ONEXTON Clindamycin Phosphate and Benzoyl Peroxide
Refer to the “Also Known As” section to reference different products that include the same medication as ONEXTON.
Drug Basics
Brand Name: ONEXTON
Generic Name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Drug Type: HUMAN PRESCRIPTION DRUG
Route: TOPICAL
Dosage Form: GEL
Data Current As Of: 2018-10-05
indications & usage
ONEXTON® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
dosage & administration
Before applying ONEXTON Gel, wash the face gently with a mild soap, rinse with warm water, and pat the skin dry. Apply a pea-sized amount of ONEXTON Gel to the face once daily. Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin.
Use of ONEXTON Gel beyond 12 weeks has not been evaluated.
ONEXTON Gel is not for oral, ophthalmic, or intravaginal use.
dosage forms & strengths
Gel, 1.2%/3.75%
Each gram of ONEXTON Gel contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin, and 37.5 mg (3.75%) benzoyl peroxide in a white to off-white, opaque, smooth gel.
warnings & precautions
colitis
Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. If significant diarrhea occurs, ONEXTON Gel should be discontinued.
Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.
Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
ultraviolet light & environmental exposure
Minimize sun exposure (including use of tanning beds or sun lamps) following drug application [see Nonclinical Toxicology (13.1) ].
drug interactions
erythromycin
Avoid using ONEXTON Gel in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.
concomitant topical medications
Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.
neuromuscular blocking agents
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. ONEXTON Gel should be used with caution in patients receiving such agents.
how supplied / storage & handling
how supplied
ONEXTON Gel, 1.2%/3.75% is a white to off-white smooth gel supplied as a 50 g pump (NDC 0187-3050-50)
dispensing instructions for the pharmacist
- Dispense ONEXTON Gel with a 10-week expiration date.
- Specify "Store at room temperature up to 25°C (77°F). Do not freeze."
storage & handling
- PHARMACIST: Prior to dispensing: Store in a refrigerator, 2° to 8°C (36° to 46°F).
- PATIENT: Store at room temperature at or below 25°C (77°F).
- Protect from freezing.
- Store pump upright.
patient counseling information
Advise the patient to read the FDA-approved patient labeling (Patient Information).
- Patients who develop allergic reactions, such as severe swelling or shortness of breath, should discontinue use and contact their physician immediately.
- ONEXTON Gel may cause irritation, such as erythema, scaling, itching, or burning, especially when used in combination with other topical acne therapies.
- Patients should limit excessive or prolonged exposure to sunlight. To minimize exposure to sunlight, a hat or other clothing should be worn. Sunscreen may also be used.
- ONEXTON Gel may bleach hair or colored fabric.
Manufactured for:
Dow Pharmaceutical Sciences, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada
U.S. Patent Numbers: 8,288,434; 9,504,704 and 9,561,208
Onexton is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
© Valeant Pharmaceuticals North America LLC
Rev. 04/2018
9432703
PATIENT INFORMATION
ONEXTON® (ON-EX-TUN)
(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75%
| Important information: For use on skin only (topical use). Do not get ONEXTON Gel in your mouth, eyes, vagina, on your lips, or on cuts or open wounds. |
What is ONEXTON Gel?
ONEXTON Gel is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older. ONEXTON Gel contains clindamycin phosphate and benzoyl peroxide.
It is not known if ONEXTON Gel is safe and effective for use longer than 12 weeks.
It is not known if ONEXTON Gel is safe and effective in children under 12 years of age.
Who should not use ONEXTON Gel?
Do not use ONEXTON Gel if you have:
- had an allergic reaction to clindamycin, benzoyl peroxide, lincomycin, or any of the ingredients in ONEXTON Gel. See the end of this leaflet for a complete list of ingredients in ONEXTON Gel.
- Crohn’s disease or ulcerative colitis.
- had inflammation of the colon (colitis), or severe diarrhea with past antibiotic use.
What should I tell my doctor before using ONEXTON Gel?
Before using ONEXTON Gel, tell your doctor about all of your medical conditions, including if you:
- plan to have surgery with general anesthesia.
