Precautions
Clindesse is a vaginal cream medicine used to treat bacterial vaginal infections in women who are not pregnant. It is not known if Clindesse is safe and effective in pregnant women. It not known if Clindesse is safe and effective in females who have not yet reached puberty. What are the possible side effects of Clindesse?
What is Clindesse cream used for?
Last updated on Nov 1, 2018. Clindesse is indication for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerellavaginitis, nonspecific vaginitis, Corynebacteriumvaginitis, or anaerobic vaginosis) in non-pregnant women.
What is the indication of Clindesse?
How Supplied/Storage and Handling. Clindesse (clindamycin phosphate) Vaginal Cream, 2%, is available in cartons containing one single-dose, pre-filled disposable applicator (NDC 45802-042-01). Each applicator delivers approximately 5 g of vaginal cream containing approximately 100 mg of clindamycin.
How is Clindesse supplied/storage and handling?
To use Clindesse, hold the applicator firmly and pull the ring back to fully extend the plunger. Gently insert the applicator into the vagina as far as it will comfortably go. Push the plunger to release the cream. Remove the applicator from the vagina and throw it away. Only one dose of Clindesse is required.
How do I use Clindesse?
Is Clindesse a one time use?
Clindesse is a single-dose therapy used to treat vaginal infections (bacterial vaginosis) caused by certain bacteria in non-pregnant women. Clindesse Cream is a topical lincomycin antibiotic. It works by slowing the growth of certain bacteria. The recommended dose is a single applicatorful at any time of the day.
Can Clindesse give you a yeast infection?
SIDE EFFECTS: Although uncommon, mild stomach upset may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly. Infrequently, vaginal discomfort/burning/itching/discharge may occur or worsen. These symptoms may be due to a new vaginal infection (e.g., yeast/fungal infection).
What all does Clindesse treat?
Clindesse is a vaginal cream medicine used to treat bacterial vaginal infections in women who are not pregnant....Clindesse may cause serious side effects, including diarrhea.fungal infection in your vagina. ... headache.back pain.constipation.urinary tract infection.
How long does Clindesse stay in the vagina?
Clindesse (clindamycin) contains mineral oil which can weaken rubber or latex products like condoms and vaginal diaphragms. The mineral oil stays in your vagina for 5 days after you use Clindesse (clindamycin).
How do I know clindamycin is working?
Once you start taking clindamycin, you'll likely notice an improvement in your symptoms after a day or two. If your symptoms aren't improving at all or seem to be getting worse after taking clindamycin for a few days, follow up with your healthcare provider.
Is clindamycin good for bacterial Vag?
Clindamycin is also an effective treatment for bacterial vaginosis but is more expensive and is associated with diarrhea and, infrequently, colitis. In nonpregnant women, topical clindamycin 2 percent vaginal cream or metronidazole vaginal gel have rates of cure similar to those for oral treatment.
Can clindamycin treat chlamydia and gonorrhea?
Official answer. Clindamycin may be helpful in treating Chlamydia infections, but there are more popular antibiotics for this condition. The mainstay of therapy for chlamydia includes appropriate antibiotic treatment such as tetracyclines, azithromycin or erythromycin.
Does Clindesse burn?
Although uncommon, mild stomach upset may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly. Rarely, vaginal discomfort/burning/itching/discharge may occur or worsen. These symptoms may be due to a new vaginal infection (such as a yeast/fungal infection).
Does clindamycin cream leak out?
Clindamycin may weaken rubber or latex, causing a condom or diaphragm to break. Do not use a condom or diaphragm for birth control for 3 days after you stop using the suppositories, or for 5 days after you stop using the cream. This medicine may leak out of your vagina during the day.
Is clindamycin an antifungal?
Clindamycin exhibits a broad spectrum of antimicrobial activity, including Gram-positive aerobes/anaerobes, Gram-negative anaerobes and select protozoa (Toxoplasma gondii, Plasmodium falciparum, Babesia spp.) and fungi (Pneumocystis jiroveci).
What causes BV infection?
BV is a result of an imbalance of “good” and “harmful” bacteria in a vagina. Douching, not using condoms, and having new or multiple sex partners can upset the normal balance of vaginal bacteria, increasing your risk for getting BV.
