Naproxen Merck

Naproxen Merck may be available in the countries listed below.

Ingredient matches for Naproxen Merck

Naproxen

Naproxen is reported as an ingredient of Naproxen Merck in the following countries:

• Netherlands

International Drug Name Search

TobraDex

Generic Name: tobramycin and dexamethasone

Dosage Form: ophthalmic suspension
TobraDex®

(tobramycin and dexamethasone ophthalmic suspension) Sterile

DESCRIPTION

TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.

The chemical structures for tobramycin and dexamethasone are presented below:

Tobramycin

Empirical Formula: C18H37N5O9

Chemical Name: O - 3 - Amino - 3 - deoxy - α - D - glucopyranosyl - (1→4) - O - [2,6 - diamino - 2,3,6 - trideoxy - α - D - ribo - hexopyranosyl - (1→6)] - 2 - deoxy - L - streptamine

Dexamethasone

Empirical Formula: C22H29FO5

Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione

Each mL of TobraDex® (tobramycin and dexamethasone ophthalmic suspension) contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactives: tyloxapol, edetate disodium, sodium chloride, hydroxyethyl cellulose, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH) and purified water.

CLINICAL PHARMACOLOGY

Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid.

The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms:

Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain susceptible to tobramycin.

No data are available on the extent of systemic absorption from TobraDex® (tobramycin and dexamethasone ophthalmic suspension); however, it is known that some systemic absorption can occur with ocularly applied drugs. If the maximum dose of TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is given for the first 48 hours (two drops in each eye every 2 hours) and complete systemic absorption occurs, which is highly unlikely, the daily dose of dexamethasone would be 2.4 mg. The usual physiologic replacement dose is 0.75 mg daily. If TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is given after the first 48 hours as two drops in each eye every 4 hours, the administered dose of dexamethasone would be 1.2 mg daily.

INDICATIONS AND USAGE

TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:

Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

CONTRAINDICATIONS

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

WARNINGS

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction does occur, discontinue use.

Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

PRECAUTIONS

General

The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. When multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the contents. Contact lenses should not be worn during the use of this product.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted to evaluate the carcinogenic or mutagenic potential. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100 mg/kg/day.

Pregnancy Category C

Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy. Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. TobraDex® (tobramycin and dexamethasone ophthalmic suspension) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available. The most frequent adverse reactions to topical ocular tobramycin [TOBREX® (tobramycin ophthalmic solution)] are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection. The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

OVERDOSAGE

Clinically apparent signs and symptoms of an overdosage of TobraDex® (tobramycin and dexamethasone ophthalmic suspension) punctate keratitis, erythema, increased lacrimation, edema and lid itching may be similar to adverse reaction effects seen in some patients.

DOSAGE AND ADMINISTRATION

One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

HOW SUPPLIED

Sterile ophthalmic suspension in 2.5 mL (NDC 0065-0647-25), 5 mL (NDC 0065-0647-05) and 10 mL (NDC 0065-0647-10) DROP-TAINER® dispensers.

STORAGE: Store at 8°-27°C (46°-80°F).

Store suspension upright and shake well before using.

Rx Only

©2002, 2006, 2010 Alcon, Inc.

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Printed in USA

Revised: April 2010

9001599-0410

PRINCIPAL DISPLAY PANEL

NDC 0065-0647-25

Alcon®

TobraDex®

(tobramycin and

dexamethasone

ophthalmic

suspension)

2.5 mL           Sterile

TobraDex  tobramycin and dexamethasone  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0647 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 3 mg  in 1 mL DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   TYLOXAPOL   EDETATE DISODIUM   SODIUM CHLORIDE   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   SODIUM SULFATE   SULFURIC ACID   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0065-0647-25 2.5 mL In 1 BOTTLE, PLASTIC None 2 0065-0647-05 5 mL In 1 BOTTLE, PLASTIC None 3 0065-0647-10 10 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050592	09/15/1988

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 07/2011Alcon Laboratories, Inc.

More TobraDex resources

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

• TobraDex Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• TobraDex ST Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Tobradex Advanced Consumer (Micromedex) - Includes Dosage Information


• Tobradex Consumer Overview

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Fluoxetine

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Ranitex

Ranitex may be available in the countries listed below.

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Ranitidine

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Donadin

Donadin may be available in the countries listed below.

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Povidone Iodine

Povidone-Iodine is reported as an ingredient of Donadin in the following countries:

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Bismuth

CAS registry number (Chemical Abstracts Service)

0007440-69-9

Chemical Formula

Bi

Molecular Weight

208

Therapeutic Categories

Dermatological agent

Astringent agent

Treatment of peptic ulcer

Antidiarrhoeal agent

Intestinal adsorbent

Foreign Names

• Bismutum (Latin)
• Bismut (German)
• Bismuth (French)

Generic Names

• Bismuth-209 (IS)
• EINECS 231-177-4 (IS)
• HSDB 2078 (IS)
• Bismuth-campho-carbonicum (IS)
• Bismuth-subcamphocarbonicum (IS)
• Bismutum camphocarbonicum (IS)
• Cardyl (IS)
• Solmuth (IS)
• Wismutcamphercarbonat (IS)
• Wismut-tris (IS: D-2-oxo-3-bornancarboxylat)

Brand Names

• Bismorectal
  Vifor, Switzerland



• Bismutol
  Cofana, Peru



• Amygdorectol
  Actipharm, Switzerland



• Amygdorectol (pediatric)
  Actipharm, Switzerland



• Bismutal (Bismuth and Guaifenesin)
  Rougier, Canada



• Rectamigdol
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International Drug Name Search

Glossary

IS	Inofficial Synonym

Click for further information on drug naming conventions and International Nonproprietary Names.

