Saturday, 31 March 2012

Coagulation Factor VIIa (Recombinant)


Pronunciation: koe-AG-yoo-lay-shun FAK-tor
Generic Name: Coagulation Factor VIIa (Recombinant)
Brand Name: Novoseven


Coagulation Factor VIIa (Recombinant) is used for:

Treating or preventing bleeding episodes in certain patients with bleeding problems such as hemophilia A or B, acquired hemophilia, or congenital FVII deficiency.


Coagulation Factor VIIa (Recombinant) is a clotting factor. It works by activating the body's clotting system.


Do NOT use Coagulation Factor VIIa (Recombinant) if:


  • you are allergic to any ingredient in Coagulation Factor VIIa (Recombinant)

  • you are allergic to mouse, hamster, or cow proteins

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



Before using Coagulation Factor VIIa (Recombinant):


Some medical conditions may interact with Coagulation Factor VIIa (Recombinant). 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 kidney problems, hardening of the arteries, disseminated intravascular coagulation (DIC), an infection of the blood or tissues, or blood conditions other than hemophilia

  • if you have a blood clot or history of blood clots

  • if you have a crush injury

  • if you are also using another type of coagulation factor VIIa

Some MEDICINES MAY INTERACT with Coagulation Factor VIIa (Recombinant). Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Activated or nonactivated prothrombin complex concentrates because the risk of blood clots may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Coagulation Factor VIIa (Recombinant) 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 Coagulation Factor VIIa (Recombinant):


Use Coagulation Factor VIIa (Recombinant) as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Coagulation Factor VIIa (Recombinant) is usually given as an injection at your doctor's office, hospital, or clinic.

  • If you miss a dose of Coagulation Factor VIIa (Recombinant), contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Coagulation Factor VIIa (Recombinant).



Important safety information:


  • Lab tests, including bleeding time, may be performed while you use Coagulation Factor VIIa (Recombinant). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Coagulation Factor VIIa (Recombinant) while you are pregnant. It is not known if Coagulation Factor VIIa (Recombinant) is found in breast milk. Do not breast-feed while taking Coagulation Factor VIIa (Recombinant).


Possible side effects of Coagulation Factor VIIa (Recombinant):


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:



Headache; joint aches; mild fever; mild pain, swelling, or redness at the injection site; nausea; vomiting.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding at the injection site; bloody stools; calf or stomach pain, tenderness, or swelling; chest pain; confusion; dizziness; fainting; numbness of an arm or leg; one-sided weakness; shortness of breath; sudden severe headache or vomiting; swelling; uncontrolled bleeding; vision or speech changes; vomiting blood or material that looks like coffee grounds; wheezing.



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: Coagulation Factor VIIa (Recombinant) side effects (in more detail)


If OVERDOSE is suspected:


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


Proper storage of Coagulation Factor VIIa (Recombinant):

Coagulation Factor VIIa (Recombinant) is usually handled and stored by a health care provider. If you are using Coagulation Factor VIIa (Recombinant) at home, store Coagulation Factor VIIa (Recombinant) as directed by your pharmacist or health care provider. Keep Coagulation Factor VIIa (Recombinant) out of the reach of children and away from pets.


General information:


  • If you have any questions about Coagulation Factor VIIa (Recombinant), please talk with your doctor, pharmacist, or other health care provider.

  • Coagulation Factor VIIa (Recombinant) 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 Coagulation Factor VIIa (Recombinant). 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 Coagulation Factor VIIa (Recombinant) resources


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


Compare Coagulation Factor VIIa (Recombinant) with other medications


  • Factor VII Deficiency
  • Hemophilia A
  • Hemophilia B

Thursday, 29 March 2012

Cemill 500


Generic Name: ascorbic acid (Oral route)


as-KORE-bik AS-id


Commonly used brand name(s)

In the U.S.


