AZITHROMYCIN  - azithromycin tablet, film coated 
Lake Erie Medical DBA Quality Care Products LLC

----------

Azithromycin 500 mg

17 18 3 3 2



max


CONTRAINDICATIONS ; WARNINGS; PRECAUTIONS: Drug Interactions

PRECAUTIONS



CONTRAINDICATIONS WARNINGS: PRECAUTIONS max PRECAUTIONS: Geriatric Use

DOSAGE AND ADMINISTRATION



Information related to pharmacokinetics in pediatric patients is approved for Bayer Pharmaceutical Corporation's ciprofloxacin drug products. However, due to Bayer's marketing exclusivity rights, this drug product, produced by Hikma Pharmaceuticals, is not labeled for pediatric use, except for inhalational anthrax (post-exposure). in vitro In vitro in vitro.

in vitro INDICATIONS AND USAGE Enterococcus faecalis
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus saprophyticus
Streptococcus pneumoniae

Streptococcus pyogenes Campylobacter jejuni                                Proteus mirabilis
Citrobacter diversus                                 Proteus vulgaris
Citrobacter freundii                                   Providencia rettgeri
Enterobacter cloacae                               Providencia stuartii
Escherichia coli                                       Pseudomonas aeruginosa
Haemophilus influenzae                          Salmonella typhi
Haemophilus parainfluenzae                  Serratia marcescens

Klebsiella pneumoniae                           Shigella boydii
Moraxella catarrhalis                             Shigella dysenteriae
Morganella morganii                              Shigella flexneri
Neisseria gonorrhoeae                          Shigella sonnei


Bacillus anthracis in vitro INDICATIONS AND USAGE  INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION

in vitro but their clinical significance is unknown

in vitro
Staphylococcus haemolyticus
Staphylococcus hominis
Streptococcus pneumoniae

Acinetobacter Iwoffi                   Pasteurella multocida      
Aeromonas hydrophila               Salmonella enteritidis
Edwardsiella tarda                    Vibrio cholerae
Enterobacter aerogenes            Vibrio parahaemolyticus
Klebsiella oxytoca                     Vibrio vulnificus
Legionella pneumophila            Yersinia enterocolitica

 
Burkholderia cepacia Stenotrophomonas maltophilia Bacteroides fragilis Clostridium difficile
1

Enterobacteriaceae , Enterococcus faecalis , Staphylococcus Streptococcus pneumoniae , Streptococcus pyogenes , Pseudomonas aeruginosa

a


H. influenzae Haemophilus 1
b C. jejuni o o 2
c N. gonorrhoeae 2 o 3 3



Enterobacteriaceae Enterococcus faecalis Staphylococcus Streptococcus pneumoniae Streptococcus pyogenes Pseudomonas aeruginosa

a

DOSAGE AND ADMINISTRATION Urinary Tract Infections Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, Enterococcus faecalis.

Acute Uncomplicated Cystitis in females
Escherichia coli Staphylococcus saprophyticus.

Chronic Bacterial Prostatitis
Escherichia coli Proteus mirabilis.

Lower Respiratory Tract Infections
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae. Moraxella catarrhalis

Streptococcus pneumoniae.

Acute Sinusitis
Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis.

Skin and Skin Structure Infections
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes.

Bone and Joint Infections
Enterobacter cloacae, Serratia marcescens, Pseudomonas aeruginosa.

Complicated Intra-Abdominal Infections
Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, Bacteroides fragilis.

Infectious Diarrhea
Escherichia coli Campylobacter jejuni, Shigella boydii , Shigella dysenteriae, Shigella flexneri Shigella sonnei

Typhoid Fever (Enteric Fever)
Salmonella typhi.



Uncomplicated cervical and urethral gonorrhea
Neisseria gonorrhoeae. Complicated Urinary Tract Infections and Pyelonephritis Escherichia coli.

