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:

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

  
  


• liver disease;


• kidney disease;


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  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:

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  shallow breathing, slow heartbeat;

  
  


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  seizure (convulsions);

  
  


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  cold, clammy skin;

  
  


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  confusion;

  
  


• 
  

  severe weakness or dizziness; or

  
  


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  feeling light-headed, fainting.

  
  

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

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  constipation;

  
  


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  warmth, tingling, or redness under your skin;

  
  


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  nausea, vomiting, diarrhea, loss of appetite;

  
  


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  dizziness, headache;

  
  


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  dry mouth;

  
  


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  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

More Hydralazine Tablets resources

• Hydralazine Tablets Side Effects (in more detail)
• Hydralazine Tablets Use in Pregnancy & Breastfeeding
• Drug Images
• Hydralazine Tablets Drug Interactions
• Hydralazine Tablets Support Group
• 1 Review for Hydralazines - Add your own review/rating

Compare Hydralazine Tablets with other medications

• Heart Failure
• High Blood Pressure
• Hypertensive Emergency

hydrochlorothiazide and methyldopa

Generic Name: hydrochlorothiazide and methyldopa (HYE droe KLOR oh THYE a zide and METH il DOE pa)

Brand Names: Aldoril 15, Aldoril 25, Aldoril D30, Aldoril D50

What is hydrochlorothiazide and methyldopa?

Methyldopa lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels (veins and arteries) to relax (widen) and your heart to beat more slowly and easily.

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

The combination of hydrochlorothiazide and methyldopa is used to treat high blood pressure (hypertension).

Hydrochlorothiazide and methyldopa may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrochlorothiazide and methyldopa?

You should not use this medication if you are allergic to methyldopa (Apresoline) or hydrochlorothiazide, if you are unable to urinate, or if you have liver disease (including cirrhosis or hepatitis), or a history of liver problems caused by taking methyldopa. Do not use hydrochlorothiazide and methyldopa if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before using hydrochlorothiazide and methyldopa, tell your doctor if you have kidney disease (or are on dialysis), angina pectoris (chest pain), glaucoma, asthma, gout, lupus, diabetes, an allergy to sulfa drugs or penicillin, or if you have ever had a stroke.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

There are many other drugs that can interact with hydrochlorothiazide and methyldopa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

What should I discuss with my doctor before taking hydrochlorothiazide and methyldopa?

Do not use hydrochlorothiazide and methyldopa if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to methyldopa (Apresoline) or hydrochlorothiazide, or if you have:

• 
  

  liver disease (including cirrhosis or hepatitis);

  
  


• 
  

  a history of liver problems caused by taking methyldopa; or

  
  


• 
  

  if you are unable to urinate.

  
  

To make sure you can safely take hydrochlorothiazide and methyldopa, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease (or if you are on dialysis);

  
  


• 
  

  angina pectoris (chest pain);

  
  


• 
  

  glaucoma;

  
  


• 
  

  asthma;

  
  


• 
  

  gout;

  
  


• 
  

  lupus;

  
  


• 
  

  diabetes;

  
  


• 
  

  an allergy to sulfa drugs or penicillin; or

  
  


• 
  

  if you have ever had a stroke.

  
  

FDA pregnancy category C. It is not known whether hydrochlorothiazide and methyldopa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hydrochlorothiazide and methyldopa 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.

How should I take hydrochlorothiazide and methyldopa?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Your blood pressure will need to be checked often. Your liver function may also need to be tested. Visit your doctor regularly.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide and methyldopa. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood and urine may both be tested if you have been vomiting or are dehydrated.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using a thiazide diuretic.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and methyldopa. You may need to stop using the medicine for a short time. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture, heat, and light.

See also: Hydrochlorothiazide and methyldopa dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking hydrochlorothiazide and methyldopa?

Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and methyldopa.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Avoid exposure to sunlight or tanning beds. Hydrochlorothiazide and methyldopa can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Hydrochlorothiazide and methyldopa side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using hydrochlorothiazide and methyldopa and call your doctor at once if you have a serious side effect such as:

• 
  

  eye pain, vision problems;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  chest pain, slow heart rate, feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  
  


• 
  

  joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions);

  
  


• 
  

  numbness, drooping, or loss of movement in one side of your face;

  
  


• 
  

  jerky or rolling muscle movements you cannot control;

  
  


• 
  

  high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  fever, skin rash, bruising, severe tingling, numbness; or

  
  


• 
  

  severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling;severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

  
  

Less serious side effects may include:

• 
  

  stomach cramps, diarrhea, constipation;

  
  


• 
  

  depressed mood, trouble concentrating;

  
  


• 
  

  joint pain;

  
  


• 
  

  muscle pain or weakness;

  
  


