Pfizerpen

Pfizerpen Manufacturers

• Roerig
  

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  Pfizerpen | Roerig

  

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  Severe infections due to Susceptible Strains of Streptococci, Pneumococci, and Staphylococci–bacteremia, pneumonia, endocarditis, pericarditis, empyema, meningitis, and other severe infections–a minimum of 5 million units daily.

  Syphilis–Aqueous penicillin G may be used in the treatment of acquired and congenital syphilis, but because of the necessity of frequent dosage, hospitalization is recommended. Dosage and duration of therapy will be determined by age of patient and stage of the disease.

  Gonorrheal endocarditis–a minimum of 5 million units daily.

  Meningococcic meningitis–1–2 million units intramuscularly every 2 hours, or continuous IV drip of 20–30 million units/day.

  Actinomycosis–1–6 million units/day for cervicofacial cases; 10–20 million units/day for thoracic and abdominal disease.

  Clostridial infections–20 million units/day; penicillin is adjunctive therapy to antitoxin.

  Fusospirochetal infections–severe infections of oropharynx, lower respiratory tract, and genital area–5–10 million units/day.

  Rat-bite fever (Spirillum minus or Streptobacillus moniliformis)–12–15 million units/day for 3–4 weeks.

  Listeria infections (Listeria monocytogenes)
  Neonates–500,000 to 1 million units/day.
  Adults with meningitis–15–20 million units/day for 2 weeks.
  Adults with endocarditis–15–20 million units/day for 4 weeks.

  Pasteurella infections (Pasteurella multocida)
  Bacteremia and meningitis 4–6 million units/day for 2 weeks.

  Erysipeloid (Erysipelothrix insidiosa)
  Endocarditis–2–20 million units/day for 4–6 weeks.

  Gram-negative bacillary infections (E. coli, Enterobacter aerogenes, A. faecalis, Salmonella, Shigella and Proteus mirabilis)
  Bacteremia–20–80 million units/day.

  Diphtheria (carrier state)–300,000–400,000 units of penicillin/day in divided doses for 10–12 days.

  Anthrax–A minimum of 5 million units of penicillin/day in divided doses until cure is effected.

  For prophylaxis against bacterial endocarditis1 in patients with congenital heart disease or rheumatic or other acquired valvular heart disease, when undergoing dental procedures or surgical procedures of the upper respiratory tract, use a combined parenteral-oral regimen. One million units of aqueous crystalline penicillin G (30,000 units/kg in children) intramuscularly, mixed with 600,000 units procaine penicillin G (600,000 units for children) should be given one-half to one hour before the procedure. Oral penicillin V (phenoxymethyl penicillin), 500 mg for adults or 250 mg for children less than 60 lb, should be given every 6 hours for 8 doses. Doses for children should not exceed recommendations for adults for a single dose or for a 24 hour period.

  Reconstitution

  The following table shows the amount of solvent required for solution of various concentrations:

  Approx. Desired
  Concentration
  (units/mL) Approx. Volume (mL)
  1,000,000
  units Solvent for Vial of
  5,000,000
  units Infusion Only
  20,000,000
  units 50,000 20.0 – – 100,000 10.0 – – 250,000 4.0 18.2 75.0 500,000 1.8 8.2 33.0 750,000 – 4.8 – 1,000,000 – 3.2 11.5

  When the required volume of solvent is greater than the capacity of the vial, the penicillin can be dissolved by first injecting only a portion of the solvent into the vial, then withdrawing the resultant solution and combining it with the remainder of the solvent in a larger sterile container.

  Buffered Pfizerpen (penicillin G potassium) for Injection is highly water soluble. It may be dissolved in small amounts of Water for Injection, or Sterile Isotonic Sodium Chloride Solution for Parenteral Use. All solutions should be stored in a refrigerator. When refrigerated, penicillin solutions may be stored for seven days without significant loss of potency.

  Buffered Pfizerpen for Injection may be given intramuscularly or by continuous intravenous drip for dosages of 500,000, 1,000,000, or 5,000,000 units. It is also suitable for intrapleural, intraarticular, and other local instillations.

  THE 20,000,000 UNIT DOSAGE MAY BE ADMINISTERED BY INTRAVENOUS INFUSION ONLY.

  (1) Intramuscular Injection

  Keep total volume of injection small. The intramuscular route is the preferred route of administration. Solutions containing up to 100,000 units of penicillin per mL of diluent may be used with a minimum of discomfort. Greater concentration of penicillin G per mL is physically possible and may be employed where therapy demands. When large dosages are required, it may be advisable to administer aqueous solutions of penicillin by means of continuous intravenous drip.

  (2) Continuous Intravenous Drip

  Determine the volume of fluid and rate of its administration required by the patient in a 24 hour period in the usual manner for fluid therapy, and add the appropriate daily dosage of penicillin to this fluid. For example, if an adult patient requires 2 liters of fluid in 24 hours and a daily dosage of 10 million units of penicillin, add 5 million units to 1 liter and adjust the rate of flow so the liter will be infused in 12 hours.