  • Ascocid

  • C-500

  • Cecon

  • Cemill 1000

  • Cemill 500

  • Cevi-Bid

  • C-Time w/Rose Hips

  • Mega-C

  • One-Gram C

  • Protexin

  • Sunkist Vitamin C

In Canada


  • Ce-Vi-Sol

  • Revitalose-C-1000

  • Revitonus C-1000 Yellow Ampule

  • Vitamin C Powder

Available Dosage Forms:


  • Tablet

  • Powder

  • Powder for Solution

  • Capsule, Liquid Filled

  • Tablet, Chewable

  • Granule

  • Capsule

  • Syrup

  • Powder for Suspension

  • Liquid

  • Solution

  • Tablet, Extended Release

  • Lozenge/Troche

  • Capsule, Extended Release

  • Wafer

Therapeutic Class: Nutritive Agent


Pharmacologic Class: Vitamin C


Uses For Cemill 500


Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Ascorbic acid, also known as vitamin C, is necessary for wound healing. It is needed for many functions in the body, including helping the body use carbohydrates, fats, and protein. Vitamin C also strengthens blood vessel walls.


Lack of vitamin C can lead to a condition called scurvy, which causes muscle weakness, swollen and bleeding gums, loss of teeth, and bleeding under the skin, as well as tiredness and depression. Wounds also do not heal easily. Your health care professional may treat scurvy by prescribing vitamin C for you.


Some conditions may increase your need for vitamin C. These include:


  • AIDS (acquired immune deficiency syndrome)

  • Alcoholism

  • Burns

  • Cancer

  • Diarrhea (prolonged)

  • Fever (prolonged)

  • Infection (prolonged)

  • Intestinal diseases

  • Overactive thyroid (hyperthyroidism)

  • Stomach ulcer

  • Stress (continuing)

  • Surgical removal of stomach

  • Tuberculosis

Also, the following groups of people may have a deficiency of vitamin C:


  • Infants receiving unfortified formulas

  • Smokers

  • Patients using an artificial kidney (on hemodialysis)

  • Patients who undergo surgery

  • Individuals who are exposed to long periods of cold temperatures

Increased need for vitamin C should be determined by your health care professional.


Vitamin C may be used for other conditions as determined by your health care professional.


Claims that vitamin C is effective for preventing senility and the common cold, and for treating asthma, some mental problems, cancer, hardening of the arteries, allergies, eye ulcers, blood clots, gum disease, and pressure sores have not been proven. Although vitamin C is being used to reduce the risk of cardiovascular disease and certain types of cancer, there is not enough information to show that these uses are effective.


Injectable vitamin C is given by or under the supervision of a health care professional. Other forms of vitamin C are available without a prescription.


Once a medicine or dietary supplement 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, vitamin C is used in certain patients with the following medical conditions:


  • Overdose of iron (to help another drug in decreasing iron levels in the body)

  • Methemoglobinemia (a blood disease)

Importance of Diet


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


Vitamin C is found in various foods, including citrus fruits (oranges, lemons, grapefruit), green vegetables (peppers, broccoli, cabbage), tomatoes, and potatoes. It is best to eat fresh fruits and vegetables whenever possible since they contain the most vitamins. Food processing may destroy some of the vitamins. For example, exposure to air, drying, salting, or cooking (especially in copper pots), mincing of fresh vegetables, or mashing potatoes may reduce the amount of vitamin C in foods. Freezing does not usually cause loss of vitamin C unless foods are stored for a very long time.


Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.


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


  • For U.S.—

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

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

  • For Canada—

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

Normal daily recommended intakes for vitamin C are generally defined as follows:





























PersonsU.S.

(mg)
Canada

(mg)
Infants and children

Birth to 3 years of age
30–4020
4 to 6 years of age4525
7 to 10 years of age4525
Adolescent and adult males50–6025–40
Adolescent and adult females50–6025–30
Pregnant females7030–40
Breast-feeding females90–9555
Smokers10045–60

Before Using Cemill 500


If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Problems in children have not been reported with intake of normal daily recommended amounts.


Geriatric


Problems in older adults have not been reported with intake of normal daily recommended amounts.


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this dietary supplement 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.


  • Amygdalin

  • Deferoxamine

Using this dietary supplement with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Indinavir

Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Blood problems—High doses of vitamin C may cause certain blood problems

  • Type 2 diabetes mellitus—Very high doses of vitamin C may interfere with tests for sugar in the urine

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency—High doses of vitamin C may cause hemolytic anemia

  • Kidney stones (history of)—High doses of vitamin C may increase risk of kidney stones in the urinary tract

Proper Use of ascorbic acid

This section provides information on the proper use of a number of products that contain ascorbic acid. It may not be specific to Cemill 500. Please read with care.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (capsules, tablets, oral solution, syrup):
    • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
      • For the U.S.

      • Adult and teenage males—50 to 60 milligrams (mg) per day.

      • Adult and teenage females—50 to 60 mg per day.

      • Pregnant females—70 mg per day.

      • Breast-feeding females—90 to 95 mg per day.

      • Smokers—100 mg per day.

      • Children 4 to 10 years of age—45 mg per day.

      • Children birth to 3 years of age—30 to 40 mg per day.

      • For Canada

      • Adult and teenage males—25 to 40 mg per day.

      • Adult and teenage females—25 to 30 mg per day.

      • Pregnant females—30 to 40 mg per day.

      • Breast-feeding females—55 mg per day.

      • Smokers—45 to 60 mg per day.

      • Children 4 to 10 years of age—25 mg per day.

      • Children birth to 3 years of age—20 mg per day.


    • To treat deficiency:
      • Adults and teenagers—Treatment dose is determined by prescriber for each individual based on the severity of deficiency. The following dose has been determined for scurvy: 500 mg a day for at least 2 weeks.

      • Children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency. The following dose has been determined for scurvy: 100 to 300 mg a day for at least 2 weeks.



For those individuals taking the oral liquid form of vitamin C:


  • This preparation is to be taken by mouth even though it comes in a dropper bottle.

  • This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

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 taking a vitamin for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins.


Storage


Store the dietary supplement 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 Cemill 500


Vitamin C is not stored in the body. If you take more than you need, the extra vitamin C will pass into your urine. Very large doses may also interfere with tests for sugar in diabetics and with tests for blood in the stool.


Cemill 500 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 - with high doses
  • Side or lower back pain

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:


Less common or rare - with high doses
  • Diarrhea

  • dizziness or faintness (with the injection only)

  • flushing or redness of skin

  • headache

  • increase in urination (mild)

  • nausea or vomiting

  • stomach cramps

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: Cemill 500 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 Cemill 500 resources


  • Cemill 500 Side Effects (in more detail)
  • Cemill 500 Use in Pregnancy & Breastfeeding
  • Cemill 500 Drug Interactions
  • Cemill 500 Support Group
  • 0 Reviews for Cemill 500 - Add your own review/rating


  • Cemill 500 Concise Consumer Information (Cerner Multum)

  • Ascorbic Acid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ascorbic Acid Monograph (AHFS DI)

  • Acerola Natural MedFacts for Professionals (Wolters Kluwer)

  • Acerola Natural MedFacts for Consumers (Wolters Kluwer)

  • Ascot Concise Consumer Information (Cerner Multum)

  • Cecon Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cenolate Injection MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cevi-Bid Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Cemill 500 with other medications


  • Dietary Supplementation
  • Scurvy
  • Urinary Acidification

Wednesday, 28 March 2012

Ipratropium Aguettant




Ipratropium Aguettant may be available in the countries listed below.


Ingredient matches for Ipratropium Aguettant



Ipratropium

Ipratropium Bromide is reported as an ingredient of Ipratropium Aguettant in the following countries:


  • Tunisia

Ipratropium Bromide monohydrate (a derivative of Ipratropium Bromide) is reported as an ingredient of Ipratropium Aguettant in the following countries:


  • France

International Drug Name Search

Saturday, 24 March 2012

Multi Vitamin with Fluoride





Dosage Form: tablet, chewable
Unknown Title

Multi-Vitamin With Fluoride Chewable Tablets

Rx Only






























*Daily Value not established
Supplement Facts
Serving Size: 1 Chewable Tablet
Amount Per Tablet% Daily Value Adults & children 4 years or more
Vitamin A .................................. 2500 IU50%
Vitamin C ..................................... 60 mg100%
Vitamin D .................................... 400 IU100%
Vitamin E ...................................... 15 IU50%
Thiamin (B1) ............................ 1.05 mg70%
Riboflavin (B2) ........................... 1.2 mg71%
Niacin ....................................... 13.5 mg68%
Vitamin (B6) ............................. 1.05 mg53%
Folate ......................................... 0.3 mg75%
Vitamin B12 .............................. 4.5 mcg75%
Fluoride (as sodium fluoride) ... 0.25 mg*

Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.


