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 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco IV may be switched to Ciprofloxacin 0.3% Thephaco Tablets when clinically indicated at the discretion of the physician (Table 2).
Table 2: Equivalent AUC Dosing Regimens
Ciprofloxacin 0.3% Thephaco
Oral Dosage
Equivalent Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco Tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, Ciprofloxacin 0.3% Thephaco Tablets may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin 0.3% Thephaco Tablets
Assure adequate hydration of patients receiving Ciprofloxacin 0.3% Thephaco Tablets to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Instruct the patient of the appropriate Ciprofloxacin 0.3% Thephaco Tablets administration.
What other drugs will affect Ciprofloxacin 0.3% Thephaco?
Do not take Ciprofloxacin 0.3% Thephaco together with tizanidine (Zanaflex).
Tell your doctor about all other medicines you use, especially:
a blood thinner such as warfarin (Coumadin, Jantoven);
an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or
steroid medication (prednisone and others).
This list is not complete and other drugs may interact with Ciprofloxacin 0.3% Thephaco. 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 0.3% Thephaco 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 0.3% Thephaco, 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 0.3% Thephaco together with class IA or III antiarrhythmics as Ciprofloxacin 0.3% Thephaco may have an additive effect on the QT interval.
Chelation Complex Formation: The simultaneous administration of Ciprofloxacin 0.3% Thephaco (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 0.3% Thephaco. Consequently, Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco with a vitamin K antagonist (eg, warfarin, acenocoumarol, phenprocoumon or fluindione).
Glibenclamide: In particular cases, concurrent administration of Ciprofloxacin 0.3% Thephaco and glibenclamide containing products can intensify the action of glibenclamide (hypoglycemia).
Probenecid: Probenecid interferes with renal secretion of Ciprofloxacin 0.3% Thephaco. Co-administration of probenecid and Ciprofloxacin 0.3% Thephaco increases the Ciprofloxacin 0.3% Thephaco serum concentrations.
Metoclopramide: Metoclopramide accelerates the absorption of Ciprofloxacin 0.3% Thephaco (oral) resulting in a shorter time to reach maximum plasma concentrations. No effect was seen on the bioavailability of Ciprofloxacin 0.3% Thephaco.
Omeprazole: Concomitant administration of Ciprofloxacin 0.3% Thephaco and omeprazole containing medicinal products results in a slight reduction of Cmax and AUC of Ciprofloxacin 0.3% Thephaco.
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 0.3% Thephaco. Associated with the increased serum concentrations was a potentiated hypotensive and sedative effect. Tizanidine containing medicinal products must not be administered together with Ciprofloxacin 0.3% Thephaco.
Other Xanthine Derivatives: On concurrent administration of Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco, 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 0.3% Thephaco 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 0.3% Thephaco, similar effects can be expected upon concomitant administration.
Ropinirole: It was shown in a clinical study that concomitant use of ropinirole with Ciprofloxacin 0.3% Thephaco, 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 0.3% Thephaco.
Lidocaine: It was demonstrated in healthy subjects that concomitant use of lidocaine containing medicinal products with Ciprofloxacin 0.3% Thephaco, 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 0.3% Thephaco associated with side effects may occur upon concomitant administration.
Clozapine: Following concomitant administration of Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco 500 mg. Therefore, caution should be used in prescribing Ciprofloxacin 0.3% Thephaco concomitantly with sildenafil taking into consideration the risks and the benefits.
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References
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).
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).
The results of a survey conducted on ndrugs.com for Ciprofloxacin 0.3% Thephaco are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ciprofloxacin 0.3% Thephaco. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
Consumer reported frequency of use
No survey data has been collected yet
1 consumer reported doses
What doses of Ciprofloxacin 0.3% Thephaco drug you have used? The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Ciprofloxacin 0.3% Thephaco drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
Users
%
201-500mg
1
100.0%
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