Covis Pharmaceuticals Inc

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Covis Pharmaceuticals Inc Drugs

Cough Baby

Cough Baby

2.1 Dosing Information

The recommended starting dose of DUTOPROL (metoprolol succinate extended release and hydrochlorothiazide) is 25 mg/12.5 mg taken orally once daily with or without food. Depending on the blood pressure response, the dose may be titrated at intervals of 2 weeks to a maximum recommended dose of 200 mg/25 mg (two DUTOPROL 100 mg/12.5 mg tablets) once daily [see Clinical Studies (14)].

For specific advice on blood pressure goals, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

2.2 Use with and Switching from other Anti-Hypertensive Drugs

DUTOPROL may be administered with other antihypertensive drugs. Patients titrated to the individual components (metoprolol succinate and hydrochlorothiazide) may instead receive the corresponding dose of DUTOPROL.

A patient whose blood pressure is inadequately controlled by metoprolol succinate alone or hydrochlorothiazide alone may be switched to DUTOPROL.
Lanoxin

Lanoxin

General

Recommended dosages of digoxin may require considerable modification because of individual sensitivity of the patient to the drug, the presence of associated conditions, or the use of concurrent medications.

Parenteral administration of digoxin should be used only when the need for rapid digitalization is urgent or when the drug cannot be taken orally. Intramuscular injection can lead to severe pain at the injection site, thus intravenous administration is preferred. If the drug must be administered by the intramuscular route, it should be injected deep into the muscle followed by massage. No more than 200 mcg (2 mL) should be injected into a single site.

LANOXIN Injection Pediatric can be administered undiluted or diluted with a 4-fold or greater volume of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. The use of less than a 4-fold volume of diluent could lead to precipitation of the digoxin. Immediate use of the diluted product is recommended.

If tuberculin syringes are used to measure very small doses, one must be aware of the problem of inadvertent overadministration of digoxin. The syringe should not be flushed with the parenteral solution after its contents are expelled into an indwelling vascular catheter.

Slow infusion of LANOXIN Injection Pediatric is preferable to bolus administration. Rapid infusion of digitalis glycosides has been shown to cause systemic and coronary arteriolar constriction, which may be clinically undesirable. Caution is thus advised and LANOXIN Injection Pediatric should probably be administered over a period of 5 minutes or longer. Mixing of LANOXIN Injection Pediatric with other drugs in the same container or simultaneous administration in the same intravenous line is not recommended.

In selecting a dose of digoxin, the following factors must be considered:
The body weight of the patient. Doses should be calculated based upon lean (i.e., ideal) body weight. The patient’s renal function, preferably evaluated on the basis of estimated creatinine clearance. The patient’s age. Infants and children require different doses of digoxin than adults. Also, advanced age may be indicative of diminished renal function even in patients with normal serum creatinine concentration (i.e., below 1.5 mg/dL). Concomitant disease states, concurrent medications, or other factors likely to alter the pharmacokinetic or pharmacodynamic profile of digoxin (see PRECAUTIONS).
Serum Digoxin Concentrations

In general, the dose of digoxin used should be determined on clinical grounds. However, measurement of serum digoxin concentrations can be helpful to the clinician in determining the adequacy of digoxin therapy and in assigning certain probabilities to the likelihood of digoxin intoxication. About two-thirds of adults considered adequately digitalized (without evidence of toxicity) have serum digoxin concentrations ranging from 0.8 to 2.0 ng/mL. However, digoxin may produce clinical benefits even at serum concentrations below this range. About two-thirds of adult patients with clinical toxicity have serum digoxin concentrations greater than 2.0 ng/mL. However, since one-third of patients with clinical toxicity have concentrations less than 2.0 ng/mL, values below 2.0 ng/mL do not rule out the possibility that a certain sign or symptom is related to digoxin therapy. Rarely, there are patients who are unable to tolerate digoxin at serum concentrations below 0.8 ng/mL. Consequently, the serum concentration of digoxin should always be interpreted in the overall clinical context, and an isolated measurement should not be used alone as the basis for increasing or decreasing the dose of the drug.

To allow adequate time for equilibration of digoxin between serum and tissue, sampling of serum concentrations should be done just before the next scheduled dose of the drug. If this is not possible, sampling should be done at least 6 to 8 hours after the last dose, regardless of the route of administration or the formulation used. On a once-daily dosing schedule, the concentration of digoxin will be 10% to 25% lower when sampled at 24 versus 8 hours, depending upon the patient’s renal function. On a twice-daily dosing schedule, there will be only minor differences in serum digoxin concentrations whether sampling is done at 8 or 12 hours after a dose.

If a discrepancy exists between the reported serum concentration and the observed clinical response, the clinician should consider the following possibilities:
Analytical problems in the assay procedure. Inappropriate serum sampling time. Administration of a digitalis glycoside other than digoxin. Conditions (described in WARNINGS and PRECAUTIONS) causing an alteration in the sensitivity of the patient to digoxin. Serum digoxin concentration may decrease acutely during periods of exercise without any associated change in clinical efficacy due to increased binding of digoxin to skeletal muscle.
Heart Failure

Adults

See the full prescribing information for LANOXIN Injection for specific recommendations.

