Ciprofloxacin 250MG TABLET Dosage

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Dosage of Ciprofloxacin 250MG TABLET in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Ciprofloxacin 250MG TABLET Tablets should be administered orally as described in the appropriate Dosage Guidelines tables.

Dosage in Adults

The determination of dosage and duration 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.

Table 1: Adult Dosage Guidelines
1. Generally Ciprofloxacin 250MG TABLET should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).

2. Used in conjunction with metronidazole.

3. Begin drug administration as soon as possible after suspected or confirmed exposure.

Infection

Dose

Frequency

Usual Durations1

Urinary Tract

250 to 500 mg

every 12 hours

7 to 14 days

Acute Uncomplicated Cystitis

250 mg

every 12 hours

3 days

Chronic Bacterial Prostatitis

500 mg

every 12 hours

28 days

Lower Respiratory Tract

500 to 750 mg

every 12 hours

7 to 14 days

Acute Sinusitis

500 mg

every 12 hours

10 days

Skin and Skin Structure

500 to 750 mg

every 12 hours

7 to 14 days

Bone and Joint

500 to 750 mg

every 12 hours

4 to 8 weeks

Complicated Intra–Abdominal2

500 mg

every 12 hours

7 to 14 days

Infectious Diarrhea

500 mg

every 12 hours

5 to 7 days

Typhoid Fever

500 mg

every 12 hours

10 days

Uncomplicated Urethral and

Cervical Gonococcal Infections

250 mg

single dose

single dose

Inhalational anthrax

(post-exposure)3

500 mg

every 12 hours

60 days

Plague3

500 to 750 mg

every 12 hours

14 days

Conversion of IV to

Oral Dosing in Adults

Patients whose therapy is started with Ciprofloxacin 250MG TABLET IV may be switched to Ciprofloxacin 250MG TABLET Tablets when clinically indicated at the discretion of the physician (Table 2).

Table 2: Equivalent AUC Dosing Regimens
Ciprofloxacin 250MG TABLET

Oral Dosage

Equivalent Ciprofloxacin 250MG TABLET IV Dosage

250 mg Tablet every 12 hours

200 mg intravenous every 12 hours

500 mg Tablet every 12 hours

400 mg intravenous every 12 hours

750 mg Tablet every 12 hours

400 mg intravenous every 8 hours

Dosage in Pediatric Patients

Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin 250MG TABLET Tablets should be administered as described in Table 3.

Table 3: Pediatric Dosage Guidelines
1. The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

2. Begin drug administration as soon as possible after suspected or confirmed exposure.

3. Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.

Infection

Dose

Frequency

Total Duration

Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)

10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg)

Every 12 hours

10 to 21 days1

Inhalational Anthrax (Post-Exposure)2

15 mg/kg (maximum 500 mg per dose)

Every 12 hours

60 days

Plague2,3

15 mg/kg (maximum 500 mg per dose)

Every 12 to 8 hours

10 to 21 days

Dosage Modifications in Patients with Renal Impairment

Ciprofloxacin 250MG TABLET 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, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.

Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function
Creatinine Clearance (mL/min)

Dose

> 50

See Usual Dosage.

30 to 50

250 to 500 mg every12 hours

5 to 29

250 to 500 mg every 18 hours

Patients on hemodialysis or Peritoneal dialysis

250 to 500 mg every 24 hours (after dialysis)

When only the serum creatinine concentration is known, the following formulas 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.

In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73 m2).

Important Administration Instructions

With Multivalent Cations

Administer Ciprofloxacin 250MG TABLET Tablets at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.

With Dairy Products

Concomitant administration of Ciprofloxacin 250MG TABLET Tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, Ciprofloxacin 250MG TABLET Tablets may be taken with a meal that contains these products.

Hydration of Patients Receiving Ciprofloxacin 250MG TABLET Tablets

Assure adequate hydration of patients receiving Ciprofloxacin 250MG TABLET Tablets to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.

Instruct the patient of the appropriate Ciprofloxacin 250MG TABLET Tablets administration.

What other drugs will affect Ciprofloxacin 250MG TABLET?

Do not take Ciprofloxacin 250MG TABLET together with tizanidine (Zanaflex).

Tell your doctor about all other medicines you use, especially:

This list is not complete and other drugs may interact with Ciprofloxacin 250MG TABLET. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Ciprofloxacin 250MG TABLET interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Ciprofloxacin 250MG TABLET, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Class IA or III Antiarrhythmics: Precaution should be taken when using Ciprofloxacin 250MG TABLET together with class IA or III antiarrhythmics as Ciprofloxacin 250MG TABLET may have an additive effect on the QT interval.

Chelation Complex Formation: The simultaneous administration of Ciprofloxacin 250MG TABLET (oral) and multivalent cation-containing medicinal products and mineral supplements (eg, calcium, magnesium, aluminum, iron), polymeric phosphate binders (eg, sevelamer, lanthanum carbonate), sucralfate or antacids, and highly buffered drugs (eg, didanosine tablets) containing magnesium, aluminum or calcium reduce the absorption of Ciprofloxacin 250MG TABLET. Consequently, Ciprofloxacin 250MG TABLET should be administered either 1-2 hrs before or at least 4 hrs after these preparations. This restriction does not apply to antacids belonging to the class of H2-receptor blockers.

