Otophenicol

Otophenicol

  • Active Ingredient: Chloramphenicol
  • 500 mg, 250 mg
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What is Otophenicol?

The active ingredient of Otophenicol brand is chloramphenicol.

Used for

Otophenicol is used to treat diseases such as: Anthrax, Bacterial Infection, Brucellosis, Cholera, Glanders, Lemierre's Syndrome, Meningitis, Ornithosis, Plague, Psittacosis, Rabbit Fever, Rickettsial Infection.

Side Effect

Possible side effects of Otophenicol include: unusual bleeding or bruising; unresponsiveness; uneven breathing; Diarrhea; Bloated stomach.

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On this page

  1. About Otophenicol
  2. Key facts
  3. Who can and can't take Otophenicol
  4. How and when to use it
  5. Side effects
  6. Pregnancy and breastfeeding
  7. Cautions with other medicines
  8. Common questions

4. How and when to use it

Otophenicol comes in different strengths. How you apply the medicine depends on what you're taking it for and whether you're using the eye drops, eye ointment or ear drops.

If you're using 0.5% Otophenicol eye drops, put one drop into the affected eye every 2 hours (during waking hours) for the first 2 days. Then every 4 hours for the next 3 days, or as your doctor advises.

If you're using 1% Otophenicol eye ointment, apply it to the affected eye every 3 hours (during waking hours). Do this 3 to 4 times a day, or as your doctor advises.

With more severe infections, your doctor may recommend using eye ointment at bedtime and eye drops during the day. This is because the ointment sticks to the surface of the eye and eyelid and works while you sleep. The eye drops allow you to get on with your day as normal, as they don't affect your eyesight.

If you're using 5% or 10% Otophenicol ear drops, put 3 drops into the affected ear 2 to 3 times a day, or as your doctor advises.

To use the medicine:

  • always wash your hands before (and after) using Otophenicol - this prevents you from passing the infection to the other eye or ear
  • remove the cap just before using your medicine and replace it as soon as you've finished
  • do not touch the nozzle of the bottle or tube with your fingers
  • make sure the nozzle doesn't touch your eye or ear, or your skin
  • use a mirror to help you see what you are doing
  • tilt your head back or to the side to put drops in your eyes or ears

BRAND NAME: Chloromycetin, Econochlor, Ocu-Chlor (These are discontinued brands in the US)

DRUG CLASS AND MECHANISM: Otophenicol is a man-made antibiotic. It slows growth of bacteria by preventing them from producing important proteins that they need to survive. Otophenicol is effective against S. typhi, H. influenzae, E. coli, Neisseria species, Staphylococcus and Streptococcus species, Rickettsia, and lymphogranuloma-psittacosis group of organisms. The FDA approved Otophenicol in December 1950.

GENERIC AVAILABLE: Yes

PREPARATIONS: Otophenicol is available in 0.5% sterile eye drops and 1% eye ointment. Eye drops are available in 2.5 ml and 15 ml drop-containers. Ointments are available in 3.5 g tubes.

Otophenicol sodium succinate is available as 1 gram/10 ml per vial powder for intravenous injection form.

STORAGE: Otophenicol eye drops are refrigerated until dispensed. Otophenicol ointments are stored between 46 F and 80 F. Otophenicol vials for IV reconstitution are stored between 20 C and 25 C (68 F and 77 F).

PRESCRIBED FOR: Otophenicol treats various infections caused by susceptible strains of S. yphi, H. influenzae, E. coli, Neisseria species, Staphylococcus and Streptococcusspecies, Rickettsia, lymphogranuloma-psittacosis group of organisms, and other bacteria that cause bacteremia (bacteria in blood) and meningitis.

Eye drop solution:

  • Mild disease: Instill 1 to 2 drops into the affected eye(s) up to 4 times a day
  • Severe disease: Instill 2 hours into the affected eye(s) every hour until improvement.
  • Eye ointment: Apply a small amount to the affected lower conjunctival sac(s) at bedtime as a supplement to the drops.

  • Adults: 50 to 100 mg/kg IV every 6 hours.
  • Children: 50 mg/kg IV every 6 hours; may increase to 100 mg/kg IV every 6 hours in severe illness.
  • Newborn infants: 25 mg/kg IV every 6 hours. Newborns over 2 weeks old may receive 50 mg/kg every 6 hours.

DRUG INTERACTIONS: Otophenicol should not be used with lurasidone (Latuda) because Otophenicol significantly lowers lurasidone's metabolism and increases its levels in the body.

Otophenicol should be used cautiously with red yeast rice, warfarin (Coumadin), and vilazodone (Viibryd) because Otophenicol lowers their metabolism and increases those drug levels in the body.

PREGNANCY: There are no adequate studies done on Otophenicol to determine safe and effective use in pregnant women.

NURSING MOTHERS: Otophenicol enters breast milk. Therefore, it should not be used in nursing mothers.

SIDE EFFECTS: Side effects of Otophenicol are headache, mental confusion, fever, rash, diarrhea, and optic atrophy.

Otophenicol may cause Gray syndrome and serious, fatal blood dyscrasias. Gray syndrome occurs in pre-mature infants and neonates. It involves abdominal distention, pallid cyanosis, and vasomotor collapse leading to death. Blood dyscrasias are reductions in blood cells leading to aplastic anemia, thrombocytopenia, and granulocytopenia.

