Friday, October 5, 2012

Striant


Generic Name: testosterone (Buccal route)

tes-TOS-ter-one

Commonly used brand name(s)

In the U.S.


  • Striant

Available Dosage Forms:


  • Patch, Extended Release

Therapeutic Class: Endocrine-Metabolic Agent


Pharmacologic Class: Androgen


Uses For Striant


Testosterone are male hormones. Some are naturally produced in the body and are responsible for the growth and development of male sex organs


This medicine 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, testosterone is used in certain patients with the following medical conditions:


  • Female-to-male transsexualism in patients with gender identity disorder, (person who is born as a woman but adapts to a man's lifestyle, sees herself as a man, and feels like a man instead of a woman)

Before Using Striant


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


Studies on this medicine have been done only on adult patients, and there is no specific information comparing use of testosterone in children with use in other age groups


Geriatric


This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However older men may be at increased risk for development of prostatic hyperplasia and prostatic cancer.


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 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.


  • Anisindione

  • Bupropion

  • Dicumarol

  • Paclitaxel

  • Paclitaxel Protein-Bound

  • Phenprocoumon

  • Warfarin

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.


  • Licorice

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:


  • Breast cancer (in males) or

  • Prostate cancer—Androgens can cause growth of these tumors.

  • Diabetes mellitus (sugar diabetes)—Testosterone may decrease blood sugar levels. Careful monitoring of blood glucose should be done.

  • Heart disease or

  • Kidney disease or

  • Liver disease—These conditions can be worsened by the fluid retention (keeping too much water in the body) that can be caused by androgens. Also, liver disease can prevent the body from removing the medicine from the bloodstream as fast as it normally would. This could increase the chance of side effects occurring.

  • Sleep apnea—This condition may become worse, especially in patients with risk factors such as obesity or chronic lung disease.

Proper Use of Striant


Importance of reading the patient directions carefully before using the buccal system


Proper administration technique


Proper dosing. Use this medicine only as directed.


Proper storage


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 buccal dosage form:
    • For testosterone hormone replacement in men
      • Adults—30 milligrams (mg) applied to your upper gum above the left or right incisor twice a day



Missed Dose


Call your doctor or pharmacist for instructions.


If the buccal system fails to properly adhere to the gum or should fall off during the 12-hour dosing interval, the old one should be removed and a new buccal system applied. If the old one falls out within 4 hours before the next dose, a new system should be applied and it may remain in place until the time of the next regularly scheduled dosing. 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 Striant


If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits to check your progress during therapy.


For patients with diabetes mellitus (sugar diabetes), this medicine may lower blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.


Tell your doctor if you have too frequent or persistent erections of the penis.


Tell your doctor if you have any nausea, vomiting, changes in skin color or swelling of the ankles.


Tell your doctor if you experience any breathing problems, including those while you sleep.


Regularly check your gums where the buccal system is applied to check for any abnormalities and report findings to your doctor.


Striant Side Effects


Symptoms of Overdose

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


  • Blurred vision

  • headache

  • sudden and severe inability to speak

  • seizures

  • slurred speech

  • temporary blindness

  • weakness in arm and/or leg on one side of the body, sudden and severe

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
  • Gum or mouth irritation

Less common
  • Abnormal liver function test

  • abnormal renal function

  • bad unusual or unpleasant (after) taste

  • bleeding gums

  • blemishes on the skin, pimples

  • blurred vision

  • breast enlargement

  • breast pain

  • buccal inflammation

  • change in taste

  • cough

  • crying

  • depersonalization

  • diarrhea

  • difficulty breathing

  • discouragement

  • dry mouth

  • dizziness

  • dysphoria

  • euphoria

  • fear

  • feeling sad or empty

  • fever or chills

  • gum blister

  • gum pain

  • headache

  • hoarseness

  • indigestion

  • irritability;

  • itching skin

  • loss of appetite

  • loss of interest or pleasure

  • lower back or side pain

  • mental depression

  • mouth ulcers

  • nausea

  • nervousness

  • noisy breathing

  • paranoia

  • painful or difficult urination

  • passing of gas

  • pounding in the ears

  • quick to react or overreact emotionally

  • rapidly changing moods

  • redness and swelling of gums

  • shortness of breath

  • slow or fast heartbeat

  • stomach cramps

  • stomach pain, fullness or discomfort

  • stinging of lips

  • swelling of gums

  • swelling or inflammation of the mouth

  • swelling of the nose

  • taste bitter

  • tightness in chest

  • tiredness

  • toothache

  • trouble concentrating

  • trouble sleeping

  • unusual tiredness or weakness

  • vomiting

  • wheezing

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: Striant 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 Striant resources


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


  • Striant MedFacts Consumer Leaflet (Wolters Kluwer)

