histrelin acetate Subcutaneous

his-TREL-in

Commonly used brand name(s)

In the U.S.

• Supprelin LA


• Vantas

Available Dosage Forms:

• Kit


• Implant

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Gonadotropin Releasing Hormone Agonist

Uses For histrelin acetate

Histrelin is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. It works in the brain to reduce the blood levels of sex hormones, such as testosterone and estrogen. The histrelin implant is placed under the skin. The implant releases small amounts of histrelin in the body every day for 12 months.

Histrelin (Vantas®) is used to treat advanced prostate cancer in adults. It will reduce the level of testosterone, a male hormone, in the blood. Testosterone makes most prostate cancers grow. Histrelin is not a cure for prostate cancer, but it may help relieve the symptoms.

Histrelin (Supprelin® LA) is used to treat central precocious puberty (CPP) in children. CPP is a condition where puberty begins at an unusually early age. This usually means puberty occurs before 8 years of age in girls and before 9 years of age in boys. Histrelin works by reducing the amount of sex hormones (eg, estrogen and testosterone) in the blood.

histrelin acetate is available only with your doctor's prescription.

Before Using histrelin acetate

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 histrelin acetate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to histrelin acetate 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

The Vantas® form of histrelin should not be used in children.

Appropriate studies have not been performed on the relationship of age to the effects of the Supprelin® LA form of histrelin in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of histrelin (eg, Supprelin® LA, Vantas®) in geriatric patients.

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

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 histrelin acetate. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or


• Heart attack, history of or


• Heart disease or


• Hyperglycemia (high blood sugar) or


• Kidney problems (reduced urine flow) or


• Nerve problems in the spine from cancer lesions in the bones or


• Problems passing urine or


• Stroke, history of—Use with caution. May make these conditions worse in men.

Proper Use of histrelin acetate

A doctor or other trained health professional will give you or your child histrelin acetate. The histrelin implant will be placed under the skin of the upper arm.

Your doctor will treat the upper arm with a numbing medicine and then cut a small incision to insert the implant. The incision will be closed with either stitches or surgical strips. A pressure bandage will be placed over the arm and left in place for 24 hours.

Do not remove the surgical strips. Allow them to fall off on their own after several days. If the incision has been stitched, your doctor will remove the stitches or they will dissolve after several days.

After the implant is inserted, you or your child should keep the arm clean and dry. Do not swim or bathe for 24 hours. You should avoid any heavy lifting or strenuous exercise for the first 7 days after the implant is inserted.

You or your child may have some pain, redness, or bruising at the site where the implant is placed. If your arm has not healed within 2 weeks after you received the implant or if you continue to have redness or pain, call your doctor.

The implant will be left in place for one year (12 months) and then removed. If needed, your doctor will insert a new implant to continue treatment for another year.

histrelin acetate comes with patient instructions. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using histrelin acetate

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the implant is in the proper place and if it is working properly.

For female patients: You should not receive histrelin acetate if you are pregnant or may become pregnant. Using histrelin acetate while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

For children using Supprelin® LA: The medicine can cause a brief increase in blood levels of some hormones. During this time, you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. If your child's symptoms do not improve within 4 weeks, or if they get worse, call your doctor.

For male patients:

• When you start using histrelin acetate, some of your symptoms might get worse for a short time. You might also have new symptoms such as bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating. The symptoms should improve in a few weeks. Tell your doctor if you have any new symptoms or your symptoms get worse.


• histrelin acetate may cause your blood sugar level to increase. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.


• histrelin acetate may increase your risk of having a heart attack or stroke. Check with your doctor right away if you have chest pain or discomfort; difficulty with speaking; headache; pain or discomfort in the arms, jaw, back or neck; shortness of breath; sweating; or vomiting while using the medicine.

histrelin acetate 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:

Rare

• Bloody urine


• decreased frequency or amount of urine


• increased thirst


• loss of appetite


• lower back or side pain


• nausea


• swelling of the face, fingers, or lower legs


• trouble with breathing


• unusual tiredness or weakness


• vomiting


• weight gain

Incidence not known

• Abdominal or stomach pain


• bloating of the abdomen or stomach


• dark urine


• light-colored stools


• yellow eyes or skin

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

• Decrease in testicle size


• feeling of warmth


• local infection, irritation, redness, or swelling on the skin where the implant was placed


• redness of the face, neck, arms, and upper chest


• sudden sweating

Less common

• Decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• flushing or redness of the skin


• headache


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• sleeplessness


• swelling of the breast or breast soreness in both females and males


• trouble sleeping


• unusually warm skin

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: histrelin acetate Subcutaneous side effects (in more detail)

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More histrelin acetate Subcutaneous resources

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

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Hepatitis B Immune Globulin

Class: Serums
ATC Class: J06BB04
VA Class: IM100
Brands: HepaGam B, HyperHEP B, Nabi-HB

Introduction

Specific immune globulin (hyperimmune globulin).¹¹⁰ Hepatitis B immune globulin (HBIG) contains antibody to hepatitis B surface antigen (anti-HBs) prepared from plasma of donors with high titers of anti-HBs and is used to provide temporary passive immunity to hepatitis B virus (HBV).^{101 112 116 128 129 132}

Uses for Hepatitis B Immune Globulin

Prevention of Perinatal Hepatitis B Virus (HBV) Infection

Prevention of perinatal HBV infection in neonates born to hepatitis B surface antigen-positive (HBsAg-positive) women.^{101 128 129 132}

A combined regimen that includes active immunization with hepatitis B vaccine (HepB vaccine) and passive immunization with hepatitis B immune globulin (HBIG) is 85–95% effective in preventing acute and chronic HBV infection in infants born to women positive for both HBsAg and HBeAg.^{101 112 128}

HBIG has been used alone for prevention of perinatal HBV infection in neonates born to HBsAg-positive women, but use of passive immunization alone is no longer recommended since a regimen that includes both HBIG and HepB vaccine is more effective.^{112 a}

ACIP and AAP recommend routine serologic screening of all pregnant women during an early prenatal visit (e.g., first trimester) to determine their HBsAg status, even if they were tested previously or have already been vaccinated against HBV.^{101 128 129} Women who were not tested prenatally, those who engage in behaviors that put them at high risk for HBV (e.g., >1 sex partner in the previous 6 months, HBsAg-positive sex partner, evaluation or treatment for sexually transmitted diseases (STDs), recent or current injection drug abuse) and those with clinical hepatitis should be tested for HBsAg status when admitted to the hospital for delivery.^{101 128}

To prevent perinatal HBV infection, ACIP and AAP recommend that all neonates born to HBsAg-positive women receive a dose of HBIG and a dose of HepB vaccine as soon as possible after birth (within 12 hours of birth), regardless of gestational age or birthweight.^{101 124 126 127 128} For neonates <2 kg, do not count the birth vaccine dose toward completion of the HepB vaccine series; begin usual 3-dose vaccine series when infant is 1 month of age.^{101 128 127}

If maternal HBsAg status is unknown at birth, give infant the first dose of HepB vaccine (within 12 hours of birth).^{101 124 127 128} Determine mother's HBsAg status as quickly as possible and, if positive, give infant a dose of HBIG as soon as possible (no later than 7 days of age).^{101 124 127} For neonates weighing <2 kg, if the mother's HBsAg status cannot be determined within 12 hours of birth, give a dose of HBIG as soon as possible (within 12 hours of birth) and do not count the birth vaccine dose toward completion of the HepB vaccine series; begin usual 3-dose vaccine series when infant is 1 month of age.^{101 127 128}

