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Side Effects & Adverse Reactions
Treated turkeys must not be slaughtered for food during treatment or for one day after last treatment. Do not use in turkeys producing eggs for human consumption.
Legal Issues
There is currently no legal information available for this drug.
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For the treatment of erysipelas in turkeys (caused by Erysipelothrix rhusiopathiae).
History
There is currently no drug history available for this drug.
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There are no additional details available for this product.
Sources
Penicillin G Potassium Manufacturers
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G.c. Hanford Manufacturing Co.
Penicillin G Potassium | G.c. Hanford Manufacturing Co.
Administer orally at a dosage of 1,500,000 units of penicillin per gallon (3.8 liters) of drinking water for 5 consecutive days.
Combine contents and approximately 1 1/2 pints (710 mL) of water in a glass or plastic container. Stir to dissolve. Allow concentrated solution to stand until the foam disappears. The concentrated solution should be used up or discarded within one hour after preparation.
Automatic Watering Systems - Pour the concentrated solution into a glass or plastic container then add enough water to make 2.6 gallons (9.9 liters) of stock solution. [This amount of solution will medicate 333 gallons (1260 liters) of drinking water]. The automatic waterer should be adjusted to deliver 1 ounce (30 mL) of stock solution per gallon (3.8 liters) of drinking water. In automatic watering systems, prepare fresh solutions daily.
Gravity Flow Watering Systems - Pour the concentrated solution into enough water to make 333 gallons (1260 liters) of drinking water. In gravity flow watering systems,prepare fresh solutions every 12 hours.
Drinking water prepared as directed above will contain 1,500,000 units of penicillin G per gallon (3.8 liters).
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Sandoz Inc
Penicillin G Potassium | Sandoz Inc
Buffered Penicillin G Potassium for Injection, USP may be given intravenously or intramuscularly. The usual dose recommendations are as follows:
CLINICAL INDICATION DOSAGE * Because of its short half-life, Penicillin G is administered in divided doses, usually every 4 to 6 hours with the exception of meningococcal meningitis/septicemia, i.e., every 2 hours.Serious infections due to susceptible strains of streptococci (including S. pneumoniae) and staphylococci-septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis
5 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4 to 6 hours
Anthrax
Minimum of 8 million units/day in divided doses every 6 hours. Higher doses may be required depending on susceptibility of organism.
Actinomycosis
Cervicofacial disease
1 to 6 million units/day*
Thoracic and abdominal disease
10 to 20 million units/day*
Clostridial infections
Botulism (adjunctive therapy to antitoxin)
20 million units/day*
Gas gangrene (debridement and/or surgery as
indicated)Tetanus (adjunctive therapy to human tetanus
immune globulin)Diphtheria (adjunctive therapy to antitoxin and for the prevention of the carrier state)
2 to 3 million units/day in divided doses for 10 to 12 days*
Erysipelothrix endocarditis
12 to 20 million units/day for 4 to 6 weeks*
Fusospirochetosis (severe infections of the oropharnyx [Vincent’s], lower respiratory tract and genital area)
5 to 10 million units/day*
Listeria infections
Meningitis
15 to 20 million units/day for 2 weeks*
Endocarditis
15 to 20 million units/day for 4 weeks*
Pasteurella infections including bacteremia and meningitis
4 to 6 million units/day for 2 weeks*
Haverhill fever, Rat-bite fever
12 to 20 million units/day
for 3 to 4 weeks*Disseminated gonococcal infections, such as meningitis endocarditis, arthritis, etc., caused by penicillin-susceptible organisms
10 million units/day*; duration depends on the type of infection
Syphilis (neurosyphilis)
12 to 24 million units/day, as 2 to 4 MU every 4 hours for 10 to 14 days; many experts recommend additional therapy with Benzathine PCN G 2.4 MU IM weekly for 3 doses after completion of IV therapy
Meningococcal meningitis and/or septicemia
24 million units/day as 2 million units every 2 hours
Pediatric patientsThis product should not be administered to patients requiring less than one million units per dose. (see PRECAUTIONS – Pediatric Use).
