Ciprofloxacin Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Ciprofloxacin Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

WARNING:
Fluoroquinolones, including ciprofloxacin, 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 (SeeWARNINGS

CIPROFLOXACIN HYDROCHLORIDE DESCRIPTION


Ciprofloxacin Hydrochloride



CLINICAL PHARMACOLOGY

Absorption


Dose (mg)Maximum Serum Concentration (Area Under Curve (AUC) (



Parameters500 mg q12h, P.O400 mg q12h, I.V.750 mg q12h, P.O400 mg q8h, I.V.* **
Distribution



Metabolism
 CONTRAINDICATIONS WARNINGSPRECAUTIONS: Drug Interactions).

Excretion
The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Approximately 40 to 50% of an orally administered dose is excreted in the urine as unchanged drug. After a 250 mg oral dose, urine concentrations of ciprofloxacin usually exceed 200during the first two hours and are approximately 30at 8 to 12 hours after dosing. The urinary excretion of ciprofloxacin is virtually complete within 24 hours after dosing. The renal clearance of ciprofloxacin, which is approximately 300 mL/minute, exceeds the normal glomerular filtration rate of 120 mL/minute. Thus, active tubular secretion would seem to play a significant role in its elimination. Co-administration of probenecid with ciprofloxacin results in about a 50% reduction in the ciprofloxacin renal clearance and a 50% increase in its concentration in the systemic circulation. Although bile concentrations of ciprofloxacin are several fold higher than serum concentrations after oral dosing, only a small amount of the dose administered is recovered from the bile as unchanged drug. An additional 1 to 2% of the dose is recovered from the bile in the form of metabolites. Approximately 20 to 35% of an oral dose is recovered from the feces within 5 days after dosing. This may arise from either biliary clearance or transintestinal elimination.

Drug-drug Interactions
When ciprofloxacin tablets are given concomitantly with food, there is a delay in the absorption of the drug, resulting in peak concentrations that occur closer to 2 hours after dosing rather than 1 hour. The overall absorption of ciprofloxacin tablets, however, is not substantially affected. Concurrent administration of antacids containing magnesium hydroxide or aluminum hydroxide may reduce the bioavailability of ciprofloxacin by as much as 90%. (SeePRECAUTIONS.)
The serum concentrations of ciprofloxacin and metronidazole were not altered when these two drugs were given concomitantly.
Concomitant administration with tizanidine is contraindicated (SeeCONTRAINDICATIONS).
Concomitant administration of ciprofloxacin with theophylline decreases the clearance of theophylline resulting in elevated serum theophylline levels and increased risk of a patient developing CNS or other adverse reactions. Ciprofloxacin also decreases caffeine clearance and inhibits the formation of paraxanthine after caffeine administration. (SeeWARNINGS,PRECAUTIONS.)

Special Populations
Pharmacokinetic studies of the oral (single dose) and intravenous (single and multiple dose) forms of ciprofloxacin indicate that plasma concentrations of ciprofloxacin are higher in elderly subjects (>65 years) as compared to young adults. Although the Cmax is increased 16-40%, the increase in mean AUC is approximately 30%, and can be at least partially attributed to decreased renal clearance in the elderly. Elimination half-life is only slightly (~20%) prolonged in the elderly. These differences are not considered clinically significant. (SeePRECAUTIONS: Geriatric Use.)
In patients with reduced renal function, the half-life of ciprofloxacin is slightly prolonged. Dosage adjustments may be required. (SeeDOSAGE AND ADMINISTRATION.)
In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. The kinetics of ciprofloxacin in patients with acute hepatic insufficiency, however, have not been fully elucidated.

