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Topcare Milk Of Magnesia

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Pantoprazole Sodium Del...

Pantoprazole Sodium Delayed-release

2.1 Recommended Dosing Schedule

Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. † Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
Short-Term Treatment of Erosive Esophagitis Associated With GERD

  Adults

40 mg

Once daily for up to 8 weeks*

  Children (5 years and older)

    ≥ 15 kg to < 40 kg

20 mg

Once daily for up to 8 weeks

    ≥ 40 kg

40 mg

Maintenance of Healing of Erosive Esophagitis

  Adults

40 mg

Once daily

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

  Adults

40 mg

Twice daily†

2.2 Administration Instructions

Directions for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions Formulation Route Instructions* * Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be split, chewed, or crushed.
Delayed-Release Tablets

Oral

Swallowed whole, with or without food

Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.
Gabapentin

Gabapentin

Gabapentin is given orally with or without food. Patients should be informed that, should they break the scored 600 or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within several days of breaking the scored tablet should be discarded.

If gabapentin dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).

Postherpetic Neuralgia

In adults with postherpetic neuralgia, gabapentin therapy may be initiated as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.

Epilepsy

Gabapentin is recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.

Patients >12 Years of Age: The effective dose of gabapentin is 900 to 1800 mg/day and given in divided doses (three times a day) using 600 or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 600 or 800 mg tablets three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well-tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours.

Pediatric Patients Age 3 to 12 Years: The starting dose should range from 10 to 15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in patients 5 years of age and older is 25 to 35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatric.) Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin and other commonly used antiepileptic drugs, the addition of gabapentin does not alter the plasma levels of these drugs appreciably.

If gabapentin is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.

Dosage in Renal Impairment

Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault:

for females CCr = (0.85)(140-age)(weight)/[(72)(SCr)]

for males CCr = (140-age)(weight)/[(72)(SCr)]

in which age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL.

Dosage adjustment in patients ≥ 12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).
Table 6. Gabapentin Dosage Based on Renal Function Renal Function Total Daily Dose Regimen Creatinine Clearance Dose Range (mg) (mL/min) (mg/day) a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
≥60

900 to 3600

300 TID

400 TID

600 TID

800 TID

1200 TID

>30 to 59

400 to 1400

200 BID

300 BID

400 BID

500 BID

700 BID

>15 to 29

200 to 700

200 QD

300 QD

400 QD

500 QD

700 QD

15a

100 to 300

100 QD

125 QD

150 QD

200 QD

300 QD

Post-Hemodialysis Supplemental Dose (mg)b

Hemodialysis

125b

150b

200b

250b

350b

The use of gabapentin in patients <12 years of age with compromised renal function has not been studied.

Dosage in Elderly

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
Levofloxacin

Levofloxacin

2.1 Dosage in Adult Patients with Normal Renal Function

The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.

These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION(2.3)].

Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
* Due to the designated pathogens [see INDICATIONS AND USAGE ( 1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae(including multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Klebsiellapneumoniae, Moraxella catarrhalis, Chlamydophilapneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae[see INDICATIONS AND USAGE (1.2)]. § Due to Streptococcus pneumoniae(excluding multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Mycoplasma pneumoniae, or Chlamydophilapneumoniae [see INDICATIONS AND USAGE(1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis, Pseudomonasaeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES(14.9)]. ß The safety of levofloxacin tabletsin adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4), and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablettherapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Type of Infection*

Dosed Every 24 Hours

Duration (days)†

Nosocomial Pneumonia

750 mg

7 to 14

Community Acquired Pneumonia‡

500 mg

7 to 14

Community Acquired Pneumonia§

750 mg

5

Acute Bacterial Sinusitis

750 mg

5

500 mg

10 to 14

Acute Bacterial Exacerbation of Chronic Bronchitis

500 mg

7

Complicated Skin and Skin Structure Infections (SSSI)

750 mg

7 to 14

Uncomplicated SSSI

500 mg

7 to 10

Chronic Bacterial Prostatitis

500 mg

28

Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶

750 mg

5

Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#

250 mg

10

Uncomplicated Urinary Tract Infection

250 mg

3

Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß

500 mg

60ß

Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß

see Table 2 below (2.2)

60ß

Plague, adult and pediatric patients > 50 kgà

500 mg

10 to 14

Pediatric patients < 50 kg and ≥ 6 months of age

see Table 2 below (2.2)

10 to 14

2.2 Dosage in Pediatric Patients

The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.

Table 2 : Dosage in Pediatric Patients ≥ 6 Months of Age
* Due to Bacillus anthracis [see INDICATIONS AND USAGE (1.13)] and Yersinia pestis[see INDICATIONS AND USAGE (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10),USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection*

Dose

Freq. Once every

Duration†

Inhalational Anthrax (post-exposure)‡,§

Pediatric patients > 50 kg

500 mg

24 hr

60 days§

Pediatric patients < 50 kg and ≥ 6 months of age

8 mg/kg (not to exceed 250 mg per dose)

12 hr

60 days§

Plague¶

Pediatric patients > 50 kg

500 mg

24 hr

10 to 14 days

Pediatric patients < 50 kg and ≥ 6 months of age

8 mg/kg (not to exceed 250 mg per dose)

12 hr

10 to 14 days

2.3 Dosage Adjustment in Adults with Renal Impairment

Administer levofloxacin tabletswith caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.

No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.

In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see USE IN SPECIFIC POPULATIONS (8.6)].

Table 3 shows how to adjust dose based on creatinine clearance.

Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance ˂ 50 mL/min)

Dosage in Normal Renal Function Every 24 hours

Creatinine Clearance 20 to 49 mL/min

Creatinine Clearance

10 to 19 mL/min

Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)

750 mg

750 mg every 48 hours

750 mg initial dose, then

500 mg every 48 hours

750 mg initial dose, then

500 mg every 48 hours

500 mg

500 mg initial dose, then 250 mg every 24 hours

500 mg initial dose, then

250 mg every 48 hours

500 mg initial dose, then

250 mg every 48 hours

250 mg

No dosage adjustment required

250 mg every 48 hours.

If treating uncomplicated UTI, then no dosage adjustment is required

No information on dosing adjustment is available

2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

Levofloxacin tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].

2.5 Administration Instructions

Food and LevofloxacinTablets

Levofloxacin tablets can be administered without regard to food.

Hydration for Patients Receiving LevofloxacinTablets

Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].

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