Aphena Pharma Solutions - New Jersey, Llc

Aphena Pharma Solutions - New Jersey, Llc Drugs

• Citalopram
  

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  Citalopram

  

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  Citalopram tablets, USP should be administered once daily, in the morning or evening, with or without food.

  Initial Treatment

  Citalopram tablets, USP should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day at an interval of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.

  Special Populations

  20 mg/day is the recommended dose for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor (see WARNINGS).

  No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram tablets, USP should be used with caution in patients with severe renal impairment.

  Treatment of Pregnant Women During the Third Trimester

  Neonates exposed to citalopram tablets, USP and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with citalopram tablets, USP during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram tablets, USP in the third trimester.

  Maintenance Treatment

  It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram tablets, USP in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram tablets, USP (20 to 60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of citalopram tablets, USP 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.

  Discontinuation of Treatment with Citalopram Tablets, USP

  Symptoms associated with discontinuation of citalopram tablets, USP and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

  Switching Patients To or From a Monoamine Oxidase Inhibitor

  At least 14 days should elapse between discontinuation of an MAOI and initiation of citalopram tablets, USP therapy. Similarly, at least 14 days should be allowed after stopping citalopram tablets, USP before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).

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• Doxycycline Hyclate
  

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  Doxycycline Hyclate

  

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  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.

  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 doxycycline 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 or 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 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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• Ciprofloxacin
  

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  Ciprofloxacin

  

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  ADULTS

  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, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate)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†     Urinary Tract    Acute Uncomplicated    Mild/Moderate    Severe/Complicated 250 mg250 mg500 mg q 12 hq 12 hq 12 h     3 Days     7 to 14 Days    7 to 14 Days    Chronic Bacterial Prostatitis        Mild/Moderate 500 mg q 12 h     28 Days    Lower Respiratory Tract        Mild/Moderate    Severe/Complicated 500 mg750 mg q 12 hq 12 h     7 to 14 days     7 to 14 days    Acute Sinusitis        Mild/Moderate 500 mg q 12 h     10 days    Skin and Skin Structure        Mild/Moderate    Severe/Complicated 500 mg750 mg q 12 hq 12 h     7 to 14 Days     7 to 14 Days    Bone and Joint        Mild/Moderate    Severe/Complicated 500 mg750 mg q 12 hq 12 h     ≥ 4 to 6 weeks    ≥ 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 *  used in conjunction with metronidazole †   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). ** 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.

  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      500 mg Tablet q 12 h      750 mg Tablet q 12 h           200 mg I.V. q 12 h          400 mg I.V. 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 > 5030 – 505 – 29Patients on hemodialysis orPeritoneal dialysis    See Usual Dosage.               250 – 500 mg q 12 h             250 – 500 mg q 18 h      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) 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.

  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 ComplicatedUrinary TractorPyelonephritis Intravenous 6 to 10 mg/kg(maximum 400 mg perdose; not to be exceededeven in patients weighing > 51 kg) Every 8hours 10-21 days* (patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceededeven in patients weighing> 51 kg) Every 12 hours InhalationalAnthrax(Post-Exposure)** Intravenous 10 mg/kg(maximum 400 mg perdose) Every 12hours 60 days Oral 15 mg/kg(maximum 500 mg per dose) Every 12 hours

  * 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.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.

  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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