( B ₆ ) Pronunciation: (peer-ih-DOX-een HIGH-droe-KLOR-ide)
Class: Vitamin, water-soluble

Trade Names:
Pyridoxine Hydrochloride
- Tablets 10 mg
- Tablets 25 mg
- Tablets 50 mg
- Tablets 100 mg
- Tablets 200 mg
- Tablets 250 mg
- Tablets, extended-release 200 mg
- Capsules 500 mg
- Solution 200 mg per 5 mL

Trade Names:
Pyri-500
- Tablets 500 mg

Trade Names:
Rodex
- Capsules 150 mg

Trade Names:
Vitabee-6
- Injection 100 mg/mL

Hexa-Betalin (Canada)

Pharmacology

Vitamin B ₆ functions as coenzyme in amino acid, carbohydrate, and lipid metabolism.

Pharmacokinetics

Absorption

Absorbed by passive diffusion in the jejunum and to a lesser extent in the ileum.

Distribution

Primarily stored in the liver, lesser amount in the muscle and brain. Not protein bound.

Metabolism

Metabolized in the liver and converted to 4-pyridoxic acid metabolite.

Elimination

Excreted mostly as 4-pyridoxic acid in the urine. The t _½ is 15 to 20 days.

Indications and Usage

Pyridoxine deficiency, including inadequate diet, drug-induced causes (eg, isoniazid, hydralazine, oral contraceptives) or inborn errors of metabolism. Parenteral use is indicated when oral therapy is not feasible.

Unlabeled Uses

Treatment of hydrazine poisoning, PMS, hyperoxaluria type I, nausea and vomiting in pregnancy, sideroblastic anemia associated with high serum iron, carpal tunnel syndrome, tardive dyskinesia.

Contraindications

Standard considerations.

Dosage and Administration

Dietary Deficiency
Adults

PO / IM / IV 10 to 20 mg/day for 3 wk.

Drug-Induced Deficiency Anemia or Neuritis
Adults

PO / IM / IV 100 to 200 mg/day for 3 wk; follow with 25 to 100 mg/day.

Neuropathy
Adults

PO / IM / IV 50 to 200 mg/day.

Vitamin B ₆ Dependency Syndrome
Adults

PO / IM / IV 600 mg, followed by 30 mg/day for life. Dependency has been noted in adults administered 200 mg/day.

Pyridoxine-dependent infants

IM / IV 10 to 100 mg, followed by 2 to 100 mg/day.

Metabolic Disorders
Adults

PO / IM / IV 100 to 500 mg/day.

Isoniazid Poisoning
Adults and children

IV 4 g IV followed by 1 g IM every 30 min until pyridoxine dose equal to isoniazid dose has been given.

General Advice

• Instruct patient to swallow enteric-coated preparation whole and not to break, crush or chew.
• When giving via IM route, rotate sites.
• IV preparation may be given undiluted or added to standard compatible IV solutions.

Storage/Stability

Store all forms of drug at room temperature in tightly closed, light-resistant containers. Avoid freezing injection.

Drug Interactions

Cycloserine, isoniazid, hydralazine, oral contraceptives, penicillamine

Increased need for pyridoxine.

Levodopa

Decreased effect of levodopa. (Interaction does not occur with levodopa/carbidopa in combination with pyridoxine.)

Phenytoin

Phenytoin serum levels may be decreased.

Incompatibility

Incompatible with alkaline solutions, iron salts and oxidizing agents (parenteral).

Laboratory Test Interactions

May result in false-positive urobilinogen in the spot test using Ehrlich reagent.

Adverse Reactions

CNS

Neuropathy; unstable gait; drowsiness; somnolence.

EENT

Perioral numbness.

Miscellaneous

Numbness of feet; decreased sensation to touch, temperature or vibration; paresthesia; low serum folic acid levels; burning/stinging at IM injection site; photoallergic reaction; ataxia.

Precautions

Pregnancy

Category A . ( Category C in doses that exceed the RDA.)

Lactation

Excreted in breast milk; may inhibit lactation.

Children

Safety and efficacy not established in doses exceeding nutritional requirements.

Overdosage

Symptoms

Ataxia, sensory neuropathy.

Patient Information

• Emphasize importance of complying with prescribed dietary recommendations.
• Teach patient about foods high in B ₆ (whole grain cereals, meat [eg, liver], potatoes, green vegetables, legumes [eg, lima beans], yeast and bananas).
• If patient is self-medicating with vitamin supplements, caution that megadosing may cause adverse reactions such as unsteady gait, impaired hand coordination and numbness of feet.

