• Mitafar indications
• Uses of Mitafar in details
• Mitafar description
• Mitafar dosage
• Mitafar interactions
• Mitafar side effects
• Mitafar contraindications

What is Mitafar?

Mitafar belongs to a group of medicines called antiprotozoals. It is used to treat diarrhea that is caused by certain types of protozoa (tiny, one-celled animals).

Mitafar is available only with your healthcare professional's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, Mitafar is used in certain patients with the following medical condition:

• Intestinal parasitic infections

Mitafar indications

Diarrhea Caused by Giardia Lamblia or Cryptosporidium Parvum

Mitafar for

Oral Suspension (patients 1 year of age and older) and Mitafar Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.

Limitations Of Use

Mitafar for

Oral Suspension and Mitafar Tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.

How should I use Mitafar?

Use Mitafar suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Mitafar suspension with food.
• Shake well before using.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Mitafar suspension, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mitafar suspension.

Uses of Mitafar in details

Use: Labeled Indications

Diarrhea, infectious: Treatment of diarrhea caused by Cryptosporidium parvum or Giardia lamblia

Off Label Uses

Clostridioides (formerly Clostridium) difficile infection

Current evidence from small, controlled trials regarding the use of Mitafar in the management of C. difficile infection suggests that it may be comparable to the use of oral metronidazole or vancomycin. The Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology (SHEA) clinical practice guidelines for C. difficile infection state that Mitafar is considered a probable effective alternative for primary C. difficile infection in adults without specific recommendations for use. Larger controlled trials are needed.

Cryptosporidiosis-associated diarrhea in HIV-infected patients

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, Mitafar may be considered as an alternative agent in the management of diarrhea caused by Cryptosporidium in HIV-infected patients (must be used in combination with optimized antiretroviral therapy (ART), electrolyte replacement, and symptomatic treatment and rehydration).

Mitafar description

Mitafar, also known by the brand name Mitafar, is a synthetic nitrothiazolyl-salicylamide derivative and an anti-protozoal agent. It is approved for treatment of infectious diarrhea caused by Cryptosporidium parvum and Giardia lamblia in patients 1 year of age and older. Following oral administration it is rapidly hydrolyzed to its active metabolite, tizoxanide, which is 99% protein bound. Peak concentrations are observed 1–4 hours after administration. It is excreted in the urine, bile and feces. Untoward effects include abdominal pain, vomiting and diarrhea. [Wikipedia]

Mitafar dosage

Mitafar Dosage

Generic name: Mitafar 500mg

Dosage form: tablet; powder, for oral suspension

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

2.1 Recommended Dosage and Important Administration Instructions

Important Administration Instructions for Pediatric Patients 11 years of Age or Younger:

Mitafar tablets should not be administered to pediatric patients 11 years of age or younger because a single tablet contains a greater amount of Mitafar than the recommended dosing in this pediatric age group.

Table 1. Recommended Dosage

2.2 Directions for Mixing Mitafar for

Oral Suspension

Reconstitute Mitafar for

Oral Suspension as follows:

• Measure 48 mL of water for preparation of the 100 mg/5 mL suspension
• Tap bottle until all powder flows freely.
• Add approximately one-half of the 48 mL of water required for reconstitution and shake vigorously to suspend powder.
• Add remainder of water and again shake vigorously

Keep container tightly closed, and shake the suspension well before each administration. The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded.

More about Mitafar (Mitafar)

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Consumer resources

• Mitafar
• Mitafar suspension
• Mitafar (Advanced Reading)

Professional resources

• Mitafar (AHFS Monograph)
• Mitafar (FDA)

Related treatment guides

• Ascariasis
• Giardiasis
• Dwarf Tapeworm Infection (Hymenolepis nana)
• Amebiasis
• Cryptosporidiosis

Mitafar interactions

See also:
What other drugs will affect Mitafar?

Tizoxanide is highly bound to plasma protein (>99.9%). Therefore, caution should be used when administering Mitafar concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin). In vitro metabolism studies have demonstrated that tizoxanide has no significant inhibitory effect on cytochrome P450 enzymes. Although no drug-drug interaction studies have been conducted in vivo, it is expected that no significant interaction would occur when Mitafar is co-administered with drugs that either are metabolized by or inhibit cytochrome P450 enzymes.

Mitafar side effects

See also:
What are the possible side effects of Mitafar?

Clinical Trials 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 safety of Mitafar was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received Mitafar Tablets or Mitafar for

Oral Suspension at the recommended dose for at least three days. In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with Mitafar Tablets or Mitafar for

Oral Suspension, the most common adverse reactions were abdominal pain, headache, chromaturia and nausea ( > 2%).

Safety data were analyzed separately for 280 HIV-uninfected subjects ≥ 12 years of age receiving Mitafar at the recommended dose for at least three days in 5 placebo-controlled clinical trials and for 256 HIV-uninfected subjects 1 through 11 years of age in 7 controlled clinical trials. There were no differences between the adverse reactions reported for Mitafar-treated subjects based upon age.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Mitafar. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following is a list of adverse reactions spontaneously reported with Mitafar Tablets which were not included in clinical trial listings:

Gastrointestinal disorders: diarrhea, gastroesophageal reflux disease

Nervous System disorders: dizziness

Respiratory, thoracic and mediastinal disorders: dyspnea

Skin and subcutaneous tissue disorders: rash, urticaria

Mitafar contraindications

See also:
What is the most important information I should know about Mitafar?

Hypersensitivity

Mitafar Tablets and Mitafar for

Oral Suspension are contraindicated in patients with a prior hypersensitivity to Mitafar or any other ingredient in the formulations.

Active ingredient matches for Mitafar:

Nitazoxanide in Mexico.

References

1. DailyMed. "NITAZOXANIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "NITAZOXANIDE". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "NITAZOXANIDE". http://www.drugbank.ca/drugs/DB00507 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology