Teat Spray

Dosage Form: FOR ANIMAL USE ONLY

FOR COMMERCIAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

NOT FOR HUMAN USE

CAUTION

CAUTION


Harmful if swallowed, eye irritant.

FIRST AID:

Avoid contact with skin and eyes. Contact can cause severe irritation. Get medical attention. If ingested, drink large amounts of water or milk. DO NOT induce vomiting. Get immediate attention. Avoid repeated contact with skin and hands. Use rubber gloves to avoid skin irritation. If contact occurs, wash thoroughly with clean water.

EMERGENCY: CHEMTREC 800-424-9300

Prior to milking, dip teats in undiluted Teat Spray 5000. Wipe off with a clean towel after 15 to 30 seconds.

After milking apply Teat Spray 5000 by dipping. Do not rinse or wash off. Allow teats to dry before letting

cows outdoors in cold weather to guard against chapping.

Teat Spray 5000

Iodine Teat Spray

An aid in Reducing the Spread of Organisms

Which May Cause Mastitis

ACTIVE INGREDIENTS:

Iodine.........................................0.5%

INACTIVE INGREDIENTS............99.5%

Wausau Chemical Corporation

2001 North River Drive

Wausau, WI 54403-0953 U.S.A.

Teat Spray 5000  iodine  solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 64892-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 0.5 L  in 100 L

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 64892-001-16 18.9 L In 1 DRUM None 2 64892-001-17 56.78 L In 1 DRUM None 3 64892-001-18 113.6 L In 1 DRUM None 4 64892-001-21 208.2 L In 1 DRUM None 5 64892-001-88 1040 L In 1 DRUM None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/14/2000

Labeler - Wausau Chemical (006136220)

Establishment
Name	Address	ID/FEI	Operations
Wausau Chemical		006136220	manufacture

Revised: 09/2000Wausau Chemical

Nicorette Freshmint 4mg Gum (McNeil Products Ltd)

1. Name Of The Medicinal Product

Nicorette Freshmint 4 mg Gum or NicAssist Minty Fresh 4 mg Gum

2. Qualitative And Quantitative Composition

Chewing Gum containing 4mg nicotine, as nicotine resinate.

For excipients see section 6.1

3. Pharmaceutical Form

Medicated Chewing Gum

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette Freshmint 4 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

Nicorette Freshmint 4 mg Gum is indicated in pregnant and lactating women making a quit attempt.

4.2 Posology And Method Of Administration

Adults and Children over 12 years of age

Nicorette Freshmint 4 mg Gum should be chewed slowly according to the instructions.

The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2mg nicotine gum is indicated. If more than 20 cigarettes per day are smoked, 4mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.

Nicorette Freshmint 4mg Gum should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur.

Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Gum and as soon as they are able, reduce the number of gums used until they have stopped completely.

Smokers aiming to reduce cigarettes should use Nicorette Freshmint 4mg Gum, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.

As soon as they are ready smokers should aim to quit smoking completely.

Maximum daily dose: 15 pieces per day.

When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing Nicorette Freshmint 4mg Gum are recommended to contact their pharmacist or doctor for advice.

For those using the 4mg gum, switching to the 2mg gum may be helpful when stopping treatment or reducing the number of gums used each day.

The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.

4.3 Contraindications

Hypersensitivity to nicotine or any component of the chewing gum.

Nicorette Freshmint 4 mg Gum is contraindicated in children under the age of 12 years.

4.4 Special Warnings And Precautions For Use

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Freshmint 4mg Gum presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Freshmint 4mg Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Renal or hepatic impairment: Nicorette Freshmint 4mg Gum should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Freshmint 4mg Gum should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.

Excipients: Nicorette Freshmint 4mg Gum also contains butylated hydroxy toluene (E321); this may cause irritation to the mucous membranes.

Denture warning: Smokers who wear dentures may experience difficulty in chewing Nicorette Freshmint 4mg Gum. The chewing gum may stick to, and may in rare cases damage dentures.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable Nicorette Freshmint 4mg Gum may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the fetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Nicorette Freshmint 4mg Gum may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Freshmint 4mg Gum has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment.

Excessive consumption of Nicorette Freshmint 4mg Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping.

Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation.

Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4mg nicotine gum is used; slower chewing and the use of the 2mg nicotine gum (if necessary more frequently) will usually overcome this problem.

The chewing gum may stick to, and may in rare cases damage dentures.

