Wednesday, March 28, 2012

K-Lyte Cl


Generic Name: potassium supplement (Oral route, Parenteral route)


Commonly used brand name(s)

In the U.S.


  • Effer-K

  • Glu-K

  • K+Care ET

  • K-Lyte

  • K-Lyte Cl

  • K-Tab

  • Potassimin

  • Tri-K

  • Urocit-K 10

In Canada


  • K-10 Solution

  • Kaochlor 10

  • Kaochlor 20

  • Kaon

  • K-Lor

  • K-Lyte/Ci

  • Potassium Chloride

  • Potassium-Rougier

  • Roychlor

Available Dosage Forms:


  • Tablet, Effervescent

  • Solution

  • Capsule

  • Tablet, Extended Release

  • Powder for Suspension, Extended Release

  • Tablet

  • Powder for Suspension

  • Liquid

  • Elixir

  • Granule

  • Capsule, Extended Release

  • Powder for Solution

Uses For K-Lyte Cl


Potassium is needed to maintain good health. Although a balanced diet usually supplies all the potassium a person needs, potassium supplements may be needed by patients who do not have enough potassium in their regular diet or have lost too much potassium because of illness or treatment with certain medicines.


There is no evidence that potassium supplements are useful in the treatment of high blood pressure.


Lack of potassium may cause muscle weakness, irregular heartbeat, mood changes, or nausea and vomiting.


Injectable potassium is administered only by or under the supervision of your doctor. Some forms of oral potassium may be available in stores without a prescription. Since too much potassium may cause health problems, you should take potassium supplements only if directed by your doctor.


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.


The following table includes some potassium-rich foods.






























































Food (amount)Milligrams

of potassium
Milliequivalents

of potassium
Acorn squash, cooked

(1 cup)
89623
Potato with skin, baked

(1 long)
84422
Spinach, cooked

(1 cup)
83821
Lentils, cooked

(1 cup)
73119
Kidney beans, cooked

(1 cup)
71318
Split peas, cooked

(1 cup)
71018
White navy beans, cooked

(1 cup)
66917
Butternut squash, cooked

(1 cup)
58315
Watermelon

(1/16)
56014
Raisins

(½ cup)
55314
Yogurt, low-fat, plain

(1 cup)
53114
Orange juice, frozen

(1 cup)
50313
Brussel sprouts, cooked

(1 cup)
49413
Zucchini, cooked, sliced

(1 cup)
45612
Banana

(medium)
45112
Collards, frozen, cooked

(1 cup)
42711
Cantaloupe

(¼)
41211
Milk, low-fat 1%

(1 cup)
3489
Broccoli, frozen, cooked

(1 cup)
3329

The daily amount of potassium 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.

Because lack of potassium is rare, there is no RDA or RNI for this mineral. However, it is thought that 1600 to 2000 mg (40 to 50 milliequivalents [mEq]) per day for adults is adequate.


Remember:


  • The total amount of potassium that you get every day includes what you get from food and what you may take as a supplement. Read the labels of processed foods. Many foods now have added potassium.

  • Your total intake of potassium should not be greater than the recommended amounts, unless ordered by your doctor. In some cases, too much potassium may cause muscle weakness, confusion, irregular heartbeat, or difficult breathing.

Before Using K-Lyte Cl


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


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


Although there is no specific information comparing use of potassium supplements in children with use in other age groups, they are not expected to cause different side effects or problems in children than they do 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 potassium supplements in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.


Older adults may be at a greater risk of developing high blood levels of potassium (hyperkalemia).


Pregnancy


Potassium supplements have not been shown to cause problems in humans.


Breast Feeding


Potassium supplements pass into breast milk. However, this medicine has not been reported to cause problems in nursing babies.


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


  • Amantadine

  • Atropine

  • Belladonna

  • Belladonna Alkaloids

  • Benztropine

  • Biperiden

  • Clidinium

  • Darifenacin

  • Dicyclomine

  • Eplerenone

  • Glycopyrrolate

  • Hyoscyamine

  • Methscopolamine

  • Oxybutynin

  • Procyclidine

  • Scopolamine

  • Solifenacin

  • Tolterodine

  • Trihexyphenidyl

Using dietary supplements 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.


  • Alacepril

  • Amiloride

  • Benazepril

  • Canrenoate

  • Captopril

  • Cilazapril

  • Delapril

  • Enalaprilat

  • Enalapril Maleate

  • Fosinopril

  • Imidapril

  • Indomethacin

  • Lisinopril

  • Moexipril

  • Pentopril

  • Perindopril

  • Quinapril

  • Ramipril

  • Spirapril

  • Spironolactone

  • Temocapril

  • Trandolapril

  • Triamterene

  • Zofenopril

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 dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Addison's disease (underactive adrenal glands) or

  • Dehydration (excessive loss of body water, continuing or severe)

  • Type 2 diabetes mellitus or

  • Kidney disease—Potassium supplements may increase the risk of hyperkalemia (high blood levels of potassium), which may worsen or cause heart problems in patients with these conditions.

  • Diarrhea (continuing or severe)—The loss of fluid in combination with potassium supplements may cause kidney problems, which may increase the risk of hyperkalemia (high blood levels of potassium).

  • Heart disease—Potassium supplements may make this condition worse.

  • Intestinal or esophageal blockage—Potassium supplements may damage the intestines.

  • Stomach ulcer—Potassium supplements may make this condition worse.

Proper Use of potassium supplement

This section provides information on the proper use of a number of products that contain potassium supplement. It may not be specific to K-Lyte Cl. Please read with care.


For patients taking the liquid form of this medicine:


  • This medicine must be diluted in at least one-half glass (4 ounces) of cold water or juice to reduce its possible stomach-irritating or laxative effect.

  • If you are on a salt (sodium)-restricted diet, check with your doctor before using tomato juice to dilute your medicine. Tomato juice has a high salt content.

For patients taking the soluble granule, soluble powder, or soluble tablet form of this medicine:


  • This medicine must be completely dissolved in at least one-half glass (4 ounces) of cold water or juice to reduce its possible stomach-irritating or laxative effect.

  • Allow any "fizzing" to stop before taking the dissolved medicine.

  • If you are on a salt (sodium)-restricted diet, check with your doctor before using tomato juice to dilute your medicine. Tomato juice has a high salt content.

For patients taking the extended-release tablet form of this medicine:


  • Swallow the tablets whole with a full (8-ounce) glass of water. Do not chew or suck on the tablet.

  • Some tablets may be broken or crushed and sprinkled on applesauce or other soft food. However, check with your doctor or pharmacist first, since this should not be done for most tablets.

  • If you have trouble swallowing tablets or if they seem to stick in your throat, check with your doctor. When this medicine is not properly released, it can cause irritation that may lead to ulcers.

For patients taking the extended-release capsule form of this medicine:


  • Do not crush or chew the capsule. Swallow the capsule whole with a full (8-ounce) glass of water.

  • Some capsules may be opened and the contents sprinkled on applesauce or other soft food. However, check with your doctor or pharmacist first, since this should not be done for most capsules.

Take this medicine immediately after meals or with food to lessen possible stomach upset or laxative action.


Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important if you are also taking both diuretics (water pills) and digitalis medicines for your heart.


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 potassium bicarbonate

  • For oral dosage forms (tablets for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—25 to 50 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For potassium bicarbonate and potassium chloride

  • For oral dosage form (granules for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For oral dosage form (tablets for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20, 25, or 50 mEq dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For potassium bicarbonate and potassium citrate

  • For oral dosage form (tablets for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—25 or 50 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For potassium chloride

  • For long-acting oral dosage form (extended-release capsules):
    • To replace potassium lost by the body:
      • Adults and teenagers—40 to 100 milliequivalents (mEq) a day, divided into two or three smaller doses during the day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.


    • To prevent potassium loss:
      • Adults and teenagers—16 to 24 mEq a day, divided into two or three smaller doses during the day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For long-acting oral dosage forms (liquid for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 mEq mixed into one-half glass of cold water or juice, taken one to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mEq of potassium per kilogram (kg) (0.45 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed in water or juice.



  • For oral dosage form (powder for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—15 to 25 mEq dissolved in four to six ounces of cold water, taken two or four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mEq per kg (0.45 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be mixed into water or juice.



  • For oral dosage form (powder for suspension):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 mEq dissolved in two to six ounces of cold water, taken one to five times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For long-acting oral dosage form (extended-release tablets):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—6.7 to 20 mEq taken three times a day. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For oral dosage form (liquid for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight a day, taken in smaller doses during the day. The solution should be completely mixed into water or juice.



  • For oral dosage form (tablets):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—5 to 10 mEq taken two to four times a day. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For potassium gluconate and potassium chloride

  • For oral dosage form (liquid for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 milliequivalents (mEq) diluted in 2 tablespoonfuls or more of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.



  • For oral dosage form (powder for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 mEq mixed in 2 tablespoonfuls or more of cold water or juice taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is base on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kg (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.



  • For potassium gluconate and potassium citrate

  • For oral dosage form (liquid for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kg (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.



