Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
PRILOSEC
Overview
What is PRILOSEC?
The active ingredient in PRILOSEC (omeprazole) Delayed-Release
Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,
5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1-benzimidazole, a compound that inhibits gastric acid
secretion. Its empirical formula is CHNOS, with a
molecular weight of 345.42. The structural formula is:
STRUCTURE IMAGE
Omeprazole is a white to off-white crystalline powder that melts with
decomposition at about 155°C. It is a weak base, freely soluble in ethanol and
methanol, and slightly soluble in acetone and isopropanol and very slightly
soluble in water. The stability of omeprazole is a function of pH; it is rapidly
degraded in acid media, but has acceptable stability under alkaline conditions.
The active ingredient in PRILOSEC (omeprazole magnesium) for Delayed Release
Oral Suspension, is
5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole,
magnesium salt (2:1)
Omeprazole magnesium is a white to off white powder with a melting point with
degradation at 200°C. The salt is slightly soluble (0.25 mg/ml) in water at
25°C, and it is soluble in methanol. The half-life is highly pH dependent.
The empirical formula for omeprazole magnesium is (CHNOS) Mg, the molecular weight is 713.12
and the structural formula is
STRUCTURE IMAGE 2
PRILOSEC is supplied as delayed-release capsules for oral administration.
Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole
in the form of enteric-coated granules with the following inactive ingredients:
cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, hypromellose,
lactose, mannitol, sodium lauryl sulfate and other ingredients. The capsule
shells have the following inactive ingredients: gelatin-NF, FD and C Blue #1,
FD and C Red #40, D and C Red #28, titanium dioxide, synthetic black iron oxide,
isopropanol, butyl alcohol, FD and C Blue #2, D and C Red #7 Calcium Lake, and,
in addition, the 10 mg and 40 mg capsule shells also contain D and C Yellow #10.
Each packet of PRILOSEC For Delayed-Release Oral Suspension contains either
2.8 mg or 11.2 mg of omeprazole magnesium (equivalent to 2.5 mg or 10 mg of
omeprazole ), in the form of enteric-coated granules with the following inactive
ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose,
magnesium stearate, methacrylic acid copolymer C, polysorbate, sugar spheres,
talc, and triethyl citrate, and also inactive granules. The inactive granules
are composed of the following ingredients: citric acid, crospovidone, dextrose,
hydroxypropyl cellulose, iron oxide and xantham gum. The omeprazole granules and
inactive granules are constituted with water to form a suspension and are given
by oral, nasogastric or direct gastric administration.
What does PRILOSEC look like?
What are the available doses of PRILOSEC?
Sorry No records found.
What should I talk to my health care provider before I take PRILOSEC?
Sorry No records found
How should I use PRILOSEC?
PRILOSEC is indicated for short-term treatment of active duodenal
ulcer in adults. Most patients heal within four weeks. Some patients may require
an additional four weeks of therapy.
PRILOSEC in combination with clarithromycin and amoxicillin, is indicated for
treatment of patients with infection and
duodenal ulcer disease (active or up to 1-year history) to eradicate in adults.
PRILOSEC, in combination with clarithromycin is indicated for treatment of
patients with infection and duodenal ulcer
disease to eradicate in adults.
Eradication of has been shown to reduce
the risk of duodenal ulcer recurrence [
].
Among patients who fail therapy, PRILOSEC with clarithromycin is more likely
to be associated with the development of clarithromycin resistance as compared
with triple therapy. In patients who fail therapy, susceptibility testing should
be done. If resistance to clarithromycin is demonstrated or susceptibility
testing is not possible, alternative antimicrobial therapy should be instituted.
[], and the clarithromycin package insert, Microbiology
section.)
PRILOSEC is indicated for short-term treatment (4-8 weeks) of
active benign gastric ulcer in adults. [ ]
Symptomatic GERD
PRILOSEC is indicated for the treatment of heartburn and other symptoms
associated with GERD in pediatric patients and adults.
