Data from FDA - Curated by EPG Health - Last updated 21 December 2016
Other most commonly reported
1 % in patients treated with clindamycin phosphate and tretinoin gel) were nasopharyngitis, pharyngolaryngeal
(6.1) To report SUSPECTED
6.1 Clinical Studies Experience Because clinical trials are conducted under prescribed conditions,
Patients were 12 years and older and were treated once daily for 12 weeks.
1 % of patients treated with clindamycin phosphate and tretinoin gel were compared to
Formulations used in all treatment arms were in the clindamycin phosphate and tretinoin vehicle gel.
PATIENTS WITH AT LEAST ONE AR 497 (27) 342 (24) 225 (27) 91 (22) Nasopharyngitis 65 (4) 64 (5) 16 (2) 5 (1) Pharyngolaryngeal
In Studies 1 and 2,
Analysis over the twelve week period demonstrated that cutaneous
One open-label 12-month
Eighteen out of 442 subjects (4 %)
2 DOSAGE & ADMINISTRATION At bedtime, squeeze a pea-sized amount of medication onto one fingertip, dot onto the chin, cheeks, nose, and forehead, then
Clindamycin phosphate and tretinoin gel should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes.
Clindamycin phosphate and tretinoin gel is not for oral, ophthalmic, or intravaginal use.
Apply a pea-sized amount to the entire face once daily at bedtime.
Do not apply to eyes, mouth, angles of the nose, or mucous membranes.
(2) Clindamycin phosphate and tretinoin gel is not for oral, ophthalmic, or intravaginal use.
8 USE IN SPECIFIC POPULATIONS 8.1 PREGNANCY Pregnancy Category C. There are
Clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential
Clindamycin phosphate and tretinoin gel was tested for maternal and developmental toxicity in New Zealand White Rabbits with topical doses of 60, 180 and 600 mg/kg/day.
Clindamycin phosphate and tretinoin gel at 600 mg/kg/day (approximately 12 times the
For purposes of comparisons of the animal exposure to human exposure, the
Clindamycin Teratology (Segment II) studies using clindamycin were performed orally in
Tretinoin In oral Segment III studies in
With widespread use of any drug, a
Thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin.
The significance of these spontaneous reports in terms of risk to the fetus is not known.
Dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 40 times the
Oral tretinoin has been shown to be fetotoxic in
8.3 NURSING MOTHERS It is not known whether clindamycin is excreted in human milk following use of clindamycin phosphate and tretinoin gel.
However, orally and parenterally administered clindamycin has been reported to appear in breast milk.
Because of the
It is not known whether tretinoin is excreted in human milk.
Because many drugs are excreted in human milk,
8.4 PEDIATRIC USE
Clinical trials of clindamycin phosphate and tretinoin gel included patients 12 to 17 years of age.
[See Clinical Studies (14)] 8.5 GERIATRIC USE Clinical studies of clindamycin phosphate and tretinoin gel did not include
|Agency product number||5688UTC01R|
|Date Last Revised||30-09-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Actavis Pharma, Inc.|