Hydrocodone/Phenylephrine/Pyrilamine Liquid

Generic Name: Hydrocodone/Phenylephrine/Pyrilamine (hye-droe-KOE-done/fen-ill-EF-rin/peer-IL-a-meen)
Brand Name: Examples include Codimal DH and Poly Hist HC

Hydrocodone/Phenylephrine/Pyrilamine Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Hydrocodone/Phenylephrine/Pyrilamine Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Hydrocodone/Phenylephrine/Pyrilamine Liquid if:

• you are allergic to any ingredient in Hydrocodone/Phenylephrine/Pyrilamine Liquid or any other codeine- or morphine-related medicine (eg, codeine)


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Hydrocodone/Phenylephrine/Pyrilamine Liquid:

Some medical conditions may interact with Hydrocodone/Phenylephrine/Pyrilamine 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 fast, slow, or irregular heartbeat, heart blood vessel problems, or other heart problems


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); high blood pressure; diabetes; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have or recently have had any head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hydrocodone/Phenylephrine/Pyrilamine Liquid's side effects


• Cimetidine, digoxin, or droxidopa because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased


• Naltrexone because it may decrease Hydrocodone/Phenylephrine/Pyrilamine Liquid's effectiveness


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Hydrocodone/Phenylephrine/Pyrilamine Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Hydrocodone/Phenylephrine/Pyrilamine Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydrocodone/Phenylephrine/Pyrilamine 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 Hydrocodone/Phenylephrine/Pyrilamine Liquid:

Use Hydrocodone/Phenylephrine/Pyrilamine Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Hydrocodone/Phenylephrine/Pyrilamine Liquid by mouth with or without food.


• 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 Hydrocodone/Phenylephrine/Pyrilamine Liquid, 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 Hydrocodone/Phenylephrine/Pyrilamine Liquid.

Important safety information:

• Hydrocodone/Phenylephrine/Pyrilamine Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Hydrocodone/Phenylephrine/Pyrilamine Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take diet or appetite control medicines while you take Hydrocodone/Phenylephrine/Pyrilamine Liquid without checking with your doctor.


• Hydrocodone/Phenylephrine/Pyrilamine Liquid has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Hydrocodone/Phenylephrine/Pyrilamine Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Hydrocodone/Phenylephrine/Pyrilamine Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Hydrocodone/Phenylephrine/Pyrilamine Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Hydrocodone/Phenylephrine/Pyrilamine Liquid for a few days before the tests.


• Tell your doctor or dentist that you take Hydrocodone/Phenylephrine/Pyrilamine Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Hydrocodone/Phenylephrine/Pyrilamine Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Hydrocodone/Phenylephrine/Pyrilamine Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrocodone/Phenylephrine/Pyrilamine Liquid while you are pregnant. It is not known if Hydrocodone/Phenylephrine/Pyrilamine Liquid is found in breast milk. Do not breast-feed while taking Hydrocodone/Phenylephrine/Pyrilamine Liquid.

When used for long periods of time or at high doses, Hydrocodone/Phenylephrine/Pyrilamine 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 Hydrocodone/Phenylephrine/Pyrilamine Liquid stops working well. Do not take more than prescribed.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Hydrocodone/Phenylephrine/Pyrilamine Liquid. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Hydrocodone/Phenylephrine/Pyrilamine Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Hydrocodone/Phenylephrine/Pyrilamine 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; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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 or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble sleeping; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Hydrocodone/Phenylephrine/Pyrilamine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Hydrocodone/Phenylephrine/Pyrilamine Liquid:

Store Hydrocodone/Phenylephrine/Pyrilamine Liquid 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 Hydrocodone/Phenylephrine/Pyrilamine Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Hydrocodone/Phenylephrine/Pyrilamine Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Hydrocodone/Phenylephrine/Pyrilamine 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 Hydrocodone/Phenylephrine/Pyrilamine 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.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Hydrocodone/Phenylephrine/Pyrilamine resources