Erosive Esophagitis
PRILOSEC is indicated for the short-term treatment (4-8 weeks) of erosive
esophagitis that has been diagnosed by endoscopy in pediatric patients and
adults. [ ]
The efficacy of PRILOSEC used for longer than 8 weeks in these patients 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 erosive
esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of
omeprazole may be considered.
PRILOSEC is indicated to maintain healing of erosive esophagitis
in pediatric patients and adults.
Controlled studies do not extend beyond 12 months. [ ]
PRILOSEC is indicated for the long-term treatment of pathological
hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine
adenomas and systemic mastocytosis) in adults.
PRILOSEC Delayed-Release Capsules should be taken before eating.
In the clinical trials, antacids were used concomitantly with PRILOSEC.
Patients should be informed that the PRILOSEC Delayed-Release Capsule should
be swallowed whole.
For patients unable to swallow an intact capsule, alternative administration
options are available. []
The recommended adult oral dose of PRILOSEC is 20 mg once daily.
Most patients heal within four weeks. Some patients may require an additional
four weeks of therapy.
Triple Therapy
(PRILOSEC/clarithromycin/amoxicillin)
Dual Therapy (PRILOSEC/clarithromycin)
The recommended adult oral dose is 40 mg once daily for 4-8
weeks.
The recommended adult oral dose for the treatment of patients
with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4
weeks. The recommended adult oral dose for the treatment of patients with
erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4
to 8 weeks.
The recommended adult oral dose is 20 mg daily. [ ]
The dosage of PRILOSEC in patients with pathological
hypersecretory conditions varies with the individual patient. The recommended
adult oral starting dose is 60 mg once daily. Doses should be adjusted to
individual patient needs and should continue for as long as clinically
indicated. Doses up to 120 mg three times daily have been administered. Daily
dosages of greater than 80 mg should be administered in divided doses. Some
patients with Zollinger-Ellison syndrome have been treated continuously with
PRILOSEC for more than 5 years.
For the treatment of GERD and maintenance of healing of erosive
esophagitis, the recommended daily dose for pediatric patients– 1 to 16 years of
age is as follows:
On a per kg basis, the doses of omeprazole required to heal erosive
esophagitis in pediatric patients are greater than those for adults.
Alternative administrative options can be used for pediatric patients unable
to swallow an intact capsule [
].
PRILOSEC is available as a delayed-release capsule or as a
delayed-release oral suspension.
For patients who have difficulty swallowing capsules, the contents of a
PRILOSEC Delayed-Release Capsule can be added to applesauce. One tablespoon of
applesauce should be added to an empty bowl and the capsule should be opened.
All of the pellets inside the capsule should be carefully emptied on the
applesauce. The pellets should be mixed with the applesauce and then swallowed
immediately with a glass of cool water to ensure complete swallowing of the
pellets. The applesauce used should not be hot and should be soft enough to be
swallowed without chewing. The pellets should not be chewed or crushed. The
pellets/applesauce mixture should not be stored for future use.
PRILOSEC For Delayed-Release Oral Suspension should be administered as
follows:
For patients with a nasogastric or gastric tube in place:
What interacts with PRILOSEC?
Sorry No Records found
What are the warnings of PRILOSEC?
Sorry No Records found
What are the precautions of PRILOSEC?
Sorry No Records found
What are the side effects of PRILOSEC?
Sorry No records found
What should I look out for while using PRILOSEC?
PRILOSEC Delayed-Release Capsules are contraindicated in patients
with known hypersensitivity to any component of the formulation.
Hypersensitivity reactions may include anaphylaxis, anaphylactic shock,
angioedema, bronchospasm, interstitial nephritis, and urticaria [].
What might happen if I take too much PRILOSEC?
Reports have been received of overdosage with omeprazole in
humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical
dose). Manifestations were variable, but included confusion, drowsiness, blurred
vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry
mouth, and other adverse reactions similar to those seen in normal clinical
experience. [] Symptoms
were transient, and no serious clinical outcome has been reported when PRILOSEC
was taken alone. No specific antidote for omeprazole overdosage is known.
Omeprazole is extensively protein bound and is, therefore, not readily
dialyzable. In the event of overdosage, treatment should be symptomatic and
supportive.