Infants and Children

In general, divided daily dosing is recommended for infants and young children (under age 10). In the newborn period, renal clearance of digoxin is diminished and suitable dosage adjustments must be observed. This is especially pronounced in the premature infant. Beyond the immediate newborn period, children generally require proportionally larger doses than adults on the basis of body weight or body surface area. Children over 10 years of age require adult dosages in proportion to their body weight. Some researchers have suggested that infants and young children tolerate slightly higher serum concentrations than do adults.

Digitalization may be accomplished by either of two general approaches that vary in dosage and frequency of administration, but reach the same endpoint in terms of total amount of digoxin accumulated in the body.
If rapid digitalization is considered medically appropriate, it may be achieved by administering a loading dose based upon projected peak digoxin body stores. Maintenance dose can be calculated as a percentage of the loading dose. More gradual digitalization may be obtained by beginning an appropriate maintenance dose, thus allowing digoxin body stores to accumulate slowly. Steady-state serum digoxin concentrations will be achieved in approximately five half-lives of the drug for the individual patient. Depending upon the patient’s renal function, this will take between 1 and 3 weeks.
Rapid Digitalization With a Loading Dose

LANOXIN Injection Pediatric can be used to achieve rapid digitalization, with conversion to an oral formulation of LANOXIN for maintenance therapy. If patients are switched from intravenous to oral digoxin formulations, allowances must be made for differences in bioavailability when calculating maintenance dosages (see Table 1 in CLINICAL PHARMACOLOGY: Pharmacokinetics and dosing Table 5).

Intramuscular injection of digoxin is extremely painful and offers no advantages unless other routes of administration are contraindicated.

Peak digoxin body stores of 8 to 12 mcg/kg should provide therapeutic effect with minimum risk of toxicity in most patients with heart failure and normal sinus rhythm. Because of altered digoxin distribution and elimination, projected peak body stores for patients with renal insufficiency should be conservative (i.e., 6 to 10 mcg/kg) (see PRECAUTIONS).

Digitalizing and daily maintenance doses for each age group are given in Table 5 and should provide therapeutic effect with minimum risk of toxicity in most patients with heart failure and normal sinus rhythm. These recommendations assume the presence of normal renal function.

The loading dose should be administered in several portions, with roughly half the total given as the first dose. Additional fractions of this planned total dose may be given at 4- to 8-hour intervals, with careful assessment of clinical response before each additional dose. If the patient’s clinical response necessitates a change from the calculated loading dose of digoxin, then calculation of the maintenance dose should be based upon the amount actually given.
Table 5. Usual Digitalizing and Maintenance Dosages for LANOXIN®Injection Pediatric in Children With Normal Renal Function Based on Lean Body Weight
Age

IV Digitalizinga Dose (mcg/kg)

Daily IV Maintenance Doseb

(mcg/kg)

Premature

15 to 25

20% to 30% of the IV digitalizing dosec

Full-Term

20 to 30

1 to 24 Months

30 to 50

2 to 5 Years

25 to 35

25% to 35% of the IV digitalizing dosec

5 to 10 Years

15 to 30

Over 10 Years

8 to 12

a IV digitalizing doses are 80% of oral digitalizing doses.

b Divided daily dosing is recommended for children under 10 years of age.

c Projected or actual digitalizing dose providing clinical response.

In children with renal disease, digoxin dosing must be carefully titrated based on clinical response.

Gradual Digitalization With A Maintenance Dose

More gradual digitalization can also be accomplished by beginning an appropriate maintenance dose. The range of percentages provided in Table 5 can be used in calculating this dose for patients with normal renal function.

It cannot be overemphasized that these pediatric dosage guidelines are based upon average patient response and substantial individual variation can be expected. Accordingly, ultimate dosage selection must be based upon clinical assessment of the patient.

Atrial Fibrillation

Peak digoxin body stores larger than the 8 to 12 mcg/kg required for most patients with heart failure and normal sinus rhythm have been used for control of ventricular rate in patients with atrial fibrillation. Doses of digoxin used for the treatment of chronic atrial fibrillation should be titrated to the minimum dose that achieves the desired ventricular rate control without causing undesirable side effects. Data are not available to establish the appropriate resting or exercise target rates that should be achieved.

Dosage Adjustment When Changing Preparations

The differences in bioavailability between injectable LANOXIN or LANOXIN Tablets must be considered when changing patients from one dosage form to another.
Parnate

Parnate

Dosage should be adjusted to the requirements of the individual patient. Improvement should be seen within 48 hours to 3 weeks after starting therapy.

