Tuesday 31 July 2012

selenium sulfide Topical


se-LEE-nee-um SUL-fide


Commonly used brand name(s)

In the U.S.


  • Dandrex

  • Selenos

  • Selseb

  • Selsun Blue Medicated Treatment

  • Tersi Foam

In Canada


  • Versel

Available Dosage Forms:


  • Lotion

  • Cream

  • Shampoo

  • Foam

  • Suspension

Therapeutic Class: Antiseborrheic


Uses For selenium sulfide


Selenium sulfide 1% and 2.5% strengths are used on the scalp to help control the symptoms of dandruff and seborrheic dermatitis.


Selenium sulfide 2.5% strength is used also on the body to treat tinea versicolor (a type of fungus infection of the skin).


In the United States, the 2.5% strength is available only with your doctor's prescription.


Before Using selenium sulfide


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 selenium sulfide, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to selenium sulfide 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


There is no specific information comparing use of selenium sulfide in infants and children with use in other age groups; however, selenium sulfide is not expected to cause different side effects or problems in children than it does in adults.


Geriatric


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


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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


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


  • Blistered, raw, or oozing areas on your scalp or body—Use of selenium sulfide on these areas may increase the chance of absorption through the skin

Proper Use of selenium sulfide


If you are using the 2.5% strength of selenium sulfide: Use selenium sulfide only as directed. Do not use it more often than recommended on the label, unless otherwise directed by your doctor.


If you are using the 1% strength of selenium sulfide : For best results, use selenium sulfide at least 2 times a week or as directed by your doctor.


To use selenium sulfide for dandruff or seborrheic dermatitis of the scalp:


  • Before using selenium sulfide, wet the hair and scalp with lukewarm water.

  • Apply enough medicine (1 or 2 teaspoonfuls) to the scalp to work up a lather. Allow the lather to remain on the scalp for 2 to 3 minutes, then rinse.

  • Apply the medicine again and rinse well.

  • If selenium sulfide is used on light or blond, gray, or chemically treated (bleached, tinted, permanent-waved) hair, rinse your hair well for at least 5 minutes after using the medicine to lessen the chance of hair discoloration.

  • After treatment, wash your hands well.

To use selenium sulfide for tinea versicolor of the body:


  • Apply the medicine to the affected areas of your body, except for your face and genitals (sex organs).

  • Work up a lather using a small amount of water.

  • Allow the medicine to remain on your skin for 10 minutes.

  • Rinse your body well to remove all the medicine.

Do not use selenium sulfide if blistered, raw, or oozing areas are present on your scalp or the area of your body that is to be treated , unless otherwise directed by your doctor.


Keep selenium sulfide away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water.


Dosing


The dose of selenium sulfide 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 selenium sulfide. 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 lotion dosage form:
    • For dandruff or seborrheic dermatitis:
      • Adults and children—If you are using the 1% lotion, use on the scalp two times a week. If you are using the 2.5% lotion, use on the scalp two times a week for two weeks, then use one time a week or less often.

      • Infants—Use and dose must be determined by your doctor.


    • For tinea versicolor:
      • Adults and children—Use the 2.5% lotion on the body one time a day for seven days.

      • Infants—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of selenium sulfide, 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 selenium sulfide


If your condition does not get better after regular use of selenium sulfide, or if it gets worse, check with your doctor.


selenium sulfide 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:


Less common or rare
  • Skin irritation

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
  • Unusual dryness or oiliness of hair or scalp

Less common
  • Increase in normal hair loss

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: selenium sulfide Topical 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 selenium sulfide Topical resources


  • Selenium sulfide Topical Side Effects (in more detail)
  • Selenium sulfide Topical Use in Pregnancy & Breastfeeding
  • Selenium sulfide Topical Support Group
  • 3 Reviews for Selenium sulfide Topical - Add your own review/rating


  • selenium sulfide topical Concise Consumer Information (Cerner Multum)

  • Dandrex Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Selseb MedFacts Consumer Leaflet (Wolters Kluwer)

  • Selsun Concise Consumer Information (Cerner Multum)

  • Tersi Foam Prescribing Information (FDA)

  • Tersi Foam MedFacts Consumer Leaflet (Wolters Kluwer)



Compare selenium sulfide Topical with other medications


  • Seborrheic Dermatitis
  • Tinea Versicolor

Ichtiyol-Zalf




Ichtiyol-Zalf may be available in the countries listed below.


Ingredient matches for Ichtiyol-Zalf



Ichthammol

Ichthammol is reported as an ingredient of Ichtiyol-Zalf in the following countries:


  • Indonesia

International Drug Name Search

Thursday 26 July 2012

Narcan



Generic Name: naloxone (nah LOX own)

Brand Names: Narcan


What is Narcan (naloxone)?

Naloxone is an special narcotic drug that reverses the effects of other narcotic medicines.


Naloxone is used to reverse the effects of narcotic drugs used during surgery or to treat pain.


Naloxone may also be used to treat narcotic drug overdose or to diagnose narcotic drug addiction.


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


What is the most important information I should know about Narcan (naloxone)?