Copyright © 2009 Wolters Kluwer Health.

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: Pyridostigmine (peer-id-oh-STIG-meen)
Brand Name: Mestinon

Pyridostigmine Controlled-Release Tablets are used for:

Treating myasthenia gravis. It may also be used for other conditions as determined by your doctor.

Pyridostigmine Controlled-Release Tablets are a cholinesterase inhibitor. It works by improving nerve impulses in muscles so that the muscles are better able to work.

Do NOT use Pyridostigmine Controlled-Release Tablets if:

• you are allergic to any ingredient in Pyridostigmine Controlled-Release Tablets
• you are taking quinine or quinidine
• you have a stomach, intestinal, or urinary blockage

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

Before using Pyridostigmine Controlled-Release Tablets:

Some medical conditions may interact with Pyridostigmine Controlled-Release Tablets. 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 heart problems (eg, heart block, slow heartbeat), a urinary tract infection, asthma, or kidney problems

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

• Quinine or quinidine because effectiveness of Pyridostigmine Controlled-Release Tablets may be decreased
• Succinylcholine because actions and side effects may be increased by Pyridostigmine Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pyridostigmine Controlled-Release Tablets 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 Pyridostigmine Controlled-Release Tablets:

Use Pyridostigmine Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pyridostigmine Controlled-Release Tablets may be taken with or without food. Take with food if it upsets your stomach.
• Swallow Pyridostigmine Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Pyridostigmine Controlled-Release Tablets, 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 Pyridostigmine Controlled-Release Tablets.

Important safety information:

• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Pyridostigmine Controlled-Release Tablets.
• Use Pyridostigmine Controlled-Release Tablets with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pyridostigmine Controlled-Release Tablets, discuss with your doctor the benefits and risks of using Pyridostigmine Controlled-Release Tablets during pregnancy. Pyridostigmine Controlled-Release Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Pyridostigmine Controlled-Release Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pyridostigmine Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); diarrhea; fainting; increased production of saliva; increased sweating; muscle weakness; nausea; small pupils; stomach cramps; trouble breathing; vision changes; vomiting; weakness.

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 diarrhea; fainting; increased production of saliva; increased sweating; muscle weakness; nausea; small pupils; stomach cramps; trouble breathing; vision changes; vomiting; weakness.

Proper storage of Pyridostigmine Controlled-Release Tablets:

Store Pyridostigmine Controlled-Release Tablets 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 Pyridostigmine Controlled-Release Tablets out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Pyridostigmine Controlled-Release Tablets. 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: Pyridostigmine (peer-id-oh-STIG-meen)
Brand Name: Mestinon

Pyridostigmine Syrup is used for:

Treating myasthenia gravis. It may also be used for other conditions as determined by your doctor.

Pyridostigmine Syrup is a cholinesterase inhibitor. It works by improving nerve impulses in muscles so that the muscles are better able to work.

Do NOT use Pyridostigmine Syrup if:

• you are allergic to any ingredient in Pyridostigmine Syrup
• you are taking quinine or quinidine
• you have a stomach, intestinal, or urinary blockage

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

Before using Pyridostigmine Syrup:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have heart problems (eg, heart block, slow heartbeat), a urinary tract infection, asthma, or kidney problems

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

• Quinine or quinidine because effectiveness of Pyridostigmine Syrup may be decreased
• Succinylcholine because actions and side effects may be increased by Pyridostigmine Syrup

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

How to use Pyridostigmine Syrup:

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

• Pyridostigmine Syrup may be taken with or without food. Take with food if it upsets your stomach.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Pyridostigmine Syrup, 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 Pyridostigmine Syrup.

Important safety information:

• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Pyridostigmine Syrup.
• Use Pyridostigmine Syrup with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pyridostigmine Syrup, discuss with your doctor the benefits and risks of using Pyridostigmine Syrup during pregnancy. Pyridostigmine Syrup is excreted in breast milk. If you are or will be breast-feeding while you are using Pyridostigmine Syrup, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pyridostigmine Syrup:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); diarrhea; fainting; increased production of saliva; increased sweating; muscle weakness; nausea; small pupils; stomach cramps; trouble breathing; vision changes; vomiting; weakness.