WARNINGS, PRECAUTIONS, Pediatric Use, ADVERSE REACTIONS CLINICAL STUDIES ANIMAL PHARMACOLOGY
Inhalational anthrax Bacillus anthracis.

5 INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION



Pseudomonas aeruginosa



PRECAUTIONS: Drug Interactions .

Fluoroquinolones, including Ciprofloxacin Tablets, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotater cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ciprofloxacin Tablets should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

THE SAFETY AND EFFECTIVENESS OF CIPROFLOXACIN IN PREGNANT AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED. PRECAUTIONS: Pregnancy, Nursing Mothers INDICATIONS AND USAGE ADVERSE REACTIONS

ANIMAL PHARMACOLOGY PRECAUTIONS: General, Information for Patients, Drug Interactions ADVERSE REACTIONS SERIOUS AND FATAL REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AND THEOPHYLLINE.

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted (See PRECAUTIONS: Information for Patients and ADVERSE REACTIONS).

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ciprofloxacin Tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

ANIMAL PHARMACOLOGY

Central Nervous System


WARNINGS, Information for Patients, Drug Interactions

Renal Impairment


DOSAGE AND ADMINISTRATION

Photosensitivity/Phototoxicity


ADVERSE REACTIONS/Post-Marketing Adverse Events



max

WARNINGS



® DOSAGE AND ADMINISTRATION

2















in vitro


E. coli

79

Saccharomyces cerevisiae
Saccharomyces cerevisiae


in vivo





2

2 4



2
Pregnancy Category C

8

9 In utero

10 in utero

8,9 WARNINGS

2 2 WARNINGS

Ciprofloxacin, like other quinolones, causes arthropathy and histological changes in weight-bearing joints of juvenile animals resulting in lameness. (See ANIMAL PHARMACOLOGY.)

DOSAGE AND ADMINISTRATION INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION

Ciprofloxacin is indicated for the treatment of complicated urinary tract infections and pyelonephritis due to Escherichia coli. Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to the controls, including events related to joints and/or surrounding tissues. The rates of these events in pediatric patients with complicated urinary tract infection and pyelonephritis within six weeks of follow-up were 9.3% (31/335) versus 6% (21/349) for control agents. The rates of these events occurring at any time up to the one year follow-up were 13.7% (46/335) and 9.5% (33/349), respectively. The rate of all adverse events regardless of drug relationship at six weeks was 41% (138/335) in the ciprofloxacin arm compared to 31% (109/349) in the control arm. (See ADVERSE REACTIONS.)

Short-term safety data from a single trial in pediatric cystic fibrosis patients are available. In a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5 - 17 years), 67 patients received ciprofloxacin I.V. 10 mg/kg/dose q8h for one week followed by ciprofloxacin tablets 20 mg/kg/dose q12h to complete 10 - 21 days treatment and 62 patients received the combination of ceftazidime I.V. 50 mg/kg/dose q8h and tobramycin I.V. 3 mg/kg/dose q8h for a total of 10 - 21 days. Patients less than 5 years of age were not studied. Safety monitoring in the study included periodic range of motion examinations and gait assessments by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0 - 93 days). This study was not designed to determine long term effects and the safety of repeated exposure to ciprofloxacin. 

Musculoskeletal adverse events in patients with cystic fibrosis were reported in 22% of the patients in the ciprofloxacin group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the ciprofloxacin group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the ciprofloxacin group and 11% in the comparison group. Other adverse events were similar in nature and frequency between treatment arms. One of sixty-seven patients developed arthritis of the knee nine days after a ten-day course of treatment with ciprofloxacin. Clinical symptoms resolved, but an MRI showed knee effusion without other abnormalities eight months after treatment. However, the relationship of this event to the patient’s course of ciprofloxacin can not be definitively determined, particularly since patients with cystic fibrosis may develop arthralgias/arthritis as part of their underlying disease process.

Boxed Warning, WARNINGS, ADVERSE REACTIONS/Post-Marketing Adverse Event Reports).

CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION































Ciprofloxacin, administered I.V. and/or orally, was compared to a cephalosporin for treatment of complicated urinary tract infections (cUTI) or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years). The trial was conducted in the U.S., Canada, Argentina, Peru, Costa Rica, Mexico, South Africa, and Germany. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). The primary objective of the study was to assess musculoskeletal and neurological safety within 6 weeks of therapy and through one year of follow-up in the 335 ciprofloxacin- and 349 comparator-treated patients enrolled.
 
An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse events as well as all patients with an abnormal gait or abnormal joint exam (baseline or treatment-emergent). These events were evaluated in a comprehensive fashion and included such conditions as arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in a joint.

The affected joints included: knee, elbow, ankle, hip, wrist, and shoulder. Within 6 weeks of treatment initiation, the rates of these events were 9.3% (31/335) in the ciprofloxacin-treated group versus 6% (21/349) in comparator-treated patients. The majority of these events were mild or moderate in intensity. All musculoskeletal events occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment.

Radiological evaluations were not routinely used to confirm resolution of the events. The events occurred more frequently in ciprofloxacin-treated patients than control patients, regardless of whether they received I.V. or oral therapy. Ciprofloxacin-treated patients were more likely to report more than one event and on more than one occasion compared to control patients. These events occurred in all age groups and the rates were consistently higher in the ciprofloxacin group compared to the control group. At the end of 1 year, the rate of these events reported at any time during that period was 13.7% (46/335) in the ciprofloxacin-treated group versus 9.5% (33/349) comparator-treated patients.

An adolescent female discontinued ciprofloxacin for wrist pain that developed during treatment. An MRI performed 4 weeks later showed a tear in the right ulnar fibrocartilage. A diagnosis of overuse syndrome secondary to sports activity was made, but a contribution from ciprofloxacin cannot be excluded. The patient recovered by 4 months without surgical intervention.

The incidence rates of neurological events within 6 weeks of treatment initiation were 3% (9/335) in the ciprofloxacin group versus 2% (7/349) in the comparator group and included dizziness, nervousness, insomnia, and somnolence.

In this trial, the overall incidence rates of adverse events regardless of relationship to study drug and within 6 weeks of treatment initiation were 41% (138/335) in the ciprofloxacin group versus 31% (109/349) in the comparator group. The most frequent events were gastrointestinal: 15% (50/335) of ciprofloxacin patients compared to 9% (31/349) of comparator patients. Serious adverse events were seen in 7.5% (25/335) of ciprofloxacin-treated patients compared to 5.7% (20/349) of control patients. Discontinuation of drug due to an adverse event was observed in 3% (10/335) of ciprofloxacin-treated patients versus 1.4% (5/349) of comparator patients. Other adverse events that occurred in at least 1% of ciprofloxacin patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, accidental injury 3%, rhinitis 3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.
 
In addition to the events reported in pediatric patients in clinical trials, it should be expected that events reported in adults during clinical trials or post-marketing experience may also occur in pediatric patients.



PRECAUTIONS

INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .

Changes in laboratory parameters listed as adverse events without regard to drug relationship are listed below:
 
Hepatic         –   Elevations of ALT (SGPT) (1.9%), AST (SGOT) (1.7%), alkaline phosphatase (0.8%), LDH (0.4%), serum bilirubin (0.3%).
 
Hematologic  –   Eosinophilia (0.6%), leukopenia (0.4%), decreased blood platelets (0.1%), elevated blood platelets (0.1%), pancytopenia (0.1%). 
 
Renal             –   Elevations of serum creatinine (1.1%), BUN (0.9%), CRYSTALLURIA, CYLINDRURIA, AND HEMATURIA HAVE BEEN REPORTED.
 
Other changes occurring in less than 0.1% of courses were: elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, leukocytosis.

To report SUSPECTED ADVERSE EVENTS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.









