Wednesday, 30 May 2012

Amcinonide Cream


Pronunciation: am-SIN-oh-nide
Generic Name: Amcinonide
Brand Name: Cyclocort


Amcinonide Cream is used for:

Treating inflammation and itching due to certain skin conditions.


Amcinonide Cream is a topical corticosteroid. It works to reduce skin inflammation (redness, swelling, itching, and irritation) in a way that is not clearly understood.


Do NOT use Amcinonide Cream if:


  • you are allergic to any ingredient in Amcinonide Cream

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



Before using Amcinonide Cream:


Some medical conditions may interact with Amcinonide Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


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

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

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

  • if you have a skin infection, thinning of the skin, measles, tuberculosis, a positive tuberculin skin test, or chickenpox, or you have had a recent vaccination

Some MEDICINES MAY INTERACT with Amcinonide Cream. Because little, if any, of Amcinonide Cream is absorbed into the blood, the risk of it interacting with another medicine is low.


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


How to use Amcinonide Cream:


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


  • Apply a thin film of medicine to the affected area. Gently rub the medicine in until it is evenly distributed.

  • Wash your hands after applying Amcinonide Cream, unless your hands are part or the treated area.

  • Do not use a bandage or other covering or wrap on the treated skin unless directed to do so by your health care provider.

  • If you miss a dose of Amcinonide Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Amcinonide Cream.



Important safety information:


  • Amcinonide Cream is for external use only. Avoid contact with the eyes. If you get Amcinonide Cream in your eyes, flush immediately with a generous amount of cool tap water.

  • Parents should not use tight-fitting diapers or plastic pants on a child being treated in the diaper area.

  • Do not exceed the recommended dose or use Amcinonide Cream for longer than the time prescribed without checking with your doctor.

  • Do not use Amcinonide Cream for other skin conditions at a later time.

  • Amcinonide Cream contains a corticosteroid. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains hydrocortisone or any other corticosteroid. If it does or if you are uncertain, contact your doctor or pharmacist.

  • Check with your doctor before having vaccinations while using Amcinonide Cream.

  • Corticosteroids may affect the growth rate in CHILDREN and adolescents in some instances. Your child's growth may need to be checked regularly while using Amcinonide Cream.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Amcinonide Cream during pregnancy. It is unknown if Amcinonide Cream is excreted in breast milk after topical use. Do not breast-feed while you are using Amcinonide Cream.


Possible side effects of Amcinonide Cream:


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



Dryness; itching.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, redness, or peeling not present before you began using Amcinonide Cream; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.



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


See also: Amcinonide side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms of may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.


Proper storage of Amcinonide Cream:

Store Amcinonide Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Amcinonide Cream out of the reach of children and away from pets.


General information:


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

  • Amcinonide Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

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



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Amcinonide resources


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


Compare Amcinonide with other medications


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Phos-Flur


Generic Name: sodium fluoride (Oral route, Dental route, Oromucosal route)


SOE-dee-um FLOOR-ide


Commonly used brand name(s)

In the U.S.


  • APF Gel

  • Aquafresh

  • CaviRinse

  • Control Rx

  • Denta 5000 Plus

  • Dentagel

  • Dentall 1100 Plus

  • EtheDent

  • Fluorabon

  • Fluor-A-Day

  • Fluoridex Daily Defense

  • Fluoridex Daily Defense Enhanced Whitening

In Canada


  • Fluorosol

  • Koala Pals Fluoride Tooth Gel - Berrylicious Flavor

  • Pdf

  • Pedi-Dent

Available Dosage Forms:


  • Gel/Jelly

  • Tablet, Chewable

  • Paste

  • Solution

  • Liquid

  • Tablet, Enteric Coated

  • Tablet

  • Lozenge/Troche

  • Cream

Therapeutic Class: Cariostatic


Uses For Phos-Flur


Fluoride has been found to be helpful in reducing the number of cavities in the teeth. It is usually present naturally in drinking water. However, some areas of the country do not have a high enough level in the water to prevent cavities. To make up for this, extra fluoride may be added to the diet. Some children may require both dietary fluoride and topical fluoride treatments by the dentist. Use of a fluoride toothpaste or rinse may be helpful as well.


Taking extra oral fluoride does not replace good dental habits. These include eating a good diet, brushing and flossing the teeth often, and having regular dental checkups.


Fluoride may also be used for other conditions as determined by your doctor.


This medicine is available only with a prescription.


Importance of Diet


For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.


People get needed fluoride from fish, including the bones, tea, and drinking water that has fluoride added to it. Food that is cooked in water containing fluoride or in Teflon-coated pans also provides fluoride. However, foods cooked in aluminum pans provide less fluoride.


The daily amount of fluoride needed is defined in several different ways.


  • For U.S.—

  • Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

  • Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

  • For Canada—

  • Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

There is no RDA or RNI for fluoride. Daily recommended intakes for fluoride are generally defined as follows:


  • Infants and children—

  • Birth to 3 years of age: 0.1 to 1.5 milligrams (mg).

  • 4 to 6 years of age: 1 to 2.5 mg.

  • 7 to 10 years of age: 1.5 to 2.5 mg.

  • Adolescents and adults—

  • 1.5 to 4 mg.

Remember:


  • The total amount of fluoride you get every day includes what you get from the foods and beverages that you eat and what you may take as a supplement.

  • This total amount should not be greater than the above recommendations, unless ordered by your health care professional. Taking too much fluoride can cause serious problems to the teeth and bones.

Before Using Phos-Flur


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


Problems in children have not been reported with intake of normal daily recommended amounts. Doses of sodium fluoride that are too large or are taken for a long time may cause bone problems and teeth discoloration in children.


Geriatric


Problems in older adults have not been reported with intake of normal daily recommended amounts. Older people are more likely to have joint pain, kidney problems, or stomach ulcers which may be made worse by taking large doses of sodium fluoride. You should check with your health care professional.


Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


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 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.


  • Dairy Food

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:


  • Brown, white, or black discoloration of teeth or

  • Joint pain or

  • Kidney problems (severe) or

  • Stomach ulcer—Sodium fluoride may make these conditions worse.

Proper Use of sodium fluoride

This section provides information on the proper use of a number of products that contain sodium fluoride. It may not be specific to Phos-Flur. Please read with care.


Take this medicine only as directed by your health care professional. Do not take more of it and do not take it more often than ordered. Taking too much fluoride over a period of time may cause unwanted effects.


For individuals taking the chewable tablet form of this medicine:


  • Tablets should be chewed or crushed before they are swallowed.

  • This medicine works best if it is taken at bedtime, after the teeth have been thoroughly brushed. Do not eat or drink for at least 15 minutes after taking sodium fluoride.

For individuals taking the oral liquid form of this medicine:


  • This medicine is to be taken by mouth even though it comes in a dropper bottle. The amount to be taken is to be measured with the specially marked dropper.

  • Always store this medicine in the original plastic container. Fluoride will affect glass and should not be stored in glass containers.

  • This medicine may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food. However, if this medicine is mixed with foods or beverages that contain calcium, the amount of sodium fluoride that is absorbed may be reduced.

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 (lozenges, solution, tablets, or chewable tablets):
    • To prevent cavities in the teeth (not enough fluoride in the water):
      • Children—Dose is based on the amount of fluoride in drinking water in your area. Dose is also based on the child's age and must be determined by your health care professional.



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.


Precautions While Using Phos-Flur


The level of fluoride present in the water is different in different parts of the U.S. If you move to another area, check with a health care professional in the new area as soon as possible to see if this medicine is still needed or if the dose needs to be changed. Also, check with your health care professional if you change infant feeding habits (e.g., breast-feeding to infant formula), drinking water (e.g., city water to nonfluoridated bottled water), or filtration (e.g., tap water to filtered tap water).


Do not take calcium supplements or aluminum hydroxide–containing products and sodium fluoride at the same time. It is best to space doses of these two products 2 hours apart, to get the full benefit from each medicine.


Inform your health care professional as soon as possible if you notice white, brown, or black spots on the teeth. These are signs of too much fluoride in children when it is given during periods of tooth development.


Phos-Flur 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:


Sodium fluoride in drinking water or taken as a supplement does not usually cause any side effects. However, taking an overdose of fluoride may cause serious problems.


  • Sores in the mouth and on the lips (rare)

Stop taking this medicine and get emergency help immediately if any of the following effects occur:


  • Black, tarry stools

  • bloody vomit

  • diarrhea

  • drowsiness

  • faintness

  • increased watering of the mouth

  • nausea or vomiting

  • shallow breathing

  • stomach cramps or pain

  • tremors

  • unusual excitement

  • watery eyes

  • weakness

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


  • Pain and aching of bones

  • stiffness

  • white, brown, or black discoloration of the teeth—occurs only during periods of tooth development in children

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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Monday, 28 May 2012

clomipramine


kloe-MIP-ra-meen


Oral route(Capsule)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) .



Commonly used brand name(s)

In the U.S.


  • Anafranil

Available Dosage Forms:


  • Capsule

  • Tablet

Therapeutic Class: Antidepressant


Pharmacologic Class: Antidepressant, Tricyclic


Uses For clomipramine


Clomipramine is used to treat obsessive compulsive disorder (OCD). clomipramine is a tricyclic antidepressant (TCA). OCD is a nervous condition where a person has recurring thoughts or ideas, or does repetitive things because they are anxious .


Clomipramine works on the central nervous system (CNS) to relieve the symptoms of OCD. It is thought to work by increasing the activity of a chemical called serotonin in the brain .


clomipramine is available only with your doctor's prescription .


Before Using clomipramine


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 clomipramine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to clomipramine 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 clomipramine in children younger than 10 years of age. Safety and efficacy have not been established .


Geriatric


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


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 clomipramine, 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 clomipramine 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.


  • Bepridil

  • Cisapride

  • Clorgyline

  • Dronedarone

  • Grepafloxacin

  • Isocarboxazid

  • Linezolid

  • Mesoridazine

  • Methylene Blue

  • Metoclopramide

  • Moclobemide

  • Phenelzine

  • Pimozide

  • Ranolazine

  • Selegiline

  • Sparfloxacin

  • Thioridazine

  • Tranylcypromine

Using clomipramine 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.


  • Alfuzosin

  • Amiodarone

  • Amitriptyline

  • Amoxapine

  • Amprenavir

  • Apomorphine

  • Arsenic Trioxide

  • Asenapine

  • Astemizole

  • Atazanavir

  • Azithromycin

  • Chloroquine

  • Chlorpromazine

  • Ciprofloxacin

  • Citalopram

  • Clarithromycin

  • Clonidine

  • Clozapine

  • Crizotinib

  • Dasatinib

  • Desipramine

  • Dextromethorphan

  • Disopyramide

  • Dofetilide

  • Dolasetron

  • Droperidol

  • Epinephrine

  • Erythromycin

  • Etilefrine

  • Flecainide

  • Fluconazole

  • Gatifloxacin

  • Gemifloxacin

  • Granisetron

  • Halofantrine

  • Haloperidol

  • Ibutilide

  • Iloperidone

  • Imipramine

  • Indacaterol

  • Iproniazid

  • Lapatinib

  • Levofloxacin

  • Lopinavir

  • Lumefantrine

  • Mefloquine

  • Methadone

  • Methoxamine

  • Midodrine

  • Moricizine

  • Moxifloxacin

  • Nefopam

  • Nialamide

  • Nilotinib

  • Norepinephrine

  • Norfloxacin

  • Nortriptyline

  • Octreotide

  • Ofloxacin

  • Olanzapine

  • Ondansetron

  • Oxilofrine

  • Paliperidone

  • Pargyline

  • Pazopanib

  • Perflutren Lipid Microsphere

  • Phenylephrine

  • Posaconazole

  • Procainamide

  • Procarbazine

  • Prochlorperazine

  • Promethazine

  • Propafenone

  • Protriptyline

  • Quetiapine

  • Quinidine

  • Quinine

  • Rasagiline

  • Saquinavir

  • Sertraline

  • Sodium Phosphate

  • Sodium Phosphate, Dibasic

  • Sodium Phosphate, Monobasic

  • Solifenacin

  • Sorafenib

  • Sotalol

  • Sunitinib

  • Tapentadol

  • Telavancin

  • Telithromycin

  • Terfenadine

  • Tetrabenazine

  • Toloxatone

  • Toremifene

  • Tramadol

  • Trazodone

  • Trifluoperazine

  • Trimipramine

  • Vandetanib

  • Vardenafil

  • Vasopressin

  • Vemurafenib

  • Venlafaxine

  • Voriconazole

  • Ziprasidone

Using clomipramine 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

  • Arbutamine

  • Atomoxetine

  • Cannabis

  • Dicumarol

  • Enalaprilat

  • Enalapril Maleate

  • Fluvoxamine

  • Modafinil

  • Paroxetine

  • Phenprocoumon

  • S-Adenosylmethionine

  • Valproic Acid

  • Yohimbine

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


  • Grapefruit Juice

Other Medical Problems


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


  • Adrenal gland tumor (e.g., pheochromocytoma, neuroblastoma) or

  • Glaucoma, history of or

  • Heart disease or

  • Hypomania or

  • Liver disease or

  • Mania or

  • Overactive thyroid or

  • Schizophrenia or

  • Seizures, history of or

  • Urinary retention (trouble urinating), history of—Use with caution. May make these conditions worse.

  • Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or

  • Heart attack, recent—Should not be used in patients with these conditions.

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

Proper Use of clomipramine


Take clomipramine only as directed by your doctor to benefit your condition as much as possible. 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 .


It is best to take clomipramine with food .


clomipramine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one .


Dosing


The dose of clomipramine 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 clomipramine. 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 (capsules):
    • For obsessive-compulsive disorder:
      • Adults, teenagers, and children above 10 years of age—At first, 25 milligrams (mg) once a day with a meal. Your doctor may increase your dose if needed, and tell you to take the daily dose in evenly divided portions during the day. However, the dose is usually not more than 250 mg per day for adults and 200 mg per day for children.

      • Children below 10 years of age—Use and dose must be determined by your doctor .



Missed Dose


If you miss a dose of clomipramine, 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 clomipramine


It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects. Blood tests may be needed to check for any unwanted effects .


Clomipramine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away .


Do not take clomipramine if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Do not start taking a MAO inhibitor within 2 weeks of stopping clomipramine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions .


Do not stop taking clomipramine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as dizziness, headache, nausea, vomiting, trouble sleeping, irritability, high fever, or a general feeling of discomfort or illness .


clomipramine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using clomipramine.


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


Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using clomipramine. Taking clomipramine together with medicines used during surgery or dental or emergency treatments may increase the risk of side effects .


clomipramine may cause men to have problems with sex. Check with your doctor if you are having an abnormal ejaculation or decreased sexual performance or desire .


Weight changes may occur during treatment with clomipramine. Talk with your doctor if this is a concern for you .


clomipramine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to clomipramine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.


clomipramine 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
  • Bladder pain

  • bloody or cloudy urine

  • blurred vision

  • body aches or pain

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

  • confusion

  • congestion

  • continuing ringing or buzzing or other unexplained noise in ears

  • cough

  • difficult, burning, or painful urination

  • discouragement

  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

  • dryness or soreness of throat

  • excessive muscle tone

  • fear or nervousness

  • feeling sad or empty

  • fever

  • frequent urge to urinate

  • hearing loss

  • hoarseness

  • irritability

  • lack of appetite

  • loss of interest or pleasure

  • lower back or side pain

  • muscle stiffness

  • muscle tension or tightness

  • muscle twitching or jerking

  • pain or tenderness around eyes and cheekbones

  • poor concentration

  • problems in urination or increase in amount of urine

  • rhythmic movement of muscles

  • runny nose

  • shortness of breath or troubled breathing

  • sleeplessness

  • sneezing

  • stuffy nose

  • sweating

  • tender, swollen glands in neck

  • tightness of chest or wheezing

  • tiredness trouble concentrating

  • trouble in swallowing

  • trouble remembering

  • trouble sleeping

  • unable to sleep

  • unusual tiredness or weakness

  • voice changes

Less common
  • Anxiety

  • attack, assault, force

  • bloody nose

  • breast enlargement

  • burning, dry, or itching eyes

  • burning while urinating

  • changes in vision

  • chills

  • crying

  • decrease in frequency of urination

  • decrease in urine volume

  • depersonalization

  • difficulty in passing urine (dribbling)

  • difficulty in speaking

  • discharge, excessive tearing

  • dry mouth

  • dysphoria

  • earache

  • euphoria

  • fast, irregular, pounding, or racing heartbeat or pulse

  • feeling of unreality

  • headache, severe and throbbing

  • hyperventilation

  • increased clear or white vaginal discharge

  • increased watering of the mouth

  • irregular heartbeats

  • irritability

  • itching of the vagina or genital area

  • mental depression

  • nausea or vomiting

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

  • pain during sexual intercourse

  • painful urination

  • pale skin

  • panic reaction

  • paranoia

  • partial or slight paralysis

  • quick to react or overreact emotionally

  • rapidly changing moods

  • redness or swelling in ear

  • redness, pain, or swelling of eye, eyelid, or inner lining of eyelid

  • restlessness

  • sense of detachment from self or body

  • shaking

  • swelling of face, fingers, feet, and/or lower legs

  • thick, white vaginal discharge with no odor or with a mild odor

  • troubled breathing with exertion

  • unusual bleeding or bruising

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


Symptoms of overdose
  • Bigger, dilated, or enlarged pupils (black part of eye)

  • cold clammy skin

  • confusion as to time, place, or person

  • decreased awareness or responsiveness

  • disorientation

  • drowsiness to profound coma

  • hallucination

  • holding false beliefs that cannot be changed by fact

  • increased or excessive unconscious or jerking movements

  • increased sensitivity of eyes to light

  • irregular, fast or slow, or shallow breathing

  • lethargy

  • mood or other mental changes

  • pale or blue lips, fingernails, or skin

  • seizures

  • severe sleepiness

  • unusual excitement, nervousness, or restlessness

  • 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:


More common
  • Acid or sour stomach

  • bad, unusual or unpleasant aftertaste

  • belching

  • blemishes on the skin

  • blistering, crusting, irritation, itching, or reddening of skin

  • bloated

  • change in taste

  • change or problem with discharge of semen

  • changes in vision

  • constipation

  • cracked, dry, or scaly skin

  • cramps

  • darkening or lightening of skin color

  • decreased interest in sexual intercourse

  • diarrhea

  • difficulty in moving

  • dry skin

  • excess air or gas in stomach or intestines

  • feeling of warmth

  • full feeling

  • heartburn

  • heavy bleeding

  • hives or welts

  • inability to have or keep an erection

  • increased appetite

  • increased in sexual ability, desire, drive, or performance

  • increased interest in sexual intercourse

  • indigestion

  • joint pain

  • loss in sexual ability, desire, drive, or performance

  • pain

  • passing gas

  • pimples

  • redness of skin

  • redness of the face, neck, arms and occasionally, upper chest

  • shakiness in legs, arms, hands, or feet

  • skin rash

  • stomach discomfort, upset, or pain

  • swelling

  • swollen joints

  • tooth disorder

  • trembling or shaking of hands or feet

Less common
  • Absent, missed, or irregular menstrual periods

  • breast pain

  • difficulty swallowing

  • increased yawning

  • pinpoint red or purple spots on skin

  • sores, ulcers, or white spots on lips or tongue or inside the mouth

  • stopping of menstrual bleeding

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: clomipramine 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 clomipramine resources


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


  • clomipramine Concise Consumer Information (Cerner Multum)

  • Anafranil Prescribing Information (FDA)

  • Anafranil Monograph (AHFS DI)

  • Clomipramine MedFacts Consumer Leaflet (Wolters Kluwer)



Compare clomipramine with other medications


  • Depression
  • Irritable Bowel Syndrome
  • Obsessive Compulsive Disorder
  • Panic Disorder

Saturday, 26 May 2012

Aptivus Solution


Pronunciation: tye-PRAN-a-vir
Generic Name: Tipranavir
Brand Name: Aptivus

Aptivus Solution is used along with another HIV medicine (ritonavir). Serious and sometimes fatal bleeding in the brain has occurred with this combination. Contact your doctor right away if you develop symptoms of bleeding in the brain. These may include confusion, vision or speech problems, or one-sided weakness.


Serious and sometimes fatal liver problems have also been reported with this combination. Patients who have hepatitis B or C may be at greater risk. Contact your doctor at once if you develop symptoms of liver problems. Such symptoms may include yellowing of the eyes or skin, dark urine, pale stools, stomach pain or tenderness, severe or persistent nausea, or loss of appetite.


Discuss any questions or concerns with your doctor.





Aptivus Solution is used for:

Treating HIV infection. Aptivus Solution should be used with ritonavir.


Aptivus Solution is a protease inhibitor. It works by blocking the growth of an enzyme (HIV protease) that the HIV virus needs to reproduce in the body.


Do NOT use Aptivus Solution if:


  • you are allergic to any ingredient in Aptivus Solution

  • you have moderate to severe liver disease

  • you are taking alfuzosin, certain antiarrhythmics (eg, amiodarone, bepridil, flecainide, propafenone, quinidine), astemizole, certain benzodiazepines (eg, midazolam, triazolam), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), cisapride, ergot derivatives (eg, ergonovine, ergotamine), other HIV protease inhibitors (eg, saquinavir), pimozide, rifampin, salmeterol, a serotonin 5-HT1 receptor antagonist (eg, eletriptan, sumatriptan), St. John's wort, or terfenadine

  • you are taking sildenafil for pulmonary arterial hypertension (PAH)

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



Before using Aptivus Solution:


Some medical conditions may interact with Aptivus Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


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

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

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

  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide

  • if you have cholesterol or lipid problems, diabetes or a family history of diabetes, liver problems (eg, hepatitis B or C), abnormal liver function tests, kidney problems, or bleeding problems (eg, hemophilia)

  • if you take vitamin E or you have had a recent injury or other medical condition that may increase your risk of bleeding or serious bruising

  • if you will be having or have recently had surgery

  • if you have never taken another medicine for HIV infection

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


  • Certain antiarrhythmics (eg, amiodarone, bepridil, flecainide, propafenone, quinidine), astemizole, certain benzodiazepines (eg, midazolam, triazolam), cisapride, ergot derivatives (eg, ergonovine, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), pimozide, salmeterol, serotonin 5-HT1 receptor antagonists (eg, eletriptan, sumatriptan), or terfenadine because the risk of side effects, including heart or blood vessel problems, muscle problems, or severe breathing problems, may be increased

  • Alfuzosin because the risk for severe low blood pressure may be increased

  • Rifampin or St. John's wort because they may decrease Aptivus Solution's effectiveness

  • Sildenafil (when used for PAH) because the risk of its side effects may be increased by Aptivus Solution

  • Other HIV protease inhibitors (eg, saquinavir) because their effectiveness may be decreased by Aptivus Solution

  • Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), and many prescription and nonprescription medicines (eg, used for aches and pains, asthma, erectile dysfunction, PAH, diabetes, gout, high blood pressure, high cholesterol, HIV, immune system suppression, infections, inflammation, irregular heartbeat, nasal allergies, seizures), multivitamin products, and herbal or dietary supplements (eg, coenzyme Q10, garlic, ginkgo, ginseng, herbal teas, St. John's wort) may interact with Aptivus Solution, increasing the risk of side effects

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


How to use Aptivus Solution:


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


  • An extra patient leaflet is available with Aptivus Solution. Talk to your pharmacist if you have questions about this information.

  • Aptivus Solution is taken at the same time with another medicine called ritonavir. If you are taking Aptivus Solution with ritonavir capsule or solution, it can be taken with or without meals. If you are taking Aptivus Solution with ritonavir tablets, it must be taken with meals.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you are also taking didanosine, do not take it within 2 hours of taking Aptivus Solution. Check with your doctor if you have questions.

  • Taking Aptivus Solution at the same time each day will help you remember to take it.

  • Take Aptivus Solution on a regular schedule to get the most benefit from it.

  • Continue to use Aptivus Solution even if you feel well. Do not miss any doses. Failure to do so may decrease the effectiveness of Aptivus Solution and increase the risk that your HIV infection will no longer be sensitive to Aptivus Solution or to other similar medicines.

  • If you miss a dose of Aptivus Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aptivus Solution.



Important safety information:


  • Aptivus Solution may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Aptivus Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Tell your doctor or dentist that you take Aptivus Solution before you receive any medical or dental care, emergency care, or surgery.

  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Aptivus Solution. The cause and long-term effects of these changes are not known. Discuss any concerns with your doctor.

  • Aptivus Solution may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, cough, fever, shortness of breath, sore throat, weakness) after you start Aptivus Solution.

  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Aptivus Solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.

  • Aptivus Solution is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.

  • Aptivus Solution does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.

  • Aptivus Solution may increase triglyceride and lipid levels. The long-term chance of complications from these increased triglyceride and lipid levels, such as heart attack and stroke, are not known at this time.

  • Hemophilia patients - Report all bleeding episodes to your doctor.

  • Aptivus Solution may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

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

  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Aptivus Solution. To prevent pregnancy, use an extra form of birth control (eg, condoms).

