Sunday, 11 December 2011

Ocu-Phrin


Generic Name: phenylephrine (Ophthalmic route)

fen-il-EF-rin

Commonly used brand name(s)

In the U.S.


  • AK-Dilate

  • Altafrin

  • Eye Cool

  • Mydfrin

  • Neofrin

  • Neo-Synephrine

  • Ocu-Phrin

  • Prefrin Liquifilm

Available Dosage Forms:


  • Solution

Therapeutic Class: Mydriatic-Cycloplegic


Pharmacologic Class: Sympathomimetic


Chemical Class: Alkylarylamine


Uses For Ocu-Phrin


Ophthalmic phenylephrine in strengths of 2.5 and 10% is used to dilate (enlarge) the pupil. It is used before eye examinations, before and after eye surgery, and to treat certain eye conditions. In the U.S., these preparations are available only with your doctor's prescription.


Before Using Ocu-Phrin


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


Children may be especially sensitive to the effects of phenylephrine. This may increase the chance of side effects during treatment. In addition, the 10% strength is not recommended for use in infants. Also, the 2.5 and 10% strengths are not recommended for use in low birth weight infants.


Geriatric


Repeated use of 2.5 or 10% phenylephrine may increase the chance of problems during treatment with this medicine. In addition, heart and blood vessel problems have occurred more often in elderly patients than in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Clorgyline

  • Iproniazid

  • Isocarboxazid

  • Nialamide

  • Phenelzine

  • Procarbazine

  • Rasagiline

  • Selegiline

  • Tranylcypromine

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.


  • Amitriptyline

  • Amoxapine

  • Clomipramine

  • Desipramine

  • Dothiepin

  • Doxepin

  • Furazolidone

  • Imipramine

  • Lofepramine

  • Midodrine

  • Nortriptyline

  • Opipramol

  • Pargyline

  • Protriptyline

  • Trimipramine

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.


  • Guanethidine

  • Propranolol

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:


  • Type 2 diabetes mellitus or

  • Heart or blood vessel disease or

  • High blood pressure—The 2.5 and 10% strengths of phenylephrine may make the condition worse

  • Idiopathic orthostatic hypotension (a certain kind of low blood pressure)—Use of this medicine may cause a large increase in blood pressure to occur

Proper Use of phenylephrine

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


Do not use if the solution turns brown or becomes cloudy.


To use:


  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.

  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.

  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using the 2.5 or 10% eye drops:


  • It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when this medicine is used in children or in patients with heart disease or high blood pressure, since high doses of this medicine may cause an irregular heartbeat and an increase in blood pressure.

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 ophthalmic solution (eye drops) dosage form:
    • For eye redness:
      • Adults and children—Use one drop of 0.12% solution every three or four hours as needed.


    • For eye exams:
      • Adults and children—Use one drop of 2.5% solution. Depending on the eye test to be done, it will take from fifteen minutes to one or two hours for the medicine to work before you can have the eye test.


    • For use before eye surgery:
      • Adults and teenagers—Use one drop of 2.5 or 10% solution thirty to sixty minutes before the start of eye surgery.

      • Children—Use one drop of 2.5% solution thirty to sixty minutes before the start of eye surgery.


    • For certain eye conditions:
      • Adults and teenagers—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5 or 10% solution in the eye from once a day to three times a day.

      • Children—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5% solution in the eye from once a day to three times a day.



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.


For non-prescription strength eye drops, follow the package directions.


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Ocu-Phrin


If eye pain or change in vision occurs or if redness or irritation of the eye continues, gets worse, or lasts for more than 72 hours, stop using the medicine and check with your doctor.


For patients using the 2.5 or 10% eye drops:


  • After you apply this medicine to your eyes, your pupils will become unusually large. This will cause your eyes to become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor. Also, if this effect continues for longer than 12 hours after you have stopped using this medicine, check with your doctor.

