Dermadine may be available in the countries listed below.
Ingredient matches for Dermadine
Povidone Iodine
Povidone-Iodine is reported as an ingredient of Dermadine in the following countries:
- South Africa
International Drug Name Search
Tuesday, October 25, 2016
Glitazon
Glitazon may be available in the countries listed below.
Ingredient matches for Glitazon
Pioglitazone
Pioglitazone is reported as an ingredient of Glitazon in the following countries:
- Bangladesh
International Drug Name Search
Altofen
Altofen may be available in the countries listed below.
Ingredient matches for Altofen
Ketoprofen
Ketoprofen is reported as an ingredient of Altofen in the following countries:
- Indonesia
International Drug Name Search
Proctofoam HC
Generic Name: hydrocortisone and pramoxine topical (HYE droe KOR ti sone and pra MOX een)
Brand Names: Analpram E, Analpram-HC, Epifoam, HC Pramoxine, Hydropram, Novacort, Pramosone, Proctofoam HC, Rectocort HC, ZyPram
What is Proctofoam HC (hydrocortisone and pramoxine topical)?
Pramoxine is an anesthetic. It works by interfering with pain signals sent from the nerves to the brain.
Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.
The combination of hydrocortisone and pramoxine topical is used to treat pain, itching, or inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, psoriasis, insect bites, and minor burns or scrapes. This medication is also used on the rectal area to treat itching and inflammation caused by hemorrhoids, anal fissures, or other rectal irritation.
Hydrocortisone and pramoxine topical may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Proctofoam HC (hydrocortisone and pramoxine topical)?
You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.
Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or "numbing medicines."
Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.
Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.
Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone. Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.
Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.
What should I discuss with my health care provider before using Proctofoam HC (hydrocortisone and pramoxine topical)?
You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.
Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or "numbing medicines." Also tell your doctor if you have:
liver disease;
diabetes;
problems with your eyes;
a stomach or intestinal disorder;
a rectal sore or infection; or
if you use any drugs that weaken the immune system, including steroids.
Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.
FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using hydrocortisone and pramoxine topical, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone and pramoxine 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 medication on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone.
How should I use Proctofoam HC (hydrocortisone and pramoxine topical)?
Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Hydrocortisone and pramoxine topical is usually applied 3 or more times daily, depending on which form of this medication you use. Follow the label directions or your doctor's instructions about how much of this medication to use and how often. Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.
Wash your hands before and after applying this medication, unless you are using hydrocortisone and pramoxine topical to treat a hand condition.
When using this medication on the skin, apply just enough of the medication to cover the area to be treated. Rub in gently.
Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.
Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.
Before apply the rectal form of this medication (cream, lotion, or foam), clean the rectal area with mild soap and pat dry.
Use only a small amount of medicine when applying hydrocortisone and pramoxine around the outside of the rectum. You may first place the medicine onto a clean tissue and then wipe it gently onto your rectum.
When using this medication inside the rectum, insert only the applicator tip of the medicine tube or foam can into the anus, no deeper than 1 inch.
Shake the hydrocortisone and pramoxine rectal foam before each use. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days, or if your condition clears up and then comes back. Do not stop using hydrocortisone and pramoxine topical suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using the medication. Store this medication at room temperature away from moisture and heat. Keep the rectal foam canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.
What happens if I miss a dose?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. 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 hydrocortisone and pramoxine topical is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.
What should I avoid while using Proctofoam HC (hydrocortisone and pramoxine topical)?
Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin. If it does get into any of these areas, wash with water. Do not use hydrocortisone and pramoxine topical on deep skin wounds, blistered skin, severe burns, irritated skin, or large skin areas. Also avoid using this medication in open wounds.
Avoid applying other skin medications on the same treatment area with hydrocortisone and pramoxine topical, unless your doctor has told you to.
Using a steroid can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicines.
Hydrocortisone pramoxine topical side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
blurred vision, or seeing halos around lights;
uneven heartbeats;
sleep problems (insomnia);
ongoing headache;
weight gain, puffiness in your face;
increased thirst or urination, weight loss, unusual weakness;
fever, sore throat, tired feeling;
severe pain, burning, or irritation of treated skin;
rectal bleeding;
any new redness or swelling where the medicine was applied; or
itching, oozing, or other signs of infection.
Less serious side effects may include:
mild skin redness, burning, itching, dryness, or peeling;
acne;
changes in the color of treated skin;
thinning of your skin;
blistering skin; or
stretch marks.
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 Proctofoam HC (hydrocortisone and pramoxine topical)?
It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone and pramoxine. 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 Proctofoam HC resources
- Proctofoam HC Side Effects (in more detail)
- Proctofoam HC Use in Pregnancy & Breastfeeding
- Proctofoam HC Drug Interactions
- Proctofoam HC Support Group
- 3 Reviews for Proctofoam HC - Add your own review/rating
- Proctofoam HC Prescribing Information (FDA)
- Proctofoam HC Foam MedFacts Consumer Leaflet (Wolters Kluwer)
- Analpram-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Epifoam Foam MedFacts Consumer Leaflet (Wolters Kluwer)
- Epifoam Prescribing Information (FDA)
- Novacort MedFacts Consumer Leaflet (Wolters Kluwer)
- Pramosone Lotion MedFacts Consumer Leaflet (Wolters Kluwer)
- Pramosone Prescribing Information (FDA)
- Proctocream HC Prescribing Information (FDA)
Compare Proctofoam HC with other medications
- Dermatitis
- Dermatological Disorders
- Hemorrhoids
- Psoriasis
Where can I get more information?
