OMEPRAZOLE 40mg Powder for Injection

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COMPOSITION :

Omeprazole sodium Monohydrate Powder for Injection 40 mg, each vial contains : Omeprazole sodium monohydrate equivalent to Omeprazole 40 mg.

 

DESCRIPTIONS :

Omeprazole Sodium Monohydrate containing Omeprazole sodium monohydrate (equivalent to Omeprazole) is available as sterile injection powder 40 mg for reconstituted and intravenous administration.

 

INDICATIONS :

Omeprazole Sodium Monohydrate is indicated for :

  • Duodenal ulcer
  • Gastric ulcer
  • Reflux oesophagitis
  • Zollinger – Ellison syndrome

 

DOSAGE AND ADMINISTRATIONS :

  • Duodenal ulcer, gastric ulcer, and reflux oesophagitis : Patients who cannot be given oral medication can be treated parenterally with Omeprazole 40 mg once daily. The usual treatment period before transfer to oral treatment is 2 – 3 days.
  • Zollinger – Ellison syndrome : Dose should be adjusted individually. Higher doses and/or several daily doses may be required. 
  • IV treatment can be given as injection, whereby the solution for injection must be given slowly over a period of at least 2½ minutes and with a maximum rate of 4 ml/minutes.
  • Use in the elderly : Dose adjustment is not necessary.
  • Use in children : There is only limited experience of use in children.
  • Impaired renal function : Dose adjustment is not necessary.
  • Impaired hepatic function : In patients with impaired liver function clearance is greatly reduced.

 

CAUTION FOR USAGE :

Instructions for use and handling : 

Solution for injection is obtained by dissolving the freeze-dried substance in the accompanying solvent. No other solvent may be used.

The reconstituted solution for injection must be used within 4 hours.

Preparation :

NOTE : Stages 1 to 5 shall be done in immediate sequence.

  1. With a syringe, draw 10 ml of solvent from the ampoule.
  2. Slowly add approximately 5 ml of the solvent into the vial with the freeze-dried Omeprazole.
  3. Withdraw as much air as possible from the vial back into the syringe in order to reduce positive pressure. This will make it easier to add the remaining solvent.
  4. Add the remaining solvent into the vial, make sure that the syringe is empty.
  5. Rotate and shake the vial to ensure adequate mixing of Omeprazole and solvent.
  6. Reconstituted IV solution shall be kept below 25°C and shall be used within 4 hours after preparation.

 

OVERDOSAGE :

Symptoms : Dizziness, apathy, headache, tachycardia, nausea, vomiting, flatulence, diarrhea. See also ADVERSE REACTIONS.

 

CONTRAINDICATION :

Patients who known hypersensitivity to Omeprazole.

 

WARNINGS AND PRECAUTIONS :

  • Suspected ulcer disease must be verified objectively at an early by means of x-ray or endoscopy in order to avoid inadequate treatment.
  • When gastric ulcer is present or suspected or in presence of any of the following alarming symptoms : Significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena; malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate symptoms and delay diagnosis.  
  • Pregnancy and lactation :
  1. Pregnancy : As with most drugs. Omeprazole should not be given during pregnancy and lactation unless its use is considered essential. 
  2. Lactation : Omeprazole is excreted in breast milk. Influence, if any, on the child is unknown.
  • Effects on ability to drive and use machine : Omeprazole is not likely to affect the ability to drive or use machine.

 

DRUG INTERACTIONS :

Effects of Omeprazole on the pharmacokinetics of other drugs :

  • The following combinations with Omeprazole sodium monohydrate powder for injection should be avoided : Ketoconazole and Itraconazole.
  • Omeprazole might influence the absorption of other drugs due to its effect on the gastric pH. The dissolution of Ketoconazole tablets in the stomach is adversely affected if the pH of the gastric juice increases as a result of drug treatment (Antacids, secretion-inhibiting agents, Sucralfate). This leads to ineffective plasma concentration of Ketoconazole. During concomitant administration of Omeprazole and Itraconazole the plasma concentration and AUC of Itraconazole are reduced by approximately 65%, probably as a result of poorer absorption, which is dependent on pH.
  • Omeprazole inhibits the enzyme CYP2C19 and therefore increased plasma levels of other drugs (Diazepam, Warfarin, Phenytoin) metabolised via this enzyme might be expected. A dose reduction of these drugs may be necessary.
  • During concomitant administration of Clarithromycin or Erythromycin and Omeprazole the plasma concentrations of Omeprazole were increased.
  • The plasma concentrations of Omeprazole are not influenced during concomitant administration with Amoxicillin or Metronidazole.
  • In concomitant administration of Omeprazole and Atazanavir, reduced plasma levels of Atazanavir have been reported.
  • Concomitant administration of Omeprazole and Tacrolimus may increase the serum levels of Tacrolimus.

Effects of other drugs on the pharmacokinetics of Omeprazole :

  • Drugs inhibiting the enzymes CYP2C19 or CYP3A (HIV protease inhibitors, Ketoconazole, Itraconazole) might increase the plasma concentrations of Omeprazole. No interactions between Omeprazole and Antacids, Theophylline, Caffeine, Quinidine, Lidocaine, Propanolol, Metoprolol or Ethanol have been detected.

Incompatibilities :

No known incompatibility when recommended instructions are followed.

 

ADVERSE REACTIONS :  

Common General                    : Headache.
Gastrointestinal       : Diarrhoea, nausea/vomiting, constipation, abdominal pain, flatulence.
Less common General                    : Fatigue.
Skin                          : Rash, pruritus, urticaria.
Liver                        : Changes in liver function tests.
Neurological            : Paraesthesia, dizziness, drowsiness.
Psychiatric              : Sleep disturbance.
Rare General                    : Increased sweating, peripheral oedema, hyponatremia. Hypersensitivity reactions such as angioedema, fever and anaphylactic shock.
Blood                       : Leukopenia, thrombocytopenia, agranulocytosis and pancytopenia.
Endocrine                : Gynaecomastia. 
Gastrointestinal       : Dry mouth, taste disturbances, stomatitis, candidiasis 
Skin                          : Hair loss, photosensitivity, erythema multiforme.
Liver                        : Encephalopathy in patients with severe hepatic disease; hepatitis with or without jaundice, hepatic failure.
Respiratory tract     : Bronchospasm.
Musculoskeletal      : Arthralgia, muscular weakness and myalgia.
Psychiatric              : Reversible confusion, agitation, depression, aggression and hallucinations, especially in severely ill patients.
Genitourinary          : Interstitial nephritis.
Eyes                         : Blurred vision.

Isolated cases of Steven – Johnson syndrome and toxic epidermal necrolysis have been reported, but a relationship with Omeprazole could not be established. In severely ill patients, in isolated case irreversible visual disturbances have been reported in connection with treatment with high doses of Omeprazole given as intravenous injection. However, no causal relationship with Omeprazole could be established.

 

PRESENTATION :

Omeprazole Sodium Monohydrate Powder for Injection 40 mg     

Box, 1 vial @ 40 mg + 1 ampoule @ 10 ml solvent No. Reg. GKL1202345844A1

Solvent contains PEG 400; Citric acid monohydrate; Sodium hydroxide and Water for injection.

 

STORAGE :

STORE BELOW 25ºC AND DRY PLACE, PROTECT FROM LIGHT

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by : 

BERNOFARM

Sidoarjo – Indonesia

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