Veltin

DRUG DESCRIPTION

VELTIN™ (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-(l-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-?-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below:

Clindamycin phosphate:

Clindamycin phosphate structural formula illustration

Molecular Formula: C18H34ClN2O8PS                Molecular Weight: 504.97

The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-l-cyclohexen-l-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:

Tretinoin structural formula illustration

Molecular Formula: C20H28O2           Molecular Weight: 300.44

VELTIN (clindamycin phosphate and tretinoin gel) Gel contains the following inactive ingredients: butylated hydroxytoluene, carbomer 940, anhydrous citric acid, edetate disodium, methylparaben, laureth 4, propylene glycol, tromethamine, and purified water.

What are the precautions when taking clindamycin phosphate and tretinoin gel (Veltin)?

Before using this product, tell your doctor or pharmacist if you are allergic to clindamycin or to tretinoin; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain intestinal problems (e.g., regional enteritis, ulcerative colitis, colitis caused by the use of antibiotics, Clostridium difficile-associated diarrhea, Crohn's disease).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eczema.

This medication may make you more...

Read All Potential Precautions of Veltin »


Veltin Consumer (continued)

SIDE EFFECTS: Skin redness, dryness, itching, peeling, mild burning/stinging, or worsening of acne may occur during the first 2 to 4 weeks of using the medication. These effects usually decrease with continued use. A daytime moisturizer may be helpful for very dry skin (see Notes). If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Your doctor may want you to decrease how often you use the medication or stop using it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering, crusting, severe burning/swelling of the skin.

This medication may be absorbed into your bloodstream and very rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to resistant bacteria. This condition may occur weeks after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Stop using this medication and tell your doctor immediately if any of these rare but very serious side effects occur: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to clindamycin or to tretinoin; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain intestinal problems (e.g., regional enteritis, ulcerative colitis, colitis caused by the use of antibiotics, Clostridium difficile-associated diarrhea, Crohn's disease).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eczema.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Weather extremes such as wind or cold may also be irritating to the skin. Use a sunscreen daily, and wear protective clothing when outdoors. Wait until your skin has completely recovered from a sunburn before using this product.

Avoid electrolysis, waxing, and chemical depilatories for hair removal on the treated areas while using this product.

If you have recently used products containing sulfur, resorcinol, or salicylic acid, use this product with caution. Wait until the effects of such products on the skin have decreased before using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.



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