What are prescription drugs? A prescription drug is a licensed medication that is subject to regulations listed in the correspondent legislation. A prescription drug is called so because it obligatorily requires a prescription to purchase it.

The term “prescription drugs” was invented in order to distinguish them from the other type of drugs called “over-the-counter drugs”  which can be obtained without a prescription.

There exist different definitions of what drugs may be considered prescription drugs.

In USA, there is also another term for “prescription drugs” – “Rx”, which is a short form for “prescription drug”. This is an abbreviation for Latin word “recipe”, which makes an imperative form for “recipere”, meaning “take this”.

Prescription drugs are never dispensed without detailed information about the drug, which may be listed in a special monograph.

Every now and then there occur situations when we come across pills, capsules or liquids that are unidentifiable. This could be quite a worrying situation – for example, when you find some suspicious pills in your teenager son’s or daughter’s pocket. Or, it could be that you just don’t remember what are those leftover pills long forgotten in your lady’s purse.

A vast majority of pills may be identified by their characteritics, such as size, shape, colour, logos, etc. A Pill Finder is a special database with a script allowing to match names of medicines with their characteristics. If you know what your medicine looks like, there’s a good chance that a Pill Finder program may help you identify it. It is a very convenient and useful option.

Even if you don’t have troubles with unidentified pills, it is recommended that you periodically check your medicine cabinet. If there are any re-bottled or unidentified pills, see their expiry date.  If there are any expired medicines, throw them away. If possible, mmaintain all medications in their original package, with their original labeling and instructions, in order to avoid harm to your health.

Generic Name: Pyrithione Zinc (PIR-i-THYE-one zink)
Brand Name: Selsun Blue Conditioner

Pyrithione Zinc Conditioner is used for:

Treating and preventing flaking, itching, and scaling of the scalp caused by dandruff or seborrhea (crusting, oily, or scaling skin). It also moisturizes dry hair.

Pyrithione Zinc Conditioner is an antiseborrheic. It works by slowing the production of skin cells, which helps to reduce flakiness.

Do NOT use Pyrithione Zinc Conditioner if:

• you are allergic to any ingredient in Pyrithione Zinc Conditioner

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

Before using Pyrithione Zinc Conditioner:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a condition that covers a large area of the body

Some MEDICINES MAY INTERACT with Pyrithione Zinc Conditioner. Because little, if any, of Pyrithione Zinc Conditioner is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Pyrithione Zinc Conditioner 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 Pyrithione Zinc Conditioner:

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

• Apply Pyrithione Zinc Conditioner to wet hair as directed after you shampoo. Rinse well.
• For best results, use Pyrithione Zinc Conditioner at least 2 times per week or as directed by your doctor. Do not use more often than once daily.
• If you miss a dose of Pyrithione Zinc Conditioner, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Pyrithione Zinc Conditioner.

Important safety information:

• Pyrithione Zinc Conditioner is for external use only. Do not get Pyrithione Zinc Conditioner in your eyes, nose, or mouth. If you get Pyrithione Zinc Conditioner in your eyes, rinse immediately with cool water.
• If your symptoms do not get better with regular use or if they get worse, check with your doctor.
• Use of Pyrithione Zinc Conditioner is not recommended in CHILDREN younger than 2 years old without checking with your doctor.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pyrithione Zinc Conditioner while you are pregnant. It is not known if Pyrithione Zinc Conditioner is found in breast milk. If you are or will be breast-feeding while you use Pyrithione Zinc Conditioner, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Pyrithione Zinc Conditioner:

All medicines may cause side effects, but many people have no, or minor side effects. No COMMON side effects have been reported with Pyrithione Zinc Conditioner. 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); skin 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. Pyrithione Zinc Conditioner may be harmful if swallowed.

Proper storage of Pyrithione Zinc Conditioner:

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

General information:

• If you have any questions about Pyrithione Zinc Conditioner, please talk with your doctor, pharmacist, or other health care provider.
• Pyrithione Zinc Conditioner 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 Pyrithione Zinc Conditioner. 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: phenylephrine and pyrilamine (FEN il EFF rin and pir IL a meen)
Brand Names: Aldex D, Deconsal CT Tannate, K-Tan, Pyril Tann-12, Pyrlex PD, Ry-T-12, Ryna-12, Ryna-12S, Rynesa 12S, V-Tann, Viravan-S, Viravan-T

What is this drug?

