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Monday, October 17, 2016

Hespan

hetastarch in sodium chloride

Dosage Form: injection, solution
Hespan®

(6% hetastarch in 0.9% sodium chloride injection)

Hespan Description

Hespan® (6% hetastarch in 0.9% sodium chloride injection) is a sterile, nonpyrogenic solution for intravenous administration. Each 100 mL contains:

Hetastarch.............................................................................................................6 g

Sodium Chloride, USP..........................................................................................0.9 g

Water for Injection, USP...........................................................................................qs

pH adjusted with Sodium Hydroxide, NF if necessary

Concentration of Electrolytes (mEq/L): Sodium 154, Chloride 154

pH: approximately 5.9 with negligible buffering capacity

Calc. Osmolarity: approximately 309 mOsM

Hetastarch is a synthetic colloid derived from a waxy starch composed almost entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose units of the starch, and the resultant material is hydrolyzed to yield a product with a molecular weight suitable for use as a plasma volume expander and erythrocyte sedimenting agent. Hetastarch is characterized by its molar substitution and also by its molecular weight. The molar substitution is approximately 0.75 which means hetastarch has an average of approximately 75 hydroxyethyl groups for every 100 glucose units. The weight average molecular weight is approximately 600,000 with a range of 450,000 to 800,000 and with at least 80% of the polymers falling within the range of 20,000 to 2,600,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6. The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by α-1,4 linkages with occasional α-1,6 branching linkages. The degree of branching is approximately 1:20 which means that there is an average of approximately one α-1,6 branching point for every 20 glucose monomer units.

The chemical name for hetastarch is hydroxyethyl starch.

The structural formula is as follows:

Amylopectin derivative in which R2 and R3 are H or CH2CH2OH and R6 is H, CH2CH2OH, or a branching point in the starch polymer connected through an α-1,6 link to additional D-glucopyranosyl units.

Hespan® is a clear, pale yellow to amber solution. Exposure to prolonged adverse storage conditions may result in a change to a turbid deep brown or the formation of a crystalline precipitate. Do not use the solution if these conditions are evident.

The Excel® Container is Latex-free; PVC-free; and DEHP-free.

The plastic container is made from a multi-layered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector.

Hespan - Clinical Pharmacology

The plasma volume expansion produced by Hespan® approximates that of 5% Albumin (Human). Intravenous infusion of Hespan® results in expansion of plasma volume that decreases over the succeeding 24 to 36 hours. The degree of plasma volume expansion and improvement in hemodynamic state depend upon the patient's intravascular status.

Hetastarch molecules below 50,000 molecular weight are rapidly eliminated by renal excretion. A single dose of approximately 500 mL of Hespan® (approximately 30 g) results in elimination in the urine of approximately 33% of the dose within 24 hours. This is a variable process but generally results in an intravascular hetastarch concentration of less than 10% of the total dose injected by two weeks. A study of the biliary excretion of Hespan® in 10 healthy males accounted for less than 1% of the dose over a 14 day period. The hydroxyethyl group is not cleaved by the body but remains intact and attached to glucose units when excreted. Significant quantities of glucose are not produced as hydroxyethylation prevents complete metabolism of the smaller polymers.

The addition of hetastarch to whole blood increases the erythrocyte sedimentation rate. Therefore, Hespan® is used to improve the efficiency of granulocyte collection by centrifugal means.

In randomized, controlled, comparative studies of Hespan® (6% hetastarch in 0.9% sodium chloride injection) (n=92) and Albumin (n=85) in surgical patients, no patient in either treatment group had a bleeding complication and no significant difference was found in the amount of blood loss between the treatment groups.1–4

Indications and Usage for Hespan

Hespan® is indicated in the treatment of hypovolemia when plasma volume expansion is desired. It is not a substitute for blood or plasma.

The adjunctive use of Hespan® in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.

Contraindications

Hespan® is contraindicated in patients with known hypersensitivity to hydroxyethyl starch. It is also contraindicated in clinical conditions where volume overload is a potential problem, such as, congestive heart failure or renal disease with anuria or oliguria not related to hypovolemia.

Patients with pre-existing coagulation or bleeding disorders should not be given Hespan®.

Warnings

Life threatening anaphylactic/anaphylactoid reactions have been rarely reported with Hespan®; death has occurred, but a causal relationship has not been established. Patients who develop severe anaphylactic/anaphylactoid reactions may need continued supportive care until symptoms have resolved.

Hypersensitivity reactions can occur even after Hespan® has been discontinued.

Usage in Plasma Volume Expansion

Hespan® has not been adequately evaluated to establish its safety in situations other than treatment of hypovolemia in elective surgery.

Large volumes of Hespan® may transiently alter the coagulation mechanism due to hemodilution and a direct inhibitory action on Factor VIII. Administration of volumes of Hespan® that are greater than 25% of the blood volume in less than 24 hours may cause significant hemodilution reflected by lower hematocrit and plasma protein values. Administration of packed red cells, platelets, or fresh frozen plasma should be considered if clinically indicated.

Hespan® is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired. However, this risk of bleeding diminished within hours.5–6

Hematocrit may be decreased and plasma proteins diluted excessively by administration of large volumes of Hespan®. Administration of packed red cells, platelets, and fresh frozen plasma should be considered if excessive dilution occurs.

Use over extended periods: Hespan® has not been adequately evaluated to establish its safety in situations other than leukapheresis that require frequent use of colloidal solutions over extended periods. In some cases, hetastarch has been associated with coagulation abnormalities in conjunction with an acquired, reversible von Willebrand's-like syndrome and/or Factor VIII deficiency when used over a period of days. Replacement therapy should be considered if a severe Factor VIII deficiency is identified. If a coagulopathy develops, it may take several days to resolve. Certain conditions may affect the safe use of Hespan® on a chronic basis. For example, in patients with subarachnoid hemorrhage where Hespan® is used repeatedly over a period of days for the prevention of cerebral vasospasm, significant clinical bleeding may occur. Intracranial bleeding resulting in death has been reported.7

Usage in Leukapheresis

Slight declines in platelet counts and hemoglobin levels have been observed in donors undergoing repeated leukapheresis procedures using Hespan® due to the volume expanding effects of hetastarch and to the collection of platelets and erythrocytes. Hemoglobin levels usually return to normal within 24 hours. Hemodilution by Hespan® may also result in 24 hour declines of total protein, albumin, calcium, and fibrinogen levels. None of these decreases are to a degree recognized to be clinically significant risks to healthy donors.

Precautions

General

If administration is by pressure infusion, all air should be withdrawn or expelled from the bag through the medication port prior to infusion.

Caution should be used when administering Hespan® to patients allergic to corn because such patients can also be allergic to hetastarch.

If a hypersensitivity effect occurs, administration of the drug should be discontinued and appropriate treatment and supportive measures should be undertaken (see WARNINGS).