As with the management of any overdose, the possibility of multiple drug
ingestion should be considered. For current information on treatment of any drug
overdose, contact a Poison Control Center at 1-800-222-1222.
Single oral doses of omeprazole at 1350, 1339, and 1200 mg/kg were lethal to
mice, rats, and dogs, respectively. Animals given these doses showed sedation,
ptosis, tremors, convulsions, and decreased activity, body temperature, and
respiratory rate and increased depth of respiration.
How should I store and handle PRILOSEC?
Store pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWStore pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederleDivision of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, GermanyW10525C006 ET02 Rev 11/08Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWPRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature]. PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:NDCPRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDCNDCPRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:NDCNDCPRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets StorageStore PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Omeprazole belongs to a class of antisecretory compounds, the
substituted benzimidazoles, that suppress gastric acid secretion by specific
inhibition of the H/K ATPase
enzyme system at the secretory surface of the gastric parietal cell. Because
this enzyme system is regarded as the acid (proton) pump within the gastric
mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in
that it blocks the final step of acid production. This effect is dose-related
and leads to inhibition of both basal and stimulated acid secretion irrespective
of the stimulus. Animal studies indicate that after rapid disappearance from
plasma, omeprazole can be found within the gastric mucosa for a day or
more.
Antisecretory Activity
After oral administration, the onset of the antisecretory effect of
omeprazole occurs within one hour, with the maximum effect occurring within two
hours. Inhibition of secretion is about 50% of maximum at 24 hours and the
duration of inhibition lasts up to 72 hours. The antisecretory effect thus lasts
far longer than would be expected from the very short (less than one hour)
plasma half-life, apparently due to prolonged binding to the parietal H/K ATPase enzyme. When the drug is
discontinued, secretory activity returns gradually, over 3 to 5 days. The
inhibitory effect of omeprazole on acid secretion increases with repeated
once-daily dosing, reaching a plateau after four days.
Results from numerous studies of the antisecretory effect of multiple doses
of 20 mg and 40 mg of omeprazole in normal volunteers and patients are shown
below. The “max” value represents determinations at a time of maximum effect
(2-6 hours after dosing), while “min” values are those 24 hours after the last
dose of omeprazole.
Single daily oral doses of omeprazole ranging from a dose of 10 mg to 40 mg
have produced 100% inhibition of 24-hour intragastric acidity in some
patients.
Serum Gastric Effects
In studies involving more than 200 patients, serum gastrin levels increased
during the first 1 to 2 weeks of once-daily administration of therapeutic doses
of omeprazole in parallel with inhibition of acid secretion. No further increase
in serum gastrin occurred with continued treatment. In comparison with histamine
H-receptor antagonists, the median increases produced by
20 mg doses of omeprazole were higher (1.3 to 3.6 fold vs. 1.1 to 1.8 fold
increase). Gastrin values returned to pretreatment levels, usually within 1 to 2
weeks after discontinuation of therapy.
Enterochromaffin-like (ECL) Cell Effects
Human gastric biopsy specimens have been obtained from more than 3000
patients treated with omeprazole in long-term clinical trials. The incidence of
ECL cell hyperplasia in these studies increased with time; however, no case of
ECL cell carcinoids, dysplasia, or neoplasia has been found in these patients.
[ ] However, these studies are of insufficient
duration and size to rule out the possible influence of long-term administration
of omeprazole on the development of any premalignant or malignant conditions.
Other Effects
Systemic effects of omeprazole in the CNS, cardiovascular and respiratory
systems have not been found to date. Omeprazole, given in oral doses of 30 or 40
mg for 2 to 4 weeks, had no effect on thyroid function, carbohydrate metabolism,
or circulating levels of parathyroid hormone, cortisol, estradiol, testosterone,
prolactin, cholecystokinin or secretin.
No effect on gastric emptying of the solid and liquid components of a test
meal was demonstrated after a single dose of omeprazole 90 mg. In healthy
subjects, a single I.V. dose of omeprazole (0.35 mg/kg) had no effect on
intrinsic factor secretion. No systematic dose-dependent effect has been
observed on basal or stimulated pepsin output in humans.
