Dosage
PRILOSEC® Packets Dosage and Administration
PRILOSEC® Packets have once-daily dosing for pediatric and adult patients.*
*Indications for PRILOSEC® Packets for delayed-release oral suspension:
- PRILOSEC is indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) for up to 4 weeks in adults and children 1 year and older.
- In infants 1 month to less than 1 year, PRILOSEC is indicated for the short-term treatment (up to 6 weeks) of erosive esophagitis (EE) due to acid-mediated GERD.
- PRILOSEC is indicated for the treatment of symptomatic gastroesophageal reflux disease (GERD) for up to 4 weeks in adults and children 1 year and older.
Please see full Prescribing Information.
Pediatric Dosage
Recommended dosage regimen of PRILOSEC® Packets in pediatric patients for treatment of symptomatic GERD†
Indication | PRILOSEC Dosage Regimen and Duration | ||
---|---|---|---|
Patient Age | Weight-Based Dose (mg) | Regimen and Duration | |
Treatment of Symptomatic GERD | 1 to 16 years | 5 to <10 kg: 5 mg | Once daily for up to 4 weeks |
10 to <20 kg: 10 mg | |||
20 kg and greater: 20 mg | |||
Treatment of EE due to Acid-Mediated GERD | 1 to 16 years | 5 to <10 kg: 5 mg | Once daily for 4 week to 8 weeks1 |
10 to <20 kg: 10 mg | |||
20 kg and greater: 20 mg | |||
1 month to less than 1 year | 3 to <5 kg: 2.5 mg | Once daily up to 6 weeks | |
5 to <10 kg: 5 mg | |||
10 kg and greater: 10 mg | |||
Maintenance of Healing of EE due to Acid-Mediated GERD | 1 to 16 years | 5 to <10 kg: 5 mg | Once daily. Controlled studies do not extend beyond 12 months |
10 to <20 kg: 10 mg | |||
20 kg and greater: 20 mg |
1. The efficacy of PRILOSEC used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of PRILOSEC may be considered.
*Please see full Prescribing Information.
Reference: PRILOSEC [package insert]. Zug, Switzerland: Covis Pharma; 2017.
Adult Dosage
Recommended dosage regimen of PRILOSEC® Packets in adults for treatment of symptomatic GERD†
Indication | Dosage of PRILOSEC | Treatment Duration |
---|---|---|
Treatment of Symptomatic GERD | 20 mg once daily | Up to 4 weeks |
Treatment of EE due to Acid-Mediated GERD | 20 mg once daily | 4 to 8 weeks1 |
Maintenance of Healing of EE due to Acid-Mediated GERD | 20 mg once daily2 | Controlled studies do not extend beyond 12 months |
1. The efficacy of PRILOSEC used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of PRILOSEC may be considered.
2. Dosage reduction to 10 mg once daily is recommended for patients with hepatic impairment (Child-Pugh Class A, B or C) and Asian patients when used for the maintenance of healing of EE [see Prescribing Information, Use in Specific Populations and Clinical Pharmacology].
*Please see full Prescribing Information.
Reference: PRILOSEC [package insert]. Zug, Switzerland: Covis Pharma; 2017.
Administration
PRILOSEC® Packets are intended to be prepared in water and administered orally or via a nasogastric (NG) or gastric tube.
- PRILOSEC® Packets should be taken before meals.
- Antacids may be used concomitantly with PRILOSEC® Packets.
- Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, the next missed dose should not be administered, and the next dose should be taken on time. Two doses should not be administered at one time to make up for a missed dose.
Oral Administration in Water
- Empty the contents of a 2.5 mg packet into a container containing 5 mL of water.
- Empty the contents of a 10 mg packet into a container containing 15 mL of water.
- Stir.
- Leave 2 to 3 minutes to thicken.
- Stir and drink within 30 minutes.
- If any material remains after drinking, add more water, stir and drink immediately.
- PRILOSEC® Packets should be taken before meals.
- Antacids may be used concomitantly with PRILOSEC® Packets.
- Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, the next missed dose should not be administered, and the next dose should be taken on time. Two doses should not be administered at one time to make up for a missed dose.
Administration with Water via a NG or Gastric Tube (Size 6 or Larger)
- Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet). It is important to only use a catheter tipped syringe when administering through a nasogastric tube or gastric tube.
- Immediately shake the syringe and leave 2 to 3 minutes to thicken.
- Shake the syringe and inject through the nasogastric or gastric tube into the stomach within 30 minutes.
- Refill the syringe with an equal amount of water.
- Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.
Reference: PRILOSEC [package insert]. Zug, Switzerland: Covis Pharma; 2017