You should not use this medication if you are allergic to naloxone.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received this medication.


Naloxone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. If you are using any narcotic pain medication, the pain-relieving effects of the narcotic will be reversed while you are also receiving naloxone. Drinking alcohol can increase certain side effects of naloxone.

What should I discuss with my health care provider before using Narcan (naloxone)?


You should not use this medication if you are allergic to naloxone.

If possible before you receive naloxone, tell your doctor if you have:



  • heart disease;




  • seizures;




  • a history of head injury or brain tumor; or




  • a history of drug or alcohol addiction.




FDA pregnancy category C. It is not known whether naloxone 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 naloxone 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 Narcan (naloxone)?


Naloxone is injected into a muscle or under the skin, or into a vein through an IV. You will receive this injection in a clinic or hospital setting.


Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving naloxone. This will help your doctor determine how long to treat you with this medication.


What happens if I miss a dose?


Because you will receive naloxone in a clinical setting, you are not likely to miss a dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include seizure (convulsions), feeling light-headed, or fainting.


What should I avoid while using Narcan (naloxone)?


Naloxone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of naloxone.

Narcan (naloxone) 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:

  • chest pain, fast or irregular heartbeats;




  • dry cough, wheezing, feeling short of breath;




  • sweating, severe nausea or vomiting;




  • severe headache, agitation, anxiety, confusion, ringing in your ears;




  • seizure (convulsions);




  • feeling like you might pass out; or




  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).



If you are being treated for narcotic drug addiction, the expected symptoms of withdrawal would include:



  • feeling nervous, restless, or irritable;




  • body aches;




  • dizziness, weakness;




  • diarrhea, stomach pain, mild nausea;




  • fever, chills, goosebumps; or




  • sneezing, runny nose.



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 Narcan (naloxone)?


If you are using any narcotic pain medication, the pain-relieving effects of the narcotic will be reversed while you are also receiving naloxone.

Tell your doctor about all other medicines you use, especially:



  • buprenorphine (Buprenex, Subutex);




  • methohexital (Brevital); or




  • narcotic pain medication such as codeine (Tylenol #3), hydrocodone (Lortab, Vicodin, Vicoprofen), hydromorphone (Dilaudid, Palladone), oxycodone (OxyContin, Percocet), fentanyl (Actiq, Duragesic), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph), and many others.



This list is not complete and other drugs may interact with naloxone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Narcan resources


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


  • Narcan Prescribing Information (FDA)

  • Narcan Monograph (AHFS DI)

  • Narcan MedFacts Consumer Leaflet (Wolters Kluwer)

  • Naloxone Prescribing Information (FDA)



Compare Narcan with other medications


  • Opioid Overdose


Where can I get more information?


  • Your pharmacist can provide more information about naloxone.

See also: Narcan side effects (in more detail)


Tuesday 24 July 2012

Sodium Phosphates





Dosage Form: injection, solution
SODIUM PHOSPHATES

Injection, USP

45 mM P in 15 mL


(3 mM P and 4 mEq Na+/mL)


FOR ADDITIVE USE ONLY AFTER DILUTION IN I.V. FLUIDS


Plastic Vial


Rx only



Sodium Phosphates Description


Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection.


The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted.


Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate).


One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 12 mOsmol/mL (calc).


The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use.


It is provided as a 15 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit.


Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4• H2O, white, odorless crystals or granules freely soluble in water.


Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.


The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.



Sodium Phosphates - Clinical Pharmacology


Phosphorus in the form of organic and inorganic phosphate has a variety of important biochemical functions in the body and is involved in many significant metabolic and enzyme reactions in almost all organs and tissues. It exerts a modifying influence on the steady state of calcium levels, a buffering effect on acid-base equilibrium and a primary role in the renal excretion of hydrogen ion.


Phosphorus is present in plasma and other extracellular fluid, in cell membranes and intracellular fluid, as well as in collagen and bone tissues. Phosphorus in the extracellular fluid is primarily in inorganic form and plasma levels may vary somewhat with age. The ratio of disodium phosphate and monosodium phosphate in the extracellular fluid is 4 to 1 (80% to 20%) at the normal pH of 7.4. This buffer ratio varies with the pH, but owing to its relatively low concentration, it contributes little to the buffering capacity of the extracellular fluid.


Phosphorus, present in large amounts in erythrocytes and other tissue cells, plays a significant intracellular role in the synthesis of high energy organic phosphates. It has been shown to be essential to maintain red cell glucose utilization, lactate production, and the concentration of both erythrocyte adenosine triphosphate (ATP) and 2,3 diphosphoglycerate (DPG), and must be deemed as important to other tissue cells. Hypophosphatemia should be avoided during periods of total parenteral nutrition, or other lengthy periods of intravenous infusions. It has been suggested that patients receiving total parenteral nutrition receive 12 to 15 mM phosphorus per 250 g of dextrose. Serum phosphorus levels should be regularly monitored and appropriate amounts of phosphorus should be added to the infusions to maintain normal serum phosphorus levels. Intravenous infusion of inorganic phosphorus may be accompanied by a decrease in the serum level and urinary excretion of calcium. The normal level of serum phosphorus is 3.0 to 4.5 mg/100 mL in adults; 4.0 to 7.0 mg/100 mL in children.