- Your pharmacist can provide more information about hydrocortisone and pramoxine topical.
See also: Proctofoam HC side effects (in more detail)
Proloprim
Generic Name: trimethoprim (trye METH oh prim)
Brand Names: Primsol, Proloprim
What is Proloprim (trimethoprim)?
Trimethoprim is an antibiotic that fights bacteria in the body.
Trimethoprim is used to treat bladder infection caused by certain bacteria.
Trimethoprim may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Proloprim (trimethoprim)?
You should not use this medication if you are allergic to trimethoprim, or if you have any type of anemia (lack of red blood cells).
Before using trimethoprim, tell your doctor if you have kidney disease, liver disease, or a folic acid deficiency.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Trimethoprim will not treat a viral infection such as the common cold or flu. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Trimethoprim can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
What should I discuss with my healthcare provider before taking Proloprim (trimethoprim)?
You should not use this medication if you are allergic to trimethoprim, or have certain conditions. Be sure your doctor knows if you have any type of anemia (lack of red blood cells).
Before using trimethoprim, tell your doctor if you are allergic to any drugs, or if you have:
kidney disease;
liver disease; or
a folate (folic acid) deficiency.
If you have any of these conditions, you may need a dose adjustment or special tests to safely use trimethoprim.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Trimethoprim can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Proloprim (trimethoprim)?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Take your medicine with a full glass of water.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Trimethoprim will not treat a viral infection such as the common cold or flu.
This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using trimethoprim.
Store trimethoprim 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, dizziness, headache, confusion, weakness, or flu symptoms.
What should I avoid while taking Proloprim (trimethoprim)?
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Trimethoprim can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
Proloprim (trimethoprim) 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 at once if you have a serious side effect such as:
pale skin, easy bruising or bleeding;
fever, chills, sore throat, flu symptoms; or
severe blistering, peeling, and red skin rash.
Less serious side effects may include:
nausea, vomiting;
sore or swollen tongue; or
mild itching or skin rash.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Proloprim (trimethoprim)?
Tell your doctor about all other medications you use, especially phenytoin (Dilantin).
This list is not complete and there may be other drugs that can interact with trimethoprim. 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 Proloprim resources
- Proloprim Side Effects (in more detail)
- Proloprim Use in Pregnancy & Breastfeeding
- Proloprim Drug Interactions
- Proloprim Support Group
- 0 Reviews for Proloprim - Add your own review/rating
- Proloprim Prescribing Information (FDA)
- Proloprim Advanced Consumer (Micromedex) - Includes Dosage Information
- Proloprim MedFacts Consumer Leaflet (Wolters Kluwer)
- Trimethoprim Prescribing Information (FDA)
- Trimethoprim Monograph (AHFS DI)
- Primsol Solution MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Proloprim with other medications
- Bladder Infection
- Otitis Media
- Pneumocystis Pneumonia
- Prevention of Bladder infection
Where can I get more information?
- Your pharmacist can provide more information about trimethoprim.
See also: Proloprim side effects (in more detail)
Akne-Mycin
Akne-Mycin is a brand name of erythromycin topical, approved by the FDA in the following formulation(s):
AKNE-MYCIN (erythromycin - ointment; topical)
Manufacturer: DOW PHARM SCIENCES
Approval date: January 10, 1985
Strength(s): 2% [RLD]
Has a generic version of Akne-Mycin been approved?
No. There is currently no therapeutically equivalent version of Akne-Mycin available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Akne-Mycin. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Related Patents
There are no current U.S. patents associated with Akne-Mycin.
See also...
- Akne-Mycin Ointment Consumer Information (Wolters Kluwer)
- Akne-Mycin Consumer Information (Cerner Multum)
- Akne-Mycin Topical Advanced Consumer Information (Micromedex)
- Erythromycin Gel Consumer Information (Wolters Kluwer)
- Erythromycin Ointment Consumer Information (Wolters Kluwer)
- Erythromycin Pad Consumer Information (Wolters Kluwer)
- Erythromycin Solution Consumer Information (Wolters Kluwer)
- Erythromycin topical Consumer Information (Cerner Multum)
- Ery Topical Advanced Consumer Information (Micromedex)
- Sans-Acne Topical Advanced Consumer Information (Micromedex)
- Erythromycin Topical Advanced Consumer Information (Micromedex)
- Erythromycin topical AHFS DI Monographs (ASHP)
Monday, October 24, 2016
ratio-Mometasone
ratio-Mometasone may be available in the countries listed below.
Ingredient matches for ratio-Mometasone
Mometasone
Mometasone 17-(2-furoate) (a derivative of Mometasone) is reported as an ingredient of ratio-Mometasone in the following countries:
- Canada
International Drug Name Search
Verrutrix
Verrutrix may be available in the countries listed below.
Ingredient matches for Verrutrix
Salicylic Acid
Salicylic Acid is reported as an ingredient of Verrutrix in the following countries:
- Argentina
International Drug Name Search
Phenylephrine Solution
Pronunciation: fen-il-EF-rin
Generic Name: Phenylephrine
Brand Name: Examples include Neo-Synephrine and Rhinall
Phenylephrine Solution is used for:
Relieving nasal congestion due to colds, flu, hay fever, and other allergies. It may also be used for other conditions as determined by your doctor.
Phenylephrine Solution is a decongestant. It works by shrinking swollen and congested nasal tissues by constricting blood vessels. This results in relief of congestion (stuffy feeling) and improved breathing through the nose.