Postexposure Prophylaxis of Hepatitis B Virus (HBV) Infection

HBV postexposure prophylaxis (PEP) in certain individuals exposed to HBV or HBsAg-positive materials (e.g., health-care personnel, sexual or intimate contacts of HBsAg-positive individuals).^{100 109 112 116 122 128 129 132}

Depending on exposure circumstances, PEP regimen may include combined passive immunization with HBIG and active immunization with HepB vaccine to provide both short- and long-term protection.^{100 109 122 129}

Multiple-dose regimen of HBIG alone (e.g., first dose at time of exposure and second dose 1 month later) is about 75% effective in preventing HBV infection following percutaneous exposure.^{10 22 100 112 122} However, since health-care personnel and others at risk of HBV exposure are candidates for preexposure vaccination with HepB vaccine and since combined passive and active immunization is more effective than HBIG alone following perinatal HBV exposure, combined active and passive immunization is preferred when PEP is indicated following an exposure to HBsAg-positive material.^{109 112 122 129}

HBIG is most effective when administered as soon as possible after exposure (preferably within 24 hours) and may be ineffective if administered >7 days after a percutaneous exposure or >14 days after a sexual exposure.^{109 122 129}

HBIG not indicated for treatment of acute or chronic HBV infection.¹⁰¹

PEP may be indicated in susceptible, unvaccinated health-care personnel following occupational exposure to blood and other body fluids that might contain HBV.¹²² If an occupational exposure to HBV occurs, review vaccination status and vaccine-response status (if known) of exposed individual and HBsAg status of source.¹²² (See Table 1.)

If exposed individual was not previously vaccinated against HBV, initiate HepB vaccine series as soon as possible (preferably within 24 hours).¹²² In addition, if source is found to be HBsAg-positive, give a dose of HBIG as soon as possible (preferably within 24 hours).¹²²

If exposed individual was previously vaccinated against HBV and is a known responder (serum anti-HBs ≥10 mIU/mL), PEP is not necessary.¹²² If exposed individual was previously vaccinated but is a known nonresponder (serum anti-HBs <10 mIU/mL), PEP is not necessary if source is HBsAg-negative.¹²² However, if source is HBsAg-positive or known to be high-risk for HBV, give exposed individual a dose of HBIG and initiate a second HepB vaccine series as soon as possible after exposure.¹²² A 2-dose regimen of HBIG (without HepB vaccine) is preferred in individuals who already previously failed to respond to a second vaccine series.¹²²

If antibody status of exposed individual is unknown, test them for anti-HBs prior to initiation of PEP.¹²² If exposed individual is found to be a responder (serum anti-HBs ≥10 mIU/mL), PEP is not necessary.¹²² If exposed individual is found to be a nonresponder (anti-HBs levels <10 mIU/mL) and source is HBsAg-positive, give a dose of HBIG and a booster dose of HepB vaccine.¹²² If exposed individual is found to be a nonresponder and source is unknown or not available for testing, give a booster dose of HepB vaccine and recheck antibody titer in 1–2 months.¹²²

Table 1. Postexposure Prophylaxis of HBV following Occupational (Percutaneous or Mucosal) Exposure to Blood122

	Treatment when Source Is:
Vaccination and Antibody Status of Exposed Individual	HBsAg-positive	HBsAg-negative	Source Unknown or Not Available for Testing
Unvaccinated	Single HBIG dose (within 24 hours) and initiate HepB vaccine series (within 24 hours)	Initiate HepB vaccine series	Initiate HepB vaccine series
Previously vaccinated
Known responder (anti-HBs ≥10 mIU/mL)	No treatment	No treatment	No treatment
Known nonresponder (anti-HBs <10 mIU/mL)	Single HBIG dose and initiate HepB revaccination series or 2 HBIG doses (first dose as soon as possible; second dose 1 month later)	No treatment	If known high-risk source, treat as if source were HBsAg-positive
Antibody response unknown	Test exposed individual for anti-HBs	No treatment	Test exposed individual for anti-HBs
	1. If inadequate, single dose of HBIG and a booster dose of HepB vaccine		1. If inadequate, give a booster dose of HepB vaccine and recheck titer in 1–2 months
	2. If adequate, no treatment		2. If adequate, no treatment

ACIP and CDC recommend PEP with HepB vaccine with or without HBIG for victims of sexual assault (adult, adolescent, child) who are susceptible to HBV.^{109 129} PEP after a sexual assault is not necessary in those who previously received the complete HepB vaccine series.¹⁰⁹ If victim is unvaccinated or incompletely vaccinated and perpetrator is HBsAg-positive, give a dose of HBIG within 14 days of the assault (preferably within 24 hours) and initiate or complete HepB vaccine series.^{109 129}

ACIP and CDC recommend that previously unvaccinated sexual partners of individuals HbsAg-positive individuals receive PEP with a dose of HBIG and the initial dose of the HepB vaccine series (within 14 days of the most recent sexual contact).^{109 129} Completion of the vaccine series confers long-term protection in case the individual with acute HBV infection becomes chronically infected.^{109 129}

AAP recommends that unvaccinated infants <12 months of age in close contact with a mother or other primary care-giver who has acute HBV infection receive combined passive immunization with HBIG and active immunization with HepB vaccine.¹⁰¹ If the infant previously received a single dose of HepB vaccine, give the second vaccine dose if the interval is appropriate or, if it is too soon to give a vaccine dose, give a dose of HBIG.¹⁰¹ HBIG is not required if, at the time of exposure, the infant has already received ≥2 doses of HepB vaccine.¹⁰¹

Other nonsexual household contacts of individuals with acute HBV infection are not at increased risk for infection unless they have other risk factors or are exposed to the blood of the infected patient (e.g., by sharing a toothbrush or razor).^{101 109} However, encourage all household contacts of patients with acute HBV infection to receive HepB vaccine.^{101 109} If the patient with acute HBV infection becomes chronically infected (i.e., remains HBsAg-positive after 6 months), all household contacts should be vaccinated with HepB vaccine.¹⁰⁹

ACIP and CDC recommend PEP with HepB vaccine for sexual or needle-sharing partners and nonsexual household contacts of individuals with chronic HBV infection.^{109 129} Because most HBsAg-positive individuals are identified during routine screening (e.g., blood donation, prenatal evaluation) or clinical evaluation and it may be difficult to identify the time of last contact, HBIG is not considered necessary for PEP in contacts of such individuals.¹²⁹ A dose of HBIG may be indicated if the most recent sexual exposure to an HBsAg-positive individual occurred within the last 14 days.¹⁰⁹

CDC recommends that individuals wounded in bombings or other mass casualty settings who are unvaccinated or have an uncertain vaccination history receive postexposure vaccination with HepB vaccine (without HBIG).¹⁴⁴ Responders and other personnel in mass casualty settings should be managed using PEP regimens recommended for occupational exposures to HBV.¹⁴⁴ (See Table 1.)