• 
  

  restless feeling;

  
  


• 
  

  dizziness, drowsiness, headache;

  
  


• 
  

  soreness or black discoloration of your tongue;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  impotence, or loss of interest in sex.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Hydrochlorothiazide and methyldopa Dosing Information

Usual Adult Dose for Hypertension:

Initial dose: 1 tablet of (hydrochlorothiazide-methyldopa 15 mg/250 mg) 2 to 3 times a day or
1 tablet of (hydrochlorothiazide-methyldopa 25 mg/250 mg) two times a day.
Determine dosage by individual titration.
Maintenance dose: May increase to 1 tablet of (hydrochlorothiazide-methyldopa 30 mg/500 mg) orally twice a day or
1 tablet of (hydrochlorothiazide-methyldopa 50 mg/500 mg orally twice a day.

What other drugs will affect hydrochlorothiazide and methyldopa?

Tell your doctor about all other medicines you use, especially:

• 
  

  cholestyramine (Prevalite, Questran);

  
  


• 
  

  colestipol (Colestid);

  
  


• 
  

  digoxin (Lanoxin);

  
  


• 
  

  insulin or oral diabetes medication;

  
  


• 
  

  lithium (Eskalith, LithoBid);

  
  


• 
  

  a barbiturate such as phenobarbital (Solfoton);

  
  


• 
  

  medicines that contain iron, such as ferrous gluconate (Fergon, Ferralet, Simron), or ferrous sulfate (Chem-Sol, Feosol, Slow Fe, and others);

  
  


• 
  

  muscle relaxers or narcotic pain medicine;

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  other blood pressure medications;

  
  


• 
  

  a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with hydrochlorothiazide and methyldopa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More hydrochlorothiazide and methyldopa resources

• Hydrochlorothiazide and methyldopa Dosage
• Hydrochlorothiazide and methyldopa Use in Pregnancy & Breastfeeding
• Drug Images
• Hydrochlorothiazide and methyldopa Drug Interactions
• Hydrochlorothiazide and methyldopa Support Group
• 0 Reviews for Hydrochlorothiazide and methyldopa - Add your own review/rating

Compare hydrochlorothiazide and methyldopa with other medications

• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about hydrochlorothiazide and methyldopa.

hepatitis b immune globulin Intramuscular

hep-a-TYE-tis B i-MUNE-GLOB-ue-lin

Commonly used brand name(s)

In the U.S.

• Bayhep B


• HepaGam B


• HyperHEP B


• Nabi-HB


• Nabi-HB NovaPlus

Available Dosage Forms:

• Solution

Uses For hepatitis b immune globulin

Hepatitis B Immune Globulin (Human) is used to prevent hepatitis B.

Hepatitis B Immune Globulin (Human) may be used for the following patients:

• Sexual partners of persons with hepatitis B.


• Persons who may be exposed to the virus by means of blood, blood products, or human bites, such as health care workers, employees in medical facilities, patients and staff of live-in facilities and day-care programs for the developmentally disabled, morticians and embalmers, police and fire department personnel, and military personnel.


• Those who have household exposure to persons with acute hepatitis B and babies less than 12 months old whose caregiver tests positive for hepatitis B.


• Babies born to mothers who test positive for hepatitis B.

hepatitis b immune globulin is available only from your doctor or other authorized health care professional.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, hepatitis B immune globulin (human) is used to prevent infection by the hepatitis B virus in patients who have had liver transplants.

Before Using hepatitis b immune globulin

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 hepatitis b immune globulin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hepatitis b immune globulin 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

Although there is no specific information comparing use of hepatitis B immune globulin (human) in children with use in other age groups, hepatitis b immune globulin is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of hepatitis B immune globulin in the elderly with use in other age groups.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

The presence of other medical problems may affect the use of hepatitis b immune globulin. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems— Because hepatitis B immune globulin (human) is given as a shot into a muscle, it may cause more bleeding

• Immune system problems—Hepatitis B immune globulin (human) may cause severe allergic reactions

Proper Use of hepatitis b immune globulin

Hepatitis B immune globulin (human) is given as a shot into the muscle of the upper arm, upper thigh, or outer area of the buttocks.

Dosing

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

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

• For injectable dosage form:
  
  • For prevention of hepatitis B following nonsexual exposure:
    
    • Adults—Dose is based on weight and will be determined by your doctor. If you have never been vaccinated with hepatitis B virus vaccine, your doctor may start the vaccination series. If you have been vaccinated, you may need a booster.
    
    
    • Infants with mothers who test positive for hepatitis B—Dose is usually 0.5 milliliters (mL) injected into a muscle in the thigh.
    
