Cetirizine Hydrochloride

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Cetirizine Hydrochloride Recall

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Questions & Answers

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Side Effects & Adverse Reactions

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product ■ drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

■ if breast-feeding; not recommended ■ if pregnant; ask a health professional before use

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

■ if breast-feeding; not recommended ■ if pregnant; ask a health professional before use

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Cetirizine Hydrochloride Manufacturers

American Health Packaging

Cetirizine Hydrochloride | American Health Packaging

adults and children 6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

No Recall
Cardinal Health

Cetirizine Hydrochloride | Cardinal Health

adults and children 6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

No Recall
Blenheim Pharmacal, Inc.

Cetirizine Hydrochloride | Blenheim Pharmacal, Inc.

Adults and children 6
years and over
one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor

No Recall
Remedyrepack Inc.

Cetirizine Hydrochloride | Remedyrepack Inc.

No Recall
Remedyrepack Inc.

Cetirizine Hydrochloride | Remedyrepack Inc.

Adults and children 6
years and over
one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor

No Recall
Remedyrepack Inc.

Cetirizine Hydrochloride | Remedyrepack Inc.

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Lake Erie Medical Dba Quality Care Products Llc

Cetirizine Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc

Adults and children 6
years and over
one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor

No Recall
Jubilant Cadista Pharmaceuticals Inc.

Cetirizine Hydrochloride | Jubilant Cadista Pharmaceuticals Inc.

● may be taken with and without water

For Cetirizine Hydrochloride Chewable Tablets 5 mg

adults and children 6 years and over

1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours

adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Cetirizine Hydrochloride Chewable Tablets 10 mg

adults and children 6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information:

store between 20º to 25º C (68º to 77º F).

Phenylketonurics: Contains 1.68 mg Phenylalanine (a component of Aspartame) per 5 mg

Phenylketonurics: Contains 3.36 mg Phenylalanine (a component of Aspartame) per 10 mg

do not use if carton is opened or if blister unit is broken.

see bottom panel for lot number and expiration date.

No Recall
Jubilant Cadista Pharmaceuticals Inc.

Cetirizine Hydrochloride | Jubilant Cadista Pharmaceuticals Inc.

● may be taken with and without water

For Cetirizine hydrochloride chewable tablets 5 mg

adults and children 6 years and over

1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.

adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours.

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

For Cetirizine hydrochloride chewable tablets 10 mg

adults and children 6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information:

store between 20º to 25º C (68º to 77º F)

Phenylketonurics: Contains 1.68 mg Phenylalanine (a component of Aspartame) per 5 mg

Phenylketonurics: Contains 3.36 mg Phenylalanine (a component of Aspartame) per 10 mg

do not use if carton is opened or if blister unit is broken.

see bottom panel for lot number and expiration date.

No Recall
Remedyrepack Inc.

Cetirizine Hydrochloride | Remedyrepack Inc.

Adults and children 6
years and over
one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor

No Recall
Winco Foods, Llc

Cetirizine Hydrochloride | Winco Foods, Llc

adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over ask a doctor

children under 6 years of age ask a doctor

consumers with liver or kidney disease ask a doctor

No Recall
Sandoz Inc

Cetirizine Hydrochloride | Sandoz Inc

•may be taken with or without water
adults and children 6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor
Other information •Store between 20º to 25º C (68º to 77º F)

No Recall
Major Pharmaceuticals

Cetirizine Hydrochloride | Major Pharmaceuticals

may be taken with or without water adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information Store between 20 to 25 C (68 to 77 F) See end flap for expiration date and lot number

No Recall
Avpak

Cetirizine Hydrochloride | Avpak

adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over: ask a doctor

children under 6 years of age: ask a doctor

consumers with liver or kidney disease: ask a doctor

No Recall
Unique Pharmaceutical Laboratories

Cetirizine Hydrochloride |

No Recall
Unique Pharmaceutical Laboratories

Cetirizine Hydrochloride |

No Recall
Caraco Pharmaceutical Laboratories, Ltd.

Cetirizine Hydrochloride | Caraco Pharmaceutical Laboratories, Ltd.

