Veltin (Clindamycin Phosphate and Tretinoin Gel) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Veltin

Acne (Pimples) »

What is acne?

Acne (acne vulgaris, common acne) is a disease of the hair follicles of the face, chest, and back that affects almost all males and females during puberty; the only exception being teenage members of a few primitive isolated tribes living in Neolithic societies. It is not caused by bacteria, although bacteria play a role in its development. It is not unusual for some women to develop acne in their mid- to late-20s.

Acne appears on the skin as...

congested pores ("comedones"), also known as blackheads or whiteheads,
tender red bumps also known as pimples or zits,
pustules, and occasionally as
cysts (deep pimples, boils).

You can do a lot to treat your acne using products available at a drugstore or cosmetic counter that do not require a prescription. However, for tougher cases of acne, you should consult a physician for treatment options.

What...

Read the Acne (Pimples) article »

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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.

DRUG INTERACTIONS

Erythromycin

VELTIN™ (clindamycin phosphate and tretinoin gel) Gel should not be used in combination with erythromycin-containing products due to possible antagonism to the clindamycin component. In vitro studies have shown antagonism between these 2 antimicrobials. The clinical significance of this in vitro antagonism is not known.

Neuromuscular Blocking Agents

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, VELTIN (clindamycin phosphate and tretinoin gel) Gel should be used with caution in patients receiving such agents.

Last reviewed on RxList: 8/5/2010
This monograph has been modified to include the generic and brand name in many instances.