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Friday, 16 March 2012

griseofulvin

gris-ee-oh-FUL-vin

Commonly used brand name(s)

In the U.S.

Fulvicin P/G

Fulvicin-U/F

Grifulvin V

Gris-PEG

Available Dosage Forms:

Tablet

Capsule

Suspension

Therapeutic Class: Antifungal

Uses For griseofulvin

Griseofulvin belongs to the group of medicines called antifungals. It is used to treat fungus infections of the body, feet, groin and thighs, scalp, skin, fingernails, and toenails. griseofulvin may be taken alone or used along with medicines that are applied to the skin for fungus infections.

Use of griseofulvin for prevention of fungus infection have not been established.

griseofulvin is available only with your doctor's prescription.

Before Using griseofulvin

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 griseofulvin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to griseofulvin 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of griseofulvin in children. However, safety and efficacy have not been established in children up to 2 years of age.

Geriatric

No information is available on the relationship of age to the effects of griseofulvin in geriatric patients.

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. When you are taking griseofulvin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using griseofulvin 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.

Desogestrel

Dienogest

Drospirenone

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Levonorgestrel

Medroxyprogesterone Acetate

Mestranol

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Phenobarbital

Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using griseofulvin 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 griseofulvin, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of griseofulvin

Keep using griseofulvin for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Keep yourself clean to help control infection and prevent reinfection.

Griseofulvin is absorbed best when it is taken with a high fat meal, such as a cheeseburger, whole milk, or ice cream. Tell your doctor if you are on a low-fat diet.

Griseofulvin is best taken with or after meals, especially fatty ones (e.g., whole milk or ice cream). This lessens possible stomach upset and helps to clear up the infection by helping your body absorb the medicine better. However, if you are on a low-fat diet, check with your doctor.

For patients taking the oral liquid:

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

You may swallow the tablets whole or sprinkle the crushed tablets in one tablespoonful of applesauce. Swallow it immediately without chewing.

Dosing

The dose of griseofulvin 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 griseofulvin. 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 forms (microsize capsules, tablets, or suspension):
- Treatment of fungus infections of the feet and nails:
  - Adults and teenagers—500 milligrams (mg) every 12 hours.
  - Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 5 milligrams (mg) per kilogram (kg) (2.3 mg per pound) of body weight every 12 hours, or 10 milligrams (mg) per kilogram (kg) (4.6 mg per pound) of body weight once a day.
- Treatment of fungus infections of the scalp, skin, and groin:
  - Adults and teenagers—250 milligrams (mg) every 12 hours or 500 mg once a day.
  - Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 5 milligrams (mg) per kilogram (kg) (2.3 mg per pound) of body weight every 12 hours, or 10 milligrams (mg) per kilogram (kg) (4.6 mg per pound) of body weight once a day.

For oral dosage form (ultramicrosize tablets):
- Treatment of fungus infections:
  - Adults—375 milligrams (mg) per day, taken as a single dose or divided in small doses. Some patients may need 750 mg divided in small doses.
  - Children 3 years of age and older weighing over 60 pounds—Dose is based on body weight and must be determined by your doctor. The usual dose is 187.5 to 375 mg per day.
  - Children 3 years of age and older weighing 35 to 60 pounds—Dose is based on body weight and must be determined by your doctor. The usual dose is 125 to 187.5 mg per day.
  - Children up to 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of griseofulvin, 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 griseofulvin

It is very important that your doctor should check the progress of you or your child at regular visits to make sure that griseofulvin is working properly and to check for unwanted effects.

If your symptoms do not improve, or if they become worse, check with your doctor. You may need to take griseofulvin for several weeks or months before your infection gets better.

Using griseofulvin while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using griseofulvin.

Serious skin reactions can occur with griseofulvin. Stop using griseofulvin and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using griseofulvin.

Stop using griseofulvin and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Griseofulvin has been shown to cause liver and thyroid tumors in some animals. You and your doctor should discuss the good griseofulvin will do, as well as the risks of taking it.

Birth control pills containing estrogen may not work properly if you take them while you are taking griseofulvin. Unplanned pregnancies may occur. To keep from getting pregnant, use another form of birth control for up to 1 month after your last treatment. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Griseofulvin may increase the effects of alcohol. If taken with alcohol it may also cause fast heartbeat, flushing, increased sweating, or redness of the face. If you have these symptoms, do not drink alcoholic beverages while you are taking griseofulvin, unless you have checked first with your doctor.

griseofulvin may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to griseofulvin before you drive, use machines, or do other things that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Griseofulvin may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking griseofulvin:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

Wear protective clothing, including a hat. Also, wear sunglasses.

Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.

Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.

Do not use a sunlamp or tanning bed or booth.

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

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.

griseofulvin 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

Blistering, peeling, or loosening of the skin

chills

cough

diarrhea

fever

itching

joint or muscle pain

red, irritated eyes

sore throat

sores, ulcers, or white spots in the mouth or on the lips

unusual tiredness or weakness

Less common

Confusion

increased sensitivity of the skin to sunlight

skin rash, hives, or itching

soreness or irritation of the mouth or tongue

Rare

Black, tarry stools

chest pain

cloudy urine

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

numbness, tingling, pain, or weakness in the hands or feet

painful or difficult urination

shortness of breath

swollen glands

unusual bleeding or bruising

yellow eyes or skin

Incidence not known

Abdominal or stomach pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

clay-colored stools

dark urine

dizziness

headache

loss of appetite

nausea

unpleasant breath odor

vomiting of blood

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

Hives or welts

redness of the skin

Less common

Trouble with sleeping

Incidence not known

Heartburn

pain or discomfort in the chest, upper stomach, or throat

sleeplessness

unable to sleep

white patches in the mouth or throat or on the tongue

white patches with diaper rash

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.

See also: griseofulvin side effects (in more detail)

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.

More griseofulvin resources

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

griseofulvin Concise Consumer Information (Cerner Multum)

Griseofulvin Professional Patient Advice (Wolters Kluwer)

Griseofulvin Prescribing Information (FDA)

Griseofulvin Monograph (AHFS DI)

Griseofulvin Microsize Oral Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Gris-PEG Prescribing Information (FDA)

Gris-PEG Ultramicrosize Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Grisactin 250 Concise Consumer Information (Cerner Multum)

Compare griseofulvin with other medications

Dermatophytosis
Onychomycosis, Fingernail
Onychomycosis, Toenail
Tinea Barbae
Tinea Capitis
Tinea Corporis
Tinea Cruris
Tinea Pedis

abacavir and lamivudine

a-BAK-a-vir SUL-fate, la-MIV-ue-deen

Oral route(Tablet)

Fatal hypersensitivity reactions have been reported with abacavir sulfate; discontinue if hypersensitivity reaction suspected and do not restart. Patients with HLA-B*5701 allele are at high risk for hypersensitivity to abacavir sulfate; screening for allele is recommended prior to initiating or reinitiation of therapy. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues alone or in combination with other antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients co-infected with HBV and HIV who have discontinued lamivudine; monitor hepatic function upon discontinuation of therapy .

Commonly used brand name(s)

In the U.S.

Epzicom

Available Dosage Forms:

Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Abacavir

Uses For abacavir and lamivudine

Abacavir and lamivudine combination is used together with other medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Abacavir and lamivudine combination will not cure or prevent HIV infection or the symptoms of AIDS. abacavir and lamivudine helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Abacavir and lamivudine combination will not keep you from spreading HIV to other people. People who receive abacavir and lamivudine may continue to have other problems usually related to AIDS or HIV infection.

abacavir and lamivudine is available only with your doctor's prescription.

Before Using abacavir and lamivudine

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 abacavir and lamivudine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to abacavir and lamivudine 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 abacavir and lamivudine combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abacavir and lamivudine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving abacavir and lamivudine.

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

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. When you are taking abacavir and lamivudine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using abacavir and lamivudine 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.

Interferon Alfa

Ribavirin

Zalcitabine

Using abacavir and lamivudine 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.

Methadone

Tipranavir

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 abacavir and lamivudine

Take abacavir and lamivudine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not start or stop taking abacavir and lamivudine without checking first with your doctor.

abacavir and lamivudine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When your supply of abacavir and lamivudine runs low, get more from your pharmacy or from your doctor. The amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to abacavir and lamivudine and be harder to treat.

abacavir and lamivudine will be given together with other medicines for HIV infection. Take all of the medicines your doctor gives you at the right time of day. These medicines work best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicines, check with your doctor.

Abacavir and lamivudine combination contains a fixed amount of each medicine in the tablet.

abacavir and lamivudine can be taken with or without food.

Dosing

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

For oral dosage form (tablets):
- For HIV infection:
  - Adults—600 milligrams (mg) of abacavir and 300 mg of lamivudine (equal to one tablet) once a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of abacavir and lamivudine, 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 abacavir and lamivudine

It is very important that your doctor check your progress at regular visits to make sure abacavir and lamivudine is working properly. Blood tests may be needed to check for unwanted effects.

abacavir and lamivudine may cause a severe allergic reaction in some patients. This reaction usually occurs within 6 weeks after the medicine is started, but may occur at any time. If untreated, it can lead to severe low blood pressure and even death. Stop taking abacavir and lamivudine and check with your doctor immediately if you notice sudden fever, skin rash, diarrhea, nausea, stomach pain, vomiting, or a feeling of unusual tiredness or illness, cough, shortness of breath, or sore throat.

