Tinactin Aerosol Liquid Topical

Generic Name: tolnaftate (Topical route)

tol-NAF-tate

Commonly used brand name(s)

In the U.S.

• Absorbine Jr. Antifungal


• Aftate


• Blis-To-Sol


• Dermasept Antifungal


• Fungi-Guard


• Podactin


• Q-Naftate


• Tinactin


• Tinaderm


• Ting

In Canada

• Athlete's Foot Gel


• Dr. Scholl's Athlete's Foot


• Pitrex


• Scholl's Athlete's Foot Spray


• Scholl Tritin Antifungal Powder


• Scholl Tritin Antifungal Spray Powder


• Tinactin Aerosol Liquid


• Tinactin Aerosol Powder


• Tinactin Jock Itch


• Tinactin Plus


• Tinactin Plus Aerosol Powder

Available Dosage Forms:

• Ointment


• Spray


• Cream


• Lotion


• Gel/Jelly


• Powder


• Solution

Therapeutic Class: Antifungal

Uses For Tinactin Aerosol Liquid

Tolnaftate belongs to the group of medicines called antifungals. It is used to treat some types of fungus infections. It may also be used together with medicines taken by mouth for fungus infections.

Tolnaftate is available without a prescription.

Before Using Tinactin Aerosol Liquid

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

Tolnaftate should not be used on children up to 2 years of age, unless otherwise directed by your doctor. Although there is no specific information comparing use of tolnaftate in children 2 years of age and older with use in other age groups, this medicine is not expected to cause different side effects or problems in children 2 years of age and older than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of tolnaftate in the elderly with use in other age groups.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Proper Use of tolnaftate

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

Before applying tolnaftate, wash the affected area and dry thoroughly. Then apply enough medicine to cover the affected area.

Keep this medicine away from the eyes.

For patients using the powder form of this medicine:

• If the powder is used on the feet, sprinkle it between toes, on feet, and in socks and shoes.

For patients using the aerosol powder form of this medicine:

• Shake well before using.


• From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between toes, on feet, and in socks and shoes.


• Do not inhale the powder.


• Do not use near heat, near open flame, or while smoking.

For patients using the solution form of this medicine:

• If tolnaftate solution becomes a solid, it may be dissolved by warming the closed container of medicine in warm water.

For patients using the aerosol solution form of this medicine:

• Shake well before using.


• From a distance of 6 inches, spray the solution on the affected areas. If it is used on the feet, spray between toes and on feet.


• Do not inhale the vapors from the spray.


• Do not use near heat, near open flame, or while smoking.

To help clear up your infection completely, keep using this medicine for 2 weeks after burning, itching, or other symptoms have disappeared , unless otherwise directed by your doctor. Do not miss any doses.

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 topical dosage forms (aerosol powder, aerosol solution, cream, gel, powder, or topical solution):
  
  • For fungus infections:
    
    • Adults and children 2 years of age and over—Apply to the affected area(s) of the skin two times a day.
    
    
    • Children up to 2 years of age—Use is not recommended except under the advice and supervision of your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tinactin Aerosol Liquid

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

To help prevent reinfection after the period of treatment with this medicine, the powder or spray powder form of this medicine may be used each day after bathing and carefully drying the affected area.

Tinactin Aerosol Liquid Side Effects

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

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

• Skin irritation not present before use of this medicine

When you apply the aerosol solution form of this medicine, a mild temporary stinging may be expected.

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: Tinactin 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.

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 Tinactin Aerosol Liquid Topical resources

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

Compare Tinactin Aerosol Liquid Topical with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Silvadene

silver sulfadiazine

Dosage Form: cream
Silvadene® CREAM 1%

(silver sulfadiazine)

DESCRIPTION

Silvadene Cream 1% is a soft, white, water-miscible cream containing the antimicrobial agent silver sulfadiazine in micronized form, which has the following structural formula:

Each gram of Silvadene Cream 1% contains 10 mg of micronized silver sulfadiazine. The cream vehicle consists of white petrolatum, stearyl alcohol, isopropyl myristate, sorbitan monooleate, polyoxyl 40 stearate, propylene glycol, and water, with methylparaben 0.3% as a preservative. Silvadene Cream 1% (silver sulfadiazine) spreads easily and can be washed off readily with water.

CLINICAL PHARMACOLOGY

Silver sulfadiazine has broad antimicrobial activity. It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast. Results from in vitro testing are listed below.

Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine.

Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. Silver sulfadiazine acts only on the cell membrane and cell wall to produce its bactericidal effect.

Results of In Vitro Testing with Silvadene® Cream 1% (silver sulfadiazine) Concentration of Silver Sulfadiazine Number of Sensitive Strains/Total Number of Strains Tested

Genus & Species	50 μg/mL	100 μg/mL
Pseudomonas
aeruginosa	130/130	130/130
Xanthomonas (Pseudomonas)
maltophilia	7/7	7/7
Enterobacter species	48/50	50/50
Enterobacter cloacae	24/24	24/24
Klebsiella species	53/54	54/54
Escherichia coli	63/63	63/63
Serratia species	27/28	28/28
Proteus mirabilis	53/53	53/53
Morganella morganii	10/10	10/10
Providencia rettgeri	2/2	2/2
Providencia species	1/1	1/1
Proteus vulgaris	2/2	2/2
Citrobacter species	10/10	10/10
Acinetobacter
calcoaceticus	10/11	11/11
Staphylococcus aureus	100/101	100/101
Staphylococcus
epidermidis	51/51	51/51
β-Hemolytic
Streptococcus	4/4	4/4
Enterococcus species	52/53	53/53
Corynebacterium-
diphtheriae	2/2	2/2
Clostridium perfringens	0/2	2/2
Candida albicans	43/50	50/50

Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

INDICATIONS AND USAGE

Silvadene Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.

CONTRAINDICATIONS

Silvadene Cream 1% (silver sulfadiazine) is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation.

Because sulfonamide therapy is known to increase the possibility of kernicterus, Silvadene Cream 1% should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.

WARNINGS

There is potential cross-sensitivity between silver sulfadiazine and other sulfonamides. If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction.

Fungal proliferation in and below the eschar may occur. However, the incidence of clinically reported fungal superinfection is low.

The use of Silvadene Cream 1% (silver sulfadiazine) in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

PRECAUTIONS

General

If hepatic and renal functions become impaired and elimination of drug decreases, accumulation may occur and discontinuation of Silvadene Cream 1% (silver sulfadiazine) should be weighed against the therapeutic benefit being achieved.

In considering the use of topical proteolytic enzymes in conjunction with Silvadene Cream 1%, the possibility should be noted that silver may inactivate such enzymes.

Laboratory Tests

In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 mg% to 12 mg%). Therefore, in these patients it would be advisable to monitor serum sulfa concentrations. Renal function should be carefully monitored and the urine should be checked for sulfa crystals. Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term dermal toxicity studies of 24 months' duration in rats and 18 months' in mice with concentrations of silver sulfadiazine three to ten times the concentration in Silvadene Cream 1% revealed no evidence of carcinogenicity.

Pregnancy

Teratogenic Effects.

Pregnancy Category B. A reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in Silvadene Cream 1% and has revealed no evidence of harm to the fetus due to silver sulfadiazine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term. (See CONTRAINDICATIONS.)

Nursing Mothers

It is not known whether silver sulfadiazine is excreted in human milk. However, sulfonamides are known to be excreted in human milk, and all sulfonamide derivatives are known to increase the possibility of kernicterus. Because of the possibility for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Geriatric Use

Of the total number of subjects in clinical studies of Silvadene Cream 1%, seven percent were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. (See CONTRAINDICATIONS.)

Adverse Reactions

Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy.1,2,3 Leukopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within 2 to 4 days of initiation of therapy. Rebound to normal leukocyte levels follows onset within 2 to 3 days. Recovery is not influenced by continuation of silver sulfadiazine therapy. An increased incidence of leukopenia has been reported in patients treated concurrently with cimetidine.

Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis.

Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial-thickness burns by preventing conversion of the partial thickness to full thickness by sepsis. However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.

Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur. Some of the reactions, which have been associated with sulfonamides, are as follows: blood dyscrasias including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia; dermatologic and allergic reactions, including Stevens-Johnson syndrome and exfoliative dermatitis; gastrointestinal reactions; hepatitis and hepatocellular necrosis; CNS reactions; and toxic nephrosis.

DOSAGE AND ADMINISTRATION

Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. The burn wounds are then cleansed and debrided, and Silvadene Cream 1% (silver sulfadiazine) is applied under sterile conditions. The burn areas should be covered with Silvadene Cream 1% at all times. The cream should be applied once to twice daily to a thickness of approximately 1/16 inch. Whenever necessary, the cream should be reapplied to any areas from which it has been removed by patient activity. Administration may be accomplished in minimal time because dressings are not required. However, if individual patient requirements make dressings necessary, they may be used.

Reapply immediately after hydrotherapy.

Treatment with Silvadene Cream 1% should be continued until satisfactory healing has occurred, or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

HOW SUPPLIED

Silvadene Cream 1% (silver sulfadiazine) is available in jars containing 50 g (NDC 61570-131-50), 400 g (NDC 61570-131-40), and 1000 g (NDC 61570-131-98) and tubes containing 20 g (NDC 61570-131-20) and 85 g (NDC 61570-131-85).

REFERENCES

1. Caffee F, Bingham H. Leukopenia and silver sulfadiazine. J Trauma. 1982;22: 586–587.


2. Jarret F, Ellerbe S, Demling R. Acute leukopenia during topical burn therapy with silver sulfadiazine. Amer J Surg. 1978;135:818–819.


3. Kiker RG, Carvajal HF, Micak RP, Larson DL. A controlled study of the effects of silver sulfadiazine on white blood cell counts in burned children. J Trauma. 1977; 17:835–836.

Prescribing Information as of July 2003.

Distributed by:

Monarch Pharmaceuticals, Inc.

Bristol, TN 37620

(A wholly owned subsidiary of King Pharmaceuticals, Inc.)

Manufactured by:

King Pharmaceuticals, Inc.

Bristol, TN 37620

LabelGraphics1

LabelGraphics2

LabelGraphics3

LabelGraphic4

LabelGraphics5

Silvadene  silver sulfadiazine  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61570-131 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER SULFADIAZINE (SILVER SULFADIAZINE) SILVER SULFADIAZINE 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61570-131-20 1  In 1 CARTON contains a TUBE 1 20 g In 1 TUBE This package is contained within the CARTON (61570-131-20) 2 61570-131-85 1  In 1 CARTON contains a TUBE 2 85 g In 1 TUBE This package is contained within the CARTON (61570-131-85) 3 61570-131-50 50 g In 1 JAR None 4 61570-131-40 400 g In 1 JAR None 5 61570-131-98 1000 g In 1 JAR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017381	11/26/1973

Labeler - Monarch Pharmaceuticals, Inc. (809587413)

Revised: 08/2011Monarch Pharmaceuticals, Inc.

More Silvadene resources

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

• Silvadene Concise Consumer Information (Cerner Multum)


• Silvadene Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Silvadene MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Silvadene with other medications

• Burns, External

Sudal-12 Chewable

Generic Name: chlorpheniramine and pseudoephedrine (klor fen EER a meen and soo doe e FED rin)