• Hydrocodone/Phenylephrine/Pyrilamine Side Effects (in more detail)
• Hydrocodone/Phenylephrine/Pyrilamine Use in Pregnancy & Breastfeeding
• Hydrocodone/Phenylephrine/Pyrilamine Drug Interactions
• Hydrocodone/Phenylephrine/Pyrilamine Support Group
• 0 Reviews · Be the first to review/rate this drug

Hyosophen

Pronunciation: bell-a-DON-a/fee-noe-BAR-bih-tal
Generic Name: Belladonna Alkaloids/Phenobarbital
Brand Name: Examples include Donnatal and Hyosophen

Hyosophen is used for:

Treating irritable bowel syndrome and intestinal inflammation in combination with other medicines. It may also be used along with other medicines to treat intestinal ulcers. It may also be used for other conditions as determined by your doctor.

Hyosophen is an anticholinergic and barbiturate combination. It works by decreasing the motion of the muscles in the stomach and intestine and providing mild sedation.

Do NOT use Hyosophen if:

• you are allergic to any ingredient in Hyosophen


• you have previously experienced restlessness or excitement after taking phenobarbital


• you have glaucoma; severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia); a blockage of the stomach, bowel, or bladder; bowel motility problems; severe bowel inflammation (eg, ulcerative colitis); certain muscle problems (eg, myasthenia gravis); or heart problems with severe bleeding


• you have a history of the blood disorder porphyria


• you have a history of alcohol or substance abuse or dependence or may be at risk for an addiction


• you are taking methoxyflurane, sodium oxybate (GHB), or voriconazole

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

Before using Hyosophen:

Some medical conditions may interact with Hyosophen. 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 nerve problems, prostate problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, diarrhea, fever, risk factors for glaucoma, kidney or liver problems, gallbladder problems, lung or breathing problems, an overactive thyroid, high blood pressure, difficulty urinating, or ulcer


• if you have depression, pain, a history of suicidal thoughts or attempts, or are in shock


• if you have been very ill or severely weakened


• if you regularly consume alcohol

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

• Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, thioridazine), quinine, stiripentol, tricyclic antidepressants (eg, amitriptyline), valproic acid, or other anticholinergics (eg, scopolamine) because they may increase the risk of Hyosophen's side effects


• Methoxyflurane orsodium oxybate (GHB) because the risk of their side effects may be increased by Hyosophen


• Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, doxorubicin, doxycycline, erlotinib, estrogens (eg, estradiol), imatinib, metronidazole, quinidine, steroidal contraceptives (eg, birth control pills), theophylline, or voriconazole because their effectiveness may be decreased by Hyosophen


• Halothane because Hyosophen may mask the symptoms of halothane toxicity.

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

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

• Take Hyosophen by mouth with or without food.


• If you miss a dose of Hyosophen, 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 Hyosophen.

Important safety information:

• Hyosophen may cause dizziness, drowsiness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyosophen 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 are using Hyosophen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.


• Hyosophen may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Use Hyosophen with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.


• Hyosophen should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Hyosophen. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• PREGNANCY and BREAST-FEEDING: Hyosophen has been shown to 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 Hyosophen while you are pregnant. Hyosophen is found in breast milk. If you are or will be breast-feeding while you use Hyosophen, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Hyosophen 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 Hyosophen stops working well. Do not take more than prescribed.

Some people who use Hyosophen 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 Hyosophen suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, nausea, sleeplessness, body aches, seizures, and delirium.

Possible side effects of Hyosophen:

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:

Bloated feeling; blurred vision; clumsiness; constipation; decreased sweating; dizziness; drowsiness; dry mouth; excessive daytime drowsiness ("hangover effect"); feeling of a whirling motion; headache; lightheadedness; nausea; nervousness; tired feeling; trouble sleeping.

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); agitation; confusion; diarrhea; difficulty focusing eyes; disorientation; exaggerated feeling of well-being; excitement; fainting; fast or irregular heartbeat; hallucinations; loss of coordination; loss of taste; memory loss; muscle pain; pounding in the chest; severe or persistent trouble sleeping; trouble urinating; unusual weakness; very slow breathing; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Hyosophen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include change in size of pupil; deep sleep; hot, dry skin; loss of consciousness; severe dry mouth; severe or persistent headache or nausea; slowed or fast breathing; trouble swallowing; vomiting.