  • Women who take estrogens for birth control or hormone replacement may have an increased risk of rash from Aptivus Solution. Contact your doctor if you develop a rash.

  • Lab tests, including viral load, CD4 count, triglyceride and lipid levels, and liver function, may be performed while you use Aptivus Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Aptivus Solution with caution in the ELDERLY; they may be more sensitive to its effects.

  • Caution is advised when using Aptivus Solution in CHILDREN; they may be more sensitive to its effects, especially rash.

  • Use Aptivus Solution with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risk of using Aptivus Solution while you are pregnant. It is not known if Aptivus Solution is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Aptivus Solution to the baby.


Possible side effects of Aptivus Solution:


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



Cough; diarrhea; headache; nausea; tiredness; vomiting.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body fat changes; confusion; dark urine; depression; difficulty urinating; dizziness; excessive hunger, thirst, or urination; fast heartbeat; fever, chills, or sore throat; flu-like symptoms; fruit-like breath odor; itching; joint pain or stiffness; loss of appetite; mental or mood changes; mouth sores or ulcers; muscle pain; numbness or tingling; pale stools; red, blistered, swollen, or peeling skin; severe or persistent nausea; slurred speech or one-sided weakness; stomach pain or tenderness; throat tightness; unusual bruising or bleeding; unusual drowsiness or tiredness; unusual weakness; vision changes; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .


See also: Aptivus side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Aptivus Solution:

Store Aptivus Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not refrigerate or freeze. Aptivus Solution must be used within 60 days after opening the bottle. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aptivus Solution out of the reach of children and away from pets.


General information:


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

  • Aptivus Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

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



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Aptivus resources


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


Compare Aptivus with other medications


  • HIV Infection

Irbett




Irbett may be available in the countries listed below.


Ingredient matches for Irbett



Irbesartan

Irbesartan is reported as an ingredient of Irbett in the following countries:


  • Colombia

International Drug Name Search

Friday, 25 May 2012

Vasogen Cream





1. Name Of The Medicinal Product



VASOGEN CREAM


2. Qualitative And Quantitative Composition









Dimethicone (as silicone fluid 200) BP

20.0% w/w

Zinc oxide Ph.Eur.

7.5% w/w

Calamine BP

1.5% w/w


3. Pharmaceutical Form



Cream



4. Clinical Particulars



4.1 Therapeutic Indications



The prevention and treatment of nappy rash and bedsores. Local protection of skin around the stoma after ileostomy and colostomy.



4.2 Posology And Method Of Administration



Vasogen is applied topically to the skin and may be either rubbed in gently or applied thinly and left to dry. Further application can be made as required.



4.3 Contraindications



Use in patients with known hypersensitivity to the product or any of its ingredients, e.g. lanolin or phenonip. Vasogen should not be applied when it is considered that free drainage is necessary, e.g. weeping dermatitis.



4.4 Special Warnings And Precautions For Use



None



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known



4.6 Pregnancy And Lactation



No restrictions



4.7 Effects On Ability To Drive And Use Machines



Not applicable



4.8 Undesirable Effects



Side-effects such as local sensitivity reactions are extremely rare.



4.9 Overdose



Not applicable



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Dimethicone is an inert polymer which has a low surface tension and is a water repellent. It is widely used in barrier creams. Zinc oxide is a mild astringent and antiseptic. Calamine has a mild astringent activity and is widely used in various dermatological conditions.



5.2 Pharmacokinetic Properties



Not applicable



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Aluminium Hydroxide (wet gel)



Lanolin (anhydrous)



Methylcellulose



Phenonip



Purified Water



6.2 Incompatibilities



None known.



6.3 Shelf Life



3 years



6.4 Special Precautions For Storage



Do not store above 25oC.



6.5 Nature And Contents Of Container



White low-density polyethylene tube with white polypropylene cap.



Pack sizes 14, 50 and 100g.



6.6 Special Precautions For Disposal And Other Handling



None



7. Marketing Authorisation Holder










Forest Laboratories UK Limited




Riverbridge House




Anchor Boulevard




Crossways Business Park




Dartford




Kent DA2 6SL



8. Marketing Authorisation Number(S)



PL 0108/5033R



9. Date Of First Authorisation/Renewal Of The Authorisation



29 August 1989/26 March 1996



10. Date Of Revision Of The Text



March 2010



11. Legal Category


GSL




Doublebase Emollient Bath Additive





1. Name Of The Medicinal Product



DOUBLEBASE™ EMOLLIENT BATH ADDITIVE


2. Qualitative And Quantitative Composition



Liquid Paraffin 65.0% w/w.



For excipients see Section 6.1.



3. Pharmaceutical Form



Bath additive. Dye- and fragrance-free white to off-white mobile liquid.



4. Clinical Particulars



4.1 Therapeutic Indications



For the symptomatic relief of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin disorders.



4.2 Posology And Method Of Administration



Adults, including the elderly:



Shake the bottle to mix contents and add 15 to 20 ml (1½ to 2 inner capfuls) to a standard bath of water (20 cm/8 inch depth). Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Pat dry with a towel.



Infants and children:



Shake the bottle to mix contents and add 5 to 10 ml (½ to 1 inner capful) to a small bath or wash basin of water. Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Alternatively, repeatedly gently sponge over the affected areas. Pat dry with a towel.



There is no differentiation between the dosage quantities for the symptomatic relief of the conditions listed.



4.3 Contraindications



Sensitivity to any of the ingredients.



4.4 Special Warnings And Precautions For Use



Take care not to slip in the bath. Surfaces that have been in contact with the product should be cleaned with a proprietary detergent. Keep out of the reach of children. For external use only.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



The constituents are not percutaneously absorbed or toxic if ingested. There is no evidence of safety of the drug used in pregnancy or lactation, but the active constituent has been in widespread use and in similar preparations for many years without apparent ill consequence.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



Contact sensitivity reactions or mild irritant reactions may occur occasionally. In either case, treatment should be discontinued.



4.9 Overdose



Accidental ingestion may result in a purgative action due to the liquid paraffin and the oily nature of the product. Treat symptomatically. Fluid and electrolyte replacement may be necessary.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC Code: D02AX - Other emollients



For dry skin conditions it is important to use an emollient while bathing. Doublebase Emollient Bath Additive contains 65% Liquid Paraffin for its moisturising and skin softening properties, and is specially formulated to disperse in bath water.



5.2 Pharmacokinetic Properties



The active constituent is not absorbed percutaneously. Pharmacokinetic particulars are thus not relevant.



