hye-droe-MOR-fone

Commonly used brand name(s):

In the U.S.

• Dilaudid
• Dilaudid-5
• Exalgo
• Palladone

Available Dosage Forms:

• Liquid
• Tablet, Extended Release
• Capsule, Extended Release
• Tablet
• Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For hydromorphone

Hydromorphone oral liquid and tablets are used to relieve pain. The hydromorphone extended-release tablets are used to relieve moderate to severe pain in opioid-tolerant patients.

Hydromorphone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped. completely.

hydromorphone is available only with your doctor’s prescription.

Before Using hydromorphone

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 hydromorphone, the following should be considered:

Allergies

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

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydromorphone in the elderly. However, elderly patients may be more sensitive to the effects of hydromorphone than younger adults, and are more likely to have age-related lung, liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydromorphone.

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

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

Interactions with Medicines

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

• Naltrexone

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

• Adinazolam
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Aripiprazole
• Brofaromine
• Bromazepam
• Brotizolam
• Buprenorphine
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Clorgyline
• Clozapine
• Codeine
• Dantrolene
• Desflurane
• Dexmedetomidine
• Dezocine
• Diazepam
• Diphenhydramine
• Doxylamine
• Enflurane
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Fentanyl
• Flumazenil
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fospropofol
• Furazolidone
• Halazepam
• Haloperidol
• Halothane
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Iproniazid
• Isocarboxazid
• Isoflurane
• Ketamine
• Ketazolam
• Lazabemide
• Levorphanol
• Linezolid
• Lorazepam
• Lormetazepam
• Loxapine
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Mesoridazine
• Metaxalone
• Methocarbamol
• Methohexital
• Midazolam
• Moclobemide
• Molindone
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nialamide
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Olanzapine
• Opium
• Oxazepam
• Oxycodone
• Oxymorphone
• Paliperidone
• Pargyline
• Pentazocine
• Pentobarbital
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimozide
• Prazepam
• Procarbazine
• Promazine
• Promethazine
• Propofol
• Propoxyphene
• Quazepam
• Quetiapine
• Ramelteon
• Rasagiline
• Remifentanil
• Risperidone
• Secobarbital
• Selegiline
• Sevoflurane
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Thioridazine
• Thiothixene
• Toloxatone
• Tranylcypromine
• Triazolam
• Trifluoperazine
• Zaleplon
• Ziprasidone
• Zolpidem

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using hydromorphone with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use hydromorphone, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Addison’s disease (adrenal gland problem) or
• Alcohol abuse, or history of or
• Breathing or lung problems (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale, hypercapnia, hypoxia, sleep apnea) or
• CNS depression, history of or
• Drug dependence, especially narcotic abuse or dependence, history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Gallbladder disease or
• Hypothyroidism (an underactive thyroid) or
• Kyphoscoliosis (curvature of spine that can cause breathing problems) or
• Mental illness, or history of or
• Obesity, severe or
• Problems with passing urine—Use with caution. May increase risk for more serious side effects.

• Brain tumor or
• Head injuries or
• Increased pressure in your head—Some of the side effects of hydromorphone can cause serious problems in people who have these medical problems.

• Breathing problems (e.g., asthma, hypercapnia), severe or
• Respiratory depression (hypoventilation or slow breathing)—Should not be used in patients with these conditions.

• Gallbladder surgery or
• Hypotension (low blood pressure) or
• Pancreatitis (inflammation of the pancreas) or
• Seizures, history of—Use with caution. May make these conditions worse.

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

• Not opioid-tolerant (if you are not already taking a certain amount of morphine, oxycodone, or other opioid medicine) or
• Paralytic ileus (intestinal blockage) or
• Stomach or bowel problems (e.g., narrowing of the intestines, Meckel’s diverticulum, peritonitis, “short gut” syndrome), history of or
• Surgery (e.g., stomach, intestinal), history of or
• Trouble with swallowing—Exalgo® extended-release tablets should not be given in patients with these conditions.

• Stomach or digestion problems—hydromorphone may mask the diagnosis of these conditions.

Proper Use of hydromorphone

Take hydromorphone 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 for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of hydromorphone is taken for a long time, it may become habit-forming (causing mental or physical dependence).

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

If you are using the extended-release tablets:

• Hydromorphone extended-release tablets are for use in opioid-tolerant patients only. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using hydromorphone.
• hydromorphone comes with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
• Swallow the tablets whole. Do not break, crush, or chew it.
• While taking hydromorphone, part of the tablet may pass into your stools. This is normal and is nothing to worry about.

Exalgo® tablets works differently than hydromorphone tablets, even at the same dose (number of milligrams). Do not switch from the extended-release tablets to the immediate-release tablets unless your doctor tells you to.

Be careful not to handle crushed or broken tablets. If you have contact with broken or crushed tablets or spilled oral liquid, wash your skin or the affected areas with soap and water right away.

Dosing

The dose of hydromorphone 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 hydromorphone. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage form (extended-release tablets):
  • For moderate to severe pain:
    • For patients switching from other oral hydromorphone to Exalgo®:
      • Adults—The once daily starting dose is the same as the total hydromorphone dose that you are taking daily. Your doctor may increase the dose every 3 to 4 days as needed.
      • Children—Use and dose must be determined by your doctor.
    • For patients switching from oral opioids to Exalgo®:
      • Adults—At first, the dose is half of the total opioid dose that you are taking every 24 hours. Your doctor may increase the dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For patients switching from fentanyl transdermal to Exalgo®:
      • Adults—The medicine should be started at least 18 hours after the removal of the fentanyl patch. At first, the dose is 12 mg every 24 hours for each 25 microgram per hour (mcg/hr) of the transdermal fentanyl. Your doctor may increase the dose as needed.
      • Children—Use and dose must be determined by your doctor.
• For oral dosage form (liquid):
  • For pain:
    • Adults—At first, 2.5 to 10 milliliters (mL) or one-half to two teaspoonfuls every 3 to 6 hours as needed . Your doctor may increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For pain:
    • Adults—At first, 2 to 4 milligrams (mg) every 4 to 6 hours. Your doctor may increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Flush the unused medicine down the toilet.

Precautions While Using hydromorphone

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

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

hydromorphone may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

hydromorphone may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to hydromorphone before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

hydromorphone may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using hydromorphone.

If you have been using hydromorphone regularly for several weeks or more, do not change your dose or suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely, or to take another narcotic for a while, to lessen the chance of withdrawal side effects (such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping).

Using hydromorphone while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

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

hydromorphone Side Effects

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

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

Less common or rare

• Agitation
• bloody, black, or tarry stools
• blurred vision
• changes in behavior
• chest pain or discomfort
• convulsions
• decreased urination
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• lightheadedness, dizziness, or fainting
• mood or mental changes
• rapid breathing
• severe stomach pain, cramping, or burning
• severe vomiting
• shortness of breath
• slow or irregular heartbeat
• stiff neck
• sunken eyes
• thoughts of killing oneself
• trouble breathing
• unusual tiredness
• vomiting of material that looks like coffee grounds, severe and continuing
• wrinkled skin

Incidence not known

• Bluish lips or skin
• change in the ability to see colors, especially blue or yellow
• cold, clammy skin
• confusion
• cough
• decrease in the frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• difficult or troubled breathing
• dizziness
• fast, weak pulse
• headache
• heart stops
• irregular, fast or slow, or shallow breathing
• loss of appetite
• no pulse or blood pressure
• noisy breathing
• not breathing
• painful urination
• pale or blue lips, fingernails, or skin
• sleeplessness
• sweating
• tightness in the chest
• trouble sleeping
• unable to sleep
• unconscious
• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Decreased awareness or responsiveness
• increased sensitivity of the eyes to light
• no muscle tone or movement
• sleepiness or unusual drowsiness

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

• Difficulty having a bowel movement (stool)
• difficulty with moving
• muscle pain or stiffness
• nausea
• pain in the joints

Less common

• Acid or sour stomach
• back pain
• belching
• bloating or swelling of the face, arms, hands, lower legs, or feet
• diarrhea
• discouragement
• feeling sad or empty
• heartburn
• indigestion
• irritability
• loss of interest or pleasure
• muscle spasms
• pain in the arms or legs
• rapid weight gain
• stomach discomfort, upset, or pain
• tingling of the hands or feet
• trouble concentrating
• unusual weight gain or loss
• weight loss

Less common or rare

• Being forgetful
• bleeding after defecation
• change in taste
• changes in the patterns and rhythms of speech
• clumsiness
• continuing ringing or buzzing or other unexplained noise in the ears
• crying
• decreased interest in sexual intercourse
• delusions of persecution, mistrust, suspiciousness, or combativeness
• difficulty with swallowing
• difficulty with walking
• double vision
• excess air or gas in the stomach or intestines
• extra heartbeats
• feeling of constant movement of self or surroundings
• full feeling
• hearing loss
• inability to have or keep an erection
• increased appetite
• joint pain, stiffness, or swelling
• loss in sexual ability, desire, drive, or performance
• loss of balance
• loss of taste
• low body temperature
• muscle aches
• muscle twitching or jerking
• overactive reflexes
• passing gas
• rhythmic movement of muscles
• runny nose
• seeing double
• seeing, hearing, or feeling things that are not there
• sensation of spinning
• shivering
• slurred speech
• sneezing
• swelling of the feet or lower legs
• trouble with speaking
• uncomfortable swelling around the anus
• weak or feeble pulse

Incidence not known

• Bad, unusual or unpleasant (after)taste
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• chills
• constricted, pinpoint, or small pupils (black part of the eye)
• deep or fast breathing with dizziness
• drowsiness
• dry mouth
• false or unusual sense of well-being
• fear or nervousness
• feeling of warmth
• hives or welts
• muscle stiffness or tightness
• numbness of the feet, hands, and around the mouth
• redness of the skin
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed and calm
• shaking
• skin itching
• uncontrolled eye movements
• upper abdominal or stomach pain
• weight loss

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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hye-droe-MOR-fone

Commonly used brand name(s):

In the U.S.

• Dilaudid
• Dilaudid-HP

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For hydromorphone

Hydromorphone injection is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Hydromorphone acts on the central nervous system (CNS) to relieve pain.

When hydromorphone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

hydromorphone is available only with your doctor’s prescription.

Before Using hydromorphone

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 hydromorphone, the following should be considered:

Allergies

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

Pediatric

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

Geriatric

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

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

• Naltrexone

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

• Adinazolam
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Aripiprazole
• Brofaromine
• Bromazepam
• Brotizolam
• Buprenorphine
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Clorgyline
• Clozapine
• Codeine
• Dantrolene
• Desflurane
• Dexmedetomidine
• Dezocine
• Diazepam
• Diphenhydramine
• Doxylamine
• Enflurane
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Fentanyl
• Flumazenil
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fospropofol
• Furazolidone
• Halazepam
• Haloperidol
• Halothane
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Iproniazid
• Isocarboxazid
• Isoflurane
• Ketamine
• Ketazolam
• Lazabemide
• Levorphanol
• Linezolid
• Lorazepam
• Lormetazepam
• Loxapine
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Mesoridazine
• Metaxalone
• Methocarbamol
• Methohexital
• Midazolam
• Moclobemide
• Molindone
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nialamide
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Olanzapine
• Opium
• Oxazepam
• Oxycodone
• Oxymorphone
• Paliperidone
• Pargyline
• Pentazocine
• Pentobarbital
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimozide
• Prazepam
• Procarbazine
• Promazine
• Promethazine
• Propofol
• Propoxyphene
• Quazepam
• Quetiapine
• Ramelteon
• Rasagiline
• Remifentanil
• Risperidone
• Secobarbital
• Selegiline
• Sevoflurane
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Thioridazine
• Thiothixene
• Toloxatone
• Tranylcypromine
• Triazolam
• Trifluoperazine
• Zaleplon
• Ziprasidone
• Zolpidem

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using hydromorphone with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use hydromorphone, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Addison’s disease (adrenal gland problem) or
• Alcohol abuse, or history of or
• Asthma, severe, history of or
• Brain tumor, history of or
• Breathing problems, severe (e.g., hypoxia) or
• Chronic obstructive pulmonary disease (COPD) or
• Cor pulmonale (serious heart condition) or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Gallbladder disease or gallstones or
• Head injuries, history of or
• Hypothyroidism (an underactive thyroid) or
• Hypovolemia (low blood volume) or
• Kyphoscoliosis (curvature of the spine with breathing problems) or
• Problems with passing urine—Use with caution. May increase risk for more serious side effects.

• Asthma attack, acute or
• Not opioid-tolerant (not already taking narcotic analgesics) or
• Paralytic ileus (bowels stop working and may be blocked) or
• Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or
• Pancreatitis (inflammation of the pancreas) or
• Seizures, history of—Use with caution. May make these conditions worse.

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

Proper Use of hydromorphone

A nurse or other trained health professional will give you hydromorphone in a hospital. hydromorphone may be given as a shot under the skin, as a shot into one of your muscles, or through a needle placed in one of your veins.

Precautions While Using hydromorphone

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

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

hydromorphone may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

hydromorphone may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to hydromorphone before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

hydromorphone may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are receiving hydromorphone.

If you have been using hydromorphone regularly for several weeks or longer, do not suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

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

hydromorphone 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:

Incidence not known

• Abdominal or stomach pain
• bluish lips or skin
• blurred vision
• change in ability to see colors, especially blue or yellow
• chest pain or discomfort
• cold, clammy skin
• confusion
• cough
• difficult or troubled breathing
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• fast or weak pulse
• irregular, fast, slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• loss of appetite
• low blood pressure
• noisy breathing
• pale or blue lips, fingernails, or skin
• severe constipation
• severe vomiting
• shortness of breath
• sleeplessness
• slow or irregular heartbeat
• sweating
• tightness in the chest
• trouble sleeping
• unable to sleep
• unconscious
• unusual tiredness
• very slow breathing
• very slow heartbeat or pulse
• vomiting
• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Bigger, dilated, or enlarged pupils (black part of the eye)
• decreased awareness or responsiveness
• increased sensitivity of the eyes to light
• no muscle tone or movement
• sleepiness or unusual drowsiness

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

Incidence not known

• Anxiety
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• bad, unusual, or unpleasant (after) taste
• change in taste
• chills
• constricted, pinpoint, or small pupils (black part of the eye)
• decrease in the frequency of urination
• decrease in urine volume
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty in passing urine (dribbling)
• double vision
• dry mouth
• false or unusual sense of well-being
• feeling of warmth
• hives or welts
• hyperventilation
• irregular heartbeats
• irritability
• loss of appetite
• muscle stiffness or tightness
• nausea
• painful urination
• redness, pain, or swelling at the injection site
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed and calm
• seeing, hearing, or feeling things that are not there
• seeing double
• shaking
• sleepiness
• skin itching
• uncontrolled eye movements
• upper abdominal or stomach pain
• weight loss

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

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

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

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

Generic Name: Hydromorphone (HYE-droe-MOR-fone)
Brand Name: Dilaudid

Hydromorphone Suppository is used for:

Treating pain in certain patients.

Hydromorphone Suppository is an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system to reduce pain.

Do NOT use Hydromorphone Suppository if:

• you are allergic to any ingredient in Hydromorphone Suppository or any other codeine- or morphine-related medicine (eg, morphine, codeine, oxycodone)
• you have difficult or slowed breathing, chronic obstructive pulmonary disease (COPD), or right-sided heart problems (cor pulmonale), or you are having a severe asthma attack
• you are in labor
• you have severe diarrhea or other bowel problems caused by antibiotics or poisoning
• you have a brain injury or growths in the brain along with increased pressure in the brain
• you are taking sodium oxybate (GHB)

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

Before using Hydromorphone Suppository:

Some medical conditions may interact with Hydromorphone Suppository. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of lung or breathing problems (eg, asthma, emphysema, bronchitis), seizures (eg, epilepsy), adrenal gland problems, an enlarged prostate, heart problems, low blood pressure, dehydration, low blood volume, an underactive thyroid, or urinary blockage
• if you have severe drowsiness, a recent head injury, spinal problems, growths in the brain, or increased pressure in the brain
• if you have liver or kidney problems, gallbladder problems, or stomach or bowel problems (eg, inflammation), or if you have had recent stomach or bowel surgery
• if you drink alcohol regularly, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
• if you have a personal or family history of mental or mood problems, alcohol abuse, or other substance abuse or dependence
• if you are in poor health or shock, or will be having surgery

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

• Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
• Barbiturate anesthetics (eg, thiopental), cimetidine, or sodium oxybate (GHB) because the risk of severe drowsiness, coma, or slowed or difficult breathing may be increased
• Agonist/antagonist analgesics (eg, pentazocine) or naltrexone because they may decrease Hydromorphone Suppository’s effectiveness and withdrawal may occur

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

How to use Hydromorphone Suppository:

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

• Wash your hands before and after using Hydromorphone Suppository.
• If the suppository is too soft to use, put it in the refrigerator for about 15 minutes. You may also run cold water over it.
• Remove the wrapper. Moisten the suppository with cool water. Lie down on your side. Insert the pointed end of the suppository into the rectum. Use your finger to push it in completely.
• If you are taking Hydromorphone Suppository for persistent pain, take it on a regular schedule to help control the pain more effectively.
• Do not change your dose or suddenly stop taking Hydromorphone Suppository without checking with your doctor.
• If Hydromorphone Suppository is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Hydromorphone Suppository properly.
• If you miss a dose of Hydromorphone Suppository and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydromorphone Suppository.

