Clindets

Drug Substance

Proper name: Clindamycin phosphate

Chemical name: Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2- pyrrolidinecarboxamido)-1-thio-L-threo--D-galacto-octopyranoside 2-(dihydrogen phosphate)

Structural formula:

Molecular formula: C18H34ClN2O8PS

Molecular weight: 504.96

Clindamycin is a white to off-white, odourless or almost odourless, hygroscopic, crystalline powder with a bitter taste, soluble in water (1 in 2.5); slightly soluble in dehydrated alcohol and very slightly soluble in acetone. 1.2 g of clindamycin phosphate is approximately equivalent to 1 g of clindamycin base. Clindamycin phosphate has a melting point of 208E to 212EC and a pH of 3.5 - 4.5 (1% in water).

Composition

CLINDETS® contains clindamycin phosphate USP at a concentration equivalent to 1% w/v clindamycin in a vehicle of isopropyl alcohol, propylene glycol, and purified water. Each CLINDETS® pledget applicator is composed of viscose, polyolefin and nylon, and contains approximately 1 mL of clindamycin phosphate topical solution.

Clinical Trial Adverse Drug Reactions

The safety was assessed in 150 acne vulgaris patients from a placebo-controlled study in which CLINDETS® or placebo (vehicle) pledgets were applied twice daily over a period of 11 weeks. The number of patients with worsening scores of erythema, peeling and burning is presented in Table 1.

Table 1: Patients with worsening signs or symptoms of acne in a CLINDETS® Clinical Trial

Number of patients reporting common (≥1%) treatment emergent adverse reactions are provided in Table 2.

Table 2: Most common drug related adverse reactions reported by ≥1% of patients in a CLINDETS® Clinical Trial

The following additional common adverse drug reactions (≥ 1%) have been reported in clinical trials involving other clindamycin phosphate formulations:

Skin and subcutaneous disorders: pruritus, rash, stinging, dryness, oiliness, small red bumps (including gram negative folliculitis pustules).

Immune system disorders: urticaria, whealing, swollen lips.

Gastrointestinal disorders: abdominal cramping.

Post-Market Adverse Drug Reactions

Immune system disorders: allergic reaction.

Gastrointestinal disorders: bloody diarrhea, colitis (including pseudomembranous colitis) (See WARNINGS, Gastrointestinal, CDAD).

Clindamycin is a prescription medication used to treat bacterial infections of the lungs, skin, blood, bones, joints, female reproductive system, and internal organs. Clindamycin is also used to treat acne.

Clindamycin belongs to a group of drugs called lincomycin antibiotics. These work by stopping the growth of bacteria.

This medication is available as a topical cream, topical gel, topical solution, topical foam, topical swab (pledget), vaginal cream, vaginal suppository, oral capsule, oral liquid, and granules for oral solution.

This medication is also available in injectable forms to be given directly into a vein (IV) or a muscle (IM) by a healthcare professional.

Common side effects of clindmaycin include nausea, vomiting, joint pain, heartburn, pain when swallowing, and white patches in the mouth.

Serious side effects have been reported with clindamycin. See the “Clindamycin Precautions” section.

Oral:

Common side effects of oral clindamycin include the following:

• Abdominal pain
• Nausea
• Vomiting
• Diarrhea
• Rash
• Hives

Topical:

Common side effects of topical clindamycin include the following:

• Burning, itching, dryness, or redness at site of application

Injectable:

Common side effects of oral clindamycin include the following:

• Abdominal pain
• Nausea
• Vomiting
• Diarrhea
• Rash
• Hives

This is not a complete list of clindamycin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take erythromycin (E.E.S., E-Mycin, Erythrocin). Clindamycin can make erythromycin less effective and usually these medications should not be combined, especially when treating serious infections.

This is not a complete list of clindamycin drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Clindamycin falls into category B. There are no well-done studies that have been done in humans with clindamycin. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

If you take too much clindamycin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If clindamycin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• It may take several weeks to see the full effects.
• Talk with your doctor before you use other drugs or products on your skin.
• Diarrhea, bloody diarrhea, and a certain bowel problem (colitis) have happened with this medicine (Clindets). Very bad colitis may lead to death. Call your doctor right away if you have stomach pain or cramps, very bad or watery diarrhea, or bloody diarrhea. Do not try to treat diarrhea without first checking with your doctor.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (Clindets) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017