Rhofade

Pregnancy

No available data on oxymetazoline topical use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage

Data describing intranasal decongestant use in pregnant women identified a potential association between second-trimester exposure to oxymetazoline (with no decongestant exposure in the first trimester) and renal collecting system anomalies

Lactation

Unknown if distributed in human breast milk

Oxymetazoline was detected in the milk of lactating rats

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

• Rhofade^®

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use this medicine on open wounds or irritated skin. If this medicine gets in your eyes, nose, mouth, or vagina, rinse with water.

Apply a thin layer of medication to cover the entire face. Do not apply near your eyes or mouth.

Wash your hands after applying this medicine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

An overdose of oxymetazoline is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not take by mouth. Topical medicine is for use only on the skin.

Rinse with water if this medicine gets in your eyes.

General

Oxymetazoline hydrochloride is available in the following dosage form(s) and strength(s):

Cream, 1%. Each gram of cream contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8 mg (0.88%) of oxymetazoline free base.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

• Not for oral, ophthalmic, or intravaginal use.1

• Prime pump bottle before initial use and discard product from first three pumps.1

• Apply a pea-sized amount once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips.1

• Wash hands after application.1

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of oxymetazoline topical cream in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxymetazoline topical cream in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Furazolidone
• Imipramine
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lofepramine
• Melitracen
• Methylene Blue
• Metipranolol
• Moclobemide
• Nadolol
• Nialamide
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Tianeptine
• Timolol
• Tranylcypromine
• Trimipramine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood circulation problems or
• Enlarged prostate or
• Heart or blood vessel disease, severe or unstable or uncontrolled or
• Hypertension (high blood pressure), uncontrolled or
• Hypotension (low blood pressure), uncontrolled or
• Irritated skin or open sores on the face or
• Narrow-angle glaucoma or
• Raynaud syndrome or
• Sjören syndrome or
• Scleroderma or
• Stroke, history of or
• Thromboangiitis obliterans—Use with caution. May make these conditions worse.

• It is used to treat rosacea.

• If you have an allergy to Rhofade (oxymetazoline (topical)) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Rhofade with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Do not take Rhofade by mouth. Topical medicine is for use only on the skin.

Rinse with water if this medicine gets in your eyes.

Use Rhofade exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use this medicine on open wounds or irritated skin. If this medicine gets in your eyes, nose, mouth, or vagina, rinse with water.

Apply a thin layer of Rhofade to cover the entire face. Do not apply near your eyes or mouth.

Wash your hands after applying this medicine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

An overdose of oxymetazoline is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.