Carvédilol EG may be available in the countries listed below.
Ingredient matches for Carvédilol EG
Carvedilol
Carvedilol is reported as an ingredient of Carvédilol EG in the following countries:
- France
International Drug Name Search
Thursday, 29 September 2016
Vazotab Chewable Tablets
Pronunciation: BROME-fen-IR-a-meen/FEN-il-EF-rin
Generic Name: Brompheniramine/Phenylephrine
Brand Name: Examples include J-Tan D and Vazotab
Vazotab Chewable Tablets are used for:
Relieving symptoms of sinus congestion, pressure, runny nose, and sneezing caused by colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.
Vazotab Chewable Tablets are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.
Do NOT use Vazotab Chewable Tablets if:
- you are allergic to any ingredient in Vazotab Chewable Tablets
- you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
- you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Vazotab Chewable Tablets:
Some medical conditions may interact with Vazotab Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a fast, slow, or irregular heartbeat
- if you have phenylketonuria, trouble urinating, or trouble sleeping
- if you have a history of adrenal gland problems (eg, adrenal gland tumor); asthma; a blockage of your bladder, stomach, or intestines; blood vessel problems; diabetes; an enlarged prostate or other prostate problems; or glaucoma or increased pressure in the eye
- if you have a history of heart problems, high blood pressure, lung problems (eg, emphysema), seizures, sleep apnea, stroke, thyroid problems, or ulcers
Some MEDICINES MAY INTERACT with Vazotab Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
- Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Vazotab Chewable Tablets's side effects
- Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Vazotab Chewable Tablets
- Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Vazotab Chewable Tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Vazotab Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Vazotab Chewable Tablets:
Use Vazotab Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Vazotab Chewable Tablets by mouth with or without food.
- Chew Vazotab Chewable Tablets well before swallowing.
- If you miss a dose of Vazotab Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Vazotab Chewable Tablets.
Important safety information:
- Vazotab Chewable Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Vazotab Chewable Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Vazotab Chewable Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do not take diet or appetite control medicines while you are taking Vazotab Chewable Tablets without checking with your doctor.
- Vazotab Chewable Tablets has brompheniramine and phenylephrine in it. Before you start any new medicine, check the label to see if it has brompheniramine or phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.
- Vazotab Chewable Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Vazotab Chewable Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Vazotab Chewable Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Vazotab Chewable Tablets for a few days before the tests.
- Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
- Tell your doctor or dentist that you take Vazotab Chewable Tablets before you receive any medical or dental care, emergency care, or surgery.
- Use Vazotab Chewable Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.
- Caution is advised when using Vazotab Chewable Tablets in CHILDREN; they may be more sensitive to its effects, especially excitability.
- Vazotab Chewable Tablets should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.
- Different brands of Vazotab Chewable Tablets may have different dosing instructions for CHILDREN. Use Vazotab Chewable Tablets as directed by your doctor. If you are unsure of the dose to give a child, check with your doctor or pharmacist.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vazotab Chewable Tablets while you are pregnant. Do not take Vazotab Chewable Tablets in the third trimester of pregnancy. Vazotab Chewable Tablets are found in breast milk. Do not breast-feed while taking Vazotab Chewable Tablets.
Possible side effects of Vazotab Chewable Tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; dry mouth; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; decreased coordination; difficulty urinating or inability to urinate; fainting; fast or irregular heartbeat; hallucinations; mood or mental changes; persistent trouble sleeping; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; wheezing.
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: Vazotab 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 blurred vision; confusion; hallucinations; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular breathing; unusually fast, slow, or irregular heartbeat.
Proper storage of Vazotab Chewable Tablets:
Store Vazotab Chewable Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vazotab Chewable Tablets out of the reach of children and away from pets.
General information:
- If you have any questions about Vazotab Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
- Vazotab Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Vazotab Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More Vazotab resources
- Vazotab Side Effects (in more detail)
- Vazotab Use in Pregnancy & Breastfeeding
- Vazotab Drug Interactions
- Vazotab Support Group
- 0 Reviews for Vazotab - Add your own review/rating
Compare Vazotab with other medications
- Hay Fever
- Nasal Congestion
- Rhinitis
Wednesday, 28 September 2016
Sawatal LA
Sawatal LA may be available in the countries listed below.
Ingredient matches for Sawatal LA
Propranolol
Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Sawatal LA in the following countries:
- Japan
International Drug Name Search
Prilinda
Prilinda may be available in the countries listed below.
Ingredient matches for Prilinda
Ramipril
Ramipril is reported as an ingredient of Prilinda in the following countries:
- Serbia
International Drug Name Search
Vectibix
Generic Name: panitumumab (pan i TUE moo mab)
Brand Names: Vectibix
What is panitumumab?
Panitumumab is a cancer medication. It interferes with the growth of cancer cells and slows their growth and spread in your body.
Panitumumab is used to treat metastatic colorectal cancer that has progressed after treatment with other chemotherapy.
Panitumumab may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about panitumumab?
Before receiving this medication, tell your doctor if you have any allergies or breathing problems. You may not be able to receive panitumumab, or you may need a dosage adjustment or special tests during treatment.
Panitumumab may cause severe skin problems such as acne, itching, redness, skin rash, dryness, peeling, cracking, or oozing, and swelling or infection around your fingernails or toenails. This medication can also cause redness or irritation of your eyes or eyelids. More severe forms of skin problems can lead to widespread infection and possibly death. Seek emergency medical attention at the first sign of any skin rash.