Do NOT use Phenylephrine Solution if:
- you are allergic to any ingredient in Phenylephrine Solution
- you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Phenylephrine Solution:
Some medical conditions may interact with Phenylephrine 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 heart disease, diabetes, prostate problems, high blood pressure, or an overactive thyroid
Some MEDICINES MAY INTERACT with Phenylephrine Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Rauwolfia derivatives (eg, reserpine) or tricyclic antidepressants (eg, amitriptyline) because the effectiveness of Phenylephrine Solution may be decreased
- Cocaine, furazolidone, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Phenylephrine Solution may be increased
- Bromocriptine, COMT inhibitors (eg, entacapone), cocaine, or droxidopa because the actions and side effects of these medicines may be increased
- Guanethidine because its effectiveness may be decreased by Phenylephrine Solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine 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 Phenylephrine Solution:
Use Phenylephrine Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- To use nose drops, gently blow your nose. Lie down and tilt your head back. Breathe through your mouth. Insert the dropper tip in the nose no more than 1/3 inch. Try not to touch the dropper tip to the inside of your nose. Place the correct number of drops in your nose. Continue to lie down with your head tilted back for 2 minutes.
- To use a nose spray, gently blow your nose. Sit down and tilt your head back slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe gently through the open nostril and squeeze the spray container. If you are using more than 1 spray, wait for 1 to 2 minutes between sprays. After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.
- If you miss a dose of Phenylephrine Solution and are using it regularly, use it as soon as possible. If it is much more than 1 hour since your missed 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 Phenylephrine Solution.
Important safety information:
- Do not use Phenylephrine Solution for more than 3 days unless instructed otherwise by your doctor.
- Do not use Phenylephrine Solution if it is brown or contains particles.
- Phenylephrine Solution is not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Phenylephrine Solution during pregnancy. It is unknown if Phenylephrine Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Phenylephrine Solution, check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of Phenylephrine 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:
Burning or stinging in nose; dizziness; headache; increased discharge from nose; sneezing.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Phenylephrine Solution:
Store Phenylephrine Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenylephrine Solution out of the reach of children and away from pets.
General information:
- If you have any questions about Phenylephrine Solution, please talk with your doctor, pharmacist, or other health care provider.
- Phenylephrine 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 Phenylephrine 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 Phenylephrine resources
- Phenylephrine Use in Pregnancy & Breastfeeding
- Phenylephrine Drug Interactions
- Phenylephrine Support Group
- 4 Reviews for Phenylephrine - Add your own review/rating
Compare Phenylephrine with other medications
- Nasal Congestion
Ipidacrine
Scheme
Rec.INN
CAS registry number (Chemical Abstracts Service)
0062732-44-9
Chemical Formula
C12-H16-N2
Molecular Weight
188
Therapeutic Categories
Analgesic
Nootropic
Enzyme inhibitor, acetylcholinesterase
Chemical Names
2,3,5,6,7,8-Hexahydro-H-cyclopenta[b]quinolin-9-amine
9-Amino-2,3,5,6,7,8-Hexahydro-H-cyclopenta[b]quinoline
9-amino-2,3,5,6,7,8-hexahydro-1H-cyclopenta[b]chinolin (IUPAC)
9-amino-2,3,5,6,7,8-hexahydro-1H-cyclopenta[b]quinoline (WHO)
Foreign Names
- Ipidacrinum (Latin)
- Ipidacrin (German)
- Ipidacrine (French)
- Ipidacrina (Spanish)
Generic Names
- Amiridine (IS)
- Neuromidin (IS)
- UNII-CV71VTP0VN (IS)
- Ipidacrine hydrochloride hydrate (OS: JAN)
- Amiridin (IS)
- NIK-247 (IS)
Brand Names
- Neiromidin
Olainfarm, Latvia - Amiridine
Olainfarm, Latvia
International Drug Name Search
Glossary
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| WHO | World Health Organization |
Click for further information on drug naming conventions and International Nonproprietary Names.
Friday, October 21, 2016
Prascion RA
Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal)
Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet
What is Prascion RA (sulfacetamide sodium and sulfur topical)?
Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.
The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).
Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Prascion RA (sulfacetamide sodium and sulfur topical)?
You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.
Do not cover the treated skin area unless your doctor has told you to.
Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.
What should I discuss with my healthcare provider before using Prascion RA (sulfacetamide sodium and sulfur topical)?
You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.
To make sure you can safely use this medication, tell your doctor about all of your medical conditions.
FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur 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 sulfacetamide sodium and sulfur 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.
How should I use Prascion RA (sulfacetamide sodium and sulfur topical)?
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Wash your hands before and after applying this medication.
Do not cover the treated skin area unless your doctor has told you to.
Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
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.
What should I avoid while using Prascion RA (sulfacetamide sodium and sulfur topical)?
Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.
Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.
Prascion RA (sulfacetamide sodium and sulfur topical) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:
new or worsening skin rash;
joint pain;
fever; or
mouth sores.
Less serious side effects may include redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.
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 Prascion RA (sulfacetamide sodium and sulfur topical)?
It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
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Where can I get more information?
- Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.
Corzide
nadolol and bendroflumethizaide
Dosage Form: tablet
Corzide® (nadolol and bendroflumethiazide tablets)
Corzide Description
Corzide (Nadolol and Bendroflumethiazide Tablets) for oral administration combines two antihypertensive agents: CORGARD® (nadolol), a nonselective beta-adrenergic blocking agent, and NATURETIN® (bendroflumethiazide), a thiazide diuretic-antihypertensive. Formulations: 40 mg and 80 mg nadolol per tablet combined with 5 mg bendroflumethiazide. Inactive ingredients: cellulose, colorant (FD&C Blue No. 2), lactose, magnesium stearate, povidone, sodium starch glycolate, and starch.