  • For trikates

  • For oral dosage form (liquid for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—15 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken three or four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.



Missed Dose


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


Storage


Keep out of the reach of children.


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


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using K-Lyte Cl


Your doctor should check your progress at regular visits to make sure the medicine is working properly and that possible side effects are avoided. Laboratory tests may be necessary.


Do not use salt substitutes, eat low-sodium foods, especially some breads and canned foods, or drink low-sodium milk unless you are told to do so by your doctor, since these products may contain potassium. It is important to read the labels carefully on all low-sodium food products.


Check with your doctor before starting any physical exercise program, especially if you are out of condition and are taking any other medicine. Exercise and certain medicines may increase the amount of potassium in the blood.


Check with your doctor at once if you notice blackish stools or other signs of stomach or intestinal bleeding. This medicine may cause such a condition to become worse, especially when taken in tablet form.


K-Lyte Cl 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.


Stop taking this medicine and check with your doctor immediately if any of the following side effects occur:


Less common
  • Confusion

  • irregular or slow heartbeat

  • numbness or tingling in hands, feet, or lips

  • shortness of breath or difficult breathing

  • unexplained anxiety

  • unusual tiredness or weakness

  • weakness or heaviness of legs

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


Rare
  • Abdominal or stomach pain, cramping, or soreness (continuing)

  • chest or throat pain, especially when swallowing

  • stools with signs of blood (red or black color)

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


More common
  • Diarrhea

  • nausea

  • stomach pain, discomfort, or gas (mild)

  • vomiting

Sometimes you may see what appears to be a whole tablet in the stool after taking certain extended-release potassium chloride tablets. This is to be expected. Your body has absorbed the potassium from the tablet and the shell is then expelled.


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


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



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Tuesday, March 27, 2012

Temazepam



tem-AZ-e-pam


Commonly used brand name(s)

In the U.S.


  • Restoril

Available Dosage Forms:


  • Tablet

  • Capsule

Therapeutic Class: Hypnotic


Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting


Uses For temazepam


Temazepam is used to treat insomnia (trouble with sleeping). temazepam is for short-term (usually 7 to 10 days) use only. Temazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.


temazepam is available only with your doctor's prescription.


Before Using temazepam


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 temazepam, the following should be considered:


Allergies


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


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of temazepam in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of temazepam in the elderly. However, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of temazepam. Elderly patients may require a lower dose to help reduce unwanted effects.


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. When you are taking temazepam, 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 temazepam 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.


  • Alfentanil

  • Amobarbital

  • Anileridine

  • Aprobarbital

  • Butabarbital

  • Butalbital

  • Carisoprodol

  • Chloral Hydrate

  • Chlorzoxazone

  • Codeine

  • Dantrolene

  • Ethchlorvynol

  • Fentanyl

  • Fospropofol

  • Hydrocodone

  • Hydromorphone

  • Levorphanol

  • Meperidine

  • Mephenesin

  • Mephobarbital

  • Meprobamate

  • Metaxalone

  • Methocarbamol

  • Methohexital

  • Morphine

  • Morphine Sulfate Liposome

  • Oxycodone

  • Oxymorphone

  • Pentobarbital

  • Phenobarbital

  • Primidone

  • Propoxyphene

  • Remifentanil

  • Secobarbital

  • Sodium Oxybate

  • Sufentanil

  • Tapentadol

  • Thiopental

  • Zolpidem

Using temazepam 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.


  • Rifapentine

  • St John's Wort

  • Theophylline

Interactions with Food/Tobacco/Alcohol


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


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


  • Ethanol

Other Medical Problems


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


  • Alcohol or drug abuse or addiction, history of or

  • Breathing problems or lung disease or

  • Mental depression, history of or

  • Mental illness, history of—Use with caution. May make these conditions worse.

  • Kidney disease or

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

Proper Use of temazepam


Take temazepam only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.


Take temazepam just before going to bed, when you are ready to go to sleep. temazepam works very quickly to put you to sleep.


temazepam should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.


Dosing


The dose of temazepam 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 temazepam. If your dose is different, do not change it unless your doctor tells you to do so.


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


  • For oral dosage form (capsules):
    • For insomnia (trouble sleeping):
      • Adults—15 milligrams (mg) at bedtime. Your doctor may adjust your dose if needed.

      • Older adults—At first, 7.5 mg at bedtime. Your doctor may adjust your dose if needed.

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



Missed Dose


If you miss a dose of temazepam, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using temazepam


It is very important that your doctor check your progress at regular visits to make sure temazepam is working properly. Blood tests may be needed to check for any unwanted effects.