Can you drink alcohol while taking Clindesse?
Clindesse (clindamycin) treats vaginal infections and is very easy to use. Treats and prevents bacterial infections. Flagyl (metronidazole) is very good at treating certain bacterial infections, but you can't have any alcohol while on it since it'll make you throw up a lot.
Can I use clindamycin (Clindesse) if I'm pregnant?
Cleocin vaginal cream is safe and FDA-approved to use if you're pregnant during the second and third trimesters. Clindesse vaginal cream and Cleoci...
Is there a generic for clindamycin (Clindesse)?
There is a generic currently available for the Cleocin vaginal cream. The Clindesse vaginal cream and Cleocin vaginal suppositories have no generic...
Can I use clindamycin (Clindesse) if I have my period?
Yes. It is safe and effective to use clindamycin (Clindesse) if you have your period. It is recommended to avoid using tampons while you are using it.
Why can't I use tampons while using clindamycin (Clindesse)?
Tampons can both make your symptoms worse and absorb some of the clindamycin (Clindesse). They will make it harder for clindamycin (Clindesse) to t...
Why does clindamycin (Clindesse) cause yeast infections for some people?
Yeast infections are common for some women after they finish using antibiotics. This is because the antibiotics kill both the bad bacteria causing...
What is clindamycin phosphate?
DESCRIPTION. Clindamycin phosphate, a lincosamide, 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 ...
What does NOS mean in clindamycin?
NOS = not otherwise specified. The use of clindamycin may result in the overgrowth of non-susceptible fungal organisms in the vagina and may require antifungal treatment. Other reactions reported by <1% of those women treated with Clindesse include: Dermatologic: Pruritic rash.
Can clindamycin be excreted from milk?
Caution should be exercised when Clindesse is administered to a nursing woman. It is not known if c lindamycin is excreted in human milk following the use of vaginally administered clindamycin. Clindamycin has been detected in human milk after oral or parenteral administration.
Can you use Clindesse while pregnant?
Clindesse should be used during pregnancy only if clearly needed. There are no adequate and well-controlled studies of Clindesse in pregnant women. Another intravaginal formulation containing 2% clindamycin phosphate has been studied in pregnant women during the second trimester.
Does Clindesse have a pH test?
Clindesse (clindamycin phosphate) does not comply with the pH test of the USP monograph for clindamycin phosphate vaginal cream.
Is clindamycin an antibacterial?
Clindamycin is an antibacterial drug [see CLINICAL PHARMACOLOGY, Microbiology ].
Is clindamycin a neuromuscular blocker?
Orally or intravenously administered clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
What is clindamycin used for?
This medication is used to treat a certain type of vaginal infection ( bacterial vaginosis) in women who are not pregnant. Clindamycin is an antibiotic that works by stopping the growth of bacteria.
How to report clindamycin side effects in Canada?
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Before using clindamycin, tell your doctor or pharmacist if you are allergic to it; or to lincomycin; or if you have any other allergies.
Are you currently using Clindesse Cream, Extended Release?
This survey is being conducted by the WebMD marketing sciences department.
What is clindamycin (Clindesse)?
Clindamycin (Clindesse) is a lincosamide antibiotic. It's a type of antibiotic that gets rid of infections by preventing the growth and spread of certain bacteria.
What are the risks and warnings for clindamycin (Clindesse)?
Clindamycin (Clindesse) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options
How much does clindamycin (Clindesse) cost?
Clindamycin (Clindesse) is available as a generic medication and may be significantly cheaper compared to the brand version. Unless there is a specific reason you need the brand, the generic medication will be a better value. For even more savings, use a GoodRx coupon and pay just a fraction of the retail price.
How many applicators does cleocin have?
The Cleocin vaginal cream comes with 7 disposable applicators, but they are not filled ahead of time for you. This means you need to draw up the cream into each applicator from a tube. Do not reuse the applicators. You should insert the medication while lying down on your back.
What to do if you are allergic to clindamycin?
Call 911 if this happens. If you notice hives, a rash, swelling of the lips or tongue, or difficulty breathing after using clindamycin (Clindesse), get medical help right away. You should not use clindamycin (Clindesse) if you know you are allergic to clindamycin or any lincosamide antibiotics.
