7 Warnings and Precautions - 7.1.1 Pregnant Women and 7.1.2 Breast-feeding

Sep 3, 2026

This document details important warnings and precautions related to the use of a medication, specifically focusing on pregnant women and breast-feeding individuals. It outlines the dosage forms available, including film-coated tablets in strengths of 50 mg, 100 mg, 150 mg, and 200 mg, supplied in bottles and blisters. The non-medicinal ingredients for the oral dosage form are listed, such as colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and specific dye pigments. Coloration details for each tablet strength are provided, including black iron oxide, FD&C Blue #2/indigo carmine aluminum lake, red iron oxide, and yellow iron oxide. Additionally, a solution for injection is available, with a strength of 10 mg/mL in vials, containing hydrochloric acid, sodium chloride, and water for injection. The document references specific sections such as "7 Warnings and Precautions, 7.1.1 Pregnant Women" and "7 Warnings and Precautions, 7.1.2 Breast-feeding," both dated September 2022, indicating guidelines and considerations for these sensitive patient populations.

LanguageEnglish

CategoryGeneral

FormatPDF

Pages49

Reading Time17 min

AccessFree to download

7 Warnings and Precautions

7.1.1 Pregnant Women

7.1.2 Breast-feeding

FAQs

What are the available dosage forms for this medication?

The medication is available as film-coated tablets for oral administration in strengths of 50 mg, 100 mg, 150 mg, and 200 mg, and as a solution for injection for intravenous use at a strength of 10 mg/mL.

What are the non-medicinal ingredients in the film-coated tablets?

The non-medicinal ingredients include colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and specific dye pigments according to the tablet strength.

Are there any specific precautions for pregnant or breast-feeding women?

Yes, the document contains specific sections titled "7.1.1 Pregnant Women" and "7.1.2 Breast-feeding" which are dated September 2022, indicating guidance for these patient groups.

Sep 3, 2026

Upload by Ethan Miller