Important safety information:

• Hydromorphone Suppository may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol, other opiate pain medicines, or certain other medicines. Use Hydromorphone Suppository with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you take Hydromorphone Suppository; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Hydromorphone Suppository may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Hydromorphone Suppository may be habit-forming. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Misuse or abuse of Hydromorphone Suppository may cause severe side effects, including severe breathing problems, seizures, coma, and possibly death.
• Constipation is a common side effect of Hydromorphone Suppository. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Hydromorphone Suppository.
• If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
• Tell your doctor or dentist that you take Hydromorphone Suppository before you receive any medical or dental care, emergency care, or surgery.
• Use Hydromorphone Suppository with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness and breathing problems.
• Hydromorphone Suppository should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Hydromorphone Suppository may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydromorphone Suppository while you are pregnant. Hydromorphone Suppository is found in breast milk. Do not breast-feed while taking Hydromorphone Suppository.

When used for long periods of time or at high doses, Hydromorphone Suppository may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Hydromorphone Suppository stops working well. Do not take more than prescribed.

Some people who use Hydromorphone Suppository for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Dependence is unlikely to be an issue in terminally ill patients where comfort is more important. If you are taking Hydromorphone Suppository regularly, do not suddenly stop taking it without checking with your doctor. WITHDRAWAL symptoms have occurred when Hydromorphone Suppository is suddenly stopped and may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping Hydromorphone Suppository.

Possible side effects of Hydromorphone Suppository:

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

Constipation; dizziness, drowsiness; dry mouth; flushing; lightheadedness; nausea; sweating; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; seizure or persistent dizziness or drowsiness; severe or persistent headache or vomiting; shallow, slowed or difficult breathing; tremor; trouble urinating; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include bluish skin; chest pain; cold and clammy skin; coma; difficult or slow breathing; excessive sweating; limp muscles; nausea and vomiting; numbness of an arm or leg; pinpoint pupils; seizures; severe drowsiness or dizziness; slow or irregular heartbeat.

Proper storage of Hydromorphone Suppository:

Store Hydromorphone Suppository in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Hydromorphone Suppository out of the reach of children and away from pets.

General information:

• If you have any questions about Hydromorphone Suppository, please talk with your doctor, pharmacist, or other health care provider.
• Hydromorphone Suppository is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

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

Generic Name: Hydromorphone (HYE-droe-MOR-fone)
Brand Name: Dilaudid

Hydromorphone Liquid is used for:

Treating pain in certain patients.

Hydromorphone Liquid is an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system to reduce pain.

Do NOT use Hydromorphone Liquid if:

• you are allergic to any ingredient in Hydromorphone Liquid or any other codeine- or morphine-related medicine (eg, morphine, codeine, oxycodone)
• you have difficult or slowed breathing, chronic obstructive pulmonary disease (COPD), or right-sided heart problems (cor pulmonale), or you are having a severe asthma attack
• you are in labor
• you have severe diarrhea or other bowel problems caused by antibiotics or poisoning
• you have a brain injury or growths in the brain along with increased pressure in the brain
• you are taking sodium oxybate (GHB)

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

Before using Hydromorphone Liquid:

Some medical conditions may interact with Hydromorphone Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of lung or breathing problems (eg, asthma, emphysema, bronchitis), seizures (eg, epilepsy), adrenal gland problems, an enlarged prostate, heart problems, low blood pressure, dehydration, low blood volume, an underactive thyroid, or urinary blockage
• if you have severe drowsiness, a recent head injury, spinal problems, growths in the brain, or increased pressure in the brain
• if you have liver or kidney problems, gallbladder problems, or stomach or bowel problems (eg, inflammation), or if you have had recent stomach or bowel surgery
• if you drink alcohol regularly, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
• if you have a personal or family history of mental or mood problems, alcohol abuse, or other substance abuse or dependence
• if you are in poor health or shock, or will be having surgery

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

• Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
• Barbiturate anesthetics (eg, thiopental), cimetidine, or sodium oxybate (GHB) because the risk of severe drowsiness, coma, or slowed or difficult breathing may be increased
• Agonist/antagonist analgesics (eg, pentazocine) or naltrexone because they may decrease Hydromorphone Liquid’s effectiveness and withdrawal may occur

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

How to use Hydromorphone Liquid:

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

• Hydromorphone Liquid may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you are taking Hydromorphone Liquid for persistent pain, take it on a regular schedule to help control the pain more effectively.
• Do not change your dose or suddenly stop taking Hydromorphone Liquid without checking with your doctor.
• If Hydromorphone Liquid is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Hydromorphone Liquid properly.
• If you miss a dose of Hydromorphone Liquid and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydromorphone Liquid.

