If swallowing a pill is difficult,
ask your doctor about PRILOSEC^® Packets

PRILOSEC^® Packets are now
available for as little as
$9 per month.*

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Select PRILOSEC^® Packets for patients with GERD, erosive esophagitis or other acid-related conditions*

PRILOSEC^® Packets are now
available for as little as
$9 per month.^†

Download the Card

Terms and conditions apply

Dosage and Administration

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
Indication	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

*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.

Oral Administration

NG or Gastric Tube Administration

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

IMPORTANT SAFETY INFORMATION FOR PRILOSEC^® (omeprazole magnesium)

PRILOSEC may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
PRILOSEC can cause serious side effects, including:
- Kidney problems (acute interstitial nephritis), which may happen at any time during treatment with PRILOSEC. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
- Severe diarrhea, which may be caused by an infection (Clostridium difficile) in the intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
- Bone fractures, if you take multiple daily doses of PRILOSEC for a year or longer.
- Certain types of lupus erythematosus, or worsening of existing lupus, in some people who take PPIs including PRILOSEC. Call your doctor right away if you have joint pain or rash on your cheeks or arms that gets worse in the sun.
- Low vitamin B12, if you have been on PRILOSEC for more than 3 years.
- Low magnesium levels, if you take PRILOSEC for 3 months or more.
- Stomach growths called fundic gland polyps, if you take Prilosec for more than 1 year.
Do not take PRILOSEC if you are allergic to omeprazole magnesium, any of the ingredients in PRILOSEC, or are allergic to any other PPI. Do not take PRILOSEC if you are taking a medicine that contains rilpivirine.
Before taking PRILOSEC, talk to your doctor about all of your medical conditions, including if you have been told you have low magnesium levels in your blood, have liver problems, or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed.
Tell your doctor about all of the medicines you take (prescription and nonprescription), especially if you take antibiotics containing clarithromycin or amoxicillin, or if you take clopidogrel, methotrexate, St. John’s Wort, or rifampin. PRILOSEC may affect how other medicines work and other medicines may affect how PRILOSEC works.
In adults and children, the most common side effects with PRILOSEC include headache, nausea, vomiting, stomach pain, diarrhea, and gas.
In children 1 to 16 years of age, side effects with PRILOSEC also include respiratory system events and fever.

INDICATIONS AND USAGE FOR PRILOSEC^® (omeprazole magnesium)

PRILOSEC is a prescription medicine called a proton pump inhibitor (PPI), which reduces the amount of acid in your stomach. PRILOSEC is prescribed to treat heartburn and other symptoms of gastroesophageal reflux disease (GERD), in adults and children 1 year of age and older. PRILOSEC is also prescribed to heal damage to the esophagus caused by acid-mediated GERD (erosive esophagitis) in adults and children as young as 1 month of age.

PRILOSEC may be prescribed for the healing of duodenal or stomach ulcers, or with certain antibiotics to treat an infection (H. pylori) that can cause duodenal ulcers. PRILOSEC is also used for the long term treatment of conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read full Prescribing Information and Medication Guide for PRILOSEC packets.

IMPORTANT SAFETY INFORMATION FOR PRILOSEC^® (omeprazole magnesium)

PRILOSEC is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation.
Proton pump inhibitors (PPIs), including PRILOSEC, are contraindicated in patients receiving rilpivirine-containing products.
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PRILOSEC, refer to the CONTRAINDICATIONS section of their package inserts.
In adults, symptomatic response to therapy does not rule out the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
Acute interstitial nephritis has been observed in patients taking PPIs including PRILOSEC. Discontinue PRILOSEC if acute interstitial nephritis develops.
PPI therapy like PRILOSEC may be associated with increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.
PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose (multiple daily doses) and long-term (a year or longer) therapy.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including omeprazole. These events included both new onset and exacerbations. If signs or symptoms consistent with CLE or SLE are noted with PRILOSEC, discontinue and refer the patient to a specialist. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.
Fundic gland polyps risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy appropriate to the condition being treated.
Avoid concomitant use of PRILOSEC with clopidogrel, due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using PRILOSEC consider alternative anti-platelet therapy.
Daily treatment with any acid-suppressing medications over a long period of time (e.g. longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12). Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature.
Hypomagnesemia has been reported rarely with prolonged treatment with PPIs and may require discontinuing PPI therapy.
Concomitant use of PRILOSEC and St. John’s wort or rifampin can substantially decrease PRILOSEC concentrations. Avoid concomitant use.
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity, which may cause false positives in diagnostic investigations for neuroendocrine tumors. Temporarily stop PRILOSEC at least 14 days before assessing CgA levels.
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.
Concomitant use of PRILOSEC and atazanavir or nelfinavir is not recommended. PRILOSEC is expected to increase the plasma levels of saquinavir. See prescribing information for saquinavir for monitoring saquinavir-related toxicities.
Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.
PRILOSEC may interfere with the absorption of drugs for which gastric pH affects bioavailability (e.g. iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole).
PRILOSEC may increase systemic exposure of citalopram leading to an increased risk of QT prolongation. Limit the dose of citalopram to a maximum of 20 mg per day.
PRILOSEC may increase systemic exposure of cilostazol and one of its active metabolites. Consider dose reduction of cilastozol.
When taken concomitantly, PRILOSEC may cause increased exposure of several drugs, including phenytoin, digoxin, and tacrolimus. Monitor serum drug concentrations and consider dose adjustment.
PRILOSEC may cause increased exposure of diazepam. Monitor patients for increased sedation and consider dose adjustment.
PRILOSEC may cause hyper-response in gastrin secretion in response to secretin stimulation test. Temporarily stop PRILOSEC treatment at least 14 days prior to secretin stimulation test.
In adults, the most frequently reported adverse reactions (ARs) with PRILOSEC include headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.
In pediatric patients 1 to 16 years of age, the most frequently reported ARs with PRILOSEC include respiratory system events and fever.
In pediatric patients 1 month to <1 year, the most frequently reported ARs with PRILOSEC include respiratory system events and otitis media.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indications for PRILOSEC^® (omeprazole magnesium)

PRILOSEC is indicated for short-term treatment (4 to 8 weeks) of active duodenal ulcer or active benign gastric ulcer in adults.
In combination with clarithromycin and amoxicillin, PRILOSEC is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
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 short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD, and for the maintenance healing of EE due to acid-mediated GERD in patients 1 year of age and older.
PRILOSEC is indicated for the long-term treatment of pathological hypersecretory conditions (e.g. Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

Please read full Prescribing Information and Medication Guide for PRILOSEC packets.

PRILOSEC^® is a registered trademark of AstraZeneca used under license. October 2017.

Dosage and Administration

Dosage

PRILOSEC® Packets Dosage and Administration

Pediatric Dosage

Adult Dosage

Administration

IMPORTANT SAFETY INFORMATION FOR PRILOSEC® (omeprazole magnesium)

INDICATIONS AND USAGE FOR PRILOSEC® (omeprazole magnesium)

IMPORTANT SAFETY INFORMATION FOR PRILOSEC® (omeprazole magnesium)

Indications for PRILOSEC® (omeprazole magnesium)

PRILOSEC^® Packets Dosage and Administration

IMPORTANT SAFETY INFORMATION FOR PRILOSEC^® (omeprazole magnesium)

INDICATIONS AND USAGE FOR PRILOSEC^® (omeprazole magnesium)

IMPORTANT SAFETY INFORMATION FOR PRILOSEC^® (omeprazole magnesium)

Indications for PRILOSEC^® (omeprazole magnesium)