5.3 Preclinical Safety Data



No relevant information additional to that contained elsewhere in the SPC.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Isopropyl Myristate; Glycerol; Cetomacrogol 1000; Cetostearyl Alcohol; Phenoxyethanol; Purified Water.



6.2 Incompatibilities



None known.



6.3 Shelf Life



30 months.



6.4 Special Precautions For Storage



This medicinal product does not require any special storage conditions.



6.5 Nature And Contents Of Container



500 ml white high density polyethylene BOTTLE fitted with a polypropylene SCREW CAP. This is supplied as an original pack (OP).



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Dermal Laboratories



Tatmore Place, Gosmore



Hitchin, Herts SG4 7QR, UK.



8. Marketing Authorisation Number(S)



00173/0200.



9. Date Of First Authorisation/Renewal Of The Authorisation



28 March 2006.



10. Date Of Revision Of The Text



September 2007.




Monday, 21 May 2012

Acetazolamide



Class: Carbonic Anhydrase Inhibitors
ATC Class: S01EC01
VA Class: CV703
CAS Number: 59-66-5
Brands: Diamox

Introduction

Carbonic anhydrase inhibitor; nonbacteriostatic sulfonamide derivative.a b c d e


Uses for Acetazolamide


Glaucoma


Adjunctive treatment of open-angle or secondary glaucoma.c d e


Short-term use in acute angle-closure glaucoma to lower intraocular pressure (IOP) before surgery.a b c d e Should not be used for long-term treatment of angle-closure glaucoma.b c d e (See Contraindications under Cautions.)


Acute Mountain Sickness


Prevention or amelioration of symptoms (e.g., headache, lassitude, insomnia, nausea, shortness of breath, dizziness) associated with acute mountain sickness.a b c d f


Shortens the time of acclimatization.f If acute mountain sickness develops, shortens duration; does not obviate need to stop ascent or to descend.f


Also used in the treatment and prevention of high-altitude sleep disorders.c d f Decreases periodic breathing and apnea and improves oxygenation.f


Seizure Disorders


Management (in combination with other anticonvulsants) of centrencephalic epilepsies (e.g., petit mal, unlocalized seizures);c e may be ineffective for prolonged therapy.a b Has not been evaluated in controlled clinical studies in specific seizure types.a b


Edema


Adjunctive treatment of edema due to CHF or drug therapy.b c e Less potent diuretic than thiazide diuretics; metabolic acidosis resulting in loss of diuretic effect occurs after 2–4 days of continuous therapy.b


Periodic Paralysis


Has been used in the treatment of hyperkalemic and hypokalemic forms of periodic paralysis.b


Acetazolamide Dosage and Administration


Administration


Administer orally or by direct IV injection.c d e


Do not administer IM; injection is painful.b e


Oral Administration


When an oral liquid preparation is needed, crush the appropriate number of tablets and suspend in a highly flavored carbohydrate syrup.a Can suspend up to 500 mg of acetazolamide in 5 mL of syrup; suspensions containing 250 mg per 5 mL are more palatable.a Alternatively, soften a tablet in 2 teaspoonsful of hot water and add 2 teaspoonsful of honey or syrup; swallow immediately.a


When the extended-release capsules are used for glaucoma, if adequate response is not achieved with twice-daily administration of this preparation, consider using other acetazolamide preparations that are administered more frequently (i.e., tablet, parenteral preparation) to achieve IOP control.d


IV Administration


For solution and drug compatibility information, see Compatibility under Stability.


Administer IV when rapid lowering of IOP is necessary or if patient is unable to take oral medication.a e


Reconstitution

Reconstitute vial containing 500 mg of acetazolamide with 5 mL of sterile water for injection to provide a solution containing 100 mg/mL.a e


Dosage


Available as acetazolamide (oral preparations) and acetazolamide sodium; dosage expressed in terms of acetazolamide.c d e


Adjust dosage based on patient response and requirements.a


Pediatric Patients


Glaucoma

Oral

8–30 mg/kg or 300–900 mg/m2 daily in 3 divided doses has been used.a


Open-angle or Secondary Glaucoma

Oral

Children ≥12 years of age: 500 mg twice daily as extended-release capsules.d


Acute Angle-closure Glaucoma

Oral

Children ≥12 years of age: 500 mg twice daily as extended-release capsules.d


IV

5–10 mg/kg every 6 hours has been used.a


Acute Mountain Sickness

Oral

Children ≥12 years of age: 500 mg once or twice daily as extended-release capsules.d Initiate 24–48 hours before ascent; continue for 48 hours while at high altitude or longer if needed to control symptoms.d


Seizure Disorders

Oral

8–30 mg/kg daily in divided doses has been used.a c


Edema

Oral or IV

5 mg/kg or 150 mg/m2 once daily in the morning has been used.a


Adults


Glaucoma

Open-angle Glaucoma

Oral

Conventional tablets: 250 mg to 1 g daily.c For daily dosages >250 mg, administer in divided doses.c


Extended-release capsules: 500 mg twice daily.d


IV

250 mg to 1 g daily.e For daily dosages >250 mg, administer in divided doses.e


Secondary Glaucoma

Oral

Conventional tablets: 250 mg every 4 hours.c Some patients respond to short-term therapy with 250 mg twice daily.c


Extended-release capsules: 500 mg twice daily.d


IV

250 mg every 4 hours.e Some patients respond to short-term therapy with 250 mg twice daily.e


Acute Angle-closure Glaucoma

Oral

Conventional tablets: 250 mg every 4 hours. a c Alternatively, 250 mg twice daily or an initial dose of 500 mg followed by 125–250 mg every 4 hours.a c


Extended-release capsules: 500 mg twice daily.d


IV

250 mg every 4 hours.e Alternatively, 250 mg twice daily or an initial dose of 500 mg followed by 125–250 mg every 4 hours.e


Acute Mountain Sickness

Oral

Conventional tablets and extended-release capsules: 500 mg to 1 g daily in divided doses.c d Initiate 24–48 hours before ascent; continue for 48 hours while at high altitude or longer if needed to control symptoms.c d


125–250 mg twice daily starting 24 hours before ascent has been effective for prevention of acute mountain sickness; 500 mg (as extended-release capsules) every 24 hours also has been effective.f 750 mg daily may be more effective than 500 mg daily.f


125 mg at bedtime has been used for the management of high-altitude sleep disorders.f