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 diarrhea; fainting; increased production of saliva; increased sweating; muscle weakness; nausea; small pupils; stomach cramps; trouble breathing; vision changes; vomiting; weakness.

Proper storage of Pyridostigmine Syrup:

Store Pyridostigmine Syrup 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 Pyridostigmine Syrup out of the reach of children and away from pets.

General information:

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

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

Pronunciation: (pihr-id-oh-STIG-meen BROE-mide)
Class: Anticholinesterase muscle stimulant

Trade Names:
Mestinon
- Tablets 60 mg
- Tablets, extended-release 180 mg
- Syrup 60 mg/5 mL
- Injection 5 mg/mL

Mestinon-SR (Canada)

Pharmacology

Facilitates myoneural junction impulse transmission by inhibiting acetylcholine destruction by cholinesterase.

Pharmacokinetics

Elimination

Primarily excreted unchanged by the kidney.

Indications and Usage

Treatment of myasthenia gravis; reversal agent or antagonist to nondepolarizing muscle relaxants such as curariform drugs and gallamine triethiodide (IV only).

Contraindications

Mechanical intestinal or urinary obstruction; hypersensitivity to anticholinesterase agents.

Dosage and Administration

Adults

PO Individualize dosage to meet the needs of the patients.

Syrup/Conventional tablet

Average dose is ten 5 mL tsp (60 mg/5 mL) daily or ten 60 mg tablets spaced to provide max relief when max strength is needed (range is usually 1 to 25 tablets or tsp/day).

Extended-release tablets

One to three 180 mg tablets, once or twice daily with at least 6 h between doses.

IV To supplement oral dosage preoperatively and postoperatively during labor and postpartum, during myasthenic crisis, or when oral therapy is impractical, give approximately 1/30 the oral dose, either IM or very slow IV.

Neonates

IV Neonates of myasthenic mothers may have transient difficulty in swallowing, sucking, and breathing. Injectable pyridostigmine may be indicated (by symptoms and use of the edrophonium test) until syrup can be taken. Dosage requirements range from 0.05 to 0.15 mg/kg IM.

Reversal of Nondepolarizing Muscle Relaxants
Injection

Give atropine sulfate (0.6 to 1.2 mg) IV immediately prior to pyridostigmine to minimize adverse reactions. Pyridostigmine 10 or 20 mg IV is usually sufficient. Full recovery usually occurs in no more than 15 min but at least 30 min may be required.

General Advice

• Administer without regard to meals. Administer with food if GI upset occurs.
• Do not chew or crush extended-release tablet. Instruct patient to swallow tablet(s) whole.
• Store at controlled room temperature (59° to 86°F).

Drug Interactions

Atropine

May mask signs of overdosage, leading to inadvertent induction of cholinergic crisis.

Corticosteroids

The therapeutic effects of pyridostigmine may be antagonized.

Succinylcholine

Neuromuscular blockade produced by succinylcholine may be prolonged or antagonized.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Skin rash.

EENT

Miosis.

GI

Nausea; vomiting; diarrhea; abdominal cramps; increased peristalsis; increased salivation.

Musculoskeletal

Muscle cramps and fasciculation; weakness.

Respiratory

Increased bronchial secretions.

Miscellaneous

Increased sweating.

Precautions

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Renal Function

Lower doses may be required in patients with renal disease.

Bronchial asthma

Use with caution.

Cardiac dysrhythmias (IV only)

Use with caution. Transient bradycardia may occur and be relieved by atropine sulfate.

Cholinergic crisis

Observe patients closely for cholinergic reactions, particularly if the IV route is used. May be difficult to distinguish from myasthenic crisis. Differentiation is important because increasing the dose of pyridostigmine or other drugs of this class may have grave consequences in patients in cholinergic crisis.

Overdosage

Symptoms

Cholinergic crisis, characterized by increasing muscle weakness (including respiratory paralysis and death).

Patient Information

• Advise patient that dose and frequency of administration may be adjusted to achieve max benefit.
• Advise patient to take exactly as prescribed and not to change the dose or stop taking unless advised by health care provider.
• Advise patient to take prescribed dose without regard to meals but to take with food if upset stomach occurs.
• Instruct patient to contact health care provider immediately if any of the following occur: worsening muscle weakness, difficulty breathing, slow heart rate, dizziness, fainting.

Copyright © 2009 Wolters Kluwer Health.