For 5 mg:
adults and children
6 years and over
1 to 2 tablets once daily depending upon severity of
symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years
and over
1 tablet once a day; do not take more than 1 tablet in
24 hours
children under 6
years of age
ask a doctor

consumers with liver
or kidney disease
ask a doctor

For 10 mg:
adults and children
6 years and over

one 10 mg tablet once daily; do not take more than one
10 mg tablet in 24 hours. A 5 mg product may be
appropriate for less severe symptoms.
adults 65 years
and over
ask a doctor

children under 6
years of age
ask a doctor

consumers with liver
or kidney disease
ask a doctor

Other information store between 20° to 25°C (68° to 77°F)
Inactive ingredients corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, titanium dioxide
Questions or comments?
call toll free 1-800-818-4555 weekdays

No Recall
Pack Pharmaceuticals Llc

Cetirizine Hydrochloride |

No Recall
Apotheca Inc.

Cetirizine Hydrochloride |

No Recall
Torrent Pharmaceuticals Limited

Cetirizine Hydrochloride |

No Recall
Torrent Pharmaceuticals Limited

Cetirizine Hydrochloride |

No Recall
Torrent Pharmaceuticals Limited

Cetirizine Hydrochloride | Torrent Pharmaceuticals Limited

  adults and children 6 years and over
  1 to 2 tablets once daily depending upon
   severity of symptoms; do not take more than
   2 tablets in 24 hours.
  adults 65 years and over
  1 tablet once a day; do not take more than
  1 tablet in 24 hours
  children under 6 years of age
  ask a doctor
  consumers with liver or kidney disease
  ask a doctor

Other information
store between 20° to 25°C (68° to 77°F)

No Recall
Physicians Total Care, Inc.

Cetirizine Hydrochloride | Eci Pharmaceuticals, Llc

100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals.

200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals.

When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine HCl should not exceed 2 days.

No Recall
Ipca Laboratories Limited

Cetirizine Hydrochloride | Ipca Laboratories Limited

adults and children 6 yearsand over
one 10 mg tablet once daily; do not take more than one
10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

No Recall
Remedyrepack Inc.

Cetirizine Hydrochloride | Remedyrepack Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Remedyrepack Inc.

Cetirizine Hydrochloride | Remedyrepack Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Sun Pharma Global Fze

Cetirizine Hydrochloride | Sun Pharma Global Fze

may be taken with or without water
For 5 mg:

adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

For 10 mg:

adults and children 6 years and over
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

No Recall
Sun Pharma Global Fze

Cetirizine Hydrochloride | Sun Pharma Global Fze

may be taken with or without water
For 5 mg:

adults and children 6 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

For 10 mg:
adults and children 6 years and over
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

No Recall
Perrigo New York Inc

Cetirizine Hydrochloride | Perrigo New York Inc

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Apotex Corp.

Cetirizine Hydrochloride | Apotex Corp.

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Amneal Pharmaceuticals

Cetirizine Hydrochloride | Amneal Pharmaceuticals

Adults andchildren 6years andover One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms. Adults 65years andover Ask a doctor. Childrenunder 6 yearsof age ask a doctor Consumerswith liver orkidneydisease ask a doctor

No Recall
Amneal Pharmaceuticals

Cetirizine Hydrochloride | Amneal Pharmaceuticals

Adults andchildren 6years andover 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. Adults 65years andover 1 tablet once a day; do not take more than 1 tablet in 24 hours. Childrenunder 6 yearsof age ask a doctor Consumerswith liver orkidneydisease ask a doctor

No Recall
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Cetirizine Hydrochloride | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

adults and children
6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than
2 tablets in 24 hours. adults 65 years
and over 1 tablet once a day; do not take more than
1 tablet in 24 hours children under
6 years of age ask a doctor consumers with liver
or kidney disease ask a doctor adults and children
6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than
2 tablets in 24 hours. adults 65 years
and over 1 tablet once a day; do not take more than
1 tablet in 24 hours children under
6 years of age ask a doctor consumers with liver
or kidney disease ask a doctor

No Recall
Amneal Pharmaceuticals

Cetirizine Hydrochloride | Amneal Pharmaceuticals

Cetirizine hydrochloride oral solution can be taken without regard to food consumption.

Children 2 to 5 years for Chronic Urticaria: The recommended initial dose of cetirizine hydrochloride oral solution in children aged 2 to 5 years is 2.5 mg (½ teaspoonful) once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful (5 mg) once daily, or as ½ teaspoonful (2.5 mg) given every 12 hours.

