Fluor-a-Day

sodium fluoride and xylitol

Dosage Form: tablet, chewable: oral drops
FLUOR•A•DAY®

Sodium Fluoride and Xylitol

Chewable Tablets and Oral Drops

Fluor-a-Day Description

Each Fluor-a-Day® chewable tablet is sugar free, saccharin free and erythrosine (FD&C Red Dye #3) free. Fluor-a-Day® sodium fluoride and xylitol supplement is for use as a dental caries preventative in children. Each Fluor-a-Day® 1.0 mg F (full strength) chewable tablet contains 2.2 mg sodium fluoride USP (equivalent to 1.0 mg Fluoride ion) and 236.79 mg xylitol; Each Fluor-a-Day® 0.5 mg F (half-strength) chewable tablet contains 1.1 mg sodium fluoride USP (equivalent to 0.5 mg Fluoride ion) and 236.79 mg xylitol; Each Fluor-a-Day® 0.25 mg F (quarter strength) chewable tablet contains 0.55 mg sodium fluoride (equivalent to 0.25 mg Fluoride ion) and 236.79 mg xylitol. Fluor-a-Day® Drops are flavorless, colorless, and odorless. Each ml (20 drops) contains 2.50 mg fluoride ion (F) from 5.56 mg sodium fluoride (NaF), approximately 0.125 mg F per drop.

ACTIVE INGREDIENTS

Sodium Fluoride (NaF), Xylitol

OTHER INGREDIENTS

Fluor-a-Day® Chewable Tablets also contain sorbitol, artificial raspberry flavor (contains: gum arabic, maltodextrin (corn), triacetin), raspberry permaseal, magnesium stearate kosher. Fluor-a-Day® Drops also contain methylparaben and sodium hydroxide.

Fluor-a-Day - Clinical Pharmacology

Sodium fluoride acts systemically (before tooth eruption) and topically (post-eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization, and by inhibiting the cariogenic microbial process. Xylitol is a five-carbon polyol that is noncariogenic and may reduce the risk of dental caries. Xylitol is a white, odorless, sweet tasting, crystalline powder.

Indications and Usage for Fluor-a-Day

For once daily systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F-) during the period of tooth development results in a significant decrease in the incidence of dental caries.1 Fluor-a-Day® Chewable Tablets and Drops were developed to provide systemic fluoride and xylitol for use as a supplement in pediatric patients from 6 months to age 16 years living in areas where the drinking water fluoride content does not exceed 0.6 ppm F-.

Contraindications

Do not use Fluor-a-Day® Chewable Tablets or Drops in areas where the fluoride content of the drinking water exceeds 0.6 ppm F-. Chronic renal insufficiency and failure, arthralgia, gastrointestinal ulceration and osteomalacia are contraindications to fluoride therapy. Fluor-a-Day® Tablets (any strength) and Drops are not indicated for use in adults.

Warnings

Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. Keep out of reach of infants and children.

Precautions

General

Please refer to the CONTRAINDICATIONS, WARNINGS and OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 6 months is not recommended by current American Dental Association and American Academy of Pediatrics guidelines.

Drug Interactions

Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

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 for 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. This dose is at least 400 times greater than the recommended daily dose of Fluor-a-Day® Chewable Tablets or Drops. 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 have 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 doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. This dose is approximately 200 times greater than the recommended daily dose of Fluor-a-Day® Chewable Tablets or Drops.

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. 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 human milk and caution should be exercised when Fluor-a-Day® Chewable Tablets or Drops 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. This dose is at least 200 times greater than the recommended daily dose of Fluor-a-Day® Chewable Tablets or Drops. Fluor-a-Day® Chewable Tablets and Drops (any strength) are not indicated for use in adults.

Pediatric Use

The use of Fluor-a-Day® Chewable Tablets and Drops as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well controlled studies on fluoride supplementation from birth through adolescence.1-5

Geriatric Use

Fluor-a-Day® Chewable Tablets (any strength) or Drops are not indicated for use in geriatric patients.

Adverse Reactions

Allergic rash 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) has 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) has 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 of Fluor-a-Day® Chewable Tablets contains 0.25, 0.5 or 1 mg of fluoride and each dose of Fluor-a-Day® Drops contains 0.125 mg of fluoride. The treatment of choice depends upon the age of the child and the water fluoride content. A bottle of 120 0.25 mg tablets contains 30 mg fluoride. A bottle of 120 0.5 mg tablets contains 60 mg fluoride. A bottle of 120 1 mg tablets contains 120 mg fluoride. The total amount of sodium fluoride in a bottle of 120 Fluor-a-Day® Chewable Tablets (all strengths) and Drops conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes.

Fluor-a-Day Dosage and Administration

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth. Drops should be administered in juice or water. See schedule below to determine dosage.

