Prostin E2

Generic Name: dinoprostone (Vaginal route)

dye-noe-PROST-one

Vaginal route(Suppository)

Dinoprostone should be used with strict adherence to recommended dosages, and should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities .

Commonly used brand name(s)

In the U.S.

• Cervidil


• Prepidil


• Prostin E2

Available Dosage Forms:

• Tampon


• Suppository


• Gel/Jelly


• Insert, Extended Release

Therapeutic Class: Uterine Stimulant

Pharmacologic Class: Prostaglandin

Uses For Prostin E2

Dinoprostone works by causing the cervix to thin and dilate (open) and the uterus to contract (cramp) the way it does during labor.

Dinoprostone may also be used for other purposes as determined by your doctor.

Dinoprostone is to be administered only by or under the immediate care of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, dinoprostone is used in certain patients with the following medical condition:

• Unusual increase in bleeding of the uterus after delivery (postpartum hemorrhage)

Before Using Prostin E2

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.

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:

• Anemia (or history of)—Dinoprostone, when used in doses that stimulate the uterus to contract, may result in loss of blood in some patients that may require a blood transfusion

• Asthma (or history of, including childhood asthma) or


• Lung disease—Dinoprostone may cause narrowing of the blood vessels in the lungs or narrowing of the lung passages, especially when it is used in doses that stimulate the uterus to contract

• Epilepsy (or history of)—Rarely, seizures have occurred with dinoprostone when it is used in doses that stimulate the uterus to contract

• Glaucoma—Rarely, the pressure within the eye has increased and constriction of the pupils has occurred during the use of medicines like dinoprostone; this may also be a problem with dinoprostone when it is used in doses that stimulate the uterus to contract

• Heart or blood vessel disease (or history of) or


• High blood pressure (or history of) or


• Low blood pressure (history of)—Dinoprostone may cause changes in heart function or blood pressure changes; two patients with a history of heart disease had heart attacks when dinoprostone was used in doses that stimulated the uterus to contract

• Kidney disease (or history of) or


• Liver disease (or history of)—The body may not remove dinoprostone from the blood stream at the usual rate, which may make the dinoprostone work longer or cause an increased chance of side effects, especially when dinoprostone is used in doses that stimulate the uterus to contract

• Problems during delivery, history of or


• Surgery of uterus (history of) or


• Unusual vaginal bleeding—There is an increased risk of problems occurring with dinoprostone when it is used in doses that stimulate the uterus to contract

Proper Use of dinoprostone

This section provides information on the proper use of a number of products that contain dinoprostone. It may not be specific to Prostin E2. Please read with care.

After dinoprostone is given, you will need to lie down for 10 minutes to 2 hours so that the medicine can be absorbed. The length of time you must remain lying down will depend on what form of the medicine you are using.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For cervical dosage form (gel):
  
  • To thin and widen the opening of the cervix just before labor:
    
    • Adults and teenagers—Your doctor will insert 0.5 milligram (mg) (one application) of dinoprostone into the canal of your cervix. You should remain lying on your back for at least ten to thirty minutes after it has been applied.
    
    
  
  


• For vaginal dosage form (gel):
  
  • To cause the uterus to contract for labor:
    
    • Adults and teenagers—Your doctor will insert 1 milligram (mg) (one applicatorful) of dinoprostone into your vagina. You should remain lying on your back for at least thirty minutes after it has been applied. You may need another dose of 1 to 2 mg six hours after the first dose.
    
    
  
  


• For vaginal dosage form (suppositories):
  
  • To cause the uterus to contract to abort a pregnancy:
    
    • Adults and teenagers—Your doctor will insert 20 milligrams (mg) (one suppository) into your vagina every three to five hours as needed. You should remain lying on your back for at least ten minutes after it has been inserted.
    
    
  
  


• For vaginal dosage form (system):
  
  • To thin and widen the opening of the cervix just before labor:
    
    • Adults and teenagers—Your doctor will insert 10 milligrams (mg) (one system) into your vagina. You should remain lying on your back for at least two hours after it has been inserted.
    