Proper storage of Hyosophen:

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

General information:

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


• Hyosophen is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Hyosophen resources

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

• Antispasmodic Monograph (AHFS DI)


• Antispasmodic Concise Consumer Information (Cerner Multum)


• Bellatal Concise Consumer Information (Cerner Multum)


• Servira Prescribing Information (FDA)

Compare Hyosophen with other medications

• Duodenal Ulcer
• Enterocolitis
• Irritable Bowel Syndrome

Haloperidol Tablets

Pronunciation: HAL-oh-PER-i-dol
Generic Name: Haloperidol
Brand Name: Generic only. No brands available.

Haloperidol is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Haloperidol is not approved to treat mental problems caused by dementia.

Haloperidol is used for:

Treating certain mental disorders (eg, schizophrenia) and controlling symptoms associated with Tourette disorder. It also may be used to treat severe behavior problems in children and for short-term treatment in hyperactive children. It also may be used for other conditions as determined by your doctor.

Haloperidol is an antipsychotic agent. Exactly how it works is not known, but it may work by blocking certain chemicals in the brain.

Do NOT use Haloperidol if:

• you are allergic to any ingredient in Haloperidol


• you are in a coma, have Parkinson disease, or have severe central nervous system depression (eg, severe drowsiness, slow or shallow breathing)


• you have severely low levels of certain white blood cells (neutrophils)


• you are taking astemizole, dofetilide, dronedarone, nilotinib, propafenone, sodium oxybate (GHB), terfenadine, or tetrabenazine

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

Before using Haloperidol:

Some medical conditions may interact with Haloperidol. 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 the blood disease porphyria, low white blood cell levels, electrolyte problems (eg, low blood magnesium, low blood potassium), or high or low blood pressure


• if you have a history of dementia, Alzheimer disease, seizures, an abnormal electroencephalogram (EEG), thyroid problems, neuroleptic malignant syndrome (NMS), or low white blood cell levels caused by a medicine


• if you have heart problems or irregular heartbeat (eg, QT prolongation, long QT syndrome), or if a member of your family has a history of these conditions


• if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk of breast cancer


• if you are dehydrated, drink alcohol, or if you are regularly exposed to extreme heat


• if you are taking medicine that may increase the risk of a certain type of irregular heartbeat (QT prolongation) or the risk of electrolyte problems (eg, low blood potassium). Check with your doctor if you are unsure if any of your medicines may increase these risks

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

• Antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, dronedarone, flecainide, procainamide, quinidine, propafenone, sotalol), antipsychotics (eg, iloperidone, paliperidone, ziprasidone), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, ketolides (eg, telithromycin), kinase inhibitors (eg, lapatinib, nilotinib), macrolide antibiotics (eg, erythromycin), maprotiline, methadone, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin, moxifloxacin), terfenadine, or tetrabenazine because the risk of serious heart-related side effects may be increased


• Lithium because unexpected toxic effects, including weakness, severe tiredness, confusion, unusual muscle movements, and brain damage, have occurred in a few patients taking this combination. It is not known whether the combination of haloperidol and lithium may have caused this reaction. Discuss any questions or concerns with your doctor


• Tramadol because the risk of seizures may be increased


• Azole antifungals (eg, ketoconazole, itraconazole) because they may increase the risk of Haloperidol's side effects


• Rifampin because it may decrease Haloperidol's effectiveness


• Anticholinergics (eg, benztropine) or carbamazepine because it may increase the risk of Haloperidol's side-effects or decrease Haloperidol's effectiveness


• Anticoagulants (eg, warfarin), narcotic pain medicines (eg, oxycodone), or sodium oxybate (GHB) because the risk of their side effects may be increased by Haloperidol

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

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

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


• If you miss a dose of Haloperidol, take it as soon as possible. Take the remaining doses for the day at evenly spaced intervals. Do not take 2 doses at once.