Fluoride Ion Level In Drinking Water (ppm)*

Age	Less than 0.3ppm	0.3-0.6 ppm	Greater than 0.6 ppm
* 0.1 part per million (ppm) = 1 milligram/liter (mg/L) † 2.2 mg sodium fluoride contains 1 mg fluoride ion
Birth-6 months	None	None	None
6 months-3 years	0.25 mg/day†	None	None
3-6 years	0.50 mg/day†	0.25 mg/day	None
6-16 years	1.0 mg/day	0.50 mg/day	None

Dosing schedule approved by the American Dental Association, American Academy of Pediatrics, American Academy of Pediatric Dentistry

How is Fluor-a-Day Supplied

Fluor-a-Day® 1 mg F Chewable Tablets available in bottles of 120 (NDC 24338-622-16), Raspberry flavor. Fluor-a-Day® 0.5 mg F Chewable Tablets available in bottles of 120 (NDC 24338-611-16 ), Raspberry flavor. Fluor-a-Day® 0.25 mg F Chewable Tablets available in bottles of 120 (NDC 24338-602-16), Raspberry flavor. Fluor-a-Day® 0.125 mg F Drops available in bottles of 30ML (NDC 24338-656-61).

STORAGE

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

All Fluor-a-Day® products are kosher.

REFERENCES

1. Accepted Dental Therapeutics, Ed. 40, American Dental Association, Chicago, 399-402 (1984).


2. J. Jakush, New Fluoride Schedule Adopted, ADA News , 12, 14 (May 16, 1994).


3. Aasenden, R., and Peebles, T.C. "Effects of Fluoride Supplementation From Birth on Dental Caries and Fluorosis in Teenaged Children", Arch. Oral, Biol., 23, 111 - 115 (1974).


4. Hamberg, L. "Controlled Trial of Fluoride Vitamin Drops for Prevention of Caries in Children", Lancet, 1, 441-442 (1971).


5. Hennon, D.K. Stookey, G.K. and Beiswanger, B.B. "Fluoride- Vitamin Supplements: Effects on Dental Caries and Fluorosis When Used in Areas with Suboptimum Fluoride in the Water Supply", JADA, 95, 965-971 (1977)

Rx only

Manufactured in Canada

Manufactured for Arbor Pharmaceuticals Inc., Raleigh, NC 27609

REV 8/10

PRINCIPAL DISPLAY PANEL - 0.25 mg Bottle Label

NDC 24338-602-16

FLUOR•A•DAY®

CHEWABLE

Sodium Fluoride

USP and Xylitol

Chewable Tablets

0.25 mg F-

Rx only

120 Tablets

arbor™

PHARMACEUTICALS, INC.

www.arborpharma.com

PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Label

NDC 24338-611-16

FLUOR•A•DAY®

CHEWABLE

Sodium Fluoride

USP and Xylitol

Chewable Tablets

0.5 mg F-

Rx only

120 Tablets

arbor™

PHARMACEUTICALS, INC.

www.arborpharma.com

PRINCIPAL DISPLAY PANEL - 1 mg Bottle Label

NDC 24438-622-16

FLUOR•A•DAY®

CHEWABLE

Sodium Fluoride

USP and Xylitol

Chewable Tablets

1.0 mg F-

Rx only

120 Tablets

arbor™

PHARMACEUTICALS, INC.

www.arborpharma.com

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC 24338-656-16

Dental Caries Prophylaxis

FLUOR•A•DAY®

DROPS

Sodium Fluoride

Oral Solution

USP

arbor™

PHARMACEUTICALS, INC.

www.arborpharma.com

30 mL

Rx only

Fluor-a-Day  sodium fluoride and xylitol  tablet, chewable

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24338-602 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (Fluoride Ion) Fluoride Ion 0.25 mg Xylitol (Xylitol) Xylitol 236.79 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor RASPBERRY (Kosher) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24338-602-16 120 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		08/15/2010

Fluor-a-Day  sodium fluoride and xylitol  tablet, chewable

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24338-611 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (Fluoride Ion) Fluoride Ion 0.5 mg Xylitol (Xylitol) Xylitol 236.79 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor RASPBERRY (Kosher) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24338-611-16 120 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		08/15/2010

Fluor-a-Day  sodium fluoride and xylitol  tablet, chewable

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24338-622 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (Fluoride Ion) Fluoride Ion 1 mg Xylitol (Xylitol) Xylitol 236.79 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor RASPBERRY (Kosher) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24338-622-16 120 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		08/15/2010

Fluor-a-Day  sodium fluoride  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24338-656 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (Fluoride Ion) Fluoride Ion 5.56 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Methylparaben   Sodium hydroxide

Product Characteristics Color      Score      Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24338-656-61 30 mL In 1 BOTTLE, DROPPER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		08/15/2010

Labeler - Arbor Pharmaceuticals, Inc. (781796417)

Revised: 08/2010Arbor Pharmaceuticals, Inc.

More Fluor-a-Day resources

• Fluor-a-Day Side Effects (in more detail)
• Fluor-a-Day Use in Pregnancy & Breastfeeding
• Fluor-a-Day Support Group
• 0 Reviews for Fluor-a-Day - Add your own review/rating

• Fluor-A-Day Advanced Consumer (Micromedex) - Includes Dosage Information


• Fluor-A-Day Concise Consumer Information (Cerner Multum)


• Fluor-A-Day Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Fluorides Monograph (AHFS DI)


• Fluoritab Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Lozi-Flur Lozenges MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Fluor-a-Day with other medications

• Prevention of Dental Caries

erlotinib

Generic Name: erlotinib (er LOE ti nib)

Brand Names: Tarceva

What is erlotinib?

Erlotinib is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Erlotinib is used to treat non-small cell lung cancer. Erlotinib is also used in combination with other cancer medicine to treat pancreatic cancer.

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

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

Do not take erlotinib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 2 weeks after your treatment ends.