Important safety information:

• Hydromorphone Liquid may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol, other opiate pain medicines, or certain other medicines. Use Hydromorphone Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you take Hydromorphone Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Hydromorphone Liquid may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Hydromorphone Liquid may be habit-forming. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Misuse or abuse of Hydromorphone Liquid may cause severe side effects, including severe breathing problems, seizures, coma, and possibly death.
• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if this product has sulfites in it.
• Constipation is a common side effect of Hydromorphone Liquid. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Hydromorphone Liquid.
• If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
• Tell your doctor or dentist that you take Hydromorphone Liquid before you receive any medical or dental care, emergency care, or surgery.
• Use Hydromorphone Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness and breathing problems.
• Hydromorphone Liquid should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Hydromorphone Liquid may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydromorphone Liquid while you are pregnant. Hydromorphone Liquid is found in breast milk. Do not breast-feed while taking Hydromorphone Liquid.

When used for long periods of time or at high doses, Hydromorphone Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Hydromorphone Liquid stops working well. Do not take more than prescribed.

Some people who use Hydromorphone Liquid for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Dependence is unlikely to be an issue in terminally ill patients where comfort is more important. If you are taking Hydromorphone Liquid regularly, do not suddenly stop taking it without checking with your doctor. WITHDRAWAL symptoms have occurred when Hydromorphone Liquid is suddenly stopped and may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping Hydromorphone Liquid.

Possible side effects of Hydromorphone Liquid:

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

Constipation; dizziness; drowsiness; dry mouth; flushing; lightheadedness; nausea; sweating; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; seizure; severe or persistent dizziness or drowsiness; severe or persistent headache or vomiting; shallow, slowed, or difficult breathing; tremor; trouble urinating; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include bluish skin; chest pain; cold and clammy skin; coma; difficult or slow breathing; excessive sweating; limp muscles; nausea and vomiting; numbness of an arm or leg; pinpoint pupils; seizures; severe drowsiness or dizziness; slow or irregular heartbeat.

Proper storage of Hydromorphone Liquid:

Store Hydromorphone Liquid at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store Hydromorphone Liquid in the bathroom. Keep Hydromorphone Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Hydromorphone Liquid, please talk with your doctor, pharmacist, or other health care provider.
• Hydromorphone Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

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

Generic Name: Hydromorphone (hye-droe-MOR-fone)
Brand Name: Palladone

Hydromorphone Extended-Release Capsules are used for:

Treating pain in adults with constant (around-the-clock) moderate to severe pain that is expected to last for an extended period of time. Hydromorphone Extended-Release Capsules should only be started after you have been taking other narcotic (opioid) medicines and your body has gotten used to them (opioid tolerant). Hydromorphone Extended-Release Capsules are not for use as the first narcotic pain medicine prescribed for you, for short-term use, or for occasional (“as-needed”) use.

Hydromorphone Extended-Release Capsules are an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system used by the body’s natural “pain relievers.”

Do NOT use Hydromorphone Extended-Release Capsules if:

• you are allergic to any ingredient in Hydromorphone Extended-Release Capsules or any other morphine-related medicine (eg, morphine, codeine, oxycodone)
• you have diarrhea associated with poisoning, antibiotic use, a bacterial infection (from eating or drinking contaminated food or water); a stomach problem called paralytic ileus (loss of strength in the intestinal muscles)
• you have acute (sudden) or severe asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD), shallow breathing, emphysema, right-sided heart failure, or a brain injury or disease with increased pressure in the brain
• you are taking cimetidine or sodium oxybate (GHB)

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

Before using Hydromorphone Extended-Release Capsules:

Some medical conditions may interact with Hydromorphone Extended-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have or have ever had alcoholism, substance abuse, or narcotic dependence; if you consume more than 3 alcoholic drinks per day; or if you have a family history of these problems
• if you have considered or attempted suicide; or if you have major depression or hallucinations (seeing or hearing things that are not there)
• if you have an acute head injury, increased pressure in the head, brain injury or tumor, epilepsy, or seizures (convulsions)
• if you have an acute stomach or intestinal problem; chronic inflammation and ulceration of the bowel; low blood volume; recent abdominal surgery; adrenal gland problems; enlargement of the prostate gland; gallbladder problems; heart failure; lung disease, including shortness of breath; kidney or liver problems; low blood pressure; underactive thyroid; or urinary blockage or problems urinating

Some MEDICINES MAY INTERACT with Hydromorphone Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturate anesthetics (eg, thiopental), cimetidine, ketorolac, muscle relaxants (eg, cyclobenzaprine), phenothiazines (eg, thioridazine), sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe are likely to occur
• Risperidone, rifamycins (eg, rifampin), or certain pain relievers because effectiveness of Hydromorphone Extended-Release Capsules may be decreased
• Naltrexone because the effectiveness of Hydromorphone Extended-Release Capsules will be decreased and withdrawal symptoms may occur in patients who have become physically dependent on opioids
• Mexiletine because effectiveness may be decreased by Hydromorphone Extended-Release Capsules

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

How to use Hydromorphone Extended-Release Capsules:

Use Hydromorphone Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Hydromorphone Extended-Release Capsules comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Hydromorphone Extended-Release Capsules refilled.
• Hydromorphone Extended-Release Capsules may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• This capsule must be swallowed whole with water. If you cannot swallow the capsule whole, contact your doctor. Do not break, chew, dissolve, crush, or open the capsule before swallowing. Taking a broken, chewed, dissolved, or crushed capsule or its contents can release the full 24-hour dose into your body all at once. This is very dangerous. You could die from an overdose of the medicine.
• If you miss a dose of Hydromorphone Extended-Release Capsules, take it as soon as possible. Take your next dose 24 hours later. Do not double your prescribed dose of Hydromorphone Extended-Release Capsules at any time because this increases your chance of an overdose. If you are not sure what to do or you miss more than one dose, contact your doctor.

Ask your health care provider any questions you may have about how to use Hydromorphone Extended-Release Capsules.

