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Pyrinyl

30/06/10

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 Pyrinyl

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 Pyrinyl

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.

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 Pyrinyl. 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 Pyrinyl

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.

Pyrinyl 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.

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.

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pyrithione (Topical route)

30/06/10

pir-i-THYE-one

Commonly used brand name(s):

In the U.S.

2 in 1 Dandruff
Beta Med
DermaZinc
DHS Zinc
Skincure
Zincon
Znp

Available Dosage Forms:

Shampoo
Spray
Cream
Bar
Lotion
Soap

Therapeutic Class: Dermatological Agent

Chemical Class: Pyrethrums

Uses For pyrithione

Pyrithione is used to help control the symptoms of dandruff and seborrheic dermatitis of the scalp.

pyrithione is available without a prescription.

Before Using pyrithione

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 pyrithione, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pyrithione 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 pyrithione in children with use in other age groups, pyrithione 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 pyrithione in the elderly with use in other age groups, pyrithione is not expected to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of pyrithione

For best results, use pyrithione at least 2 times a week or as directed by your doctor.

To use:

Before applying this shampoo, wet the hair and scalp with lukewarm water.
Apply enough shampoo to the scalp to work up a lather and rub in well, then rinse.
Apply the shampoo again and rinse thoroughly.

Keep pyrithione away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water.

Dosing

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

For bar dosage form:
- For dandruff and seborrheic dermatitis:
  - Adults and children—Apply to the affected skin of body, face, or scalp once a day at least two times a week. Lather, massage into affected area, rinse, and repeat.

For cream dosage forms:
- For dandruff or seborrheic dermatitis:
  - Adults and children—Apply one to three times a day to affected skin on the body, face, or scalp or as directed by the doctor.
  - For Brylcreem Antidandruff—Adults: Apply to scalp once a day after shampooing and toweling hair dry. Massage into scalp for one minute.
  - Children—Use and dose must be determined by the doctor.

For lotion dosage form:
- For dandruff and seborrheic dermatitis:
  - For DermaZinc Scalp: Adults—Apply to scalp one to three times a day or as directed by the doctor.
  - For DermaZinc Spray: Adults—Apply one spray to affected skin of body, face, or scalp one to three times a day or as directed by the doctor. Medicine should cover a three-inch-square area. Treatment should continue for one week after symptoms lessen.
  - For DermaZinc Baby: Children—Apply to affected skin of face, body, or scalp one to four times a day or as directed by the doctor.

For lotion shampoo dosage forms:
- For dandruff and seborrheic dermatitis:
  - Adults and children up to 2 years of age—Use once a day as a shampoo on the scalp at least two times a week; however, may be used every day. Apply to wet hair and leave on the scalp for several minutes or massage into scalp vigorously before rinsing.
  - Children up to 2 years of age—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of pyrithione, 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 pyrithione

If your condition does not get better after regular use of pyrithione, or if it gets worse, check with your doctor.

pyrithione 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

Irritation of skin

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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Pyrithione Zinc Shampoo

30/06/10

Generic Name: Pyrithione Zinc (peer-i-THYE-one ZINK)
Brand Name: Examples include Denorex and Dermazinc

Pyrithione Zinc Shampoo is used for:

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

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

Do NOT use Pyrithione Zinc Shampoo if:

you are allergic to any ingredient in Pyrithione Zinc Shampoo

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

Before using Pyrithione Zinc Shampoo:

Some medical conditions may interact with Pyrithione Zinc Shampoo. 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 Shampoo. Because little, if any, of Pyrithione Zinc Shampoo 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 Pyrithione Zinc Shampoo 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 Shampoo:

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

Shake well before each use.
Wet hair thoroughly. Apply Pyrithione Zinc Shampoo and work into a lather. Rinse thoroughly and repeat.
For best results, use Pyrithione Zinc Shampoo 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 Shampoo, use the dose when you remember. Continue to use Pyrithione Zinc Shampoo as directed by your doctor or the package labeling.

