Cipro Information

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Anthrax draft 1/6/05
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO®
Tablets and CIPRO Oral Suspension and other antibacterial drugs, CIPRO Tablets and CIPRO Oral
Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be
caused by bacteria.
DESCRIPTION
CIPRO (ciprofloxacin hydrochloride) Tablets and CIPRO (ciprofloxacin*) Oral Suspension are synthetic broad spectrum antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluor fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3•HCl•H2O and its chemical structure is as follows: Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3 quinolinecarboxylic acid.
Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:
CIPRO film-coataed tablets are available in 100 mg, 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white to slightly yellowish. The inactive ingredients are cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and water. Ciprofloxacin Oral Suspension is available in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. Ciprofloxacin Oral Suspension is a white to slightly yellowish suspension with strawberry flavor which may contain yellow-orange droplets. It is composed of ciprofloxacin microcapsules and diluent which are mixed prior to dispensing (See instructions for USE/HANDLING). The components of the suspension have the following compositions:
Microcapsules - ciprofloxacin, povidone, methacrylic acid copolymer, hypromellose, magnesium stearate, and Polysorbate 20.CLINICAL PHARMACOLOGY
Absorption: Ciprofloxacin given as an oral tablet is rapidly and well absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability is approximately 70% with no substantial loss by first pass metabolism. Ciprofloxacin maximum serum concentrations and area under the curve are shown in the chart for the 250 mg to 1000 mg dose range.
Dose (mg) Maximum
Serum Concentration
(µg/mL)
Area Under Curve (AUC)
(µg•hr/mL)
250 1.2 4.8
500 2.4 11.6
750 4.3 20.2
1000 5.4 30.8
Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with 250, 500, or 750 mg are 0.1, 0.2, and 0.4 µg/mL, respectively. The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Serum concentrations increase proportionately with doses up to 1000 mg.
A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours. A 750 mg oral dose given every 12 hours has been shown to produce an AUC at steady-state equivalent to that produced by an intravenous infusion of 400 mg given over 60 minutes every 8 hours. A 750 mg oral dose results in a Cmax similar to that observed with a 400 mg I.V. dose. A 250 mg oral dose given every 12 hours produces an AUC equivalent to that
Diluent - medium-chain triglycerides, sucrose, lecithin, water, and strawberry flavor. with a 400 mg I.V. dose. A 250 mg oral dose given every 12 hours produces an AUC equivalent to that produced by an infusion of 200 mg ciprofloxacin given every 12 hours. Metabolism: Four metabolites have been identified in human urine which together account for approximately 15% of an oral dose. The metabolites have antimicrobial activity, but are less active than unchanged ciprofloxacin.
Excretion: The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Approximately 40 to 50% of an orally administered dose is excreted in the urine as unchanged drug. After a 250 mg oral dose, urine concentrations of ciprofloxacin usually exceed 200 µg/mL during the first two hours and are approximately 30 µg/mL at 8 to 12 hours after dosing. The urinary excretion of ciprofloxacin is virtually complete within 24 hours after dosing. The renal clearance of ciprofloxacin, which is approximately 300 mL/minute, exceeds the normal glomerular filtration rate of 120 mL/minute. Thus, active tubular secretion would seem to play a significant role in its elimination. Co-administration of probenecid with ciprofloxacin results in about a 50% reduction in the ciprofloxacin renal clearance and a 50% increase in its concentration in the systemic circulation. Although bile concentrations of ciprofloxacin are several fold higher than serum concentrations after oral dosing, only a small amount of the dose administered is recovered from the bile as unchanged drug. An additional 1 to 2% of the dose is recovered from the bile in the form of metabolites. Approximately 20 to 35% of an oral dose is recovered from the feces within 5 days after dosing. This may arise from either biliary clearance or transintestinal elimination.
With oral administration, a 500 mg dose, given as 10 mL of the 5% CIPRO Suspension (containing 250 mg ciprofloxacin/5mL) is bioequivalent to the 500 mg tablet. A 10 mL volume of the 5% CIPRO Suspension (containing 250 mg ciprofloxacin/5mL) is bioequivalent to a 5 mL volume of the 10% CIPRO Suspension (containing 500 mg ciprofloxacin/5mL).
Drug-drug Interactions: When CIPRO Tablet is given concomitantly with food, there is a delay in the absorption of the drug, resulting in peak concentrations that occur closer to 2 hours after dosing rather than 1 hour whereas there is no delay observed when CIPRO Suspension is given with food. The overall absorption of CIPRO Tablet or CIPRO Suspension, however, is not substantially affected. The pharmacokinetics of ciprofloxacin given as the suspension are also not affected by food. Concurrent administration of antacids containing magnesium hydroxide or aluminum hydroxide may reduce the bioavailability of ciprofloxacin by as much as 90%. (See PRECAUTIONS.)
The serum concentrations of ciprofloxacin and metronidazole were not altered when these two drugs were given concomitantly. Concomitant administration of ciprofloxacin with theophylline decreases the clearance of theophylline resulting in elevated serum theophylline levels and increased risk of a patient developing CNS or other adverse reactions. Ciprofloxacin also decreases caffeine clearance and inhibits the formation of paraxanthine after caffeine administration. (SeePRECAUTIONS.)
Special Populations: Pharmacokinetic studies of the oral (single dose) and intravenous (single and multiple dose) forms of ciprofloxacin indicate that plasma concentrations of ciprofloxacin are higher in elderly subjects (> 65 years) as compared to young adults. Although the Cmax is increased 16-40%, the increase in mean AUC is approximately 30%, and can be at least partially attributed to decreased renal clearance in the elderly. Elimination half-life is only slightly (~20%) prolonged in the elderly. These differences are not considered clinically significant. (See PRECAUTIONS: Geriatric Use.)
In patients with reduced renal function, the half-life of ciprofloxacin is slightly prolonged. Dosage adjustments may be required. (See DOSAGE AND ADMINISTRATION.)
In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. The kinetics of ciprofloxacin in patients with acute hepatic insufficiency, however, have not been fully elucidated. Following a single oral dose of 10 mg/kg ciprofloxacin suspension to 16 children ranging in age from 4 months to 7 years, the mean Cmax was 2.4 µg/mL (range: 1.5 – 3.4 µg/mL) and the mean AUC was 9.2 µg*h/mL (range: 5.8 – 14.9 µg*h/mL). There was no apparent age-dependence, and no notable increase in Cmax or AUC upon multiple dosing (10 mg/kg TID).
In children with severe sepsis who were given intravenous ciprofloxacin (10 mg/kg as a 1-hour infusion), the mean Cmax was 6.1 µg/mL (range: 4.6 – 8.3 µg/mL) in 10 children less than 1 year of age; and 7.2 µg/mL (range: 4.7 – 11.8 µg/mL) in 10 children between 1 and 5 years of age.
The AUC values were 17.4 µg*h/mL (range: 11.8 – 32.0 µg*h/mL) and 16.5 µg*h/mL (range: 11.0 – 23.8 µg*h/mL) in the respective age groups. These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of pediatric patients with various infections, the predicted mean half-life in children is approximately 4 - 5 hours, and the bioavailability of the oral suspension is approximately 60%.