Other ingredients: Ascorbic acid, butylated hydroxyl toluene, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, FD&C yellow #6 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, orange flavor, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.



CLINICAL PHARMACOLOGY


It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.


Multi-vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.


Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:


Ca10(PO4)6(OH)2 + 2F-  —————> Ca10(PO4)6F2 + 2OH-


(Hydroxyapatite)                                   (Fluorapatite)


Three stages of fluoride deposition in tooth enamel can be distinguished:


1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.


2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.


3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.



INDICATIONS AND USAGE


Supplementation of the diet with ten essential vitamins.


Supplementation of the diet with fluoride for caries prophylaxis.


See Dosage and Administration.


Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.


The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.


Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.



WARNINGS


As in the case of all medications, keep out of the reach of children.


Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.



PRECAUTIONS


The suggested dose of Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.


Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration.


  • If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department.

  • All sources of fluoride should be evaluated with a thorough fluoride history.

  • Patient exposure to multiple water sources can make proper prescribing complex.

  • Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth.

  • Fluoride supplements require long-term compliance on a daily basis.


ADVERSE REACTIONS


Allergic rash and other idiosyncrasies have been rarely reported.



DOSAGE AND ADMINISTRATION

















*1.0 ppm = 1 mg / liter
**2.2 mg Sodium Fluoride contains 1mg fluoride ion.
Fluoride Ion Level in Drinking Water (ppm)*
AGE<0.3 ppm0.3-0.6 ppm>0.6 ppm
4-6 years0.50 mg / day**(2 tablets)0.25 mg / day(1 tablet)None
6-16 years1.0 mg / day(4 tablets)0.50 mg / day(2 tablets)None

HOW SUPPLIED


Multi-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.


Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.


Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.


Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].


Manufactured for: Boca Pharmacal, Inc.

Coral Springs, FL 33065 www.bocapharmacal.com


1-800-354-8460 Iss. 08/11



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



[Rev 18]









MULTI-VITAMIN WITH FLUORIDE 
vitamin a, vitamin d, thiamine, riboflavin, niacin, pyridoxine, folic acid, fluoride ion, ascorbic acid, .alpha.-tocopherol-acetate-dl, cyanocobalamin  tablet, chewable










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)64376-813
Route of AdministrationORALDEA Schedule    






































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A (VITAMIN A)VITAMIN A2500 [iU]
VITAMIN D (VITAMIN D)VITAMIN D400 [iU]
THIAMINE (THIAMINE)THIAMINE1.05 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN1.2 mg
NIACIN (NIACIN)NIACIN13.5 mg
PYRIDOXINE (PYRIDOXINE)PYRIDOXINE1.05 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID0.3 mg
FLUORIDE ION (FLUORIDE ION)FLUORIDE ION0.25 mg
ASCORBIC ACID (ASCORBIC ACID)ASCORBIC ACID60 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-).ALPHA.-TOCOPHEROL ACETATE, DL-15 [iU]
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN4.5 ug






























































Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
CHOLECALCIFEROL 
CYANOCOBALAMIN 
FD&C YELLOW NO. 6 
FOLIC ACID 
GELATIN 
MEDIUM-CHAIN TRIGLYCERIDES 
MAGNESIUM STEARATE 
MANNITOL 
NIACINAMIDE 
POVIDONE 
.ALPHA.-TOCOPHEROL ACETATE 
.ALPHA.-TOCOPHEROL, DL- 
RIBOFLAVIN 
SILICON DIOXIDE 
CITRIC ACID MONOHYDRATE 
THIAMINE 
VITAMIN A ACETATE 
ASCORBIC ACID 
GLYCERYL MONOSTEARATE 
BUTYLATED HYDROXYTOLUENE 
SUCROSE 
PYRIDOXINE 
SODIUM ASCORBATE 
SODIUM CITRATE 
STARCH, CORN 
SUCRALOSE 
ORANGE 
CELLULOSE, MICROCRYSTALLINE 


















Product Characteristics
ColorORANGEScoreno score
ShapeROUND (Flat)Size13mm
FlavorORANGEImprint CodeBP;813
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
164376-813-01100 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other12/28/2011


