Efudex Topical

Generic Name: fluorouracil (Topical route)

flure-oh-URE-a-sil

Commonly used brand name(s)

In the U.S.

• Carac


• Efudex


• Fluoroplex

Available Dosage Forms:

• Cream


• Solution

Therapeutic Class: Antineoplastic, Dermatological

Pharmacologic Class: Antimetabolite

Uses For Efudex

Fluorouracil belongs to the group of medicines known as antimetabolites. When applied to the skin, it is used to treat certain skin problems, including cancer or conditions that could become cancerous if not treated.

Fluorouracil interferes with the growth of abnormal cells, which are eventually destroyed.

Fluorouracil is available only with your doctor's prescription.

Before Using Efudex

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

There is no specific information comparing use of fluorouracil on the skin in children with use in other age groups.

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 or if they cause different side effects or problems in older people. Although there is no specific information comparing use of fluorouracil on the skin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies 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 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.

• Rotavirus Vaccine, Live

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.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Metronidazole


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Tamoxifen


• Tinidazole


• Typhoid Vaccine


• Varicella Virus Vaccine


• Warfarin


• Yellow Fever Vaccine

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.

• Leucovorin


• Levamisole


• Levoleucovorin


• Phenytoin

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:

• Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency—May increase your chance of getting serious side effects.

• Other skin problems—May be aggravated

Proper Use of fluorouracil

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

Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered. Apply enough medicine each time to cover the entire affected area with a thin layer.

After washing the area with soap and water and drying carefully, use a cotton-tipped applicator or your fingertips to apply the medicine in a thin layer to your skin.

If you apply this medicine with your fingertips, make sure you wash your hands immediately afterwards, to prevent any of the medicine from accidentally getting in your eyes or mouth.

Fluorouracil may cause redness, soreness, scaling, and peeling of affected skin after 1 or 2 weeks of use. This effect may last for several weeks after you stop using the medicine and is to be expected. Sometimes a pink, smooth area is left when the skin treated with this medicine heals. This area will usually fade after 1 to 2 months. Do not stop using this medicine without first checking with your doctor. If the reaction is very uncomfortable, check with your doctor.

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 cream dosage form:
  
  • For precancerous skin condition caused by the sun:
    
    • Adults—Use the 0.5% or 1% cream on the affected areas of skin one or two times a day. The 5% cream is sometimes used on the hands.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For skin cancer:
    
    • Adults—Use the 5% cream on the affected areas of skin two times a day. Treatment may continue for several weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For topical solution dosage form:
  
  • For precancerous skin condition caused by the sun:
    
    • Adults—Use the 1% solution on the affected areas of skin one or two times a day. The 2% or 5% solution is sometimes used on the hands.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For skin cancer:
    
    • Adults—Use the 5% solution on the affected areas of skin two times a day. Treatment may continue for several weeks.
    
    
    • 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.

Precautions While Using Efudex

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

Apply this medicine very carefully when using it on your face. Avoid getting any in your eyes, nose, or mouth.

While using this medicine, and for 1 or 2 months after you stop using it, your skin may become more sensitive to sunlight than usual and too much sunlight may increase the effect of the drug. During this period of time:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat and sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Efudex 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:

• Redness and swelling of normal skin

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

More common

• Burning feeling where medicine is applied


• increased sensitivity of skin to sunlight


• itching


• oozing


• skin rash


• soreness or tenderness of skin

Less common or rare

• Darkening of skin


• scaling


• watery 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: Efudex Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Efudex Topical resources

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

Compare Efudex Topical with other medications

• Actinic Keratosis
• Basal Cell Carcinoma
• Skin Cancer

Urinary pH modifiers

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Urinary pH modifiers are agents that increase the pH of urine. They make the urine more alkaline and prevent the formation of kidney stones. Making the urine more alkaline also helps the kidneys to remove toxic substances.

See also

Medical conditions associated with urinary pH modifiers:

• Alkalosis
• Asystole
• Diabetic Ketoacidosis
• GERD
• Hyperkalemia
• Hyperuricemia Secondary to Chemotherapy
• Hyponatremia
• Indigestion
• Metabolic Acidosis
• Nephrolithiasis
• Renal Tubular Acidosis
• Urinary Alkalinization

Drug List:

Urocit-K

Neut

edetate calcium disodium

Generic Name: edetate calcium disodium (ED e tate KAL see um dye SOE dee um)

Brand Names: Calcium Disodium Versenate

What is edetate calcium disodium?

