Ciprofloxacin Hydrochloride

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• CIPROFLOXACIN HYDROCHLORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• MICROBIOLOGY
• INDICATIONS & USAGE
• CIPROFLOXACIN HYDROCHLORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• CIPROFLOXACIN HYDROCHLORIDE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• ANIMAL PHARMACOLOGY & OR TOXICOLOGY
• CLINICAL STUDIES
• REFERENCES
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

CIPROFLOXACIN HYDROCHLORIDE DESCRIPTION

CLINICAL PHARMACOLOGY

MICROBIOLOGY

INDICATIONS & USAGE

CIPROFLOXACIN HYDROCHLORIDE CONTRAINDICATIONS

WARNINGS

• ●

• ●     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 PATIENTS

• ●

• ●     that antibacterial drugs including Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg is 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 USP, 250 mg, 500 mg and 750 mg 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, Videx

• ●     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 increases the effects of tizanidine (ZanaflexPatients 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

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

CIPROFLOXACIN HYDROCHLORIDE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

ANIMAL PHARMACOLOGY & OR TOXICOLOGY

CLINICAL STUDIES

REFERENCES

SPL MEDGUIDE

• ●     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 USP. 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 USP 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 USP. 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 USP. 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 sectionWhat are the possible side effects of Ciprofloxacin Tablets USP?for more information about side effects.

• ●     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 USP. Ask your healthcare provider if you are not sure. See the list of ingredients in Ciprofloxacin Tablets USP at the end of this Medication Guide.

• ●     also take a medicine called tizanidine (ZanaflexSerious side effects from tizanidine are likely to happen.

• ●     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 USP 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 USP will harm your unborn child.

• ●     are breast-feeding or planning to breast-feed. Ciprofloxacin Tablets USP passes into breast milk. You and your healthcare provider should decide whether you will take Ciprofloxacin Tablets USP 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 USP or other fluoroquinolones may increase your risk of central nervous system effects and seizures. SeeWhat are the possible side effects of Ciprofloxacin Tablets USP?

• ●     a blood thinner (warfarin, CoumadinJantoven

• ●     tizanidine (ZanaflexYou should not take Ciprofloxacin Tablets USP if you are already taking tizanidine. SeeWho should not take Ciprofloxacin Tablets USP?

• ●     theophylline (Theo-24ElixophyllinTheochronUniphylTheolair

• ●     glyburide (MicronaseGlynaseDiabetaGlucovanceSeeWhat are the possible side effects of Ciprofloxacin Tablets USP?

• ●     phenytoin (Fosphenytoin SodiumCerebyxDilantin-125DilantinExtended Phenytoin SodiumPrompt Penytoin SodiumPhenytek

• ●     products that contain caffeine

• ●     a medicine to control your heart rate or rhythm (antiarrhythmics) SeeWhat are the possible side effects of Ciprofloxacin Tablets USP?

• ●     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 know about Ciprofloxacin Tablets USP?

• ●     methotrexate (Trexall

• ●     Probenecid (ProbalanCol-probenecid

• ●     Metoclopromide (ReglanReglan ODT

• ●     Certain medicines may keep Ciprofloxacin Tablets USP from working correctly. Take Ciprofloxacin Tablets USP 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 (VidexVidex EC

• ●      Take Ciprofloxacin Tablets USP exactly as prescribed by your healthcare provider.

• ●     Take Ciprofloxacin Tablets USP 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.

• ●     Ciprofloxacin Tablets USP can be taken with or without food.

• ●     Ciprofloxacin Tablets USP 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 USP.

• ●     Do not skip any doses, or stop taking Ciprofloxacin Tablets USP 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 about Ciprofloxacin Tablets USP?),

• ●               you have a serious allergic reaction (seeWhat are the possible side effects of Ciprofloxacin Tablets USP?), 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 USP. If this happens, Ciprofloxacin Tablets USP and other antibiotic medicines may not work in the future.

• ●     If you miss a dose of Ciprofloxacin Tablets USP, 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 take too much, call your healthcare provider or get medical help immediately.

• ●     Ciprofloxacin Tablets USP 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 USP exactly as prescribed by your healthcare provider. Do not stop taking Ciprofloxacin Tablets USP without talking with your healthcare provider. If you stop taking Ciprofloxacin Tablets USP too soon, it may not keep you from getting the anthrax disease.

• ●     Side effects may happen while you are taking Ciprofloxacin Tablets USP. When taking your Ciprofloxacin Tablets USP to prevent anthrax infection, you and your healthcare provider should talk about whether the risks of stopping Ciprofloxacin Tablets USP too soon are more important than the risks of side effects with Ciprofloxacin Tablets USP.

• ●     If you are pregnant, or plan to become pregnant while taking Ciprofloxacin Tablets USP, you and your healthcare provider should decide whether the benefits of taking Ciprofloxacin Tablets USP for anthrax are more important than the risks.

• ●      Ciprofloxacin Tablets USP 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 USP affects you.

• ●     Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin Tablets USP 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 USP, 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.

• ●      Ciprofloxacin Tablets USP can cause side effects that may be serious or even cause death. SeeWhat is the most important information I should know about Ciprofloxacin Tablets USP?

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

• ●               feel dizzy

• ●               seizures

• ●               hear voices, see things, or sense things that are not there (hallucinations)

• ●               feel restless

• ●               tremors

• ●               feel anxious or nervous

• ●               confusion

• ●               depression

• ●               trouble sleeping

• ●               nightmares

• ●               feel more suspicious (paranoia)

• ●               suicidal thoughts or acts

• ●      Serious allergic reactions:Allergic reactions can happen in people taking fluoroquinolones, including Ciprofloxacin Tablets USP, even after only one dose. Stop taking Ciprofloxacin Tablets USP 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 USP 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 USP (a liver problem).

• ●      Skin rash     

• ●      Serious heart rhythm changes(QT prolongation and torsade de pointes)     

• ●               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)     

• ●      Changes in sensation and possible nerve damage(Peripheral Neuropathy)     

• ●               pain

• ●               burning

• ●               tingling

• ●               numbness

• ●               weakness

• ●      Low blood sugar(hypoglycemia)     

• ●      Sensitivity to sunlight(photosensitivity)     

• ●      Joint Problems     

• ●               nausea

• ●               headache

• ●               diarrhea

• ●               vomiting

• ●               vaginal yeast infection

• ●               changes in liver function tests

• ●               pain or discomfort in the abdomen

• ●      Store Ciprofloxacin Tablets USP below 86(30

• ●      Active ingredient: ciprofloxacin

• ●     Inactive ingredients: pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION