Saturday, 21 August 2010

Klaretop




Klaretop may be available in the countries listed below.


Ingredient matches for Klaretop



Clarithromycin

Clarithromycin is reported as an ingredient of Klaretop in the following countries:


  • Greece

International Drug Name Search

Thursday, 19 August 2010

Oral-B Neutra Foam




Generic Name: neutral sodium fluoride

Dosage Form: dental aerosol
Package. Label Principal Display Panel NEUTRA-FOAM
Foaming Solution

(2.0% w/w Neutral Sodium Fluoride)

FOR PROFESSIONAL USE ONLY

Active Ingredient:Sodium Fluoride 2.0% w/w (0.9% or 9048 ppm fluoride ion)
DESCRIPTION:Oral-B Neutra-Foam is a mint flavored neutral aqueous foaming solution of 2.0% w/w sodium fluoride. Inactive Ingredients:Purified water, Poloxamer 407, Isobutane, Poloxamer 234, Spearmint flavor, Potassium phosphate, Sodium saccharin, Methylparaben, Sodium hydroxide, Propylparaben. CLINICAL PHARMACOLOGY: Sodium Fluoride inhibits caries formation by reducing enamel solubility and enhancing remineralization. INDICATION AND USE:A topically applied foaming solution primarily suited for patients with extensive aesthetic restorations to aid in the prevention of dental caries. CONTRAINDICATIONS:        • Do not use in patients with hypersensitivity to fluoride.

                                            • Do not use in patients with dysphagia. WARNINGS: DO NOT SWALLOW.

• Accidental ingestion of the usual treatment dose (approximately 9.0 mg of fluoride) is not harmful. In the event more than the treatment dose is swallowed, administer calcium (e.g. milk) and get medical or contact a Poison control Center right away. One bottle of Neutra-Foam contains 1.43 grams of fluoride ion which could be lethal for children and adults.

• Keep out of the reach of infants and children under 12 years.

• Pediatric patients under 12 years of age should be supervised during use of this product.

• Avoid spraying towards open flame.

• Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures over 120°F (49°C).

PRECAUTIONS: FOR PROFESSIONAL USE ONLY.

Safety and effectiveness below age 6 have not been established. There have been no long term studies with this product to evaluate carcinogenic, mutagenic or impairment of fertility potential.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No evidence of carcinogenicity was observed in female and male mice at doses ranging from 2.4 to 18.8 mg/kg sodium fluoride of body weight (3,4). Equivocal evidence of carcinogenicity was reported in male rats at doses ranging from 2.5 to 4.1 mg/kg fluoride, but no evidence of carcinogenicity was observed in female rats (3,4). In another study, no carcinogenicity was observed in rats treated with fluoride up to 25 mg/kg of body weight (5). Overall, epidemiological studies do not show an association between fluoridated drinking water and increased cancer risk in humans (7).


Fluoride ion is not mutagenic in standard bacterial systems but has been associated with genetic aberrations in cultured human cells at doses much higher than expected for human exposure (6,8). Some in vivo studies report chromosomal aberrations in rodents while other studies using similar protocols report negative results (7).


Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse reproductive effects of fluoride have been reported in animal studies, but at high concentrations sufficient to produce other manifestations of toxicity (9).



Pregnancy:Teratogenic Effects: Pregnancy Category B. Fluoride readily crosses the placenta (7,9). Animal studies (rats and rabbits) have shown that fluoride is not a teratogen (10,12,13). Maternal exposure to 18 mg Fluoride/kg of body weight did not affect maternal body weight, litter size or fetal weight and did not increase frequency of skeletal or visceral malformations (10). There are no adequate and well-controlled studies in pregnant women. Several epidemiological studies show no increase in birth defects in areas with fluoridated water compared to areas with low fluoridated water (7). However, caution should be exercised when fluoride is administered to pregnant women. Nursing mothers: Due to the relative insensitivity of human milk fluoride levels to changes in maternal fluoride intake, and due to the very low concentrations of fluoride in human milk, fluoride supplementation during lactation would not be expected to significantly affect fluoride intake by the nursing infant (11). However, caution should be exercised when fluoride is administered to nursing women. Pediatric use: The use of fluoride solutions, gels, and foams containing up to 1.23 % fluoride ion as caries preventives in pediatric patients aged 6 to 16 years is supported by clinical studies in students aged 6 to 12 years (1,2). Safety and effectiveness in pediatric patients below the age of 6 years has not been established. Please refer to CONTRAINDICATIONS and WARNINGS sections.

Geriatric use: No overall differences in safety or effectiveness have been observed between geriatric and younger patients. This drug is known to be substantially excreted by the kidney, therefore 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.