Before taking erlotinib, tell your doctor if you have lung problems (other than lung cancer), kidney or liver disease, if you are dehydrated, or if you smoke.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. This will help your doctor determine how long to treat you with erlotinib. Visit your doctor regularly.

Avoid exposure to sunlight or tanning beds. Erlotinib can cause skin rash, dryness, or other irritation. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Avoid using skin products that can cause dryness or irritation. Stop taking erlotinib and call your doctor at once if you have new or worsening lung problems (chest pain, dry cough with fever, wheezing, feeling short of breath), chest pain spreading to the arm or shoulder, sudden numbness or weakness, eye pain or irritation, rapid weight gain, urinating less than usual or not at all, severe or ongoing diarrhea or vomiting, coughing up blood, black or bloody stools, pale skin, easy bruising or bleeding, mouth sores, or a severe skin rash. There are many other drugs that can interact with erlotinib. Tell your doctor about all medications you use. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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

You should not take erlotinib if you are allergic to it.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• 
  

  lung or breathing problems (other than lung cancer);

  
  


• 
  

  kidney disease;

  
  


• 
  

  liver disease;

  
  


• 
  

  if you are dehydrated; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category D. Do not take erlotinib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 2 weeks after your treatment ends. It is not known whether erlotinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking erlotinib.

How should I take erlotinib?

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

Your doctor may occasionally change your dose to make sure you get the best results.

Take erlotinib on an empty stomach, at least 1 hour before or 2 hours after eating. Do not crush an erlotinib tablet. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water and rinse thoroughly.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. This will help your doctor determine how long to treat you with erlotinib. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

See also: Erlotinib dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember (take only on an empty stomach). 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 severe diarrhea, severe skin rash, dark urine, stomach pain, or jaundice (yellowing of your skin or eyes).

What should I avoid while using erlotinib?

Avoid taking an antacid within several hours before or after you take erlotinib. Avoid exposure to sunlight or tanning beds. Erlotinib can cause skin rash, dryness, or other irritation. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using skin products that can cause dryness or irritation, such as acne medications, harsh soaps or skin cleansers, or skin products that contain alcohol.

Avoid smoking. It can make erlotinib less effective.

Grapefruit and grapefruit juice may interact with erlotinib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Erlotinib 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 taking erlotinib and call your doctor at once if you have a serious side effect such as:

• 
  

  new or worsening lung problems such as chest pain, dry cough with fever, wheezing, rapid breathing, feeling short of breath;

  
  


• 
  

  chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  sudden numbness or weakness, sudden severe headache, or problems with vision, speech, or balance;

  
  


• 
  

  eye pain, redness, or irritation;

  
  


• 
  

  confusion, mood changes, increased thirst, urinating less than usual or not at all;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  severe or ongoing diarrhea, vomiting, or loss of appetite;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  pale or yellowed skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  white patches or sores inside your mouth or on your lips;

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  
  


• 
  

  the first sign of any type of skin rash, no matter how mild; or

  
  


• 
  

  nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  mild stomach upset, nausea, or diarrhea;

  
  


• 
  

  weight loss;

  
  


• 
  

  acne, dry skin; or

  
  


• 
  

  tired feeling.

  
  

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.

Erlotinib Dosing Information

Usual Adult Dose for Non-Small Cell Lung Cancer:

Initial dose: 150 mg once a day

The dose should be taken at least one hour before or two hours after ingestion of food.

Treatment should continue until disease progression or unacceptable toxicity occurs. There is no evidence that treatment beyond progression is beneficial.

Usual Adult Dose for Pancreatic Cancer:

Initial dose: 100 mg once a day

The dose should be taken at least one hour before or two hours after ingestion of food.

Treatment should continue until disease progression or unacceptable toxicity occurs.

What other drugs will affect erlotinib?

Many drugs can interact with erlotinib. Below is just a partial list. Tell your doctor if you are using:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  conivaptan (Vaprisol);

  
  


• 
  

  dexamethasone (Decadron, Hexadrol);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  steroid medicine (prednisone and others);

  
  


• 
  

  an antibiotic such as ciprofloxacin (Cipro), clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);

  
  


• 
  

  an antidepressant such as nefazodone;

  
  


• 
  

  antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), or saquinavir (Invirase);

  
  


• 
  

  medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil);

  
  


• 
  

  NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

  
  

This list is not complete and there are many other drugs that can interact with erlotinib. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More erlotinib resources

• Erlotinib Side Effects (in more detail)
• Erlotinib Dosage
• Erlotinib Use in Pregnancy & Breastfeeding
• Erlotinib Drug Interactions
• Erlotinib Support Group
• 13 Reviews for Erlotinib - Add your own review/rating

• erlotinib Advanced Consumer (Micromedex) - Includes Dosage Information


• Erlotinib Professional Patient Advice (Wolters Kluwer)


• Erlotinib MedFacts Consumer Leaflet (Wolters Kluwer)


• Erlotinib Monograph (AHFS DI)


• Tarceva Prescribing Information (FDA)


• Tarceva Consumer Overview

Compare erlotinib with other medications

• Non-Small Cell Lung Cancer
• Pancreatic Cancer
• Renal Cell Carcinoma

Where can I get more information?

• Your pharmacist can provide more information about erlotinib.

See also: erlotinib side effects (in more detail)

Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine

Pronunciation: a-seet-a-MIN-oh-fen/SAL-i-SIL-a-mide/FEN-il-tole-OX-a-meen/KAF-een
Generic Name: Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine
Brand Name: Examples include Cafgesic and Durabac

Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine is used for:

Treating minor aches and pains (eg, headache, muscle or joint soreness, minor toothache, menstrual cramps). It is also used to treat symptoms associated with certain conditions (eg, colds, arthritis, muscle spasm, sinusitis). It may also be used for other conditions as determined by your doctor.

Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine is an analgesic, antihistamine, and antipyretic combination. It works by blocking substances in the body that cause fever, pain, and inflammation. It also blocks histamine, which causes sneezing and itchy, watery eyes.

Do NOT use Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine if:

• you are allergic to any ingredient in Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine


• you have had a severe allergic reaction to aspirin or other salicylates (eg, rash, hives, itching, difficulty breathing, tightness in the chest)


• you have kidney or liver problems


• you are a child or teenager and have a viral infection (eg, chickenpox, flu, cold)


• you are taking sodium oxybate (GHB) or an anticoagulant (eg, warfarin)

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

Before using Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine:

Some medical conditions may interact with Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine. 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 viral infection (eg, chickenpox, flu); Kawasaki syndrome; ulcers; a blockage of your stomach, bowel, or bladder; blood or bleeding problems; blood clotting problems; heart problems; blood vessel problems; or high blood pressure.


• if you have a history of lung or breathing problems (eg, asthma, emphysema, chronic obstructive pulmonary disease [COPD]), increased pressure in the eye, glaucoma, difficulty urinating, prostate problems (eg, enlarged prostate), anxiety, trouble sleeping, or high blood sugar


• if you drink alcohol, have a history of alcohol abuse or dependence, or take a monoamine oxidase inhibitor (MAOI) (eg, phenelzine)

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

• Sodium oxybate (GHB) because serious side effects such as prolonged sedation and severe drowsiness may occur


• Anticoagulants (eg, warfarin) because the risk of side effects, including the risk of bruising or bleeding, may be increased


• Aspirin, isoniazid, MAOIs (eg, phenelzine), or quinolones (eg, ciprofloxacin) because they may increase the risk of Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine's side effects


• Theophylline because the risk of its side effects may be increased by Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine


• Barbiturates (eg, phenobarbital) because their effectiveness may be decreased by Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine 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 Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine:

Use Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine by mouth with or without food.


• If you miss a dose of Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine 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 Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine.

Important safety information:

• Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


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


• If you are taking Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine for pain or fever and your symptoms do not improve within 10 days or if they become worse, check with your doctor.


• Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine has acetaminophen, caffeine, an aspirin-like medicine, and an antihistamine in it. Before you start any new medicine, check the label to see if it has any of these ingredients in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine contains caffeine. Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).


• Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine may harm your liver or cause stomach bleeding. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine. Talk to your doctor before you take Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Tell your doctor or dentist that you take Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine before you receive any medical or dental care, emergency care, or surgery.


• Do not give Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine to a child or teenager who has chickenpox, the flu, or another viral infection. Use of Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine for treating the symptoms of a viral infection may cause a serious illness called Reye syndrome.


• Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine.


• Use Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine with caution in the ELDERLY; they may be more sensitive to its effects, especially liver and kidney problems.


• Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine while you are pregnant. Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine is found in breast milk. Do not breast-feed while taking Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine.

Possible side effects of Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine:

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:

Dizziness; drowsiness; dry mouth, nose, or throat; heartburn; nausea; thickening of mucus in the nose and throat; upset stomach.

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); bloody or black stools; blurred vision or other vision changes; dark urine; decrease in the amount of urine produced; difficulty urinating; fainting; fast or irregular heartbeat; hearing loss; involuntary trembling; loss of coordination; pale stools; ringing in the ears; seizures; severe or persistent dizziness; severe stomach pain; trouble sleeping; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.

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

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 abnormal thoughts or behavior; confusion; dark urine; excessive sweating; fast or deep breathing; fast or irregular heartbeat; general discomfort; hearing loss; high fever; involuntary trembling; ringing in the ears; seizures; severe or persistent stomach pain; trouble sleeping; vomiting; yellowing of the eyes or skin.

Proper storage of Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine:

Store Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine 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 Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine out of the reach of children and away from pets.

General information:

• If you have any questions about Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine, please talk with your doctor, pharmacist, or other health care provider.


• Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine 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 Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine resources

• Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine Use in Pregnancy & Breastfeeding
• Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine Drug Interactions
• Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine Support Group
• 0 Reviews for Acetaminophen/Salicylamide/Phenyltoloxamine/Caffeine - Add your own review/rating

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• Pain

Methylnaltrexone Bromide

Class: GI Drugs, Miscellaneous
Chemical Name: (R)-N-(cyclopropylmethyl) noroxymorphone methobromide
Molecular Formula: C₂₁H₂₆NO₄Br
CAS Number: 73232-52-7
Brands: Relistor

Introduction

Peripherally acting μ-opiate receptor antagonist;^{1 2 3 4 7 8 9 12 13} quaternary amine derivative of naltrexone.^{4 7 9 11 13}