Using temazepam while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.


temazepam may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.


temazepam will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking temazepam. Check with your doctor before taking any of the above while you are using temazepam.


temazepam may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though temazepam is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, temazepam may cause double vision or other vision problems. Make sure you know how you react to temazepam before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.


If you develop any unusual and strange thoughts or behavior while you are taking temazepam, be sure to discuss it with your doctor. Some changes that have occurred in people taking temazepam are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.


Do not stop taking temazepam without checking with your doctor first.. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior.


If you think you or someone else may have taken an overdose of temazepam, get emergency help at once. Taking an overdose of temazepam or taking alcohol or other CNS depressants with temazepam may lead to breathing problems and unconsciousness.


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


Before you have any medical tests, tell the medical doctor in charge that you are taking temazepam. The results of some tests may be affected by temazepam.


If your condition does not improve within 7 to 10 days, or if it becomes worse, check with your doctor.


temazepam 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:


Less common
  • False or unusual sense of well-being

  • fear or nervousness

  • mood or mental changes

Rare
  • Difficult or labored breathing

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

  • loss of appetite

  • loss of memory

  • nightmares

  • problems with memory

  • seeing, hearing, or feeling things that are not there

  • shakiness and unsteady walk

  • shortness of breath

  • tightness in the chest

  • trouble sleeping

  • uncontrolled eye movements

  • unsteadiness, trembling, or other problems with muscle control or coordination

  • unusual excitement, nervousness, restlessness, or irritability

  • weight loss

  • wheezing

Incidence not known
  • Muscle cramps

  • seizures

  • shakiness in the legs, arms, hands, or feet

  • stomach cramps

  • sweating

  • trembling or shaking of the hands or feet

  • vomiting

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


Symptoms of overdose
  • Blurred vision

  • change in consciousness

  • confusion

  • decreased or absent reflexes

  • difficult or troubled breathing

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

  • irregular, fast, slow, or shallow breathing

  • loss of consciousness

  • pale or blue lips, fingernails, or skin

  • shortness of breath

  • sleepiness or unusual drowsiness

  • unusual tiredness or weakness

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
  • Diarrhea

  • dry mouth

  • feeling of constant movement of self or surroundings

  • headache

  • nausea

  • sensation of spinning

  • unusual dullness or feeling of sluggishness

Rare
  • Backache

  • burning eyes

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: temazepam 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 temazepam resources


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


  • Temazepam Prescribing Information (FDA)

  • Temazepam Professional Patient Advice (Wolters Kluwer)

  • Temazepam Monograph (AHFS DI)

  • Temazepam MedFacts Consumer Leaflet (Wolters Kluwer)

  • Restoril Prescribing Information (FDA)

  • Restoril Consumer Overview



Compare temazepam with other medications


  • Insomnia


Nicotine Transdermal System




Drug Facts

Active ingredient Step 1 (in each patch)


Nicotine, 21mg delivered over 24 hours



Active ingredient Step 2 (in each patch)


Nicotine, 14mg delivered over 24 hours



Active ingredient Step 3 (in each patch)


Nicotine, 7mg delivered over 24 hours



Purpose


Stop smoking aid



Use


reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking



Warnings


If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.



Do not use


  • if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products


Ask a doctor before use if you have


  • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.

  • high blood pressure not controlled with medication. Nicotine can increase your blood pressure.

  • an allergy to adhesive tape or have skin problems because you are more likely to get rashes


Ask a doctor or pharmacist before use if you are


  • using a non-nicotine stop smoking drug

  • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.


When using this product


  • do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch.

  • If you have vivid dreams or other sleep disturbances remove this patch at bedtime


Stop use and ask a doctor if


  • skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash

  • irregular heartbeat or palpitations occur

  • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness, and rapid heartbeat


Keep out of reach of children and pets.


Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.



Directions


  • if you are under 18 years of age, ask a doctor before use

  • before using this product, read the enclosed User’s Guide for complete directions and other information

  • stop smoking completely when you begin using the patch

  • if you smoke more than 10 cigarettes per day, use according to the following 10-week schedule:











  • STEP 1STEP 2STEP 3
    Use one 21mg patch/dayUse one 14mg patch/dayUse one 7mg patch/day
    Weeks 1-6Weeks 7-8Weeks 9-10

  • if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg) for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop.

  • steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.

  • apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.

  • remove backing from patch and immediately press onto skin. Hold for 10 seconds.

  • wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling.

  • you may wear the patch for 16 or 24 hours.

  • if you crave cigarettes when you wake up, wear the patch for 24 hours.