PEP not necessary in individuals who previously received primary immunization with HepB vaccine and have serologic evidence of adequate levels of anti-HBs (≥10 mIU/mL).¹²²

PEP not necessary in individuals previously infected with HBV; such individuals are immune to reinfection.^{122 134}

Prevention of Hepatitis B Virus (HBV) Recurrence in Liver Transplant Recipients

Prevention of HBV recurrence in liver transplant recipients who are HBsAg-positive.^{132 135 136 137 138 139 140 141 142}

HBIG has been used alone or in conjunction with an antiviral (e.g., lamivudine, adefovir) to suppress HBV replication and prevent recurrence of HBV infection in patients with chronic HBV infection undergoing liver transplantation.^{132 135 136 137 138 139 140 141 142} Optimum regimens for such prophylaxis (i.e., dosage, route, and duration of HBIG; specific antiviral for a combined regimen) not established.^{135 137 138 139 140 141 142}

HepaGam B given by IV infusion is labeled by the FDA for prevention of HBV recurrence in liver transplant recipients based on interim results of a clinical study in HBsAg-positive, HBeAg-negative transplant recipients who had only low or undetectable levels of HBV replication at time of transplant.¹³²

Although safety and efficacy not established, other HBIG preparations have been administered IM or IV† for prevention of HBV recurrence in liver transplant recipients and have been used alone or in conjunction with an antiviral active against HBV.^{135 136 137 138 139 140 141 142}

Hepatitis B Immune Globulin Dosage and Administration

Administration

IM Administration

HepaGam B, HyperHEP B, and Nabi-HB: Administer by IM injection for prevention of perinatal HBV infection and for postexposure prophylaxis of HBV infection.^{112 116 128 132} Do not administer IV for this indication.^{112 116}

Inspect visually for particulate matter and discoloration.^{112 116 132}

Administer undiluted.^{116 132} Do not mix with any other drug or solution.^{116 132}

Depending on patient age, administer IM into the deltoid muscle or anterolateral thigh.^{110 112 116 128 129} To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.^{110 128 129}

For neonates and young children (up to 12 months of age), IM injections should be made into the anterolateral aspect of the thigh.^{110 128} For children 1–2 years of age, IM injections should preferably be administered into the anterolateral thigh; deltoid muscle is an alternative if muscle mass is adequate.^{110 128} For children and adolescents 3–18 years of age and adults, deltoid muscle is preferred, although anterolateral thigh is an alternative.^{110 128 129}

Because of the risk of injection-associated injury to the sciatic nerve, use gluteal region only when necessary (e.g., when a large volume or multiple doses are indicated).^{110 112 116} If use of gluteal area is considered necessary, use only the upper, outer quadrant; avoid central region.^{112 116}

Although some manufacturers recommend that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) should be performed to ensure that a blood vessel has not been entered,¹¹² ACIP and AAP state this procedure is not required because large blood vessels are not present at recommended IM injection sites.^{101 110}

May be given simultaneously with HepB vaccine (using different syringes and different injection sites) when passive immunization is considered necessary in addition to active immunization with the vaccine (e.g., in neonates born to HBsAg-positive women, PEP regimen in certain individuals exposed to HBV or HBsAg-positive materials).^{101 110 112 124 128 129 132}

IV Infusion

HepaGam B: Administer by IV infusion for prevention of HBV recurrence in liver transplant recipients.¹³² Although safety and efficacy not established, other HBIG preparations have been administered by IV infusion† for this use.^{135 136 137 140 141}

Do not mix with any other drug or solution.¹³² Administer using a separate IV line using an IV administration set via infusion pump.¹³²

Do not shake vial; avoid foaming.¹³²

Rate of Administration

HepaGam B: Administer by IV infusion at a rate of 2 mL/minute.¹³² Decrease to ≤1 mL/minute if patient develops discomfort or infusion-related adverse effects or if there is concern about the rate of infusion.¹³²

Dosage

Pediatric Patients

Prevention of Perinatal Hepatitis B Virus (HBV) Infection

Neonates Born to HBsAg-positive Women

IM

Combined passive immunization with HBIG and active immunization with HepB vaccine is indicated.^{101 124 127 128}

Give 0.5 mL of HBIG and a dose of monovalent HepB vaccine within 12 hours of birth (using different syringes and different injection sites).^{101 112 116 124 127 128 132}

If first dose of HepB vaccine is delayed for ≥3 months, manufacturer of HyperHEP B recommends a second 0.5-mL dose of HBIG at 3 months of age.¹¹² If HepB vaccine is contraindicated or not available, this manufacturer recommends second and third 0.5-mL doses of HBIG at 3 and 6 months of age, respectively.¹¹²

Neonates Born to Women with Unknown HBsAg Status

IM

Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.^{100 101 124 127 128}

Give a dose of monovalent HepB vaccine within 12 hours of birth.^{101 124 127 128} Determine HBsAg status of the mother as soon as possible.^{101 124 127 128}

If mother is found to be HBsAg-positive, give neonate 0.5 mL of HBIG as soon as possible (no later than 1 week of age).^{101 124 127 128}

If neonate was preterm and weighed <2 kg at birth, give neonate 0.5 mL of HBIG within 12 hours of birth if mother is found to be HBsAg-positive or if results are not available.^{101 127 128}

Postexposure Prophylaxis of Hepatitis B Virus (HBV) Infection

Unvaccinated or Incompletely Vaccinated Infants <12 Months of Age Exposed to Acute HBV Infection

IM

Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.^{101 112}

If mother or other primary care-giver has acute HBV infection, give 0.5 mL of HBIG and initiate or complete primary immunization with HepB vaccine.^{101 112} HBIG is not necessary if infant already received ≥2 doses of HepB vaccine.¹⁰¹

Unvaccinated or Incompletely Vaccinated Sexual Assault Victims

IM

Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.^{109 129}

If perpetrator is HBsAg-positive, give 0.06 mL/kg of HBIG within 14 days of the assault (preferably within 24 hours).^{109 129} Initiate or complete primary immunization with HepB vaccine.^{109 129}

Adults

Postexposure Prophylaxis of Hepatitis B Virus (HBV) Infection

Occupational Exposure in Susceptible Health-care Personnel

IM

When source is known to be HBsAg-positive and exposed individual is unvaccinated or a known nonresponder to HepB vaccine (anti-HBs <10 mIU/mL), combined active immunization with HepB vaccine and passive immunization with HBIG is indicated.^{122 129} (See Table 1 under Uses.)

Give 0.06 mL/kg of HBIG within 24 hours of the exposure and initiate or complete primary immunization with HepB vaccine.^{122 129}

In those who previously failed to respond to a second HepB vaccine series, give 0.06 mL/kg of HBIG within 24 hours of the exposure and 0.06 mL/kg 1 month later.¹²²

Unvaccinated or Incompletely Vaccinated Sexual Assault Victims

IM

Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.^{109 129}

If perpetrator is HBsAg-positive, give 0.06 mL/kg of HBIG within 14 days of the assault (preferably within 24 hours).^{109 129} Initiate or complete primary immunization with HepB vaccine.^{109 129}

Sexual or Intimate Exposure to Individuals with Acute HBV Infection

IM

Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.^{101 129}

Give 0.06 mL/kg of HBIG within 14 days of the last sexual or intimate exposure and initiate or complete primary immunization with HepB vaccine.^{109 129}

Prevention of HBV Recurrence in Liver Transplant Recipients (HepaGam B)

IV

Give initial dose of 20,000 international units concurrently with grafting of transplanted liver (anhepatic phase).¹³² Give 20,000 international units once daily on postoperative days 1–7, once every 2 weeks during postoperative weeks 2–12, and once monthly beginning at postoperative month 4.¹³²

Track treatment response by monitoring serum HBsAg and anti-HBs antibody levels.¹³²

