Cardiogen-82 Generator

Generic Name: rubidium rb 82 (Intravenous route)

roo-BID-e-um KLOR-ide Rb 82

Commonly used brand name(s)

In the U.S.

• Cardiogen-82 Generator

Available Dosage Forms:

• Kit

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

Uses For Cardiogen-82 Generator

Rubidium Rb 82 injection is used in adults to help diagnose heart disease. It is used in a procedure called a positron emission tomography (PET) scan to help your doctor see an image of your heart. This medicine shows how much blood is getting to your heart muscle when you are resting or exercising (stressed). Rubidium Rb 82 belongs to the group of medicines called radiopharmaceuticals (radioactive agents).

This medicine will be used only by or under the direct supervision of your doctor.

Before Using Cardiogen-82 Generator

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rubidium Rb 82 injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rubidium Rb 82 injection in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution in patients receiving rubidium Rb 82 injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure—Use with caution. May cause side effects to become worse.

Proper Use of Cardiogen-82 Generator

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have a PET scan.

You will need to urinate right away and as often as possible for at least one hour after the PET scan.

Precautions While Using Cardiogen-82 Generator

It is very important that your doctor check your progress very closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

You might receive a medicine to make your heart beat faster. This is called a pharmacologic stress test. It is used together with the PET scan to show how well your heart muscle works when it is stressed. If you have questions about this test, talk to your doctor.

While receiving this medicine, you will be exposed to radiation. If you have any questions about this, talk to your doctor.

Cardiogen-82 Generator Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Aldara

Dosage Form: cream
FULL PRESCRIBING INFORMATION

Indications and Usage for Aldara

Actinic Keratosis

Aldara Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.

Superficial Basal Cell Carcinoma

Aldara Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.

The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment, since safety and efficacy of Aldara Cream have not been established for other types of basal cell carcinomas, including nodular and morpheaform (fibrosing or sclerosing) types.

External Genital Warts

Aldara Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years old or older.

Limitations of Use

Aldara Cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations (8.4)].

Unevaluated Populations

The safety and efficacy of Aldara Cream in immunosuppressed patients have not been established.

Aldara Cream should be used with caution in patients with pre-existing autoimmune conditions.

The efficacy and safety of Aldara Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.

Aldara Dosage and Administration

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

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

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 × 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.

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.

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.

Dosage Forms and Strengths

Aldara (imiquimod) Cream, 5%, is supplied in single-use packets each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod. Aldara Cream is supplied in boxes of 12 packets each.

Contraindications

None.

Warnings and Precautions

Local Inflammatory Reactions

Intense local inflammatory reactions including skin weeping or erosion can occur after few applications of Aldara Cream and may require an interruption of dosing [see Dosage and Administration (2) and Adverse Reactions (6)]. Aldara Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.

Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling.

Severe vulvar swelling can lead to urinary retention. Dosing should be interrupted or discontinued for severe vulvar swelling.

Administration of Aldara Cream is not recommended until the skin is completely healed from any previous drug or surgical treatment.

Systemic Reactions

Flu-like signs and symptoms may accompany, or even precede, local inflammatory reactions and may include malaise, fever, nausea, myalgias and rigors. An interruption of dosing should be considered [see Adverse Reactions (6)].

Ultraviolet Light Exposure

Exposure to sunlight (including sunlamps) should be avoided or minimized during use of Aldara Cream because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing (e.g., a hat) when using Aldara Cream. Patients with sunburn should be advised not to use Aldara Cream until fully recovered. Patients who may have considerable sun exposure, e.g. due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using Aldara Cream.

Aldara Cream shortened the time to skin tumor formation in an animal photoco-carcinogenicity study [see Nonclinical Toxicology (13.1)]. The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Therefore, patients should minimize or avoid natural or artificial sunlight exposure.

Unevaluated Uses: Actinic Keratosis

Safety and efficacy have not been established for Aldara Cream in the treatment of actinic keratosis with repeated use, i.e. more than one treatment course, in the same area.

The safety of Aldara Cream applied to areas of skin greater than 25 cm2 (e.g. 5 cm × 5 cm) for the treatment of actinic keratosis has not been established [see Clinical Pharmacology (12.3)].

Unevaluated Uses: Superficial Basal Cell Carcinoma

The safety and efficacy of Aldara Cream have not been established for other types of basal cell carcinomas (BCC), including nodular and morpheaform (fibrosing or sclerosing) types. Aldara Cream is not recommended for treatment of BCC subtypes other than the superficial variant (i.e., sBCC). Patients with sBCC treated with Aldara Cream should have regular follow-up of the treatment site [see Clinical Studies (14.2)].

The safety and efficacy of treating sBCC lesions on the face, head and anogenital area have not been established.

Unevaluated Uses: External Genital Warts

Aldara Cream has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease.

Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience: Actinic Keratosis

The data described below reflect exposure to Aldara Cream or vehicle in 436 subjects enrolled in two double-blind, vehicle-controlled studies. Subjects applied Aldara Cream or vehicle to a 25 cm2 contiguous treatment area on the face or scalp 2 times per week for 16 weeks.