The usual effective dosage is 30 mg per day, usually given in divided doses. If there are no signs of improvement after a reasonable period (up to 2 weeks), then the dosage may be increased in 10 mg per day increments at intervals of 1 to 3 weeks; the dosage range may be extended to a maximum of 60 mg per day from the usual 30 mg per day.
Lanoxin

Lanoxin

2.1 Important Dosing and Administration Information

In selecting a LANOXIN dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.

Parenteral administration of digoxin should be used only when the need for rapid digitalization is urgent or when the drug cannot be taken orally. Intramuscular injection can lead to severe pain at the injection site, thus intravenous administration is preferred. If the drug must be administered by the intramuscular route, it should be injected deep into the muscle followed by massage. For adults, no more than 500 mcg of LANOXIN Injection should be injected into a single site. For pediatric patients, no more than 200 mcg of LANOXIN Injection Pediatric should be injected into a single site.

Administer the dose over a period of 5 minutes or longer and avoid bolus administration to prevent systemic and coronary vasoconstriction. Mixing of LANOXIN Injection and Injection Pediatric with other drugs in the same container or simultaneous administration in the same intravenous line is not recommended.

LANOXIN Injection and Injection Pediatric can be administered undiluted or diluted with a 4-fold or greater volume of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. The use of less than a 4-fold volume of diluent could lead to precipitation of the digoxin. Immediate use of the diluted product is recommended.

If tuberculin syringes are used to measure very small doses do not flush with the parenteral solution after its contents are expelled into an indwelling vascular catheter to avoid overadministration of digoxin.

Consider interruption or reduction in LANOXIN dose prior to electrical cardioversion [see Warnings and Precautions (5.4)].

2.2 Loading Dosing Regimen in Adults and Pediatric Patients
Table 1. Recommended LANOXIN Injection Loading Dose mcg = microgram
Age

Total IV Loading Dose (mcg/kg)      Administer half the total loading dose initially,     then ¼ the loading dose every 6-8 hours twice

Premature

15-25

Full-Term

20-30

1-24 Months

30-50

2-5 Years

25-35

5-10 Years

15-30

Adults and pediatric patients over 10 years

8-12

2.3 Maintenance Dosing in Adults and Pediatric Patients Over 10 Years Old

The maintenance dose is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)].

The recommended starting maintenance doses in adults and pediatric patients over 10 years old with normal renal function are given in Table 2. Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.
Table 2. Recommended Starting LANOXIN Injection Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old mcg = microgram
Age

     Total Intravenous Maintenance Dose,      mcg/kg/day (given once daily)

Adults and pediatric patients over 10 years

2.4-3.6

Table 3 provides the recommended (once daily) maintenance dose for adults and pediatric patients over 10 years old (to be given once daily) according to lean body weight and renal function. The doses are based on studies in adult patients with heart failure. Alternatively, the maintenance dose may be estimated by the following formula (peak body stores lost each day through elimination):

Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100(% Daily Loss = 14 + Creatinine clearance/5)

Reduce the dose of LANOXIN in patients whose lean weight is an abnormally small fraction of their total body mass because of obesity or edema.
Table 3. Recommended Maintenance Dose (in micrograms given once daily) of LANOXIN Injection in Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Function a  For adults, creatinine clearance was corrected to 70-kg body weight or 1.73 m2 body surface area. If only serum creatinine concentrations (Scr) are available, a corrected Ccr may be estimated in men as (140 – Age)/Scr. For women, this result should be multiplied by 0.85.For pediatric patients, the modified Schwartz equation may be used. The formula is based on height in cm and Scr in mg/dL where k is a constant. Ccr is corrected to 1.73 m2 body surface area. During the first year of life, the value of k is 0.33 for pre-term babies and 0.45 for term infants. The k is 0.55 for pediatric patients and adolescent girls and 0.7 for adolescent boys.GFR (mL/min/1.73 m2) = (k x Height)/Scrb  If no loading dose administeredc  The doses listed assume average body composition.
     Corrected      Creatinine Clearancea

Lean Body Weightc

     Number of Days Before Steady State Achievedb

  kg

   40

   50

   60

   70

   80

   90

   100

10 mL/min

64

80

96

112

128

144

160

19

20 mL/min

72

90

108

126

144

162

180

16

30 mL/min

80

100

120

140

160

180

200

14

40 mL/min

88

110

132

154

176

198

220

13

50 mL/min

96

120

144

168

192

216

240

12

60 mL/min

104

130

156

182

208

234

260

11

70 mL/min

112

140

168

196

224

252

280

10

80 mL/min

120

150

180

210

240

270

300

9

90 mL/min

128

160

192

224

256

288

320

8

100 mL/min

136

170

204

238

272

306

340

7

2.4 Maintenance Dosing in Pediatric Patients Less Than 10 Years Old

The starting maintenance dose for heart failure in pediatric patients less than 10 years old is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)]. The recommended starting maintenance doses for pediatric patients are given in Table 4. These recommendations assume the presence of normal renal function.
Table 4. Recommended Starting LANOXIN Injection Maintenance Dosage in Pediatric Patients Less Than 10 Years Old mcg = microgram
Age