Nadolol
Nadolol is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol is designated chemically as 1-(tert-butylamino)-3-{(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy}-2-propanol. Structural formula:
C17H27NO4 MW 309.40 CAS-42200-33-9
Bendroflumethiazide
Bendroflumethiazide is a white crystalline powder. It is soluble in alcohol and in sodium hydroxide, and insoluble in hydrochloric acid, water, and chloroform. Bendroflumethiazide is designated chemically as 3-benzyl-3,4-dihydro-6-(trifluoromethyl)-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Structural formula:
C15H14F3N3O4S2 MW 421.41 CAS-73-48-3
Corzide - Clinical Pharmacology
Nadolol
Nadolol is a nonselective beta-adrenergic receptor blocking agent. Clinical pharmacology studies have demonstrated beta-blocking activity by showing (1) reduction in heart rate and cardiac output at rest and on exercise, (2) reduction of systolic and diastolic blood pressure at rest and on exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia.
Nadolol specifically competes with beta-adrenergic receptor agonists for available beta receptor sites; it inhibits both the beta1 receptors located chiefly in cardiac muscle and the beta2 receptors located chiefly in the bronchial and vascular musculature, inhibiting the chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation proportionately. Nadolol has no intrinsic sympathomimetic activity and, unlike some other beta-adrenergic blocking agents, nadolol has little direct myocardial depressant activity and does not have an anesthetic-like membrane-stabilizing action. Animal and human studies show that nadolol slows the sinus rate and depresses AV conduction. In dogs, only minimal amounts of nadolol were detected in the brain relative to amounts in blood and other organs and tissues. Nadolol has low lipophilicity as determined by octanol/water partition coefficient, a characteristic of certain beta-blocking agents that has been correlated with the limited extent to which these agents cross the blood-brain barrier, their low concentration in the brain, and low incidence of CNS-related side effects.
In controlled clinical studies, nadolol at doses of 40 to 320 mg/day has been shown to decrease both standing and supine blood pressure, the effect persisting for approximately 24 hours after dosing.
The mechanism of the antihypertensive effects of beta-adrenergic receptor blocking agents has not been established; however, factors that may be involved include (1) competitive antagonism of catecholamines at peripheral (non-CNS) adrenergic neuron sites (especially cardiac) leading to decreased cardiac output, (2) a central effect leading to reduced tonic-sympathetic nerve outflow to the periphery, and (3) suppression of renin secretion by blockade of the beta-adrenergic receptors responsible for renin release from the kidneys.
While cardiac output and arterial pressure are reduced by nadolol therapy, renal hemodynamics are stable, with preservation of renal blood flow and glomerular filtration rate.
By blocking catecholamine-induced increases in heart rate, velocity and extent of myocardial contraction, and blood pressure, nadolol generally reduces the oxygen requirements of the heart at any given level of effort, making it useful for many patients in the long-term management of angina pectoris. On the other hand, nadolol can increase oxygen requirements by increasing left ventricular fiber length and end diastolic pressure, particularly in patients with heart failure.
Although beta-adrenergic receptor blockade is useful in treatment of angina and hypertension, there are also situations in which sympathetic stimulation is vital. For example, in patients with severely damaged hearts, adequate ventricular function may depend on sympathetic drive. Beta-adrenergic blockade may worsen AV block by preventing the necessary facilitating effects of sympathetic activity on conduction. Beta2-adrenergic blockade results in passive bronchial constriction by interfering with endogenous adrenergic bronchodilator activity in patients subject to bronchospasm and may also interfere with exogenous bronchodilators in such patients.
Absorption of nadolol after oral dosing is variable, averaging about 30 percent. Peak serum concentrations of nadolol usually occur in three to four hours after oral administration and the presence of food in the gastrointestinal tract does not affect the rate or extent of nadolol absorption. Approximately 30 percent of the nadolol present in serum is reversibly bound to plasma protein.
Unlike many other beta-adrenergic blocking agents, nadolol is not metabolized by the liver and is excreted unchanged, principally by the kidneys.
The half-life of therapeutic doses of nadolol is about 20 to 24 hours, permitting once-daily dosage. Because nadolol is excreted predominantly in the urine, its half-life increases in renal failure (see PRECAUTIONS, General, and DOSAGE AND ADMINISTRATION). Steady state serum concentrations of nadolol are attained in six to nine days with once-daily dosage in persons with normal renal function. Because of variable absorption and different individual responsiveness, the proper dosage must be determined by titration.
Exacerbation of angina and, in some cases, myocardial infarction and ventricular dysrhythmias have been reported after abrupt discontinuation of therapy with beta-adrenergic blocking agents in patients with coronary artery disease. Abrupt withdrawal of these agents in patients without coronary artery disease has resulted in transient symptoms, including tremulousness, sweating, palpitation, headache, and malaise. Several mechanisms have been proposed to explain these phenomena, among them increased sensitivity to catecholamines because of increased numbers of beta receptors.
Bendroflumethiazide
The mechanism of action of bendroflumethiazide results in an interference with the renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage all thiazides are approximately equal in their diuretic potency.
Thiazides increase excretion of sodium and chloride in approximately equivalent amounts. Natriuresis causes a secondary loss of potassium and bicarbonate.
The mechanism of the antihypertensive effect of thiazides is unknown. Thiazides do not affect normal blood pressure.
