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Drugs reference index «ClindaMax Vaginal»

ClindaMax

Generic Name: clindamycin (Vaginal route)

klin-da-MYE-sin

Intravenous routeSolution

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin phosphate and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

Because clindamycin phosphate therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated .

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin .

Intramuscular routeSolution

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin phosphate and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

Because clindamycin phosphate therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated .

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin .

Oral routePowder for Solution

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 overgrowth of C. difficile.

Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated .

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin .

Oral routeCapsule

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

Because clindamycin hydrochloride therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated .

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin .

Commonly used brand name(s):

In the U.S.

  • Cleocin Vaginal
  • ClindaMax
  • Clindesse

Available Dosage Forms:

  • Suppository
  • Cream

Therapeutic Class: Antibiotic

Chemical Class: Lincosamide

Uses For ClindaMax

Clindamycin is used to treat certain vaginal infections. It works by killing the bacteria. This medicine will not work for vaginal fungus or yeast infections.

Clindamycin is available only with your doctor's prescription.

Before Using ClindaMax

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of vaginal clindamycin in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of vaginal clindamycin in the elderly with use in other age groups.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Erythromycin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atracurium
  • Metocurine
  • Tubocurarine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Stomach or intestinal disease, history of (especially colitis, including colitis caused by antibiotics, or enteritis)—Patients with a history of stomach or intestinal disease may have an increased chance of side effects including diarrhea

Proper Use of clindamycin

This section provides information on the proper use of a number of products that contain clindamycin. It may not be specific to ClindaMax. Please read with care.

Wash your hands before and after using this medicine.

Avoid getting this medicine in your eyes. If this medicine does get into your eyes, rinse them immediately with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

Vaginal clindamycin usually comes with patient directions. Read them carefully before using this medicine.

Use clindamycin vaginal cream exactly as directed by your doctor.

  • 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. Replace the cap on the tube.
  • To insert the vaginal cream using the applicator
    • Relax while lying on your back with your knees bent.
    • Hold the full applicator in one hand. Insert it slowly into the vagina. Stop before it becomes uncomfortable.
    • Slowly press the plunger until it stops.
    • Withdraw the applicator. The medicine will be left behind in the vagina.
  • To care for the applicator
    • Throw the applicator away after you use it.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, continue using this medicine even if your menstrual period starts during the time of treatment .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For vaginal cream dosage form:
    • For bacterial vaginosis:
      • Adults and teenagers who are not pregnant—One applicatorful (100 milligrams [mg]) inserted into the vagina once a day, usually at bedtime, for three or seven days.
      • Adults and teenagers who are pregnant—One applicatorful (100 milligrams [mg]) inserted into the vagina once a day, usually at bedtime, for seven days.
      • Children—Use and dose must be determined by your doctor.
  • For vaginal cream prefilled applicator dosage form:
    • For bacterial vaginosis:
      • Adults and teenagers—One applicatorful (100 milligrams [mg]) inserted into the vagina one time at any time of the day. This is a one-day treatment.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using ClindaMax

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

It is important that you visit your doctor after you have used all your medicine to make sure that the infection is gone.

This medicine may cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.

It is important that you tell your doctor right away if diarrhea occurs while you are using this medicine or after you have finished your treatment. It could be a symptom of a serious condition that your doctor will need to diagnose and treat.

Vaginal medicines usually leak out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a minipad or sanitary napkin. Do not use tampons since they may soak up the medicine.

To help clear up your infection completely and make sure it does not return, good health habits are also required.

  • Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon or rayon) panties.
  • Wear only freshly washed panties daily.

Do not have sexual intercourse while you are using this medicine. Having sexual intercourse may reduce the strength of the medicine. This may cause the medicine to not work as well.

Do not use latex (rubber) contraceptive products such as condoms, diaphragms, or cervical caps for 72 hours after stopping treatment with vaginal clindamycin cream. The cream contains oils that weaken or harm the latex products, causing them to not work properly to prevent pregnancy. If you have any questions about this, check with your health care professional.

ClindaMax Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common
  • Itching of the vagina or genital area
  • pain during sexual intercourse
  • thick, white vaginal discharge with no odor or with mild odor
Less common
  • Diarrhea
  • dizziness
  • headache
  • nausea or vomiting
  • stomach pain or cramps
Rare
  • Burning, itching, rash, redness, swelling or other signs of skin problems not present before use of this medicine

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Itching of the vagina or genital area
  • pain during sexual intercourse
  • thick, white vaginal discharge with no odor or with mild odor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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