Dose Regimen, mcg/kg/dose      (given TWICE daily)

Premature

1.9-3.1

Full-Term

3.0-4.5

1-24 Months

4.5-7.5

2-5 Years

3.8-5.3

5-10 Years

2.3-4.5

Table 5 provides average daily maintenance dose requirements for pediatric patients less than 10 years old (to be given twice daily) with heart failure based on age, lean body weight, and renal function.
Table 5. Recommended Maintenance Dose (in micrograms given TWICE daily) of LANOXIN Injection in Pediatric Patients Less Than 10 Years of Agea Based upon Lean Body Weight and Renal Functiona a  Recommended are doses to be given twice daily.b  The modified Schwartz equation may be used to estimate creatinine clearance. See footnote a under Table 3.c  If no loading dose administered.
     Corrected      Creatinine Clearanceb

Lean Body Weight

     Number of Days Before Steady State Achievedc

  kg

   5

   10

   20

   30

   40

   50

   60

10 mL/min

8

16

32

48

64

80

96

19

20 mL/min

9

18

36

54

72

90

108

16

30 mL/min

10

20

40

60

80

100

120

14

40 mL/min

11

22

44

66

88

110

132

13

50 mL/min

12

24

48

72

96

120

144

12

60 mL/min

13

26

52

78

104

130

156

11

70 mL/min

14

28

56

84

112

140

168

10

80 mL/min

15

30

60

90

120

150

180

9

90 mL/min

16

32

64

96

128

160

192

8

100 mL/min

17

34

68

102

136

170

204

7

2.5 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels

Monitor for signs and symptoms of digoxin toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.

Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.

Interpret the serum digoxin concentration in the overall clinical context, and do not use an isolated measurement of serum digoxin concentration as the basis for increasing or decreasing the LANOXIN dose. Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [see Drug Interactions (7.4)]. If the assay is sensitive to these substances, consider obtaining a baseline digoxin level before starting LANOXIN and correct post-treatment values by the reported baseline level.

Obtain serum digoxin concentrations just before the next scheduled LANOXIN dose or at least 6 hours after the last dose. The digoxin concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing). However, there will be only minor differences in digoxin concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.

2.6 Switching from Intravenous Digoxin to Oral Digoxin

When switching from intravenous to oral digoxin formulations, make allowances for differences in bioavailability when calculating maintenance dosages (see Table 6).
Table 6. Comparison of the Systemic Availability and Equivalent Doses of Oral and Intravenous LANOXIN
Absolute      Bioavailability

Equivalent Doses (mcg)

LANOXIN Tablets

60-80%

   62.5

   125

   250

   500

LANOXIN Intravenous Injection

100%

50

100

200

400
Zantac

Zantac

Parenteral Administration

In some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or in patients who are unable to take oral medication, ZANTAC may be administered parenterally according to the following recommendations:

Intramuscular Injection: 50 mg (2 mL) every 6 to 8 hours. (No dilution necessary.)

Intermittent Intravenous Injection:

a. Intermittent Bolus: 50 mg (2 mL) every 6 to 8 hours. Dilute ZANTAC Injection, 50 mg, in 0.9% sodium chloride injection or other compatible IV solution (see Stability) to a concentration no greater than 2.5 mg/mL (20 mL). Inject at a rate no greater than 4 mL/min (5 minutes).

b. Intermittent Infusion: 50 mg (2 mL) every 6 to 8 hours. Dilute ZANTAC Injection, 50 mg, in 5% dextrose injection or other compatible IV solution (see Stability) to a concentration no greater than 0.5 mg/mL (100 mL). Infuse at a rate no greater than 5 to 7 mL/min (15 to 20 minutes).

In some patients it may be necessary to increase dosage. When this is necessary, the increases should be made by more frequent administration of the dose, but generally should not exceed 400 mg/day.

Continuous Intravenous Infusion: Add ZANTAC Injection to 5% dextrose injection or other compatible IV solution (see Stability). Deliver at a rate of 6.25 mg/hour (e.g., 150 mg [6 mL] of ZANTAC Injection in 250 mL of 5% dextrose injection at 10.7 mL/hour).

For Zollinger-Ellison patients, dilute ZANTAC Injection in 5% dextrose injection or other compatible IV solution (see Stability) to a concentration no greater than 2.5 mg/mL. Start the infusion at a rate of 1.0 mg/kg/hour. If after 4 hours either a measured gastric acid output is >10 mEq/hour or the patient becomes symptomatic, the dose should be adjusted upward in 0.5-mg/kg/hour increments, and the acid output should be remeasured. Dosages up to 2.5 mg/kg/hour and infusion rates as high as 220 mg/hour have been used.

