Ophtamycetine 0.5%
Ophtamycetine 0.5% Uses, Dosage, Side Effects, Food Interaction and all others data.
Ophtamycetine 0.5% inhibits bacterial protein synthesis by binding to 50s subunit of the bacterial ribosome, thus preventing peptide bond formation by peptidyl transferase. It has both bacteriostatic and bactericidal action against H. influenzae, N. meningitidis and S. pneumoniae.
Ophtamycetine 0.5% is a broad-spectrum antibiotic that was derived from the bacterium Streptomyces venezuelae and is now produced synthetically. Ophtamycetine 0.5% is effective against a wide variety of microorganisms, but due to serious side-effects (e.g., damage to the bone marrow, including aplastic anemia) in humans, it is usually reserved for the treatment of serious and life-threatening infections (e.g., typhoid fever). Ophtamycetine 0.5% is bacteriostatic but may be bactericidal in high concentrations or when used against highly susceptible organisms. Ophtamycetine 0.5% stops bacterial growth by binding to the bacterial ribosome (blocking peptidyl transferase) and inhibiting protein synthesis.
| Trade Name | Ophtamycetine 0.5% |
| Availability | Prescription only |
| Generic | Chloramphenicol |
| Chloramphenicol Other Names | Chloramphénicol, Chloramphenicol, Chloramphenicolum, Chlornitromycin, Cloramfenicol, Cloranfenicol, Laevomycetinum, Levomicetina, Levomycetin |
| Related Drugs | amoxicillin, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin, triamcinolone |
| Type | |
| Formula | C11H12Cl2N2O5 |
| Weight | Average: 323.129 Monoisotopic: 322.012326918 |
| Protein binding | Plasma protein binding is 50-60% in adults and 32% is premature neonates. |
| Groups | Approved, Vet approved |
| Therapeutic Class | Ear Anti-Infectives & Antiseptics, Eye Anti-Infectives & Antiseptics |
| Manufacturer | |
| Available Country | Egypt |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Ophtamycetine 0.5% is used for Ocular infections, Bacterial meningitis, Anaerobic bacterial infections, Anthrax, Brain abscess, Ehrlichiosis, Gas gangrene, Granuloma inguinale, Infections caused by H. influenzae, Listeriosis, Plague, Psittacosis, Q fever, Severe gastroenteritis, Severe melioidosis, Severe systemic infections with Camphylobacter fetus, Tularaemia, Whipple's disease, Otitis externa
Ophtamycetine 0.5% is also used to associated treatment for these conditions: Acne, Bacterial Conjunctivitis, Bacterial Conjunctivitis caused by susceptible bacteria, Bacterial Infections, Bacterial dacryocystitis, Bacterial diarrhoea, Conjunctivitis allergic, Corneal Inflammation, Eye swelling, Keratitis bacterial, Ocular Inflammation, Trachoma, Anterior eye segment inflammation, Bacterial blepharitis, Bacterial corneal ulcers, Non-purulent ophthalmic infections caused by susceptible bacteria, Superficial ocular infections, Skin disinfection
How Ophtamycetine 0.5% works
Ophtamycetine 0.5% is lipid-soluble, allowing it to diffuse through the bacterial cell membrane. It then reversibly binds to the L16 protein of the 50S subunit of bacterial ribosomes, where transfer of amino acids to growing peptide chains is prevented (perhaps by suppression of peptidyl transferase activity), thus inhibiting peptide bond formation and subsequent protein synthesis.
Dosage
Ophtamycetine 0.5% dosage
For Eye: Adults, children and infants (all age groups): One or two drops 4 to 6 times a day should be placed in the infected eyes. If necessary the frequency of dose can be increased. 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.
For Ear: 2 to 3 drops into ear canal thrice or four times daily.
Otic/Aural: Otitis externa:Instill 2-3 drops of a 5% solution into the ear bid-tid.
