Granisetron Hydrochloride

Contraindications

• Known hypersensitivity to granisetron or any ingredient in the formulation.1 33

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions, including anaphylactic reaction, shortness of breath, hypotension, and urticaria, reported rarely.1 33

Possible hypersensitivity reactions in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.1 33

General Precautions

Does not stimulate gastric or intestinal peristalsis; do not use as a substitute for nasogastric suction.1

May mask progressive ileus and/or gastric distention when used in patients undergoing abdominal surgery or in those with chemotherapy-induced nausea and vomiting.1

Specific Populations

Category B.1 33

Not known whether granisetron is distributed into milk.1 33 Caution advised if used in nursing women.1 33

Safety and efficacy of IV granisetron for chemotherapy-induced nausea and vomiting not established in children <2 years of age; safety and efficacy of IV granisetron for prevention and treatment of postoperative nausea and vomiting not established in children of any age.1

Safety and efficacy of oral granisetron not established in children of any age.33

No substantial differences in safety and efficacy for chemotherapy-induced nausea and vomiting in geriatric patients relative to younger adults.1 33

Insufficient experience with IV granisetron for postoperative nausea and vomiting in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1

Common Adverse Effects

Headache,1 33 constipation,1 33 pain,1 diarrhea,1 33 fever,1 abdominal pain,1 33 increased hepatic enzymes,1 33 asthenia,1 33 dyspepsia.33