ADVERSE REACTIONS: Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache and weakness. In patients with mucositis, gingival tissues may be hypersensitive to the flavor.


OVERDOSAGE: Accidental ingestion of large amounts of fluoride can result in acute irritation of the mouth and gastrointestinal tract as well as the development of gastrointestinal symptoms such as nausea, vomiting, diarrhea, hematemesis epigastric cramping and abdominal pain. If a large amount of fluoride equal to or greater than 5 mg fluoride/kg body weight (2.3 mg fluoride/lb body weight) is ingested, give calcium (e.g. milk, 5% calcium gluconate or calcium solution) orally to relieve gastrointestinal symptoms and admit immediately to a hospital facility. A standard treatment dose of Neutra-Foam contains approximately 9.0mg fluoride. One 165 g (5.8 oz) bottle contains approximately 1.43 g of fluoride. DOSAGE AND ADMINISTRATION: Adults and Children 6 years and over: Use foam 2 times a year. The initial time you dispense from a new bottle, gently lift upward on the nozzle to break the protective seal (thin plastic tab located adjacent to trigger). If this seal is broken do not use product. When breaking this seal, there could be an initial surge of foam from the dispenser.


• Shake bottle vigorously for 3-4 seconds prior to dispensing.

• Invert bottle 180° with nozzle tip pointed downward into tray.

• Place nozzle tip close to the tray floor and at one end of the tray arch.

Moving from one end of the tray to the other in one fluid motion, slowly press down on the trigger. (Note: foam will expand slightly to fill the tray.)

• Do not use excessive finger pressure which could result in too much foam being dispensed.

• Immediately place tray(s) in mouth. (Note: Do not fill trays with foam too far in advance of treatment as the foam will collapse and not be as effective.)

• Have patient bite down on the tray(s) lightly but firmly for up to 4 minutes.

• Remove tray(s) and have patient expectorate.

• Instruct patient not to eat, drink, or rinse for at least 30 minutes. For optimal tooth coverage, use a fluoride applicator tray which is deep enough to reach the entire vertical height of all teeth (even the molars). You can choose from single arch trays (such as CENTRAYS) or dual arch trays (CENTWINS or SOFTWINS).


HOW SUPPLIED: Neutra-Foam is available in a 5.8 oz (165 g) plastic aerosol container in mint flavor. NDC 0041-0348-06.

REFERENCES:

(1.) Wellock, W.D. and Brudevold, F.: Arch. Oral Biol., 10, 453-460 (1965) (2.) Jiang, H et al.: J. Dent, 33, 469-473 (2005) (3.) National Toxicology Program: NTP TR 393, NIH Publication 91-2842, (1990) (4.) Bucker, J.R. et al.: Int. J. Cancer 48, 733-737 (1991) (5.) Maurer, J.K. et al.: J. Natl. Cancer Inst. 82, 1118-1126 (1990) (6) Martin, G.R. et al.: Mutat. Res. 66, 159-167 (1979) (7.) Agency for Toxic Substances and Disease Registry: Toxicological Profile for Fluoride (2003)

(8.) Aardema, M.J. et al.: Mutat. Res. 331 (1), 171-172 (9.) National Research Council: Fluoride in Drinking Water (2006) (10.) Heindel, J.J. et al.: Fundam Appl Toxicol, 30, 162-177 (1996) (11.) Institute of Medicine, Food and Nutrition Board: Dietary Reference Intakes (1997) (12.) Collins, T.F. et al.: Food Chem. Toxicol. 33 (11), 951-960 (13.) Collins, T.F. et al.: Food Chem Toxicol. 39 (8), 867-876



Minute Foam Label 









ORAL-B NEUTRA-FOAM MINT 
neutral sodium fluoride  aerosol










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0041-0348
Route of AdministrationDENTALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride ion)Fluoride ion9 mg  in 1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorSPEARMINT (Spearmint flavor)Imprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10041-0348-06165 g In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/04/2000


Labeler - Oral-B Laboratories (183102243)
Revised: 10/2010Oral-B Laboratories




More Oral-B Neutra Foam resources


  • Oral-B Neutra Foam Use in Pregnancy & Breastfeeding
  • Oral-B Neutra Foam Support Group
  • 3 Reviews for Oral-B Neutra - Add your own review/rating


Compare Oral-B Neutra Foam with other medications


  • Prevention of Dental Caries

Sunday, 15 August 2010

Amoxymed




Amoxymed may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Amoxymed



Amoxicillin

Amoxicillin is reported as an ingredient of Amoxymed in the following countries:


  • Poland

International Drug Name Search

Saturday, 14 August 2010

Sinvastatina Biolipe




Sinvastatina Biolipe may be available in the countries listed below.