    
  
  
  • For prevention of hepatitis B following sexual exposure:
    
    • Adults—Dose is based on weight and will be determined by your doctor. Your doctor may start the hepatitis B virus vaccination series if the exposure has been within the last 14 days or if sexual contact is likely to continue.
    
    
  
  
  • For prevention of hepatitis B following household exposure:
    
    • Infants less than 12 months of age—Dose is usually 0.5 mL injected into a muscle in the thigh.
    
    
  
  

hepatitis b immune globulin Side Effects

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

• Back pain


• general feeling of discomfort


• headache


• muscle aches or pain


• nausea


• pain at the injection site

Less common

• Abdominal or stomach cramping


• burning, heat, and redness at the injection site


• chills


• diarrhea


• feeling as if you are going to vomit


• joint pain


• lightheadedness


• skin rash


• unusual tiredness or weakness

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: hepatitis b immune globulin Intramuscular side effects (in more detail)

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

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

More hepatitis b immune globulin Intramuscular resources

• Hepatitis b immune globulin Intramuscular Side Effects (in more detail)
• Hepatitis b immune globulin Intramuscular Use in Pregnancy & Breastfeeding
• Hepatitis b immune globulin Intramuscular Drug Interactions
• Hepatitis b immune globulin Intramuscular Support Group
• 0 Reviews for Hepatitis b immune globulin Intramuscular - Add your own review/rating

Compare hepatitis b immune globulin Intramuscular with other medications

• Exposure to Hepatitis B Virus

Urocit-K 5

Generic Name: citrate (Oral route)

Commonly used brand name(s)

In the U.S.

• Citra pH


• Cytra-K


• Cytra-K Crystals


• Liqui-DualCitra


• Polycitra-K


• Polycitra-K Crystals


• Urocit-K 10


• Urocit-K 15


• Urocit-K 5

In Canada

• Pms-Dicitrate

Available Dosage Forms:

• Tablet


• Solution


• Tablet, Extended Release


• Syrup


• Powder for Suspension

Uses For Urocit-K 5

Citrates are used to make the urine more alkaline (less acid). This helps prevent certain kinds of kidney stones. Citrates are sometimes used with other medicines to help treat kidney stones that may occur with gout. They are also used to make the blood more alkaline in certain conditions

Citrates are available only with your doctor's prescription.

Before Using Urocit-K 5

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Although there is no specific information comparing use of citrates in children with use in other age groups, these medicines are not expected to cause different side effects or problems in children than they do in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of citrates in the elderly with use in other age groups.

Pregnancy

Studies on effects in pregnancy have not been done in either humans or animals.

Breast Feeding

Although it is not known whether citrates pass into the breast milk, this medicine has not been reported to cause problems in nursing babies.

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (underactive adrenal glands) or


• Type 2 diabetes mellitus or


• Kidney disease—The potassium in potassium-containing citrates may worsen or cause heart problems in patients with these conditions.

• Diarrhea (chronic)—Treatment with citrates may not be effective; a change in dose of citrate may be needed.

• Edema (swelling of the feet or lower legs) or


• High blood pressure or


• Toxemia of pregnancy—The sodium in sodium-containing citrates may cause the body to retain (keep) water.

• Heart disease—The sodium in sodium-containing citrates may cause the body to retain (keep) water; the potassium in potassium-containing citrates may make heart disease worse.

• Intestinal or esophageal blockage—Potassium citrate tablets may cause irritation of the stomach or intestines.

• Stomach ulcer or other stomach problems—Potassium citrate–containing products may make these conditions worse.

• Urinary tract infection—Citrates may make conditions worse.

Proper Use of citrate

This section provides information on the proper use of a number of products that contain citrate. It may not be specific to Urocit-K 5. Please read with care.

For patients taking the tablet form of this medicine:

• Swallow the tablets whole. Do not crush, chew, or suck the tablet.


• Take with a full glass (8 ounces) of water.


• If you have trouble swallowing the tablets or they seem to stick in your throat, check with your doctor at once. If this medicine is not completely swallowed and not properly dissolved, it can cause severe irritation.

For patients taking the liquid form of this medicine:

• Dilute with a full glass (6 ounces) of water or juice and drink; follow with additional water, if desired.


• Chill, but do not freeze, this medicine before taking it, for a better taste.

For patients taking the crystals form of this medicine:

• Add the contents of one packet to at least 6 ounces of cool water or juice.


• Stir well to make sure the crystals are completely dissolved.


• Drink all the mixture to be sure you are taking the correct dose. Follow with additional water or juice, if desired.

Take each dose immediately after a meal or within 30 minutes after a meal or bedtime snack. This helps prevent the medicine from causing stomach pain or a laxative effect.

Drink at least a full glass (8 ounces) of water or other liquid (except milk) every hour during the day (about 3 quarts a day), unless otherwise directed by your doctor. This will increase the flow of urine and help prevent kidney stones.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important if you are also taking a diuretic (water pill) or digitalis medicine for your heart.