Table 2: Selected Adverse Reactions Occurring in > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Actinic Keratosis)

Preferred Term	Aldara Cream (n=215)	Vehicle (n=221)
Application Site Reaction	71 (33%)	32 (14%)
Upper Resp Tract Infection	33 (15%)	27 (12%)
Sinusitis	16 (7%)	14 (6%)
Headache	11 (5%)	7 (3%)
Carcinoma Squamous	8 (4%)	5 (2%)
Diarrhea	6 (3%)	2 (1%)
Eczema	4 (2%)	3 (1%)
Back Pain	3 (1%)	2 (1%)
Fatigue	3 (1%)	2 (1%)
Fibrillation Atrial	3 (1%)	2 (1%)
Infection Viral	3 (1%)	2 (1%)
Dizziness	3 (1%)	1 (<1%)
Vomiting	3 (1%)	1 (<1%)
Urinary Tract Infection	3 (1%)	1 (<1%)
Fever	3 (1%)	0 (0%)
Rigors	3 (1%)	0 (0%)
Alopecia	3 (1%)	0 (0%)

Table 3: Application Site Reactions Reported by > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Actinic Keratosis)

Included Term	Aldara Cream n=215	Vehicle n=221
Itching	44 (20%)	17 (8%)
Burning	13 (6%)	4 (2%)
Bleeding	7 (3%)	1 (<1%)
Stinging	6 (3%)	2 (1%)
Pain	6 (3%)	2 (1%)
Induration	5 (2%)	3 (1%)
Tenderness	4 (2%)	3 (1%)
Irritation	4 (2%)	0 (0%)

Local skin reactions were collected independently of the adverse reaction "application site reaction" in an effort to provide a better picture of the specific types of local reactions that might be seen. The most frequently reported local skin reactions were erythema, flaking/scaling/dryness, and scabbing/crusting. The prevalence and severity of local skin reactions that occurred during controlled studies are shown in the following table.

Table 4: Local Skin Reactions in the Treatment Area as Assessed by the Investigator (Actinic Keratosis)

	Aldara Cream (n=215)		Vehicle (n=220)
	All Grades*	Severe	All Grades*	Severe
* Mild, Moderate, or Severe
Erythema	209 (97%)	38 (18%)	206 (93%)	5 (2%)
Flaking/Scaling/Dryness	199 (93%)	16 (7%)	199 (91%)	7 (3%)
Scabbing/Crusting	169 (79%)	18 (8%)	92 (42%)	4 (2%)
Edema	106 (49%)	0 (0%)	22 (10%)	0 (0%)
Erosion/Ulceration	103 (48%)	5 (2%)	20 (9%)	0 (0%)
Weeping/Exudate	45 (22%)	0 (0%)	3 (1%)	0 (0%)
Vesicles	19 (9%)	0 (0%)	2 (1%)	0 (0%)

The adverse reactions that most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study) were local skin and application site reactions. Overall, in the clinical studies, 2% (5/215) of subjects discontinued for local skin/application site reactions. Of the 215 subjects treated, 35 subjects (16%) on Aldara Cream and 3 of 220 subjects (1%) on vehicle cream had at least one rest period. Of these Aldara Cream subjects, 32 (91%) resumed therapy after a rest period.

In the AK studies, 22 of 678 (3.2%) of Aldara-treated subjects developed treatment site infections that required a rest period off Aldara Cream and were treated with antibiotics (19 with oral and 3 with topical).

Of the 206 Aldara subjects with both baseline and 8-week post-treatment scarring assessments, 6 (2.9%) had a greater degree of scarring scores at 8-weeks post-treatment than at baseline.

Clinical Trials Experience: Superficial Basal Cell Carcinoma

The data described below reflect exposure to Aldara Cream or vehicle in 364 subjects enrolled in two double-blind, vehicle-controlled studies. Subjects applied Aldara Cream or vehicle 5 times per week for 6 weeks. The incidence of adverse reactions reported by > 1% of subjects during the studies is summarized below.

Table 5: Selected Adverse Reactions Reported by > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Superficial Basal Cell Carcinoma)

Preferred Term	Aldara Cream (n=185) N %	Vehicle (n=179) N %
Application Site Reaction	52 (28%)	5 (3%)
Headache	14 (8%)	4 (2%)
Back Pain	7 (4%)	1 (<1%)
Upper Resp Tract Infection	6 (3%)	2 (1%)
Rhinitis	5 (3%)	1 (<1%)
Lymphadenopathy	5 (3%)	1 (<1%)
Fatigue	4 (2%)	2 (1%)
Sinusitis	4 (2%)	1 (<1%)
Dyspepsia	3 (2%)	2 (1%)
Coughing	3 (2%)	1 (<1%)
Fever	3 (2%)	0 (0%)
Dizziness	2 (1%)	1 (<1%)
Anxiety	2 (1%)	1 (<1%)
Pharyngitis	2 (1%)	1 (<1%)
Chest Pain	2 (1%)	0 (0%)
Nausea	2 (1%)	0 (0%)

The most frequently reported adverse reactions were local skin and application site reactions including erythema, edema, induration, erosion, flaking/scaling, scabbing/crusting, itching and burning at the application site. The incidence of application site reactions reported by > 1% of the subjects during the 6 week treatment period is summarized in the table below.