  (3) Intrapleural or Other Local Infusion

  If fluid is aspirated, give infusion in a volume equal to ¼ or ½ the amount of fluid aspirated, otherwise, prepare as for intramuscular injection.

  (4) Intrathecal Use

  The intrathecal use of penicillin in meningitis must be highly individualized. It should be employed only with full consideration of the possible irritating effects of penicillin when used by this route. The preferred route of therapy in bacterial meningitides is intravenous, supplemented by intramuscular injection.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Sterile solution may be left in refrigerator for one week without significant loss of potency.

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  Pfizerpen | Sun Pharmaceutical Industries Limited

  

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  2.1 Epilepsy

  It is not necessary to monitor topiramate plasma concentrations to optimize topiramate therapy.
  
  On occasion, the addition of topiramate tablets to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with topiramate tablets may require adjustment of the dose of topiramate tablets.
  
  Because of the bitter taste, tablets should not be broken.
  
  Topiramate tablets can be taken without regard to meals.
  
  Monotherapy Use
  Adults and Pediatric Patients 10 Years and Older
  
  The recommended dose for topiramate tablets monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. Approximately 58% of patients randomized to 400 mg/day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day. The dose should be achieved by titration according to the following schedule (Table 1):

  
  Table 1: Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older   Morning Dose Evening Dose Week 1
  25 mg
  25 mg
  Week 2
  50 mg
  50 mg
  Week 3
  75 mg
  75 mg
  Week 4
  100 mg
  100 mg
  Week 5
  150 mg
  150 mg
  Week 6
  200 mg
  200 mg
  
  

  Children Ages 2 to <10 Years
  
  Dosing of topiramate as initial monotherapy in children 2 to < 10 years of age with partial onset or primary generalized tonic-clonic seizures was based on a pharmacometric bridging approach [see Clinical Studies (14.1)].
  
  Dosing in patients 2 to <10 years is based on weight. During the titration period, the initial dose of topiramate tablets should be 25 mg/day administered nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Dosage can be increased by 25 to 50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks of the total titration period. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25 to 50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2).

  
  Table 2: Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to <10 Years Weight (kg) Total Daily Dose (mg/day)* Minimum Maintenance Dose Total Daily Dose (mg/day)* Maximum Maintenance Dose * Administered in two equally divided doses Up to 11
  150
  250
  12 to 22
  200
  300
  23 to 31
  200
  350
  32 to 38
  250
  350
  Greater than 38
  250
  400
  
  

  Adjunctive Therapy Use
  Adults 17 Years of Age and Over - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
  The recommended total daily dose of topiramate tablets as adjunctive therapy in adults with partial onset seizures is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. It is recommended that therapy be initiated at 25 to 50 mg/day followed by titration to an effective dose in increments of 25 to 50 mg/day every week. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose.  Doses above 400 mg/day (600, 800 or 1,000 mg/day) have not been shown to improve responses in dose-response studies in adults with partial onset seizures. Daily doses above 1,600 mg have not been studied.
  
  In the study of primary generalized tonic-clonic seizures, the initial titration rate was slower than in previous studies; the assigned dose was reached at the end of 8 weeks [see Clinical Studies (14.1)].
  
  Pediatric Patients Ages 2 to 16 Years – Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
  The recommended total daily dose of topiramate tablets as adjunctive therapy for pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome.
  
  In the study of primary generalized tonic-clonic seizures, the initial titration rate was slower than in previous studies; the assigned dose of 6 mg/kg/day was reached at the end of 8 weeks [see Clinical Studies (14.1)].

  2.4 Patients with Renal Impairment

  In renally impaired subjects (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.

  2.5 Geriatric Patients (Ages 65 Years and Over)

  Dosage adjustment may be indicated in the elderly patient when impaired renal function (creatinine clearance rate <70 mL/min/1.73 m2) is evident [see Clinical Pharmacology (12.3)].

  2.6 Patients Undergoing Hemodialysis

  Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than a normal individual. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an anti-seizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed.

  2.7 Patients with Hepatic Disease

  In hepatically impaired patients, topiramate plasma concentrations may be increased.  The mechanism is not well understood.

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  Oral Dosage

  Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.

  Initial Dosage for Adults

  For outpatients, 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop.

  An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline HCl at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day.

  Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day.

  Adolescent and Elderly Patients

  In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.

  Maintenance

  The usual maintenance dosage of amitriptyline HCl is 50 to 100 mg per day. In some patients, 40 mg per day is sufficient. For maintenance therapy, the total daily dosage may be given in a single dose, preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse.

  Usage in Pediatric Patients

  In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age.

  Plasma Levels

  Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Because of increased intestinal transit time and decreased hepatic metabolism in elderly patients, plasma levels are generally higher for a given oral dose of amitriptyline hydrochloride than in younger patients. Elderly patients should be monitored carefully and quantitative serum levels obtained as clinically appropriate. Adjustments in dosage should be made according to the patient’s clinical response and not on the basis of plasma levels.2

  2 Hollister, L.E.; Monitoring Tricyclic Antidepressant Plasma Concentrations. JAMA 1979; 241(23):2530-2533.

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