When using Hespan® for plasma volume expansion, caution should be taken to avoid excessive hemodilution and circulatory overload especially in those patients at risk for developing congestive heart failure and pulmonary edema. Hespan® is primarily excreted via the kidneys so caution should be exercised in patients who have impaired renal function. Although the risk of circulatory overload is largely dependent on the clinical circumstances, use of doses higher than 20 mL/kg/24h will increase the risk significantly. Increased risk of coagulation abnormalities and bleeding is also associated with higher doses. Patients vital signs and hemoglobin, hematocrit, platelet count, prothrombin time and partial thromboplastin time should be monitored closely.

Hespan® should be used with caution in patients who have been anticoagulated with other drugs that negatively influence the coagulation system.

Regular and frequent clinical evaluation and complete blood counts (CBC) are necessary for proper monitoring of Hespan® use during leukapheresis. If the frequency of leukapheresis is to exceed the guidelines for whole blood donation, you may wish to consider the following additional tests: total leukocyte and platelet counts, leukocyte differential count, hemoglobin and hematocrit, prothrombin time (PT), and partial thromboplastin time (PTT).

Indirect bilirubin levels of 8.3 mg/L (normal 0.0–7.0 mg/L) have been reported in 2 out of 20 normal subjects who received multiple infusions of Hespan® (6% hetastarch in 0.9% sodium chloride injection). Total bilirubin was within normal limits at all times; indirect bilirubin returned to normal by 96 hours following the final infusion. The significance, if any, of these elevations is not known; however, caution should be observed before administering Hespan® to patients with a history of liver disease.

Elevated serum amylase levels may be observed temporarily following administration of Hespan® although no association with pancreatitis has been demonstrated. Serum amylase levels cannot be used to assess or to evaluate for pancreatitis for 3–5 days after administration of Hespan®. Elevated serum amylase levels persist for longer periods of time in patients with renal impairment. Hetastarch has not been shown to increase serum lipase.

One report suggests that in the presence of renal glomerular damage, larger molecules of Hespan® can leak into the urine and elevate the specific gravity. The elevation of specific gravity can obscure the diagnosis of renal failure.

Hespan® is not eliminated by hemodialysis. The utility of other extracorporeal elimination techniques has not been evaluated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies of animals have not been performed to evaluate the carcinogenic potential of hetastarch.

Teratogenic Effects

Pregnancy Category C

Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 mL) and on BD rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. When hetastarch was administered to New Zealand rabbits, BD rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident. There are no adequate and well-controlled studies in pregnant women. Hespan® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether hetastarch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hespan® is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of hetastarch in pediatric patients have not been established. Adequate, well-controlled clinical trials to establish the safety and effectiveness of Hespan® in pediatric patients have not been conducted. However, in one small double-blind study, 47 infants, children, and adolescents (ages 1 year to 15.5 years) scheduled for repair of congenital heart disease with moderate hypothermia were randomized to receive either Hespan® or Albumin as a postoperative volume expander during the first 24 hours after surgery. Thirty-eight children required colloid replacement therapy, of which 20 children received Hespan®. No differences were found in the coagulation parameters or in the amount of replacement fluids required in the children receiving 20 mL/kg or less of either colloid replacement therapy. In children who received greater than 20 mL/kg of Hespan®, an increase in prothrombin time was demonstrated (p=0.006).8 There were no neonates included in this study.

Adverse Reactions

Reported adverse reactions with hetastarch include:

General

Hypersensitivity (see WARNINGS).

Death, life-threatening anaphylactic/anaphylactoid reactions, cardiac arrest, ventricular fibrillation, severe hypotension, non-cardiac pulmonary edema, laryngeal edema, bronchospasm, angioedema, wheezing, restlessness, tachypnea, stridor, fever, chest pain, bradycardia, tachycardia, shortness of breath, chills, urticaria, pruritus, facial and periorbital edema, coughing, sneezing, flushing, erythema multiforme, and rash.

Cardiovascular

Circulatory overload, congestive heart failure, and pulmonary edema (see PRECAUTIONS).

Hematologic

Intracranial bleeding, bleeding and/or anemia due to hemodilution (see WARNINGS) and/or Factor VIII deficiency, acquired von Willebrand's-like syndrome, and coagulopathy including rare cases of disseminated intravascular coagulopathy and hemolysis.

Metabolic

Metabolic acidosis.

Other

Vomiting, peripheral edema of the lower extremities, submaxillary and parotid glandular enlargement, mild influenza-like symptoms, headaches, and muscle pains.

Hydroxyethyl starch-associated pruritus has been reported in some patients with deposits of hydroxyethyl starch in peripheral nerves.

Hespan Dosage and Administration

Dosage for Acute Use in Plasma Volume Expansion

Hespan® is administered by intravenous infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration.

Adults

The amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required although higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred (see WARNINGS and PRECAUTIONS).

Pediatric Patients

Adequate, well-controlled clinical trials to establish the safety and effectiveness of Hespan® in pediatric patients have not been conducted (see PRECAUTIONS, Pediatric Use).

Dosage in Leukapheresis

250 to 700 mL of Hespan® (6% hetastarch in 0.9% sodium chloride injection) to which citrate anticoagulant has been added is typically administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The Hespan® and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.

When stored at room temperature, Hespan® admixtures of 500–560 mL with citrate concentrations up to 2.5% were compatible for 24 hours. The safety and compatibility of additives other than citrate have not been established.

General Recommendations

Do not use plastic container in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

If administration is by pressure infusion, all air should be withdrawn or expelled from the bag through the medication port prior to infusion.

The safety and compatibility of other additives have not been established.

Directions for Use of EXCEL® Container

Caution: Before administering to the patient, review these directions:

Visual Checking

Do not remove the plastic infusion container from its overwrap until immediately before use.

While the overwrap is intact, identify the solution as Hespan®, the lot number, and the expiration date.

Check that the solution is clear.

Inspect the intact unit for signs of obvious damage. If present, the unit should not be used.

Removal of Overwrap

To open overwrap, tear at any notch located at either end of unit. After removing the overwrap, check for any leakage by squeezing container firmly. If any leaks are found, discard unit as sterility may be impaired.

Preparation for Administration (Use aseptic technique.)

Close flow control clamp of administration set.

Twist off plug from port designated "Infusion Set Port".

Insert spike of infusion set into port with a twisting motion until the set is firmly seated.

Suspend container from hanger.

Follow manufacturer's recommended procedures for the administration set.

Discontinue administration and notify physician immediately if patient exhibits signs of adverse reactions.

How is Hespan Supplied

Hespan® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.

NDC	Cat. No.	Size
Hespan® (6% hetastarch in 0.9% sodium chloride injection)
0264-1965-10	L6511	500 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Revised: September 2010

References

Diehl J., et al., Clinical Comparison of Hetastarch and Albumin in Postoperative Cardiac Patients. The Annals of Thoracic Surgery, 1982;34(6):674–679.

Gold M., et al., Comparison of Hetastarch to Albumin for Perioperative Bleeding in Patients Undergoing Abdominal Aortic Aneurysm Surgery. Annals of Surgery, 1990;211(4):482–485.

Kirklin J., et al., Hydroxyethyl Starch versus Albumin for Colloid Infusion Following Cardiopulmonary Bypass in Patients Undergoing Myocardial Revascularization. The Annals of Thoracic Surgery, 1984;37(1):40–46.

Moggio RA., et al., Hemodynamic Comparison of Albumin and Hydroxyethyl Starch in Postoperative Cardiac Surgery Patients. Critical Care Medicine, 1983;11(12):943–945.

Knutson JE., et al., Does Intraoperative Hetastarch Administration Increase Blood Loss and Transfusion Requirements After Cardiac Surgery? Anesthesia Analg., 2000;90:801–7.

Cope JT., et al., Intraoperative Hetastarch Infusion Impairs Hemostasis After Cardiac Operations. The Annals of Thoracic Surgery, 1997;63:78–83.

Damon L., Intracranial Bleeding During Treatment with Hydroxyethyl Starch. New England Journal of Medicine, 1987;317(15):964–965.

Brutocao D., et al., Comparison of Hetastarch with Albumin for Postoperative Volume Expansion in Children After Cardiopulmonary Bypass. Journal of Cardiothoracic and Vascular Anesthesia, 1996;10(3):348–351.

EXCEL and Hespan are registered trademarks of B. Braun Medical Inc.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

Y36-002-755 LD-233-1

PRINCIPAL DISPLAY PANEL - 500 mL

Hespan®

(6% hetastarch in 0.9%

sodium chloride injection)

Y94-003-110

LD-262-1

REF L6511

NDC 0264-1965-10

500 mL

EXCEL® CONTAINER

For intravenous use only.

Each 100 mL contains: Hetastarch 6 g

Sodium Chloride USP 0.9 g in Water for Injection, USP

pH adjusted with Sodium Hydroxide, NF

pH: approximately 5.9 with negligible buffering capacity

Calc. Osmolarity: approximately 309 mOsM

Electrolytes (mEq/L): Sodium 154 Chloride 154

If administration is by pressure infusion, all air

should be withdrawn or expelled from the bag

through the medication port prior to infusion.

Sterile, nonpyrogenic. Use only if solution is clear and container

and seals are intact. Single dose container. Discard unused solution.

Recommended Storage: Store at room temperature,

25ºC (77ºF). Avoid excessive heat. Protect from freezing.

Usual Dosage: See package insert for complete information.

Rx only

EXCEL and Hespan are registered trademarks of B. Braun Medical Inc.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

Y94-003-141

LD-152-3

Do not remove overwrap until ready for use. After removing the

overwrap, check for minute leaks by squeezing container firmly.

If leaks are found, discard solution as sterility may be impaired.

DO NOT INTRODUCE ADDITIVES OTHER THAN CITRATE INTO BAG.

EXP

LOT

Hespan
hetastarch in sodium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0264-1965
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HETASTARCH (HETASTARCH)	HETASTARCH	6 g in 100 mL
SODIUM CHLORIDE (SODIUM CATION)	SODIUM CHLORIDE	0.9 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
SODIUM HYDROXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0264-1965-10	12 CONTAINER In 1 CASE	contains a CONTAINER
1		500 mL In 1 CONTAINER	This package is contained within the CASE (0264-1965-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA890105	04/04/1991

Labeler - B. Braun Medical Inc. (002397347)

Revised: 07/2011B. Braun Medical Inc.

More Hespan resources

Hespan Side Effects (in more detail)
Hespan Dosage
Hespan Use in Pregnancy & Breastfeeding
Hespan Support Group
0 Reviews for Hespan - Add your own review/rating

Hespan MedFacts Consumer Leaflet (Wolters Kluwer)

Hespan Concise Consumer Information (Cerner Multum)

Hetastarch Monograph (AHFS DI)

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Blood Disorders

Friday, October 14, 2016

Hemabate

Generic Name: Carboprost Tromethamine
Class: Oxytocics
VA Class: HS875
Chemical Name: (5Z,9α,11α,13E,15S)-9,11,15-Trihydroxy-15-methyl-prosta-5,13-dien-1-oic acid
Molecular Formula: C₂₁H₃₆O₅•C₄H₁₁NO₃
CAS Number: 58551-69-2

Introduction

Stimulates uterine smooth muscle; synthetic derivative of prostaglandin F_2α.¹ ¹⁰ ¹¹ ¹⁹

Uses for Hemabate

Termination of Pregnancy

Termination of intrauterine pregnancy during the second trimester (weeks 13–20 of gestation, dated from the first day of the last menstrual period).¹ ¹⁴ ¹⁵ ¹⁶

Used after failure of another method (e.g., in the event of premature rupture of membranes with loss of hypertonic abortifacients accompanied by inadequate uterine activity, when repeated intra-amniotic drug administration needed to expel fetus); used to induce abortion after membrane rupture.¹

Postpartum Hemorrhage

Treatment of postpartum hemorrhage in the presence of uterine atony that has not responded to usual therapy (i.e., IV oxytocin, uterine massage, IM ergot alkaloids [unless contraindicated]).¹ ⁸ ⁹ ¹⁰ ¹² ¹³ ²⁰

Hemabate Dosage and Administration

General

To minimize adverse GI effects, consider pretreatment use or concurrent administration of antiemetic and antidiarrheal agents.¹ ¹⁴ ¹⁵

Administration

IM Administration

Administer by deep IM injection.¹

For postpartum hemorrhage, has been administered directly into the uterine corpus†.⁸

Dosage

Available as carboprost tromethamine; dosage is expressed in terms of carboprost.¹

Closely adhere to recommended dosage.¹ Dosage determined by uterine response.¹

Adults

Termination of Pregnancy

IM

Initially, 250 mcg.¹ ¹⁵ Alternatively, initiate with test dose of 100 mcg.¹ ¹⁵

Subsequently, 250 mcg at 1.5- to 3.5-hour intervals depending on uterine response.¹ ¹⁵ After several 250-mcg doses, may increase dose to 500 mcg if uterine contractility is inadequate.¹ ¹⁵ Maximum total dose is 12 mg.¹

Postpartum Hemorrhage

IM

Initially, 250 mcg; repeat every 15–90 minutes up to a maximum total dose of 2 mg.¹ ⁸ ¹⁰ Single dose usually adequate.¹ ¹³ ²⁰ Clinician should determine the need for additional doses and dosing interval based on clinical events.¹

Prescribing Limits

Adults

Termination of Pregnancy

IM

Maximum total dose is 12 mg; continuous administration for >2 days not recommended.¹

Postpartum Hemorrhage

IM

Maximum total dose is 2 mg.¹

Cautions for Hemabate

Contraindications

Known hypersensitivity to carboprost.¹

Acute pelvic inflammatory disease.¹

Active cardiac, pulmonary, renal, or hepatic disease.¹

Warnings/Precautions

Warnings

Administer by qualified professional personnel in a hospital where intensive care and surgical facilities are immediately available.¹

Considerations in Patients Undergoing Termination of Pregnancy

Carboprost does not affect the fetoplacental unit.¹ Possibility exists that a previable fetus could exhibit transient signs of life following carboprost-induced abortion; carboprost is not indicated if the fetus has reached the stage of viability.¹

If the pregnancy is not terminated with carboprost, complete abortion using another method.¹

Risk of cervical trauma; examine each patient for cervical injuries after abortion is complete.¹ ¹⁴ Caution in patients with a compromised (scarred) uterus.¹

Benzyl Alcohol in Neonates

Carboprost tromethamine injection contains as a preservative benzyl alcohol, which has been associated with toxicity (fatalities) in neonates.¹ (See Pediatric Use under Cautions.)