Labeler - Boca Pharmacal, Inc (170266089)

Registrant - Boca Pharmacal, Inc (170266089)









Establishment
NameAddressID/FEIOperations
Cispharma, Inc833171445MANUFACTURE
Revised: 01/2012Boca Pharmacal, Inc

Thursday, 22 March 2012

Phenoxybenzamine


Pronunciation: fen-OX-ee-BEN-za-meen
Generic Name: Phenoxybenzamine
Brand Name: Dibenzyline


Phenoxybenzamine is used for:

Treating high blood pressure and sweating caused by a certain kind of tumor (pheochromocytoma). It may also be used for other conditions as determined by your doctor.


Phenoxybenzamine is an alpha-blocker. It works by relaxing blood vessels, causing blood pressure to decrease.


Do NOT use Phenoxybenzamine if:


  • you are allergic to any ingredient in Phenoxybenzamine

  • you have a condition in which a fall in blood pressure may be undesirable

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



Before using Phenoxybenzamine:


Some medical conditions may interact with Phenoxybenzamine. 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 problems with the blood vessels of the heart or brain, heart problems, an irregular heartbeat, a lung or respiratory tract infection, or kidney problems

  • if you have a history of cancer

  • if you are taking any other medicine for blood pressure

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


  • Epinephrine because severe low blood pressure may occur

  • Levarterenol or reserpine because their effectiveness may be decreased by Phenoxybenzamine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenoxybenzamine 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 Phenoxybenzamine:


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


  • Take Phenoxybenzamine by mouth with or without food.

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

  • If you miss a dose of Phenoxybenzamine, 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 Phenoxybenzamine.



Important safety information:


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

  • Phenoxybenzamine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

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

  • Phenoxybenzamine may increase your risk of developing certain types of cancer if taken for a long period of time. Long-term use of Phenoxybenzamine is not recommended.

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

  • Lab tests, including blood pressure checks, may be performed while you use Phenoxybenzamine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Phenoxybenzamine with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness.

  • Phenoxybenzamine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Phenoxybenzamine may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Phenoxybenzamine while you are pregnant. It is not known if Phenoxybenzamine is found in breast milk. Do not breast-feed while taking Phenoxybenzamine.


Possible side effects of Phenoxybenzamine:


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; nasal congestion; stomach upset; tiredness.



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); change in sexual function; fainting; fast heartbeat; new or unusual lumps or growths; pinpoint pupils; severe dizziness or lightheadedness when sitting or standing; vomiting.



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: Phenoxybenzamine 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 fainting; fast heartbeat; severe dizziness, lightheadedness, or fainting, especially when sitting or standing; severe tiredness or weakness; vomiting.


Proper storage of Phenoxybenzamine:

Store Phenoxybenzamine 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 Phenoxybenzamine out of the reach of children and away from pets.


General information:


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

  • Phenoxybenzamine 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 Phenoxybenzamine. 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 Phenoxybenzamine resources


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


  • phenoxybenzamine Concise Consumer Information (Cerner Multum)

  • phenoxybenzamine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Dibenzyline Prescribing Information (FDA)

  • Dibenzyline Monograph (AHFS DI)



Compare Phenoxybenzamine with other medications


  • Pheochromocytoma

Ifosfamida Rontag




Ifosfamida Rontag may be available in the countries listed below.


Ingredient matches for Ifosfamida Rontag



Ifosfamide

Ifosfamide is reported as an ingredient of Ifosfamida Rontag in the following countries:


  • Argentina

International Drug Name Search

Wednesday, 21 March 2012

Sodium Chloride Injection Hospira




BACTERIOSTATIC

0.9% SODIUM CHLORIDE

Injection, USP

Rx only


Multiple-dose Plastic Vial


Multiple-dose LifeShield® Plastic Vial


NOT FOR INHALATION




WARNING: NOT FOR USE IN NEONATES.




Sodium Chloride Injection Hospira Description


This preparation is designed for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.


Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. May contain hydrochloric acid for pH adjustment. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for medication. The pH is 5.0 (4.5 to 7.0).


Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.


The semi-rigid vial 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 Chloride Injection Hospira - Clinical Pharmacology


Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl−) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance.


The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output.