Onset of action of thiazides occurs in two hours and the peak effect at about four hours. Duration of action persists for approximately six to 12 hours. Thiazides are eliminated rapidly by the kidney.
INDICATIONS
Corzide (Nadolol and Bendroflumethiazide Tablets) is indicated in the management of hypertension. This fixed combination drug is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, it may be more convenient than the separate components.
Contraindications
Nadolol
Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see WARNINGS).
Bendroflumethiazide
Bendroflumethiazide is contraindicated in anuria. It is also contraindicated in patients who have previously demonstrated hypersensitivity to bendroflumethiazide or other sulfonamide-derived drugs.
Warnings
Nadolol
Cardiac Failure—Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta-blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, if necessary, they can be used with caution in patients with a history of failure who are well compensated, usually with digitalis and diuretics. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle.
IN PATIENTS WITHOUT A HISTORY OF HEART FAILURE, continued use of beta-blockers can, in some cases, lead to cardiac failure. Therefore, at the first sign or symptom of heart failure, the patient should be digitalized and/or treated with diuretics, and the response observed closely, or nadolol should be discontinued (gradually, if possible).
Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal—Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing chronically administered nadolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of one to two weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, nadolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue nadolol therapy abruptly even in patients treated only for hypertension.
Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema)— PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD IN GENERAL NOT RECEIVE BETA-BLOCKERS. Nadolol should be administered with caution since it may block bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors.
Major Surgery—Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
Diabetes and Hypoglycemia—Beta-adrenergic blockade may prevent the appearance of premonitory signs and symptoms (e.g., tachycardia and blood pressure changes) of acute hypoglycemia. This is especially important with labile diabetics. Beta-blockade also reduces the release of insulin in response to hyperglycemia; therefore, it may be necessary to adjust the dose of antidiabetic drugs.
Thyrotoxicosis—Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blockade which might precipitate a thyroid storm.
Bendroflumethiazide
Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.
The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.
Lithium generally should not be given with diuretics; diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such concomitant therapy.
Precautions
General
Nadolol
Nadolol should be used with caution in patients with impaired renal function (see DOSAGE AND ADMINISTRATION).
Bendroflumethiazide
Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance, namely: hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance may include: dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances, such as nausea and vomiting.
Hypokalemia may develop, especially with brisk diuresis or when severe cirrhosis is present.
Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia can sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability). Concurrent administration of a potassium-sparing diuretic or potassium supplements may be indicated in these patients.
Any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.
Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Latent diabetes mellitus may become manifest during thiazide administration.
The antihypertensive effect of thiazide diuretics may be enhanced in the postsympathectomy patient.
If progressive renal impairment becomes evident, as indicated by a rising nonprotein nitrogen or blood urea nitrogen (BUN), a careful reappraisal of therapy is necessary with consideration given to withholding or discontinuing diuretic therapy.
Thiazides may decrease serum PBI levels without signs of thyroid disturbance.
Calcium excretion is decreased by thiazides. Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. The common complications of hyperparathyroidism such as renal lithiasis, bone resorption, and peptic ulceration have not been seen. Thiazides should be discontinued before carrying out tests for parathyroid function.
Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.
Information for Patients
Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of therapy without the physician’s advice. Although cardiac failure rarely occurs in properly selected patients, patients being treated with beta-adrenergic blocking agents should be advised to consult the physician at the first sign or symptom of impending failure.
The patient should also be advised of a proper course in the event of an inadvertently missed dose.
The patient should be informed of symptoms that would suggest potential adverse effects and told to report them promptly.
Laboratory Tests
Serum electrolyte levels should be regularly monitored (see WARNINGS, Bendroflumethiazide, also PRECAUTIONS, General, Bendroflumethiazide).
Drug Interactions
Nadolol
When administered concurrently the following drugs may interact with beta-adrenergic receptor blocking agents:
Anesthetics, general—exaggeration of the hypotension induced by general anesthetics (see WARNINGS, Nadolol, Major Surgery).
Antidiabetic drugs (oral agents and insulin)—hypoglycemia or hyperglycemia; adjust dosage of antidiabetic drug accordingly (see WARNINGS, Nadolol, Diabetes and Hypoglycemia).
Catecholamine-depleting drugs (e.g., reserpine)—additive effect; monitor closely for evidence of hypotension and/or excessive bradycardia (e.g., vertigo, syncope, postural hypotension).
Digitalis glycosides—Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Response to Treatment for Anaphylactic Reaction—While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
Bendroflumethiazide
When administered concurrently the following drugs may interact with thiazide diuretics:
Alcohol, barbiturates, or narcotics—potentiation of orthostatic hypotension may occur.
Amphotericin B, corticosteroids, or corticotropin (ACTH)—may intensify electrolyte imbalance, particularly hypokalemia. Monitor potassium levels; use potassium replacements if necessary.
Anticoagulants (oral)—dosage adjustments of anticoagulant medication may be necessary since bendroflumethiazide may decrease their effects.
Antigout medications—dosage adjustments of antigout medication may be necessary since bendroflumethiazide may raise the level of blood uric acid.
Other antihypertensive medications (e.g., ganglionic or peripheral adrenergic blocking agents)—dosage adjustments may be necessary since bendroflumethiazide may potentiate their effects.
Antidiabetic drugs (oral agents and insulin)—since thiazides may elevate blood glucose levels, dosage adjustments of antidiabetic agents may be necessary.
Calcium salts—increased serum calcium levels due to decreased excretion may occur. If calcium must be prescribed monitor serum calcium levels and adjust calcium dosage accordingly.