Pediatric Use

While limited data exist on the administration of IV ranitidine to children, the recommended dose in pediatric patients is for a total daily dose of 2 to 4 mg/kg, to be divided and administered every 6 to 8 hours, up to a maximum of 50 mg given every 6 to 8 hours. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients. Limited data in neonatal patients (less than 1 month of age) receiving ECMO have shown that a dose of 2 mg/kg is usually sufficient to increase gastric pH to >4 for at least 15 hours. Therefore, doses of 2 mg/kg given every 12 to 24 hours or as a continuous infusion should be considered.

Dosage Adjustment for Patients With Impaired Renal Function

The administration of ranitidine as a continuous infusion has not been evaluated in patients with impaired renal function. On the basis of experience with a group of subjects with severely impaired renal function treated with ZANTAC, the recommended dosage in patients with a creatinine clearance <50 mL/min is 50 mg every 18 to 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatric Use and PRECAUTIONS: Geriatric Use).

Stability

Undiluted, ZANTAC Injection tends to exhibit a yellow color that may intensify over time without adversely affecting potency. ZANTAC Injection is stable for 48 hours at room temperature when added to or diluted with most commonly used IV solutions, e.g., 0.9% sodium chloride injection, 5% dextrose injection, 10% dextrose injection, lactated ringer's injection, or 5% sodium bicarbonate injection.

ZANTAC Injection Premixed in flexible plastic containers is sterile through the expiration date on the label when stored under recommended conditions.

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

Zantac

Parenteral Administration

In some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or in patients who are unable to take oral medication, ZANTAC Injection may be administered parenterally according to the following recommendations:

Intramuscular Injection: 50 mg (2 mL) every 6 to 8 hours. (No dilution necessary.)

Intermittent Intravenous Injection:

a. Intermittent Bolus: 50 mg (2 mL) every 6 to 8 hours. Dilute ZANTAC Injection, 50 mg, in 0.9% sodium chloride injection or other compatible IV solution (see Stability) to a concentration no greater than 2.5 mg/mL (20 mL). Inject at a rate no greater than 4 mL/min (5 minutes).

b. Intermittent Infusion: 50 mg (2 mL) every 6 to 8 hours. Dilute ZANTAC Injection, 50 mg, in 5% dextrose injection or other compatible IV solution (see Stability) to a concentration no greater than 0.5 mg/mL (100 mL). Infuse at a rate no greater than 5 to 7 mL/min (15 to 20 minutes).

In some patients it may be necessary to increase dosage. When this is necessary, the increases should be made by more frequent administration of the dose, but generally should not exceed 400 mg/day.

Continuous Intravenous Infusion: Add ZANTAC Injection to 5% dextrose injection or other compatible IV solution (see Stability). Deliver at a rate of 6.25 mg/hour (e.g., 150 mg [6 mL] of ZANTAC Injection in 250 mL of 5% dextrose injection at 10.7 mL/hour).

For Zollinger-Ellison patients, dilute ZANTAC Injection in 5% dextrose injection or other compatible IV solution (see Stability) to a concentration no greater than 2.5 mg/mL. Start the infusion at a rate of 1.0 mg/kg/hour. If after 4 hours either a measured gastric acid output is >10 mEq/hour or the patient becomes symptomatic, the dose should be adjusted upward in 0.5-mg/kg/hour increments, and the acid output should be remeasured. Dosages up to 2.5 mg/kg/hour and infusion rates as high as 220 mg/hour have been used.

Pediatric Use

While limited data exist on the administration of IV ranitidine to children, the recommended dose in pediatric patients is for a total daily dose of 2 to 4 mg/kg, to be divided and administered every 6 to 8 hours, up to a maximum of 50 mg given every 6 to 8 hours. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients. Limited data in neonatal patients (less than 1 month of age) receiving ECMO have shown that a dose of 2 mg/kg is usually sufficient to increase gastric pH to >4 for at least 15 hours. Therefore, doses of 2 mg/kg given every 12 to 24 hours or as a continuous infusion should be considered.

Dosage Adjustment for Patients With Impaired Renal Function

The administration of ranitidine as a continuous infusion has not been evaluated in patients with impaired renal function. On the basis of experience with a group of subjects with severely impaired renal function treated with ZANTAC, the recommended dosage in patients with a creatinine clearance <50 mL/min is 50 mg every 18 to 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatric Use and PRECAUTIONS: Geriatric Use).

Stability

Undiluted, ZANTAC Injection tends to exhibit a yellow color that may intensify over time without adversely affecting potency. ZANTAC Injection is stable for 48 hours at room temperature when added to or diluted with most commonly used IV solutions, e.g., 0.9% sodium chloride injection, 5% dextrose injection, 10% dextrose injection, lactated ringer's injection, or 5% sodium bicarbonate injection.

