Hydroquinone/

Vitamin A

Generic Name: Hydroquinone/Vitamin A (HYE-droe-kwin-one/VYE-ta-min 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. 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 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.

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.

Generic Name: hydrochlorothiazide and reserpine (hye droe klor oh THYE a zide and re SER peen)
Brand Names: Hydropres-25, Hydropres-50, Hydroserpine

What is Hydroserpine (hydrochlorothiazide and reserpine)?

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

Hydrochlorothiazide is a thiazide diuretic (water pill). It helps to lower your blood pressure and decrease edema (swelling) by increasing the amount of salt and water you lose in your urine.

Together, hydrochlorothiazide and reserpine are used to treat high blood pressure (hypertension).

Hydrochlorothiazide and reserpine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Hydroserpine (hydrochlorothiazide and reserpine)?

Stand up slowly from a sitting or lying position. Hydrochlorothiazide and reserpine may make you feel dizzy. Do not stop taking hydrochlorothiazide and reserpine suddenly. Even if you feel better, you need this medication to control your condition. Stopping suddenly could cause severe high blood pressure, anxiety, and other dangerous side effects.

Tell your doctor and dentist that you are taking this medication before having surgery.

Who should not take Hydroserpine (hydrochlorothiazide and reserpine)?

Do not take hydrochlorothiazide and reserpine if you have an allergy to sulfa-based drugs such as sulfa antibiotics. You may have an allergic reaction to hydrochlorothiazide.

You must not take hydrochlorothiazide and reserpine if you

• have peptic ulcer disease (stomach ulcers);

• have ulcerative colitis;

• are suffering from depression (especially if you have suicidal thoughts);

• are receiving electroconvulsive shock therapy; or

• are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate).

Before taking this medication, tell your doctor if you have

• gallstones or other stomach problems,

• kidney or liver disease,

• diabetes,

• gout,

• a collagen vascular disease such as systemic lupus erythematosus,

• high cholesterol or triglyceride levels,

• pancreatitis,

• asthma, or

• any type of heart disease.

You may require a lower dose or special monitoring during therapy with hydrochlorothiazide and reserpine if you have any of these conditions.

Hydrochlorothiazide and reserpine is in the FDA pregnancy category C. This means that it is not known whether hydrochlorothiazide will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Hydrochlorothiazide and reserpine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from hydrochlorothiazide and reserpine therapy. You may require a lower dose of this medication. Hydrochlorothiazide and reserpine has not been approved for use by children.

How should I take Hydroserpine (hydrochlorothiazide and reserpine)?

Take hydrochlorothiazide and reserpine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take hydrochlorothiazide and reserpine with food or milk if it upsets your stomach.

Do not stop taking hydrochlorothiazide and reserpine suddenly. Stopping suddenly could make your condition much worse or cause very serious side effects.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a hydrochlorothiazide and reserpine overdose include low blood pressure (fainting, dizziness, weakness); sleepiness; uncontrollable hand, leg, or arm movements; a slow pulse; low body temperature; diarrhea; increased urination; vomiting; and slow breathing.

What should I avoid while taking Hydroserpine (hydrochlorothiazide and reserpine)?

Avoid a diet high in salt. Too much salt will cause your body to retain water and will decrease the effects of hydrochlorothiazide.

Use caution when rising from a sitting or lying position, especially first thing in the morning. You may become dizzy while taking hydrochlorothiazide and reserpine and you may fall and injure yourself if you get up quickly.

Do not let yourself become overheated in hot weather or during exercise. Also avoid standing for long periods of time and use caution if you have a fever. These situations increase the effects of hydrochlorothiazide and reserpine, and you may become very dizzy.

Avoid prolonged exposure to sunlight. Hydrochlorothiazide may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable. Avoid alcohol. It will greatly increase the effects of hydrochlorothiazide and reserpine.

Do not take any over the counter cough, cold, allergy, sleep, or diet medications without first asking your doctor or pharmacist. These will interfere with your hydrochlorothiazide and reserpine therapy.

Use caution when you are driving, climbing ladders, or performing other hazardous activities until you know how hydrochlorothiazide and reserpine affects you. If it makes you dizzy or drowsy, avoid these activities.

Tell your doctor and dentist that you are taking this medication before having surgery.

Hydroserpine (hydrochlorothiazide and reserpine) side effects

If you experience any of the following serious side effects, stop taking hydrochlorothiazide and reserpine and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• a very irregular heartbeat;

• heart failure (shortness of breath, swelling of ankles or legs, sudden weight gain of 5 pounds or more);

• chest pain;

• unusual fatigue;

• abnormal bleeding or bruising;

• yellow skin or eyes;

• confusion; or

• little or no urine.

Other, less serious side effects may be more likely to occur. Continue to take hydrochlorothiazide and reserpine and talk to your doctor if you experience

• fatigue or drowsiness;

• dizziness (avoid standing up too quickly and use caution when performing hazardous activities);

• anxiety, depression, or nightmares;

• diarrhea, nausea, vomiting, or an acid stomach (take hydrochlorothiazide and reserpine with food or milk if it upsets your stomach);

• stuffy nose or a dry mouth (sucking on ice chips or sugarless hard candy may relieve a dry mouth);

• blurred vision;

• tingling or numbness in your arms, legs, hands, or feet;

• excessive urination;

• muscle weakness or cramps;

• increased hunger or thirst;

• weight gain;

• sensitivity to sunlight; or

• impotence or difficulty ejaculating.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Hydroserpine (hydrochlorothiazide and reserpine)?

Do not take hydrochlorothiazide and reserpine if you are taking a monoamine oxidase inhibitor (MAOI), or if you have taken one in the last 14 days. MAOIs, used to treat depression, include isocarboxazid (Marplan), phenelzine (Nardil), and tranylcypromine (Parnate).