  • Striant Prescribing Information (FDA)

  • Striant Consumer Overview

  • Testosterone Prescribing Information (FDA)

  • Testosterone Professional Patient Advice (Wolters Kluwer)

  • Testosterone Monograph (AHFS DI)

  • AndroGel Prescribing Information (FDA)

  • AndroGel Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Androderm Prescribing Information (FDA)

  • Androderm Patch MedFacts Consumer Leaflet (Wolters Kluwer)

  • Androgel Consumer Overview

  • Axiron Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Axiron Consumer Overview

  • Axiron Prescribing Information (FDA)

  • Delatestryl MedFacts Consumer Leaflet (Wolters Kluwer)

  • Delatestryl Prescribing Information (FDA)

  • Depo-Testosterone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Depo-Testosterone Prescribing Information (FDA)

  • Fortesta Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fortesta Consumer Overview

  • Testim Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Testim Prescribing Information (FDA)

  • Testosterone Cypionate Prescribing Information (FDA)

  • Testosterone Enanthate Prescribing Information (FDA)



Compare Striant with other medications


  • Hypogonadism, Male


Wednesday, October 3, 2012

Sedapap


Generic Name: acetaminophen and butalbital (a SEET a MIN oh fen and bue TAL bi tal)

Brand Names: Bupap, Cephadyn, Marten-Tab, Phrenilin, Phrenilin Forte, Promacet, Sedapap


What is Sedapap (acetaminophen and butalbital)?

Acetaminophen is a pain reliever and fever reducer.


Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.


The combination of acetaminophen and butalbital is used to treat tension headaches. This medicine is not for treating headaches that come and go.


Acetaminophen and butalbital may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Sedapap (acetaminophen and butalbital)?


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Before you take acetaminophen and butalbital, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease, a stomach or intestinal disorder, or a history of drug or alcohol addiction.


Butalbital may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking Sedapap (acetaminophen and butalbital)?


Do not use this medication if you are allergic to acetaminophen (Tylenol) or butalbital, or if you have porphyria. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Butalbital may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

To make sure you can safely take acetaminophen and butalbital, tell your doctor if you have any of these other conditions:


  • liver disease;

  • kidney disease;


  • a stomach or intestinal disorder; or




  • a history of drug or alcohol addiction.



Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.


FDA pregnancy category C. It is not known whether acetaminophen and butalbital will harm an unborn baby, but it can cause seizures in a newborn if the mother takes the medication late in pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen and butalbital can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.


How should I take Sedapap (acetaminophen and butalbital)?


Take exactly as prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Take this medicine with a full glass of water. Do not stop using acetaminophen and butalbital suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using this medication.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using acetaminophen and butalbital.


If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and butalbital. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?


Since acetaminophen and butalbital is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and butalbital can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.


Overdose symptoms may also include extreme drowsiness, confusion, fainting, shallow breathing, or no breathing.


What should I avoid while taking Sedapap (acetaminophen and butalbital)?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Sedapap (acetaminophen and butalbital) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • fast or pounding heart rate, feeling short of breath;




  • feeling like you might pass out;




  • confusion, depression;




  • feeling restless, excited, or agitated;




  • seizure (convulsions); or




  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects include:



  • headache, dizziness, drowsiness, shaky feeling;




  • drunk feeling;




  • vomiting, constipation;




  • heartburn, trouble swallowing;




  • numbness or tingly feeling;




  • dry mouth;




  • sweating or urinating more than usual;




  • leg pain, tired muscles;




  • stuffy nose, ear pain, ringing in your ears; or




  • mild itching.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Sedapap (acetaminophen and butalbital)?


Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by butalbital. Tell your doctor if you regularly use any of these medicines.

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



  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).



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



More Sedapap resources


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


  • Axocet MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cephadyn Advanced Consumer (Micromedex) - Includes Dosage Information

  • Phrenilin Prescribing Information (FDA)

  • Tencon Prescribing Information (FDA)



Compare Sedapap with other medications


  • Headache


Where can I get more information?


  • Your pharmacist can provide more information about acetaminophen and butalbital.

See also: Sedapap side effects (in more detail)



Sunday, September 30, 2012

Tri Vita-Bets with Fluoride


Generic Name: multivitamin with fluoride (MUL tee VYE ta min with FLOOR ide)

Brand Names: Multi Vita Bets and Fluoride, Poly Vitamin with Fluoride, Poly-Vi-Flor, Soluvite F, Tri-Vi-Flor, Tri-Vitamin with Fluoride


What is Tri Vita-Bets with Fluoride (multivitamin with fluoride)?

Multivitamins provide essential vitamins and minerals that are not taken in to the body through diet.


Fluoride strengthens tooth enamel, which helps prevent dental cavities. In most major U.S. communities, fluoride is put into the water supply.