Theophylline: Concurrent administration of Ciprofloxacin 250MG TABLET and theophylline can cause an undesirable increase in the serum theophylline concentration. This can lead to theophylline-induced side effects; in very rare cases, these side effects can be life-threatening or fatal. If concurrent use of the 2 products is unavoidable, the serum theophylline concentration should therefore be checked and the theophylline dose appropriately reduced.

Cyclosporin: A transient rise in the concentration of serum creatinine was observed when Ciprofloxacin 250MG TABLET and cyclosporin were administered simultaneously. Therefore, it is necessary to control the serum creatinine concentrations in these patients frequently (twice a week).

Vitamin K Antagonists: Simultaneous administration of Ciprofloxacin 250MG TABLET with a vitamin K antagonist may augment its anticoagulant effects. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of Ciprofloxacin 250MG TABLET to the increase in International Normalized Ratio (INR) is difficult to assess. The INR should be monitored frequently during and shortly after co-administration of Ciprofloxacin 250MG TABLET with a vitamin K antagonist (eg, warfarin, acenocoumarol, phenprocoumon or fluindione).

Glibenclamide: In particular cases, concurrent administration of Ciprofloxacin 250MG TABLET and glibenclamide containing products can intensify the action of glibenclamide (hypoglycemia).

Probenecid: Probenecid interferes with renal secretion of Ciprofloxacin 250MG TABLET. Co-administration of probenecid and Ciprofloxacin 250MG TABLET increases the Ciprofloxacin 250MG TABLET serum concentrations.

Metoclopramide: Metoclopramide accelerates the absorption of Ciprofloxacin 250MG TABLET (oral) resulting in a shorter time to reach maximum plasma concentrations. No effect was seen on the bioavailability of Ciprofloxacin 250MG TABLET.

Omeprazole: Concomitant administration of Ciprofloxacin 250MG TABLET and omeprazole containing medicinal products results in a slight reduction of Cmax and AUC of Ciprofloxacin 250MG TABLET.

Tizanidine: In a clinical study in healthy subjects, there was an increase in tizanidine serum concentrations (Cmax increase: 7-fold, range: 4- to 21-fold; AUC increase: 10-fold, range: 6- to 24-fold) when given concomitantly with Ciprofloxacin 250MG TABLET. Associated with the increased serum concentrations was a potentiated hypotensive and sedative effect. Tizanidine containing medicinal products must not be administered together with Ciprofloxacin 250MG TABLET.

Other Xanthine Derivatives: On concurrent administration of Ciprofloxacin 250MG TABLET and caffeine or pentoxifylline (oxpentifylline) containing products, raised serum concentrations of these xanthine derivatives were reported.

Methotrexate: Renal tubular transport of methotrexate may be inhibited by concomitant administration of Ciprofloxacin 250MG TABLET, potentially leading to increased plasma levels of methotrexate. This might increase the risk of methotrexate-associated toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant Ciprofloxacin 250MG TABLET therapy is indicated.

Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Animal studies have shown that the combination of very high doses of quinolones (gyrase inhibitors) and certain nonsteroidal anti-inflammatory agents (but not acetylsalicylic acid) can provoke convulsions.

Duloxetine: In clinical studies, it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme eg, fluvoxamine, may result in an increase of AUC and Cmax of duloxetine. Although no clinical data are available on a possible interaction with Ciprofloxacin 250MG TABLET, similar effects can be expected upon concomitant administration.

Ropinirole: It was shown in a clinical study that concomitant use of ropinirole with Ciprofloxacin 250MG TABLET, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively. Monitoring ropinirole-related side effects dose adjustment as appropriate is recommended during and shortly after co-administration with Ciprofloxacin 250MG TABLET.

Lidocaine: It was demonstrated in healthy subjects that concomitant use of lidocaine containing medicinal products with Ciprofloxacin 250MG TABLET, a moderate inhibitor of CYP450 1A2 isozyme, reduces clearance of IV lidocaine by 22%. Although lidocaine treatment was well tolerated, a possible interaction with Ciprofloxacin 250MG TABLET associated with side effects may occur upon concomitant administration.

Clozapine: Following concomitant administration of Ciprofloxacin 250MG TABLET 250 mg with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after co-administration with Ciprofloxacin 250MG TABLET are advised.

Sildenafil: Cmax and AUC of sildenafil were increased approximately 2-fold in healthy subjects after an oral dose of 50 mg given concomitantly with Ciprofloxacin 250MG TABLET 500 mg. Therefore, caution should be used in prescribing Ciprofloxacin 250MG TABLET concomitantly with sildenafil taking into consideration the risks and the benefits.


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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. FDA/SPL Indexing Data. "5E8K9I0O4U: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (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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