For treatment of acute mountain sickness, some experts recommend 250 mg given within 24 hours of onset of symptoms and a second 250-mg dose 8 hours later.f


Seizure Disorders

Oral

Conventional tablets: 8–30 mg/kg daily in divided doses.c


Usual dosage range: 375 mg to 1 g daily.c


When used in conjunction with other anticonvulsants, initiate at 250 mg once daily and increase dosage as needed.c


IV

8–30 mg/kg daily in divided doses; usual dosage range is 375 mg to 1 g daily.e


When given in conjunction with other anticonvulsants, initiate at 250 mg once daily and increase dosage as needed.e


Edema

CHF

Oral

Conventional tablets: Initially, 250–375 mg (5 mg/kg) once daily in the morning.c


If patient fails to lose edema fluid after initial response, hold drug for 1 day. c To avoid loss of diuretic effect, administer intermittently (on alternate days or for 2 days followed by a drug-free day).c


IV

Initially, 250–375 mg (5 mg/kg) once daily in the morning.e


If patient fails to lose edema fluid after initial response, hold drug for 1 day.e To avoid loss of diuretic effect, administer intermittently (on alternate days or for 2 days followed by a drug-free day).e


Drug-induced Edema

Oral

Conventional tablets: 250–375 mg once daily for 1 or 2 days, alternating with a drug-free day.c


IV

250–375 mg once daily for 1 or 2 days, alternating with a drug-free day.e


Periodic Paralysis

Oral

250 mg 2 to 3 times daily has been used.a


Prescribing Limits


When used in glaucoma or seizure disorders, dosage >1 g daily is not associated with additional clinical benefit.c d e


When used for diuresis, increasing dosage does not produce greater response and may result in decreased response.c d e


Special Populations


Geriatric Patients


Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.d


Cautions for Acetazolamide


Contraindications



  • Marked impairment of hepatic function.c d e Cirrhosis.c d e (See Hepatic Impairment under Cautions.)




  • Depressed serum concentrations of sodium and/or potassium.c d e




  • Adrenocortical insufficiency.c d e




  • Hyperchloremic acidosis.c d e




  • Marked impairment of renal function.c d e




  • Long-term treatment of angle-closure glaucoma; further closure of the angle may occur while worsening of glaucoma is masked by lower IOP.b c d e




  • Hypersensitivity to acetazolamide or any ingredients in the formulation.c d e



Warnings/Precautions


Sensitivity Reactions


Sulfonamide Sensitivity Reactions

Serious adverse events (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, other blood dyscrasias) associated with sulfonamide therapy possible.b c d e


Discontinue if signs of hypersensitivity, blood dyscrasias, or other serious reactions occur.b c e


General Precautions


CNS Effects

Drowsiness and/or paresthesia reported with high dosages.b c d e


Respiratory Effects

Caution in patients with pulmonary obstruction, emphysema, or advanced pulmonary disease where alveolar ventilation may be impaired.b c d e Acetazolamide may precipitate or aggravate acidosis in these patients.c d e


Laboratory Monitoring

Monitor for hematologic reactions associated with sulfonamides; obtain a CBC and platelet count before therapy and periodically during therapy.c d e Discontinue the drug if clinically important changes occur.c d e


Monitor serum electrolytes periodically for electrolyte imbalances (i.e., hyponatremia, hypokalemia, metabolic acidosis).c d e


Glucose Concentrations

Increased or decreased blood glucose concentrations reported.d Caution in patients with impaired glucose tolerance or diabetes mellitus.b


Specific Populations


Pregnancy

Category C.c d e


Lactation

Discontinue nursing or the drug.c d e


Pediatric Use

Conventional tablets and parenteral preparation: Manufacturers state that safety and efficacy not established.c e


Extended-release capsules: Safety and efficacy not established in pediatric patients <12 years of age. d


Growth retardation has been reported in children receiving long-term therapy with extended-release capsules.d


Geriatric Use

Risk of metabolic acidosis (may be severe) in geriatric patients with reduced renal function.d


Hepatic Impairment

Avoid use in patients with marked hepatic impairment, including those with cirrhosis, because of the risk of developing hepatic encephalopathy.c d e (See Contraindications.)


Renal Impairment

Avoid use in patients with marked renal impairment.c d e (See Contraindications.)


Common Adverse Effects


Paresthesias, hearing dysfunction or tinnitus, anorexia, altered taste, nausea, vomiting, diarrhea, polyuria, drowsiness, confusion.c e


Interactions for Acetazolamide


Specific Drugs and Laboratory Tests

























































Drug or Test



Interaction



Comments



Amphetamine



Decreased urinary excretion of amphetamines; potentiates the effects of amphetaminesd



Amphotericin B



Possible enhanced potassium depletionb



Antidiabetic agents (oral agents, insulin)



May interfere with the hypoglycemic responseb



Aspirin



Increased risk of toxicityc d e



Avoid concomitant use in patients receiving high-dose aspirinc d e h



Carbonic anhydrase inhibitors, topical



Additive systemic effectsd g



Concomitant use not recommendedd g



Corticosteroids



Possible enhanced potassium depletionb



Cyclosporine



Possible increased plasma cyclosporine concentrationsd



Digitalis glycosides



Acetazolamide-induced hypokalemia may potentiate toxicity of digitalisb



Folic acid antagonists



Potential antifolate effectd



Lithium



Increased renal excretion of lithium and decreased lithium concentrationsd



Monitor patientb



Methenamine



May interfere with urinary antiseptic effect of methenamined



Phenytoin



Altered metabolism of phenytoin; increased serum phenytoin concentrations; increased risk of phenytoin-associated osteomalaciab d



Caution advisedd



Primidone



Possible decreased serum concentration of primidone and its metabolites; possible decreased anticonvulsant effectd



Caution advisedd



Quinidine



Decreased urinary excretion of quinidined



Sodium bicarbonate



Increased risk of renal calculusd



Tests for urinary protein



False-positive results with tests that use bromophenol blue reagent (Albustix) or sulfosalicylic acidb



Tests, theophylline concentrations



Interferes with high-performance liquid chromatography (HPLC) assay for theophyllined


Acetazolamide Pharmacokinetics


Absorption


Bioavailability


Well absorbed from GI tract.a b Peak plasma concentrations attained within 1–4 or 3–6 hours following administration of conventional tablets or extended-release capsules, respectively.d


Onset


Following IV administration, reduction in IOP occurs in 2 minutes.b


Following administration of conventional tablets or extended-release capsules, reduction in IOP occurs in 1 or 2 hours, respectively.b