Multivitamin with fluoride is used as a supplement to the diet of infants and children who do not receive adequate fluoride through drinking water. Multivitamin with fluoride is also used to prevent tooth decay in people treated with radiation, which may cause dryness of the mouth and increased risk of tooth decay.


Multivitamin with fluoride may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Tri Vita-Bets with Fluoride (multivitamin with fluoride)?


Taking in too much fluoride can cause an irreversible condition called fluorosis. This condition can permanently damage teeth and possibly other cells in the body.


Do not use this medicine without the advice of a doctor. Multivitamin with fluoride should not be used if the level of fluoride in the drinking water is adequate (0.6 parts per million or higher).Check with your local water department if you are unsure about the level of fluoride in the drinking water.

Be sure that a child using this medicine is not taking in extra amounts of fluoride by swallowing toothpaste, or drinking water from sources that contain adequate levels of fluoride.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may cause your body to absorb less of the multivitamin with fluoride. Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with fluoride. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

What should I discuss with my healthcare provider before taking Tri Vita-Bets with Fluoride (multivitamin with fluoride)?


Taking in too much fluoride can cause an irreversible condition called fluorosis. This condition can permanently damage teeth and possibly other cells in the body.


Do not use this medicine without the advice of a doctor. Multivitamin with fluoride should not be used if the level of fluoride in the drinking water is adequate (0.6 parts per million or higher). Check with your local water department if you are unsure about the level of fluoride in the drinking water. FDA pregnancy category C. It is not know if multivitamin with fluoride it harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Multivitamin with fluoride can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Tri Vita-Bets with Fluoride (multivitamin with fluoride)?


Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.


Take each dose of this medicine with a full glass of water.

The chewable tablet must be chewed or allowed to dissolve in the mouth before swallowing it. You may also allow the tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products).


Do not give a chewable tablet to a child younger than 4 years old. The child may choke on the tablet. Use only liquid forms of this medicine in young children.

Measure the liquid form of multivitamin with fluoride using a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


The liquid may also be mixed with water, fruit juice, or infant formula.


It is important to take multivitamin with fluoride regularly to get the most benefit.


Brush teeth regularly, at least two times each day or after meals. This will help prevent tooth discoloration.


Store this medication at room temperature away from moisture and heat. Do not allow the liquid to freeze.

Keep multivitamin with fluoride in the original contain it came in. Storing multivitamin with fluoride in a glass container can ruin the medication.


What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, muscle stiffness, or seizures (convulsions).


What should I avoid while taking Tri Vita-Bets with Fluoride (multivitamin with fluoride)?


Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with fluoride. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Be sure that a child using this medicine is not taking in extra amounts of fluoride by swallowing toothpaste, or drinking water from sources that contain adequate levels of fluoride.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may cause your body to absorb less of the multivitamin with fluoride.

Tri Vita-Bets with Fluoride (multivitamin with fluoride) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause the tooth enamel to become discolored. This is a rare side effect that has occurred mainly with large doses or long-term use of multivitamin with fluoride. Stop using this medication and call your dentist or doctor at once if you notice any change in the appearance of your teeth.


Less serious side effects may include:



  • stomach upset;




  • headache; or




  • weakness.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Tri Vita-Bets with Fluoride (multivitamin with fluoride)?


There may be other drugs that can affect multivitamin with fluoride. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Tri Vita-Bets with Fluoride resources


  • Tri Vita-Bets with Fluoride Use in Pregnancy & Breastfeeding
  • Tri Vita-Bets with Fluoride Drug Interactions
  • 0 Reviews for Tri Vita-Bets with Fluoride - Add your own review/rating


  • Multivitamin with Fluoride Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • MVC-Fluoride Prescribing Information (FDA)



Compare Tri Vita-Bets with Fluoride with other medications


  • Vitamin/Mineral Supplementation and Deficiency


Where can I get more information?


  • Your pharmacist can provide more information about multivitamin with fluoride.



Saturday, September 29, 2012

Stimate


Generic Name: desmopressin (Nasal route, Oral route, Injection route)

des-moe-PRES-in

Injection route(Solution)

Desmopressin acetate is not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have factor VIII antibodies .



Commonly used brand name(s)

In the U.S.


  • DDAVP

  • DDAVP Rhinal Tube

  • Minirin

  • Stimate

Available Dosage Forms:


  • Solution

  • Spray

  • Tablet

Therapeutic Class: Endocrine-Metabolic Agent


Pharmacologic Class: Vasopressin (class)


Uses For Stimate


Desmopressin is a hormone taken through the nose, by mouth, or given by injection to prevent or control the frequent urination, increased thirst, and loss of water associated with diabetes insipidus (water diabetes). It is used also to control bed-wetting and frequent urination and increased thirst associated with certain types of brain injuries or brain surgery. Desmopressin works by acting on the kidneys to reduce the flow of urine.