MICROBIOLOGY



INDICATIONS AND USAGE








INDICATIONS AND USAGEINHALATIONAL ANTHRAX - ADDITIONAL INFORMATION









Susceptibility Tests

Dilution Techniques


MIC (Interpretation

MIC (Interpretation


MIC (Interpretation


OrganismMIC (* *
Diffusion Techniques



Zone Diameter (mm)Interpretation

Zone Diameter (mm)Interpretation


Zone Diameter (mm)Interpretation


OrganismZone Diameter (mm)* *


INDICATIONS & USAGE

DOSAGE AND ADMINISTRATION

Adult Patients









11




1


Pediatric Patients (1 to 17 years of age)

WARNINGSPRECAUTIONS, Pediatric UseADVERSE REACTIONSCLINICAL STUDIESANIMAL PHARMACOLOGY

Adult and Pediatric Patients

INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION



CIPROFLOXACIN HYDROCHLORIDE CONTRAINDICATIONS


PRECAUTIONS, Drug Interactions

WARNINGS

Tendinopathy and Tendon Rupture:


Pregnant Women
PRECAUTIONS: PregnancyNursing Mothers

Pediatrics
INDICATIONS AND USAGEADVERSE REACTIONS
ANIMAL PHARMACOLOGY

Cytochrome P450 (CYP450)


Central Nervous System Disorders
PRECAUTIONS: GeneralInformation for PatientsDrug InteractionsADVERSE REACTIONS

Theophylline


Hypersensitivity Reactions


  • ●
  • ●     vasculitis; arthralgia; myalgia; serum sickness;
  • ●     allergic pneumonitis;
  • ●     interstitial nephritis; acute renal insufficiency or failure;
  • ●     hepatitis; jaundice; acute hepatic necrosis or failure;
  • ●     anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
PRECAUTIONS: Information for PatientsADVERSE REACTIONS

Pseudomembranous Colitis




Peripheral neuropathy


Syphilis


PRECAUTIONS

General
ANIMAL PHARMACOLOGY

Central Nervous System
WARNINGS, Information for PatientsDrug Interactions

Renal Impairment
DOSAGE AND ADMINISTRATION

Photosensitivity/Phototoxicity
ADVERSE REACTIONSADVERSE REACTIONS/ Post-Marketing Adverse Events



INFORMATION FOR PATIENTS


  • ●
  • ●     that antibacterial drugs including ciprofloxacin tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ciprofloxacin tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ciprofloxacin tablets or other antibacterial drugs in the future.
  • ●     that ciprofloxacin may be taken with or without meals and to drink fluids liberally. As with other quinolones, concurrent administration of ciprofloxacin with magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder, other highly buffered drugs or with other products containing calcium, iron or zinc should be avoided. Ciprofloxacin may be taken two hours before or six hours after taking these products. Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of ciprofloxacin may be significantly reduced; however, ciprofloxacin may be taken with a meal that contains these products.
  • ●     that ciprofloxacin may be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction.
  • ●     that photosensitivity/phototoxicity has been reported in patients receiving quinolones. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, patients should contact their physician.
  • ●     that peripheral neuropathies have been associated with ciprofloxacin use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, they should discontinue treatment and contact their physicians.
  • ●     that ciprofloxacin may cause dizziness and lightheadedness; therefore, patients should know how they react to this drug before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination.
  • ●     that ciprofloxacin increase the effects of tizanidine. Patients should not use ciprofloxacin if they are already taking tizanidine.
  • ●     that ciprofloxacin may increase the effects of theophylline and caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones.
  • ●     that convulsions have been reported in patients receiving quinolones, including ciprofloxacin, and to notify their physician before taking this drug if there is a history of this condition.
  • ●     that ciprofloxacin has been associated with an increased rate of adverse events involving joints and surrounding tissue structures (like tendons) in pediatric patients (less than 18 years of age). Parents should inform their child's physician if the child has a history of joint-related problems before taking this drug. Parents of pediatric patients should also notify their child's physician of any joint-related problems that occur during or following ciprofloxacin therapy. (SeeWARNINGS,PRECAUTIONS, Pediatric UseandADVERSE REACTIONS.)
  • ●     that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

