Ciprofloxacin Aurus Overdose

Did you have any side effects with this medicine?
sponsored

What happens if I overdose Ciprofloxacin Aurus?

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 Aurus extended-release tablets:

Store Ciprofloxacin Aurus 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 Aurus extended-release tablets out of the reach of children and away from pets.

Overdose of Ciprofloxacin Aurus in details

When 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.
sponsored

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 Aurus (< 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 Aurus between 125 and 300 mg/kg.

DOSAGE AND ADMINISTRATION

Adults

Ciprofloxacin Aurus 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 Aurus serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of Ciprofloxacin Aurus serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION. Total duration of Ciprofloxacin Aurus 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 Aurus

+

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

Conversion of I.V. to

Oral Dosing in Adults

Ciprofloxacin Aurus Tablets and Ciprofloxacin Aurus

Oral Suspension for oral administration are available.

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

Equivalent AUC Dosing Regimens
Ciprofloxacin Aurus

Oral Dosage

Equivalent Ciprofloxacin Aurus 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 Aurus 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 Aurus 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 Aurus serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of Ciprofloxacin Aurus 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 Aurus 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 Aurus 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 Aurus Injection, USP. If the concomitant use of Ciprofloxacin Aurus 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 Aurus 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 Aurus 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.

What should I avoid while taking Ciprofloxacin Aurus?

Do not take Ciprofloxacin Aurus 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 Aurus. They could make the medication less effective.

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

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

Ciprofloxacin Aurus 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 Aurus 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 Aurus warnings

Warnings 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.
sponsored

Patients should be advised:

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

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

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

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

· that concomitant administration of Ciprofloxacin Aurus 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 Aurus should be administered at least 4 hours before or 2 hours after these products.

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

· that Ciprofloxacin Aurus may be associated with hypersensitivity reactions, even following a single dose, and to discontinue Ciprofloxacin Aurus 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 Aurus and to discontinue therapy if phototoxicity occurs.

· that peripheral neuropathies have been associated with Ciprofloxacin Aurus 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 Aurus.

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

Patient Leaflet

Ciprofloxacin Aurus (Ciprofloxacin Aurus hydrochloride) Extended-Release Tablets

PROQUIN® XR

(prōkwin)

(Ciprofloxacin Aurus hydrochloride)

Extended-Release Tablets, 500 mg

This leaflet contains important information about Ciprofloxacin Aurus (Ciprofloxacin Aurus 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 Aurus. Ciprofloxacin Aurus can be prescribed only by a doctor. If you have any questions about Ciprofloxacin Aurus, talk to your doctor. Only your doctor can tell you if Ciprofloxacin Aurus is right for you.

What is Ciprofloxacin Aurus?

Ciprofloxacin Aurus 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 Aurus will treat infections other than bladder infections. Ciprofloxacin Aurus, 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 Aurus.

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

How should I take Ciprofloxacin Aurus?

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

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

· Do not split, crush, or chew Ciprofloxacin Aurus tablets. Ciprofloxacin Aurus 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 Aurus tablet a day, even if you miss a dose.

· Do not take Ciprofloxacin Aurus 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 Aurus if taken at the same time. Take Ciprofloxacin Aurus at least 4 hours before or 2 hours after antacids that contain magnesium or aluminum. Ciprofloxacin Aurus 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 Aurus?

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

Ciprofloxacin Aurus 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 Aurus, talk to your doctor before taking this medication.

Ciprofloxacin Aurus is not recommended for children.

What should I tell my doctor before taking Ciprofloxacin Aurus?

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 Aurus 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 Aurus?

Ciprofloxacin Aurus is generally well tolerated. The most common side effects with Ciprofloxacin Aurus 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 Aurus is not causing dizziness or lightheadedness.

Rare cases of allergic reactions have been reported in patients receiving quinolones, including Ciprofloxacin Aurus, even after just one dose. Stop taking Ciprofloxacin Aurus 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 Aurus.