When you begin taking abacavir and lamivudine, you will be given a warning card which describes symptoms of severe allergic reactions that may be caused by abacavir and lamivudine combination. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.

If you must stop using abacavir because of an allergic reaction, you should never use the medicine again. Return the unused medicine to your doctor or pharmacist. A worse reaction, possibly even death, can occur if you use the medicine again. Tell your doctor right away if you have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past.

Two rare but serious reactions to abacavir and lamivudine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort or cramping; dark urine; decreased appetite; diarrhea; general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.

When you start taking HIV medicines, your immune system may get stronger. If you have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.

abacavir and lamivudine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex such as using latex condoms, even if your partner also has HIV. Do not share needles, toothbrushes, and razor blades with anyone.

abacavir and lamivudine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.

abacavir and lamivudine may increase your risk of having a heart attack. This is more likely to occur if you already have heart disease, high blood pressure, high cholesterol or fats in the blood, or if you smoke.

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.

abacavir and lamivudine 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

Hypersensitivity reaction, including abdominal or stomach pain; cough; diarrhea; fever; headache; nausea; numbness or tingling of the face, feet, or hands; pain in the joints; pain in the muscles; shortness of breath; skin rash; sore throat; swelling of the feet or lower legs; unusual feeling of discomfort or illness; unusual tiredness or weakness; or vomiting

Incidence not known

Blistering, peeling, or loosening of the skin

bloating

burning, numbness, tingling, or painful sensations

chest pain

chills

constipation

convulsions

dark urine

decreased appetite

diarrhea

difficulty with swallowing

dizziness

fast heartbeat

fast, shallow breathing

feeling of fullness

general feeling of discomfort

hives or welts

indigestion

itching

light-colored stools

loss of appetite

loss of bladder control

muscle cramping

muscle spasm or jerking of all extremities

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

redness of the skin

red skin lesions, often with a purple center

sleepiness

sores, ulcers, or white spots on the lips or in the mouth

sudden loss of consciousness

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tightness in the chest

troubled breathing with exertion

unsteadiness or awkwardness

unusual bleeding or bruising

upper right abdominal or stomach pain

weakness in the arms, hands, legs, or feet

wheezing

yellow eyes and skin

More common

Abnormal dreams

burning feeling in the chest or stomach

fear

feeling of constant movement of self or surroundings

lightheadedness

nervousness

sensation of spinning

severe and throbbing headache

sleeplessness

stomach upset

tenderness in the stomach area

trouble with sleeping

unable to sleep

Incidence not known

Abnormal breathing sounds

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

dry mouth

flushed, dry skin

fruit-like breath odor

gaining weight around your neck, upper back, breast, face, or waist

hair loss

increased hunger

increased thirst

increased urination

muscle weakness

sweating

swelling or inflammation of the mouth

thinning of the hair

unexplained weight loss

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.

See also: abacavir and lamivudine side effects (in more detail)

More abacavir and lamivudine resources

Abacavir and lamivudine Side Effects (in more detail)
Abacavir and lamivudine Dosage
Abacavir and lamivudine Use in Pregnancy & Breastfeeding
Abacavir and lamivudine Drug Interactions
Abacavir and lamivudine Support Group
1 Review for Abacavir and lamivudine - Add your own review/rating

Compare abacavir and lamivudine with other medications

HIV Infection
Nonoccupational Exposure

Thursday, 15 March 2012

Nasabid SR

Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, SOO doe ee FED rin)

Brand Names: Altarussin PE, Ambifed, Ambifed-G, Biotuss PE, Congestac, D-Feda II, Despec-SR, Dynex, Entex PSE, ExeFen, ExeFen-IR, Guiatex II SR, Levall G, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Mucinex D Max Strength, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Respaire-30, Respaire-60 SR, Robitussin PE, Robitussin Severe Congestion, Ru-Tuss Jr., Sinutab Non Drying, Stamoist E, SudaTex-G, Tenar PSE, Touro LA, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA

What is Nasabid SR (guaifenesin and pseudoephedrine)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

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

The combination of guaifenesin and pseudoephedrine is used to treat stuffy nose, sinus congestion, and cough caused by allergies or the common cold.

Guaifenesin and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Nasabid SR (guaifenesin and pseudoephedrine)?