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

Directions for Dispensing

Pharmacy Bulk Package—Not for Direct Infusion: The pharmacy bulk package is for use in a pharmacy admixture service only under a laminar flow hood. The closure should be penetrated only once with a sterile transfer set or other sterile dispensing device, which allows measured distribution of the contents, and the contents dispensed in aliquots using aseptic technique. CONTENTS SHOULD BE USED AS SOON AS POSSIBLE FOLLOWING INITIAL CLOSURE PUNCTURE. DISCARD ANY UNUSED PORTION WITHIN 24 HOURS OF FIRST ENTRY. Following closure puncture, container should be maintained below 30°C (86°F) under a laminar flow hood until contents are dispensed.
Plaquenil

Plaquenil

There is currently no dosage information available for this product. We apologize for any inconvenience.
Rilutek

Rilutek

The recommended dose for RILUTEK is 50 mg every 12 hours. No increased benefit can be expected from higher daily doses, but adverse events are increased.

RILUTEK tablets should be taken at least an hour before, or two hours after, a meal to avoid a food-related decrease in bioavailability.

Special Populations

Patients with Impaired Hepatic Function

see WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY.
Kayexalate

Kayexalate

Suspension of this drug should be freshly prepared and not stored beyond 24 hours.

The average daily adult dose of the resin is 15 g to 60 g. This is best provided by administering 15 g (approximately 4 level teaspoons) of KAYEXALATE one to four times daily. One gram of KAYEXALATE contains 4.1 mEq of sodium; one level teaspoon contains approximately 3.5 g of KAYEXALATE and 15 mEq of sodium. (A heaping teaspoon may contain as much as 10 g to 12 g of KAYEXALATE.) Since the in vivo efficiency of sodium-potassium exchange resins is approximately 33 percent, about one third of the resin's actual sodium content is being delivered to the body.

In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation.

Each dose should be given as a suspension in a small quantity of water or, for greater palatability, in syrup. The amount of fluid usually ranges from 20 mL to 100 mL, depending on the dose, or may be simply determined by allowing 3 mL to 4 mL per gram of resin. Healthcare professionals should follow full aspiration precautions when administering this product, such as placing and maintaining the patient in an upright position while the resin is being administered.

The resin may be introduced into the stomach through a plastic tube and, if desired, mixed with a diet appropriate for a patient in renal failure.

The resin may also be given, although with less effective results, in an enema consisting (for adults) of 30 g to 50 g every six hours. Each dose is administered as a warm emulsion (at body temperature) in 100 mL of aqueous vehicle. The emulsion should be agitated gently during administration. The enema should be retained as long as possible and followed by a cleansing enema.

After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped in place. The resin is then suspended in the appropriate amount of aqueous vehicle at body temperature and introduced by gravity, while the particles are kept in suspension by stirring. The suspension is flushed with 50 mL or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. A somewhat thicker suspension may be used, but care should be taken that no paste is formed, because the latter has a greatly reduced exchange surface and will be particularly ineffective if deposited in the rectal ampulla. The suspension is kept in the sigmoid colon for several hours, if possible. Then, the colon is irrigated with nonsodium containing solution at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used.

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

KAYEXALATE should not be heated for to do so may alter the exchange properties of the resin.
Uroxatral

Uroxatral

The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, Uroxatral should be taken with food and with the same meal each day. The tablets should not be chewed or crushed.
Nilandron

Nilandron

The recommended dosage is 300 mg once a day for 30 days, followed thereafter by 150 mg once a day. NILANDRON tablets can be taken with or without food.
Fortaz

Fortaz

Dosage

The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient.

The guidelines for dosage of FORTAZ are listed in Table 5. The following dosage schedule is recommended.
Table 5. Recommended Dosage Schedule * Although clinical improvement has been shown, bacteriologic cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis. † The higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis.
Dose

Frequency

Adults

Usual recommended dosage

1 gram IV or IM

q8-12hr

Uncomplicated urinary tract infections

250 mg IV or IM

q12hr

Bone and joint infections

2 grams IV

q12hr

Complicated urinary tract infections

500 mg IV or IM

q8-12hr

Uncomplicated pneumonia; mild skin and skin-structure infections

500 mg-1 gram IV or IM

q8hr

Serious gynecologic and intra-abdominal infections

2 grams IV

q8hr

Meningitis

2 grams IV

q8hr

Very severe life-threatening infections, especially in immunocompromised patients

2 grams IV

q8hr

Lung infections caused by Pseudomonas spp. in patients with cystic fibrosis with normal renal function*

30-50 mg/kg IV to a maximum of 6 grams per day

q8hr

Neonates (0-4 weeks)

30 mg/kg IV

q12hr

Infants and children

(1 month-12 years)

30-50 mg/kg IV to a maximum of 6 grams per day†

q8hr

Impaired Hepatic Function

No adjustment in dosage is required for patients with hepatic dysfunction.

Impaired Renal Function

Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate [GFR] <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of FORTAZ may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 6.
Table 6. Recommended Maintenance Dosages of FORTAZ in Renal Insufficiency
NOTE: IF THE DOSE RECOMMENDED IN Table 5 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN Table 6, THE LOWER DOSE SHOULD BE USED.

Creatinine Clearance (mL/min)

Recommended Unit Dose

of FORTAZ

Frequency of Dosing

50-31

1 gram

q12hr

30-16

1 gram

q24hr

15-6

500 mg

q24hr

<5

500 mg

q48hr

When only serum creatinine is available, the following formula (Cockcroft's equation)5 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:

Males: Creatinine clearance (mL/min) =

Weight (kg) x (140 - age)

72 x serum creatinine (mg/dL)

Females: 0.85 x male value

In patients with severe infections who would normally receive 6 grams of FORTAZ daily were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency may be increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organism.

In pediatric patients as for adults, the creatinine clearance should be adjusted for body surface area or lean body mass, and the dosing frequency should be reduced in cases of renal insufficiency.

In patients undergoing hemodialysis, a loading dose of 1 gram is recommended, followed by 1 gram after each hemodialysis period.

FORTAZ can also be used in patients undergoing intraperitoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of FORTAZ may be given, followed by 500 mg every 24 hours. In addition to IV use, FORTAZ can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 L of dialysis fluid.

Note: Generally FORTAZ should be continued for 2 days after the signs and symptoms of infection have disappeared, but in complicated infections longer therapy may be required.

Administration

FORTAZ may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh. Intra-arterial administration should be avoided (see PRECAUTIONS).

Intramuscular Administration

For IM administration, FORTAZ should be constituted with one of the following diluents: Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride Injection. Refer to Table 7.

Intravenous Administration

The IV route is preferable for patients with bacterial septicemia, bacterial meningitis, peritonitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or pending.

For direct intermittent IV administration, constitute FORTAZ as directed in Table 7 with Sterile Water for Injection. Slowly inject directly into the vein over a period of 3 to 5 minutes or give through the tubing of an administration set while the patient is also receiving one of the compatible IV fluids (see COMPATIBILITY AND STABILITY).

For IV infusion, constitute the 500-mg, 1-gram, or 2-gram vial and add an appropriate quantity of the resulting solution to an IV container with one of the compatible IV fluids listed under the COMPATIBILITY AND STABILITY section.

Intermittent IV infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing ceftazidime, it is desirable to discontinue the other solution.

TwistVialTM vials are to be constituted only with 50 or 100 mL of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or 0.45% Sodium Chloride Injection in compatible flexible diluent containers (see Instructions for Constitution). TwistVialTM vials that have been joined to compatible diluent containers and activated to dissolve the drug are stable for 12 hours at room temperature or for 3 days under refrigeration. Joined vials that have not been activated may be used within a 14-day period; this period corresponds to that for use of compatible diluent containers following removal of the outer packaging (overwrap).

Freezing solutions of FORTAZ is not recommended.
Table 7. Preparation of Solutions of FORTAZ * To obtain a dose of 500 mg, withdraw 5.0 mL from the vial following reconstitution. † To obtain a dose of 1 g, withdraw 10.0 mL from the vial following reconstitution. ‡ To obtain a dose of 2 g, withdraw 11.5 mL from the vial following reconstitution.
Size

Amount of Diluent to be Added

(mL)

Approximate Available Volume

(mL)

Approximate Ceftazidime Concentration

(mg/mL)

Intramuscular

500-mg vial

1.5

1.8

280

1-gram vial

3.0

3.6

280

Intravenous

500-mg vial

5.3

5.7*

100

1-gram vial

10.0

10.8†

100

2-gram vial

10.0

11.5‡

170

Pharmacy bulk package

6-gram vial

26

30

200

All vials of FORTAZ as supplied are under reduced pressure. When FORTAZ is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use please follow the recommended techniques of constitution described on the detachable Instructions for Constitution section of this insert.

Solutions of FORTAZ, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

However, if concurrent therapy with FORTAZ and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

Directions for Use of FORTAZ Frozen in Galaxy® Plastic Containers

FORTAZ supplied as a frozen, sterile, iso-osmotic, nonpyrogenic solution in plastic containers is to be administered after thawing either as a continuous or intermittent IV infusion. The thawed solution is stable for 8 hours at room temperature or for 3 days if stored under refrigeration. Do not refreeze.

Thaw container at room temperature (25°C) or under refrigeration (5°C). Do not force thaw by immersion in water baths or by microwave irradiation. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Mix after solution has reached room temperature. Check for minute leaks by squeezing bag firmly. Discard bag if leaks are found as sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear and seal is intact.

Use sterile equipment.

Caution

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for Administration
1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set.
Zinacef

Zinacef

Dosage

Adults

The usual adult dosage range for ZINACEF is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin‑structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750-mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5-gram dose every 8 hours is recommended.

In bone and joint infections, a 1.5-gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to therapy with ZINACEF. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of ZINACEF.