Brand Names: AccuHist Drops, Allerest Maximum Strength, Brexin L.A., Colfed-A, D-Amine-SR, Dayquil Allergy, Deconamine, Dicel, Dicel Chewables, Dura-Tap/PD, Durafed, Duratuss DA, Dynahist-ER Pediatric, Genaphed Plus, Histade, Histex, Kronofed-A, Kronofed-A-Jr, LoHist-D, Mintex, Neutrahist Drops, Re2+30, Rescon-Ed, Suclor, SudaHist, Sudal-12 Chewable, Sudal-12 Tannate, Sudogest Cold & Allergy, SudoGest Sinus & Allergy, Tavist-DA, Triaminic Cold and Allergy, Triaminic Softchew Cold and Allergy, Triaminic Softchews Allergy Runny Nose and Congestion

What is Sudal-12 Chewable (chlorpheniramine and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine and pseudoephedrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sudal-12 Chewable (chlorpheniramine and pseudoephedrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my healthcare provider before taking Sudal-12 Chewable (chlorpheniramine and pseudoephedrine)?

Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have:

• 
  

  severe or uncontrolled high blood pressure;

  
  


• 
  

  severe coronary artery disease;

  
  


• 
  

  narrow angle glaucoma;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  if you are unable to urinate; or

  
  


• 
  

  if you are having an asthma attack.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  circulation problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  a seizure disorder such as epilepsy;

  
  


• 
  

  asthma, emphysema or chronic bronchitis; or

  
  


• 
  

  urination problems or an enlarged prostate.

  
  

FDA pregnancy category C. It is not known whether chlorpheniramine and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether chlorpheniramine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Sudal-12 Chewable (chlorpheniramine and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking Sudal-12 Chewable (chlorpheniramine and pseudoephedrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Sudal-12 Chewable (chlorpheniramine and pseudoephedrine) side effects

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

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness; or

  
  


• 
  

  seizure (black-out or convulsions).

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry nose or mouth;

  
  


• 
  

  nausea, stomach pain, constipation, loss of appetite;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  feeling restless or excited (especially in children).

  
  

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 Sudal-12 Chewable (chlorpheniramine and pseudoephedrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

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

• 
  

  mecamylamine (Inversine);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  reserpine;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.

  
  

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

More Sudal-12 Chewable resources

• Sudal-12 Chewable Use in Pregnancy & Breastfeeding
• Drug Images
• Sudal-12 Chewable Drug Interactions
• Sudal-12 Chewable Support Group
• 1 Review for Sudal-12 Chewable - Add your own review/rating

• AccuHist Drops Prescribing Information (FDA)


• Biohist LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Deconamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Deconamine SR Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Duotan Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• QDALL 24-Hour Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sudal-12 Chewable with other medications

• Hay Fever
• Sinusitis

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine and pseudoephedrine.

Symax SR Extended-Release Tablets

Pronunciation: HYE-oh-SYE-a-meen
Generic Name: Hyoscyamine
Brand Name: Examples include Levbid and Symax SR

Symax SR Extended-Release Tablets are used for:

Treating certain stomach, intestinal, and bladder conditions, including spasms. It is used to control stomach secretions and cramps. It is used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.

Symax SR Extended-Release Tablets are an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.

Do NOT use Symax SR Extended-Release Tablets if:

• you are allergic to any ingredient in Symax SR Extended-Release Tablets


• you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)


• you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding

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

Before using Symax SR Extended-Release Tablets:

Some medical conditions may interact with Symax SR Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma


• if you have diarrhea or fever, have been very ill, or are in poor health

Some MEDICINES MAY INTERACT with Symax SR Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Symax SR Extended-Release Tablets's side effects


• Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Symax SR Extended-Release Tablets


• Ketoconazole or metoclopramide because their effectiveness may be decreased by Symax SR Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Symax SR Extended-Release Tablets 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 Symax SR Extended-Release Tablets:

Use Symax SR Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Symax SR Extended-Release Tablets are usually taken 30 to 60 minutes before a meal. Follow your doctor's instructions for taking Symax SR Extended-Release Tablets.


• Swallow Symax SR Extended-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Symax SR Extended-Release Tablets may be broken in half before taking. If you have trouble swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.


