Capastat

Pronunciation: KAP-ree-oh-MYE-sin
Generic Name: Capreomycin
Brand Name: Capastat

Capastat should be used with extreme caution in patients with hearing or kidney problems, because it may increase hearing problems or kidney damage. Other injectable medicines used to treat tuberculosis (eg, streptomycin, viomycin) should not be used along with Capastat because the risk of hearing or kidney problems may be further increased. Other medicines that may cause hearing or kidney problems (eg, amikacin, colistin, gentamicin, kanamycin, neomycin, polymyxin A, tobramycin, vancomycin) should be used with extreme caution.

Safety and effectiveness of Capastat in pregnancy or in children have not been confirmed.

Capastat is used for:

Treating lung infections caused by certain strains of tuberculosis (TB). It is used with other medications, and it is only used in those patients who have not responded to or cannot use other specific medicines.

Capastat is a polypeptide antibiotic. It works by killing or stopping the growth of TB organisms.

Do NOT use Capastat if:

• you are allergic to any ingredient in Capastat


• you are taking other injectable medicines for TB (eg, streptomycin, viomycin)

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

Before using Capastat:

Some medical conditions may interact with Capastat. 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 hearing problems, kidney problems, liver problems, blood electrolyte (eg, sodium, potassium) problems, Parkinson disease, nerve impairment, or myasthenia gravis

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

• Nondepolarizing muscle relaxants (eg, pancuronium) because their actions and the risk of their side effects may be increased by Capastat


• Amikacin, colistin, gentamicin, kanamycin, neomycin, polymyxin A, streptomycin, tobramycin, vancomycin, or viomycin because the risk of serious hearing or kidney side effects may be increased

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

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

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


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


• Capastat may turn a pale straw color that might darken with time. This is normal.


• To clear up your infection completely, use Capastat for the full course of treatment. Keep using it even if you feel better in a few days.


• 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 Capastat, contact your doctor right away.

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

Important safety information:

• Capastat only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Capastat for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Capastat may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


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


• Lab tests, including kidney function, liver function, blood calcium levels, blood potassium levels, blood magnesium levels, or hearing tests, may be performed while you use Capastat. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


• Capastat is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Capastat, contact your doctor. You will need to discuss the benefits and risks of using Capastat while you are pregnant. It is not know if Capastat is found in breast milk. If you are or will be breast feeding while you are using Capastat, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Capastat:

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:

Pain, swelling, redness, or a hard lump at the injection site.

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); decreased hearing or hearing loss; decreased urination or other urination problems; fever, chills, or sore throat; hearing loss; ringing in the ears; sensation that the room is spinning; severe bleeding at the injection site; signs of electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping).

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: Capastat 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 dizziness; loss of ability to hear high tones; ringing in the ears; sensation that the room is spinning.

Proper storage of Capastat:

Capastat is usually handled and stored by a health care provider. If you are using Capastat at home, store Capastat as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Capastat out of the reach of children and away from pets.

General information:

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


• Capastat 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 Capastat. 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 Capastat resources

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

Compare Capastat with other medications

• Tuberculosis, Active

Theophylline Sustained-Release Capsules

Pronunciation: thee-OF-i-lin
Generic Name: Theophylline
Brand Name: Theo 24

Theophylline Sustained-Release Capsules are used for:

Preventing and treating symptoms and blockage of airway due to asthma or other lung diseases (eg, emphysema, bronchitis). It may also be used for other conditions as determined by your doctor.

Theophylline Sustained-Release Capsules are a xanthine derivative. It works by relaxing the muscle around the airways in the lungs, which allows them to widen and makes breathing easier. It also improves contraction of the diaphragm (the major breathing muscle) and decreases the response of the airways to irritants.

Do NOT use Theophylline Sustained-Release Capsules if:

• you are allergic to any ingredient in Theophylline Sustained-Release Capsules, similar medicines (eg, aminophylline), or xanthines (eg, caffeine, chocolate)


• you are using large amounts of other products that contain xanthine (such as chocolate or caffeinated drinks)


• you are taking dipyridamole intravenously (IV), febuxostat, halothane, or St. John's wort

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

Before using Theophylline Sustained-Release Capsules:

Some medical conditions may interact with Theophylline Sustained-Release Capsules. 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 a history of heart problems (eg, congestive heart failure, cor pulmonale), an irregular heartbeat, liver problems (eg, cirrhosis, hepatitis), viral infection, thyroid problems, increased acid levels in the body, brain or nerve problems, or seizures (eg, epilepsy)


• if you are in shock or have a fever, an ulcer, a severe infection, cystic fibrosis, or fluid in the lungs (pulmonary edema)


• if you smoke, are stopping or starting smoking, or are exposed to the smoke from cigarettes or marijuana


• if you are in the last 3 months of pregnancy

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

• Aminoglutethimide, barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), isoproterenol, moricizine, rifampin, St. John's wort, or sulfinpyrazone because they may decrease Theophylline Sustained-Release Capsules's effectiveness