Generic Name: pyridoxine (vitamin B6) (peer ih DOCK seen)
Brand names: Nestrex, Vitelle Nestrex, Vitamin B6

What is pyridoxine?

Pyridoxine is vitamin B6. Vitamins are naturally occurring substances necessary for many processes in the body. Pyridoxine is important for the breakdown of protein, fats, and carbohydrates (sugars) in the foods we eat.

Pyridoxine is used to prevent and to treat deficiencies of pyridoxine that may be caused by an inadequate diet, medications, or genetic problems with metabolism.

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

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

Do not take more pyridoxine than is prescribed for you or than is directed on the package.

Who should not take pyridoxine?

Before taking pyridoxine, talk to your doctor, pharmacist, or health care professional if you have any other medical conditions, allergies, or if you take other medicines or other herbal/health supplements.

Pyridoxine is in the FDA pregnancy category A. This means that pyridoxine is considered to be safe for use during pregnancy. Pyridoxine requirements increase during pregnancy. Talk to your doctor before taking pyridoxine if you are pregnant. Pyridoxine passes into breast milk. Pyridoxine requirements may increase during pregnancy. Doses larger than the recommended daily allowance should be used cautiously under the supervision of a doctor. Talk to your doctor before taking pyridoxine if you are breast-feeding.

How should I take pyridoxine?

Take pyridoxine exactly as directed by your doctor or as directed on the package. 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 take more pyridoxine than is prescribed for you or than is directed on the package. Store pyridoxine at room temperature away from moisture and heat.

See also: Pyridoxine dosage in more detail

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 missed dose and take only the next regularly scheduled dose. Do not take a double dose.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a pyridoxine overdose may include poor coordination; staggering; numbness; decreased sensation to touch, temperature, and vibration; and tiredness for up to six months.

What should I avoid while taking pyridoxine?

There are no restrictions on food, beverages, or activities while you are taking pyridoxine unless otherwise directed by your doctor.

Pyridoxine side effects

Stop taking pyridoxine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other side effects may also occur. Talk to your doctor if you experience

• decreased sensation to touch, temperature, and vibration;

• poor coordination;

• staggering;

• numb feet;

• awkwardness of the hands;

• numbness around the mouth; and

• tiredness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Pyridoxine Dosing Information

Usual Adult Dose for Drug Induced Vitamin/Mineral Deficiency:

Drug Induced Neuritis:
Cycloserine: 100 to 300 mg/day orally in divided doses.
Isoniazid or penicillamine: 100 to 200 mg/day orally for 3 weeks or 25 to 100 mg/day for prophylaxis.
Oral contraceptives: 25 to 30 mg/day orally.

Acute Intoxication:
Hydralazine: 25 mg/kg. One-third of the dose should be administered IM and the remainder administered as an IV infusion over 3 hours.
Isoniazid: 1 to 4 grams IV as a first dose, then 1 g IM every 30 minutes until the total required dose has been administered (given with other anticonvulsants as needed). The total dose administered should equal the amount of isoniazid ingested.
Mushroom ingestion (genus Gyromitra): 25 mg/kg IV infused over 15 to 30 minutes. Repeat as needed to a maximum total daily dose of 15 to 20 g.

Usual Adult Dose for Dietary Supplement:

Pyridoxine Deficiency:
2.5 to 10 mg daily until clinical signs of deficiency are corrected.

Usual Adult Dose for Anemia:

Sideroblastic, hereditary: 200 to 600 mg orally daily. If adequate response obtained, dose may be decreased to 30 to 50 mg orally daily.

If therapeutic response is not obtained after 1 to 2 months of pyridoxine therapy, a different therapy should be considered.

Usual Adult Dose for Nausea/Vomiting:

Of Pregnancy:
25 mg orally every 8 hours.

Usual Pediatric Dose for Drug Induced Vitamin/Mineral Deficiency:

Drug Induced Neuritis (cycloserine, isoniazid, hydralazine, penicillamine) :
Treatment: 10 to 50 mg/day.
Prophylaxis: 1 to 2 mg/kg/day

Acute Intoxication:
Hydralazine: 25 mg/kg: One-third of the dose should be administered IM and the remainder administered as an IV infusion over 3 hours.
Isoniazid: 1 to 4 grams IV administered as a first dose, then 1 g every 30 minutes until the total required dose has been administered. The total dose administered should equal the amount of isoniazid ingested.
Mushroom ingestion (genus Gyromitra): 25 mg/kg IV. Repeat as needed up to a maximum total dose of 15 to 20 g.