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admin — Sun, 06 Jan 2008 03:06:18 +0000

COLORADO SPRINGS, Colo. - It could be a birthday party, an anniversary celebration, a cruise, a night out at a buffet restaurant, a Super Bowl soiree or the monthlong eat-a-thon that takes place between Thanksgiving and Christmas. No matter the occasion where food rules, it can be a hazard to the 91 million or so Americans who take prescription drugs. It’s just too easy to forget about possible drug interactions when faced with platefuls of desserts, cocktails and a tempting assortment of foods.(online cipro)

Though some drug interactions cause only mild discomfort, other drugs can produce moderate to severe side effects when combined with certain foods or drinks. Think high-fat foods, grapefruit, dairy or alcohol.(online cipro)

“I don’t want to make it sound scary, but all drugs have toxic potential,” said Taula Moyers, pharmacy clinical coordinator for Memorial Health System in Colorado Springs, Colo. “Some of them can cause renal problems, some of them can cause liver problems. It’s going to be totally dependent on the drug and the extent of the (online cipro) interaction.”

Some common food-drug interactions include:

Drinking grapefruit juice while on Lipitor, the most popular drug prescribed to lower cholesterol, increases the amount of Lipitor in the bloodstream, which can increase adverse effects like muscle pain, weakness and stiffness.Sular, a high blood pressure medication, shouldn’t be taken with high-fat foods for the same reason - the interaction increases the amount of drug in the bloodstream, increasing the side effects.Cipro, an antibiotic prescribed to treat bacterial infections, as well as other antibiotics in its class, can bind with dairy products, preventing proper absorption. However, unlike Lipitor, a patient can ingest dairy products while on their treatment - just not at the same time as taking the pill.Monoamine oxidase (online cipro) inhibitors, a class of antidepressants, interact with foods rich in tyramine, which is found in processed foods, grapes, smoked meats and fish.Over-the-counter drugs such as Tylenol, Midol and cough and cold products, which all contain acetaminophen, can cause liver damage when combined with large amounts of alcohol. (online cipro)

To avoid being served a dish or drink you can’t have, Moyers suggested party-goers and hosts talk about restrictions beforehand.”It’s important that any time you go out to eat that whoever’s doing the cooking be aware of any dietary concerns people have,” she said. “Be upfront about any dietary restrictions.”Doctors typically outline potential reactions with foods, drinks and drugs when a drug is prescribed, and to further prevent confusion, many pharmacies have methods of flagging prescriptions that interact.However, some doctors don’t explain interactions well (or at all,online cipro), and patients who visit multiple doctors or pharmacies can create further communication gaps.”There is a lot of pressure put on the consumer to be aware of the potential for interactions with all medications,” said Michael DeLuca, pharmacist and spokesman for pdrhealth.com, a medical resource run by Thomson Healthcare. “It is essential that consumers effectively communicate to their doctors and pharmacists all of the things they are taking.”

The best defense against a drug interaction mix-up is full disclosure. Be sure to make your doctors aware of all herbs, vitamins and medications, including over-the-counter drugs.Pharmacies often provide consumers with a printout of common side effects and interactions, and pharmacists can explain how and when to (online cipro) take a certain medication.For quick reference, check out pdrhealth.com and click on “Interaction checker,” which calculates drug, food and drink interactions.However, speak to your medical professional about your findings - some drugs that interact are prescribed intentionally, and a pharmacist or doctor can answer further questions. You should not stop or start any drug without the OK of your doc.