Dosage is designed to provide serum anti-HBs levels >500 international units/L.¹³² Adjust dosage if anti-HBs levels do not increase to ≥500 international units/L within the first postoperative week.¹³² In such cases, increase dosage to 10,000 international units every 6 hours until target anti-HBs level is reached.¹³² Individuals with surgical bleeding or abdominal fluid drainage (>500 mL) and those undergoing plasmapheresis are particularly susceptible to extensive loss of circulating anti-HBs.¹³²

Cautions for Hepatitis B Immune Globulin

Contraindications

• 
  

  HepaGam B: Individuals with history of anaphylactic or severe systemic reactions to parenteral human immune globulin.¹³²

  
  


• 
  

  HyperHEP B: Manufacturer states no known contraindications.¹¹²

  
  


• 
  

  Nabi-HB: Individuals with history of anaphylactic or severe systemic reactions to human immune globulin.¹¹⁶

  
  

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Because HBIG is prepared from pooled human plasma, it is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).^{112 116 117 132}

Improved donor screening, viral-inactivation procedures (e.g., solvent/detergent treatment), and/or filtration procedures have reduced, but not completely eliminated, risk of pathogen transmission with plasma-derived preparations.^{100 104 112 116 132}

Solvent/detergent inactivation processes apparently can inactivate lipid-enveloped viruses (e.g., HBV, hepatitis C virus [HCV], HIV type 1 and type 2 [HIV-1 and HIV-2]), but are less effective against viruses that do not have a lipid envelope (e.g., hepatitis A virus [HAV], parvovirus B-19).^{116 132} Certain filtering procedures are effective in reducing levels of some enveloped and non-enveloped viruses.¹³²

Because no purification method has been shown to be totally effective in removing the risk of viral infectivity from plasma-derived preparations and because new blood-borne viruses or other disease agents may emerge which may not be inactivated by the manufacturing process or the chemical (solvent/detergent) treatment procedures currently used, administer HBIG only when a benefit is expected.^{112 116 132}

Any infection believed to have been transmitted by HBIG should be reported to the manufacturer.^{112 116 132}

Individuals with Bleeding Disorders

Because bleeding may occur following IM administration in individuals with thrombocytopenia or a bleeding disorder (e.g., hemophilia) or in those receiving anticoagulant therapy, use caution in such individuals.^{110 112 116 132} Administer IM in these patients only if expected benefits outweigh potential risks.^{112 116 132}

ACIP states that IM injections can be used in individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the injection can be administered with reasonable safety.¹¹⁰ In these cases, use a fine needle (23 gauge) to administer the dose and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.¹¹⁰ If patient is receiving antihemophilia therapy, administer the IM dose shortly after a scheduled dose of such therapy.¹¹⁰

Advise individual and/or their family about the risk of hematoma from IM injections.¹¹⁰

Blood Glucose Testing

HBIG preparations that contain maltose (HepaGam B) may cause falsely elevated results in blood glucose determinations that use glucose dehydrogenase pyrroloquinequinone (GDH-PQQ).^{132 133} (See Specific Drugs and Laboratory Tests under Interactions.)

Sensitivity Reactions

Hypersensitivity Reactions

Although not reported to date with HBIG, anaphylaxis has been reported rarely following administration of human immune globulins.^{112 116 132}

Use caution in individuals with history of systemic allergic reactions to immune globulins.¹¹²

Epinephrine should be readily available in case anaphylaxis occurs.^{112 132} If hypotension or a hypersensitivity reaction (e.g., anaphylaxis) occurs, immediately discontinue HBIG and institute appropriate therapy as indicated.¹³²

Selective IgA Deficiency

Use caution in individuals with specific IgA deficiency; these individuals may have antibodies to IgA or may develop such antibodies following administration of HBIG preparations containing IgA.^{116 132} Anaphylaxis could occur.^{116 132}

HepaGam B contains <40 mcg/mL and Nabi-HB contains <100 mcg/mL of IgA.^{116 132} Weigh potential benefits against potential for hypersensitivity reaction.^{116 132}

General Precautions

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.^{110 130}

Recommendations regarding use in HIV-infected individuals or use in neonates born to HIV-infected women are the same as those for individuals who are not infected with HIV.^{110 126 127 130}

Infusion Reactions

HyperHEP B administered by IV infusion may be associated with certain adverse effects related to the rate of infusion.¹³² Do not exceed recommended infusion rate (2 mL/minute).¹³² Monitor closely during and immediately following infusion.¹³²

Serologic Testing

All infants born to HBsAg-positive women should undergo serologic testing at 9–18 months of age (usually at next well-child visit) to document whether the combined regimen of active immunization with HepB vaccine and passive immunization with HBIG prevented perinatal HBV infection.^{101 128} Do not test before 9 months of age to avoid detecting anti-HBs passively acquired from the HBIG dose administered at birth and to maximize the likelihood of detecting late HBV infections.¹⁰¹ This follow-up serologic testing not necessary in infants born to HBsAg-negative women.^{101 128}

Prior to initiation of HBV postexposure prophylaxis, serologic testing usually is indicated to determine immune status of individuals exposed to HBV or HBsAg-positive materials (e.g., health-care personnel, sexual or intimate contacts of individuals with acute HBV infection).¹²² In those who have had sexual or intimate exposure to individuals with acute HBV infection, such testing should be done only if it will not delay administration of HBIG beyond 14 days.¹⁰⁹

If a combined regimen of HBIG and HepB vaccine is used for postexposure prophylaxis following exposure to HBV or HBsAg-positive materials, postvaccination testing for anti-HBs should not be performed until 3–4 months after the HBIG dose.¹²² (See Specific Drugs and Laboratory Tests under Interactions.)

Specific Populations

Pregnancy

Category C.^{112 116 132}

Because of potential risks to the neonate from exposure to HBV infection, pregnancy is not considered a contraindication to use of HBIG when indicated.¹²²

ACIP states there are no known risks associated with use of immune globulins for passive immunization in pregnant women.¹¹⁰

Lactation

Not known whether HBIG is distributed into milk; use caution.^{116 132}

Pediatric Use

HepaGam B: Labeled by the FDA for use in neonates and children.¹³²

HyperHEP B and Nabi-HB: Although safety and efficacy not established in infants and children,^{112 116} safety and efficacy of similar HBIG preparations have been demonstrated in infants and children.¹¹⁶

HBIG is used in conjunction with HepB vaccine for postexposure prophylaxis in neonates born to HBsAg-positive mothers and for postexposure prophylaxis in unvaccinated children <12 months of age whose mother or primary care-giver has acute HBV infection.^{101 112 132} (See Uses.)

