Chloroptic (Chloramphenicol)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Chloroptic (Chloramphenicol)

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Chloroptic®
(chloramphenicol) Ophthalmic Solution, USP 0.5% sterile

WARNING

Bone marrow hypoplasia including aplastic anemia and death has been reported following topical application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.

DRUG DESCRIPTION

Chloroptic® (chloramphenicol ophthalmic solution, USP) is a topical anti-infective product for ophthalmic use.

Structural Formula

C11H12Cl12N205

Mol Wt 323.13

Chemical Name:

D-threo-(-)-2,2-Dichloro-N-143-hydroxy-a-(hydroxymethyl)..

p-nitrophenethyl] acetamide

Contains:

Active: chloramphenicol

0.5% (5mg/ml)

Preservative: chlorobutanol (chloral deny.) 0.5%;

Inactives: polyethylene glycol 300; polyoxyl 40 stearate; sodium hydroxide or hydrochloric acid to adjust PH; and purified water.

Last reviewed on RxList: 1/2/2005
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

INDICATIONS

Chioramphenicol should be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. (See Boxed Warning)

Chloroptic (chloramphenicol) is indicated for the treatment of surface ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms. Chloramphenicol is active against the following common bacterial eye pathogens: Staphylococcus aureus; streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzea, Klebsiella/Enterobacter species; Moraxella lacunata (Morax-Axenfeld bacillus); and Neisseria species. Chloramphenicol does not provide adequate coverage against: Pseudomonas aeruginosa or Serratia marcescens.

DOSAGE AND ADMINISTRATION

One or two drops 4 to 6 times a day for the first 72 hours should be placed in the lower conjunctival sac. Treatment should be continued for approximately 7 days but should not be continued for more than three weeks without re-evaluation by the prescribing physician.

HOW SUPPLIED

Chloroptic (chloramphenicol ophthalmic solution, USP) is supplied in the following sizes:

2.5 mL - NDC 11980-109-03

7.5 mL - NDC 11980-109-08

NOTE : Refrigerate until dispensed. Then store below 30°C (86F). Discard solution within 21 days from date dispensed.

U.S. Patent 3,702,364 Revised July 2000 ©2000 Allergan, Inc. Irvine, CA 92612

Last reviewed on RxList: 1/2/2005
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

SIDE EFFECTS

Exact incidence figures are not available since no denominator of treated patients is available.

The most serious reaction following prolonged or frequent intermittent use of topical chloramphenicol is bone marrow aplasia.

The most frequently reported adverse reactions have been burning, stinging, ocular irritation, and conjunctival hyperemia. Blood dyscrasias, allergic or inflammatory reactions due to individual hypersensitivity, angioneurotic edema, urticaria, vesicular and maculopapular dermatitis have also been reported (See Warnings and Box Warning).

Read the Chloroptic (chloramphenicol) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 1/2/2005
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

WARNINGS

SEE BOXED WARNING

Occasionally one sees hematopoietic toxicity with the use of systemic chloramphenicol, and rarely with topical administration. This type of blood dyscrasia is generally a dose-related toxic effect on bone marrow and is usually reversible on cessation of the drug. Rare cases of aplastic anemia have been reported with prolonged (months to years) or frequent intermittent (over months and years) use of topical chloramphenicol.

PRECAUTIONS

General

The prolonged use of antibiotics may occasionally result in overgrowth of nonsusceptible organisms, including fungi. If new infections appear during medication or clinical improvement is not observed within 1 week, the drug should be discontinued and appropriate measures should be taken.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies have been conducted in animals or in humans to evaluate the carcinogenic potential or effects on fertility with chloramphenicol. However, there is some clinical evidence that aplastic anemia due to chloramphenicol may be associated with subsequent development of leukemia.

Pregnancy

Pregnancy Category C. Chloramphenicol has been shown to be embryocidal and teratogenic in rat, mouse, rabbit and chicken embryos/fetuses (see below). There are no adequate and well-controlled studies in pregnant women. Chloramphenicol has been shown to cross the placental barrier, but it is not known whether chloramphenicol can cause fetal harm when administered to a pregnant woman. Chloramphenicol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Embryotoxic effects : Significantly lower numbers of live fetuses and an increase in the number of early embryonic resorptions occurred after pregnant rats were treated orally with 500 mg/kg (equivalent to 5800 times the recommended maximum daily adult topical ophthalmic dose) from days 5 to 15 of their pregnancy. Similar findings were seen with groups receiving higher oral doses (1000 mg/kg or 2000 mg/kg) at various dosing intervals. Female mice receiving 1000 mg/kg orally from days 6 to 12 of their pregnancy showed a significant increase in the number of resorptions. Female rabbits receiving the same oral dosing (1000 mg/kg) from days 8 to 11 had an increase in the number of resorptions of embryos without placentation. Chloramphenicol (2.5 mg) injected into chicken eggs resulted in a 20% embryo mortality rate one day after administration, which increased to 100% embryo mortality on the 11th day of incubation.

