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omeprazole, clarithromycin, amoxicillin
Overview
What is Omeclamox-Pak?
Omeclamox - Pak consists of a pack of ten individual daily administration cards, each containing two omeprazole delayed-release 20 mg capsules, USP, two clarithromycin 500 mg tablets, USP, and four amoxicillin 500 mg capsules, USP, for oral administration.
Omeprazole Delayed-Release Capsules, USP
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. Each omeprazole delayed release capsule contains 20 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, lactose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl acetate. The capsule shells contain: D&C Red #28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide.
Clarithromycin Tablets, USP
Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each tablet for oral administration contains 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Opadry II (White), povidone, stearic acid, and talc. Opadry II (White) contains hypromellose, polyethylene glycol, polydextrose, titanium dioxide and triacetin.
Amoxicillin Capsules, USP
Amoxicillin capsules contain amoxicillin trihydrate equivalent to 500 mg of amoxicillin. Amoxicillin capsules USP also contain cellulose microcrystalline and magnesium stearate. The capsule shell contains yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide.
What does Omeclamox-Pak look like?
What are the available doses of Omeclamox-Pak?
Pack of 10 daily administration cards for morning and evening dosing, each containing:
What should I talk to my health care provider before I take Omeclamox-Pak?
How should I use Omeclamox-Pak?
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Omeclamox-Pak and other antibacterial drugs, Omeclamox-Pak should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg, each given twice daily, for 10 days, in the morning and evening before eating a meal. Inform patients that omeprazole, clarithromycin, and amoxicillin should not be crushed or chewed, and should be swallowed whole. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
What interacts with Omeclamox-Pak?
Sorry No Records found
What are the warnings of Omeclamox-Pak?
Sorry No Records found
What are the precautions of Omeclamox-Pak?
Sorry No Records found
What are the side effects of Omeclamox-Pak?
Sorry No records found
What should I look out for while using Omeclamox-Pak?
Known hypersensitivity to omeprazole, any macrolide antibiotic, any penicillin, or any component of the formulations. ()
Coadministration with pimozide, ergotamine or dihydroergotamine. (, , )
What might happen if I take too much Omeclamox-Pak?
In case of an overdose, patients should contact a physician, poison control center, or emergency room. There is neither a pharmacologic basis nor data suggesting an increased toxicity of the combination compared to individual components.
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 your local Poison Control Center at 1-800-222-1222.
Omeprazole
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.
Clarithromycin
Amoxicillin
Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood concentrations may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin can be removed from circulation by hemodialysis.
How should I store and handle Omeclamox-Pak?
Methadone hydrochloride tablets, USP contains methadone which is a controlled substance. Like fentanyl, morphine, oxycodone, hydromorphone, and oxymorphone, methadone is controlled under Schedule II of the Federal Controlled Substances Act. Methadone hydrochloride tablets, USP may be targeted for theft and diversion by criminals . Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].FOR YOUR PROTECTION:Methadone hydrochloride tablets, USP contains methadone which is a controlled substance. Like fentanyl, morphine, oxycodone, hydromorphone, and oxymorphone, methadone is controlled under Schedule II of the Federal Controlled Substances Act. Methadone hydrochloride tablets, USP may be targeted for theft and diversion by criminals . Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].FOR YOUR PROTECTION:Methadone hydrochloride tablets, USP contains methadone which is a controlled substance. Like fentanyl, morphine, oxycodone, hydromorphone, and oxymorphone, methadone is controlled under Schedule II of the Federal Controlled Substances Act. Methadone hydrochloride tablets, USP may be targeted for theft and diversion by criminals . Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].FOR YOUR PROTECTION:Omeclamox®-Pak is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs:Omeprazole Delayed-Release Capsules, USP, 20 mg Two opaque hard gelatin lavender and grey capsules, with ‘R 158’ and ‘OMEPRAZOLE 20 mg’ imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets.Clarithromycin Tablets, USP, 500 mg Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with ‘54 312’ on one side and plain on the other side.Amoxicillin Capsules, USP, 500 mg Four opaque hard gelatin yellow capsules, marked ‘GG 849’. Each capsule contains amoxicillin trihydrate equivalent to 500 mg am amoxicillin NDC 66220-422-02 Carton containing 10 daily administration cardsNDC 66220-422-01 Daily administration cardStore at controlled room temperature between 20°C and 25°C (68°F and 77°F). Protect from light and moisture.Omeclamox®-Pak