Ciprofloxacin Alvia Overdose

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How old is patient?

What happens if I overdose Ciprofloxacin Alvia?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ciprofloxacin Alvia extended-release tablets:

Store Ciprofloxacin Alvia extended-release tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ciprofloxacin Alvia extended-release tablets out of the reach of children and away from pets.

Overdose of Ciprofloxacin Alvia in details

infoWhen a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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In the event of acute overdosage, the patient should be carefully observed and given supportive treatment, including monitoring of renal function. Adequate hydration must be maintained. Only a small amount of Ciprofloxacin Alvia (< 10%) is removed from the body after hemodialysis or peritoneal dialysis.

In mice, rats, rabbits and dogs, significant toxicity including tonic/clonic convulsions was observed at intravenous doses of Ciprofloxacin Alvia between 125 and 300 mg/kg.

DOSAGE AND ADMINISTRATION

Adults

Ciprofloxacin Alvia Injection, USP should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation.

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

ADULT DOSAGE GUIDELINES
*
DUE TO THE DESIGNATED PATHOGENS
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 Alvia serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of Ciprofloxacin Alvia serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION. Total duration of Ciprofloxacin Alvia administration (IV or oral) for inhalational anthrax (post-exposure) is 60 days.
Infection* Severity Dose Frequency Usual Duration
Urinary Tract Mild/Moderate Severe/Complicated 200 mg

400 mg

q12h

ql2h (or q 8h)

7-14 Days

7-14 Days

Lower Respiratory Tract Mild/Moderate Severe/Complicated 400 mg

400 mg

q12h

q8h

7-14 Days

7-14 Days

Nosocomial Pneumonia Mild/Moderate/Severe 400 mg q8h 10-14 Days
Skin and Skin Structure Mild/Moderate Severe/Complicated 400 mg

400 mg

q12h

q8h

7-14 Days

7-14 Days

Bone and Joint Mild/Moderate Severe/Complicated 400 mg

400 mg

q12h

q8h

≥ 4-6 Weeks

≥ 4-6 Weeks

Intra-Abdominal † Complicated 400 mg q12h 7-14 Days
Acute inusitis Mild/Moderate 400 mg q12h 10 Days
Chronic Bacterial Prostatitis Mild/Moderate 400 mg q12h 28 Days
Empirical Therapy

in

Febrile Neutropenic

Patients

Severe

Ciprofloxacin Alvia

+

Piperacillin

400 mg

50 mg/kg

Not to exceed

24g/day

q8h

q4h

7-14 Days

Inhalational anthrax (post-exposure)‡ 400 mg q12h 60 Days

Ciprofloxacin Alvia Injection, USP should be administered by intravenous infusion over a period of 60 minutes.

Conversion of I.V. to

Oral Dosing in Adults

Ciprofloxacin Alvia Tablets and Ciprofloxacin Alvia

Oral Suspension for oral administration are available.

Parenteral therapy may be switched to oral Ciprofloxacin Alvia when the condition warrants, at the discretion of the physician.

Equivalent AUC Dosing Regimens
Ciprofloxacin Alvia

Oral Dosage

Equivalent Ciprofloxacin Alvia Injection, USP Dosage
250 mg Tablet q 12 h 200 mg IV q 12 h
500 mg Tablet q 12 h 400 mg IV q 12 h
750 mg Tablet q 12 h 400 mg IV q 8 h

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Adults with Impaired Renal Function

Ciprofloxacin Alvia 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 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) Dosage
> 30 See usual dosage
5 - 29 200-400 mg q 18-24 hr

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

Men: Creatinine clearance (mL/min) = Weight (kg) x (140-age)

72 x serum creatinine (mg/dL)

Women: 0.85 x the value calculated for men.

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

For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.

Pediatrics

Ciprofloxacin Alvia Injection, USP should be administered 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.

Dosing and initial route of therapy (i.e., IV 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 IV 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 Alvia serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of Ciprofloxacin Alvia serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION.
Infection Route of Administration Dose

(mg/kg)

Frequency Total

Duration

Complicated Urinary Tract or Pyelonephritis (patients from1 to 17 years of age)

Intravenous

6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing >51 kg) Every 8 hours 10-21 days*

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).