Do not give this medication to a child younger than 4 years old. Alwayss 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 furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

What should I discuss with my healthcare provider before taking Nasabid SR (guaifenesin and pseudoephedrine)?

You should not use this medication if you are allergic to guaifenesin or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

heart disease or high blood pressure;

diabetes; or

a thyroid disorder.

It is not known whether guaifenesin and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Guaifenesin and pseudoephedrine may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Nasabid SR (guaifenesin and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough and cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. 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 crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-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.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take with food if this medicine upsets your stomach. Do not take guaifenesin and pseudoephedrine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

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

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

What happens if I miss a dose?

Since cough or cold medicine is taken when 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.

What should I avoid while taking Nasabid SR (guaifenesin and pseudoephedrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and pseudoephedrine.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

Nasabid SR (guaifenesin and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

fast, pounding, or uneven heartbeat;

severe dizziness, anxiety, or nervousness;

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

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

Less serious side effects may include:

dizziness or headache;

feeling restless or excited;

sleep problems (insomnia);

mild nausea, vomiting, or stomach upset;

mild loss of appetite;

warmth, redness, or tingly feeling under your skin; or

skin rash or itching.

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

What other drugs will affect Nasabid SR (guaifenesin and pseudoephedrine)?

Tell your doctor about all other medicines you use, especially:

methyldopa (Aldomet);

blood pressure medications;

a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

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

This list is not complete and other drugs may interact with guaifenesin and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Nasabid SR resources

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

Congestac MedFacts Consumer Leaflet (Wolters Kluwer)

Entex PSE Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Mucinex D Prescribing Information (FDA)

Mucinex D Consumer Overview

Pseudovent Consumer Overview

Robitussin Severe Congestion MedFacts Consumer Leaflet (Wolters Kluwer)

Zephrex LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Nasabid SR with other medications

Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about guaifenesin and pseudoephedrine.

See also: Nasabid SR side effects (in more detail)

Wednesday, 14 March 2012

Fulvestrant

Class: Antineoplastic Agents
VA Class: AN500
Chemical Name: 4′ - [2 - [[(2aE,4E,5′S,6S,6′R,7R,8E,11R,13R,15S,17aR,20R,20aR,20bS) - 6′ - Ethyl - 3′,4′,5′,6,6′,7,10,11,14,15,17a,20,20a,20b - tetradecahydro - 20,20b - dihydroxy - 5′,6,8,19 - furo[4,3,2 - pq][2,6]benzodioxacyclooctadecin - 13,2′[2H]pyran] - 7 - yl]oxy]ethyl] - N - methylmethanesulfonanilide
Molecular Formula: C₃₂H₄₇F₅O₃S
CAS Number: 129453-61-8
Brands: Faslodex

Introduction

Antineoplastic agent; estrogen antagonist.¹ ²

Uses for Fulvestrant

Breast Cancer

Treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen (e.g., tamoxifen) therapy.¹ ² ⁴

Efficacy in premenopausal women (e.g., those with functioning ovaries, as evidenced by menstruation and/or premenopausal LH, FSH, and estradiol concentrations) with advanced breast cancer not established.¹

Fulvestrant Dosage and Administration

General

Commercially available as one 5-mL prefilled syringe containing 250 mg (5 mL) of fulvestrant or two 5-mL prefilled syringes, each containing 125 mg (2.5 mL) of fulvestrant (total dose of 250 mg), with safety needles.¹ ⁴

Consult manufacturer’s prescribing information for details on assembly and proper use of safety needle.¹

Administration

IM Administration

Administer IM slowly at the dorsogluteal site or into the upper outer quadrant of the gluteal muscle.¹ ³ Administer as a single 5-mL injection or 2 concurrent 2.5-mL injections, which may be administered bilaterally.¹

Prior to administration, remove injection from refrigeration and keep at room temperature for up to 1 hour or roll gently between the hands.³ ⁴

Dosage

Adults

Breast Cancer

IM

250 mg once monthly.¹ ² ³

Special Populations

Hepatic Impairment

Dosage adjustments not required in patients with mild hepatic impairment.¹ Safety and efficacy not established in patients with moderate to severe hepatic impairment.¹

Geriatric Patients

Dosage adjustments not required.¹

Cautions for Fulvestrant

Contraindications

Known or suspected pregnancy.¹

Known hypersensitivity to fulvestrant, benzyl alcohol, or any ingredient in the formulation.¹ ⁴

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm;¹ teratogenicity and embryolethality demonstrated in animals.¹

Excluded pregnancy prior to administering the first dose of fulvestrant, and avoid pregnancy during therapy.¹ If used during pregnancy or patient becomes pregnant, apprise of potential hazard to the fetus or potential risk for loss of the pregnancy.¹

Hematologic Disorders

Use not recommended in patients with bleeding diatheses or thrombocytopenia or in those receiving anticoagulant therapy because of IM administration.¹

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Distributed into milk in rats; not known whether fulvestrant is distributed into human milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established.¹

Geriatric Use

Slightly lower objective response rates in patients ≥65 years of age than in younger adults.¹ No substantial difference in pharmacokinetics relative to younger adults.¹

Hepatic Impairment

No substantial differences in safety or pharmacokinetics in patients with mild hepatic impairment relative to patients with normal hepatic function.¹ Safety and efficacy not established in patients with moderate to severe hepatic impairment.¹

Renal Impairment

Not studied in patients with renal impairment; however plasma fulvestrant concentrations in women with creatinine clearances of ≥30 mL/minute were similar to those in women with normal renal function.¹

Common Adverse Effects

Adverse GI effects¹ ² (e.g., nausea,¹ ⁵ ⁶ vomiting,¹ ⁵ ⁶ constipation,¹ ⁵ ⁶ diarrhea,¹ ⁵ ⁶ abdominal pain¹ ⁵ ⁶ ), headache,¹ ⁵ ⁶ pain (e.g., back pain),¹ ⁵ asthenia,¹ vasodilation (hot flushes),¹ ² ⁵ ⁶ pharyngitis¹ ⁵ ⁶ .

Interactions for Fulvestrant

Metabolized by CYP3A4 and non-CYP routes.¹

Does not inhibit CYP1A2, 2C9, 2C19, 2D6, or 3A4 in vitro.¹

Drugs Affecting Hepatic Microsomal Enzymes

Inducers of CYP: pharmacokinetic interactions unlikely.¹

Specific Drugs

Drug	Interaction	Comments
Midazolam	Pharmacokinetc interactions unlikely¹
Rifampin	Pharmacokinetc interactions unlikely¹

Fulvestrant Pharmacokinetics

Absorption

Bioavailability

Following IM administration, peak plasma concentrations are attained at about 7 days and are maintained over a period of at least one month.¹ Following IM injection of 250 mg once every month, steady-state plasma concentrations are attained after 3–6 doses.¹

Distribution

Extent

Extensively and rapidly distributed, principally into the extravascular space.¹

Has been shown to cross the placenta and distribute into milk in rats.¹

Plasma Protein Binding

99% (mainly VLDL, LDL, and HDL lipoprotein fractions).¹

Elimination

Metabolism

Metabolized mainly in the liver.¹ Fulvestrant metabolism appears to involve combinations of a number of possible biotransformation pathways analogous to those of endogenous steroids.¹ Identified metabolites are either less active or exhibit similar activity to fulvestrant in antiestrogen models.¹

In vitro studies indicate that CYP3A4 is the only enzyme involved in fulvestrant oxidation; however, the relative contribution of CYP and non-CYP routes in vivo currently is not known.¹

Elimination Route

Rapidly cleared by the hepatobiliary route with excretion primarily via feces (approximately 90%); renal elimination is negligible (<1%).¹

Half-life

Approximately 40 days.¹

Stability

Storage

Parenteral

Injection

Refrigerate at 2–8°C.¹ Protect from light; store in original carton until time of use.^a

ActionsActions

An estrogen antagonist; a 7α-alkylsulfinyl analog of estradiol.¹ ²

Does not possess estrogen-agonist activity.¹

Competitively binds to and down-regulates estrogen receptors in human breast cancer cells.¹ ²

Inhibits the growth of tamoxifen-resistant as well as estrogen-sensitive human breast cancer (MCF-7) cell lines in vitro and in vivo.¹ ²

May block the uterotropic action of estradiol.¹ ²

Does not exhibit peripheral steroidal effects in postmenopausal women.¹

Advice to Patients

Necessity of advising women to use an effective method of contraception while receiving therapy.⁴ Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed.¹ Advise pregnant women of risk to the fetus.¹

Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses.¹

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Fulvestrant
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IM use only	50 mg/mL (125 and 250 mg)	Faslodex (with alcohol, benzyl alcohol, and castor oil; 2.5-mL or 5-mL prefilled disposable syringe)	AstraZeneca

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2004. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. AstraZeneca. Faslodex (fulvestrant) injection prescribing information. Wilmington, DE; 2002 Apr.