Cardiac glycosides—enhanced possibility of digitalis toxicity associated with hypokalemia. Monitor potassium levels; use potassium replacement if necessary.
Cholestyramine resin and colestipol HCl—may delay or decrease absorption of bendroflumethiazide. Sulfonamide diuretics should be taken at least one hour before or four to six hours after these medications.
Diazoxide—enhanced hyperglycemic, hyperuricemic, and antihypertensive effects. Be cognizant of possible interaction; monitor blood glucose and serum uric acid levels.
Lithium salts—may enhance lithium toxicity due to reduced renal clearance. Avoid concurrent use; if lithium must be prescribed monitor serum lithium levels and adjust lithium dosage accordingly. (See WARNINGS.)
MAO inhibitors—dosage adjustments of one or both agents may be necessary since hypotensive effects are enhanced.
Nondepolarizing muscle relaxants, preanesthetics and anesthetics used in surgery (e.g., tubocurarine chloride and gallamine triethiodide)—effects of these agents may be potentiated; dosage adjustments may be required. Monitor and correct any fluid and electrolyte imbalances prior to surgery if feasible.
Nonsteroidal anti-inflammatory agents—in some patients, the administration of a nonsteroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing or thiazide diuretics. Therefore, when bendroflumethiazide and nonsteroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Methenamine—possible decreased effectiveness due to alkalinization of the urine.
Pressor amines (e.g., norepinephrine)—decreased arterial responsiveness, but not sufficient to preclude effectiveness of the pressor agent for therapeutic use. Use caution in patients taking both medications who undergo surgery. Administer preanesthetic and anesthetic agents in reduced dosage, and if possible, discontinue bendroflumethiazide one week prior to surgery.
Probenecid or sulfinpyrazone—increased dosage of these agents may be necessary since bendroflumethiazide may have hyperuricemic effects.
Drug/Laboratory Test Interactions
Bendroflumethiazide may produce false-negative results with the phentolamine and tyramine tests; may interfere with the phenolsulfonphthalein test due to decreased excretion; and it may cause diagnostic interference of serum electrolyte levels, blood and urine glucose levels, and a decrease in serum PBI levels without signs of thyroid disturbance.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Nadolol
In chronic oral toxicologic studies (one to two years) in mice, rats, and dogs, nadolol did not produce any significant toxic effects. In two-year oral carcinogenicity studies in rats and mice, nadolol did not produce any neoplastic, preneoplastic, or nonneoplastic pathologic lesions. In fertility and general reproductive performance studies in rats, nadolol caused no adverse effect.
Bendroflumethiazide
Studies have not been performed to evaluate carcinogenic potential, mutagenesis, or whether this drug adversely affects fertility in males or females.
Pregnancy—Teratogenic Effects
Nadolol
Category C. In animal reproduction studies with nadolol, evidence of embryo-and fetotoxicity was found in rabbits, but not in rats or hamsters, at doses 5 to 10 times greater (on a mg/kg basis) than the maximum indicated human dose. No teratogenic potential was observed in any of these species.
There are no adequate and well-controlled studies in pregnant women. Nadolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates whose mothers are receiving nadolol at parturition have exhibited bradycardia, hypoglycemia, and associated symptoms.
Bendroflumethiazide
Category C. Animal reproduction studies have not been conducted with bendroflumethiazide. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bendroflumethiazide should be given to a pregnant woman only if clearly needed.
Pregnancy—Nonteratogenic Effects
Thiazides cross the placental barrier and appear in cord blood. The use of thiazides in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in the adult.
Nursing Mothers
Both nadolol and bendroflumethiazide are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from both drugs, a decision should be made whether to discontinue nursing or to discontinue therapy taking into account the importance of Corzide (Nadolol and Bendroflumethiazide Tablets) to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of Corzide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reaction to this drug may be greater in patients with impaired function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Adverse Reactions
Nadolol
Most adverse effects have been mild and transient and have rarely required withdrawal of therapy.
Cardiovascular—Bradycardia with heart rates of less than 60 beats per minute occurs commonly, and heart rates below 40 beats per minute and/or symptomatic bradycardia were seen in about 2 of 100 patients. Symptoms of peripheral vascular insufficiency, usually of the Raynaud type, have occurred in approximately 2 of 100 patients. Cardiac failure, hypotension, and rhythm/conduction disturbances have each occurred in about 1 of 100 patients. Single instances of first degree and third degree heart block have been reported; intensification of AV block is a known effect of beta-blockers (see also CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
Central Nervous System—Dizziness or fatigue has been reported in approximately 2 of 100 patients; paresthesias, sedation, and change in behavior have each been reported in approximately 6 of 1000 patients.
Respiratory—Bronchospasm has been reported in approximately 1 of 1000 patients (see CONTRAINDICATIONS and WARNINGS).
Gastrointestinal—Nausea, diarrhea, abdominal discomfort, constipation, vomiting, indigestion, anorexia, bloating, and flatulence have been reported in 1 to 5 of 1000 patients.
Miscellaneous—Each of the following has been reported in 1 to 5 of 1000 patients: rash; pruritus; headache; dry mouth, eyes, or skin; impotence or decreased libido; facial swelling; weight gain; slurred speech; cough; nasal stuffiness; sweating; tinnitus; blurred vision. Reversible alopecia has been reported infrequently.
The following adverse reactions have been reported in patients taking nadolol and/or other beta-adrenergic blocking agents, but no causal relationship to nadolol has been established.
Central Nervous System—Reversible mental depression progressing to catatonia; visual disturbances; hallucinations; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability with slightly clouded sensorium, and decreased performance on neuropsychometrics.
Gastrointestinal—Mesenteric arterial thrombosis; ischemic colitis; elevated liver enzymes.
Hematologic—Agranulocytosis; thrombocytopenic or nonthrombocytopenic purpura.
Allergic—Fever combined with aching and sore throat; laryngospasm; respiratory distress.
Miscellaneous—Pemphigoid rash; hypertensive reaction in patients with pheochromocytoma; sleep disturbances; Peyronie’s disease.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with nadolol.
Bendroflumethiazide
Gastrointestinal—Nausea, vomiting, cramping and anorexia are not uncommon; diarrhea, constipation, gastric irritation, abdominal bloating, jaundice (intrahepatic cholestatic jaundice), hepatitis, and sialadenitis occasionally occur; and pancreatitis has been reported.
Central Nervous System—Dizziness, vertigo, paresthesia, headache, and xanthopsia occasionally occur.
Hematologic—Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, and aplastic anemia have been reported.
Dermatologic-Hypersensitivity—Purpura, exfoliative dermatitis, pruritus, ecchymosis, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), respiratory distress including pneumonitis, fever, and anaphylactic reactions occasionally occur; photosensitivity and rash have been reported.
Cardiovascular—Orthostatic hypotension may occur and may be potentiated by coadministration with certain other drugs (e.g., alcohol, barbiturates, narcotics, other antihypertensive medications, etc.; see PRECAUTIONS, Drug Interactions).
Other—Muscle spasm, weakness, or restlessness is not uncommon; hyperglycemia, glycosuria, metabolic acidosis in diabetic patients, hyperuricemia, allergic glomerulonephritis, and transient blurred vision occasionally occur.
Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.
Overdosage
In the event of overdosage, nadolol may cause excessive bradycardia, cardiac failure, hypotension, or bronchospasm.
In addition to the expected diuresis, overdosage of bendroflumethiazide may produce varying degrees of lethargy which may progress to coma with minimal depression of respiration and cardiovascular function and without significant serum electrolyte changes or dehydration. The mechanism of thiazide-induced CNS depression is unknown. Gastrointestinal irritation may occur. Transitory increase in BUN has been reported, and serum electrolyte changes may occur, especially in patients with impaired renal function.
Treatment
Nadolol can be removed from the general circulation by hemodialysis. In determining the duration of corrective therapy, note must be taken of the long duration of the effect of nadolol. In addition to gastric lavage, the following measures should be employed, as appropriate.
Excessive Bradycardia—Administer atropine (0.25 to 1.0 mg). If there is no response to vagal blockade, administer isoproterenol cautiously.
Cardiac Failure—Administer a digitalis glycoside and diuretic. It has been reported that glucagon may also be useful in this situation.
Hypotension—Administer vasopressors, e.g., epinephrine or levarterenol. (There is evidence that epinephrine may be the drug of choice.)
Bronchospasm—Administer a beta2-stimulating agent and/or a theophylline derivative.
Stupor or Coma—Supportive therapy as warranted.
Gastrointestinal Effects—Symptomatic treatment as needed.
BUN and/or Serum Electrolyte Abnormalities—Institute supportive measures as required to maintain hydration, electrolyte balance, respiration, and cardiovascular and renal function.
Corzide Dosage and Administration
DOSAGE MUST BE INDIVIDUALIZED (SEE INDICATIONS). Corzide MAY BE ADMINISTERED WITHOUT REGARD TO MEALS.
Bendroflumethiazide is usually given at a dose of 5 mg daily. The usual initial dose of nadolol is 40 mg once daily whether used alone or in combination with a diuretic. Bendroflumethiazide in Corzide is 30 percent more bioavailable than that of 5 mg Naturetin tablets. Conversion from 5 mg NATURETIN to Corzide represents a 30 percent increase in dose of bendroflumethiazide.
The initial dose of Corzide (Nadolol and Bendroflumethiazide Tablets) may therefore be the 40 mg/5 mg tablet once daily. When the antihypertensive response is not satisfactory, the dose may be increased by administering the 80 mg/5 mg tablet once daily.
When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure.
Dosage Adjustment in Renal Failure—Absorbed nadolol is excreted principally by the kidneys and, although nonrenal elimination does occur, dosage adjustments are necessary in patients with renal impairment. The following dose intervals are recommended:
| Creatinine Clearance (mL/min/1.73 m2) | Dosage Interval (hours) |
| >50 | 24 |
| 31–50 | 24–36 |
| 10–30 | 24–48 |
| <10 | 40–60 |
How is Corzide Supplied
Corzide (Nadolol and Bendroflumethiazide Tablets)
- 40 mg nadolol combined with 5 mg bendroflumethiazide in bottles of 100 tablets (NDC 60793-283-01).
- 80 mg nadolol combined with 5 mg bendroflumethiazide in bottles of 100 tablets (NDC 60793-284-01).
Round, biconvex tablets are white to bluish white with dark blue specks. Each tablet has a full bisect bar. Tablet identification numbers: 40 mg/5 mg combination embossed with KPI/283 on the scored side and Corzide 40/5 on the other; 80 mg/5 mg combination embossed with KPI/284 on the scored side and Corzide 80/5 on the other.
Storage
Keep bottle tightly closed. Store at room temperature; avoid excessive heat.
Rx Only
Prescribing Information as of February 2011.