Some people receiving a panitumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have a fever or chills during the injection.
The side effects of panitumumab may not appear when you first start using the medication. Severe skin or eye reactions may occur up to 2 weeks after the start of your treatment. These effects may not clear up for weeks or even months after you stop receiving panitumumab.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Panitumumab can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
This medication may affect a woman's fertility (ability to have children). You may also have irregular menstrual periods while receiving panitumumab.
What should I discuss with my health care provider before receiving panitumumab?
This medication may cause severe skin problems such as acne, itching, redness, skin rash, dryness, peeling, cracking, or oozing, and swelling or infection around your fingernails or toenails. More severe forms of skin problems can lead to widespread infection and possibly death. Seek emergency medical attention at the first sign of any skin rash. Do not use this medication if you are allergic to panitumumab.
Before receiving this medication, tell your doctor if you have any allergies or breathing problems. You may not be able to receive panitumumab, or you may need a dose adjustment or special tests to safely receive this medication.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether panitumumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
This medication may affect a woman's fertility (ability to have children). You may also have irregular menstrual periods while receiving panitumumab.
How is panitumumab given?
Panitumumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 90 minutes to complete.
Before you receive this medication, you may need to undergo a biopsy to make sure panitumumab is the right medication to treat your cancer.
Panitumumab is usually given once every 2 weeks. Follow your doctor's instructions.
What happens if I miss a dose?
Contact your doctor if you miss an appointment for your panitumumab injection.
What happens if I overdose?
Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a panitumumab overdose are unknown.
What should I avoid while taking panitumumab?
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Panitumumab can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
Panitumumab side effects
Some people receiving a panitumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have a fever or chills during the injection.
Some of the side effects of panitumumab may not appear when you first start using the medication. Severe skin or eye reactions may occur up to 2 weeks after the start of your treatment. These effects may not clear up for weeks or even months after you stop receiving panitumumab.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
swelling of your hands or ankles;
acne, dryness, peeling, cracking, bleeding, oozing, pus, or any other sign of skin infection;
cough or wheezing, running out of breath easily;
white patches or sores inside your mouth or on your lips;
drowsiness, restless feeling, confusion, muscle stiffness, fast or uneven heart rate, chest pain;
redness, swelling, or irritation of your eyes or eyelids; or
swelling or infection around your fingernails or toenails.
Less serious side effects may include:
nausea, vomiting, stomach pain;
diarrhea or constipation; or
tired feeling.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect panitumumab?
There may be other drugs that can interact with panitumumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More Vectibix resources
- Vectibix Side Effects (in more detail)
- Vectibix Use in Pregnancy & Breastfeeding
- Vectibix Drug Interactions
- Vectibix Support Group
- 0 Reviews for Vectibix - Add your own review/rating
- Vectibix Prescribing Information (FDA)
- Vectibix Monograph (AHFS DI)
- Vectibix Advanced Consumer (Micromedex) - Includes Dosage Information
- Vectibix Consumer Overview
- Vectibix MedFacts Consumer Leaflet (Wolters Kluwer)
- Panitumumab Professional Patient Advice (Wolters Kluwer)
Compare Vectibix with other medications
- Colorectal Cancer
Where can I get more information?
- Your doctor can provide more information about panitumumab.
See also: Vectibix side effects (in more detail)
Tuesday, 27 September 2016
Vasocidin
Generic Name: sulfacetamide and prednisolone ophthalmic (SUL fa SEET a mide and pred NIS oh lone off THAL mik)
Brand Names: Blephamide, Blephamide S.O.P., Ocu-Lone C
What is Vasocidin (sulfacetamide and prednisolone ophthalmic)?
Sulfacetamide is an antibiotic. It is used to treat bacterial infections.
Prednisolone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.
Sulfacetamide and prednisolone ophthalmic is used to treat bacterial infections of the eyes.
Sulfacetamide and prednisolone ophthalmic may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Vasocidin (sulfacetamide and prednisolone ophthalmic)?
Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.
Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.
Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.
Who should not use Vasocidin (sulfacetamide and prednisolone ophthalmic)?
Do not use sulfacetamide and prednisolone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.
Do not use sulfacetamide and prednisolone ophthalmic if you have ever had an allergic reaction to a sulfa-based drug.
It is not known whether sulfacetamide and prednisolone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether sulfacetamide and prednisolone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.
How should I use Vasocidin (sulfacetamide and prednisolone ophthalmic)?
Use sulfacetamide and prednisolone ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Wash your hands before using your eyedrops or ointment.
To apply the eyedrops:
Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.
To apply the ointment:
Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.
Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store sulfacetamide and prednisolone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.
What happens if I miss a dose?
Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.
What happens if I overdose?
An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.
What should I avoid while using Vasocidin (sulfacetamide and prednisolone ophthalmic)?
Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Sulfacetamide and prednisolone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.
Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.
Avoid other eye medications unless your doctor approves.
Vasocidin (sulfacetamide and prednisolone ophthalmic) side effects
Serious side effects are not expected with this medication.
Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Vasocidin (sulfacetamide and prednisolone ophthalmic)?
Do not use this medication with other eyedrops that contain nitrates (e.g., silver nitrate).
Avoid other eye medications unless they are approved by your doctor.
Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).
Drugs other than those listed here may also interact with sulfacetamide and prednisolone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
More Vasocidin resources
- Vasocidin Side Effects (in more detail)
- Vasocidin Use in Pregnancy & Breastfeeding
- Vasocidin Drug Interactions
- Vasocidin Support Group
- 0 Reviews for Vasocidin - Add your own review/rating
- Vasocidin Prescribing Information (FDA)
- Vasocidin Drops MedFacts Consumer Leaflet (Wolters Kluwer)
- Blephamide Suspension MedFacts Consumer Leaflet (Wolters Kluwer)
- Blephamide Prescribing Information (FDA)
- Blephamide S.O.P. Ointment MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Vasocidin with other medications
- Blepharitis
- Conjunctivitis, Bacterial
- Keratitis
- Keratoconjunctivitis
- Uveitis
Where can I get more information?
- Your pharmacist has additional information about sulfacetamide and prednisolone ophthalmic written for health professionals that you may read.
See also: Vasocidin side effects (in more detail)
GelTears
GelTears may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
UK matches:
- GelTears (Bausch & Lomb U.K Limited) (SPC)
Ingredient matches for GelTears
Carbomer
Carbomer is reported as an ingredient of GelTears in the following countries:
- Ireland
- United Kingdom
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Ginedermofix Vaginal
Ginedermofix Vaginal may be available in the countries listed below.
Ingredient matches for Ginedermofix Vaginal
Sertaconazole
Sertaconazole nitrate (a derivative of Sertaconazole) is reported as an ingredient of Ginedermofix Vaginal in the following countries:
- Spain
International Drug Name Search
Secto Flea Powder
Secto Flea Powder may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Secto Flea Powder
Permethrin
Permethrin is reported as an ingredient of Secto Flea Powder in the following countries:
- United Kingdom
International Drug Name Search
Monday, 26 September 2016
Timoptic-XE Ocumeter
Generic Name: timolol (Ophthalmic route)
TIM-oh-lol
Commonly used brand name(s)
In the U.S.
- Betimol
- Istalol
- Timoptic Ocudose
- Timoptic Ocumeter
- Timoptic Ocumeter Plus
- Timoptic-XE Ocumeter
- Timoptic-XE Ocumeter Plus
Available Dosage Forms:
- Solution
- Gel Forming Solution
Therapeutic Class: Antiglaucoma
Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective
Uses For Timoptic-XE Ocumeter
Timolol is used alone or together with other medicines to treat increased pressure in the eye that is caused by open-angle glaucoma or a condition called ocular (eye) hypertension. This medicine is a beta-blocker .
This medicine is available only with your doctor's prescription .
Before Using Timoptic-XE Ocumeter
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
Appropriate studies have not been performed on the relationship of age to the effects of timolol in the pediatric population. Safety and efficacy have not been established .
Geriatric
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of timolol in the elderly .
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
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Albuterol
- Amiodarone
- Arformoterol
- Bambuterol
- Bitolterol
- Broxaterol
- Clenbuterol
- Clonidine
- Colterol
- Diltiazem
- Dronedarone
- Epinephrine
- Fenoldopam
- Fenoterol
- Formoterol
- Hexoprenaline
- Indacaterol
- Isoetharine
- Levalbuterol
- Metaproterenol
- Pirbuterol
- Procaterol
- Reproterol
- Rimiterol
- Ritodrine
- Salmeterol
- Terbutaline
- Timolol
- Tretoquinol
- Tulobuterol
- Verapamil
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acarbose
- Aceclofenac
- Acemetacin
- Acetohexamide
- Alclofenac
- Alfuzosin
- Amlodipine
- Apazone
- Arbutamine
- Benfluorex
- Benoxaprofen
- Bromfenac
- Bufexamac
- Bunazosin
- Carprofen
- Chlorpropamide
- Cimetidine
- Clometacin
- Clonixin
- Dexketoprofen
- Diclofenac
- Diflunisal
- Digoxin
- Dipyrone
- Doxazosin
- Droxicam
- Etodolac
- Etofenamate
- Felbinac
- Felodipine
- Fenbufen
- Fenoprofen
- Fentiazac
- Floctafenine
- Flufenamic Acid
- Flurbiprofen
- Gliclazide
- Glimepiride
- Glipizide
- Gliquidone
- Glyburide
- Guar Gum
- Ibuprofen
- Indomethacin
- Indoprofen
- Insulin
- Insulin Aspart, Recombinant
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Isoxicam
- Ketoprofen
- Ketorolac
- Lacidipine
- Lercanidipine
- Lornoxicam
- Manidipine
- Meclofenamate
- Mefenamic Acid
- Meloxicam
- Metformin
- Methyldopa
- Mibefradil
- Miglitol
- Moxisylyte
- Nabumetone
- Naproxen
- Nicardipine
- Nifedipine
- Niflumic Acid
- Nilvadipine
- Nimesulide
- Nimodipine
- Nisoldipine
- Nitrendipine
- Oxaprozin
- Oxyphenbutazone
- Phenoxybenzamine
- Phentolamine
- Phenylbutazone
- Pirazolac
- Piroxicam
- Pirprofen
- Pranidipine
- Prazosin
- Propyphenazone
- Proquazone
- Quinidine
- Repaglinide
- St John's Wort
- Sulindac
- Suprofen
- Tamsulosin
- Tenidap
- Tenoxicam
- Terazosin
- Tiaprofenic Acid
- Tolazamide
- Tolbutamide
- Tolmetin
- Trimazosin
- Troglitazone
- Urapidil
- Zomepirac
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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:
- Asthma or
- Bradycardia (slow heartbeat) or
- Chronic obstructive pulmonary disease (COPD), severe or
- Heart block or
- Heart failure—Should not use in patients with these conditions .