General Precautions

Musculoskeletal Effects

Proliferation of long bones reported in neonates receiving long-term therapy with alprostadil (prostaglandin E₁).¹ ²² No evidence that short-term administration of carboprost has similar effects on bone.¹

Concomitant Diseases

Caution in patients with history of asthma, seizure disorders, diabetes, or anemia.¹ ²⁴

Fever

Transient fever (i.e., temperature elevations >1.1°C) reported in approximately 12.5% of patients.¹ When used for termination of pregnancy, may be difficult to distinguish drug-induced temperature elevations from post-abortion endometritis.¹

Cardiovascular Effects

Increased BP reported.¹ ¹³ ²⁰ Increase in BP was observed in 4% of women receiving the drug for postpartum hemorrhage in 1 study; specific treatment for hypertension was not needed.¹ ¹³

Caution in patients with hypertension, hypotension, or cardiovascular disease.¹

Chorioamnionitis

Chorioamnionitis may contribute to postpartum uterine atony and hemorrhage; individuals with chorioamnionitis experiencing postpartum hemorrhage have failed to respond to carboprost.¹ ⁸ ⁹ ¹⁰ ¹² ¹³

Specific Populations

Pregnancy

Category C.¹

Pediatric Use

Not indicated in pediatric patients.¹

Large amounts of benzyl alcohol (i.e., 100–400 mg/kg daily) have been associated with toxicity (fatal “gasping syndrome”) in neonates;¹ ² ³ ⁴ ⁵ ⁶ ⁷ each mL of carboprost tromethamine injection contains 9.45 mg of benzyl alcohol.¹

Hepatic Impairment

Caution in patients with hepatic disease, including jaundice.¹ Contraindicated in patients with active hepatic disease.¹

Renal Impairment

Caution in patients with renal disease.¹ Contraindicated in patients with active renal disease.¹

Common Adverse Effects

Vomiting,¹ ¹⁰ ¹⁴ ¹⁵ ¹⁸ ²⁰ diarrhea,¹ ¹⁰ ¹³ ¹⁴ ¹⁵ ¹⁸ nausea,¹ ¹³ ²⁰ fever,¹ ²⁰ flushing.¹ ¹⁴ ¹⁵

Interactions for Hemabate

May increase activity of other oxytocic agents; concomitant use not recommended.¹

Hemabate Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following IM administration; peak plasma concentrations attained in 20–30 minutes.¹ ¹¹ ²¹

Onset

When used for postpartum hemorrhage, increase in uterine tone and decreased bleeding noted after about 45 minutes.¹³

Elimination

Metabolism

Metabolized principally via ω-oxidation and to limited extent via ω-oxidation to a number of metabolites.¹⁹ Metabolized more slowly than naturally occurring prostaglandin F_2α.¹¹ ¹⁵ ¹⁷ ¹⁹ ²¹

Elimination Route

Excreted in urine (83%), mainly as metabolites.¹⁹

Stability

Storage

Parenteral

Injection

2–8°C.¹

ActionsActions

Elicits pharmacologic responses usually produced by endogenous prostaglandin F_2α; more potent and has longer duration of activity on the uterus than prostaglandin F_2α.¹⁵ ¹⁷ ¹⁸

Increases the amplitude and frequency of uterine contractions throughout pregnancy; uterine response to the drug increases with the duration of pregnancy.²³

After delivery, uterine contractions impede uterine blood flow.¹

Produces cervical dilation.¹⁵

Produces contraction of vascular smooth muscle; may result in increased BP.¹ ¹⁰ ²⁰

Causes stimulation of the smooth muscle of the GI tract, increasing GI motility.¹ ¹⁸

Stimulates transient bronchoconstriction in some patients.¹ ¹²

Advice to Patients

Importance of women informing clinicians if they plan to breast-feed.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Carboprost Tromethamine
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection	250 mcg (of carboprost)/mL	Hemabate (with benzyl alcohol)	Pfizer

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Pharmacia & Upjohn. Hemabate (carboprost tromethamine) injection prescribing information. New York, NY; 2006 Mar.

2. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356-8. [IDIS 175725] [PubMed 6889041]

3. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12(2):10-11.

4. Centers for Disease Control. Neonatal deaths associated with use of benzyl alcohol. MMWR. 1982; 31:290-1. [IDIS 150868] [PubMed 6810084]

5. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. [IDIS 160823] [PubMed 7133084]

6. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288-92. [PubMed 6440575]

7. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344-6. [IDIS 181207] [PubMed 6695984]

8. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Postpartum hemorrhage. Practice Bulletin No. 76. Obstet Gynecol. 2006; 108:1039-47. [PubMed 17012482]

9. Oleen MA, Mariano JP. Controlling refractory atonic postpartum hemorrhage with Hemabate sterile solution. Am J Obstet Gynecol. 1990; 16:205-8.

10. Briggs GG, Wan SR. Drug therapy during labor and delivery, part 2. Am J Health-Syst Pharm. 2006; 63:1131-9. [PubMed 16754739]

11. Bygdeman M. Pharmacokinetics of prostaglandins. Best Pract Res Clin Obstet Gynaecol. 2003; 17:707-16. [PubMed 12972009]

12. Dildy GA. Postpartum hemorrhage: new management options. Clin Obstet Gynecol. 2002; 45:330-44. [PubMed 12048393]

13. Hayashi RH, Castillo MS, Noah ML. Management of severe postpartum hemorrhage with prostaglandin F_2α analogue. Obstet Gynecol. 1984; 63:806-8. [PubMed 6610143]

14. World Health Organization task force on the use of prostaglandins for regulation of fertility. Prostaglandins and abortion. I. Intramuscular administration of 15-methyl prostaglandin F_2α for induction of abortion in weeks 10 to 20 of pregnancy. Am J Obstet Gynecol. 1977; 129:593-6. [PubMed 920759]

15. Schwallie PC, Lamborn KR. Induction of abortion by intramuscular administration of (15S)-15-methyl PGF2α: an overview of 815 cases. J Reprod Med. 1979; 23:289-93. [PubMed 392084]

16. Stubblefield PG, Carr-Ellis S, Borgatta L. Methods for induced abortion. Obstet Gynecol. 2004; 104:174-85. [PubMed 15229018]

17. Bygdeman M, Swahn ML. Uterine contractility during pregnancy and the effect of abortifacient drugs. Bailliere's Clin Obstet Gynecol. 1990; 4:249-61.