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

Important safety information:

Pyrithione Zinc Shampoo is for external use only. Do not get Pyrithione Zinc Shampoo in your eyes, nose, or mouth. If you get Pyrithione Zinc Shampoo in your eyes, rinse immediately with cool water.
If your symptoms do not improve with regular use or if they become worse, consult your doctor.
Different brands of Pyrithione Zinc Shampoo may have different dosing instructions for CHILDREN on the package labeling. Follow the dosing instructions provided on the package labeling or by your doctor. If you are unsure of the dose to give a child, check with your doctor or pharmacist.
Use of Pyrithione Zinc Shampoo is not recommended in CHILDREN younger than 2 years of age without checking with your doctor.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pyrithione Zinc Shampoo, discuss with your doctor the benefits and risks of using Pyrithione Zinc Shampoo during pregnancy. It is unknown if Pyrithione Zinc Shampoo is excreted in breast milk. If you are or will be breast-feeding while you are using Pyrithione Zinc Shampoo, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pyrithione Zinc Shampoo:

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 Shampoo. 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); 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 Shampoo may be harmful if swallowed.

Proper storage of Pyrithione Zinc Shampoo:

Store Pyrithione Zinc Shampoo at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Pyrithione Zinc Shampoo out of the reach of children and away from pets.

General information:

If you have any questions about Pyrithione Zinc Shampoo, please talk with your doctor, pharmacist, or other health care provider.
Pyrithione Zinc Shampoo 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 Shampoo. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

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Pyrilamine Tannate

30/06/10

Pronunciation: (pir-IL-a-meen TAN-nate)
Class: Antihistamine

Trade Names:
Pyrlex
- Suspension 12 mg per 5 mL

Pharmacology

Suppresses symptoms of allergic rhinitis.

Indications and Usage

Symptomatic relief of acute rhinitis and nasal congestion associated with the common cold, seasonal and perennial allergic rhinitis, sinusitis, and other respiratory tract conditions.

Contraindications

Newborns; breast-feeding women; hypersensitivity.

Dosage and Administration

Adults and Children 12 yr of age and older

PO 12 to 24 mg (5 to 10 mL) every 12 h (max, 48 mg per 24 h).

Children 6 to 12 yr of age

PO 12 mg (5 mL) every 12 h (max, 24 mg per 24 h).

Children 2 to 6 yr of age

PO 6 mg (2.5 mL) every 12 h (max, 12 mg per 24 h).

General Advice

Shake well before using.

Storage/Stability

Store at 59° to 86°F. Protect from light and freezing.

Drug Interactions

Alcohol, CNS depressants (eg, hypnotics, sedatives, tranquilizers)

May have additive CNS effects (eg, increased drowsiness).

Antihypertensives (eg, mecamylamine, methyldopa, reserpine, veratrum alkaloids)

Antihypertensive effects may be reduced.

Beta-blockers (eg, propranolol)

Effects of pyrilamine may be increased.

MAOIs

Do not use with or within 14 days after stopping MAOI therapy.

Sympathomimetics

Increased risk of mild sedation or stimulation.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

CNS depression, drowsiness, sedation.

EENT

Dryness of mucous membranes.

GI

GI effects.

Genitourinary

Urinary retention in patients with prostatic hypertrophy.

Precautions

Monitor

Monitor renal function in elderly patients.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 2 yr of age.

Elderly

Use with caution because of increased likelihood of decreased renal function, increasing the risk of dizziness, hypertension, and sedation.

Renal Function

Risk of toxicity may be increased in patients with renal function impairment.

Special Risk Patients

Use with caution in patients with CV disease, diabetes, hypertension, hyperthyroidism, narrow-angle glaucoma, or prostatic hypertrophy.

Paradoxical effect

May cause excitation, particularly in children.

Phenylketonuria

Contains phenylalanine.

Overdosage

Symptoms

Atropine-like signs and symptoms, CNS stimulation or depression. CNS depression, convulsions, death, diminished mental alertness, excitation, hallucinations, or respiratory or cardiac arrest in infants and children.

Patient Information

Caution patients to avoid drinking alcoholic beverages and using other depressants.
Advise patients that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness or coordination.

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pyrimethamine

30/06/10

Generic Name: pyrimethamine (PIR i METH a meen)
Brand Names: Daraprim

What is pyrimethamine?

Pyrimethamine is an antiparasitic drug. It prevents the growth and reproduction of parasites.

Pyrimethamine is used to treat and prevent malaria. Pyrimethamine is also used in the treatment of toxoplasmosis.