DRUG INTERACTIONS


WARNINGS

DOSAGE AND ADMINISTRATION










CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



















PREGNANCY

Teratogenic Effects

Pregnancy Category C



WARNINGS
WARNINGS

NURSING MOTHERS



PEDIATRIC USE

ANIMAL PHARMACOLOGY

Inhalational Anthrax (Post-Exposure)
DOSAGE AND ADMINISTRATIONINHALATIONAL ANTHRAX - ADDITIONAL INFORMATION

Complicated Urinary Tract Infection and Pyelonephritis
ADVERSE REACTIONSCLINICAL STUDIES

Cystic Fibrosis



GERIATRIC USE

Boxed Warning,WARNINGS,and ADVERSE REACTIONS/Post-Marketing Adverse Event Reports
CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION


CIPROFLOXACIN HYDROCHLORIDE ADVERSE REACTIONS

Adverse Reactions in Adult Patients

















Adverse Reactions in Pediatric Patients




CiprofloxacinComparator* **



Post-Marketing Adverse Event Reports

PRECAUTIONS
INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION

Adverse Laboratory Changes



OVERDOSAGE






DOSAGE & ADMINISTRATION

ADULTS




InfectionSeverityDoseFrequencyUsual Durations* * INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION
Conversion of I.V. to Oral Dosing in Adults
CLINICAL PHARMACOLOGY

Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage
Adults with Impaired Renal Function


Creatinine Clearance (mL/min)Dose



DOSAGE AND ADMINISTRATIONPEDIATRICS
ADVERSE REACTIONSCLINICAL STUDIES


InfectionRoute of AdministrationDose (mg/kg)FrequencyTotal Duration* INHALATIONAL ANTHRAXADDITIONAL INFORMATION*

HOW SUPPLIED





















ANIMAL PHARMACOLOGY & OR TOXICOLOGY

WARNINGS





CLINICAL STUDIES

Complicated Urinary Tract Infection and PyelonephritisEfficacy in Pediatric Patients





CiprofloxacinComparator* *
INHALATIONAL ANTHRAX IN ADULTS AND PEDIATRICS - ADDITIONAL INFORMATION
DOSAGE AND ADMINISTRATIONPRECAUTIONS, Pediatric Use




REFERENCES











SPL MEDGUIDE

CIPROFLOXACIN TABLETS, USP
CIPROFLOXACIN EXTENDED-RELEASE TABLETS


What is the most important information I should know about ciprofloxacin tablets?


  • ●     Tendons are tough cords of tissue that connect muscles to bones.
  • ●     Pain, swelling, tears, and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of all ages who take fluoroquinolone antibiotics, including ciprofloxacin tablets. The risk of getting tendon problems is higher if you:
  • ●               are over 60 years of age
  • ●               are taking steroids (corticosteroids)
  • ●               have had a kidney, heart, or lung transplant.
  • ●     Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors.
  • ●     Other reasons for tendon ruptures can include:
  • ●               physical activity or exercise
  • ●               kidney failure
  • ●               tendon problems in the past, such as in people with rheumatoid arthritis (RA)
  • ●     Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking ciprofloxacin tablets until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. Talk to your healthcare provider about the risk of tendon rupture with continued use of ciprofloxacin tablets. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
  • ●     Tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin tablets. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.
  • ●     Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
  • ●               hear or feel a snap or pop in a tendon area
  • ●               bruising right after an injury in a tendon area
  • ●               unable to move the affected area or bear weight
  • ●     See the section "What are the possible side effects of ciprofloxacintablets?for more information about side effects.

What are ciprofloxacin tablets?





Who should not take ciprofloxacin tablets?

  • ●     have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in ciprofloxacin tablets. Ask your healthcare provider if you are not sure. See the list of ingredients in ciprofloxacin tablets at the end of this Medication Guide.
  • ●     also take a medicine called tizanidine (Zanaflex). Serious side effects from tizanidine are likely to happen.

