Veltin
Name: Veltin
Indications
VELTIN™ (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Side effects
Adverse Reactions in Clinical Studies
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
The safety data reflect exposure to VELTIN (clindamycin phosphate and tretinoin gel) Gel in 1,104 patients with acne vulgaris. Patients were 12 years or older and were treated once daily in the evening for 12 weeks. Adverse reactions that were reported in ≥ 1% of patients treated with VELTIN (clindamycin phosphate and tretinoin gel) Gel are presented in Table 1.
Table 1: Treatment-Related Adverse Reactions Reported by ≥ 1% of Subjects
| VELTIN (clindamycin phosphate and tretinoin gel) Gel N=1104 n (%) | ClindamycinGel N=1091 n (%) | TretinoinGel N=1084 n(%) | VehicleGel N=552 n (%) | |
| Patients with at least one adverse reaction | 140(13) | 38(3) | 141 (13) | 17(3) |
| Application site dryness | 64(6) | 12(1) | 62(6) | 3(1) |
| Application site irritation | 50(5) | 4( < 1) | 57(5) | 5(1) |
| Application site exfoliation | 50(5) | 2( < 1) | 56(5) | 2( < 1) |
| Application site erythema | 40(4) | 6(1) | 39(4) | 3(1) |
| Application site pruritus | 26(2) | 7(1) | 23(2) | 6(1) |
| Sunburn | 11(1) | 6(1) | 7(1) | 3(1) |
| Application site dermatitis | 6(1) | 0(0) | 8(1) | 1( < 1) |
Local skin reactions actively assessed at baseline and end of treatment with a score > 0 are presented in Table 2.
Table 2: VELTIN (clindamycin phosphate and tretinoin gel) GEL-Treated Patients with Local Skin Reactions
| VELTIN GEL | VEHICLE GEL | |||
| Local Reaction | Baseline N=476 N(%) | End of Treatment N=409 N(%) | Baseline N=219 N(%) | End of Treatment N=209 N(%) |
| Erythema | 24% | 21% | 31% | 35% |
| Scaling | 8% | 19% | 14% | 12% |
| Dryness | 11% | 22% | 18% | 13% |
| Burning | 8% | 13% | 8% | 4% |
| Itching | 17% | 15% | 22% | 14% |
During the twelve weeks of treatment, each local skin reaction peaked at week 2 and gradually reduced thereafter.
Proper Use of clindamycin and tretinoin
This section provides information on the proper use of a number of products that contain clindamycin and tretinoin. It may not be specific to Veltin. Please read with care.
It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become too dry or irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.
This medicine is for use on the skin only. Do not get it in your eyes, mouth, nose, on the corners of your nose, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
To use:
- Wash your hands with soap and water before and after using this medicine.
- Before applying this medicine, wash your face with warm water and a mild soap, rinse well, and pat dry.
- Apply just enough medicine to lightly cover the affected areas, and rub it in gently but well. A pea-sized amount is enough to cover the whole face.
- You should not wash your face too often, 2 or 3 times a day is enough. Washing your face too often may dry your skin and make the acne worse.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For topical dosage form (gel):
- For acne:
- Adults and teenagers—Apply to the affected area(s) of the skin once a day, at bedtime.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For acne:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Veltin
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
Stop using this medicine and call your doctor right away if you start having severe, watery diarrhea or bloody diarrhea. This could be a sign of a serious side effect. Do not take any medicine for diarrhea without checking first with your doctor. Some medicines may make your diarrhea worse or make it last longer.
This medicine may make your skin more sensitive to sunlight, wind, and cold weather. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. You may need to wear protective clothing, such as a hat.
Skin reactions can occur when you use this medicine, such as dryness, redness, peeling, burning, or stinging. Stop using this medicine and call your doctor right away if your skin becomes very red, swollen, blistered, or crusted.
This medicine may also cause a temporary change in skin color (lighter or darker). Talk to your doctor if this concerns you.
Tell your doctor if you are planning to have a surgery before using this medicine. This medicine may affect how certain anesthesia medicines (medicines used during surgery to make you numb) work.
Do not use any other medicines on the treated skin areas without asking your doctor. Avoid using any skin care products that can dry or irritate your skin. These include rough skin cleansers, soaps, or products that contain alcohol, spices, or lime.
What do I need to tell my doctor BEFORE I take Veltin?
- If you have an allergy to clindamycin, tretinoin, or any other part of Veltin (clindamycin and tretinoin).
- 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.
- If you are using any products that have erythromycin.
- If you have any of these health problems: History of Crohn's disease, regional enteritis, ulcerative colitis, or very loose stools called antibiotic-associated colitis.
This is not a list of all drugs or health problems that interact with this medicine.
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 Veltin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
How is this medicine (Veltin) best taken?
Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Do not take Veltin by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
- Put on at bedtime.
- Wash your hands before and after use.
- Clean affected part before use. Make sure to dry well.
- Put a thin layer on the affected skin and rub in gently.
- To gain the most benefit, do not miss doses.
What do I do if I miss a dose?
- Put on a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not put on 2 doses or extra doses.