Generic Name: Carbetapentane/Guaifenesin/Phenylephrine (car-beta-PEN-tane/gwye-FEN-e-sin/FEN-il-EF-rin)
Brand Name: Examples include Gentex-LQ and Levall

Gentex-LQ Solution is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Gentex-LQ Solution is a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Gentex-LQ Solution if:

  • you are allergic to any ingredient in Gentex-LQ Solution
  • you have an overactive thyroid, uncontrolled high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
  • you take droxidopa or 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 Gentex-LQ Solution:

Some medical conditions may interact with Gentex-LQ Solution. 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 glaucoma or increased pressure in the eye, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems (eg, pheochromocytoma), mental or mood problems (eg, depression), trouble sleeping, an overactive thyroid, seizures, or stroke
  • if you have a chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus
  • if you are in poor health or are very overweight

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

  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Gentex-LQ Solution’s side effects
  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
  • Alpha-blockers (eg, prazosin) or bromocriptine because the risk of their side effects may be increased by Gentex-LQ Solution
  • Guanadrel, guanethidine, mecamylamine, medicines for high blood pressure, methyldopa, or reserpine because their effectiveness may be decreased by Gentex-LQ Solution

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

Use Gentex-LQ Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Gentex-LQ Solution by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Drinking extra fluids while you are taking Gentex-LQ Solution is recommended. Check with your doctor for instructions.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you miss a dose of Gentex-LQ Solution, 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 Gentex-LQ Solution.

Important safety information:

  • Gentex-LQ Solution may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Gentex-LQ Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not use medicines that may cause drowsiness (eg, sleep adis, muscle relaxers) while you are using Gentex-LQ Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicine may cause drowsiness.
  • Do not take appetite suppressants while you are taking Gentex-LQ Solution without checking with your doctor.
  • Gentex-LQ Solution has phenylephrine, carbetapentane, and guaifenesin in it. Before you start any new medicine, check the label to see if it has phenylephrine, carbentapentane, or guaifenesin in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do not use Gentex-LQ Solution for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
  • 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 become worse, check with your doctor.
  • If your cough persists for more than 1 week or is accompanied by a fever, rash, headache, or sore throat, contact your health care provider. A persistent cough could be a sign of a serious condition.
  • Gentex-LQ Solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Gentex-LQ Solution.
  • Tell your doctor or dentist that you take Gentex-LQ Solution before you receive any medical or dental care, emergency care, or surgery.
  • Use Gentex-LQ Solution with caution in the ELDERLY; they may be more sensitive to its effects.
  • Caution is advised when using Gentex-LQ Solution in CHILDREN; they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gentex-LQ Solution while you are pregnant. It is not known if Gentex-LQ Solution is found in breast milk. Do not breast-feed while taking Gentex-LQ Solution.

Possible side effects of Gentex-LQ Solution:

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:

Diarrhea; dizziness; excitability; headache; irritability; nausea; trouble sleeping.

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); difficulty urinating; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, anxiety, nervousness); paleness; seizures; severe or persistent dizziness, lightheadedness, or headache; tremor.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include bizarre behavior; blurred vision; confusion; difficulty urinating; fast or shallow breathing; hallucinations; paleness; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Gentex-LQ Solution:

Store Gentex-LQ Solution between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Gentex-LQ Solution out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Gentex-LQ Solution. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

30/06/10

Gentamicin/

Prednisolone

Generic Name: Gentamicin/Prednisolone (jen-ta-MYE-sin/pred-NISS-oh-lone)
Brand Name: Pred-G

Gentamicin/Prednisolone is used for:

Treating inflammation (swelling, warmth, redness, pain) of the eyes and eyelids when infection or risk of infection is present.

Gentamicin/Prednisolone is an antibiotic and corticosteroid combination. The antibiotic works by killing sensitive bacteria. Exactly how the corticosteroid works is unknown.