    
  
  

Prostin E2 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.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

• Fast or slow heartbeat


• hives


• increased pain of the uterus


• pale, cool, blotchy skin on arms or legs


• pressing or painful feeling in chest


• shortness of breath


• swelling of face, inside the nose, and eyelids


• tightness in chest


• trouble in breathing


• weak or absent pulse in arms or legs


• wheezing

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:

More common

• Abdominal or stomach cramps


• diarrhea


• fever


• nausea


• vomiting

Less common or rare

• Chills or shivering


• constipation


• flushing


• headache


• swelling of the genital area (vulva)


• tender or mildly bloated abdomen or stomach

This procedure may still result in some effects, which occur after the procedure is completed, that need medical attention. Check with your doctor if any of the following side effects occur:

• Chills or shivering (continuing)


• fever (continuing)


• foul-smelling vaginal discharge


• pain in lower abdomen


• unusual increase in bleeding of the uterus

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.

See also: Prostin E2 side effects (in more detail)

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.

More Prostin E2 resources

• Prostin E2 Side Effects (in more detail)
• Prostin E2 Use in Pregnancy & Breastfeeding
• Prostin E2 Drug Interactions
• Prostin E2 Support Group
• 0 Reviews for Prostin E2 - Add your own review/rating

• Prostin E2 Prescribing Information (FDA)


• Prostin E2 Concise Consumer Information (Cerner Multum)


• Cervidil Inserts MedFacts Consumer Leaflet (Wolters Kluwer)


• Cervidil Prescribing Information (FDA)


• Prepidil Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Prepidil Prescribing Information (FDA)

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• Abortion
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Protegra

Pronunciation: MUL-ti-VYE-ta-mins/MIN-er-als
Generic Name: Multivitamins with Minerals
Brand Name: Examples include Protegra and Vicon Forte

Protegra is used for:

Treating or preventing low levels of vitamins and minerals in the body. It may also be used for other conditions as determined by your doctor.

Protegra is a vitamin and mineral supplement. It works by providing extra vitamins and minerals to the body.

Do NOT use Protegra if:

• you are allergic to any ingredient in Protegra

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

Before using Protegra:

Some medical conditions may interact with Protegra. 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

Some MEDICINES MAY INTERACT with Protegra.

Ask your health care provider if Protegra 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 Protegra:

Use Protegra as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Protegra by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Protegra, 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 Protegra.

Important safety information:

• Do not take large doses of vitamins while you use Protegra unless your doctor tells you to.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Protegra while you are pregnant. It is not known if Protegra is found in breast milk. If you are or will be breast-feeding while you use Protegra, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Protegra:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Protegra. 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).

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.

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 nausea; vomiting.

Proper storage of Protegra:

Store Protegra at room temperature. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Protegra out of the reach of children and away from pets.

General information:

• If you have any questions about Protegra, please talk with your doctor, pharmacist, or other health care provider.


• Protegra is 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.

This information is a summary only. It does not contain all information about Protegra. 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 Protegra resources

• Protegra Use in Pregnancy & Breastfeeding
• Protegra Drug Interactions
• Protegra Support Group
• 4 Reviews for Protegra - Add your own review/rating

• multivitamin Concise Consumer Information (Cerner Multum)


• Folplex Prescribing Information (FDA)


• Foltabs 800 Prescribing Information (FDA)


• Infuvite Pediatric Prescribing Information (FDA)


• Nephrocaps Prescribing Information (FDA)


• Nephrocaps


• Renal Caps Prescribing Information (FDA)


• Vitamin A Monograph (AHFS DI)

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• Vitamin/Mineral Supplementation and Deficiency

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)

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• Patent Ductus Arteriosus

Prosed EC

Generic Name: atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid (Oral route)

AT-roe-peen SUL-fate, hye-oh-SYE-a-meen SUL-fate, meth-EN-a-meen, METH-i-leen BLOO, FEN-il sal-I-si-late, ben-ZOE-ik AS-id

Commonly used brand name(s)

In the U.S.