Duration


Following IV administration, reduction in IOP persists for 4–5 hours.b


Following administration of conventional tablets or extended-release capsules, reduction in IOP persists for 8–12 or 18–24 hours, respectively.b d


Food


Extended-release capsules: Food does not affect absorption.d


Distribution


Extent


Distributed into erythrocytes, renal cortex, and aqueous humor of eye.a d


Crosses the placenta.a b


Distributed into milk in dogs; not known whether distributed into human milk.a


Elimination


Elimination Route


Excreted principally in the urine as unchanged drug.a


Stability


Storage


Oral


Tablets

Tight, light-resistant container at 15–30°C.c


Capsules

20–25°C.d


Parenteral


Powder for Injection

15–30°C.e


Reconstituted solutions prepared using sterile water for injection are stable for 3 days at 2–8°C or 12 hours at 15–30°C.e


Use reconstituted solutions within 12 hours to minimize the risk of microbial contamination.e


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Parenteral


Solution CompatibilityHID


















Compatible



Dextran 6% in dextrose 5%



Dextran 6% in sodium chloride 0.9%



Dextrose–Ringer's injection combinations



Dextrose-Ringer’s injection, lactated, combinations



Dextrose-saline combinations



Dextrose 2½, 5, or 10% in water



Fructose 10% in sodium chloride 0.9%



Fructose 10% in water



Invert sugar 5 and 10% in sodium chloride 0.9%



Invert sugar 5 and 10% in water



Ionosol products



Ringer's injection



Ringer's injection, lactated



Sodium chloride 0.45 or 0.9%



Sodium lactate (1/6) M


Drug CompatibilityHID





Admixture Compatibility

Compatible



Cimetidine HCl



Ranitidine HCl





Y-Site Compatibility

Variable



Diltiazem HCl


ActionsActions



  • Noncompetitive reversible inhibitor of the carbonic anhydrase enzyme.b d c e




  • Reduces the formation of hydrogen and bicarbonate ions from carbon dioxide and water, thereby reducing availability of these ions for active transport into secretions.b




  • Decreases aqueous humor secretion and IOP.b c d




  • Increases urinary excretion of bicarbonate, sodium, and potassium due to decrease in hydrogen ions in the renal tubules.b Decreases reabsorption of water, increases urine volume, urine becomes alkaline.b




  • When used as a diuretic, plasma bicarbonate concentration is decreased and chloride concentration may be increased, resulting in metabolic acidosis.b In the presence of acidosis, diuretic effect ceases.b




  • In acute mountain sickness, the effect of acetazolamide on acid-base balance (i.e., increased renal excretion of bicarbonate that leads to metabolic acidosis) results in compensatory hyperventilation and improved oxygenation.f




  • Exact mechanism of anticonvulsant activity unclear; may be due to metabolic acidosis, inhibition of carbonic anhydrase in the CNS, or other mechanisms.b



Advice to Patients



  • Risk of adverse effects, including sensitivity reactions; discontinue therapy and consult clinician if signs of sensitivity occur.c d e




  • When used to prevent acute mountain sickness, importance of gradual ascent.c f Use of acetazolamide does not obviate need to stop ascent if acute mountain sickness develops or descend if severe forms of altitude sickness (e.g., high attitude pulmonary or cerebral edema) occur.c f




  • Potential for the drug to impair mental alertness or impair vision (myopia); use caution when driving a vehicle or operating machinery until effects on individual are known.d




  • Advise patients with pulmonary obstruction or emphysema that the drug may precipitate or aggravate acidosis.c d




  • Advise patients with diabetes or impaired glucose tolerance that increases and decreases in blood glucose have occurred in acetazolamide-treated patients.d




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., high-dose aspirin), as well as concomitant diseases.c d e




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c d e




  • Importance of informing patients of other precautionary information.c d e (See Cautions.)



Preparations


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


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name























Acetazolamide

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules, extended-release



500 mg



Diamox



Duramed



Tablets



125 mg*



Acetazolamide Tablets



Mutual, Taro, United Research



250 mg*



Acetazolamide Tablets



Lannett, Mutual, Taro, Watson


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name













Acetazolamide Sodium

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



For injection, for IV use



500 mg (of acetazolamide)*



Acetazolamide Sodium for Injection



Bedford, Hospira


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


AcetaZOLAMIDE 125MG Tablets (TARO): 90/$45.99 or 180/$79.98


AcetaZOLAMIDE 250MG Tablets (LANNETT): 60/$37.99 or 180/$89.97


AcetaZOLAMIDE 500MG 12-hr Capsules (ZYDUS PHARMACEUTICALS (USA)): 100/$310.01 or 300/$909.95


Diamox Sequels 500MG 12-hr Capsules (TEVA PHARMACEUTICALS USA): 60/$329.59 or 180/$955.83



Disclaimer

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


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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



a. AHFS drug information 2007. McEvoy GK, ed. Acetazolamide. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2880-1.



b. AHFS drug information 2007. McEvoy GK, ed. Carbonic Anhydrase Inhibitors General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2877-80.



c. Mutual Pharmaceutical Company, Inc. Acetazolamide tablet prescribing information. Philadelphia, PA; 2001 Sept.



d. Duramed Pharmaceuticals, Inc. Diamox (acetazolamide) extended release capsule prescribing information. Pomona, NY; 2005 Apr.



e. Bedford Laboratories. Acetazolamide injection powder, lyophilized, for solution prescribing information. Bedford, OH; 2002 Oct.



f. Committee to Advice on Tropical Medicine and Travel (CATMAT). Statement on high-altitude illnesses: an advisory committee statement (ACS). Can Commun Dis Rep. 2007; 33:1-20.



g. Alcon. Azopt (brinzolamide) ophthalmic suspension 1% prescribing information. Fort Worth, TX; 2003 Dec.



h. AHFS Drug Information 2007. McEvoy GK, ed. Salicylates General Statement. Bethesda, MD: American Society of Health-System Pharmacists. 2007:2011-23.



HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3-5.



More Acetazolamide resources


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  • Acetazolamide Prescribing Information (FDA)

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  • acetazolamide Concise Consumer Information (Cerner Multum)



Compare Acetazolamide with other medications


  • Edema
  • Epilepsy
  • Glaucoma
  • Hydrocephalus
  • Mountain Sickness / Altitude Sickness
  • Pseudotumor Cerebri
  • Seizure Prevention