Usual Pediatric Dose for Dietary Supplement:

Pyridoxine Deficiency:
5 to 25 mg/day orally for 3 weeks followed by 1.5 to 2.5 mg/day from a multivitamin product.

Usual Pediatric Dose for Seizures:

Pyridoxine-dependent seizures:
10 to 100 mg PO, IM, or IV initially, followed by 2 to 100 mg orally daily.

What other drugs will affect pyridoxine?

Before taking pyridoxine, tell your doctor if you are taking any of the following medications:

• levodopa (Dopar, Larodopa, Sinemet, Atamet);

• phenobarbital (Luminal, Solfoton); or

• phenytoin (Dilantin).

You may not be able to take pyridoxine, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with pyridoxine. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines or herbal/health supplements.

Where can I get more information?

• Your doctor, pharmacist, or health care provider may have more information about pyridoxine.

• Consultation with a licensed health care professional is advisable before using any herbal/health supplement. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial and coordination of treatment among all health care providers involved may be advantageous. Remember, keep this and all other prescription drug products, over-the-counter drug products, and herbal/health supplements out of the reach of children.
• 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: 1.04. Revision Date: 4/12/2009 4:37:25 PM.

Generic Name: phenazopyridine (fen AY zoe PIR i deen)
Brand Names: Azo-Gesic, Azo-Standard, Baridium, Phenazo, Prodium, Pyridiate, Pyridium, Re-Azo, Uricalm, Uristat

What is phenazopyridine?

Phenazopyridine is a pain reliever that affects the lower part of your urinary tract (bladder and urethra).

Phenazopyridine is used to treat pain, burning, increased urination, and increased urge to urinate. These symptoms are usually caused by infection, injury, surgery, catheter, or other conditions that irritate the lower urinary tract.

Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection.

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

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

Do not take this medication if you are allergic to phenazopyridine, or if you have kidney disease. Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection. To avoid stomach upset, take phenazopyridine with food.

Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.

Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.

Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.

Stop taking this medication and call your doctor at once if you have pale skin, fever, confusion, yellowing of your skin or eyes, increased thirst, swelling, or if you urinate less than usual or not at all.

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

Do not take this medication if you are allergic to phenazopyridine, or if you have kidney disease.

Before using phenazopyridine, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;

• diabetes; or

• a condition called G6PD (glucose-6-phosphate dehydrogenase) deficiency.

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

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether phenazopyridine 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.

How should I take phenazopyridine?

Take phenazopyridine 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.

Take this medicine with a full glass of water. To avoid stomach upset, take phenazopyridine with food.

Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.

Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.

Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.

This medication can cause you to have false results with glucose or ketone urine tests. Tell any doctor who treats you that you are using phenazopyridine.

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. 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 yellowed skin, fever, confusion, weakness, urinating less than usual, nausea, vomiting, swelling, numbness, or blue-colored skin.

What should I avoid while taking phenazopyridine?

Avoid wearing soft contact lenses while you are taking phenazopyridine. The medication can cause permanent staining of soft contact lenses.

Phenazopyridine 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 phenazopyridine and call your doctor at once if you have any of these serious side effects:

• pale skin, fever, confusion or weakness;

• jaundice (yellowing of your skin or eyes);

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

• swelling, weight gain, feeling short of breath; or

• blue or purple coloring in your skin.

Less serious side effects may include:

• headache;

• dizziness;

• stomach pain, upset stomach; or

• skin 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 phenazopyridine?

There may be other drugs that can interact with phenazopyridine. 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 phenazopyridine.

• 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: 3.02. Revision Date: 4/12/2009 4:37:06 PM.

Generic Name: pyridostigmine (py rid o STIG meen)
Brand names: Mestinon, Mestinon Timespan, Regonol

What is pyridostigmine?

Pyridostigmine affects chemicals in the body that are involved in the communciation between nerve impulses and muscle movement.

Pyridostigmine is used to treat the symptoms of myasthenia gravis. It is also used in military personnel who have been exposed to nerve gas.

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

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

Do not use pyridostigmine if you have a serious stomach condition called peritonitis, or if you have a bladder or bowel obstruction.

Before using pyridostigmine, tell your doctor if you have asthma or kidney disease.

The amount and timing of this medicine is extremely important to the success of your treatment. Carefully follow your doctor’s instructions about how much medicine to take and when to take it.

