Betasept

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with chlorhexidine including the following:

• Allergic symptoms. Tell your health care provider right away if you have some or all of the following symptoms of allergic symptoms.
  • skin rash
  • itch
  • generalized swelling
  • breathing difficulties
  • light headedness
  • rapid heart rate
  • upset stomach
  • diarrhea
• Pain or swelling. Notify your dentist promptly if pain, swelling, or other problems occur. (Some mild to moderate sensitivity is normal during the first week after placement of chip)

Do not use chlorhexidine if you have a known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

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.

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

Chlorhexidine chip falls into category C. There are no well-controlled studies that have been done in pregnant women. Chlorhexidine chip should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

You should not use chlorhexidine topical if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any allergies to food, dyes, animals, or medicines.

It is not known whether chlorhexidine topical will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether chlorhexidine topical passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Be very careful when using chlorhexidine topical on a child younger than 2 months old. This medicine may cause severe irritation or chemical burns on a very young child.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Chlorhexidine topical is for use only on the skin.

Rinse the skin before applying chlorhexidine topical. Apply only enough medicine to cover the area you are treating. Do not apply this medicine to deep cuts, scrapes, or open skin wounds.

To use chlorhexidine topical soap, apply only enough to cover the area you are treating. Wash the area gently, then rinse thoroughly with plain water. Avoid using over large areas of skin.

This medicine is made under sterile conditions, but its contents are not sterilized. It is possible for bacteria to get inside the product and contaminate it, which could spread infection. To avoid contaminating your medicine with bacteria:

• Use only the swab, pad, or applicator provided with your medicine.

• If no applicator is provided, use only a clean cotton ball or cotton swab to apply this medicine.

• Do not touch the tip of the medicine bottle with your fingers or touch it to your skin.

• Do not dilute the medicine with water or other liquid.

• Use the applicator (pad, swab, or other dressing) only once. Throw away after one use.

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

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

If this medicine is packaged in a single-use foil wrapper or other container, use it only once. Throw away after one use, even if there is still medicine left in it. Do not save for later use.

Chlorhexidine can cause a rare but serious allergic reaction that may be life-threatening. Get emergency medical help if you have signs of an allergic reaction: hives, severe skin rash; wheezing, difficult breathing; cold sweats, feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using chlorhexidine topical and call your doctor at once if you have:

• severe burning, itching, or redness;

• blistering or peeling;

• swelling or severe skin rash; or

• any other severe irritation of treated skin.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Chlorhexidine belongs to a group of medicines called antiseptic antibacterial agents. It is used to clean the skin after an injury, before surgery, or before an injection. Chlorhexidine is also used to clean the hands before a procedure. It works by killing or preventing the growth of bacteria on the skin.

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

Because of chlorhexidine's potential for causing excessive skin irritation and the risk of increased absorption through the skin, use in children less than 2 months of age is not recommended.

Geriatric

No information is available on the relationship of age to the effects of chlorhexidine in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Deep or open skin wounds—Some products should not be used for this condition. Use the medicine only as directed by your doctor.

Chlorhexidine Gluconate 0.5% Topical Solution (Towelette)
-Hands should be rubbed vigorously with the towelette for approximately 15 seconds, with particular attention to the nails and interdigital spaces. Water and further toweling are not required.

Use: As a hand antiseptic to reduce bacteria that could cause disease

Chlorhexidine Gluconate 0.75% Topical Solution/Hand Wash:
-Wet hands with water, then apply approximately 5 mL into cupped hands and wash vigorously for 30 seconds. Personnel should wash and dry hands thoroughly.

Use: As a healthcare personnel hand wash to reduce bacteria that could cause disease

Chlorhexidine Gluconate 2% Topical Solution:
-SURGICAL HAND SCRUB: Remove jewelry, wet hands and forearms with water and dispense 5 grams into hands. Hands and forearms should be washed/scrubbed for 3 minutes, then rinsed thoroughly with water; hands and forearms should be washed for an additional 3 minutes with 5 grams, rinsed with water, and thoroughly dried.
-HEALTHCARE PERSONNEL HAND WASH: Hands should be wet with water, then 5 grams of this drug should be applied into the hands and washed vigorously for 30 seconds. Hands should be rinsed and dried thoroughly.
-SKIN PREPARATION: The preparation should be applied with gentle back-and-forth strokes for approximately 30 seconds (dry surgical sites) to 2 minutes (moist surgical sites) and allowed to dry completely (e.g., at least 3 minutes with hairless sites, and up to 1 hour in hair).
-SKIN WOUND/GENERAL SKIN CLEANSER: The affected area should be thoroughly rinsed with water, then the minimum amount of product to cover the area should be applied and washed gently. The affected area should be rinsed thoroughly with water.

Uses:
-As a surgical hand scrub to significantly reduce the number of microorganisms on the hands and forearms prior to surgery or patient care
-As a healthcare personnel hand wash to help reduce bacteria that may cause disease
-As a skin wound/general skin cleanser to reduce bacteria on the skin

Chlorhexidine Gluconate 4% Topical Solution
-SURGICAL HAND SCRUB: Wet hands and forearms with water and dispense 5 grams OR 1 sponge into hands, paying particular attention to the nails, cuticles, and interdigital spaces. Hands and forearms should be washed/scrubbed for 3 minutes, then rinsed thoroughly with water; hands and forearms should be washed for an additional 3 minutes with 5 grams and rinsed with water, and the treated areas should be dried thoroughly.
-HEALTHCARE PERSONNEL HAND WASH: Hands should be wet with water, then 5 grams of this drug should be applied into the hands and washed vigorously for 15 seconds. Hands should be rinsed and dried thoroughly.
-PATIENT PREOPERATIVE SKIN PREPARATION: The solution should be applied liberally to the surgical side and swabbed for at least 2 minutes; the area should be dried with a sterile towel. The site should then be swabbed for 2 minutes and dried with a sterile towel.
-SKIN WOUND AND GENERAL SKIN CLEANSING: The affected area should be thoroughly rinsed with water, then the minimum amount of product to cover the area should be applied and washed gently. The affected area should be rinsed thoroughly with water.

Comments:
-Nails, cuticles, and interdigital spaces may be washed with a nail brush/pick.
-If included, the sponge should be used to create a lather, and then used to apply the solution to the hands and forearms.

Uses:
-As a surgical hand scrub to significantly reduce the number of microorganisms on the hands and forearms before surgery or patient care
-As a healthcare professional hand wash to reduce bacteria that may cause disease
-As a patient preoperative skin preparation for the preparation of the patient's skin prior to surgery
-As a skin wound and general skin cleanser

Chlorhexidine Gluconate 92 mg Topical Dressing
-The patch should be placed on cleansed skin surrounding a percutaneous device, with the white foam side facing the skin. Percutaneous devices should be placed along the slit portion of the patch, and then the edges of the patch should be pushed together until they touch.
-Duration of treatment: Up to 7 days

Comments:
-The patch may turn yellow during use, but efficacy of the patch is unaffected.
-Patients with highly exuding wounds may require more frequent patch changes.

Uses:
-Absorb exudate and cover a wound caused by vascular/non-vascular percutaneous medical devices (e.g., IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally inserted coronary catheters, mid-line catheters, drains, chest tubes, externally placed orthopedic pins, epidural catheters)
-Reduce local infections, catheter-related blood stream infections (CRBSI) and skin colonization of microorganisms related to CRBSI in patients with central venous/arterial catheters

Data not available