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

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

The combination of phenylephrine and pyrilamine is used to treat runny or stuffy nose, sneezing, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Phenylephrine and pyrilamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about this drug?

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 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. 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.

What should I discuss with my health care provider before taking this drug?

Do not use this medication if you are allergic to phenylephrine or pyrilamine, or to other antihistamines, decongestants, diet pills, stimulants, or ADHD medications. 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 phenylephrine and pyrilamine, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease or high blood pressure;

• diabetes;

• a thyroid disorder;

• glaucoma;

• kidney disease;

• an enlarged prostate; or

• problems with urination.

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

FDA pregnancy category C. This medication may be harmful to an unborn baby. 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.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take this drug?

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. Cold medicine is usually taken for only a short time until your symptoms clear up.

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.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. 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.

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.

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.

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

What happens if I miss a dose?

Since cold or allergy 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. Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking this drug?

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. Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pyrilamine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications.

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.

Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine. 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 or decongestant.

This drug 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 heartbeat;

• severe dizziness, anxiety, restless feeling, or nervousness, confusion, hallucinations, unusual thoughts or behavior;

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

• urinating less than usual or not at all; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

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

• dry mouth;

• warmth, tingling, or redness under your skin;

• blurred vision;

• dizziness, drowsiness;

• problems with memory or concentration;

• 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 this drug?

Before taking phenylephrine and pyrilamine, tell your doctor if you are also taking:

• a diuretic (water pill);

• salicylates such as aspirin, Novasal, Doan’s Extra Strength, Salflex, Tricosal, and others;

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

• atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

• bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);

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

• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with phenylephrine and pyrilamine. 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 phenylephrine and pyrilamine.

• 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: 1.02. Revision Date: 4/12/2009 4:43:48 PM.

Generic Name: acetaminophen/chlorpheniramine/phenylpropanolamine (a seet a MIN oh fen/klor fen IR a meen/fen ill proe pa NOLE a meen)
Brand Names: Chlor-Trimeton Sinus, Coricidin D, Pyrroxate, Sinulin, Triaminicin

What is Pyrroxate (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Acetaminophen is a pain reliever and a fever reducer. It is used to treat many conditions such as: headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal passages to open up.

Acetaminophen/chlorpheniramine/phenylpropanolamine is used to treat nasal congestion; itchy, watery eyes; itchy throat; sneezing; headache; fever; and other symptoms associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Acetaminophen/chlorpheniramine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Pyrroxate (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen/chlorpheniramine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking acetaminophen/chlorpheniramine/phenylpropanolamine. Alcohol may also cause damage to the liver when it is taken with acetaminophen.

Who should not take Pyrroxate (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease. You may not be able to take acetaminophen/chlorpheniramine/phenylpropanolamine. Do not take acetaminophen/chlorpheniramine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,
• liver disease,

• diabetes,

• glaucoma,

• any type of heart disease or high blood pressure,

• thyroid disease,

• emphysema or chronic bronchitis, or

• difficulty urinating or an enlarged prostate.

You may not be able to take acetaminophen/chlorpheniramine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether acetaminophen/chlorpheniramine/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and can harm a nursing baby. 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 acetaminophen/chlorpheniramine/phenylpropanolamine. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Pyrroxate (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Take acetaminophen/chlorpheniramine/phenylpropanolamine 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. Do not crush, chew, or break any long-acting or extended- or sustained-release forms of this medication that are intended to release slowly. Swallow them whole. If you are unsure about the formulation of the medicine, ask your pharmacist for help. If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

To ensure that you get a correct dose, measure the liquid form of acetaminophen/chlorpheniramine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is directed. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never take more than 2 grams (2000 mg) per day.

Do not take acetaminophen/chlorpheniramine/phenylpropanolamine for longer than 7 to 10 days in a row. If your symptoms do not improve, if they get worse or if you have a fever, see your doctor.

Store acetaminophen/chlorpheniramine/phenylpropanolamine 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 the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an acetaminophen/chlorpheniramine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, vomiting, abdominal pain, diarrhea, seizures, confusion, sweating, and an irregular heartbeat.

What should I avoid while taking Pyrroxate (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen/chlorpheniramine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking acetaminophen/chlorpheniramine/phenylpropanolamine. Alcohol may also cause damage to the liver when it is taken with acetaminophen.