Ciprofloxacin Aurus has rarely been associated with inflammation of the tendons. Stop taking Ciprofloxacin Aurus 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 Aurus. Tell your doctor if you have experienced convulsions in the past. Quinolones, including Ciprofloxacin Aurus, have been rarely associated with other central nervous system events including confusion, tremors, hallucinations, and depression. Stop taking Ciprofloxacin Aurus and call your doctor right away if you get any of these symptoms.

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

How should I store Ciprofloxacin Aurus?

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

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

General information about Ciprofloxacin Aurus

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Ciprofloxacin Aurus for a condition for which it was not prescribed. Do not give Ciprofloxacin Aurus 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 Aurus. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Ciprofloxacin Aurus 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 Aurus?

Active Ingredient: Ciprofloxacin Aurus hydrochloride

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

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

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

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ciprofloxacin Aurus tablets 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 Aurus precautions

Certain 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.
sponsored

Tendinopathy and Tendon Rupture

Fluoroquinolones, including Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl), 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 rotator 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 Aurus (Ciprofloxacin Aurus hcl) 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.

Exacerbation of Myasthenia Gravis

Fluoroquinolones, including Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl), have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) in patients with known history of myasthenia gravis..

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including Ciprofloxacin Aurus. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.

Other Serious and Sometimes Fatal Reactions

Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including Ciprofloxacin Aurus. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

Theophylline

Serious and fatal reactions have been reported in patients receiving theophylline concurrently with fluoroquinolones, including Ciprofloxacin Aurus. These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure. Although similar adverse effects have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) cannot be eliminated. If concomitant use cannot be avoided, serum concentrations of theophylline should be monitored and dosage adjustments made as appropriate.

Central Nervous System Effects

Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving quinolones, including Ciprofloxacin Aurus. Ciprofloxacin Aurus may also cause CNS events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. The reactions may occur following the first dose. If these reactions occur in patients receiving Ciprofloxacin Aurus, the drug should be discontinued and appropriate measures instituted. As with all quinolones, Ciprofloxacin Aurus should be used with caution in patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction).

Clostridium difficile-Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl), 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 represent 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.

Peripheral Neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dyesthesias, and weakness have been reported in patients receiving quinolones, including Ciprofloxacin Aurus. Ciprofloxacin Aurus should be discontinued if the patient experiences symptoms of neuropathy, including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position, sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.

Arthropathic Effects in Animals

Ciprofloxacin Aurus, as with other members of the quinolone class, causes arthropathy and/or chondroplasia in immature dogs. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. The relevance of these findings to the clinical use of Ciprofloxacin Aurus is unknown..

Photosensitivity/Phototoxicity

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if phototoxicity occurs.

Development of Drug Resistant Bacteria

Prescribing Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Patient Counseling Information

Use Only for Uncomplicated Urinary Tract Infection

Inform patients that Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) is only approved to treat uncomplicated urinary tract infections and to contact their healthcare provider if they do not feel better or if they develop fever and back pain while or after taking Ciprofloxacin Aurus.

Tendon Disorders

Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) treatment. The risk of severe tendon disorders with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Myasthenia Gravis Syndrome

Fluoroquinolones like Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Patients should call their healthcare provider right away if you have any worsening muscle weakness or breathing problems.

Hypersensitivity

Inform patients that Ciprofloxacin Aurus may be associated with hypersensitivity reactions; even following a single dose. Instruct patients to discontinue Ciprofloxacin Aurus and contact their healthcare provider at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.

Convulsions

Inform patients that convulsions have been reported in patients taking fluoroquinolones, including Ciprofloxacin Aurus and to notify their physician before taking this drug if they have a history of convulsions.

Neurologic Adverse Effects (e.g., dizziness, lightheadedness)

Instruct patients to wait to see how they react to Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination.

Clostridium difficile-Associated Diarrhea

Inform patients 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, instruct patients to contact their physician as soon as possible.