Ocu-Phrin Side Effects


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


Check with your doctor as soon as possible if any of the following side effects occur:


Symptoms of too much medicine being absorbed into the body - Less common with 10% solution; rare with 2.5% or weaker solution
  • Dizziness

  • fast, irregular, or pounding heartbeat

  • increased sweating

  • increase in blood pressure

  • paleness

  • trembling

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


More common with 2.5 or 10% solution
  • Burning or stinging of eyes

  • headache or browache

  • sensitivity of eyes to light

  • watering of eyes

Less common
  • Eye irritation not present before use of this medicine

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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More Ocu-Phrin resources


  • Ocu-Phrin Use in Pregnancy & Breastfeeding
  • Ocu-Phrin Drug Interactions
  • Ocu-Phrin Support Group
  • 0 Reviews for Ocu-Phrin - Add your own review/rating


  • AK-Dilate Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • AK-Dilate Concise Consumer Information (Cerner Multum)

  • Altafrin Drops MedFacts Consumer Leaflet (Wolters Kluwer)



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Monday, 5 December 2011

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Thursday, 24 November 2011

One Touch Advanced Gel




Generic Name: benzocaine, butamben, tetracaine hydrochloride

Dosage Form: gel




Caution: Rx Only.

Do not use in eyes.  Keep out of reach of children.


Directions: Read package insert.

Press top of container to dispense desired amount.

Dispense 200 mg of gel (a bead approximately

1/4 to 1/2 inches long) by gently depressing the

pump.  Dispensing a bead in excess of 400 mg is

contraindicated.  Spread thinly and evenly over the

desired area using a cotton swab.


Active Ingredients: Benzocaine 14.0%,

Butamben 2.0%, Tetracaine Hydrochloride 2.0%

Inactive Ingredients: Benzalkonium Chloride

0.5%, Cetyl Dimethyl Ethyl Ammonium Bromide

0.005%, in a bland water-soluble base.
NDC 62565-901-01

OneTouch

Advanced



Topical Anesthetic Gel

OneTouch Advanced

is indicated for anesthesia of

accessible mucous membrane.



Cool Mint

Net Wt. 32 g



Store in a cool dry place.






Manufactured for:

HAGER

WORLDWIDE

Odessa, FL  33556 USA



Item #6256590101




Made in U.S.A.   Rev. 05/09

OneTouch

Advanced


Topical Anesthetic Gel                                                                                                                                                                           Rx Only









Active Ingredients:
Benzocaine
14.0%
Butamben
2.0%
Tetracaine Hydrochloride
2.0%
Inactive Ingredients:






Benzalkonium chloride
0.5%
Cetyl Dimethyl Ethyl Ammonium Bromide
0.005%
In bland, water-soluble base.

Action

The onset of OneTouch Advanced-produced anesthesia is rapid (approximately

30 seconds) and the duration of anesthesia is typically 30-60 minutes, when

used as directed. This effect is due to the rapid onset, but short duration of

action of Benzocaine coupled with the slow onset, but extended duration of

Tetracaine HCI and bridged by the intermediate action of Butamben.


It is believed that all of these agents act by reversibly blocking nerve conduc-­

tion. Speed and duration of action is determined by the ability of the agent to

be absorbed by the mucous membrane and nerve sheath and then to diffuse

out, and ultimately be metabolized (primarily by plasma cholinesterases) to inert

metabolites which are excreted in the urine.

Indications

OneTouch Advanced Gel is a topical anesthetic indicated for the production

of anesthesia of all accessible mucous membrane except the eyes. OneTouch

Advanced Gel is indicated for use to control pain in the mouth.



Dosage and Administration

Only a limited quantity is OneTouch Advanced Gel is required for anesthesia.


Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently

depressing the pump.  Dispensing a bead of gel in excess of 400 mg is contrain-­

dicated. Spread thinly and evenly over the desired area using a cotton swab.


An appropriate pediatric dosage has not been established for OneTouch Ad-­

vanced Gel.


Dosages should be reduced in the debilitated elderly, acutely ill, and very young

patients.


