Twinject

Generic Name: epinephrine (Injection route)

ep-i-NEF-rin

Commonly used brand name(s)

In the U.S.

• Adrenaclick


• Adrenalin


• Adrenalin Chloride


• Epipen


• Epipen Jr


• Twinject

Available Dosage Forms:

• Injectable


• Solution

Therapeutic Class: Anaphylaxis Agent

Pharmacologic Class: Adrenergic

Chemical Class: Alkylarylamine

Uses For Twinject

Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.

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

Before Using Twinject

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

No information is available on the relationship of age to the effects of epinephrine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of epinephrine injection in geriatric patients. However, elderly patients are more likely to have age-related heart disease which may require caution in patients receiving epinephrine injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

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

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

• Dihydroergotamine


• Isocarboxazid


• Linezolid


• Phenelzine


• Tranylcypromine

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

• Amitriptyline


• Amoxapine


• Bucindolol


• Carteolol


• Carvedilol


• Clomipramine


• Desipramine


• Dilevalol


• Dothiepin


• Doxepin


• Entacapone


• Halothane


• Imipramine


• Levobunolol


• Lofepramine


• Metipranolol


• Nadolol


• Nortriptyline


• Opipramol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Protriptyline


• Rasagiline


• Sotalol


• Tertatolol


• Timolol


• Trimipramine

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.

• Labetalol

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:

• Angina pectoris (severe chest pain) or


• Blood vessel problems or


• Diabetes mellitus (sugar diabetes) or


• Heart attack or


• Heart disease or


• Heart rhythm problems or


• Hypertension (high blood pressure) or


• Overactive thyroid or


• Parkinson's disease—Use with caution. May make these conditions worse.

Proper Use of epinephrine

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

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

If you are using this medicine at home, make sure you or any of your family members understand exactly how to give them. Also, tell your doctor if you or your caregiver has severe arthritis of the hands. If you have any questions about this, check with your doctor.

This medicine is injected under your skin or into the muscle of your outer thigh only. Do not inject this medicine into a vein or into the muscle of your buttocks. To do so, may increase the chance of having serious side effects.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine comes in an auto-injector syringe and needle kit that contains the correct dose of medicine your doctor has prescribed.

You may need to use more than one injection if your allergic reaction does not get better after the first shot.

Carry this medicine with you at all times for emergency use in case you have a severe allergic reaction.

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 injection dosage form:
  
  • For allergic reactions:
    
    • Adults and children weighing above 30 kilograms (66 pounds)—0.3 milligram (mg) injected under the skin or into the muscle of your thigh.
    
    
    • Adults and children weighing 15 to 30 kilograms (33 to 66 pounds)—0.15 milligram (mg) injected under the skin or into the muscle of your thigh.
    
    
  
  

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the injection kits at room temperature, away from heat, moisture, and direct light. Do not store the medicine in the refrigerator or freezer. Keep the auto-injector in its case or tube.

Check the injection kits regularly to make sure that the liquid has not changed its color. Do not use this medicine if the liquid has changed its color, or if there are solids in the liquid.

Do not reuse the remaining portion of the medicine that is left in the auto-injector. Throw away the auto-injector after you have used it.

Precautions While Using Twinject

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Anaphylaxis is a life-threatening reaction and requires immediate medical attention. Check with your doctor right away, or go to an emergency room as soon as possible, even if you feel better after using this medicine.

This medicine may affect 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.

Do not inject this medicine into your hands or feet. There is already less blood flow to the hands and feet, and epinephrine could make that worse and cause damage to these tissues. If you accidentally inject epinephrine into your hands or feet, check with your doctor or go to the hospital emergency room right away.

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

Twinject 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:

Incidence not known

• Abnormal or decreased touch sensation


• arm, back or jaw pain


• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• dizziness


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


• fear or nervousness


• headache


• nausea or vomiting


• paleness of the skin


• pounding in the ears


• restlessness


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


• shortness of breath


• slow or fast heartbeat


• stroke


• sweating


• trembling or shaking of the hands or feet


• troubled breathing


• unusual tiredness or weakness


• wheezing

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

Symptoms of overdose

• Agitation


• coldness of the skin


• coma


• confusion


• decreased urine output


• depression


• drowsiness


• hostility


• irritability


• lethargy


• lightheadedness, dizziness, or fainting


• muscle twitching


• pounding, slow heartbeat


• rapid weight gain


• rapid, deep breathing


• seizures


• stomach cramps


• stupor


• swelling of the face, ankles, or hands

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: Twinject 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 Twinject resources

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

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• Allergic Reactions
• Asthma, acute
• Asystole
• AV Heart Block
• COPD, Acute
• Electromechanical Dissociation
• Shock

Trecator-SC

Generic Name: ethionamide (e thye on AM ide)

Brand Names: Trecator

What is Trecator-SC (ethionamide)?