Morphine Suspension

Pronunciation: MOR-feen
Generic Name: Morphine
Brand Name: DepoDur

Morphine Suspension is used for:

Treating pain following surgery. It may also be used for other conditions as determined by your doctor.

Morphine Suspension is a narcotic pain reliever. It works in the brain to decrease pain. It may also affect other body systems (eg, breathing and circulatory systems) at higher doses.

Do NOT use Morphine Suspension if:

• you are allergic to any ingredient in Morphine Suspension


• you have severe diarrhea, bowel problems caused by antibiotics or food poisoning, a blockage of your stomach or bowel, or certain other severe bowel problems (eg, bowel paralysis)


• you have difficult or slowed breathing, severely decreased blood circulation (circulatory shock), a recent head injury, growths in the brain (eg, tumors), or increased pressure in the brain


• if you have severe asthma, or if you are having an asthma attack


• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or if you have taken an MAOI within the past 14 days


• you are taking sodium oxybate (GHB)

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

Before using Morphine Suspension:

Some medical conditions may interact with Morphine Suspension. 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 lung or breathing problems (eg, asthma, emphysema, bronchitis, chronic obstructive pulmonary disease [COPD]), sleep apnea (you stop breathing when you sleep), curvature of the spine (eg, kyphoscoliosis), heart problems (eg, cor pulmonale), low blood pressure, dehydration, or low blood volume


• if you have liver problems, kidney problems, adrenal gland problems (eg, Addison disease), an underactive thyroid, a blockage of your bladder, an enlarged prostate, or trouble urinating


• if you have a history of bowel blockage or other stomach or bowel problems (eg, inflammation), pancreas or gallbladder problems, or recent stomach or bowel surgery


• if you have severe drowsiness or a history of seizures (eg, epilepsy)


• if you drink alcohol regularly, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts


• if you have a personal or family history of mental or mood problems, alcohol abuse, or other substance abuse or dependence


• if you are in poor health or are overweight

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

• Antiemetics (eg, metoclopramide), phenothiazines (eg, chlorpromazine), sleeping medicines (eg, zolpidem), or tranquilizers (eg, olanzapine) because the risk of breathing problems, low blood pressure, severe drowsiness, or coma may be increased


• Barbiturate anesthetics (eg, thiopental), cimetidine, MAOIs (eg, phenelzine), muscle relaxants (eg, carisoprodol), or sodium oxybate (GHB) because the risk of confusion, severe drowsiness, severe breathing problems, and coma may be increased


• Mixed narcotic agonists/antagonists (eg, pentazocine), naltrexone, or rifampin because they may decrease Morphine Suspension's effectiveness


• Diuretics (eg, furosemide, hydrochlorothiazide) or trovafloxacin because their effectiveness may be decreased by Morphine Suspension

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

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

• Morphine Suspension is usually given as an injection at your doctor's office, hospital, or clinic.


• If you miss a dose of Morphine Suspension contact your doctor.

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

Important safety information:

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


• Do not drink alcohol while you are using Morphine Suspension.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Morphine Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Morphine Suspension may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Tell your doctor or dentist that you received Morphine Suspension before you have any medical or dental care, emergency care, or surgery.


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


• Use Morphine Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially severe breathing problems.


• Morphine Suspension should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these 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 Morphine Suspension while you are pregnant. Morphine Suspension is found in breast milk. Check with your doctor to see whether or not you should breast-feed within 48 hours after receiving Morphine Suspension.

When used for long periods of time or at high doses, Morphine Suspension may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Morphine Suspension stops working well. Do not take more than prescribed.

Some people who use Morphine Suspension for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Morphine Suspension suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Morphine Suspension:

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; dizziness; drowsiness; headache; lightheadedness; nausea; 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); confusion; delirium; difficulty urinating; disorientation; fainting; fast, slow, or irregular heartbeat; fever; flushing of the face; hallucinations; mood or mental changes; numbness or tingling; seizures; severe dizziness or lightheadedness; severe drowsiness; severe or persistent vomiting or constipation, shortness of breath; slowed or difficult breathing; tremor; trouble sleeping; unusual sweating; vision changes.

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.

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 cold and clammy skin; convulsions; deep sleep; dizziness; lightheadedness; loss of consciousness; severe drowsiness; slowed breathing; slowed heartbeat.

Proper storage of Morphine Suspension:

Morphine Suspension is usually handled and stored by a health care provider. If you are using Morphine Suspension at home, store Morphine Suspension as directed by your pharmacist or health care provider.

General information:

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


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


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


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

This information is a summary only. It does not contain all information about Morphine Suspension. 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.