Do NOT use Gentamicin/Prednisolone if:

  • you are allergic to any ingredient in Gentamicin/Prednisolone or to other corticosteroids (eg, prednisone)
  • you have a viral infection of the eye (eg, herpes), a fungal or tuberculosis infection of the eye, certain untreated eye infections (eg, infections producing pus or discharge), or vaccinia or chickenpox infection

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

Before using Gentamicin/Prednisolone:

Some medical conditions may interact with Gentamicin/Prednisolone. 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 thinning of the eye tissues (eg, cornea, sclera), other eye problems (eg, glaucoma, cataracts, nerve damage), or diabetes
  • if you have certain untreated eye infections (eg, infections producing pus or discharge) or if you have recently had cataract surgery

Some MEDICINES MAY INTERACT with Gentamicin/Prednisolone. Because little, if any, of Gentamicin/Prednisolone is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Gentamicin/Prednisolone 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 Gentamicin/Prednisolone:

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

  • Shake well before each use.
  • To use Gentamicin/Prednisolone in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
  • To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
  • Soft contact lenses may absorb a chemical in Gentamicin/Prednisolone. Do not wear contact lenses while you are using Gentamicin/Prednisolone. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
  • If your doctor prescribed more than 1 eye medicine, find out the best order for using each medicine.
  • If you miss a dose of Gentamicin/Prednisolone, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Gentamicin/Prednisolone.

Important safety information:

  • If your symptoms do not get better within 2 days or if they get worse, check with your doctor.
  • Lab tests, including eye pressure, may be performed while you use Gentamicin/Prednisolone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Gentamicin/Prednisolone should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gentamicin/Prednisolone while you are pregnant. It is not known if Gentamicin/Prednisolone is found in breast milk after use in the eye. Do not breast-feed while using Gentamicin/Prednisolone.

Possible side effects of Gentamicin/Prednisolone:

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:

Mild burning or stinging.

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); changes in vision; eye pain, itching, redness, swelling, irritation, or sores not present when you began using Gentamicin/Prednisolone.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Gentamicin/Prednisolone:

Store Gentamicin/Prednisolone at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Avoid temperature above 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Gentamicin/Prednisolone out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Gentamicin/Prednisolone. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Gentasol

30/06/10

Generic Name: gentamicin ophthalmic (JEN ta MYE sin off THAL mik)
Brand Names: Garamycin Ophthalmic, Gentak, Gentasol, Ocu-Mycin

What is Gentasol (gentamicin ophthalmic)?

Gentamicin ophthalmic is an antibiotic.

Gentamicin ophthalmic is used to treat bacterial infections of the eyes.

Gentamicin 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 Gentasol (gentamicin 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.

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 ducts.

Who should not use Gentasol (gentamicin ophthalmic)?

Do not use gentamicin ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only. It is not known whether gentamicin ophthalmic will harm an unborn baby. Do not use gentamicin ophthalmic without first talking to your doctor if you are pregnant. It is also not known whether gentamicin ophthalmic passes into breast milk. Do not use gentamicin ophthalmic without first talking to your doctor if you are breast-feeding a baby.


How should I use Gentasol (gentamicin ophthalmic)?

Use gentamicin 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 the 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 the 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 gentamicin ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

What happens if I miss a dose?

Use 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 use 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 Gentasol (gentamicin ophthalmic)?

Use caution when driving, operating machinery, or performing other hazardous activities. Gentamicin ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment. After applying this medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with gentamicin ophthalmic unless otherwise directed by your doctor.

Gentasol (gentamicin ophthalmic) side effects

Serious side effects are not expected to occur during treatment with this medication.

Commonly, some eye 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 Gentasol (gentamicin ophthalmic)?

Do not use other eye drops or medications during treatment with gentamicin ophthalmic unless otherwise directed by your doctor.

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

Where can I get more information?

  • Your pharmacist has additional information about gentamicin ophthalmic written for health professionals that you may read.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 5.02. Revision Date: 4/12/2009 4:42:12 PM.

 

Gentasol Drops

30/06/10

Generic Name: Gentamicin (jen-ta-MYE-sin)
Brand Name: Examples include Gentasol and Gentak

Gentasol Drops are used for:

Treating surface eye infections caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Gentasol Drops are a topical antibiotic. It works by slowing the growth of, or killing, sensitive bacteria.

Do NOT use Gentasol Drops if:

  • you are allergic to any ingredient in Gentasol Drops

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

Before using Gentasol Drops:

Tell your health care provider 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

Some MEDICINES MAY INTERACT with Gentasol Drops. Because little, if any, of Gentasol Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Gentasol Drops 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 Gentasol Drops:

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

  • Gentasol Drops are for use in the eye. Avoid contact with other mucous membranes.
  • Soft contact lenses may absorb a chemical in Gentasol Drops. Do not wear contact lenses while you are using Gentasol Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
  • To use Gentasol Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
  • To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
  • To clear up your infection completely, use Gentasol Drops for the full course of treatment. Keep using it even if you feel better in a few days.
  • Using Gentasol Drops at the same times each day will help you to remember to use it.
  • If you miss a dose of Gentasol Drops, use 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 use 2 doses at once.