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

Important safety information:

• Haloperidol may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Haloperidol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do NOT drink alcohol while you are using Haloperidol.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Haloperidol; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do NOT take more than the recommended dose or suddenly stop taking Haloperidol without checking with your doctor.


• Haloperidol may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Haloperidol. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Tell your doctor or dentist that you take Haloperidol before you receive any medical or dental care, emergency care, or surgery.


• NMS is a possibly fatal syndrome that can be caused by Haloperidol. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.


• Some patients who take Haloperidol may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Haloperidol in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Haloperidol.


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


• Haloperidol may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Haloperidol may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.


• Haloperidol may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.


• Lab tests, including complete blood cell counts, may be performed while you use Haloperidol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Haloperidol with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements.


• Haloperidol should not be used in CHILDREN younger than 3 years old; 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 taking Haloperidol while you are pregnant. Using Haloperidol during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Haloperidol is found in breast milk. Do not breast-feed while taking Haloperidol.

Possible side effects of Haloperidol:

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; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; restlessness; stomach upset; trouble sleeping.

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); blurred vision or other vision changes; chest pain; confusion; dark urine; decreased or difficult urination; decreased sexual ability; dehydration; difficulty speaking or swallowing; drooling; enlarged breasts; excessive or unusual sweating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, abnormal thinking, agitation, anxiety, depression); missed menstrual period or other menstrual changes; nipple discharge; prolonged, painful erection; rigid or stiff muscles; seizures; severe or persistent dizziness, headache, or vomiting; shortness of breath or unusual cough; shuffling walk; uncontrolled muscle movements (eg, of the arms, legs, tongue, jaw, cheeks; tremors; twitching); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Haloperidol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; muscle rigidity, tremor, or weakness; rapid or irregular pulse; slow or shallow breathing; unusual drowsiness or deep sleep; very dry mouth.

Proper storage of Haloperidol:

Store Haloperidol 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 Haloperidol out of the reach of children and away from pets.

General information:

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


• Haloperidol is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Haloperidol resources

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

Compare Haloperidol with other medications

• Dementia
• ICU Agitation
• Mania
• Nausea/Vomiting
• Psychosis
• Tourette's Syndrome

hydromorphone injection

Generic Name: hydromorphone (injection) (hy dro MOR fone)

Brand Names: Dilaudid, Dilaudid-HP

What is hydromorphone injection?

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

Hydromorphone injection is used to treat moderate to severe pain.

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

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

Hydromorphone may be habit-forming and should be used only by the person it was prescribed for. Hydromorphone injection should never be shared with another person, especially someone who has a history of drug abuse or addiction. Do not drink alcohol while you are receiving hydromorhphone. 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 can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not stop using hydmorphone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

You should not receive hydromorphone injection 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.

What should I discuss with my healthcare provider before receiving hydromorphone injection?

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 use hydromorphone injection if you are having an asthma attack. Hydromorphone may be habit-forming and should be used only by the person it was prescribed for. Hydromorphone should never be shared with another person, especially someone who has a history of drug abuse or addiction.

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

• 
  

  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. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydromorphone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

You should not use hydromorphone injection unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include fentanyl (Actiq, Duragesic), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), oxymorphone (Opana), and any other forms of hydromorphone. 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 is hydromorphone injection used?

This medication is given as an injection through a needle placed under your skin or into a muscle. You will receive this injection in a clinic or hospital setting.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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

Do not stop using hydromorphone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

What happens if I miss a dose?

Since hydromorphone is usually given by a healthcare provider, it is not likely that you will miss a dose.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. 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 receiving hydromorphone injection?

Do not drink alcohol while you are using this medication. Dangerous side effects or death can occur when alcohol is combined with hydromorphone. Check your food and medicine labels to be sure these products do not contain alcohol. Hydromorphone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Hydromorphone injection side effects

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

• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  cold, clammy skin;

  
  


• 
  

  confusion;

  
  


• 
  

  severe weakness or dizziness; or

  
  


• 
  

  feeling light-headed, fainting.