• Prosed EC


• Trac Tabs


• Urised

Available Dosage Forms:

• Tablet


• Tablet, Enteric Coated

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Atropine

Chemical Class: Salicylate, Non-Aspirin

Uses For Prosed EC

Atropine , hyoscyamine , methenamine , methylene blue, phenyl salicylate , and benzoic acid combination medicine is an anticholinergic, anti-infective, and analgesic. It is given by mouth to help relieve the discomfort caused by urinary tract infections; however, it will not cure the infection itself. This combination medicine may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Before Using Prosed EC

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

Unusual excitement, nervousness, restlessness or irritability, and unusual warmth, dryness, and flushing of skin are more likely to occur in children, who are usually more sensitive to the effects of atropine and hyoscyamine (contained in this combination medicine). Also, when atropine and hyoscyamine are given to children during hot weather, a rapid increase in body temperature may occur. In infants and children, especially those with spastic paralysis or brain damage, this medicine may be more likely to cause severe side effects.

Geriatric

Confusion or memory loss, constipation, difficult urination, excitement, agitation, drowsiness, or dryness of mouth may be more likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of atropine and hyoscyamine. Also, this combination medicine may cause eye pain in patients who have untreated glaucoma.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Benzoic Acid

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Methylene BlueBenzyl BenzoateMethenamineAtropineHyoscyamine

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ambenonium


• Amitriptyline


• Amoxapine


• Bupropion


• Citalopram


• Clomipramine


• Desipramine


• Desvenlafaxine


• Doxepin


• Duloxetine


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Imipramine


• Isocarboxazid


• Linezolid


• Maprotiline


• Mirtazapine


• Nortriptyline


• Paroxetine


• Phenelzine


• Potassium


• Protriptyline


• Selegiline


• Sertraline


• Tranylcypromine


• Trimipramine


• Venlafaxine


• Vilazodone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Buspirone


• Nefazodone


• Trazodone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Arbutamine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Bleeding problems (severe)—This combination medicine may increase heart rate, which would make bleeding problems worse

• Brain damage (in children)—May increase the central nervous system (CNS) effects of this combination medicine

• Colitis (severe) or


• Dryness of mouth (severe or continuing) or


• Enlarged prostate or


• Fever or


• Glaucoma or


• Heart disease or


• Hernia (hiatal) or


• High blood pressure or


• Intestinal blockage or other intestinal or stomach problems or


• Lung disease or


• Myasthenia gravis or


• Toxemia of pregnancy or


• Urinary tract blockage or difficult urination—This combination medicine may make these conditions worse

• Dehydration or


• Kidney disease or


• Liver disease—Higher levels of medicine may result and increase the risk of side effects

• Overactive thyroid—May increase the heart rate

Proper Use of atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid

This section provides information on the proper use of a number of products that contain atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid. It may not be specific to Prosed EC. Please read with care.

While you are taking this combination medicine, it is important for your urine to be acidic. To do this, your doctor may recommend that you eat more protein and such foods as cranberries (especially cranberry juice with vitamin C added), plums, or prunes. You should avoid foods that make the urine more alkaline, such as most fruits (especially citrus fruits and juices), milk, and other dairy products.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Each dose should be taken with a full glass (8 ounces) of water or other liquid (except citrus juices and milk). Drink plenty of water or other liquids every day, unless otherwise directed by your doctor. Drinking enough liquids will help your kidneys work better and lessen your discomfort.

To help clear up your infection completely, keep taking this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

In order for this medicine to work well, your urine must be acid (pH 5.5 or below). To make sure that your urine is acid:

• Before you start taking this medicine, check your urine with phenaphthazine paper or another test to see if it is acid. If you have any questions about this, check with your health care professional.


• You may need to change your diet; however, check with your doctor first if you are on a special diet (for example, for diabetes). To help make your urine more acid you should avoid most fruits (especially citrus fruits and juices), milk and other dairy products, and other foods which make the urine more alkaline. Eating more protein and foods such as cranberries (especially cranberry juice with vitamin C added), plums, or prunes may also help. If your urine is still not acid enough, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For relief of urinary tract symptoms:
    
    • Adults and children 12 years of age and older—1 to 2 tablets four times a day.
    
    
    • Children 6 to 12 years of age—Dose must be determined by the doctor.
    