Your doctor may occasionally change your dose to make sure you get the best results from this medication. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

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

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

Do not use pyridostigmine if you have a bladder or bowel obstruction.

Before using pyridostigmine, tell your doctor if you have:

• asthma; or

• kidney disease;

If you have any of these conditions, you may not be able to use pyridostigmine, or you may need a dosage adjustment or special tests during treatment.

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. It is not known whether pyridostigmine 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.

How should I take pyridostigmine?

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.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Measure the liquid form of pyridostigmine 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 where you can get one.

The amount and timing of this medicine is extremely important to the success of your treatment. Carefully follow your doctor’s instructions about how much medicine to take and when to take it.

Your doctor may occasionally change your dose to make sure you get the best results from this medication. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

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

Store pyridostigmine at room temperature away from moisture and heat.

See also: Pyridostigmine dosage in more detail

What happens if I miss a dose?

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 the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Symptoms of a pyridostigmine overdose may include extreme muscle weakness, nausea, vomiting, diarrhea, sweating, and muscle cramps, or weakness.

What should I avoid while taking pyridostigmine?

There are no restrictions on food, beverages, or activity while using pyridostigmine unless your doctor has told you otherwise.

Pyridostigmine side effects

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

• extreme muscle weakness;

• severe vomiting or diarrhea;

• vision problems; or

• muscle cramps or twitching.

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

• sweating or urinating more than usual;

• drooling, watery eyes;

• warmth or tingly feeling;

• mild nausea, vomiting, or stomach pain;

• mild itching or skin rash; or

• muscle or joint pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Pyridostigmine Dosing Information

Usual Adult Dose for Nerve Agent Pretreatment:

Soman pretreatment:
30 mg orally every 8 hours starting at least 8 hours before anticipated nerve gas exposure.

Pyridostigmine is not effective and should not be taken at the time of, or after exposure to, nerve agents. Immediate treatment with parenteral atropine and pralidoxime is required if nerve agent exposure occurs.

Pretreatment has been used for up to 14 to 21 days.

Pyridostigmine has also been used as nerve agent pretreatment (NAPP) against other substances. In animal studies, pretreatment, together with atropine and pralidoxime postexposure treatment, was effective in increasing survival after tabun and soman poisoning, variably effective against cyclosarin, and ineffective against sarin and VX.

Usual Adult Dose for Reversal of Nondepolarizing Muscle Relaxants:

10 to 20 mg by slow IV injection.
Atropine sulfate 0.6 to 1.2 mg IV is recommended immediately before pyridostigmine injection.

Airway and ventilation should be maintained until recovery of normal respiration.

Usual Adult Dose for Myasthenia Gravis:

Oral:
Immediate-release tablets and syrup:
Initial dose: 60 mg orally 3 times daily.
Maintenance dose: Increase dose as needed in intervals of at least 48 hours. Results of dose adjustments may take several days to become apparent. Effective doses have range from 60 mg to 1500 mg per day in 3 to 6 divided doses.

Sustained-release tablets: 180 to 540 mg orally once or twice daily, not more often than 6-hour intervals. May be used with immediate-release tablets or syrup to provide accurate dose titration and optimal control of symptoms.

Parenteral:
2 to 5 mg IM or slow IV every 2 to 3 hours. To supplement oral dosage pre- and postoperatively, during labor and postpartum, during myasthenic crisis (differentiate between cholinergic and myasthenic crisis before administering), or when oral therapy is not possible, one-thirtieth of the oral dose (i.e., 2 mg IV for every 60 mg oral) may be given.

The use of continuous IV infusions at rates of 2 to 4 mg/hour, has been reported in the management of myasthenic crisis.

Usual Pediatric Dose for Reversal of Nondepolarizing Muscle Relaxants:

Parenteral:
<18 years: 0.05 to 0.25 mg/kg (maximum 10 mg) IM or slow IV once. Atropine sulfate IV is recommended immediately before pyridostigmine injection.

Airway and ventilation should be maintained until recovery of normal respiration.

Usual Pediatric Dose for Myasthenia Gravis:

Parenteral:
<18 years: 0.05 to 0.15 mg/kg (maximum 10 mg) every 4 to 6 hours IM or slow IV
Differentiate between cholinergic and myasthenic crisis before administering.

A benzyl alcohol-free formulation should be used for neonates.

Oral:
<30 days: 5 mg every 4 to 6 hours
1 month to 18 years: 7 mg/kg/day in 5 to 6 divided doses

What other drugs will affect pyridostigmine?