Desmopressin is also given by injection to treat some patients with certain bleeding problems such as hemophilia or von Willebrand's disease.


Desmopressin 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 this use is not included in product labeling, desmopressin is used in certain patients to determine the cause of Cushing's syndrome.


Before Using Stimate


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 performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of nasal desmopressin in children and infants. However, infants may be more sensitive to the effects of nasal desmopressin, which may require caution in patients receiving this medicine .


Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of oral desmopressin in infants and children with diabetes insipidus. However, safety and efficacy have not been established in children below 6 years of age with bed-wetting problems .


Appropriate studies have not been performed on the relationship of age to the effects of desmopressin injection in infants below 3 months of age for the treatment of hemophilia A or Von Willebrand's disease, and in children below 12 years of age with diabetes insipidus. Safety and efficacy have not been established in these age groups .


Geriatric


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


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


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


Interactions with Medicines


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


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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:


  • Blood clots—Use with caution. Desmopressin injection may worsen this condition .

  • Cystic fibrosis or

  • Dehydration or

  • Fluid or electrolyte imbalance or

  • Heart failure—Loss of sodium from the blood and serious side effects may be more likely to occur in patients with these conditions .

  • Headache, severe, or migraine or

  • Heart or blood vessel disease or

  • High blood pressure—Large doses of desmopressin can cause an increase or decrease in blood pressure.

  • Hyponatremia, or history of or

  • Kidney problems—Desmopressin should NOT be used in patients with these conditions .

  • Stuffy nose caused by cold or allergy—May prevent nasal desmopressin from being absorbed through the lining of the nose into the blood stream.

Proper Use of desmopressin

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


Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.


Your doctor may want you to decrease the amount of fluids that you drink while you are using this medicine .


For patients using the nasal solution form of this medicine:


  • This medicine comes with patient instructions. Read and follow these instructions carefully.

  • Before using the medicine, gently blow your nose to clear the nostrils.

  • If you are using the nasal spray for the first time, you will need to prime the spray. To do this, press the pump down four times or until some of the medicine sprays out. If you have not used the medicine for one week or longer, re-prime the pump by pressing once.

  • Do not use the nasal spray more times than the number indicated on the label. If you do, you may not receive the correct amount of medicine.

  • After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.

  • The Rhinal Tube is a soft plastic tube with numbers (doses) marked on the side. Draw the drops into the tube until the liquid reaches the number of your dose. Put one end of the tube into your nose and the other end into your mouth. Blow gently until all the medicine has sprayed into your nose. Do not let any medicine run down through the tube into your mouth.

  • After using the rhinal tube, wash it with water and shake thoroughly until no more water is left. Put the seal back on the dropper tip and close the bottle with the plastic cap .

For patients using the tablet form of this medicine:


  • Do not drink water or any other liquids from 1 hour before to 8 hours after taking the tablets .

For patients using the injection form of this medicine:


  • A nurse or other trained health professional will give you this medicine. Sometimes you, a family member, or a friend can also be taught to give your medicine .

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 nasal dosage form (nasal solution):
    • For preventing or controlling diabetes insipidus (water diabetes):
      • Adults and teenagers—0.1 to 0.4 milliliters (ml) or 10 to 40 micrograms (mcg) given as a single dose or divided into two or three doses a day .

      • Children 3 months to 12 years of age— 0.05 to 0.3 milliliters (ml) or 5 to 30 micrograms (mcg) given as a single dose or divided into two doses a day .

      • Children up to 3 months of age—Use and dose must be determined by your doctor .



  • For oral dosage form (tablets):
    • For preventing or controlling diabetes insipidus (water diabetes):
      • Adults, teenagers, and children—At first, 0.05 milligram (mg) two times a day. Then, your doctor may change the dose to 0.1 to 0.8 mg. The dose may be divided into several doses a day.


    • For controlling bed-wetting:
      • Adults, teenagers, and children 6 years of age or older—At first, 0.2 mg once a day at bedtime. Then, your doctor may increase the dose to as much as 0.6 mg a day.

      • Children up to 6 years of age—Use and dose must be determined by your doctor .



  • For parenteral dosage form (injection):
    • For preventing or controlling frequent urination:
      • Adults and teenagers—2 to 4 mcg injected into a vein or under the skin. This dose is usually divided into two doses a day, one given in the morning, and the other given in the evening.

      • Children up to 12 years of age—Use and dose must be determined by your doctor .


    • For treating some bleeding problems such as hemophilia or von Willebrand's disease (Type I):
      • Adults, teenagers, and children 11 months of age or older weighing more than 10 kg (22 pounds)—The dose is based on body weight and must be determined by your doctor. It is usually 0.3 micrograms (mcg) per kilogram (kg) (0.14 mcg per pound) of body weight mixed in 50 milliliters (mL) of 0.9% sodium chloride. This solution is injected into a vein slowly over fifteen to thirty minutes. Your doctor may repeat this treatment if needed.