Ethionamide is an antibiotic. It prevents the growth of bacteria in your body.

Ethionamide is used to treat tuberculosis (TB).

Ethionamide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Trecator-SC (ethionamide)?

Take all of the ethionamide that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Ethionamide may cause stomach upset, a loss of appetite, a metallic taste in your mouth, or excessive salivation (mouth watering). Notify your doctor if these side effects are persistent or severe.

Who should not take Trecator-SC (ethionamide)?

Before taking this medication, tell your doctor if you

• 
  

  have ever had an allergic reaction to ethionamide;

  
  


• 
  

  have liver disease; or

  
  


• 
  

  have diabetes mellitus.

  
  

You may not be able to take ethionamide, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether ethionamide will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether ethionamide will harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Trecator-SC (ethionamide)?

Take ethionamide exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water.

Ethionamide can be taken with or without food. Taking ethionamide with food may decrease stomach upset.

Take all of the ethionamide that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Ethionamide is usually combined with one or more other tuberculosis medicines.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an ethionamide overdose are unknown.

What should I avoid while taking Trecator-SC (ethionamide)?

There are no restrictions on foods, beverages, or activities during treatment with ethionamide unless your doctor directs otherwise.

Trecator-SC (ethionamide) side effects

If you experience any of the following serious side effects, stop taking ethionamide and seek emergency medical attention:

• 
  

  an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

  
  


• 
  

  yellow skin or eyes;

  
  


• 
  

  dark urine;

  
  


• 
  

  numbness or tingling in your hands or feet;

  
  


• 
  

  seizures;

  
  


• 
  

  blurred or double vision; or

  
  


• 
  

  confusion or abnormal behavior.

  
  

Other, less serious side effects may be more likely to occur. Continue to take ethionamide and talk to your doctor if you experience

• 
  

  nausea, vomiting, or loss of appetite;

  
  


• 
  

  a metallic taste in your mouth;

  
  


• 
  

  excessive salivation;

  
  


• 
  

  diarrhea;

  
  


• 
  

  unusual fatigue or weakness;

  
  


• 
  

  headache;

  
  


• 
  

  mild dizziness;

  
  


• 
  

  tremors (shaking); or

  
  


• 
  

  a rash.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Trecator-SC (ethionamide)?

The risk of seizures may be increased when ethionamide is used in combination with cycloserine (Seromycin) or isoniazid (Nydrazid). Special monitoring may be necessary if you are taking a combination of these medicines.

Drugs other than those listed here may also interact with ethionamide. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.

More Trecator-SC resources

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

• Trecator-SC Advanced Consumer (Micromedex) - Includes Dosage Information


• Ethionamide Professional Patient Advice (Wolters Kluwer)


• Ethionamide Monograph (AHFS DI)


• Ethionamide MedFacts Consumer Leaflet (Wolters Kluwer)


• Trecator Prescribing Information (FDA)

Compare Trecator-SC with other medications

• Tuberculosis, Active

Where can I get more information?

• Your pharmacist has additional information about ethionamide written for health professionals that you may read.

See also: Trecator-SC side effects (in more detail)

Triamcinolone Paste

Generic Name: triamcinolone acetonide

Dosage Form: dental paste
TRIAMCINOLONE ACETONIDE DENTAL PASTE USP, 0.1%

Rx only

Triamcinolone Paste Description

Triamcinolone Acetonide Dental Paste USP, 0.1% contains the corticosteroid triamcinolone acetonide in an adhesive vehicle suitable for application to oral tissues. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16,17-acetal with acetone. The structural formula of triamcinolone acetonide is as follows:

Each gram of Triamcinolone Acetonide Dental Paste USP, 0.1% contains 1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base.

