Wednesday, 8 August 2012

Anbesol Liquid


Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B


What is Anbesol Liquid (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.


Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.


There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.


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


What is the most important information I should know about Anbesol Liquid (benzocaine topical)?


There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.


Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.


Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.


Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.


If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.


What should I discuss with my health care provider before using Anbesol Liquid (benzocaine topical)?


Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

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



  • asthma, bronchitis, emphysema, or other breathing disorder;




  • heart disease;




  • a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or




  • if you smoke.




FDA pregnancy category C. It is not known whether benzocaine 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 benzocaine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Anbesol Liquid (benzocaine topical)?


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


Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.


This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.


To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.


Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.


If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.


Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?


Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Anbesol Liquid (benzocaine topical)?


Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.


Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.


Anbesol Liquid (benzocaine topical) side effects


Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:



  • headache, tired feeling, confusion;




  • fast heart rate;




  • feeling light-headed or short of breath; and




  • pale, blue, or gray appearance of your skin, lips, or fingernails.




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 benzocaine topical and call your doctor at once if you have any of these other serious side effects:

  • headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);




  • severe burning, stinging, or sensitivity where the medicine is applied;




  • swelling, warmth, or redness; or




  • oozing, blistering, or any signs of infection.



Less serious side effects may include:



  • mild stinging, burning, or itching where the medicine is applied;




  • skin tenderness or redness; or




  • dry white flakes where the medicine was applied.



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 Anbesol Liquid (benzocaine topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. 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.



More Anbesol Liquid resources


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


  • Anbesol Liquid Advanced Consumer (Micromedex) - Includes Dosage Information

  • Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

  • Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)

  • OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Anbesol Liquid with other medications


  • Aphthous Ulcer
  • Oral and Dental Conditions


Where can I get more information?


  • Your pharmacist can provide more information about benzocaine topical.

See also: Anbesol side effects (in more detail)


Tuesday, 7 August 2012

Humalog Mix 75/25


Generic Name: insulin lispro protamine and insulin lispro (Subcutaneous route)


IN-su-lin LIS-pro PROE-ta-meen, ree-KOM-bi-nant, IN-su-lin LIS-pro, ree-KOM-bi-nant


Commonly used brand name(s)

In the U.S.


  • Humalog Mix 50/50

  • Humalog Mix 75/25

Available Dosage Forms:


  • Suspension

Therapeutic Class: Antidiabetic


Pharmacologic Class: Insulin Lispro, Recombinant


Uses For Humalog Mix 75/25


Insulin lispro protamine and insulin lispro is a combination of a fast-acting insulin and an intermediate-acting type of human insulin. Insulin is used by people with diabetes to help keep blood sugar levels under control. If you have diabetes, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health.


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


Before Using Humalog Mix 75/25


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 have not been performed on the relationship of age to the effects of insulin lispro protamine and insulin lispro combination in the pediatric population. Safety and efficacy have not been established.


Geriatric


Although appropriate studies on the relationship of age to the effects of insulin lispro protamine and insulin lispro combination have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of this medicine in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require an adjustment of dose in patients receiving this medicine.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal 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


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 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.


  • Alatrofloxacin

  • Balofloxacin

  • Ciprofloxacin

  • Clinafloxacin

  • Enoxacin

  • Fleroxacin

  • Flumequine

  • Gatifloxacin

  • Gemifloxacin

  • Grepafloxacin

  • Levofloxacin

  • Lomefloxacin

  • Moxifloxacin

  • Norfloxacin

  • Ofloxacin

  • Pefloxacin

  • Prulifloxacin

  • Rufloxacin

  • Sparfloxacin

  • Temafloxacin

  • Tosufloxacin

  • Trovafloxacin Mesylate

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.


  • Acebutolol

  • Alprenolol

  • Atenolol

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bitter Melon

  • Bucindolol

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Clorgyline

  • Dilevalol

  • Esmolol

  • Fenugreek

  • Glucomannan

  • Guar Gum

  • Iproniazid

  • Isocarboxazid

  • Labetalol

  • Levobunolol

  • Mepindolol

  • Metipranolol

  • Metoprolol

  • Moclobemide

  • Nadolol

  • Nebivolol

  • Nialamide

  • Oxprenolol

  • Pargyline

  • Penbutolol

  • Phenelzine

  • Pindolol

  • Procarbazine

  • Propranolol

  • Psyllium

  • Selegiline

  • Sotalol

  • Talinolol

  • Tertatolol

  • Timolol

  • Toloxatone

  • Tranylcypromine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


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:


  • Emotional disturbances or

  • Illness or

  • Stress—These conditions increase blood sugar and may increase the amount of insulin you need.

  • Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.

  • Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.

  • Kidney disease or

  • Liver disease—Effects of insulin lispro protamine and insulin lispro combination may be increased because of the slower removal of the medicine from the body.

Proper Use of insulin lispro protamine and insulin lispro

This section provides information on the proper use of a number of products that contain insulin lispro protamine and insulin lispro. It may not be specific to Humalog Mix 75/25. Please read with care.


Each package of insulin lispro protamine and insulin lispro combination contains a patient information leaflet. Read this leaflet carefully before beginning your treatment and each time you refill for any new information, and make sure you understand:


  • How to prepare the medicine.

  • How to inject the medicine.

  • How to use disposable insulin delivery device.

  • How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., under the skin of your abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.


When used as a mealtime insulin, this insulin combination should be taken within 15 minutes before a meal.


Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.


You should never mix insulin lispro protamine and insulin lispro combination with other insulin injections without checking with your doctor first. These injections are usually done separately. If you have questions about this, ask your doctor or pharmacist.


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 injection dosage form:
    • For diabetes mellitus:
      • Adults—The dose is based on your blood sugar and must be determined by your doctor.

      • 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 in the refrigerator. Do not freeze.


After a cartridge has been inserted into a pen, you may store the cartridge and pen at room temperature, not in the refrigerator, for up to 10 days.


Precautions While Using Humalog Mix 75/25


Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.


Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine. Blood tests may be needed to check for unwanted effects.


It is very important to follow carefully any instructions from your health care team about:


  • Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.

  • Other medicines—Do not take other medicines during the time you are taking this medicine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

  • Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.

  • Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:


  • Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

  • Keep an extra supply of insulin and syringes with needles or injection devices on hand in case high blood sugar occurs.

  • Keep some kind of quick-acting sugar handy to treat low blood sugar.

  • Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

This medicine may cause a serious allergic reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; shortness of breath; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection.


Too much insulin lispro protamine and insulin lispro combination can cause hypoglycemia (low blood sugar). Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; depression; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.


If symptoms of low blood sugar occur, eat glucose tablets or gel to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.


Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.


Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.


If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.


Humalog Mix 75/25 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
  • Anxiety

  • blurred vision

  • chills

  • cold sweats

  • coma

  • confusion

  • convulsions

  • cool, pale skin

  • cough

  • decreased urine

  • depression

  • difficulty swallowing

  • dizziness

  • dry mouth

  • fast heartbeat

  • flushing or redness of the skin

  • headache

  • hives

  • increased hunger

  • increased thirst

  • irregular heartbeat

  • itching

  • loss of appetite

  • mood changes

  • muscle pain or cramps

  • nausea or vomiting

  • nervousness

  • nightmares

  • numbness or tingling in the hands, feet, or lips

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

  • seizures

  • shakiness

  • shortness of breath

  • skin rash

  • slurred speech

  • sweating

  • swelling

  • tightness in the chest

  • unusual tiredness or weakness

  • unusually warm skin

  • wheezing

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:


Incidence not known
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

  • redistribution or accumulation of body fat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Humalog Mix 75/25 side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


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More Humalog Mix 75/25 resources


  • Humalog Mix 75/25 Side Effects (in more detail)
  • Humalog Mix 75/25 Use in Pregnancy & Breastfeeding
  • Humalog Mix 75/25 Drug Interactions
  • Humalog Mix 75/25 Support Group
  • 1 Review for Humalog Mix 75/25 - Add your own review/rating


  • Humalog Mix 75/25 Concise Consumer Information (Cerner Multum)

  • Humalog Mix 75/25 Pens MedFacts Consumer Leaflet (Wolters Kluwer)

  • Humalog Mix 75/25 Prescribing Information (FDA)

  • HumaLog Mix 75/25 Vials MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Humalog Mix 75/25 with other medications


  • Diabetes, Type 1
  • Diabetes, Type 2

Sunday, 5 August 2012

Sterilube


Generic Name: ocular lubricant (OK yoo lar LOO bri kant)

Brand Names: Artificial Tears, Celluvisc, Clear Eyes CLR, Comfort Tears, Dry Eye Relief, GenTeal, Isopto Tears, Lacri-Lube S.O.P., Lacrisert, Lubricant Eye Drops, Moisture Drops, Oasis Tears, Opti-Free Rewetting Drops, optive, Refresh, Soothe, Sterilube, Systane, Systane Balance, Tears Again, Tears Naturale, Tears Renew, TheraTears, Ultra Fresh, Visine Tears


What is Sterilube (ocular lubricant)?

There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.


Ocular lubricant is a solution specially formulated to moisten the eyes.


Ocular lubricant is used to relieve burning, irritation, and discomfort caused by dry eyes.

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


What is the most important information I should know about Sterilube (ocular lubricant)?


There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.


You should not use an ocular lubricant if you are allergic to it. Ocular lubricant will not treat or prevent an eye infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any type of infection in your eye.


Do not allow the dropper or tube tip to touch any surface, including the eyes or hands. If the dropper or tube becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.


Stop using ocular lubricant and call your doctor if you have severe burning, stinging, irritation, eye pain, or vision changes.

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.


Talk with your doctor if your symptoms do not improve or if they get worse while you are using ocular lubricant.

What should I discuss with my healthcare provider before using Sterilube (ocular lubricant)?


You should not use an ocular lubricant if you are allergic to it. Ocular lubricant will not treat or prevent an eye infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any type of infection in your eye.


Ocular lubricant is not expected to harm an unborn baby. Ask a doctor or pharmacist about using ocular lubricant if you are pregnant. It is not known whether ocular lubricant passes into breast milk or if it could harm a nursing baby. Ask a doctor or pharmacist about using ocular lubricant if you are pregnant.

How should I use Sterilube (ocular lubricant)?


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


Do not use this medication while wearing contact lenses. Eye medication may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medication before putting your contact lenses in. Wash your hands before using ocular lubricant.

To apply the eye drops:



  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.




  • Use only the number of drops your doctor has prescribed.




  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.




  • Do not use the eye drops if the liquid has changed colors or has particles in it.



To apply the ointment:



  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip.




  • Squeeze out a ribbon of ointment 1/2-inch long into the lower eyelid pocket without touching the tip of the tube to your eye. Look down and close your eyes for a few minutes. Rolling your eyes around gently will help spread the ointment evenly.




  • After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.



Do not allow the dropper or tube tip to touch any surface, including the eyes or hands. If the dropper or tube becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.


Talk with your doctor if your symptoms do not improve or if they get worse while you are using ocular lubricant. Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle or tube tightly closed when not in use.

What happens if I miss a dose?


Since ocular lubricant is used on an as needed basis, you are not likely to miss a dose.


What happens if I overdose?


An overdose of ocular lubricant is not expected to be dangerous.


What should I avoid while using Sterilube (ocular lubricant)?


This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.


Avoid using other medications in your eyes during treatment with ocular lubricant unless your doctor tells you to.


Sterilube (ocular lubricant) 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 ocular lubricant and call your doctor if you have a serious side effect such as:

  • severe burning, stinging, or eye irritation after using the medication;




  • eye pain; or




  • vision changes.



Less serious side effects may include:



  • mild eye burning or irritation;




  • itching or redness of your eyes;




  • watery eyes;




  • blurred vision; or




  • unpleasant taste in your mouth.



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


What other drugs will affect Sterilube (ocular lubricant)?


It is not likely that other drugs you take orally or inject will have an effect on ocular lubricant used in the eyes. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Sterilube resources


  • Sterilube Use in Pregnancy & Breastfeeding
  • Sterilube Support Group
  • 0 Reviews for Sterilube - Add your own review/rating


  • FreshKote Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Genteal Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lacri-Lube S.O.P. Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lacrisert Prescribing Information (FDA)

  • Lacrisert Insert MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lacrisert Advanced Consumer (Micromedex) - Includes Dosage Information

  • Murine Tears Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Murocel Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Refresh Redness Relief Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Refresh liquigel



Compare Sterilube with other medications


  • Eye Dryness/Redness


Where can I get more information?


  • Your pharmacist can provide more information about ocular lubricant.


Primaxin IV


Generic Name: imipenem and cilastatin (Intravenous route, Intramuscular route)


im-i-PEN-em, sye-la-STAT-in SOE-dee-um


Commonly used brand name(s)

In the U.S.


  • Primaxin IM

  • Primaxin IV

Available Dosage Forms:


  • Powder for Solution

Therapeutic Class: Antibiotic


Pharmacologic Class: Beta-Lactam


Chemical Class: Carbapenem


Uses For Primaxin IV


Imipenem and cilastatin combination is used in the treatment of infections caused by bacteria. It works by killing bacteria or preventing their growth. This medicine will not work for colds, flu, or other virus infections.