      • Children 3 months of age or older weighing 10 kg (22 pounds) or less—The dose is based on body weight and must be determined by your doctor. It is usually 0.3 micrograms (mcg) per kilogram (kg) (0.14 mcg per pound) of body weight mixed in 10 mL of 0.9% sodium chloride. This solution is injected into a vein slowly over fifteen to thirty minutes. Your doctor may repeat this treatment if needed.

      • Children up to 3 months of age—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.


Has a bulleted list describing how to handle missed doses for various possible dosing schedules.


Storage


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.


Store as directed on the label or by your health care professional.


Precautions While Using Stimate


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


This medicine lowers the amount of sodium in your blood. Check with your doctor right away if you have confusion, nausea, vomiting, muscle cramps or spasms, or unusual tiredness or weakness .


Check with your doctor right away and stop using this medicine if you have fever, severe vomiting or diarrhea, or other conditions that may make you thirsty (such as during hot weather or having a strenuous exercise). This medicine may cause fluid or electrolyte imbalance which can lead to seizures and other serious conditions .


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


Desmopressin may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you use this medicine .


Stimate 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:


Rare
  • Chills

  • confusion

  • convulsions (seizures)

  • decreased urination

  • drowsiness

  • fast heartbeat

  • fever

  • headache (continuing)

  • shortness of breath, tightness in chest, trouble in breathing, or wheezing

  • skin rash, hives, or itching

  • weight gain (rapid)

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
  • Abdominal or stomach cramps

  • flushing or redness of skin

  • nausea

  • pain in the vulva (genital area outside of the vagina)

With intranasal (through the nose) use
  • Cough

  • nosebleed

  • runny or stuffy nose

  • sneezing

  • sore throat

With intravenous use
  • Pain, redness, or swelling at place of injection

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: Stimate 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 Stimate resources


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


  • Stimate nasal Concise Consumer Information (Cerner Multum)

  • Stimate Spray MedFacts Consumer Leaflet (Wolters Kluwer)

  • Stimate Prescribing Information (FDA)

  • Desmopressin Prescribing Information (FDA)

  • DDAVP Prescribing Information (FDA)

  • DDAVP Concise Consumer Information (Cerner Multum)

  • DDAVP MedFacts Consumer Leaflet (Wolters Kluwer)

  • Desmopressin Acetate Monograph (AHFS DI)

  • Minirin Spray MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Stimate with other medications


  • Hemophilia A
  • von Willebrand's Disease


Friday, September 28, 2012

Solia


Generic Name: ethinyl estradiol and desogestrel (EH thih nill ess tra DYE ole and des oh JESS trel)

Brand Names: Apri, Cesia, Cyclessa, Desogen, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet


What is Solia (ethinyl estradiol and desogestrel)?

Ethinyl estradiol and desogestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.


Ethinyl estradiol and desogestrel are used as contraception to prevent pregnancy.


Ethinyl estradiol and desogestrel may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Solia (ethinyl estradiol and desogestrel)?


Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.


Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.


What should I discuss with my healthcare provider before taking Solia (ethinyl estradiol and desogestrel)?


This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

  • a history of a stroke or blood clot;




  • circulation problems (especially if caused by diabetes);




  • a hormone-related cancer such as breast or uterine cancer;




  • abnormal vaginal bleeding;




  • liver disease or liver cancer;




  • severe high blood pressure;




  • severe migraine headaches;




  • a heart valve disorder; or




  • a history of jaundice caused by birth control pills.



Before using this medication, tell your doctor if you have any of the following conditions. You may need a dosage adjustment or special tests to safely take birth control pills.



  • high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;




  • high cholesterol or if you are overweight;




  • a history of depression;




  • gallbladder disease;




  • diabetes;




  • seizures or epilepsy;




  • a history of irregular menstrual cycles; or




  • a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.




The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Solia (ethinyl estradiol and desogestrel)?


Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).


You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.


The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.


You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.


If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.


Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.


Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?


Missing a pill increases your risk of becoming pregnant. Follow the directions on the patient information sheet provided with your medicine. If you do not have an information sheet, call your doctor for instructions if you miss a dose.


If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.


If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.


If you miss two "active" pills in a row in week 3, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.


If you miss three "active" tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.


If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.


What should I avoid while taking Solia (ethinyl estradiol and desogestrel)?


Do not smoke while using this medication, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.


Solia (ethinyl estradiol and desogestrel) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;




  • sudden headache, confusion, problems with vision, speech, or balance;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • a change in the pattern or severity of migraine headaches;




  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);




  • swelling in your hands, ankles, or feet;




  • a breast lump; or




  • symptoms of depression (sleep problems, weakness, mood changes).