2. Curran M, Wiseman L. Fulvestrant. Drugs. 2001; 61:807-13. [PubMed 11398912]

3. Anon. Administration for Faslodex a monthly IM injection. From Faslodex website ()

4. AstraZeneca, Wilmington, DE: personal communication

5. Osborne CK, Pippen J, Jones SE et al. Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol. 2002;20:3386-95

6. Howell A, Robertson JFR, Albano JQ et al. Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol. 2002;20:3396-403

a. AstraZeneca. Faslodex (fulvestrant) injection prescribing information. Wilmington, DE; 2002 Jul.

More Fulvestrant resources

Fulvestrant Side Effects (in more detail)
Fulvestrant Use in Pregnancy & Breastfeeding
Fulvestrant Support Group
3 Reviews for Fulvestrant - Add your own review/rating

Fulvestrant MedFacts Consumer Leaflet (Wolters Kluwer)

Fulvestrant Professional Patient Advice (Wolters Kluwer)

fulvestrant Intramuscular Advanced Consumer (Micromedex) - Includes Dosage Information

Faslodex Prescribing Information (FDA)

Faslodex Consumer Overview

Compare Fulvestrant with other medications

Breast Cancer
Breast Cancer, Metastatic

Tuesday, 13 March 2012

galantamine

ga-LAN-ta-meen

Commonly used brand name(s)

In the U.S.

Razadyne

Razadyne ER

Razadyne IR

Available Dosage Forms:

Tablet

Capsule, Extended Release

Solution

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Cholinesterase Inhibitor, Centrally/Peripherally Acting

Uses For galantamine

Galantamine is used to treat the symptoms of mild to moderate Alzheimer's disease. Galantamine will not cure Alzheimer's disease, and it will not stop the disease from getting worse. However, galantamine can improve thinking ability in some patients with Alzheimer's disease

In Alzheimer's disease, many chemical changes take place in the brain. One of the earliest and biggest changes is that there is less of a chemical called acetylcholine (ACh). ACh helps the brain to work properly. Galantamine slows the breakdown of ACh, so it can build up and have a greater effect. However, as Alzheimer's disease gets worse, there will be less and less ACh, so galantamine may not work as well.

galantamine is available only with your doctor's prescription.

Before Using galantamine

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 galantamine, the following should be considered:

Allergies

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

Studies on galantamine have been done only in adult patients, and there is no specific information comparing use of galantamine in children with use in other age groups. Use in children is not recommended.

Geriatric

Galantamine levels are higher in older adults than in healthy young subjects.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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. When you are taking galantamine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using galantamine 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.

Amitriptyline

Fluoxetine

Fluvoxamine

Ketoconazole

Oxybutynin

Paroxetine

Quinidine

Tolterodine

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 galantamine

Dosing

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

If you are taking the tablets or oral solution: Take galantamine with your morning and evening meals.

If you are taking the extended-release capsules: Take galantamine with your morning meal.

Follow the instruction sheet for the proper dosing of the oral solution and ask your doctor or pharmacist if you have any questions.

Make sure that you are drinking plenty of fluids while you are taking galantamine.

For oral dosage forms (oral solution and tablets):
- For treatment of Alzheimer's disease:
  - Adults—To start, take 4 mg (milligrams) two times a day. Your doctor may increase your dose gradually if you are doing well on galantamine.

For long acting oral dosage forms (extended-release capsules):
- For treatment of Alzheimer's disease:
  - Adults—To start, take 8 mg one time a day. Your doctor may increase your dose gradually if you are doing well on galantamine.

Missed Dose

If you miss a dose of galantamine, 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.

Do not take your morning and evening doses close together.

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 galantamine

It is very important that your doctor check you at regular visits.

Tell your doctor if your symptoms get worse, or if you notice any new symptoms.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Galantamine causes a large number of patients to have problems with their stomachs and intestines. Tell your doctor about any nausea, vomiting, diarrhea, stomach pain or loss of appetite.

If you think you or someone else may have taken an overdose of galantamine, get emergency help at once. Taking an overdose of galantamine may lead to convulsions (seizures) or shock. Some signs of shock are large pupils, irregular breathing, and fast weak pulse. Other signs of an overdose are severe nausea and vomiting, increasing muscle weakness, greatly increased sweating, and greatly increased watering of the mouth.