    
    • Children up to 6 years of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Prosed EC

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

These medicines may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

This medicine may cause some people to have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not able to see well. If your vision continues to be blurred, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take this medicine within 2 or 3 hours of taking antacids or medicine for diarrhea. Taking antacids or antidiarrhea medicines and this medicine too close together may prevent this medicine from working properly.

Prosed EC 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.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Blurred vision


• eye pain


• skin rash or hives

Symptoms of overdose

• Blood in urine and/or stools


• diarrhea


• dizziness


• drowsiness (severe)


• fast heartbeat


• flushing or redness of face


• headache (severe or continuing)


• lower back pain


• pain or burning while urinating


• ringing or buzzing in the ears


• shortness of breath or troubled breathing


• sweating


• unusual tiredness or weakness

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:

Less common

• Difficult urination (more common with large doses taken over a prolonged period of time)


• dryness of mouth, nose, or throat


• nausea or vomiting


• stomach upset or pain (more common with large doses taken over a prolonged period of time)

This medicine may cause your urine and/or stools to turn blue or blue-green. This is to be expected while you are taking this medicine.

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.

More Prosed EC resources

• Prosed EC Use in Pregnancy & Breastfeeding
• Prosed EC Drug Interactions
• Prosed EC Support Group
• 0 Reviews for Prosed EC - Add your own review/rating

• Darcalma Concise Consumer Information (Cerner Multum)


• Darcalma Prescribing Information (FDA)


• Darpaz Prescribing Information (FDA)


• Phosenamine Prescribing Information (FDA)


• Phosphasal Prescribing Information (FDA)


• Prosed/DS MedFacts Consumer Leaflet (Wolters Kluwer)


• Urelle Prescribing Information (FDA)


• Uribel Prescribing Information (FDA)


• Urimax Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Urised MedFacts Consumer Leaflet (Wolters Kluwer)


• Uritact-EC Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ustell Prescribing Information (FDA)


• Uta MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Prosed EC with other medications

• Urinary Tract Infection

Protopam Chloride

Generic Name: pralidoxime (Injection route)

pral-i-DOX-eem

Commonly used brand name(s)

In the U.S.

• Protopam Chloride

Available Dosage Forms:

• Powder for Solution


• Injectable

Therapeutic Class: Nerve Gas Antidote

Uses For Protopam Chloride

Pralidoxime injection is used together with another medicine called atropine to treat poisoning caused by organic phosphorus pesticides (e.g., diazinon, malathion, mevinphos, parathion, and sarin) and by organophosphate chemicals (“nerve gases”) used in chemical warfare.

Pralidoxime injection is also used to treat overdose of medicines (e.g., ambenonium, neostigmine, pyridostigmine), that are used to treat myasthenia gravis. Poisoning with these chemicals or medicines causes your muscles, including the muscles that help you breathe, to become weak. Pralidoxime is used to help you get back strength in your muscles.

This medicine is to be given only by or under the direct supervision of a doctor or trained military personnel.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, pralidoxime has been used in some patients to treat poisoning caused by certain carbamate pesticides.

Before Using Protopam Chloride

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pralidoxime injection in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pralidoxime injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving pralidoxime 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:

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Myasthenia gravis (severe muscle weakness)—Use with caution. May make this condition worse.

Proper Use of Protopam Chloride

A nurse or other trained health professional will give you this medicine in a hospital or clinic. You may also be taught how to give your medicine at home. This medicine is preferably given through a needle placed in one of your veins. It may also be given as a shot under your skin or into a muscle.

This medicine is available in two forms: a vial and an autoinjector.

For patients using the pralidoxime autoinjector (automatic injection device):

• You will be trained to use the pralidoxime autoinjector by a medic or other trained military personnel. You will also be told the conditions under which it should be used.


• The autoinjector also comes with patient directions. Read them carefully before you actually need to use this medicine. Then, when an emergency arises, you will know how to inject the pralidoxime.


• It is important that you do not remove the safety cap on the autoinjector until you are ready to use it. This prevents spillage of the medicine from the device during storage and handling.


• To use the pralidoxime autoinjector:
  
  • Remove the gray safety cap.
  
  
  • Place the black tip of the device on the thigh, with the injector pointed straight at the thigh.
  
