Aldara

Aldara Manufacturers

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  Aldara | 3m Pharmaceuticals

  

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  The application frequency for Aldara Cream is different for each indication.

  Aldara is not for oral, ophthalmic, or intravaginal use.

  2.1 Actinic Keratosis

  Aldara Cream should be applied 2 times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). The treatment area is defined as one contiguous area of approximately 25 cm2 (e.g., 5 cm x 5 cm) on the face (e.g. forehead or one cheek) or on the scalp. Examples of 2 times per week application schedules are Monday and Thursday, or Tuesday and Friday. Aldara Cream should be applied to the entire treatment area and rubbed in until the cream is no longer visible. No more than one packet of Aldara Cream should be applied to the contiguous treatment area at each application. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

  It is recommended that patients wash their hands before and after applying Aldara Cream. Before applying the cream, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly (at least 10 minutes).

  Contact with the eyes, lips and nostrils should be avoided.

  Local skin reactions in the treatment area are common. [see Adverse Reactions (6.1, 6.5)] A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods. Response to treatment cannot be adequately assessed until resolution of local skin reactions. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.

  Aldara Cream is packaged in single-use packets, with 12 packets supplied per box. Patients should be prescribed no more than 3 boxes (36 packets) for the 16-week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused.

  2.2 Superficial Basal Cell Carcinoma

  Aldara Cream should be applied 5 times per week for a full 6 weeks to a biopsy-confirmed superficial basal cell carcinoma. An example of a 5 times per week application schedule is to apply Aldara Cream, once per day, Monday through Friday. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

  It is recommended that patients wash their hands before and after applying Aldara Cream. The patient should wash the treatment area with mild soap and water before applying the cream, and allow the area to dry thoroughly.

  The target tumor should have a maximum diameter of 2 cm and be located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet). The treatment area should include a 1 cm margin of skin around the tumor. Sufficient cream should be applied to cover the treatment area, including 1 centimeter of skin surrounding the tumor. Aldara Cream should be rubbed into the treatment area until the cream is no longer visible.

  Table 1. Amount of Aldara Cream to Use for sBCC

  Target Tumor Diameter

  Size of Cream Droplet to be Used (diameter)

  Approximate Amount of Aldara to be Used

  0.5 to < 1.0 cm

  4 mm

  10 mg

  ≥ 1.0 to < 1.5 cm

  5 mm

  25 mg

  ≥ 1.5 to 2.0 cm

  7 mm

  40 mg

  Contact with the eyes, lips and nostrils should be avoided.

  Local skin reactions in the treatment area are common.[see Adverse Reactions (6.2, 6.5)] A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction.

  Early clinical clearance cannot be adequately assessed until resolution of local skin reactions (e.g. 12 weeks post-treatment). Local skin reactions or other findings (e.g. infection) may require that a patient be seen sooner than the post-treatment assessment for clinical clearance. If there is clinical evidence of persistent tumor at the post-treatment assessment for clinical clearance, a biopsy or other alternative intervention should be considered. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered; the safety and efficacy of a repeat course of Aldara Cream treatment have not been established. If any suspicious lesion arises in the treatment area at any time after a determination of clinical clearance, the patient should seek a medical evaluation. [see Clinical Studies (14.2)].

  Aldara Cream is packaged in single-use packets, with 12 packets supplied per box. Patients should be prescribed no more than 3 boxes (36 packets) for the 6-week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused.

  2.3 External Genital Warts

  Aldara Cream should be applied 3 times per week to external genital/perianal warts. Aldara Cream treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Examples of 3 times per week application schedules are: Monday, Wednesday, Friday or Tuesday, Thursday, Saturday. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for 6 -10 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

  It is recommended that patients wash their hands before and after applying Aldara Cream.

  A thin layer of Aldara Cream should be applied to the wart area and rubbed in until the cream is no longer visible. The application site should not be occluded. Following the treatment period the cream should be removed by washing the treated area with mild soap and water.

  Local skin reactions at the treatment site are common. [see Adverse Reactions (6.3, 6.5)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. Treatment may resume once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.

  Aldara Cream is packaged in single-use packets which contain sufficient cream to cover a wart area of up to 20 cm2; use of excessive amounts of cream should be avoided.

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• Graceway Pharmaceuticals, Llc
  

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  Aldara | Graceway Pharmaceuticals, Llc

  

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  The application frequency for Aldara Cream is different for each indication.

  Aldara is not for oral, ophthalmic, or intravaginal use.

  2.1 Actinic Keratosis

  Aldara Cream should be applied 2 times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). The treatment area is defined as one contiguous area of approximately 25 cm2 (e.g., 5 cm x 5 cm) on the face (e.g. forehead or one cheek) or on the scalp. Examples of 2 times per week application schedules are Monday and Thursday, or Tuesday and Friday. Aldara Cream should be applied to the entire treatment area and rubbed in until the cream is no longer visible. No more than one packet of Aldara Cream should be applied to the contiguous treatment area at each application. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

  It is recommended that patients wash their hands before and after applying Aldara Cream. Before applying the cream, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly (at least 10 minutes).

  Contact with the eyes, lips and nostrils should be avoided.