Geriatric Use

Nabi-HB: Clinical studies did not include sufficient numbers of adults ≥65 years of age to determine whether geriatric adults respond differently than younger individuals.¹¹⁶ Other reported clinical experience has not identified differences in responses between geriatric and younger individuals.¹¹⁶

Common Adverse Effects

IM injection: Injection site reactions (pain, tenderness, swelling, erythema),^{112 116 122} headache,^{116 132} myalgia,¹¹⁶ malaise,¹¹⁶ GI effects (nausea, vomiting),^{116 132} flu or cold symptoms,¹³² lightheadedness/fainting.¹³²

IV infusion: Tremor and hypotension reported with HepaGam B given by IV infusion.¹³² Chills, fever, headache, vomiting, allergic reactions, nausea, arthralgia, moderate low back pain have been reported with other IV immune globulins.¹³²

Interactions for Hepatitis B Immune Globulin

Inactivated Vaccines and Toxoids

Immune globulins, including HBIG, are not expected to have a clinically important effect on the immune response to inactivated vaccines or toxoids; inactivated vaccines, recombinant vaccines, polysaccharide vaccines, or toxoids may be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after HBIG.^{101 110} Neonates born to HBsAg-positive women who receive combined passive immunization with HBIG and active immunization with HepB vaccine at birth can receive other age-appropriate vaccines according to the usually recommend childhood immunization schedule.¹¹⁰

Live Vaccines

Antibodies present in immune globulins, including HBIG, may interfere with the immune response to certain live virus vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rotavirus vaccine live oral, rubella virus vaccine live, varicella virus vaccine live); these vaccines should not be administered simultaneously with or for specified intervals before or after HBIG.^{101 110 128 131 132} (See Specific Drugs and Laboratory Tests under Interactions.) There is no evidence that immune globulin preparations interfere with the immune response to yellow fever virus vaccine live, typhoid vaccine live oral, influenza virus vaccine live intranasal, or poliovirus vaccine live oral (OPV; no longer commercially available in the US).^{101 110}

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Hepatitis B (HepB) vaccine	Passively acquired antibody to hepatitis B surface antigen (anti-HBs), which is present in HBIG, does not appear to interfere with the active immune response to HepB vaccine112	When combined active immunization with HepB vaccine and passive immunization with HBIG is indicated, the first dose of vaccine should be administered simultaneously with HBIG (using different syringes and injection sites)122 128 129 132 HepaGam B: May be given concurrently with (at a different site) or up to 1 month preceding HepB vaccine without impairing the active immune response to the vaccine132
Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)		Recommendations for use of immune globulins in patients receiving immunosuppressive agents are the same as those for patients not receiving such agents130
Influenza vaccine	Intranasal live influenza vaccine: No evidence that immune globulin preparations interfere with the immune response to the vaccine110 Parenteral inactivated influenza vaccine: Interference with the immune response to this inactivated vaccine is not expected110	Intranasal live influenza vaccine or parenteral inactivated influenza vaccine may be given simultaneously with or at any interval before or after HBIG110
Measles, mumps, and rubella vaccine (MMR)	HBIG may interfere with the immune response to measles virus vaccine live and rubella virus vaccine live; the effect of HBIG on the immune response to mumps virus vaccine live is unknown101 110 128 132	MMR (or its individual components) should not be administered simultaneously with or within 3 months before or after HBIG101 110 128 132 If a dose of MMR (or its individual components) is given simultaneously with or within 14 days before or after a dose of HBIG, the MMR dose (or its individual components) should be repeated >3 months after the HBIG dose unless serologic testing is feasible and indicates a response to the vaccine was attained101 110 132
Rotavirus vaccine	Safety and efficacy data not available regarding use of rotavirus vaccine in infants who have received an immune globulin within 42 days131	If possible, defer dose of rotavirus vaccine until 42 days (6 weeks) after the immune globulin; use a shorter interval if the 42-day deferral would result in the first dose of rotavirus vaccine being scheduled at ≥13 weeks of age110
Tests for anti-HBs	Anti-HBs present in serum for 2–6 months following a dose of HBIG and may result in positive tests for anti-HBs that reflect passively-acquired antibody rather than an immune response to HepB vaccine122 128 129	In neonates who receive postexposure prophylaxis with both HBIG and HepB vaccine (i.e., those born to HBsAg-positive mothers), do not perform postvaccination testing for anti-HBs to confirm an immunologic response to the vaccine until ≥9 months of age to avoid detecting passively-acquired antibody from HBIG128 If a combined regimen of HBIG and HepB vaccine is used for postexposure prophylaxis following exposure to HBV or HBsAg-positive materials, do not perform postvaccination testing for anti-HBs until 3–4 months after the HBIG dose122
Tests for glucose	Maltose contained in HepaGam B may interfere with blood glucose monitoring systems based on glucose dehydrogenase pyrroloquinequinone (GDH-PQQ) and cause falsely elevated blood glucose results; this may result in inappropriate insulin administration and life-threatening hypoglycemia or may mask true hypoglycemia132 133	Use only glucose-specific test methods not affected by maltose (e.g., glucose dehydrogenase nicotine adenine dinucleotide [GDH-NAD], glucose oxidase, glucose hexokinase) in patients receiving HepaGam B132 133 Carefully review product information for the blood glucose testing meter and test strips to determine if the testing system is appropriate;132 133 if any uncertainty exi

hydromorphone rectal

Generic Name: hydromorphone (rectal) (hye dro MOR fone)

Brand Names: Dilaudid

What is hydromorphone rectal?

Hydromorphone is in a group of drugs called narcotic pain relievers. It is similar to morphine.

Hydromorphone rectal is used to treat moderate to severe pain.

Hydromorphone rectal may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about hydromorphone rectal?

Do not use hydromorphone with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. You may have withdrawal symptoms when you stop using this medication after using it over a long period of time. Do not stop using hydromorphone suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Hydromorphone may be habit-forming and should be used only by the person it was prescribed for. Hydromorphone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydromorphone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Never use more hydromorphone than is prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not take hydromorphone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for using the rectal suppository. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

What should I discuss with my healthcare provider before using hydromorphone rectal?

Do not use this medication if you are allergic to hydromorphone, or if you have breathing problems such as an asthma attack.

Before using hydromorphone, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  asthma, COPD, sleep apnea, or other breathing disorders;

  
  


• liver disease;


• kidney disease;


• 
  

  underactive thyroid;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  enlarged prostate, urination problems;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

If you have any of these conditions, you may not be able to use hydromorphone, or you may need a dosage adjustment or special tests during treatment.

Hydromorphone may be habit-forming and should be used only by the person it was prescribed for. Hydromorphone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydromorphone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to anyone younger than 18 years old. Older adults may be more sensitive to the effects of this medicine.

How should I use hydromorphone rectal?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Never use more hydromorphone than is prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not take hydromorphone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for using the rectal suppository. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down after inserting it and hold in the suppository for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are using hydromorphone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using hydromorphone. You may need to stop using the medicine for a short time.

You may have withdrawal symptoms when you stop using this medication after using it over a long period of time. Withdrawal symptoms include feeling restless or irritable, blurred vision, runny nose, watery eyes, yawning, sweating, tingly feeling under your skin, sleep problems, weakness, muscle spasms, severe back or stomach pain, muscle cramps, hot and cold flashes, nausea, vomiting, diarrhea, weight loss, and fast heart rate. Do not stop using hydromorphone suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store the suppositories in the refrigerator and do not allow them to freeze.

What happens if I miss a dose?

Since hydromorphone is sometimes used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Try to use the medicine at a time when you can lie down afterward and hold the medicine in. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of hydromorphone can be fatal.

Symptoms of a hydromorphone overdose may include extreme drowsiness, muscle weakness, confusion, cold and clammy skin, pinpoint pupils, shallow breathing, slow heart rate, fainting, or coma.

What should I avoid while using hydromorphone rectal?

Do not drink alcohol while you are using hydromorphone. Dangerous side effects or death can occur when alcohol is combined with hydromorphone. Check the label of any other medicines you take to be sure they do not contain alcohol.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by hydromorphone, which could result in extreme drowsiness or coma.