Imipenem and cilastatin combination is used to treat infections in many different parts of the body. It is sometimes given with other antibiotics.


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


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, imipenem and cilastatin combination is used in certain patients with the following medical conditions:


  • Febrile neutropenia (treatment)

  • Melioidosis (treatment)

Before Using Primaxin IV


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


This medicine has been tested in a limited number of children 12 years of age and older and, in effective doses, has not been reported to cause different side effects or problems in children than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of imipenem and cilastatin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy 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 receiving 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.


  • Ganciclovir

  • Theophylline

  • Valganciclovir

  • Valproic Acid

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.


  • Cyclosporine

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:


  • Central nervous system (CNS) disorders (for example, brain disease or history of seizures)—Patients with nervous system disorders, including seizures, may be more likely to have side effects

  • Kidney disease—Patients with kidney disease may be more likely to have side effects

Proper Use of imipenem and cilastatin

This section provides information on the proper use of a number of products that contain imipenem and cilastatin. It may not be specific to Primaxin IV. Please read with care.


To help clear up your infection completely, imipenem and cilastatin combination must be given for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, it must be given on a regular schedule.


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 injection dosage form:
    • For bacterial infections:
      • Adults and children 12 years of age and over—250 milligrams (mg) to 1 gram injected into a vein every six to eight hours; or 500 to 750 mg injected into a muscle every twelve hours, depending on how severe your infection is.

      • Children up to 12 years of age—Use and dose must be determined by your doctor.



Precautions While Using Primaxin IV


Some patients may develop tremors or seizures while receiving this medicine. If you already have a history of seizures and you are taking anticonvulsants, you should continue to take them unless otherwise directed by your doctor.


In some patients, imipenem and cilastatin combination may cause diarrhea.


  • Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor . Diarrhea medicines may make your diarrhea worse or make it last longer.

  • For mild diarrhea, diarrhea medicine containing kaolin (e.g., Kaopectate liquid) or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your 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 health care professional.

Primaxin IV Side Effects


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


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


More common
  • Confusion

  • convulsions (seizures)

  • dizziness

  • pain at place of injection

  • skin rash, hives, itching, fever, or wheezing

  • tremors

Less common
  • Dizziness

  • increased sweating

  • nausea or vomiting

  • unusual tiredness or weakness

Rare
  • Fever

  • severe abdominal or stomach cramps and pain

  • watery and severe diarrhea, which may also be bloody (these side effects may also occur up to several weeks after you stop receiving this medicine)

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
  • Diarrhea

  • nausea and vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Primaxin IV side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Primaxin IV resources


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


  • Primaxin IV Prescribing Information (FDA)

  • Primaxin IV Concise Consumer Information (Cerner Multum)

  • Primaxin IV MedFacts Consumer Leaflet (Wolters Kluwer)

  • Imipenem-Cilastatin Professional Patient Advice (Wolters Kluwer)

  • Primaxin IM MedFacts Consumer Leaflet (Wolters Kluwer)

  • Primaxin IM Prescribing Information (FDA)



Compare Primaxin IV with other medications


  • Aspiration Pneumonia
  • Bacteremia
  • Bacterial Infection
  • Bone infection
  • Bronchitis
  • Deep Neck Infection
  • Endocarditis
  • Endometritis
  • Febrile Neutropenia
  • Intraabdominal Infection
  • Joint Infection
  • Kidney Infections
  • Meningitis
  • Nosocomial Pneumonia
  • Pelvic Infections
  • Peritonitis
  • Pneumonia
  • Pneumonia with Cystic Fibrosis
  • Septicemia
  • Skin and Structure Infection
  • Skin Infection
  • Urinary Tract Infection

Friday, 3 August 2012

Covonia Night Time Formula





1. Name Of The Medicinal Product



Covonia Night Time Formula.


2. Qualitative And Quantitative Composition








Dextromethorphan Hydrobromide Ph.Eur.




6.65mg/5ml dose.




Diphenhydramine Hydrochloride Ph.Eur.




10.0mg/5ml dose.



Excipients : Each 5ml contains Liquid Maltitol 1.125g, Ethanol (alcohol) 7.3 Vol %



For full list of excipients see section 6.1



3. Pharmaceutical Form



Oral Solution.



4. Clinical Particulars



4.1 Therapeutic Indications



For the night time symptomatic relief of unproductive cough and congestive symptoms associated with colds.



4.2 Posology And Method Of Administration



Posology



Adults, the Elderly and Children over 12 years



3 X 5ml spoonfuls at bedtime. Repeat after 6 hours if required



4.3 Contraindications



Contraindicated in known hypersensitivity to any of the ingredients. Contraindicated in persons under treatment with monoamine oxidase inhibitors or within 2 weeks of discontinuation of MAOI use.



Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to patients in, or at risk of developing, respiratory failure.



Covonia Night Time Formula should not be used in liver dysfunction. It should not be administered to patients where cough is associated with asthma or patients with productive cough.



4.4 Special Warnings And Precautions For Use



Precautions for use



Because of their antimuscarinic properties antihistamines should be used with care in conditions such as closed angle glaucoma, urinary retention, prostatic hyperplasia or pyeloduodenal obstruction. Caution should also be exercised in patients with epilepsy or severe cardiovascular disorders. Caution is needed for the use of dextromethorphan in patients with a history of asthma.



Patients with rare hereditary problems of fructose intolerance should not take this medicine.



It also contains 7.3vol% ethanol (alcohol), i.e. up to 870mg per dose, equivalent to 22ml of beer or 9ml of wine per dose.



Harmful if suffering from alcoholism.



Special warnings



If symptoms persist consult your doctor.



Keep out of the reach and sight of children.



Do not exceed the stated dose.



Causes drowsiness which may continue the next day. If affected to not drive or operate machinery.



Avoid alcoholic drink.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Dextromethorphan should not be used in persons under treatment with monoamine oxidase inhibitors or within 2 weeks of discontinuation of MAOI use in view of the potential risk of a severe or fatal interaction. Cimetidine inhibits the metabolism of opioid analgesics.



Diphenhydramine has additive sedative effects with alcohol and other CNS depressants. It may also have additive antimuscarinic effects with antimuscarinic drugs.



4.6 Pregnancy And Lactation



Although dextromethorphan and diphenhydramine have been in widespread use for many years, insufficient data are available on their use during pregnancy. Use during pregnancy is inadvisable unless there is a clear need. Caution should, therefore, be exercised by balancing the potential benefits of treatment against any possible hazards.



It is not known if dextromethorphan or its metabolites are excreted in human breast milk. Diphenhydramine is excreted in breast milk but the amount has not been quantified. Covonia Night Time Formula is, therefore, best avoided during breast feeding.



4.7 Effects On Ability To Drive And Use Machines



Diphenhydramine may cause drowsiness, persons so affected should be advised not to drive or to operate machinery.



4.8 Undesirable Effects



Side-effects are uncommon with dextromethorphan. Rarely, drowsiness, nausea, vomiting, dizziness and gastro-intestinal disturbances may occur.



The most common effects of diphenhydramine are drowsiness and a lowered ability to concentrate. Other effects include dizziness, nausea, nervousness, ataxia, abnormal vision, tremor and vomiting. Antimuscarinic effects may include dry mouth, thickened mucous secretions, palpitations and urinary tract dysfunction. Administration of antihistamines has also been associated with rash, angioedema, convulsions and paresthesias.



4.9 Overdose



Acute overdose of dextromethorphan does not usually result in serious signs and symptoms unless very large amounts have been ingested. Signs and symptoms of substantial overdose may include nausea and vomiting, CNS disturbances (hyperexcitability, irritability, mental confusion, lethargy, somnolence, ataxia, auditory and visual hallucinations), nystagmus and respiratory depression.



Mild cases of diphenhydramine overdose are mainly characterised by prominent antimuscarinic effects including dry mouth, headache, nausea, tachycardia and urinary retention. Larger doses produce depression or stimulation of the CNS. In small children, the stimulatory effects predominate and clinical features include hallucinations and convulsions. Adults usually develop drowsiness first, then convulse and lapse into coma at later stage. Fever and flushing is seen in children but is uncommon in adults.



Gastric lavage should be used if indicated. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children. Convulsions can be controlled with diazepam. Other treatment is supportive and symptomatic and may include artificial respiration, external cooling for hyperpyrexia and intravenous fluids.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC Code: RO5 DA – Opium Alkaloids and Derivatives



Dextromethorphan



Dextromethorphan is a non-opioid, centrally acting cough suppressant. It raises the threshold for the cough reflex in the medulla oblongata. In therapeutic doses, it has no significant analgesic, respiratory depressant, euphoriant or dependence-producing properties. It does not inhibit ciliary function.