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

• atropine (Donnatal, and others);

• belladonna;

• clidinium (Quarzan);

• dicyclomine (Bentyl);

• glycopyrrolate (Robinul);

• hyoscyamine (Anaspaz, Cystospaz, Levsin);

• mepenzolate (Cantil);

• methantheline (Provocholine);

• methscopolamine (Pamine);

• propantheline (Pro-Banthine);

• scopolamine (Transderm-Scop);

• antibiotics such as neomycin (Mycafradin, Neo-Tab), kanamycin (Kantrex), or streptomycin; or

• heart rhythm medications such as quinidine (Quinidex, Quinaglute), procainamide (Procan, Pronestyl), disopyramide (Norpace), mexiletine (Mexitil), tocainide (Tonocard), flecainide (Tambocor), propafenone (Rythmol), esmolol (Brevibloc), propranolol (Inderal), metoprolol (Toprol), amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), sotalol (Betapace).

If you are using any of these drugs, you may not be able to use pyridostigmine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect pyridostigmine. 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 has more information about pyridostigmine written for health professionals that you may read.

• 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 4:37:12 PM.

Generic Name: acetaminophen and codeine (Oral route)

a-seet-a-MIN-oh-fen, KOE-deen FOS-fate

Commonly used brand name(s):

In the U.S.

• APAP w/Codeine
• Capital w/Codeine
• Pyregesic-C
• Tylenol w/Codeine
• Tylenol w/Codeine #3
• Tylenol w/Codeine #4
• Tylenol with Codeine No. 3
• Vopac

Available Dosage Forms:

• Tablet
• Capsule
• Elixir
• Suspension
• Solution

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Codeine

Uses For Pyregesic-C

Acetaminophen and codeine oral suspension is used to relieve mild to moderate pain. The oral tablets are used to relieve mild to moderately severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

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

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

This medicine is available only with your doctor’s prescription.

Before Using Pyregesic-C

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

Appropriate studies have not been performed on the relationship of age to the effects of acetaminophen and codeine oral suspension in children younger than 3 years of age. Safety and efficacy have not been established.

No information is available on the relationship of age to the effects of acetaminophen and codeine tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of acetaminophen and codeine combination in geriatric patients.

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

• Naltrexone

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

• Adinazolam
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Bromazepam
• Brotizolam
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Dezocine
• Diazepam
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flunitrazepam
• Flurazepam
• Halazepam
• Hydrocodone
• Hydromorphone
• Ketazolam
• Levorphanol
• Lorazepam
• Lormetazepam
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nitrazepam
• Nordazepam
• Opium
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Phenobarbital
• Prazepam
• Propoxyphene
• Quazepam
• Remifentanil
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Triazolam

Using this medicine 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.

• Acenocoumarol
• Carbamazepine
• Isoniazid
• Phenytoin
• Warfarin
• Zidovudine

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.

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

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage
• Ethanol

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:

• Addison’s disease (adrenal gland problem) or
• Alcohol abuse, history of or
• Breathing problems (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia) or
• CNS depression or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Hypothyroidism (an underactive thyroid) or
• Problems with passing urine—Use with caution. May increase risk for more serious side effects.

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

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

• Respiratory depression (hypoventilation or slow breathing)—Use with caution. May make this conditions worse.

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

Proper Use of acetaminophen and codeine

This section provides information on the proper use of a number of products that contain acetaminophen and codeine. It may not be specific to Pyregesic-C. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.

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

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

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 oral dosage form (suspension):
  • For mild to moderate pain:
    • Adults—15 milliliters (mL) or 1 tablespoonful every 4 hours as needed.
    • Children 7 to 12 years of age—10 mL (2 teaspoonfuls) 3 or 4 times per day.
    • Children 3 to 6 years of age—5 mL (1 teaspoonful) 3 or 4 times per day.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For mild to moderately severe pain:
    • Adults—15 to 60 milligrams (mg) of codeine and 300 to 1000 mg of acetaminophen every 4 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 360 mg of codeine and 4000 mg of acetaminophen per 24 hours.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Pyregesic-C

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

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

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

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

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

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

• Contact your doctor right away if you have extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an “ultra-rapid metabolizer of codeine”. Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

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

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of certain tests may be affected by this medicine.