Teratogenicity : When given to female orally at 2000 mg/kg from days 6 to 8 of pregnancy, 36% of the fetuses exhibited either an omphalocele or an umbilical hernia, with costal fusions. Fetuses of the rats treated with 1000 mg/kg orally from days 7 to 12 of pregnancy or 2000 mg/kg from days 11 to 13, and of mice treated with 1000 mg/kg from days 6 to 12, had a higher incidence of missing ossification of the phalangeal nuclei of the forelegs and hindlegs; and of the 5th stemebra. This correlated with a decrease in the average weight of the fetuses. Rabbit fetuses displayed more frequent absence of the phalangeal nuclei of the forelegs than control when pregnant rabbits received 500 mg/kg orally on days 6 to 15 of pregnancy, More frequent missing ossification of the phalangeal nuclei of the forelegs and hindlegs and an increase in the number of unevenly ossified vertebrae was seen in the fetuses of rabbits when pregnant females were given 1000 mg/kg from days 6 to 9 of pregnancy.

Teratogenic effects of Chloramphenicol (0.5 mg when injected into chicken eggs, included malformations of the beak, eyes and legs.

Nursing Mothers

Chloramphenicol appears in human milk following oral administration of the drug. Systemic absorption of chloramphenicol may occur when applied topically. Because of the potential for serious, adverse reactions in nursing infants from chloramphenicol, 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

The safety and efficacy in pediatric patients below 1 year of age have not been established.

Geriatric Use

No overall difference in safety or effectiveness have been observed between elderly and younger, adult patients.

Last reviewed on RxList: 1/2/2005
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

OVERDOSE

No information available.

CONTRAINDICATIONS

This product is contraindicated in persons sensitive to any of its components.

Last reviewed on RxList: 1/2/2005
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

CLINICAL PHARMACOLOGY

Microbiology

Chloramphenicol is a broad-spectrum antibiotic originally isolated from Streptomyces venezuelae. It is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Chloramphenicol has been shown to be active against the following organisms:

Aerobic gram-positive microorganisms

Staphylococcus aureus

streptococci, including Streptococcus pneumoniae

Aerobic gram-negative microorganisms:

Enterobacter sp.

Escherichia coli

Haemophilus influenzae

Klebsiella sp.

Moraxella lucunata (Morax-Axenfeld bacillus)

Nesseria sp.

This product does not provide adequate coverage against Pseudomonas aeruginosa or Serratia marcescens.

Bacteriological studies should be performed to determine the causative organisms and their susceptibilities to chloramphenicol.

Last reviewed on RxList: 1/2/2005
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

PATIENT INFORMATION

Do not touch bottle tip to any surface as this may contaminate the solution.

Last reviewed on RxList: 1/2/2005
This monograph has been modified to include the generic and brand name in many instances.

>

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

PATIENT INFORMATION

Do not touch bottle tip to any surface as this may contaminate the solution.

Last reviewed on RxList: 1/2/2005
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Chloroptic Patient Information Including Side Effects

Brand Names: Chloroptic, Chloroptic S.O.P.

Generic Name: chloramphenicol ophthalmic (Pronunciation: klor am FEN i kole)

What is chloramphenicol ophthalmic (Chloroptic)?

Chloramphenicol is an antibiotic.

The ophthalmic form of chloramphenicol is used to treat bacterial infections of the eyes.

Chloramphenicol ophthalmic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of chloramphenicol ophthalmic (Chloroptic)?

Serious side effects are not expected with this medication. Rarely, prolonged use of this medication has damaged bone marrow. Call your doctor if you experience extreme fatigue or unusual bleeding or bruising.

More commonly, some burning, stinging, irritation, itching, redness, blurred vision, or sensitivity to light may occur. Continue to use chloramphenicol ophthalmic and talk to your doctor about any side effects that you experience.

Read the Chloroptic (chloramphenicol) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about chloramphenicol ophthalmic (Chloroptic)?

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 ducts.

Side Effects Centers

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Chloroptic Patient Information including How Should I Take

What should I discuss with my healthcare provider before using chloramphenicol ophthalmic (Chloroptic)?

Do not use chloramphenicol ophthalmic if you have a viral or fungal infection in your eye. It is used only to treat infections caused by bacteria.

It is not known whether chloramphenicol ophthalmic will harm an unborn baby. Do not use chloramphenicol ophthalmic without first talking to your doctor if you are pregnant.

It is also not known whether chloramphenicol ophthalmic passes into breast milk. Do not use chloramphenicol ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use chloramphenicol ophthalmic (Chloroptic)?

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

Side Effects Centers

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Chloroptic Patient Information including If I Miss a Dose

What happens if I miss a dose (Chloroptic)?

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 (Chloroptic)?

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 chloramphenicol ophthalmic (Chloroptic)?

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. Chloramphenicol 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.

What other drugs will affect chloramphenicol ophthalmic (Chloroptic)?

Avoid using other eyedrops or eye medications unless they are approved by your doctor.

Drugs other than those listed here may also interact with chloramphenicol 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 chloramphenicol 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 1996-2009 Cerner Multum, Inc. Version: 3.08. Revision date: 6/30/04.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com