Acetaminophen/chlorpheniramine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen/chlorpheniramine/phenylpropanolamine is taken with any of these medications.

Pyrroxate (acetaminophen/chlorpheniramine/phenylpropanolamine) side effects

If you experience any of the following rare but serious side effects, stop taking acetaminophen/chlorpheniramine/phenylpropanolamine and seek emergency medical attention or notify your doctor immediately:

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

• liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue);

• blood problems (easy or unusual bleeding or bruising); or

• low blood sugar (fatigue, increased hunger or thirst, dizziness, or fainting).

Other, less serious side effects may be more likely to occur. Continue to take acetaminophen/chlorpheniramine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• dryness of the eyes, nose, and mouth;

• drowsiness or dizziness;

• blurred vision;

• difficulty urinating; or

• excitation in children.

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 Pyrroxate (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Do not take acetaminophen/chlorpheniramine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Urine glucose tests for diabetics may produce false results while you are taking acetaminophen. Talk to your doctor if you have diabetes and you notice changes in blood glucose levels during treatment with acetaminophen/chlorpheniramine/phenylpropanolamine.

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medicines while taking acetaminophen/chlorpheniramine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenylpropanolamine, acetaminophen, or other similar drugs, and you may accidentally take too much of these medicines.

Acetaminophen/chlorpheniramine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen/chlorpheniramine/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with acetaminophen/chlorpheniramine/phenylpropanolamine. 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 acetaminophen/chlorpheniramine/ phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

There are many formulations of acetaminophen/chlorpheniramine/ phenylpropanolamine available over the counter. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.03. Revision Date: 2/13/04 4:04:14 PM.

pir-VIN-ee-um

Uses For pyrvinium

Pyrvinium is used to treat pinworms (enterobiasis). It will not work for other types of worm infections (for example, roundworms or tapeworms).

Pyrvinium is available only with your doctor’s prescription.

Before Using pyrvinium

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pyrvinium, the following should be considered:

Allergies

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

Pediatric

Pyrvinium has been studied in children and, in effective doses, has not been reported to cause different side effects or problems in children than it does in adults. However, because of limited experience, caution is recommended in children weighing less than 10 kilograms (22 pounds). Older children are more likely to have stomach upset after receiving large doses.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

Proper Use of pyrvinium

No special preparations (for example, special diets, fasting, other medicines, laxatives, or enemas) are necessary before, during, or immediately after you take pyrvinium.

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Pinworms may be easily passed from one person to another, especially among persons in the same household. Therefore, all household members may have to be treated at the same time to prevent their infection or reinfection. Also, all household members may have to be treated again in 2 to 3 weeks to clear up the infection completely. Make sure each family member takes the correct amount, since the dose may be different for each person.

To help clear up your infection completely, take pyrvinium exactly as directed by your doctor. Read the instructions on the label and follow them carefully. The amount of medicine you need is based on your weight. You must take the exact amount if the medicine is going to work. A second course of pyrvinium is usually required to clear up the infection completely.

Dosing

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

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

• For the oral suspension dosage form:
  • Adults and children: Dose is based on body weight and will be determined by your doctor. It is taken as a single dose and is repeated in 2 to 3 weeks.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using pyrvinium

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Pyrvinium may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. For a day or two after taking pyrvinium:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

In some patients, pinworms may return after treatment with pyrvinium. Washing (not shaking) all bedding and nightclothes (pajamas) after treatment may help to prevent this. Some doctors may also recommend other measures to help keep your infection from returning. If you have any questions about this, check with your doctor.

pyrvinium Side Effects

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

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

Rare

• Skin rash

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

Rare

• Diarrhea
• increased sensitivity of skin to sunlight
• nausea and vomiting
• stomach cramps

pyrvinium is a dye and will color your stools red. This color is not harmful and will disappear in a few days. Pyrvinium may also stain clothing red. If vomiting occurs, the vomit will be red in color.

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

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

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

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

pir-i-METH-a-meen, sul-fa-DOX-een

Commonly used brand name(s):

In the U.S.

