Friday, October 16, 2009

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Prilosidâ„¢ Capsules (Omeprazole)



It is a gastric proton pump inhibitor. Omeprazole is a substituted benzimidazole derivative acting on the final step of acid production & therefore controls intragastric acidity irrespective of stimulus. It markedly inhibits basal and stimulated gastric acid secretion. Thus it is antisecretory drug which is very effective for rapidly healing peptic ulcers & erosive oesophagitis & for reducing gastric acid hyper-secretion in patients with Zollinger-Ellison syndrome.

Working
The drug acts by relaxing blood vessels so that blood passes through them more easily. This further helps to lower blood pressure.

Dosage
Gastric ulcer: 20 mg once daily for 8 weeks in sever cases increase to0 40 mg once daily
Duodenal ulcer: 20 mg once daily for 4 weeks.
Zollinger Ellison Syndrome: 60 mg once daily.
Maintenance therapy: 20 0120 mg adjusted to response.

Contra- Indications: Hypersensitivity, neonates

Side Effects
The drug has certain side effects, that can affect individuals in different ways. The following are some of the side effects, that are often associated with the drug:

* Skin rash
* Nausea
* Headache
* Constipation
* Flatulence

INDICATIONS
Duodenal Ulcer (adults)

Prilosid 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.
Gastric Ulcer (adults)


Prilosid Capsules (Omeprazole)

Prilosid is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer in adults.

PRECAUTIONS
Concomitant Gastric Malignancy

Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.
Atrophic Gastritis

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.

CONTRAINDICATIONS
Omeprazole

Prilosid Delayed-Release Capsules are contraindicated in patients with known hypersensitivity to any component of the formulation.
Clarithromycin

Clarithromycin is contraindicated in patients with a known hypersensitivity to any macrolide antibiotic.

Concomitant administration of clarithromycin with cisapride, pimozide, or terfenadine is contraindicated. There have been post-marketing reports of drug interactions when clarithromycin and/or erythromycin are co-administered with cisapride, pimozide, or terfenadine resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of hepatic metabolism of these drugs by erythromycin and clarithromycin. Fatalities have been reported. (Please refer to full prescribing information for clarithromycin before prescribing.)

Presentation
Prilosid
Capsules Strip of 10 Capsules







Omeprazole is widely used proton pump inhibitor for treating various types of gastrointestinal ulcers, dyspepsia gastroesophageal reflux disease (GORD/GERD) and Zollinger-Ellison syndrome. The drug is one of the most widely prescribed all over the globe and is also available over the counter in some countries.

It is a gastric proton pump inhibitor. Omeprazole is a substituted benzimidazole derivative acting on the final step of acid production & therefore controls intragastric acidity irrespective of stimulus. It markedly inhibits basal and stimulated gastric acid secretion. Thus it is antisecretory drug which is very effective for rapidly healing peptic ulcers & erosive oesophagitis & for reducing gastric acid hyper-secretion in patients with Zollinger-Ellison syndrome.

What are omeprazole capsules?

OMEPRAZOLE (Prilosec®) prevents the production of acid in the stomach. It reduces symptoms and prevents injury to the esophagus, stomach, or intestines in patients with gastroesophageal reflux disease (GERD) or ulcers. Omeprazole is also useful in conditions that cause excessive stomach acid production such as Zollinger-Ellison syndrome and certain cancers. Generic omeprazole capsules are available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• liver disease
• an unusual or allergic reaction to omeprazole, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take omeprazole capsules by mouth. Follow the directions on the prescription label. Swallow the capsules whole with a drink of water; do not crush, break or chew. The capsules can be opened and the contents sprinkled on a small amount of applesauce or yogurt, given with fruit juices, or swallowed immediately with water. Omeprazole works best if taken on an empty stomach. It is best to take the capsules 30 to 60 minutes before breakfast. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What drug(s) may interact with omeprazole?

• ampicillin
• diazepam
• digoxin
• disulfiram
• doxercalciferol
• iron salts
• itraconazole, ketoconazole, voriconazole or other prescription medicines for fungus or yeast infections
• phenytoin
• tacrolimus
• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking omeprazole?

It can take several days of therapy with omeprazole before your stomach condition improves. Check with your prescriber or health care professional if your condition does not improve, or if it gets worse. You can take antacids for the occasional relief of pain unless your prescriber or health care professional tells you otherwise.

What side effects may I notice from taking omeprazole?

Serious side effects are rare. Side effects that you should report to your prescriber or health care professional as soon as possible:
• blood in urine
• chest pain or tightness
• dark yellow or brown urine
• fever or sore throat
• pain or difficulty passing urine
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• shortness of breath
• skin rash
• unusual bleeding or bruising
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• headache
• diarrhea or constipation

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.

Possible side effects of omeprazole
If you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives), stop taking omeprazole and seek emergency medical attention. Other, less serious side effects may be more likely to occur. Continue to take Generic Prilosec and talk to your doctor if you experience drowsiness, dizziness, or headache; diarrhea, increased gas, or bloating; or itching. Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Drug interactions with omeprazole?
Before taking Generic Prilosec, tell your doctor if you are taking any of the following medicines: warfarin (Coumadin); digoxin (Lanoxin, Lanoxicaps); a medicine for insomnia or anxiety such as diazepam (Valium), alprazolam (Xanax), lorazepam (Ativan), temazepam (Restoril), clorazepate (Tranxene), chlordiazepoxide (Librium), and others; cyclosporine (Neoral, Sandimmune); phenytoin (Dilantin); theophylline (Theo-Dur, Theochron, Theolair, Elixophyllin, Slo-Phyllin, others); itraconazole (Sporanox) or ketoconazole (Nizoral); ampicillin (Omnipen, Principen); or iron (Feosol, Mol-Iron, Fergon, Femiron, others).

Prilosec is used for treating heartburn or irritation of the esophagus caused by gastroesophageal reflux disease (GERD).
It may also be used for short-term treatment of ulcers of the stomach or small intestines. It may also be used with certain antibiotics to treat ulcers of the small intestines and to help prevent them from coming back. It may also be used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

How to use

Use Prilosec as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Prilosec by mouth on an empty stomach before eating.
  • Swallow Prilosec whole. Do not break, crush, chew, or open Prilosec before swallowing.
  • If you have trouble swallowing the capsule, add 1 tablespoon of applesauce to an empty bowl. Open the capsule and empty the pellets onto the applesauce. Mix the pellets with the applesauce and swallow the mixture at once, followed by a glass of cool water. The applesauce used should not be hot and should be soft enough to be swallowed with out chewing. Do not chew or crush the pellets. Do not store the mixture for further use.
  • You may take antacids while you are using Prilosec, if you are directed to do so by your doctor.
  • If you also take an imidazole antifungal (eg, ketoconazole), take it at least 2 hours before taking Prilosec.
  • If you also take sucralfate, take Prilosec at least 30 minutes before taking sucralfate.
  • Continue to take Prilosec even if you feel well. Do not miss any doses. Drug Class and Mechanism

Prilosec is a proton pump inhibitor. It works by decreasing the amount of acid produced in the stomach.

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