®

Weight (kg) x (140 - age)







ADVERSE REACTIONS CLINICAL STUDIES


Bacillus anthracis 5 INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION

2

Ciprofloxacin Tablets USP, are available as white, round, film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with "WW927" on one side.

Ciprofloxacin Tablets, USP area also available as white, capsule shaped, film-coated tablets containing 500 mg or 750 mg ciprofloxacin. The 500 mg tablet is coded with "WW928" on one side. The 750 mg tablet is coded with "WW929" on one side. Ciprofloxacin Tablets, USP 250 mg and 500 mg are available in bottles of 30's, 100's and 500's.

Ciprofloxacin Tablets, USP 750 mg are available in bottles of 50's and 100's and Unit Dose Boxes of 100 tablets.

                                                        Strength                Tablet Identification

Bottles of 30's:                                    250 mg                        WW927
                                                            500 mg                        WW928
Bottles of 50's:                                    750 mg                        WW929
Bottles of 100's:                                  250 mg                        WW927
                                                            500 mg                        WW928
                                                            750 mg                        WW929
Bottles of 500's:                                  250 mg                        WW927
                                                            500 mg                        WW928
Unit Dose Boxes of 100                      250 mg                        WW927
                                                            500 mg                        WW928
                                                            750 mg                        WW929

   

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP using a child-resistant closure.

max

WARNINGS



® DOSAGE AND ADMINISTRATION

2















in vitro


E. coli

79

Saccharomyces cerevisiae
Saccharomyces cerevisiae


in vivo





2

2 4



2
Pregnancy Category C

8

9 In utero

10 in utero

8,9 WARNINGS

2 2 WARNINGS

Ciprofloxacin, like other quinolones, causes arthropathy and histological changes in weight-bearing joints of juvenile animals resulting in lameness. (See ANIMAL PHARMACOLOGY.)

DOSAGE AND ADMINISTRATION INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION

Ciprofloxacin is indicated for the treatment of complicated urinary tract infections and pyelonephritis due to Escherichia coli. Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to the controls, including events related to joints and/or surrounding tissues. The rates of these events in pediatric patients with complicated urinary tract infection and pyelonephritis within six weeks of follow-up were 9.3% (31/335) versus 6% (21/349) for control agents. The rates of these events occurring at any time up to the one year follow-up were 13.7% (46/335) and 9.5% (33/349), respectively. The rate of all adverse events regardless of drug relationship at six weeks was 41% (138/335) in the ciprofloxacin arm compared to 31% (109/349) in the control arm. (See ADVERSE REACTIONS.)

Short-term safety data from a single trial in pediatric cystic fibrosis patients are available. In a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5 - 17 years), 67 patients received ciprofloxacin I.V. 10 mg/kg/dose q8h for one week followed by ciprofloxacin tablets 20 mg/kg/dose q12h to complete 10 - 21 days treatment and 62 patients received the combination of ceftazidime I.V. 50 mg/kg/dose q8h and tobramycin I.V. 3 mg/kg/dose q8h for a total of 10 - 21 days. Patients less than 5 years of age were not studied. Safety monitoring in the study included periodic range of motion examinations and gait assessments by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0 - 93 days). This study was not designed to determine long term effects and the safety of repeated exposure to ciprofloxacin. 

Musculoskeletal adverse events in patients with cystic fibrosis were reported in 22% of the patients in the ciprofloxacin group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the ciprofloxacin group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the ciprofloxacin group and 11% in the comparison group. Other adverse events were similar in nature and frequency between treatment arms. One of sixty-seven patients developed arthritis of the knee nine days after a ten-day course of treatment with ciprofloxacin. Clinical symptoms resolved, but an MRI showed knee effusion without other abnormalities eight months after treatment. However, the relationship of this event to the patient’s course of ciprofloxacin can not be definitively determined, particularly since patients with cystic fibrosis may develop arthralgias/arthritis as part of their underlying disease process.

Boxed Warning, WARNINGS, ADVERSE REACTIONS/Post-Marketing Adverse Event Reports).

CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION

WARNING Fluoroquinolones, including Ciprofloxacin Tablets, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS).

CIPROFLOXACIN - ciprofloxacin tablet, film coated 
West-ward Pharmaceutical Corp

----------

Ciprofloxacin Tablets, USP



Tendon rupture or swelling of the tendon (tendinitis)




Call your healthcare provider if you think your condition is not getting better while you are taking Ciprofloxacin Tablets.

Do not take Ciprofloxacin Tablets if you:

See “What is the most important information I should know about Ciprofloxacin Tablets?”

Tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. Ciprofloxacin Tablets and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:

Ask your healthcare provider if you are not sure if any of your medicines are listed above.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.


If you have been prescribed Ciprofloxacin Tablets after being exposed to anthrax:

Other serious side effects of Ciprofloxacin Tablets include:

Seizures have been reported in people who take fluoroquinolone antibiotics including Ciprofloxacin Tablets. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking Ciprofloxacin Tablets will change your risk of having a seizure.

Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of Ciprofloxacin Tablets. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:

Skin rash may happen in people taking ciprofloxacin tablets even after only one dose. Stop taking ciprofloxacin tablets at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ciprofloxacin tablets.

Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ciprofloxacin Tablets may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:

Pseudomembranous colitis can happen with most antibiotics, including Ciprofloxacin Tablets. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including Ciprofloxacin Tablets. Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

Ciprofloxacin Tablets may need to be stopped to prevent permanent nerve damage.

People who take Ciprofloxacin Tablets and other fluoroquinolone medicines with the oral anti-diabetes medicine glyburide (Micronase, Glynase, Diabeta, Glucovance)can get low blood sugar (hypoglycemia) which can sometimes be severe. Tell your healthcare provider if you get low blood sugar with Ciprofloxacin Tablets. Your antibiotic medicine may need to be changed.

See “What should I avoid while taking Ciprofloxacin Tablets?” 

Increased chance of problems with joints and tissues around joints in children under 18 years old. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with Ciprofloxacin Tablets.

The most common side effects of Ciprofloxacin Tablets include:

These are not all the possible side effects of Ciprofloxacin Tablets. Tell your healthcare provider about any side effect that bothers you, or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Store at

Keep Ciprofloxacin Tablets and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ciprofloxacin Tablets for a condition for which it is not prescribed. Do not give Ciprofloxacin Tablets to other people, even if they have the same symptoms that you have. They may harm them.

This Medication Guide summarizes the most important information about Ciprofloxacin Tablets. If you would like more information about Ciprofloxacin Tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Ciprofloxacin Tablets that is written for healthcare professionals. For more information call 1-866-850-2876.

Active ingredient: ciprofloxacin

Inactive ingredients: colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline  cellulose, polyacrylate dispersion (methylacrylate and ethylacrylate copolymer), polyethylene glycol, purified water, simethicone emulsion, sodium starch glycolate, talc, and titanium dioxide.

Revised March 2009

This Medication Guide has been approved by the U.S. Food and Drug Administration.

 
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
Distributor 

Manufactured by:
Hikma Pharmaceuticals
P.O. Box 182400
Amman 11118 - Jordan  
 
 

Revised: 06/2010 West-ward Pharmaceutical Corp

image of labelimage of label


AZITHROMYCIN 
azithromycin   tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 35356-017 (64679-964)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN (AZITHROMYCIN) AZITHROMYCIN 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
CROSCARMELLOSE SODIUM  
MAGNESIUM TRISILICATE  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
HYDROXYPROPYL CELLULOSE  
SODIUM LAURYL SULFATE  
HYPROMELLOSES  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL  
Product Characteristics
Color white Score no score
Shape OVAL Size 17mm
Flavor Imprint Code W964
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 35356-017-03 3 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065405 11/09/2010

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical DBA Quality Care Products LLC 831276758 relabel
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 677320212 manufacture
Revised: 11/2010 Lake Erie Medical DBA Quality Care Products LLC