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• tricyclic antidepressants such as amitriptyline (Elavil, Endep) or doxepin (Sinequan), which may decrease the effects of hydrochlorothiazide and reserpine;
• other commonly used tricyclic antidepressants, including amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), and protriptyline (Vivactil);

• digoxin (Lanoxin) or quinidine (Cardioquin, Quinidex, Quinora, Quinaglute), which will increase the risk that you will experience an irregular heartbeat when it is taken with hydrochlorothiazide and reserpine;

• barbiturates such as phenobarbital (Luminal, Solfoton), amobarbital (Amytal), and secobarbital (Seconal), which may cause extreme sleepiness or dizziness if taken with hydrochlorothiazide and reserpine;

• narcotic pain relievers such as codeine (Tylenol #3, Tylenol #4, others), propoxyphene (Darvon, Darvocet, Wygesic), oxycodone (Percodan, Percocet, Tylox), meperidine (Demerol), and morphine (MS Contin, Duramorph, others), which also may cause extreme sleepiness or dizziness if taken with hydrochlorothiazide and reserpine;

• steroid medications such as hydrocortisone (Hydrocortone, Cortef), prednisone (Deltasone, Orasone), prednisolone (Delta Cortef, Prelone), methylprednisolone (Medrol), betamethasone (Celestone), and dexamethasone (Decadron, Hexadrol), which may increase the side effects of hydrochlorothiazide;

• prescription and over-the-counter cough, cold, allergy, diet, and sleeping pills, which may affect your condition or your treatment with hydrochlorothiazide and reserpine;

• the cholesterol-lowering drugs cholestyramine (Questran) and colestipol (Colestid), which may decrease the effects of hydrochlorothiazide;

• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Advil), ketoprofen (Orudis, Orudis KT, Oruvail), and naproxen (Naprosyn, Anaprox, Aleve), which may also decrease the effects of hydrochlorothiazide and may increase the risk of damage to your kidneys (tell your doctor if you are taking these medications so that your therapy can be monitored);
• other commonly used NSAIDs, including diclofenac (Cataflam, Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), mefenamic acid (Ponstel), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), and tolmetin (Tolectin);

• oral antidiabetic drugs such as glipizide (Glucotrol), glyburide (Micronase, Glynase, Diabeta), chlorpropamide (Diabinese), tolazamide (Tolinase), and tolbutamide (Orinase), which may not lower your blood sugar as well (your diabetes therapy may have to be adjusted);

• lithium (Lithobid, Eskalith, others), which should not be taken with hydrochlorothiazide because serious side effects may result; or

• other drugs that also lower blood pressure, including acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carteolol (Cartrol), labetolol (Trandate, Normodyne), propranolol (Inderal), pindolol (Visken), timolol (Blocadren), benazepril (Lotensin), enalapril (Vasotec), captopril (Capoten), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), ramipril (Altace), amlodipine (Norvasc), bepridil (Vascor), diltiazem (Cardizem, Dilacor), felodipine (Plendil), isradipine (Dynacirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), and verapamil (Calan, Veralan, Isoptin).

Drugs other than those listed here may also interact with hydrochlorothiazide and reserpine or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has additional information about hydrochlorothiazide and reserpine written for health professionals that you may read.

What does my medication look like?

Hydrochlorothiazide and reserpine is available with a prescription under the brand name Hydropres. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Hydrochlorothiazide/reserpine strengths are as follows:

• Hydropres 25 (25 mg/0.125 mg)–green, round, scored, compressed tablets

• Hydropres 50 (50 mg/0.125 mg)–green, round, scored compressed tablets

• 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: 4.02. Revision Date: 2/19/03 4:27:33 PM.

Generic Name: chlorpheniramine, hydrocodone, and pseudoephedrine (klor feh NEER ah meen, hye droe KOE doe N, sue do eh FEH drin)
Brand Names: Atuss HD, Atuss HS, Cordron-HC, Cordron-HC NR, Histinex PV, Hydrocof-HC, Hydrotuss HC, Hyphed, Notuss-Forte, P-V-Tussin Syrup, Pediatex HC, Q-V Tussin

What is Hydrotuss HC (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is in a group of drugs called narcotics and is similar to codeine. Hydrocodone is a cough suppressant that affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine, hydrocodone, and pseudoephedrine is used to treat cough, sneezing, itching, watery eyes, runny nose, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Chlorpheniramine, hydrocodone, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Hydrotuss HC (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not take this medication with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. This medication 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.

What should I discuss with my healthcare provider before taking Hydrotuss HC (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Do not use this medication if you are allergic to hydrocodone or other narcotic pain relievers such as fentanyl (Actiq, Duragesic), hydromorphone (Dilaudid, Palladone), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), and oxymorphone (Opana). Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking chlorpheniramine, hydrocodone, and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

• kidney or liver disease;

• heart disease or high blood pressure;

• enlarged prostate or urination problems;

• diabetes;

• glaucoma;

• a thyroid disorder;

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

• 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;

• mental illness; or

• a history of drug or alcohol addiction.

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

FDA pregnancy category C. Hydrocodone 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. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

How should I take Hydrotuss HC (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cough or cold medicine is usually taken for only a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of hydrocodone can be fatal. Overdose symptoms may include extreme dizziness or drowsiness, confusion, feeling restless or nervous, cold and clammy skin, warmth or tingly feeling, nausea, vomiting, slow or shallow breathing, slow heart rate, pinpoint pupils, fainting, seizure (convulsions), or coma.

What should I avoid while taking Hydrotuss HC (chlorpheniramine, hydrocodone, and pseudoephedrine)?

This medication 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.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Do not drink alcohol while you are taking this medication. Alcohol can increase some of the side effects of chlorpheniramine, hydrocodone, and pseudoephedrine. Do not take this medication with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Life-threatening side effects may result.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Chlorpheniramine and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains chlorpheniramine or pseudoephedrine.