  • if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning

  • the used patch should be removed and a new one applied to a different skin site at the same time each day

  • do not wear more than one patch at a time

  • do not cut patch in half or into smaller pieces

  • do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours

  • stop using the patch at the end of 10 weeks. If you started with STEP 2, stop using the patch at the end of 8 weeks. If you still feel the need to use the patch, talk to your doctor.

To increase your success in quitting:


  1. You must be motivated to quit.

  2. Complete the full treatment program, applying a new patch every day.

  3. Use with a support program as described in the enclosed User's Guide.

  • Not for sale to those under 18 years of age.

  • Proof of age required.

  • Not for sale in vending machines or from any source where proof of age cannot be verified.


Inactive ingredients


ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings



Other information


store at 20 – 25oC (68 – 77oF)


*NICODERM is a licensed trademark of GlaxoSmithKline group of companies.


Distributed by Target Corporation


Minneapolis, MN 55403


Made in Switzerland


© 2010 Target Brands, Inc.


All Rights Reserved. Shop Target.com


What is the nicotine patch and how is it used?


The nicotine patch is a small, nicotine-containing patch. When you put on a nicotine patch, nicotine passes through the skin and into your body. The nicotine patch is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 24 or 16 hour period you wear the nicotine patch. This helps to reduce cravings you may have for nicotine.


For your family's protection, nicotine patches are supplied in child-resistant pouches. Do not use if individual pouch/packet is damaged or open.


Read carton and enclosed User's Guide before using this product. Keep the carton and User's Guide. They contain important information.



Questions and comments?


call toll-free 1-888-367-7919


(English/Spanish) weekdays


Send comments/questions to:


GCSP 5.4376.4C


Consumer Relations


P.O Box 13398


Research Triangle Park, NC 27709-9627



Principal Display Panel


NDC 11673-194-02


nicotine patch


Nicotine Transdermal System


21mg delivered over 24 hours


stop smoking aid


Compare to NicoDerm® CQ®*


Includes User's Guide with behavior support program enrollment form


If you smoke more than 10 cigarettes per day: start with step 1


If you smoke 10 or less cigarettes per day: start with step 2


up & up


STEP 1


14 PATCHES


14 CLEAR PATCHES, 21 mg EACH




Principal Display Panel


NDC 11673-195-02


nicotine patch


Nicotine Transdermal System


14mg delivered over 24 hours


stop smoking aid


Compare to NicoDerm® CQ®*


Includes User's Guide with behavior support program enrollment form


If you smoke more than 10 cigarettes per day: start with step 1


If you smoke 10 or less cigarettes per day: start with step 2


up & up


STEP 2


14 PATCHES


14 CLEAR PATCHES, 14 mg EACH




Principal Display Panel


NDC 11673-196-02


nicotine patch


Nicotine Transdermal System


7mg delivered over 24 hours


stop smoking aid


Compare to NicoDerm® CQ®*


Includes User's Guide


FOR USE AFTER COMPLETING STEP 2


If you smoke more than 10 cigarettes per day: start with step 1


If you smoke 10 or less cigarettes per day: start with step 2


up & up


STEP 3


14 PATCHES


14 CLEAR PATCHES, 7 mg EACH










NICOTINE  TRANSDERMAL SYSTEM
nicotine  patch, extended release










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)11673-194
Route of AdministrationTRANSDERMALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE)NICOTINE21 mg  in 24 h








Inactive Ingredients
Ingredient NameStrength
HIGH DENSITY POLYETHYLENE 
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
111673-194-0214 PATCH In 1 CARTONcontains a PATCH
124 h In 1 PATCHThis package is contained within the CARTON (11673-194-02)
211673-194-017 PATCH In 1 CARTONcontains a PACKET
224 h In 1 PACKETThis package is contained within the CARTON (11673-194-01)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02016502/16/2000







NICOTINE  TRANSDERMAL SYSTEM
nicotine  patch, extended release










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)11673-195
Route of AdministrationTRANSDERMALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE)NICOTINE14 mg  in 24 h








Inactive Ingredients
Ingredient NameStrength
HIGH DENSITY POLYETHYLENE 
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
111673-195-0214 PATCH In 1 CARTONcontains a PATCH
124 h In 1 PATCHThis package is contained within the CARTON (11673-195-02)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02016502/16/2000







NICOTINE  TRANSDERMAL SYSTEM
nicotine  patch, extended release










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)11673-196
Route of AdministrationTRANSDERMALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE)NICOTINE7 mg  in 24 h