Diphenhydramine



Diphenhydramine is an ethanolamine H1 histamine receptor antagonist. It possesses antitussive, sedative, antimuscarinic and antiemetic properties. Antihistamines, like diphenhydramine, are useful for controlling nasal itching, sneezing and rhinorrhoea but are less effective for the relief of nasal congestion.



5.2 Pharmacokinetic Properties



Dextromethorphan



Dextromethorphan is rapidly absorbed from the gastrointestinal tract following oral administration. It is subject to extensive presystematic metabolism resulting in very low peak plasma concentrations of 1.8ng/ml within 2.5 hours of an oral dose. Peak concentrations of the main metabolite, dextrophan occur 1-2 hours after ingestion. The terminal plasma elimination half-life of dextrophan is about three hours.



It is not known if dextromethorphan or dextrophan is excreted into breast milk or crosses the placenta.



Dextromethorphan is extensively metabolised in the liver. It is mainly metabolised to dextrophan by O-demethylation involving the cytochrome P45011D6 isozyme, which is then conjugated by UDP-glucuronosyl transferases. Up to 9% of individuals have been found to be poor metabolisers and the half-life of dextromethorphan may be extremely prolonged in these people.



Less than 1% of the dose of dextromethorphan is excreted in the faeces. Urinary excretion of parent drug and metabolites accounts for up to 50% of the ingested dose over 24 hours.



Diphenhydramine



Diphenhydrainine is well absorbed from the gastrointestinal tract but its availability varies between 26 and 60% due to first pass metabolism. Peak plasma concentrations are achieved about 1 to 4 hours after oral administration. The plasma elimination half-life is 3.3 hours.



Diphenhydramine is widely distributed throughout the body including the CNS. It crosses the placenta and has been detected in breast milk. It is highly (85-98%) bound to plasma proteins.



Orientals have lower plasma levels, lower protein binding and a higher volume of distribution and higher plasma clearance, but not half-life, than Caucasians.



Diphenhydramine is extensively metabolised mainly in the liver. It is N-demethylated to monodesmethyldiphenhydramine and didesmethyldiphenhydramine. The resultant primary amine is oxidatively deaminated to yield the carboxylic acid, diphenylmethoxy acetic acid which may be conjugated with glutamine or glycine.



Diphenhydramine is excreted mainly in the urine with very little excreted as unchanged drug.



5.3 Preclinical Safety Data



Dextromethorphan



A 13 weeks dietary study in rats has shown no evidence of toxicity at the 0.1mg/kg dextromethorphan level. Dextromethorphan has been reported to have no mutagenic potential in two species and no effect on perinatal or postnatal mortality in high doses.



Diphenhydramine



In the rat, administration of 12mg/kg i.p. diphenhydramine hydrochloride has been reported to produce foetal mortality and mortality in the offspring up to the tenth day after birth. Doses up to 20 and 25 times the human dose (on a mg/kg basis) exert no teratogenic effects in rats and rabbits.



There is no evidence for diphenydramine being mutagenic or carcinogenic in man.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Sodium Benzoate



Ethanol (96%)



Hydroxyethylcellulose. (Natrosol G PH).



Povidone K30.



Glycerol.



Liquid Sorbitol Non-Crystallising.



Liquid Maltitol



Saccharin Sodium.



Capsicum Tincture.



Menthol.



Peppermint Oil.



Anise Oil.



Citric Acid Monohydrate.



Macrogol Cetostearyl Ether



Caramel.



Blackcurrant Flavour 1122267 – containing propylene glycol.



6.2 Incompatibilities



None.



6.3 Shelf Life



36 months.



6.4 Special Precautions For Storage



Store below 25°C. Protect from light.



6.5 Nature And Contents Of Container



150ml amber soda glass bottle with 28mm tamper evident child resistant closure with EPE/ Saranex liner.



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Thornton & Ross Ltd.



Linthwaite Laboratories



Huddersfield



HD7 5QH.



8. Marketing Authorisation Number(S)



PL: 00240/0042



9. Date Of First Authorisation/Renewal Of The Authorisation



23.09.97



10. Date Of Revision Of The Text



04/05/2010




Thursday, 2 August 2012

Tylenol w/Codeine


Generic Name: acetaminophen and codeine (Oral route)


a-seet-a-MIN-oh-fen, KOE-deen FOS-fate


Oral route(Tablet)

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg/day, and often involve more than one acetaminophen-containing product .



Commonly used brand name(s)

In the U.S.