Hydrotuss HC (chlorpheniramine, hydrocodone, and pseudoephedrine) 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 any of these serious side effects:

• fast, pounding, or uneven heartbeats;

• shallow breathing, slow heartbeat;

• severe dizziness, fainting, anxiety, restless feeling, nervousness, or tremor;

• confusion, hallucinations, unusual thoughts or behavior;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

• urinating less than usual or not at all; or

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects may include:

• blurred vision;

• dry mouth;

• nausea, vomiting, stomach pain, constipation, mild loss of appetite;

• mild dizziness, drowsiness;

• problems with memory or concentration;

• ringing in your ears;

• warmth, tingling, or redness under your skin;

• restless or excitability (especially in children);

• sleep problems (insomnia); or

• skin rash 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.

What other drugs will affect Hydrotuss HC (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• cimetidine (Tagamet);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• zidovudine (Retrovir, AZT);

• antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

• aspirin or salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others);

• a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others;

• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

• a diuretic (water pill), or blood pressure medication;

• medication to treat irritable bowel syndrome;

• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril); or

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

This list is not complete and there may be other drugs that can interact with chlorpheniramine, hydrocodone, and pseudoephedrine. 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.

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine, hydrocodone, and pseudoephedrine.

• 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: 2.07. Revision Date: 4/12/2009 4:41:03 PM.

Generic Name: hydrocortisone and pramoxine topical (HYE droe KOR ti sone and pra MOX een)
Brand Names: Analpram E, Analpram-HC, Epifoam, HC Pramoxine, Hydropram, Novacort, Pramosone, Proctofoam HC, Rectocort HC, ZyPram

What is Hydropram (hydrocortisone and pramoxine topical)?

Pramoxine is an anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

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

The combination of hydrocortisone and pramoxine topical is used to treat pain, itching, or inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, psoriasis, insect bites, and minor burns or scrapes. This medication is also used on the rectal area to treat itching and inflammation caused by hemorrhoids, anal fissures, or other rectal irritation.

Hydrocortisone and pramoxine topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Hydropram (hydrocortisone and pramoxine topical)?

You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.

Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or “numbing medicines.”

Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor’s advice. Children are more sensitive to the effects of topical hydrocortisone. Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.

What should I discuss with my health care provider before using Hydropram (hydrocortisone and pramoxine topical)?

You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.

Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or “numbing medicines.” Also tell your doctor if you have:

• liver disease;

• diabetes;

• problems with your eyes;

• a stomach or intestinal disorder;

• a rectal sore or infection; or

• if you use any drugs that weaken the immune system, including steroids.

Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using hydrocortisone and pramoxine topical, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone and pramoxine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor’s advice. Children are more sensitive to the effects of topical hydrocortisone.

How should I use Hydropram (hydrocortisone and pramoxine topical)?

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

Hydrocortisone and pramoxine topical is usually applied 3 or more times daily, depending on which form of this medication you use. Follow the label directions or your doctor’s instructions about how much of this medication to use and how often. Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.

Wash your hands before and after applying this medication, unless you are using hydrocortisone and pramoxine topical to treat a hand condition.

When using this medication on the skin, apply just enough of the medication to cover the area to be treated. Rub in gently.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions.

Before apply the rectal form of this medication (cream, lotion, or foam), clean the rectal area with mild soap and pat dry.

Use only a small amount of medicine when applying hydrocortisone and pramoxine around the outside of the rectum. You may first place the medicine onto a clean tissue and then wipe it gently onto your rectum.

When using this medication inside the rectum, insert only the applicator tip of the medicine tube or foam can into the anus, no deeper than 1 inch.

Shake the hydrocortisone and pramoxine rectal foam before each use. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days, or if your condition clears up and then comes back. Do not stop using hydrocortisone and pramoxine topical suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using the medication. Store this medication at room temperature away from moisture and heat. Keep the rectal foam canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

An overdose of hydrocortisone and pramoxine topical is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Hydropram (hydrocortisone and pramoxine topical)?

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin. If it does get into any of these areas, wash with water. Do not use hydrocortisone and pramoxine topical on deep skin wounds, blistered skin, severe burns, irritated skin, or large skin areas. Also avoid using this medication in open wounds.

Avoid applying other skin medications on the same treatment area with hydrocortisone and pramoxine topical, unless your doctor has told you to.

Using a steroid can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicines.

Hydrocortisone pramoxine topical 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 any of these serious side effects:

• blurred vision, or seeing halos around lights;

• uneven heartbeats;

• sleep problems (insomnia);

• ongoing headache;

• weight gain, puffiness in your face;

• increased thirst or urination, weight loss, unusual weakness;

• fever, sore throat, tired feeling;

• severe pain, burning, or irritation of treated skin;

• rectal bleeding;

• any new redness or swelling where the medicine was applied; or

• itching, oozing, or other signs of infection.

Less serious side effects may include:

• mild skin redness, burning, itching, dryness, or peeling;

• acne;

• changes in the color of treated skin;

• thinning of your skin;

• blistering skin; or

• stretch marks.

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.

What other drugs will affect Hydropram (hydrocortisone and pramoxine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone and pramoxine. 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 and pramoxine topical.

• 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: 2.04. Revision Date: 03/04/2010 12:01:57 PM.

Generic Name: hydrochlorothiazide and reserpine (hye droe klor oh THYE a zide and re SER peen)
Brand Names: Hydropres-25, Hydropres-50, Hydroserpine

What is Hydropres-25 (hydrochlorothiazide and reserpine)?

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

Hydrochlorothiazide is a thiazide diuretic (water pill). It helps to lower your blood pressure and decrease edema (swelling) by increasing the amount of salt and water you lose in your urine.

Together, hydrochlorothiazide and reserpine are used to treat high blood pressure (hypertension).

Hydrochlorothiazide and reserpine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Hydropres-25 (hydrochlorothiazide and reserpine)?