Important safety information:

• Hydromorphone Extended-Release Capsules may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Hydromorphone Extended-Release Capsules. Using Hydromorphone Extended-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Hydromorphone Extended-Release Capsules. Hydromorphone Extended-Release Capsules will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Hydromorphone Extended-Release Capsules may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit or stand up slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Do not drink alcohol while you are using Hydromorphone Extended-Release Capsules.
• Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.
• If you continue to have pain, your pain worsens, or you have side effects that concern you, contact your health care provider immediately.
• Constipation is a common side effect of Hydromorphone Extended-Release Capsules. Talk to your health care provider about using laxatives or stool softeners to prevent or treat constipation while taking Hydromorphone Extended-Release Capsules.
• Before you have any medical or dental surgery or emergency treatment, tell the doctor or dentist that you are taking Hydromorphone Extended-Release Capsules.
• Use Hydromorphone Extended-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects, especially the possible decreased breathing and drowsiness effects.
• Hydromorphone Extended-Release Capsules are not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Hydromorphone Extended-Release Capsules during pregnancy. Hydromorphone Extended-Release Capsules are excreted in breast milk. Do not breast-feed while taking Hydromorphone Extended-Release Capsules.

Use of Hydromorphone Extended-Release Capsules can lead to TOLERANCE. When using for an extended period, Hydromorphone Extended-Release Capsules may not work as well and may require different dosing. Talk with your doctor if Hydromorphone Extended-Release Capsules stops working well.

Long-term use of Hydromorphone Extended-Release Capsules can lead to physical DEPENDENCE. The early sign of addiction is medicine ineffectiveness. Dependence is not an issue in terminal illness pain where pain comfort is more important. If using Hydromorphone Extended-Release Capsules for an extended period of time, do not suddenly stop taking Hydromorphone Extended-Release Capsules without your doctor’s approval. WITHDRAWAL symptoms have occurred when Hydromorphone Extended-Release Capsules are suddenly stopped and may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping. Contact you doctor if you notice any of these symptoms after stopping this medication.

Possible side effects of Hydromorphone Extended-Release Capsules:

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

Constipation; drowsiness; dry mouth; general body discomfort; headache; infection; itching; sleepiness; sweating; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; feeling faint or dizzy; hallucinations; pounding in the chest; seizure; shallow breathing; urination problems; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/DNN/), or emergency room immediately. Symptoms may include bluish skin; cold/clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizure (convulsions).

Proper storage of Hydromorphone Extended-Release Capsules:

Store Hydromorphone Extended-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hydromorphone Extended-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Hydromorphone Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Hydromorphone Extended-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

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

Generic Name: Hydrocodone/Homatropine (HIGH-droe-KOE-dohn/hoe-MA-troe-peen)
Brand Name: Examples include Hycodan and Hydromet

Hydromet Syrup is used for:

Temporary relief of cough. It may also be used for other conditions as determined by your doctor.

Hydromet Syrup is an anticholinergic and narcotic cough suppressant combination. The anticholinergic works by drying up secretions and the narcotic depresses the cough reflex in the brain.

Do NOT use Hydromet Syrup if:

• you are allergic to any ingredient in Hydromet Syrup or any morphine-related medicine (eg, codeine, oxycodone)
• you have diarrhea due to food poisoning or pseudomembranous colitis
• you are taking sodium oxybate (GHB)

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

Before using Hydromet Syrup:

Some medical conditions may interact with Hydromet Syrup. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine (including any cough-and-cold products or medicines that cause drowsiness), herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have arteriosclerosis (hardening of the arteries) or other heart problems (eg, congestive heart failure)
• if you have high blood pressure, thyroid problems, stomach problems (eg, surgery, severe inflammatory bowel disease, chronic constipation, obstruction), or liver disease
• if you use alcohol or are dependent on drugs
• if you have lung disease (eg, asthma, history of severe breathing problems), a seizure disorder, serious head injury or brain disease, psychiatric problems (eg, suicidal thoughts), glaucoma, or sleep apnea

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

• Barbiturate anesthetics (eg, thiopental), cimetidine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic pain medicines (eg, codeine), and sodium oxybate (GHB) because they may increase the risk of Hydromet Syrup’s side effects
• Naltrexone because it may decrease Hydromet Syrup’s effectiveness

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

How to use Hydromet Syrup:

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

• Take Hydromet Syrup by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Hydromet Syrup and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydromet Syrup.

Important safety information:

• Hydromet Syrup may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Hydromet Syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• If your symptoms do not get better within 7 days or if you develop a high fever or persistent headache, check with your doctor.
• Hydromet Syrup may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Hydromet Syrup.
• Use Hydromet Syrup with caution in the ELDERLY; they may be more sensitive to its effects.
• Hydromet Syrup should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Hydromet Syrup can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydromet Syrup while you are pregnant. It is not known if Hydromet Syrup is found in breast milk. Do not breast-feed while taking Hydromet Syrup.

Some people who use Hydromet Syrup for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Hydromet Syrup suddenly, you may have WITHDRAWAL symptoms. These may include feeling unwell or unhappy, anxious or irritable, dizzy, confused, or agitated. You may also have nausea, unusual skin sensations, mood swings, headache, trouble sleeping, or sweating. If you need to stop Hydromet Syrup, your doctor will lower your dose over time.

Possible side effects of Hydromet Syrup:

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

Blurred vision; constipation; dizziness; drowsiness; dry mouth, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; flushing; rapid or pounding heartbeat; redness of face; severe drowsiness or dizziness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include agitation; coma; confusion; deep sleep or loss of consciousness; difficulty breathing; diminished mental alertness; hallucinations; hot or cold skin; large and unchanging pupils; sedation; seizures; shaking; sleeplessness; slow heartbeat; slowed breathing.