Manufactured by: King Pharmaceuticals, Inc., Bristol, TN 37620
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| NDA | NDA018647 | 05/25/1983 | |
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| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA018647 | 05/25/1983 | |
| Labeler - King Pharmaceuticals, Inc. (809587413) |
More Corzide resources
- Corzide Side Effects (in more detail)
- Corzide Dosage
- Corzide Use in Pregnancy & Breastfeeding
- Corzide Drug Interactions
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Methylphenidate Controlled-Release Tablets
Pronunciation: METH-il-FEN-i-date
Generic Name: Methylphenidate
Brand Name: Examples include Methylin ER and Ritalin SR
Use Methylphenidate Controlled-Release Tablets with caution if you have a history of emotional problems, or alcohol or substance abuse. Abuse of Methylphenidate Controlled-Release Tablets may cause it to not work as well. Abuse may also lead to addiction and severe mental changes. Do not suddenly stop using Methylphenidate Controlled-Release Tablets. Depression and other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it.
Methylphenidate Controlled-Release Tablets are used for:
Treating attention deficit disorder (ADD). It is also used to treat uncontrollable periods of daytime sleep (narcolepsy). It may also be used for other conditions as determined by your doctor.
Methylphenidate Controlled-Release Tablets are a central nervous system stimulant. Exactly how it works is not known.
Do NOT use Methylphenidate Controlled-Release Tablets if:
- you are allergic to any ingredient in Methylphenidate Controlled-Release Tablets
- you have severe anxiety, agitation, or tension
- you have glaucoma
- you have motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome
- you have serious heart problems (eg, heart defect, irregular heartbeat)
- you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Methylphenidate Controlled-Release Tablets:
Some medical conditions may interact with Methylphenidate Controlled-Release Tablets. 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 history of high blood pressure, heart problems (eg, heart failure, fast or irregular heartbeat), a recent heart attack, or if a family member has a history of irregular heartbeat or sudden death
- if you have a history of seizures or abnormal electroencephalograms (EEGs)
- if you have a history of overactive thyroid, chronic fatigue, cystic fibrosis, or stomach or bowel problems (eg, blockage, inflammation, narrowing)
- if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems
Some MEDICINES MAY INTERACT with Methylphenidate Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- MAOIs (eg, phenelzine) because severe high blood pressure may occur
- Clonidine because serious side effects may occur
- Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by Methylphenidate Controlled-Release Tablets
- Medicines for high blood pressure (eg, guanethidine, metoprolol) because their effectiveness may be decreased by Methylphenidate Controlled-Release Tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Methylphenidate Controlled-Release Tablets 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 Methylphenidate Controlled-Release Tablets:
Use Methylphenidate Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Methylphenidate Controlled-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Methylphenidate Controlled-Release Tablets refilled.
- Take Methylphenidate Controlled-Release Tablets by mouth in the morning with or without food.
- Swallow Methylphenidate Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
- If you miss a dose of Methylphenidate Controlled-Release Tablets, 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 Methylphenidate Controlled-Release Tablets.
Important safety information:
- Methylphenidate Controlled-Release Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Methylphenidate Controlled-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose without checking with your doctor.
- If your symptoms do not get better within 1 month or if they get worse, check with your doctor.
- Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or another serious problem, talk with your doctor about other therapies to treat your condition.
- Tell your doctor or dentist that you take Methylphenidate Controlled-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use Methylphenidate Controlled-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Methylphenidate Controlled-Release Tablets may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take Methylphenidate Controlled-Release Tablets.
- Caution is advised when using Methylphenidate Controlled-Release Tablets in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.
- Methylphenidate Controlled-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Methylphenidate Controlled-Release Tablets while you are pregnant. It is not known if Methylphenidate Controlled-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Methylphenidate Controlled-Release Tablets, check with your doctor. Discuss any possible risks to your baby.
When used for long periods of time or at high doses, Methylphenidate Controlled-Release Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Methylphenidate Controlled-Release Tablets stops working well. Do not take more than prescribed.
Some people who use Methylphenidate Controlled-Release Tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Methylphenidate Controlled-Release Tablets. If you do, you may have WITHDRAWAL symptoms. These may include depression or other mental problems. If you need to stop Methylphenidate Controlled-Release Tablets, your doctor will lower your dose over time.
Possible side effects of Methylphenidate Controlled-Release Tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; drowsiness; headache; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping.
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; joint pain; purple or brownish red spots on the skin); behavior changes (eg, aggression, hostility, restlessness); blurred vision or other vision problems; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, anxiety, depression, irritability, panic attacks, persistent crying, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; tremor; uncontrolled speech or muscle movements; yellowing of the eyes or skin.
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: Methylphenidate 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 may include confusion; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; muscle twitching; seizures; severe or persistent headache; tremors; unusual sweating; vomiting.
Proper storage of Methylphenidate Controlled-Release Tablets:
Store Methylphenidate Controlled-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Methylphenidate Controlled-Release Tablets out of the reach of children and away from pets.
General information:
- If you have any questions about Methylphenidate Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
- Methylphenidate Controlled-Release Tablets are 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 Methylphenidate Controlled-Release Tablets. 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 Methylphenidate resources
- Methylphenidate Side Effects (in more detail)
- Methylphenidate Use in Pregnancy & Breastfeeding
- Drug Images
- Methylphenidate Drug Interactions
- Methylphenidate Support Group
- 242 Reviews for Methylphenidate - Add your own review/rating
Compare Methylphenidate with other medications
- ADHD
- Depression
- Fatigue
- Narcolepsy
- Obesity
- Severe Mood Dysregulation
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