Shionogi Inc.

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Oral: one capsule every four hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

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      Tonsillitis and/or Pharyngitis

      The recommended dose of MOXATAG is 775 mg once daily taken within 1 hour of finishing a meal for 10 days.  The full 10-day course of therapy should be completed for effective treatment of tonsillitis and/or pharyngitis secondary to S. pyogenes.  

      Do not chew or crush tablet. 

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      ULESFIA® Lotion is not for oral, ophthalmic, or intravaginal use.

      Using the guidelines in Table 1, apply sufficient ULESFIA® Lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat application after 7 days. Avoid contact with eyes.  

Table 1: ULESFIA® Lotion Usage Guideline Hair Length Amount ofULESFIA® Lotionper Application    Ounces 8 oz bottle Size Short 0-2 inches 4-6 oz  ½-¾ bottle 2-4 inches 6-8 oz ¾-1 bottle Medium 4-8 inches 8-12 oz 1-1½ bottles 8-16 inches 12-24 oz 1½-3 bottles Long 16-22 inches 24-32 oz  3-4 bottles Over 22 inches 32-48 oz  4-6 bottles

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Do NOT chew, break, or split the tablet.

Adults (17 years of age and over)

For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of tramadol can be improved by initiating therapy with a titration regimen. The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, RYBIX ODT 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.

For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, RYBIX ODT 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours, not to exceed 400 mg per day.

Place RYBIX ODT tablet on the tongue until it completely disintegrates and then swallow it. It may take approximately one minute for the tablet to disintegrate on the tongue. Tablet may be taken with or without water.

Individualization of Dose

Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.

In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of RYBIX ODT be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.

The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours.

In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day.

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The dosage of Robinul® or Robinul® Forte should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of glycopyrrolate is 8 mg.

Robinul (glycopyrrolate, 1 mg) tablets. The recommended initial dosage of Robinul for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of one tablet twice a day is frequently adequate.

Robinul Forte (glycopyrrolate, 2 mg) tablets. The recommended dosage of Robinul Forte for adults is one tablet two or three times daily at equally spaced intervals.

Robinul tablets are not recommended for use in pediatric patients under the age of 12 years.

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2.1 Recommended Dosing

Dosage of Orapred ODT should be individualized according to the severity of the disease and the response of the patient. For pediatric patients, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.

Do not break or use partial Orapred ODT tablets. Use an appropriate formulation of prednisolone if indicated dose cannot be obtained using Orapred ODT. This may become important in the treatment of conditions that require tapering doses that cannot be adequately accommodated by Orapred ODT, e.g., tapering the dose below 10 mg.

The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) per day, depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time, there is a lack of satisfactory clinical response, Orapred should be discontinued and the patient placed on other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Orapred ODT for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Orapred ODT are packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The blister pack should then be peeled open, and the orally disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without the assistance of water. Orally disintegrating tablet dosage forms are friable and are not intended to be cut, split, or broken.

Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for one month have been shown to be effective.

Pediatric In pediatric patients, the initial dose of Orapred may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m2bsa/day).

Nephrotic Syndrome The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m2/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m2/day.

Asthma The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone or methylprednisolone in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is   1 -2 mg/kg/day in single or divided doses.

It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.

2.2 Recommended Monitoring

Blood pressure, body weight, routine laboratory studies, including serum potassium and fasting blood glucose, should be obtained at regular intervals during prolonged therapy. Appropriate diagnostic studies should be performed in patients with known or suspected peptic ulcer disease and in patients at risk for reactivation of latent tuberculosis infections.

2.3 Corticosteroid Comparison Chart

For the purpose of comparison, one 10 mg Orapred ODT tablet (13.4 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids:

      Betamethasone 1.75 mg       Paramethasone 4 mg       Cortisone 50 mg       Prednisolone 10 mg       Dexamethasone 1.75 mg       Prednisone 10 mg       Hydrocortisone 40 mg       Triamcinolone 8 mg       Methylprednisolone 8 mg

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

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The initial dose of Orapred may vary from 1.67 mL to 20 mL (5 to 60 mg prednisolone base) per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time, there is a lack of satisfactory clinical response, Orapred should be discontinued and the patient placed on other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Orapred for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4 to 8 mg dexamethasone every other day for one month have been shown to be effective.

In pediatric patients, the initial dose of Orapred may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m2bsa/day).

The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m2/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m2/day.

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone or methylprednisolone in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses. It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.

For the purpose of comparison, 5 mL of Orapred (20.2 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids:

Cortisone, 75 Triamcinolone, 12 Hydrocortisone, 60 Paramethasone, 6 Prednisolone, 15 Betamethasone, 2.25 Prednisone, 15 Dexamethasone, 2.25 Methylprednisolone, 12

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

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There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with FORTAMET® or any other pharmacologic agent. Dosage of FORTAMET® must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of FORTAMET® Extended-Release Tablets in adults is 2500 mg.