Table 6: Application Site Reactions Reported by > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Superficial Basal Cell Carcinoma)

Included Term	Aldara Cream n=185	Vehicle n=179
Itching	30 (16%)	1 (1%)
Burning	11 (6%)	2 (1%)
Pain	6 (3%)	0 (0%)
Bleeding	4 (2%)	0 (0%)
Erythema	3 (2%)	0 (0%)
Papule(s)	3 (2%)	0 (0%)
Tenderness	2 (1%)	0 (0%)
Infection	2 (1%)	0 (0%)

Local skin reactions were collected independently of the adverse reaction "application site reaction" in an effort to provide a better picture of the specific types of local reactions that might be seen. The prevalence and severity of local skin reactions that occurred during controlled studies are shown in the following table.

Table 7: Local Skin Reactions in the Treatment Area as Assessed by the Investigator (Superficial Basal Cell Carcinoma)

	Aldara Cream n=184		Vehicle n=178
	All Grades*	Severe	All Grades*	Severe
* Mild, Moderate, or Severe
Erythema	184 (100%)	57 (31%)	173 (97%)	4 (2%)
Flaking/Scaling	167 (91%)	7 (4%)	135 (76%)	0 (0%)
Induration	154 (84%)	11 (6%)	94 (53%)	0 (0%)
Scabbing/Crusting	152 (83%)	35 (19%)	61 (34%)	0 (0%)
Edema	143 (78%)	13 (7%)	64 (36%)	0 (0%)
Erosion	122 (66%)	23 (13%)	25 (14%)	0 (0%)
Ulceration	73 (40%)	11 (6%)	6 (3%)	0 (0%)
Vesicles	57 (31%)	3 (2%)	4 (2%)	0 (0%)

The adverse reactions that most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study) were local skin and application site reactions; 10% (19/185) of subjects received rest periods. The average number of doses not received per subject due to rest periods was 7 doses with a range of 2 to 22 doses; 79% of subjects (15/19) resumed therapy after a rest period. Overall, in the clinical studies, 2% (4/185) of subjects discontinued for local skin/application site reactions.

In the sBCC studies, 17 of 1266 (1.3%) Aldara-treated subjects developed treatment site infections that required a rest period and treatment with antibiotics.

Clinical Trials Experience: External Genital Warts

In controlled clinical trials for genital warts, the most frequently reported adverse reactions were local skin and application site reactions.

Some subjects also reported systemic reactions. Overall, 1.2% (4/327) of the subjects discontinued due to local skin/application site reactions. The incidence and severity of local skin reactions during controlled clinical trials are shown in the following table.

Table 8: Local Skin Reactions in the Treatment Area as Assessed by the Investigator (External Genital Warts)

	Aldara Cream				Vehicle
	Females n=114		Males n=156		Females n=99		Males n=157
	All Grades*	Severe	All Grades*	Severe	All Grades*	Severe	All Grades*	Severe
* Mild, Moderate, or Severe
Erythema	74 (65%)	4 (4%)	90 (58%)	6 (4%)	21 (21%)	0 (0%)	34 (22%)	0 (0%)
Erosion	35 (31%)	1 (1%)	47 (30%)	2 (1%)	8 (8%)	0 (0%)	10 (6%)	0 (0%)
Excoriation/ Flaking	21 (18%)	0 (0%)	40 (26%)	1 (1%)	8 (8%)	0 (0%)	12 (8%)	0 (0%)
Edema	20 (18%)	1 (1%)	19 (12%)	0 (0%)	5 (5%)	0 (0%)	1 (1%)	0 (0%)
Scabbing	4 (4%)	0 (0%)	20 (13%)	0 (0%)	0 (0%)	0 (0%)	4 (3%)	0 (0%)
Induration	6 (5%)	0 (0%)	11 (7%)	0 (0%)	2 (2%)	0 (0%)	3 (2%)	0 (0%)
Ulceration	9 (8%)	3 (3%)	7 (4%)	0 (0%)	1 (1%)	0 (0%)	1 (1%)	0 (0%)
Vesicles	3 (3%)	0 (0%)	3 (2%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)

Remote site skin reactions were also reported. The severe remote site skin reactions reported for females were erythema (3%), ulceration (2%), and edema (1%); and for males, erosion (2%), and erythema, edema, induration, and excoriation/flaking (each 1%).

Selected adverse reactions judged to be probably or possibly related to Aldara Cream are listed below.

Table 9: Selected Treatment Related Reactions (External Genital Warts)

	Females		Males
	Aldara Cream n=117	Vehicle n=103	Aldara Cream n=156	Vehicle n=158
* Incidences reported without regard to causality with Aldara Cream.
Application Site Disorders:
Application Site Reactions
Wart Site:
Itching	38 (32%)	21 (20%)	34 (22%)	16 (10%)
Burning	30 (26%)	12 (12%)	14 (9%)	8 (5%)
Pain	9 (8%)	2 (2%)	3 (2%)	1 (1%)
Soreness	3 (3%)	0 (0%)	0 (0%)	1 (1%)
Fungal Infection*	13 (11%)	3 (3%)	3 (2%)	1 (1%)
Systemic Reactions:
Headache	5 (4%)	3 (3%)	8 (5%)	3 (2%)
Influenza-like symptoms	4 (3%)	2 (2%)	2 (1%)	0 (0%)
Myalgia	1 (1%)	0 (0%)	2 (1%)	1 (1%)

Adverse reactions judged to be possibly or probably related to Aldara Cream and reported by more than 1% of subjects included:

Application Site Disorders: burning, hypopigmentation, irritation, itching, pain, rash, sensitivity, soreness, stinging, tenderness.