Peripheral Neuropathies

Advise patients if symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, they should discontinue treatment and contact their physician.

Photosensitivity

Advise to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl). If patients need to be outdoors when taking Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl), instruct them to 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, instruct patients to contact their physician.

Administration with Food, Fluids, and Concomitant Medications

Instruct patients to:

Drug Interactions

Instruct patients to inform their healthcare provider if they are taking theophylline. Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) may increase the effects of theophylline and some other prescription or over-the-counter medications, when taken concurrently with Ciprofloxacin Aurus.

Instruct patients to inform their healthcare provider if they are taking antacids and other multivalent cation containing prescription or over-the-counter medications. Such products can reduce the absorption of Ciprofloxacin Aurus.

Use of Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) Sample Pack Advise the patient that the sample pack contains only one dose for the first day of treatment with Proquin® XR (Ciprofloxacin Aurus hcl). Complete treatment requires 3 doses. The patient must fill a prescription for the remaining two doses.

Human Milk Feeding

Advise women to avoid feeding their infants with their milk during treatment with Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl). Women should either discontinue feeding or pump and discard their milk during treatment and for 24 hours after the last dose.

Antibacterial Resistance

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

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Rodent carcinogenicity studies were not required. Two in vitro mutagenicity tests were conducted with Ciprofloxacin Aurus:

Bacterial Reverse Mutation Assay; negative for mutagenicity in the presence and absence of an S9 metabolic activation system.

Chinese Hamster Ovary (CHO) Chromosomal Aberration Assay; positive for inducing chromosomal aberrations.

In addition to the in vitro genotoxicity assays, an in vivo rat micronucleus study with Ciprofloxacin Aurus was negative.

Fertility studies performed with male and female rats at oral doses of Ciprofloxacin Aurus up to 600 mg/kg/day (approximately 10-fold the recommended 500 mg therapeutic dose based upon body surface area) revealed no evidence of impairment.

Use In Specific Populations

Pregnancy (Teratogenic Effects. Pregnancy Category C)

There are no adequate and well-controlled studies of Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) in pregnant women. However, human data on more than 500 infants from two controlled cohort studies do not show an increased risk for major congenital malformations overall in infants exposed to Ciprofloxacin Aurus during the first trimester of pregnancy or at other times during pregnancy. The risks to a developing musculoskeletal system were not fully evaluated. Animal studies in rats and rabbits demonstrated variations or anomalies in fetal skeletal development and increased embryo-fetal mortality. These effects occurred at clinically relevant doses but also in the presence of maternal toxicity. Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

A controlled, prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to Ciprofloxacin Aurus and 68% first trimester exposures) during gestation. Following in-utero exposure to fluoroquinolones during embryogenesis, there was no associated increased risk of major malformations. The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group. Rates of spontaneous abortions, prematurity and low birth weight did not differ between the study groups, and there were no clinically significant musculoskeletal dysfunctions up to one year of age in Ciprofloxacin Aurus exposed children.

A controlled, retrospective cohort study of more than 30,000 infants enrolled in Medicaid included 588 infants exposed to Ciprofloxacin Aurus during pregnancy (average 8 day exposure), and 439 exposures occurred during the first trimester. Compared to a control group with no antibiotic exposure and a control group with exposure to a nonteratogenic antibiotic commonly used during pregnancy, infants exposed to Ciprofloxacin Aurus during the first trimester (or other times during pregnancy) did not demonstrate an increased risk for major congenital malformations overall. The study was powered to rule out a two fold increased risk for major malformations. The study was not designed to fully assess abnormal musculoskeletal development.

Another prospective observational study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures). There were 70 Ciprofloxacin Aurus exposures, all within the first trimester. The malformation rates among live-born babies exposed to Ciprofloxacin Aurus and to fluoroquinolones overall were both within the background rates for congenital malformations in the general population. There was no specific patterns of congenital abnormalities and no clear adverse reactions due to in-utero exposure to Ciprofloxacin Aurus.