The small volume of fluid and amount of sodium chloride provided by Bacteriostatic 0.9% Sodium Chloride Injection, USP, when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants.


Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).


Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.



Indications and Usage for Sodium Chloride Injection Hospira


This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.



Contraindications


Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population.


Parenteral preparations with benzyl alcohol should not be used for fluid or sodium chloride replacement.


Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthetic procedures.



Warnings


Benzyl alcohol, a preservative in Bacteriostatic Sodium Chloride Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group. Preservative-free Sodium Chloride Injection should be used for flushing intravascular catheters. Where a sodium chloride solution is required for preparing or diluting medications for use in neonates, only preservative-free Sodium Chloride Injection should be used.



Precautions


Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.


Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.



Pregnancy Category C. Animal reproduction studies have not been conducted with Bacteriostatic 0.9% Sodium Chloride Injection, USP. It is also not known whether Bacteriostatic 0.9% Sodium Chloride Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic 0.9% Sodium Chloride Injection containing additives should be given to a pregnant woman only if clearly needed.



Pediatric Use


The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. However, due to potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol are contraindicated in this patient population.



Drug Interactions


Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.


Use aseptic technique for single or multiple entry and withdrawal from all containers.


When diluting or dissolving drugs, mix thoroughly and use promptly.


Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.


Do not use unless the solution is clear and seal intact.



Adverse Reactions


Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.


If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.


Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg neonate or infant is potentially capable of producing blood pressure changes.



Overdosage


Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of sodium chloride or fluid overload except possibly in neonates and very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS.



Sodium Chloride Injection Hospira Dosage and Administration


The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.


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 Chloride Injection Hospira Supplied


Bacteriostatic 0.9% Sodium Chloride Injection, USP is supplied in multiple-dose 10, 20 and 30 mL plastic fliptop vials (List No. 1966) or in multiple-dose 10 and 30 mL plastic LifeShield® fliptop vials* (List No. 1966).


*Intended for use with the LifeShield® Blunt Cannula.


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


Revised: April, 2005


 


©Hospira 2005        EN - 1169        Printed in USA


HOSPIRA, INC., LAKE FOREST, IL 60045 USA



RL-0355










SODIUM CHLORIDE 
sodium chloride  injection










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0409-1966
Route of AdministrationINTRAVENOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION)SODIUM CHLORIDE9 mg  in 1 mL








Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL9 mg  in 1 mL
WATER 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














































Packaging
#NDCPackage DescriptionMultilevel Packaging
10409-1966-0725 VIAL In 1 CARTONcontains a VIAL, MULTI-DOSE
130 mL In 1 VIAL, MULTI-DOSEThis package is contained within the CARTON (0409-1966-07)
20409-1966-1225 VIAL In 1 CARTONcontains a VIAL, MULTI-DOSE
210 mL In 1 VIAL, MULTI-DOSEThis package is contained within the CARTON (0409-1966-12)
30409-1966-1425 VIAL In 1 CARTONcontains a VIAL, MULTI-DOSE
330 mL In 1 VIAL, MULTI-DOSEThis package is contained within the CARTON (0409-1966-14)
40409-1966-0425 VIAL In 1 CARTONcontains a VIAL, MULTI-DOSE
410 mL In 1 VIAL, MULTI-DOSEThis package is contained within the CARTON (0409-1966-04)
50409-1966-0525 VIAL In 1 CARTONcontains a VIAL, MULTI-DOSE
520 mL In 1 VIAL, MULTI-DOSEThis package is contained within the CARTON (0409-1966-05)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01880008/19/2011


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

More Sodium Chloride Injection Hospira resources


  • Sodium Chloride Injection Hospira Drug Interactions
  • Sodium Chloride Injection Hospira Support Group
  • 0 Reviews for Sodium Chloride - Add your own review/rating


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  • Postural Orthostatic Tachycardia Syndrome

Monday, 19 March 2012

Loperamide Capsules



Pronunciation: loe-PER-a-mide
Generic Name: Loperamide
Brand Name: Imodium


Loperamide Capsules is used for:

Treating symptoms of certain types of diarrhea. It is also used to decrease the amount of discharge from an ileostomy. It may also be used for to treat other conditions as determined by your doctor.