Remote Site Reactions: bleeding, burning, itching, pain, tenderness, tinea cruris.

Body as a Whole: fatigue, fever, influenza-like symptoms.

Central and Peripheral Nervous System Disorders: headache.

Gastro-Intestinal System Disorders: diarrhea.

Musculo-Skeletal System Disorders: myalgia.

Clinical Trials Experience: Dermal Safety Studies

Provocative repeat insult patch test studies involving induction and challenge phases produced no evidence that Aldara Cream causes photoallergenicity or contact sensitization in healthy skin; however, cumulative irritancy testing revealed the potential for Aldara Cream to cause irritation, and application site reactions were reported in the clinical studies [see Adverse Reactions (6)].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Aldara Cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Application Site Disorders: tingling at the application site.

Body as a Whole: angioedema.

Cardiovascular: capillary leak syndrome, cardiac failure, cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope.

Endocrine: thyroiditis.

Gastro-Intestinal System Disorders: abdominal pain.

Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma.

Hepatic: abnormal liver function.

Infections and Infestations: herpes simplex.

Musculo-Skeletal System Disorders: arthralgia.

Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation, paresis, suicide.

Respiratory: dyspnea.

Urinary System Disorders: proteinuria, dysuria, urinary retention.

Skin and Appendages: exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypertrophic scar.

Vascular: Henoch-Schonlein purpura syndrome.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C:

Note: The Maximum Recommended Human Dose (MRHD) was set at 2 packets per treatment of Aldara Cream (25 mg imiquimod) for the animal multiple of human exposure ratios presented in this label. If higher doses than 2 packets of Aldara Cream are used clinically, then the animal multiple of human exposure would be reduced for that dose. A non-proportional increase in systemic exposure with increased dose of Aldara Cream was noted in the clinical pharmacokinetic study conducted in actinic keratosis subjects [see Clinical Pharmacology (12.3)]. The AUC after topical application of 6 packets of Aldara Cream was 8 fold greater than the AUC after topical application of 2 packets of Aldara Cream in actinic keratosis subjects. Therefore, if a dose of 6 packets per treatment of Aldara Cream was topically administered to an individual, then the animal multiple of human exposure would be either 1/3 of the value provided in the label (based on body surface area comparisons) or 1/8 of the value provided in the label (based on AUC comparisons). The animal multiples of human exposure calculations were based on weekly dose comparisons for the carcinogenicity studies described in this label. The animal multiples of human exposure calculations were based on daily dose comparisons for the reproductive toxicology studies described in this label.

Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1, 5 and 20 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6–15) to pregnant female rats. In the presence of maternal toxicity, fetal effects noted at 20 mg/kg/day (577× MRHD based on AUC comparisons) included increased resorptions, decreased fetal body weights, delays in skeletal ossification, bent limb bones, and two fetuses in one litter (2 of 1567 fetuses) demonstrated exencephaly, protruding tongues and low-set ears. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 5 mg/kg/day (98× MRHD based on AUC comparisons).

Intravenous doses of 0.5, 1 and 2 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6–18) to pregnant female rabbits. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 2 mg/kg/day (1.5× MRHD based on BSA comparisons), the highest dose evaluated in this study, or 1 mg/kg/day (407× MRHD based on AUC comparisons).

A combined fertility and peri- and post-natal development study was conducted in rats. Oral doses of 1, 1.5, 3 and 6 mg/kg/day imiquimod were administered to male rats from 70 days prior to mating through the mating period and to female rats from 14 days prior to mating through parturition and lactation. No effects on growth, fertility, reproduction or post-natal development were noted at doses up to 6 mg/kg/day (87× MRHD based on AUC comparisons), the highest dose evaluated in this study. In the absence of maternal toxicity, bent lim

Pentrax Gold

Generic Name: coal tar topical (KOL TAR TOP ik al)

Brand Names: Balnetar, Betatar Gel, Coal Tar, Cutar, Denorex, Denorex Dry Scalp, Denorex Extra Strength, Denorex Medicated Shampoo and Conditioner, DHS Tar Shampoo, Doak Tar, Doak Tar Oil, Elta Tar, Fototar, G-TAR, Ionil T, Ionil T Plus, MG 217 Psoriasis, MG217 Medicated Tar, Neutrogena T/Derm, Neutrogena T/Gel, Neutrogena T/Gel Extra Strength, Oxipor VHC, PC Tar, Pentrax, Pentrax Gold, Polytar, Psoriasin, Psorigel, T/Gel Conditioner, Tegrin Medicated, Tegrin Medicated Soap, Therapeutic, Theraplex T, Zetar

What is coal tar?

Coal tar is a by-product of coal processing.

Coal tar topical (for the skin) is used to treat the skin symptoms of psoriasis, including dryness, redness, flaking, scaling, and itching. Coal tar is not a cure for psoriasis, and it will provide only temporary relief of skin symptoms.

Coal tar may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about coal tar?

You should not use this medication if you are allergic to coal tar.

Before using coal tar, tell your doctor if you are allergic to any drugs, or if you are receiving ultraviolet radiation treatment for your psoriasis.