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

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

Stop taking pyrimethamine and seek medical attention at the first sign of a skin rash, sore throat, paleness of the skin, unusual bruising under the skin, or swelling of the tongue. These may be early symptoms of serious side effects of pyrimethamine. Pyrimethamine may cause stomach upset or vomiting. Take each dose with food to lessen this side effect.

What should I discuss with my healthcare provider before taking pyrimethamine?

Before taking pyrimethamine, tell your doctor if you have

had an allergic reaction to previous treatment with pyrimethamine,
megaloblastic anemia due to folate deficiency,
seizures or epilepsy,
kidney disease, or
liver disease.

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

Pyrimethamine is in the FDA pregnancy category C. This means that it is not known whether pyrimethamine will be harmful to an unborn baby. Do not take pyrimethamine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Pyrimethamine passes into breast milk and may be harmful to a nursing infant. Do not take pyrimethamine without first talking to your doctor if you are breast-feeding a baby.

How should I take pyrimethamine?

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

Take each dose with a full glass of water. Take pyrimethamine with food to lessen stomach upset. Store pyrimethamine 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 only take the next regularly scheduled dose. Do not take a double dose of the medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a pyrimethamine overdose may include abdominal pain, nausea, severe vomiting (possibly with blood in the vomit), anxiety or excitability, and seizures.

What should I avoid while taking pyrimethamine?

There are no restrictions on foods, beverages, or activities during treatment with pyrimethamine unless otherwise directed by your doctor.

Pyrimethamine side effects

Stop taking pyrimethamine and seek emergency medical attention if you experience an allergic reaction (swelling of the lips, tongue, or face; difficulty breathing; closing of the throat; or hives) during treatment with pyrimethamine. Stop taking pyrimethamine and seek medical attention at the first sign of a skin rash, sore throat, paleness of the skin, unusual bruising under the skin, or swelling of the tongue. These may be early symptoms of serious side effects of pyrimethamine.

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

nausea, vomiting, or loss of appetite;
insomnia;
headache;
lightheadedness; or
dryness of the mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pyrimethamine Dosing Information

Usual Adult Dose for Malaria Prophylaxis:

25 mg orally once a week. Prophylaxis should begin one week prior to departure and continue for at least 6 to 10 weeks following exposure.

Usual Adult Dose for Toxoplasmosis:

Initially: 50 to 75 mg orally once a day with 1 to 4 g of a sulfonamide (e.g., sulfadoxine, sulfadiazine). Continue for 1 to 3 weeks, depending on response and tolerance. Dosage for each drug may then be reduced by one-half and continued for an additional 4 or 5 weeks. Patients receiving pyrimethamine should also receive folinic acid.

Usual Adult Dose for Toxoplasmosis — Prophylaxis:

1 mg/kg or 15 mg/m2 (max 25 mg) orally every day plus folinic acid (leucovorin) 5 mg orally every 3 days plus sulfadiazine 85 to 120 mg/kg/day divided into 2 to 4 oral doses. Clindamycin 20 to 30 mg/kg/day may be used in place of sulfadiazine as an alternative regimen.

Usual Adult Dose for Pneumocystis Pneumonia Prophylaxis:

50 to 75 mg orally once a week. Pyrimethamine is used in combination with dapsone and leucovorin. This is considered an alternative regimen for patients who do not tolerate trimethoprim-sulfamethoxazole.

Usual Pediatric Dose for Malaria Prophylaxis:

Less than 4 years: 6.25 mg orally once a week.

4 to 10 years: 12.5 mg orally once a week.

Usual Pediatric Dose for Toxoplasmosis:

Newborns and infants:
Initial: 2 mg/kg/day orally divided every 12 hours for 2 days, then 1 mg/kg/day once daily given with sulfadiazine for the first 6 months; next 6 months: 1 mg/kg/day 3 times per week with sulfadiazine; oral folinic acid 5 to 10 mg 3 times per week should be administered to prevent hematological toxicity.

1 to 12 years: 2 mg/kg/day divided every 12 hours for 3 days followed by 1 mg/kg/day (maximum 25 mg/day) once daily or divided twice daily for 4 weeks given with sulfadiazine; oral folinic acid 5 to 10 mg 3 times per week should be administered to prevent hematological toxicity.