Reported adverse events associated with Nicorette 2mg and 4mg gum include:

Body System	Incidence*	Reported adverse event
Nervous system disorders:	Very common:	Headache
	Common:	Dizziness
Cardiac disorders:	Uncommon:	Palpitations
	Very rare:	Reversible atrial fibrillation
Gastrointestinal disorders:	Very common:	Gastrointestinal discomfort, hiccups, nausea
	Common:	Vomiting
Skin and subcutaneous tissue disorders:	Uncommon:	Erythema, urticaria
General disorders and administration site conditions:	Very common:	Sore mouth or throat, jaw-muscle ache
	Rare:	Allergic reactions including angioedema

* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Drugs used in nicotine dependence

ATC code: N07B A01

The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette Freshmint 4 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.

Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt..

5.2 Pharmacokinetic Properties

Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 - 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.

5.3 Preclinical Safety Data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Core Gum

Polacrilin

Chewing gum base, containing butylated hydroxy toluene (E321)

Xylitol

Peppermint oil

Sodium carbonate, anhydrous

Acesulfame Potassium

Levomenthol

Magnesium oxide, light

Quinoline yellow Al lake (E104)

Talcum

Nitrogen, food grade

Coating

Xylitol

Peppermint oil

Acacia

Titanium dioxide (E171)

Carnauba wax

Quinoline yellow Al lake (E104)

6.2 Incompatibilities

None known

6.3 Shelf Life

3 Years

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

Blister packed strips each containing 15 pieces supplied in packs of 15, 30, 105 and 210 pieces.

Blister packed strips each containing 6 pieces supplied in packs of 12 pieces.

Blister packed strips each containing 10 pieces supplied in packs of 10 pieces.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Dispose of Nicorette Gum sensibly.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

8. Marketing Authorisation Number(S)

PL 15513/0174

9. Date Of First Authorisation/Renewal Of The Authorisation

21 January 2008

10. Date Of Revision Of The Text

31 January 2012

Thymoglobulin

Generic Name: antithymocyte globulin rabbit (Intravenous route)

an-tye-THYE-moe-site GLOB-ue-lin RAB-it

Intravenous route(Powder for Solution)

Should only be used by physicians experienced in immunosuppressive therapy for the management of renal transplant patients .

Commonly used brand name(s)

In the U.S.

• Thymoglobulin

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immune Suppressant

Uses For Thymoglobulin

Anti-thymocyte globulin (rabbit) is an immunosuppressant. It is used to reduce the body's natural immunity in patients who receive kidney transplants.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Anti-thymocyte globulin (rabbit) works by preventing the white blood cells from doing this.

The effect of anti-thymocyte globulin (rabbit) on the white blood cells may also reduce the body's ability to fight infections. Before you begin treatment, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Anti-thymocyte globulin (rabbit) is to be administered only by or under the immediate supervision of your doctor.

Before Using Thymoglobulin

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

Although there is no specific information comparing use of anti-thymocyte globulin (rabbit) in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 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 anti-thymocyte globulin (rabbit) in the elderly with use in other age groups.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Allergic to rabbit protein (history of)—Risk of serious allergic reaction, bleeding, and infection.

• Infection—Anti-thymocyte globulin (rabbit) decreases your body's ability to fight infection.

Proper Use of Thymoglobulin

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:
  
  • To treat kidney transplant rejection:
    
    • Adults—1.5 milligrams for every kilogram (2.2 pounds) of your body weight injected into a vein every day for 7 to 14 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Precautions While Using Thymoglobulin

Treatment with anti-thymocyte globulin (rabbit) may also increase the chance of getting other infections. If you can, avoid people with colds or other infections. If you think you are getting a cold or other infection, check with your doctor.

This medicine commonly causes fever and chills within a few hours after the first dose. These effects should be less after the second dose. However, check with your doctor or nurse immediately if you have chest pain, rapid or irregular heartbeat, shortness of breath or wheezing, or swelling of the face or throat after any dose.

Thymoglobulin 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.

Because of the way that anti-thymocyte globulin (rabbit) acts on the body, there is a chance that it may cause effects that may not occur until years after the medicine is used. These delayed effects may include certain types of cancer, such as lymphomas and skin cancers. Discuss these possible effects with your doctor.

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:

More common

• Black, tarry stools


• bladder pain


• chest pain


• chills


• cloudy or bloody urine


• cold


• confusion


• cough or hoarseness


• fast heartbeat


• fever


• flu-like symptoms


• frequent urge to urinate


• high blood pressure


• irregular or slow heartbeat


• lower back or side pain


• numbness or tingling around lips hands, or feet


• painful or difficult urination


• shortness of breath or troubled breathing


• sore throat


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


• swollen glands


• tiredness or weakness


• unexplained anxiety


• unusual bleeding or bruising


• weakness or heaviness of legs

Less common

• Burning or stinging of skin


• painful cold sores or blisters on lips, nose, eyes, or genitals

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

• Abdominal pain


• diarrhea


• difficult or labored breathing


• dizziness


• general feeling of discomfort or illness


• headache


• loss of strength or energy


• muscle pain or weakness


• nausea


• pain


• swelling of ankles, feet, and fingers


• tightness in chest


• unusual weak feeling


• wheezing

Less common

• White patches on mouth, tongue, or throat

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: Thymoglobulin 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 Thymoglobulin resources

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

• Thymoglobulin Prescribing Information (FDA)


• Thymoglobulin rabbit Concise Consumer Information (Cerner Multum)


• Thymoglobulin Monograph (AHFS DI)


• Thymoglobulin MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Thymoglobulin with other medications

• Renal Transplant

Tavist

Generic Name: clemastine (CLEM as teen)

Brand Names: Allerhist-1, Contac 12 Hour Allergy, Tavist, Tavist-1

What is clemastine?

Clemastine is an antihistamine. Clemastine blocks the effects of the naturally occurring chemical histamine in your body.

Clemastine is used to treat sneezing, runny nose, itching watery eyes, hives, rashes, itching, and other symptoms of allergies and the common cold.

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

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

Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking clemastine.

Who should not take clemastine?

Do not take clemastine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  an enlarged prostate, bladder problems, or difficulty urinating;

  
  


• 
  

  an overactive thyroid (hyperthyroidism);

  
  


• 
  

  hypertension or any type of heart problems; or

  
  


• 
  

  asthma.

  
  

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

Clemastine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take clemastine without first talking to your doctor if you are pregnant. Clemastine passes into breast milk. Infants are especially sensitive to the effects of antihistamines, and serious side effects could occur in a nursing baby. Clemastine is not recommended if you are breast-feeding a baby. Do not take clemastine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from clemastine. You may require a lower dose of this medication.

How should I take clemastine?

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

Take each dose with a full glass of water.

Clemastine can be taken with or without food.

To ensure that you get a correct dose, measure the syrup form of clemastine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is prescribed for you. The maximum amount of clemastine that you should take in 1 day is 8.04 mg.

Store clemastine 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 dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a clemastine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking clemastine?

Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking clemastine.

Clemastine side effects

Stop taking clemastine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

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

• 
  

  sleepiness, fatigue, or dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

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 clemastine?

Do not take clemastine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These may contain medicines similar to clemastine, which could lead to an overdose of antihistamine.

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• 
  

  anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);

  
  


• 
  

  medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or

  
  


• 
  

  any other medications that make you feel drowsy, sleepy, or relaxed.

  
  

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

More Tavist resources

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

• Tavist Consumer Overview


• Clemastine Prescribing Information (FDA)


• Allerhist-1 MedFacts Consumer Leaflet (Wolters Kluwer)


• Clemastine Fumarate Monograph (AHFS DI)

Compare Tavist with other medications

• Allergic Reactions
• Hay Fever
• Urticaria

Where can I get more information?

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

See also: Tavist side effects (in more detail)

Temodar

Pronunciation: TEM-oh-ZOL-oh-mide
Generic Name: Temozolomide
Brand Name: Temodar

Temodar is used for:

Treating certain types of brain tumors in certain patients. It may also be used for other conditions as determined by your doctor.

Temodar is an antineoplastic agent. It works by stopping cancer cells from growing and reproducing.

Do NOT use Temodar if:

• you are allergic to any ingredient in Temodar, including if you have developed red, swollen, blistered, or peeling skin after taking a previous dose of Temodar or oral temozolomide


• you are allergic to dacarbazine

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

Before using Temodar:

Some medical conditions may interact with Temodar. 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 able to become pregnant


• 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 pneumonia, kidney, or liver problems


• if you have bone marrow depression, including low white blood cell counts or low blood platelet levels

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

• Corticosteroids (eg, prednisone) because the risk of severe infection may be increased


• Valproic acid because it may increase the risk of Temodar's side effects

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

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

• An extra patient leaflet is available with Temodar. Talk to your pharmacist if you have questions about this information.


• Temodar is usually given as an infusion at your doctor's office, hospital, or clinic. If you will be using Temodar at home, a health care provider will teach you how to use it. Be sure you understand how to use Temodar. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Temodar if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Temodar, contact your doctor right away.

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

Important safety information:

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


• Nausea, vomiting, and loss of appetite are common with Temodar. Ask your doctor or pharmacist for ways to decrease these effects if they occur.