Do not use coal tar to treat the skin of your groin or rectal area.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Coal tar can make your skin more sensitive to sunlight and sunburn may result. Stop using coal tar and call your doctor at once if you have severe stinging, burning, swelling, or other irritation of the treated skin. Do not use coal tar to treat large skin areas. Do not use coal tar over long periods of time without your doctor's advice.

Call your doctor if your symptoms do not improve, or if they get worse after using coal tar.

Coal tar is not a cure for psoriasis, and it will provide only temporary relief of skin symptoms.

What should I discuss with my health care provider before using coal tar?

You should not use this medication if you are allergic to coal tar.

Before using coal tar, tell your doctor if you are allergic to any drugs, or if you are receiving ultraviolet radiation treatment for your psoriasis.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether coal tar passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Coal tar products may contain lanolin, mineral oil, or other emulsifiers. Check the label of any coal tar product you are using. Talk with your doctor before using coal tar if you are allergic to any of the ingredients.

How should I use coal tar?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Apply coal tar cream, lotion, ointment, or solution according the directions on the medication label. Some forms of coal tar may be applied 1 to 4 times per day.

To use coal tar bath oil, pour 1 to 3 capfuls into a warm bath before bathing. The oil can make the bathtub slippery. Take care to avoid a fall.

Shake the coal tar shampoo well just before each use. Use enough shampoo to create a rich lather. Massage the shampoo into your scalp and rinse thoroughly. Apply the shampoo a second time and leave it on your scalp for 5 minutes. Rinse thoroughly. Do not use coal tar to treat large skin areas. Do not use coal tar over long periods of time without your doctor's advice.

Call your doctor if your symptoms do not improve, or if they get worse after using coal tar.

Coal tar shampoo may discolor blond or colored hair. This effect is usually temporarily.

Some forms of coal tar can stain fabric or other surfaces.

Store coal tar at room temperature away from moisture and heat. Keep the medicine tightly closed with not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a coal tar overdose are not known.

What should I avoid while using coal tar?

Avoid getting this medication in your eyes. If this does occur, rinse with water.

Do not use coal tar to treat the skin of your groin or rectal area.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Coal tar can make your skin more sensitive to sunlight and sunburn may result.

Coal tar side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using coal tar and call your doctor at once if you have severe stinging, burning, swelling, or other irritation of the treated skin.

Less serious side effects may include mild skin irritation or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect coal tar?

Do not use coal tar together with other psoriasis medications unless your doctor tells you to.

There may be other drugs that can interact with coal tar. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Pentrax Gold resources

• Pentrax Gold Use in Pregnancy & Breastfeeding
• Pentrax Gold Support Group
• 0 Reviews for Pentrax Gold - Add your own review/rating

• Betatar Gel Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Coal Tar Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Denorex Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Doak Tar Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Fototar Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• MG217 Medicated Tar Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Psoriasin Prescribing Information (FDA)

Compare Pentrax Gold with other medications

• Dermatitis
• Psoriasis
• Seborrheic Dermatitis

Where can I get more information?

• Your pharmacist can provide more information about coal tar.

Prostin VR Pediatric

alprostadil

Dosage Form: injection
Prostin VR Pediatric®

alprostadil injection, USP

500 micrograms per mL

WARNING

Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with Prostin VR Pediatric Sterile Solution. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and Prostin VR Pediatric should be used where ventilatory assistance is immediately available.

Prostin VR Pediatric Description

Prostin VR Pediatric Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1.0 mL dehydrated alcohol.

The chemical name for alprostadil is (11α,13E,15S)-11,15 dihydroxy-9-oxo-prost-13-en-1-oic acid, and the molecular weight is 354.49.

Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water.

Structural Formula

Prostin VR Pediatric - Clinical Pharmacology

Alprostadil (prostaglandin E1) is one of a family of naturally occurring acidic lipids with various pharmacologic effects. Vasodilation, inhibition of platelet aggregation, and stimulation of intestinal and uterine smooth muscle are among the most notable of these effects. Intravenous doses of 1 to 10 micrograms of alprostadil per kilogram of body weight lower the blood pressure in mammals by decreasing peripheral resistance. Reflex increases in cardiac output and rate accompany the reduction in blood pressure.

Smooth muscle of the ductus arteriosus is especially sensitive to alprostadil, and strips of lamb ductus markedly relax in the presence of the drug. In addition, administration of alprostadil reopened the closing ductus of new-born rats, rabbits, and lambs. These observations led to the investigation of alprostadil in infants who had congenital defects which restricted the pulmonary or systemic blood flow and who depended on a patent ductus arteriosus for adequate blood oxygenation and lower body perfusion.

In infants with restricted pulmonary blood flow, about 50% responded to alprostadil infusion with at least a 10 torr increase in blood pO2 (mean increase about 14 torr and mean increase in oxygen saturation about 23%). In general, patients who responded best had low pretreatment blood pO2 and were 4 days old or less.

In infants with restricted systemic blood flow, alprostadil often increased pH in those having acidosis, increased systemic blood pressure, and decreased the ratio of pulmonary artery pressure to aortic pressure.