  
  • Press hard into the thigh until the autoinjector functions. Hold in place for several seconds. Remove the autoinjector and dispose of it as directed.
  
  
  • Massage the injected area for 10 seconds.
  
  

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For treatment of organic phosphorus pesticide poisoning:
    
    • Adults and teenagers—At first, 1000 to 2000 milligrams (mg) injected into a vein usually as an infusion in 100 milliliters (mL) of normal saline, over a 15- to 30-minute period. The dose may be repeated after one hour, and then every eight to twelve hours if muscle weakness persists.
    
    
    • Children and teenagers 16 years of age and younger—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 to 50 milligrams (mg) per kilogram (kg) (9.07 to 22.7 mg per pound) of body weight injected into a vein. The dose may be repeated after one hour, and then every ten to twelve hours if muscle weakness persists.
    
    
  
  
  • For treatment of organic phosphorus chemical (“nerve gas”) poisoning:
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—600 milligrams (mg) or 2 milliliters (mL) injected into a muscle. The dose may be repeated fifteen minutes after the first dose and fifteen minutes after the second dose, if needed.
    
    
    • Children and teenagers 16 years of age and younger weighing less than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is 15 milligrams (mg) per kilogram (kg) of body weight injected into the muscles of the thighs. The dose may be repeated fifteen minutes after the first dose and fifteen minutes after the second dose, if needed.
    
    
  
  
  • For treatment of overdose of medicines used to treat myasthenia gravis:
    
    • Adults and teenagers—At first, 1000 to 2000 milligrams (mg) injected into a vein. Then, 250 mg is injected into a vein every five minutes.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Protopam Chloride

Your doctor will check your progress closely while you or your child 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. Blood tests may be needed to check for unwanted effects.

Call your doctor right away if you or your child have fast heartbeat, difficulty or trouble with breathing, increased muscle weakness, or severe tiredness after receiving this medicine.

This medicine will add to the effects of CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Protopam Chloride 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.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blurred or double vision


• change in near or distance vision


• difficult or rapid breathing


• difficulty in focusing the eyes


• difficulty with speaking


• dizziness


• fast, pounding, or irregular heartbeat or pulse


• muscle stiffness or weakness


• pain at the injection site (after injection into a muscle)

Incidence not known

• Deep or fast breathing with dizziness


• numbness of the feet, hands, and around the mouth

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:

More common

• Drowsiness


• headache


• nausea

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.

See also: Protopam Chloride side effects (in more detail)

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.

More Protopam Chloride resources

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

• Protopam Chloride Concise Consumer Information (Cerner Multum)


• Pralidoxime Chloride Monograph (AHFS DI)

Compare Protopam Chloride with other medications

• Anticholinesterase Overdose
• Nerve Agent Poisoning
• Organophosphate Poisoning

Prostin VR Pediatric

Generic Name: alprostadil (Intraurethral route, Intravenous route, Intracavernosal route)

al-PROS-ta-dil

Intravenous route(Solution)

Apnea is experienced by about 10% to 12% of neonates with congenital heart defects treated with alprostadil injection. 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 alprostadil injection should be used only where ventilatory assistance is immediately available .

Commonly used brand name(s)

In the U.S.

• Caverject


• Edex


• Muse


• Prostin VR Pediatric

In Canada

• Muse Micro

Available Dosage Forms:

• Powder for Solution


• Kit


• Suppository


• Solution

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Prostaglandin

Uses For Prostin VR Pediatric

Alprostadil belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. Alprostadil is used to produce erections in some men who need treatment for erectile dysfunction (sexual impotence). This medicine causes an erection because it increases the blood flow to the penis.

Alprostadil injection should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.

Alprostadil is used alone or with medical tests to help diagnose erectile dysfunction that may be caused by nerve or blood vessel problems in the penis.

Alprostadil is available only with your doctor's prescription.

