Subjects Dose (mg) 8400

N = 18 100 200 400

—————————————————————————————————————————————

Cmax (mcg/mL) Males (n=8) 1.90 (16.6) 3.63 (20.1) 7.10 (23.0)

Females (n=10) 2.18 (21.9) 4.04 (17.3) 8.00 (22.0)

—————————————————————————————————————————————

Tmax (h) Males (n=8) 1.38 (0.58-3.00) 1.13 (0.50-2.00) 0.88 (0.25-2.00)

Females (n=10) 1.50 (0.42-4.25) 1.17 (0.50-1.75) 0.83 (0.33-2.00)

—————————————————————————————————————————————

AUC0–12(mcgh/mL) Males (n=8) 9.55 (19.1) 18.75 (22.1) 35.18 (20.6)

Females (n=10) 10.63 (23.2) 20.00 (21.0) 37.33 (17.8)

—————————————————————————————————————————————

AUC0–∞(mcg•h/mL) Males (n=8) 10.40 (19.7) 20.13 (24.4) 38.48 (20.9)

Females(n=10) 11.70 (25.5) 22.08 (23.3) 41 .50(18 .1 )

—————————————————————————————————————————————

aValues are mean (%CV).

Cmax: Maximum observed concentration

Tmax: Time of maximum observed concentration

AUC0–12: Area under the plasma concentration-time curve from time 0 to 12 hours post-dose

AUC0–∞: Area under the plasma concentration-time curve from time 0 to infinity

TABLE 2 Mean (%CV) Pharmacokinetic Parameters of Cefixime in Healthy Elderly Subjectsa (> 65 Years Old)

Dose (mg) 8400

Parameter Subjects 100 200 400

—————————————————————————————————————————————

Cmax (mcg/mL) Males (n=8) 1.90 (16.6) 3.63 (20.1) 7.10 (23.0)

Females (n=10) 2.18 (21.9) 4.04 (17.3) 8.00 (22.0)

—————————————————————————————————————————————

Tmax (h) Males (n=8) 1.38 (0.58-3.00) 1.13 (0.50-2.00) 0.88 (0.25-2 . 00 )

Females(n=10 ) 1 . 50(0 . 42 -4 . 25 ) 1 . 17(0 . 50 -1 . 75 ) 0 . 83 (0 . 33 -2 . 00 )

—————————————————————————————————————————————

AUC0 – 12(mcgh/mL) Males (n=8) 9.55 (19.1) 18.75 (22.1) 35.18 (20.6)

Females(n=10 ) 10.63 (23.2) 20.00 (21.0) 37 .33(17 . 8 )

—————————————————————————————————————————————

AUC0 –∞(mcg•h/mL)(b) Males(n=8 ) 10 . 40(19 . 7 ) 20 . 13(24 . 4 ) 38 . 48 (20 . 9 )

Females(n=10) 11.70 (25.5) 22.08 (23.3) 41 .50(18 . 1 )

—————————————————————————————————————————————

aValues are mean (%CV).

bAUC0- ∞: Area under the plasma concentration – time curve from time 0 extrapolated to infinity

TABLE 3 Mean (%CV) Pharmacokinetic Parameters of Cefixime in Healthy Elderly Males (> 65 Years Old) and Females (> 65 Years Old)(a,b)

Dose (mg)(c) 8400

Parameter Subjects 100 200 400 800

—————————————————————————————————————————————

Cmax(mcg/mL) Males (n=8) 1.90 (16.6) 3.63 (20.1) 7.10 (23.0) 10.13 (25.7)

Females(n=8 ) 2 . 18(21 . 9 ) 4 . 04(17 . 3 ) 8.00 (22.0) 11 .67(21 . 5 )

—————————————————————————————————————————————

Tmax h) Males (n=8) 1.38 (0.58-3.00) 1.13 (0,50-2,00) 0,88 (0 , 25 -2 , 00) 0.67 (0.08-1 . 00)

Females(n=8 ) 1 . 50(0 . 42 -4 . 25 ) 1 . 17(0 . 50 -1 . 75 ) 0.83 (0,33-2,00) 0.58 (0.08-1.17)

—————————————————————————————————————————————

AUC0 –12 (mcg•h/mL)(d) Males (n=8) 9 , 55(19 , 1 ) 18 , 75(22 , 1 ) 35,18 (20,6) 51 , 20(21 , 3 )