Edetate calcium disodium is a chelating (KEE-late-ing) agent. A chelating agent is capable of removing a heavy metal, such as lead or mercury, from the blood.

Edetate calcium disodium is used to treat lead poisoning.

Edetate calcium disodium may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about edetate calcium disodium?

You should not receive this medication if you are unable to urinate, or if you have active hepatitis or kidney disease.

Edetate calcium disodium is given as an injection through a needle placed into a vein or muscle. You will receive this injection in a hospital or emergency setting.

When injected into a vein, edetate calcium disodium must be given slowly through an IV infusion and can take up to 12 hours to complete.

If possible before you receive this medication, tell your caregivers if you kidney disease.

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

What should I discuss with my health care provider before receiving edetate calcium disodium?

You should not receive this medication if you are unable to urinate, or if you have active hepatitis or kidney disease.

If possible, before you receive edetate calcium disodium, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need a dose adjustment or special tests to safely receive this medication.

FDA pregnancy category B. Edetate calcium disodium is not expected to be harmful to an unborn baby. However, tell your doctor if you are pregnant before receiving this medication. It is not known whether edetate calcium disodium passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation, it may not be possible before you are treated with edetate calcium disodium to tell your caregivers if you are pregnant or breast-feeding. However, make sure any doctor caring for your pregnancy or your baby knows that you have received this medication.

How is edetate calcium disodium given?

Edetate calcium disodium is given as an injection through a needle placed into a vein or muscle. You will receive this injection in a hospital or emergency setting.

When injected into a vein, edetate calcium disodium must be given slowly through an IV infusion and can take up to 12 hours to complete.

To be sure this medication is helping your condition and not causing harmful side effects, your blood and urine will need to be tested often. Your heart rate will be constantly monitored through electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. This will help your doctor determine how long to treat you with edetate calcium disodium.

What happens if I miss a dose?

Since edetate calcium disodium is given by a healthcare provider, it is not likely that you will miss a dose.

What happens if I overdose?

Tell your caregivers right away if you think you have received too much of this medicine. An overdose of edetate calcium disodium is not expected to produce life-threatening symptoms.

What should I avoid after receiving edetate calcium disodium?

Follow your doctor's instructions about the amount of liquids you should drink while being treated with this medication. In some cases, drinking too much liquid can cause a harmful electrolyte imbalance.

Edetate calcium disodium 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. Tell your caregivers at once if you have any of these serious side effects:

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  
  


• 
  

  swelling, weight gain, feeling short of breath;

  
  


• 
  

  feeling like you might pass out; or

  
  


• 
  

  fast, slow, or uneven heart rate.

  
  

Less serious side effects include:

• 
  

  fever, chills, tired feeling, and muscle or joint pain;

  
  


• 
  

  numbness or tingly feeling;

  
  


• 
  

  tremors;

  
  


• 
  

  runny or stuffy nose, sneezing, water eyes;

  
  


• 
  

  mild skin rash;

  
  


• 
  

  headache; or

  
  


• 
  

  pain where the medicine was injected.

  
  

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.

Edetate calcium disodium Dosing Information

Usual Adult Dose for Lead Poisoning -- Mild:

For asymptomatic adult patients whose blood lead level is 20 mcg/dL (World Health Organization recommended upper allowable level):

1000 mg/m2/day given intravenously or intramuscularly

Therapy of lead poisoning in adult patients with edetate calcium disodium is continued over a period of five days. Therapy is then interrupted for 2 to 4 days to allow redistribution of the lead and to prevent severe depletion of zinc and other essential metals. Two courses of treatment are usually employed; however, it depends on severity of the lead toxicity and the patient's tolerance of the drug.

Edetate calcium disodium is equally effective whether administered intravenously or intramuscularly. The intramuscular route is used for all patients with overt lead encephalopathy.

Usual Adult Dose for Lead Poisoning -- Severe:

When the blood lead level is > 70 mcg/dL or clinical symptoms consistent with lead poisoning are present, it is recommended that edetate calcium disodium be used in conjunction with BAL (dimercaprol). Clinician should consult latest published protocols and/or a local poison control information center for dosing.

Usual Pediatric Dose for Lead Poisoning -- Mild:

For asymptomatic pediatric patients whose blood lead level is 20 mcg/dL (World Health Organization recommended upper allowable level):

1000 mg/m2/day given intravenously or intramuscularly

Therapy of lead poisoning in pediatric patients with edetate calcium disodium is continued over a period of five days. Therapy is then interrupted for 2 to 4 days to allow redistribution of the lead and to prevent severe depletion of zinc and other essential metals. Two courses of treatment are usually employed; however, it depends on severity of the lead toxicity and the patient's tolerance of the drug.

