Actavis Mid Atlantic Llc

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Actavis Mid Atlantic Llc Drugs

Theophylline

Theophylline

General Considerations:

The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400-1600 mg/day in adults <60 years old and 10-36 mg/kg/day in children 1-9 years old). For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either sub-therapeutic or potentially toxic serum theophylline concentrations in individual patients. For example, at a dose of 900 mg/d in adults <60 years or 22 mg/kg/d in children 1-9 years, the steady-state peak serum theophylline concentration will be <10 mcg/mL in about 30% of patients, 10-20 mcg/mL in about 50% and 20-30 mcg/mL in about 20% of patients. The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects.

Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, if judged to be clinically indicated, in small increments (See Table V). Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum theophylline concentrations to reach the new steady state. Dosage adjustment should be guided by serum theophylline concentration measurement (see PRECAUTIONS, Laboratory Tests and DOSAGE AND ADMINISTRATION, Table VI). Health care providers should instruct patients and care givers to discontinue any dosage that causes adverse effects, to withhold the medication until these symptoms are gone and to then resume therapy at a lower, previously tolerated dosage (see WARNINGS).

If the patient’s symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements (see WARNINGS and PRECAUTIONS), serum theophylline concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum theophylline concentrations should be monitored at frequent intervals, e.g., every 24 hours.

Theophylline distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight.

Table V contains theophylline dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for theophylline dosage adjustment based upon serum theophylline concentrations. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, these recommendations should serve as the upper limit for dosage adjustments in order to decrease the risk of potentially serious adverse events associated with unexpected large increases in serum theophylline concentration.

Table V. Dosing initiation and titration (as anhydrous theophylline).*

Infants <1 year old.

Initial Dosage.

Premature Neonates:

< 24 days postnatal age; 1.0 mg/kg every 12 hr

≥ 24 days postnatal age; 1.5 mg/kg every 12 hr

Full term infants and infants up to 52 weeks of age:

Total daily dose (mg) = [(0.2 x age in weeks)+5.0] x (Kg body Wt).

up to age 26 weeks; divide dose into 3 equal amounts administered at 8 hour intervals.

>26 weeks of age; divide dose into 4 equal amounts administered at 6 hour intervals.

Final Dosage.Adjusted to maintain a peak steady-state serum theophylline concentration of 5-10 mcg/mL in neonates and 10-15 mcg/mL in older infants (see Table VI). Since the time required to reach steady-state is a function of theophylline half-life, up to 5 days may be required to achieve steady-state in a premature neonate while only 2-3 days may be required in a 6 month old infant without other risk factors for impaired clearance in the absence of a loading dose. If a serum theophylline concentration is obtained before steady-state is achieved, the maintenance dose should not be increased, even if the serum theophylline concentration is <10 mcg/mL.
B. Children (1-15 years) and adults (16-60 years) without risk factors for impaired clearance. Titration Step Children < 45 kg Children > 45 kg and adults 1. Starting Dosage 12-14 mg/kg/day up to a maximum of 300 mg/day divided Q4-6 hrs* 300 mg/day divided Q6-8 hrs* 2. After 3 days, if tolerated, increase dose to: 16 mg/kg/day up to a maximum of 400 mg/day divided Q4-6 hrs* 400 mg/day divided Q6-8 hrs* 3. After 3 more days, if tolerated, increase dose to: 20 mg/kg/day up to a maximum of 600 mg/day divided Q4-6 hrs* 600 mg/day divided Q6-8 hrs*
C. Patients With Risk Factors For Impaired Clearance, The Elderly (>60 Years), And Those In Whom It Is Not Feasible To Monitor Serum Theophylline Concentrations:

In children 1-15 years of age, the final theophylline dose should not exceed 16 mg/kg/day up to a maximum of 400 mg/day in the presence of risk factors for reduced theophylline clearance (see WARNINGS) or if it is not feasible to monitor serum theophylline concentrations.

In adolescents ≥16 years and adults, including the elderly, the final theophylline dose should not exceed 400 mg/day in the presence of risk factors for reduced theophylline clearance (see WARNINGS) or if it is not feasible to monitor serum theophylline concentrations.

D. Loading Dose for Acute Bronchodilatation:

An inhaled beta-2 selective agonist, alone or in combination with a systemically administered corticosteroid, is the most effective treatment for acute exacerbations of reversible airways obstruction. Theophylline is a relatively weak bronchodilator, is less effective than an inhaled beta-2 selective agonist and provides no added benefit in the treatment of acute bronchospasm. If an inhaled or parenteral beta agonist is not available, a loading dose of an oral immediate release theophylline can be used as a temporary measure. A single 5 mg/kg dose of theophylline, in a patient who has not received any theophylline in the previous 24 hours, will produce an average peak serum theophylline concentration of 10 mcg/mL (range 5-15 mcg/mL). If dosing with theophylline is to be continued beyond the loading dose, the guidelines in Sections A.1.b., B.3, or C., above, should be utilized and serum theophylline concentration monitored at 24 hour intervals to adjust final dosage.

* Patients with more rapid metabolism, clinically identified by higher than average dose requirements, should receive a smaller dose more frequently to prevent breakthrough symptoms resulting from low trough concentrations before the next dose. A reliably absorbed slow-release formulation will decrease fluctuations and permit longer dosing intervals.
Table VI. Dosage adjustment guided by serum theophylline concentration. Peak Serum Concentration Dosage Adjustment Dose reduction and/or serum theophylline concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce theophylline clearance occur (e.g., sustained fever), or a drug that interacts with theophylline is added or discontinued (see WARNINGS). <9.9 mcg/mL If symptoms are not controlled and current dosage is tolerated, increase dose about 25%. Recheck serum concentration after three days for further dosage adjustment. 10 to 14.9 mcg/mL If symptoms are controlled and current dosage is tolerated, maintain dose and recheck serum concentration at 6-12 month intervals.¶ If symptoms are not controlled and current dosage is tolerated consider adding additional medication(s) to treatment regimen. 15-19.9 mcg/mL Consider 10% decrease in dose to provide greater margin of safety even if current dosage is tolerated.¶ 20-24.9 mcg/mL Decrease dose by 25% even if no adverse effects are present. Recheck serum concentration after 3 days to guide further dosage adjustment. 25-30 mcg/mL Skip next dose and decrease subsequent doses at least 25% even if no adverse effects are present. Recheck serum concentration after 3 days to guide further dosage adjustment. If symptomatic, consider whether overdose treatment is indicated (see recommendations for chronic overdosage). >30 mcg/mL Treat overdose as indicated (see recommendations for chronic overdosage). If theophylline is subsequently resumed, decrease dose by at least 50% and recheck serum concentration after 3 days to guide further dosage adjustment.
Triacin-c

Triacin-c

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.
Usual Dose: Teaspoonfuls (5 mL) Adults and children 12 years and older 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls (40 mL) in 24 hours. Children 6 to under 12 years 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours. Children 2 to under 6 years ½ teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 2 teaspoonfuls
Aminophylline

Aminophylline

General Considerations:

The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400-1600 mg/day in adults <60 years old and 10-36 mg/kg/day in children 1-9 years old). For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either sub-therapeutic or potentially toxic serum theophylline concentrations in individual patients. For example, at a dose of 900 mg/d in adults <60 years or 22 mg/kg/d in children 1-9 years, the steady-state peak serum theophylline concentration will be <10 mcg/mL in about 30% of patients, 10-20 mcg/mL in about 50% and 20-30 mcg/mL in about 20% of patients. The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects.

Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, if judged to be clinically indicated, in small increments (See Table V). Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum theophylline concentrations to reach the new steady state. Dosage adjustment should be guided by serum theophylline concentration measurement (see PRECAUTIONS, Laboratory Tests and DOSAGE AND ADMINISTRATION, Table VI). Health care providers should instruct patients and care givers to discontinue any dosage that causes adverse effects, to withhold the medication until these symptoms are gone and to then resume therapy at a lower, previously tolerated dosage (see WARNINGS).

If the patient’s symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements (see WARNINGS and PRECAUTIONS), serum theophylline concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum theophylline concentrations should be monitored at frequent intervals, e.g., every 24 hours.

Theophylline distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight.

Table V contains theophylline dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for theophylline dosage adjustment based upon serum theophylline concentrations. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, these recommendations should serve as the upper limit for dosage adjustments in order to decrease the risk of potentially serious adverse events associated with unexpected large increases in serum theophylline concentration.

Table V. Dosing initiation and titration (anhydrous theophylline equivalent listed in parentheses).*,†

A. Infants <1 year old.

A. 1. Initial Dosage.

a. Premature Neonates:

i. <24 days postnatal age; 1.0 (**1.17) mg/kg every 12 hr

ii.≥ 24 days postnatal age; 1.5 (**1.75) mg/kg every 12 hr

b. Full term infants and infants up to 52 weeks of age:

A. 1. a. Total theophylline daily dose (mg) = [(0.2) x age in weeks)+5.0] x (Kg body Wt).

{**Total aminophylline daily dose (mg) = [(0.23 x age in weeks) + 5.0] x (Kg body Wt).

i. up to age 26 weeks; divide dose into 3 equal amounts administered at 8 hour intervals.

ii. >26 weeks of age; divide dose into 4 equal amounts administered at 6 hour intervals.

2. Final Dosage.

Adjusted to maintain a peak steady-state serum theophylline concentration of 5-10 mcg/mL in neonates and 10-15 mcg/mL in older infants (see Table VI). Since the time required to reach steady-state is a function of theophylline half-life, up to 5 days may be required to achieve steady-state in a premature neonate while only 2-3 days may be required in a 6 month old infant without other risk factors for impaired clearance in the absence of a loading dose. If a serum theophylline concentration is obtained before steady-state is achieved, the maintenance dose should not be increased, even if the serum theophylline concentration is <10 mcg/mL.
B. Children (1-15 years) and adults (16-60 years) without risk factors for impaired clearance. Titration Step Children <45 kg Children > 45 kg and adults 1. Starting Dosage 12-14 (**14-16.3) mg/kg/day up to a maximum of 300 (**350) mg/day divided Q4-6 hrs* 300 (**350) mg/day divided Q6-8 hrs* 2. After 3 days, if tolerated, increase dose to: 16 (**18.7) mg/kg/day up to a maximum of 400 (**466.7) mg/day divided Q4-6 hrs* 400 (**466.7) mg/day divided Q6-8 hrs* 3. After 3 more days, if tolerated, increase dose to: 20 (**23.3) mg/kg/day up to a maximum of 600 (**700) mg/day divided Q4-6 hrs* 600 (**700) mg/day divided Q6-8 hrs*
C.Patients With Risk Factors For Impaired Clearance, The Elderly (>60 Years), And

Those In Whom It Is Not Feasible To Monitor Serum Theophylline Concentrations:

In children 1-15 years of age, the final aminophylline dose should not exceed 16 (**18.7) mg/kg/day up to a maximum of 400 (**466.7) mg/day in the presence of risk factors for reduced theophylline clearance (see WARNINGS) or if it is not feasible to monitor serum theophylline concentrations.

In adolescents ≥ 16 years and adults, including the elderly, the final aminophylline dose should not exceed 400 (**466.7) mg/day in the presence of risk factors for reduced theophylline clearance (see WARNINGS) or if it is not feasible to monitor serum theophylline concentrations.

D.Loading Dose for Acute Bronchodilatation:

An inhaled beta-2 selective agonist, alone or in combination with a systemically administered corticosteroid, is the most effective treatment for acute exacerbations of reversible airways obstruction. Theophylline is a relatively weak bronchodilator, is less effective than an inhaled beta-2 selective agonist and provides no added benefit in the treatment of acute bronchospasm. If an inhaled or parenteral beta agonist is not available, a loading dose of an oral immediate release theophylline can be used as a temporary measure. A single 5 (**5.8) mg/kg dose of aminophylline, in a patient who has not received any theophylline in the previous 24 hours, will produce an average peak serum theophylline concentration of 10 mcg/mL (range 5-15 mcg/mL). If dosing with theophylline is to be continued beyond the loading dose, the guidelines in Sections A.1.b., B.3, or C., above, should be utilized and serum theophylline concentration monitored at 24 hour intervals to adjust final dosage.

* Patients with more rapid metabolism, clinically identified by higher than average dose

requirements, should receive a smaller dose more frequently to prevent breakthrough symptoms resulting from low trough concentrations before the next dose. A reliably absorbed slow-release formulation will decrease fluctuations and permit longer dosing intervals.

† For products containing theophylline salts, the appropriate dose of the theophylline salt should

be substituted for the anhydrous theophylline dose. To calculate the equivalent dose for theophylline salts, divide the anhydrous theophylline dose listed below by 0.65 for oxtriphylline, and by 0.5 for the calcium salicylate and sodium glycinate salts. Each 5 mL contains 105 mg of anhydrous aminophylline (equivalent to 90 mg of anhydrous theophylline).
Table VI. Dosage adjustment guided by serum theophylline concentration. Peak Serum Concentration Dosage Adjustment <9.9 mcg/mL If symptoms are not controlled and current dosage is tolerated, increase dose about 25%. Recheck serum concentration after three days for further dosage adjustment. 10 to 14.9 mcg/mL If symptoms are controlled and current dosage is tolerated, maintain dose and recheck serum concentration at 6-12 month intervals.¶ If symptoms are not controlled and current dosage is tolerated consider adding additional medication(s) to treatment regimen. 15-19.9 mcg/mL Consider 10% decrease in dose to provide greater margin of safety even if current dosage is tolerated. 20-24.9 mcg/mL Decrease dose by 25% even if no adverse effects are present. Recheck serum concentration after 3 days to guide further dosage adjustment. 25-30 mcg/mL Skip next dose and decrease subsequent doses at least 25% even if no adverse effects are present. Recheck serum concentration after 3 days to guide further dosage adjustment. If symptomatic, consider whether overdose treatment is indicated (see recommendations for chronic overdosage). >30 mcg/mL Treat overdose as indicated (see recommendations for chronic overdosage). If theophylline is subsequently resumed, decrease dose by at least 50% and recheck serum concentration after 3 days to guide further dosage adjustment.
Dose reduction and/or serum theophylline concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce theophylline clearance occur (e.g., sustained fever), or a drug that interacts with theophylline is added or discontinued (see WARNINGS).
Enulose

Enulose

Oral

Adult: The usual adult, oral dosage is 2 to 3 tablespoonfuls (30 to 45 mL, containing 20 g to 30 g of lactulose) three or four times daily. The dosage may be adjusted every day or two to produce 2 or 3 soft stools daily.

Hourly doses of 30 to 45 mL of lactulose solution may be used to induce the rapid laxation indicated in the initial phase of the therapy of portal-systemic encephalopathy. When the laxative effect has been achieved, the dose of lactulose may then be reduced to the recommended daily dose. Improvement in the patient’s condition may occur within 24 hours but may not begin before 48 hours or even later.

Continuous long-term therapy is indicated to lessen the severity and prevent the recurrence of portal-systemic encephalopathy. The dose of lactulose for this purpose is the same as the recommended daily dose.

Pediatric: Very little information on the use of lactulose in young children and adolescents has been recorded. As with adults, the subjective goal in proper treatment is to produce 2 or 3 soft stools daily. On the basis of information available, the recommended initial daily oral dose in infants is 2.5 to 10 mL in divided doses. For older children and adolescents the total daily dose is 40 to 90 mL. If the initial dose causes diarrhea, the dose should be reduced immediately. If diarrhea persists, lactulose should be discontinued.

Rectal

When the adult patient is in the impending coma or coma stage of portal-systemic encephalopathy and the danger of aspiration exists, or when the necessary endoscopic or intubation procedures physically interfere with the administration of the recommended oral doses, lactulose solution may be given as a retention enema via a rectal balloon catheter. Cleansing enemas containing soap suds or other alkaline agents should not be used.

Three hundred mL of lactulose solution should be mixed with 700 mL of water or physiologic saline and retained for 30 to 60 minutes. Lactulose enema may be repeated every 4 to 6 hours. If this lactulose enema is inadvertently evacuated too promptly, it may be repeated immediately.

The goal of treatment is reversal of the coma stage in order that the patient may be able to take oral medication. Reversal of coma may take place within 2 hours of the first enema in some patients. Lactulose given orally in the recommended doses, should be started before lactulose by enema is stopped entirely.
Albuterol Sulfate

Albuterol Sulfate

The usual dosage for adults and children 12 years and older is 2.5 mg of albuterol administered 3 to 4 times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, administer the contents of one unit-dose vial (3 mL of 0.083% nebulizer solution) by nebulization. The flow rate is regulated to suit the particular nebulizer so that the albuterol sulfate inhalation solution will be delivered over approximately 5 to 15 minutes.

The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During treatment, most patients gain optimum benefit from regular use of the nebulizer solution.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.
Albuterol Sulfate

Albuterol Sulfate

The following dosages of Albuterol Sulfate Syrup are expressed in terms of albuterol base.

Usual Dosage:

Adults And Children Over 14 Years Of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.

Children 6 To 14 Years Of Age: The usual starting dosage for children 6 to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.

Children 2 To 6 Years Of Age: Dosing in children 2 to 6 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.

Dosage Adjustment:

Adults And Children Over 14 Years Of Age: For Adults and children over 14 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.

Children From 6 To 14 Years Of Age Who Fail To Respond To The Initial Starting Dosage Of 2 mg Four Times A Day: For children 6 to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).

Children 2 To 6 Years Of Age Who Do Not Respond Satisfactorily To The Initial Dosage: For children from 2 to 6 years of age who do not respond satisfactorily to the initial starting dosage, the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day.

Elderly Patients And Those Sensitive To Beta-Adrenergic Stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.
Halobetasol Propionate

Halobetasol Propionate

Apply a thin layer of Halobetasol Propionate Ointment, 0.05% to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Halobetasol propionate ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Halobetasol propionate ointment should not be used with occlusive dressings.
Triamcinolone Acetonide...

Triamcinolone Acetonide

Topical corticosteroids are generally applied to the affected area as a thin film from two 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.
Albuterol Sulfate Syrup...

Albuterol Sulfate Syrup

The following dosages of Albuterol Sulfate Syrup are expressed in terms of albuterol base.

Usual Dosage:

Adults And Children Over 14 Years Of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.

Children Over 6 To 14 Years Of Age: The usual starting dosage for children over 6 to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.

Children 2 To 6 Years Of Age:Dosing in children 2 to 6 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.

Dosage Adjustment:

Adults And Children Over 14 Years Of Age:For adults and children over 14 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.

Children Over 6 To 14 Years Of Age Who Fail To Respond To The Initial Starting Dosage Of 2 mg Four Times A Day: For children over 6 to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).

Children 2 To 6 Years Of Age Who Do Not Respond Satisfactorily To The Initial Dosage: For children from 2 to 6 years of age who do not respond satisfactorily to the initial starting dosage, the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day.

Elderly Patients And Those Sensitive To Beta-adrenergic Stimulators:The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.
Nystatin Suspension

Nystatin Suspension

Infants: 2 mL (approximately ½ teaspoon) (200,000 units) four times daily. Place one-half of dose, 1 mL (approximately ¼ teaspoon), in each side of mouth and avoid feeding for 5 to 10 minutes.

NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

Children and Adults: 4-6 mL (approximately 1 teaspoon) (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.

Continue treatment for at least 48 hours, after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.
Acetaminophen And Codei...

Acetaminophen And Codeine Phosphate Solution

Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciable increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

Acetaminophen and codeine phosphate oral solution contains 120 mg of acetaminophen and 12 mg of codeine phosphate per 5 mL (teaspoonful) and is given orally.

The recommended dose of codeine phosphate in children is 0.5 mg/kg body weight. The usual doses are:

Children: (7 to 12 years): 10 mL (2 teaspoonfuls) 3 or 4 times daily.

(3 to 6 years): 5 mL (1 teaspoonful) 3 or 4 times daily.

(under 3 years): safe dosage has not been established.

Adults: 15 mL (1 tablespoonful) every 4 hours as needed.
Cromolyn Sodium Solutio...

Cromolyn Sodium Solution

For management of bronchial asthma in adults and pediatric patients (two years of age and over), the usual starting dosage is the contents of one ampule administered by nebulization four times a day at regular intervals.

Drug stability and safety of cromolyn sodium when mixed with other drugs in a nebulizer have not been established.

Patients with chronic asthma should be advised that the effect of cromolyn sodium inhalation solution therapy is dependent upon its administration at regular intervals, as directed. Cromolyn sodium inhalation solution should be introduced into the patient’s therapeutic regimen when the acute episode has been controlled, the airway has been cleared and the patient is able to inhale adequately.

For the prevention of acute bronchospasm which follows exercise or exposure to cold dry air, environmental agents (e.g., animal danders, toluene diisocyanate, pollutants), etc., the usual dose is the contents of one ampule administered by nebulization shortly before exposure to the precipitating factor.

It should be emphasized to the patient that the drug is poorly absorbed when swallowed and is not effective by this route of administration.

For additional information, see the accompanying leaflet entitled Living a Full Life withAsthma.

Cromolyn Sodium Therapy in Relation to Other Treatments for Asthma: Non-steroidal agents: Cromolyn sodium inhalation solution should be added to the patient’s existing treatment regimen (e.g., bronchodilators). When a clinical response to cromolyn sodium is evident, usually within two to four weeks, and if the asthma is under good control, an attempt may be made to decrease concomitant medication usage gradually.

If concomitant medications are eliminated or required on no more than a prn basis, the frequency of administration of cromolyn sodium inhalation solution may be titrated downward to the lowest level consistent with the desired effect. The usual decrease is from four to three ampules per day. It is important that the dosage be reduced gradually to avoid exacerbation of asthma. It is emphasized that in patients whose dosage has been titrated to fewer than four ampules per day, an increase in the dose of cromolyn sodium and the introduction of, or increase in, symptomatic medications may be needed if the patient’s clinical condition deteriorates.

Corticosteroids: In patients chronically receiving corticosteroids for the management of bronchial asthma, the dosage should be maintained following the introduction of cromolyn sodium inhalation solution. If the patient improves, an attempt to decrease corticosteroids should be made. Even if the corticosteroid-dependent patient fails to show symptomatic improvement following cromolyn sodium administration, the potential to reduce corticosteroids may nonetheless be present. Thus, gradual tapering of corticosteroid dosage may be attempted. It is important that the dose be reduced slowly, maintaining close supervision of the patient to avoid an exacerbation of asthma.

It should be borne in mind that prolonged corticosteroid therapy frequently causes an impairment in the activity of the hypothalamic-pituitary-adrenal axis and a reduction in the size of the adrenal cortex. A potentially critical degree of impairment or insufficiency may persist asymptomatically for some time even after gradual discontinuation of adrenocortical steroids. Therefore, if a patient is subjected to significant stress, such as a severe asthmatic attack, surgery, trauma, or severe illness while being treated or within one year (occasionally up to two years) after corticosteroid treatment has been terminated, consideration should be given to reinstituting corticosteroid therapy. When respiratory function is impaired, as may occur in severe exacerbation of asthma, a temporary increase in the amount of corticosteroids may be required to regain control of the patient’s asthma.

It is particularly important that great care be exercised if, for any reason, cromolyn sodium inhalation solution is withdrawn in cases where its use has permitted a reduction in the maintenance dose of corticosteroids. In such cases, continued close supervision of the patient is essential since there may be sudden reappearance of severe manifestations of asthma which will require immediate therapy and possible reintroduction of corticosteroids.
Phenytoin Suspension

Phenytoin Suspension

(NOT FOR PARENTERAL USE)

Serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form. The free acid form of phenytoin is used in phenytoin oral suspension and chewable tablets. All other phenytoin products are formulated with the sodium salt. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.

General:Dosage should be individualized to provide maximum benefit. In some cases serum blood level determinations may be necessary for optimal dosage adjustments – the clinically effective serum level is usually 10-20 mcg/mL. With recommended dosage, a period of seven to ten days may be required to achieve steady-state blood levels with phenytoin and changes in dosage (increase or decrease) should not be carried out at intervals shorter than seven to ten days.

Adult Dose: Patients who have received no previous treatment may be started on one teaspoonful (5 mL) of phenytoin oral suspension three times daily, and the dose is then adjusted to suit individual requirements. An increase to five teaspoonfuls daily may be made, if necessary.

Pediatric Dose: Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years and adolescents may require the minimum adult dose (300 mg/day).
Sulfatrim

Sulfatrim

Not recommended for use in infants less than 2 months of age.

Urinary Tract Infections And Shigellosis In Adults And Children And Acute Otitis Media In Children:

Adults:

The usual adult dosage in the treatment of urinary tract infections is 4 teaspoonfuls (20 mL) of the suspension every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.

Children:

The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of his dosage:

Children: 2 months of age or older.
Weight Dose – every12 hours lb kg Teaspoonfuls 22 10 1 (5 mL) 44 20 2 (10 mL) 66 30 3 (15 mL) 88 40 4 (20 mL)
For Patients With Impaired Renal Function:

When renal function is impaired, a reduced dosage should be employed using the following table:
Creatinine Clearance (mL/min) Recommended Dosage Regimen Above 30 Usual standard regimen 15 - 30 ½ the usual regimen Below 15 Use not recommended
Acute Exacerbations Of Chronic Bronchitis In Adults:

The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 4 teaspoonfuls (20 mL) of the suspension every 12 hours for 14 days.

Pneumocystis Carinii Pneumonia:

Treatment:

Adults and children:

The recommended dosage for treatment of patients with documented Pneumocystis carinii pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.7 The following table is a guideline for the upper limit of this dosage.
Weight Dose – every 6 hours lb kg Teaspoonfuls 18 8 1 (5 mL) 35 16 2 (10 mL) 53 24 3 (15 mL) 70 32 4 (20 mL) 88 40 5 (25 mL) 106 48 6 (30 mL) 141 64 8 (40 mL) 176 80 10 (50 mL)
For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.

Prophylaxis:

Adults:

The recommended dosage for prophylaxis in adults is 800 mg sulfamethoxazole and 160 mg trimethoprim daily.8

Children:

For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.9 The following table is a guideline for the attainment of this dosage in children:
Body Surface Dose – every Area 12 hours (m2) Teaspoonfuls 0.26 ½ (2.5 mL) 0.53 1 (5 mL) 1.06 2 (10 mL)
Travelers’ Diarrhea In Adults:

For the treatment of travelers’ diarrhea, the usual adult dosage is 4 teaspoonfuls (20 mL) of the suspension every 12 hours for 5 days.
Nystatin And Triamcinol...

Nystatin And Triamcinolone Acetonide Ointment

A thin film of nystatin and triamcinolone acetonide ointment is usually applied to the affected areas twice daily in the morning and evening.

The preparation should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests).

Nystatin and triamcinolone acetonide ointment should not be used with occlusive dressings.
Chlorhexidine Gluconate...

Chlorhexidine Gluconate Rinse

Chlorhexidine Gluconate Oral Rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate should be reevaluated and given a thorough prophylaxis at intervals no longer than six months.

Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is ½ fl. oz. (marked in cup) of undiluted chlorhexidine gluconate oral rinse. Patients should be instructed to not rinse with water, or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine gluconate oral rinse. Chlorhexidine Gluconate Oral Rinse is not intended for ingestion and should be expectorated after rinsing.
Lice Treatment

Lice Treatment

Inspect
all household members should be checked by another person for lice and/or nits (eggs) use a magnifying glass in bright light to help you see the lice and nits (eggs) use a tool, such as a comb or two unsharpened pencils to lift and part the hair look for tiny nits near the scalp, beginning at the back of the neck and behind the ears small sections of hair (1-2 inches wide) should be examined at a time unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched. if either lice or nits (eggs) are found, treat with Permethrin Lotion 1%
Treat
wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Permethrin Lotion 1%. Rinse with water. towel dry hair so it is damp but not wet shake the bottle of Permethrin Lotion 1% well completely saturate the hair and scalp with Permethrin Lotion 1%. Begin to apply Permethrin Lotion 1% behind the ears and at the back of the neck. keep Permethrin Lotion 1% out of the eyes. Protect the eyes with a washcloth or towel. leave Permethrin Lotion 1% on the hair for 10 minutes, but no longer rinse with warm water towel dry hair and comb out tangles if live lice are seen seven days or more after the first treatment, a second treatment should be given
Remove Lice/Nits
remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out. use the nit comb provided and make sure the hair remains slightly damp while removing nits if the hair dries during combing, dampen it slightly with water part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours). start at the top of the head on the section you have picked with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair. use clips to pin back each strand of hair after you have combed out the nits clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back. after combing, recheck the entire head for nits and repeat combing if necessary check the affected head daily to remove any nits that you might have missed
Other information
read all the directions in the Consumer Information Insert and warnings before use. Keep the carton. It contains important information. store at 20° to 25°C (68° to 77°F)
Cyproheptadine Hydrochl...

Cyproheptadine Hydrochloride Syrup

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Although intended primarily for administration to children, the syrup is also used for administration to adults who cannot swallow tablets.

Children: The total daily dosage for children may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day (0.11 mg/lb/day) or 8 mg per square meter of body surface (8 mg/m2).

Age 2 to 6 years: The usual dose is 2 mg (one teaspoonful) two or three times a day, adjusted as necessary to the size and response of the patient. The dose is not to exceed 12 mg a day.

Age 7 to 14 years: The usual dose is 4 mg (two teaspoonsful) two or three times a day, adjusted as necessary to the size and response of the patient. The dose is not to exceed 16 mg a day.

Adults: The total daily dose for adults should not exceed 0.5 mg/kg/day (0.23 mg/lb/day). The therapeutic range is 4 to 20 mg a day, with the majority of patients requiring 12 to 16 mg a day. An occasional patient may require as much as 32 mg a day for adequate relief. It is suggested that dosage be initiated with 4 mg (two teaspoonsful) three times a day and adjusted according to the size and response of the patient.
Promethazine Hydrochlor...

Promethazine Hydrochloride And Phenylephrine Hydrochloride Syrup

Promethazine hydrochloride and phenylephrine hydrochloride syrup is contraindicated for children under 2 years of age (see WARNINGS – Black Box Warning and Use in Pediatric Patients).

The recommended doses are given in the following table:

Adults And Children 12 Years And Over

1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 6 To Under 12 Years Of Age

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 2 To Under 6 Years Of Age

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours.
Miconazole Nitrate Supp...

Miconazole Nitrate Suppository

Miconazole Nitrate Vaginal Suppositories USP, 200 mg: One suppository (miconazole nitrate, 200 mg) is inserted intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures to rule out other pathogens.
Betamethasone Valerate

Betamethasone Valerate

Betamethasone Valerate Cream 0.1% and Betamethasone Valerate Ointment 0.1% are generally applied to the affected area as a thin film one to three times daily depending on the severity of the condition. Dosage once or twice a day is often effective. 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.
Acetasol Hc

Acetasol Hc

Carefully remove all cerumen and debris to allow solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of solution 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.
Hair Regrowth Treatment...

Hair Regrowth Treatment For Men

apply one mL 2 times a day directly onto the scalp in the area of hair thinning or hair loss area spread the liquid evenly over the hair loss area. If you use your fingers, wash hands with soap and warm water immediately. using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Other Information
see hair loss pictures on side of this carton before use, read all information on carton and enclosed leaflet keep the carton. It contains important information. hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men. in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2% store at controlled room temperature 20( to 25(C (68( to 77(F). Keep tightly closed.
Hair Regrowth Treatment...

Hair Regrowth Treatment

part your hair and apply one mL 2 times a day directly onto the scalp in the area of hair thinning/loss using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Other information
see hair loss pictures on side of this carton before use, read all information on carton and enclosed leaflet keep this carton. It contains important information. in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, the following response to minoxidil topical solution 2% for men was reported: 26% of men reported moderate to dense hair regrowth after using minoxidil topical solution 2% for men for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). This compares with 11% of men reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 4 months (11% had moderate to dense regrowth; 31% had minimal regrowth). store at controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.
Triple Antibiotic

Triple Antibiotic

clean affected area apply a small amount (equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage
Other Information
Store at controlled room temperature 59º - 86ºF (15º - 30ºC). Protect from freezing.
Phenytoin Suspension

Phenytoin Suspension

Serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form. The free acid form of phenytoin is used in Phenytoin Oral Suspension, USP. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.

General

Dosage should be individualized to provide maximum benefit. In some cases serum blood level determinations may be necessary for optimal dosage adjustments—the clinically effective serum level is usually 10–20 mcg/mL. With recommended dosage, a period of seven to ten days may be required to achieve steady-state blood levels with phenytoin and changes in dosage (increase or decrease) should not be carried out at intervals shorter than seven to ten days.

Adult Dose

Patients who have received no previous treatment may be started on one teaspoonful (5 mL) of Phenytoin Oral Suspension, USP three times daily, and the dose is then adjusted to suit individual requirements. An increase to five teaspoonfuls daily may be made, if necessary.

Dosing in Special Populations

Patients with Renal or Hepatic Disease

Due to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia, the interpretation of total phenytoin plasma concentrations should be made with caution. Unbound phenytoin concentrations may be more useful in these patient populations.

Elderly Patients

Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required.

Pediatric

Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years and adolescents may require the minimum adult dose (300 mg/day).
Ranitidine Solution

Ranitidine Solution

Active Duodenal Ulcer: The current recommended adult oral dosage of ranitidine for duodenal ulcer is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) twice daily. An alternative dosage of 300 mg or 20 mL of syrup (4 teaspoonfuls of syrup equivalent to 300 mg of ranitidine) once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated (see Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily, is as effective as the 150 mg dose.

Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

Maintenance Of Healing Of Duodenal Ulcers: The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) at bedtime.

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome): The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) twice a day. In some patients it may be necessary to administer ranitidine 150 mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.

Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) twice a day.

Maintenance Of Healing Of Gastric Ulcers: The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) at bedtime.

GERD: The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) twice a day.

Erosive Esophagitis: The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) 4 times a day.

Maintenance Of Healing Of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) twice a day.

Pediatric Use: The safety and effectiveness of ranitidine have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of ranitidine in neonatal patients (less than 1 month of age) to make dosing recommendations.

The following 3 subsections provide dosing information for each of the pediatric indications.

Treatment Of Duodenal And Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.

Maintenance Of Healing Of Duodenal And Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.

Treatment Of GERD And Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg per day, usually given as 2 divided doses.

Dosage Adjustment For Patients With Impaired Renal Function: On the basis of experience with a group of subjects with severely impaired renal function treated with ranitidine, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) every 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: Geriatrics and PRECAUTIONS: Geriatric Use).
Nystatin Ointment

Nystatin Ointment

Nystatin Ointment USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. The ointment does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.
Hydrocortisone

Hydrocortisone

Topical corticosteroids are generally applied to the affected area as a thin film from two 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.
Clotrimazole And Betame...

Clotrimazole And Betamethasone Dipropionate

Gently massage sufficient clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day, in the morning and evening.

Clotrimazole and betamethasone dipropionate cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.

Clotrimazole and betamethasone dipropionate cream should not be used longer than 4 weeks in the treatment of tinea pedis and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.

Clotrimazole and betamethasone dipropionate cream should not be used with occlusive dressings.
Permethrin

Permethrin

Adults and children: Thoroughly massage permethrin cream into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult. The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple and forehead. ONE APPLICATION IS GENERALLY CURATIVE.

Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.
Prometh With Codeine

Prometh With Codeine

The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.

It is important that promethazine hydrochloride and codeine phosphate syrup is measured with an accurate measuring device (see PRECAUTIONS-Information for Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.

The average effective dose for adults and children (12 years and over) is: 1 teaspoonful (5mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.

The average effective dose for children 6 years to under 12 years of age is ½ to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
Betamethasone Dipropion...

Betamethasone Dipropionate

Apply a thin film of Betamethasone Dipropionate Cream 0.05% to the affected skin areas once daily. In some cases, a twice-daily dosage may be necessary.

Betamethasone Dipropionate Cream is not to be used with occlusive dressings.
Acyclovir Suspension

Acyclovir Suspension

Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

Treatment of Chickenpox: Children (2 Years Of Age And Older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

Adults and Children Over 40 kg: 800 mg 4 times daily for 5 days.

Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir oral suspension should be modified as shown in Table 3:
Table 3: Dosage Modification for Renal Impairment Creatinine Adjusted Dosage Regimen Normal Clearance Dose Dosage Regimen (mL/min/1.73m2) (mg) Dosage Interval 200 mg every 4 hours >10 200 every 4 hours, 5 x daily 0-10 200 every 12 hours 400 mg every 12 hours >10 400 every 12 hours 0-10 200 every 12 hours 800 mg every 4 hours >25 800 every 4 hours, 5 x daily 10-25 800 every 8 hours 0-10 800 every 12 hours
Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

Bioequivalence of Dosage Forms: Acyclovir oral suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
Betamethasone Dipropion...

Betamethasone Dipropionate Ointment

Apply a thin film of Betamethasone Dipropionate Ointment 0.05% to the affected skin areas once daily. In some cases, a twice-daily dosage may be necessary.

Betamethasone Dipropionate Ointment is not to be used with occlusive dressings.
Childrens Ibuprofen

Childrens Ibuprofen

this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed measuring cup if needed, repeat dose every 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (tsp or mL) under 2 years ask a doctor 24 – 35 lbs 2 – 3 years 1 tsp or 5 mL 36 – 47 lbs 4 – 5 years 1½ tsp or 7.5 mL 48 – 59 lbs 6 – 8 years 2 tsp or 10 mL 60 – 71 lbs 9 – 10 years 2½ tsp or 12.5 mL 72 – 95 lbs 11 years 3 tsp or 15 mL
Other information
each teaspoon contains: sodium 2 mg do not use if printed neckband is broken or missing store between 20 - 25°C (68 - 77°F) see bottom panel for lot number and expiration date
Clobetasol Propionate L...

Clobetasol Propionate Lotion

Clobetasol Propionate Lotion, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.

Clobetasol Propionate Lotion, 0.05% should be applied to the affected skin areas twice daily and rubbed in gently and completely.

The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Clobetasol Propionate Lotion, 0.05% contains a topical corticosteroid; therefore treatment should be limited to 2 consecutive weeks for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and up to 2 additional weeks in localized lesions (less than 10% body surface area) of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with Clobetasol Propionate Lotion, 0.05%.

Unless directed by physician, Clobetasol Propionate Lotion, 0.05% should not be used with occlusive dressings.
Clobetasol Propionate S...

Clobetasol Propionate Shampoo

Clobetasol propionate shampoo, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.

Clobetasol propionate shampoo, 0.05%, should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing.

The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.

Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying clobetasol propionate shampoo, 0.05%.

Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.

Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after 4 weeks of treatment with clobetasol propionate shampoo, 0.05%, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary. Clobetasol propionate shampoo, 0.05%, should not be used with occlusive dressings (shower cap or bathing cap) unless directed by a physician.
Hydrocortisone

Hydrocortisone

Topical corticosteroids are generally applied to the affected area as a thin film from 2 to 4 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.
Betamethasone Dipropion...

Betamethasone Dipropionate Ointment

Apply a thin film of Betamethasone Dipropionate Ointment (Augmented), 0.05% to the affected skin once or twice daily. Betamethasone Dipropionate Ointment (Augmented), 0.05% is a super-high potency topical corticosteroid. Treatment with Betamethasone Dipropionate Ointment (Augmented), 0.05% should be limited to 50 g per week.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Betamethasone Dipropionate Ointment (Augmented), 0.05% should not be used with occlusive dressings.

Betamethasone Dipropionate Ointment (Augmented), 0.05% should not be applied to the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.
Promethazine Vc With Co...

Promethazine Vc With Codeine

It is important that Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Syrup is measured with an accurate measuring device (see PRECAUTIONS-Information for Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.

The combination of promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.

The average effective dose is given in the following table:
Adults (12 years 5 mL every 4 to 6 hours not to exceed of age and over) (1 teaspoonful) 30.0 mL in 24 hours. Children (6 years to under 2.5 mL to 5 mL every 4 to 6 hours not to exceed 12 years) (½ to 1 teaspoonful) 30.0 mL in 24 hours.
HOW SUPPLIED

Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.

Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP.

Manufactured by:

Actavis Mid Atlantic LLC

1877 Kawai Road

Lincolnton, NC 28092 USA

FORM NO. 1629

Rev. 02/13

VC1275
Hydrocortisone Maximum ...

Hydrocortisone Maximum Strength

Adults and children 2 years of age and older
apply to affected area not more than 3 to 4 times daily
Children under 2 years of age
do not use, consult a doctor
For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor
Hydrocortisone With Alo...

Hydrocortisone With Aloe Maximum Strength

Adults and children 2 years of age and older
apply to affected area not more than 3 to 4 times daily
Children under 2 years of age
do not use, consult a doctor
For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor
Metronidazole Lotion

Metronidazole Lotion

Apply a thin layer to the affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes. Patients may use cosmetics after waiting for the Metronidazole Topical Lotion to dry (not less than 5 minutes).
Fluocinonide Solution

Fluocinonide Solution

Fluocinonide topical solution 0.05% should be applied to the affected area as a thin film from two 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.
Desonide

Desonide

Desonide Cream or Lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Desonide Cream and Lotion should not be used with occlusive dressings.
Nystatin

Nystatin

Nystatin Cream USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions however are best treated with nystatin topical powder.

The cream does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.
Feverall Children

Feverall Children

this product does not contain directions or warnings for adult use do not use more than directed remove wrapper carefully insert suppository well up into the rectum Dosing Chart Age Dose under 3 years Do not use unless directed by a doctor 3 to 6 years Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
Other information
store at 2º-27ºC (35º-80ºF) do not use if imprinted suppository wrapper is opened or damaged
Feverall Adults

Feverall Adults

do not use more than directed remove wrapper carefully insert suppository well up into the rectum adults and children 12 years and older: 1 suppository every 4 to 6 hours while symptoms last do not exceed 6 suppositories in any 24-hour period children under 12 years: ask a doctor
Other information
store at 2º-27ºC (35º-80ºF) do not use if imprinted suppository wrapper is opened or damaged
Feverall Junior

Feverall Junior

do not use more than directed remove wrapper carefully insert suppository well up into the rectum Dosing Chart Age Dose under 6 years do not use 6 to 12 years Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours) adults and children 12 years and older Use 2 suppositories every 4 to 6 hours (maximum of 6 doses)
Other information
store at 2º-27ºC (35º-80ºF) do not use if imprinted suppository wrapper is opened or damaged
Feverall Infants

Feverall Infants

this product does not contain directions or warnings for adult use do not use more than directed remove wrapper carefully insert suppository well up into the rectum Dosing Chart Age Dose under 6 months Do not use unless directed by a doctor 6 to 11 months Use 1 suppository every 6 hours (maximum of 4 doses in 24 hours) 12 to 36 months Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
Other information
store at 2º-27ºC (35º-80ºF) do not use if imprinted suppository wrapper is opened or damaged
Prometh With Dextrometh...

Prometh With Dextromethorphan

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS Black Box Warning and Use in Pediatric Patients).

The average effective dose is given in the following table:
Adults 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours. Children 6 years to under 12 years ½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 20 mL in 24 hours. Children 2 years to under 6 years ¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours, not to exceed 10 mL in 24 hours.
Clotrimazole

Clotrimazole

• before using this product, read the enclosed pamphlet• fill the applicator and insert one applicatorful of cream into the vagina, preferably at bedtime. Repeat this procedure 7 days in a row. Wash applicator after each use.• for relief of external vulvar itching, squeeze a small amount of cream onto your finger and gently spread the cream onto the irritated area of the vulva. Use once or twice a day for up to 7 days as needed to relieve external vulvar itching. The cream should not be used for vulvar itching due to causes other than a yeast infection.
Hydrocortisone Maximum ...

Hydrocortisone Maximum Strength

Store at room temperature 59°-86°F (15°-30°C). Before using any medication, read all label directions. Keep carton, it contains important information.
Tretinoin

Tretinoin

Tretinoin Cream should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Application may cause a transient feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment. Alterations of dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once-daily dosing frequencies.

During the early weeks of therapy, an apparent increase in number and exacerbation of inflammatory acne lesions may occur. This is due, in part, to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen.

Patients treated with tretinoin cream may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied (see PRECAUTIONS section).
Levetiracetam Solution

Levetiracetam Solution

2.1 Important Administration Instructions

Levetiracetam is given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (oral solution), and renal function.

Prescribe the oral solution for pediatric patients with body weight less than or equal to 20 kg. Prescribe the oral solution for pediatric patients with body weight above 20 kg.

When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

2.2 Partial Onset Seizures

Adults 16 Years and OlderIn clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Pediatric PatientsDosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

4 Years to less than 16 YearsTreatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

2.4 Primary Generalized Tonic-Clonic Seizures

Adults 16 Years and OlderTreatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

Pediatric Patients Ages 6 to less than 16 YearsTreatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight less than or equal to 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)].

2.5 Adult Patients with Impaired Renal Function

Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

Then CLcr is adjusted for body surface area (BSA) as follows:
Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance Dosage (mg) Frequency (mL/min/1.73m2) 1Following dialysis, a 250 to 500 mg supplemental dose is recommended Normal > 80 500 to 1,500 Every 12 hours Mild 50 – 80 500 to 1,000 Every 12 hours Moderate 30 – 50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis – 500 to 1,0001 Every 24 hours1
Griseofulvin Suspension...

Griseofulvin Suspension

Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium-depending on rate of growth-fingernails, at least 4 months; toenails, at least 6 months.

General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. In some forms of tinea pedis, yeasts and bacteria may be involved as well as dermatophytes. Griseofulvin will not eradicate these associated bacterial or yeast infections.

Adults: 0.5 g daily (125 mg four times a day, 250 mg twice a day, or 500 mg/day). Patients with less severe or 300 extensive infections may require less, whereas those with widespread lesions may require a starting dose of 0.75 g to 1.0 g/day. This may be reduced gradually to 0.5 g or less after a response has been noted. In all cases, the dosage should be individualized.

Pediatric patients (older than 2 years): A dosage of 10 mg/kg daily is usually adequate (pediatric patients from 30 to 50 lbs, 125 mg to 250 mg daily; pediatric patients over 50 lbs, 250 mg to 500 mg daily, in divided doses). Dosage should be individualized, as with adults. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

Safety is not established at higher doses than recommended.
Antifungal

Antifungal

wash the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks if condition lasts longer, contact a doctor this product is not effective on the scalp or nails
Miconazole 7

Miconazole 7

before using this product read the enclosed consumer information leaflet for complete instructions and information adults and children 12 years of age and over: insert 1 suppository into the vagina at bedtime for 7 nights in a row. Wash applicator after use. children under 12 years: ask a doctor
Other Information
do not purchase if carton is open each suppository is individually wrapped. Do not use if wrapper is missing or damaged. store at room temperature 15° - 30°C (59° - 86°F), avoid heat over 30°C or 86°F.
Miconazole 7

Miconazole 7

before using this product read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use. use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed. children under 12 years of age: ask a doctor
Hydromet

Hydromet

Adults: One (1) teaspoonful (5 mL) every four to six hours as needed; do not exceed six (6) teaspoonfuls in 24 hours.

Children 6 to 12 years of age: One-half (½) teaspoonful (2.5 mL) every four to six hours as needed; do not exceed three (3) teaspoonfuls in 24 hours.

Actavis Mid Atlantic Llc

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Actavis Mid Atlantic Llc Drugs