- Blood vessel disease (especially blood vessels of the brain) or
- Stroke, history of—Use with caution. This medicine may worsen these conditions .
- Diabetes or
- Hyperthyroidism (overactive thyroid) or
- Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .
- Lung disease—Use with caution. May cause difficulty with breathing in patients with this condition .
- Myasthenia gravis—May worsen symptoms of this condition, such as muscle weakness .
Proper Use of timolol
This section provides information on the proper use of a number of products that contain timolol. It may not be specific to Timoptic-XE Ocumeter. Please read with care.
Shake the regular eye drops well just before each use. If you are using the gel-forming eye drops, turn the bottle upside down and shake it once. You do not need to shake the gel-forming eye drops more than once .
To use the eye drops (solution and gel):
- First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
- Immediately after using the medicine, wash your hands to remove any medicine that may be on them.
- To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines .
If your doctor ordered two different eye medicines to be used together, wait at least 10 minutes after the regular eye drops before using the second medicine. This will help prevent the second medicine from “washing out” the first one. The gel-forming eye drops should always be the last medicine used if two medicines are ordered. Wait 10 minutes before using the gel-forming eye drops .
You should not use the regular eye drops if you have contact lenses in your eyes. Remove your contact lenses before you use this medicine. Wait at least 15 minutes after you use the medicine before putting the contact lenses back in .
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 glaucoma or ocular hypertension:
- For ophthalmic gel-forming solution dosage form (eye drops):
- Adults—One drop in the affected eye(s) once a day.
- Children—Use and dose must be determined by your doctor .
- For ophthalmic solution dosage form (eye drops):
- Adults—One drop in the affected eye(s) two times a day.
- Children—Use and dose must be determined by your doctor .
- For ophthalmic gel-forming solution dosage form (eye drops):
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Timoptic-XE Ocumeter
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .
If itching, redness, swelling, or other signs of eye or eyelid irritation occur, stop using this medicine and check with your doctor. These signs may mean that you are allergic to this medicine .
Timolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .
This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .
The gel-forming eye drops may cause blurred vision or other vision problems that last about 30 seconds to 5 minutes after you put them in your eye. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. If these eye changes are bothersome, check with your doctor .
Timoptic-XE Ocumeter Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Blurred vision
- burning or stinging in eye
- Arm, back, or jaw pain
- blisters, hives, welts, or itching
- blue lips, fingernails, or skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in vision
- chest pain or discomfort
- chest tightness or heaviness
- confusion about identity, place, and time
- continuing ringing or buzzing or other unexplained noise in ears
- coughing that sometimes produces a pink frothy sputum
- depression
- difficult, fast, noisy breathing, sometimes with wheezing
- difficulty in chewing, swallowing, or talking
- dilated neck veins
- discharge, excessive tearing
- disturbed color perception
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- double vision
- drooping eyelids
- dry or itching eyes
- extreme fatigue
- false sense of well-being
- fast, slow, irregular, pounding, or racing heartbeat or pulse
- fear, nervousness
- feeling of having something in the eye
- fever and chills
- flashes of light, floaters in vision
- general feeling of discomfort or illness
- hair loss
- halos around lights
- headaches
- inability to speak
- increased sweating
- irregular, fast or slow, or shallow breathing
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- loss of vision
- memory loss
- mood swings
- muscle or joint pain
- muscle weakness
- nausea
- night blindness
- no blood pressure or pulse
- overbright appearance of lights
- pain, tension, and weakness upon walking that subsides during periods of rest
- pale skin
- paleness or cold feeling in fingertips, toes, hands, and feet
- personality changes
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of skin
- redness, pain, swelling or irritation of eye, eyelid, or inner lining of eyelid
- seeing double
- seeing, hearing, or feeling things that are not there
- seizures
- severe numbness, especially on one side of the face or body
- severe or sudden headache
- severe tiredness
- shortness of breath or troubled breathing
- skin irritation or rash, including rash that looks like psoriasis
- slurred speech
- sore throat
- stopping of heart
- sweating
- swelling of face, fingers, feet, lower legs, and ankles
- swollen glands
- temporary blindness
- tingling or pain in fingers or toes when exposed to cold
- tunnel vision
- unconsciousness
- unusual tiredness or weakness
- weakness in arm and/or leg on one side of the body, sudden and severe
- weight gain
- wheezing
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:
Less common
- Acid or sour stomach
- belching
- body aches or pain
- diarrhea
- dry mouth
- ear congestion
- hearing loss
- heartburn
- indigestion
- lack or loss of strength
- loss of appetite
- loss of voice
- nightmares
- runny nose
- sleepiness or unusual drowsiness
- sleeplessness
- sneezing
- stomach discomfort, upset, or pain
- stuffy nose
- trouble sleeping
- unable to sleep
- weight loss
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: Timoptic-XE Ocumeter side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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More Timoptic-XE Ocumeter resources
- Timoptic-XE Ocumeter Side Effects (in more detail)
- Timoptic-XE Ocumeter Use in Pregnancy & Breastfeeding
- Timoptic-XE Ocumeter Drug Interactions
- Timoptic-XE Ocumeter Support Group
- 0 Reviews for Timoptic-XE Ocumeter - Add your own review/rating
Compare Timoptic-XE Ocumeter with other medications
- Glaucoma, Open Angle
- Intraocular Hypertension
Tegaserod
In the US, Tegaserod (tegaserod systemic) is a member of the drug class serotoninergic neuroenteric modulators and is used to treat Constipation - Chronic and Irritable Bowel Syndrome.