CLINICAL INDICATION DOSAGESerious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S. pneumoniae) and meningococcus
150,000 units/kg/day divided in equal doses every 4 to 6 hours; duration depends on infecting organism and type of infection.
Meningitis caused by susceptible strains of pneumococcus and meningococcus
250,000 units/kg/day divided in equal doses every 4 hours for 7 to 14 days depending on the infecting organism (maximum dose of 12 to 20 million units/day)
Disseminated Gonococcal infections (penicillin-susceptible strains)
weight less than 45 kg:
Arthritis
100,000 units/kg/day in 4 equally divided doses for 7 to 10 days
Meningitis
250,000 units/kg/day in equal doses every 4 hours for 10 to 14 days
Endocarditis
250,000 units/kg/day in equal doses every 4 hours for 4 weeks
Arthritis, meningitis, endocarditis
weight 45 kg or greater: 10 million units/day in 4 equally divided doses with the duration of therapy depending on the type of infection
Syphilis (congenital and neurosyphilis) after the newborn period
200,000 to 300,000 units/kg/day (administered as 50,000 units/kg every 4 to 6 hours) for 10 to 14 days
Diphtheria (adjunctive therapy to antitoxin and for prevention of the carrier state)
150,000 to 250,000 units/kg/day in equal doses every 6 hours for 7 to 10 days
Rat-bite fever; Haverhill fever (with endocarditis caused by S. moniliformis)
150,000 to 250,000 units/kg/day in equal doses every 4 hours for 4 weeks
Renal ImpairmentPenicillin G is relatively nontoxic, and dosage adjustments are generally required only in cases of severe renal impairment.
The recommended dosage regimens are as follows: Creatinine clearance less than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8 to 10 hours.
Uremic patients with a creatinine clearance greater than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 4 to 5 hours.
Additional dosage modifications should be made in patients with hepatic disease and renal impairment.
For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for Group A β-hemolytic streptococcal infections should be maintained for at least 10 days to reduce the risk of rheumatic fever.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Preparation of SolutionSolutions of penicillin should be prepared as follows: Loosen powder. Hold vial horizontally and rotate it while slowly directing the stream of diluent against the wall of the vial. Shake vial vigorously after all the diluent has been added. Depending on the route of administration, use Sterile Water for Injection, USP or Sterile Isotonic Sodium Chloride Solution for Parenteral use.
Note: Penicillins are rapidly inactivated in the presence of carbohydrate solutions at alkaline pH.
ReconstitutionThe following table shows the amount of solvent required for solution of various concentrations:
Approx. Desired
Concentration
(units/mL) Approx. Volume for
1,000,000 units (mL) Solvent for Vial of
5,000,000 units (mL) Infusion Only
20,000,000 units (mL)100,000
9.8
--
--
250,000
3.8
18
72
500,000
1.8
8
31.5
750,000
--
4.7
--
1,000,000
--
3
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.
Penicillin G Potassium for Injection, USP 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 Penicillin G Potassium 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 installations.
THE 20,000,000 UNIT (20 MILLION 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 doses 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 of 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 1/4 or 1/2 the amount of fluid aspirated, otherwise, prepare as for an 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.
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App Pharmaceuticals, Llc
Penicillin G Potassium | App Pharmaceuticals, Llc
Penicillin G Potassium for Injection, USP should be administered by intravenous infusion. The usual dose recommendations are as follows:
Adult patients
(*) Because of its short half-life, Penicillin G is administered in divided doses, usually every 4 to 6 hours with the exception of meningococcal meningitis/septicemia, i.e., every 2 hours.
CLINICAL INDICATION
DOSAGE
Serious infections due to susceptible strains of streptococci (including S. pneumoniae)
12 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4 to 6 hours.
-septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis
Serious infections due to susceptible strains of staphylococci
5 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4 to 6 hours.
-septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis
Anthrax
Minimum of 8 million units/day in divided doses every 6 hours. Higher does may be required depending on susceptibility of organism.
Actinomycosis
Cervicofacial disease
Thoracic and abdominal disease
1 to 6 million units/day(*)
10 to 20 million units/day(*)
Clostridial infections
Botulism (adjunctive therapy to antitoxin)
Gas gangrene (debridement and/or surgery as indicated)
Tetanus (adjunctive therapy to human tetanus immune globulin)
20 million units/day(*)
Diphtheria (adjunctive therapy to antitoxin and for prevention of the carrier state)
2 to 3 million units/day in divided doses for 10 to 12 days(*)
Erysipelothrix endocarditis
12 to 20 million units/day for 4 to 6 weeks(*)
Fusospirochetosis (severe infections of the oropharynx [Vincent’s], lower respiratory tract and genital area)
5 to 10 million units/day(*)
Listeria infections
Meningitis
Endocarditis
15 to 20 million units/day for 2 weeks(*)
15 to 20 million units/day for 4 weeks(*)
Pasteurella infections including bacteremia and meningitis
4 to 6 million units/day for 2 weeks(*)
Haverhill fever, Rat-bite fever
12 to 20 million units/day for 3 to 4 weeks(*)
Disseminated gonococcal infections, such as meningitis, endocarditis, arthritis, etc., caused by penicillin-susceptible organisms
10 million units/day(*), duration depends on the type of infection
Syphilis (neurosyphilis)
12 to 24 million units/day, as 2 to 4 MU every 4 hours for 10 to 14 days; many experts recommend additional therapy with Benzathine PCN G 2.4 MU IM weekly for 3 doses after completion of IV therapy
Meningococcal meningitis and/or septicemia
24 million units/day as 2 million units every 2 hours
Pediatric patientsThis product should not be administered to patients requiring less than one million units per dose (see PRECAUTIONS, Pediatric Use).
CLINICAL INDICATION
DOSAGE
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S. pneumoniae) and meningococcus
150,000 to 300,000 units/kg/day divided in equal doses every 4 to 6 hours, duration depends on infecting organism and type of infection
Meningitis caused by susceptible strains of pneumococcus and meningococcus
250,000 units/kg/day divided in equal doses every 4 hours for 7 to 14 days depending on the infecting organism (maximum dose of 12 to 20 million units/day)
Disseminated Gonococcal Infections (penicillin-susceptible strains)
Weight less than 45 kg:
Arthritis
100,000 units/kg/day in 4 equally divided doses for 7 to 10 days
Meningitis
250,000 units/kg/day in equal doses every 4 hours for 10 to 14 days
Endocarditis
250,000 units/kg/day in equal doses every 4 hours for 4 weeks
Arthritis, meningitis, endocarditis
Weight 45 kg or greater: 10 million units/day in 4 equally divided doses with the duration of therapy depending on the type of infection
Syphilis (congenital and neurosyphilis) after the newborn period
200,000 to 300,000 units/kg/day (administered as 50,000 units/kg every 4 to 6 hours) for 10 to 14 days
Diphtheria (adjunctive therapy to antitoxin and for prevention of the carrier state)
150,000 to 250,000 units/kg/day in equal doses
every 6 hours for 7 to 10 days
Rat-bite fever; Haverhill fever (with endocarditis caused by S. moniliformis)
150,000 to 250,000 units/kg/day in equal doses every 4 hours for 4 weeks
Renal Impairment
Penicillin G is relatively nontoxic, and dosage adjustments are generally required only in cases of severe renal impairment. The recommended dosage regimens are as follows:
Creatinine clearance less than 10 mL/min/1.73 m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8 to 10 hours.
Uremic patients with a creatinine clearance greater than 10 mL/min/1.73 m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 4 to 5 hours. Additional dosage modifications should be made in patients with hepatic disease and renal impairment.