Less serious side effects may include:



  • mild nausea, vomiting, bloating, stomach cramps;




  • breast pain, tenderness, or swelling;




  • freckles or darkening of facial skin;




  • increased hair growth, loss of scalp hair;




  • changes in weight or appetite;




  • problems with contact lenses;




  • vaginal itching or discharge;




  • changes in your menstrual periods, decreased sex drive; or




  • headache, nervousness, dizziness, tired feeling.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Solia (ethinyl estradiol and desogestrel)?


Some drugs can make birth control pills less effective, which may result in pregnancy. Before using this medication, tell your doctor if you are using any of the following drugs:



  • acetaminophen (Tylenol) or ascorbic acid (vitamin C);




  • an antibiotic;




  • phenylbutazone (Azolid, Butazolidin);




  • St. John's wort;




  • seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;




  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or




  • HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.



This list is not complete and there may be other drugs that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Solia resources


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


  • Solia Prescribing Information (FDA)

  • Apri Prescribing Information (FDA)

  • Caziant Prescribing Information (FDA)

  • Cesia Prescribing Information (FDA)

  • Cyclessa Prescribing Information (FDA)

  • Cyclessa Advanced Consumer (Micromedex) - Includes Dosage Information

  • Desogen Prescribing Information (FDA)

  • Desogen Consumer Overview

  • Desogen MedFacts Consumer Leaflet (Wolters Kluwer)

  • Emoquette Prescribing Information (FDA)

  • Kariva Prescribing Information (FDA)

  • Mircette Consumer Overview

  • Mircette Prescribing Information (FDA)

  • Ortho-Cept Prescribing Information (FDA)

  • Reclipsen Prescribing Information (FDA)

  • Velivet Prescribing Information (FDA)



Compare Solia with other medications


  • Abnormal Uterine Bleeding
  • Birth Control
  • Endometriosis
  • Gonadotropin Inhibition
  • Polycystic Ovary Syndrome


Where can I get more information?


  • Your pharmacist can provide more information about ethinyl estradiol and desogestrel.

See also: Solia side effects (in more detail)



Tranzgel





Dosage Form: gel
Tranzgel HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL

ACTIVE INGREDIENTS:


ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, ACONITUM NAPELLUS 3X HPUS, ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X  HPUS, BELLADONNA 3X HPUS, BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, MILLEFOLIUM 1X HPUS, HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, COLCHICINUM 3X HPUS



INACTIVE INGREDIENTS:


PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE



NDC 35781-0194-5


Tranzgel


HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL


RX ONLY NET CONTENTS 1.7 FL OZ (50 ML)


GENSCO LABORATORIES, LLC


FOR COMPLETE PRESCRIBING INFORMATION, SEE PACKAGE INSERT. STORE AT ROOM TEMPERATURE.




MANUFACTURED BY FORMULATED SOLUTIONS


CLEARWATER, FL 33760


US PATENT #5,654,337





MANUFACTURED FOR GENSCO LABORATORIES, LLC


INVERNESS, FL 34452


352.726.6284


866.608.6284


WWW.Tranzgel.COM



TRANZ GEL


HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL


RX ONLY NET CONTENTS 1.7 FL OZ (50 ML)


GENSCO LABORATORIES





MANUFACTURED BY


FORMULATED SOLUTIONS, LLC


CLEARWATER FL 33760


US PATENT #5,654,337





MANUFACTURED BY


GENSCO LABORATORIES, LLC


INVERNESS, FL 34452


352.726.6284


866.608.6284


WWW.Tranzgel.COM





ACTIVE INGREDIENTS:


ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, ACONITUM NAPELLUS 3X HPUS, ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X  HPUS, BELLADONNA 3X HPUS, BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, MILLEFOLIUM 1X HPUS, HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, COLCHICINUM 3X HPUS



INACTIVE INGREDIENTS:


PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE



For complete prescribing information, see package insert. Store at room temperature.



DESCRIPTION


A homeopathic topical analgesic gel that contains the active ingredients indicated below in the corresponding concentrations.



ACTIVE INGREDIENTS:


50 PARTS EACH: ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, 30 PARTS: ACONITUM NAPELLUS 3X HPUS, 15 PARTS EACH: ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X  HPUS, 10 PARTS: BELLADONNA 3X HPUS, 5 PARTS EACH: BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, 3 PARTS MILLEFOLIUM 1X HPUS, 1 PART EACH: HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, .01 PART COLCHICINUM 3X HPUS



INACTIVE INGREDIENTS:


PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE



Physical Information


PHYSICAL INFORMATION


A clear amber colored, viscous gel with a slight floral smell.