• If you also take antacids, ask your doctor or pharmacist how to take them with Symax SR Extended-Release Tablets.


• If you miss a dose of Symax SR Extended-Release Tablets, 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 Symax SR Extended-Release Tablets.

Important safety information:

• Symax SR Extended-Release Tablets may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Symax SR Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Symax SR Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


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


• Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.


• Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.


• Proper dental care is important while you are taking Symax SR Extended-Release Tablets. Brush and floss your teeth and visit the dentist regularly.


• Symax SR Extended-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Tell your doctor or dentist that you take Symax SR Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Use Symax SR Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.


• Caution is advised when using Symax SR Extended-Release Tablets in CHILDREN; they may be more sensitive to its effects, including excitability.


• Symax SR Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Symax SR Extended-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Symax SR Extended-Release Tablets while you are pregnant. Symax SR Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while taking Symax SR Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Symax SR Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Symax SR 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 disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.

Proper storage of Symax SR Extended-Release Tablets:

Store Symax SR Extended-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Symax SR Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Symax SR Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Symax SR Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about Symax SR Extended-Release Tablets. 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 Symax SR resources

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

Compare Symax SR with other medications

• Anesthesia
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• Endoscopy or Radiology Premedication
• Irritable Bowel Syndrome
• Urinary Incontinence

Tamoxifen

ta-MOX-i-fen

Oral route(Tablet)

Serious and life-threatening uterine malignancies, stroke, and pulmonary embolism have been associated with tamoxifen use in the risk reduction setting (women with Ductal Carcinoma in Situ (DCIS) and women at high risk for breast cancer). Some of these adverse events were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer .

Commonly used brand name(s)

In the U.S.

• Nolvadex


• Soltamox

Available Dosage Forms:

• Solution


• Tablet

Therapeutic Class: Antiestrogen

Uses For tamoxifen

Tamoxifen is a medicine that blocks the effects of the estrogen hormone in the body. It is used to treat breast cancer in women or men. It may also be used to treat other kinds of cancer, as determined by your doctor.

Tamoxifen also may be used to reduce the risk of developing breast cancer in women who have a high risk of developing breast cancer. Women at high risk for developing breast cancer are at least 35 years of age and have a combination of risk factors that make their chance of developing breast cancer 1.67% or more over the next 5 years. Your doctor will help to determine your risk of developing breast cancer.

• The following are risk factors that may increase your chance of developing breast cancer:


• If you have close family members (mother, sister, or daughter) with breast cancer.


• If you have ever had a breast biopsy or if high-risk changes in your breast(s) have been found from a breast biopsy.


• If you have never been pregnant or if your first pregnancy occurred at a late age.


• If your first menstrual period occurred at an early age.

The exact way that tamoxifen works against cancer is not known, but it may be related to the way it blocks the effects of estrogen on the body.

Before you begin treatment with tamoxifen, you and your doctor should talk about the good tamoxifen will do as well as the risks of using it.

Tamoxifen is available only with your doctor's prescription.

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

• Breast cancer, neoadjuvant treatment for hormone receptor-positive disease in postmenopausal women.


• Cancer of the endometrium (lining of the uterus).


• Malignant melanoma (a certain type of skin cancer).

Before Using tamoxifen

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 tamoxifen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tamoxifen 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.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of tamoxifen in the elderly with use in other age groups, tamoxifen 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	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 tamoxifen, 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 tamoxifen 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.

• Warfarin

Using tamoxifen 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.

• Acenocoumarol


• Cyclophosphamide


• Dicumarol


• Fluorouracil


• Fluoxetine


• Genistein


• Ipriflavone


• Methotrexate


• Mitomycin


• Paroxetine


• Phenprocoumon


• Red Clover


• Ritonavir


• Sertraline


• St John's Wort

Using tamoxifen 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.

• Aldesleukin


• Aminoglutethimide


• Anastrozole


• Bexarotene


• Letrozole


• Rifampin

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 tamoxifen. Make sure you tell your doctor if you have any other medical problems, especially:

• For all patients


• Blood problems or


• Cataracts or other eye problems—Tamoxifen may also cause these problems.

• High cholesterol levels in the blood—Tamoxifen can increase cholesterol levels.

• When used for reducing the risk for developing breast cancer in high-risk women or in women with Ductal Carcinoma in Situ (DCIS)


• Blood clots (or history of) or


• Pulmonary embolism (or history of) or


• Stroke or


• Uterine (womb) cancer—May increase risk of serious side effects from tamoxifen.

Proper Use of tamoxifen

Use tamoxifen only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Tamoxifen sometimes causes mild nausea and vomiting. However, it may have to be taken for several weeks or months to be effective. Even if you begin to feel ill, do not stop using tamoxifen without first checking with your doctor. Ask your health care professional for ways to lessen these effects.

Swallow the tablets whole with a drink of water. You can take the tablets with or without food.

If you vomit shortly after taking a dose of tamoxifen, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing

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

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

• For oral dosage form (tablets):
  
  • For breast cancer in women or men:
    
    • Adults—20 to 40 milligrams (mg) daily.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For reducing the risk of developing breast cancer in high-risk women:
    
    • Adults—20 milligrams (mg) a day for five years.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For reducing the risk of developing invasive breast cancer in women with ductal carcinoma in situ:
    
    • Adults—20 milligrams (mg) a day for five years.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Call your doctor or pharmacist for instructions.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using tamoxifen

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

A woman should contact her doctor right away if she develops:

• Changes in vaginal discharge or


• Changes in vision or


• Coughing up blood or


• Leg swelling or tenderness or


• Menstrual irregularities or


• New breast lumps or


• Pelvic pain or pressure or


• Sudden chest pain or


• Unexplained shortness of breath or


• Vaginal bleeding

If you seek medical attention for any reason, be sure to tell your doctor that you take tamoxifen or have taken tamoxifen.

For women: Tamoxifen may make you more fertile. It is best to use some type of birth control while you are taking it. However, do not use oral contraceptives (“the Pill”) since they may change the effects of tamoxifen. Tell your doctor right away if you think you have become pregnant while taking tamoxifen.

tamoxifen Side Effects

Because of the way tamoxifen acts on the body, there is a chance that it might cause unwanted effects that may not occur until months or years after the medicine is used. Tamoxifen increases the chance of cancer of the uterus (womb) in some women taking it. Tamoxifen may cause blockages to form in a vein, lung, or brain. In women, tamoxifen may cause cancer or other problems of the uterus (womb). It also causes liver cancer in rats. In addition, tamoxifen has been reported to cause cataracts and other eye problems. Discuss these possible effects with your doctor.

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

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

Less common or rare

• Anxiety


• blistering, peeling, or loosening of the skin and mucous membranes


• blurred vision


• cataracts in the eyes or other eye problems


• change in vaginal discharge


• chest pain


• chills


• confusion


• cough


• dizziness


• fainting


• fast heartbeat


• fever


• hoarseness


• lightheadedness


• lower back or side pain


• pain or feeling of pressure in the pelvis


• pain or swelling in the legs


• pain, redness, or swelling in your arm or leg


• painful or difficult urination


• rapid shallow breathing


• shortness of breath or trouble with breathing


• skin rash or itching over the entire body


• sweating


• weakness or sleepiness


• wheezing


• vaginal bleeding


• yellow eyes or skin

Incidence not known

• Bloating


• constipation


• darkened urine


• diarrhea


• difficulty with breathing


• indigestion


• itching


• joint or muscle pain


• large, hard skin blisters


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


• loss of appetite


• nausea


• pain in the stomach or side, possibly radiating to the back


• red, irritated eyes


• red skin lesions, often with a purple center


• sore throat


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


• unusual tiredness or weakness


• vomiting

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

More common

• Absent, missed, or irregular periods


• decrease in the amount of urine


• feeling of warmth


• menstrual changes


• noisy, rattling breathing


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


• skin changes


• stopping of menstrual bleeding


• swelling of the fingers, hands, feet, or lower legs


• troubled breathing at rest


• weight gain or loss


• white or brownish vaginal discharge

Less common or rare

• Abdominal or stomach cramps


• black, tarry stools


• bleeding gums


• blood in the urine or stools


• bluish color changes in skin color


• bone pain


• decreased interest in sexual intercourse


• discouragement


• feeling sad or empty


• hair loss or thinning of the hair


• headache


• inability to have or keep an erection


• irritability


• itching in the genital area


• loss of interest or pleasure


• loss in sexual ability, desire, drive, or performance


• nausea or vomiting (mild)


• pain


• pinpoint red spots on the skin


• skin rash or dryness


• stomach or pelvic discomfort, aching, or heaviness


• swelling


• trouble concentrating


• trouble with sleeping


• unusual bleeding or bruising

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: tamoxifen 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 tamoxifen resources

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

• tamoxifen Concise Consumer Information (Cerner Multum)


• Tamoxifen MedFacts Consumer Leaflet (Wolters Kluwer)


• Tamoxifen Prescribing Information (FDA)


• Nolvadex Prescribing Information (FDA)


• Nolvadex Monograph (AHFS DI)


• Soltamox Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Soltamox Prescribing Information (FDA)

Compare tamoxifen with other medications

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Spectam Water Soluble Concentrate

Dosage Form: FOR ANIMAL USE ONLY
Spectam Water Soluble Concentrate (spectinomycin) NADA 038-661, Approved by FDA Bimeda, Inc. Division of Cross Vetpharm Group

Indications:

As an aid in the prevention or control of losses due to CRD associated with M. gallisepticum (PPLO).  Administer two (2) grams per gallon of water as the only source of drinking water for the first three days of life and for one day following each vaccination.


As an aid in controlling infectious synovitis due to Mycoplasma synoviae in broiler chickens.  Administer one (1) gram per gallon of water as the only source of drinking water for the first three to five days of life.


For increased rate of weight gain and improved feed efficiency in floor-raised broiler chickens.  Administer one-half (1/2) gram per gallon of water as the only source of drinking water for the first three days of life and for one day following each vaccination.

Dosage and Administration:

To provide 2 g/gal:  Dissolve contents in 250 gallons of water.  For proportioners, dissolve contents of 1/2 package in 1 gallon of water.  Meter at 1 oz/gal.

To provide 1 g/gal:  Dissolve contents in 500 gallons of water.   For proportioners, dissolve contents of 1/2 package in 2 gallons of water.  Meter at 1 oz/gal.

To provide 1/2 g/gal:  Dissolve contents of 1/2 package in 500 gallons of water.  For proportioners, dissolve contents of 1/2 package in 4 gallons of water.  Meter at one (1) oz/gal.

DO NOT administer this drug within 5 days of slaughter.  DO NOT administer to laying chickens.

Precautions:

Rarely, some individuals who handle spectinomycin develop serious reactions involving skin, nails and eyes.  Individuals who have experienced rash or other evidence of allergic reaction should avoid further contact with spectinomycin.

Storage and Handling:

Store at controlled room temperature 20degree C - 25degree C (68degree F - 77degree F), excursions permitted between 15degree C - 30degree C (59degree F - 86degree F).

General Precautions:

Take Time Observe Label Directions

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Package Label.Principle Display Panel:

Spectam Water Soluble Concentrate

(spectinomycin)

Anti-Infective

for growing chickens

Each 1000g contains:  Spectinomycin dihydrochloride pentahydrate equivalent to spectinomycin activity ..... 500.00g

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Restricted Drug (California) - Use Only as Directed

NADA 038-661, Approved by FDA

Net Contents:

1000g (35.27 oz)

Manufactured by:

Bimeda, Inc.

Le Sueur, MN 56058

Spectam Water Soluble Concentrate  spectinomycin  powder, for solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 12487-5485 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength spectinomycin (spectinomycin) spectinomycin 500.00 g  in 1000 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 12487-5485-1 1000 g In 1 JAR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA038661	06/17/1969

Labeler - Osborn (043653216)

Revised: 10/2010Osborn

Tigecycline

Generic Name: tigecycline (tye ge SYE kleen)

Brand Names: Tygacil

What is tigecycline?

Tigecycline is an antibiotic that fights bacteria in the body.

Tigecycline is used to treat many different bacterial infections of the skin or the digestive system, as well as pneumonia.

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

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

Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Tigecycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using tigecycline.

You should not use this medication if you are allergic to tigecycline. Children should not use tigecycline. Tigecycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Before using tigecycline, tell your doctor if you are allergic to a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap). Also tell your doctor if you have liver disease or if you are using a blood thinner such as warfarin (Coumadin, Jantoven).

You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection, and how to properly mix and store the medication.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Avoid exposure to sunlight or tanning beds. Tigecycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What should I discuss with my healthcare provider before using tigecycline?

You should not use this medication if you are allergic to tigecycline.

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

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  liver disease;

  
  


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  if you are using a blood thinner such as warfarin (Coumadin, Jantoven); or

  
  


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  if you are allergic to a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap).

  
  

Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Tell your doctor right away if you become pregnant during treatment.

Tigecycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using tigecycline.

It is not known whether tigecycline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Children should not use tigecycline. Tigecycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

How should I use tigecycline?

Tigecycline is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Tigecycline must be given slowly, and the IV infusion can take up to 60 minutes to complete.

Tigecycline is a powder medicine that must be mixed with a liquid (diluent) in an IV bag before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Prepare your dose only when you are ready to give yourself an injection. After mixing, the liquid should appear as a yellow or orange color. Do not use the medication if it has changed to green or black, or if it has any particles in it. Call your doctor for a new prescription.

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

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Tigecycline will not treat a viral infection such as the common cold or flu.

Store unmixed powder at room temperature away from moisture and heat.

Mixed medicine must be used within 24 hours if you keep it at room temperature.

Tigecycline mixed in an IV bag with sodium chloride or dextrose solution may be stored in a refrigerator and used within 48 hours.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while using tigecycline?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using tigecycline and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Tigecycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Tigecycline side effects

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

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  diarrhea that is watery or bloody;

  
  


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  severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;

  
  


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

  
  


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

  
  

Less serious side effects may include:

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  dizziness, sleep problems (insomnia);

  
  


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  headache; or

  
  


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  vaginal itching or discharge.

  
  

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.

Tigecycline Dosing Information

Usual Adult Dose for Intraabdominal Infection:

100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration: 5 to 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Skin or Soft Tissue Infection:

100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration: 5 to 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Skin and Structure Infection:

100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration: 5 to 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Pneumonia:

Community acquired: 100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration: 7 to 14 days, depending on the nature and severity of the infection

What other drugs will affect tigecycline?

Do not give any of the following drugs through the same IV line used to give your tigecycline injection:

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  amphotericin (Amphocin, Fungizone);

  
  


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  amphotericin B lipid complex (Abelcet);

  
  


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  diazepam (Valium); or

  
  


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  esomeprazole (Nexium I.V.).

  
  

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

More tigecycline resources

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

• tigecycline Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Tigecycline Professional Patient Advice (Wolters Kluwer)


• Tigecycline MedFacts Consumer Leaflet (Wolters Kluwer)


• Tigecycline Monograph (AHFS DI)


• Tygacil Prescribing Information (FDA)


• Tygacil Consumer Overview

Compare tigecycline with other medications

• Intraabdominal Infection
• Pneumonia
• Skin and Structure Infection
• Skin Infection

Where can I get more information?

• Your pharmacist can provide more information about tigecycline.

See also: tigecycline side effects (in more detail)