Fluticasone Propionate

Fluticasone Propionate Manufacturers

• Gw Laboratories, Inc
  

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  Fluticasone Propionate | Gw Laboratories, Inc

  

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

  Fluticasone Propionate 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 Fluticasone Propionate Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

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• Physicians Total Care, Inc.
  

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  Fluticasone Propionate | Physicians Total Care, Inc.

  

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  Fluticasone Propionate Cream, 0.05% may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS - Pediatric Use). The safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients below 3 months of age have not been established.

  Atopic Dermatitis

  Apply a thin film of Fluticasone Propionate Cream, 0.05% to the affected skin areas once or twice daily. Rub in gently.

  Other Corticosteroid-Responsive Dermatoses

  Apply a thin film of Fluticasone Propionate Cream, 0.05% 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.

  Fluticasone Propionate Cream, 0.05% should not be used with occlusive dressings. Fluticasone Propionate Cream, 0.05% 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 fluticasone propionate cream, 0.05%, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

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• G & W Laboratories, Inc.
  

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  Fluticasone Propionate | St Marys Medical Park Pharmacy

  

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  Hypertension Initial Therapy:

  In patients with uncomplicated essential hypertension not on diuretic therapy, the recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, an increase in dose should be considered. Doses up to 80 mg have been used but do not appear to give greater effect. If blood pressure is not controlled with Lisinopril Tablets alone, a low dose of a diuretic may be added. Hydrochlorothiazide, 12.5 mg has been shown to provide an additive effect. After the addition of a diuretic, it may be possible to reduce the dose of Lisinopril Tablets.

  Diuretic Treated Patients:

  In hypertensive patients who are currently being treated with a diuretic, symptomatic hypotension may occur occasionally following the initial dose of Lisinopril Tablets. The diuretic should be discontinued, if possible, for two to three days before beginning therapy with Lisinopril Tablets to reduce the likelihood of hypotension. (See WARNINGS.) The dosage of Lisinopril Tablets should be adjusted according to blood pressure response. If the patient"s blood pressure is not controlled with Lisinopril Tablets alone, diuretic therapy may be resumed as described above.

  If the diuretic cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS andPRECAUTIONS, Drug Interactions.)

  Concomitant administration of Lisinopril Tablets with potassium supplements, potassium salt substitutes, or potassium sparing diuretics may lead to increases of serum potassium. (See PRECAUTIONS.)

  Dosage Adjustment in Renal Impairment:

  The usual dose of Lisinopril Tablets (10 mg) is recommended for patients with creatinine clearance > 30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≥ 10 mL/min ≤ 30 mL/min (serum creatinine ≥ 3 mg/dL), the first dose is 5 mg once daily. For patients with creatinine clearance < 10 mL/min (usually on hemodialysis) the recommended initial dose is 2.5 mg. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.

  *See WARNINGS, Anaphylactoid Reactions During Membrane Exposure.

  **Dosage or dosing interval should be adjusted depending on the blood pressure response.

   Creatinine  Initial  Clearance  Dose  Renal status  mL/min  mg/day  Normal Renal Function to Mild  >30 mL/min  10 mg  Impairment  Moderate to Severe Impairment  ≥10≤30mL/min  5 mg  Dialysis Patients*  <10mL/min  2.5 mg** Heart Failure

  Lisinopril Tablets are indicated as adjunctive therapy with diuretics and (usually) digitalis. The recommended starting dose is 5 mg once a day. When initiating treatment with lisinopril in patients with heart failure, the initial dose should be administered under medical observation, especially in those patients with low blood pressure (systolic blood pressure below 100 mmHg). The mean peak blood pressure lowering occurs six to eight hours after dosing. Observation should continue until blood pressure is stable. The concomitant diuretic dose should be reduced, if possible, to help minimize hypovolemia which may contribute to hypotension. (See WARNINGS  and PRECAUTIONS, Drug Interactions.) The appearance of hypotension after the initial dose of Lisinopril Tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

  The usual effective dosage range is 5 to 40 mg per day administered as a single daily dose. The dose of Lisinopril Tablets can be increased by increments of no greater than 10 mg, at intervals of no less than 2 weeks to the highest tolerated dose, up to a maximum of 40 mg daily. Dose adjustment should be based on the clinical response of individual patients.

  Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia:

  In patients with heart failure who have hyponatremia (serum sodium < 130 mEq/L) or moderate to severe renal impairment (creatinine clearance ≤ 30 mL/min or serum creatinine > 3 mg/dL), therapy with Lisinopril Tablets should be initiated at a dose of 2.5 mg once a day under close medical supervision. (See WARNINGS  and PRECAUTIONS, Drug Interactions.)

  Acute Myocardial Infarction:

  In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, the first does of Lisinopril Tablets is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg of Lisinopril Tablets once daily. Dosing should continue for six weeks. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers.

  Patients with a low systolic blood pressure (≤ 120 mmHg) when treatment is started or during the first 3 days after the infarct should be given a lower 2.5 mg oral dose of Lisinopril Tablets (see WARNINGS ). If hypotension occurs (systolic blood pressure ≤100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) Lisinopril Tablets should be withdrawn. For patients who develop symptoms of heart failure, see DOSAGE AND ADMINISTRATION, Heart Failure.

  Dosage Adjustment in Patients With Myocardial Infarction with Renal Impairment:

  In acute myocardial infarction, treatment with Lisinopril Tablets should be initiated with caution in patients with evidence of renal dysfunction, defined as serum creatinine concentration exceeding 2 mg/dL. No evaluation of dosing adjustments in myocardial infarction patients with severe renal impairment has been performed.

  Use in Elderly

  In general, the clinical response was similar in younger and older patients given similar doses of Lisinopril Tablets. Pharmacokinetic studies, however indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients, so that dosage adjustments should be made with particular caution.

  Pediatric Hypertensive Patients ≥6 years of age

  The usual recommended starting dose is 0.07 mg/kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients. (SeeCLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism  and Pharmacodynamics and Clinical Effects.)

  Lisinopril Tablets are not recommended in pediatric patients <6 years or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2 (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism andPharmacodynamicsand Clinical Effects andPRECAUTIONS).

  Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)

  Add 10 mL of Purified Water USP to a polyethylene terephthalate (PET) bottle containing ten 20 mg Lisinopril Tablets and shake for at least one minute. Add 30 mL of Bicitra[1] diluent and 160 mL of Ora Sweet SF™[2] to the concentrate in the PET bottle and gently shake for several seconds to disperse the ingredients. The suspension should be stored at or below 25°C (77°F) and can be stored for up to four weeks. Shake the suspension before each use.

  [1] Registered trademark of Alza Corporation

  [2] Trademark of Paddock Laboratories, Inc.

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• Global Pharmaceuticals, Division Of Impax Laboratories Inc.
  

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  Fluticasone Propionate | Global Pharmaceuticals, Division Of Impax Laboratories Inc.

  

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

  Atopic Dermatitis: Apply a thin film of fluticasone propionate cream to the affected skin areas once or twice daily. Rub in gently.

  Other Corticosteroid-Responsive Dermatoses: Apply a thin film of fluticasone propionate 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.

  Fluticasone propionate cream should not be used with occlusive dressings. Fluticasone propionate 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 fluticasone propionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

  CLINICAL STUDIES

  Psoriasis Studies: In 2 vehicle-controlled studies, fluticasone propionate cream applied twice daily was significantly more effective than the vehicle in the treatment of moderate to severe psoriasis. The investigator’s global evaluation after 28 days of treatment is shown in Table 3.