US matches:
- Tegaserod
- Tegaserod Maleate
Scheme
Rec.INN
ATC (Anatomical Therapeutic Chemical Classification)
A03AE02
CAS registry number (Chemical Abstracts Service)
0145158-71-0
Chemical Formula
C16-H23-N5-O
Molecular Weight
301
Therapeutic Category
Serotonin antagonist
Chemical Names
1-[[(5-Methoxyindol-3-yl)methylene]amino]-3-pentylguanidine (WHO)
1-{[(5-Methoxyindol-3-yl)methyliden]amino}-3-pentylguanidin (IUPAC)
Hydrazinecarboximidamide, 2-[(5-methoxy-1H-indol-3-yl)methylene]-N-pentyl- (USAN)
Foreign Names
- Tegaserodum (Latin)
- Tegaserod (German)
- Tegaserod (French)
- Tegaserod (Spanish)
Generic Names
- Tegaserod (OS: BAN, USAN)
- SDZ-HTF 919 (IS)
- Tegaserod Maleate (OS: USAN)
- HTF 919 (IS: Novartis)
- SDZ HTF 919 (IS)
Brand Names
- Altezerod
Altius, Argentina - Colonaid
Recalcine, Chile; Recalcine, Ecuador - Doresa
Incepta, Bangladesh - Gasprid
Garmisch, Colombia - Serod
Aristopharma, Bangladesh - Tegarid
Renata, Bangladesh - Tegod
ACI, Bangladesh - Tesod
Square, Bangladesh - Tibs
Eskayef, Bangladesh - Zelmac
Novartis, Argentina; Novartis, Bangladesh; Novartis, Indonesia - Coloserod
Lazar, Argentina - Procinet
Quesada, Argentina - Siir
Lafrancol, Colombia - Tegarod
Cinetic, Argentina - Tegaserod MK
MK, Colombia - Tegaserod Richet
Richet, Argentina - Tegibs
Torrent, India - Tegibs-6
Torrent, Vietnam - Tegod
Cipla, India - Ther
Chile, Chile - Zelmac
Novartis, Brazil; Novartis, Chile; Novartis, China; Novartis, Colombia; Novartis, Ecuador; Novartis, Hong Kong; Novartis, Israel; Novartis, Mexico; Novartis, Malaysia; Novartis, Oman; Novartis, Serbia; Novartis, Singapore; Novartis, Thailand; Novartis, Venezuela; Novartis, Vietnam; Novartis Pharmaceuticals, Peru - Zelnorm
Novartis, Philippines
International Drug Name Search
Glossary
| BAN | British Approved Name |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Click for further information on drug naming conventions and International Nonproprietary Names.
Toposar
etoposide
Dosage Form: injection
Toposar™ (Etoposide Injection, USP)
Rx only
Toposar (etoposide injection, USP) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.
Toposar Description
Toposar (etoposide injection, USP) (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. It has a molecular weight of 588.58 and a molecular formula of C29H32O13.
Toposar is available for intravenous use as a sterile 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 g (50 mL) sterile multiple dose vials. The pH of the clear, yellow liquid is 3.0 to 4.0.
Each mL contains: 20 mg etoposide, 2 mg citric acid anhydrous, 80 mg polysorbate 80, 650 mg polyethylene glycol 300, dehydrated alcohol 33.2% (v/v).
The structural formula is:
Toposar - Clinical Pharmacology
Etoposide has been shown to cause metaphase arrest in chick fibroblasts. Its main effect, however, appears to be at the G2 portion of the cell cycle in mammalian cells. Two different dose-dependent responses are seen. At high concentrations (10 mcg/mL or more), lysis of cells entering mitosis is observed. At low concentrations (0.3 to 10 mcg/mL), cells are inhibited from entering prophase. It does not interfere with microtubular assembly. The predominant macromolecular effect of etoposide appears to be the induction of DNA strand breaks by an interaction with DNA topoisomerase II or the formation of free radicals.
Pharmacokinetics
On intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution half-life of about 1.5 hours and terminal elimination half-life ranging from 4 to 11 hours. Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m2 and, like the terminal elimination half-life, are independent of dose over a range 100-600 mg/m2. Over the same dose range, the areas under the plasma concentration vs time curves (AUC) and the maximum plasma concentration (Cmax) values increase linearly with dose. Etoposide does not accumulate in the plasma following daily administration of 100 mg/m2 for 4 to 5 days.
The mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m2. Etoposide enters the CSF poorly. Although it is detectable in CSF and intracerebral tumors, the concentrations are lower than in extracerebral tumors and in plasma. Etoposide concentrations are higher in normal lung than in lung metastases and are similar in primary tumors and normal tissues of the myometrium. In vitro, etoposide is highly protein bound (97%) to human plasma proteins. An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children. In a study determining the effect of other therapeutic agents on the in vitro binding of carbon-14 labeled etoposide to human serum proteins, only phenylbutazone, sodium salicylate, and aspirin displaced protein-bound etoposide at concentrations achieved in vivo.
Etoposide binding ratio correlates directly with serum albumin in patients with cancer and in normal volunteers. The unbound fraction of etoposide significantly correlated with bilirubin in a population of cancer patients. Data have suggested a significant inverse correlation between serum albumin concentration and free fraction of etoposide. (See PRECAUTIONS section.)
After intravenous administration of 14C-etoposide (100-124 mg/m2), mean recovery of radioactivity in the urine was 56% of the dose at 120 hours, 45% of which was excreted as etoposide; fecal recovery of radioactivity was 44% of the dose at 120 hours.
In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours. The mean renal clearance of etoposide is 7 to 10 mL/min/m2 or about 35% of the total body clearance over a dose range of 80 to 600 mg/m2. Etoposide, therefore, is cleared by both renal and nonrenal processes, i.e., metabolism and biliary excretion. The effect of renal disease on plasma etoposide clearance is not known.
Biliary excretion of unchanged drug and/or metabolites is an important route of etoposide elimination as fecal recovery of radioactivity is 44% of the intravenous dose. The hydroxy acid metabolite [4'-demethylepipodophyllic acid-9-(4,6-O-(R)-ethylidene-β-D-glucopyranoside)], formed by opening of the lactone ring, is found in the urine of adults and children. It is also present in human plasma, presumably as the trans isomer. Glucuronide and/or sulfate conjugates of etoposide are also excreted in human urine. Only 8% or less of an intravenous dose is excreted in the urine as radiolabeled metabolites of 14C-etoposide. In addition, O-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme pathway to produce the corresponding catechol.
After either intravenous infusion or oral capsule administration, the Cmax and AUC values exhibit marked intra- and inter-subject variability.
In adults, the total body clearance of etoposide is correlated with creatinine clearance, serum albumin concentration, and nonrenal clearance. Patients with impaired renal function receiving etoposide have exhibited reduced total body clearance, increased AUC and a lower volume of distribution at steady state. (See PRECAUTIONS section.) Use of cisplatin therapy is associated with reduced total body clearance. In children, elevated serum SGPT levels are associated with reduced drug total body clearance. Prior use of cisplatin may also result in a decrease of etoposide total body clearance in children.
Although some minor differences in pharmacokinetic parameters between age and gender have been observed, these differences were not considered clinically significant.
Indications and Usage for Toposar
Toposar is indicated in the management of the following neoplasms:
Refractory Testicular Tumors
Toposar in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.
Small Cell Lung Cancer
Etoposide injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
Contraindications
Toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.
Warnings
Patients being treated with Toposar must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported. Dose-limiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of Toposar: platelet count, hemoglobin, white blood cell count, and differential. The occurrence of a platelet count below 50,000/mm3 or an absolute neutrophil count below 500/mm3 is an indication to withhold further therapy until the blood counts have sufficiently recovered.
Physicians should be aware of the possible occurrence of an anaphylactic reaction manifested by chills, fever, tachycardia, bronchospasm, dyspnea, and hypotension. Higher rates of anaphylactic-like reactions have been reported in children who received infusions at concentrations higher than those recommended. The role that concentration of infusion (or rate of infusion) plays in the development of anaphylactic-like reactions is uncertain. (See ADVERSE REACTIONS section.) Treatment is symptomatic. The infusion should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician.
For parenteral administration, Toposar should be given only by slow intravenous infusion (usually over a 30- to 60-minute period) since hypotension has been reported as a possible side effect of rapid intravenous injection.
Pregnancy
Etoposide can cause fetal harm when administered to a pregnant woman. Etoposide has been shown to be teratogenic in mice and rats.
In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20th of the human dose on a mg/m2 basis) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher doses of 1.2 and 3.6 mg/kg/day (about 1/7th and 1/2 of human dose on a mg/m2 basis) resulted in 90 and 100% embryonic resorptions. In mice, a single 1.0 mg/kg (1/16th of human dose on a mg/m2 basis) dose of etoposide administered intraperitoneally on days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. An I.P. dose of 1.5 mg/kg (about 1/10th of human dose on a mg/m2 basis) on day 7 of gestation caused an increase in the incidence of intrauterine death and fetal malformations and a significant decrease in the average fetal body weight.
Women of childbearing potential should be advised to avoid becoming pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be warned of the potential hazard to the fetus.
Etoposide should be considered a potential carcinogen in humans. The occurrence of acute leukemia with or without a preleukemic phase has been reported in rare instances in patients treated with etoposide alone or in association with other neoplastic agents. The risk of development of a preleukemic or leukemic syndrome is unclear. Carcinogenicity tests with etoposide have not been conducted in laboratory animals.