Triamcinolone Paste - Clinical Pharmacology

Like other topical corticosteroids, triamcinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of absorption through the oral mucosa is determined by multiple factors including the vehicle, the integrity of the mucosal barrier, the duration of therapy, and the presence of inflammation and/or other disease processes. Once absorbed through the mucous membranes, the disposition of corticosteroids is similar to that of systemically administered corticosteroids. Corticosteroids are bound to the plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys; some corticosteroids and their metabolites are also excreted into the bile.

Indications and Usage for Triamcinolone Paste

Triamcinolone Acetonide Dental Paste USP, 0.1% is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

Contraindications

Triamcinolone Acetonide Dental Paste USP, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

Precautions

General:

Triamcinolone Acetonide Dental Paste USP, 0.1% may cause local adverse reactions. If irritation develops, Triamcinolone Acetonide Dental Paste USP, 0.1% should be discontinued and appropriate therapy instituted. Allergic contact sensitization with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant mucosal infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Triamcinolone Acetonide Dental Paste USP, 0.1% should be discontinued until the infection has been adequately controlled.

If significant regeneration or repair of oral tissues has not occurred in seven days, additional investigation into the etiology of the oral lesion is advised.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, glucosuria, and other adverse effects known to occur with parenterally-administered steroid preparations; therefore, it may be advisable to periodically evaluate patients on prolonged therapy with corticosteroid-containing dental pastes for evidence of HPA axis suppression (see PRECAUTIONS, Laboratory Tests). If HPA axis suppression is noted, an attempt should be made to withdraw the drug or to reduce the frequency of application. Recovery of HPA axis function is generally prompt and complete upon discontinuation of therapy.

Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed by the physician or dentist. It is for oral use only; it is not intended for ophthalmic or dermatological use.

Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

Patients should report any signs of adverse reactions.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician or dentist.

Laboratory Tests

A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to evaluate triamcinolone acetonide for potential to induce carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy Category C:  Teratogenic effects. Triamcinolone acetonide has been shown to induce teratogenic effects in several species. In mice and rabbits, triamcinolone acetonide induced an increased incidence of cleft palate at dosages of approximately 120 mcg/kg/day and 24 mcg/kg/day, respectively (approximately 12 times and 10 times the amount in a typical daily human dose of Triamcinolone Acetonide Dental Paste USP, 0.1% when compared following normalization of the data on the basis of body surface area estimates, respectively). In monkeys, triamcinolone acetonide induced cranial skeletal malformations at the lowest dosage studied (500 mcg/kg/day), which was approximately 200 times the amount in a typical daily human dose of Triamcinolone Acetonide Dental Paste USP, 0.1% when compared following normalization of the data on the basis of body surface area estimates. There are no adequate and well-controlled studies in pregnant women. However, a retrospective analysis of birth defects among children born to mothers that used drugs of the same class as Triamcinolone Acetonide Dental Paste USP, 0.1% (corticosteroids) during pregnancy found an approximately 3 times increased incidence of cleft palate. Triamcinolone Acetonide Dental Paste USP, 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether oral application of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when corticosteroid-containing dental pastes are prescribed for a nursing woman.

Pediatric Use

The safety and efficacy of Triamcinolone Acetonide Dental Paste USP, 0.1% in children is unknown. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's Syndrome than mature patients because of a larger skin surface area to body weight ratio. Administration of corticosteroid-containing dental pastes to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Geriatric Use

Clinical studies of Triamcinolone Acetonide Dental Paste USP, 0.1% did not include sufficient numbers of subjects age 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Adverse Reactions

The following local adverse reactions may occur with corticosteroid-containing dental pastes: burning, itching, irritation, dryness, blistering or peeling not present prior to therapy, perioral dermatitis, allergic contact dermatitis, maceration of the oral mucosa, secondary infection, and atrophy of the oral mucosa.

Also, see PRECAUTIONS for potential effects of systemic absorption.

Triamcinolone Paste Dosage and Administration

Press a small dab (about 1/4 inch) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film. Do not rub in. Attempting to spread this preparation may result in granular, gritty sensation and cause it to crumble. After application, however, a smooth, slippery film develops.

The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night. Depending on the severity of symptoms, it may be necessary to apply the preparation two or three times a day, preferably after meals. If significant repair or regeneration has not occurred in seven days, further investigation is advisable.