FORTAMET® should be taken with a full glass of water once daily with the evening meal. FORTAMET® should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.

During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to FORTAMET® and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of FORTAMET®, either when used as monotherapy or in combination with sulfonylurea or insulin.

Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.

Short-term administration of FORTAMET® may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.

Recommended Dosing Schedule

The usual starting dose of FORTAMET® (metformin hydrochloride) Extended-Release Tablets is 1000 mg taken with a full glass of water once daily with the evening meal, although 500 mg may be utilized when clinically appropriate. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2500 mg once daily with the evening meal (see CLINICAL PHARMACOLOGY, Clinical Studies).

In randomized trials, patients currently treated with immediate-release metformin were switched to FORTAMET®. Results of this trial suggest that patients receiving immediate-release metformin treatment may be safely switched to FORTAMET® once daily at the same total daily dose, up to 2500 mg once daily. Following a switch from immediate-release metformin to FORTAMET®, glycemic control should be closely monitored and dosage adjustments made accordingly (see CLINICAL PHARMACOLOGY, Clinical Studies).

Pediatrics– There is no pediatric information available for FORTAMET®.

Transfer From Other Antidiabetic Therapy

When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to FORTAMET®, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

Concomitant FORTAMET® and Oral Sulfonylurea Therapy in Adult Patients

If patients have not responded to four weeks of the maximum dose of FORTAMET® monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing FORTAMET® at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (also known as glibenclamide). With concomitant FORTAMET® and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant FORTAMET® and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken (see Package Insert of the respective sulfonylurea).

If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of FORTAMET® and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without FORTAMET®.

Concomitant FORTAMET® and Insulin Therapy in Adult Patients

The current insulin dose should be continued upon initiation of FORTAMET® therapy. FORTAMET® therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of FORTAMET® should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose for FORTAMET® Extended-Release Tablets is 2500 mg. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and FORTAMET®. Further adjustment should be individualized based on glucose-lowering response.

Specific Patient Populations

FORTAMET® is not recommended for use in pregnancy, and is not recommended in patients below the age of 17 years.

The initial and maintenance dosing of FORTAMET® should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of FORTAMET®.

Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly (see WARNINGS).

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For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of Fexmid for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE.)

Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).

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The dose of Triglide is 160 mg once daily.

Patients should be placed on an appropriate lipid-lowering diet before receiving Triglide and should continue this diet during treatment with Triglide.

Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.

Triglide tablets can be given without regard to meals. Patients should be advised to swallow Triglide tablets whole. Do not crush, break, dissolve, or chew tablets.

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Carefully consider the potential benefits and risks of NAPRELAN® and other treatment options before deciding to use NAPRELAN®. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with NAPRELAN®, the dose and frequency should be adjusted to suit an individual patient’s needs.

For the relief of:

Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis

The recommended starting dose of NAPRELAN® Tablets in adults is two NAPRELAN® 375 mg tablets (750 mg) once daily, one NAPRELAN® 750 mg (750 mg) once daily, or two NAPRELAN® 500 mg tablets (1000 mg) once a daily. Patients already taking naproxen 250 mg, 375 mg, or 500 mg twice daily (morning and evening) may have their total daily dose replaced with NAPRELAN® Tablets as a single daily dose.

During long-term administration, the dose of NAPRELAN® Tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of NAPRELAN® Tablets well, the dose may be increased to two NAPRELAN® 750 mg tablets (1500 mg), or three NAPRELAN® 500 mg tablets (1500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required. When treating patients, especially at the higher dose levels, the physician should observe sufficient increased clinical benefit to offset the potential increased risk (see CLINICAL PHARMACOLOGY). The lowest effective dose should be sought and used in every patient. Symptomatic improvement in arthritis usually begins within one week; however, treatment for two weeks may be required to achieve a therapeutic benefit.

A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see PRECAUTIONS). Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly it is prudent to use the lowest effective dose.

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One tablet every four hours. Total daily dosage should not exceed 5 tablets.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

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Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effects of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone and acetaminophen tablets, USP are given orally.

The usual adult dosage of  oxycodone and acetaminophen tablets, USP are as follows. The total daily dosage of acetaminophen should not exceed 4 grams.