Females (n=8) 10.63 (23.2) 20.00 (21.0) 37,33 (17 , 8 ) 55 .83(19 . 4 )

—————————————————————————————————————————————

AUC0 –∞ (mcg•h/mL)(e) Males(n=8 ) 10 , 40(19 , 7 ) 20 , 13(24 , 4 ) 38,48 (20,9) 54 , 88(22 , 2 )

Females(n=8 ) 11.70 (25.5) 22.08 (23.3) 41,50 (18 . 1 ) 58 , 58(20 . 5 )

aValues are mean (%CV).

bAUC0- ∞: Area under the plasma concentration – time curve from time 0 extrapolated to infinity

cThe 8400 mg dose was administered as four 2200-mg doses given as 600 mg every 4 hours for 12 hours.

dAUC0 –12 (mcg•h/mL): Area under the plasma concentration – time curve from time 0 to 12 hours.

eAUC0 –∞ (mcg•h/mL): Area under the plasma concentration – time curve from time 0 extrapolated to infinity.

TABLE 4 Mean (%CV) Pharmacokinetic Parameters of Cefixime in Healthy Elderly Males (> 65 Years Old) and Females (> 65 Years Old)(a,b)

Dose (mg)(c) 8400

Parameter Subjects 100 200 400 800

—————————————————————————————————————————————

Cmax(mcg/mL) Males (n=8) 1.90 (16.6) 3.63 (20.1) 7.10 (23.0) 10.13 (25.7)

Females(n=8 ) 2 . 18(21 . 9 ) 4 . 04(17 . 3 ) 8.00 (22.0) 11 .67(21 . 5 )

—————————————————————————————————————————————

Tmax h) Males (n=8) 1.38 (0.58-3.00) 1.13 (0,50-2,00) 0,88 (0 , 25 -2 , 00) 0.67 (0.08-1 . 00)

Females(n=8 ) 1 . 50(0 . 42 -4 . 25 ) 1 . 17(0 . 50 -1 . 75 ) 0.83 (0,33-2,00) 0.58 (0.08-1.17)

—————————————————————————————————————————————

AUC0 –12 (mcg•h/mL)(d) Males (n=8) 9 , 55(19 , 1 ) 18 , 75(22 , 1 ) 35,18 (20,6) 51 , 20(21 , 3 )

Females (n=8) 10.63 (23.2) 20.00 (21.0) 37,33 (17 , 8 ) 55 .83(19 . 4 )

—————————————————————————————————————————————

AUC0 –∞ (mcg•h/mL)(e) Males(n=8 ) 10 , 40(19 , 7 ) 20 , 13(24 , 4 ) 38,48 (20,9) 54 , 88(22 , 2 )

Females(n=8 ) 11.70 (25.5) 22.08 (23.3) 41,50 (18 . 1 ) 58 , 58(20 . 5 )

aValues are mean (%CV).

bAUC0- ∞: Area under the plasma concentration – time curve from time 0 extrapolated to infinity

cThe 8400 mg dose was administered as four 2200-mg doses given as 600 mg every 4 hours for 12 hours.

dAUC0 –12 (mcg•h/mL): Area under the plasma concentration – time curve from time 0 to 12 hours.

eAUC0 –∞ (mcg•h/mL): Area under the plasma concentration – time curve from time 0 extrapolated to infinity.

Dosage and administration

The usual dose of cefixime is 400 mg once daily. For some infections, a higher dosage of 800 mg may be needed. The400-mg tablet should not be chewed or crushed; it should be swallowed whole with a glass of water.

Cefixime can be taken with or without food. If you take it with food, your body will absorb less of the medication. To get the most benefit from cefixime, take it at evenly spaced times. Avoid taking antacids within 2 hours before or after you take cefixime.

If you are taking cefixime to prevent gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

To take cefixime suspension:

· Use the measuring spoon or syringe that comes with the medication. Ask your pharmacist for help if you are unsure of how to measure your dose.

· Shake the bottle well before each dose.

· Open the bottle by pressing down on the cap and turning it.

· To take by mouth, open the capsule and sprinkle the medicine into a half-teaspoon (2.5-mL) of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

· The 200-mg capsule for oral suspension provides approximately 125 mg cefixime as cefixime trihydrate. After reconstitution with water, each 5 mL of suspension contains approximately 27.5 mg (27.5 mg/5 mL),41.25 mg (41.25 mg/5 mL), or 54.8 mg (54.8 mg/5 mL) cefixime as cefixime trihydrate.