How much does clindamycin cost?
Prices for clindamycin (Clindesse) start at just $ 27.44 with a GoodRx coupon. They’re fast, easy-to-use and free!
How to fill a prefilled applicator?
To fill the applicator if you are not using a pre-filled applicator. Remove cap from the tube. Screw one of the applicators onto the tube. Always use a new applicator. Never use one that has been used before. Squeeze the medicine into the applicator slowly until it is full. Remove the applicator from the tube.
What is Clindesse used for?
Clindesse is indication for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerellavaginitis, nonspecific vaginitis, Corynebacteriumvaginitis, or anaerobic vaginosis) in non-pregnant women.
What is the name of the phosphate in clindamycin?
The chemical name for clindamycin phosphate is methyl 7-chloro- 6,7,8-trideoxy-6- (1-methyl- trans - 4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- (alpha)-D-galacto- octopyranoside 2- (dihydrogen phosphate). It has a molecular weight of 504.95, and the molecular formula is C 18 H 34 CIN 2 O 8 PS. The structural formula is represented below:
What is the AUC of Clindamycin?
Following a single intravaginal application of Clindesse cream to 20 healthy women, the mean (range) AUC 0-inf and C max estimates were 175 (38.6 to 541) ng/mL●hr and 6.6 (0.8 to 39) ng/mL, respectively. The mean C max of clindamycin for Clindesse was approximately 0.3%, 0.1%, and 7.6% of that observed after the administration of a 150 mg Cleocin oral capsule (2.5 mcg/mL), a 600 mg Cleocin intravenous injection (10.9 mcg/mL), and a single dose of 100 mg of Cleocin Vaginal Cream (86.5 ng/mL), respectively. The peak serum concentration of clindamycin was attained approximately 20 hours post dosing for Clindesse.
How much clindamycin is in a vaginal cream?
This applicator delivers approximately 5 g of vaginal cream containing approximately 100 mg of clindamycin.
Can clindamycin be excreted from milk?
Caution should be exercised when Clindesse is administered to a nursing woman. It is not known if c lindamycin is excreted in human milk following the use of vaginally administered clindamycin. Clindamycin has been detected in human milk after oral or parenteral administration.
Does Clindesse have AUCs?
Clindesse affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to an oral or intravenous dose of clindamycin [ see Clinical Pharmacology (12.1) ]. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available.
Can you take Clindesse with lincosamide?
Do not administer Clindesse to individuals with a history of hypersensitivity to clindamycin or other lincosamides. Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme, and anaphylactoid reactions [ see Adverse Reactions (6.2) ].
What are the possible side effects of Clindesse?
Clindesse may cause serious side effects, including diarrhea. One type of diarrhea is caused by an infection in your intestines called Clostridium difficile-associated diarrhea (CDAD). If you have diarrhea after you use Clindesse, call your healthcare provider.
What are the ingredients in Clindesse?
Inactive ingredients: edetate disodium, glycerol monoisostearate, lecithin, methylparaben, microcrystalline wax, mineral oil, polyglyceryl-3-oleate, propylparaben, purified water, silicon dioxide and sorbitol solution
How long can you use Clindesse?
Patients can choose to use Clindesse anytime – day or night 1,2
What are the most common adverse reactions to Clindesse?
Most common adverse reactions (≥2%) of patients and at a higher rate in the Clindesse group than in the placebo group are vaginosis fungal (14%), headache (7%), back pain (5%), constipation (2%) and urinary tract infection (2%). Back to Page.
What is 2% clindamycin?
Clindesse® (clindamycin phosphate) Vaginal Cream, 2% is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginitis) in non-pregnant women.
Can you take Clindesse with lincosamide?
Do not administer Clindesse to individuals with a history of hypersensitivity to clindamycin or other lincosamides. Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme and anaphylactoid reactions. Do not administer Clindesse to patients with regional enteritis, ulcerative colitis or a history of Clostridium difficile -associated diarrhea.
Can you use Clindesse 5 days after treatment?
Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse.
Can you use Clindesse for colitis?
Do not administer Clindesse to patients with regional enteritis, ulcerative colitis or a history of Clostridium difficile -associated diarrhea. Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis.