What other drugs will affect pyrimethamine?

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

auranofin (Ridaura);
aurothioglucose (Solganal); or
or gold sodium thiomalate (Aurolate, Myochrysine).

You may not be able to take pyrimethamine, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with pyrimethamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

Your pharmacist can provide more information about pyrimethamine.

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.

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pyrimethamine (Oral route)

30/06/10

pir-i-METH-a-meen

Commonly used brand name(s):

In the U.S.

Daraprim

Available Dosage Forms:

Tablet

Therapeutic Class: Antimalarial

Pharmacologic Class: Folic Acid Antagonist

Uses For pyrimethamine

Pyrimethamine is an antiprotozoal medicine. Antiprotozoals work by killing protozoa (tiny, one-celled animals) or preventing their growth. Some protozoa are parasites that can cause many different kinds of infections in the body.

pyrimethamine is used with one or more other medicines to treat and prevent malaria and to treat toxoplasmosis. pyrimethamine may also be used for other problems as determined by your doctor.

Pyrimethamine 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 these uses are not included in product labeling, pyrimethamine is used in certain patients with the following medical conditions:

Isosporiasis (treatment and prevention)
Pneumocystis carinii pneumonia (treatment)

For patients taking pyrimethamine for Pneumocystis carinii pneumonia:

Pyrimethamine is used in combination with other medicines for mild to moderate pneumonia in patients who cannot take standard treatment.

Before Using pyrimethamine

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, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pyrimethamine 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

Pyrimethamine has been used in children and, in effective doses, has not been shown 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 or if they cause different side effects or problems in older people. There is no specific information comparing use of pyrimethamine 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

Interactions with Medicines

Using pyrimethamine 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 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 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

Proper Use of pyrimethamine

Keep pyrimethamine out of the reach of children. Overdose is especially dangerous in children.

If pyrimethamine upsets your stomach or causes vomiting, it may be taken with meals or a snack.

If you are taking pyrimethamine to treat malaria, take the number of tablets your doctor told you to take (up to 3) once, as a single dose, along with other medicine your doctor gave you. If you develop a fever and are not near a medical facility, and are taking pyrimethamine to treat what you think may possibly be malaria, take the number of tablets your doctor told you to take (up to 3) once, as a single dose.

pyrimethamine works best when you take it on a regular schedule. If you are to take two doses a day, one dose may be taken with breakfast and the other one with the evening meal. Make sure that you do not miss any doses. If you have any questions about this, check with your health care professional.

Dosing

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

For the treatment of malaria:
- Adults and adolescents: 25 milligrams of pyrimethamine daily together with a sulfonamide for 2 days. These two medicines may also be taken with other medicine. This will be determined by your doctor.
- Children: Dose is based on body weight and will be determined by the doctor. Pyrimethamine may be taken together with other medicines.
For the treatment of toxoplasmosis:
- Adults and adolescents: Starting dose if 50 to 75 milligrams of pyrimethamine daily taken together with other medicines for several weeks. After one to three weeks, your doctor may lower your dose. The proper dose for you must be determined by the doctor.
- Children: Dose is based on body weight and must be determined by the doctor.
For the prevention of malaria:
- Adults and adolescents: 25 milligrams taken once a week.
- Children: Dose is based on age and must be determined by the doctor.

Missed Dose

If you miss a dose of pyrimethamine, 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

It is very important that your doctor check you at regular visits for any blood problems that may be caused by pyrimethamine, especially if you will be taking pyrimethamine in high doses for toxoplasmosis.

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

If pyrimethamine 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. Do not miss any doses.

