Veltin Information
Veltin (Clindamycin) Indications And Usage
Veltin (Clindamycin) ™ (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Veltin (Clindamycin) Dosage And Administration
Veltin (Clindamycin) Gel should be applied once daily in the evening, gently rubbing the medication to lightly cover the entire affected area. Approximately a pea sized amount will be needed for each application. Avoid the eyes, lips, and mucous membranes.
Veltin (Clindamycin) Gel is not for oral, ophthalmic, or intravaginal use.
Veltin (Clindamycin) Dosage Forms And Strengths
Veltin (Clindamycin) Gel, containing clindamycin phosphate 1.2% and tretinoin 0.025%, is a yellow, opaque topical gel. Each gram of Veltin (Clindamycin) Gel contains, as dispensed, 10 mg (1%) clindamycin as clindamycin phosphate, and 0.25 mg (0.025%) tretinoin solubilized in an aqueous based gel.
Veltin (Clindamycin) Contraindications
Veltin (Clindamycin) Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis.
Veltin (Clindamycin) Warnings And Precautions
Systemic absorption of clindamycin has been demonstrated following topical use. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. If significant diarrhea occurs, Veltin (Clindamycin) Gel should be discontinued.
Severe colitis has occurred following oral or 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 a 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 and stool assay for toxin may be helpful diagnostically.
Veltin (Clindamycin) Use In Specific Populations
Pregnancy Category C. There are no well-controlled studies in pregnant women treated with Veltin (Clindamycin) Gel. Veltin (Clindamycin) Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A limit teratology study performed in Sprague Dawley rats treated topically with Veltin (Clindamycin) Gel or 0.025% tretinoin gel at a dose of 2 mL/kg during gestation days 6 to 15 did not result in teratogenic effects. Although no systemic levels of tretinoin were detected, craniofacial and heart abnormalities were described in drug-treated groups. These abnormalities are consistent with retinoid effects and occurred at 16 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison. For purposes of comparison of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of Veltin (Clindamycin) Gel applied daily to a 50 kg person.
Clindamycin
Reproductive developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (480 and 240 times the recommended clinical dose based on body surface area comparison, respectively) or subcutaneous doses of clindamycin up to 180 mg/kg/day (140 and 70 times the recommended clinical dose based on body surface area comparison, respectively) revealed no evidence of teratogenicity.
Tretinoin
Oral tretinoin has been shown to be teratogenic in mice, rats, hamsters, rabbits, and primates. It was teratogenic and fetotoxic in Wistar rats when given orally at doses greater than 1 mg/kg/day (32 times the recommended clinical dose based on body surface area comparison). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomologous monkey, a species in which tretinoin metabolism is closer to humans than in other species examined, fetal malformations were reported at oral doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (324 times the recommended clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related teratogenic effects and increased abortion rates were reported in pigtail macaques.
With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin. Although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to fetus is not known.
Safety and effectiveness of Veltin (Clindamycin) Gel in pediatric patients below the age of 12 years have not been established.
Clinical trials of Veltin (Clindamycin) Gel included 2,086 patients 12-17 years of age with acne vulgaris.
Veltin (Clindamycin) Description
Veltin (Clindamycin) (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025%, is a fixed combination of two solubilized active ingredients in an aqueous based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.
The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl--4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L--α-D--octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below:
Clindamycin phosphate:
Molecular Formula: CHClNOPS
Molecular Weight: 504.97
The chemical name for tretinoin is all- 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds.
The structural formula for tretinoin is represented below:
Tretinoin:
Molecular Formula: CHO
Molecular Weight: 300.44
Veltin (Clindamycin) Gel contains the following inactive ingredients: butylated hydroxytoluene, carbomer 940, anhydrous citric acid, edetate disodium, methylparaben, laureth 4, propylene glycol, tromethamine, and purified water.
Veltin (Clindamycin) Clinical Pharmacology
Clindamycin
[See Microbiology ().]
Tretinoin
Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedone formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.
No microbiology studies were conducted in the clinical trials with this product.
Mechanism of Action
Clindamycin binds to the 50S ribosomal subunit of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis. Clindamycin has been shown to have activity against , an organism that has been associated with acne vulgaris; however, the clinical significance of this activity against was not examined in clinical studies with Veltin (Clindamycin) Gel. resistance to clindamycin has been documented.
Inducible Clindamycin Resistance
The treatment of acne with antimicrobials is associated with the development of antimicrobial resistance in as well as other bacteria (e.g. ). The use of clindamycin may result in developing inducible resistance in these organisms. This resistance is not detected by routine susceptibility testing.
Cross Resistance
Resistance to clindamycin is often associated with resistance to erythromycin.
Veltin (Clindamycin) Clinical Studies
The safety and efficacy of Veltin (Clindamycin) Gel, applied once daily for the treatment of acne vulgaris, was evaluated in 12-week multicenter, randomized, blinded studies in subjects 12 years and older.
Treatment response was defined as the percent of subjects who had a two grade improvement from baseline to Week 12 based on the Investigator’s Global Assessment (IGA) and a mean absolute change from baseline to Week 12 in two out of three (total, inflammatory and non-inflammatory) lesion counts. The IGA scoring scale used in all the clinical trials for Veltin (Clindamycin) Gel is as follows:
In Study 1, 1649 subjects were randomized to Veltin (Clindamycin) Gel, Clindamycin gel, Tretinoin gel, and vehicle gel. The median age of subjects was 17 years old and 58% were females. At baseline, subjects had an average of 71 total lesions of which the mean number of inflammatory lesions was 25.5 lesions and the mean number of non-inflammatory lesions was 45.1 lesions. The majority of subjects enrolled with a baseline IGA score of 3. The efficacy results at week 12 are presented in Table 3.
The safety and efficacy of clindamycin-tretinoin gel was also evaluated in two additional 12-week, multi-centered, randomized, blinded, studies in patients 12 years and older. A total of 2219 subjects with mild-to-moderate acne vulgaris were treated once daily for 12 weeks. Of the 2219 subjects, 634 subjects were treated with clindamycin-tretinoin gel. These studies demonstrated consistent outcomes.
Veltin (Clindamycin) How Supplied/storage And Handling
Veltin (Clindamycin) Gel is supplied as follows:
30 g aluminum tubes NDC 0145-0071-30
60 g aluminum tubes NDC 0145-0071-60
Veltin (Clindamycin) Patient Counseling Information
[See FDA-approved Patient Labeling].
In the event a patient treated with Veltin (Clindamycin) Gel experiences severe diarrhea or gastrointestinal discomfort, Veltin (Clindamycin) Gel should be discontinued and a physician should be contacted.
VEL:PI2
Veltin (Clindamycin)
Veltin (Clindamycin)