18. Karim SMM, Sharma SD. Termination of second trimester pregnancy with 15 methyl analogues of prostaglandins E₂ and F_2α. J Obstet Gynaecol Br Commonw. 1972; 79:737-43. [PubMed 5070889]

19. Hansson G, Granström E. Metabolism of 15-methyl-prostaglandin F₂α in the cynomologus monkey and the human female. Biochem Med. 1977; 18:420-39. [PubMed 413545]

20. Buttino L, Garite TJ. The use of 15 methyl F₂α prostaglandin (prostin 15M) for the control of postpartum hemorrhage. Am J Perinatol. 1986; 3:241-3. [PubMed 3487334]

21. Bergström S, Greén K, Bygdeman M. Metabolism and pharmaco-kinetics of 15 methyl PGF_2α and its ester after administration via various routes. Prostaglandins. 1976; 12 (Suppl):17-26.

22. Pharmacia. Prostin VR Pediatric (alprostadil) injection prescribing information. Kalamazoo, MI; 2002 Sep.

23. AHFS Drug Information 2007. McEvoy GK, ed. Dinoprostone. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3267-9.

24. Pfizer, Morris Plains, NJ: Personal communication.

More Hemabate resources

Hemabate Side Effects (in more detail)
Hemabate Use in Pregnancy & Breastfeeding
Hemabate Support Group
0 Reviews for Hemabate - Add your own review/rating

Hemabate Prescribing Information (FDA)

Hemabate Concise Consumer Information (Cerner Multum)

Hemabate Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Hemabate with other medications

Abortion
Postpartum Bleeding

Humulin 50/50

Generic Name: insulin isophane and insulin regular (IN su lin EYE soe fane and IN su lin REG ue lar)

Brand Names: HumuLIN 50/50, HumuLIN 70/30, HumuLIN 70/30 Pen, NovoLIN 70/30, NovoLIN 70/30 Innolet, NovoLIN 70/30 PenFill, Relion NovoLIN 70/30 Innolet, ReliOn/NovoLIN 70/30

What is Humulin 50/50 (insulin isophane and insulin regular)?

Insulin isophane and insulin regular is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin isophane and insulin regular is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin isophane and insulin regular is used to treat diabetes.

Insulin isophane and insulin regular may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Humulin 50/50 (insulin isophane and insulin regular)?

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

What should I discuss with my healthcare provider before using Humulin 50/50 (insulin isophane and insulin regular)?

Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin isophane and insulin regular, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

FDA pregnancy category B. This medication is not expected to 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 insulin isophane and insulin regular 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.

How should I use Humulin 50/50 (insulin isophane and insulin regular)?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Insulin isophane and insulin regular is given as an injection (shot) under your skin. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

Carefully shake or rotate the insulin vial (bottle) several times to thoroughly mix the insulin isophane and insulin regular before each use. Shake the mixture until it looks cloudy or milky. Do not use the mixture if has clumps or white particles in it after mixing, or if the white substance remains at the bottom of the vial. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your insulin isophane and insulin regular dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials or injection pens: Keep in the carton and store in a refrigerator. Do not freeze. Throw away any insulin not used before the expiration date on the medicine label. Storing after your first use: Keep the "in-use" vials or injection pens at cool room temperature, away from heat and light, and use prior to the expiration date. Throw an in-use injection pen 10 days after the first use, even if there is still medicine left in it.

Do not freeze insulin isophane and insulin regular, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Since insulin isophane and insulin regular is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin isophane and insulin regular, be sure to eat a meal or snack within 30 to 60 minutes. Do not use extra insulin isophane and insulin regular to make up a missed dose.

It is important to keep insulin isophane and insulin regular on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using Humulin 50/50 (insulin isophane and insulin regular)?

Do not change the brand of insulin isophane and insulin regular or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin isophane and insulin regular.

Humulin 50/50 (insulin isophane and insulin regular) side effects

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin isophane and insulin regular. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin isophane and insulin regular.

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 Humulin 50/50 (insulin isophane and insulin regular)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

albuterol (Proventil, Ventolin);

clonidine (Catapres);

reserpine;

guanethidine (Ismelin); or

beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.

There are many other medicines that can increase or decrease the effects of insulin isophane and insulin regular on lowering your blood sugar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Humulin 50/50 resources

Humulin 50/50 Side Effects (in more detail)
Humulin 50/50 Use in Pregnancy & Breastfeeding
Humulin 50/50 Drug Interactions
Humulin 50/50 Support Group
0 Reviews for Humulin 50/50 - Add your own review/rating

Humulin 50/50 Pens MedFacts Consumer Leaflet (Wolters Kluwer)

Humulin 50/50 Prescribing Information (FDA)

Humulin 70/30 Prescribing Information (FDA)

Novolin 70/30 Prescribing Information (FDA)

Novolin 70/30 InnoLets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Humulin 50/50 with other medications

Diabetes, Type 1
Diabetes, Type 2
Gestational Diabetes

Where can I get more information?

Your pharmacist can provide more information about insulin isophane and insulin regular.

See also: Humulin 50/50 side effects (in more detail)

Humatrope Vial

Pronunciation: SOE-ma-TROE-pin
Generic Name: Somatropin (rDNA origin - Refrigerated)
Brand Name: Humatrope

Humatrope Vial is used for:

Treating certain children or adults when the body does not produce enough growth hormone. It is also used to treat certain children who are not growing normally because of Turner syndrome or certain other conditions (eg, idiopathic short stature, short stature homeobox-containing gene [SHOX] deficiency). It may also be used for other conditions as determined by your doctor.

Humatrope Vial is a growth hormone. It works by stimulating growth in patients who do not make enough natural growth hormone.