Do not use hydromorphone if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you use hydromorphone before the MAO inhibitor has cleared from your body. Hydromorphone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Hydromorphone rectal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  cold, clammy skin;

  
  


• 
  

  confusion;

  
  


• 
  

  severe weakness or dizziness; or

  
  


• 
  

  feeling light-headed, fainting.

  
  

Less serious side effects are more likely to occur, such as:

• 
  

  constipation;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  nausea, vomiting, diarrhea, loss of appetite;

  
  


• 
  

  dizziness, headache;

  
  


• 
  

  dry mouth;

  
  


• 
  

  sweating;

  
  


• 
  

  itching; or

  
  


• 
  

  sleep problems (insomnia).

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Hydromorphone Dosing Information

Usual Adult Dose for Pain:

Doses should be titrated to appropriate analgesic effects while minimizing adverse effects. When changing routes of administration, it should be noted that oral doses are less than one-half as effective as parenteral doses. Oral doses may be only one fifth as effective as parenteral doses.

Oral: Initial: Opiate-naive: 1 to 2 mg/dose every 3 to 4 hours as needed; patients with prior opiate exposure may tolerate higher initial doses
Usual dose: 2 to 4 mg/dose; oral doses up to 8 mg have been used

Note: The American Pain Society recommends an initial oral dose of 4 to 8 mg for severe pain in adults.

Chronic pain: Oral: Patients taking opioids chronically may become tolerant and require doses higher than the usual dosage range to maintain the desired effect. Tolerance can be managed by appropriate dose titration. There is no optimal or maximal dose for hydromorphone in chronic pain. The appropriate dose is one that relieves pain throughout its dosing interval without causing unmanageable side effects.

IV: Initial: Opiate-naive: 0.2 to 0.6 mg/dose every 2 to 4 hours as needed; patients with prior opiate exposure may tolerate higher initial doses.

Patient-controlled analgesia (PCA):
All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Doses, lockouts, and limits should be adjusted based on required loading dose, age, state of health, and presence of opioid tolerance. The lower end of dosing range should be used for opioid-naive patients. Assess patient and pain control at regular intervals and adjust settings if needed.
Usual concentration: 0.2 mg/mL
Demand dose: Usual initial: 0.1 to 0.2 mg; usual range: 0.05 to 0.4 mg
Lockout interval: Usual initial: 6 minutes; usual range: 5 to 10 minutes

IM, subcutaneous:
Note: IM use may result in variable absorption and a lag time to peak effect.
Initial: Opiate-naive: 0.8 to 1 mg every 4 to 6 hours as needed; patients with prior opioid exposure may require higher initial doses; usual dosage range: 1 to 2 mg every 3 to 6 hours as needed.

Rectal: 3 mg (1 suppository) every 4 to 8 hours as needed.

IV: Critically ill adult patients: 0.7 to 2 mg (based on 70 kg patient) every 1 to 2 hours as needed. More frequent dosing may be needed (e.g., mechanically ventilated patients).
IV continuous infusion: Usual dosage range: 0.5 to 1 mg/hour (based on 70 kg patient) or 7 to 15 mcg/kg/hour

Epidural:
Bolus dose: 0.8 to 1.5 mg
Infusion concentration: 0.05 to 0.075 mg/mL
Infusion rate: 0.04 to 0.4 mg/hour
Demand dose: 0.15 mg
Lockout interval: 30 minutes

Hydromorphone extended release tablets:
Hydromorphone extended release tablets are indicated for opioid tolerant patients only. Patient must not be started on hydromorphone extended release tablets as their first opioid.

Hydromorphone extended release tablets should be swallowed whole and should not be broken, crushed, dissolved, or chewed before swallowing. The tablets are to be administered every 24 hours with or without food.

The dose range of hydromorphone extended release tablets studied in clinical trials is 8 mg to 64 mg.

Patients receiving oral immediate-release hydromorphone may be converted to hydromorphone extended release tablets by administering a starting dose equivalent to the patient's total daily oral hydromorphone dose, taken once daily. The dose of hydromorphone extended release tablets can be titrated every 3 to 4 days until adequate pain relief with tolerable side effects has been achieved.

It is critical to accurately initiate the dosing regimen individually for each patient. Overestimating the hydromorphone extended release tablets dose when converting patients from another opioid medication can result in fatal overdose with the first dose. In the selection of the initial dose of hydromorphone extended release tablets, the following should be noted:
-the daily dose, potency, and specific characteristics of the opioid the patient has been taking previously;
-the reliability of the relative potency estimate used to calculate the equivalent hydromorphone dose needed;
-the patient's degree of opioid tolerance;
-the age, general condition, and medical status of the patient;
-concurrent non-opioid analgesics and other medications, such as those with central nervous system activity;
-the type and severity of the patient's pain;
-the balance between pain control and adverse effects;
-risk factors for abuse, addiction, or diversion, including a prior history of abuse, addiction, or diversion.

Dosing recommendations, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Conversion from Oral Opioids to hydromorphone extended release tablets:
For conversion from other opioids to hydromorphone extended release tablets, physicians and other healthcare professionals are advised to refer to published relative potency data, keeping in mind that conversion ratios are only approximate. In general, therapy with hydromorphone extended release tablets should be started by administering 50% of the calculated total daily dose of hydromorphone extended release tablets every 24 hours. The initial dose of hydromorphone extended release tablets can be titrated until adequate pain relief with tolerable side effects has been achieved.

Conversion from transdermal fentanyl to hydromorphone extended release tablets:
Eighteen hours following the removal of the transdermal fentanyl patch, hydromorphone extended release tablets treatment can be initiated. For each 25 mcg/hr fentanyl transdermal dose the equianalgesic dose of hydromorphone extended release tablets is 12 mg every 24 hours. An appropriate starting dose of hydromorphone extended release tablets is 50% of the calculated total daily dose every 24 hours.

Individualization of Dosage:
Once therapy is initiated, assess pain relief and other opioid adverse reactions frequently.

Titrate patients to adequate analgesia with dose increases not more often than every 3 to 4 days, in order to attain steady-state plasma concentrations of hydromorphone at each dose.

As a guideline, consider dosage increases of 25% to 50% of the current daily dose of hydromorphone extended release tablets for each titration step.

If more than two doses of rescue medication are needed within a 24 hour period for two consecutive days, the dose of hydromorphone extended release tablets may need to be titrated upward.

Administer hydromorphone extended release tablets no more frequently than every 24 hours.

During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and the caregiver/family.

Maintenance of Therapy:
During chronic therapy with hydromorphone extended release tablets, assess the continued need for around-the-clock opioid therapy periodically. Continue to assess patients for their clinical risks for opioid abuse, addiction, or diversion particularly with high-dose formulations. If patients need to titrate while on maintenance therapy, follow the same method outlined above to reestablish pain control.

Usual Adult Dose for Cough:

1 mg orally every 3 to 4 hours as needed.

Usual Pediatric Dose for Pain:

Doses should be titrated to appropriate analgesic effects while minimizing adverse effects. When changing routes of administration, it should be noted that oral doses are less than one-half as effective as parenteral doses. Oral doses may be only one fifth as effective as parenteral doses.