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

Pyregesic-C 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

• Difficult or troubled breathing
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• shortness of breath

Incidence not known

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• cough or hoarseness
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever with or without chills
• general feeling of tiredness or weakness
• hives
• itching
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• tightness in the chest
• unusual bleeding or bruising
• unusual tiredness or weakness
• wheezing

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

Symptoms of overdose

• Abdominal or stomach pain
• bloody or cloudy urine
• chills
• constricted, pinpoint, or small pupils (black part of the eye)
• convulsion
• dark urine
• headache
• increased sweating
• light-colored stools
• loss of appetite
• loss of consciousness
• nausea
• sudden decrease in the amount of urine
• unpleasant breath odor
• vomiting
• vomiting of blood
• yellow eyes or skin

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

• Drowsiness
• lightheadedness
• relaxed and calm
• sleepiness

Incidence not known

• Difficulty having a bowel movement (stool)
• false or unusual sense of well-being

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.

Pyrethrins/

Piperonyl Foam

Generic Name: Pyrethrins/Piperonyl (pye-REE-thrins/pye-PEER-i-nil)
Brand Name: RID

Pyrethrins/Piperonyl Foam is used for:

Treating head, pubic (crab), or body lice.

Pyrethrins/Piperonyl Foam is a pediculicide combination. It works by interfering with the nerves of the lice, which causes death of the lice.

Do NOT use Pyrethrins/Piperonyl Foam if:

• you are allergic to any ingredient in Pyrethrins/Piperonyl Foam

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

Before using Pyrethrins/Piperonyl Foam:

Some medical conditions may interact with Pyrethrins/Piperonyl Foam. 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, including ragweed
• if you have a skin infection or skin irritation

Some MEDICINES MAY INTERACT with Pyrethrins/Piperonyl Foam. Because little, if any, of Pyrethrins/Piperonyl Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

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

Use Pyrethrins/Piperonyl Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pyrethrins/Piperonyl Foam is for external use only. Pyrethrins/Piperonyl Foam is not to be used for lice in the eyebrows or eyelashes. Contact a doctor if lice are present in these areas.
• Shake well before use.
• Use Pyrethrins/Piperonyl Foam on dry hair.
• Apply to the affected area until all hair is completely wet. Allow Pyrethrins/Piperonyl Foam to remain on the affected area for no more than 10 minutes. Add sufficient warm water to form a lather and shampoo as usual. Rinse completely. Close eyes tightly and protect them with a washcloth or towel when rinsing Pyrethrins/Piperonyl Foam out of the hair.
• Use a fine-toothed comb to remove dead lice or eggs (nits) from hair.
• Check daily for any lice or eggs that you missed.
• Repeat this treatment in 7 to 10 days to kill any newly hatched lice.
• If infestation continues, contact a doctor for other treatments.
• If you miss a dose of Pyrethrins/Piperonyl Foam, use it as soon as you remember. Continue to use it as directed by your doctor.

Ask your health care provider any questions you may have about how to use Pyrethrins/Piperonyl Foam.

Important safety information:

• Do not get Pyrethrins/Piperonyl Foam in your eyes, vagina, nose, or mouth. If you get Pyrethrins/Piperonyl Foam in your eyes, flush them with cool tap water.
• Do not inhale Pyrethrins/Piperonyl Foam. Use Pyrethrins/Piperonyl Foam in a well-ventilated area.
• All hats, scarves, coats, clothes, underwear, and bed linens should be dry cleaned or washed in hot water and dried on the hot cycle of the dryer for at least 20 minutes. Hair combs and brushes should also be cleaned in hot water.
• All members of the household should be examined for the presence of lice and treated if lice are found.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Pyrethrins/Piperonyl Foam during pregnancy. It is unknown if Pyrethrins/Piperonyl Foam is excreted in breast milk. If you are or will be breast-feeding while you are using Pyrethrins/Piperonyl Foam, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pyrethrins/Piperonyl Foam:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the proper use of Pyrethrins/Piperonyl Foam. 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); eye irritation; infection; persistent skin or scalp irritation; skin tenderness.

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 coughing; diarrhea; difficulty breathing; headache; nausea; unusual dizziness or drowsiness; vomiting.

Proper storage of Pyrethrins/Piperonyl Foam:

Store Pyrethrins/Piperonyl Foam 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. Do not store at temperatures above 110 degrees F (43 degrees C). Keep Pyrethrins/Piperonyl Foam out of the reach of children and away from pets.

General information:

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