Intravenously infused phosphorus not taken up by the tissues is excreted almost entirely in the urine. Plasma phosphorus is believed to be filterable by the renal glomeruli, and the major portion of filtered phosphorus (greater than 80%) is actively reabsorbed by the tubules. Many modifying influences tend to alter the amount excreted in the urine.


Sodium is the principal cation of extracellular fluid. It comprises more than 90% of the total cations at its normal plasma concentration of approximately 142 mEq/liter. While the sodium ion can diffuse across cell membranes, intracellular sodium is maintained at a much lower concentration than extracellular sodium through the expenditure of energy by the cell (so called “sodium cation pump”). Loss of intracellular potassium ion is usually accompanied by an increase in intracellular sodium ion.


When serum sodium concentration is low, the secretion of antidiuretic hormone (ADH) by the pituitary is inhibited, thereby preventing water reabsorption by the distal renal tubules. On the other hand, adrenal secretion of aldosterone increases renal tubular reabsorption of sodium in an effort to re-establish normal serum sodium concentration.



Indications and Usage for Sodium Phosphates


Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.


The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.



Contraindications


Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.



Warnings


Sodium Phosphates Injection, USP, 3 mM P/mL must be diluted and thoroughly mixed before use.


To avoid phosphorus intoxication, infuse solutions containing sodium phosphate slowly. Infusing high concentrations of phosphorus may result in a reduction of serum calcium and symptoms of hypocalcemic tetany. Calcium levels should be monitored.


Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.


In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.


WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.


Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.



Precautions


Do not administer unless solution is clear and seal is intact. Discard unused portion.


Phosphorus replacement therapy with sodium phosphate should be guided primarily by the serum phosphorus level and the limits imposed by the accompanying sodium (Na+) ion.


Use with caution in patients with renal impairment, cirrhosis, cardiac failure and other edematous or sodium-retaining states.


Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.



Pregnancy Category C: Animal reproduction studies have not been conducted with sodium phosphate. It is also not known whether sodium phosphate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium phosphate should be given to a pregnant woman only if clearly needed.



Pediatric Use: The safety and effectiveness of sodium phosphate has been established in pediatric patients (neonates, infants, children and adolescents).



Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between 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.


Sodium ions and phosphorus are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.



Adverse Reactions


Adverse reactions involve the possibility of phosphorus intoxication. Phosphorus intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany. See WARNINGS.



Overdosage


In the event of overdosage, discontinue infusions containing sodium phosphate immediately and institute corrective therapy to restore depressed serum calcium and to reduce elevated serum sodium levels. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.



Sodium Phosphates Dosage and Administration


Sodium Phosphates Injection, USP, 3 mM P/mL is administered intravenously only after dilution and thorough mixing in a larger volume of fluid. The dose and rate of administration are dependent upon the individual needs of the patient. Serum sodium, phosphorus and calcium levels should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of millimoles (mM) of phosphorus.


In patients on total parenteral nutrition, approximately 12 to 15 mM of phosphorus (equivalent to 372 to 465 mg elemental phosphorus) per liter bottle of TPN solution containing 250 g dextrose is usually adequate to maintain normal serum phosphorus, though larger amounts may be required in hypermetabolic states. The amount of sodium and phosphorus which accompanies the addition of sodium phosphate also should be kept in mind, and if necessary, serum sodium levels should be monitored.


The suggested dose of phosphorus for infants receiving TPN is 1.5 to  2 mM P/kg/day.


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.



How is Sodium Phosphates Supplied


Sodium Phosphates Injection, USP, 3 mM P/mL is supplied as a 15 mL (45 mM P total) partial-fill single-dose container as follows: List No. 7391, Plastic Vial.


Each container is partially filled to provide air space needed for complete vacuum withdrawal of the contents into the I.V. container.


Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]


Revised: October, 2004


 


©Hospira 2004        EN - 0492        Printed in USA


HOSPIRA, INC., LAKE FOREST, IL 60045 USA



RL-0580










SODIUM PHOSPHATES 
sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0409-7391
Route of AdministrationINTRAVENOUSDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (PHOSPHORUS and SODIUM CATION)SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE276 mg  in 1 mL
SODIUM PHOSPHATE, DIBASIC ANHYDROUS (PHOSPHORUS and SODIUM CATION)SODIUM PHOSPHATE, DIBASIC ANHYDROUS142 mg  in 1 mL






Inactive Ingredients
Ingredient NameStrength
WATER 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10409-7391-7225 VIAL In 1 TRAYcontains a VIAL, SINGLE-DOSE
115 mL In 1 VIAL, SINGLE-DOSEThis package is contained within the TRAY (0409-7391-72)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01889208/31/2011


Labeler - Hospira, Inc. (141588017)
Revised: 08/2011Hospira, Inc.