Preparation of Ciprofloxacin Alvia Injection, USP for Administration

Vials (Injection Concentrate)

THIS PREPARATION MUST BE DILUTED BEFORE USE. The intravenous dose should be prepared by aseptically withdrawing the concentrate from the vial of Ciprofloxacin Alvia Injection, USP. This should be diluted with a suitable intravenous solution to a final concentration of l-2mg/mL. The resulting solution should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.

If the Y-type or "piggyback" method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of Ciprofloxacin Alvia Injection, USP. If the concomitant use of Ciprofloxacin Alvia Injection, USP and another drug is necessary each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.

Flexible Containers

Ciprofloxacin Alvia Injection, USP is also available as a 0.2% premixed solution in 5% dextrose in flexible containers of 100 mL or 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described above.

Compatibility and Stability

Ciprofloxacin Alvia Injection 1% (10 mg/mL), when diluted with the following intravenous solutions to concentrations of 0.5 to 2.0 mg/mL, is stable for up to 14 days at refrigerated or room temperature storage.

  • 0.9% Sodium Chloride Injection, USP
  • 5% Dextrose Injection, USP
  • Sterile Water for Injection
  • 10% Dextrose for Injection
  • 5% Dextrose and 0.225% Sodium Chloride for Injection
  • 5% Dextrose and 0.45% Sodium Chloride for Injection
  • Lactated Ringer’s for Injection

What should I avoid while taking Ciprofloxacin Alvia?

Do not take Ciprofloxacin Alvia with dairy products such as milk or yogurt, or with calcium-fortified juice. You may eat or drink these products as part of a regular meal, but do not use them alone when taking Ciprofloxacin Alvia. They could make the medication less effective.

Avoid taking the following medicines within 6 hours before or 2 hours after you take Ciprofloxacin Alvia. These other medicines can make Ciprofloxacin Alvia much less effective when taken at the same time:

  • antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate (Carafate);

  • didanosine (Videx) powder or chewable tablets;

  • a phosphate binder such as lanthanum carbonate (Fosrenol) or sevelamer (Renagel); or

  • vitamin or mineral supplements that contain calcium, iron, or zinc.

Avoid caffeine while you are taking Ciprofloxacin Alvia, because the medication can make the effects of caffeine stronger.

Ciprofloxacin Alvia may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Ciprofloxacin Alvia can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Ciprofloxacin Alvia warnings

infoWarnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Patients should be advised:

· that antibacterial drugs, including Ciprofloxacin Alvia, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ciprofloxacin Alvia 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 Alvia or other antibacterial drugs in the future.

· that Ciprofloxacin Alvia should only be used to treat uncomplicated urinary tract infections (also known as bladder infections). The safety and efficacy of Ciprofloxacin Alvia to treat other urinary tract or non-urinary tract infections have not been studied.

· that Ciprofloxacin Alvia should be taken with a main meal of the day, preferably the evening meal. The patient should not take more than one Ciprofloxacin Alvia tablet per day, even if the patient misses a dose.

· that Ciprofloxacin Alvia tablets should be taken whole and never split, crushed, or chewed.

· that concomitant administration of Ciprofloxacin Alvia with aluminum or magnesium-containing antacids, sucralfate, VIDEX (didanosine) chewable buffered tablets or pediatric powder, metal cations such as iron and calcium, and multivitamin preparations containing zinc should be avoided. Ciprofloxacin Alvia should be administered at least 4 hours before or 2 hours after these products.

· that Ciprofloxacin Alvia should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, since the absorption of Ciprofloxacin Alvia may be significantly reduced. However, Ciprofloxacin Alvia may be taken with a meal that contains these products.

· that Ciprofloxacin Alvia may be associated with hypersensitivity reactions, even following a single dose, and to discontinue Ciprofloxacin Alvia at the first sign of a skin rash or other allergic reaction and contact their physician.

· to avoid excessive sunlight or artificial ultraviolet (UV) light while receiving Ciprofloxacin Alvia and to discontinue therapy if phototoxicity occurs.

· that peripheral neuropathies have been associated with Ciprofloxacin Alvia use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, patients should discontinue treatment and contact their physician.