Children 6 months to <2 years for Perennial Allergic Rhinitis and Chronic Urticaria: The recommended dose of cetirizine hydrochloride oral solution in children 6 months to 23 months of age is 2.5 mg (½ teaspoonful) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoonful (2.5 mg) every 12 hours.

No Recall
Amneal Pharmaceuticals

Cetirizine Hydrochloride | Amneal Pharmaceuticals Of New York, Llc

use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information store between 20° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF NECKBAND IMPRINTED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSSING.

No Recall
Amneal Pharmaceuticals

Cetirizine Hydrochloride | Reckitt Benckiser Llc

shake bottle well before use measure only with dosing cup provided. Do not use dosing cup with other products. dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours,
not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours,
not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours,
not to exceed 5 mL in 24 hours children under 4 years of age do not use

No Recall
Perrigo New York Inc

Cetirizine Hydrochloride | Perrigo New York Inc

use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Rebel Distributors Corp

Cetirizine Hydrochloride | Rebel Distributors Corp

adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information
Store between 20 to 25 C (68 to 77 F)

No Recall
Rebel Distributors Corp

Cetirizine Hydrochloride | Rebel Distributors Corp

adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over: ask a doctor

children under 6 years of age: ask a doctor

consumers with liver or kidney disease: ask a doctor

No Recall
Trimarc Labs

Cetirizine Hydrochloride | Trimarc Labs

         Directions:

         Adults and children 6 years and over:   One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.

           A 5 mg product may be appropriate for less severe symptoms.
Adults 65 years and over:    Ask a doctor Children under 6 years of age:    Ask a doctor Consumer with liver or kidney disease:    Ask a doctor

No Recall
Unichem Pharmaceuticals (Usa), Inc.

Cetirizine Hydrochloride | Unichem Pharmaceuticals (usa), Inc.

For 5 mg adults and children 6 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over
1 tablet once a day; do not take more than 1 tablet in 24 hours.
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
For 10 mg adults and children 6 years and over
One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.
A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or
kidney disease
ask a doctor

No Recall
Unichem Pharmaceuticals (Usa), Inc.

Cetirizine Hydrochloride | Unichem Pharmaceuticals (usa), Inc.

For 5 mg adults and children 6 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over
1 tablet once a day; do not take more than 1 tablet in 24 hours.
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
For 10 mg adults and children 6 years and over
One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.
A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

No Recall
Physicians Total Care, Inc.

Cetirizine Hydrochloride | Physicians Total Care, Inc.

adults and children
6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than
2 tablets in 24 hours. adults 65 years
and over 1 tablet once a day; do not take more than
1 tablet in 24 hours children under
6 years of age ask a doctor consumers with liver
or kidney disease ask a doctor

No Recall
Dr.reddy’s Laboratories Limited

Cetirizine Hydrochloride | Dr.reddy's Laboratories Limited

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Ohm Laboratories Inc.

Cetirizine Hydrochloride | Ohm Laboratories Inc.

adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over: ask a doctor

children under 6 years of age: ask a doctor

consumers with liver or kidney disease: ask a doctor

No Recall
Major Pharmaceuticals

Cetirizine Hydrochloride | Teva Pharmaceuticals Usa Inc

2.1 Depressive Episodes Associated With Bipolar I Disorder
Adults – Administer olanzapine and fluoxetine capsules once daily in the evening, generally beginning with the 6 mg/25 mg (mg olanzapine/mg equivalent fluoxetine) capsule. While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of olanzapine and fluoxetine capsules has not been studied. Make dosage adjustments, if indicated, according to efficacy and tolerability. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine capsules in a dose range of olanzapine 6 mg to 12 mg and fluoxetine 25 mg to 50 mg [see Clinical Studies (14.1)]. The safety of doses above 18 mg of olanzapine and 75 mg of fluoxetine has not been evaluated in adult clinical studies. Periodically reexamine the need for continued pharmacotherapy.

Children and Adolescents (10 to 17 years of age) — Information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s olanzapine and fluoxetine hydrochloride capsules. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Specific Populations
Start olanzapine and fluoxetine capsules, 3 mg/25 mg or 6 mg/25 mg in patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine and fluoxetine capsules (female gender, geriatric age, nonsmoking status) or those patients who may be pharmacodynamically sensitive to olanzapine. Titrate slowly and adjust dosage as needed in patients who exhibit a combination of factors that may slow metabolism. Olanzapine and fluoxetine capsules have not been systematically studied in patients > 65 years of age or in patients < 10 years of age [see Warnings and Precautions (5.21), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3, 12.4)].