Alprostadil must be infused continuously because it is very rapidly metabolized. As much as 80% of the circulating alprostadil may be metabolized in one pass through the lungs, primarily by β- and ω- oxidation. The metabolites are excreted primarily by the kidney, and excretion is essentially complete within 24 hours after administration. No unchanged alprostadil has been found in the urine, and there is no evidence of tissue retention of alprostadil or its metabolites.

Indications and Usage for Prostin VR Pediatric

Prostin VR Pediatric Sterile Solution is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects.

In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response.

Prostin VR Pediatric should be administered only by trained personnel in facilities that provide pediatric intensive care.

Contraindications

None.

Warnings

See WARNING box.

NOTE: Prostin VR Pediatric Sterile Solution must be diluted before it is administered. See dilution instructions in DOSAGE AND ADMINISTRATION section.

The administration of Prostin VR Pediatric to neonates may result in gastric outlet obstruction secondary to antral hyperplasia. This effect appears to be related to duration of therapy and cumulative dose of the drug. Neonates receiving Prostin VR Pediatric at recommended doses for more than 120 hours should be closely monitored for evidence of antral hyperplasia and gastric outlet obstruction.

Prostin VR Pediatric should be infused for the shortest time and at the lowest dose that will produce the desired effects. The risks of long-term infusion of Prostin VR Pediatric should be weighed against the possible benefits that critically ill infants may derive from its administration.

Precautions

General Precautions

Cortical proliferation of the long bones, first observed in dogs, has also been observed in infants during long-term infusions of alprostadil. The cortical proliferation in infants regressed after withdrawal of the drug.

In infants treated with Prostin VR Pediatric at the usual doses for 10 hours to 12 days and who died of causes unrelated to ductus structural weakness, tissue sections of the ductus and pulmonary arteries have shown intimal lacerations, a decrease in medial muscularity and disruption of the medial and internal elastic lamina. Localized and aneurysmal dilatations and vessel wall edema also were seen compared to a series of pathological specimens from infants not treated with Prostin VR Pediatric. The incidence of such structural alterations has not been defined.

Because alprostadil inhibits platelet aggregation, use Prostin VR Pediatric cautiously in neonates with bleeding tendencies.

Prostin VR Pediatric should not be used in neonates with respiratory distress syndrome. A differential diagnosis should be made between respiratory distress syndrome (hyaline membrane disease) and cyanotic heart disease (restricted pulmonary blood flow). If full diagnostic facilities are not immediately available, cyanosis (pO2 less than 40 torr) and restricted pulmonary blood flow apparent on an X-ray are appropriate indicators of congenital heart defects.

Necessary Monitoring

In all neonates, arterial pressure should be monitored intermittently by umbilical artery catheter, auscultation, or with a Doppler transducer. Should arterial pressure fall significantly, decrease the rate of infusion immediately.

In infants with restricted pulmonary blood flow, measure efficacy of Prostin VR Pediatric by monitoring improvement in blood oxygenation. In infants with restricted systemic blood flow, measure efficacy by monitoring improvement of systemic blood pressure and blood pH.

Drug Interactions

No drug interactions have been reported between Prostin VR Pediatric and the therapy standard in neonates with restricted pulmonary or systemic blood flow. Standard therapy includes antibiotics, such as penicillin and gentamicin; vasopressors, such as dopamine and isoproterenol; cardiac glycosides; and diuretics, such as furosemide.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term carcinogenicity studies and fertility studies have not been done. The Ames and Alkaline Elution assays reveal no potential for mutagenesis.

Adverse Reactions

Central Nervous System

Apnea has been reported in about 12% of the neonates treated. (See WARNING box.) Other common adverse reactions reported have been fever in about 14% of the patients treated and seizures in about 4%. The following reactions have been reported in less than 1% of the patients: cerebral bleeding, hyperextension of the neck, hyperirritability, hypothermia, jitteriness, lethargy, and stiffness.

Cardiovascular System

The most common adverse reactions reported have been flushing in about 10% of patients (more common after intraarterial dosing), bradycardia in about 7%, hypotension in about 4%, tachycardia in about 3%, cardiac arrest in about 1%, and edema in about 1%. The following reactions have been reported in less than 1% of the patients: congestive heart failure, hyperemia, second degree heart block, shock, spasm of the right ventricle infundibulum, supraventricular tachycardia, and ventricular fibrillation.

Respiratory System

The following reactions have been reported in less than 1% of the patients: bradypnea, bronchial wheezing, hypercapnia, respiratory depression, respiratory distress, and tachypnea.

Gastrointestinal System

See WARNINGS

The most common adverse reaction reported has been diarrhea in about 2% of the patients. The following reactions have been reported in less than 1% of the patients: gastric regurgitation, and hyperbilirubinemia.

Hematologic System

The most common hematologic event reported has been disseminated intravascular coagulation in about 1% of the patients. The following events have been reported in less than 1% of the patients: anemia, bleeding, and thrombocytopenia.

Excretory System

Anuria and hematuria have been reported in less than 1% of the patients.

Skeletal System

Cortical proliferation of the long bones has been reported. See PRECAUTIONS.

Miscellaneous

Sepsis has been reported in about 2% of the patients. Peritonitis has been reported in less than 1% of the patients. Hypokalemia has been reported in about 1%, and hypoglycemia and hyperkalemia have been reported in less than 1% of the patients.