Precautions
General
In all instances where the use of etoposide is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions. Most such adverse reactions are reversible if detected early. If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgment of the physician. Reinstitution of Toposar therapy should be carried out with caution, and with adequate consideration of the further need for the drug and alertness as to possible recurrence of toxicity.
Patients with low serum albumin may be at an increased risk for etoposide associated toxicities.
Drug Interactions
High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease in total body clearance of etoposide compared to etoposide alone.
Laboratory Tests
Periodic complete blood counts should be done during the course of etoposide treatment. They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy. At least one determination should be done prior to each dose of etoposide.
Renal Impairment
In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance:
| Measured Creatinine Clearance | >50 mL/min | 15-50 mL/min |
| etoposide | 100% of dose | 75% of dose |
Subsequent etoposide dosing should be based on patient tolerance and clinical effect.
Data are not available in patients with creatinine clearances <15 mL/min and further dose reduction should be considered in these patients.
Carcinogenesis, Mutagenesis, Impairment of Fertility
(see WARNINGS section)
Etoposide has been shown to be mutagenic in Ames assay.
Treatment of Swiss-Albino mice with 1.5 mg/kg I.P. of etoposide on day 7 of gestation increased the incidence of intrauterine death and fetal malformations as well as significantly decreased the average fetal body weight. Maternal weight gain was not affected.
Irreversible testicular atrophy was present in rats treated with etoposide intravenously for 30 days at 0.5 mg/kg/day (about 1/16th of the human dose on a mg/m2 basis).
Pregnancy
Teratogenic Effects
Pregnancy "Category D."
(See WARNINGS section.)
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from etoposide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Toposar contains polysorbate 80. In premature infants, a life-threatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia, and ascites has been associated with an injectable vitamin E product containing polysorbate 80. Anaphylactic reactions have been reported in pediatric patients. (See WARNINGS section.)
Geriatric Use
Clinical studies of etoposide for the treatment of refractory testicular tumors did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Of more than 600 patients in four clinical studies in the NDA databases who received etoposide or etoposide phosphate in combination with other chemotherapeutic agents for the treatment of small cell lung cancer (SCLC), about one third were older than 65 years. When advanced age was determined to be a prognostic factor for response or survival in these studies, comparisons between treatment groups were performed for the elderly subset. In the one study (etoposide in combination with cyclophosphamide and vincristine compared with cyclophosphamide and vincristine or cyclophosphamide, vincristine, and doxorubicin) where age was a significant prognostic factor for survival, a survival benefit for elderly patients was observed for the etoposide regimen compared with the control regimens. No differences in myelosuppression were seen between elderly and younger patients in these studies except for an increased frequency of WHO Grade III or IV leukopenia among elderly patients in a study of etoposide phosphate or etoposide in combination with cisplatin. Elderly patients in this study also had more anorexia, mucositis, dehydration, somnolence, and elevated BUN levels than younger patients.
In five single-agent studies of etoposide phosphate in patients with a variety of tumor types, 34% of patients were age 65 years or more. WHO Grade III or IV leukopenia, granulocytopenia, and asthenia were more frequent among elderly patients.
Postmarketing experience also suggests that elderly patients may be more sensitive to some of the known adverse effects of etoposide, including myelosuppression, gastrointestinal effects, infectious complications, and alopecia.
Although some minor differences in pharmacokinetic parameters between elderly and nonelderly patients have been observed, these differences were not considered clinically significant.
Etoposide and its metabolites are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS: Renal Impairment for recommended dosing adjustments in patients with renal impairment).
Adverse Reactions
The following data on adverse reactions are based on both oral and intravenous administration of etoposide as a single agent, using several different dose schedules for treatment of a wide variety of malignancies.
Hematologic Toxicity
Myelosuppression is dose related and dose limiting, with granulocyte nadirs occurring 7 to 14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported.
The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with etoposide in association with other antineoplastic agents. (See WARNINGS section.)
Gastrointestinal Toxicity
Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy. Mild to severe mucositis/esophagitis may occur. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion.
Hypotension
Transient hypotension following rapid intravenous administration has been reported in 1% to 2% of patients. It has not been associated with cardiac toxicity or electrocardiographic changes. No delayed hypotension has been noted. To prevent this rare occurrence, it is recommended that etoposide injection be administered by slow intravenous infusion over a 30- to 60-minute period. If hypotension occurs, it usually responds to cessation of the infusion and administration of fluids or other supportive therapy as appropriate. When restarting the infusion, a slower administration rate should be used.
Allergic Reactions
Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea, and/or hypotension have been reported to occur in 0.7% to 2% of patients receiving intravenous etoposide and in less than 1% of the patients treated with the oral capsules. These reactions have usually responded promptly to the cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines, or volume expanders as appropriate; however, the reactions can be fatal. Hypertension and/or flushing have also been reported. Blood pressure usually normalizes within a few hours after cessation of the infusion. Anaphylactic-like reactions have occurred during the initial infusion of etoposide.
Facial/tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm, back pain, and/or loss of consciousness have sometimes occurred in association with the above reactions. In addition, an apparent hypersensitivity-associated apnea has been reported rarely.
Rash, urticaria, and/or pruritus have infrequently been reported at recommended doses. At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported.
Alopecia
Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients.