· that if they experience pain, inflammation, or rupture of a tendon to discontinue treatment, to inform their physician, and to rest and refrain from exercise.

· to contact their doctor if they do not feel better of if they develop fever and back pain while or after taking Ciprofloxacin Alvia.

· that Ciprofloxacin Alvia 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 Alvia 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 Alvia, and to notify their physician before taking this drug if there is a history of this condition.

Patient Leaflet

Ciprofloxacin Alvia (Ciprofloxacin Alvia hydrochloride) Extended-Release Tablets

PROQUIN® XR

(prōkwin)

(Ciprofloxacin Alvia hydrochloride)

Extended-Release Tablets, 500 mg

This leaflet contains important information about Ciprofloxacin Alvia (Ciprofloxacin Alvia hydrochloride) extended-release tablets and should be read before you begin treatment. This leaflet does not replace talking with your doctor about your medical condition or your treatment. This leaflet does not list all benefits and risks of Ciprofloxacin Alvia. Ciprofloxacin Alvia can be prescribed only by a doctor. If you have any questions about Ciprofloxacin Alvia, talk to your doctor. Only your doctor can tell you if Ciprofloxacin Alvia is right for you.

What is Ciprofloxacin Alvia?

Ciprofloxacin Alvia is an antibiotic in the class known as "quinolones" that is used to treat adults with simple (uncomplicated) urinary tract infections (also known as "bladder infections") caused by bacteria. It is not known if Ciprofloxacin Alvia will treat infections other than bladder infections. Ciprofloxacin Alvia, like all other antibiotics, does not kill viruses.

You should contact your doctor if you do not feel better or if you develop fever and back pain while or after taking Ciprofloxacin Alvia.

Ciprofloxacin Alvia tablets are blue and contain 500 mg of active drug.

How should I take Ciprofloxacin Alvia?

· Ciprofloxacin Alvia should be taken once a day for 3 days shortly after a main meal of the day, preferably the evening meal. Ciprofloxacin Alvia does not work as well if you take it without a meal. You should try to take Ciprofloxacin Alvia at about the same time each day.

· Take Ciprofloxacin Alvia for all 3 days, even if you are feeling better. If you stop taking Ciprofloxacin Alvia before all 3 doses, Ciprofloxacin Alvia may not cure your bladder infection.

· Do not split, crush, or chew Ciprofloxacin Alvia tablets. Ciprofloxacin Alvia tablets must be swallowed whole. Tell your doctor if you cannot swallow tablets whole. Your doctor will prescribe a different medicine for you.

· Do not take more than one Ciprofloxacin Alvia tablet a day, even if you miss a dose.

· Do not take Ciprofloxacin Alvia at the same time that you drink milk or juices with added calcium, unless you drink them with a main meal.

· Many antacids and multivitamins may interfere with the absorption of Ciprofloxacin Alvia if taken at the same time. Take Ciprofloxacin Alvia at least 4 hours before or 2 hours after antacids that contain magnesium or aluminum. Ciprofloxacin Alvia should also be taken at least 4 hours before or 2 hours after sucralfate, VIDEX® (didanosine) chewable buffered tablets or pediatric powder, iron, calcium, and vitamins that contain zinc.

Who should not take Ciprofloxacin Alvia?

Do not take Ciprofloxacin Alvia if you are allergic to or have ever had a severe reaction to Ciprofloxacin Alvia or to any other "quinolone" antibiotics.

Ciprofloxacin Alvia is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. If you are pregnant or planning to become pregnant while taking Ciprofloxacin Alvia, talk to your doctor before taking this medication.

Ciprofloxacin Alvia is not recommended for children.

What should I tell my doctor before taking Ciprofloxacin Alvia?

Tell you doctor about all of your medical conditions, including if you have or ever had seizures (epilepsy), asthma, or liver or kidney problems.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Ciprofloxacin Alvia and certain other medicines can affect each other. You may have to adjust the times you take certain other medicines, vitamins, and herbal supplements. Especially, tell your doctor if you take: theophylline, VIDEX® (didanosine) chewable buffered tablets or pediatric powder; warfarin (Coumadin®); glyburide (Glucovance®, Micronase®, DiaBeta®); phenytoin (Dilantin®); sucralfate (Carafate®); or antacids or vitamins that contain magnesium, calcium, aluminum, iron, or zinc.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist.