Do NOT use Humatrope Vial if:

you are allergic to any ingredient in Humatrope Vial or in the diluent

you have active or recurring cancer or brain tumor, or you currently receive treatment for cancer

you have severe breathing problems (eg, respiratory failure) or a serious illness caused by complications from a surgery or injury

you have a certain type of eye problem caused by diabetes (diabetic retinopathy)

the patient is a child who has Prader-Willi syndrome and is severely overweight or has severe breathing problems (eg, respiratory infection, history of airway blockage or sleep apnea)

the patient is a child who has epiphyseal closure (bone growth is complete)

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

Before using Humatrope Vial:

Some medical conditions may interact with Humatrope Vial. 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 kidney or liver problems, lung or breathing problems (eg, airway blockage, respiratory infection, sleep apnea), an underactive thyroid, heart problems, high blood pressure, ear or hearing problems (eg, repeated ear infections), pancreas problems, or endocrine problems (eg, pituitary or adrenal gland problems)

if you have a history of diabetes or high blood sugar levels, or if a member of your family has had diabetes

if you have a history of leukemia, other types of cancer (eg, skin cancer), or any unusual growths or tumors (especially in the brain)

if you have curvature of the spine (scoliosis), Prader-Willi syndrome, or a certain eye problem called papilledema (swelling of the area around your optic nerve)

if you are very overweight or have had a recent major surgery or injury

Some MEDICINES MAY INTERACT with Humatrope Vial. Tell your health care provider if you are taking any other medicines, especially any of the following:

Corticosteroids (eg, prednisone) or estrogens because they may decrease Humatrope Vial's effectiveness

Anticonvulsants (eg, carbamazepine) or cyclosporine because the risk of their side effects may be increased by Humatrope Vial

Insulin or other medicines for diabetes because their effectiveness may be decreased by Humatrope Vial

This may not be a complete list of all interactions that may occur. Ask your health care provider if Humatrope Vial 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 Humatrope Vial:

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

An extra patient leaflet is available with Humatrope Vial. Talk to your pharmacist if you have questions about this information.

Humatrope Vial is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Humatrope Vial. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Do NOT shake Humatrope Vial. Swirl gently to mix.

Humatrope Vial should be clear and colorless. Do not use Humatrope Vial if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.

Be sure to rotate your injection site as directed to help avoid thickening or hardening of the skin.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of Humatrope Vial, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Humatrope Vial.

Important safety information:

Severe and sometimes fatal lung and breathing problems have occurred with the use of Humatrope Vial in certain children with Prader-Willi syndrome. These children were usually either very overweight or had severe breathing problems (eg, airway blockage, sleep apnea, lung or airway infection). The risk may be greater in boys. Children with Prader-Willi syndrome should have certain breathing tests before they start Humatrope Vial. They should be monitored for signs of lung or airway infection. They should also have effective weight control. Contact the doctor at once if the patient develops irregular breathing during sleep, new or increased snoring, or symptoms of lung or airway infection (eg, fever, coughing, sore throat, shortness of breath, chest pain or discomfort).

Rarely, children using Humatrope Vial have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.

Rarely, increased blood pressure in the head has been reported in patients using somatropin. The risk may be greater in patients with Turner syndrome or Prader-Willi syndrome. Symptoms usually occurred within the first 8 weeks after the start of treatment. The symptoms have gone away after the dose was lowered or treatment was stopped. Discuss any questions or concerns with your doctor. Contact your doctor right away if you develop symptoms such as vision changes or severe headache, nausea, or vomiting.

Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Humatrope Vial. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.

Humatrope Vial may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

Diabetes patients - Humatrope Vial may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Lab tests, including blood sugar levels, eye exams, and thyroid function, may be performed while you use Humatrope Vial. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Humatrope Vial with caution in the ELDERLY; they may be more sensitive to its effects.

Caution is advised when using Humatrope Vial in CHILDREN; they may be more sensitive to its effects, especially pancreas inflammation.

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

Possible side effects of Humatrope Vial:

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:

Back pain; headache; increased cough; mild flu-like symptoms; mild swelling (eg, of the hands or feet); muscle or joint pain; redness or itching at the injection site; sore throat; stuffy or runny nose.

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); breast enlargement in males; burning, tingling, or numbness; change in appearance or size of a mole; chest pain or discomfort; confusion; ear pain, discharge, or discomfort; fever; hearing problems; hip or knee pain; limp; nausea or vomiting; new growth on the skin; one-sided weakness; persistent or severe cough or sore throat; severe or persistent muscle or joint pain; severe or persistent stomach or back pain; severe or persistent swelling of the hands, ankles, or feet; shortness of breath; slurred speech; snoring or irregular breathing during sleep; sudden, severe, or persistent headache or dizziness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; 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: Humatrope 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 swelling of the hands, ankles, or feet; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; fast heartbeat; flushing; increased sweating; increased thirst, hunger, or urination; vision changes; unusual weakness).

Proper storage of Humatrope Vial:

Store new (unopened) vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use Humatrope Vial past the expiration date on the product label.

After mixing with the provided diluent, store vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away mixed vials after 14 days, even if they still contain medicine. If you mix Humatrope Vial with sterile water or bacteriostatic water for injection, check with your doctor or pharmacist about how to store Humatrope Vial.

Contact your pharmacist if you have any questions about how to properly store Humatrope Vial. Keep Humatrope Vial out of the reach of children and away from pets.

General information:

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

Humatrope Vial 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.

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

This information is a summary only. It does not contain all information about Humatrope Vial. 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

More Humatrope resources

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

Compare Humatrope with other medications

Adult Human Growth Hormone Deficiency
Hypopituitarism
Idiopathic Short Stature
Pediatric Growth Hormone Deficiency
Short Stature for Age
Turner's Syndrome

Humate-P

Pronunciation: AN-tee-hee-moe-FIL-ik FAK-tor/von WILL-a-brand FAK-tor
Generic Name: Antihemophilic Factor/von Willebrand Factor (Human)
Brand Name: Humate-P

Humate-P is used for:

Preventing and controlling bleeding in adult patients with hemophilia A. It is also used to control certain types of bleeding episodes (eg, due to injury or surgery) in patients with von Willebrand disease.

Humate-P is a human clotting factor complex prepared from pooled human plasma. It works by increasing the amount of clotting factor VIII and von Willebrand factor in the blood. This helps the blood to clot properly, which helps to stop bleeding.

Do NOT use Humate-P if:

you are allergic to any ingredient in Humate-P

you have had a severe allergic reaction to other medicines that contain antihemophilic factor or von Willebrand factor

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

Before using Humate-P:

Some medical conditions may interact with Humate-P. 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 blood clots in the legs, lungs, or eye, or if you are at risk for developing blood clots

Some MEDICINES MAY INTERACT with Humate-P. However, no specific interactions with Humate-P are known at this time.

Ask your health care provider if Humate-P 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 Humate-P:

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

Humate-P may be given as an injection at your doctor's office, hospital, or clinic. If you will be using Humate-P at home, a health care provider will teach you how to use it. Be sure you understand how to use Humate-P. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Do not shake Humate-P.

Do not use Humate-P if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Use Humate-P within 3 hours after mixing.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of Humate-P, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Humate-P.

Important safety information:

Humate-P comes from human blood. Rarely, patients receiving products that come from human blood have developed certain viral infections (eg, parvovirus B19, hepatitis A). Discuss any questions or concerns with your doctor. Contact your doctor if you develop symptoms such as fever, rash, joint aches or pain, loss of appetite, nausea, vomiting, unusual tiredness, or yellowing of the eyes or skin.

Discuss with your doctor whether you should receive a hepatitis A and hepatitis B vaccine.

Patients receiving products that come from human blood have a very rare risk of developing a central nervous system disease called Creutzfeldt-Jakob disease. Discuss any questions or concerns with your doctor.