Oral:Bacterial meningitis, Anaerobic bacterial infections, Anthrax, Brain abscess, Ehrlichiosis, Gas gangrene, Granuloma inguinale, Infections caused by H. influenzae, Listeriosis, Plague, Psittacosis, Q fever, Severe gastroenteritis, Severe melioidosis, Severe systemic infections with Camphylobacter fetus, Tularaemia, Whipple's disease:
- Adult:50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
- Child:Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 wk: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Side Effects
Oral: GI symptoms; bleeding; peripheral and optic neuritis, visual impairment, blindness; encephalopathy, confusion, delirium, mental depression, headache. Haemolysis in patients with G6PD deficiency.
ophthalmic application: Hypersensitivity reactions including rashes, fever and angioedema.
Ear drops: Ototoxicity.
Toxicity
Oral, mouse: LD50 = 1500 mg/kg; Oral, rat: LD50 = 2500 mg/kg. Toxic reactions including fatalities have occurred in the premature and newborn; the signs and symptoms associated with these reactions have been referred to as the gray syndrome. Symptoms include (in order of appearance) abdominal distension with or without emesis, progressive pallid cyanosis, vasomotor collapse frequently accompanied by irregular respiration, and death within a few hours of onset of these symptoms.
Precaution
Impaired renal or hepatic function; premature and full-term neonates. Monitor plasma concentrations to avoid toxicity.
Interaction
Decreased effects of iron and vitamin B12 in anaemic patients. Phenobarbitone and rifampin reduce efficacy of chloramphenicol. Impairs the action of oral contraceptives.
Food Interaction
- Take on an empty stomach.
Ophtamycetine 0.5% Drug Interaction
Moderate: cyanocobalamin, cyanocobalaminUnknown: aspirin, aspirin, epinephrine, epinephrine, sulfamethoxazole / trimethoprim, sulfamethoxazole / trimethoprim, glycerin, glycerin, acetaminophen, acetaminophen, valproic acid, valproic acid, pyridoxine, pyridoxine, cholecalciferol, cholecalciferol, phytonadione, phytonadione
Ophtamycetine 0.5% Disease Interaction
Major: colitis, bone marrow suppression, renal/liver disease
Elimination Route
Rapidly and completely absorbed from gastrointestinal tract following oral administration (bioavailability 80%). Well absorbed following intramuscular administration (bioavailability 70%). Intraocular and some systemic absorption also occurs after topical application to the eye.
Half Life
Half-life in adults with normal hepatic and renal function is 1.5 - 3.5 hours. In patients with impaired renal function half-life is 3 - 4 hours. In patients with severely impaired hepatic function half-life is 4.6 - 11.6 hours. Half-life in children 1 month to 16 years old is 3 - 6.5 hours, while half-life in infants 1 to 2 days old is 24 hours or longer and is highly variable, especially in low birth-weight infants.
Pregnancy & Breastfeeding use
Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Contraindication
History of hypersensitivity or toxic reaction to the drug; pregnancy, lactation; porphyria; parenteral admin for minor infections or as prophylaxis; preexisting bone marrow depression or blood dyscrasias.
Storage Condition
Cap/susp: Store at temp not exceeding 30°C.
Ophth/otic preparation: Store between 2-8°C. Do not freeze. Protect from light.
Innovators Monograph
You find simplified version here Ophtamycetine 0.5%
Ophtamycetine 0.5% contains Chloramphenicol see full prescribing information from innovator Ophtamycetine 0.5% Monograph, Ophtamycetine 0.5% MSDS, Ophtamycetine 0.5% FDA label
FAQ
What is Ophtamycetine 0.5% used for?
Ophtamycetine 0.5% is an antibiotic useful for the treatment of a number of bacterial infections. This includes use as an eye ointment to treat conjunctivitis. By mouth or by injection into a vein, it is used to treat meningitis, plague, cholera, and typhoid fever. It's mainly used to treat eye infections (such as conjunctivitis) and sometimes ear infections.
How safe is Ophtamycetine 0.5%?
Ophtamycetine 0.5% is safe for most adults and children. For most eye infections, you'll usually start to see an improvement within 2 days of using Ophtamycetine 0.5%. For ear infections, you should begin to feel better after a few days.
How does Ophtamycetine 0.5% work?
Ophtamycetine 0.5% is a bacteriostatic by inhibiting protein synthesis. It prevents protein chain elongation by inhibiting the peptidyl transferase activity of the bacterial ribosome.