How is Triamcinolone Paste Supplied

Triamcinolone Acetonide Dental Paste USP, 0.1%

Tubes containing 5 g of dental paste

NDC 64980-320-05

Storage

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

Distributed by:

Rising Pharmaceuticals, Inc.

Allendale, NJ 07401

Manufactured by:

Lyne Laboratories, Inc.

Brockton, MA 02301

R1-10/06

Rising®                     NDC 64980-320-05

Triamcinolone Acetonide

Dental Paste USP, 0.1%

Rx only

5g                            Read all sides

TRIAMCINOLONE ACETONIDE  triamcinolone acetonide  paste

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64980-320 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE) TRIAMCINOLONE ACETONIDE 1 mg  in 1 g

Inactive Ingredients Ingredient Name Strength GELATIN   PECTIN, CITRUS   CARBOXYMETHYLCELLULOSE SODIUM

Product Characteristics Color      Score      Shape Size Flavor VANILLA (Vanilla) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64980-320-05 48 CARTON In 1 BOX contains a CARTON 1 1 TUBE In 1 CARTON This package is contained within the BOX (64980-320-05) and contains a TUBE 1 5 g In 1 TUBE This package is contained within a CARTON and a BOX (64980-320-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040771	07/07/2010

Labeler - Rising Pharmaceuticals, Inc. (041241766)

Registrant - Lyne Laboratories, Inc. (053510459)

Establishment
Name	Address	ID/FEI	Operations
Lyne Laboratories, Inc.		053510459	manufacture

Revised: 09/2011Rising Pharmaceuticals, Inc.

More Triamcinolone Paste resources

• Triamcinolone Paste Use in Pregnancy & Breastfeeding
• Triamcinolone Paste Drug Interactions
• Triamcinolone Paste Support Group
• 22 Reviews for Triamcinolone - Add your own review/rating

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Sacrosidase

Generic Name: sacrosidase (sak ROE si dase)

Brand Names: Sucraid

What is sacrosidase?

Sacrosidase is a yeast-based enzyme that replaces an enzyme called sucrase which is normally produced in the body. Sucrase helps the body breakdown and process certain sugars during digestion.

In people who lack the sucrase enzyme, sugar can pass into the intestines where it can interact with bacteria. This can cause bloating, gas, stomach pain, nausea, and vomiting.

Sacrosidase is used to treat sucrase deficiency that occurs in people with congenital sucrase-isomaltase deficiency (CSID).

CSID is a genetic enzyme deficiency and sacrosidase will not cure this condition.

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

What is the most important information I should know about sacrosidase?

Sacrosidase is used to treat sucrase deficiency that occurs in people with congenital sucrase-isomaltase deficiency (CSID). CSID is a genetic enzyme deficiency and sacrosidase will not cure this condition.

You should not use this medication if you are allergic to yeast, yeast products, glycerin (glycerol), or papain (Accuzyme, Ethezyme, Gladase, Kovia, and others).

Before using sacrosidase, tell your doctor if you have diabetes. Sacrosidase changes the way your body absorbs sugar and your glucose levels may change. Your doctor will tell you if any of your medication doses need to be changed.

This medication sometimes causes an allergic reaction. Before you start the medication, your doctor may recommend a sacrosidase skin test to make sure you are not allergic to the medication.

Sacrosidase is usually taken with each meal or snack. It is best to take one half of the dose when you start eating and take the other half during your meal or snack.

Measure your dose using the scoop provided with this medication.

Sacrosidase liquid should be mixed with 2 to 4 ounces of water, milk, or baby formula that is no hotter than room temperature. Do not mix with warm or hot liquids or the medication will not be as effective. Do not mix sacrosidase with fruit juice or drink fruit juice when taking the medication.

You may need to avoid eating a lot of starch (found mainly in rice, potatoes, corn, pasta, and bread). Follow your doctor's instructions about any special diet while you are taking sacrosidase.

What should I discuss with my health care provider before taking sacrosidase?

You should not use this medication if you are allergic to yeast, yeast products, glycerin (glycerol), or papain (Accuzyme, Ethezyme, Gladase, Kovia, and others).

Before using sacrosidase, tell your doctor if you have diabetes. Sacrosidase changes the way your body absorbs sugar and your glucose levels may change. Your doctor will tell you if any of your medication doses need to be changed.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Tell your doctor if you are breast-feeding a baby while taking sacrosidase.