  
  

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

• 
  

  constipation;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  nausea, vomiting, diarrhea, loss of appetite;

  
  


• 
  

  dizziness, headache;

  
  


• 
  

  pain or tenderness where the injection was given;

  
  


• 
  

  dry mouth;

  
  


• 
  

  sweating;

  
  


• 
  

  itching; or

  
  


• 
  

  sleep problems (insomnia).

  
  

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 (e.g., mechanically ventilated patients).
IV continuous infusion: Usual dosage range: 0.5 to 1 mg/hour (based on 70 kg patient) or 7 to 15 mcg/kg/hour

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Usual Adult Dose for Cough:

1 mg orally every 3 to 4 hours as needed.

Usual Pediatric Dose for Pain:

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

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

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

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

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

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

Usual Pediatric Dose for Cough:

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

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

What other drugs will affect hydromorphone injection?

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

There may be other drugs not listed that can interact with hydromorphone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More hydromorphone resources

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

Compare hydromorphone with other medications

• Anesthetic Adjunct
• Cough
• Pain

Where can I get more information?

• Your pharmacist can provide more information about hydromorphone injection.

See also: hydromorphone side effects (in more detail)

Hydroquinone/Vitamin A

Pronunciation: HYE-droe-kwin-one/VYE-ta-min A
Generic Name: Hydroquinone/Vitamin A
Brand Name: Alustra

Hydroquinone/Vitamin A is used for:

Bleaching freckles, age spots, and other skin discolorations that may occur due to pregnancy, skin trauma, use of birth control pills, or other hormone replacement therapy. It may also be used for other conditions as determined by your doctor.

Hydroquinone/Vitamin A is a combination depigmenting agent and vitamin A. It works by lightening the skin.

Do NOT use Hydroquinone/Vitamin A if:

• you are allergic to any ingredient in Hydroquinone/Vitamin A

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

Before using Hydroquinone/Vitamin A:

Some medical conditions may interact with Hydroquinone/Vitamin A. 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 asthma or damaged or irritated skin


• if you are unusually sensitive to sunlight or must be outside for prolonged periods of time

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

• Products that contain benzoyl peroxide or hydrogen peroxide because side effects, such as a dark staining of the skin, may occur


• Medicines that contain phenol, resorcinol, or salicylic acid because the risk of side effects may be increased


• Fluoroquinolones (eg, levofloxacin), phenothiazines (eg, chlorpromazine), sulfonamides (eg, glipizide, sulfamethoxazole), tetracyclines (eg, doxycycline), or thiazide diuretics (eg, hydrochlorothiazide) because the risk of sunburn may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydroquinone/Vitamin A 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 Hydroquinone/Vitamin A:

Use Hydroquinone/Vitamin A as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Hydroquinone/Vitamin A comes with an additional patient leaflet. Read it carefully and reread it each time you get Hydroquinone/Vitamin A refilled.


• Hydroquinone/Vitamin A is for external use only.


• Before using Hydroquinone/Vitamin A for the first time, apply a small amount to an unbroken patch of skin and check in 24 hours for itching, blistering, or excessive redness or irritation. If these side effects develop, contact your doctor.


• Wash your hands before and after using Hydroquinone/Vitamin A, unless your hands are a part of the treated area.


• Remove all cosmetics with a mild soap before applying Hydroquinone/Vitamin A. Gently dry the area.


• Apply enough medicine to cover the affected area and gently rub it in until it is evenly distributed.


• If you miss a dose of Hydroquinone/Vitamin A, use it as soon as possible. If it is almost time for you 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 Hydroquinone/Vitamin A.

Important safety information:

• 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 using contains sulfites.


• Hydroquinone/Vitamin A may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Hydroquinone/Vitamin A. Use a sunscreen and wear protective clothing if you must be outside for a prolonged period.


• If your symptoms do not improve within 2 months or if they become worse, check with your doctor.