Pyrimethamine, especially in high doses, 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.

pyrimethamine Side Effects

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

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

Less common

Black, tarry stools
blood in urine or stools
cough or hoarseness
fever or chills
irritation or soreness of tongue
lower back or side pain
painful or difficult urination
pinpoint red spots on skin
unusual bleeding or bruising

Rare

Bleeding or crusting sores on lips
chest pain or discomfort
muscle cramps or pain
redness, blistering, peeling, or loosening of skin
skin rash
sores, ulcers, and/or white spots in mouth
sore throat
unusual tiredness or weakness

Frequency not known

Blood in urine
diarrhea
difficulty swallowing
dizziness
fainting spells
fast, slow, or irregular heartbeat
hives
itching
joint or muscle pain
lightheadedness
pale skin
pounding or rapid pulse
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
rapid breathing
red, irritated eyes
red skin lesions, often with a purple center
shortness of breath
swollen glands
tightness in chest
unexplained bleeding or bruising
wheezing

Symptoms of overdose

Abdominal or stomach pain
convulsions (seizures)
increased excitability
vomiting (severe and continuing)

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:

Less common

Diarrhea
loss of appetite
nausea
vomiting

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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pyrimethamine and sulfadoxine

30/06/10

Generic Name: pyrimethamine and sulfadoxine (PIR i METH a meen and SUL fa DOX een)
Brand Names: Fansidar

What is pyrimethamine and sulfadoxine?

Pyrimethamine is an antiparasitic drug. It prevents the growth and reproduction of parasites.

Sulfadoxine is a sulfa drug that fights bacteria in the body.

The combination of pyrimethamine and sulfadoxine is used to treat malaria, a disease caused by parasites. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Pyrimethamine and sulfadoxine is usually given when other anti-malaria medications may not be as effective in treatment or prevention.

Pyrimethamine and sulfadoxine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about pyrimethamine and sulfadoxine?

Do not use this medication if you have ever had a serious allergic reaction to pyrimethamine or sulfadoxine. Stop taking the medicine and call your doctor at once if you have any signs of skin rash, no matter how mild. You should not use this medication if you are allergic to sulfa drugs, or if you have liver or kidney disease (if using the medication long-term), a blood cell disorder (such as anemia), if you are in late pregnancy, or if you are breast-feeding a baby. Take the pyrimethamine and sulfadoxine tablet after a meal, with plenty of water or other fluid. Swallow the tablet whole, do not break or chew it. Drink plenty of water to keep your kidneys working and prevent kidney stones while taking this medication. You should not take pyrimethamine and sulfadoxine for longer than 2 years without a doctor’s advice.

In addition to taking pyrimethamine and sulfadoxine, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

What should I discuss with my health care provider before taking pyrimethamine and sulfadoxine?

You should not use this medication if you are allergic to pyrimethamine, sulfadoxine, or other sulfa drugs, or if you have certain conditions. Be sure your doctor knows if you have:

liver or kidney disease (if using the medication long-term);
a blood cell disorder (such as anemia);
anemia caused by a folic acid deficiency;
if you are in late pregnancy; or
if you are breast-feeding.

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

liver or kidney disease; or
glucose-6-phosphate dehydrogenase (G6PD) deficiency.

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. Malaria is more likely to cause death in a pregnant woman. If you are pregnant, talk with your doctor about the risks of traveling to areas where malaria is common. Do not use this medication if you are breast-feeding a baby. Do not give this medication to a child without a doctor’s advice. Babies younger than 2 months old should not receive pyrimethamine and sulfadoxine.

How should I take pyrimethamine and sulfadoxine?

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

Take the pyrimethamine and sulfadoxine tablet after a meal, with plenty of water or other fluid. Swallow the tablet whole, do not break or chew it. Drink plenty of water to keep your kidneys working and prevent kidney stones while taking this medication.

To treat malaria, this medication is usually given as a single dose of 1/2 to 3 tablets. Follow your doctor’s instructions.

If you are taking this medicine to prevent malaria, start taking it 1 or 2 days before entering an area where malaria is common. Take the medication every day during your stay and for 4 to 6 weeks after you leave.

You should not take pyrimethamine and sulfadoxine for longer than 2 years without a doctor’s advice.

In addition to taking pyrimethamine and sulfadoxine, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

If you take this medication for longer than 3 months, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Contact your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.

Store pyrimethamine and sulfadoxine 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, wait until then to take the medicine and skip the missed dose. 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 nausea, vomiting, loss of appetite, fever, chills, sore throat, swollen tongue, or seizure (convulsions).

What should I avoid while taking pyrimethamine and sulfadoxine?

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds) while taking this medication.