Before Using Prostin VR Pediatric

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.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Heparin

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:

• Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased

• Bleeding problems—Chance of bleeding at the place of injection may be increased

• Infection of penis or


• Red or itchy (inflamed) penis—Conditions may worsen with the use of alprostadil suppositories. Also, local skin problems and minor bleeding from inserting the suppository may occur

• Conditions causing thickened blood or slower blood flow, including leukemia; multiple myeloma (tumors of the bone marrow); polycythemia, sickle cell disease, or thrombocythemia (blood problems) or

• Priapism (history of)—Patients with these conditions have an increased risk of priapism (erection lasting longer than 6 hours) while using alprostadil

Proper Use of alprostadil

This section provides information on the proper use of a number of products that contain alprostadil. It may not be specific to Prostin VR Pediatric. Please read with care.

Special patient directions come with the suppositories and some of the injection medicines. Read the directions carefully before using the medicine.

For the injections—There are several alprostadil products that can be injected. Although the injection method is the same, the mixing procedures are different. Be sure you know which of these products you will be using and the proper way to mix the injection.

• One product called Alprostadil for Injection (brand names Caverject and Edex) is available as a powder in an injection bottle (vial). Caverject must be mixed with a solution called Bacteriostatic Water for Injection USP. Edex must be mixed with a solution called Sodium Chloride Injection USP. The solution for mixing comes with your product and may be already loaded into a syringe or contained in another injection bottle (vial).


• Another product is called Alprostadil Injection (brand names Prostin VR Pediatric and Prostin VR). Although the medicine is already in solution, it is much too strong to be injected into the penis. The solution must be mixed (diluted) with another liquid that is sold as a separate prescription, called 0.9% Sodium Chloride Injection USP. In most cases, a pharmacist will make this solution for you, giving you the proper strength that you need. Check with your doctor or pharmacist to make sure the solution has been diluted before using it.

It is important to follow several steps to prepare your alprostadil injection correctly. Before drawing up the medicine into the syringe:

• Wash your hands with soap and water.


• Set the bottles on a clean surface. Wipe the top of the injection bottles with an alcohol swab. Do not wipe the needle. Throw away the alcohol swab.


• You may need to attach the needle to the syringe. Do not take the cap off yet.

How to mix Caverject:

• If the syringe already contains the Bacteriostatic Water for Injection USP, then you need only add the plunger to the syringe. To do this:
  
  • Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force.
  
  
  • Hold the syringe by the barrel (not the plunger) and take the cap off the needle.
  
  
  • You are now ready to mix the water and the powder. Skip to the directions under the title, “To mix the water and powder."
  
  


• If the syringe does not already contain the Bacteriostatic Water for Injection USP, you must withdraw 1 milliliter (mL) of it from the bottle provided. To do this:
  
  • Pick up the syringe and take the cap off the needle. Pull the plunger back to the 1-mL mark on the syringe. This pulls air into the syringe. Insert the needle into rubber top of the bottle while it is upright and inject the 1 mL of air into the bottle.
  
  
  • Turn the bottle upside down using one hand. Be sure the tip of the needle is covered by solution.
  
  
  • With your other hand, pull the plunger back slowly to withdraw 1 mL of solution into the syringe. Remove the needle and skip to the directions under the title, "To mix the water and powder."
  
  


• To mix the water and powder:
  
  • Insert the needle into the bottle of alprostadil and inject 1 milliliter of Bacteriostatic Water for Injection USP from your syringe into the bottle of alprostadil.
  
  
  • Remove the needle from the bottle, holding the barrel of the syringe.
  
  
  • Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle.
  
  
  • Follow the directions below, “How to draw your dose into the syringe."
  
  

How to mix Edex:

• The syringe already contains the Sodium Chloride Injection USP. You need only attach the needle to the syringe and add the plunger. To do this:
  
  • Remove the needle from its package. Do not remove the needle cap. Gently screw the needle into place on the syringe tip.
  
  
  • Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force.
  
  
  • Hold the syringe by the barrel (not the plunger) and take the cap off the needle.
  
  
  • You are now ready to mix the Sodium Chloride Injection USP and the powder.
  
  
  • Insert the needle into the bottle of alprostadil and inject 1.2 milliliters of the Sodium Chloride Injection USP from your syringe into the bottle of alprostadil.
  
  
  • Remove the needle from the bottle, holding the barrel of the syringe.
  
  
  • Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle.
  
