Clindesse

Clindesse is part of the drug classes:

• Gynecological Antibiotics

• Antiinfectives for treatment of acne

• Lincosamides

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.

Take clindamycin exactly as prescribed.

Oral:

This medication is available as an oral capsule, an oral liquid, and granules for oral solution.

Take oral forms of clindamycin with a full glass of water so that the medicine will not irritate your throat.

Topical:

This medication is available as a topical cream, topical gel, topical solution, topical foam, topical swab (pledget), vaginal cream, and vaginal suppository. The topical products are used for treating acne and are applied 1 to 2 times a day. The vaginal products are usually used once a day.

Injectable:

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

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of clindamycin at the same time.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Clindamycin vaginal is usually used at bedtime for 3 to 7 nights in a row.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands with soap and water before and after applying this medicine.

Apply clindamycin vaginal using only the disposable applicators provided with the medicine. Use a new applicator each time you use the medicine, then throw the applicator away. Do not clean or reuse a disposable applicator.

Clindamycin vaginal can cause burning or irritation if you accidentally get it in your eyes. If this does happen, rinse with plenty of cool water.

If you need surgery, tell the surgeon ahead of time that you are using clindamycin vaginal. You may need to stop using the medicine for a short time.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Clindamycin vaginal will not treat a viral infection such as the flu or a common cold.

Call your doctor if your symptoms do not improve, or if they get worse while using clindamycin vaginal.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture and heat. Keep the tube tightly closed when not in use.

• It is used to treat vaginal infections.
• It may be given to you for other reasons. Talk with the doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where this medicine is used.
• Vaginal itching or discharge.
• Pain when passing urine.
• Trouble passing urine.

• 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.

This information should not be used to decide whether or not to take Clindesse or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Clindesse. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Clindesse is an intravaginal cream containing clindamycin phosphate 2%. Each pre-filled, single-dose applicator delivers approximately 5 g of cream containing approximately 100 mg of clindamycin.

Two clinical studies were conducted to evaluate the efficacy of Clindesse for the treatment of bacterial vaginosis. A clinical diagnosis of bacterial vaginosis was defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerellamorphotype, and (c) absent or few white blood cells.

In a randomized, double-blind, placebo-controlled, clinical study involving 144 non-pregnant female patients aged 18 to 64 with a baseline Nugent score ≥4, Clindesse demonstrated statistically significantly higher cure rates over placebo as measured by therapeutic cure, clinical cure, and Nugent score cure (Table 2) assessed at 21-30 days after administration of the drug. Therapeutic cure was a composite endpoint which required both clinical cure and Nugent score cure. Clinical cure required normal vaginal discharge, vaginal pH < 4.7, < 20% clue cells on wet mount preparation, and negative “whiff” test (detection of amine odor on addition of 10% KOH solution to sample of the vaginal discharge). A Nugent score of 0-3 was considered a Nugent score cure. The Nugent scoring is based on microscopic examination of the Gram’s stained vaginal smears for quantification of specific bacterial morphotypes. Cure rates were consistently higher for Clindesse compared to placebo for the following demographic subsets: age, race, height, weight, sexual behavior, and recalcitrant infection status.

Table 2. Efficacy of Clindesse for Treatment of Bacterial Vaginosis in a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

N = number of patients in treatment group (modified intent-to-treat population defined as all subjects randomized who received at least one dose of study medication, and who had a baseline Nugent score of at least 4)

†Treatment difference = Clindesse minus placebo cure rates

In a second controlled clinical study involving 432 patients aged 18 to 78 with a baseline Nugent score of ≥4, 221 women self-administered a single dose of Clindesse, and 211 women self-administered a single daily dose of a formulation of clindamycin vaginal cream for 7 days. A single dose of Clindesse was shown to be similar to 7 daily doses of the clindamycin vaginal cream for treatment of bacterial vaginosis as measured by therapeutic cure, clinical cure of Nugent score cure assessed at 21-30 days after administration of the drug in the modified intent-to-treat population (Table 3) and for the per protocol population (Table 4). The study endpoints were identical to those described above for the placebo-controlled study. Statistical analyses did not reveal any significant differences when controlling for the following demographic variables: age, race, height, weight, sexual behavior, and recalcitrant infection status.

The cure rates reported in the clinical studies with Clindesse were based on resolution of 4 out of 4 Amsel criteria and a Nugent score of < 4, while the criteria for cure in previous clinical studies with the clindamycin vaginal cream were based solely on resolution of 2 out of 4 Amsel criteria, resulting in higher reported rates of cure for bacterial vaginosis.

Table 3. Efficacy of Clindesse in Treatment of Bacterial Vaginosis in a Randomized, Investigator-Blind, Active-Controlled Comparative Study – Modified-Intent-to-Treat

†Treatment difference = Clindesse minus clindamycin vaginal cream cure rates

N = number of patients in treatment group (modified intent-to-treat population defined as all subjects randomized who received at least one dose of study medication, and who had a baseline Nugent score of at least 4)

Table 4. Efficacy of Clindesse in Treatment of Bacterial Vaginosis in a Randomized, Investigator-Blind, Active-Controlled Comparative Study – Per Protocol

†Treatment difference = Clindesse minus clindamycin vaginal cream cure rates

N = number of patients in treatment group (per protocol population defined as all subjects included in the modified intent-to-treat population who completed the study without significant protocol violation)

‡Four subject (2 from each treatment group) did not have complete Nugent scores and were not included in the Nugent Score cure analysis

• Avoid contact with the eyes. Burning and irritation can occur. If contact does occur, rinse the eye with large amounts of cool tap water.
• Do not have sexual intercourse or use other vaginal products, such as tampons or douches, while using Clindesse.
• Use a sanitary napkin rather than a tampon to prevent staining of clothes and bed linens.
• This cream contains mineral oil that may weaken latex products such as condoms and diaphragms. Therefore, do not use these products within 5 days of using this product. They may not provide adequate birth control and you may become pregnant.
• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor. This could be a symptom of a serious side effect requiring immediate medical attention.
• Be sure to use Clindesse for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Clindesse may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medication while you are pregnant. It is not known if Clindesse is found in breast milk. If you are or will be breast-feeding while you use this medication, check with your doctor. Discuss any possible risks to your baby.