Treatment of Pregnant Women — When treating pregnant women with fluoxetine, a component of olanzapine and fluoxetine capsules, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalizations, respiratory support, and tube feeding [see Use in Specific Populations (8.1)].
2.4 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with olanzapine and fluoxetine capsules. Conversely, at least 5 weeks should be allowed after stopping olanzapine and fluoxetine capsules before starting an MAOI intended to treat psychiatric disorders [seeContraindications (4.1)].
2.5 Use of Olanzapine and Fluoxetine Capsules With Other MAOIs Such as Linezolid or Methylene Blue
Do not start olanzapine and fluoxetine capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].

In some cases, a patient already receiving olanzapine and fluoxetine capsule therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue are judged to outweigh the risks of serotonin syndrome in a particular patient, olanzapine and fluoxetine capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with olanzapine and fluoxetine capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.7)].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with olanzapine and fluoxetine capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.7)].
2.6 Discontinuation of Treatment With Olanzapine and Fluoxetine Capsules
Symptoms associated with discontinuation of fluoxetine, a component of olanzapine and fluoxetine capsules, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5.25)].

No Recall
Premier Value

Cetirizine Hydrochloride | Chain Drug Consortium, Llc

• adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours • children under 12 years: ask a doctor

No Recall
Pack Pharmaceuticals Llc

Cetirizine Hydrochloride | Pack Pharmaceuticals Llc

Adults and children 6
years and over
one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor

No Recall
Torrent Pharmaceuticals Limited

Cetirizine Hydrochloride | Torrent Pharmaceuticals Limited

adults and children 6 years
  and over
  one 10 mg tablet once daily; do not take more
  than one 10 mg tablet in 24 hours. A 5 mg
  product may be appropriate for less severe
symptoms.
  adults 65 years and over
  ask a doctor
  children under 6 years of age
  ask a doctor
  consumers with liver or kidney
  disease
  ask a doctor

Other information
store between 20° to 25°C (68° to 77°F)

No Recall
Aidarex Pharmaceuticals Llc

Cetirizine Hydrochloride | Aidarex Pharmaceuticals Llc

Adults and children 6
years and over
one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor

No Recall
Dispensing Solutions, Inc.

Cetirizine Hydrochloride | Dispensing Solutions, Inc.

adults and children 6 years and over
One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
Other information Store between 20 to 25 C (68 to 77 F)

No Recall
Select Brand

Cetirizine Hydrochloride | Select Brand

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Army & Air Force Exchange Service

Cetirizine Hydrochloride | Army & Air Force Exchange Service

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Tris Pharma Inc

Cetirizine Hydrochloride | Tris Pharma Inc

DIRECTIONS

■ use only with enclosed dosing cup
adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Other information

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ do not use if carton is opened or neckband imprinted “sealed for protection” is broken or missing

No Recall
Tris Pharma Inc

Cetirizine Hydrochloride | Tris Pharma Inc

Directions

■ use only with enclosed dosing cup
adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severityof symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Other information

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ do not use if carton is opened or neckband imprinted “sealed for protection” is broken or missing

No Recall
Topco Associates Llc

Cetirizine Hydrochloride | Topco Associates Llc

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Publix Super Markets Inc

Cetirizine Hydrochloride | Publix Super Markets Inc

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Valu Merchandisers Company

Cetirizine Hydrochloride | Valu Merchandisers Company

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Cvs Pharmacy

Cetirizine Hydrochloride | Cvs Pharmacy

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Family Dollar Services, Inc.

Cetirizine Hydrochloride | Family Dollar Services, Inc.

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Sunmark

Cetirizine Hydrochloride | Sunmark

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Shopko Stores Operating Co., Llc

Cetirizine Hydrochloride | Shopko Stores Operating Co., Llc

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Medline Industries, Inc.

Cetirizine Hydrochloride | Medline Industries, Inc.

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Bryant Ranch Prepack

Cetirizine Hydrochloride | Bryant Ranch Prepack

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Rugby Laboratories Inc

Cetirizine Hydrochloride | Rugby Laboratories Inc

Adults and children 6 years and over take one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. Adults 65 years and over ask a doctor. Children under 6 years of age ask a doctor Consumers with liver or kidney disease ask a doctor

No Recall
Northstar Rx Llc

Cetirizine Hydrochloride | Salix Pharmaceuticals, Inc.

2.1 Dosage
The recommended dosage regimen is 1 metered dose administered rectally twice daily for 2 weeks followed by 1 metered dose administered rectally once daily for 4 weeks.
2.2 Administration Instructions
Advise patients:
UCERIS rectal foam is only to be applied rectally. It is not for oral use. Before using UCERIS rectal foam, use the bathroom to empty your bowels. Each applicator is coated with a lubricant. If additional lubrication is needed, petrolatum or petroleum jelly can also be used. Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use. UCERIS rectal foam can be used in a standing, lying or sitting position (e.g., while using the toilet). Apply UCERIS rectal foam in the morning and the evening for the first 2 weeks of treatment; then once daily in the evening for the next 4 weeks. When applied in the evening, use immediately prior to bedtime. Try not to empty your bowels again until the next morning. Avoid concomitant use of CYP3A4 inhibitors (e.g., ketoconazole, grapefruit juice) during treatment with UCERIS rectal foam.

No Recall
Remedyrepack Inc.

Cetirizine Hydrochloride | Remedyrepack Inc.

Adults and children 6
years and over
one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor

No Recall
Remedyrepack Inc.

Cetirizine Hydrochloride | Remedyrepack Inc.

Adults and children 6
years and over
one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor

No Recall
Remedyrepack Inc.

Cetirizine Hydrochloride | Remedyrepack Inc.

Adults and children 6
years and over
one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Cetirizine Hydrochloride | Taro Pharmaceuticals U.s.a., Inc.

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Mckesson

Cetirizine Hydrochloride | Mckesson

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Avkare, Inc.

Cetirizine Hydrochloride | Avkare, Inc.

adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over: ask a doctor

children under 6 years of age: ask a doctor

consumers with liver or kidney disease: ask a doctor

No Recall
Medvantx, Inc.

Cetirizine Hydrochloride | Medvantx, Inc.

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.
A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

No Recall
Chain Drug Consortium, Llc

Cetirizine Hydrochloride | Chain Drug Consortium, Llc

may be taken with or without water
adults and children 6 years and over
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

No Recall
Clinical Solutions Wholesale

Cetirizine Hydrochloride | Clinical Solutions Wholesale

Adults and children 6
years and over

one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.

Adults 65 years and over

Ask a doctor

Children under 6 years of age

Ask a doctor

Consumers with liver or kidney disease

Ask a doctor

No Recall
Kaiser Foundation Hospitals

Cetirizine Hydrochloride | Kaiser Foundation Hospitals

Adult and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. Adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours. Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor

No Recall
Kaiser Foundation Hospitals

Cetirizine Hydrochloride | Kaiser Foundation Hospitals

Adult and children 6 years and over One 10 mg tablet once daily: do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. Adults 65 years and over Ask a doctor Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor

No Recall
Mylan Institutional Inc.

Cetirizine Hydrochloride | Mylan Institutional Inc.

adults and children
6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.
A 5 mg product may be appropriate for less severe symptoms.

adults 65 years
and over

ask a doctor

children under
6 years of age

ask a doctor

consumers with liver
or kidney disease

ask a doctor

No Recall
Kinray

Cetirizine Hydrochloride | Kinray

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Mylan Pharmaceuticals Inc.

Cetirizine Hydrochloride | Mylan Pharmaceuticals Inc.

adults and children 6 years and over

1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.

adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

No Recall
Proficient Rx Lp

Cetirizine Hydrochloride | Proficient Rx Lp

adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over: ask a doctor

children under 6 years of age: ask a doctor

consumers with liver or kidney disease: ask a doctor

No Recall
Cardinal Health

Cetirizine Hydrochloride | Cardinal Health

Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.

The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.