What are the common side effects of Ophtamycetine 0.5%?
Common side effects of Ophtamycetine 0.5% are include:
- not enough red blood cells produced (aplastic anemia)
- bone marrow suppression
- diarrhea
- inflammation of the small intestine and the colon (enterocolitis)
- accumulation of chloramphenicol especially in newborns (gray syndrome)
- headache
- nausea
- nightmares
- inflammation of the optic nerve
- weakness and numbness in your hands and feet
- rash
- inflamed and sore mouth
- vomiting
Is Ophtamycetine 0.5% safe during pregnancy?
There is a wealth of clinical data demon-strating that Ophtamycetine 0.5% is safe to use in pregnancy if it is not circulating at the time of delivery, since the drug will cause gray syndrome in neonates. It does not seem to harm the fetus, however, which makes it safe to use during most of the pregnancy.
Is Ophtamycetine 0.5% safe during breastfeeding?
If Ophtamycetine 0.5% is considered the appropriate treatment it can be used as normal by breastfeeding mothers. Use of Ophtamycetine 0.5% during breastfeeding is considered to be of concern by the American Academy of Pediatrics; according to some experts, this drug should be avoided.
Can I drink alcohol with Ophtamycetine 0.5%?
Yes, you can drink alcohol with Ophtamycetine 0.5%.
Can I drive after taking Ophtamycetine 0.5%?
Ophtamycetine 0.5% shouldn't affect you being able to drive or cycle. However, if you experience stinging or burning immediately after applying the eye drops, do not drive or operate machinery immediately. Wait until your eyes are comfortable again and your vision is clear.
When should be taken of Ophtamycetine 0.5%?
Your doctor may recommend using eye ointment at bedtime and eye drops during the day.If you're using 1% Ophtamycetine 0.5% eye ointment, apply it to the affected eye every 3 hours. Do this 3 to 4 times a day, or as your doctor advises.
Can I take Ophtamycetine 0.5% on empty stomach?
Ophtamycetine 0.5% is best taken with a full glass of water on an empty stomach (either 1 hour before or 2 hours after meals), unless otherwise directed by your doctor.
Who should not take Ophtamycetine 0.5%?
If you have liver problems, decreased kidney function, a patient who is producing milk and breastfeeding, anemia due to depressed bone marrow you should not take Ophtamycetine 0.5%.
What happen if I overdose on Ophtamycetine 0.5%?
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How long does Ophtamycetine 0.5% take to work?
You'll usually start to see an improvement within 2 days of using Ophtamycetine 0.5%. For ear infections, you should begin to feel better after a few days. Your eyes may sting for a short time after using the eye drops or ointment.
What is the half-life of Ophtamycetine 0.5%?
The apparent half-life of Ophtamycetine 0.5% was extremely variable, ranging from 1.7 to 12.0 hours with a mean of 5.1 hours. Apparent half-lives were inversely correlated with age.
Can I take Ophtamycetine 0.5% for a long time?
Prolonged use of Ophtamycetine 0.5% eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms. If any new infection appears during the treatment, the antibiotic should be discontinued and appropriate measures taken.
How long can I take Ophtamycetine 0.5%?
Do not use them for more than 5 days, unless your doctor tells you to. This is because your eyes can become more sensitive or you could get another eye infection.
When should I stop taking Ophtamycetine 0.5%?
Eye ointment use the ointment until the eye appears normal and for 2 days afterwards. Do not use it for more than a week, unless your doctor tells you to. Ear drops use the drops for up to a week. Avoid using the medicine for longer than this unless your doctor tells you to.
What happen If I missed dose of Ophtamycetine 0.5%?
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Can Ophtamycetine 0.5% affect my fertility?
There's no firm evidence to suggest that taking chloramphenicol will reduce fertility in either men or women.
Can Ophtamycetine 0.5% affects my kidney?
Though Ophtamycetine 0.5% was found to be hepatotoxic, there is no strong evidence to suggest that Ophtamycetine 0.5% is nephrotoxic according to this study, There was no noticeable pathological changes observe from renal histopathology.
