Coly-Mycin S Otic

DRUG DESCRIPTION

Coly-Mycin« S Otic with Neomycin and Hydrocortisone (colistin sulfate with neomycin and hydrocortisone ) (colistin sulfateŚneomycin sulfateŚ thonzonium bromideŚhydrocortisone acetate otic suspension) is a sterile antibacterial and antiinflammatory aqueous suspension containing in each mL: Colistin base activity, 3 mg (as the sulfate); Neomycin base activity, 3.3 mg (as the sulfate); Hydrocortisone acetate, 10 mg (1%); Thonzonium bromide, 0.5 mg (0.05%); Polysorbate 80, acetic acid, and sodium acetate in a buffered aqueous vehicle. Thimerosal (mercury derivative), 0.002%, is added as a preservative. It is a nonviscous liquid, buffered at pH 5, for instillation into the canal of the external ear or direct application to the affected aural skin.

The structural formulas of colistin sulfate (mixture of Colistin A & B), neomycin sulfate (mixture of neomycin A, B & C), hydrocortisone acetate ((11?)-21-(acetyloxy)-11,17-dihydroxypregn) methyl]-2 pyrimidinylamino] ethyl]-N,N-dimethyl-1 hexadecanaminium, bromide) are represented below:

 Coly-Mycin«S Otic with Neomycin and Hydrocortisone (colistin sulfateŚneomycin sulfateŚthonzonium bromideŚhydrocortisone acetate) Structural Formula Illustration

What are the possible side effects of colistin, hydrocortisone, neomycin, and thonzonium (Coly Mycin S, Coly-Mycin S, Cortisporin-TC)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • skin rash, redness, swelling, itching, dryness, or scaling;
  • hearing loss; or
  • urinating less than usual or not at all.

This is not a complete list of side...

Read All Potential Side Effects and See Pictures of Coly-Mycin S Otic

What are the precautions when taking colistin sulfate with neomycin and hydrocortisone (Coly-Mycin S Otic)?

Before using this medication, tell your doctor or pharmacist if you are allergic to neomycin, colistin, hydrocortisone, or thonzonium; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like thimerosal), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other ear problems (e.g., a hole in your eardrum, middle ear infection), an ear infection caused by a virus (e.g., herpes simplex, varicella).

Before using...

Read All Potential Precautions of Coly-Mycin S Otic


Coly-Mycin S Otic Consumer (continued)

SIDE EFFECTS: This medication may temporarily sting or burn your ear for a minute or two when applied. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this rare but very serious side effect occurs: hearing problems (e.g., hearing loss).

Use of this medication for prolonged or repeated periods may result in a new fungal ear infection. Do not use it for longer than prescribed. Contact your doctor if you notice new or worsening symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), redness of the ears, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to neomycin, colistin, hydrocortisone, or thonzonium; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like thimerosal), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other ear problems (e.g., a hole in your eardrum, middle ear infection), an ear infection caused by a virus (e.g., herpes simplex, varicella).

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.


Coly-Mycin S Otic Patient Information Including Side Effects

Brand Names: Coly Mycin S, Coly-Mycin S, Cortisporin-TC

Generic Name: colistin, hydrocortisone, neomycin, and thonzonium (otic) (Pronunciation: koe LIS tin, HYE droe KOR ti sone, NEE oh MYE sin, thon ZOE nee um)

  • What is colistin, hydrocortisone, neomycin, and thonzonium (Coly-Mycin S Otic)?
  • What are the possible side effects of colistin, hydrocortisone, neomycin, and thonzonium (Coly-Mycin S Otic)?
  • What is the most important information I should know about colistin, hydrocortisone, neomycin, and thonzonium (Coly-Mycin S Otic)?
  • What should I discuss with my health care provider before using colistin, hydrocortisone, neomycin, and thonzonium (Coly-Mycin S Otic)?
  • How should I use colistin, hydrocortisone, neomycin, and thonzonium (Coly-Mycin S Otic)?
  • What happens if I miss a dose (Coly-Mycin S Otic)?
  • What happens if I overdose (Coly-Mycin S Otic)?
  • What should I avoid while using colistin, hydrocortisone, neomycin, and thonzonium (Coly-Mycin S Otic)?
  • What other drugs will affect colistin, hydrocortisone, neomycin, and thonzonium (Coly-Mycin S Otic)?
  • Where can I get more information?

What is colistin, hydrocortisone, neomycin, and thonzonium (Coly-Mycin S Otic)?

Colistin and neomycin are antibiotics that fight bacteria.

Hydrocortisone is in a class of drugs called steroids. Hydrocortisone prevents the release of substances in the body that cause inflammation.

Thonzonium is a wetting agent.

The combination of colistin, hydrocortisone, neomycin, and thonzonium otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Colistin, hydrocortisone, neomycin, and thonzonium otic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of colistin, hydrocortisone, neomycin, and thonzonium (Coly-Mycin S Otic)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • skin rash, redness, swelling, itching, dryness, or scaling;
  • hearing loss; or
  • urinating less than usual or not at all.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about colistin, hydrocortisone, neomycin, and thonzonium (Coly-Mycin S Otic)?

You should not use colistin, hydrocortisone, neomycin, and thonzonium if you are allergic to any of the drugs contained in this combination, or if you have a ruptured ear drum..

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing.

Stop using this medication and call your doctor at once if you have a skin rash, redness, swelling, itching, dryness, or scaling.

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