Strength

Usual Adult Dose

 Maximal Daily Dose 

5 mg/400 mg

One Tablet every 6 hours as needed for pain

10 Tablets

7.5 mg/400 mg

One Tablet every 6 hours as needed for pain

8 Tablets

10 mg/400 mg

One Tablet every 6 hours as needed for pain

6 Tablets

Cessation of Therapy

In patients treated with oxycodone and acetaminophen tablets, USP for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

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Carefully consider the potential benefits and risks of PONSTEL and other treatment options before deciding to use PONSTEL. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with PONSTEL, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of acute pain in adults and adolescents ≥14 years of age, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours as needed, usually not to exceed one week.4

For the treatment of primary dysmenorrhea, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours, given orally, starting with the onset of bleeding and associated symptoms. Clinical studies indicate that effective treatment can be initiated with the start of menses and should not be necessary for more than 2 to 3 days.5

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Furadantin should be given with food to improve drug absorption and, in some patients, tolerance.

Adults

50-100 mg four times a day -- the lower dosage level is recommended for uncomplicated urinary tract infections.

Pediatric Patients

5-7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

The following table is based on an average weight in each range receiving 5 to 6 mg/kg of body weight per 24 hours, given in four divided doses. It can be used to calculate an average dose of Furadantin Oral Suspension (25 mg/5mL) for pediatric patients.

Table 3: Pediatric Dosing Table Weight in Kilograms (kg) Pediatric Doses (milliliters) and Frequency 7 kg to 11 kg 2.5 mL Four times Daily 12 kg to 21 kg 5 mL Four times Daily 22 kg to 30 kg 7.5 mL Four times Daily 31 kg to 41 kg 10 mL Four times Daily 42 kg or greater See Adult Dose

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.

For long-term suppressive therapy in adults, a reduction of dosage to 50-100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG TERM THERAPY.

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Dosage should be individualized according to the needs and responses of the patient.

Adults

Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

Children (6 years and over)

Methylin should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.

If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.

Methylin should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.

Adults

Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

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Dosage should be individualized according to the needs and responses of the patient.

Directions – Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.

Adults

Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

Children (6 years and over)

Methylin should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

Chewable Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.

If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.

Methylin should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.

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Keflex is administered orally.

Adults — The adult dosage ranges from 1 to 4 g daily in divided doses. The 750 mg strength should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Keflex greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

Pediatric Patients — The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

In severe infections, the dosage may be doubled.

In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of Keflex should be administered for at least 10 days.

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The dosage of SULAR must be adjusted to each patient's needs. Therapy usually should be initiated with 17 mg orally once daily, then increased by 8.5 mg per week or longer intervals, to attain adequate control of blood pressure. Usual maintenance dosage is 17 to 34 mg once daily. Blood pressure response increases over the 8.5 - 34 mg daily dose range but adverse event rates also increase. Doses beyond 34 mg once daily are not recommended. SULAR has been used safely with diuretics, ACE inhibitors, and beta-blocking agents. Patients over age 65, or patients with impaired liver function are expected to develop higher plasma concentrations of nisoldipine. Their blood pressure should be monitored closely during any dosage adjustment. A starting dose not exceeding 8.5 mg daily is recommended in these patient groups. SULAR tablets should be administered orally once daily. SULAR should be taken on an empty stomach (1 hour before or 2 hours after a meal). Grapefruit products should be avoided before and after dosing. SULAR is an extended release dosage form and tablets should be swallowed whole, not bitten, divided or crushed.

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2.1 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)

The recommended dosing range is 20-60 mg/day, in single doses taken in the evening at bedtime. 

2.2   Elderly Patients

The usual recommended starting dose in elderly patients (age≥65 years) is 20 mg once a day given in the evening at bedtime. Higher doses should be used only after careful consideration of the potential risks and benefits [see Use in Specific Populations (8.5) and Warnings and Precautions (5.1)].

2.3   Co-administration with Other Drugs

Patients Taking Danazol, Diltiazem, Dronedarone, or Verapamil The dose of Altoprev should not exceed 20 mg/day [see Warnings and Precautions (5.1)].

Patients Taking AmiodaroneThe dose of Altoprev should not exceed 40 mg/day. [see Warnings and Precautions (5.1) and Drug Interactions (7.6)].

2.4   Dosage in Patients With Renal Impairment

In patients with severe renal impairment (creatinine clearance <30 mL/min), dosage increases above 20 mg/day should only be considered if the expected benefit exceeds the increased risk of myopathy/rhabdomyolysis. [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]

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Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

Xodol® 5/300 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg): The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.