Edetate calcium disodium is equally effective whether administered intravenously or intramuscularly. The intramuscular route is used for all patients with overt lead encephalopathy and this route is preferred by some for young pediatric patients.

Usual Pediatric Dose for Lead Poisoning -- Severe:

When the blood lead level is > 70 mcg/dL or clinical symptoms consistent with lead poisoning are present, it is recommended that edetate calcium disodium be used in conjunction with BAL (dimercaprol). Clinician should consult latest published protocols and/or a local poison control information center for dosing.

What other drugs will affect edetate calcium disodium?

The following drugs can interact with edetate calcium disodium. Tell your doctor if you are using any of these:

• 
  

  insulin zinc (Iletin Lente); or

  
  


• 
  

  steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

  
  

This list is not complete and there may be other drugs that can interact with edetate calcium disodium. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More edetate calcium disodium resources

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

• Edetate calcium disodium


• Edetate Calcium Disodium Monograph (AHFS DI)


• Calcium Disodium Versenate Prescribing Information (FDA)

Compare edetate calcium disodium with other medications

• Lead Poisoning, Mild
• Lead Poisoning, Severe

Where can I get more information?

• Your doctor or pharmacist can provide more information about edetate calcium disodium.

See also: edetate calcium disodium side effects (in more detail)

Ed-Spaz

hyoscyamine sulfate

Dosage Form: tablet, orally disintegrating
Ed-Spaz

NDC 0485-0082-01

HYOSCYAMINE SULFATE

ORALLY DISINTEGRATING

TABLETS, 0.125 MG

Rx Only

Ed-Spaz Description

Hyoscyamine sulfate orally disintegrating tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration.

Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The molecular formula is (C17H23NO3)2•H2SO4•2H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structural formula:

Each tablet also contains as inactive ingredients: mannitol, croscarmellose sodium and magnesium stearate.

Ed-Spaz - Clinical Pharmacology

Hyoscyamine sulfate inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Hyoscyamine sulfate also controls excessive pharyngeal, tracheal and bronchial secretions.

Hyoscyamine sulfate is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, hyoscyamine sulfate disappears rapidly from the blood and is distributed throughout the entire body. The half-life of hyoscyamine sulfate is 2 to 3½ hours. Hyoscyamine sulfate is partly hydrolyzed to tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12 hours. Only traces of this drug are found in breast milk. Hyoscyamine sulfate passes the blood brain barrier and the placental barrier.

Indications and Usage for Ed-Spaz

Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a "drying agent" in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.

Contraindications

Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

Warnings

In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.

Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short term memory loss, hallucinations, dysarthria, ataxia, euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.

Precautions

General

Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension, and renal disease. Investigate any tachycardia before giving any anticholinergic drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.

Information for Patients

Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness, or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.

Use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution.

Drug Interactions

Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.

Antacids may interfere with the absorption of hyoscyamine sulfate. Administer hyoscyamine sulfate before meals; antacids after meals.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of hyoscyamine sulfate.

Pregnancy

Category C

Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine sulfate should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Hyoscyamine sulfate is excreted in human milk. Caution should be exercised when hyoscyamine sulfate is administered to a nursing woman.

Geriatric Use

Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

Adverse Reactions

All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.

Overdosage

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree of which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable.

Ed-Spaz Dosage and Administration

Dosage may be adjusted according to the conditions and severity of symptoms. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg must be placed on top of the tongue when it will dissolve in seconds, then swallow with saliva. Administering with liquid is not necessary.

Adults and pediatric patients 12 years of age and older

1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

Pediatric patients 2 to under 12 years of age

½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

How is Ed-Spaz Supplied

Ed-Spaz Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg are white, round, flat beveled edge tablets debossed "634" on one side and a score line on other side.

Bottles of 100 NDC 0485-0082-01

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP.

Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured by:

Belcher Pharmaceuticals, Inc.

6911 Bryan Dairy Road

Largo, FL 33777

Manufactured for:

Edwards Pharmaceutical, Inc.

