Medical  Explorer

Custom Search

Drugs A to Z  :  A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  R  S  T  U  V  W  X  Y  Z
Medicinal Ingredients : A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

Beauty Products : A  B  C  D  E  F  G  I  M  N  O  P  R  S  T  V

Aging      Allergies     Alzheimer's      Arthritis    Asthma      Bacteria   new Cancer    Chickenpox     Colds     Constipation      Diabetes      Epilepsy     Fatigue     Fever     Genetics       Haemorrhoids       newHeadaches      Hepatitis    Immunity      Infection      Insomnia       Leprosy       Menopause      Obesity      Osteoporosis     Other Diseases    Pain      PMS     Parasites     Sinusitis     newStroke     Toxicology    Urology




Arthritis medications
Acupuncture
Alcohol
Patients
newGeneral Health
Medicinal food
Chinese medicine
Nutrients
Smoking
Vitamins
OTC Drugs
Health Products
Therapy
Symptom
Parasitology
 
 

Milosec (Omeprazole 20 mg)Milosec

 

Composition
Each capsule contains Omeprazole Pellets equivalent to Omeprazole 20 mg.


Product Description
Opaque pink-reddish brown capsule No.2, imprinted "Frx Frx" in black color, containing off-white enteric coated pellet.

Pharmacodynamics
Omeprazole reduces gastric acid secretion through a highly selective mechanism of action. It produces specific dose-dependent inhibition of the enzyme H+/K+ ATPase (the proton pump) in the parietal cell.


As this action inhibits the final stage of gastric acid formation, there is an effective inhibition of both basal and stimulated acid secretion irrespective of the stimulus to acid formation. Omeprazole has no effect on acetylcholine or histamine receptors and no clinically significant pharmacodynamic effects have been observed other than those explained by the effect of omeprazole on acid secretion. The onset of action is rapid and reversible control of gastric secretion is achieved with once-daily dosing.

Pharmacokinetics
Omeprazole is rapidly but variably absorbed after oral doses. Absorption is not affected by food.


Omeprazole is acid-labile and pharmacokinetics may vary between the various formulations developed to improve oral bioavailability. The absorption of omeprazole also appears to be dose-dependent; increasing the dosage above 40 mg has been reported to increase the plasma concentrations in a non-linear fashion because of saturable first-pass hepatic-metabolism. In addition, absorption is higher after long term use.


Omeprazole is almost completely metabolized in the liver, primarily by the cytochrome P450 isoenzyme CYPZC19 to form hydroxyomeprazole and to a small extent by CYP3A to form omeprazole sulfone. The metabolites are inactive, and are excreted mostly in the urine and to a lesser extent in bile. The elimination half-life from plasma is reported to be about 0.5 to 3 hours. Omeprazole is about 95% bound to plasma-proteins.

Mode of Administration
Oral route.

Indications
Treatment of duodenal ulcer, gastric ulcer, reflux esophagitis and symptomatic gastroesophageal reflux disease. Helicobacter pylori eradication in peptic ulcer disease. Management of Zollinger-Ellison syndrome.

Dosage
Duodenal Ulcer: Recommended Dosage : Milosec 20 mg once daily. Symptom relief is rapid and in most patients, healing occurs within 2 weeks. For those patients who may have fully healed after the initial course, healing usually occurs during a further 2-week treatment period.


In patients with poorly responsive duodenal ulcer, Milosec 40 mg once daily has been used and healing is usually achieved within 4 weeks.


For the prevention of relapse in patients with duodenal ulcer, the recommended dose is Milosec 20 mg once daily. If needed, the dose can be increased to 40 mg once daily.


The effectiveness of Milosec is not affected by concomitant NSAID treatment, and the usual duration of treatment is recommended.


Gastric Ulcer: Recommended Dosage : Milosec 20 mg once daily. Symptom relief is rapid and in most patients, healing occurs within 4 weeks. For those patients who may not have fully healed after the initial course, healing usually occurs during a further 4-weeks treatment period.


In patients with poorly responsive gastric ulcer, Milosec 40 mg once daily has been used and healing is usually achieved within 8 weeks.


For the prevention of relapse in patients with poorly responsive gastric ulcer, the recommended dose is Milosec 20 mg once daily. If needed, the dose can be increased to Milosec 40 mg once daily.


The effectiveness of Milosec is not affected by concomitant NSAID treatment and the usual duration of treatment is recommended.


Helicobacter pylori (Hp) Eradication Regimens in Peptic Ulcer Disease:
Triple Therapy Regimens: Milosec 20 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice a day for 1 week; or Milosec 20 mg, clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg), all twice a day for 1 week; or Milosec 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg both 3 times a day for 1 week.


Dual Therapy Regimens: Milosec 40-80 mg daily with amoxicillin 1.5 g daily in divided doses for 2 weeks ; or Milosec 40 mg once daily and clarithromycin 500 mg 3 times a day for 2 weeks.