galantamine 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

Chest pain or discomfort

Shortness of breath

Incidence not known

Attack, assault, force

bloody or black, tarry stools

confusion

constipation

convulsions

decreased urination

dry mouth

increase in heart rate

increased thirst

irregular heartbeat

mood changes

muscle pain or cramps

numbness or tingling in hands, feet, or lips

rapid breathing

severe stomach pain

sunken eyes

vomiting of blood or material that looks like coffee grounds

wrinkled skin

Symptoms of overdose

Cramping

defecation or urination, uncontrolled

dizziness

drooling

fainting

increased sweating

low blood pressure

muscle weakness

seizures

slow heart beat

severe nausea or vomiting

slow or troubled breathing

tearing of the eyes

watering of the mouth

More common

Bladder pain

bloody or cloudy urine

diarrhea

difficult, burning, or painful urination

discouragement

feeling sad or empty

frequent urge to urinate

irritability

loss of appetite

loss of interest or pleasure

lower back or side pain

nausea

tiredness

trouble concentrating

vomiting

weight loss

Less common

Abdominal pain

pale skin

troubled breathing with activity

slow or irregular heartbeat (less than 50 beats per minute)

light-headedness

dizziness or fainting

unusual tiredness or weakness

indigestion

headache

blood in urine

lower back pain

pain or burning while urinating

trouble sleeping

unable to sleep

sleepiness

sleeplessness

stuffy nose

unusual bleeding or bruising

unusual drowsiness

high or low blood pressure

tremor

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.

See also: galantamine side effects (in more detail)

More galantamine resources

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

galantamine Concise Consumer Information (Cerner Multum)

Galantamine MedFacts Consumer Leaflet (Wolters Kluwer)

Galantamine Prescribing Information (FDA)

Galantamine Hydrobromide Monograph (AHFS DI)

Razadyne Prescribing Information (FDA)

Razadyne ER Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare galantamine with other medications

Alzheimer's Disease

Prevident 5000 Dry Mouth

sodium fluoride

Dosage Form: gel, dentifrice
Colgate®

PreviDent®5000ppm

DRY MOUTH1 Rx ONLY

1.1% Sodium Fluoride

Prescription Strength Toothpaste

1: Formulated for Dry Mouth Sufferers

Prevident 5000 Dry Mouth Description

Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride for use as a dental caries preventative in adults and pediatric patients.

Active Ingredient

Sodium fluoride 1.1% (w/w)

Inactive Ingredients

water, sorbitol, hydrated silica, propylene glycol, glycerin, PEG-40 hydrogenated castor oil, dipotassium phosphate, poloxamer 407, flavor, PVM/MA copolymer, xanthan gum, sodium benzoate, sodium hydroxide, sodium saccharin, cocamidopropyl betaine, cetylpyridinium chloride, potassium sorbate, pectin, FD&C blue no. 1

Prevident 5000 Dry Mouth - Clinical Pharmacology

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

Indications and Usage for Prevident 5000 Dry Mouth

A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Contraindications

Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Warnings

Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of reach of infants and children.

Precautions

General

Not for systemic treatment. DO NOT SWALLOW.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.

Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.

Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Pregnancy

Teratogenic Effects

Pregnancy Category B

It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers

It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

Pediatric Use

The use of PreviDent® 5000 Dry Mouth in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11 to 14 years conducted by Englander et al. 2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

Geriatric Use

Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5

Adverse Reactions

Allergic reactions and other idiosyncrasies have been rarely reported.

Overdosage

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of PreviDent® 5000 Dry Mouth contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 610 mg fluoride.

Prevident 5000 Dry Mouth Dosage and Administration

Follow these instructions unless otherwise instructed by your dental professional:

Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 Dry Mouth to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste.

After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, ages 6-16 years, expectorate after use and rinse mouth thoroughly.

How is Prevident 5000 Dry Mouth Supplied

3.4 FL OZ (100 mL) in plastic bottles. Soothing Mint: NDC 0126-0016-61

STORAGE

Store at Controlled Room Temperature, 68-77°F (20-25°C)

REFERENCES

American Dental Association, Accepted Dental Therapeutics Ed. 40 (Chicago, 1984): 405-407.

H.R. Englander et al., JADA 75 (1967): 638-644.

H.R. Englander et al., JADA 78 (1969): 783-787.

H.R. Englander et al., JADA 83 (1971): 354-358.

Data on file, Colgate Oral Pharmaceuticals.

Questions? Comments? Please Call 1-800-962-2345

www.colgateprofessional.com

Colgate Oral Pharmaceuticals, Inc.

a subsidiary of Colgate-Palmolive Company

New York, NY 10022 U.S.A.