• Do not use products containing benzoyl peroxide or hydrogen peroxide with Hydroquinone/Vitamin A because your skin may become darkly stained. The stain can be removed by stopping use of the peroxide product and washing your skin with soap and water.


• Do not use other medicines or products on your skin, especially products that dry or irritate the skin, without first discussing it with your doctor.


• Avoid getting Hydroquinone/Vitamin A in your eyes, nose, or mouth. If you get Hydroquinone/Vitamin A in your eyes, rinse thoroughly with water.


• Do not exceed the recommended dose or use Hydroquinone/Vitamin A for longer than prescribed without checking with your doctor.


• Hydroquinone/Vitamin A may be harmful if swallowed. If you or someone you know may have taken Hydroquinone/Vitamin A by mouth, contact your local poison control center or emergency room immediately.


• Use Hydroquinone/Vitamin A with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while using Hydroquinone/Vitamin A, discuss with your doctor the benefits and risks of using Hydroquinone/Vitamin A during pregnancy. It is unknown if Hydroquinone/Vitamin A is excreted in breast milk. If you are or will be breast-feeding while you are using Hydroquinone/Vitamin A, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Hydroquinone/Vitamin A:

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

Mild burning or redness.

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); blistering; blue-black darkening of the skin; cracking or excessive dryness, redness, stinging, or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Hydroquinone/Vitamin A side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; bone pain; change in texture of hair or nails; drowsiness; dry, scaly skin; headache; itching; nausea; vomiting.

Proper storage of Hydroquinone/Vitamin A:

Store Hydroquinone/Vitamin A 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 Hydroquinone/Vitamin A out of the reach of children and away from pets.

General information:

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


• Hydroquinone/Vitamin A is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Hydroquinone/Vitamin A resources

• Hydroquinone/Vitamin A Side Effects (in more detail)
• Hydroquinone/Vitamin A Use in Pregnancy & Breastfeeding
• Hydroquinone/Vitamin A Support Group
• 2 Reviews for Hydroquinone/Vitamin A - Add your own review/rating

Compare Hydroquinone/Vitamin A with other medications

• Dermatological Disorders

Hydroxyzine Tablets

Generic Name: hydroxyzine hydrochloride

Dosage Form: tablet, film coated
HydrOXYzine Hydrochloride Tablets USP

Revised: June 2009

Rx only                    190944

DESCRIPTION

Hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-(p- Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride.

M.W. 447.83           

Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water.

Hydroxyzine Hydrochloride Tablets USP, 10 mg, 25 mg and 50 mg contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Hydroxyzine Hydrochloride Tablets USP, 25 mg and 50 mg also contain D&C Yellow No. 10 and FD&C Blue No. 2.

CLINICAL PHARMACOLOGY

Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. Hydroxyzine hydrochloride is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system.

Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated.

Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity.

Hydroxyzine is rapidly absorbed from the gastrointestinal tract and hydroxyzine hydrochloride’s clinical effects are usually noted within 15 to 30 minutes after oral administration.

INDICATIONS AND USAGE

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.

The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

CONTRAINDICATIONS

Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.

Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to it.

PRECAUTIONS

THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NONNARCOTIC ANALGESICS AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine their dosage should be reduced.

Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydroxyzine hydrochloride. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

Geriatric Use

A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

The extent of renal excretion of hydroxyzine has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely.

ADVERSE REACTIONS

Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature.

Anticholinergic: Dry mouth.

Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.

OVERDOSAGE

The most common manifestation of hydroxyzine hydrochloride overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and norepinephrine or metaraminol. Do not use epinephrine as hydroxyzine hydrochloride counteracts its pressor action.

There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

DOSAGE AND ADMINISTRATION

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50-100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses and over 6 years, 50-100 mg daily in divided doses.

For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses and over 6 years, 50-100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50-100 mg in adults, and 0.6 mg/kg of body weight in children.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

HOW SUPPLIED

Hydroxyzine Hydrochloride Tablets USP, 10 mg are 7/32”, unscored, round, orange, film-coated tablets imprinted DAN and 5522 supplied in bottles of 100 and 500.

