Vancocin HCl Pulvules (Oral)

Vancomycin, when taken by mouth, is used to treat Clostridioides difficile-associated diarrhea (also known as C diff). C diff is a type of bacteria that causes severe diarrhea. Oral vancomycin is also used to treat enterocolitis caused by a specific bacteria (for example, Staphylococcus aureus).

Vancomycin is part of a group of medicines called antibiotics. It works by killing bacteria or stopping them from growing. It will not work for colds, flu, or other viral infections.

This medicine is available only with your doctor's prescription.

It is important for your doctor to check you and your child's progress at regular visits to ensure that this medicine is working properly and that the colitis is completely cleared up. Blood, urine, and hearing tests may be needed to check for unwanted effects.

If you or your child's symptoms do not improve within a few days, or if they get worse, contact your doctor.

Contact your doctor immediately if you or your child have blood in the urine, a change in how often you urinate or the amount of urine, difficulty breathing, nausea, vomiting, swelling in the feet or lower legs, or weakness during and after treatment with this medicine. These may be signs of a serious kidney problem.

Contact your doctor immediately if you have a sudden decrease in hearing or loss of hearing, which may come with dizziness and ringing in the ears. Inform your doctor if you or your child experience dizziness or lightheadedness, a feeling of constant movement of oneself or surroundings, or a sensation of spinning. These may be symptoms of damage to your hearing or sense of balance.

This medicine may cause serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD). Contact your doctor immediately if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

If you are taking this medicine for diarrhea caused by other antibiotics, do not take any other diarrhea medicine without first checking with your doctor. Other medicines for diarrhea may make your diarrhea worse or make it last longer.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will need to consider the risks of taking the medicine against the benefits it may provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies conducted so far have not shown any specific problems in children that would limit the use of vancomycin. Its safety and effectiveness have been confirmed.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the use of vancomycin. However, older adults are more likely to have age-related kidney issues, which may require careful monitoring and dosage adjustments for those taking vancomycin.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The interactions listed here are based on their potential significance and are not a complete list.

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

• Amikacin
• Aspirin
• Cholera Vaccine, Live
• Gentamicin
• Piperacillin
• Tobramycin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both of the medicines.

• Succinylcholine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Hearing problems—Use with caution. This may worsen the condition.

• Kidney disease or
• Other inflammatory bowel disorders—May increase the risk of more serious 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, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bladder pain
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody or cloudy urine
• Decreased urine
• Difficult, burning, or painful urination
• Dry mouth
• Fever
• Frequent urge to urinate
• Increased thirst
• Irregular heartbeat
• Loss of appetite
• Lower back or side pain
• Mood changes
• Muscle pain or cramps
• Nausea
• Numbness or tingling in the hands, feet, or lips
• Seizures
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Vomiting

Less common

• Change in the frequency of urination or amount of urine
• Drowsiness
• Trouble breathing
• Weakness

Rare

• Hives, skin rash
• Redness or other discoloration of the skin
• Scaling or welting of the skin

Incidence not known

• Black, tarry stools
• Bleeding gums
• Blistering, peeling, or loosening of the skin
• Blurred vision
• Chest pain or tightness
• Chills
• Confusion
• Continuing ringing or buzzing or other unexplained noise in the ears
• Cough
• Difficulty with swallowing
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fast heartbeat
• Feeling of constant movement of self or surroundings
• Feeling of fullness in the ears
• Hearing loss
• Itching
• Joint or muscle pain
• Loss of balance
• Lower back or side pain
• Pale skin
• Pinpoint red spots on the skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Ringing or buzzing in the ears
• Sensation of spinning
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Sweating
• Swollen glands
• Unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• Bitter or unpleasant taste
• Excess air or gas in the stomach or bowels
• Headache
• Mouth irritation
• Passing gas
• Stomach pain

Incidence not known

• Depression
• Difficulty having a bowel movement
• Trouble sleeping

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

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

In the U.S.

• Firvanq
• Vancocin HCl Pulvules

Available Dosage Forms:

• Powder for Solution
• Capsule
• Powder for Suspension

Therapeutic Class: Antibiotic

Chemical Class: Glycopeptide

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Swallow the capsule whole. Do not crush, open, or chew it.

If you are using the oral liquid:

• Shake the medicine well before each use.
• Use a specially marked measuring spoon, oral syringe, or medicine cup to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.
• Do not use after the expiration date on the label. The medicine may not work properly after that date. Check with your pharmacist if you have any questions about this.

If you are also using cholestyramine or colestipol for your colitis, do not take vancomycin by mouth within 3 to 4 hours of taking either of these medicines. Doing so may keep vancomycin from working properly.

Keep using this medicine for the full treatment time, even if you begin to feel better after a few days. Your infection may not clear up if you stop using the medicine too soon.

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 oral dosage forms (capsules or oral liquid): For treatment of C. difficile-associated diarrhea: Adults—125 milligrams (mg) 4 times a day for 10 days. Children—Dose is based on body weight and must be determined by the doctor. The usual dose is 40 milligrams per kilogram (mg/kg) of body weight, divided into 3 or 4 doses, and taken for 7 to 10 days. However, dose is usually not more than 2000 mg per day. For treatment of Staphylococcal enterocolitis: Adults—500 to 2000 milligrams (mg) divided into 3 or 4 doses for 7 to 10 days. Children—Dose is based on body weight and must be determined by the doctor. The usual dose is 40 milligrams per kilogram (mg/kg) of body weight, divided into 3 or 4 doses, and taken for 7 to 10 days. However, dose is usually not more than 2000 mg per day.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the capsules at room temperature, away from heat, moisture, and direct light.

Store the oral liquid in the refrigerator for up to 14 days. Do not freeze. Throw away any unused medicine after 14 days, or if the liquid becomes cloudy or has particles in it.

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