Xodol® 7.5/300 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/300 mg): The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

Xodol® 10/300 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/300 mg): The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

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2.1 Recommended Dosage

The recommended dosage of DORIBAX® is 500 mg administered every 8 hours by intravenous infusion over one hour in patients ≥18 years of age. The recommended dosage and administration by infection is described in Table 1:

Table 1: Dosage of DORIBAX® by Infection * Duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated. † Duration can be extended up to 14 days for patients with concurrent bacteremia.  Infection  Dosage  Frequency  Infusion Time (hours)  Duration  Complicated intra-abdominal infection  500 mg  every 8 hours  1  5–14 days*  Complicated UTI, including pyelonephritis  500 mg  every 8 hours  1  10 days* † 

2.2 Patients with Renal Impairment

Table 2: Dosage of DORIBAX® in Patients with Renal Impairment * [see Preparation of 250 mg DORIBAX ® dose using the 250 mg vial and Preparation of 250 mg DORIBAX ® dose using the 500 mg vial ( 2.3)]  Estimated CrCl (mL/min)  Recommended Dosage Regimen of DORIBAX®  > 50  No dosage adjustment necessary  ≥ 30 to ≤ 50  250 mg* administered intravenously (over 1 hour) every 8 hours  > 10 to < 30  250 mg* administered intravenously (over 1 hour) every 12 hours

The following formula may be used to estimate CrCl. The serum creatinine used in the formula should represent a steady state of renal function. 

 Males: Creatinine clearance (mL/min) =  weight (kg) × (140 - age in years) 72 × serum creatinine (mg/dL)  Females: Creatinine clearance (mL/min) =  0.85 × value calculated for males

DORIBAX® is hemodialyzable; however, there is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

2.3 Preparation of Solutions

DORIBAX® does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparation of the infusion solution.

To prepare DORIBAX® infusions in Baxter Minibag Plus™ infusion bags consult the infusion bag manufacturer's instructions.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. DORIBAX® infusions range from clear, colorless solutions to solutions that are clear and slightly yellow. Variations in color within this range do not affect the potency of the product.

Preparation of 500 mg DORIBAX® dose using the 500 mg vial

Constitute the 500 mg vial with 10 mL of sterile water for injection or 0.9% sodium chloride injection (normal saline) and gently shake to form a suspension. The resultant concentration is approximately 50 mg/mL. CAUTION: THE CONSTITUTED SUSPENSION IS NOT FOR DIRECT INJECTION. Withdraw the suspension using a syringe with a 21 gauge needle and add it to an infusion bag containing 100 mL of normal saline or 5% dextrose; gently shake until clear. The final infusion solution concentration is approximately 4.5 mg/mL.

Preparation of 250 mg DORIBAX® dose using the 250 mg vial

Constitute the 250 mg vial with 10 mL of sterile water for injection or 0.9% sodium chloride injection (normal saline) and gently shake to form a suspension. The resultant concentration is approximately 25 mg/mL. CAUTION: THE CONSTITUTED SUSPENSION IS NOT FOR DIRECT INJECTION. Withdraw the suspension using a syringe with a 21 gauge needle and add it to an infusion bag containing either 50 or 100 mL of normal saline or 5% dextrose; gently shake until clear. The final infusion solution concentration is approximately 4.2 mg/mL (50 mL infusion bag) or approximately 2.3 mg/mL (100 mL infusion bag).

Preparation of 250 mg DORIBAX® dose using the 500 mg vial

Constitute the 500 mg vial with 10 mL of sterile water for injection or 0.9% sodium chloride injection (normal saline) and gently shake to form a suspension. The resultant concentration is approximately 50 mg/mL. CAUTION: THE CONSTITUTED SUSPENSION IS NOT FOR DIRECT INJECTION. Withdraw the suspension using a syringe with a 21 gauge needle and add it to an infusion bag containing 100 mL of normal saline or 5% dextrose; gently shake until clear. Remove 55 mL of this solution from the bag and discard. Infuse the remaining solution, which contains 250 mg (approximately 4.5 mg/mL).

2.4 Compatibility

The compatibility of DORIBAX® with other drugs has not been established. DORIBAX® should not be mixed with or physically added to solutions containing other drugs.

2.5 Storage of Constituted Solutions

Upon constitution with sterile water for injection or 0.9% sodium chloride (normal saline) injection, DORIBAX® suspension in the vial may be held for 1-hour prior to transfer and dilution in the infusion bag.

Following dilution of the suspension with normal saline or 5% dextrose, DORIBAX® infusions stored at room temperature or under refrigeration should be completed according to the times in Table 3.

Table 3: Storage and Stability Times of Infusion Solutions Prepared in Normal Saline or 5% Dextrose  Infusion prepared in  Stability Time at Room Temp. (includes room temperature storage and infusion time)  Stability time at 2–8°C (Refrigeration) (includes refrigerator storage and infusion time)  Normal saline  12 hours  72 hours  5% Dextrose  4 hours  24 hours

Constituted DORIBAX® suspension or DORIBAX® infusion should not be frozen. This storage information applies also to DORIBAX® diluted in Baxter Minibag Plus™.

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OSPHENA is an estrogen agonist/antagonist which has agonistic effects on the endometrium. Generally, when a product with estrogen agonistic effects on the endometrium is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin [see Warnings and Precautions (5.2)].

Use of OSPHENA should be for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

2.1 Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause

Take one 60 mg tablet with food once daily.