Loperamide Capsules is an antidiarrheal agent. It works by slowing the movement of bowel contents.


Do NOT use Loperamide Capsules if:


  • you are allergic to any ingredient in Loperamide Capsules

  • you have stomach pain without diarrhea

  • you have constipation, stomach bloating, or bloody stools

  • the patient is a child younger than 2 years (24 months) old

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



Before using Loperamide Capsules:


Some medical conditions may interact with Loperamide Capsules. 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 bloody diarrhea; mucus in your stool; fever; bowel problems (eg, inflammation, blockage, enlarged colon); or diarrhea caused by food poisoning, antibiotic use, or bacterial infection

  • if you have AIDS or liver problems

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


  • Quinidine or ritonavir because they may increase the risk of Loperamide Capsules's side effects

  • Saquinavir because its effectiveness may be decreased by Loperamide Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Loperamide Capsules 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 Loperamide Capsules:


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


  • Take Loperamide Capsules by mouth with or without food.

  • Drinking extra fluids is recommended while you have diarrhea. Check with your doctor if you have questions.

  • If you miss a dose of Loperamide Capsules and are taking it regularly, 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 Loperamide Capsules.



Important safety information:


  • Loperamide Capsules may cause drowsiness, dizziness, or tiredness. These effects may be worse if you take it with alcohol or certain medicines. Use Loperamide Capsules 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 or use for longer than 48 hours without checking with your doctor.

  • If your diarrhea does not get better within 48 hours or if it gets worse, contact your doctor.

  • If you develop a fever, stomach bloating or swelling, or blood in your stools, contact your doctor.

  • Loperamide Capsules is used to treat the symptoms of diarrhea, but will not treat the condition causing the diarrhea. Check with your doctor if you have any questions or concerns about the cause of your diarrhea.

  • Caution is advised when using Loperamide Capsules in CHILDREN; they may be more sensitive to its effects, especially dehydration.

  • Do not use Loperamide Capsules in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Loperamide Capsules while you are pregnant. Loperamide Capsules is found in breast milk. Do not breast-feed while taking Loperamide Capsules.


Possible side effects of Loperamide Capsules:


All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. 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); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.



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: Loperamide 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 constipation; decreased urination; nausea; severe drowsiness or constipation; vomiting.


Proper storage of Loperamide Capsules:

Store at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Loperamide Capsules out of the reach of children and away from pets.


General information:


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

  • Loperamide Capsules 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 Loperamide Capsules. 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 Loperamide resources


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


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  • Diarrhea
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Sunday, 18 March 2012

Clomid



Generic Name: clomiphene (Oral route)

KLOE-mi-feen

Commonly used brand name(s)

In the U.S.


  • Clomid

  • Serophene

Available Dosage Forms:


  • Tablet

Therapeutic Class: Female Reproductive Agent


Pharmacologic Class: Gonadotropin


Uses For Clomid


Clomiphene is used as a fertility medicine in some women who are unable to become pregnant.


Clomiphene probably works by changing the hormone balance of the body. In women, this causes ovulation to occur and prepares the body for pregnancy.


Clomiphene may also be used for other conditions in both females and males as determined by your doctor.


The following information applies only to female patients taking clomiphene. Check with your doctor if you are a male and have any questions about the use of clomiphene.


Clomiphene is available only with your doctor's prescription.


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


  • Certain problems of the male sexual organs caused by pituitary or hypothalamus gland problems (diagnosis)

  • Male infertility caused by low production of sperm

  • Problems with the corpus luteum (mature egg)

For males taking this medicine for treatment of infertility caused by low sperm production:


  • To help decide on the best treatment for your medical problem, tell your doctor:
    • if you have ever had any unusual or allergic reaction to clomiphene.

    • if you have any of the following medical problems:
      • Liver disease

      • Mental depression

      • Thrombophlebitis



  • If you miss a dose of this medicine, take it as soon as possible. If you do not remember until it is time for the next dose, take both doses together; then go back to your regular dosing schedule. If you miss more than one dose, check with your doctor.

  • It is important that your doctor check your progress at regular visits to find out if clomiphene is working and to check for unwanted effects.

  • This medicine may cause vision problems, dizziness, or lightheadedness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not clear-headed or able to see well.