Uses for Methylnaltrexone Bromide

Opiate-induced Constipation

Treatment of opiate-induced constipation in patients with advanced illness who are receiving palliative care and have had an insufficient response to laxative therapy.^{1 2}

Methylnaltrexone Bromide Dosage and Administration

Administration

Sub-Q Administration

Administer by sub-Q injection into the upper arm, abdomen, or thigh.¹ Use abdomen or thigh for self-administration; may use upper arm if not self-administered.¹

Rotate injection sites.¹ Do not inject into areas where skin is bruised, tender, red, hard, or where scars or stretch marks are present.¹

Dosage

Available as methylnaltrexone bromide; dosage expressed in terms of the salt.¹

Adults

Opiate-induced Constipation

Sub-Q

Base dosage on patient’s weight (see Table 1).¹ Give one dose every other day as needed.¹ Do not exceed one dose per 24-hour period.¹

Determine injection volume by multiplying the patient’s weight in kg by 0.0075 (or in pounds by 0.0034) and rounding up to nearest 0.1 mL.¹

Table 1. Methylnaltrexone Injection Volume and Dosage

Patient Weight (kg)	Injection Volume	Dosage
<38	See below	0.15 mg/kg1 2
38 to <62	0.4 mL	8 mg1 2
62 to 114	0.6 mL	12 mg1 2
>114	See below	0.15 mg/kg1 2

Prescribing Limits

Adults

Opiate-induced Constipation

Sub-Q

Maximum one dose per 24-hour period.^{1 2} Use beyond 4 months not studied.¹

Special Populations

Hepatic Impairment

No dosage adjustment required in mild or moderate hepatic impairment; not studied in patients with severe hepatic impairment.^{1 10}

Renal Impairment

Mild or moderate renal impairment: Dosage adjustment not required.¹

Severe renal impairment (<30 mL/minute): Decrease dosage by 50%.^{1 2} (See Special Populations under Pharmacokinetics.)

End-stage renal disease requiring dialysis: Not studied.^{1 10}

Geriatric Patients

No dosage adjustment required.¹

Cautions for Methylnaltrexone Bromide

Contraindications

• 
  

  Known or suspected mechanical GI obstruction.¹

  
  

Warnings/Precautions

Severe or Persistent Diarrhea

Discontinue if severe or persistent diarrhea develops.¹

Peritoneal Catheters

Not studied in patients with peritoneal catheters.¹

Abuse and Dependence

No known risk of abuse or dependency.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹ Use caution.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 14}

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹

Hepatic Impairment

Systemic exposure not substantially altered in patients with mild or moderate hepatic impairment (Child-Pugh class A or B).¹ Not studied in patients with severe hepatic impairment.^{1 10}

Renal Impairment

Dosage adjustments necessary based on degree of renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Not studied in patients with end-stage renal disease requiring dialysis.^{1 10}

Common Adverse Effects

Transient abdominal pain,^{1 2 7 9} flatulence,^{1 2 4 7 9} nausea,^{1 2 7} dizziness,^{1 2 7} diarrhea.^{1 2 7}

Interactions for Methylnaltrexone Bromide

Weak inhibitor of CYP2D6 in vitro;^{1 2 13} no substantial inhibitory effect on CYP isoenzymes 1A2, 2A6, 2C9, 2C19, or 3A4.¹

Renally Excreted Drugs

Potential for interactions with drugs eliminated by active renal tubular secretion not studied.¹

Specific Drugs

Drug	Interaction
Dextromethorphan	No substantial effect on metabolism of dextromethorphan1 2 13

Methylnaltrexone Bromide Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following sub-Q administration.¹

Onset

Laxation within 30 minutes in about 30% of patients; within 4 hours in about 50–60% of patients.¹

Distribution

Extent

Moderate tissue distribution.¹

Distributed into milk in rats; not known whether distributed into human milk.¹

Plasma Protein Binding

11–15%.^{1 13}

Elimination

Metabolism

Metabolized to several minor metabolites.¹ Not appreciably demethylated to form naltrexone.^{1 4 13}

Elimination Route

Excreted principally as unchanged drug in urine (50%) and in feces.^{1 13}

Half-life

Approximately 8 hours.¹

Special Populations

Mild or moderate hepatic impairment does not affect systemic exposure; not studied in patients with severe hepatic impairment.^{1 10}

Severe renal impairment (Cl_cr <30 mL/minute) decreases renal clearance 8- to 9-fold and doubles AUC.¹ (See Renal Impairment under Dosage and Administration.)

Not studied in patients with end-stage renal disease requiring dialysis.^{1 10}

Stability

Storage

Parenteral

Solution

20–25°C (may be exposed to 15–30°C).¹ Do not freeze; protect from light.¹ Vials for single use only; discard remainder.¹

Once drawn into syringe, if immediate administration is not possible, store at room temperature; administer within 24 hours.¹

ActionsActions

• 
  

  Peripherally acting μ-opiate receptor antagonist;^{1 7 8 9 12 13} quaternary amine derivative of naltrexone.^{4 7 9 11 13}

  
  


• 
  

  Blocks μ-opiate receptors in the GI tract, blocking intestinal smooth muscle relaxation caused by opiates and thereby reversing opiate-induced slowing of GI transit time.^{1 2 4}

  
  


• 
  

  Does not readily cross blood-brain barrier; therefore, does not affect opiate analgesic activity or precipitate opiate withdrawal, unlike centrally active opiate antagonists (e.g., naltrexone, naloxone).^{1 2 3 4 5 7 8 9 11 12 13}