More Sodium Phosphates resources


  • Sodium Phosphates Use in Pregnancy & Breastfeeding
  • Sodium Phosphates Drug Interactions
  • Sodium Phosphates Support Group
  • 14 Reviews for Sodium Phosphates - Add your own review/rating


Compare Sodium Phosphates with other medications


  • Bowel Preparation
  • Constipation

Ocufen





1. Name Of The Medicinal Product



Ocufen®


2. Qualitative And Quantitative Composition



Flurbiprofen sodium 0.03% w/v



3. Pharmaceutical Form



Eye drops.



4. Clinical Particulars



4.1 Therapeutic Indications



Ocufen is indicated for



1) the inhibition of intraoperative miosis. Ocufen does not have intrinsic mydriatic properties and does not replace mydriatic agents.



2) the management of post-operative and post-laser trabeculoplasty inflammation in the anterior segment of the eye in patients in whom steroid therapy is not recommended.



4.2 Posology And Method Of Administration



Adult dosage: For the inhibition of intraoperative miosis, 1 drop is instilled every half hour starting 2 hours before surgery. The final drop should be given not less than 30 minutes before surgery.



To control post-operative and post-laser trabeculoplasty inflammation the dosing regimen above should be followed. Beginning twenty-four hours after surgery, one drop is administered four times daily for at least one week after laser trabeculoplasty or for two to three weeks after other surgery.



In accordance with standard practice, other topical medication should not be co-administered with Ocufen. When administering other topical medications, a minimum interval of 5 minutes between instillations is recommended.



Use in children: Safety and effectiveness in children have not been established.



Administration: Topical by instillation into the conjunctival sac.



4.3 Contraindications



Ocufen is contra-indicated in epithelial herpes simplex keratitis (dendritic keratitis) and in individuals hypersensitive to any component of the medication.



The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Ocufen is contra-indicated in individuals who have previously exhibited sensitivities to these drugs.



Use of Ocufen is contra-indicated in patients with known haemostatic defects or who are receiving other medications which may prolong bleeding time. Ocufen is contra- indicated for intraocular use during surgical procedures.



4.4 Special Warnings And Precautions For Use



Wound healing may be delayed with the use of Ocufen.



There have been reports that Ocufen may cause an increased bleeding tendency of ocular tissues in conjunction with surgery.



Patients with a history of herpes simplex keratitis should be monitored closely.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in some surgical patients treated with Ocufen.



4.6 Pregnancy And Lactation



Use in pregnancy: Safety of use in pregnant women has not been established. Ocufen should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



The most frequent adverse reactions reported with the use of Ocufen are transient burning and stinging on instillation, and other minor signs of ocular irritation.



4.9 Overdose



No adverse effects are likely to be experienced following overdosage.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Flurbiprofen sodium is a non steroidal anti inflammatory agent which inhibits prostaglandin synthesis by inhibition of the cyclo-oxygenase enzyme.



Ophthalmic surgery causes prostaglandin release, with the effect that prostaglandin- mediated miosis may occur.



Treatment with Ocufen prior to surgery has been shown to inhibit intra-operative miosis and it is believed that this is brought about by inhibition of ocular prostaglandin release.



The sympathetic nervous system is not affected by this mechanism and acetylcholine- induced miosis has not been found to be inhibited in clinical trials.



Prostaglandins have also been shown to be mediators of certain kinds of intraocular inflammatory processes. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humour barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.



5.2 Pharmacokinetic Properties



Flurbiprofen concentrations of 213 ng/ml in aqueous humour have been reported following half hourly treatment for two hours preceding surgery.



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber which are additional to that already included in the Summary of Product Characteristics.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Liquifilm® (polyvinyl alcohol)



Potassium chloride



Sodium chloride



Sodium citrate dihydrate



Citric acid monohydrate



Sodium hydroxide or



Hydrochloric acid (to adjust pH)



Purified water



6.2 Incompatibilities



None known.



6.3 Shelf Life



The shelf life is 24 months for the unopened vial. The vial should be discarded after a single dose.



6.4 Special Precautions For Storage



Store at or below 25oC.



6.5 Nature And Contents Of Container



Clear, plastic unit dose vial, each containing 0.4 ml of solution.



6.6 Special Precautions For Disposal And Other Handling



Each vial of Ocufen should be used for a single dose and discarded after use.



7. Marketing Authorisation Holder



Allergan Limited



Marlow International



The Parkway



Marlow



Buckinghamshire SL7 1YL



United Kingdom



8. Marketing Authorisation Number(S)



PL 00426/0069



9. Date Of First Authorisation/Renewal Of The Authorisation



28th June 1991/17th May 2005



10. Date Of Revision Of The Text



24th November 2006




Sunday 22 July 2012

EC-Naprosyn Enteric-Coated Tablets


Pronunciation: na-PROX-en
Generic Name: Naproxen
Brand Name: EC-Naprosyn

EC-Naprosyn Enteric-Coated Tablets are a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, a heart attack, stroke). The risk may be greater if you already have heart problems or if you take EC-Naprosyn Enteric-Coated Tablets for a long time. Do not use EC-Naprosyn Enteric-Coated Tablets right before or after bypass heart surgery.


