Dificid

The active ingredient in Dificid is fidaxomicin. Fidaxomicin is a macrolide antibiotic that works by blocking an enzyme called RNA polymerase. This mechanism of action prevents the bacteria from reproducing and spreading.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Dificid. However, the following is a synopsis of the general guidelines for the use of Dificid:

• Dificid is typically taken by mouth twice a day with or without food. If using the suspension, ensure to use the dosing syringe provided to ensure accuracy of dosing. The duration of treatment is typically about 10 days, but this may vary depending on the severity of the infection. Consult your healthcare provider for further information.
• Dificid should be used exactly as prescribed. Do not stop the course of treatment if you start to feel better unless directed by a healthcare provider. Doing so may contribute to bacterial resistance and result in the infection coming back.
• Dificid has minimal systemic absorption meaning that most of it does not reach the blood but instead stays in the stomach and the intestines. For this reason, Dificid may not be suitable for bacterial infections other than CDAD.
• Dificid does not work for viral infections.
• If your infection becomes worse or does not get better after completing a course of Dificid, follow up with your healthcare provider.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

The most common side effects of Dificid seen in clinical trials include:

• Nausea
• Vomiting
• Stomach pain
• Gastrointestinal hemorrhage or bleeding in the stomach or intestines
• Anemia or low red blood cell count
• Neutropenia or a low white blood cell count

Children or pediatric patients may also experience the following adverse reactions in addition to those listed above:

• Fever
• Diarrhea
• Constipation
• Rash
• Increased liver enzyme levels

Some individuals may experience serious side effects while using Dificid. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a serious allergic reaction such as difficulty breathing, hives, or swelling of the face, eyes, or tongue

These are not all of the possible side effects of Dificid. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Dificid, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• An allergy to macrolide antibiotics such as azithromycin or clarithromycin
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Do not use Dificid if you have:

• An allergy to fidaxomicin or any of the other ingredients found in Dificid

Dificid will start to work against the infection right after the first dose. However, depending on the severity, you may not notice the effects until after a few days of regular use.

When Dificid is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions.

Dificid is available in various dosage forms. Dificid film-coated tablets are available in the following strengths:

• 200 mg

Dificid granules for oral suspension are available in the following strengths:

• 40 mg/mL

Dificid should be stored at room temperature away from light and out of the reach of children.

Dificid is manufactured by the pharmaceutical company Merck & Co., Inc.

Currently, there is no generic available of the brand name Dificid. Eligible patients with private insurance may qualify for additional coverage from the manufacturer to help offset some of the cost. Visit Dificid.com for more information.

Consult your doctor or pharmacist before stopping or changing your dose while taking Dificid. It is important that you finish the full course of therapy unless your doctor recommends discontinuing this medication.

It is unknown whether Dificid can cause harm to your unborn child. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Dificid can pass into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.