  
  


• 
  

  Exhibits greater affinity for μ-opiate receptors than for κ-opiate receptors; does not interact with δ-opiate receptors nor substantially bind to nonopiate receptors.^{9 12 13}

  
  


• 
  

  2–4% of the opiate antagonist activity and potency of naloxone;¹³ possesses some μ-receptor agonist activity.^{6 12 13}

  
  

Advice to Patients

• 
  

  Importance of patient and/or caregiver reading the manufacturer’s patient information prior to initiation of therapy and with each refill.¹

  
  


• 
  

  Advise patients to use the prescribed needles and syringes when administering methylnaltrexone.¹

  
  


• 
  

  Importance of discontinuing methylnaltrexone therapy following cessation of opiate analgesic therapy.¹

  
  


• 
  

  For self-administration, instruct patient and/or caregiver regarding proper dosage and administration, including the use of aseptic technique and proper disposal of needles and syringes.¹

  
  


• 
  

  Importance of never taking more than one dose in a 24-hour period.¹

  
  


• 
  

  Advise patients that laxation may occur within 30 minutes after a dose and that close proximity to a toilet is advised after drug administration.¹

  
  


• 
  

  Importance of discontinuing methylnaltrexone and informing clinician if severe or persistent diarrhea occurs or if adverse effects (e.g., transient abdominal pain, nausea, vomiting) persist or worsen during therapy.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Methylnaltrexone Bromide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for subcutaneous use	12 mg/0.6 mL	Relistor (with syringe, retractable 27-gauge needle, and alcohol swabs)	Wyeth

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 August 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Wyeth Pharmaceuticals. Relistor (methylnaltrexone bromide) subcutaneous injection prescribing information. Philadelphia, PA; 2008 Apr.

2. Anon. Methylnaltrexone (Relistor) for opioid-induced constipation. Med Lett Drugs Ther. 2008; 50:63-4.

3. McNicol ED, Boyce D, Schumann R et al. Mu-opioid antagonists for opioid-induced bowel dysfunction. Cochrane Database Syst Rev. 2008; 2:CD006332. [PubMed 18425947]

4. Kraft MD. Emerging pharmacologic options for treating postoperative ileus. Am J Health-Syst Pharm. 2007; 64(Suppl 13):S13-20. [PubMed 17909271]

5. Becker G, Galandi D, Blum HE. Peripherally acting opioid antagonists in the treatment of opiate-related constipation: a systematic review. J Pain Symptom Manage. 2007; 35:547-65.

6. Beattie DT, Cheruvu M, Mai N et al. The in vitro pharmacology of the peripherally restricted opioid receptor antagonists, alvimopan, ADL 08-0011 and methylnaltrexone. Naunyn Schmiedebergs Arch Pharmacol. 2007; 375:205-20. [PubMed 17340127]

7. Thomas J, Karver S, Cooney GA et al. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008; 358:2332-43. [PubMed 18509120]

8. Berde C, Nurko S. Opioid side effects— mechanism-based therapy. N Engl J Med. 2008; 358:2400-2. [PubMed 18509126]

9. Yuan CS. Methylnaltrexone mechanisms of action and effects on opioid bowel dysfunction and other opioid adverse effects. Ann Pharmacother. 2007; 41:984-93. [PubMed 17504835]

10. Food and Drug Administration. Center for Drug Evaluation and Research: Application number 21–964: Medical Review(s). From FDA website .

11. Shaiova L, Rim F, Friedman D et al. A review of methylnaltrexone, a peripheral opioid receptor antagonist, and its role in opioid-induced constipation. Palliat Support Care. 2007; 5:161-6. [PubMed 17578067]

12. Reichle FM, Conzen PF. Methylnaltrexone, a new peripheral μ-receptor antagonist for the prevention and treatment of opioid-induced extracerebral side effects. Curr Opin Investig Drugs. 2008; 9:90-100. [PubMed 18183536]

13. Kraft MD. Methylnaltrexone, a new peripherally acting mu-opioid receptor antagonist being evaluated for the treatment of postoperative ileus. Expert Opin Investig Drugs. 2008; 17:1365-77. [PubMed 18694369]

14. Wyeth Laboratories, Collegeville, PA: Personal communication.

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• Methylnaltrexone Bromide Side Effects (in more detail)
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• Constipation, Chronic
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Qutenza

Generic Name: capsaicin topical (kap SAY sin TOP i kal)

Brand Names: Axsain, Capsicum Oleoresin, Capsin, Capzasin Back and Body, Capzasin Quick Relief, Capzasin-HP, Capzasin-P, Castiva Warming, Dolorac, Icy Hot PM, Icy Hot with Capsaicin, Menthac Arthritis Cream with Capsaicin, Qutenza, Salonpas Gel-Patch, Salonpas Pain Patch with Capsaicin, Sloan's Liniment, Trixaicin, Trixaicin HP, Zostrix, Zostrix Diabetic Foot Pain, Zostrix Foot Pain, Zostrix Neuropathy, Zostrix Sports, Zostrix-HP

What is capsaicin topical?

Capsaicin is the active ingredient in chili peppers that makes them hot. Capsaicin is used in medicated creams and lotions to relieve muscle or joint pain.