EC-Naprosyn Enteric-Coated Tablets may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.





EC-Naprosyn Enteric-Coated Tablets are used for:

Treating rheumatoid arthritis, osteoarthritis, juvenile arthritis, and ankylosing spondylitis. It may also be used for other conditions as determined by your doctor.


EC-Naprosyn Enteric-Coated Tablets are an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.


Do NOT use EC-Naprosyn Enteric-Coated Tablets if:


  • you are allergic to any ingredient in EC-Naprosyn Enteric-Coated Tablets

  • you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or another NSAID (eg, ibuprofen, celecoxib)

  • you have recently had or will be having bypass heart surgery

  • you are in the last 3 months of pregnancy

  • you are taking an H2 blocker (eg, ranitidine), sucralfate, or another medicine that contains naproxen

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



Before using EC-Naprosyn Enteric-Coated Tablets:


Some medical conditions may interact with EC-Naprosyn Enteric-Coated 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 kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)

  • if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation

  • if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk of any of these diseases

  • if you have poor health, dehydration or low fluid volume; low blood sodium levels; you are on a low-salt (sodium) diet; or you drink alcohol, smoke, or have a history of alcohol abuse

Some MEDICINES MAY INTERACT with EC-Naprosyn Enteric-Coated Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), aspirin, corticosteroids (eg, prednisone), heparin, other NSAIDs (eg, ibuprofen), rivaroxaban, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased

  • Probenecid because it may increase the risk of EC-Naprosyn Enteric-Coated Tablets's side effects

  • H2 blockers (eg, ranitidine) or sucralfate because they may decrease EC-Naprosyn Enteric-Coated Tablets's effectiveness

  • Bisphosphonates (eg, alendronate), cyclosporine, hydantoins (eg, phenytoin), lithium, methotrexate, quinolones (eg, ciprofloxacin), sulfonamides (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by EC-Naprosyn Enteric-Coated Tablets

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by EC-Naprosyn Enteric-Coated Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if EC-Naprosyn Enteric-Coated 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 EC-Naprosyn Enteric-Coated Tablets:


Use EC-Naprosyn Enteric-Coated Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • EC-Naprosyn Enteric-Coated Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get EC-Naprosyn Enteric-Coated Tablets refilled.

  • Take EC-Naprosyn Enteric-Coated Tablets by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.

  • Swallow EC-Naprosyn Enteric-Coated Tablets whole. Do not break, crush, or chew before swallowing.

  • Take EC-Naprosyn Enteric-Coated Tablets with a full glass of water (8 oz/240 mL) as directed by your doctor.

  • If you take antacids or cholestyramine, ask your doctor or pharmacist how to take them with EC-Naprosyn Enteric-Coated Tablets.

  • If you miss a dose of EC-Naprosyn Enteric-Coated Tablets, 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 EC-Naprosyn Enteric-Coated Tablets.



Important safety information:


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

  • Serious stomach ulcers or bleeding can occur with the use of EC-Naprosyn Enteric-Coated Tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking EC-Naprosyn Enteric-Coated Tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • EC-Naprosyn Enteric-Coated Tablets has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do not take aspirin while you are using EC-Naprosyn Enteric-Coated Tablets unless your doctor tells you to.

  • Do not switch between different forms of EC-Naprosyn Enteric-Coated Tablets (eg, tablets, suspension) unless your doctor tells you to. They may not provide the same amount of medicine to your body.

  • EC-Naprosyn Enteric-Coated Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take EC-Naprosyn Enteric-Coated Tablets.

  • Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use EC-Naprosyn Enteric-Coated Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use EC-Naprosyn Enteric-Coated Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.

  • EC-Naprosyn Enteric-Coated Tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: EC-Naprosyn Enteric-Coated Tablets may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using EC-Naprosyn Enteric-Coated Tablets while you are pregnant. EC-Naprosyn Enteric-Coated Tablets should not be used during labor. EC-Naprosyn Enteric-Coated Tablets are found in breast milk. Do not breast-feed while taking EC-Naprosyn Enteric-Coated Tablets.


Possible side effects of EC-Naprosyn Enteric-Coated 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:



Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset; stuffy nose.



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

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mental or mood changes; numbness of an arm or leg; one-sided weakness; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: EC-Naprosyn 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 decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.


Proper storage of EC-Naprosyn Enteric-Coated Tablets:

Store EC-Naprosyn Enteric-Coated Tablets 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 EC-Naprosyn Enteric-Coated Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about EC-Naprosyn Enteric-Coated Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • EC-Naprosyn Enteric-Coated 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 summary only. It does not contain all information about EC-Naprosyn Enteric-Coated 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 EC-Naprosyn resources


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


Compare EC-Naprosyn with other medications


  • Ankylosing Spondylitis
  • Aseptic Necrosis
  • Back Pain
  • Bursitis
  • Costochondritis
  • Diffuse Idiopathic Skeletal Hyperostosis
  • Dysautonomia
  • Fever
  • Frozen Shoulder
  • Gout, Acute
  • Headache
  • Juvenile Rheumatoid Arthritis
  • Muscle Pain
  • Osteoarthritis
  • Pain
  • Period Pain
  • Rheumatoid Arthritis
  • Sciatica
  • Spondylolisthesis
  • Tendonitis

Climara


Generic Name: estrogen (Oral route, Parenteral route, Topical application route, Transdermal route)


Commonly used brand name(s)

In the U.S.


