Versapharm Incorporated

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Versapharm Incorporated Drugs

Pyridoxine Hydrochlorid...

Pyridoxine Hydrochloride

As a dietary supplement for adults, take one tablet daily with a full glass of water, preferably after a meal.
Pyridoxine Hydrochlorid...

Pyridoxine Hydrochloride

As a dietary supplement for adults, take one tablet daily with a full glass of water, preferably after a meal.
Ciclopirox Solution

Ciclopirox Solution

Ciclopirox topical solution, 8%, should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy. Careful consideration of the appropriate nail management program should be given to patients with diabetes (see PRECAUTIONS).

Nail Care By Health Care Professionals

Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders.

Nail Care By Patient

Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after Ciclopirox topical solution, 8%, is removed with alcohol.

Ciclopirox topical solution, 8%, should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. The Ciclopirox topical solution, 8%, should be applied evenly over the entire nail plate.

If possible, Ciclopirox topical solution, 8%, should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).

The Ciclopirox topical solution, 8%, should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy.
Rifampin

Rifampin

Rifampin can be administered by the oral route (see INDICATIONS AND USAGE).

See CLINICAL PHARMACOLOGY for dosing information in patients with renal failure.

Tuberculosis

Adults: 10 mg/kg, in a single daily administration, not to exceed 600 mg/day.

Pediatric Patients: 10-20 mg/kg, not to exceed 600 mg/day.

It is recommended that oral rifampin be administered once daily, either 1 hour before or 2 hours after a meal with a full glass of water.

Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide [e.g., RIFATER®]5 is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.

Following the initial phase, treatment should be continued with rifampin and isoniazid [RIFAMATE®]6. for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.

Meningococcal Carriers

Adults: For adults, it is recommended that 600 mg rifampin be administered twice daily for two days.

Pediatric Patients: Pediatric patients 1 month of age or older: 10 mg/kg (not to exceed 600 mg per dose) every 12 hours for two days.

Pediatric patients under 1 month of age: 5 mg/kg every 12 hours for two days.

Preparation of Extemporaneous Oral Suspension

For pediatric and adult patients in whom capsule swallowing is difficult or where lower doses are needed, a liquid suspension may be prepared as follows:

Rifampin 1% w/v suspension (10 mg/mL) can be compounded using Simple Syrup (Syrup NF):
1. Empty the contents of four Rifampin 300 mg capsules or eight Rifampin 150 mg capsules onto a piece of weighing paper. 2. If necessary, gently crush the capsule contents with a spatula to produce a fine powder. 3. Transfer the rifampin powder blend to a 4-ounce amber glass or plastic (high density polyethylene [HDPE], polypropylene, or polycarbonate) prescription bottle. 4. Rinse the paper and spatula with 20 mL of syrup, and add the rinse to the bottle. Shake vigorously. 5. Add 100 mL of syrup to the bottle and shake vigorously.
This compounding procedure results in a 1% w/v suspension containing 10 mg rifampin/mL. Stability studies indicate that the suspension is stable when stored at room temperature (25 ± 3°C) or in a refrigerator (2-8°C) for four weeks. This extemporaneously prepared suspension must be shaken well prior to administration.
Lindane Shampoo

Lindane Shampoo

Most patients will require only 1 ounce of Lindane Shampoo. Based on the length and density of hair, some patients may require 2 ounces of Lindane Shampoo.

Apply shampoo directly to dry hair without adding water. Work thoroughly into the hair and allow to remain in place for 4 minutes only. Special attention should be given to the fine hairs along the neck. After 4 minutes, add small quantities of water to hair until a good lather forms. Immediately rinse all lather away. Avoid unnecessary contact of lather with other body surfaces. Do not prescribe more than 2 ounces for larger adults. Do not retreat. (See boxed WARNINGS.)

Patients should be provided specific information on use of product. (See PRECAUTIONS: Information for Patients and Lindane Shampoo Medication Guide.)

A Lindane Shampoo Medication Guide must be given to the patient each time LINDANE Shampoo is dispensed as required by law. The Lindane Shampoo Medication Guide is an important part of the risk management program for the patient.
Lindane Lotion

Lindane Lotion

Apply a thin layer of Lindane Lotion over all skin from the neck down. One ounce is sufficient for an average adult. Do not prescribe more than 2 ounces for larger adults. Apply only once. Wash off in 8 to 12 hours. Do not retreat. (See boxed WARNINGS.)