Inactive Ingredients
Ingredient NameStrength
HIGH DENSITY POLYETHYLENE 
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
111673-196-0214 PATCH In 1 CARTONcontains a PATCH
124 h In 1 PATCHThis package is contained within the CARTON (11673-196-02)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02016502/16/2000


Labeler - Target (006961700)
Revised: 02/2010Target




More Nicotine Transdermal System resources


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


Compare Nicotine Transdermal System with other medications


  • Smoking Cessation


Sunday, March 25, 2012

Karidium Drops


Pronunciation: SOE-dee-um FLOOR-ide
Generic Name: Sodium Fluoride
Brand Name: Examples include Fluor-A-Day, Fluoritab, and Kardium


Karidium Drops are used for:

Preventing cavities in children older than 6 months of age when the amount of fluoride in the water supply is too low.


Karidium Drops are a mineral. It works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth.


Do NOT use Karidium Drops if:


  • you are allergic to any ingredient in Karidium Drops

  • your drinking water has a fluoride content greater than 0.6 parts per million (ppm)

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



Before using Karidium Drops:


Some medical conditions may interact with Karidium Drops. 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 joint pain, kidney problems, softening of your bones (osteomalacia, rickets), or stomach or intestinal ulcers

Some MEDICINES MAY INTERACT with Karidium Drops. However, no specific interactions with Karidium Drops are known at this time.


Ask your health care provider if Karidium Drops 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 Karidium Drops:


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


  • Take Karidium Drops by mouth with or without food. Do not eat or drink dairy products within 1 hour before or 2 hours after taking Karidium Drops.

  • Do not take an antacid that has aluminum, calcium, or magnesium in it for several hours after you take Karidium Drops.

  • Use the dropper that comes with Karidium Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • Certain brands of Karidium Drops should be mixed in juice or water before you take it. Contact your doctor or pharmacist if you are unsure if you should mix Karidium Drops in juice or water.

  • Certain brands of Karidium Drops should be taken at bedtime after you brush your teeth unless your doctor tells you otherwise. Contact your doctor or pharmacist if you are unsure when to take Karidium Drops.

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

Ask your health care provider any questions you may have about how to use Karidium Drops.



Important safety information:


  • Do NOT use more than the dose recommended by your doctor or dentist.

  • Notify your dentist if your teeth become spotted or stained.

  • Karidium Drops should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.

  • Caution is advised when using Karidium Drops in CHILDREN younger than 6 years of age. The appropriate dose of Karidium Drops depends on the child's age and the amount of fluoride in the drinking water. Talk with your doctor if you have questions about the appropriate dose for your child or the amount of fluoride in your drinking water.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while using Karidium Drops, contact your doctor. You will need to discuss the benefits and risks of using Karidium Drops while you are pregnant. It is not known if Karidium Drops are found in breast milk. If you are or will be breast-feeding while you are using Karidium Drops, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Karidium Drops:


All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Karidium Drops. 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).



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: Karidium 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 bloody vomit or vomit that looks like coffee grounds; diarrhea; fast or irregular heartbeat; increased drooling; muscle weakness; nausea; seizures; slow or shallow breathing; sore tongue; stomach pain or cramping; tremor; vomiting.


Proper storage of Karidium Drops:

Store Karidium Drops at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Karidium Drops out of the reach of children and away from pets.


General information:


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

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

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

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

This information is a summary only. It does not contain all information about Karidium Drops. 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 Karidium resources


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


Compare Karidium with other medications


  • Prevention of Dental Caries


Monday, March 19, 2012

Stalevo 125


Generic Name: carbidopa, entacapone, and levodopa (Oral route)


lee-voe-DOE-pa, kar-bi-DOE-pa, en-TAK-a-pone


Commonly used brand name(s)

In the U.S.


  • Stalevo 100

  • Stalevo 125

  • Stalevo 150

  • Stalevo 50

  • Stalevo 75

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antiparkinsonian


Pharmacologic Class: Dopamine Precursor


Uses For Stalevo 125


Carbidopa, entacapone, and levodopa combination is used to treat Parkinson's disease, sometimes called shaking palsy. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord).


Dopamine is a naturally occurring substance in the brain that helps provide control of movement and activities such as walking and talking. In patients with Parkinson's disease, there is not enough dopamine in some parts of the brain. Levodopa (a component of this medicine) enters the brain and helps replace the missing dopamine, which allows people to function better. By increasing the amount of dopamine in the brain, levodopa helps control symptoms and helps you to perform daily activities such as dressing, walking, and handling utensils.