What should I tell my healthcare provider before taking ciprofloxacin tablets?
What is the most important information I should know aboutciprofloxacin tablets?

  • ●     have tendon problems
  • ●     have central nervous system problems (such as epilepsy)
  • ●     have nerve problems
  • ●     have or anyone in your family has an irregular heartbeat, especially a condition calledQT prolongation
  • ●     have a history of seizures
  • ●     have kidney problems. You may need a lower dose of ciprofloxacin tablets if your kidneys do not work well.
  • ●     have rheumatoid arthritis (RA) or other history of joint problems
  • ●     have trouble swallowing pills
  • ●     are pregnant or planning to become pregnant. It is not known if ciprofloxacin tablets will harm your unborn child.
  • ●     are breast-feeding or planning to breast-feed. Ciprofloxacin tablets passes into breast milk. You and your healthcare provider should decide whether you will take ciprofloxacin tablets or breast-feed.

  • ●     an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take ciprofloxacin tablets or other fluoroquinolones may increase your risk of central nervous system effects and seizures. SeeWhat are the possible side effects ofciprofloxacin tablets?.
  • ●     a blood thinner (warfarin, CoumadinJantoven
  • ●     tizanidine (ZanaflexYou should not take ciprofloxacin tablets if you are already taking tizanidine. SeeWhoshould not takeciprofloxacin tablets?
  • ●     theophylline (Theo-24ElixophyllinTheochronUniphylTheolair
  • ●     glyburide (MicronaseGlynaseDiabetaGlucovanceSeeWhat are the possible side effects ofciprofloxacin tablets?
  • ●     phenytoin(Fosphenytoin SodiumCerebyxDilantin-125DilantinExtended Phenytoin SodiumPrompt Penytoin SodiumPhenytek
  • ●     products that contain caffeine
  • ●     a medicine to control your heart rate or rhythm (antiarrhythmics) SeeWhatare the possible side effects ofciprofloxacin tablets?
  • ●     an anti-psychotic medicine
  • ●     a tricyclic antidepressant
  • ●     a water pill (diuretic)
  • ●     a steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury. SeeWhat is the most important information I should knowabout ciprofloxacin tablets?
  • ●     methotrexate (Trexall
  • ●     Probenecid (ProbalanCol-probenecid
  • ●     Metoclopromide (ReglanReglan ODT
  • ●     Certain medicines may keep ciprofloxacin tablets from working correctly. Take ciprofloxacin tablets either 2 hours before or 6 hours after taking these products:
  • ●               an antacid, multivitamin, or other product that has magnesium, calcium, aluminum, iron, or zinc
  • ●               sucralfate (Carafate
  • ●               didanosine (VidexVidexEC).



How should I take ciprofloxacin tablets?
  • ●      Take ciprofloxacin tablets exactly as prescribed by your healthcare provider.
  • ●     Take ciprofloxacin tablets in the morning and evening at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you can not swallow the tablet whole.
  • ●     Take ciprofloxacin extended-release tablets one time each day at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you cannot swallow the tablet whole.
  • ●     Ciprofloxacin tablets can be taken with or without food.
  • ●     Ciprofloxacin tablets should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that contains these products.
  • ●     Drink plenty of fluids while taking ciprofloxacin tablets.
  • ●     Do not skip any doses, or stop taking ciprofloxacin tablets even if you begin to feel better, until you finish your prescribed treatment, unless:
  • ●               you have tendon effects (seeWhat is the most important information I should know aboutciprofloxacin tablets?),
  • ●               you have a serious allergic reaction (seeWhat are the possible side effects of ciprofloxacin tablets?), or
  • ●               your healthcare provider tells you to stop.
  • ●     This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to ciprofloxacin tablets. If this happens, ciprofloxacin tablets and other antibiotic medicines may not work in the future.
  • ●     If you miss a dose of ciprofloxacin tablets, take it as soon as you remember. Do not take two doses at the same time, and do not take more than two doses in one day.
  • ●     If you miss a dose of ciprofloxacin extended-release tablets, take it as soon as you remember. Do not take more than one dose in one day.
  • ●     If you take too much, call your healthcare provider or get medical help immediately.