Greater than 6 months and greater than 10 kg:
Oral: Usual initial dose: 0.03 mg/kg/dose every 4 hours as needed; usual dose range: 0.03 to 0.06 mg/kg/dose
IV: Usual initial dose: 0.01 mg/kg/dose every 3 to 6 hours as needed
IV continuous infusion: Usual initial dose: 0.003 to 0.005 mg/kg/hour

Children and Adolescents less than 50 kg:
Oral: 0.03 to 0.08 mg/kg/dose every 3 to 4 hours as needed
The American Pain Society recommends an initial oral dose of 0.06 mg/kg for severe pain in children.
IV: 0.015 mg/kg/dose every 3 to 6 hours as needed.
IV continuous infusion: Usual initial dose: 0.003 to 0.005 mg/kg/hour (maximum: 0.2 mg/hour)
IV: Patient-controlled analgesia (PCA): Opiate-naive:
5 to 12 years and less than 50 kg:
PCA has been used in children as young as 5 years of age. However, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.
Usual concentration: 0.2 mg/mL
Demand dose: Usual initial dose: 0.003 to 0.004 mg/kg/dose; usual dose range: 0.003 to 0.005 mg/kg/dose
Lockout: Usual initial: 5 doses/hour
Lockout interval: Range: 6 to 10 minutes
Usual basal rate: up to 0.004 mg/kg/hour

Greater than 50 kg:
Oral: Initial: Opiate-naive: 1 to 2 mg/dose every 3 to 4 hours as needed
Patients with prior opiate exposure may tolerate higher initial doses.

IV: Initial: Opiate-naive: 0.2 to 0.6 mg/dose every 2 to 4 hours as needed.
Patients with prior opiate exposure may tolerate higher initial doses.

Patient-controlled analgesia (PCA):
All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Doses, lockouts, and limits should be adjusted based on required loading dose, age, state of health, and presence of opioid tolerance. The lower end of dosing range should be used for opioid-naive patients. Assess patient and pain control at regular intervals and adjust settings if needed.
Usual concentration: 0.2 mg/mL
Demand dose: Usual initial: 0.1 to 0.2 mg; usual range: 0.05 to 0.4 mg
Lockout interval: Usual initial: 6 minutes; usual range: 5 to 10 minutes
IM, subcutaneous:
Note: IM use may result in variable absorption and a lag time to peak effect.
Initial dose for opiate-naive patients: 0.8 to 1 mg every 4 to 6 hours as needed; patients with prior opioid exposure may require higher initial doses; usual dosage range: 1 to 2 mg every 3 to 6 hours as needed.
Rectal: 3 mg (1 suppository) every 4 to 8 hours as needed.

Usual Pediatric Dose for Cough:

6 to 12 years: 0.5 mg orally every 3 to 4 hours as needed.

Greater than 12 years: 1 mg orally every 3 to 4 hours as needed.

What other drugs will affect hydromorphone rectal?

Do not use hydromorphone with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Before using hydromorphone, tell your doctor if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex). If you are using any of these drugs, you may not be able to use hydromorphone, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect hydromorphone. 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.

More hydromorphone resources

• Hydromorphone Side Effects (in more detail)
• Hydromorphone Dosage
• Hydromorphone Use in Pregnancy & Breastfeeding
• Drug Images
• Hydromorphone Drug Interactions
• Hydromorphone Support Group
• 165 Reviews for Hydromorphone - Add your own review/rating

Compare hydromorphone with other medications

• Anesthetic Adjunct
• Cough
• Pain

Where can I get more information?

• Your pharmacist has information about hydromorphone rectal written for health professionals that you may read.

See also: hydromorphone side effects (in more detail)

Hydralazine Tablets

Generic Name: hydralazine hydrochloride

Dosage Form: tablet
HYDRALAZINE HYDROCHLORIDE TABLETS, USP

Rx only

DESCRIPTION:

HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is:

HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64.

Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6.

CLINICAL PHARMACOLOGY:

Although the precise mechanism of action of hydrALAZINE is not fully understood, the major effects are on the cardiovascular system. HydrALAZINE apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. HydrALAZINE, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state.

The peripheral vasodilating effect of hydrALAZINE results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance; and an increased heart rate, stroke volume, and cardiac output. The preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. HydrALAZINE usually increases renin activity in plasma, presumably as a result of increased secretion of renin by the renal juxtaglomerular cells in response to reflex sympathetic discharge. This increase in renin activity leads to the production of angiotensin II, which then causes stimulation of aldosterone and consequent sodium reabsorption. HydrALAZINE also maintains or increases renal and cerebral blood flow.

HydrALAZINE is rapidly absorbed after oral administration, and peak plasma levels are reached at 1 to 2 hours. Plasma levels of apparent hydrALAZINE decline with a half-life of 3 to 7 hours. Binding to human plasma protein is 87%. Plasma levels of hydrALAZINE vary widely among individuals. HydrALAZINE is subject to polymorphic acetylation; slow acetylators generally have higher plasma levels of hydrALAZINE and require lower doses to maintain control of blood pressure. HydrALAZINE undergoes extensive hepatic metabolism; it is excreted mainly in the form of metabolites in the urine.

INDICATIONS AND USAGE:

Essential hypertension, alone or as an adjunct.

CONTRAINDICATIONS:

Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.

WARNINGS:

In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests.)

PRECAUTIONS:

General:

Myocardial stimulation produced by hydrALAZINE can cause anginal attacks and ECG changes of myocardial ischemia. The drug has been implicated in the production of myocardial infarction. It must, therefore, be used with caution in patients with suspected coronary artery disease.

The “hyperdynamic” circulation caused by hydrALAZINE may accentuate specific cardiovascular inadequacies. For example, hydrALAZINE may increase pulmonary artery pressure in patients with mitral valvular disease. The drug may reduce the pressor responses to epinephrine. Postural hypotension may result from hydrALAZINE but is less common than with ganglionic blocking agents. It should be used with caution in patients with cerebral vascular accidents.

In hypertensive patients with normal kidneys who are treated with hydrALAZINE, there is evidence of increased renal blood flow and a maintenance of glomerular filtration rate. In some instances where control values were below normal, improved renal function has been noted after administration of hydrALAZINE. However, as with any antihypertensive agent, hydrALAZINE should be used with caution in patients with advanced renal damage.

Peripheral neuritis, evidenced by paresthesia, numbness, and tingling, has been observed. Published evidence suggests an antipyridoxine effect, and that pyridoxine should be added to the regimen if symptoms develop.

Information for Patients:

Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.

Laboratory Tests:

Complete blood counts and antinuclear antibody titer determinations are indicated before and periodically during prolonged therapy with hydrALAZINE even though the patient is asymptomatic. These studies are also indicated if the patient develops arthralgia, fever, chest pain, continued malaise, or other unexplained signs or symptoms.

A positive antinuclear antibody titer requires that the physician carefully weigh the implications of the test results against the benefits to be derived from antihypertensive therapy with hydrALAZINE.

Blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, and purpura, have been reported. If such abnormalities develop, therapy should be discontinued.

Drug/Drug Interactions:

MAO inhibitors should be used with caution in patients receiving hydrALAZINE.

When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydrALAZINE, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydrALAZINE are used concomitantly.

