Panadol

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  Panadol | Pfizer Laboratories Div Pfizer Inc

  

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  2.1 Recommended Dosing

  The recommended dose and schedule of BOSULIF is 500 mg orally once daily with food. Continue treatment with BOSULIF until disease progression or patient intolerance.

  If a dose is missed beyond 12 hours, the patient should skip the dose and take the usual prescribed dose on the following day.

  2.2 Dose Escalation

  Consider dose escalation to 600 mg once daily with food in patients who do not reach complete hematological response (CHR) by week 8 or a complete cytogenetic response (CCyR) by week 12, who did not have Grade 3 or higher adverse reactions, and who are currently taking 500 mg daily.

  2.3 Dose Adjustments for Non-Hematologic Adverse Reactions

  Elevated liver transaminases: If elevations in liver transaminases greater than 5×institutional upper limit of normal (ULN) occur, withhold BOSULIF until recovery to less than or equal to 2.5×ULN and resume at 400 mg once daily thereafter. If recovery takes longer than 4 weeks, discontinue BOSULIF. If transaminase elevations greater than or equal to 3×ULN occur concurrently with bilirubin elevations greater than 2×ULN and alkaline phosphatase less than 2×ULN (Hy's law case definition), discontinue BOSULIF [see Warnings and Precautions (5.3)].

  Diarrhea: For NCI CTCAE Grade 3–4 diarrhea (increase of greater than or equal to 7 stools/day over baseline/pretreatment), withhold BOSULIF until recovery to Grade less than or equal to 1. BOSULIF may be resumed at 400 mg once daily [see Warnings and Precautions (5.1)].

  For other clinically significant, moderate or severe non-hematological toxicity, withhold BOSULIF until the toxicity has resolved, then consider resuming BOSULIF at 400 mg once daily. If clinically appropriate, consider re-escalating the dose of BOSULIF to 500 mg once daily.

  2.4 Dose Adjustments for Myelosuppression

  Dose reductions for severe or persistent neutropenia and thrombocytopenia are described below (Table 1).

  Table 1: Dose Adjustments for Neutropenia and Thrombocytopenia * Absolute Neutrophil Count ANC* less than 1000×106/L
  or
  Platelets less than 50,000×106/L Withhold BOSULIF until ANC greater than or equal to1000×106/L and platelets greater than or equal to 50,000×106/L.
  Resume treatment with BOSULIF at the same dose if recovery occurs within 2 weeks. If blood counts remain low for greater than 2 weeks, upon recovery, reduce dose by 100 mg and resume treatment.
  If cytopenia recurs, reduce dose by an additional 100 mg upon recovery and resume treatment.
  Doses less than 300 mg/day have not been evaluated. 2.5 Concomitant Use With CYP3A Inhibitors

  Avoid the concomitant use of strong or moderate CYP3A inhibitors with BOSULIF as an increase in bosutinib plasma concentration is expected (strong CYP3A inhibitors include boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole. Moderate CYP3A inhibitors include amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit products, imatinib and verapamil) [see Drug Interactions (7.1)].

  2.6 Concomitant Use With CYP3A Inducers

  Avoid the concomitant use of strong or moderate CYP3A inducers with BOSULIF as a large reduction in exposure is expected (strong CYP3A inducers include carbamazepine, phenytoin, rifampin and St. John's Wort. Moderate CYP3A inducers include bosentan, efavirenz, etravirine, modafinil and nafcillin) [see Drug Interactions (7.2)].

  2.7 Recommended Starting Dosage with Hepatic Impairment or Renal Impairment Organ Function Status Recommended Starting Dosage Normal hepatic and renal function 500 mg once daily Hepatic impairment   Mild (Child-Pugh A), Moderate (Child-Pugh B) or severe (Child-Pugh C) 200 mg daily Renal impairment   Creatinine clearance 30 to 50 mL/min 400 mg daily   Creatinine clearance less than 30 mL/min 300 mg daily [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)].

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• Glaxosmithkline Consumer Healthcare Lp
  

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  Panadol | Roerig

  

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  Buffered Penicillin G Potassium for Injection, USP may be given intravenously or intramuscularly. The usual dose recommendations are as follows:

  Adult patients CLINICAL INDICATION DOSAGE * 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. 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 4–6 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 4–6 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
    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 the prevention of the carrier state)
  2 to 3 million units/day in divided doses for 10–12 days* Erysipelothrix endocarditis
  12 to 20 million units/day for 4–6 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 3–4 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 2–4 MU every 4 hours for 10–14 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 patients

  This 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 4–6 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 7–14 days depending on the infecting organism (maximum dose of 12–20 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 7–10 days
  Meningitis 250,000 units/kg/day in equal doses every 4 hours for 10–14 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 equally divided doses with the duration of therapy depending on the type of infection
  Syphilis (congenital and neurosyphilis) after the newborn period 200,000–300,000 units/kg/day (administered as 50,000 units/kg every 4–6 hours) for 10–14 days
  Diphtheria (adjunctive therapy to antitoxin and for prevention of the carrier state)
  150,000–250,000 units/kg/day in equal doses every 6 hours for 7–10 days Rat-bite fever; Haverhill fever (with endocarditis caused by S. moniliformis) 150,000–250,000 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/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8–10 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 4–5 hours. Additional dosage modification 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 atleast 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 20.0 – – 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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  Panadol | Fresenius Kabi Usa, Llc

  

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  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy
  

  Ondansetron injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Adults:

  The recommended adult intravenous dosage of ondansetron is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)].  The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy.  Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron.

  Pediatrics:

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of ondansetron is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.2, 12.3)].  The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy.  Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron.  The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting
  

  Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility have not been established.  In particular, this applies to alkaline solutions as a precipitate may form.

  Adults:

  The recommended adult intravenous dosage of ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery.  Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults.  While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied.  In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics:

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg.  The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery.  Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron.

  2.3 Stability and Handling
  

  After dilution, do not use beyond 24 hours.  Although ondansetron injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright.  Potency and safety are not affected.  If a precipitate is observed, resolubilize by shaking the vial vigorously.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function
  

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.  There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy
  

  Ondansetron injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Adults:

  The recommended adult intravenous dosage of ondansetron is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)].  The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy.  Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron.

  Pediatrics:

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of ondansetron is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.2, 12.3)].  The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy.  Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron.  The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting
  

  Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility have not been established.  In particular, this applies to alkaline solutions as a precipitate may form.

  Adults:

  The recommended adult intravenous dosage of ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery.  Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults.  While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied.  In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics:

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg.  The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery.  Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron.

  2.3 Stability and Handling
  

  After dilution, do not use beyond 24 hours.  Although ondansetron injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright.  Potency and safety are not affected.  If a precipitate is observed, resolubilize by shaking the vial vigorously.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function
  

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.  There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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  Panadol | Cardinal Health

  

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  While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

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