Other Toxicities
The following adverse reactions have been infrequently reported: abdominal pain, aftertaste, constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness, optic neuritis, interstitial pneumonitis/pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, and toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis.
Hepatic toxicity, generally in patients receiving higher doses of the drug than those recommended, has been reported with etoposide. Metabolic acidosis has also been reported in patients receiving higher doses.
Reports of extravasation with swelling have been received postmarketing. Rarely extravasation has been associated with necrosis and venous induration.
The incidences of adverse reactions in the table that follows are derived from multiple data bases from studies in 2,081 patients when etoposide was used either orally or by injection as a single agent.
| ADVERSE DRUG EFFECT | PERCENT RANGE OF REPORTED INCIDENCE |
| Hematologic toxicity | |
| Leukopenia (less than 1,000 WBC/mm3) | 3-17 |
| Leukopenia (less than 4,000 WBC/mm3) | 60-91 |
| Thrombocytopenia (less than 50,000 platelets/mm3) | 1-20 |
| Thrombocytopenia (less than 100,000 platelets/mm3) | 22-41 |
| Anemia | 0-33 |
| Gastrointestinal toxicity | |
| Nausea and vomiting | 31-43 |
| Abdominal pain | 0-2 |
| Anorexia | 10-13 |
| Diarrhea | 1-13 |
| Stomatitis | 1-6 |
| Hepatic | 0-3 |
| Alopecia | 8-66 |
| Peripheral neurotoxicity | 1-2 |
| Hypotension | 1-2 |
| Allergic reaction | 1-2 |
Overdosage
No proven antidotes have been established for etoposide overdosage.
Toposar Dosage and Administration
Note: Plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used withundiluted etoposide injection.
Toposar
The usual dose of Toposar in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m2/day on days 1 through 5 to 100 mg/m2/day on days 1, 3, and 5.
In small cell lung cancer, the Toposar dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m2/day for 4 days to 50 mg/m2/day for 5 days.
For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section.
Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from any toxicity.
The dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior x-ray therapy or chemotherapy which may have compromised bone marrow reserve.
Administration Precautions
As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of Toposar. Skin reactions associated with accidental exposure to etoposide may occur. The use of gloves is recommended. If Toposar solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water.
Preparation for Intravenous Administration
Toposar must be diluted prior to use with either 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, to give a final concentration of 0.2 to 0.4 mg/mL. If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur. Hypotension following rapid intravenous administration has been reported, hence, it is recommended that the Toposar solution be administered over a 30- to 60-minute period. A longer duration of administration may be used if the volume of fluid to be infused is a concern. Toposar should not be given by rapid intravenous injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration (see DESCRIPTION section) prior to administration whenever solution and container permit.
Stability
Unopened vials of Toposar are stable until the date indicated on the package at room temperature (25°C). Vials diluted as recommended to a concentration of 0.2 to 0.4 mg/mL are stable for 96 and 24 hours, respectively, at room temperature (25°C) under normal room fluorescent light in both glass and plastic containers.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
How is Toposar Supplied
Toposar (etoposide injection, USP) 20 mg/mL is supplied as follows:
| NDC Number | Contents | Size |
| 0703-5653-01 | 100 mg | 5 mL Multiple Dose Vials |
| 0703-5656-01 | 500 mg | 25 mL Multiple Dose Vials |
| 0703-5657-01 | 1 gram | 50 mL Multiple Dose Vials |
All are available individually packaged.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
DO NOT FREEZE.
REFERENCES
- ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
- Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, National Institutes of Health; 1983. US Dept of Health and Human Services, Public Health Service publication NIH 83-2621.
- AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1591.
- National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
- Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983;1:426-428.
- Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983;33:258-263.
- American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.
- Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.). Am J Health-SystPharm. 1996;53:1669-1685.
Manufactured by:
Teva Parenteral Medicines, Inc.
Irvine, CA 92618
Rev. A 9/2011
PRINCIPAL DISPLAY PANEL
Toposar (etoposide injection, USP) 20 mg/mL (100 mg/5 mL) Vial Carton Text
NDC 0703-5653-01
Rx only
Toposar™
(etoposide
injection, USP)
20 mg/mL
(100 mg/5 mL)
Warning: Cytotoxic Agent
Must Be Diluted Before IV Infusion
5 mL Multiple Dose Vial
TEVA
PRINCIPAL DISPLAY PANEL
Toposar (etoposide injection, USP) 20 mg/mL (500 mg/25 mL) Vial Carton Text
NDC 0703-5656-01
Rx only
Toposar™
(etoposide
injection, USP)
20 mg/mL
(500 mg/25 mL)
Warning: Cytotoxic Agent
Must Be Diluted Before IV Infusion
25 mL Multiple Dose Vial
TEVA
PRINCIPAL DISPLAY PANEL
Toposar (etoposide injection, USP) 20 mg/mL (1 gram/ 50 mL)Vial Carton Text
NDC 0703-5657-01
Rx only
Toposar™
(etoposide
injection, USP)
20 mg/mL
(1 gram/50 mL)
Warning: Cytotoxic Agent
Must Be Diluted Before IV Infusion
50 mL Multiple Dose Vial
TEVA
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| ANDA | ANDA074529 | 10/06/2011 | |
| Labeler - Teva Parenteral Medicines, Inc (794362533) |
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