Pyrimethamine and sulfadoxine 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 pyrimethamine and sulfadoxine and call your doctor at once if you have any of these serious side effects:

the first sign of any skin rash, no matter how mild;
a severe blistering, peeling, and red skin rash;
pale skin, easy bruising or bleeding;
feeling tired, weak, or dizzy;
hallucinations, seizure (convulsions);
urinating less than usual or not at all;
jaundice (yellowing of the skin or eyes); or
fever, chills, sore throat, swollen tongue, joint pain, cough, feeling short of breath.

Less serious side effects may include:

mild stomach pain, feeling full;
slight hair loss;
headache;
muscle weakness;
depression, nervousness;
ringing in your ears; or
sleep problems (insomnia).

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

Pyrimethamine and sulfadoxine Dosing Information

Usual Adult Dose for Malaria:

2 or 3 tablets taken orally as a single dose, following a 3 to 7 day course of quinine (650 mg every 8 hours).

Usual Adult Dose for Malaria Prophylaxis:

1 tablet orally every week beginning 1 or 2 days before departure to an endemic area; continue administration during the stay and for 4 to 6 weeks after returning.

Alternative: 2 tablets every 2 weeks beginning 1 or 2 days before departure to an endemic area; continue administration during the stay and for 4 to 6 weeks after returning.

Usual Adult Dose for Pneumocystis Pneumonia Prophylaxis:

1 tablet (25/500 mg) orally once or twice a week.

Pyrimethamine-sulfadoxine is generally not recommended for PCP prophylaxis unless trimethoprim-sulfamethoxazole, pentamidine, dapsone/pyrimethamine/leucovorin, atovaquone, or dapsone cannot be used.

Usual Pediatric Dose for Malaria:

>2 months:
5-10 kg: One-half tablet orally one time
11-20 kg: 1 tablet orally one time
21-30 kg: 1.5 tablet orally one time
31-45 kg: 2 tablets orally one time
>45 kg: 3 tablets orally one time

A 3 to 7-day course of quinine should precede the pyrimethamine-sulfadoxine dose.

Usual Pediatric Dose for Malaria Prophylaxis:

> 2 months:
5-10 kg: 1/4 (0.25) tablet orally once a week
11-20 kg: 1/2 (0.5) tablet orally once a week
21-30 kg: 3/4 (0.75) tablet orally once a week
31-45 kg: 1 tablet orally once a week
>45 kg: 1.5 tablet orally once a week

Begin 1 or 2 days before departure to an endemic area; continue administration during the stay and for 4 to 6 weeks after returning.

What other drugs will affect pyrimethamine and sulfadoxine?

Tell your doctor about any other anti-malaria medications you are taking.

The following drugs can interact with pyrimethamine and sulfadoxine. Tell your doctor if you are using any of these:

chloroquine (Aralen); or
sulfa drugs (Bactrim, Gantanol, Septra, and others);

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

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.

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pyridoxine (Oral route, Injection route)

30/06/10

pir-i-DOX-een

Commonly used brand name(s):

In the U.S.

Aminoxin
Pyri-500
Rodex
Vitabee 6

Available Dosage Forms:

Injectable
Solution
Tablet
Capsule
Tablet, Extended Release
Tablet, Enteric Coated

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin B

Uses For pyridoxine

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Pyridoxine (vitamin B 6) is necessary for normal breakdown of proteins, carbohydrates, and fats.

Some conditions may increase your need for pyridoxine. These include:

Alcoholism
Burns
Diarrhea
Dialysis
Heart disease
Intestinal problems
Liver disease
Overactive thyroid
Stress, long-term illness, or serious injury
Surgical removal of stomach

In addition, infants receiving unfortified formulas such as evaporated milk may need additional pyridoxine.

Increased need for pyridoxine should be determined by your health care professional.

Lack of pyridoxine may lead to anemia (weak blood), nerve damage, seizures, skin problems, and sores in the mouth. Your doctor may treat these problems by prescribing pyridoxine for you.

Claims that pyridoxine is effective for treatment of acne and other skin problems, alcohol intoxication, asthma, hemorrhoids, kidney stones, mental problems, migraine headaches, morning sickness, and menstrual problems, or to stimulate appetite or milk production have not been proven.