• Temodar may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Temodar may increase your risk of developing a certain blood problem (myelodysplastic syndrome [MDS]) or a second cancer. Talk to your doctor if you have any questions or concerns.


• Temodar may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Tell your doctor or dentist that you take Temodar before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including complete blood cell counts, may be performed while you use Temodar. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Temodar with caution in the ELDERLY; they may be more sensitive to its effects.


• Temodar should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• Men who take Temodar should always use a condom when having sex with a woman who is pregnant or may become pregnant. Do this for as long as you take Temodar.


• PREGNANCY and BREAST-FEEDING: Temodar may cause harm to the fetus. Do not become pregnant while you are using it. Use an effective form of birth control while you are taking Temodar. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Temodar while you are pregnant. It is not known if Temodar is found in breast milk. Do not breast-feed while taking Temodar.

Possible side effects of Temodar:

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:

Anxiety; back pain; breast pain; constipation; cough; diarrhea; dizziness; drowsiness; dry skin; hair loss; headache; joint pain; loss of appetite; mild stomach pain; mouth or tongue sores; muscle aches; nausea; taste changes; tiredness; trouble sleeping; vomiting; weakness; weight gain.

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); chest pain; confusion; coughing up blood; depression; difficulty swallowing; increased, difficult, or painful urination; fever, chills, or sore throat; loss of bladder control; loss of coordination; memory loss; muscle pain or weakness; numbness, burning, or tingling; pain, irritation, itching, warmth, swelling, or redness at the injection site; paralysis on one side of the body; persistent cough; red, swollen, peeling, or blistered skin; seizures; severe or persistent headache, nausea, or vomiting; severe or persistent tiredness or weakness; shortness of breath; small red or purple spots under the skin; speech changes; sudden or unusual weight gain; swelling of the ankles, feet, or hands; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); unusual bruising or bleeding; trouble walking; vision changes (eg, blurred vision, double vision).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Temodar 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 fever or severe bruising or bleeding.

Proper storage of Temodar:

Temodar is usually handled and stored by a health care provider. If you are using Temodar at home, store Temodar as directed by your pharmacist or health care provider. Keep Temodar out of the reach of children and away from pets.

General information:

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


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


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


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

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

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

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Taxotere

Generic Name: Docetaxel
Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: [2aR - [2aα,4β,4aβ,6β,9α(αR*,βS*),11α,12α,12aα,12bα]] - 12b - (acetyloxy) - 12 - (benzoyloxy) - 2a,3,4,4a,5,6,9,10,11,12,12a,12b - dodecahydro - 4,6,11 - trihydroxy - 4a,8,13,13 - tetramethyl - 5 - oxo - 7,11 - methano - 1H - cyclodeca[3,4]benz[1,2 - b]oxet - 9 - yl ester β-[[(1,1-dimethylethoxy)carbonyl]amino]-α-hydroxybenzenepropanoic acid
Molecular Formula: C₄₃H₅₃NO₁₄
CAS Number: 114977-28-5

• Treatment-related Mortality


• 
  

  Incidence of treatment-related mortality increased in patients with abnormal hepatic function, patients receiving higher doses, and patients with non-small cell lung carcinoma previously treated with platinum-based chemotherapy who received docetaxel monotherapy at a dose of 100 mg/m².^a Approximately half of deaths reported in breast cancer patients occurred during the first cycle; most deaths were due to sepsis.¹

  
  

• Hepatic Impairment


• 
  

  Docetaxel should not be administered to patients with serum total bilirubin >ULN, or patients with serum AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase >2.5 times ULN.¹ These patients are at increased risk for grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death.¹ Increased risk for grade 4 febrile neutropenia, but not toxic death, in patients with isolated elevations of AST or ALT >1.5 times ULN.¹

  
  


• 
  

  Obtain and review bilirubin, AST, ALT, and alkaline phosphatase values prior to each cycle.¹

  
  

• Hematologic Monitoring


• 
  

  Docetaxel should not be administered to patients with neutrophil counts <1500/mm³.¹

  
  


• 
  

  Monitor blood cell counts frequently.¹

  
  

• Hypersensitivity


• 
  

  Severe hypersensitivity reactions (hypotension and/or bronchospasm, generalized rash/erythema) reported in patients who received the recommended 3-day dexamethasone premedication.¹ Hypersensitivity reactions requiring discontinuance reported in patients who did not receive dexamethasone premedication.¹ Hypersensitivity reactions resolved following discontinuance of the infusion and appropriate treatment.¹

  
  


• 
  

  Do not administer to patients with a history of severe hypersensitivity reactions to docetaxel or polysorbate 80.¹

  
  

• Fluid Retention


• 
  

  Severe fluid retention (poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, pronounced abdominal distention, ascites) reported in patients despite receiving the 3-day dexamethasone premedication.¹

  
  

• Experience of Supervising Clinician


• 
  

  Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹ Adequate diagnostic and treatment facilities should be readily available to manage complications.¹

  
  

Introduction

Semisynthetic taxoid; an antineoplastic agent.^{1 2 3 4 5 6 7 8}

Uses for Taxotere

Breast Cancer

Treatment of locally advanced or metastatic breast cancer after failure of prior chemotherapy.^{a 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 40 54 b}

Non-small Cell Lung Carcinoma

Monotherapy of locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.^{a 54 59 60 61 b}

In combination with cisplatin for treatment of unresectable locally advanced or metastatic non-small cell lung cancer in patients who have not previously received chemotherapy for this condition;^a also used in combination with carboplatin.^b

Taxotere Dosage and Administration

General

• 
  

  All patients should be premedicated before docetaxel administration to prevent severe hypersensitivity reactions and to reduce the incidence and severity of fluid retention.¹

  
  


• 
  

  Oral dexamethasone 8 mg twice daily for 3 days, starting 1 day prior to docetaxel administration, can be given.^a

  
  


• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastics.^a

  
  

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.¹

Handle cautiously (by trained nonpregnant personnel); use protective equipment (e.g., gloves) and wash hands after removal of the gloves.¹

Immediately treat accidental contact with skin by thoroughly washing with soap and water; immediately treat accidental contact with mucous membranes by thoroughly washing with water.¹

Administer through polyethylene-lined administration sets.^{1 36} Use of inline filters is neither required nor recommended.³⁷

Dilution

Docetaxel for injection concentrate requires 2 dilutions prior to administration.¹

Remove vials from refrigerator and allow to stand at room temperature for approximately 5 minutes. Add the contents of the diluent vial to the vial of docetaxel for injection concentrate, to give a solution containing docetaxel 10 mg/mL.¹

Mix this solution by repeated inversions for at least 45 seconds; do not shake.^a If foaming occurs, allow solution to stand for a few minutes to allow foam to dissipate; all foam does not have to dissipate to continue preparation.^a

Withdraw the appropriate dose with a calibrated syringe and inject into 250 mL of either 0.9% sodium chloride injection or 5% dextrose injection to produce a final docetaxel concentration of 0.3–0.74 mg/mL.^a

If doses larger than 200 mg of docetaxel are required, increase volume of IV solution accordingly so that a docetaxel concentration of 0.74 mg/mL is not exceeded.^a

Rate of Administration

Administer over 1 hour.¹

Dosage

Adults

Breast Cancer

IV

60–100 mg/m² in repeated 3-week cycles.¹

Dosage adjustment during treatment may be necessary.¹ In patients initially dosed at 100 mg/m² who experience febrile neutropenia, neutrophil count <500/mm³ for more than 1 week, severe or cumulative cutaneous reactions, or peripheral neuropathy, reduce dose by 25% (e.g., from 100 to 75 mg/m²) for subsequent courses of therapy.^{1 37} If the patient continues to experience these reactions, reduce dosage from 75 to 55 mg/m² or discontinue.¹ Discontinue entirely if >grade 3 peripheral neuropathy develops.^a

Higher doses may be tolerated by patients who are dosed initially at 60 mg/m² and who do not experience febrile neutropenia, neutrophil count <500/mm³ for more than 1 week, severe or cumulative cutaneous reactions, or peripheral neuropathy.¹

Non-small Cell Lung Carcinoma

IV

Treatment after failure of platinum-based chemotherapy: 75 mg/m² in repeated 3-week cycles.^a Higher doses (i.e., 100 mg/m²) associated with increased hematologic toxicity, infection, and treatment-related mortality.^a

Chemotherapy-naive patients: 75 mg/m² immediately followed by cisplatin in repeated 3-week cycles.^a

Dosage adjustment during treatment may be necessary.^a In patients who are dosed initially at 75 mg/m² after failure of platinum-based chemotherapy who experience febrile neutropenia, neutrophil count <500/mm³ for more than 1 week, severe or cumulative cutaneous reactions, or other grade 3/4 nonhematologic toxicities, withhold until toxicity resolves and then resume at 55 mg/m².^a Discontinue entirely if >grade 3 peripheral neuropathy develops.^a

In chemotherapy-naive patients who are dosed initially at 75 mg/m² in conjunction with cisplatin whose nadir platelet count during the previous course is <25,000/mm³, or who experience febrile neutropenia or serious nonhematologic toxicities, reduce dose to 65 mg/m² for subsequent cycles.^a In patients who need further dose reduction, a dose of 50 mg/m² is recommended.^a

Prescribing Limits

Adults

Breast Cancer

IV

100 mg/m².¹

Special Populations

Hepatic Impairment

Not recommended in patients with hepatic impairment.¹ (See Hepatic Impairment under Boxed Warning.)