  • ●     Ciprofloxacin tablets has been approved to lessen the chance of getting anthrax disease or worsening of the disease after you are exposed to the anthrax bacteria germ.
  • ●     Take ciprofloxacin tablets exactly as prescribed by your healthcare provider. Do not stop taking ciprofloxacin tablets without talking with your healthcare provider. If you stop taking ciprofloxacin tablets too soon, it may not keep you from getting the anthrax disease.
  • ●     Side effects may happen while you are taking ciprofloxacin tablets. When taking your ciprofloxacin tablets to prevent anthrax infection, you and your healthcare provider should talk about whether the risks of stopping ciprofloxacin tablets too soon are more important than the risks of side effects with ciprofloxacin tablets.
  • ●     If you are pregnant, or plan to become pregnant while taking ciprofloxacin tablets, you and your healthcare provider should decide whether the benefits of taking ciprofloxacin tablets for anthrax are more important than the risks.

What should I avoid while taking ciprofloxacin tablets?
  • ●      Ciprofloxacin tablets can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how ciprofloxacin tablets affects you.
  • ●     Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin tablets can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while taking ciprofloxacin tablets, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of ciprofloxacin tablets?
What is the most important information I should know aboutciprofloxacin tablets?

  • ●     Central Nervous System Effects: 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.









  • ●     Serious allergic reactions: Allergic reactions can happen in people taking fluoroquinolones, including ciprofloxacin tablets, even after only one dose. Stop taking ciprofloxacin tablets and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
  • ●               hives
  • ●               trouble breathing or swallowing
  • ●               swelling of the lips, tongue, face
  • ●               throat tightness, hoarseness
  • ●               rapid heartbeat
  • ●               faint
  • ●               yellowing of the skin or eyes. Stop taking ciprofloxacin tablets and tell your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ciprofloxacin tablets (a liver problem).
  • ●     Skin rash: 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.
  • ●     Serious heart rhythm changes (QT prolongation and torsades de pointes): 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:
  • ●               who are elderly
  • ●               with a family history of prolonged QT interval,
  • ●               with low blood potassium (hypokalemia),
  • ●               who take certain medicines to control heart rhythm (antiarrhythmics).
  • ●     Intestine infection (Pseudomembranous colitis): 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.
  • ●     Changes in sensation and possible nerve damage (Peripheral Neuropathy): 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:
  • ●               pain
  • ●               burning
  • ●               tingling
  • ●               numbness
  • ●               weakness

  • ●     Low blood sugar (hypoglycemia): 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.
  • ●     Sensitivity to sunlight (photosensitivity): SeeWhat should I avoid while takingciprofloxacin tablets?
  • ●     Joint Problems: 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.

  • ●     nausea
  • ●     headache
  • ●     diarrhea
  • ●     vomiting
  • ●     vaginal yeast infection
  • ●     changes in liver function tests
  • ●     pain or discomfort in the abdomen



How should I store ciprofloxacin tablets?
  • ●      Ciprofloxacin Tablets:

  • ●     Ciprofloxacin Extended-Release Tablets:



General Information about ciprofloxacin tablets



What are the ingredients in ciprofloxacin tablets?
  • ●      Ciprofloxacin Tablets:


  • ●     Ciprofloxacin Extended-Release Tablets:










PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Ciprofloxacin Hydrochloride

Ciprofloxacin Hydrochloride

Ciprofloxacin Hydrochloride

Ciprofloxacin Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-431(NDC:55111-126)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN 250 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
Hypromellose 2910 (5 Mpa.s)
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 14 mm R;126 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-431-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075593 2011-07-29


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