CLINICAL PHARMACOLOGY


According to traditional homeopathic literature and Material Medica, the following ingredients provide the following attributes:





INGREDIENTS                     COMMON NAME               INDICATIONS


Arnica Montana                  Mountain arnica               Stimulates healing of injured tissues wounds, contusions, hematomas, neuralgia myalgia, analgesia




Calendula Officianalis         Calendula                           Inflammation


Hamamelis Virginiana         Witch-hazel                        Analgesic


Millefolium                             Yarrow                               Hematomas


Belladonna                           Banewort                           Inflammation locally


Aconitum Napellus            Monk's hood                       Neuralgia, rheumatism hemostasis, analgeisa


Chamomilla                           Chamomile                           Inflammation, nausea


Colchicinum                        Colchicine                              Inflammation and gout


Symphytum Officinale      Comfrey                                  Neuropathy, contusions, tendonitis, arthritis


Bellis Perennis                     Daisy                                    brusing, edema, arthralgia


Echinacea Angustifolia      Narrow leaf cone flower         Inflammation, myalgia


Echinacia purpurea            purple cone flower               Inflammation, myalgia


Hypericum perforatum      st. john's wort                        neuropathic pains







INDICATIONS AND USAGE


The drug is indicated for the relief of symptoms, including pain and inflammation associated with arthritis or trauma (such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic, edema, post surgical edema, hematoma, general swelling of joints and soft tissues) to areas such as hand, wrist elbow, shoulder, neck, back, knees, ankles, feet and toes.



CONTRAINDICATIONS


This drug should not be used by those sensitive to Arnica or any of the other listed ingredients.



WARNINGS AND PRECAUTIONS


For external use only. direct patient not to ingest TRANZEL and to avoid contact with they eyes, mucous membranes, wounds, and damaged skin. If a rash develops, patient should discontinue use until rash clears. After the disappearance of rash, patient can try Tranzgel again on a test area and monitor the site for additional results. If no rash or redness results, then patient can resume use. However, if the rash persists or redevelops, use should be discontinued.


Direct the patient to keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed.


In the homeopathic concentrations used to make Tranzgel, there are no known or expected interactions with other drugs or laboratory tests. In addition, the homeopathic concentrations used are below any levels with known or suspected toxicities.



OVERDOSAGE


According to toxicology studies, a patient would have to orally ingest a minimum of 22 bottles of Tranzgel to experience any initial toxic effects.



ADVERSE REACTIONS


Rarely, allergic skin reactions may occur. These effects are transient and will clear after a few days.



Apply a thin layer (1 drop covers an area of skin 2 inches by 2 inches) to the affected area 3-4 times daily and rub in gently. Applications of less than 3-4 times a day will not produce optimum results. Excess drops may be wiped from the area.



Package size: 1.7 fl oz (50 ml) airless pump dispensing bottle


US PATENT 5,654,337


NDC 35781-0194-5



STORE AT ROOM TEMPERATURE


Manufactured by


Formulated Solutions, LLC


Clearwater, FL 33760





Manufactured for


Gensco Laboratories, LLC


Inverness, FL 34452


352-726-6284


866-608-6284


www.Tranzgel.com















Tranzgel 
echinacea angustifolia, echinacea purpurea, aconitum napellus, arnica montana, calendula officianalis, hamamelis virginiana, belladonna, bellis perennis, chamomillia, millefolium, hypericum perforatum, symphytum officinale, colchicinum  gel










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)35781-0194
Route of AdministrationTRANSDERMALDEA Schedule    












































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA ANGUSTIFOLIA (ECHINACEA ANGUSTIFOLIA)ECHINACEA ANGUSTIFOLIA1 [hp_X]  in 50 mL
ECHINACEA PURPUREA (ECHINACEA PURPUREA)ECHINACEA PURPUREA1 [hp_X]  in 50 mL
ACONITUM NAPELLUS (ACONITUM NAPELLUS)ACONITUM NAPELLUS3 [hp_X]  in 50 mL
ARNICA MONTANA (ARNICA MONTANA)ARNICA MONTANA3 [hp_X]  in 50 mL
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP)CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 50 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK)HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]  in 50 mL
ATROPA BELLADONNA (ATROPA BELLADONNA)ATROPA BELLADONNA3 [hp_X]  in 50 mL
BELLIS PERENNIS (BELLIS PERENNIS)BELLIS PERENNIS1 [hp_X]  in 50 mL
CHAMOMILE (CHAMOMILE)CHAMOMILE1 [hp_X]  in 50 mL
ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM)ACHILLEA MILLEFOLIUM1 [hp_X]  in 50 mL
HYPERICUM OIL (HYPERICUM OIL)HYPERICUM OIL6 [hp_X]  in 50 mL
COMFREY ROOT (COMFREY ROOT)COMFREY ROOT4 [hp_X]  in 50 mL
COLCHICINE (COLCHICINE)COLCHICINE3 [hp_X]  in 50 mL
















Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL MYRISTATE 
LECITHIN, SOYBEAN 
UREA 
DOCUSATE SODIUM 
SODIUM HYDROXIDE 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
135781-0194-51 BOTTLE In 1 CARTONcontains a BOTTLE, DISPENSING
150 mL In 1 BOTTLE, DISPENSINGThis package is contained within the CARTON (35781-0194-5)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/01/2010


Labeler - Gensco Laboratories, LLC (831042325)









Establishment
NameAddressID/FEIOperations
Formulated Solutions143266687manufacture
Revised: 09/2010Gensco Laboratories, LLC




Tuesday, September 25, 2012

Serostim


Generic Name: somatropin (soe ma TROE pin)

Brand Names: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive


What is Serostim (somatropin)?

Somatropin is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.


Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.


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


What is the most important information I should know about Serostim (somatropin)?


Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.


Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.


If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.


Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes.

What should I discuss with my healthcare provider before using Serostim (somatropin)?


Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin. You should not use this medication if you are allergic to somatropin, or if you have:

  • diabetic retinopathy (a serious eye condition caused by diabetes);




  • cancer; or




  • Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.



You should also not use somatropin if you have a serious medical condition after having:



  • open heart surgery or stomach surgery;




  • trauma or other medical emergency; or




  • breathing problems (such as lung failure).



To make sure you can safely take somatropin, tell your doctor if you have any of these other conditions:



  • liver disease;




  • kidney disease (or if you are on dialysis);




  • diabetes;




  • a pituitary gland disorder;




  • scoliosis;




  • high blood pressure (hypertension);




  • a pancreas disorder (especially in children);




  • a history of cancer;




  • carpal tunnel syndrome;




  • underactive thyroid; or




  • a brain tumor or lesion.




FDA pregnancy category B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive. FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby.

How should I use Serostim (somatropin)?


Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.

Somatropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.


Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Do not inject this medicine into skin or muscle that is red, sore, infected, or injured.


Do not shake the medication bottle or you may ruin the medicine. When mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested often. Your eyes may also need to be checked. Visit your doctor regularly.


If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome.


If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use.


How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.


Throw away any somatropin left over after the expiration date on the label has passed.


What happens if I miss a dose?


Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?


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

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.


What should I avoid while using Serostim (somatropin)?


If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.


Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Serostim (somatropin) side effects


If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;




  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss;




  • sudden and severe pain behind your eyes, vision changes;




  • swelling in your head, face, hands, or feet; or




  • numbness or tingling in your wrist, hand, or fingers.



Less serious side effects may include:



  • headache, feeling tired;




  • redness, soreness, swelling, rash, itching, pain, or bruising where the medicine was injected;




  • pain in your arms or legs, joint stiffness or pain;




  • muscle pain; or




  • cold symptoms such as stuffy nose, sneezing, sore throat.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Serostim (somatropin)?


Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Do not change the dose of your diabetes medication without your doctor's advice.


Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone, methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your doses may need to be adjusted. Do not stop using a steroid suddenly. Follow your doctor's instructions.


Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral, Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.


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



More Serostim resources


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


  • Serostim MedFacts Consumer Leaflet (Wolters Kluwer)

  • Serostim Prescribing Information (FDA)

  • Serostim Advanced Consumer (Micromedex) - Includes Dosage Information

  • Somatropin Professional Patient Advice (Wolters Kluwer)

  • Genotropin Prescribing Information (FDA)

  • Genotropin Advanced Consumer (Micromedex) - Includes Dosage Information

  • Genotropin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Humatrope Cartridge MedFacts Consumer Leaflet (Wolters Kluwer)

  • Humatrope Prescribing Information (FDA)

  • Norditropin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Norditropin Prescribing Information (FDA)

  • Nutropin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Nutropin Prescribing Information (FDA)

  • Nutropin AQ MedFacts Consumer Leaflet (Wolters Kluwer)

  • Nutropin AQ Prescribing Information (FDA)

  • Nutropin Depot Prescribing Information (FDA)

  • Omnitrope Prescribing Information (FDA)

  • Omnitrope Consumer Overview

  • Omnitrope MedFacts Consumer Leaflet (Wolters Kluwer)

  • Saizen Prescribing Information (FDA)

  • Saizen MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tev-Tropin Prescribing Information (FDA)

  • Tev-Tropin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zorbtive Prescribing Information (FDA)

  • Zorbtive Consumer Overview

  • Zorbtive MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Serostim with other medications


  • AIDS Related Wasting
  • Cachexia
  • Short Stature for Age


Where can I get more information?


  • Your pharmacist can provide more information about somatropin.

See also: Serostim side effects (in more detail)