Renal Impairment

Dosage adjustment does not appear to be necessary.³⁷

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.^a

Cautions for Taxotere

Contraindications

• 
  

  Known hypersensitivity to docetaxel, polysorbate 80, or any other ingredient in the formulation.¹

  
  


• 
  

  Baseline neutrophil count <1500/mm³.¹

  
  

Warnings/Precautions

Warnings

Adequate Patient Evaluation and Monitoring

Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹

Patients must have recovered from acute toxicities (e.g., neutrophils recovered to >1500/mm³, platelets to >100,000/mm³) of previous cytotoxic therapy before each cycle.¹

Prior to and during therapy, assess serum bilirubin, AST and/or ALT, and alkaline phosphatase concentrations.¹ Frequent monitoring of blood cell counts also recommended.¹

Hematologic Effects

Frequency and severity of hematologic toxicity, febrile reactions and infections, and rates of septic death increase with dose and presence of hepatic dysfunction.^{1 7 22}

Neutropenia (i.e., neutrophils <2000/mm³) occurs in essentially all patients receiving doses of 60–100 mg/m² and is dose related; grade 4 neutropenia (<500/mm³) reported in >75% of patients.¹ Neutrophil nadir at day 7–8;^{1 8 13 14 19 20} the median duration of grade 4 neutropenia is about 7 days.^{1 5 7 13}

Cardiovascular Toxicity

Severe fluid retention reported despite 3 days of dexamethasone premedication.^{1 3} (See Fluid Retention in Boxed Warning.)

Peripheral edema usually begins in lower extremities and appears to be completely (although sometimes slowly) reversible;^{1 3 a} generally responds to standard measures, including sodium restriction and oral diuretics.^{1 3 13 25}

Patients should be premedicated with oral corticosteroids to reduce the incidence and severity of fluid retention.¹ (See General under Dosage and Administration.)

Monitor patients with preexisting effusions beginning with the first dose.¹

Fetal/Neonatal Morbidity and Mortality

Embryotoxic and fetotoxic in animals.¹ If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard or potential risk of losing pregnancy.^a (See Pregnancy under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Severe reactions, characterized by hypotension and/or bronchospasm or generalized rash/erythema, reported in some patients despite receiving recommended 3 days of dexamethasone premedication.¹ Hypersensitivity reactions requiring discontinuance reported in patients who did not receive corticosteroid premedication.^a

Patients should be premedicated with oral corticosteroids to reduce the severity of hypersensitivity reactions.¹ (See General under Dosage and Administration.)

Closely observe for hypersensitivity reactions, especially during the first and second infusions.¹

Reactions may occur within a few minutes following initiation of the infusion.^{1 9 25} Interruption of therapy generally is not needed for mild reactions (e.g., flushing, localized skin reactions);^{1 13 15 18 19 20 23} consider decreasing the infusion rate until symptoms resolve.³⁷

Discontinue immediately and treat if severe reaction occurs.¹

Do not administer to any patient who experienced a severe hypersensitivity reaction during a previous course.¹

Dermatologic Effects

Localized erythema of the extremities with edema followed by desquamation reported.¹

Adjust dosage if severe skin toxicity occurs.¹ (See Dosage under Dosage and Administration.)

Major Toxicities

Nervous System Effects

Severe neurosensory symptoms (paresthesia, dysesthesia, pain) reported.¹ Reduce dosage if occurs (see Dosage under Dosage and Administration); if symptoms persist, discontinue docetaxel.¹ Discontinue docetaxel in patients who develop >grade 3 peripheral neuropathy.^a

Asthenia reported; symptoms of fatigue and weakness may last a few days to several weeks and may be associated with deterioration of performance status in patients with progressive disease.¹

General Precautions

Patients who respond to docetaxel may not experience an improvement and/or may experience worsening in performance status.¹ The relationship between changes in performance status, response to therapy, and treatment-related adverse effects not established.¹

Prescribing and Dispensing Precautions

Ensure accuracy of prescription; similarity of spelling of Taxotere (docetaxel) and Taxol (paclitaxel) may result in errors.⁶²

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Discontinue nursing because of potential risk to nursing infants.¹

Pediatric Use

Safety and efficacy in pediatric patients <16 years of age not established.^{1 37}

Geriatric Use

Geriatric patients ≥65 years of age receiving docetaxel with cisplatin experienced a higher incidence of diarrhea, infections, peripheral edema, and stomatitis than younger adults.^a

Hepatic Impairment

Increased incidence of treatment-related mortality in patients with abnormal liver function.¹ (See Hepatic Impairment in Boxed Warning.)