• Fansidar

Available Dosage Forms:

• Tablet

Therapeutic Class: Antimalarial Sulfonamide Combination

Pharmacologic Class: Folic Acid Antagonist

Chemical Class: Sulfonamide

Uses For pyrimethamine and sulfadoxine

Sulfadoxine , a sulfa medicine, and pyrimethamine combination is used to treat malaria. pyrimethamine and sulfadoxine may also be used to prevent malaria in people who are living in, or will be traveling to, an area where there is a chance of getting malaria. Sulfadoxine and pyrimethamine combination may also be taken with other medicines for malaria, or may be used for other problems as determined by your doctor.

Since sulfadoxine and pyrimethamine combination may cause some serious side effects, it generally is used only to prevent or treat serious malaria infections in areas where it is known that other medicines may not work.

pyrimethamine and sulfadoxine is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, sulfadoxine and pyrimethamine combination is used in certain patients with the following medical condition:

• Isosporiasis (prevention)

Before Using pyrimethamine and sulfadoxine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pyrimethamine and sulfadoxine, the following should be considered:

Allergies

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

Pediatric

Sulfadoxine and pyrimethamine combination should not be used in infants up to 2 months of age.

Geriatric

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

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

• Aurothioglucose

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

• Methotrexate
• Sulfamethoxazole
• Trimethoprim
• Zidovudine

Using pyrimethamine and sulfadoxine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Lorazepam

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Anemia or other blood problems—Patients with these problems may have an increase in side effects involving the blood

• Kidney disease or
• Liver disease—Patients with kidney and/or liver disease may have an increased chance of side effects

• Porphyria—pyrimethamine and sulfadoxine may cause an attack of porphyria

• Seizure disorders, such as epilepsy—High doses of pyrimethamine and sulfadoxine may increase the chance of convulsions (seizures)

Proper Use of pyrimethamine and sulfadoxine

Do not give pyrimethamine and sulfadoxine to infants younger than 2 months of age unless otherwise directed by your doctor. Also, keep pyrimethamine and sulfadoxine out of the reach of children. Overdose is especially dangerous in children.

Sulfa-containing medicines are best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects (e.g., kidney stones) of pyrimethamine and sulfadoxine. If pyrimethamine and sulfadoxine upsets your stomach or causes vomiting, it may be taken with meals or a snack.

For patients taking pyrimethamine and sulfadoxine to prevent malaria :

• Your doctor may want you to start taking pyrimethamine and sulfadoxine 1 to 2 weeks before you travel to an area where there is a chance of getting malaria. This will help you to see how you react to the medicine. Also, it will allow time for your doctor to change your medicine if you have a reaction to pyrimethamine and sulfadoxine.
• Also, you should keep taking pyrimethamine and sulfadoxine while you are in the area and for 4 weeks after you leave the area. No medicine will protect you completely from malaria. However, to protect you as completely as possible, it is important that you keep taking pyrimethamine and sulfadoxine for the full time your doctor ordered. Also, if fever develops during your travels or within 2 months after you leave the area, check with your doctor immediately.
• pyrimethamine and sulfadoxine works best when you take it on a regular schedule. For example, if you are to take it once a week, it is best to take it on the same day each week. Do not miss any doses. If you have any questions about this, check with your health care professional.

For patients taking pyrimethamine and sulfadoxine to treat malaria :

• To help clear up your infection completely, take pyrimethamine and sulfadoxine exactly as directed by your doctor.

For patients taking pyrimethamine and sulfadoxine to self-treat presumed malaria:

• After you take pyrimethamine and sulfadoxine to self-treat presumed malaria, you should continue to take your other medicine for malaria once a week.

Dosing

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

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

• For treatment of malaria:
  • Adults and teenagers: 3 tablets as a single dose on the third day of quinine therapy.
  • Children: Dose is based on body weight and must be determined by your doctor.
• For self-treatment of presumed malaria:
  • Adults and teenagers: 3 tablets as a single dose when you get a fever and medical care is not available.
  • Children 2 months of age and older: Dose is based on body weight and must be determined by your doctor. The dose may range from ½ tablet to 3 tablets taken as a single dose.
• For prevention of malaria:
  • Adults and teenagers: 1 tablet once every seven days, or 2 tablets once every fourteen days.
  • Children 2 months of age and older: Dose is based on body weight and must be determined by your doctor. The dose may range from ¼ tablet to ¾ tablet taken once every seven days, or ½ tablet to 1½ tablets taken once every fourteen days.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using pyrimethamine and sulfadoxine

If pyrimethamine and sulfadoxine causes skin rash, itching, redness, sores in the mouth or on the genitals (sex organs), or sore throat, check with your doctor immediately. These may be early warning signs of more serious skin or related problems that could develop later.

