Onexton Gel
Name: Onexton Gel
- Onexton Gel onexton gel dosage
- Onexton Gel 12 mg
- Onexton Gel drug
- Onexton Gel 128 mg
- Onexton Gel action
Onexton Gel Dosage and 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 and 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.
Contraindications
Hypersensitivity
Onexton Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with Onexton Gel [see Adverse Reactions (6.2)].
Colitis/Enteritis
Onexton Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1)].
Adverse Reactions
The following adverse reaction is described in more detail in the Warnings and Precautions section of the label:
• Colitis [see Warnings and Precautions (5.1)].Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates observed in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
These adverse reactions occurred in less than 0.5% of subjects treated with Onexton Gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).
During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions either were the same as baseline or increased and peaked around Week 4 and were near or improved from baseline levels by Week 12. The percentage of subjects that had symptoms present before treatment (at baseline), during treatment, and the percent with symptoms present at Week 12 are shown in Table 1.
| Before Treatment (Baseline) | During Treatment | End of Treatment (Week 12) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Mild | Mod.* | Severe | Mild | Mod.* | Severe | Mild | Mod.* | Severe | |
| * Mod. = Moderate | |||||||||
| Erythema | 20 | 6 | 0 | 28 | 5 | <1 | 15 | 2 | 0 |
| Scaling | 10 | 1 | 0 | 19 | 3 | 0 | 10 | <1 | 0 |
| Itching | 14 | 3 | <1 | 15 | 3 | 0 | 7 | 2 | 0 |
| Burning | 5 | <1 | <1 | 7 | 1 | <1 | 3 | <1 | 0 |
| Stinging | 5 | <1 | 0 | 7 | 0 | <1 | 3 | 0 | <1 |
Postmarketing Experience
Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin phosphate/benzoyl peroxide.
Onexton Gel - Clinical Pharmacology
Mechanism of Action
Clindamycin: Clindamycin is a lincosamide antibacterial [see Clinical Pharmacology (12.4)].
Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects, but the precise mechanism of action is unknown.
Pharmacokinetics
The systemic absorption of Onexton Gel has not been evaluated. The systemic absorption of clindamycin was investigated in an open-label, multiple-dose trial in 16 adult subjects with moderate to severe acne vulgaris treated with 1 gram of a marketed gel containing clindamycin 1%/benzoyl peroxide 2.5% applied to the face once daily for 30 days. This product has the same formulation as Onexton Gel but with a lower concentration of benzoyl peroxide. Twelve subjects (75%) had at least one quantifiable clindamycin plasma concentration above the lower limit of quantification (LOQ = 0.5 ng/mL) on Day 1 or Day 30. On Day 1, the mean (± standard deviation) peak plasma concentrations (Cmax) was 0.78 ± 0.22 ng/mL (n=9 with measurable concentrations), and the mean AUC0-t was 5.29 ± 0.81 h.ng/mL (n=4). On Day 30, the mean Cmax was 1.22 ± 0.88 ng/mL (n=10), and the mean AUC0-t was 8.42 ± 6.01 h.ng/mL (n=6). Clindamycin plasma concentrations were below LOQ in all subjects at 24 hours post-dose on the three tested days (Day 1, 15, and 30).
Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.
Microbiology
Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing bacterial protein synthesis.
Clindamycin and benzoyl peroxide individually have been shown to have in vitro activity against Propionibacterium acnes, an organism which has been associated with acne vulgaris. In an in vitro study, the MIC for benzoyl peroxide against Propionibacterium acnes is 128 mg/L. The clinical significance of this activity against P. acnes is not known.
P. acnes resistance to clindamycin has been documented. Resistance to clindamycin is often associated with resistance to erythromycin.
How Supplied/Storage and 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)