In life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required. In bacterial meningitis, the dosage should not exceed 3 grams every 8 hours. The recommended dosage for uncomplicated gonococcal infection is 1.5 grams given intramuscularly as a single dose at 2 different sites together with 1 gram of oral probenecid. For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5-gram dose administered intravenously just before surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously or intramuscularly every 8 hours when the procedure is prolonged.

For preventive use during open heart surgery, a 1.5-gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.

Impaired Renal Function

A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism (see Table 4).
Table 4. Dosage of ZINACEF in Adults With Reduced Renal Function a Since ZINACEF is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis.
Creatinine Clearance (mL/min)

Dose

Frequency

>20

750 mg-1.5 grams

q8h

10-20

750 mg

q12h

<10

750 mg

q24ha

When only serum creatinine is available, the following formula4 (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

Males: Creatinine clearance (mL/min) =

Weight (kg) x (140 - age)

72 x serum creatinine (mg/dL)

Females: 0.85 x male value

Note: As with antibiotic therapy in general, administration of ZINACEF should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

Pediatric Patients Above 3 Months of Age

Administration of 50 to 100 mg/kg/day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime. The higher dosage of 100 mg/kg/day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.

In bone and joint infections, 150 mg/kg/day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of ZINACEF.

In cases of bacterial meningitis, a larger dosage of ZINACEF is recommended, 200 to 240 mg/kg/day intravenously in divided doses every 6 to 8 hours.

In pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults.

Preparation of Solution and Suspension

The directions for preparing ZINACEF for both IV and IM use are summarized in Table 5.

For Intramuscular Use

Each 750-mg vial of ZINACEF should be constituted with 3.0 mL of Sterile Water for Injection. Shake gently to disperse and withdraw completely the resulting suspension for injection.

For Intravenous Use

Each 750-mg vial should be constituted with 8.3 mL of Sterile Water for Injection. Withdraw completely the resulting solution for injection.

Each 1.5-gram vial should be constituted with 16.0 mL of Sterile Water for Injection, and the solution should be completely withdrawn for injection.

The 7.5-gram pharmacy bulk vial should be constituted with 77 mL of Sterile Water for Injection; each 8 mL of the resulting solution contains 750 mg of cefuroxime.
Table 5. Preparation of Solution and Suspension a NOTE: ZINACEF is a suspension at IM concentrations.b 8 mL of solution contains 750 mg of cefuroxime; 16 mL contains 1.5 grams of cefuroxime.
Strength

Amount of Diluent to Be Added

(mL)

Volume

to Be Withdrawn

Approximate Cefuroxime Concentration

(mg/mL)

750-mg Vial

3.0 (IM)

Totala

225

750-mg Vial

8.3 (IV)

Total

90

1.5-gram Vial

16.0 (IV)

Total

90

7.5-gram Pharmacy bulk package

77 (IV)

Amount Neededb

95

Administration

After constitution, ZINACEF may be given intravenously or by deep IM injection into a large muscle mass (such as the gluteus or lateral part of the thigh). Before injecting intramuscularly, aspiration is necessary to avoid inadvertent injection into a blood vessel.

Intravenous Administration

The IV route may be preferable for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks because of lowered resistance, particularly if shock is present or impending.

For direct intermittent IV administration, slowly inject the solution into a vein over a period of 3 to 5 minutes or give it through the tubing system by which the patient is also receiving other IV solutions.

For intermittent IV infusion with a Y-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing ZINACEF, it is advisable to temporarily discontinue administration of any other solutions at the same site.

TwistVialTM vials are to be constituted only with 50 or 100 mL of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or 0.45% Sodium Chloride Injection in compatible flexible diluent containers (see Instructions for Constitution). TwistVialTM vials that have been joined to compatible diluent containers and activated to dissolve the drug are stable for 24 hours at room temperature or for 7 days under refrigeration. Joined vials that have not been activated may be used within a 14-day period; this period corresponds to that for use of compatible containers following removal of the outer packaging (overwrap).

Freezing solutions of ZINACEF is not recommended.

For continuous IV infusion, a solution of ZINACEF may be added to an IV infusion pack containing one of the following fluids: 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; or 1/6 M Sodium Lactate Injection.

Solutions of ZINACEF, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

However, if concurrent therapy with ZINACEF and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

Directions for Use of ZINACEF Frozen in Galaxy® Plastic Containers

ZINACEF supplied as a frozen, sterile, iso-osmotic, nonpyrogenic solution in plastic containers is to be administered after thawing either as a continuous or intermittent IV infusion. The thawed solution of the premixed product is stable for 28 days if stored under refrigeration (5°C) or for 24 hours if stored at room temperature (25°C). Do not refreeze.

Thaw container at room temperature (25°C) or under refrigeration (5°C). Do not force thaw by immersion in water baths or by microwave irradiation. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Mix after solution has reached room temperature. Check for minute leaks by squeezing bag firmly. Discard bag if leaks are found as sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear and seal is intact.

Use sterile equipment.

Caution

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for Administration

1. Suspend container from eyelet support.

2. Remove protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

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