Capsaicin used on the body causes a sensation of heat that activates certain nerve cells. With regular use of capsaicin, this heating effect reduces the amount of substance P, a chemical that acts as a pain messenger in the body.

Capsaicin topical is used for temporary relief of muscle or joint pain caused by strains, sprains, arthritis, bruising, or backaches. Capsaicin topical is also used to treat nerve pain (neuralgia) in people who have had herpes zoster, or "shingles."

Capsaicin topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about capsaicin topical?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies or serious medical conditions. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

Capsaicin can cause a burning sensation, which is usually mild and should lessen over time with continued use. If the burning sensation causes significant discomfort, wash the treated skin area with soap and cool water. Stop using the medication and call your doctor if you have severe burning or redness where the medicine was applied.

Avoid getting capsaicin topical in your mouth or eyes or near your nose.

Do not apply to open wounds or irritated skin, and avoid getting the medicine on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. Accidental swallowing of capsaicin can cause problems with swallowing or breathing.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days.

What should I discuss with my healthcare provider before using capsaicin topical?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies (especially to plants), or if you have a serious medical condition.

It is not known whether capsaicin topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether capsaicin topical passes into breast milk or if it could harm a nursing baby. Do not apply capsaicin topical to your breast area if you are breast-feeding a baby. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

How should I use capsaicin topical?

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

Capsaicin can cause a burning sensation wherever it is applied. This sensation is usually mild and should gradually lessen over time with continued regular use of the medicine.

Do not apply capsaicin topical to open wounds, or to skin that is sunburned, windburned, dry, chapped, or otherwise irritated. Do not get this medication in your mouth or eyes, or near your nose where you might inhale it. If it does get into any of these areas, rinse thoroughly with water.

Also avoid getting this medication on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

To keep the medication from getting on your fingers when you apply it, you may use a rubber glove, finger cot, cotton ball, or clean tissue to apply the medicine.

Make sure your skin is clean and dry before you apply capsaicin topical.

When using capsaicin topical cream or lotion, apply a thin layer to the affected area and rub in gently until completely absorbed.

To use capsaicin topical liquid or stick, uncap the applicator and press it firmly on your skin to apply the medication. Massage gently onto the affected are until completely absorbed.

Capsaicin topical may be used up to 4 times daily or as directed on the medicine label.

To apply a capsaicin topical patch, remove the liner and apply the patch to your skin over the area of pain. Press the edges firmly into place. Remove the patch and apply a new patch 1 or 2 times daily if needed.

Wash your hands with soap and water immediately after applying capsaicin topical or handling the topical patch. If you have applied the medicine to your hands or fingers to treat pain in those areas, wait at least 30 minutes before washing your hands. Do not cover treated skin with a bandage or heating pad, which can increase the burning sensation. You may cover the skin with clothing.

Avoid taking a bath or shower within 1 hour before or after you apply capsaicin topical to your skin. Also avoid swimming or vigorous exercise. Warm water or perspiration can increase the burning sensation caused by capsaicin.

If the burning sensation caused by capsaicin is painful or causes significant discomfort, wash the treated skin area with soap and cool water.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed. Pain relief should occur gradually as the substance P in your body is decreased in the nerve cells.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days. Store capsaicin topical at room temperature away from moisture and heat, in a place where children and pets cannot get to it.

Capsaicin topical liquid is flammable. Do not use or store near fire or open flame.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply capsaicin more than 4 times in one day, or use extra medicine to make up a missed dose .

A missed dose of capsaicin topical will not cause harm but may make the medication less effective reducing substance P and relieving your pain.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222, especially if anyone has accidentally swallowed it.

Accidental swallowing of capsaicin can cause severe burning in or around the mouth, watery eyes, runny nose, and trouble swallowing or breathing.

Applying too much capsaicin topical to the skin can cause severe burning or redness.

What should I avoid while using capsaicin topical?

Avoid inhaling the odor or dried residue of capsaicin topical. Inhaling capsaicin can cause coughing, sneezing, or watery eyes, and can irritate your throat or lungs.

Avoid touching your eyes, mouth, nose, genitals, or rectum until the medication has been washed off your hands. Also avoid handling food while the medication is still on your hands.

Avoid exposing treated skin to sunlight, sunlamps, tanning beds, or a hot tub. Capsaicin can cause a burning sensation that may be made worse by heat.

Do not use other medicated skin products, including muscle pain creams or lotions, on areas where you have applied capsaicin, unless your doctor has told you to.

Capsaicin topical side effects

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

• 
  

  severe burning or irritation where the medicine was applied;

  
  


• 
  

  skin redness where the medicine was applied; or

  
  


• 
  

  trouble breathing or swallowing (after accidental inhalation of capsaicin odor or dried residue).

  
  

Less serious side effects may include a mild burning sensation that can last for several hours or days, especially after your first use of capsaicin topical.

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 capsaicin topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied capsaicin. But many drugs can interact with each other. 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.

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• Qutenza Side Effects (in more detail)
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• Qutenza Prescribing Information (FDA)


• Qutenza Consumer Overview


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• Osteoarthritis
• Pain
• Peripheral Neuropathy
• Persisting Pain, Shingles

Where can I get more information?

• Your pharmacist can provide more information about capsaicin topical.

