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Uses
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
History
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Other Information
DESCRIPTION: Pramosone® Lotion is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water.
Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below.
hydrocortisone acetate
Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-
C23H32O6; mol. wt.: 404.50
pramoxine hydrochloride
4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride
C17H27NO3.HCl; mol. wt.: 329.87
Sources
Pramosone Manufacturers
- Sebela Pharmaceuticals Inc.
Pramosone | Sebela Pharmaceuticals Inc.
DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Lotion should be shaken well before use. 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.
- Sebela Pharmaceuticals Inc.
Pramosone | Sebela Pharmaceuticals Inc.
DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
- Sebela Pharmaceuticals Inc.
Pramosone | Sebela Pharmaceuticals Inc.
DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Lotion should be shaken well before use. 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.
- Ferndale Laboratories, Inc.
Pramosone | Target Corporation
take every 4 to 6 hours do not take more than 6 doses in 24 hours swallow whole; do not crush, chew or dissolve adults and children 12 years of age and over take 1 to 2 capsules children 6 to under 12 years of age take 1 capsule children under 6 years of age do not use - Ferndale Laboratories, Inc.
Pramosone | Costco Wholesale Company
• if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:Weeks 1 to 6
Weeks 7 to 9
Weeks 10 to 12
1 lozenge every
1 to 2 hours
1 lozenge every
2 to 4 hours
1 lozenge every
4 to 8 hours
• nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider. - Ferndale Laboratories, Inc.
- Ferndale Laboratories, Inc.
Pramosone | Camber Pharmaceuticals, Inc.
2.1 Dosage for Postherpetic NeuralgiaIn adults with postherpetic neuralgia, gabapentin may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.
2.2 Dosage for Epilepsy with Partial Onset SeizuresPatients 12 years of age and above
The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin tablets is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Administer gabapentin tablets three times a day using 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.
Pediatric Patients Age 3 to 11 years
The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of gabapentin in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
2.3 Dosage Adjustment in Patients with Renal ImpairmentDosage adjustment in patients 12 years of age and older with compromised renal function or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):
TABLE 1. Gabapentin Tablets Dosage Based on Renal Function
Renal Function Creatinine Clearance
(mL/min)
Total Daily Dose Range
(mg/day)
Dose Regimen
(mg)
≥60
900-3600
300 TID
400 TID
600 TID
800 TID
1200 TID
>30-59
400-1400
200 BID
300 BID
400 BID
500 BID
700 BID
>15-29
200-700
200 QD
300 QD
400 QD
500 QD
700 QD
15a
100-300
100 QD
125 QD
150 QD
200 QD
300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
125b
150b
200b
250b
350b
TID = Three times a day; BID = Two times a day; QD = Single daily dose
a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:
The use of gabapentin tablets in patients less than 12 years of age with compromised renal function has not been studied.
2.4 Dosage in ElderlyBecause elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
2.5 Administration InformationAdminister gabapentin orally with or without food.
Inform patients that, should they divide the scored 600 mg or 800 mg gabapentin tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within 28 days of dividing the scored tablet should be discarded.
If the gabapentin dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
- Ferndale Laboratories, Inc.
- Ferndale Laboratories, Inc.
Pramosone | Ferndale Laboratories, Inc.
Topical corticosteroids are generally applied to the affected areas as a thin film three to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.
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