However, when intragastric pH is maintained at 4.0 or above, basal pepsin
output is low, and pepsin activity is decreased.
As do other agents that elevate intragastric pH, omeprazole administered for
14 days in healthy subjects produced a significant increase in the intragastric
concentrations of viable bacteria. The pattern of the bacterial species was
unchanged from that commonly found in saliva. All changes resolved within three
days of stopping treatment.
The course of Barrett’s esophagus in 106 patients was evaluated in a U.S.
double-blind controlled study of PRILOSEC 40 mg twice daily for 12 months
followed by 20 mg twice daily for 12 months or ranitidine 300 mg twice daily for
24 months. No clinically significant impact on Barrett’s mucosa by antisecretory
therapy was observed. Although neosquamous epithelium developed during
antisecretory therapy, complete elimination of Barrett’s mucosa was not
achieved. No significant difference was observed between treatment groups in
development of dysplasia in Barrett’s mucosa and no patient developed esophageal
carcinoma during treatment. No significant differences between treatment groups
were observed in development of ECL cell hyperplasia, corpus atrophic gastritis,
corpus intestinal metaplasia, or colon polyps exceeding 3 mm in diameter [].
Absorption
PRILOSEC Delayed-Release Capsules contain an enteric-coated granule
formulation of omeprazole (because omeprazole is acid-labile), so that
absorption of omeprazole begins only after the granules leave the stomach.
Absorption is rapid, with peak plasma levels of omeprazole occurring within 0.5
to 3.5 hours. Peak plasma concentrations of omeprazole and AUC are approximately
proportional to doses up to 40 mg, but because of a saturable first-pass effect,
a greater than linear response in peak plasma concentration and AUC occurs with
doses greater than 40 mg. Absolute bioavailability (compared with intravenous
administration) is about 30-40% at doses of 20-40 mg, due in large part to
presystemic metabolism. In healthy subjects the plasma half-life is 0.5 to 1
hour, and the total body clearance is 500-600 mL/min.
Based on a relative bioavailability study, the AUC and C of PRILOSEC (omeprazole magnesium) for Delayed-Release Oral
Suspension were 87% and 88% of those for PRILOSEC Delayed-Release Capsules,
respectively.
The bioavailability of omeprazole increases slightly upon repeated
administration of PRILOSEC Delayed-Release Capsules.
PRILOSEC Delayed-Release Capsule 40 mg was bioequivalent when administered
with and without applesauce. However, PRILOSEC Delayed-Release Capsule 20 mg was
not bioequivalent when administered with and without applesauce. When
administered with applesauce, a mean 25% reduction in C was observed without a significant change in AUC for
PRILOSEC Delayed-Release Capsule 20 mg. The clinical relevance of this finding
is unknown.
Distribution
Protein binding is approximately 95%.
Metabolism
Omeprazole is extensively metabolized by the cytochrome P450 (CYP) enzyme
system.
Excretion
Following single dose oral administration of a buffered solution of
omeprazole, little if any unchanged drug was excreted in urine. The majority of
the dose (about 77%) was eliminated in urine as at least six metabolites. Two
were identified as hydroxyomeprazole and the corresponding carboxylic acid. The
remainder of the dose was recoverable in feces. This implies a significant
biliary excretion of the metabolites of omeprazole. Three metabolites have been
identified in plasma — the sulfide and sulfone derivatives of omeprazole, and
hydroxyomeprazole. These metabolites have very little or no antisecretory
activity.
Combination Therapy with Antimicrobials
Omeprazole 40 mg daily was given in combination with clarithromycin 500 mg
every 8 hours to healthy adult male subjects. The steady state plasma
concentrations of omeprazole were increased (C,
AUC, and T increases of
30%, 89% and 34% respectively) by the concomitant administration of
clarithromycin. The observed increases in omeprazole plasma concentration were
associated with the following pharmacological effects. The mean 24-hour gastric
pH value was 5.2 when omeprazole was administered alone and 5.7 when
co-administered with clarithromycin.