See also: Qutenza side effects (in more detail)

Moxatag

Generic Name: amoxicillin (Oral route)

a-mox-i-SIL-in

Commonly used brand name(s)

In the U.S.

• Amoxicot


• Amoxil


• DisperMox


• Moxatag


• Moxilin


• Trimox

In Canada

• Amoxil Pediatric


• Apo-Amoxi


• Apo-Amoxi Sugar-Free


• Gen-Amoxicillin


• Med Amoxicillin


• Novamoxin


• Novamoxin Reduced Sugar


• Nu-Amoxi


• Riva-Amoxicillin


• Scheinpharm Amoxicillin


• Zimamox

Available Dosage Forms:

• Tablet


• Tablet, Chewable


• Tablet for Suspension


• Powder for Suspension


• Tablet, Extended Release


• Capsule

Therapeutic Class: Antibiotic

Pharmacologic Class: Penicillin, Aminopenicillin

Uses For Moxatag

Amoxicillin is used to treat bacterial infections in many different parts of the body. It is also used with other medicines (e.g., clarithromycin, lansoprazole) to treat H. pylori infection and duodenal ulcers.

Amoxicillin belongs to the group of medicines known as penicillin antibiotics. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Moxatag

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin in children. However, newborns and infants 3 months of age and younger have incompletely developed kidney functions, which may need a lower dose of this medicine.

Geriatric

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

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 this medicine, 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 this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Methotrexate


• Venlafaxine

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

• Acenocoumarol


• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Khat


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Probenecid


• 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Allergy to penicillins or cephalosporin antibiotics (e.g., cefaclor, cefadroxil, cephalexin, Ceftin®, or Keflex®) or


• Mononucleosis (viral infection)—Should not be used in patients with these conditions.

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

• Phenylketonuria (PKU)—The chewable tablet contains phenylalanine, which can make this condition worse.

Proper Use of amoxicillin

This section provides information on the proper use of a number of products that contain amoxicillin. It may not be specific to Moxatag. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

For patients using the oral liquid:

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


• You may mix the oral liquid with a baby formula, milk, fruit juice, water, ginger ale, or another cold drink. Be sure the child drinks all of the mixture immediately.

Keep using this medicine 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.

Dosing

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

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

• For oral dosage forms (capsules, powder for suspension, and tablets):
  
  • For bacterial infections:
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every 8 hours, or 500 to 875 mg every 12 hours.
    
    
    • Children and infants older than 3 months of age weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 milligrams (mg) per kilogram (kg) of body weight per day, divided and given every 8 hours, or 25 to 45 mg per kg of body weight per day, divided and given every 12 hours.
    
    
    • Infants 3 months of age and younger—Dose is based on body weight and must be determined by your doctor. The usual dose is 30 mg per kg of body weight per day, divided and given every 12 hours.
    
    
  
  
  • For treatment of gonorrhea:
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—3-grams (g) taken as a single dose.
    
    
    • Children 2 years of age and older weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 milligrams (mg) per kilogram (kg) of body weight per day, combined with 25 mg per kg of probenecid, taken as a single dose.
    
    
    • Children younger than 2 years of age—Use is not recommended.
    
    
  
  
  • For treatment of H. pylori infection:
    
    • Adults—
      
      • Dual therapy: 1000 milligrams (mg) of amoxicillin and 30 mg of lansoprazole, each given three times a day (every 8 hours) for 14 days.
      
      
      • Triple therapy: 1000 mg of amoxicillin, 500 mg of clarithromycin, and 30 mg of lansoprazole, all given two times a day (every 12 hours) for 14 days.
      
      
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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.

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

You may store the oral liquid in the refrigerator. Throw away any unused medicine after 14 days. Do not freeze.

Precautions While Using Moxatag

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

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a skin rash; itching; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, mouth, or throat after you or your child receive this medicine.

Amoxicillin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

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

In some young patients, tooth discoloration may occur while using this medicine. The teeth may appear to have brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.

Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include a condom, a diaphragm, or a contraceptive foam or jelly.

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.

Moxatag 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:

Incidence not known

• Abdominal or stomach cramps or tenderness


• back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the urine


• bloody nose


• chest pain


• chills


• clay-colored stools


• cough


• dark urine


• diarrhea


• diarrhea, watery and severe, which may also be bloody


• difficulty with breathing


• difficulty with swallowing


• dizziness


• fast heartbeat


• feeling of discomfort


• fever


• general body swelling


• headache


• heavier menstrual periods


• hives or welts


• increased thirst


• inflammation of the joints


• itching


• joint or muscle pain


• loss of appetite


• muscle aches


• nausea or vomiting


• nosebleeds


• pain


• pain in the lower back


• pain or burning while urinating


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


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


• rash


• red, irritated eyes


• redness, soreness, or itching skin


• shortness of breath


• sore throat


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


• sores, welting, or blisters


• sudden decrease in the amount of urine


• swollen, lymph glands


• tenderness


• tightness in the chest


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight loss


• vomiting of blood


• watery or bloody diarrhea


• wheezing


• yellow eyes or skin

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

Less common

• Bad, unusual, or unpleasant (after) taste


• change in taste

Incidence not known

• Agitation


• black, hairy tongue


• changes in behavior


• confusion


• convulsions


• discoloration of the tooth (brown, yellow, or gray staining)


• dizziness


• sleeplessness


• trouble with sleeping


• 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.

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