Stand up slowly from a sitting or lying position. Hydrochlorothiazide and reserpine may make you feel dizzy. Do not stop taking hydrochlorothiazide and reserpine suddenly. Even if you feel better, you need this medication to control your condition. Stopping suddenly could cause severe high blood pressure, anxiety, and other dangerous side effects.

Tell your doctor and dentist that you are taking this medication before having surgery.

Who should not take Hydropres-25 (hydrochlorothiazide and reserpine)?

Do not take hydrochlorothiazide and reserpine if you have an allergy to sulfa-based drugs such as sulfa antibiotics. You may have an allergic reaction to hydrochlorothiazide.

You must not take hydrochlorothiazide and reserpine if you

• have peptic ulcer disease (stomach ulcers);

• have ulcerative colitis;

• are suffering from depression (especially if you have suicidal thoughts);

• are receiving electroconvulsive shock therapy; or

• are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate).

Before taking this medication, tell your doctor if you have

• gallstones or other stomach problems,

• kidney or liver disease,

• diabetes,

• gout,

• a collagen vascular disease such as systemic lupus erythematosus,

• high cholesterol or triglyceride levels,

• pancreatitis,

• asthma, or

• any type of heart disease.

You may require a lower dose or special monitoring during therapy with hydrochlorothiazide and reserpine if you have any of these conditions.

Hydrochlorothiazide and reserpine is in the FDA pregnancy category C. This means that it is not known whether hydrochlorothiazide will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Hydrochlorothiazide and reserpine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from hydrochlorothiazide and reserpine therapy. You may require a lower dose of this medication. Hydrochlorothiazide and reserpine has not been approved for use by children.

How should I take Hydropres-25 (hydrochlorothiazide and reserpine)?

Take hydrochlorothiazide and reserpine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take hydrochlorothiazide and reserpine with food or milk if it upsets your stomach.

Do not stop taking hydrochlorothiazide and reserpine suddenly. Stopping suddenly could make your condition much worse or cause very serious side effects.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a hydrochlorothiazide and reserpine overdose include low blood pressure (fainting, dizziness, weakness); sleepiness; uncontrollable hand, leg, or arm movements; a slow pulse; low body temperature; diarrhea; increased urination; vomiting; and slow breathing.

What should I avoid while taking Hydropres-25 (hydrochlorothiazide and reserpine)?

Avoid a diet high in salt. Too much salt will cause your body to retain water and will decrease the effects of hydrochlorothiazide.

Use caution when rising from a sitting or lying position, especially first thing in the morning. You may become dizzy while taking hydrochlorothiazide and reserpine and you may fall and injure yourself if you get up quickly.

Do not let yourself become overheated in hot weather or during exercise. Also avoid standing for long periods of time and use caution if you have a fever. These situations increase the effects of hydrochlorothiazide and reserpine, and you may become very dizzy.

Avoid prolonged exposure to sunlight. Hydrochlorothiazide may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable. Avoid alcohol. It will greatly increase the effects of hydrochlorothiazide and reserpine.

Do not take any over the counter cough, cold, allergy, sleep, or diet medications without first asking your doctor or pharmacist. These will interfere with your hydrochlorothiazide and reserpine therapy.

Use caution when you are driving, climbing ladders, or performing other hazardous activities until you know how hydrochlorothiazide and reserpine affects you. If it makes you dizzy or drowsy, avoid these activities.

Tell your doctor and dentist that you are taking this medication before having surgery.

Hydropres-25 (hydrochlorothiazide and reserpine) side effects

If you experience any of the following serious side effects, stop taking hydrochlorothiazide and reserpine and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• a very irregular heartbeat;

• heart failure (shortness of breath, swelling of ankles or legs, sudden weight gain of 5 pounds or more);

• chest pain;

• unusual fatigue;

• abnormal bleeding or bruising;

• yellow skin or eyes;

• confusion; or

• little or no urine.

Other, less serious side effects may be more likely to occur. Continue to take hydrochlorothiazide and reserpine and talk to your doctor if you experience

• fatigue or drowsiness;

• dizziness (avoid standing up too quickly and use caution when performing hazardous activities);

• anxiety, depression, or nightmares;

• diarrhea, nausea, vomiting, or an acid stomach (take hydrochlorothiazide and reserpine with food or milk if it upsets your stomach);

• stuffy nose or a dry mouth (sucking on ice chips or sugarless hard candy may relieve a dry mouth);

• blurred vision;

• tingling or numbness in your arms, legs, hands, or feet;

• excessive urination;

• muscle weakness or cramps;

• increased hunger or thirst;

• weight gain;

• sensitivity to sunlight; or

• impotence or difficulty ejaculating.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Hydropres-25 (hydrochlorothiazide and reserpine)?

Do not take hydrochlorothiazide and reserpine if you are taking a monoamine oxidase inhibitor (MAOI), or if you have taken one in the last 14 days. MAOIs, used to treat depression, include isocarboxazid (Marplan), phenelzine (Nardil), and tranylcypromine (Parnate).

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• tricyclic antidepressants such as amitriptyline (Elavil, Endep) or doxepin (Sinequan), which may decrease the effects of hydrochlorothiazide and reserpine;
• other commonly used tricyclic antidepressants, including amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), and protriptyline (Vivactil);

• digoxin (Lanoxin) or quinidine (Cardioquin, Quinidex, Quinora, Quinaglute), which will increase the risk that you will experience an irregular heartbeat when it is taken with hydrochlorothiazide and reserpine;

• barbiturates such as phenobarbital (Luminal, Solfoton), amobarbital (Amytal), and secobarbital (Seconal), which may cause extreme sleepiness or dizziness if taken with hydrochlorothiazide and reserpine;

• narcotic pain relievers such as codeine (Tylenol #3, Tylenol #4, others), propoxyphene (Darvon, Darvocet, Wygesic), oxycodone (Percodan, Percocet, Tylox), meperidine (Demerol), and morphine (MS Contin, Duramorph, others), which also may cause extreme sleepiness or dizziness if taken with hydrochlorothiazide and reserpine;

• steroid medications such as hydrocortisone (Hydrocortone, Cortef), prednisone (Deltasone, Orasone), prednisolone (Delta Cortef, Prelone), methylprednisolone (Medrol), betamethasone (Celestone), and dexamethasone (Decadron, Hexadrol), which may increase the side effects of hydrochlorothiazide;

• prescription and over-the-counter cough, cold, allergy, diet, and sleeping pills, which may affect your condition or your treatment with hydrochlorothiazide and reserpine;

• the cholesterol-lowering drugs cholestyramine (Questran) and colestipol (Colestid), which may decrease the effects of hydrochlorothiazide;

• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Advil), ketoprofen (Orudis, Orudis KT, Oruvail), and naproxen (Naprosyn, Anaprox, Aleve), which may also decrease the effects of hydrochlorothiazide and may increase the risk of damage to your kidneys (tell your doctor if you are taking these medications so that your therapy can be monitored);
• other commonly used NSAIDs, including diclofenac (Cataflam, Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), mefenamic acid (Ponstel), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), and tolmetin (Tolectin);

• oral antidiabetic drugs such as glipizide (Glucotrol), glyburide (Micronase, Glynase, Diabeta), chlorpropamide (Diabinese), tolazamide (Tolinase), and tolbutamide (Orinase), which may not lower your blood sugar as well (your diabetes therapy may have to be adjusted);

• lithium (Lithobid, Eskalith, others), which should not be taken with hydrochlorothiazide because serious side effects may result; or

• other drugs that also lower blood pressure, including acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carteolol (Cartrol), labetolol (Trandate, Normodyne), propranolol (Inderal), pindolol (Visken), timolol (Blocadren), benazepril (Lotensin), enalapril (Vasotec), captopril (Capoten), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), ramipril (Altace), amlodipine (Norvasc), bepridil (Vascor), diltiazem (Cardizem, Dilacor), felodipine (Plendil), isradipine (Dynacirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), and verapamil (Calan, Veralan, Isoptin).

Drugs other than those listed here may also interact with hydrochlorothiazide and reserpine or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has additional information about hydrochlorothiazide and reserpine written for health professionals that you may read.

What does my medication look like?

Hydrochlorothiazide and reserpine is available with a prescription under the brand name Hydropres. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Hydrochlorothiazide/reserpine strengths are as follows:

• Hydropres 25 (25 mg/0.125 mg)–green, round, scored, compressed tablets

• Hydropres 50 (50 mg/0.125 mg)–green, round, scored compressed tablets

• 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: 4.02. Revision Date: 2/19/03 4:27:33 PM.

Generic Name: hydrochlorothiazide and reserpine (hye droe klor oh THYE a zide and re SER peen)
Brand Names: Hydropres-25, Hydropres-50, Hydroserpine

What is Hydropres-50 (hydrochlorothiazide and reserpine)?

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

Hydrochlorothiazide is a thiazide diuretic (water pill). It helps to lower your blood pressure and decrease edema (swelling) by increasing the amount of salt and water you lose in your urine.

Together, hydrochlorothiazide and reserpine are used to treat high blood pressure (hypertension).

Hydrochlorothiazide and reserpine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Hydropres-50 (hydrochlorothiazide and reserpine)?

Stand up slowly from a sitting or lying position. Hydrochlorothiazide and reserpine may make you feel dizzy. Do not stop taking hydrochlorothiazide and reserpine suddenly. Even if you feel better, you need this medication to control your condition. Stopping suddenly could cause severe high blood pressure, anxiety, and other dangerous side effects.

Tell your doctor and dentist that you are taking this medication before having surgery.

Who should not take Hydropres-50 (hydrochlorothiazide and reserpine)?

Do not take hydrochlorothiazide and reserpine if you have an allergy to sulfa-based drugs such as sulfa antibiotics. You may have an allergic reaction to hydrochlorothiazide.

You must not take hydrochlorothiazide and reserpine if you

• have peptic ulcer disease (stomach ulcers);

• have ulcerative colitis;

• are suffering from depression (especially if you have suicidal thoughts);

• are receiving electroconvulsive shock therapy; or

• are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate).

Before taking this medication, tell your doctor if you have

• gallstones or other stomach problems,

• kidney or liver disease,

• diabetes,

• gout,

• a collagen vascular disease such as systemic lupus erythematosus,

• high cholesterol or triglyceride levels,

• pancreatitis,

• asthma, or

• any type of heart disease.

You may require a lower dose or special monitoring during therapy with hydrochlorothiazide and reserpine if you have any of these conditions.

Hydrochlorothiazide and reserpine is in the FDA pregnancy category C. This means that it is not known whether hydrochlorothiazide will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Hydrochlorothiazide and reserpine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from hydrochlorothiazide and reserpine therapy. You may require a lower dose of this medication. Hydrochlorothiazide and reserpine has not been approved for use by children.

How should I take Hydropres-50 (hydrochlorothiazide and reserpine)?

Take hydrochlorothiazide and reserpine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take hydrochlorothiazide and reserpine with food or milk if it upsets your stomach.

Do not stop taking hydrochlorothiazide and reserpine suddenly. Stopping suddenly could make your condition much worse or cause very serious side effects.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a hydrochlorothiazide and reserpine overdose include low blood pressure (fainting, dizziness, weakness); sleepiness; uncontrollable hand, leg, or arm movements; a slow pulse; low body temperature; diarrhea; increased urination; vomiting; and slow breathing.

What should I avoid while taking Hydropres-50 (hydrochlorothiazide and reserpine)?

Avoid a diet high in salt. Too much salt will cause your body to retain water and will decrease the effects of hydrochlorothiazide.

Use caution when rising from a sitting or lying position, especially first thing in the morning. You may become dizzy while taking hydrochlorothiazide and reserpine and you may fall and injure yourself if you get up quickly.