For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for Group A β-hemolytic streptococcal infections should be maintained for at least 10 days to reduce the risk of rheumatic fever. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
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
-
-
100,000
10
-
-
250,000
4
18.2
75
500,000
1.8
8.2
33
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 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 at 2º to 8ºC (36º to 46ºF). When refrigerated, penicillin solutions may be stored for seven days without significant loss of potency. DISCARD UNUSED SOLUTION AFTER 7 DAYS.
Buffered Penicillin G Potassium 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, intra-articular, 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 1/4 or 1/2 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.
Renal Impairment
Penicillin G is relatively nontoxic, and dosage adjustments are generally required only in cases of severe renal impairment. The recommended dosage regimens are as follows:
Creatinine clearance less than 10 mL/min/1.73 m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8 to 10 hours.
Uremic patients with a creatinine clearance greater than 10 mL/min/1.73 m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 4 to 5 hours. Additional dosage modifications should be made in patients with hepatic disease and renal impairment.
For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for Group A β-hemolytic streptococcal infections should be maintained for at least 10 days to reduce the risk of rheumatic fever. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
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
-
-
100,000
10
-
-
250,000
4
18.2
75
500,000
1.8
8.2
33
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 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 at 2º to 8ºC (36º to 46ºF). When refrigerated, penicillin solutions may be stored for seven days without significant loss of potency. DISCARD UNUSED SOLUTION AFTER 7 DAYS.
Buffered Penicillin G Potassium 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, intra-articular, 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 1/4 or 1/2 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.
-
Vetoquinol N.-a., Inc.
-
Wg Critical Care, Llc
Penicillin G Potassium | Wg Critical Care, Llc
Penicillin G potassium may be given intravenously or intramuscularly. The usual dose recommendations are as follows:
Adult Patients(*)Because of its short half-life, Penicillin G is administered in divided doses, usually every 4-6 hours with the exception of meningococcal meningitis/septicemia, i.e., every 2 hours.
* Because of its short half-life, Penicillin G is administered in divided doses, usuallyevery 4-6 hours with the exception of meningococcal meningitis/septicemia, i.e., every 2 hours. Clinical Indication Dosage Serious infections due to susceptible strains of streptococci (including S. pneumoniae) -septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis 12 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4 to 6 hours. Serious infections due to susceptible strains of staphylococci-septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis 5 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4 to 6 hours. Anthrax Minimum of 8 million units/day in divided doses every 6 hours. Higher doses may be required depending on susceptibility of organism. Actinomycosis Cervico-facial disease 1 to 6 million units/day * Thoracic and abdominal disease 10 to 20 million units/day * Clostridial Infections Botulism (adjunctive therapy to antitoxin) 20 million units/day * Gas gangrene (debridement and/or surgery as indicated) Tetanus (adjunctive therapy to human tetanus immune globulin) Diphtheria (adjunctive therapy to antitoxin and for the prevention of the carrier state) 2 to 3 million units/day in divided doses for 10 to 12 days* Erysipelothrix endocarditis 12 to 20 million units/day for 4 to 6 weeks* Fusospirochetosis (severe infections of the oropharynx [Vincent’s], lower respiratory tract and genital area) 5 to 10 million units/day * Listeria infections Meningitis 15 to 20 million units/day for 2 weeks * Endocarditis 15 to 20 million units/day for 4 weeks* Pasteurella infections including bacteremia and meningitis 4 to 6 million units/day for 2 weeks* Haverhill fever, Rat-bite fever 12 to 20 million units/day for 3 to 4 weeks*Disseminated gonococcal infections,
such as meningitis, endocarditis,
arthritis, etc., caused by penicillinsusceptible
organisms 10 million units/day*; duration depends on the type of infection Syphilis (neurosyphilis)12 to 24 million units/day, as 2 to 4 MU every 4 hours for 10 to 14 days; many experts recommend additional therapy with Benzathine PCN G 2.4 MU IM weekly for 3 doses after completion of IV therapy Meningococcal meningitis and/or septicemia