Tell your doctor or dentist that you take Humate-P before you receive any medical or dental care, emergency care, or surgery. Blood clotting tests will be performed if you have surgery.

Lab tests, including blood clotting tests, blood hematocrit levels, factor VIII levels, or von Willebrand factor levels, may be performed while you use Humate-P. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Humate-P should be used with extreme caution in NEWBORNS; safety and effectiveness in newborns have not been confirmed.

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

Possible side effects of Humate-P:

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:

Mild numbness or tingling.

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); back or stomach pain; calf pain, swelling, or tenderness; chest pain; coughing up blood; dark urine; fever or chills; new or worsening bruising or bleeding; shortness of breath; yellowing of the skin or eyes.

See also: Humate-P 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.

Proper storage of Humate-P:

Store Humate-P in the refrigerator or at room temperature up to 77 degrees. Store away from heat and light. Do not freeze. Do not refrigerate after mixing. Do not use Humate-P past the expiration date on the container. Keep Humate-P out of the reach of children and away from pets.

General information:

If you have any questions about Humate-P, please talk with your doctor, pharmacist, or other health care provider.

Humate-P 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.

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

This information is a summary only. It does not contain all information about Humate-P. 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

More Humate-P resources

Humate-P Side Effects (in more detail)
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Hyperlyte CR

Dosage Form: injection, solution, concentrate
Hyperlyte CR

Hyperlyte® CR

Multi-Electrolyte Concentrate (20 mL/dose)

PHARMACY BULK PACKAGE

NOT FOR DIRECT INFUSION

FOR INTRAVENOUS INFUSION ONLY. MUST BE DILUTED PRIOR TO INJECTION. Contains no phosphate.

Hyperlyte CR Description

A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion.

Hyperlyte® CR (Multi-Electrolyte Concentrate) is a sterile, nonpyrogenic, concentrated solution of intra- and extracellular electrolytes, excluding phosphate. No bacteriostatic or antimicrobial agent has been added.

Each 20 mL contains: Potassium Acetate USP 1.96 g; Sodium Chloride USP 1.17 g; Sodium Acetate Trihydrate USP 0.68 g; Magnesium Chloride Hexahydrate USP 0.51 g; Calcium Chloride Dihydrate USP 0.37 g; Water for Injection USP qs

pH adjusted with Glacial Acetic Acid USP as needed

pH: 5.2 (5.0-5.4); Calculated Osmolarity: 5500 mOsmol/liter

Concentration of Electrolytes (mEq/20 mL dose): Sodium 25; Potassium 20; Calcium 5; Magnesium 5; Chloride 30; Acetate 30

The formulas of the active ingredients are:

Ingredients	Molecular Formula	Molecular Weight
Potassium Acetate USP	CH3COOK	98.14
Sodium Chloride USP	NaCl	58.44
Sodium Acetate Trihydrate USP	CH3COONa•3H2O	136.08
Magnesium Chloride Hexahydrate USP	MgCl2•6H2O	203.30
Calcium Chloride Dihydrate USP	CaCl2•2H2O	147.02

Hyperlyte CR - Clinical Pharmacology

Hyperlyte® CR provides a source of intra- and extracellular electrolytes in suitable amounts, to help maintain normal cellular metabolism during total parenteral nutrition (TPN) and other parenteral therapy in adults. Use of properly diluted Hyperlyte® CR meets most adult daily electrolyte requirements and provides adjunctive therapy for replenishment of depleted electrolyte stores.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Potassium is the chief cation of body cells (160 mEq/liter of intracellular water) and is concerned with the maintenance of body fluid composition and electrolyte balance. Potassium participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability.

Magnesium, a principal cation of soft tissue, is primarily involved in enzyme activity associated with the metabolism of carbohydrates and protein. Magnesium is also involved in neuromuscular irritability.

Acetate is an organic ion which is a hydrogen ion acceptor, contributes bicarbonate during its metabolism to carbon dioxide and water, and serves as an alkalinizing agent.

Indications and Usage for Hyperlyte CR

Hyperlyte® CR is indicated for use as a supplement to parenteral nutritional solutions containing amino acids, dextrose and/or other calorie sources delivered by central venous or peripheral infusion, to facilitate amino acid utilization and maintain electrolyte balance in adults.

Hyperlyte® CR (Multi-Electrolyte Concentrate) is also indicated as a source of replacement electrolytes for the depleted adult patient during parenteral therapy.

Contraindications

Hyperlyte® CR is contraindicated in clinical conditions where the administration of potassium, sodium, calcium, magnesium, or chloride could be clinically detrimental.

Hyperlyte® CR is not intended for pediatric use.

Warnings

Strongly hypertonic solution. Must be properly diluted and thoroughly mixed before injection.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Contains no phosphate. Patients receiving TPN solutions containing concentrated dextrose may also require phosphate in addition to Hyperlyte® CR.

Each 20 mL dose contains 20 mEq of potassium. Patient requirements should be carefully evaluated prior to the addition of any potassium salt to a solution containing Hyperlyte® CR.

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema.

Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.

Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate should be done with great care in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency.

Precautions

General

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added.

This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

Blood levels of sodium, potassium, calcium, magnesium, phosphorus and chloride should be monitored frequently during parenteral nutrition or intravenous therapy, and the daily dosage of electrolytes may require tailoring to meet individual needs. In tissue electrolyte depletion, addition of certain electrolytes may be required to meet individual patient needs.

Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients.

Care must be exercised in administering solutions containing up to 30 mEq of sodium and 40 mEq of potassium per liter to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

Potassium therapy should be guided by serial electrocardiograms since plasma levels are not necessarily indicative of tissue potassium levels.

Solutions containing potassium, magnesium or calcium should be used with caution in the presence of cardiac disease, particularly when accompanied by renal disease. Parenteral magnesium or calcium should be administered with extreme caution to patients receiving digitalis preparations.

Extraordinary electrolyte and fluid losses are not necessarily corrected by infusion of solutions containing Hyperlyte® CR. In order to avoid deficits, special consideration must be given to replacement of excessive fluid and electrolyte losses in such conditions as protracted vomiting or diarrhea, nasogastric suction, or fistula drainage.

If both phosphate and Hyperlyte® CR are to be added to the solution for TPN administration, add the Hyperlyte® CR to one container (either to the amino acids or the concentrated dextrose) and add the phosphate to the other to avoid physical incompatibilities between calcium and phosphorus.

Solutions containing acetate should be used with caution. Excess administration may result in metabolic alkalosis.

If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration.

Use only if solution is clear and vacuum is present. Discard the container no later than 4 hours after initial closure puncture.

Laboratory Tests

Periodic laboratory determinations are necessary to monitor changes in electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Drug Interactions

Administration of barbiturates, narcotics, hypnotics or systemic anesthetics should be adjusted and used with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with Hyperlyte® CR (Multi-Electrolyte Concentrate).

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Hyperlyte® CR (Multi-Electrolyte Concentrate). It is also not known whether Hyperlyte® CR can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyperlyte® CR should be given to a pregnant woman only if clearly needed.