Injectable pyridoxine is given by or under the supervision of a health care professional. Other forms of pyridoxine are available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Pyridoxine is found in various foods, including meats, bananas, lima beans, egg yolks, peanuts, and whole-grain cereals. Pyridoxine is not lost from food during ordinary cooking, although some other forms of vitamin B 6 are.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of pyridoxine needed is defined in several different ways.

For U.S.—
Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person’s age, sex, and physical condition (e.g., pregnancy).
Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada—
Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for pyridoxine are generally defined as follows:

Infants and children—
- Birth to 3 years of age: 0.3 to 1 milligram (mg).
- 4 to 6 years of age: 1.1 mg.
- 7 to 10 years of age: 1.4 mg.
Adolescent and adult males—1.7 to 2 mg.
Adolescent and adult females—1.4 to 1.6 mg.
Pregnant females—2.2 mg.
Breast-feeding females—2.1 mg.

Before Using pyridoxine

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pyridoxine 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

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Breast Feeding

Interactions with Medicines

Using this dietary supplement 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.

Altretamine

Interactions with Food/Tobacco/Alcohol

Proper Use of pyridoxine

Dosing

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

For oral dosage forms (capsules, tablets, oral solution):
- To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
  - Adult and teenage males—1.7 to 2 milligrams (mg) per day.
  - Adult and teenage females—1.4 to 1.6 mg per day.
  - Pregnant females—2.2 mg per day.
  - Breast-feeding females—2.1 mg per day.
  - Children 7 to 10 years of age—1.4 mg per day.
  - Children 4 to 6 years of age—1.1 mg per day.
  - Children birth to 3 years of age—0.3 to 1 mg per day.
- To treat deficiency:
  - Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

To use the extended-release capsule form of this dietary supplement:

Swallow the capsule whole.
Do not crush, break, or chew before swallowing.
If the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

To use the extended-release tablet form of this dietary supplement:

Swallow the tablet whole.
Do not crush, break, or chew before swallowing.

Missed Dose

If you miss a dose of pyridoxine, 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.

pyridoxine 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:

With large doses

Clumsiness
numbness of hands or feet

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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Pyridoxine (Vitamin B6 Extended-Release Tablets

30/06/10

Generic Name: Pyridoxine (Vitamin B6 (peer-i-DOX-een)
Brand Name: Generic only. No brands available.

Pyridoxine (Vitamin B6 Extended-Release Tablets are used for:

Treating or preventing low levels of pyridoxine (vitamin B₆). It may also be used for other conditions as determined by your doctor.

Pyridoxine (Vitamin B6 Extended-Release Tablets are a vitamin. It works by increasing the blood levels of pyridoxine (vitamin B₆).

Do NOT use Pyridoxine (Vitamin B6 Extended-Release Tablets if:

you are allergic to any ingredient in Pyridoxine (Vitamin B6 Extended-Release Tablets

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

Before using Pyridoxine (Vitamin B6 Extended-Release Tablets:

Some medical conditions may interact with Pyridoxine (Vitamin B6 Extended-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

Some MEDICINES MAY INTERACT with Pyridoxine (Vitamin B6 Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Hydantoins (eg, phenytoin) or levodopa because effectiveness may be decreased by Pyridoxine (Vitamin B6 Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pyridoxine (Vitamin B6 Extended-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 Pyridoxine (Vitamin B6 Extended-Release Tablets:

Use Pyridoxine (Vitamin B6 Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Pyridoxine (Vitamin B6 Extended-Release Tablets may be taken with or without food.
Swallow Pyridoxine (Vitamin B6 Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
If you miss a dose of Pyridoxine (Vitamin B6 Extended-Release Tablets and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pyridoxine (Vitamin B6 Extended-Release Tablets.

Important safety information:

Pyridoxine (Vitamin B6 Extended-Release Tablets may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pyridoxine (Vitamin B6 Extended-Release Tablets. Using Pyridoxine (Vitamin B6 Extended-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Do not take large doses of vitamins (megadoses or megavitamin therapy) unless directed to by your doctor.
Pyridoxine (Vitamin B6 Extended-Release Tablets contains pyridoxine (vitamin B₆). Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pyridoxine. If it does or if you are uncertain, contact your doctor or pharmacist.
If you are taking 200 mg per day or more of Pyridoxine (Vitamin B6 Extended-Release Tablets regularly, do not suddenly stop taking Pyridoxine (Vitamin B6 Extended-Release Tablets without checking with your doctor.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pyridoxine (Vitamin B6 Extended-Release Tablets, discuss with your doctor the benefits and risks of using Pyridoxine (Vitamin B6 Extended-Release Tablets during pregnancy. Pyridoxine (Vitamin B6 Extended-Release Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Pyridoxine (Vitamin B6 Extended-Release Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pyridoxine (Vitamin B6 Extended-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); decreased sensation of touch, temperature, or vibration; loss of coordination; numbness of the feet or around the mouth; numbness or tingling of the skin.

