Vosol Hc Otic

DRUG DESCRIPTION

Hydrocortisone and Acetic Acid Otic Solution, USP contains Hydrocortisone (1%) and acetic acid, glacial (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%) and benzethonium chloride (0.02%), sodium acetate (0.015%) and citric acid (0.2%).

Acetic acid has a molecular formula of CH3COOH with molecular weight of 60.05. The structural formula is:

Hydrocortisone is a Synthetic Steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11b)-. Hydrocortisone has a molecular formula of C21H30O5 with molecular weight 362.46. The structural formula is:

Hydrocortisone and acetic acid is available as a nonaqueous otic solution buffered at pH (2.0 to 4.0) for use in the external ear canal.

What are the precautions when taking hydrocortisone and acetic acid (Vosol Hc Otic)?

Before using this medication, tell your doctor or pharmacist if you are allergic to acetic acid or hydrocortisone; or to other corticosteroids (e.g., betamethasone); or if you have any other allergies. This product may contain inactive ingredients, 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: hole in the eardrum (perforated tympanic membrane), certain viral infections (e.g., herpes simplex, vaccinia, chickenpox).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: ear injuries/surgeries.

During pregnancy, this medication...

Read All Potential Precautions of Vosol Hc Otic


Vosol Hc Otic Consumer (continued)

SIDE EFFECTS: Temporary stinging and burning may occur when the medication is first dropped into the ear. If any of 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 any of these unlikely but serious side effects occur: increased or new redness/swelling/pain in or around the ears.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), 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 acetic acid or hydrocortisone; or to other corticosteroids (e.g., betamethasone); or if you have any other allergies. This product may contain inactive ingredients, 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: hole in the eardrum (perforated tympanic membrane), certain viral infections (e.g., herpes simplex, vaccinia, chickenpox).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: ear injuries/surgeries.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

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



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