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

Important safety information:

  • Gentasol Drops may cause blurred vision. Use Gentasol Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Gentasol Drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
  • Be sure to use Gentasol Drops 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 Gentasol Drops 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.
  • Do not use Gentasol Drops for future eye problems without checking with your doctor.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gentasol Drops while you are pregnant. If you are or will be breast-feeding while you use Gentasol Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gentasol Drops:

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:

Bloodshot eye; burning or stinging of the eye.

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); delayed healing of the cornea; hallucinations; redness, itching or swelling of the eyelids; ulcers of the cornea.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Gentasol Drops:

Store Gentasol Drops at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, light, and moisture. Do not freeze. Keep Gentasol Drops out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Gentasol Drops. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

GentaVed

30/06/10

Generic Name: gentamicin sulfate and betamethasone valerate
Dosage Form: FOR ANIMAL USE ONLY

GentaVed Topical Spray

Principal Display Panel

Front Panel

GentaVed
Topical Spray

(GENTAMICIN SULFATE WITH
BETAMETHASONE VALERATE)

TOPICAL SPRAY
VETERINARY

Net Contents: 60 mL

VEDCO

Caution: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

ANADA 200-388, Approved by FDA

Each mL contains: gentamicin sulfate
equivalent to 0.57 mg gentamicin base,
betamethasone valerate equivalent to
0.284 mg betamethasone, 163 mg
isopropyl alcohol, propylene glycol,
methylparaben and propylparaben as
preservatives, purified water q.s.
Hydrochloric acid may be added to adjust pH.

For topical use in dogs only.

Usual dose: Two depressions of the
sprayer head 2 to 4 times daily for 7 days.

Keep out of Reach of Children.
For animal use only.

Read accompanying directions carefully.
Store upright between 2oC and 30oC
(36oF and 86oF)

Manufactured For
VEDCO, INC.
St. Joseph, MO 64507

Description

DESCRIPTION: Each mL contains: gentamicin sulfate equivalent to 0.57 mg
gentamicin base, betamethasone valerate equivalent to 0.284 mg betamethasone,
163 mg isopropyl alcohol, propylene glycol, methylparaben and propylparaben as
preservatives, purified water q.s. Hydrochloric acid may be added to adjust pH.

Chemistry, Pharmacology and Toxicity

CHEMISTRY: Gentamicin is a mixture of aminoglycoside antibiotics derived from the
fermentation of Micromonospora purpurea. Gentamicin sulfate is a mixture of sulfate
salts of the antibiotics produced in this fermentation. The salts are weakly acidic
and freely soluble in water.

Gentamicin sulfate contains not less than 500 micrograms of gentamicin base per
milligram.

Betamethasone valerate is a synthetic glucocorticoid.

PHARMACOLOGY: Gentamicin, a broad-spectrum antibiotic, is a highly
effective topical treatment for bacterial infection of the skin In vitro,
gentamicin is bactericidal against a wide variety of gram-positive and gram-
negative bacteria isolated from domestic animals. 1,2 Specifically, gentamicin is
active against the following organisms isolated from canine skin: Alcaligenes
sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, indole-positive
and -negative Proteus sp., Escherichia coli, Enterobacter sp.,  Staphlyococcus sp.
and Streptococcus sp.

Betamethasone valerate emerged from intensive research as the most
promising of some 50 newly synthesized corticosteroids in the
experimental model described by McKenzie,3 et al. This human bioassay
technique has been found reliable for evaluating vasoconstrictor
properties of new topical corticosteroids and is useful in predicting clinical
efficacy.

Betamethasone valerate in veterinary medicine has been shown to provide
anti-inflammatory and antipruritic activity in the topical management of
corticosteroid-responsive infected superficial lesions in dogs.

TOXICITY: Gentamicin sulfate with betamethasone valerate topical spray
was well-tolerated in an abraded skin study in dogs. No treatment-related
toxicological changes in the skin were observed.

Systemic effects directly related to treatment were confined to histological
changes in the adrenals, liver and kidney and to organ-to-body
weight ratios of adrenals. All were dose related, were typical for or not
unexpected with corticosteroid therapy and were considered reversible
with cessation of treatment.





Warning

WARNING: Clinical and experimental data have demonstrated that
corticosteroids administered orally or parenterally to animals may induce the
first stage of parturition when administered during the last trimester of
pregnancy and may precipitate premature parturition followed by dystocia,
fetal death, retained placenta and metritis.