Do not let yourself become overheated in hot weather or during exercise. Also avoid standing for long periods of time and use caution if you have a fever. These situations increase the effects of hydrochlorothiazide and reserpine, and you may become very dizzy.

Avoid prolonged exposure to sunlight. Hydrochlorothiazide may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable. Avoid alcohol. It will greatly increase the effects of hydrochlorothiazide and reserpine.

Do not take any over the counter cough, cold, allergy, sleep, or diet medications without first asking your doctor or pharmacist. These will interfere with your hydrochlorothiazide and reserpine therapy.

Use caution when you are driving, climbing ladders, or performing other hazardous activities until you know how hydrochlorothiazide and reserpine affects you. If it makes you dizzy or drowsy, avoid these activities.

Tell your doctor and dentist that you are taking this medication before having surgery.

Hydropres-50 (hydrochlorothiazide and reserpine) side effects

If you experience any of the following serious side effects, stop taking hydrochlorothiazide and reserpine and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• a very irregular heartbeat;

• heart failure (shortness of breath, swelling of ankles or legs, sudden weight gain of 5 pounds or more);

• chest pain;

• unusual fatigue;

• abnormal bleeding or bruising;

• yellow skin or eyes;

• confusion; or

• little or no urine.

Other, less serious side effects may be more likely to occur. Continue to take hydrochlorothiazide and reserpine and talk to your doctor if you experience

• fatigue or drowsiness;

• dizziness (avoid standing up too quickly and use caution when performing hazardous activities);

• anxiety, depression, or nightmares;

• diarrhea, nausea, vomiting, or an acid stomach (take hydrochlorothiazide and reserpine with food or milk if it upsets your stomach);

• stuffy nose or a dry mouth (sucking on ice chips or sugarless hard candy may relieve a dry mouth);

• blurred vision;

• tingling or numbness in your arms, legs, hands, or feet;

• excessive urination;

• muscle weakness or cramps;

• increased hunger or thirst;

• weight gain;

• sensitivity to sunlight; or

• impotence or difficulty ejaculating.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Hydropres-50 (hydrochlorothiazide and reserpine)?

Do not take hydrochlorothiazide and reserpine if you are taking a monoamine oxidase inhibitor (MAOI), or if you have taken one in the last 14 days. MAOIs, used to treat depression, include isocarboxazid (Marplan), phenelzine (Nardil), and tranylcypromine (Parnate).

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• tricyclic antidepressants such as amitriptyline (Elavil, Endep) or doxepin (Sinequan), which may decrease the effects of hydrochlorothiazide and reserpine;
• other commonly used tricyclic antidepressants, including amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), and protriptyline (Vivactil);

• digoxin (Lanoxin) or quinidine (Cardioquin, Quinidex, Quinora, Quinaglute), which will increase the risk that you will experience an irregular heartbeat when it is taken with hydrochlorothiazide and reserpine;

• barbiturates such as phenobarbital (Luminal, Solfoton), amobarbital (Amytal), and secobarbital (Seconal), which may cause extreme sleepiness or dizziness if taken with hydrochlorothiazide and reserpine;

• narcotic pain relievers such as codeine (Tylenol #3, Tylenol #4, others), propoxyphene (Darvon, Darvocet, Wygesic), oxycodone (Percodan, Percocet, Tylox), meperidine (Demerol), and morphine (MS Contin, Duramorph, others), which also may cause extreme sleepiness or dizziness if taken with hydrochlorothiazide and reserpine;

• steroid medications such as hydrocortisone (Hydrocortone, Cortef), prednisone (Deltasone, Orasone), prednisolone (Delta Cortef, Prelone), methylprednisolone (Medrol), betamethasone (Celestone), and dexamethasone (Decadron, Hexadrol), which may increase the side effects of hydrochlorothiazide;

• prescription and over-the-counter cough, cold, allergy, diet, and sleeping pills, which may affect your condition or your treatment with hydrochlorothiazide and reserpine;

• the cholesterol-lowering drugs cholestyramine (Questran) and colestipol (Colestid), which may decrease the effects of hydrochlorothiazide;

• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Advil), ketoprofen (Orudis, Orudis KT, Oruvail), and naproxen (Naprosyn, Anaprox, Aleve), which may also decrease the effects of hydrochlorothiazide and may increase the risk of damage to your kidneys (tell your doctor if you are taking these medications so that your therapy can be monitored);
• other commonly used NSAIDs, including diclofenac (Cataflam, Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), mefenamic acid (Ponstel), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), and tolmetin (Tolectin);

• oral antidiabetic drugs such as glipizide (Glucotrol), glyburide (Micronase, Glynase, Diabeta), chlorpropamide (Diabinese), tolazamide (Tolinase), and tolbutamide (Orinase), which may not lower your blood sugar as well (your diabetes therapy may have to be adjusted);

• lithium (Lithobid, Eskalith, others), which should not be taken with hydrochlorothiazide because serious side effects may result; or

• other drugs that also lower blood pressure, including acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carteolol (Cartrol), labetolol (Trandate, Normodyne), propranolol (Inderal), pindolol (Visken), timolol (Blocadren), benazepril (Lotensin), enalapril (Vasotec), captopril (Capoten), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), ramipril (Altace), amlodipine (Norvasc), bepridil (Vascor), diltiazem (Cardizem, Dilacor), felodipine (Plendil), isradipine (Dynacirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), and verapamil (Calan, Veralan, Isoptin).

Drugs other than those listed here may also interact with hydrochlorothiazide and reserpine or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has additional information about hydrochlorothiazide and reserpine written for health professionals that you may read.

What does my medication look like?

Hydrochlorothiazide and reserpine is available with a prescription under the brand name Hydropres. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Hydrochlorothiazide/reserpine strengths are as follows:

• Hydropres 25 (25 mg/0.125 mg)–green, round, scored, compressed tablets

• Hydropres 50 (50 mg/0.125 mg)–green, round, scored compressed tablets

• 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: 4.02. Revision Date: 2/19/03 4:27:33 PM.