What are the possible side effects of Ciprofloxacin Alvia?

Ciprofloxacin Alvia is generally well tolerated. The most common side effects with Ciprofloxacin Alvia include vaginal yeast infection and headache. Less common side effects include nausea, diarrhea, dizziness, and abdominal pain.

You should be careful about driving or operating machinery until you are sure the Ciprofloxacin Alvia is not causing dizziness or lightheadedness.

Rare cases of allergic reactions have been reported in patients receiving quinolones, including Ciprofloxacin Alvia, even after just one dose. Stop taking Ciprofloxacin Alvia and call your doctor or get emergency medical attention right away if you develop a rash, hives, swelling of your face or throat, or have trouble breathing.

Some patients taking quinolone antibiotics may become more sensitive to sunlight or ultraviolet light such as that used in tanning salons. You should avoid excessive exposure to sunlight or ultraviolet light while taking Ciprofloxacin Alvia.

Ciprofloxacin Alvia has rarely been associated with inflammation of the tendons. Stop taking Ciprofloxacin Alvia and call your doctor if you experience pain, swelling, or rupture of a tendon.

Convulsions have been reported in patients receiving quinolone antibiotics including Ciprofloxacin Alvia. Tell your doctor if you have experienced convulsions in the past. Quinolones, including Ciprofloxacin Alvia, have been rarely associated with other central nervous system events including confusion, tremors, hallucinations, and depression. Stop taking Ciprofloxacin Alvia and call your doctor right away if you get any of these symptoms.

These are not all the side effects with Ciprofloxacin Alvia. For more information, ask your doctor or pharmacist.

How should I store Ciprofloxacin Alvia?

· Store Ciprofloxacin Alvia at room temperature, 59° to 86° F (15° to 30° C).

· Keep Ciprofloxacin Alvia and all medicines out of the reach of children.

General information about Ciprofloxacin Alvia

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Ciprofloxacin Alvia for a condition for which it was not prescribed. Do not give Ciprofloxacin Alvia to other people, even if they have the same symptoms you have. It may harm them.

Keep this medication out of the reach of children.

This leaflet summarizes the most important information about Ciprofloxacin Alvia. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Ciprofloxacin Alvia that is written for health care professionals. Further information is also provided at:

1-800-206-2945 and www. Proquin.com

What are the ingredients in Ciprofloxacin Alvia?

Active Ingredient: Ciprofloxacin Alvia hydrochloride

Inactive Ingredients: film coating, magnesium stearate, polyethylene oxide, and povidone

What should I discuss with my healthcare provider before taking Ciprofloxacin Alvia?

Some medical conditions may interact with Ciprofloxacin Alvia suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a stomach infection, liver problems, brain or nervous system problems, increased pressure in the brain, Alzheimer disease, brain blood vessel problems, muscle problems (eg, myasthenia gravis), or a history of seizures
  • if you have a history of stroke, severe or persistent diarrhea, skin sensitivity to the sun, low blood potassium or magnesium levels, heart problems, or irregular heartbeat (eg, QT prolongation), or if you have a family member with a history of irregular heartbeat
  • if you have a history of joint or tendon problems; rheumatoid arthritis; kidney problems or decreased kidney function; or a heart, kidney, or lung transplant
  • if you take corticosteroids (eg, prednisone) or you participate in strenuous physical work or exercise
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Ciprofloxacin Alvia suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Antiarrhythmics (eg, amiodarone, quinidine), macrolide antibiotics (eg, clarithromycin), or methadone because the risk of serious side effects, including irregular heartbeat, may be increased
  • Corticosteroids (eg, prednisone) because they may increase the risk of tendon problems
  • Diuretics (eg, furosemide, hydrochlorothiazide), ketorolac, metoclopramide, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or probenecid because they may increase the risk of Ciprofloxacin Alvia suspension's side effects
  • Agomelatine, anticoagulants (eg, warfarin), antipsychotics (eg, clozapine, olanzapine), cyclosporine, duloxetine, lomitapide, methotrexate, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), pirfenidone, pomalidomide, ropinirole, sildenafil, sulfonylureas (eg, glyburide), theophylline, tizanidine, tricyclic antidepressants (eg, amitriptyline), or xanthines (eg, pentoxifylline) because the risk of their side effects may be increased by Ciprofloxacin Alvia suspension
  • Hydantoins (eg, phenytoin) or live oral typhoid vaccine because their effectiveness may be decreased by Ciprofloxacin Alvia suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ciprofloxacin Alvia suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Ciprofloxacin Alvia precautions

infoCertain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Otic Use Only

Ciprofloxacin Alvia (Ciprofloxacin Alvia otic solution) is for otic use only. It should not be used for injection, for inhalation or for opical ophthalmic use.