The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (e.g., sevelamer, lanthanum carbonate) or sucralfate, Videx®† (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 6 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX: Additional Information.
Infection

Severity

Dose

Frequency

Usual Durations*

Urinary Tract

Acute Uncomplicated

250 mg

q 12 h

3 Days

Mild/Moderate

250 mg

q 12 h

7 to 14 Days

Severe/Complicated

500 mg

q 12 h

7 to 14 Days

Chronic Bacterial Prostatitis

Mild/Moderate

500 mg

q 12 h

28 Days

Lower Respiratory Tract

Mild/Moderate

500 mg

q 12 h

7 to 14 Days

Severe/Complicated

750 mg

q 12 h

7 to 14 Days

Acute Sinusitis

Mild/Moderate

500 mg

q 12 h

10 Days

Skin and Skin Structure

Mild/Moderate

500 mg

q 12 h

7 to 14 Days

Severe/Complicated

750 mg

q 12 h

7 to 14 Days

Bone and Joint

Mild/Moderate

500 mg

q 12 h

≥ 4 to 6 Weeks

Severe/Complicated

750 mg

q 12 h

≥ 4 to 6 Weeks

Intra-Abdominal†

Complicated

500 mg

q 12 h

7 to 14 Days

Infectious Diarrhea

Mild/Moderate/Severe

500 mg

q 12 h

5 to 7 Days

Typhoid Fever

Mild/Moderate

500 mg

q 12 h

10 Days

Urethral and Cervical Gonococcal Infections

Uncomplicated

250 mg

Single Dose

Single Dose

Inhalational Anthrax (post-exposure)‡

500 mg

q 12 h

60 Days
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing Regimens
Ciprofloxacin Oral Dosage

Equivalent Ciprofloxacin I.V. Dosage

250 mg Tablet q 12 h

200 mg I.V. q 12 h

500 mg Tablet q 12 h

400 mg I.V. q 12 h

750 mg Tablet q 12 h

400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min)

Dose

> 50

See Usual Dosage.

30 to 50

250 mg to 500 mg q 12 h

5 to 29

250 mg to 500 mg q 18 h

Patients on hemodialysis or
Peritoneal dialysis

250 mg to 500 mg q 24 h
(after dialysis)

When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

The serum creatinine should represent a steady-state of renal function.

In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)

Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 6 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX IN ADULTS AND PEDIATRICS: Additional Information.
Infection

Route of Administration

Dose (mg/kg)

Frequency

Total Duration

Complicated Urinary Tract or Pyelonephritis

Intravenous

6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)

Every 8 hours

10 to 21 days*

(patients from 1 to 17 years of age)

Oral

10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)

Every 12 hours

Inhalational Anthrax (Post-Exposure)†

Intravenous

10 mg/kg (maximum 400 mg per dose)

Every 12 hours

60 days

Oral

15 mg/kg (maximum 500 mg per dose)

Every 12 hours

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).

No Recall
Sandoz Inc

Cetirizine Hydrochloride | Sandoz Inc

• may be taken with or without water
adults and children 6 years and over

1 to 2 tablets once daily; depending upon severity of symptoms; do not take more than 2 tablets in 24 hours

adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor
Other information • Store between 20º to 25º C (68º to 77º F)

No Recall
Sandoz Inc

Cetirizine Hydrochloride | Sandoz Inc

adults and children 6 years and over

One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor
Other information • Store between 20º to 25º C (68º to 77º F)

No Recall
Sandoz Inc

Cetirizine Hydrochloride | Sandoz Inc

adults and children 6 years and over

1 to 2 tablets once daily; depending upon severity of symptoms; do not take more than 2 tablets in 24 hours

adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor
Other information • Store between 20º to 25º C (68º to 77º F)

No Recall
Preferred Pharmaceuticals, Inc.

Cetirizine Hydrochloride | Preferred Pharmaceuticals, Inc.

Adults and children 6
years and over

one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.

Adults 65 years and over

Ask a doctor

Children under 6 years of age

Ask a doctor

Consumers with liver or kidney disease

Ask a doctor

No Recall
Preferred Pharmaceuticals, Inc.

Cetirizine Hydrochloride |

No Recall
Aurohealth Llc

Cetirizine Hydrochloride | Aurohealth Llc

For 5 mg:
adults and children 6 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over
1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

For 10 mg:
adults and children 6 years and over
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

No Recall
Aurohealth Llc

Cetirizine Hydrochloride | Aurohealth Llc

For 5 mg:
adults and children 6 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
adults 65 years and over
1 tablet once a day; do not take more than 1 tablet in 24 hours.
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

For 10 mg:
adults and children 6 years and over
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

No Recall