Proxa-A

COMPOSITION

Proxa-A 500 Tablet : Each flim coated tablet contains Nitazoxanide INN 500 mg.

INDICATIONS

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
· Amebiasis and helminth infections.

DOSAGE AND ADMINISTRATIO

12 Years: 500mg bid with food for 3 days.

CONTRAINDICATIONS

Known hypersensitivity to Proxa-A (Nitazoxanide) or any other ingredient in the formulations.

PRECAUTIONS

Proxa-A (Nitazoxanide) should be administered with caution to patients with hepatic, renal and biliary disease.

SIDE-EFFECTS

Proxa-A (Nitazoxanide) is generally well tolerated. In placebo-controlled clinical trials, the incidence of side-effects did not differ significantly from those of the placebo. None of the 613 pediatric patients discontinued therapy because of side-effects. In controlled and uncontrolled clinical studies pediatric patients who received Proxa-A (Nitazoxanide) the side-effects were abdominal pain, vomiting and headache. These were typically mild and transient in nature, side-effects occurring in less than 1% of patients are anorexia, flatulence, appetite increase, malaise, sweating and dizziness.

DRUG INTERACTIONS

Proxa-A (Nitazoxanide) is highly bound to plasma protein (>99.9%) Therefore, caution should be used when administering Proxa-A (Nitazoxanide) concurrently with other highly plasma protein-bound drugs with narrow therapeutic window.

USE IN PREGNANCY AND LACTATION

Pregnancy Category B: This drug should be used during pregnancy only if clearly needed. It is not know whether Proxa-A (Nitazoxanide) is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Proxa-A (Nitazoxanide) is administered to a nursing woman.

STORAGE PRECAUTION

Store at a cool & dry place, protect from light & moisture. Keep out of reach of children.

COMMERCIAL PACK

Proxa-A 500 Tablet : Box cotaining 3 x10’s tablets in blister strips.

Manufactured by:

Ad-Din Pharmaceuticals Ltd.