Alinia

Nitazoxanide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• stomach pain
• headache
• upset stomach
• vomiting
• discolored urine

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• skin rash
• itching

Nitazoxanide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Stop taking nitazoxanide and seek emergency medical attention if you experience a rare allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take the medication and talk to your doctor if you experience

• abdominal pain;
• nausea;
• diarrhea;
• vomiting; or
• headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Contraindications

Hypersensitivity

Cautions

Safety and efficacy not established in HIV+ or immunodeficient patients

Effects in hepatic/renal impairment unknown; use caution

Safety and efficacy of suspension in children <1 year not established

Safety and efficacy of tablets in children <12 years not established

Drug interaction overview

• • Tizoxanide (active metabolite of nitazoxanide) is highly bound to plasma protein (>99.9%)
  • Monitor for adverse reactions if nitazoxanide is coadministered with other highly protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (eg, warfarin)
  • The prescribing information recommends avoiding concurrent warfarin use

Dosage Forms And Strengths

ALINIA Tablets (500 mg)

Round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. Each tablet contains 500 mg of nitazoxanide.

ALINIA For Oral Suspension (100 mg/5 mL)

Pink-colored powder formulation that, when reconstituted as directed, contains 100 mg nitazoxanide/5 mL. The reconstituted suspension has a pink color and strawberry flavor.

ALINIA Tablets (500 mg)

ALINIA tablets are round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 12 and 30 tablets.

Bottles of 12 tablets NDC 67546-111-14
Bottles of 30 tablets NDC 67546-111-12

Store the tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]

ALINIA For Oral Suspension (100 mg/5 mL)

ALINIA for oral suspension is a pink-colored powder formulation that, when reconstituted as directed, contains 100 mg nitazoxanide/5 mL. The reconstituted suspension has a pink color and strawberry flavor. Alinia for oral suspension is available as:

Bottles of 60 mL NDC 27437-106-01

Store the unsuspended powder at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]

The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded [see DOSAGE AND ADMINISTRATION]

Romark, L.C., 3000 Bayport Drive, Suite 200, Tampa, FL 33607. Revised: Jul 2016

Limited information on nitazoxanide overdosage is available. Single oral doses of up to 4000 mg nitazoxanide have been administered to healthy adult volunteers without significant adverse effects. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be observed and given symptomatic and supportive treatment. There is no specific antidote for overdose with ALINIA. Because tizoxanide is highly protein bound ( > 99.9%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• nausea, stomach pain;

• headache; or

• discolored urine.

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.

Antiprotozoal; nitrothiazolyl-salicylamide derivative.1 2

Contraindications

• Hypersensitivity to nitazoxanide or any ingredient in the formulation.1

Warnings/Precautions

General Precautions

Individuals with diabetes mellitus and/or their caregivers should be informed that reconstituted nitazoxanide oral suspension contains 1.48 g of sucrose/5 mL.1

Has not been more effective than placebo for treatment of diarrhea caused by C. parvum in HIV-infected or immunocompromised patients.1 2 12 15

Safety and efficacy for treatment of diarrhea caused by Giardia notestablished in immunocompromised individuals, including those with HIV infection.1

Specific Populations

Category B.1

Not known whether distributed into milk.1 Caution advised if used in nursing women.1

Safety and efficacy not established in children <1 year of age.1

Experience in those ≥65 years of age insufficient to determine whether they respond differently than younger adults.1

The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease or drug therapy should be considered.1 Caution advised in geriatric patients with renal and/or hepatic impairment.1

Use with caution;1 pharmacokinetics not evaluated.1

Use with caution;1 pharmacokinetics not evaluated.1

Common Adverse Effects

Abdominal pain, diarrhea, nausea, vomiting, headache.1

It is very important that your doctor check your progress at regular visits and to check for unwanted effects.

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

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.

Limited information on nitazoxanide overdosage is available. Single oral doses of up to 4000 mg nitazoxanide have been administered to healthy adult volunteers without significant adverse effects. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be observed and given symptomatic and supportive treatment. There is no specific antidote for overdose with Alinia. Because tizoxanide is highly protein bound (>99.9%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

Alinia Tablets and Alinia for Oral Suspension contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a light yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy- N-(5-nitro-2-thiazolyl)benzamide. The molecular formula is C 12H 9N 3O 5S and the molecular weight is 307.3. The structural formula is:

Alinia Tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, pregelatinized corn starch, hydroxypropyl methylcellulose, sucrose, sodium starch glycollate, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, FD&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 2 Aluminum Lake.

Alinia for Oral Suspension, when reconstituted with 48 mL of water, produces 60 mL of a homogeneous suspension with a pink color that contains 100 mg nitazoxanide per 5 mL and the following inactive ingredients: sodium benzoate, sucrose, xanthan gum, microcrystalline cellulose and carboxymethylcellulose sodium, anhydrous citric acid, sodium citrate dihydrate, maltodextrin, modified food starch, triacetin, FD&C Red No. 40 and artificial strawberry flavoring.

NDC 67546-111-12

Alinia (nitazoxanide) tablets

500 mg

Rx Only 30 TABLETS

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.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions 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 ALINIA was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received ALINIA Tablets or ALINIA for Oral Suspension at the recommended dose for at least three days. In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with ALINIA Tablets or ALINIA 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 ALINIA 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 ALINIA-treated subjects based upon age.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of ALINIA. 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 ALINIA 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

Read the entire FDA prescribing information for Alinia (Nitazoxanide)

Applies to nitazoxanide: oral powder for suspension, oral tablet

Along with its needed effects, nitazoxanide (the active ingredient contained in Alinia) 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 immediately if any of the following side effects occur while taking nitazoxanide:

• Diarrhea

Some side effects of nitazoxanide 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:

• Abdominal or stomach pain
• headache
• nausea
• urine changes

• Dizziness
• heartburn
• hives or welts, itching, or skin rash
• redness of the skin
• trouble breathing
• vomiting

Contraindications

Hypersensitivity

Cautions

Safety and efficacy not established in HIV+ or immunodeficient patients

Effects in hepatic/renal impairment unknown; use caution

Safety and efficacy of suspension in children