Common Adverse Effects

Alopecia, myelosuppression (neutropenia, leukopenia, anemia), fluid retention, neurosensory effects, nausea, diarrhea, stomatitis.¹

Interactions for Taxotere

Appears to be metabolized by CYP3A4.¹

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors, inducers, or substrates of CYP3A.¹

Specific Drugs

Drug	Interaction
Cisplatin	Pharmacokinetic interaction unlikelya
Cyclosporine	Possible interactiona
Dexamethasone	No effect on docetaxel protein binding1
Erythromycin	Possible increased plasma docetaxel concentrationsa
Ketoconazole	Possible increased plasma docetaxel concentrationsa
Nifedipine	Possible increased plasma docetaxel concentrationsa

Taxotere Pharmacokinetics

Distribution

Extent

Not known whether docetaxel is distributed into milk.¹

Plasma Protein Binding

94–97%.¹

Elimination

Metabolism

Metabolized by CYP3A4 isoenzyme.¹

Elimination Route

Eliminated in feces (75%) and in urine (6%), mainly as metabolites; <8% recovered in feces as unchanged drug within 48 hours.¹

Half-life

Half-lives for the α, β, and γ phases are about 4 minutes, 36 minutes, and 11.1 hours, respectively.¹

Special Populations

Clearance reduced and systemic exposure increased in patients with mild to moderate hepatic impairment (serum AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase >2.5 times ULN).¹ Wide interindividual variation; insufficient data for dosage recommendation.¹

Stability

Storage

Parenteral

For Injection Concentrate

2–25°C in the original package to protect from bright light.¹ Freezing does not adversely affect the product.¹

Polysorbate 80 (in docetaxel injection) can cause leaching of diethylhexyl phthalate (DEHP) from PVC containers or administration sets.³⁶ Do not permit contact of undiluted docetaxel for injection concentrate with plasticized PVC equipment or devices.^{1 36} Stored diluted docetaxel solutions in glass or polypropylene containers or in plastic (polypropylene or polyolefin) bags and administer through polyethylene-lined administration sets.^{1 36}

Docetaxel solutions that have been diluted to 10 mg/mL (initial dilution) may be stored at room temperature or in the refrigerator for up to 8 hours.¹

Docetaxel solutions that have been diluted to 0.3–0.74 mg/mL (final dilution for infusion) should be used within 4 hours (including the 1 hour for administration).¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^{a HID}

Compatible
Dextrose 5% in water
Sodium chloride 0.9%

Drug Compatibility

Y-site CompatibilityHID

Compatible
Acyclovir sodium
Amifostine
Amikacin sulfate
Aminophylline
Ampicillin sodium
Ampicillin sodium–sulbactam sodium
Aztreonam
Bumetanide
Buprenorphine HCl
Butorphanol tartrate
Calcium gluconate
Cefazolin sodium
Cefepime HCl
Cefotaxime sodium
Cefoxitin sodium
Ceftazidime
Ceftizoxime sodium
Ceftriaxone sodium
Cefuroxime sodium
Chlorpromazine HCl
Cimetidine HCl
Ciprofloxacin
Clindamycin phosphate
Co-trimoxazole
Dexamethasone sodium phosphate
Diphenhydramine HCl
Dobutamine HCl
Dopamine HCl
Doxycycline hyclate
Droperidol
Enalaprilat
Famotidine
Fluconazole
Furosemide
Ganciclovir sodium
Gemcitabine HCl
Gentamicin sulfate
Granisetron HCl
Haloperidol lactate
Heparin sodium
Hydrocortisone sodium phosphate
Hydrocortisone sodium succinate
Hydromorphone HCl
Hydroxyzine HCl
Imipenem–cilastatin sodium
Leucovorin calcium
Lorazepam
Magnesium sulfate
Mannitol
Meperidine HCl
Meropenem
Mesna
Metoclopramide HCl
Metronidazole
Morphine sulfate
Ofloxacin
Ondansetron HCl
Oxaliplatin
Palonosetron HCI
Pemetrexed disodium
Piperacillin sodium–tazobactam sodium
Potassium chloride
Prochlorperazine edisylate
Promethazine HCl
Ranitidine HCl
Ringer’s injection, lactated
Sodium bicarbonate
Ticarcillin disodium–clavulanate potassium
Tobramycin sulfate
Vancomycin HCl
Zidovudine
Incompatible
Amphotericin B
Doxorubicin HCl liposome injection
Methylprednisolone sodium succinate
Nalbuphine HCl