is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs:Omeprazole Delayed-Release Capsules, USP, 20 mg Two opaque hard gelatin lavender and grey capsules, with ‘R 158’ and ‘OMEPRAZOLE 20 mg’ imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets.Clarithromycin Tablets, USP, 500 mg Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with ‘54 312’ on one side and plain on the other side.Amoxicillin Capsules, USP, 500 mg Four opaque hard gelatin yellow capsules, marked ‘GG 849’. Each capsule contains amoxicillin trihydrate equivalent to 500 mg am amoxicillin NDC 66220-422-02 Carton containing 10 daily administration cardsNDC 66220-422-01 Daily administration cardStore at controlled room temperature between 20°C and 25°C (68°F and 77°F). Protect from light and moisture.Omeclamox®-Pak is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs:Omeprazole Delayed-Release Capsules, USP, 20 mg Two opaque hard gelatin lavender and grey capsules, with ‘R 158’ and ‘OMEPRAZOLE 20 mg’ imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets.Clarithromycin Tablets, USP, 500 mg Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with ‘54 312’ on one side and plain on the other side.Amoxicillin Capsules, USP, 500 mg Four opaque hard gelatin yellow capsules, marked ‘GG 849’. Each capsule contains amoxicillin trihydrate equivalent to 500 mg am amoxicillin NDC 66220-422-02 Carton containing 10 daily administration cardsNDC 66220-422-01 Daily administration cardStore at controlled room temperature between 20°C and 25°C (68°F and 77°F). Protect from light and moisture.Omeclamox®-Pak is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs:Omeprazole Delayed-Release Capsules, USP, 20 mg Two opaque hard gelatin lavender and grey capsules, with ‘R 158’ and ‘OMEPRAZOLE 20 mg’ imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets.Clarithromycin Tablets, USP, 500 mg Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with ‘54 312’ on one side and plain on the other side.Amoxicillin Capsules, USP, 500 mg Four opaque hard gelatin yellow capsules, marked ‘GG 849’. Each capsule contains amoxicillin trihydrate equivalent to 500 mg am amoxicillin NDC 66220-422-02 Carton containing 10 daily administration cardsNDC 66220-422-01 Daily administration cardStore at controlled room temperature between 20°C and 25°C (68°F and 77°F). Protect from light and moisture.Omeclamox®-Pak is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs:Omeprazole Delayed-Release Capsules, USP, 20 mg Two opaque hard gelatin lavender and grey capsules, with ‘R 158’ and ‘OMEPRAZOLE 20 mg’ imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets.Clarithromycin Tablets, USP, 500 mg Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with ‘54 312’ on one side and plain on the other side.Amoxicillin Capsules, USP, 500 mg Four opaque hard gelatin yellow capsules, marked ‘GG 849’. Each capsule contains amoxicillin trihydrate equivalent to 500 mg am amoxicillin NDC 66220-422-02 Carton containing 10 daily administration cardsNDC 66220-422-01 Daily administration cardStore at controlled room temperature between 20°C and 25°C (68°F and 77°F). Protect from light and moisture.Omeclamox®-Pak is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs:Omeprazole Delayed-Release Capsules, USP, 20 mg Two opaque hard gelatin lavender and grey capsules, with ‘R 158’ and ‘OMEPRAZOLE 20 mg’ imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets.Clarithromycin Tablets, USP, 500 mg Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with ‘54 312’ on one side and plain on the other side.Amoxicillin Capsules, USP, 500 mg Four opaque hard gelatin yellow capsules, marked ‘GG 849’. Each capsule contains amoxicillin trihydrate equivalent to 500 mg am amoxicillin NDC 66220-422-02 Carton containing 10 daily administration cardsNDC 66220-422-01 Daily administration cardStore at controlled room temperature between 20°C and 25°C (68°F and 77°F). Protect from light and moisture.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Omeprazole is an antisecretory drug whereas clarithromycin and amoxicillin are antibacterial drugs [See Clinical Pharmacology ()].
Non-Clinical Toxicology
Known hypersensitivity to omeprazole, any macrolide antibiotic, any penicillin, or any component of the formulations. ()Coadministration with pimozide, ergotamine or dihydroergotamine. (, , )
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
Butalbital and acetaminophen may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
Clarithromycin has demonstrated adverse effects on pregnancy outcomes and/or embryo-fetal development in monkeys, rats, mice, and rabbits at doses that produced plasma concentrations 2 to 17 times the serum concentrations achieved in humans at the maximum recommended human dose.
Clarithromycin should be used in pregnant women only in clinical circumstances where no alternative therapy is appropriate, and the potential benefit to the patient outweighs the potential risk to the fetus [See Use in Specific Populations ( )].
The following serious adverse reactions are described elsewhere in the labeling:
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.
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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
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