24 million units/day as 2 million unitsMeningococcal meningitis and/or
septicemia 24 million units/day as 2 million units every 2 hours Pediatric PatientsThis product should not be administered to patients requiring less than one million units per dose. (see PRECAUTIONS, Pediatric Use)
Clinical Indication Dosage Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S. pneumoniae) and meningococcus 150,000 - 300,000 units/kg/day divided in equal doses every 4 to 6 hours; duration depends on infecting organ-ism and type of infection Meningitis caused by susceptible strains of pneumococcus and menin-gococcus 250,000 units/kg/day divided in equal doses every 4 hours for 7 to 14 days depending on the infecting organism (maximum dose of 12 to 20 million units/day) Disseminated Gonococcal infections (penicillin –susceptible strains) Weight less than 45 kg.: Arthritis 100,000 units/kg/day in 4 equally divided doses for 7 to 10 days Meningitis 250,000 units/kg/day in equal doses every 4 hours for 10 to 14 days Endocarditis 250,000 units/kg/day in equal doses every 4 hours for 4 weeks Arthritis, meningitis, endocarditis Weight 45 kg or greater: 10 million units/day in 4 equally divided doses with the duration of therapy depending on type of infection Syphilis (congenital and neurosyphilis) after the newborn period 200,000 to 300,000 units/kg/day (administered as 50,000 units/kg every 4 to 6 hours) for 10 to 14 days Diphtheria (adjunctive therapy to antitoxin and for prevention of the carrier state) 150,000 to 250,000 units/kg/day in equal doses every 6 hours for 7 to 10 days Rat-bite fever; Haverhill fever (with endocarditis caused by S. moniliformis) 150,000 to 250,000 units/kg/day in equal doses every 4 hours for 4 weeksRenal Impairment: Penicillin G is relatively nontoxic, and dosage adjustments are generally required only in cases of severe renal impairment. The recommended dosage regimens are as follows:
Creatinine clearance less than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8 to 10 hours.
Uremic patients with a creatinine clearance greater than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 4 to 5 hours. Additional dosage modifications should be made in patients with hepatic disease and renal impairment.
For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for Group A β-hemolytic streptococcal infections should be maintained for at least 10 days to reduce the risk of rheumatic fever. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Preparation of Solution: Solutions of penicillin should be prepared as follows: Loosen powder. Hold vial horizontally and rotate it while slowly directing the stream of diluent against the wall of the vial. Shake vial vigorously after all the diluent has been added. Depending on the route of administration, use Sterile Water for Injection, USP or Sterile Isotonic Sodium Chloride for Parenteral use.
Note: Penicillins are rapidly inactivated in the presence of carbohydrate solutions at alkaline pH.
Reconstitution: The following table shows the amount of solvent required for solution of various concentrations:
Approx. Desired
Concentration
(units/ mL)Approx. Volume
for 1,000,000
units (mL)Solvent for Vial of
5,000,000
units (mL)Infusion Only
20,000,000
units (mL) 50,000 20 - - 100,000 10 - - 250,000 4 18.2 75 500,000 1.8 8.2 33 750,000 - 4.8 - 1,000,000 - 3.2 11.5When 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.
Penicillin G potassium 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.
Penicillin G potassium 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 UNITS (20 MILLION UNITS) 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 doses 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 an 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.
-
Baxter Healthcare Corporation
Penicillin G Potassium | Mylan Pharmaceuticals Inc.
Carvedilol tablets should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
2.2 Left Ventricular Dysfunction Following Myocardial InfarctionDOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with carvedilol tablets may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that carvedilol tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.
2.3 HypertensionDOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol tablets is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about one hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of carvedilol is seen within 7 to 14 days. Total daily dose should not exceed 50 mg.
Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.
2.4 Hepatic ImpairmentCarvedilol tablets should not be given to patients with severe hepatic impairment [see Contraindications (4)].
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