Patients should be provided specific information on use of product. (See PRECAUTIONS: Information for Patients and the Medication Guide.) Patients should be instructed on proper use of Lindane Lotion, especially the amount to apply, how long to leave on and the need to avoid retreatment. Patients should be informed that itching occurs after the successful killing of scabies (mites) and continued itching is not necessarily an indication for retreatment with Lindane Lotion.

A Lindane Lotion Medication Guide must be given to the patient each time Lindane Lotion is dispensed, as required by law. The Lindane Lotion Medication Guide is an important part of the risk management program for the patient.
Isonarif

Isonarif

In general, therapy should be continued until bacterial conversion and maximal improvement have occurred.

Adults: Two Rifampin and Isoniazid Capsules, USP (600 mg rifampin, 300 mg isoniazid) once daily, administeredone hour before or two hours after a meal.

Concomitant administration of pyridoxine (B6) is recommended in the malnourished, in those predisposed toneuropathy (e.g., diabetic), and in adolescents.

Susceptibility Testing, Rifampin

Rifampin susceptibility powders are available for both direct and indirect methods of determining the susceptibility of strains of mycobacteria. The MIC's of susceptible clinical isolates when determined in 7H10 or other non-eggcontainingmedia have ranged from 0.1 to 2 mcg/mL. Quantitative methods that require measurement of zonediameters give the most precise estimates of antibiotic susceptibility. One such procedure has been recommendedfor use with discs for testing susceptibility to rifampin. Interpretations correlate zone diameters from the disc testwith MIC (minimal inhibitory concentration) values for rifampin.
Pyrazinamide

Pyrazinamide

Pyrazinamide should always be administered with other effective antituberculous drugs. It is administered for the initial 2 months of a 6-month or longer treatment regimen for drug-susceptible patients. Patients who are known or suspected to have drug-resistant disease should be treated with regimens individualized to their situation.

Pyrazinamide frequently will be an important component of such therapy.

Patients with concomitant HIV infection may require longer courses of therapy. Physicians treating such patients should be alert to any revised recommendations from CDC for this group of patients.

Usual dose: Pyrazinamide is administered orally, 15 to 30 mg/kg once daily. Older regimens employed 3 or 4 divided doses daily, but most current recommendations are for once a day. Three grams per day should not be exceeded. The CDC recommendations do not exceed 2 g per day when given as a daily regimen (see table).

Alternatively, a twice weekly dosing regimen (50 to 75 mg/kg twice weekly based on lean body weight) has been developed to promote patient compliance with a regimen on an outpatient basis. In studies evaluation the twice weekly regimen, doses of pyrazinamide in excess of 3 g twice weekly have been administered. This exceeds the recommended maximum 3 g/daily dose. However, an increased incidence of adverse reactions has not been reported.

This table is taken from the CDC-American Thoracic Society joint recommendations.4
Recommended Drugs for the Initial Treatment of Tuberculosis in Children and Adults * Doses based on weight should be adjusted as weight changes. † In persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg. Daily Dose* Drug Children Adults Isoniazid
10 to 20 mg/kg
PO or IM
5 mg/kg
PO or IM Rifampin
10 to 20 mg/kg
PO
10 mg/kg
PO Pyrazinamide
15 to 30 mg/kg
PO
15 to 30 mg/kg
PO Streptomycin
20 to 40 mg/kg
IM
15 mg/kg†
IM Ethambutol
15 to 25 mg/kg
PO
15 to 25 mg/kg
PO * In persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg. Maximal Daily Dose in Children and Adults Drug Isoniazid 300 mg Rifampin 600 mg Pyrazinamide 2 g Streptomycin 1 g* Ethambutol 2.5 g Twice Weekly Dose Drug Children Adults Isoniazid
20 to 40 mg/kg
Max. 900 mg
15 mg/kg
Max. 900 mg Rifampin
10 to 20 mg/kg
Max. 600 mg
10 mg/kg
Max. 600 mg Pyrazinamide 50 to 70 mg/kg 50 to 70 mg/kg Streptomycin
25 to 30 mg/kg
IM
25 to 30 mg/kg
IM Ethambutol 50 mg/kg 50 mg/kg
Definition of abbreviations: PO = per-orally; IM = intramuscularly.
Isoniazid

Isoniazid

(See alsoINDICATIONS AND USAGE): NOTE: For preventive therapy of tuberculous infection and treatment of tuberculosis, it is recommended that physicians be familiar with the following publications: (1) the recommendations of the Advisory Council for the Elimination of Tuberculosis, published in the MMWR: vol 42; RR-4, 1993 and (2) Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, American Journal of Respiratory and Critical Care Medicine: vol 149; 1359-1374, 1994.