Rev. 11/08 P10001050

PRINCIPAL DISPLAY PANEL - 100 mL Bottle

NDC 0126-0016-61

Colgate®

PreviDent®

5000ppm

DRY MOUTH*

1.1% Sodium Fluoride

*Formulated for Dry Mouth Sufferers

PRESCRIPTION STRENGTH

TOOTHPASTE

SLS Free Formula

SOOTHING MINT

3.4 FL OZ (100 mL)

Rx ONLY

PREVIDENT 5000 DRY MOUTH
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0126-0016
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (fluoride ion)	Sodium fluoride	13.5 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0126-0016-61	100 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		07/06/2009

Labeler - Colgate-Palmolive Company (055002195)

Revised: 07/2009Colgate-Palmolive Company

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Prevention of Dental Caries

Sunday, 11 March 2012

M-END DMX Liquid

Pronunciation: SOO-doe-e-FED-rin/DEX-brome-fen-IR-a-meen/DEX-troe-meth-OR-fan
Generic Name: Pseudoephedrine/Dexbrompheniramine/Dextromethorphan
Brand Name: M-END DMX

M-END DMX Liquid is used for:

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

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

Do NOT use M-END DMX Liquid if:

you are allergic to any ingredient in M-END DMX Liquid

you have severe or uncontrolled high blood pressure, severe heart blood vessel disease, fast heartbeat, or severe heart problems

you are unable to urinate or are having an asthma attack

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

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

Before using M-END DMX Liquid:

Some medical conditions may interact with M-END DMX Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, thyroid problems, or trouble sleeping

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

if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; trouble urinating; or an enlarged prostate or other prostate problems

if you take medicine for high blood pressure

MEDICINES MAY INTERACT with M-END DMX Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Abiraterone, beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of M-END DMX Liquids side effects

Bromocriptine or hydantoins (eg, phenytoin) because their side effects may be increased by M-END DMX Liquid

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by M-END DMX Liquid

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

How to use M-END DMX Liquid:

Use M-END DMX Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

M-END DMX Liquid may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

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 M-END DMX Liquid and you are taking it regularly, 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 M-END DMX Liquid.

Important safety information:

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

Do not drink alcohol while you are using M-END DMX Liquid.

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

Do not take diet or appetite control medicines while you are taking M-END DMX Liquid without checking with your doctor.

M-END DMX Liquid has a decongestant, antihistamine, or cough suppressant in it. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do not use M-END DMX Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, or smoking). However, you may use it for these conditions if your doctor tells you to.

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

If new symptoms occur, or if cough or nasal congestion persists for more than 1 week, gets worse or returns, or occurs along with a fever, rash, or persistent headache, check with your doctor. A persistent cough may be a sign of a serious condition.

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

M-END DMX Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking M-END DMX Liquid for a few days before the tests.

Tell your doctor or dentist that you take M-END DMX Liquid before you receive any medical or dental care, emergency care, or surgery.

Use M-END DMX Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.

Caution is advised when using M-END DMX Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.

M-END DMX Liquid should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.

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

Possible side effects of M-END DMX Liquid:

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

Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression, nervousness); seizures; severe or persistent dizziness, drowsiness, light-headedness, or headache; severe dryness of mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).

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

See also: M-END DMX side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of M-END DMX Liquid:

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

General information:

If you have any questions about M-END DMX Liquid, please talk with your doctor, pharmacist, or other health care provider.

M-END DMX Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

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M-END DMX Use in Pregnancy & Breastfeeding
M-END DMX Drug Interactions
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Cough and Nasal Congestion

Friday, 16 March 2012

griseofulvin

Commonly used brand name(s)

Uses For griseofulvin

Before Using griseofulvin

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of griseofulvin

Dosing

Missed Dose

Storage

Precautions While Using griseofulvin

griseofulvin Side Effects

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abacavir and lamivudine

Commonly used brand name(s)

Uses For abacavir and lamivudine

Before Using abacavir and lamivudine

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of abacavir and lamivudine

Dosing

Missed Dose

Storage

Precautions While Using abacavir and lamivudine

abacavir and lamivudine Side Effects

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Thursday, 15 March 2012

Nasabid SR

What is Nasabid SR (guaifenesin and pseudoephedrine)?

What is the most important information I should know about Nasabid SR (guaifenesin and pseudoephedrine)?

What should I discuss with my healthcare provider before taking Nasabid SR (guaifenesin and pseudoephedrine)?

How should I take Nasabid SR (guaifenesin and pseudoephedrine)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Nasabid SR (guaifenesin and pseudoephedrine)?

Nasabid SR (guaifenesin and pseudoephedrine) side effects

What other drugs will affect Nasabid SR (guaifenesin and pseudoephedrine)?

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Where can I get more information?

Wednesday, 14 March 2012

Fulvestrant

Introduction

Uses for Fulvestrant

Breast Cancer

Fulvestrant Dosage and Administration

General

Administration

IM Administration

Dosage

Adults

Breast Cancer

IM

Special Populations

Hepatic Impairment

Geriatric Patients

Cautions for Fulvestrant

Contraindications

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

Hematologic Disorders

Specific Populations

Pregnancy

Lactation

Pediatric Use