Additionally, corticosteroids administered to dogs, rabbits and rodents
during pregnancy have produced cleft palate. Other congenital anomalies,
including deformed forelegs, phocomelia and anasarca, have been
reported in offspring of dogs which received corticosteroids during
pregnancy.

Indications and contraindications

INDICATIONS: For the treatment of infected superficial lesions in dogs
caused by bacteria susceptible to gentamicin.

CONTRAINDICATIONS: If hypersensitivity of any of the components
occurs, discontinue treatment and institute appropriate therapy.

Dosage and Administration:

DOSAGE AND ADMINISTRATION: Prior to treatment, remove excessive
hair and clean the lesion and adjacent area. Hold bottle upright 3 to 6
inches from the lesion and depress the sprayer head twice. Administer 2
to 4 times daily for 7 days.

Each depression of the sprayer head delivers 0.7 mL of Gentamicin
Sulfate With Betamethasone Valerate Topical Spray.

Side Effects and Precautions

SIDE EFFECTS: Side effects such as SAP and SGPT enzyme
elevations, weight loss, anorexia, polydipsia and polyuria have occurred
following parenteral or systemic use of synthetic corticosteroids in dogs.
Vomiting and diarrhea (occasionally bloody) have been observed in dogs.

Cushing’s syndrome in dogs has been reported in association with
prolonged or repeated steroid therapy.

PRECAUTIONS: Antibiotic susceptibility of the pathogenic organism(s)
should be determined prior to use of this preparation. Use of topical
antibiotics may permit overgrowth of non-susceptible bacteria, fungi or
yeasts. If this occurs, treatment should be instituted with other
appropriate agents as indicated.

Administration of recommended dose beyond 7 days may result in
delayed wound healing. Animals treated longer than 7 days should be
monitored closely.

Avoid ingestion. Oral or parenteral use of corticosteroids, depending on
dose, duration and specific steroid may result in inhibition of endogenous
steroid production following drug withdrawal.

In patients presently receiving or recently withdrawn from systemic
corticosteroids treatments, therapy with a rapidly acting corticosteroid
should be considered in especially stressful situations.

If ingestion should occur, patients should be closely observed for the
usual signs of adrenocorticoid overdosage, which includes sodium
retention, potassium loss, fluid retention, weight gains, polydipsia and/or
polyuria. Prolonged use or overdosage may produce adverse
immunosuppressive effects.

How Supplied and Storage

HOW SUPPLIED: Plastic spray bottles containing 60 mL, 120 mL and
240 mL of Gentamicin Sulfate with Betamethasone Valerate Topical Spray.

Store upright between 2oC and 30oC (36oF and 86oF).

References

REFERENCES:

1. Hennessy, PW, et al. In vitro activity of gentamicin against bacteria
isolated from domestic animals.  Veterinary Medicine/Small Animal
Clinician. November 1971; 1118-1122.

2. Bachmann, HJ, et al. Comparative in vitro activity of gentamicin and
other antibiotics against bacteria isolated from clincial samples from
dogs, cats, horses and cattle. Veterinary Medicine/Small Animal
Clinician. October 1975; 1218-1222.

3. McKenzie, HW and Atkinson, RM. Topical activities of betamethasone
esters in Man. Arch Derm. May 1964;741-746.

June 2009

Manufactured for: VEDCO INC.
St. Joseph, MO 64507

Bottle Label Image

Bottle Label

GentaVed TOPICAL SPRAY 
gentamicin sulfate and betamethasone valerate  spray
Product Information
Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 50989-712
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE (GENTAMICIN) GENTAMICIN 0.57 mg  in 1 mL
BETAMETHASONE VALERATE (BETAMETHASONE) BETAMETHASONE 0.284 mg  in 1 mL
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 163 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
METHYLPARABEN  
PROPYLPARABEN  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 50989-712-19 12 BOTTLE In 1 BOX contains a BOTTLE
1 60 mL In 1 BOTTLE This package is contained within the BOX (50989-712-19)
2 50989-712-75 12 BOTTLE In 1 BOX contains a BOTTLE
2 120 mL In 1 BOTTLE This package is contained within the BOX (50989-712-75)
3 50989-712-43 12 BOTTLE In 1 BOX contains a BOTTLE
3 240 mL In 1 BOTTLE This package is contained within the BOX (50989-712-43)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200388 11/15/2009

Labeler - Vedco, Inc. (021634266)
Registrant - American Animal Health, Inc. (102617875)
Establishment
Name Address ID/FEI Operations
American Pharmaceuticals and Cosmetics, Inc. 038023805 manufacture, analysis

Revised: 11/2009Vedco, Inc.








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