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 loss of coordination; numbness of the hands and feet.

Proper storage of Pyridoxine (Vitamin B6 Extended-Release Tablets:

Store Pyridoxine (Vitamin B6 Extended-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pyridoxine (Vitamin B6 Extended-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Pyridoxine (Vitamin B6 Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Pyridoxine (Vitamin B6 Extended-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 Pyridoxine (Vitamin B6 Extended-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.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,P

Comments (0)

Pyridoxine (Vitamin B6)

30/06/10

Generic Name: Pyridoxine (Vitamin B6) (peer-i-DOX-een)
Brand Name: Generic only. No brands available.

Pyridoxine (Vitamin B6) is used for:

Treating or preventing low levels of pyridoxine (vitamin B₆). It may also be used for other conditions as determined by your doctor.

Pyridoxine (Vitamin B6) is a vitamin. It works by increasing the blood levels of pyridoxine (vitamin B₆).

Do NOT use Pyridoxine (Vitamin B6) if:

you are allergic to any ingredient in Pyridoxine (Vitamin B6)

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

Before using Pyridoxine (Vitamin B6):

Some medical conditions may interact with Pyridoxine (Vitamin B6). 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

Some MEDICINES MAY INTERACT with Pyridoxine (Vitamin B6). Tell your health care provider if you are taking any other medicines, especially any of the following:

Hydantoins (eg, phenytoin) or levodopa because effectiveness may be decreased by Pyridoxine (Vitamin B6).

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pyridoxine (Vitamin B6) 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 Pyridoxine (Vitamin B6):

Use Pyridoxine (Vitamin B6) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Pyridoxine (Vitamin B6) is usually administered as an injection at your doctor’s office, hospital, or clinic. If you are using Pyridoxine (Vitamin B6) at home, carefully follow the injection procedures taught to you by your health care provider.
If Pyridoxine (Vitamin B6) contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
If you miss a dose of Pyridoxine (Vitamin B6) and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pyridoxine (Vitamin B6).

Important safety information:

Pyridoxine (Vitamin B6) may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pyridoxine (Vitamin B6). Using Pyridoxine (Vitamin B6) alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Do not take large doses of vitamins (megadoses or megavitamin therapy) unless directed to by your doctor.
Pyridoxine (Vitamin B6) contains pyridoxine (vitamin B₆). Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pyridoxine. If it does or if you are uncertain, contact your doctor or pharmacist.
If you are using 200 mg per day or more of Pyridoxine (Vitamin B6) regularly, do not suddenly stop taking Pyridoxine (Vitamin B6) without checking with your doctor.
Use Pyridoxine (Vitamin B6) with extreme caution in CHILDREN. Safety and effectiveness has not been established.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pyridoxine (Vitamin B6), discuss with your doctor the benefits and risks of using Pyridoxine (Vitamin B6) during pregnancy. Pyridoxine (Vitamin B6) is excreted in breast milk. If you are or will be breast-feeding while you are using Pyridoxine (Vitamin B6), check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pyridoxine (Vitamin B6):

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sensation of touch, temperature, or vibration; loss of coordination; numbness of the feet or around the mouth; numbness or tingling of the skin.

If OVERDOSE is suspected:

Proper storage of Pyridoxine (Vitamin B6):

Store Pyridoxine (Vitamin B6) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pyridoxine (Vitamin B6) out of the reach of children and away from pets.

General information:

If you have any questions about Pyridoxine (Vitamin B6), please talk with your doctor, pharmacist, or other health care provider.
Pyridoxine (Vitamin B6) 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 Pyridoxine (Vitamin B6). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,P

Comments (0)

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