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• Ciprofloxacin Hydrochlo...
  

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  Ciprofloxacin Hydrochloride

  

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  DOSAGE AND ADMINISTRATION - ADULTS

  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.

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

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.

  ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations * * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † 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 serum concentrations achieved in humans, reasonably likely to predict clinical benefit 4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)‡ 500 mg q 12 h 60 Days

  Conversion of I.V. to Oral Dosing in Adults

  Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h

  Adults with Impaired Renal Function

  Ciprofloxacin 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. 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) Dose > 50 See Usual Dosage 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)

  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) × (140 - age) 72 × serum creatinine (mg/dL) Women: 0.85 × 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.

  DOSAGE AND ADMINISTRATION – PEDIATRICS

  Ciprofloxacin tablets should be administered orally 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. (See ADVERSE REACTIONS and CLINICAL STUDIES.)

  Dosing and initial route of therapy (i.e., I.V. 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 I.V. 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 Infection Route of Administration Dose (mg/kg) Frequency Total Duration * 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 serum concentrations achieved in humans, reasonably likely to predict clinical benefit 5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Complicated Urinary Tract or Pyelonephritis(patients from 1 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).

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• Fluconazole
  

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  Fluconazole

  

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  Dosage and Administration in Adults

  Single Dose

  Vaginal candidiasis

  The recommended dosage of fluconazole for vaginal candidiasis is 150 mg as a single oral dose.

  Multiple Dose

  SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.

  The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient's response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.

  Oropharyngeal candidiasis

  The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.

  Esophageal candidiasis

  The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.

  Systemic candida infections

  For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.

  Urinary tract infections and peritonitis

  For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparitive studies of small numbers of patients.

  Crytococcal Meningitis

  The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily.

  Prophylaxis in Patients Undergoing Bone Marrow Transplantation

  The recommended fluconazole daily dosage for the prevention of candidiasis of patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.

  Dosage and Administration in Children

  The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:

  Pediatric Patients Adults * * Some older children may have clearances similar to that of adults. Absolute doses exceeding 600 mg/day are not recommended. 3 mg/kg 100 mg 6 mg/kg 200 mg 12** mg/kg 400 mg

  Experience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns (see CLINICAL PHARMACOLOGY). Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding fluconazole pharmacokinetics in full-term newborns is available.

  Oropharyngeal candidiasis

  The recommended dosage of fluconazole for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.

  Esophageal candidiasis

  For the treatment of esophageal candidiasis, the recommended dosage of fluconazole in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least 2 weeks following the resolution of symptoms.

  Systemic candida infections

  For the treatment of candidemia and disseminated Candida infections, daily doses of 6 to 12 mg/kg/day have been used in an open, noncomparative study of a small number of children.

  Cryptococcal meningitis

  For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of fluconazole is 6 mg/kg once daily.

  Dosage in Patients With Impaired Renal Function

  Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:

  Creatinine Clearance (mL/min) Percent of Recommended Dose > 50 100% ≤ 50 (no dialysis) 50% Regular dialysis 100% after each dialysis

  These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.

  When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:

  Males: Weight (kg) × (140-age)

  72 × serum creatinine (mg/100 mL)

  Females: 0.85 × above value

  Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:

  K × linear length or height (cm)

  serum creatinine (mg/100 mL)

  (Where K = 0.55 for children older than 1 year and 0.45 for infants.)

  Adminstration

  Fluconazole Tablets can be taken with or without food.

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• Doxycycline Hyclate
  

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  Doxycycline Hyclate

  

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  Other dosage forms of doxycycline may be more appropriate to meet some of the dosing recommendations listed below.

  THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

  Adults:

  The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours.

  In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

  For children above eight years of age:

  The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used.

  The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.

  When used in streptococcal infections, therapy should be continued for 10 days.

  Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS).

  If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.

  Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment.

  Uncomplicated gonococcal infections in adults (except anorectal infections in men):

  100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.

  Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis:

  100 mg, by mouth, twice a day for 7 days.

  Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum:

  100 mg, by mouth, twice a day for 7 days.

  Syphilis - early:

  Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice a day for 2 weeks.

  Syphilis of more than one year's duration:

  Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.

  Acute epididymo-orchitis caused by N. gonorrhoeae:

  100 mg, by mouth, twice a day for at least 10 days.

  Acute epididymo-orchitis caused by C. trachomatis:

  100 mg, by mouth, twice a day for at least 10 days.

  For the prophylaxis of malaria:

  For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.

  Inhalational anthrax (post-exposure):

  ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.

  CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.

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