  • Alora

  • Cenestin

  • Climara

  • Divigel

  • Elestrin

  • Emcyt

  • Enjuvia

  • Esclim

  • Estinyl

  • EstroGel

  • Evamist

  • Femtrace

  • Gynodiol

  • Menest

  • Menostar

  • Ogen .625

  • Ogen 1.25

  • Ogen 2.5

  • Premarin

  • Vivelle

  • Vivelle-Dot

In Canada


  • Estraderm

  • Estradot Transdermal

  • Estradot Transdermal Therapeutic System

  • Estradot Transdermal Therapeutic System

  • Estrogel

  • Oesclim

  • Rhoxal-Estradiol Derm 50

  • Rhoxal-Estradiol Derm 75

  • Roxal-Estradiol Derm 100

  • Vivelle 100 Mcg

  • Vivelle 25 Mcg

Available Dosage Forms:


  • Tablet

  • Patch, Extended Release

  • Gel/Jelly

  • Spray

  • Emulsion

  • Tablet, Enteric Coated

  • Capsule

Uses For Climara


Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.


The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.


Estrogens are prescribed for several reasons:


  • To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).

  • To help prevent weakening of bones (osteoporosis) in women past menopause.

  • In the treatment of selected cases of breast cancer in men and women.

  • In the treatment of cancer of the prostate in men.

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


There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.


Estrogens are available only with your doctor's prescription.


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


  • Gender identity disorder, male-to-female transsexualism (person who is born as a man but adapts to a woman's lifestyle, sees himself as a woman, and feels like a woman instead of a man.

  • Osteoporosis caused by lack of estrogen before menopause.

  • Turner's syndrome (a genetic disorder).

Before Using Climara


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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


Use of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.


This medicine may be used to start puberty in teenagers with some types of delayed puberty.


Geriatric


Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.


Pregnancy


Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.


Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.


Breast Feeding


Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.


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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.


  • Rotavirus Vaccine, Live

Using medicines in this class 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.


  • Adenovirus Vaccine Type 4, Live

  • Adenovirus Vaccine Type 7, Live

  • Bacillus of Calmette and Guerin Vaccine, Live

  • Boceprevir

  • Felbamate

  • Influenza Virus Vaccine, Live

  • Isotretinoin

  • Measles Virus Vaccine, Live

  • Mumps Virus Vaccine, Live

  • Paclitaxel

  • Paclitaxel Protein-Bound

  • Rotavirus Vaccine, Live

  • Rubella Virus Vaccine, Live

  • Smallpox Vaccine

  • St John's Wort

  • Theophylline

  • Tizanidine

  • Tranexamic Acid

  • Typhoid Vaccine

  • Varicella Virus Vaccine

  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


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


For all patients


  • Asthma or

  • Calcium, too much or too little in blood or

  • Diabetes or

  • Epilepsy or seizures or

  • Heart problems or

  • Kidney problems or

  • Liver tumors, benign or

  • Lupus erythematosus, systemic or

  • Migraine headaches—Estrogens may worsen these conditions.

  • Blood clotting problems, or history of during previous estrogen therapy—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.

  • Breast cancer or

  • Bone cancer or

  • Cancer of the uterus or

  • Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.

  • Bulging eyes or

  • Double vision or

  • Migraine headache or

  • Vision changes, sudden onset including or

  • Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

  • Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.

  • Endometriosis or

  • Gallbladder disease or gallstones, or history of or

  • High cholesterol or triglycerides, or history of or

  • Liver disease, or history of or

  • Pancreatitis (inflammation of pancreas) or

  • Porphyria—Estrogens may worsen these conditions. Although estrogens can improve blood cholesterol, they can worsen blood triglycerides for some people.

  • Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

For males treated for breast or prostate cancer:


  • Blood clots or

  • Heart or circulation disease or

  • Stroke—Males with these medical problems may be more likely to have clotting problems while taking estrogens; the high doses of estrogens used to treat male breast or prostate cancer have been shown to increase the chances of heart attack, phlebitis (inflamed veins) caused by a blood clot, or blood clots in the lungs.

Proper Use of estrogen

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


Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.


This medicine usually comes with patient information or directions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.


For patients taking any of the estrogens by mouth or by injection:


  • Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch):


  • Wash and dry your hands thoroughly before and after handling the patch.

  • Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.

  • Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.

  • Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.

  • If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.

  • Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion):


  • Washing and drying hands thoroughly before each application.

  • Apply while you are sitting comfortably. Apply one pouch to each leg every morning.

  • Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.

  • Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.

  • Rub any remaining emulsion on both hands on the buttocks.

  • Washing and drying hands thoroughly after application.