Tissue need not be dried prior to application of OneTouch Advanced Gel. One-

Touch Advanced Gel should be applied directly to the site where pain control is

required. Anesthesia is produced within one minute with an approximate duration

of thirty minutes. Each 200 mg dose of OneTouch Advanced Gel contains 28 mg

of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCI.


Adverse Reactions

Hypersensitivity Reactions: Unpredictable adverse reactions (i.e. hypersensi-­

tivity, including anaphylaxis) are extremely rare.


Localized allergic reactions may occur after prolonged or repeated use of any

aminobenzoate anesthetic. The most common adverse reaction caused by

local anesthetics is contact dermatitis characterized by erythema and pruritus

that may progress to vesiculation and oozing. This occurs most commonly in

patients following prolonged self-medication, which is contraindicated. If rash,

urticaria, edema, or other manifestations of allergy develop during use, the drug

should be discontinued. To minimize the possibility of a serious allergic reaction,

OneTouch Advanced Gel should not be applied for prolonged periods except

under continual supervision. Dehydration of the epithelium or an escharotic ef-­

fect may also result from prolonged contact.

Precaution: On rare occasions, methemoglobinemia has been reported in

connection with the use of benzocaine-containing products. Care should be

used not to exceed the maximum recommended dosage (see Dosage and

Administration). If a patient becomes cyanotic, treat appropriately to counteract

(such as with methylene blue, if medically indicated).


Use in Pregnancy: Safe use of One Touch Advanced Gel has not been

established with respect to possible adverse effects upon fetal development.

Therefore, OneTouch Advanced Gel should not be used during early pregnancy,

unless in the judgement of a physician, the potential benefits outweigh the un-­

known hazards. Routine precaution for the use of any topical anesthetic should

be observed when OneTouch Advanced Gel is used.

Contraindications

OneTouch Advanced Gel is not suitable and should never be used for injection.

Do not use on the eyes. To avoid excessive systemic absorption, OneTouch

Advanced Gel should not be applied to large areas of denuded or inflamed

tissue. OneTouch Advanced Gel should not be administered to patients who are

hypersensitive to any of its ingredients or to patients known to have cholinest-­

erase deficiencies. Tolerance may vary with status of the patient.

 

OneTouch Advanced Gel should not be used under dentures or cotton rolls, as

retention of the active gel ingredients under a denture or cotton roll could pos-­

sibly cause an escharotic effect. Routine precaution for the use of any topical

anesthetic should be observed when using OneTouch Advanced Gel.



How-Supplied

OneTouch Advanced Gel, 32 g jar











Cool Mint
NDC 62565-901-01
Strawberry Ice
NDC 62565-902-01
Bubble Gum
NDC 62565-903-01
Cherry
NDC 62565-904-01

Manufactured for

HAGER

WORLDWIDE

13322 Byrd Drive

Odessa, FL 33556 USA


Made in U.S.A.        Rev. 6/09







ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL  COOL MINT
benzocaine, butamben, tetracaine hydrochloride  gel










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)62565-901
Route of AdministrationTOPICAL, DENTALDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE)BENZOCAINE28 mg  in .2 g
BUTAMBEN (BUTAMBEN)BUTAMBEN4 mg  in .2 g
TETRACAINE HYDROCHLORIDE (TETRACAINE)TETRACAINE HYDROCHLORIDE4 mg  in .2 g






Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE1 mg  in .2 g


















Product Characteristics
Colorgreen (GREEN)Score    
ShapeSize
FlavorMINT (COOL MINT)Imprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
162565-901-011 JAR In 1 BOXcontains a JAR
132 g In 1 JARThis package is contained within the BOX (62565-901-01)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2009


Labeler - HAGER WORLDWIDE, INC. (009277971)

Registrant - HAGER WORLDWIDE, INC. (009277971)









Establishment
NameAddressID/FEIOperations
HAGER WORLDWIDE, INC.009277971manufacture
Revised: 11/2011HAGER WORLDWIDE, INC.




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  • One Touch Advanced Gel Use in Pregnancy & Breastfeeding
  • One Touch Advanced Gel Support Group
  • 0 Reviews · Be the first to review/rate this drug

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