Dosing

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

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

• For potassium citrate


• For oral dosage form (tablets):
  
  • To make the urine more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 1.08 to 2.16 grams three times a day with meals. Some people may take 1.62 grams four times a day with meals or within thirty minutes after a meal or bedtime snack. Your doctor may change your dose if needed. However, most people usually will not take more than 10.8 grams a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For potassium citrate and citric acid


• For oral dosage form (solution):
  
  • To make the urine or blood more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 2 to 3 teaspoonfuls of solution, mixed with water or juice, four times a day, after meals and at bedtime. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  
  • To make the urine more alkaline (less acidic):
    
    • Children—At first, 1 to 3 teaspoonfuls of solution, mixed with water or juice, four times a day after meals and at bedtime. Your doctor may change the dose if needed.
    
    
  
  


• For oral dosage form (crystals for solution):
  
  • To make the urine or blood more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 3.3 grams of potassium citrate, mixed with water or juice, four times a day, after meals and at bedtime. Your doctor may change the dose if needed.
    
    
    • Children—Use is not recommended.
    
    
  
  

• For potassium citrate and sodium citrate


• For oral dosage form (tablets):
  
  • To make the urine more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 1 to 4 tablets after meals and at bedtime.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For sodium citrate and citric acid


• For oral dosage form (solution):
  
  • To make the urine and blood more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 2 to 6 teaspoonfuls of solution four times a day, after meals and at bedtime. The solution should be mixed in one to three ounces of water. Your doctor may change the dose if needed. However, most people will usually not take more than five ounces a day.
    
    
  
  
  • To make the blood more alkaline (less acidic):
    
    • Adults—1 to 2 tablespoonfuls as a single dose. You may mix it in one to two tablespoonfuls of water.
    
    
  
  
  • To make the contents of the stomach less acidic before surgery:
    
    • Children—At first, 1 to 3 teaspoonfuls of solution four times a day, after meals and at bedtime. The solution should be mixed in one to three ounces of water. Your doctor may change the dose if needed.
    
    
  
  

• For tricitrates


• For oral dosage form (solution):
  
  • To make the urine and blood more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 1 to 2 tablespoonfuls of solution four times a day, after meals and at bedtime. Your doctor may change the dose if needed.
    
    
  
  
  • To make the contents of the stomach less acidic before surgery:
    
    • Adults—1 tablespoonful as a single dose. You should mix the solution in one tablespoonful of water.
    
    
  
  
  • To make the urine or blood more alkaline (less acidic):
    
    • Children—At first, 5 to 10 mL four times a day after meals and at bedtime. Your doctor may change the dose if needed.
    
    
  
  

Missed Dose

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

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Urocit-K 5

It is important that your doctor check your progress at regular visits. This is to make sure the medicine is working properly and to check for unwanted effects.

Do not eat salty foods or use extra table salt on your food while you are taking citrates. This will help prevent kidney stones and unwanted effects.

Check with your doctor before starting any strenuous physical exercise, especially if you are out of condition and are taking any other medication. Exercise and certain medications may increase the amount of potassium in the blood.

For patients taking potassium citrate–containing medicines:

• Do not use salt substitutes and low-salt milk unless told to do so by your doctor. They may contain potassium.


• Check with your doctor at once if you are taking the tablet form and notice black, tarry stools or other signs of stomach or intestinal bleeding.


• Do not be alarmed if you notice what appears to be a whole tablet in the stool after taking potassium citrate tablets. Your body has received the proper amount of medicine from the tablet and has expelled the tablet shell. However, it is a good idea to check with your doctor also.


• If you are on a potassium-rich or potassium-restricted diet, check with your health care professional. Potassium citrate–containing medicines contain a large amount of potassium.

For patients taking sodium citrate–containing medicines:

• If you are on a sodium-restricted diet, check with your health care professional. Sodium citrate–containing medicines contain a large amount of sodium.

Urocit-K 5 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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

• Abdominal or stomach pain or cramping (severe)


• black, tarry stools


• vomiting (severe), sometimes with blood

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

• Confusion


• convulsions (seizures)


• dizziness


• high blood pressure


• irregular or fast heartbeat


• irritability


• mood or mental changes


• muscle pain or twitching


• nervousness or restlessness


• numbness or tingling in hands, feet, or lips


• shortness of breath, difficult breathing, or slow breathing


• swelling of feet or lower legs


• unexplained anxiety


• unpleasant taste


• unusual tiredness or weakness


• weakness or heaviness of legs

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

Less common

• Abdominal or stomach soreness or pain (mild)


• diarrhea or loose bowel movements


• nausea or vomiting

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.

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