Proper storage of Hydromet Syrup:

Store Hydromet Syrup at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hydromet Syrup out of the reach of children and away from pets.

General information:

• If you have any questions about Hydromet Syrup, please talk with your doctor, pharmacist, or other health care provider.
• Hydromet Syrup is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

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

Generic Name: hydromorphone (oral) (HYE droe MOR fone)
Brand Names: Dilaudid, Dilaudid-5, Exalgo

What is hydromorphone?

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

Hydromorphone is used to treat moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain.

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

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

Hydromorphone may be habit-forming and should be used only by the person it was prescribed for. Never share hydromorphone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take hydromorphone in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Hydromorphone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop using hydromorphone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using hydromorphone.

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

Do not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, methadone, morphine, Oxycontin, Darvocet, Percocet, Vicodin, Lortab, and many others). You should also not take hydromorphone if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus. Hydromorphone may be habit-forming and should be used only by the person it was prescribed for. Never share hydromorphone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

If you have any of these other conditions, you may need a hydromorphone dose adjustment or special tests:

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

• liver or 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.

FDA pregnancy category C. It is not known whether hydromorphone will harm an unborn baby. Hydromorphone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using hydromorphone. 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.

You should not use an extended-release form of hydromorphone (such as Palladone) unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Older adults may be more sensitive to the effects of this medicine.

How should I use hydromorphone?

Take exactly as prescribed. Never take hydromorphone in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take the pill form of this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Avoid getting hydromorphone liquid on your skin. It can be absorbed through your skin, and you may get too large a dose.

Do not stop using hydromorphone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using hydromorphone. Store this medication at room temperature, away from heat, moisture, and light. Keep track of the amount of medicine used from each new bottle. Hydromorphone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet.

Throw away any unused liquid hydromorphone that is older than 90 days.

What happens if I miss a dose?

Since hydromorphone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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.

Extended-release hydromorphone is not for use on an as-needed basis for pain.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydromorphone can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while using hydromorphone?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol. Hydromorphone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Hydromorphone 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:

• nausea, vomiting, constipation, loss of appetite;

• warmth, tingling, or redness under your skin;

• dizziness, headache;

• dry mouth;

• sweating; or

• itching.

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

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 (eg, 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.

6 months to one year with a weigh g
reater 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

1 to 12 years and 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?

Do not take hydromorphone with 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 taking 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.

This list is not complete and other drugs may interact with hydromorphone. 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.

Where can I get more information?

• Your pharmacist can provide more information about hydromorphone.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.01. Revision Date: 04/27/2010 4:10:13 PM.

Generic Name: hydrocortisone, neomycin, and polymyxin B otic (HYE droe KOR ti sone, NEE oh MYE sin, POL ee MIX in B)
Brand names: Cort-Biotic, Cortatrigen, Cortatrigen Modified, Cortisporin Otic, Cortomycin, Oti-Sone, Pediotic, …show all 15 brand names.Drotic, Masporin Otic, Otocort Sterile Solution, Otimar, AK-Spore HC Otic Suspension, Otocort Sterile Suspension, UAD Otic, Antibiotic Ear

What is hydrocortisone, neomycin, and polymyxin B otic?

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Neomycin and polymyxin B are antibiotics that fight bacteria.

The combination of hydrocortisone, neomycin, and polymyxin B otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Hydrocortisone, neomycin, and polymyxin B otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about hydrocortisone, neomycin, and polymyxin B otic?

You should not use this medication if you are allergic to hydrocortisone, neomycin, or polymyxin B, or if you have a ruptured ear drum, or an ear infection caused by chickenpox, or herpes infection (simplex or zoster).

Before using this medication, tell your doctor if you have herpes (simplex or zoster), chickenpox or small pox, any ear infection that causes blistering, asthma or sulfite allergy, or if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing. Stop using this medication and call your doctor at once if you have skin rash, redness, swelling, itching, dryness, scaling, severe burning or stinging, or other irritation in or around the ear. Other serious side effects include new signs of infection, hearing loss, or urinating less than usual or not at all.

What should I discuss with my health care provider before using hydrocortisone, neomycin, and polymyxin B otic?

You should not use this medication if you are allergic to hydrocortisone, neomycin, or polymyxin B, or if you have:

• a ruptured ear drum; or

• an ear infection caused by chickenpox, or herpes infection (simplex or zoster).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• herpes (simplex or zoster);

• chickenpox or small pox;

• any ear infection that causes blistering;

• asthma or sulfite allergy; or

• if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

FDA pregnancy category C. It is not known whether hydrocortisone, neomycin, and polymyxin B otic ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrocortisone and colistin 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 use this medication in a child younger than 2 years old.

How should I use hydrocortisone, neomycin, and polymyxin B otic?

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

Before using this medication, clean and dry your ear canal with sterile cotton.

Shake the ear drops well just before you measure a dose.

This medication is usually given as 4 to 5 drops into the affected ear every 6 to 8 hours. Children may need to use fewer drops. Follow your doctor’s instructions about how much medication you should use and how often.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.

As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in the ear and keep it moist by adding more of the medication every 4 to 8 hours. Replace the cotton at least every 24 hours. Follow your doctor’s instructions about the use of cotton with this medication.

Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include hearing problems, or urinating less than usual.

What should I avoid while using hydrocortisone, neomycin, and polymyxin B otic?

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

Hydrocortisone, neomycin, and polymyxin B otic side effects

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

• skin rash, redness, swelling, itching, dryness, scaling, or other irritation in or around the ear;

• severe burning, stinging, or other irritation when using the medication;

• new signs of infection;

• hearing loss; or

• urinating less than usual or not at all.

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.