For Treatment of Tuberculosis

Isoniazid is used in conjunction with other effective anti-tuberculosis agents. Drug susceptibility testing should be performed on the organisms initially isolated from all patients with newly diagnosed tuberculosis. If the bacilli become resistant, therapy must be changed to agents to which the bacilli are susceptible.

Usual Oral Dosage (depending on the regimen used):
Adults: 5 mg/kg up to 300 mg daily in a single dose; or 15 mg/kg up to 900 mg day, two or three times/week Children: 10-15 mg/kg up to 300 mg daily in a single dose; or 20-40 mg/kg up to 900 mg/day, two or three time/week
Patients with Pulmonary Tuberculosis Without HIV Infection

There are 3 regimen options for the initial treatment of tuberculosis in children and adults:

Option 1: Daily isoniazid, rifampin, and pyrazinamide for 8 weeks followed by 16 weeks of isoniazid and rifampin daily or 2-3 times weekly. Ethambutol or streptomycin should be added to the initial regimen until sensitivity to isoniazid and rifampin is demonstrated. The addition of a fourth drug is optional if the relative prevalence of isoniazid-resistant Mycobacterium tuberculosis isolates in the community is less than or equal to four percent.

Option 2: Daily isoniazid, rifampin, pyrazinamide, and streptomycin or ethambutol for 2 weeks followed by twice weekly administration of the same drugs for 6 weeks, subsequently twice weekly isoniazid and rifampin for 16 weeks.

Option 3: Three times weekly with isoniazid, rifampin, pyrazinamide, and ethambutol or streptomycin for 6 months.

*All regimens given twice weekly or 3 times weekly should be administered by directly observed therapy (see also Directly Observed Therapy).

The above treatment guidelines apply only when the disease is caused by organisms that are susceptible to the standard antituberculous agents. Because of the impact of resistance to isoniazid and rifampin on the response to therapy, it is essential that physicians initiating therapy for tuberculosis be familiar with the prevalence of drug resistance in their communities. It is suggested that ethambutol not be used in children whose visual acuity cannot be monitored.

Patients with Pulmonary Tuberculosis and HIV Infection

The response of the immunologically impaired host to treatment may not be as satisfactory as that of a person with normal host responsiveness. For this reason, therapeutic decisions for the impaired host must be individualized. Since patients co-infected with HIV may have problems with malabsorption, screening of antimycobacterial drug levels, especially in patients with advanced HIV disease, may be necessary to prevent the emergence of MDRTB.

Patients with Extra pulmonary Tuberculosis

The basic principles that underlie the treatment of pulmonary tuberculosis also apply to Extra pulmonary forms of the disease. Although there have not been the same kinds of carefully conducted controlled trials of treatment of Extra pulmonary tuberculosis as for pulmonary disease, increasing clinical experience indicates that a 6 to 9 month short-course regimens is effective. Because of the insufficient data, miliary tuberculosis, bone/joint tuberculosis, and tuberculous meningitis in infants and children should receive 12 months therapy.

Bacteriologic evaluation of Extra pulmonary tuberculosis may be limited by the relative inaccessibility of the sites of disease. Thus, response to treatment often must be judged on the basis of clinical and radiographic findings.

The use of adjunctive therapies such as surgery and corticosteroids is more commonly required in Extra pulmonary tuberculosis than in pulmonary disease. Surgery may be necessary to obtain specimens for diagnosis and to treat such processes as constrictive pericarditis and spinal cord compression from Pott's Disease. Corticosteriods have been shown to be of benefit in preventing cardiac constriction from tuberculous pericarditis and in decreasing the neurologic sequelae of all stages of tuberculosis meningitis, especially when administered early in the course of the disease.

Pregnant Women with Tuberculosis

The options listed above must be adjusted for the pregnant patient. Streptomycin interferes with in utero development of the ear and may cause congenital deafness. Routine use of pyrazinamide is also not recommended in pregnancy because of inadequate teratogenicity data. The initial treatment regimen should consist of isoniazid and rifampin. Ethambutol should be included unless primary isoniazid resistance is unlikely (isoniazid resistance rate documented to be less than 4%).