To ensure healing in patients with active ulcer diseases, see further dosage recommendations for duodenal and gastric ulcer.


In each regimen, if the patient is still Hp positive, therapy may be repeated.


Reflux Esophagitis: Recommended Dosage : Milosec 20 mg once daily. Symptom relief is rapid and in most patients, healing occurs within 4 weeks. For those patients who may not have fully healed after the initial course, healing usually occurs during a further 4-week treatment period.


In patients with severe reflux esophagitis, Milosec 40 mg once daily has been used and healing is usually achieved within 8 weeks.


For the long-term management of patients with healed reflux esophagitis, the recommended dose is Milosec 20 mg once daily. If needed, the dose can be increased to 40 mg once daily.


Symptomatic Gastroesophageal Reflux Disease: Recommended Dosage : Milosec 20 mg daily. Symptom relief is rapid. Patients may respond adequately to 20 mg daily, and therefore individual dose adjustment should be considered. If symptom control has not been achieved after 4-week treatment with Milosec 20 mg daily, further investigation is recommended.


Zollinger-Ellison Syndrome: Recommended Initial Dosage : Milosec 60 mg daily.


The dosage should be adjusted individually and treatment continued as long as clinically indicated. All patients with severe disease and inadequate response to other therapies have been effectively controlled and > 90% of the patients maintained on doses of Milosec 20-120 mg daily. With doses >80 mg daily, the dose should be divided and given twice daily.


Impaired Renal and Liver Function: Dose adjustment in patients with impaired renal or liver function is not required.

Children: There is no experience with Milosec in children.
Elderly: No dose adjustment is necessary in the elderly.

Contraindications
Known hypersensitivity to omeprazole.

Precautions
Should not be used in children.
Should not be given during pregnancy and lactation unless its use in considered essential.
When gastric ulcer is suspected, the possibility of malignancy should be excluded as treatment may alleviate symptoms and delay diagnosis.

Interactions With Other Medicaments
Milosec can prolong the elimination of diazepam, warfarin and phenytoin, drugs that are metabolised by oxidation in the liver. Monitoring of patients also receiving warfarin or phenytoin is recommended and a reduction of dose of warfarin and phenytoin may be necessary.


No interaction with propranolol or theophylline has been found, but there may be interactions with other drugs also metabolised via the cytochrome P-450 enzyme system. No interactions with concomitantly administered antacids have been found.


Pregnancy and Lactation
Milosec should not be given during pregnancy and lactation unless its use is considered essential. Animal studies have not shown evidence of any hazard from the administration of Milosec during pregnancy and lactation and there is no evidence of foetal toxicity or teratogenic effect.

Side Effects
Skin
Skin rash, urticaria and pruritus have been reported, usually resolving after discontinuation of treatment.


Central and peripheral nervous system
Headache is a common side effect. Dizziness, paraesthesia, somnolence, insomnia and vertigo are rare. In isolated cases, reversible mental confusion, agitation, depression and hallucination predominantly in severely ill patients have occurred. Increased sweating, peripheral oedema and blurred vision have been reported in isolated cases.


Gastrointestinal
Diarrhoea, constipation, nausea, vomiting, flatulence and abdominal pain.


Hepatic
Rarely increased in liver enzymes. In isolated cases, encephalopathy in patients with pre-existing severe liver disease; hepatitis with or without jaundice and hepatic failure have been reported.


Endocrine
In isolated cases, gynaecomastia has been reported.


Haematological
In isolated cases, leukopenia, thrombocytopenia, agranulocytosis and pancytopenia have been reported.


Musculoskeletal
In isolated cases, arthralgia, muscular weakness and myalgia have been reported.

Symptoms and Treatment of Overdose
There is no information available on the effects of overdosage in man and specific recommendations for treatment cannot be given. Single oral doses of up to 400 mg have been well tolerated.


Signs and Symptoms : The following effects have been selected on the basis of their potential Clinical significance, such as : blurred vision; confusion; diaphoresis (increased sweating); drowsiness; dryness of mouth; flushing; headache; nausea; tachycardia (fast or irregular heartbeat)


Treatment of overdose : Since there is no specific antidote for overdose with omeprazole, treatment should be symptomatic and supportive. Due to extensive protein binding, omeprazole is not readily dialyzable. Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.


Packaging Available
Blister of 2x7 capsules / carton

 

Shelf life

3 years

Abdomen
Blood
Bone
Breast
Ear

Eye

Face
Hair

Head

Heart
Kidney
Liver
Limbs
Lungs
newMind
Mouth
Muscles
Nails

Neck

newNerves
Nose

Skin

Teeth

Throat

Tongue
 
Health news
 
Cardiovascular Guide
 
Natural Remedies
 
Treatment of Cancer
 
Women's Health
 
Irritable bowel syndrome
 
Common Childhood Illnesses
 
Prescribed Drugs
 
 

     
         
     

 

Disclaimer