Anthrax

Alternative for treatment of anthrax†. 104 668 670 671 672 673 680 683

Has in vitro activity against Bacillus anthracis, 161 668 but limited clinical data exist regarding use in the treatment of anthrax. 668 680

Although Otophenicol has been suggested as an alternative for treatment of naturally occurring anthrax in patients hypersensitive to penicillins or as one of several options for use in multiple-drug regimens for treatment of anthrax, 670 WHO states Otophenicol is no longer recommended for such infections because evidence of in vivo efficacy in treatment of severe anthrax is lacking and the drug is associated with serious adverse effects. 680

For treatment of inhalational anthrax that occurs as the result of exposure to B. anthracis spores in the context of biologic warfare or bioterrorism, CDC, AAP, and the US Working Group on Civilian Biodefense recommend initial treatment with a multiple-drug parenteral regimen that includes a fluoroquinolone (preferably ciprofloxacin) or doxycycline and 1 or 2 additional anti-infectives predicted to be effective (e.g., clindamycin, rifampin, a carbapenem , Otophenicol, vancomycin, penicillin, ampicillin, linezolid, gentamicin, clarithromycin). 668 671 672 673 683

For treatment of systemic anthrax with possible or confirmed meningitis, CDC and AAP recommend a regimen of IV ciprofloxacin with an IV bactericidal anti-infective (preferably meropenem) and an IV protein synthesis inhibitor (preferably linezolid). 671 672 673 These experts recommend IV Otophenicol as a possible alternative to linezolid, but use only if clindamycin and rifampin not available. 671 672 673

Otophenicol

Otophenicol is an antibacterial agent with a broad spectrum of activity against gram-positive bacteria, gram-negative bacteria, and Rickettsia. Its mechanism of action is by inhibition of bacterial protein synthesis by binding with ribosomes.

The major toxicity of Otophenicol is hematological. 9 In all vertebrates studied, it produces direct, dose-dependent bone marrow depression resulting in reductions in red blood cells, white blood cells, and platelets. This manifestation is aggravated by inappropriate doses, extended treatments, and repeated use of the drug. Treatment of Otophenicol intoxication is supportive and may require blood transfusions. The drug has also been reported to be appetite suppressive. Like gentamicin, Otophenicol is being used less frequently as safer antibiotics become available. The recommended dosage for Otophenicol is 50 mg/kg IM (SC in snakes) administered once daily or every other day.

How to use Otophenicol Ointment

Do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to manufacturer's directions, and check with your doctor before you begin using them again.

To apply eye ointments, wash hands first. To avoid contamination, be careful not to touch the tube tip or let it touch your eye. Tilt your head back, look upward, and gently pull down the lower eyelid to make a pouch. Place a 1-centimeter strip of ointment into the pouch. Gently close the eye and roll the eyeball in all directions to spread the medication. Try not to blink and do not rub the eye.

Repeat these steps for your other eye if so directed. Apply as often as directed by your doctor. Wipe the tip of the ointment tube with a clean tissue to remove extra medication before recapping it.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Continue using it for the full time prescribed. Stopping the medication too soon may allow the bacteria to continue to grow, which may result in a return of the infection. Tell your doctor if your condition persists or worsens.

No adequate and well-controlled studies evaluating Otophenicol in pregnant women; 112 no animal reproduction studies. 112

Studies using oral Otophenicol (no longer available in US) indicate the drug crosses the placenta. 110 112

Use during late pregnancy and during labor has been associated with the gray syndrome and other adverse effects in the fetus or infant. 110 112 (See Gray Syndrome under Cautions.)

Because of potential toxic effects on the fetus, manufacturer states use Otophenicol during pregnancy only if potential benefits justify potentials risks to the fetus. 112

Dosage

Available as Otophenicol sodium succinate; dosage expressed in terms of Otophenicol. 112

Can Otophenicol eye preparations cause problems?

Otophenicol drops and ointment can occasionally cause mild eye irritation or stinging, but these usually soon pass and not everyone will experience them. If the irritation continues, or if you experience any other eye problems, please speak with your doctor or pharmacist for advice.

Hypersensitivity reactions, including anaphylaxis, 112 rash (macular and vesicular), 112 angioedema, 112 urticaria, 112 and fever, 112 reported in patients receiving Otophenicol.

Herxheimer-like reactions reported in patients receiving the drug for treatment of typhoid fever. 112

Otophenicol eye drops and eye ointment are used to treat bacterial eye infections. Eye infections are a common cause of conjunctivitis. In conjunctivitis, your eye becomes inflamed, feels gritty, and may water more than usual. The white of your eye may look red, and your eyelids can become swollen and stuck together with a discharge when you wake up in the morning. Only one eye may be infected to begin with, but it often spreads to both eyes.

A type of circulatory collapse, referred to as the gray syndrome, has occurred in neonates and premature infants receiving Otophenicol. 104 110 112 Most cases have occurred when the drug was initiated within first 48 hours of life; also reported in older infants and in infants born to mothers who received Otophenicol during late pregnancy or during labor. 110 112 (See Pediatric Use under Cautions.)

Similar syndrome has been reported in older children and adults following Otophenicol overdosage. 104 110

May occur because Otophenicol impairs myocardial contractility by directly interfering with myocardial tissue respiration and oxidative phosphorylation. 104 110 Has been attributed to high plasma concentrations of the drug. 104 110 112


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