This medicine is a combination of three different medicines. This medicine is known as a levodopa therapy. The difference between this medicine and other levodopa treatments is that this medicine contains entacapone. Entacapone helps levodopa last longer by blocking a substance called COMT enzyme. This enzyme breaks down levodopa before it reaches the brain. When less levodopa is broken down, more is available to the brain. Increased availability of levodopa may lead to smoother and steadier levels of dopamine in the brain, which may provide better symptom control for longer periods each day. This may lead to improvement in daily activities.


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


Before Using Stalevo 125


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


Allergies


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


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of carbidopa, entacapone, and levodopa combination in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date in elderly patients up to age 75 years have not demonstrated geriatrics-specific problems that would limit the usefulness of carbidopa, entacapone, and levodopa combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, and cardiovascular insufficiency, which may require extra caution.


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


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


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Clorgyline

  • Iproniazid

  • Isocarboxazid

  • Linezolid

  • Nialamide

  • Pargyline

  • Phenelzine

  • Procarbazine

  • Selegiline

  • Toloxatone

  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Apomorphine

  • Bitolterol

  • Desipramine

  • Dobutamine

  • Dopamine

  • Epinephrine

  • Iproniazid

  • Isocarboxazid

  • Isoetharine

  • Isoniazid

  • Isoproterenol

  • Linezolid

  • Methyldopa

  • Moclobemide

  • Nialamide

  • Norepinephrine

  • Pargyline

  • Phenelzine

  • Procarbazine

  • Tranylcypromine

  • Venlafaxine

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


  • Bromperidol

  • Bupropion

  • Droperidol

  • Ferric Ammonium Citrate

  • Fosphenytoin

  • Indinavir

  • Iron

  • Kava

  • Metoclopramide

  • Phenylalanine

  • Phenytoin

  • Spiramycin

  • Tyrosine

Interactions with Food/Tobacco/Alcohol


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


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


  • High Protein Food

Other Medical Problems


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


  • Asthma or

  • Biliary obstruction or blockage or

  • Colitis (inflammation of the colon) or

  • Depression, history of or

  • Dyskinesia (abnormal muscle movements) or

  • Endocrine or metabolic disease or

  • Heart attack, history of or

  • Heart or blood vessel disease, severe or

  • Heart rhythm problems (e.g., ventricular tachycardia) or

  • Hypotension (low blood pressure) or

  • Kidney disease or

  • Liver disease or

  • Lung disease, severe or

  • Psychosis (mental disorder), or history of or

  • Wide-angle glaucoma (eye pressure problem)—Use with caution. May make these conditions worse.

  • Melanoma (skin tumor), history of or

  • Narrow–angle glaucoma (eye pressure problem) or

  • Skin lesions, undiagnosed (rashes that involve changes in color or texture of the skin)—Should not be used in patients with these conditions.

  • Peptic ulcer, history of—May increase risk of stomach or bowel hemorrhage.

Proper Use of carbidopa, entacapone, and levodopa

This section provides information on the proper use of a number of products that contain carbidopa, entacapone, and levodopa. It may not be specific to Stalevo 125. Please read with care.


Take this medicine exactly as directed, and every time that you are supposed to take it. It is important that you do not stop taking your medicine unless ordered by your doctor. It is also important to not start taking other medicines for your Parkinson's disease without first talking with your doctor.


Since protein may interfere with the body's response to levodopa, high protein diets should be avoided. Intake of normal amounts of protein should be spaced equally throughout the day, or taken as directed by your doctor.


You may experience a “wearing-off” effect towards the end of the dosing interval. You should tell your doctor if you have problems with this that affect your every day life. Your doctor may want to adjust your dose.


This medicine begins to release its ingredients 30 minutes after you take it.


If you are taking multivitamin tablets or plan to start taking them, discuss this first with your doctor. Iron salts (in vitamins) may keep this medicine from working properly.


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 forms (capsules or tablets):
    • For Parkinson's disease:
      • Adults—The starting dose is usually the same as the current dose you are taking. If you are starting this medicine for the first time, your doctor may want to start you on a carbidopa and levodopa combination with entacapone and gradually switch you over to this combination.

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



Missed Dose


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


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using Stalevo 125


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


Do not take this medicine if you have taken a monoamine oxidase (MAO) inhibitor (e.g. phenelzine [Nardil®] or tranylcypromine [Parnate®]) in the past 2 weeks.


Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.


Check with your doctor right away if you are having convulsions (seizures); difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).


This medicine may cause dizziness, trouble in controlling movements, or trouble in concentrating or seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.


Dizziness, lightheadedness, or fainting may occur with this medicine, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may also help. If this problem continues or gets worse, check with your doctor.


This medicine may cause diarrhea, and in some cases it can be severe. It can occur months after starting this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.