  • 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. When this medicine is used for short periods of time at low doses, serious side effects usually are rare. However, check with your doctor if any of the following side effects occur:
    • Less common or rare

    • Blurred vision; decreased or double vision or other vision problems; seeing flashes of light; sensitivity of eyes to light; yellow eyes or skin


  • Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:
    • Less common or rare

    • Breast enlargement; dizziness or lightheadedness; headache; mental depression; nausea or vomiting; nervousness; restlessness; tiredness; trouble in sleeping


Before Using Clomid


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Unusually large ovary or

  • Cyst on ovary—Clomiphene may cause the cyst to increase in size

  • Endometriosis—Inducing ovulation (including using clomiphene) may worsen endometriosis because the body estrogen level is increased; estrogen can cause growth of endometriosis implants

  • Fibroid tumors of the uterus—Clomiphene may cause fibroid tumors to increase in size

  • Inflamed veins due to blood clots—Clomiphene may make condition worse

  • Liver disease (or history of)—Clomiphene may make any liver disease worse

  • Mental depression—Existing depression may become worse because of hormone changes caused by clomiphene

  • Unusual vaginal bleeding—Some irregular vaginal bleeding is a sign that the lining of the uterus is growing too much or is a sign of cancer of the uterus lining; these problems must be ruled out before clomiphene is used because clomiphene can make these conditions worse

Proper Use of clomiphene

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


Take this medicine only as directed by your doctor. If you are to begin on Day 5, count the first day of your menstrual period as Day 1. Beginning on Day 5, take the correct dose every day for as many days as your doctor ordered. To help you to remember to take your dose of medicine, take it at the same time every day.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For treating infertility:
      • Adults—50 milligrams (mg) a day for five days of a menstrual cycle. The treatment is usually started on the fifth day of your menstrual period. If you do not have menstrual cycles, you can begin taking your medicine at any time. If you do not become pregnant after the first course, your doctor may increase your dose a little at a time up to 250 mg a day. Your treatment may be repeated until you do become pregnant or for up to four treatment cycles.



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 do not remember until it is time for the next dose, take both doses together; then go back to your regular dosing schedule. If you miss more than one dose, check with your doctor.


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 Clomid


It is very important that your doctor check your progress at regular visits to make sure this medicine is working and to check for unwanted effects.


At certain times in your menstrual cycle, your doctor may want you to use an ovulation prediction test kit. Follow your doctor's instructions carefully. Ovulation is controlled by luteinizing hormone (LH). LH is present in the blood and urine in very small amounts during most of the menstrual cycle but rises suddenly for a short time in the middle of the menstrual cycle. This sharp rise, the LH surge, usually causes ovulation within about 30 hours. A woman is most likely to become pregnant if she has intercourse within the 24 hours after detecting the LH surge. Ovulation prediction test kits are used to test for this large amount of LH in the urine. This method is better for predicting ovulation than measuring daily basal body temperature. It is important that intercourse take place at the correct time to give you the best chance of becoming pregnant.


There is a chance that clomiphene may cause birth defects if it is taken after you become pregnant. Stop taking this medicine and tell your doctor immediately if you think you have become pregnant while still taking clomiphene.


This medicine may cause blurred vision, difficulty in reading, or other changes in vision. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not clear-headed or able to see well. If these reactions are especially bothersome, check with your doctor.


Clomid Side Effects


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


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


More common
  • Bloating

  • stomach or pelvic pain

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


Less common or rare
  • Blurred vision

  • decreased or double vision or other vision problems

  • seeing flashes of light

  • sensitivity of eyes to light

  • yellow eyes or skin

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


More common
  • Hot flashes

Less common or rare
  • Breast discomfort

  • dizziness or lightheadedness

  • headache

  • heavy menstrual periods or bleeding between periods

  • mental depression

  • nausea or vomiting

  • nervousness

  • restlessness

  • tiredness

  • trouble in sleeping

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: Clomid side effects (in more detail)



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More Clomid resources


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


  • Clomid Prescribing Information (FDA)

  • Clomid Consumer Overview

  • Clomid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Clomiphene Prescribing Information (FDA)

  • Clomiphene Citrate Monograph (AHFS DI)

  • Serophene Prescribing Information (FDA)



Compare Clomid with other medications


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