How should I take sacrosidase?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Sacrosidase is usually taken with each meal or snack. It is best to take one half of the dose when you start eating and take the other half during your meal or snack.

Measure your dose using the scoop provided with sacrosidase. Rinse the scoop after each use and allow it to dry thoroughly.

Sacrosidase liquid should be mixed with 2 to 4 ounces of water, milk, or baby formula that is no hotter than room temperature. Do not mix with warm or hot liquids or the medication will not be as effective. Do not mix sacrosidase with fruit juice or drink fruit juice when taking the medication.

This medication sometimes causes an allergic reaction. Before you start the medication, your doctor may recommend a sacrosidase skin test to make sure you are not allergic to the medication.

Your doctor may instruct you to take your first dose of sacrosidase in a place where you have access to emergency medical care. A severe allergic reaction could occur that may require immediate care.

Store this medication in the refrigerator, protected from light. Do not freeze. Recap the bottle after each use.

When you first open a bottle of sacrosidase, write the date on the label. Throw away any unused sacrosidase 4 weeks after first opening the bottle.

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, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of sacrosidase is not likely to produce any symptoms.

What should I avoid while taking sacrosidase?

You may need to avoid eating a lot of starch (found mainly in rice, potatoes, corn, pasta, and bread). Follow your doctor's instructions about any special diet while you are taking sacrosidase.

Follow your doctor's instructions about any other restrictions on food or beverages while you are using sacrosidase.

Sacrosidase side effects

Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  stomach pain;

  
  


• 
  

  nausea, vomiting;

  
  


• 
  

  diarrhea, constipation;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  headache;

  
  


• 
  

  nervous feeling; or

  
  


• 
  

  increased thirst and dry, hot skin.

  
  

Some of these may be symptoms of your condition and not actual side effects of sacrosidase.

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 sacrosidase?

There may be other drugs that can interact with sacrosidase. 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 sacrosidase resources

• Sacrosidase Side Effects (in more detail)
• Sacrosidase Use in Pregnancy & Breastfeeding
• Sacrosidase Support Group
• 0 Reviews · Be the first to review/rate this drug

• sacrosidase Advanced Consumer (Micromedex) - Includes Dosage Information


• Sacrosidase MedFacts Consumer Leaflet (Wolters Kluwer)


• Sacrosidase Monograph (AHFS DI)


• Sucraid Prescribing Information (FDA)

Where can I get more information?

• Your pharmacist can provide more information about sacrosidase.

See also: sacrosidase side effects (in more detail)

Tofranil

Generic Name: imipramine (im IP ra meen)

Brand Names: Tofranil, Tofranil-PM

What is Tofranil (imipramine)?

Imipramine is in a group of drugs called tricyclic antidepressants. Imipramine affects chemicals in the brain that may become unbalanced.

Imipramine is used to treat symptoms of depression.

Imipramine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Tofranil (imipramine)?

Do not use imipramine if you have recently had a heart attack, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking Tofranil (imipramine)?

Do not use this medication if you are allergic to imipramine, or if you have recently had a heart attack. Do not use imipramine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take imipramine before the MAO inhibitor has cleared from your body.

Before taking imipramine, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  heart disease;

  
  


• 
  

  a history of heart attack, stroke, or seizures;

  
  


• 
  

  bipolar disorder (manic-depression);

  
  


• kidney or liver disease;


• 
  

  overactive thyroid;

  
  


• 
  

  diabetes (imipramine may raise or lower blood sugar);

  
  


• 
  

  adrenal gland tumor (pheochromocytoma);

  
  


• 
  

  glaucoma; or

  
  


• 
  

  problems with urination.

  
  

If you have any of these conditions, you may not be able to use imipramine, or you may need a dosage adjustment or special tests during treatment.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Imipramine 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. Do not give this medication to anyone younger than 18 years old without the advice of a doctor.

How should I take Tofranil (imipramine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking imipramine. You may need to stop using the medicine for a short time.

Do not stop using imipramine without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take up to 3 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 3 weeks of treatment. Store imipramine at room temperature away from moisture and heat.

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. An overdose of imipramine can be fatal.

Symptoms of an imipramine overdose may include uneven heartbeats, extreme drowsiness, agitation, vomiting, blurred vision, sweating, muscle stiffness, swelling, shortness of breath, blue lips or fingernails, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking Tofranil (imipramine)?

Avoid drinking alcohol. It can cause dangerous side effects when taken together with imipramine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants). They can add to sleepiness caused by imipramine.

Grapefruit and grapefruit juice may interact with imipramine. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

Imipramine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Imipramine can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Tofranil (imipramine) 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 any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heart rate;

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  confusion, hallucinations, or seizure (convulsions);

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  restless muscle movements in your eyes, tongue, jaw, or neck;

  
  


• 
  

  urinating more or less than usual;

  
  


• 
  

  extreme thirst with headache, nausea, vomiting, and weakness;

  
  


• 
  

  skin rash, bruising, severe tingling, numbness, pain, or muscle weakness.

  
  

Less serious side effects may be more likely to occur, such as:

• 
  

  nausea, vomiting, stomach pain, loss of appetite;

  
  


• 
  

  constipation or diarrhea;

  
  


• 
  

  dry mouth, unpleasant taste;

  
  


• 
  

  weight changes;

  
  


• 
  

  weakness, lack of coordination;

  
  


• 
  

  feeling dizzy, drowsy, or tired;

  
  


• 
  

  nightmares;

  
  


• 
  

  blurred vision, headache, ringing in your ears;

  
  


• 
  

  breast swelling (in men or women); or

  
  


• 
  

  decreased sex drive, impotence, or difficulty having an orgasm.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tofranil (imipramine)?

Before taking imipramine, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Before taking imipramine, tell your doctor if you are currently using any of the following drugs:

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  clonidine (Catapres);

  
  


• 
  

  guanethidine (Ismelin);

  
  


• 
  

  methylphenidate (Concerta, Ritalin, Daytrana); or

  
  


• 
  

  heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

  
  

If you are using any of these drugs, you may not be able to use imipramine, or you may need dosage adjustments or special tests during treatment.

There are many other medicines that can interact with imipramine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Tofranil resources

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

• Tofranil MedFacts Consumer Leaflet (Wolters Kluwer)


• Tofranil Advanced Consumer (Micromedex) - Includes Dosage Information


• Tofranil Prescribing Information (FDA)


• Imipramine Professional Patient Advice (Wolters Kluwer)


• Imipramine Prescribing Information (FDA)


• Imipramine Hydrochloride Monograph (AHFS DI)


• Tofranil-PM Prescribing Information (FDA)


• Tofranil-PM MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Tofranil with other medications

• ADHD
• Depression
• Interstitial Cystitis
• Night Terrors
• Pain
• Panic Disorder
• Primary Nocturnal Enuresis

Where can I get more information?

• Your pharmacist has information about imipramine written for health professionals that you may read.

See also: Tofranil side effects (in more detail)

Tolbutamide

tole-BUE-ta-mide

Commonly used brand name(s)

In the U.S.

• Tol-Tab

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: 1st Generation Sulfonylurea

Uses For tolbutamide

Tolbutamide is used to treat high blood sugar levels caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future.

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Tolbutamide belongs to a class of drugs called sulfonylureas. It causes your pancreas to release more insulin into the blood stream.

tolbutamide is available only with your doctor's prescription.

Before Using tolbutamide

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 tolbutamide, the following should be considered:

Allergies

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

Pediatric

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

Geriatric

No information is available on the relationship of age to the effects of tolbutamide in geriatric patients. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require an adjustment of dosage in patients receiving tolbutamide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tolbutamide, 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 tolbutamide 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.

• Acarbose


• Alatrofloxacin


• Balofloxacin


• Ciprofloxacin


• Clinafloxacin


• Disopyramide


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

Using tolbutamide 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.

• Acebutolol


• Aceclofenac


• Acemetacin


• Alclofenac


• Alprenolol


• Apazone


• Aprepitant


• Aspirin


• Atenolol


• Benoxaprofen


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bromfenac


• Bucindolol


• Bufexamac


• Carprofen


• Carteolol


• Carvedilol


• Celiprolol


• Chloramphenicol


• Clometacin


• Clonixin


• Clorgyline


• Dexketoprofen


• Diclofenac


• Dicumarol


• Diflunisal


• Dilevalol


• Dipyrone


• Droxicam


• Esmolol


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Fenugreek


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Fosaprepitant


• Fosphenytoin


• Ginkgo Biloba


• Glucomannan


• Guar Gum


• Ibuprofen


• Indomethacin


• Indoprofen


• Iproniazid


• Isocarboxazid


• Isoxicam


• Ketoconazole


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nialamide


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxprenolol


• Oxyphenbutazone


• Pargyline


• Penbutolol


• Phenelzine


• Phenylbutazone


• Phenytoin


• Pindolol


• Pirazolac


• Piroxicam


• Pirprofen


• Procarbazine


• Propranolol


• Propyphenazone


• Proquazone


• Psyllium


• Rifapentine


• Selegiline


• Sotalol


• Sulfadiazine


• Sulfamethoxazole


• Sulfaphenazole


• Sulindac


• Suprofen


• Talinolol


• Tenidap


• Tenoxicam


• Tertatolol


• Tiaprofenic Acid


• Timolol


• Tolmetin


• Toloxatone


• Tranylcypromine


• Trimethoprim


• Voriconazole


• Zomepirac

Interactions with Food/Tobacco/Alcohol

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

Using tolbutamide with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use tolbutamide, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Alcohol intoxication or


• Underactive adrenal glands or


• Underactive pituitary glands or


• Undernourished condition or


• Weakened physical condition or


• Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking tolbutamide.

• Diabetic ketoacidosis (ketones in the blood) or


• Type I diabetes—Should not be used in patients with these conditions.

• Fever or


• Infection or


• Surgery or


• Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin.

• Heart disease—Use with caution. May make this condition worse.

• Kidney disorder or


• Liver disorder—Higher blood levels of tolbutamide may occur, which may cause serious problems.

Proper Use of tolbutamide

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Dosing

The dose of tolbutamide 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 tolbutamide. 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 type 2 diabetes:
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 1000 to 2000 milligrams (mg) per day, taken in the morning or in divided doses. Your doctor may adjust your dose if needed. The dose is usually not more than 3000 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Precautions While Using tolbutamide

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

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.


• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines.

Check with your doctor right away if you start having chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while you are using tolbutamide. These may be symptoms of a serious heart problem, including a heart attack.

Tolbutamide can cause low blood sugar. However, this can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take tolbutamide with another type of diabetes medicine. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

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

tolbutamide 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

• Abdominal or stomach pain


• chills


• clay-colored stools


• dark urine


• diarrhea


• dizziness


• fever


• headache


• itching


• loss of appetite


• nausea


• rash


• unpleasant breath odor


• unusual tiredness or weakness


• vomiting of blood

Incidence not known

• Agitation


• back or leg pains


• bleeding gums


• blood in urine or stools


• bloody, black, or tarry stools


• chest pain


• coma


• confusion


• convulsions


• cough or hoarseness


• decreased urine output


• depression


• difficulty breathing


• fast or irregular heartbeat


• fatigue


• fever with or without chills


• fluid-filled skin blisters


• general body swelling


• general feeling of tiredness or weakness


• high fever


• hostility


• increased thirst


• irritability


• lethargy


• light-colored stools


• lower back or side pain


• muscle pain or cramps


• muscle twitching


• nosebleeds


• painful or difficult urination


• pale skin


• pinpoint red spots on skin


• rapid weight gain


• seizures


• sensitivity to the sun


• shortness of breath


• sore throat


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


• stupor


• swelling of face, ankles, or hands


• swollen or painful glands


• tightness in the chest


• unexplained bleeding or bruising


• wheezing


• yellow eyes or skin

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

Symptoms of overdose

• Anxiety


• blurred vision


• cold sweats


• cool, pale skin


• increased hunger


• nervousness


• nightmares


• shakiness


• slurred speech

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

• Belching


• indigestion


• pain in the chest below the breastbone


• passing of gas


• stomach pain, fullness, or discomfort

Less common

• Flushing or redness of skin


• unusually warm skin

Incidence not known

• Change in taste or bad, unusual, or unpleasant (after)taste


• increased sensitivity of skin to sunlight


• redness or other discoloration of skin


• severe sunburn

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: tolbutamide 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 tolbutamide resources

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

• tolbutamide Concise Consumer Information (Cerner Multum)


• Tolbutamide Prescribing Information (FDA)


• Tolbutamide Professional Patient Advice (Wolters Kluwer)


• Tolbutamide MedFacts Consumer Leaflet (Wolters Kluwer)


• Tolbutamide Monograph (AHFS DI)

Compare tolbutamide with other medications

• Diabetes, Type 2