Hydrocortisone, neomycin, and polymyxin B otic Dosing Information

Usual Adult Dose for Otitis Externa:

Solution or suspension: Instill 4 drops into the affected ear(s) 3 to 4 times daily.

Usual Adult Dose for Otitis Media:

Mastoidectomy infection and fenestration cavity infection:
Suspension: Instill 4 drops into the affected ear(s) 3 to 4 times daily.

Usual Pediatric Dose for Otitis Externa:

>2 years:
Solution or suspension: Instill 3 drops into the affected ear(s) 3 to 4 times daily.

Usual Pediatric Dose for Otitis Media:

>2 years:
Mastoidectomy infection and fenestration cavity infection:
Suspension: Instill 3 drops into the affected ear(s) 3 to 4 times daily.

What other drugs will affect hydrocortisone, neomycin, and polymyxin B otic?

It is not likely that other drugs you take orally or inject will have an effect on hydrocortisone, neomycin, and polymyxin B used in the ears. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone, neomycin, and polymyxin B otic.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.03. Revision Date: 11/19/2009 2:59:51 PM.

Hydrocortisone/

Diphenhydramine Spray

Generic Name: Hydrocortisone/Diphenhydramine (HYE-droe-KOR-ti-sone/DYE-fen-HYE-dra-meen)
Brand Name: HC DermaPax

Hydrocortisone/Diphenhydramine Spray is used for:

Treating inflammation and itching caused by minor skin irritations (eg, poison ivy, poison oak, insect bites). It may also be used for other conditions as determined by your doctor.

Hydrocortisone/Diphenhydramine Spray contains a topical corticosteroid and an antihistamine. The corticosteroid works by reducing skin inflammation (redness, swelling, itching, and irritation). The antihistamine works by blocking the action of histamine, which reduces the symptoms of an allergic reaction.

Do NOT use Hydrocortisone/Diphenhydramine Spray if:

• you are allergic to any ingredient in Hydrocortisone/Diphenhydramine Spray

Contact your doctor or health care provider right away if this applies to you.

Before using Hydrocortisone/Diphenhydramine Spray:

Some medical conditions may interact with Hydrocortisone/Diphenhydramine Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have any kind of skin infection, cuts, scrapes, sunburn, or lessened blood flow to your skin
• if you have had a recent vaccination; have measles, tuberculosis (TB), chickenpox, or shingles; or have had a positive TB test
• if you have a history of the blood disease porphyria
• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Hydrocortisone/Diphenhydramine Spray. However, no specific interactions with Hydrocortisone/Diphenhydramine Spray are known at this time.

Ask your health care provider if Hydrocortisone/Diphenhydramine Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hydrocortisone/Diphenhydramine Spray:

Use Hydrocortisone/Diphenhydramine Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a small amount of medicine to the affected area as directed by your doctor or on the package labeling.
• Wash your hands after you apply Hydrocortisone/Diphenhydramine Spray, unless your hands are part of the treated area.
• Do not bandage or cover the treated skin area unless directed by your doctor.
• If you miss a dose of Hydrocortisone/Diphenhydramine Spray and you are using it regularly, apply it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydrocortisone/Diphenhydramine Spray.

Important safety information:

• Hydrocortisone/Diphenhydramine Spray is for external use only. Do not get Hydrocortisone/Diphenhydramine Spray in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.
• Do not use Hydrocortisone/Diphenhydramine Spray on the face, in the groin area, or under the armpits. Do not use Hydrocortisone/Diphenhydramine Spray to treat diaper rash.
• Do not use more than the recommended dose or use for longer than 7 days without checking with your doctor.
• If your symptoms do not get better within 7 days, if they get worse, or if they clear up and then come back, check with your doctor.
• Check with your doctor before you have any vaccines while you are using Hydrocortisone/Diphenhydramine Spray.
• Do not use Hydrocortisone/Diphenhydramine Spray for other skin conditions at a later time.
• Do not use other medicines or products on your skin without first checking with your doctor.
• Overuse of topical products may worsen your condition.
• Hydrocortisone/Diphenhydramine Spray has hydrocortisone and diphenhydramine in it. Before you start any new prescription or nonprescription medicine, check the label to see if it has hydrocortisone or diphenhydramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Tell your doctor or dentist that you take Hydrocortisone/Diphenhydramine Spray before you receive any medical or dental care, emergency care, or surgery.
• Serious side effects may occur if too much of Hydrocortisone/Diphenhydramine Spray is absorbed through the skin. This may be more likely to occur if you use Hydrocortisone/Diphenhydramine Spray over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Hydrocortisone/Diphenhydramine Spray. The risk is greater in children. Do not use more than the recommended dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Hydrocortisone/Diphenhydramine Spray.
• Hydrocortisone/Diphenhydramine Spray should not be used in CHILDREN younger than 2 years old without first checking with the child’s doctor; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrocortisone/Diphenhydramine Spray while you are pregnant. It is not known if Hydrocortisone/Diphenhydramine Spray is found in breast milk after topical use. If you are or will be breast-feeding while you use Hydrocortisone/Diphenhydramine Spray, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hydrocortisone/Diphenhydramine Spray:

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

Dryness; mild stinging, burning, or itching.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Hydrocortisone/Diphenhydramine Spray; excessive hair growth; inflamed hair follicles; inflammation around the mouth; thinning, softening, or discoloration of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Hydrocortisone/Diphenhydramine Spray:

Store Hydrocortisone/Diphenhydramine Spray at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Hydrocortisone/Diphenhydramine Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Hydrocortisone/Diphenhydramine Spray, please talk with your doctor, pharmacist, or other health care provider.
• Hydrocortisone/Diphenhydramine Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hydrocortisone/Diphenhydramine Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.