  Local skin reactions in the treatment area are common [see Adverse Reactions (6.1, 6.5)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods. Response to treatment cannot be adequately assessed until resolution of local skin reactions. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.

  Aldara Cream is packaged in single-use packets, with 12 packets supplied per box. Patients should be prescribed no more than 36 packets for the 16-week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused.

  2.2 Superficial Basal Cell Carcinoma

  Aldara Cream should be applied 5 times per week for a full 6 weeks to a biopsy-confirmed superficial basal cell carcinoma. An example of a 5 times per week application schedule is to apply Aldara Cream, once per day, Monday through Friday. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

  It is recommended that patients wash their hands before and after applying Aldara Cream. The patient should wash the treatment area with mild soap and water before applying the cream, and allow the area to dry thoroughly.

  The target tumor should have a maximum diameter of 2 cm and be located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet). The treatment area should include a 1 cm margin of skin around the tumor. Sufficient cream should be applied to cover the treatment area, including 1 centimeter of skin surrounding the tumor. Aldara Cream should be rubbed into the treatment area until the cream is no longer visible.

  Table 1. Amount of Aldara Cream to Use for sBCC

  Target Tumor Diameter

  Size of Cream Droplet to be Used (diameter)

  Approximate Amount of Aldara to be Used

  0.5 to < 1.0 cm

  4 mm

  10 mg

  ≥ 1.0 to < 1.5 cm

  5 mm

  25 mg

  ≥ 1.5 to 2.0 cm

  7 mm

  40 mg

  Contact with the eyes, lips and nostrils should be avoided.

  Local skin reactions in the treatment area are common [see Adverse Reactions (6.2, 6.5)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction.

  Early clinical clearance cannot be adequately assessed until resolution of local skin reactions (e.g. 12 weeks post-treatment). Local skin reactions or other findings (e.g. infection) may require that a patient be seen sooner than the post-treatment assessment for clinical clearance. If there is clinical evidence of persistent tumor at the post-treatment assessment for clinical clearance, a biopsy or other alternative intervention should be considered. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered; the safety and efficacy of a repeat course of Aldara Cream treatment have not been established. If any suspicious lesion arises in the treatment area at any time after a determination of clinical clearance, the patient should seek a medical evaluation [see Clinical Studies (14.2)].

  Aldara Cream is packaged in single-use packets, with 12 packets supplied per box. Patients should be prescribed no more than 36 packets for the 6-week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused.

  2.3 External Genital Warts

  Aldara Cream should be applied 3 times per week to external genital/perianal warts. Aldara Cream treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Examples of 3 times per week application schedules are: Monday, Wednesday, Friday or Tuesday, Thursday, Saturday. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for 6 -10 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

  It is recommended that patients wash their hands before and after applying Aldara Cream.

  A thin layer of Aldara Cream should be applied to the wart area and rubbed in until the cream is no longer visible. The application site should not be occluded. Following the treatment period the cream should be removed by washing the treated area with mild soap and water.

  Local skin reactions at the treatment site are common [see Adverse Reactions (6.3, 6.5)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. Treatment may resume once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.

  Aldara Cream is packaged in single-use packets which contain sufficient cream to cover a wart area of up to 20 cm2; use of excessive amounts of cream should be avoided.

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• Medicis Pharmaceutical Corp
  

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  Aldara | Greenstone Llc

  

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  The dosage of Nifedipine capsules needed to suppress angina and that can be tolerated by the patient must be established by titration. Excessive doses can result in hypotension.

  Therapy should be initiated with the 10 mg capsule. The starting dose is one 10 mg capsule, swallowed whole, 3 times/day. The usual effective dose range is 10–20 mg three times daily. Some patients, especially those with evidence of coronary artery spasm, respond only to higher doses, more frequent administration, or both. In such patients, doses of 20–30 mg three or four times daily may be effective. Doses above 120 mg daily are rarely necessary. More than 180 mg per day is not recommended.

  In most cases, Nifedipine capsules titration should proceed over a 7–14 day period so that the physician can assess the response to each dose level and monitor the blood pressure before proceeding to higher doses.

  If symptoms so warrant, titration may proceed more rapidly provided that the patient is assessed frequently. Based on the patient's physical activity level, attack frequency, and sublingual nitroglycerin consumption, the dose of Nifedipine capsules may be increased from 10 mg t.i.d. to 20 mg t.i.d. and then to 30 mg t.i.d. over a three-day period.

  In hospitalized patients under close observation, the dose may be increased in 10 mg increments over four- to six-hour periods as required to control pain and arrhythmias due to ischemia. A single dose should rarely exceed 30 mg.

  Avoid co-administration of nifedipine with grapefruit juice (see CLINICAL PHARMACOLOGY and PRECAUTIONS: Other Interactions).

  No "rebound effect" has been observed upon discontinuation of Nifedipine capsules. However, if discontinuation of Nifedipine capsules is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.

  Co-Administration with Other Antianginal Drugs

  Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during Nifedipine capsules titration. See PRECAUTIONS, Drug Interactions, for information on co-administration of Nifedipine capsules with beta blockers or long-acting nitrates.

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