The plasma levels of clarithromycin and 14-hydroxy-clarithromycin were
increased by the concomitant administration of omeprazole. For clarithromycin,
the mean C was 10% greater, the mean C was 27% greater, and the mean AUC
was 15% greater when clarithromycin was administered with omeprazole than when
clarithromycin was administered alone. Similar results were seen for
14-hydroxy-clarithromycin, the mean C was 45% greater,
the mean C was 57% greater, and the mean AUC was 45% greater. Clarithromycin concentrations in the
gastric tissue and mucus were also increased by concomitant administration of
omeprazole.
Special Populations
Geriatric Population
The elimination rate of omeprazole was somewhat decreased in the elderly, and
bioavailability was increased. Omeprazole was 76% bioavailable when a single 40
mg oral dose of omeprazole (buffered solution) was administered to healthy
elderly volunteers, versus 58% in young volunteers given the same dose. Nearly
70% of the dose was recovered in urine as metabolites of omeprazole and no
unchanged drug was detected. The plasma clearance of omeprazole was 250 mL/min
(about half that of young volunteers) and its plasma half-life averaged one
hour, about twice that of young healthy volunteers.
Pediatric Use
The pharmacokinetics of omeprazole have been investigated in pediatric
patients 2 to 16 years of age:
Following comparable mg/kg doses of omeprazole, younger children (2 to 5
years of age) have lower AUCs than children 6 to16 years of age or adults; AUCs
of the latter two groups did not differ. [ ]
Hepatic Impairment
In patients with chronic hepatic disease, the bioavailability increased to
approximately 100% compared with an I.V. dose, reflecting decreased first-pass
effect, and the plasma half-life of the drug increased to nearly 3 hours
compared with the half-life in normals of 0.5-1 hour. Plasma clearance averaged
70 mL/min, compared with a value of 500-600 mL/min in normal subjects. Dose
reduction, particularly where maintenance of healing of erosive esophagitis is
indicated, for the hepatically impaired should be considered.
Renal Impairment
In patients with chronic renal impairment, whose creatinine clearance ranged
between 10 and 62 mL/min/1.73 m, the disposition of
omeprazole was very similar to that in healthy volunteers, although there was a
slight increase in bioavailability. Because urinary excretion is a primary route
of excretion of omeprazole metabolites, their elimination slowed in proportion
to the decreased creatinine clearance. No dose reduction is necessary in
patients with renal impairment.
Asian Population
In pharmacokinetic studies of single 20 mg omeprazole doses, an increase in
AUC of approximately four-fold was noted in Asian subjects compared with
Caucasians. Dose reduction, particularly where maintenance of healing of erosive
esophagitis is indicated, for Asian subjects should be considered.
Omeprazole and clarithromycin dual therapy and omeprazole,
clarithromycin and amoxicillin triple therapy have been shown to be active
against most strains of
and in clinical infections as described in the
Helicobacter
Helicobacter pylori
Clarithromycin pretreatment resistance rates were 3.5% (4/113) in the
omeprazole/clarithromycin dual therapy studies (4 and 5) and 9.3% (41/439) in
omeprazole/clarithromycin/amoxicillin triple therapy studies (1, 2, and 3).
Amoxicillin pretreatment susceptible isolates (≤ 0.25 µg/mL) were found in
99.3% (436/439) of the patients in the omeprazole/clarithromycin/amoxicillin
triple therapy studies (1, 2, and 3). Amoxicillin pretreatment minimum
inhibitory concentrations (MICs) > 0.25 µg/mL occurred in 0.7% (3/439) of the
patients, all of whom were in the clarithromycin and amoxicillin study arm. One
patient had an unconfirmed pretreatment amoxicillin minimum inhibitory
concentration (MIC) of > 256 µg/mL by Etest.
Patients not eradicated of following
omeprazole/clarithromycin/amoxicillin triple therapy or
omeprazole/clarithromycin dual therapy will likely have clarithromycin resistant
isolates. Therefore, clarithromycin
susceptibility testing should be done, if possible. Patients with clarithromycin
resistant should not be treated with any of
the following: omeprazole/clarithromycin dual therapy,
omeprazole/clarithromycin/amoxicillin triple therapy, or other regimens which
include clarithromycin as the sole antimicrobial agent.