111 W. Mulberry St.

Ripley, MS 38663

May 2010

L18I

R-0510

PRINCIPAL DISPLAY PANEL - 0.125 mg Tablet Bottle Label

NDC 0485-0082-01

Ed-Spaz

Hyoscyamine Sulfate Orally

Disintegrating

Tablets

0.125 mg

100 Tablets

Rx only

Ed-Spaz  hyoscyamine sulfate  tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0485-0082 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.125 mg

Inactive Ingredients Ingredient Name Strength mannitol   croscarmellose sodium   magnesium stearate

Product Characteristics Color WHITE Score 2 pieces Shape ROUND (FLAT, BEVELED EDGE) Size 6mm Flavor Imprint Code 634 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0485-0082-01 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		05/12/2010

Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)

Establishment
Name	Address	ID/FEI	Operations
BELCHER PHARMACEUTIALS, INC.		829721302	MANUFACTURE, PACK, LABEL, ANALYSIS

Revised: 05/2010EDWARDS PHARMACEUTICALS, INC.

More Ed-Spaz resources

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

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• Anesthesia
• Crohn's Disease
• Endoscopy or Radiology Premedication
• Irritable Bowel Syndrome
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Sinvastatina Dislipina

Sinvastatina Dislipina may be available in the countries listed below.

Ingredient matches for Sinvastatina Dislipina

Simvastatin

Simvastatin is reported as an ingredient of Sinvastatina Dislipina in the following countries:

• Portugal

International Drug Name Search

Cycloserine

Pronunciation: sigh-kloe-SER-een
Generic Name: Cycloserine
Brand Name: Seromycin

Cycloserine is used for:

Treating tuberculosis (TB) in the lungs and other places in the body (including the kidneys) when treatment with other medicines has not been effective. Cycloserine should be used in combination with other medicines. It may also be used to treat certain urinary tract infections.

Cycloserine is an antibiotic. It works by blocking the growth of the bacterial cell wall.

Do NOT use Cycloserine if:

• you are allergic to any ingredient in Cycloserine


• you have depression, severe anxiety, psychosis (bizarre behavior or thoughts), epilepsy, or severe kidney problems


• you have alcoholism or you drink excessive amounts of alcohol

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

Before using Cycloserine:

Some medical conditions may interact with Cycloserine. 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 regularly consume alcoholic beverages or have a history of alcoholism


• if you have anxiety, kidney or liver problems, or the blood disease porphyria

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

• Ethionamide because the risk of toxic side effects may be increased


• Isoniazid because the risk of side effects such as drowsiness or dizziness may be increased

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

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

• Cycloserine may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• To clear up your infection completely, continue to use Cycloserine even if you feel well. Do not miss any doses.


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

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

Important safety information:

• Cycloserine may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Cycloserine. Using Cycloserine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not drink alcohol while you are using Cycloserine.


• Cycloserine is effective only against bacteria. It is not effective for treating viral infections (eg, the common cold)


• It is important to use Cycloserine for the full course of treatment. Failure to do so may decrease the effectiveness of Cycloserine and increase the risk that the bacteria will no longer be sensitive to Cycloserine and will not be able to be treated by this or certain other antibiotics in the future.


• Long-term or repeated use of Cycloserine may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.


• LAB TESTS, including complete blood cell counts, kidney and liver function, and the level of Cycloserine in the blood, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Cycloserine with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is unknown if Cycloserine can cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Cycloserine during pregnancy. Cycloserine is excreted in breast milk. Do not breast feed while taking Cycloserine.

Possible side effects of Cycloserine:

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); aggression; bizarre behavior; coma; confusion; depression; disorientation; dizziness; drowsiness; exaggerated reflexes; excessive irritability; feeling of a whirling motion; headache; memory loss; mental or mood changes; mood swings; numbness or tingling of the skin; paralysis; seizures; slurred speech or other speech problems; swelling of the hands or feet; tremors; thoughts of suicide; unusual tiredness or weakness.

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: Cycloserine 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 abnormal skin sensations; bizarre thoughts or behavior; confusion; dizziness; drowsiness; excessive irritability; feeling of a whirling motion; headache; hyperirritability; loss of consciousness; paralysis; seizures; slurred speech.

Proper storage of Cycloserine:

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

General information:

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


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


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


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

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

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

• Cycloserine Professional Patient Advice (Wolters Kluwer)


• Cycloserine Monograph (AHFS DI)


• Cycloserine


• Seromycin Prescribing Information (FDA)


• cycloserine Concise Consumer Information (Cerner Multum)


• cycloserine Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Cycloserine with other medications

• Tuberculosis, Active
• Tuberculosis, Extrapulmonary

Azitromicina 3Z

Azitromicina 3Z may be available in the countries listed below.

Ingredient matches for Azitromicina 3Z

Azithromycin

Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Azitromicina 3Z in the following countries:

• Portugal

International Drug Name Search