Malaria is spread by mosquitoes. If you are living in, or will be traveling to, an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

• If possible, sleep under mosquito netting to avoid being bitten by malaria-carrying mosquitoes.
• Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
• Apply mosquito repellant to uncovered areas of the skin from dusk through dawn when mosquitoes are out.

For patients taking pyrimethamine and sulfadoxine to prevent malaria :

• It is very important that your doctor check your progress at regular visits. pyrimethamine and sulfadoxine may cause blood problems, especially if it is taken for a long time.
• If pyrimethamine and sulfadoxine causes anemia, your doctor may want you to take leucovorin (e.g., folinic acid, Wellcovorin) to help clear up the anemia. If so, it is important to take the leucovorin every day while you are taking pyrimethamine and sulfadoxine. Do not miss any doses.
• Sulfadoxine and pyrimethamine combination may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.
• Sulfadoxine and pyrimethamine combination may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking pyrimethamine and sulfadoxine:
  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
  • Wear protective clothing, including a hat. Also, wear sunglasses.
  • Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
  • Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
  • Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

For patients taking pyrimethamine and sulfadoxine to self-treat presumed malaria:

• Seek medical help as soon as possible, especially if your symptoms do not improve within 48 hours.

pyrimethamine and sulfadoxine Side Effects

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

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

More common

• Fever
• increased sensitivity of skin to sunlight
• irritation or soreness of tongue
• skin rash

Less common

• Black, tarry stools
• bleeding or crusting sores on lips
• blood in urine or stools
• chest pain
• chills
• cough or hoarseness
• loss of appetite
• lower back or side pain
• muscle cramps or pain
• nausea
• painful or difficult urination
• pinpoint red spots on skin
• redness, blistering, peeling, or loosening of skin
• sore mouth
• sore throat
• sores, ulcers, and/or white spots in mouth
• sores on lips
• swelling in upper abdominal area
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Rare

• Abdominal or stomach pain
• changes in facial skin color
• constipation
• fast or irregular breathing
• tenderness, itching, or burning of skin
• puffiness or swelling of the eyelids or around the eyes
• shortness of breath, troubled breathing, tightness in chest, and/or wheezing
• swelling of front part of neck

Symptoms of overdose

• Bleeding or bruising (severe)
• clumsiness or unsteadiness
• convulsions (seizures)
• fever and sore throat
• irritation or soreness of tongue
• loss of appetite
• unusual tiredness or weakness
• trembling
• vomiting (severe)

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

More common

• Anxiety
• diarrhea
• drowsiness
• headache
• nervousness

Less common

• Pain in joints

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

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

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

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

Pyrimethamine/

Sulfadoxine

Generic Name: Pyrimethamine/Sulfadoxine (peer-i-METH-a-meen/sul-fa-DOX-een)
Brand Name: Fansidar

Pyrimethamine/Sulfadoxine is used for:

Treating and preventing malaria when other medicines (eg, chloroquine) are not effective or appropriate.

Pyrimethamine/Sulfadoxine is an antimalarial agent. It works by blocking the formation of folinic acid within the malaria organism, which kills the parasite.

Do NOT use Pyrimethamine/Sulfadoxine if:

• you are allergic to pyrimethamine or any other ingredient in Pyrimethamine/Sulfadoxine
• you are pregnant and at term or you are breast-feeding
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
• you have severe kidney or liver problems or certain blood problems (eg, anemia due to folate deficiency)
• the patient being treated is younger than 2 months of age

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

Before using Pyrimethamine/Sulfadoxine:

Some medical conditions may interact with Pyrimethamine/Sulfadoxine. 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
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of asthma, severe allergies, kidney or liver problems, the blood disease porphyria or other blood problems, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, seizures, alcohol abuse, or depression
• if you have diarrhea, a stomach or intestinal infection, or a sore throat

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

• Methotrexate because side effects may be increased by Pyrimethamine/Sulfadoxine

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

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

• Take Pyrimethamine/Sulfadoxine after a meal.
• Swallow Pyrimethamine/Sulfadoxine whole. Do not break, crush, or chew before swallowing.
• Drinking extra fluids while you are taking Pyrimethamine/Sulfadoxine is recommended. Check with your doctor for instructions.
• If you miss a dose of Pyrimethamine/Sulfadoxine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pyrimethamine/Sulfadoxine.