Treatment of Patients with Multi-Drug Resistant Tuberculosis (MDRTB)

Multiple-drug resistant tuberculosis (i.e., resistance to at least isoniazid and rifampin) presents difficult treatment problems. Treatment must be individualized and based on susceptibility studies. In such cases, consultation with an expert in tuberculosis is recommended.

Directly Observed Therapy (DOT)

A major cause of drug-resistant tuberculosis is patient non-compliance with treatment. The use of DOT can help assure patient compliance with drug therapy. DOT is the observation of the patient by a health care provider or other responsible person as the patient ingests anti-tuberculosis medications. DOT can be achieved with daily, twice weekly or thrice weekly regimens, and is recommended for all patients.

For Preventative Therapy of Tuberculosis

Before isoniazid preventive therapy is initiated, bacteriologically positive or radiographically progressive tuberculosis must be excluded. Appropriate evaluations should be performed if Extra pulmonary tuberculosis is suspected.

Adults over 30 Kg: 300 mg per day in a single dose.

Infants and Children: 10 mg/kg (up to 300 mg daily) in a single dose. In situations where adherence with daily preventative therapy cannot be assured, 20-30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of administration8.

Continuous administration of isoniazid for a sufficient period is an essential part of the regimen because relapse rates are higher if chemotherapy is stopped prematurely. In the treatment of tuberculosis, resistant organisms may multiply and the emergence of resistant organisms during the treatment may necessitate a change in the regimen.

For following patient compliance: the Potts-Cozart test9, a simple colorimetric6 method of checking for isoniazid in the urine, is a useful tool for assuring patient compliance, which is essential for effective tuberculosis control. Additionally, isoniazid test strips are also available to check patient compliance.

Concomitant administration of pyridoxine (B6) is recommended in the malnourished and in those predisposed to neuropathy (e.g., alcoholics and diabetics).
Trihexyphenidyl Hydroch...

Trihexyphenidyl Hydrochloride Syrup

Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age.Whether trihexyphenidyl may best be given before or after meals should be determined by the way the patient reacts. Postencephalitic patients, who are usually more prone to excessive salivation, may prefer to take it after meals and may, in addition, require small amounts of atropine which, under such circumstances, is sometimes an effective adjuvant. If trihexyphenidyl tends to dry the mouth excessively, it may be better to take it before meals, unless it causes nausea. If taken after meals, the thirst sometimes induced can be allayed by mint candies, chewing gum or water.

Abrupt withdrawal of treatment for parkinsonism may result in acute exacerbation of parkinsonism symptoms; therefore, abrupt withdrawal should be avoided.

Abrupt withdrawal of treatment may result in neuroleptic malignant syndrome (NMS) (See WARNINGS).

Idiopathic Parkinsonism

As initial therapy for parkinsonism, 1 mg of trihexyphenidyl hydrochloride may be administered the first day. The dose may then be increased by 2 mg increments at intervals of three to five days, until a total of 6 to 10 mg is given daily. The total daily dose will depend upon what is found to be the optimal level. Many patients derive maximum benefit from this daily total of 6 to 10 mg, but some patients, chiefly those in the postencephalitic group, may require a total daily dose of 12 to 15 mg.

Drug-Induced Parkinsonism

The size and frequency of the trihexyphenidyl dose needed to control extrapyramidal reactions to commonly employed tranquilizers, notably the phenothiazines, thioxanthenes, and butyrophenones, must be determined empirically. The total daily dosage usually ranges between 5 and 15 mg although, in some cases, these reactions have been satisfactorily controlled with as little as 1 mg daily. It may be advisable to commence therapy with a single 1 mg dose. If the extrapyramidal manifestations are not controlled in a few hours, the subsequent doses may be progressively increased until satisfactory control is achieved. Satisfactory control may sometimes be more rapidly achieved by temporarily reducing the dosage of the tranquilizer when instituting trihexyphenidyl therapy and then adjusting the dosage of both drugs until the desired ataractic effect is retained without onset of extrapyramidal reactions.

It is sometimes possible to maintain the patient on a reduced trihexyphenidyl dosage after the reactions have remained under control for several days. Instances have been reported in which these reactions have remained in remission for long periods after trihexyphenidyl therapy was discontinued.