Amoxicillin Susceptibility Test Results and
Clinical/Bacteriological Outcomes
In the triple therapy clinical trials, 84.9% (157/185) of the patients in the
omeprazole/clarithromycin/amoxicillin treatment group who had pretreatment
amoxicillin susceptible MICs (≤ 0.25 µg/mL) were eradicated of and 15.1% (28/185) failed therapy. Of the 28
patients who failed triple therapy, 11 had no post-treatment susceptibility test
results and 17 had post-treatment isolates
with amoxicillin susceptible MICs. Eleven of the patients who failed triple
therapy also had post-treatment isolates
with clarithromycin resistant MICs.
Susceptibility Test for Helicobacter pylori
The reference methodology for susceptibility testing of is agar dilution MICs.
One to three microliters of an inoculum equivalent to a No. 2 McFarland standard
(1 x 10 - 1 x 10 CFU/mL for
) are inoculated directly onto freshly
prepared antimicrobial containing Mueller-Hinton agar plates with 5% aged
defibrinated sheep blood (≥ 2 weeks old). The agar dilution plates are incubated
at 35°C in a microaerobic environment produced by a gas generating system
suitable for campylobacters. After 3 days of incubation, the MICs are recorded
as the lowest concentration of antimicrobial agent required to inhibit growth of
the organism. The clarithromycin and amoxicillin MIC values should be
interpreted according to the following criteria:
Non-Clinical Toxicology
PRILOSEC Delayed-Release Capsules are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [].See and for interaction with CNS drugs and alcohol.
Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents
Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with amoxicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by is a primary cause of “antibiotic-associated colitis.”
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against colitis.
Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking clarithromycin, the patient should be apprised of the potential hazard to the fetus. (See Warnings in prescribing information for clarithromycin.)
Co-administration of omeprazole and clarithromycin has resulted in increases in plasma levels of omeprazole, clarithromycin, and 14-hydroxy-clarithromycin. [ ]
Concomitant administration of clarithromycin with cisapride or pimozide, is contraindicated.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described below reflects exposure to PRILOSEC Delayed-Release Capsules in 3096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome. The international clinical trials were double blind and open-label in design. The most common adverse reactions reported (i.e., with an incidence rate greater or equal to 2%) from PRILOSEC-treated patients enrolled in these studies included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%).
Additional adverse reactions that were reported with an incidence ≥1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%).
The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less.
The clinical trial safety profile in pediatric patients who received PRILOSEC Delayed-Release Capsules was similar to that in adult patients. Unique to the pediatric population, however, adverse reactions of the respiratory system were most frequently reported in both the 1 to greater than 2 and 2 to 16 year age groups (75.0% and 18.5%, respectively). Similarly, fever was frequently reported in the 1 to 2 year age group (33.0%) and accidental injuries were reported frequently in the 2 to 16 year age group (3.8%). [ ]
In clinical trials using either dual therapy with PRILOSEC and clarithromycin, or triple therapy with PRILOSEC, clarithromycin, and amoxicillin, no adverse reactions unique to these drug combinations were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone.
Dual Therapy (PRILOSEC/clarithromycin)
Adverse reactions observed in controlled clinical trials using combination therapy with PRILOSEC and clarithromycin (n = 346) that differed from those previously described for PRILOSEC alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%). (For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section).
Triple Therapy (PRILOSEC/clarithromycin/amoxicillin)
The most frequent adverse reactions observed in clinical trials using combination therapy with PRILOSEC, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone. (For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections).
The following adverse reactions have been identified during post-approval use of PRILOSEC Delayed-Release Capsules. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.
Body As a Whole:
Skin
Cardiovascular:
Endocrine:
Gastrointestinal:
Hepatic:
Metabolic/Nutritional:
Musculoskeletal:
Nervous System/Psychiatric:
Respiratory:
Skin:
Special Senses:
Ocular:
Urogenital:
Hematologic:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
514Total User Reviews
User Reviews
Learn about
User Reviews
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).