Takepron OD Patient Counseling Information

Advise the patient to read the FDA approved patient labeling (Medication Guide and Instructions for Use).
Adverse Reactions: Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with: Hypersensitivity Reactions (see Contraindications); Acute Interstitial Nephritis (see Acute Interstitial Nephritis under Precautions); Clostridium difficile Associated Diarrhea (Clostridium difficile Associated Diarrhea under Precautions); Bone Fracture (see Bone Fractures under Precautions); Cutaneous and Systemic Lupus Erythematosus (see Cutaneous and Systemic Lupus Erythematosus under Precautions); Cyanocobalamin (Vitamin B-12) Deficiency (see Cyanocobalamin (Vitamin B-12) Deficiency under Precautions); Hypomagnesemia (see Hypomagnesemia under Precautions).
Administration: TAKEPRON is available as an orally disintegrating tablet. Both are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented as follows (see Important Administration Information under Dosage & Administration).
TAKEPRON should be taken before eating.
TAKEPRON OD Tab should not be crushed or chewed.
Phenylketonurics: Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet.
Administration Options: TAKEPRON OD Tablets - Orally Disintegrating Tablets: TAKEPRON OD Tablets should not be broken or cut.
TAKEPRON OD Tablets should not be chewed.
Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed.
The tablet typically disintegrates in less than one minute.
Alternatively, for children or other patients who have difficulty swallowing tablets, TAKEPRON OD Tablets can be delivered in two different ways.
TAKEPRON OD Tablets - Oral Syringe: For administration via oral syringe, TAKEPRON OD Tablets can be administered as follows: Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water.
Shake gently to allow for a quick dispersal.
After the tablet has dispersed, administer the contents within 15 minutes.
Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.
TAKEPRON OD Tablets - Nasogastric Tube (≥8 French) Administration: For administration via a nasogastric tube, TAKEPRON OD Tablets can be administered as follows: Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water.
Shake gently to allow for a quick dispersal.
After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes.
Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube.