Pharmaderm A Division Of Fougera Pharmaceuticals Inc.

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Pharmaderm A Division Of Fougera Pharmaceuticals Inc. Drugs

A4208-24 Spinal 24g Spr...

A4208-24 Spinal 24g Sprote

Apply a thin film of Pandel® (hydrocortisone probutate) Cream, 0.1% to the affected area once or twice a day depending on the severity of the condition. Massage gently until the medication disappears.

Occlusive dressings may be used for the management of refractory lesions of psoriasis and other deep-seated dermatoses, such as localized neurodermatitis (lichen simplex chronicus).

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

Pandel® (hydrocortisone probutate) Cream, 0.1% should not be used with occlusive dressings unless directed by the physician. Pandel® (hydrocortisone probutate) Cream, 0.1% should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings.
Kerydin

Kerydin

Apply KERYDIN to affected toenails once daily for 48 weeks.

KERYDIN should be applied to the entire toenail surface and under the tip of each toenail being treated.

KERYDIN is for topical use only and not for oral, ophthalmic, or intravaginal use.
Cutivate

Cutivate

Apply a thin film of CUTIVATE® Ointment to the affected skin areas twice daily. Rub in gently.

Avoid use with occulusive dressing.

CUTIVATE® Ointment is for topical use only; it is not for ophthalmic, oral or intravaginal use.
Zonalon

Zonalon

A thin film of Zonalon® Cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of Zonalon® Cream when used for greater than 8 days. Chronic use beyond eight days may result in higher systemic levels and should be avoided. Use of Zonalon® Cream for longer than 8 days may result in an increased likelihood of contact sensitization.

The risk for sedation may increase with greater body surface area application of Zonalon® Cream (See WARNINGS section). Clinical experience has shown that drowsiness is significantly more common in patients applying Zonalon® Cream to over 10% of body surface area; therefore, patients with greater than 10% of body surface area (see WARNINGS section) affected should be particularly cautioned concerning possible drowsiness and other systemic adverse effects of doxepin. If excessive drowsiness occurs, it may be necessary to do one or more of the following: reduce the body surface area treated, reduce the number of applications per day, reduce the amount of cream applied, or discontinue the drug.

Occlusive dressings may increase the absorption of most topical drugs; therefore, occlusive dressings should not be utilized with Zonalon® Cream.
Pamine

Pamine

The average dosage of Pamine® Tablets is 2.5 mg one-half hour before meals and 2.5 to 5 mg at bedtime. A starting dose of 12.5 mg daily will be clinically effective in most patients without the production of appreciable side effects.

If the patient is experiencing symptoms such as severe abdominal pain or cramping which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5 mg one-half hour before meals and at bedtime. If very unpleasant side effects develop promptly, the daily dosage should be reduced. If neither symptomatic relief nor side effects appear, the daily dosage may be increased. Some patients have tolerated 30 mg daily with no unpleasant reactions.

Patients whose dosage has been reduced to eliminate or modify side effects often continue to show adequate response both subjectively in relief of symptoms and objectively as measured by antisecretory effects.

The ultimate aim of therapy is to arrive at a dosage which provides maximal clinical effectiveness with a minimum of unpleasant side effects. Many patients report no side effects on a dosage which gives complete relief of symptoms. On the other hand, some patients have reported severe side effects without appreciable symptomatic relief. Such patients must be considered unsuited for this therapy. Usually they have been or will prove to be similarly intolerant to other anticholinergic drugs. If methscopolamine bromide is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.
Temovate

Temovate

Apply a thin layer of TEMOVATE® Gel to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

TEMOVATE® Gel is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

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

TEMOVATE® Gel should not be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with TEMOVATE® Gel, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
Temovate

Temovate

Apply a thin layer of TEMOVATE® Cream or Ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

TEMOVATE® Cream and Ointment are super-high potency topical corti-costeroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

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

TEMOVATE® Cream and Ointment should not be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with TEMOVATE® Cream or Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
Entsol

Entsol

Directions:
Important - Keep container in vertical position during use. Insert nozzle in one nostril. Lightly press down on applicator with finger. Repeat the same in other nostril. Spray 2 to 6 times daily or as instructed by a physician. Wipe nozzle clean after each use.
Zazole

Zazole

One full applicator (5 g) of Zazole® Vaginal Cream 0.4% (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of Zazole® Vaginal Cream 0.4% is not affected by menstruation.
Temovate Scalp Applicat...

Temovate Scalp Application

TEMOVATE® Scalp Application should be applied to the affected scalp areas twice daily, once in the morning and once at night.

TEMOVATE® Scalp Application is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.

TEMOVATE® Scalp Application is not to be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with TEMOVATE® Scalp Application, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
Temovate

Temovate

Apply a thin layer of TEMOVATE E® (clobetasol propionate emollient cream) Emollient, 0.05% to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

TEMOVATE E® Emollient is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g/week should not be used.

In moderate to severe plaque-type psoriasis, TEMOVATE E® Emollient applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age has not been studied.

TEMOVATE E® Emollient should not be used with occlusive dressings.
Pamine

Pamine

The average dosage of Pamine® Tablets is 2.5 mg one-half hour before meals and 2.5 to 5 mg at bedtime. A starting dose of 12.5 mg daily will be clinically effective in most patients without the production of appreciable side effects.

If the patient is experiencing symptoms such as severe abdominal pain or cramping which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5 mg one-half hour before meals and at bedtime. If very unpleasant side effects develop promptly, the daily dosage should be reduced. If neither symptomatic relief nor side effects appear, the daily dosage may be increased. Some patients have tolerated 30 mg daily with no unpleasant reactions.

Patients whose dosage has been reduced to eliminate or modify side effects often continue to show adequate response both subjectively in relief of symptoms and objectively as measured by antisecretory effects.

The ultimate aim of therapy is to arrive at a dosage which provides maximal clinical effectiveness with a minimum of unpleasant side effects. Many patients report no side effects on a dosage which gives complete relief of symptoms. On the other hand, some patients have reported severe side effects without appreciable symptomatic relief. Such patients must be considered unsuited for this therapy. Usually they have been or will prove to be similarly intolerant to other anticholinergic drugs. If methscopolamine bromide is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.
Solaraze

Solaraze

Solaraze® Gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Solaraze® Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered.
Apexicon E

Apexicon E

ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) should be applied to the affected areas as a thin film from one to three times daily depending on the severity or resistant nature 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 initiated.
Zazole

Zazole

One Zazole® Vaginal Suppository (terconazole vaginal suppositories, 80 mg) should be administered 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 and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of terconazole vaginal suppositories is not affected by menstruation.
Oxistat

Oxistat

OXISTAT® Cream or Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. OXISTAT® Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed.

Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that may extend to the neck, arms, and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea (pityriasis) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.
Veregen

Veregen

2.1 General Dosing Information

Veregen® is to be applied three times per day to all external genital and perianal warts.

Apply about an 0.5 cm strand of the Veregen® to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Patients should wash their hands before and after application of Veregen®.

It is not necessary to wash off the ointment from the treated area prior to the next application.

Veregen® is not for ophthalmic, oral, intravaginal, or intra-anal use.

2.2 Treatment Period

Treatment with Veregen® should be continued until complete clearance of all warts, however no longer than 16 weeks.

Local skin reactions (e.g. erythema) at the treatment site are frequent. Nevertheless, treatment should be continued when the severity of the local skin reaction is acceptable.
Adoxa

Adoxa

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours or 50 mg every 6 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

For pediatric patients above eight years of age: The recommended dosage schedule for pediatric patients weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For pediatric patients over 100 pounds the usual adult dose should be used.

Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.

Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.

Primary and secondary syphilis: 300 mg a day in divided doses for at least 10 days.

Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth, twice a day for at least 7 days.

Nongonococcal urethritis caused by C. trachomatis and U. urealyticum: 100 mg, by mouth, twice a day for at least 7 days.

Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.

Inhalational anthrax (post-exposure):

ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.

CHILDREN: weighing less than 100 pounds (45 kg): 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 pounds or more should receive the adult dose.

When used in streptococcal infections, therapy should be continued for 10 days.

Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.) If gastric irritation occurs, doxycycline may be given with food. Ingestion of a high fat meal has been shown to delay the time to peak plasma concentrations by an average of one hour and 20 minutes. However, in the same study, food enhanced the average peak concentration by 7.5% and the area under the curve by 5.7%.
Cutivate

Cutivate

CUTIVATE® Cream may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of CUTIVATE® Cream in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS: Pediatric Use). The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established.

Atopic Dermatitis: Apply a thin film of CUTIVATE® Cream to the affected skin areas once or twice daily. Rub in gently.

Other Corticosteroid-Responsive Dermatoses: Apply a thin film of CUTIVATE® Cream to the affected skin areas twice daily. Rub in gently.

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.

CUTIVATE® Cream should not be used with occlusive dressings. CUTIVATE® Cream should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with CUTIVATE® Cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
Tyzine Pediatric

Tyzine Pediatric

Adults and Children 6 Years and Over

Tyzine® 0.1% Nasal Solution

It is recommended that 2 to 4 drops of Tyzine® 0.1% Nasal Solution be instilled in each nostril as needed, never more often than every three hours. Less frequent administration is usually sufficient since relief is maintained for four hours or longer in most cases, and often for as long as eight hours. Bedtime instillation usually assures sleep undisturbed by the need for remedication before morning, or by insomnia from central stimulation.

Tyzine® 0.1% Nasal Spray

It is recommended to squeeze quickly and firmly three or four times Tyzine® 0.1% Nasal Spray in each nostril as needed, never more often than every three hours. Less frequent administration is usually sufficient since relief is maintained for four hours or longer in most cases, and often for as long as eight hours. Bedtime instillation usually assures sleep undisturbed by the need for remedication before morning, or by insomnia from central stimulation.

Children 2 to 6 Years of Age

Tyzine® 0.05 % Pediatric Nasal Drops

Note: Do not use Tyzine® 0.1% Nasal Solution or Tyzine® 0.1% Nasal Spray

It is recommended that 2 to 3 drops of Tyzine® 0.05% Pediatric Nasal Drops be instilled in each nostril as needed, and never more often than every three hours. Relief usually lasts for several hours, so that instillation is usually needed only every four to six hours. Instillation of nose drops can be most conveniently accomplished with the patient in the lateral head-low position.
Albuterol Sulfate

Albuterol Sulfate

Apply a thin film of CUTIVATE® Lotion to the affected skin areas once daily. Rub in gently.

Discontinue use when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

The safety and efficacy of CUTIVATE® Lotion have not been established beyond 4 weeks of use.

Avoid use with occlusive dressings or application to the diaper area [see Warnings and Precautions (5.1) and (5.2)].

CUTIVATE® Lotion is for topical use only, and not for ophthalmic, oral, or intravaginal use.
Acetaminophen

Acetaminophen

Apply a thin layer of Temovate® E to the affected skin areas twice daily and rub in gently and completely. Wash hands after each application.

Temovate® E is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used.

In moderate to severe plaque-type psoriasis, Temovate® E applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 grams per week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended.

Temovate® E should not be used with occlusive dressings.
Pramegel

Pramegel

Directions:
• adults and children 12 years and over: apply to affected area 3 to 4 times daily • children under 12 years of age: ask a doctor

Pharmaderm A Division Of Fougera Pharmaceuticals Inc.

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Pharmaderm A Division Of Fougera Pharmaceuticals Inc. Drugs