Overdosage

Apnea, bradycardia, pyrexia, hypotension, and flushing may be signs of drug overdosage. If apnea or bradycardia occurs, discontinue the infusion, and provide appropriate medical treatment. Caution should be used in restarting the infusion. If pyrexia or hypotension occurs, reduce the infusion rate until these symptoms subside. Flushing is usually a result of incorrect intraarterial catheter placement, and the catheter should be repositioned.

Prostin VR Pediatric Dosage and Administration

The preferred route of administration for Prostin VR Pediatric Sterile Solution is continuous intravenous infusion into a large vein. Alternatively, Prostin VR Pediatric may be administered through an umbilical artery catheter placed at the ductal opening. Increases in blood pO2 (torr) have been the same in neonates who received the drug by either route of administration.

Begin infusion with 0.05 to 0.1 micrograms alprostadil per kilogram of body weight per minute. A starting dose of 0.1 micrograms per kilogram of body weight per minute is the recommended starting dose based on clinical studies; however, adequate clinical response has been reported using a starting dose of 0.05 micrograms per kilogram of body weight per minute. After a therapeutic response is achieved (increased pO2 in infants with restricted pulmonary blood flow or increased systemic blood pressure and blood pH in infants with restricted systemic blood flow), reduce the infusion rate to provide the lowest possible dosage that maintains the response. This may be accomplished by reducing the dosage from 0.1 to 0.05 to 0.025 to 0.01 micrograms per kilogram of body weight per minute. If response to 0.05 micrograms per kilogram of body weight per minute is inadequate, dosage can be increased up to 0.4 micrograms per kilogram of body weight per minute although, in general, higher infusion rates do not produce greater effects.

Dilution Instructions

To prepare infusion solutions, dilute 1 mL of Prostin VR Pediatric Sterile Solution with Sodium Chloride Injection USP or Dextrose Injection USP. Undiluted Prostin VR Pediatric Sterile Solution may interact with the plastic sidewalls of volumetric infusion chambers causing a change in the appearance of the chamber and creating a hazy solution. Should this occur, the solution and the volumetric infusion chamber should be replaced.

When using a volumetric infusion chamber, the appropriate amount of intravenous infusion solution should be added to the chamber first. The undiluted Prostin VR Pediatric Sterile Solution should then be added to the intravenous infusion solution, avoiding direct contact of the undiluted solution with the walls of the volumetric infusion chamber.

Dilute to volumes appropriate for the pump delivery system available. Prepare fresh infusion solutions every 24 hours. Discard any solution more than 24 hours old.

Sample Dilutions and Infusion Rates to Provide a Dosage of 0.1 Micrograms per Kilogram of Body Weight per Minute

Add 1 ampoule (500 micrograms) alprostadil to:	Approximate Concentration of resulting solution (micrograms/mL)	Infusion rate (mL/min per kg of body weight)
Example: To provide 0.1 micrograms/kilogram of body weight per minute to an infant weighing 2.8 kilograms using a solution of 1 ampoule Prostin VR Pediatric in 100 mL of saline or dextrose: INFUSION RATE = 0.02 mL/min per kg × 2.8 kg = 0.056 mL/min or 3.36 mL/hr.
250 mL	2	0.05
100 mL	5	0.02
50 mL	10	0.01
25 mL	20	0.005

How is Prostin VR Pediatric Supplied

Prostin VR Pediatric Sterile Solution is available in packages of 5—1 mL ampoules (NDC 0009-3169-01) and as a package of 5×1 mL ampoules (NDC 0009-3169-06). Each mL contains 500 micrograms alprostadil in dehydrated alcohol.

Store Prostin VR Pediatric Sterile Solution in a refrigerator at 2° to 8°C (36° to 46°F).

Rx only

LAB-0013-2.0

PRINCIPAL DISPLAY PANEL - 1 mL ampoule

1 mL     NDC 0009-3169-01     Rx only

Prostin VR Pediatric®

alprostadil injection, USP

FOR INTRAVASCULAR USE ONLY

500 mcg*

Refrigerate at 2° to 8°C (36° to 46°F).

DOSAGE AND USE:

See accompanying prescribing

information. Dilute before using.

*Each mL contains: 500 micrograms

alprostadil in dehydrated alcohol.

Distributed by Pharmacia & Upjohn Co

Division of Pfizer Inc, NY, NY 10017

811 764 513

FPO: RSS

LOT

EXP

PRINCIPAL DISPLAY PANEL - 5-1 mL Ampoules Package

NDC 0009-3169-06

Contains 5 of NDC 0009-3169-01

5-1 mL Ampoules                  Rx only

Prostin VR Pediatric®

alprostadil injection, USP

FOR INTRAVASCULAR USE ONLY

500 mcg*

Pfizer

Distributed by

Pharmacia & Upjohn Co

Division of Pfizer Inc, NY, NY 10017

PROSTIN   VR PEDIATRIC alprostadil  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-3169 Route of Administration INTRAVENOUS, INTRAVASCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alprostadil (alprostadil) alprostadil 500 ug  in 1 mL

Inactive Ingredients Ingredient Name Strength alcohol

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0009-3169-06 5 AMPULE In 1 PACKAGE contains a AMPULE (0009-3169-01) 1 0009-3169-01 1 mL In 1 AMPULE This package is contained within the PACKAGE (0009-3169-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018484	10/16/1981