If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.


Check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These may be symptoms of a condition called rhabdomyolysis.


Stop using this medicine and check with your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while being treated with this medicine.


It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.


It is possible that a dark color (red, brown, or black) may appear in saliva, urine, or sweat after taking this medicine. The color may cause some of your garments to become discolored. This is normal and nothing to worry about.


It is possible that you may become nauseous, especially when you are first starting your medicine.


Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.


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


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


Stalevo 125 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-Entacapone
  • Twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Incidence not known-Carbidopa and Levodopa and/or Levodopa alone
  • Bleeding gums

  • bloody or black, tarry stools

  • bloody or cloudy urine

  • change in size, shape, or color of an existing mole

  • changes in skin color

  • chest pain, discomfort, or tightness

  • constipation

  • constricted pupil

  • convulsions

  • cough

  • difficult or labored breathing

  • difficulty with speaking

  • drooling

  • drooping eyelid (ptosis)

  • facial dryness

  • fast, irregular, or pounding heartbeat

  • fever with or without chills

  • general feeling of illness

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • hoarseness

  • high or low blood pressure

  • large, flat, blue, or purplish patches in the skin

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • loss of appetite

  • loss of bladder control

  • lower abdominal or stomach pain

  • lower back or side pain

  • mole that leaks fluid or bleeds

  • muscle cramps or spasms

  • muscle pain or stiffness

  • muscle trembling, jerking, or stiffness

  • nausea

  • pain

  • painful or difficult urination

  • pinpoint red spots on the skin

  • raised red swellings on the skin, the buttocks, legs, or ankles

  • restlessness

  • seizures

  • severe mental changes

  • shakiness and unsteady walk

  • shuffling walk

  • sore throat

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

  • sweating

  • swollen glands

  • trembling, or other problems with muscle control or coordination

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • vomiting

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-Entacapone
  • Absence of or decrease in body movement

  • diarrhea

  • dizziness

  • urine discoloration

Less common-Entacapone
  • Acid or sour stomach

  • anxiety

  • belching

  • bitter, sour, or unusual taste in the mouth

  • bloated

  • burning feeling in the chest or stomach

  • dry mouth

  • excess air or gas in the stomach or intestines

  • fear

  • full feeling

  • heartburn

  • hyperventilation

  • increased sweating

  • indigestion

  • irritability

  • lack or loss of strength

  • nervousness

  • passing gas

  • restlessness

  • sleepiness or unusual drowsiness

  • stomach discomfort or upset

  • swollen mouth and tongue

  • tenderness in the stomach area

  • trouble sleeping

  • urge to have bowel movement

  • wheezing

Incidence not known-Carbidopa and Levodopa and/or Levodopa alone
  • Being forgetful

  • bladder pain

  • blurred vision

  • body aches or pain

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

  • burning and upper abdominal or stomach pain

  • burning sensation of the tongue

  • clenching, gnashing, or grinding teeth

  • confusion about identity, place, and time

  • dark saliva

  • dark sweat

  • decreased mental acuity

  • difficulty swallowing

  • discouragement

  • double vision

  • ear congestion

  • enlarged pupils

  • excessive watering of the mouth

  • fainting

  • false or unusual sense of well-being

  • feeling like you will pass out

  • feeling of warmth

  • feeling sad or empty

  • flushing

  • hair loss

  • headache

  • hiccups

  • hives or welts

  • increased blinking

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

  • increased interest in sexual intercourse

  • lack of appetite

  • large, hard skin blisters

  • leg pain

  • loss of voice

  • muscle spasm, especially of the neck and back

  • nasal congestion

  • nightmares

  • numbness

  • pain in the chest below the breastbone

  • painful or prolonged erection of the penis

  • pharyngeal pain

  • pounding in the ears

  • problems with memory or speech

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

  • runny nose

  • sense of stimulation

  • skin rash

  • sleeplessness

  • slow movement

  • slow or fast heartbeat

  • slow reflexes

  • sneezing

  • swelling

  • tremor, increased

  • trouble concentrating

  • trouble recognizing objects

  • trouble thinking and planning

  • urinary frequency

  • urinary retention

  • weight gain

  • weight 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: Stalevo25 side effects (in more detail)



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More Stalevo 125 resources


  • Stalevo 125 Side Effects (in more detail)
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  • Stalevo 125 Drug Interactions
  • 0 Reviews for Stalevo25 - Add your own review/rating


  • Stalevo 125 Concise Consumer Information (Cerner Multum)

  • Carbidopa/Entacapone/Levodopa MedFacts Consumer Leaflet (Wolters Kluwer)



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