Drug/Food Interactions:

Administration of hydrALAZINE with food results in higher plasma levels.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

In a lifetime study in Swiss albino mice, there was a statistically significant increase in the incidence of lung tumors (adenomas and adenocarcinomas) of both male and female mice given hydrALAZINE continuously in their drinking water at a dosage of about 250 mg/kg per day (about 80 times the maximum recommended human dose). In a 2-year carcinogenicity study of rats given hydrALAZINE by gavage at dose levels of 15, 30, and 60 mg/kg/day (approximately 5 to 20 times the recommended human daily dosage), microscopic examination of the liver revealed a small, but statistically significant, increase in benign neoplastic nodules in male and female rats from the high-dose group and in female rats from the intermediate-dose group. Benign interstitial cell tumors of the testes were also significantly increased in male rats from the high-dose group. The tumors observed are common in aged rats and a significantly increased incidence was not observed until 18 months of treatment. HydrALAZINE was shown to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one of two rat and one rabbit hepatocyte in vitro DNA repair studies. Additional in vivo and in vitro studies using lymphoma cells, germinal cells, and fibroblasts from mice, bone marrow cells from Chinese hamsters and fibroblasts from human cell lines did not demonstrate any mutagenic potential for hydrALAZINE.

The extent to which these findings indicate a risk to man is uncertain. While long-term clinical observation has not suggested that human cancer is associated with hydrALAZINE use, epidemiologic studies have so far been insufficient to arrive at any conclusions.

Pregnancy Category C:

Animal studies indicate that hydrALAZINE is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones.

There are no adequate and well-controlled studies in pregnant women. Although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydrALAZINE should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Nursing Mothers:

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

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of hydrALAZINE in pediatric patients. The usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. Dosage may be increased gradually over the next 3 to 4 weeks to a maximum of 7.5 mg/kg or 200 mg daily.

ADVERSE REACTIONS:

Adverse reactions with hydrALAZINE are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency.

Common: Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris

Less Frequent:Digestive: constipation, paralytic ileus.

• Cardiovascular: hypotension, paradoxical pressor response, edema.


• Respiratory: dyspnea


• Neurologic: peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety.


• Genitourinary: difficulty in urination


• Hematologic: blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly.


• Hypersensitivity Reactions: rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis.


• Other: nasal congestion, flushing, lacrimation, conjunctivitis.

OVERDOSAGE:

Acute Toxicity: No deaths due to acute poisoning have been reported. Highest known dose survived: adults, 10 g orally.

Oral LD50 in rats: 173 and 187 mg/kg.

Signs and Symptoms: Signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing.

Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock.

Treatment: There is no specific antidote.

The gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. An activated charcoal slurry may be instilled if conditions permit. These manipulations may have to be omitted or carried out after cardiovascular status has been stabilized, since they might precipitate cardiac arrhythmias or increase the depth of shock.

Support of the cardiovascular system is of primary importance. Shock should be treated with plasma expanders. If possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia.

Tachycardia responds to beta blockers. Digitalization may be necessary, and renal function should be monitored and supported as required.

No experience has been reported with extracorporeal or peritoneal dialysis.

DOSAGE AND ADMINISTRATION:

Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels.

The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE.

In a few resistant patients, up to 300 mg of hydrALAZINE daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.

HOW SUPPLIED:

HydrALAZINE Hydrochloride Tablets, USP:

10 mg - Orange, round, unscored tablets debossed with ‘H’ on one side and ‘38’ on the other side in bottles of 100 (NDC code: 31722-519-01), 500 (NDC code: 31722-519-05, and 1000 (NDC code: 31722-519-10).

25 mg - Orange, round, unscored tablets debossed with ‘H’ on one side and ‘39’ on the other side in bottles of 100 (NDC code: 31722-520-01), 500 (NDC code: 31722-520-05, and 1000 (NDC code: 31722-520-10).

50 mg - Orange, round, unscored tablets debossed with ‘H’ on one side and ‘40’ on the other side in bottles of 100 (NDC code: 31722-521-01), 500 (NDC code: 31722-521-05), and 1000 (NDC code: 31722-521-10).

100 mg - Orange, round, unscored tablets debossed with ‘H’ on one side and ‘41’ on the other side in bottles of 100 (NDC code: 31722-522-01) and 500 (NDC code: 31722-522-05).

Dispense in a tight, light-resistant container as defined in the USP.

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured for:

Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854

By: Hetero Drugs Limited

2005566-00

Jeedimetla, Hyderabad- 500 055, India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HYDRALAZINE HYDROCHLORIDE  hydralazine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 31722-519 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   FD&C YELLOW NO. 6

Product Characteristics Color ORANGE Score no score Shape ROUND Size 5mm Flavor Imprint Code H;38 Contains

Packaging # NDC Package Description Multilevel Packaging 1 31722-519-01 12 BOTTLE In 1 CASE contains a BOTTLE 1 100 TABLET In 1 BOTTLE This package is contained within the CASE (31722-519-01) 2 31722-519-05 12 BOTTLE In 1 CASE contains a BOTTLE 2 500 TABLET In 1 BOTTLE This package is contained within the CASE (31722-519-05) 3 31722-519-10 12 BOTTLE In 1 CASE contains a BOTTLE 3 1000 TABLET In 1 BOTTLE This package is contained within the CASE (31722-519-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040901	01/01/2010

HYDRALAZINE HYDROCHLORIDE  hydralazine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 31722-520 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   FD&C YELLOW NO. 6

Product Characteristics Color ORANGE Score no score Shape ROUND Size 6mm Flavor Imprint Code H;39 Contains

Packaging # NDC Package Description Multilevel Packaging 1 31722-520-01 12 BOTTLE In 1 CASE contains a BOTTLE 1 100 TABLET In 1 BOTTLE This package is contained within the CASE (31722-520-01) 2 31722-520-05 12 BOTTLE In 1 CASE contains a BOTTLE 2 500 TABLET In 1 BOTTLE This package is contained within the CASE (31722-520-05) 3 31722-520-10 12 BOTTLE In 1 CASE contains a BOTTLE 3 1000 TABLET In 1 BOTTLE This package is contained within the CASE (31722-520-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040901	01/01/2010

HYDRALAZINE HYDROCHLORIDE  hydralazine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 31722-521 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   FD&C YELLOW NO. 6

Product Characteristics Color ORANGE Score no score Shape ROUND Size 8mm Flavor Imprint Code H;40 Contains

Packaging # NDC Package Description Multilevel Packaging 1 31722-521-01 12 BOTTLE In 1 CASE contains a BOTTLE 1 100 TABLET In 1 BOTTLE This package is contained within the CASE (31722-521-01) 2 31722-521-05 12 BOTTLE In 1 CASE contains a BOTTLE 2 500 TABLET In 1 BOTTLE This package is contained within the CASE (31722-521-05) 3 31722-521-10 12 BOTTLE In 1 CASE contains a BOTTLE 3 1000 TABLET In 1 BOTTLE This package is contained within the CASE (31722-521-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040901	01/01/2010

HYDRALAZINE HYDROCHLORIDE  hydralazine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 31722-522 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 100 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   FD&C YELLOW NO. 6

Product Characteristics Color ORANGE Score no score Shape ROUND Size 11mm Flavor Imprint Code H;41 Contains

Packaging # NDC Package Description Multilevel Packaging 1 31722-522-01 12 BOTTLE In 1 CASE contains a BOTTLE 1 100 TABLET In 1 BOTTLE This package is contained within the CASE (31722-522-01) 2 31722-522-05 12 BOTTLE In 1 CASE contains a BOTTLE 2 500 TABLET In 1 BOTTLE This package is contained within the CASE (31722-522-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040901	01/01/2010

Labeler - Camber Pharmaceuticals (826774775)

Establishment
Name	Address	ID/FEI	Operations
Hetero Labs limited		676162024	MANUFACTURE

Revised: 08/2011Camber Pharmaceuticals

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