  • APAP w/Codeine

  • Capital w/Codeine

  • Pyregesic-C

  • Tylenol w/Codeine

  • Tylenol w/Codeine #3

  • Tylenol w/Codeine #4

  • Tylenol with Codeine No. 3

  • Vopac

Available Dosage Forms:


  • Tablet

  • Capsule

  • Elixir

  • Suspension

  • Solution

Therapeutic Class: Opioid/Acetaminophen Combination


Chemical Class: Codeine


Uses For Tylenol w/Codeine


Acetaminophen and codeine oral suspension is used to relieve mild to moderate pain. The oral tablets are used to relieve mild to moderately severe pain.


Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.


Codeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.


When codeine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.


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


Before Using Tylenol w/Codeine


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 have not been performed on the relationship of age to the effects of acetaminophen and codeine oral suspension in children younger than 3 years of age. Safety and efficacy have not been established.


No information is available on the relationship of age to the effects of acetaminophen and codeine tablets in the pediatric population. Safety and efficacy have not been established.


Geriatric


No information is available on the relationship of age to the effects of acetaminophen and codeine combination in geriatric patients.


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.


  • Naltrexone

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.


  • Adinazolam

  • Alfentanil

  • Alprazolam

  • Amobarbital

  • Anileridine

  • Aprobarbital

  • Bromazepam

  • Brotizolam

  • Buprenorphine

  • Butabarbital

  • Butalbital

  • Butorphanol

  • Carisoprodol

  • Chloral Hydrate

  • Chlordiazepoxide

  • Chlorzoxazone

  • Clobazam

  • Clonazepam

  • Clorazepate

  • Codeine

  • Dantrolene

  • Dezocine

  • Diazepam

  • Estazolam

  • Ethchlorvynol

  • Fentanyl

  • Flunitrazepam

  • Flurazepam

  • Halazepam

  • Hydrocodone

  • Hydromorphone

  • Ketazolam

  • Levorphanol

  • Lorazepam

  • Lormetazepam

  • Medazepam

  • Meperidine

  • Mephenesin

  • Mephobarbital

  • Meprobamate

  • Metaxalone

  • Methocarbamol

  • Methohexital

  • Midazolam

  • Morphine

  • Morphine Sulfate Liposome

  • Nalbuphine

  • Nitrazepam

  • Nordazepam

  • Opium

  • Oxazepam

  • Oxycodone

  • Oxymorphone

  • Pentazocine

  • Pentobarbital

  • Phenobarbital

  • Prazepam

  • Propoxyphene

  • Quazepam

  • Remifentanil

  • Secobarbital

  • Sodium Oxybate

  • Sufentanil

  • Tapentadol

  • Temazepam

  • Thiopental

  • Triazolam

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

  • Carbamazepine

  • Isoniazid

  • Phenytoin

  • Warfarin

  • Zidovudine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Cabbage

  • Ethanol

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:


  • Addison's disease (adrenal gland problem) or

  • Alcohol abuse, history of or

  • Breathing problems (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia) or

  • CNS depression or

  • Drug dependence, especially narcotic abuse or dependence, or history of or

  • Enlarged prostate (BPH, prostatic hypertrophy) or

  • Hypothyroidism (an underactive thyroid) or

  • Problems with passing urine—Use with caution. May increase risk for more serious side effects.

  • Allergy to sulfites or

  • Asthma—Tylenol® with codeine tablets contains sodium metabisulfite, which can cause allergic reactions in patients with these conditions.

  • Brain tumor or

  • Head injuries or

  • Increased pressure in the head—Some of the side effects of codeine can cause serious problems in people who have these medical problems.

  • Kidney disease or

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

  • Respiratory depression (hypoventilation or slow breathing)—Use with caution. May make this condition worse.

  • Stomach or digestion problems—This medicine may mask the diagnosis of these conditions.

Proper Use of acetaminophen and codeine

This section provides information on the proper use of a number of products that contain acetaminophen and codeine. It may not be specific to Tylenol w/Codeine. 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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.


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


This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).


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 form (suspension):
    • For mild to moderate pain:
      • Adults—15 milliliters (mL) or 1 tablespoonful every 4 hours as needed.

      • Children 7 to 12 years of age—10 mL (2 teaspoonfuls) 3 or 4 times per day.

      • Children 3 to 6 years of age—5 mL (1 teaspoonful) 3 or 4 times per day.

      • Children younger than 3 years of age—Use and dose must be determined by your doctor.