  • To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

If you are using the Evamist® transdermal spray:


  • Spray the medicine on your skin on the inside of your forearm, between the elbow and the wrist.

  • Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid to come nearer with your child, wear clothes with long sleeves to cover the application site.

  • If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.

  • Do not allow your pets to lick or touch the arm where the medicine was sprayed.

Dosing


The dose medicines in this class 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 these medicines. 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 conjugated estrogens

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least 3 months.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.


    • For treating ovary problems (female hypogonadism or for starting puberty):
      • Adults and teenagers—0.3 to 0.625 milligram (mg) a day. Your doctor may want you to take the medicine only on certain days of the month.


    • For treating ovary problems (failure or removal of both ovaries):
      • Adults—1.25 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—1.25 to 2.5 milligram (mg) three times a day.



  • For injection dosage form:
    • For controlling abnormal bleeding of the uterus:
      • Adults—25 milligrams (mg) injected into a muscle or vein. This may be repeated in six to twelve hours if needed.



  • For esterified estrogens

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least three months.


    • For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
      • Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (failure or removal of both ovaries):
      • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (female hypogonadism):
      • Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating symptoms of menopause:
      • Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—1.25 to 2.5 mg three times a day.



  • For estradiol

  • For oral dosage form:
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least 3 months.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
      • Adults—At first, 1 to 2 milligrams (mg) one time per day for at least 3 months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication.


    • For treating prostate cancer:
      • Adults—1 to 2 milligrams (mg) three times a day.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.5 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.



  • For topical emulsion dosage form (skin lotion):
    • For treating symptoms of menopause:
      • Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.



  • For transdermal dosage form (skin patches):
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
      • For the Climara patches

      • Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.

      • For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches

      • Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.



  • For estradiol cypionate

  • For injection dosage form:
    • For treating ovary problems (female hypogonadism):
      • Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.


    • For treating symptoms of menopause:
      • Adults—1 to 5 milligrams (mg) injected into a muscle every 3 to 4 weeks.



  • For estradiol valerate

  • For injection dosage form:
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—10 to 20 milligrams (mg) injected into a muscle every 4 weeks as needed.


    • For treating prostate cancer:
      • Adults—30 milligrams (mg) injected into a muscle every 1 or 2 weeks.



  • For estrone

  • For injection dosage form:
    • For controlling abnormal bleeding of the uterus:
      • Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.1 to 0.5 milligram (mg) injected into a muscle 2 or 3 times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—0.1 to 1 milligram (mg) a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.


    • For treating prostate cancer:
      • Adults—2 to 4 milligrams (mg) injected into a muscle 2 or 3 times a week.



  • For estropipate

  • For oral dosage form (tablets):
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—1.5 to 9 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.75 milligram (mg) a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.



  • For ethinyl estradiol

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—1 milligram (mg) three times a day.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—0.05 milligram (mg) one to three times a day for 3 to 6 months. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—0.15 to 3 milligrams (mg) a day.


    • For treating symptoms of menopause:
      • Adults—0.02 to 0.05 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.



  • For ethinyl estradiol and norethindrone

  • For oral dosage form (tablets):
    • For treating symptoms of menopause:
      • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.


    • To prevent loss of bone (osteoporosis):
      • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


If you miss a dose of this medicine, apply 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.


If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.


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 Climara


It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.


In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.


Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb). Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.


If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.


Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.


Tell the doctor in charge that you are using this medicine before having any laboratory test because some results may be affected.


Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to Evamist® transdermal spray.


Do not allow your pets to lick or touch the arm where Evamist® transdermal spray was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.


Climara Side Effects


Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:


The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.


Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.


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.


The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.


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


More common
  • Breast pain (in females and males)

  • fast heartbeat

  • fever

  • hives

  • hoarseness

  • increased breast size (in females and males)

  • irritation of the skin

  • itching of the skin

  • joint pain, stiffness, or swelling

  • rash

  • redness of the skin

  • shortness of breath

  • swelling of the eyelids, face, lips, hands, or feet

  • swelling of the feet and lower legs

  • tightness in the chest

  • troubled breathing or swallowing

  • weight gain (rapid)

  • wheezing

Less common or rare
  • Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)

  • chest pain

  • chills

  • cough

  • heavy non-menstrual vaginal bleeding

  • lumps in, or discharge from, breast (in females and males)

  • pains in the stomach, side, or abdomen

  • yellow eyes or skin

Rare - for males being treated for breast or prostate cancer only
  • Headache (sudden or severe)

  • loss of coordination (sudden)

  • loss of vision or change of vision (sudden)

  • pains in the chest, groin, or leg, especially in the calf of leg

  • shortness of breath (sudden and unexplained)

  • slurring of speech (sudden)