ActionsActions

• 
  

  A semisynthetic taxoid produced from the needles of the European yew (Taxus baccata) tree.^{1 2 3 4 5 6} Structurally and pharmacologically similar to paclitaxel.^{2 4 5 7 8}

  
  


• 
  

  Disrupts the microtubular network in cells that is essential for mitotic and interphase cellular function.¹

  
  

Advice to Patients

• 
  

  Importance of recognizing and reporting adverse effects including myelosuppressive effects, infectious complications, and cutaneous reactions.¹

  
  


• 
  

  Importance of reading the patient information leaflet.¹

  
  


• 
  

  Probable alopecia.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy and advise pregnant women of risk to fetus.¹

  
  


• 
  

  Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illness.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Docetaxel

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection concentrate, for IV infusion	40 mg (of anhydrous docetaxel) per mL (20 or 80 mg)	Taxotere (with bacteriostatic water for injection containing alcohol 13% w/w diluent)	Aventis

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Rhone-Poulenc Rorer Pharmaceuticals Inc. Taxotere (docetaxel) for injection concentrate prescribing information. Collegeville, PA; 1996 May.

2. Bissery MC, Nohynek G, Sanderink G-J et al. Docetaxel (Taxotere): a review of preclinical and clinical experience. Part I: preclinical experience. Anti-Cancer Drugs. 1995; 6:339-68. [PubMed 7670132]

3. Cortes JE, Pazdur R. Docetaxel. J Clin Oncol. 1995; 13:2643-55. [IDIS 356145] [PubMed 7595719]

4. Pazdur R, Kudelka AP, Kavanagh JJ et al. The taxoids: paclitaxel (Taxol) and docetaxel (Taxotere. Cancer Treat Rev. 1993; 19:351-86. [PubMed 8106152]

5. Eisenhauer EA, Trudeau M. An overview of phase II studies of docetaxel in patients with metastatic breast cancer. Eur J Cancer. 1995; 31A(Suppl 4):S11-3. [PubMed 7577098]

6. Gelmon K. The taxoids: paclitaxel and docetaxel. Lancet. 1994; 344:1267-72. [IDIS 338182] [PubMed 7967989]

7. Huizing MT, Sewberath Misser VH, Pieters RC et al. Taxanes: a new class of antitumor agents. Cancer Invest. 1995; 13:381-404. [PubMed 7627725]

8. Pronk LC, Stoter G, Verweij J. Docetaxel (Taxotere): single agent activity, development of combination treatment and reducing side-effects. Cancer Treat Rev. 1995; 21:463-78. [PubMed 8556719]

9. Verweij J, Clavel M, Chevalier B. Paclitaxel (Taxol) and docetaxel (Taxotere: not simply two of a kind. Ann Oncol. 1994; 5:495-505. [PubMed 7918121]

10. Abrams JS, Moore TD, Friedman M. New chemotherapeutic agents for breast cancer. Cancer. 1994; 74:1164-76. [IDIS 334183] [PubMed 7913662]

11. Eisenhauer EA. Docetaxel: current status and future prospects. J Clin Oncol. 1995; 13:2865-8. [IDIS 357156] [PubMed 8523048]

12. Capri G, Tarenzi E, Fulfaro F et al. The role of taxanes in the treatment of breast cancer. Semin Oncol. 1996; 23(Suppl 2):68-75. [PubMed 8614849]

13. Ravdin PM, Burris HA III, Cook G et al. Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer. J Clin Oncol. 1995; 13:2879-85. [IDIS 357157] [PubMed 8523050]

14. Valero V, Holmes FA, Walters RS et al. Phase II trial of docetaxel: a new, highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer. J Clin Oncol. 1995; 13:2886-94. [IDIS 357158] [PubMed 8523051]

15. ten Bokkel Huinink WW, Prove AM, Piccart M et al. A phase II trial with docetaxel (Taxotere) in second line treatment with chemotherapy for advanced breast cancer: a study of the EORTC Early Clinical Trials Group. Ann Oncol. 1994; 5:527-32. [PubMed 7918124]

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