  • For oral dosage form (tablets):
    • For mild to moderately severe pain:
      • Adults—15 to 60 milligrams (mg) of codeine and 300 to 1000 mg of acetaminophen every 4 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 360 mg of codeine and 4000 mg of acetaminophen per 24 hours.

      • 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


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Tylenol w/Codeine


It is very important that your doctor check the progress of you or your child while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.


It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal this medicine.


This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.


This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.


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


This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.


This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.


Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.


For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):


  • Contact your doctor right away if you have extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.


Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.


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


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, especially those containing acetaminophen (Tylenol (R)), and herbal or vitamin supplements.


Tylenol w/Codeine Side Effects


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


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


More common
  • Difficult or troubled breathing

  • irregular, fast or slow, or shallow breathing

  • pale or blue lips, fingernails, or skin

  • shortness of breath

Incidence not known
  • Black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • cough or hoarseness

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • fever with or without chills

  • general feeling of tiredness or weakness

  • hives

  • itching

  • lower back or side pain

  • painful or difficult urination

  • pinpoint red spots on the skin

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

  • skin rash

  • sore throat

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

  • tightness in the chest

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Abdominal or stomach pain

  • bloody or cloudy urine

  • chills

  • constricted, pinpoint, or small pupils (black part of the eye)

  • convulsion

  • dark urine

  • headache

  • increased sweating

  • light-colored stools

  • loss of appetite

  • loss of consciousness

  • nausea

  • sudden decrease in the amount of urine

  • unpleasant breath odor

  • vomiting

  • vomiting of blood

  • 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:


More common
  • Drowsiness

  • lightheadedness

  • relaxed and calm

  • sleepiness

Incidence not known
  • Difficulty having a bowel movement (stool)

  • false or unusual sense of well-being

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tylenol w/Codeine side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Tylenol w/Codeine resources


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


Compare Tylenol w/Codeine with other medications


  • Cough
  • Osteoarthritis
  • Pain

Wednesday, 1 August 2012

Fluor-A-Day


Generic Name: fluoride (FLOR ide)

Brand Names: Altaflor, Ethedent Chewable, Fluor-A-Day, Fluoritab, Flura-Drops, Flura-Loz, Flura-Tab, Karidium, Lozi-Flur, Luride, Nafrinse, Pharmaflur, Pharmaflur 1.1


What is Fluor-A-Day (fluoride)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.


Fluoride is used as a medication to prevent tooth decay in people that have a low level of fluoride in their drinking water. Fluoride is also used to prevent tooth decay in people who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.


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


What is the most important information I should know about Fluor-A-Day (fluoride)?


You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.


Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.


What should I discuss with my healthcare provider before taking Fluor-A-Day (fluoride)?


You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.


Talk to your doctor and dentist before taking fluoride if you are pregnant or could become pregnant during treatment. Talk to your doctor and dentist before taking fluoride if you are breast-feeding. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age; the American Academy of Pediatrics recommends fluoride supplementation by children until the age of 16 years of age. Do not give a 1-mg tablet to a child younger than 3 years old, or when your drinking water fluoride content is equal to or greater than 0.3 ppm.

How should I take Fluor-A-Day (fluoride)?


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.


Take this medicine with a full glass of water. Do not take fluoride with milk or other dairy products. Calcium can make it harder for your body to absorb fluoride.

Suck on the fluoride lozenge until it dissolves completely in your mouth. Do not chew the lozenge or swallow it whole.


The chewable forms of fluoride can be chewed, swallowed, dissolved in the mouth, added to drinking water or fruit juice, or added to water for use in infant formula or other food.


The fluoride drops can be taken by mouth undiluted, or mixed with fluid or food.


If you mix fluoride with food or water, drink or eat this mixture right away. Do not save it for later use.


It is important to take fluoride regularly to get the most benefit.


Store fluoride at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).


What should I avoid while taking Fluor-A-Day (fluoride)?


Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.


Fluor-A-Day (fluoride) 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. Call your doctor if you have any of the following side effects:

  • discolored teeth;




  • weakened tooth enamel; or




  • any changes in the appearance of your teeth.



Less serious side effects may include:



  • stomach upset;




  • headache; or




  • weakness.



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 Fluor-A-Day (fluoride)?


There may be other drugs that can interact with fluoride. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



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 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

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

  • Epiflur Prescribing Information (FDA)

  • Fluor-a-Day Prescribing Information (FDA)

  • 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


Where can I get more information?


  • Your pharmacist can provide more information about fluoride.

See also: Fluor-A-Day side effects (in more detail)