Important safety information:

• Pyrimethamine/Sulfadoxine may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pyrimethamine/Sulfadoxine. Using Pyrimethamine/Sulfadoxine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• If you have had a severe allergic reaction to Pyrimethamine/Sulfadoxine or any other sulfonamide medicine (eg, sulfisoxazole, sulfamethoxazole, glyburide, probenecid), contact your doctor or pharmacist before taking Pyrimethamine/Sulfadoxine. A severe reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to Pyrimethamine/Sulfadoxine or if a certain medicine is a sulfonamide, contact your doctor or pharmacist.
• It is important to use Pyrimethamine/Sulfadoxine for the full course of treatment. Failure to do so may decrease the effectiveness of Pyrimethamine/Sulfadoxine and increase the risk that the bacteria will no longer be sensitive to Pyrimethamine/Sulfadoxine and will not be able to be treated by this or certain other antibiotics in the future.
• Pyrimethamine/Sulfadoxine may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• Pyrimethamine/Sulfadoxine may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Pyrimethamine/Sulfadoxine. Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
• Diabetes patients – Pyrimethamine/Sulfadoxine may cause low blood sugar (eg, increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting). It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you do not have a reliable source of glucose available, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or nondiet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To prevent hypoglycemia, eat meals on a regular schedule and do not skip meals.
• LAB TESTS, including complete blood cell counts and liver and kidney function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Pyrimethamine/Sulfadoxine with caution in the ELDERLY because they may be more sensitive to its effects.
• Pyrimethamine/Sulfadoxine is not recommended for use in CHILDREN younger than 2 months of age. Safety and effectiveness in this age group have not been confirmed.
• If you are traveling to an area where malaria is common, avoid becoming pregnant while using Pyrimethamine/Sulfadoxine and for 3 months after the last dose. Talk with your doctor about using effective contraception.
• PREGNANCY and BREAST-FEEDING: Pyrimethamine/Sulfadoxine may cause harm to the fetus. Avoid becoming pregnant while taking Pyrimethamine/Sulfadoxine. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Pyrimethamine/Sulfadoxine during pregnancy. Pyrimethamine/Sulfadoxine is excreted in breast milk. Do not breast-feed while taking Pyrimethamine/Sulfadoxine.

Possible side effects of Pyrimethamine/Sulfadoxine:

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:

Diarrhea; dizziness; headache; nausea; 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); cough; dark urine; decreased urination; depression; hallucinations; joint pain; lack of coordination; persistent sore throat, fever, or chills; red, swollen, or blistered skin; ringing in the ears; seizures; shortness of breath; sores on the mouth or lips; stomach pain; swelling or stinging of the tongue; tingling or numbness of the skin; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. 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 chills; crystals in the urine; loss of appetite; seizures; shaking; swelling of the tongue; vomiting.

Proper storage of Pyrimethamine/Sulfadoxine:

Store Pyrimethamine/Sulfadoxine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pyrimethamine/Sulfadoxine out of the reach of children and away from pets.

General information:

• If you have any questions about Pyrimethamine/Sulfadoxine, please talk with your doctor, pharmacist, or other health care provider.
• Pyrimethamine/Sulfadoxine 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 Pyrimethamine/Sulfadoxine. 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: pyrethrum extract and piperonyl butoxide (Topical route)

pye-REE-thrum EX-trackt, PIP-er-oh-nil byoo-TOX-ide

Commonly used brand name(s):

In the U.S.

• A200 Maximum Strength
• A200 Time-Tested Formula
• Lice-X
• Licide
• Medi-Lice Maximum Strength
• Pronto Maximum Strength
• Pyrinex
• Pyrinyl
• Rid
• Tisit

Available Dosage Forms:

• Gel/Jelly
• Liquid
• Shampoo
• Kit
• Foam

Therapeutic Class: Pediculicide

Chemical Class: Pyrethrums

Uses For Pyrinex

Medicine containing pyrethrins is used to treat head, body, and pubic lice infections. This medicine is absorbed by the lice and destroys them by acting on their nervous systems. It does not affect humans in this way. The piperonyl butoxide is included to make the pyrethrins more effective in killing the lice. This combination medicine is known as a pediculicide.