  
  • Follow the directions below, “How to draw your dose into the syringe."
  
  

How to mix Prostin VR or Prostin VR Pediatric:

• You will need to get exact mixing instructions from your doctor or pharmacist if you are given two solutions to be mixed. Follow them carefully, asking the pharmacist or doctor any questions that you might have before injecting the medicine.


• After you or the pharmacist has mixed these solutions, follow the directions below, “How to draw your dose into the syringe."

How to draw your dose into the syringe (for all injection products):

• Check the solution to make sure it is clear. Do not use the mixture if you can see anything solid in the solution or if the solution is cloudy or colored.


• After the alprostadil solution is mixed and the needle is inserted into the alprostadil bottle, turn the bottle with the syringe as a unit upside down in one hand. Be sure the tip of the needle is covered by the solution. With your other hand, pull the plunger back slowly to draw the correct dose of the medicine into the syringe.


• Hold the syringe with the measuring scale at eye level to see that the proper dose is withdrawn and to check for air bubbles. To remove air bubbles, tap gently on the measuring scale of the syringe to move any bubbles to the top of the syringe near the needle.


• If your dose measures too low in the syringe, withdraw more solution from the bottle. If there is too much medicine in the syringe, put some back into the bottle. Then check your dose again.


• Remove the needle from the bottle, holding the barrel of the syringe, not the plunger.


• Place the cover back on the needle. You are now ready to inject your dose. Follow the directions below, “How to give the alprostadil injection."

How to give the alprostadil injection:

• Choose a spot on your penis as directed by your doctor where you will give the injection.


• Clean the injection site with alcohol. Sitting upright or slightly reclined, hold your penis against the side of your thigh so that it cannot move.


• Remove the cover from the needle and hold the needle at a 90-degree angle to the place of injection.


• Insert the needle until almost all of the metal part of the needle is inserted into the penis.


• Do not inject the medicine just under the surface of the skin, at the top or head of the penis, or at the base of the penis near the scrotum or testes. Avoid injecting the medicine into blood vessels that you can see.


• Press the plunger down slowly, taking 5 to 10 seconds to release the dose into the penis.


• The injection is usually not painful. If the injection is very painful or if you notice bruising or swelling at the place of injection, that means you are injecting the medicine under the skin. Stop, withdraw the needle, and reposition it properly before continuing with the injection.


• Remove the needle and recap it.


• After you have completed the injection, put pressure on the place of injection for about 5 minutes or until any bleeding stops. This will prevent bruising. Then massage your penis as instructed by your doctor. This helps the medicine spread to all parts of the penis, so that the medicine will work better.

Choose a different place of injection each time you use the medicine to prevent skin problems. This includes switching the place of injection from the right side of the penis for one injection to the left side for the next injection.

After a single-use injection is mixed, the medicine must be used immediately. Throw away any unused mixture in the syringe. It cannot be stored for a later injection.

Do not reuse your needles.

How to throw away the syringes and bottles safely:

Dispose of your materials properly. Caverject comes in a plastic case that can be permanently locked with the red locking device that is included with the packaging. When the case label is removed, you can see a hole in the center of the case. The red locking device can be inserted and, by firmly pressing it down with your thumb, you will permanently lock the case. The locked case is safe to be thrown away.

If you do not have the plastic case or are using Prostin VR or Prostin VR Pediatric injection, unscrew the needle from the barrel of the syringe. Then bend, break, or cut the needle into two pieces with wire cutters. The pieces can be placed in a heavy plastic container, such as a bleach container, and thrown away. Or you may give them to a health care professional to throw away. If you have any questions about disposing of the syringe and needles, ask your health care professional.

For suppositories—Before inserting the suppository, you should urinate. The small amount of urine normally left in your urethra will help dissolve the suppository after it is inserted.

How to insert suppositories:

• Remove the delivery device containing the suppository from the foil. Remove the cap from the applicator stem.


• Stretch your penis upward to extend its length, pressing your penis top and bottom. Gently insert the delivery stem up to its collar into your urethra (located at the top of the penis). If you have pain or a pulling feeling in the penis, withdraw the device and start again.