Usage Instructions
Read the Patient Information Leaflet that comes with this product for instructions on the proper use of this medication. Consult your doctor or pharmacist if you have any questions. This product is for vaginal use only. Wash your hands before and after use. Avoid contact of this cream with your eyes.
Storage
Store at room temperature away from heat and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed.
Indications and Usage For Clindesse
This medication is used to treat a certain type of vaginal infection (bacterial vaginosis) in women who are not pregnant.
May Treat: Clostridium perfringens empyema · Staphylococcus aureus osteomyelitis · Staphylococcus aureus skin and skin structure infection · Acne vulgaris · Anaerobic endometritis and more
Drug Class: Acne Therapy Topical - Anti-infective · Lincosamide Antibiotics · Vaginal Antibacterial - Lincosamides
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Does not adversely affect lactation
May Treat: Clostridium perfringens empyema · Staphylococcus aureus osteomyelitis · Staphylococcus aureus skin and skin structure infection · Acne vulgaris · Anaerobic endometritis and more
Drug Class: Acne Therapy Topical - Anti-infective · Lincosamide Antibiotics · Vaginal Antibacterial - Lincosamides
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Does not adversely affect lactation
Alcohol: Limit intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
- For cream with applicator products : If available, read the patient package insert. Usually used at bedtime. Use at the same time(s) daily as directed. Refrain from intercourse during therapy. Can cause damage to diaphragms or condoms. Ask doctor before use in other conditions.
- For cream, extended release products : Insert into the vagina as directed. Usually given only 1 time.
- For gel products : This medication is for treatment of acne. Wash and dry affected area before applying. Apply a thin layer to affected areas. Avoid contact with eyes, inside of nose or mouth. May take months for full benefit of therapy. Wash hands before and after using. Call doctor if you are not getting better. Report severe diarrhea or abdominal pain to doctor.
- For cream with applicator products : If available, read the patient package insert. Usually used at bedtime. Use at the same time(s) daily as directed. Refrain from intercourse during therapy. Can cause damage to diaphragms or condoms. Ask doctor before use in other conditions.
- For cream, extended release products : Insert into the vagina as directed. Usually given only 1 time.
- For gel products : This medication is for treatment of acne. Wash and dry affected area before applying. Apply a thin layer to affected areas. Avoid contact with eyes, inside of nose or mouth. May take months for full benefit of therapy. Wash hands before and after using. Call doctor if you are not getting better. Report severe diarrhea or abdominal pain to doctor.
- For lotion products : Shake well.
- For solution, non-oral products : Keep medicine away from heat or flames.
- For swab, medicated products : Use medicated swab once and then discard.
- For vial products : Drug is given by a nurse or a doctor. Redness/pain/swelling may occur at injection site. Space doses evenly throughout the day. Success is dependent on completing therapy course. Watch for oral thrush or vaginal yeast infections. Review all drugs you are taking with your doctor.
Clindesse Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
- Treatment of Bacterial Vaginosis
Clindesse is indication for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerellavaginitis, nonspecific vaginitis, Corynebacteriumvaginitis, or anaerobic vaginosis) in non-pregnant women.
Adverse Reactions
- The recommended dose is the complete contents of a single pre-filled applicator containing 5 g of Clindesse cream administered once intravaginally at any time of the day. Not for ophthalmic, dermal, or oral use.
Use in Specific Populations
- 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.
Overdosage
- Hypersensitivity
Do not administer Clindesse to individuals with a history of hypersensitivity to clindamycin or other lincosamides. Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme, and anaphylactoid reactions [see Adverse Reactions (6.2)]. - History of Bowel Disease
Do not administer Clindesse to patients with regional enteritis, ulcerative colitis, or a history of Clostridium difficile-associated diarrhea.
Clindesse Description
- Clostridium difficile-Associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgr… - Use with Condoms and Vaginal Contraceptive Diaphragms
This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. During this time pe…
Clindesse - Clinical Pharmacology
- Clinical Study Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflec… - Other Clindamycin Formulations
Clindesse affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to an oral or intravenous dose of clindamycin [see Clinical Pharmacology (12.1)]. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin ad…