Generic Name: Hydroquinone (hye-droe-KWIN-own)
Brand Name: Examples include Esoterica and Melquin

Hydroquinone Cream is used for:

Lightening freckles, age spots, and other skin discolorations associated with pregnancy, skin trauma, birth control pills, or hormone replacement therapy. It may also be used for other conditions as determined by your doctor.

Hydroquinone Cream is a skin-bleaching agent. It works by inhibiting an enzyme reaction in skin cells.

Do NOT use Hydroquinone Cream if:

• you are allergic to any ingredient in Hydroquinone Cream
• you are pregnant

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

Before using Hydroquinone Cream:

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

• if you are 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

Some MEDICINES MAY INTERACT with Hydroquinone Cream. However, no specific interactions with Hydroquinone Cream are known at this time.

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

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

• Before using Hydroquinone Cream 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 effects develop, contact your doctor as soon as possible and do not use Hydroquinone Cream on other areas.
• Wash and completely dry the affected areas. Gently rub the medicine in until it is evenly distributed. Wash your hands immediately after using Hydroquinone Cream, unless your hands are part of the treated area.
• If you miss a dose of Hydroquinone Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

• Protect your skin from the sun during and after the use of Hydroquinone Cream. Limit sun exposure, use a sunscreen, and wear protective clothing to cover the treated areas.
• Hydroquinone Cream is for external use only. Avoid getting Hydroquinone Cream in your eyes, nose, or mouth, or on your lips. If you get Hydroquinone Cream in your eyes, wash them out with water and contact your doctor. If you get Hydroquinone Cream on your lips or in your nose or mouth, rinse with water.
• Do not use Hydroquinone Cream on irritated or injured skin.
• Do not use Hydroquinone Cream with products that contain hydrogen peroxide or benzoyl peroxide. This may cause a dark staining of your skin. The staining can be removed by stopping use of the peroxide and washing your skin with soap and water.
• Do not use Hydroquinone Cream with other medicines containing resorcinol, phenol, or salicylic acid unless otherwise directed by your doctor.
• 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.
• Hydroquinone Cream is not recommended for use 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, discuss with your doctor the benefits and risks of using Hydroquinone Cream during pregnancy. It is unknown if Hydroquinone Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Hydroquinone Cream, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Hydroquinone Cream:

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 or cracking of the skin if applied around eyes or nose; minor redness or mild burning sensation at application site.

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; excessive 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. 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.

Proper storage of Hydroquinone Cream:

Store Hydroquinone Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Hydroquinone Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Hydroquinone Cream, please talk with your doctor, pharmacist, or other health care provider.
• Hydroquinone Cream 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 Hydroquinone Cream. 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 High-Potency (HYE-droe-MOR-fone)
Brand Name: Dilaudid-HP

Hydromorphone High-Potency is used for:

Treating moderate to severe pain in narcotic-tolerant patients who require larger than usual doses to provide adequate pain relief.

Hydromorphone High-Potency 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 High-Potency if:

• you are allergic to any ingredient in Hydromorphone High-Potency or any other codeine- or morphine-related medicine (eg, morphine, codeine, oxycodone)
• you are NOT already receiving large amounts of injectable narcotics
• 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 High-Potency:

Some medical conditions may interact with Hydromorphone High-Potency. Tell your health care provider 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 are allergic to latex
• 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 High-Potency. 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 High-Potency’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 High-Potency 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 High-Potency:

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

• Hydromorphone High-Potency is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using Hydromorphone High-Potency at home, a health care provider will teach you how to use it. Be sure you understand how to use Hydromorphone High-Potency. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Hydromorphone High-Potency if it is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you are taking Hydromorphone High-Potency 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 High-Potency without checking with your doctor.
• If Hydromorphone High-Potency is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Hydromorphone High-Potency properly.
• If you miss a dose of Hydromorphone High-Potency 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 High-Potency.

Important safety information:

• Hydromorphone High-Potency 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 High-Potency 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 High-Potency; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Hydromorphone High-Potency 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.
• This product contains a very large amount of hydromorphone. Do not confuse this product with other injectable forms of hydromorphone. If you have any questions about whether you should use this product or another injectable form of hydromorphone, contact your doctor or other health care provider.
• Hydromorphone High-Potency 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 High-Potency may cause severe side effects, including severe breathing problems, seizures, coma, and possibly death.
• Constipation is a common side effect of Hydromorphone High-Potency. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Hydromorphone High-Potency.
• 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 High-Potency before you receive any medical or dental care, emergency care, or surgery.
• Use Hydromorphone High-Potency with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness and breathing problems.
• Hydromorphone High-Potency should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Hydromorphone High-Potency 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 High-Potency while you are pregnant. Hydromorphone High-Potency is found in breast milk. Do not breast-feed while taking Hydromorphone High-Potency.

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

Some people who use Hydromorphone High-Potency 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 High-Potency regularly, do not suddenly stop taking it without checking with your doctor. WITHDRAWAL symptoms have occurred when Hydromorphone High-Potency 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 High-Potency.

Possible side effects of Hydromorphone High-Potency:

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 High-Potency:

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

General information:

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

Brand names: Dilaudid

Why is Hydromorphone hydrochloride prescribed?

Dilaudid, a narcotic analgesic, is prescribed for the relief of moderate to severe pain such as that due to:

Biliary colic (pain caused by an obstruction in the gallbladder or bile duct)
Burns
Cancer
Heart attack
Injury (soft tissue and bone)
Renal colic (sharp lower back and groin pain usually caused by the passage of a stone through the ureter)
Surgery

Most important fact about Hydromorphone hydrochloride

High dose tolerance leading to mental and physical dependence can occur with the use of Dilaudid when it is taken repeatedly. Physical dependence (need for continual doses to prevent withdrawal symptoms) can occur after only a few days of narcotic use, although it usually takes several weeks.

How should you take Hydromorphone hydrochloride?