This medicine is available without a prescription.

Before Using Pyrinex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Although there is no specific information comparing use of pyrethrins and piperonyl butoxide combination in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pyrethrins and piperonyl butoxide combination medicine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Inflammation of the skin (severe)—Use of pyrethrins and piperonyl butoxide combination may make the condition worse

Proper Use of pyrethrum extract and piperonyl butoxide

This section provides information on the proper use of a number of products that contain pyrethrum extract and piperonyl butoxide. It may not be specific to Pyrinex. Please read with care.

Pyrethrins and piperonyl butoxide combination medicine usually comes with patient directions. Read them carefully before using this medicine.

Use this medicine only as directed. Do not use more of it and do not use it more often than recommended on the label. To do so may increase the chance of absorption through the skin and the chance of side effects.

Keep pyrethrins and piperonyl butoxide combination medicine away from the mouth and do not inhale it. This medicine is harmful if swallowed or inhaled.

To lessen the chance of inhaling this medicine, apply it in a well-ventilated room (for example, one with free flowing air or with a fan turned on).

Keep this medicine away from the eyes and other mucous membranes, such as the inside of the nose, mouth, or vagina, because it may cause irritation. If you accidentally get some in your eyes, flush them thoroughly with water at once.

Do not apply this medicine to the eyelashes or eyebrows . If they become infected with lice, check with your doctor.

To use the gel or solution form of this medicine:

• Apply enough medicine to thoroughly wet the dry hair and scalp or skin. Allow the medicine to remain on the affected areas for exactly 10 minutes.
• Then, thoroughly wash the affected areas with warm water and soap or regular shampoo. Rinse thoroughly and dry with a clean towel.

To use the shampoo form of this medicine:

• Apply enough medicine to thoroughly wet the dry hair and scalp or skin. Allow the medicine to remain on the affected areas for exactly 10 minutes.
• Then use a small amount of water and work shampoo into the hair and scalp or skin until a lather forms. Rinse thoroughly and dry with a clean towel.

After rinsing and drying, use a nit removal comb (special fine-toothed comb, usually included with this medicine) to remove the dead lice and eggs (nits) from hair.

Immediately after using this medicine, wash your hands to remove any medicine that may be on them.

This medicine should be used again in 7 to 10 days after the first treatment in order to kill any newly hatched lice.

Lice can easily move from one person to another by close body contact. This can happen also by direct contact with such things as clothing, hats, scarves, bedding, towels, washcloths, hairbrushes and combs, or the hair of infected persons. Therefore, all members of your household should be examined for lice and receive treatment if they are found to be infected.

To use this medicine for pubic (crab) lice:

• Your sexual partner may also need to be treated, since the infection may spread to persons in close contact. If your partner is not being treated or if you have any questions about this, check with your doctor.

Dosing

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

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

• For topical dosage forms (gel, solution shampoo, and topical solution):
  • For head, body, or pubic lice:
    • Adults and children—Use one time, then repeat one time in seven to ten days.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Pyrinex

To prevent reinfection or spreading of the infection to other people, good health habits are also required. These include the following:

• For head lice
  • Machine wash all clothing (including hats, scarves, and coats), bedding, towels, and washcloths in very hot water and dry them by using the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in a plastic bag for 2 weeks.
  • Shampoo all wigs and hairpieces.
  • Wash all hairbrushes and combs in very hot soapy water (above 130 °F) for 5 to 10 minutes and do not share them with other people.
  • Clean the house or room by thoroughly vacuuming upholstered furniture, rugs, and floors.
• For body lice
  • Machine wash all clothing, bedding, towels, and washcloths in very hot water and dry them by using the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in a plastic bag for 2 weeks.
  • Clean the house or room by thoroughly vacuuming upholstered furniture, rugs, and floors.
• For pubic lice
  • Machine wash all clothing (especially underwear), bedding, towels, and washcloths in very hot water and dry them by using the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in a plastic bag for 2 weeks.
  • Scrub toilet seats frequently.

Pyrinex Side Effects

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

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

Less common or rare

• Skin irritation not present before use of this medicine
• skin rash or infection
• sneezing (sudden attacks of)
• stuffy or runny nose
• wheezing or difficulty in breathing

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

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

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