Labor and Delivery

As reported in the literature, electrolyte containing solutions have been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

Nursing Mothers

Because many drugs are excreted in human milk, caution should be exercised when solutions containing electrolytes are administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric populations have not been established.

See WARNINGS and CONTRAINDICATIONS .

Geriatric Use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

See WARNINGS.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

Symptoms may result from an excess or deficit of one or more of the ions present in the final infusate. Therefore, frequent monitoring of blood electrolyte levels is essential.

Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.

Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea.

The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest.

Potassium deficits result in disruption of neuromuscular functions, and intestinal ileus and dilatation.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.

Abnormally high plasma levels of calcium can result in depression, amnesia, headaches, drowsiness, disorientation, syncope, hallucinations, hypotonia of both skeletal and smooth muscles, dysphagia, arrhythmias and coma.

Calcium deficits can result in neuromuscular hyperexcitability, including cramps and convulsions.

Abnormally high plasma levels of magnesium can result in flushing, sweating, hypotension, circulatory collapse, and depression of cardiac and central nervous system function. Respiratory depression is the most immediate threat to life.

Magnesium deficits can result in tachycardia, hypertension, hyperirritability and psychotic behavior.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Overdosage

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition and institute appropriate corrective treatment.

In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels.

Treatment of hyperkalemia includes the following:

Dextrose Injection USP, 10% or 25% containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL per hour.

Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema.

Hemodialysis and peritoneal dialysis. The use of potassium-containing foods or medications must be eliminated. However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

Hyperlyte CR Dosage and Administration

Not for direct patient injection.

Hyperlyte® CR (Multi-Electrolyte Concentrate) in Pharmacy Bulk Package is for prescription compounding of intravenous admixtures only. Not for direct patient injection. Dilute to appropriate strength with suitable intravenous fluid prior to administration.

For adults, one 20 mL dose of Hyperlyte® CR should be added to each liter of amino acid/dextrose solution (TPN) or other suitable intravenous solution.

Hyperlyte® CR contains no phosphate. It may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions in this solution should be considered when phosphate is present in the additive solution in order to avoid precipitation.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.

How is Hyperlyte CR Supplied

Hyperlyte® CR (Multi-Electrolyte Concentrate) is supplied sterile and nonpyrogenic in Pharmacy Bulk Package with solid stoppers, packaged 12 per case.

Canada DIN	NDC	Cat. No.	Size
Hyperlyte® CR (Multi-Electrolyte Concentrate)
01924311	0264-1943-20	S9432	250 mL

Revised: March 2009

Hyperlyte is a registered trademark of B. Braun Medical Inc.

Directions for Use of Pharmacy Bulk Package in B. Braun Glass Containers

Warning: Not for direct infusion. For preparation of admixtures for intravenous infusion.

The pharmacy bulk package is for use in a Pharmacy Admixture Service only. Use of this product is restricted to a suitable work area, such as a laminar flow hood.

Additives should not be made to Pharmacy Bulk Packages.

Designed for use with a vented sterile dispensing set. Use 18 to 22 gauge needle size for spiking/admixing or withdrawing solutions from the glass bottle.

Before use, perform the following checks:

Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.

Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. In checking for cracks, do not be confused by normal surface marks and seams on bottom and sides of bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle.

To remove the outer closure, lift the tear tab and pull up, over, and down until it is below the stopper (see Figure 1). Use a circular pulling motion on the tab until it breaks away.

Grasp and remove the metal disk, exercising caution not to touch the exposed sterile stopper surface.

Check for vacuum at first puncture of stopper. Insert the spike fully into the outlet port of the stopper (see Figure 2) and promptly invert the bottle. Verify vacuum by observing rising air bubbles. Do not use the bottle if vacuum is not present. Refer to Directions for Use of set to be used.

If set insertion is not performed immediately following removal of protective metal disk, swab stopper with a suitable disinfectant.

Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

After admixture and during use, reinspect the solution frequently. If any evidence of solution contamination or instability is found, discontinue use immediately.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4

Y36-002-688

Package Insert

Rx only

PRINCIPAL DISPLAY PANEL - 250 mL

250 mL

Canada DIN 01924311

NDC 0264-1943-20

S9432

Hyperlyte® CR

(Multi-Electrolyte Concentrate)

(20 mL/dose)

PHARMACY BULK PACKAGE

NOT FOR DIRECT INFUSION

Each 20 mL contains:

Potassium Acetate USP 1.96 g; Sodium Chloride USP

1.17 g; Sodium Acetate•3H2O USP 0.68 g

Magnesium Chloride•6H2O USP 0.51 g

Calcium Chloride•2H2O USP 0.37 g

Water for Injection USP qs

pH adjusted with Glacial Acetic Acid USP as needed

pH: 5.2 (5.0-5.4); Calc. Osmolarity: 5500 mOsmol/liter

B. Braun Medical Inc.

Irvine, CA USA 92614-5895

Opened: Date Time

Electrolytes (mEq/20 mL dose):

Na+ 25 K+ 20 Ca++ 5
Mg++ 5 Cl– 30 Acetate 30

Contains no more than 45 μg/L of aluminum.

Sterile, nonpyrogenic.

Pharmacy Bulk Package. No antimicrobial or bacteriostatic

agent has been added.

Recommended Storage:

Room temperature (25°C). Avoid excessive heat.

Protect from freezing. See Package Insert.

WARNING: Not for direct infusion. For prescription

compounding of intravenous admixtures only.

Concentrated solution – dilute to appropriate strength

with suitable intravenous fluid prior to administration.

Use only if solution is clear and vacuum is present.

Discard the container no later than 4 hours after initial

closure puncture.

Rx only

Hyperlyte is a registered trademark of B. Braun Medical Inc.

In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4

Y37-002-289

Made in USA

HYPERLYTE CR
multi electrolyte concentrate injection, solution, concentrate

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0264-1943
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM ACETATE (POTASSIUM CATION)	POTASSIUM ACETATE	1.96 g in 20 mL
SODIUM CHLORIDE (SODIUM CATION)	SODIUM CHLORIDE	1.17 g in 20 mL
SODIUM ACETATE (SODIUM CATION)	SODIUM ACETATE	0.68 g in 20 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION)	MAGNESIUM CHLORIDE	0.51 g in 20 mL
CALCIUM CHLORIDE (CALCIUM CATION)	CALCIUM CHLORIDE	0.37 g in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0264-1943-20	12 CONTAINER In 1 CASE	contains a CONTAINER
1		250 mL In 1 CONTAINER	This package is contained within the CASE (0264-1943-20)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		06/21/2011

Labeler - B. Braun Medical Inc. (002397347)

Revised: 06/2011B. Braun Medical Inc.

More Hyperlyte CR resources

Hyperlyte CR Side Effects (in more detail)
Hyperlyte CR Drug Interactions
Hyperlyte CR Support Group
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