• Allopurinol, beta-blockers (eg, propranolol), cimetidine, disulfiram, enoxacin, estrogen, febuxostat, fluvoxamine, interferon alpha, macrolide antibiotics (eg, clarithromycin, erythromycin), methotrexate, mexiletine, oral contraceptives (birth control pills), pentoxifylline, propafenone, quinolone antibiotics (eg, ciprofloxacin), tacrine, thiabendazole, ticlopidine, troleandomycin, verapamil, viloxazine, or zileuton because they may increase the risk of Theophylline Sustained-Release Capsules's side effects


• Ephedrine because the risk of side effects, such as nausea, nervousness, and trouble sleeping, may be increased


• Halothane because the risk of side effects such as irregular heartbeat may be increased


• Ketamine because the risk of seizures may be increased


• Adenosine, benzodiazepines (eg, diazepam, flurazepam, lorazepam, midazolam), dipyridamole IV, lithium, or nondepolarizing muscle relaxants (eg, pancuronium) because their effectiveness may be decreased by Theophylline Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Theophylline Sustained-Release Capsules 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 Theophylline Sustained-Release Capsules:

Use Theophylline Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Some foods may change the effectiveness or increase the side effects of Theophylline Sustained-Release Capsules. Talk to your doctor about how you should take Theophylline Sustained-Release Capsules with regard to food. Do not suddenly change your diet or eating habits without first checking with your doctor.


• Swallow Theophylline Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.


• Take Theophylline Sustained-Release Capsules at about the same time(s) each day. If you are using more than 1 dose per day, try to take the second dose 10 to 12 hours after your first dose and before the evening meal. Check with your doctor or pharmacist if you have questions about how to take Theophylline Sustained-Release Capsules.


• If you are using 1 dose per day, take Theophylline Sustained-Release Capsules in the morning unless your doctor tells you otherwise.


• Continue to take Theophylline Sustained-Release Capsules even if you feel well. Do not miss any doses.


• If you miss a dose of Theophylline Sustained-Release Capsules, 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 Theophylline Sustained-Release Capsules.

Important safety information:

• Drinking alcohol may increase the risk of side effects of Theophylline Sustained-Release Capsules. Talk to your doctor before drinking alcohol while you are taking Theophylline Sustained-Release Capsules.


• Tell your doctor or dentist that you take Theophylline Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.


• Do not take more than the recommended dose or use more often than prescribed without checking with your doctor. If your symptoms become worse, contact your doctor.


• Carry an ID card at all times that says you take Theophylline Sustained-Release Capsules.


• Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).


• Notify your doctor if you develop a new illness, especially if it is accompanied by fever; if a chronic illness becomes worse; or if you start or stop smoking cigarettes or marijuana.


• Tell your doctor if another doctor prescribes a new medicine or tells you to stop using a medicine that you have already been taking. Tell your doctor if you start or stop any medicine, either prescription or over the counter.


• Theophylline Sustained-Release Capsules will not stop an asthma attack once one has started. Be sure to always carry appropriate rescue medicine (eg, bronchodilator inhaler) with you in case of an asthma attack.


• If you have more than one doctor, be sure to tell each of your doctors that you are taking Theophylline Sustained-Release Capsules.


• Diabetes patients - Theophylline Sustained-Release Capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Theophylline Sustained-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Theophylline Sustained-Release Capsules.


• Lab tests, including blood theophylline levels, may be performed while you use Theophylline Sustained-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Theophylline Sustained-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Theophylline Sustained-Release Capsules in CHILDREN, especially children younger than 1 year old; they may be more sensitive to its effects. Children may be more likely to experience mild, temporary behavior changes.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Theophylline Sustained-Release Capsules while you are pregnant. Theophylline Sustained-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Theophylline Sustained-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Theophylline Sustained-Release Capsules:

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:

Irritability; mild, temporary caffeine-like effects (eg, headache, nausea, diarrhea, trouble sleeping); mild, temporary changes in behavior; restlessness; temporary increased urination.

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); confusion; dizziness; fast breathing; fast or irregular heartbeat; heart rhythm problems; seizures; severe or persistent nausea, diarrhea, or headache; sleeplessness; tremors; 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: Theophylline 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 agitation; chest pain; confusion; decreased urination; fast or irregular heartbeat; headache; increased thirst; irritability; loss of appetite; muscle pain or tenderness; nausea; nervousness; persistent increased urination; restlessness; seizures; severe or persistent diarrhea; stomach pain; tremors or twitching; vomiting, especially of blood.

Proper storage of Theophylline Sustained-Release Capsules:

Store Theophylline Sustained-Release Capsules at room temperature below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Theophylline Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Theophylline Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Theophylline Sustained-Release Capsules 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 Theophylline Sustained-Release Capsules. 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 Theophylline resources

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

Compare Theophylline with other medications

• Apnea of Prematurity
• Asthma, acute
• Asthma, Maintenance

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

Compare Temodar with other medications

• Anaplastic Astrocytoma
• Anaplastic Oligodendroglioma
• Glioblastoma Multiforme
• Melanoma
• Melanoma, Metastatic