Published data do not suggest increased rates of prematurity, spontaneous abortions, or birth weight in women exposed to Ciprofloxacin Aurus during pregnancy, but these data are very limited.

In embryo/fetal developmental toxicity studies, pregnant rats and rabbits received oral doses of Ciprofloxacin Aurus up to 600 mg/kg/day in rats and 30 mg/kg/day in rabbits. In rats, fetal skeletal variations occurred at the maternally toxic dose of 600 mg/kg/day (approximately 1.8-fold the recommended 500 mg therapeutic dose based upon plasma AUC measure of systemic exposure). In pregnant rabbits, the maternally toxic 30 mg/kg/day dose resulted in abortions and reductions in body weight gain. Embryo/fetal lethality and skeletal developmental effects also occurred in rabbits at this dose level (approximately 1.2-fold the recommended therapeutic dose based upon body surface area), while the maternally toxic 10 mg/kg/day dose level did not induce embryo/fetal developmental effects. A peri/postnatal developmental toxicity study conducted in pregnant/lactating female rats exhibited no developmental effects in offspring at the highest dose level of 600 mg/kg/day. Both the 300 and 600 mg/kg/day dose levels were maternally toxic to the pregnant dams based upon slight body weight gain reduction. There was no evidence of compound-related fetal malformation in any of the reproductive toxicity studies.

Nursing Mothers

Ciprofloxacin Aurus is excreted in human milk. In one study, ten lactating women received oral Ciprofloxacin Aurus 750 mg every 12 hours. Peak human milk concentrations of Ciprofloxacin Aurus following the third dose averaged 3.79 mcg/mL (S.D. 1.26), and these levels decreased to a mean of 0.02 mcg/mL at 24 hours after the third dose. Based on these concentrations, the maximum daily infant dose of Ciprofloxacin Aurus through human milk is about 0.569 mg/kg per day, about 2.8% of the approved 20 mg/kg dose in children one year of age or older.

Because of the potential for serious adverse reactions in infants from Ciprofloxacin Aurus, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of Ciprofloxacin Aurus to the mother. During short courses of therapy, nursing mothers may express and discard milk. Human milk feeding can resume 24 hours after the last dose of Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl).

Pediatric Use

The safety and effectiveness of Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) in pediatric patients and adolescents less than 18 years of age have not been established. Quinolones, including Ciprofloxacin Aurus, cause arthropathy in juvenile animals

Geriatric Use

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Ciprofloxacin Aurus. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur.

Clinical experience with Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) did not include sufficient number of subjects 65 years of age or older to determine whether they respond differently than younger subjects. Reported clinical experience with other formulations of Ciprofloxacin Aurus has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. Ciprofloxacin Aurus is substantially excreted by the kidney and the risk of adverse reactions may be greater in patients with impaired renal function. No alteration of dosage is necessary for patients greater than 65 years of age with normal renal function.

In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using Ciprofloxacin Aurus with concomitant drugs that can result in prolongation of the QT interval (e.g. class IA or class III antiarrhythmics) or in patients with risk factors for torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia).

Renal Impairment

Ciprofloxacin Aurus 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 alternate pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. No dosage adjustment is required for patients with mild to moderate renal impairment. The efficacy of Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) has not been studied in patients with severe renal impairment.

Hepatic Impairment

No dosage adjustment is required with Ciprofloxacin Aurus (Ciprofloxacin Aurus hcl) in patients with stable chronic cirrhosis. However, the pharmacokinetics of Ciprofloxacin Aurus in patients with acute hepatic impairment has not been fully elucidated.

What happens if I miss a dose of Ciprofloxacin Aurus?

When 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.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take 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).

Reviews

Consumer reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 29 here

Information checked by Dr. Sachin Kumar, MD Pharmacology

| Privacy Policy
This site does not supply any medicines. It contains prices for information purposes only.
© 2003 - 2024 ndrugs.com All Rights Reserved