  • weakness or numbness in the arm or leg

Incidence not known
  • Abdominal or stomach bloating

  • abdominal or stomach cramps

  • acid or sour stomach

  • anxiety

  • backache

  • belching

  • blindness

  • blistering, peeling, or loosening of the skin

  • blue-yellow color blindness

  • blurred vision

  • change in vaginal discharge

  • changes in skin color

  • changes in vision

  • chest discomfort

  • clay-colored stools

  • clear or bloody discharge from nipple

  • confusion

  • constipation

  • convulsions

  • dark urine

  • decrease in the amount of urine

  • decreased vision

  • depression

  • diarrhea

  • difficulty with breathing

  • difficulty with speaking

  • dimpling of the breast skin

  • dizziness

  • double vision

  • dry mouth

  • eye pain

  • fainting

  • fluid-filled skin blisters

  • full feeling in upper abdomen or stomach

  • full or bloated feeling or pressure in the stomach

  • headache

  • heartburn

  • inability to move the arms, legs, or facial muscles

  • inability to speak

  • incoherent speech

  • increased urination

  • indigestion

  • inverted nipple

  • irregular heartbeats

  • light-colored stools

  • lightheadedness

  • loss of appetite

  • loss of bladder control

  • lump under the arm

  • metallic taste

  • migraine headache

  • mood or mental changes

  • muscle cramps in the hands, arms, feet, legs, or face

  • muscle pain

  • muscle spasm or jerking of all extremities

  • muscle weakness

  • nausea

  • noisy breathing

  • numbness or tingling of the hands, feet, or face

  • pain in the ankles or knees

  • pain or discomfort in the arms, jaw, back or neck

  • pain or feeling of pressure in the pelvis

  • pain, tenderness, swelling of the foot or leg

  • painful or tender cysts in the breasts

  • painful, red lumps under the skin, mostly on the legs

  • pains in the chest, groin, or legs, especially calves of the legs

  • partial or complete loss of vision in the eye

  • pelvic pain

  • persistent crusting or scaling of nipple

  • pinpoint red or purple spots on the skin

  • prominent superficial veins over affected area

  • red, irritated eyes

  • redness or swelling of the breast

  • sensitivity to the sun

  • severe headaches of sudden onset

  • skin thinness

  • skin warmth

  • slow speech

  • sore on the skin of the breast that does not heal

  • sore throat

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

  • stomach discomfort, upset, or pain

  • sudden loss of consciousness

  • sudden loss of coordination

  • sudden onset of shortness of breath for no apparent reason

  • sudden onset of slurred speech

  • sudden vision changes

  • swelling of the abdominal or stomach area

  • swelling of the fingers or hands

  • thirst

  • tremor

  • unpleasant breath odor

  • unusual tiredness or weakness

  • vomiting

  • vomiting of blood

  • weight loss

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
  • Abnormal growth filled with fluid or semisolid material

  • accidental injury

  • bladder pain

  • bloated full feeling

  • bloody or cloudy urine

  • body aches or pain

  • coating or white patches on tongue

  • congestion

  • cough producing mucus

  • decrease in amount of urine

  • difficult, burning, or painful urination

  • discouragement

  • dryness of the throat

  • ear congestion or pain

  • excess air or gas in the stomach or intestines

  • fear

  • feeling of warmth

  • feeling sad or empty

  • frequent urge to urinate

  • general feeling of discomfort or illness

  • headache, severe and throbbing

  • increased clear or white vaginal discharge

  • irritability

  • itching of the vaginal, rectal or genital areas

  • lack of appetite

  • lack or loss of strength

  • loss of interest or pleasure

  • mild dizziness

  • neck pain

  • nervousness

  • pain

  • pain during sexual intercourse

  • painful or difficult urination

  • pain or tenderness around the eyes and cheekbones

  • passing gas

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

  • runny nose

  • skin irritation or redness where skin patch was worn

  • shivering

  • sleeplessness

  • sneezing

  • sore mouth or tongue

  • stuffy nose

  • sudden sweating

  • tender, swollen glands in the neck

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

  • tiredness

  • trouble concentrating

  • trouble sleeping

  • unable to sleep

  • voice changes

Less common
  • Blemishes on the skin

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

  • burning or stinging of the skin

  • diarrhea (mild)

  • difficulty with moving

  • dizziness (mild)

  • increased hair growth, especially on the face

  • lower abdominal or stomach pain or pressure

  • mood or mental changes

  • muscle stiffness

  • painful cold sores or blisters on the lips, nose, eyes, or genitals

  • pimples

  • pounding in the ears

  • problems in wearing contact lenses

  • slow heartbeat

  • tooth or gum pain

  • unusual decrease in sexual desire (in males)

  • unusual increase in sexual desire (in females)

  • white or brownish vaginal discharge

Incidence not known
  • Abnormal turning out of cervix

  • changes in appetite

  • dull ache or feeling of pressure or heaviness in the legs

  • flushed, dry skin

  • fruit-like breath odor

  • increased hunger

  • irritability

  • large amount of triglyceride in the blood

  • leg cramps

  • patchy brown or dark brown discoloration of the skin

  • poor insight and judgment

  • problems with memory or speech

  • trouble recognizing objects

  • trouble thinking and planning

  • trouble walking

  • twitching, uncontrolled movements of the tongue, lips, face, arms, or legs

  • unexpected or excess milk flow from the breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).


This medicine may cause loss or thinning of the scalp hair in some people.


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.



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.