  Table 3: Physician’s Assessment of Clinical Response

  Fluticasone Propionate Cream Vehicle Study 1
  (n = 59) Study 2
  (n = 74) Study 1
  (n = 66) Study 2
  (n = 75) Cleared 8% 1% 3% 1% Excellent 29% 28% 11% 17% Good 27% 34% 20% 28% Fair 27% 15% 33% 25% Poor 7% 22% 24% 27% Worse 2% 0 9% 1%

  The clinical signs of psoriasis were scored on a scale of 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The mean improvements over baseline in the clinical signs at the end of treatment are shown in Table 4.

  Table 4: Clinical Signs: Mean Improvements Over Baseline

  Fluticasone Propionate Cream Vehicle Study 1 Study 2 Study 1 Study 2 Erythema 1.19 1.07 0.55 0.84 Thickening 1.22 1.17 0.81 0.97 Scaling 1.53 1.39 0.95 1.21

  Atopic Dermatitis Studies: In 2 controlled 28-day studies, fluticasone propionate cream once daily was equivalent to fluticasone propionate cream twice daily in the treatment of moderate to severe eczema. The investigator’s global evaluation after 28 days of treatment is shown in Table 5.

  Table 5: Physician’s Assessment of Clinical Response

  Fluticasone Propionate Cream Once Daily Fluticasone Propionate Cream Twice Daily Study 1
  (n = 64) Study 2
  (n = 106) Study 1
  (n = 65) Study 2
  (n = 100) Cleared 30% 20% 48% 21% Excellent 42% 32% 32% 50% Good 17% 26% 5% 12% Fair 3% 14% 6% 10% Poor 5% 3% 8% 4% Worse 3% 6% 2% 3%

  The clinical signs and symptoms of atopic dermatitis were scored on a scale of 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The mean improvements over baseline at the end of treatment are shown in Table 6.

  Table 6: Clinical Signs and Symptoms:
  Mean Improvements Over Baseline

  Fluticasone Propionate Cream Once Daily Fluticasone Propionate Cream Twice Daily Study 1 Study 2 Study 1 Study 2 Erythema 1.7 1.5 1.8 1.7 Pruritus 2.1 1.6 2.1 1.7 Thickening 1.6 1.3 1.6 1.5 Lichenification 1.2 1.2 1.2 1.3 Vesiculation 0.5 0.4 0.5 0.5 Crusting 0.6 0.7 0.8 0.8

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• Perrigo New York Inc
  

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  Fluticasone Propionate | Perrigo New York Inc

  

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  Fluticasone Propionate Cream, 0.05% may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS - Pediatric Use). The safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients below 3 months of age have not been established.

  Atopic Dermatitis -

  Apply a thin film of Fluticasone Propionate Cream, 0.05% to the affected skin areas once or twice daily. Rub in gently.

  Other Corticosteroid-Responsive Dermatoses -

  Apply a thin film of Fluticasone Propionate Cream, 0.05% 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.

  Fluticasone Propionate Cream, 0.05% should not be used with occlusive dressings. Fluticasone Propionate Cream, 0.05% 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 fluticasone propionate cream, 0.05%, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

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• Direct Rx
  

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  Fluticasone Propionate | Direct Rx

  

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

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

  Other Corticosteroid-Responsive Dermatoses: Apply a thin film of Fluticasone Propionate 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.

  Fluticasone Propionate Cream should not be used with occlusive dressings. Fluticasone Propionate 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 Fluticasone Propionate Cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

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• E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
  

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  Fluticasone Propionate | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

  

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  Fluticasone Propionate Cream, 0.05% may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS: Pediatric Use). The safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients below 3 months of age have not been established.

  Atopic Dermatitis: Apply a thin film of Fluticasone Propionate Cream, 0.05% to the affected skin areas once or twice daily. Rub in gently.

  Other Corticosteroid-Responsive Dermatoses: Apply a thin film of Fluticasone Propionate Cream, 0.05% 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.

  Fluticasone Propionate Cream, 0.05% should not be used with occlusive dressings. Fluticasone Propionate Cream, 0.05% 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 fluticasone propionate cream, 0.05% safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

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