Concomitant Use with Levodopa

When trihexyphenidyl is used concomitantly with levodopa, the usual dose of each may need to be reduced. Careful adjustment is necessary, depending on side effects and degree of symptom control. A trihexyphenidyl dosage of 3 to 6 mg daily, in divided doses, is usually adequate.

Concomitant Use with Other Parasympathetic Inhibitors

Trihexyphenidyl may be substituted, in whole or in part, for other parasympathetic inhibitors. The usual technique is partial substitution initially, with progressive reduction in the other medication as the dose of trihexyphenidyl is increased.

The total daily intake of trihexyphenidyl hydrochloride oral solution USP is tolerated best if divided into 3 doses and taken at mealtimes. High doses (>10 mg daily) may be divided into 4 parts, with 3 doses administered at mealtimes and the fourth at bedtime.
Aminocaproic Acid

Aminocaproic Acid

An identical dosage regimen may be followed by administering aminocaproic acid tablets or aminocaproic acid oral solution as follows:

For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 5 aminocaproic acid 1000 mg tablets or 10 aminocaproic acid 500 mg tablets (5 g) or 20 milliliters of aminocaproic acid oral solution (5 g) be administered during the first hour of treatment, followed by a continuing rate of 1 aminocaproic acid 1000 mg tablet or 2 aminocaproic acid 500 mg tablets (1 g) or 5 milliliters of aminocaproic acid oral solution (1.25 g) per hour. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding has been controlled.
Pitressin

Pitressin

Apply a thin film of Clindamycin Phosphate Topical Solution twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded.

Pledget: Remove pledget from jar just before use. Do not use if the seal under the cap is broken. Discard after single use.

Keep all liquid dosage forms in containers tightly closed.
Desoximetasone Gel

Desoximetasone Gel

Apply a thin film of Desoximetasone Gel 0.05% to the affected skin areas twice daily. Rub in gently.
Zosyn

Zosyn

Apply a thin film of desoximetasone cream USP, 0.25% to the affected skin areas twice daily. Rub in gently.
Triamcinolone Acetonide...

Triamcinolone Acetonide Lotion

Topical corticosteroids are generally applied to the affected area as a thin film from three to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Temazepam

Temazepam

Ethambutol hydrochloride should not be used alone, in initial treatment or in retreatment. Ethambutol hydrochloride should be administered on a once every 24-hour basis only. Absorption is not significantly altered by administration with food. Therapy, in general, should be continued until bacteriological conversion has become permanent and maximal clinical improvement has occurred.

Ethambutol hydrochloride is not recommended for use in pediatric patients under 13 years of age since safe conditions for use have not been established.

Initial Treatment

In patients who have not received previous antituberculous therapy, administer ethambutol hydrochloride 15 mg/kg (7 mg/lb) of body weight, as a single oral dose once every 24 hours. In the more recent studies, isoniazid has been administered concurrently in a single, daily, oral dose.

Retreatment

In patients who have received previous antituberculous therapy, administer ethambutol hydrochloride 25 mg/kg (11 mg/lb) of body weight, as a single oral dose once every 24 hours. Concurrently administer at least one other antituberculous drug to which the organisms have been demonstrated to be susceptible by appropriate in vitro tests. Suitable drugs usually consist of those not previously used in the treatment of the patient. After 60 days of ethambutol hydrochloride administration, decrease the dose to 15 mg/kg (7 mg/lb) of body weight, and administer as a single oral dose once every 24 hours.

During the period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations are advised.

See Table for easy selection of proper weight-dose tablet(s).

Weight-Dose Table

15 mg/kg (7 mg/lb) Schedule

Weight Range

Pounds

Kilograms

Daily Dose

In mg

Under 85 lbs.

Under 37 kg

500

85 - 94.5

37 – 43

600

95 - 109.5

43 – 50

700

110 - 124.5

50 – 57

800

125 - 139.5

57 – 64

900

140 - 154.5

64 – 71

1000

155 - 169.5

71 – 79

1100

170 - 184.5

79 – 84

1200

185 - 199.5

84 – 90

1300

200 - 214.5

90 – 97

1400

215 and Over

Over 97

1500

25 mg/kg (11 mg/lb) Schedule

Under 85 lbs.

Under 38 kg

900

85 - 92.5

38 - 42

1000

93 - 101.5

42 - 45.5

1100

102 - 109.5

45.5 – 50

1200

110 - 118.5

50 – 54

1300

119 - 128.5

54 – 58

1400

129 - 136.5

58 – 62

1500

137 - 146.5

62 – 67

1600

147 - 155.5

67 – 71

1700

156 - 164.5

71 – 75

1800

165 - 173.5

75 – 79

1900

174 - 182.5

79 – 83

2000

183 - 191.5

83 – 87

2100

192 - 199.5

87 – 91

2200

200 - 209.5

91 – 95

2300

210 - 218.5

95 – 99

2400

219 and Over

Over 99

2500
Binosto

Binosto

Myorisan should be administered with a meal (see PRECAUTIONS: Information for Patients).

The recommended dosage range for Myorisan is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1 mg/kg/day,8 it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2 mg/kg/day, as tolerated. Failure to take Myorisan with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.

The safety of once daily dosing with Myorisan has not been established. Once daily dosing is not recommended.

If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Myorisan, even in low doses, has not been studied, and is not recommended. It is important that Myorisan be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Myorisan on bone loss is unknown (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure).

Contraceptive measures must be followed for any subsequent course of therapy (see PRECAUTIONS).
Table 4 Myorisan Dosing by Body Weight (Based on Administration With Food) * See DOSAGE AND ADMINISTRATION: the recommended dosage range is 0.5 to 1 mg/kg/day.
Body Weight

Total mg/day

kilograms

pounds

0.5 mg/kg

1 mg/kg

2 mg/kg*

40

88

20

40

80

50

110

25

50

100

60

132

30

60

120

70

154

35

70

140

80

176

40

80

160

90

198

45

90

180

100

220

50

100

200

INFORMATION FOR PHARMACISTS

Access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) to obtain an authorization and the "do not dispense to patient after" date. Myorisan must only be dispensed in no more than a 30-day supply.

REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM.

A Myorisan Medication Guide must be given to the patient each time Myorisan is dispensed, as required by law. This Myorisan Medication Guide is an important part of the risk management program for the patient.
Clindamycin Hydrochlori...

Clindamycin Hydrochloride

Ethosuximide is administered by the oral route. The initial dose for patients 3 to 6 years of age is one teaspoonful (250 mg) per day; for patients 6 years of age and older, 2 teaspoonfuls (500 mg) per day. The dose thereafter must be individualized according to the patient's response. Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations.

Ethosuximide may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.
Desoximetasone Ointment...

Desoximetasone Ointment

Apply a thin film of desoximetasone ointment USP, 0.25% to the affected skin areas twice daily. Rub in gently.
Demeclocycline Hydrochl...

Demeclocycline Hydrochloride

Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided.

Concomitant therapy: Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and by iron-containing preparations. Foods and some dairy products also interfere with absorption. Oral forms of tetracycline should be given at least 1 hour before or 2 hours after meals.

In patients with renal impairment: (See WARNINGS.) Tetracyclines should be used cautiously in patients with impaired renal function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

In patients with liver impairment: Tetracyclines should be used cautiously in patients with impaired liver function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses. Administration of adequate amounts of fluid with the oral formulations of tetracyclines is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)

Adults: Usual daily dose - Four divided doses of 150 mg each or two divided doses of 300 mg each.

For pediatric patients above eight years of age: Usual daily dose, 7 to 13 mg per kg body weight per day, depending upon the severity of the disease, divided into two to four doses not to exceed adult dosage of 600 mg per day.

Gonorrhea patients sensitive to penicillin may be treated with demeclocycline administered as an initial oral dose of 600 mg followed by 300 mg every 12 hours for four days to a total of 3 grams.
Ethosuximide

Ethosuximide

Ethosuximide is administered by the oral route. The initial dose for patients 3 to 6 years of age is one capsule (250 mg) per day; for patients 6 years of age and older, 2 capsules (500 mg) per day. The dose thereafter must be individualized according to the patient's response. Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations.

Ethosuximide may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.
Erythromycin Solution

Erythromycin Solution

The Erythromycin Pledgets USP, 2% should be rubbed over the affected area twice a day (morning and evening) after skin is thoroughly washed with warm water and soap and patted dry. Acne lesions on the face, neck, shoulder, chest, and back may be treated in this manner. Additional pledgets may be used, if needed. Each pledget should be used once and discarded. Wash hands after application. Close jar tightly after each use. Drying and peeling may be controlled by reducing the frequency of applications.

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Versapharm Incorporated Drugs