Somac Injection

Generic Name: Pantoprazole
Product Name: Somac Injection

Indication

Somac (pantoprazole) is a medication given for the control of the amount of acid produced in the stomach. It is often given as a tablet, but in case this is inappropriate (e.g. if a person is unable to swallow), an injectable form of the drug is available.

Somac may be used in the treatment of a range of conditions, including:

• Duodenal ulcer;
• Gastric ulcer;
• Reflux oesophagitis;
• Gastrointestinal lesions which have been treated with H₂ receptor antagonist medication, but which have failed to heal;
• Zollinger-Ellison syndrome.

Somac may also be used to stopping the return of symptoms of reflux oesophagitis in individuals who have previously had moderate–severe symptoms of reflux, but have been successfully treated.

Somac is available in several different forms. For more information on other available forms, see Somac Tablets (20mg or 40mg on Prescription), Somac Granules (40mg on Prescription) and Somac Heartburn Relief (Over-the-Counter).

Action

The active ingredient in Somac injection is pantoprazole, which belongs to a group of medications known as proton pump inhibitors. These medications control an enzyme called H⁺/K⁺-ATPase which produces gastric acid in the parietal cells of the stomach. By controlling this enzyme, pantoprazole decreases the amount of acid produced by the stomach. When acid production is controlled, symptoms like acid reflux and stomach lesions caused by excessive acid production are also controlled.

Dose advice

Dose information

When Somac (pantoprazole) is given by means of an injection into the vein (intravenously), the medication is made up from a powder and dissolved in a solution so that it can enter the blood stream. Then the same or similar dose that is received in the tablet is given into the blood over a period of a several minutes. This procedure normally takes place in a hospital or medical centre, under medical supervision.

Contraindications

Somac injection should not be taken in certain situations. Your doctor will discuss alternatives that will be more suitable for you. Do not take Somac tablets if you have:

• Allergies to any of the medication’s components;
• Cirrhosis;
• Moderate to severe liver failure;
• Are currently taking atazanavir.

Precautions

Some circumstances need special consideration before taking Somac injection. Tell your doctor if you have any of the following:

• Significant unintentional weight loss;
• Recurrent vomiting;
• Difficulty swallowing;
• Vomiting blood;
• Anaemia;
• Black ‘tarry’ stools;
• Suspected or confirmed gastric ulcer;

Use in children

The use of Somac injection in children has not been studied.

Use in pregnancy

Somac injection is a Pregnancy Category B3 medication. The safety of use during pregnancy has not been established. Somac injection should not be used if you are pregnant or planning to become pregnant.

Use while breastfeeding

Somac injection should not be used if you are breastfeeding or planning to breastfeed.

Schedule

Somac injection is Schedule 4 – prescription only medication.¹

Common side effects

All medicines have side effects. Most commonly the side effects are minor; however, some can be more serious. Usually the benefits of taking a medication outweigh the associated side effects. Your doctor would have considered these side effects before starting you on Somac injection.

Common side effects are those which occur in more than 1% of patients given Somac injection. These include:

• Fatigue;
• Asthenia;
• Increased sweating;
• Headache;
• Diarrhoea;
• Severe belching;
• Constipation or flatulence;
• Dry mouth;
• Upper abdominal pain;
• Metallic taste.

Uncommon side effects

Side effects which occur in less than 1% of patients given Somac injection are considered uncommon. Patients do not necessarily experience any of these side effects, so do not become alarmed by this list:

• Dizziness;
• Nausea and vomiting;
• Allergic skin reactions, including pruritus and skin rash;
• Blurred vision.

Rare side effects occur in less than 0.1% of patients given Somac injection. These include:

• Fever;
• Anaphylactic reactions including anaphylactic shock and peripheral oedema;
• Hypertension;
• Rectal disorder;
• Colonic polyp;
• Joint pain;
• Psychiatric disorders, including depression, hallucination, disorientation and confusion. These conditions are particularly likely in patients who have previously experienced psychiatric disorders, and those who are already suffering from a psychiatric disorder may find that their symptoms become worse. Psychiatric disorders are also more common in patients who have an increased risk for these conditions (e.g. patients who have direct relatives who have a psychiatric condition);
• Anaemia;
• Sepsis.

Very rare side effects occur in less than 0.01% of people given Somac injection. They include:

• Chest pain;
• Hot flushes;
• Circulatory collapse;
• Reduced movement;
• Speech disorder;
• Faecal discolouration;
• Increased saliva;
• Tinnitus;
• Increased liver enzymes;
• Hepatic failure;
• Cholestatic hepatitis;
• Bilirubinaemia;
• Jaundice;
• Hypertriglyceridaemia;
• Muscle pain;
• Pain, including skeletal pain;
• Interstitial nephritis;
• Thrombocytopaenia;
• Increased bleeding;
• Anxiety;
• Leukopaenia;
• Breathlessness;
• Angioedema;
• Urticaria;
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Lyell’s syndrome and photosensitivity;
• Changes to sense of smell and taste;
• Flushing;
• Conjunctivitis.

If you experience any of the listed side effects, or any other symptoms which appear abnormal or unusual, please tell your doctor.

References

1. Product Information: Somac Injection. North Ryde, NSW: Nycomed Pty Ltd; 30 November 2006.
2. Pantoprazole sodium [online]. St Leonards, NSW: MIMS Online; 16 July 2007 [cited 14 July 2009]. Available from: URL link
3. Pantoprazole [online]. Adelaide, SA: Australian Medicines Handbook; July 2009 [cited 24 April 2009]. Available from: URL link

For further information talk to your doctor.