Hydroxyzine Hydrochloride Tablets USP, 25 mg are 7/32”, unscored, round, green, film-coated tablets imprinted DAN and 5523 supplied in bottles of 100, 500 and 1000.

Hydroxyzine Hydrochloride Tablets USP, 50 mg are 10/32”, unscored, round, yellow, film-coated tablets imprinted DAN and 5565 supplied in bottles of 100, 500 and 1000.

Dispense in a tight container with child-resistant closure.

Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Manufactured By:

Watson Pharma Private Ltd.

Verna, Salcette Goa 403 722 INDIA

Distributed By:

Watson Pharma, Inc.

Corona, CA 92880 USA

Revised: June 2009                                                                        190944

                                                                                                             0609B

PRINCIPAL DISPLAY PANEL

NDC 0591-5522-01

HydrOXYzine

Hydrochloride

Tablets USP

10mg

100 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0591-5523-01

HydrOXYzine

Hydrochloride

Tablets USP

25 mg

100 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0591-3423-01

HydrOXYzine

Hydrochloride

Tablets USP

50 mg

100 Tablets

HYDROXYZINE HYDROCHLORIDE  hydroxyzine hydrochloride  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0591-5522 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   COLLOIDAL SILICON DIOXIDE   CROSCARMELLOSE SODIUM   FD&C YELLOW NO. 6   HYPROMELLOSES   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POLYSORBATE 80   TITANIUM DIOXIDE

Product Characteristics Color ORANGE Score no score Shape ROUND Size 6mm Flavor Imprint Code DAN;5522 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0591-5522-01 100 TABLET In 1 BOTTLE None 2 0591-5522-05 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088348	11/21/2011

HYDROXYZINE HYDROCHLORIDE  hydroxyzine hydrochloride  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0591-5523 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   COLLOIDAL SILICON DIOXIDE   CROSCARMELLOSE SODIUM   FD&C YELLOW NO. 6   HYPROMELLOSES   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POLYSORBATE 80   TITANIUM DIOXIDE   D&C YELLOW NO. 10   FD&C BLUE NO. 2

Product Characteristics Color GREEN Score no score Shape ROUND Size 6mm Flavor Imprint Code DAN;5523 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0591-5523-01 100 TABLET In 1 BOTTLE None 2 0591-5523-05 500 TABLET In 1 BOTTLE None 3 0591-5523-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088349	11/21/2011

HYDROXYZINE HYDROCHLORIDE  hydroxyzine hydrochloride  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0591-3423 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   COLLOIDAL SILICON DIOXIDE   CROSCARMELLOSE SODIUM   FD&C YELLOW NO. 6   HYPROMELLOSES   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POLYSORBATE 80   TITANIUM DIOXIDE   D&C YELLOW NO. 10   FD&C BLUE NO. 2

Product Characteristics Color YELLOW Score no score Shape ROUND Size 8mm Flavor Imprint Code DAN;5565 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0591-3423-01 100 TABLET In 1 BOTTLE None 2 0591-3423-05 500 TABLET In 1 BOTTLE None 3 0591-3423-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088350	11/21/2011

Labeler - Watson Laboratories, Inc. (966714656)

Establishment
Name	Address	ID/FEI	Operations
Watson Laboratories, Inc. - Florida		014759176	LABEL, LABEL, LABEL, PACK, PACK, PACK

Establishment
Name	Address	ID/FEI	Operations
Watson Pharma Private Limited		677605709	ANALYSIS, ANALYSIS, ANALYSIS, LABEL, LABEL, LABEL, MANUFACTURE, MANUFACTURE, MANUFACTURE, PACK, PACK, PACK

Revised: 11/2011Watson Laboratories, Inc.

More Hydroxyzine Tablets resources

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

Compare Hydroxyzine Tablets with other medications

• Allergic Urticaria
• Allergies
• Anxiety
• Interstitial Cystitis
• Nausea/Vomiting
• Pain
• Pruritus
• Sedation