Ingredient matches for Sinvastatina Biolipe



Simvastatin

Simvastatin is reported as an ingredient of Sinvastatina Biolipe in the following countries:


  • Portugal

International Drug Name Search

Norfloxacina Jet




Norfloxacina Jet may be available in the countries listed below.


Ingredient matches for Norfloxacina Jet



Norfloxacin

Norfloxacin is reported as an ingredient of Norfloxacina Jet in the following countries:


  • Italy

International Drug Name Search

Thursday, 12 August 2010

Lomac




Lomac may be available in the countries listed below.


Ingredient matches for Lomac



Omeprazole

Omeprazole is reported as an ingredient of Lomac in the following countries:


  • Czech Republic

  • Ethiopia

  • India

  • Latvia

  • Slovakia

  • Vietnam

International Drug Name Search

Wednesday, 11 August 2010

Ketotifen CF




Ketotifen CF may be available in the countries listed below.


Ingredient matches for Ketotifen CF



Ketotifen

Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Ketotifen CF in the following countries:


  • Netherlands

International Drug Name Search

Monday, 9 August 2010

Differin Lotion


Pronunciation: a-DAP-a-leen
Generic Name: Adapalene
Brand Name: Differin


Differin Lotion is used for:

Treating severe acne. It may also be used for other conditions as determined by your doctor.


Differin Lotion is a retinoid-like compound. Exactly how it works is not known. However, it helps the skin cells renew quicker and decreases blackhead formation.


Do NOT use Differin Lotion if:


  • you are allergic to any ingredient in Differin Lotion

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



Before using Differin Lotion:


Some medical conditions may interact with Differin Lotion. 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 eczema or sunburn

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


  • Products that contain resorcinol, salicylic acid, or sulfur because the risk of skin irritation may be increased

Ask your health care provider if Differin Lotion 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 Differin Lotion:


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


  • Differin Lotion is for external use only. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. Exposure of Differin Lotion to the eye may cause swelling, redness, and irritation.

  • Do not apply Differin Lotion to cuts, damaged or sunburned skin, or eczema.

  • Use Differin Lotion in the evening before bedtime unless directed otherwise by your doctor.

  • Before applying Differin Lotion, clean the area to be treated with mild soap or soapless cleanser and gently dry.

  • Apply a thin film of Differin Lotion to the entire face and other affected areas, as directed by your doctor. Use an amount about the size of a nickel (3 to 4 pumps) to cover the entire face. Rub in gently. Wash your hands immediately after using Differin Lotion.

  • A mild sensation of warmth or slight stinging may occur shortly after using Differin Lotion.

  • If you miss a dose of Differin Lotion, use 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 use 2 doses at once. If several applications are missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Differin Lotion.



Important safety information:


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

  • Do not use more than the recommended dose or more often than prescribed without checking with your doctor. Doing so will not make Differin Lotion work faster or better, but may increase the risk of skin irritation.

  • Acne may worsen temporarily when you begin using Differin Lotion. This is normal and not a cause for concern. Continue to use Differin Lotion. If your condition does not improve within 12 weeks, check with your doctor.

  • Do not use other medicines or skin products on the affected area without first checking with your doctor. Some other products may increase the risk of skin irritation.

  • Skin moisturizers may be used if necessary. Do not use moisturizers that contain alpha hydroxy or glycolic acids.

  • Certain cosmetic procedures, such as waxing, should not be performed on treated skin because of possible irritation.

  • Cosmetics may be used while using Differin Lotion. After using cosmetics, thoroughly wash and dry the affected area before applying Differin Lotion.

  • Wind and cold temperatures can also irritate the affected skin.

  • Differin Lotion 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 Differin Lotion while you are pregnant. It is not known if Differin Lotion is found in breast milk. If you are or will be breast-feeding while you use Differin Lotion, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Differin Lotion:


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:



Dry skin; feeling of warmth; irritation; itching; peeling; redness; scaling; temporary burning and stinging.



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); blistering; crusting; excessive redness or peeling; swelling.



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: Differin 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. Differin Lotion may be harmful if swallowed.


Proper storage of Differin Lotion:

Store Differin Lotion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Do not freeze or refrigerate. Keep Differin Lotion out of the reach of children and away from pets.


General information:


  • If you have any questions about Differin Lotion, please talk with your doctor, pharmacist, or other health care provider.

  • Differin Lotion 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 Differin Lotion. 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 Differin resources


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


Compare Differin with other medications


  • Acne