Take Dilaudid exactly as prescribed by your doctor. Never increase the amount you take without your doctor’s approval.

• If you miss a dose…
  Take the forgotten dose as soon as you remember. If it is almost time for the next dose, skip the one you missed and go back to your regular schedule. Never try to “catch up” by doubling the dose.

• Storage instructions…
  Tablets and liquid should be stored at room temperature. Protect from light and extreme cold or heat. Suppositories should be stored in the refrigerator.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Dilaudid.

• Side effects may include:
  Anxiety, constipation, dizziness, drowsiness, fear, impairment of mental and physical performance, inability to urinate, mental clouding, mood changes, nausea, restlessness, sedation, sluggishness, troubled and slowed breathing, vomiting

Why should Hydromorphone hydrochloride not be prescribed?

If you are sensitive to or have ever had an allergic reaction to Dilaudid or narcotic painkillers, you should not take Hydromorphone hydrochloride. Make sure that your doctor is aware of any drug reactions that you have experienced.

Additionally, you should not take Dilaudid if you suffer from severe, uncontrolled breathing difficulties or uncontrolled asthma.

Dilaudid cannot be used in pregnant women during labor or delivery.

Special warnings about Hydromorphone hydrochloride

Do not stop taking Hydromorphone hydrochloride without your doctor’s approval. Abruptly stopping Dilaudid could cause withdrawal symptoms within the first 24 hours, including restlessness, tearing or watery eyes, dilated pupils, runny nose, yawning, sweating, goosebumps, and restless sleep. These symptoms could increase during the next 72 hours, and new withdrawal symptoms may appear, including irritability, anxiety, weakness, muscle spasms, severe backache, stomach or leg pain, insomnia, vomiting, and diarrhea.

Dilaudid may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

Dilaudid should be used with caution if you are in a weakened condition or if you have a severe liver or kidney disorder, hypothyroidism (underactive thyroid gland), Addison’s disease (adrenal gland failure), severe lung problems, an enlarged prostate, a urethral stricture (narrowing of the urethra), low blood pressure, or a head injury.

It’s important to tell the doctor if you’ve ever suffered from alcoholism or other drug dependencies. Abusing Dilaudid, or combining it with other nervous system depressants, can cause serious—and possibly life-threatening—side effects.

Dilaudid suppresses the cough reflex; therefore, the doctor will be cautious about prescribing Dilaudid after an operation or for patients with a lung disease.

High doses of Dilaudid may produce labored or slowed breathing. This drug also affects centers that control breathing rhythm and may produce irregular breathing. People who already have breathing difficulties should be very careful about taking Dilaudid. Be especially cautious if you have chronic obstructive pulmonary disease or a condition that reduces oxygen to the tissues (hypoxia) or causes an excess of carbon dioxide in the blood (hypercapnia).

Let the doctor know if you’re scheduled to have any surgical procedures involving the biliary tract, since Dilaudid could increase the chance of muscle spasms in this area.

Narcotics such as Dilaudid may mask or hide the symptoms of sudden or severe abdominal conditions, making diagnosis and treatment difficult.

Dilaudid can cause seizures when taken in high doses and, if you have a seizure disorder, can make the seizures worse.

Be sure to tell the doctor if you’re sensitive to sulfites (preservatives commonly found in red wine), since Dilaudid contains this substance.

Possible food and drug interactions when taking Hydromorphone hydrochloride

Dilaudid is a central nervous system depressant and intensifies the effects of alcohol. Do not drink alcohol while taking Hydromorphone hydrochloride.

If Dilaudid is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Dilaudid with the following:

Antiemetics (drugs that prevent or lessen nausea and vomiting such as prochlorperazine and promethazine)
Antihistamines such as diphenhydramine
General anesthetics
Opioid antagonists such as naloxone and nelmefene
Other central nervous system depressants such as pentobarbital, temazepam
Other narcotic analgesics such as meperidine and oxycodone
Phenothiazines such as chlorpromazine
Sedative/hypnotics such as diazepam, triazolam
Tranquilizers such as alprazolam
Tricyclic antidepressants such as amitriptyline and imipramine

Special information if you are pregnant or breastfeeding

Do not take Dilaudid if you are pregnant or plan to become pregnant unless you are directed to do so by your doctor. Drug dependence occurs in newborns when the mother has taken narcotic drugs regularly during pregnancy. Withdrawal signs include irritability and excessive crying, tremors, overactive reflexes, increased breathing rate, increased stools, sneezing, yawning, vomiting, and fever. Dilaudid may appear in breast milk and could affect a nursing infant. If Hydromorphone hydrochloride is essential to your health, your doctor may advise you to discontinue breastfeeding your baby until your treatment is finished.

Recommended dosage

ADULTS

Tablets

The usual starting dose of Dilaudid tablets is 2 to 4 milligrams every 4 to 6 hours as determined by your doctor. Severity of pain, your individual response, and your size are used to determine your exact dosage.

Liquid

The usual dose of Dilaudid liquid is one-half to 2 teaspoonfuls every 3 to 6 hours. In some cases, the dosage may be higher.

Suppositories

Dilaudid suppositories (3 milligrams) may provide relief for a longer period of time. The usual adult dose is 1 suppository inserted rectally every 6 to 8 hours or as directed by your doctor.

CHILDREN

The safety and effectiveness of Dilaudid have not been established in children.

OLDER ADULTS

Be very careful when using Dilaudid. Your doctor will prescribe a dose individualized to suit your needs.

Overdosage

• Symptoms of Dilaudid overdose include:
  Bluish tinge to skin, cold and clammy skin, constricted pupils, coma, extreme sleepiness progressing to a state of unresponsiveness, labored or slowed breathing, limp, weak muscles, low blood pressure, slow heart rate

In severe overdosage, the patient may stop breathing. Shock, heart attack, and death can occur.

If you suspect an overdose, seek emergency medical treatment immediately.