Labeler - Pharmacia and Upjohn Company (829076566)

Establishment
Name	Address	ID/FEI	Operations
Pharmacia and Upjohn Company		829076566	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Pfizer Manufacturing Belgium NV		370156507	MANUFACTURE

Revised: 04/2009Pharmacia and Upjohn Company

More Prostin VR Pediatric resources

• Prostin VR Pediatric Side Effects (in more detail)
• Prostin VR Pediatric Use in Pregnancy & Breastfeeding
• Prostin VR Pediatric Drug Interactions
• Prostin VR Pediatric Support Group
• 0 Reviews for Prostin VR Pediatric - Add your own review/rating

• Prostin VR Pediatric Advanced Consumer (Micromedex) - Includes Dosage Information


• Prostin VR Pediatric injectable and transurethral Concise Consumer Information (Cerner Multum)


• Alprostadil Monograph (AHFS DI)


• Alprostadil MedFacts Consumer Leaflet (Wolters Kluwer)


• Edex MedFacts Consumer Leaflet (Wolters Kluwer)


• Muse Suppository MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Prostin VR Pediatric with other medications

• Patent Ductus Arteriosus

Xiral SR Sustained-Release Tablets

Pronunciation: KLOR-fen-IR-a-meen/SOO-doe-e-FED-rin/METH-skoe-POL-a-meen
Generic Name: Chlorpheniramine/Pseudoephedrine/Methscopolamine
Brand Name: Examples include Dallergy PSE and Relcof PSE

Xiral SR Sustained-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Xiral SR Sustained-Release Tablets are an antihistamine, decongestant, and anticholinergic combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use Xiral SR Sustained-Release Tablets if:

• you are allergic to any ingredient in Xiral SR Sustained-Release Tablets


• you are pregnant or breast-feeding


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days


• you have severe heart blood vessel disease, severe high blood pressure, narrow-angle glaucoma, severe bleeding, severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia), peptic ulcer, a blockage of your stomach or bowel, bowel motility problems, severe bowel inflammation (eg, ulcerative colitis), certain muscle problems (eg, myasthenia gravis), or uncontrolled bleeding


• you are unable to urinate or are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xiral SR Sustained-Release Tablets:

Some medical conditions may interact with Xiral SR Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of diabetes, an enlarged prostate, bladder or kidney problems, high blood pressure, diarrhea, asthma, nerve problems, heart problems, blood clots, a hiatal hernia, an adrenal gland tumor, glaucoma, breathing problems during sleep, seizures, myasthenia gravis (muscle weakness), or an overactive thyroid

Some MEDICINES MAY INTERACT with Xiral SR Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-blockers (eg, guanethidine, methyldopa, prazosin), beta-blockers (eg, atenolol), diuretics (eg, furosemide, hydrochlorothiazide), furazolidone, or MAOIs (eg, phenelzine) because the risk of high or low blood pressure may be increased


• Alkalizers (eg, calcium or magnesium antacids), anticholinergics (eg, atropine, benztropine, dicyclomine), carbonic anhydrase inhibitors (eg, acetazolamide), ergotamine, sodium bicarbonate, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Xiral SR Sustained-Release Tablets's side effects


• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because the risk of their side effects may be increased by Xiral SR Sustained-Release Tablets


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Xiral SR Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xiral SR Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xiral SR Sustained-Release Tablets:

Use Xiral SR Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Xiral SR Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Do not take Xiral SR Sustained-Release Tablets at the same time as an antacid, certain medicines for diarrhea (eg, attapulgite, bismuth, kaolin, pectin), or ketoconazole. Take these medicines 2 or 3 hours before or after you take Xiral SR Sustained-Release Tablets.


• Swallow Xiral SR Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Xiral SR Sustained-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.


• If you miss a dose of Xiral SR Sustained-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Xiral SR Sustained-Release Tablets.

Important safety information:

• Xiral SR Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Xiral SR Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• If your symptoms do not get better within 7 days or if they get worse or you develop a high fever or persistent headache, check with your doctor.


• Xiral SR Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.


• Xiral SR Sustained-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Xiral SR Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Do not take diet or appetite control medicines while you are taking Xiral SR Sustained-Release Tablets without checking with your doctor.


• Xiral SR Sustained-Release Tablets has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Xiral SR Sustained-Release Tablets.


• Xiral SR Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you are taking Xiral SR Sustained-Release Tablets.


• Tell your doctor or dentist that you take Xiral SR Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - Xiral SR Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Use Xiral SR Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Xiral SR Sustained-Release Tablets in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: It is not known if Xiral SR Sustained-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xiral SR Sustained-Release Tablets while you are pregnant. Xiral SR Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Xiral SR Sustained-Release Tablets.

Possible side effects of Xiral SR Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Xiral SR side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include deep sleep or loss of consciousness; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing.

Proper storage of Xiral SR Sustained-Release Tablets:

Store Xiral SR Sustained-Release Tablets in a tightly closed container between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xiral SR Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Xiral SR Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Xiral SR Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Xiral SR Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Xiral SR resources

• Xiral SR Side Effects (in more detail)
• Xiral SR Use in Pregnancy & Breastfeeding
• Xiral SR Drug Interactions
• Xiral SR Support Group
• 0 Reviews for Xiral SR - Add your own review/rating

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