• Press the button down slowly as far as it will go. This releases the suppository into the urethra. After holding the delivery device within your penis still for 5 seconds, carefully rock the penis and delivery device as a unit from side to side. This helps remove the suppository from the device.


• Remove the delivery device while your penis is upright. Look at the device to make sure that the suppository was completely released.


• Repeat the process if a part of the suppository remains in the device.


• After the suppository is completely released, roll your penis between your hands for 10 seconds. This helps to dissolve the suppository. If you feel any stinging, continue this motion to help stop it.


• Sitting, standing, or walking for 10 minutes while an erection is developing helps increase the blood flow to your penis to gain a proper erection.

How to throw away the suppository delivery device safely:

• Replace the cap on the delivery device. After storing it in the foil, fold and throw away.

For injections or suppositories—This medicine usually begins to work in about 5 to 10 minutes. You should attempt intercourse within 10 to 30 minutes after using the medicine. An erection may continue after ejaculation.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the treatment of erectile dysfunction:
  
  • For injection dosage form:
    
    • Adults—1.25 to 60 micrograms (mcg) as a single dose once a day. Your exact dose will be determined by your doctor. Inject this medicine very slowly into your penis as shown to you by your doctor ten to thirty minutes before intercourse. Allow five to ten seconds to completely inject the dose. Do not inject more than one dose within twenty-four hours. Also, do not use this medicine for more than two days in a row or more than three times a week.
    
    
  
  
  • For suppository dosage form:
    
    • Adults—125, 250, 500, or 1000 mcg as a single dose once a day. Your exact dose will be determined by your doctor. Insert this medicine into the urethra of your penis as shown to you by your doctor ten to thirty minutes before intercourse. Do not insert more than two doses within twenty-four hours.
    
    
  
  

Storage

Store in the refrigerator. Do not freeze.

You may store the suppositories in the refrigerator, but do not freeze them.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Alprostadil for Injection while in the powder form can be stored at room temperature (between 15 and 25 °C or 59 and 77 °F) for 3 months. After it is mixed, the solution must be used immediately. Suppositories may be stored at room temperature

Precautions While Using Prostin VR Pediatric

Do not use alprostadil if you have a penile implant unless advised by doctor.

If using the alprostadil suppository, use a condom when having sexual intercourse with a pregnant female. Although harm to the fetus is unlikely, using a condom will protect the fetus from exposure to this medicine. If a woman can become pregnant, use of contraceptive methods is recommended because the effects of this medicine on early pregnancy are not known.

Use alprostadil exactly as directed by your doctor . Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the erection lasts too long and does not reverse when it should. This condition is called priapism. If the erection is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.

Contact your doctor immediately if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.

If you notice bleeding at the place where you injected the medicine, put pressure on the spot until the bleeding stops. If it doesn't stop within 10 minutes, check with your doctor.

Prostin VR Pediatric 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.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Curving of penis with pain during erection


• erection continuing for 4 to 6 hours


• erection continuing longer than 6 hours with severe and continuing pain of the penis


• swelling in or pain of the testes

Symptoms of too much medicine being absorbed into the body

• Dizziness


• faintness


• pelvic pain


• flu-like symptoms

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:

More common

• Bleeding at place of injection, short-term


• mild bleeding or spotting from urethra (suppository only)


• pain at place of injection


• painful erection


• stinging of urethra (suppository only)

Rare

Female partners may experience itching or stinging of vagina when you first begin using the alprostadil suppository. These side effects may not be caused from the medicine but may result if female partner has not had frequent or recent sexual intercourse.

• Bruising or clotted blood in penis at place of injection, usually caused by an incorrect injection

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.

See also: Prostin VR Pediatric side effects (in more detail)

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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 Prescribing Information (FDA)


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


• Alprostadil MedFacts Consumer Leaflet (Wolters Kluwer)


• Alprostadil Prescribing Information (FDA)


• Alprostadil Monograph (AHFS DI)


• Caverject Prescribing Information (FDA)


• Edex MedFacts Consumer Leaflet (Wolters Kluwer)


• Muse Prescribing Information (FDA)


• Muse Suppository MedFacts Consumer Leaflet (Wolters Kluwer)

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