- are pregnant or plan to become pregnant. It is not known if ONEXTON Gel will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ONEXTON Gel passes into your breast milk. ONEXTON Gel contains the medicine clindamycin. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk. You and your doctor should decide if you will use ONEXTON Gel while breastfeeding.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and skin products you use. Using other topical acne products may increase the irritation of your skin when used with ONEXTON Gel.
- Especially tell your doctor if you take a medicine that contains erythromycin. ONEXTON Gel should not be used with products that contain erythromycin.
How should I use ONEXTON Gel?
- Use ONEXTON Gel exactly as your doctor tells you to use it.
- Apply ONEXTON Gel to your face 1 time each day.
- Before you apply ONEXTON Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry.
- To apply ONEXTON Gel to your face, use the pump to dispense 1 pea-sized amount of ONEXTON Gel onto your fingertip (See Figure 1). One pea-sized amount of ONEXTON Gel should be enough to cover your entire face.
| Figure 1 
|
- Dot the 1 pea-sized amount of ONEXTON Gel onto six areas of your face (chin, left cheek, right cheek, nose, left forehead, right forehead). See Figure 2.
| Figure 2 
|
- After applying the ONEXTON Gel this way, spread the gel over your face and gently rub it in. It is important to spread the gel over your whole face.
- Wash your hands with soap and water after applying ONEXTON Gel.
- If your doctor tells you to put ONEXTON Gel on other areas of your skin with acne, be sure to ask how much you should use.
- Do not use more ONEXTON Gel than prescribed.
What should I avoid while using ONEXTON Gel?
- Limit your time in sunlight. Avoid using tanning beds or sun lamps. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing, and a sunscreen with SPF 15 rating or higher.
- Avoid getting ONEXTON Gel in your hair or on colored fabric. ONEXTON Gel may bleach hair or colored fabric.
What are possible side effects with ONEXTON Gel?
ONEXTON Gel may cause serious side effects, including:
- Inflammation of the colon (colitis). Stop using ONEXTON Gel and call your doctor right away if you have severe watery diarrhea or bloody diarrhea.
- Allergic reactions. Stop using ONEXTON Gel, call your doctor and get help right away if you get severe itching, swelling of your face, eyes, lips, tongue, or throat, or trouble breathing.
The most common side effect with ONEXTON Gel is skin irritation. Stop using ONEXTON Gel and call your doctor if you have a skin rash or burning, or your skin becomes very red, itchy, or swollen.
Talk to your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects with ONEXTON Gel.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Valeant Pharmaceuticals North America LLC at 1-800-321-4576.
How should I store ONEXTON Gel?
- Store ONEXTON Gel at room temperature at or below 77°F (25°C). Do not freeze.
- Store pump upright.
- Keep the container tightly closed.
- The expiration date of ONEXTON Gel is 10 weeks from the date you fill your prescription. Safely throw away expired ONEXTON Gel.
Keep ONEXTON Gel and all medicines out of reach of children.
General information about the safe and effective use of ONEXTON Gel
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ONEXTON Gel for a condition for which it was not prescribed. Do not give ONEXTON Gel to other people, even if they have the same symptoms you have. It may harm them. You can also ask your doctor or pharmacist for information about ONEXTON Gel that is written for health professionals.
What are the ingredients in ONEXTON Gel?
Active ingredients: clindamycin phosphate 1.2% and benzoyl peroxide 3.75%
Inactive ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water
Manufactured for:
Dow Pharmaceutical Sciences, a division ofValeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
By: Valeant Pharmaceuticals International, Inc., Laval, Quebec H7L 4A8, Canada
U.S. Patent Numbers: 8,288,434; 9,504,704 and 9,561,208
Onexton is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
© Valeant Pharmaceuticals North America LLC
For more information about ONEXTON Gel, call 1-800-321-4576.
This Patient Information has been approved by the U.S. Food and Drug Administration.
9432703
Rev. 04/2018
PRINCIPAL DISPLAY PANEL - 50 gram Carton
NDC 0187-3050-50
Rx only
ONEXTON ®
(Clindamycin Phosphate and
Benzoyl Peroxide) Gel, 1.2%/3.75%
For Topical Use Only
Not for ophthalmic, oral or intravaginal use
KEEP OUT OF REACH OF CHILDREN
One premixed 50-gram pump dispenser
Ortho Dermatologics
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