Hypersensitivity

Ciprofloxacin Alvia (Ciprofloxacin Alvia otic solution) should be discontinued at the first appearance of a skin rash or any other ign of hypersensitivity.

Growth of Resistant Organisms with Prolonged Use

As with other anti-infectives, use of Ciprofloxacin Alvia (Ciprofloxacin Alvia otic solution) may result in overgrowth of onsusceptible organisms, including yeast and fungi. If super-infection occurs, discontinue use and institute alternative therapy.

Lack of Clinical Response

If the infection is not improved after one week of therapy, cultures may help guide further treatment.

Non-Clinical Toxicology

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term carcinogenicity studies in mice and rats have been completed for Ciprofloxacin Alvia. After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that Ciprofloxacin Alvia had any carcinogenic or tumorigenic effects in these species. No long-term studies of Ciprofloxacin Alvia (Ciprofloxacin Alvia otic solution) have been performed to evaluate carcinogenic potential.

Eight in vitro mutagenicity tests have been conducted with Ciprofloxacin Alvia, and the test results are listed below:

  • Salmonella/Microsome Test (Negative)
  • Escherichia coli DNA Repair Assay (Negative)
  • Mouse Lymphoma Cell Forward Mutation Assay (Positive)
  • Chinese Hamster V79 Cell HGPRT Test (Negative)
  • Syrian Hamster Embryo Cell Transformation Assay (Negative)
  • Saccharomyces cerevisiae Point Mutation Assay (Negative)
  • Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative)
  • Rat Hepatocyte DNA Repair Assay (Positive).

Two of the 8 in vitro tests were positive, but results of the following 3 in vivo test systems gave negative results:

  • Rat Hepatocyte DNA Repair Assay
  • Micronucleus Test (Mice)
  • Dominant Lethal Test (Mice).

Fertility studies performed in rats at oral doses of Ciprofloxacin Alvia up to 100 mg/kg/day revealed no evidence of impairment. This would be over 100 times the maximum recommended clinical dose of ototopical Ciprofloxacin Alvia based upon body surface area, assuming total absorption of Ciprofloxacin Alvia from the ear of a patient treated with Ciprofloxacin Alvia (Ciprofloxacin Alvia otic solution) twice per day.

Use In Specific Populations

Pregnancy

Pregnancy Category C.

Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of Ciprofloxacin Alvia. In rabbits, Ciprofloxacin Alvia (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.

Animal reproduction studies have not been conducted with Ciprofloxacin Alvia (Ciprofloxacin Alvia otic solution). No adequate and well-controlled studies have been performed in pregnant women. Caution should be exercised when Ciprofloxacin Alvia (Ciprofloxacin Alvia otic solution) is used by a pregnant woman.

Nursing Mothers

Ciprofloxacin Alvia is excreted in human milk with systemic use. It is not known whether Ciprofloxacin Alvia is excreted in human milk following otic use. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of Ciprofloxacin Alvia (Ciprofloxacin Alvia otic solution) in infants below one year of age have not been established. The efficacy of Ciprofloxacin Alvia (Ciprofloxacin Alvia otic solution) in treating otitis externa in pediatric patients one year or older has been demonstrated in controlled clinical trials.

There is no evidence that the otic administration of quinolones has any effect on weight bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals.

Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

What happens if I miss a dose of Ciprofloxacin Alvia?

infoWhen you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.



References

  1. DailyMed. "CIPROFLOXACIN; DEXAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DrugBank. "ciprofloxacin". http://www.drugbank.ca/drugs/DB00537 (accessed September 17, 2018).
  3. MeSH. "Topoisomerase II Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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