TRUSTAN : Uses In South Africa- Dosage, Side Effects & Safety

RxZest Editorial Team Members

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TRUSTAN USES

If you have been prescribed TRUSTAN for acid-related stomach or food pipe problems, it helps to know exactly what it does, how to take it properly, and when to get medical advice. TRUSTAN contains esomeprazole, a medicine that lowers the amount of acid your stomach makes. This can help relieve symptoms such as heartburn and can also help certain ulcers heal.

Quick facts: TRUSTAN is an S4 medicine in South Africa. It comes as 20 mg and 40 mg gastric resistant tablets. It is used for conditions linked to too much stomach acid, including gastro-oesophageal reflux disease (GORD), preventing ulcers linked to certain pain medicines, treating Helicobacter pylori infection together with antibiotics, and Zollinger-Ellison syndrome. It can be taken with food or on an empty stomach.

What it is and what it is used for

Active ingredient and medicine type

TRUSTAN contains esomeprazole as the active ingredient. It belongs to a group of medicines called proton pump inhibitors. These medicines reduce the production of acid in the stomach.

TRUSTAN is available in two strengths:

  • TRUSTAN 20 mg: contains 20 mg esomeprazole (as magnesium trihydrate)
  • TRUSTAN 40 mg: contains 40 mg esomeprazole (as magnesium trihydrate)

What it is used for

You may be given TRUSTAN for one of these reasons:

  • Gastro-oesophageal reflux disease (GORD)
    This includes treatment and prevention of reflux disease, where acid from the stomach moves up into the food pipe and causes pain, inflammation and heartburn.
  • Prevention of ulcers caused by NSAIDs
    These are pain and anti-inflammatory medicines called non-steroidal anti-inflammatory drugs.
  • Helicobacter pylori infection
    TRUSTAN may be used together with suitable antibiotics to treat ulcers linked to this bacteria.
  • Hypersecretory conditions including Zollinger-Ellison syndrome
    This refers to conditions where the body produces too much stomach acid, including hormone-producing tumours that cause excess acid.

How it works (simple explanation)

If you are taking TRUSTAN, it is working by switching down the stomach’s acid pump. Your stomach normally makes acid to help with digestion, but sometimes too much acid causes burning, irritation or ulcers. By lowering that acid, TRUSTAN gives the irritated areas a chance to settle and heal.

This is why it may help if you have:

  • frequent heartburn
  • inflammation in the food pipe from acid reflux
  • ulcers linked to certain medicines
  • ulcer problems linked to Helicobacter pylori
  • conditions where the stomach produces far too much acid

Who should NOT use this medicine

Do not use if you…

  • are allergic or hypersensitive to esomeprazole
  • are allergic to other proton pump inhibitors
  • are allergic to any of the other ingredients in TRUSTAN
  • are taking HIV medicines atazanavir or nelfinavir

Age restriction

  • Do not use TRUSTAN in children younger than 12 years. There is no experience with TRUSTAN in this age group, and it is not recommended for children under 12.

Warnings and precautions (Read before use)

Before you take TRUSTAN, there are some situations where you should be especially careful.

Get medical advice urgently if you notice warning symptoms

Speak to your doctor immediately if you:

  • are losing weight without trying
  • vomit blood or food
  • pass black or blood-stained stools
  • develop stomach pain or indigestion

These symptoms need prompt attention.

Kidney concerns

TRUSTAN can increase the risk of a kidney problem called tubulointerstitial nephritis, which can lead to kidney failure. Watch out for symptoms such as:

  • increased urine output
  • blood in the urine
  • dark urine
  • drowsiness or confusion
  • swelling anywhere in the body

Liver and kidney problems

If you have severe liver problems, your doctor may want to reduce your dose. If you have severe kidney problems, you should also discuss this with your doctor.

Severe diarrhoea

Tell your doctor if you develop severe debilitating diarrhoea that does not improve. The source describes this as Clostridium difficile-associated diarrhoea, with symptoms such as:

  • watery stools
  • stomach pain
  • fever

Blood tests and monitoring

If you are due for a specific blood test called Chromogranin A, let your doctor know that you are taking TRUSTAN.

Bone fracture risk with long-term use

Taking a proton pump inhibitor such as TRUSTAN for more than one year may slightly increase the risk of fractures in the:

  • hip
  • wrist
  • spine

Tell your doctor if you have osteoporosis or if you are taking corticosteroids, because these can increase fracture risk.

Skin rash in the sun

If you get a rash, especially on areas exposed to the sun, tell your doctor as soon as possible. You may need to stop treatment. Also mention it if you have joint pain at the same time.

Vitamin B12 and magnesium

TRUSTAN, like other acid-blocking medicines, may reduce the absorption of vitamin B12 on long-term therapy. This is especially important if you already have low body stores or other risk factors for poor B12 absorption.

If you have been on TRUSTAN for more than three months, your magnesium levels may drop. Low magnesium may cause:

  • fatigue
  • involuntary muscle contractions
  • disorientation
  • convulsions
  • dizziness
  • increased heart rate

Low magnesium can also lead to low potassium or low calcium. Your doctor may decide to do regular blood tests to monitor this.

Driving and using machines

TRUSTAN has a moderate influence on the ability to drive and use machines. It may cause:

  • dizziness
  • blurred vision

Because people respond differently, do not drive or use machinery until you know how TRUSTAN affects you.

Sugar content

TRUSTAN tablets contain sucrose, which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, speak to them before taking this medicine.

Pregnancy, planning pregnancy, and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning a baby, you should ask your doctor, pharmacist or another healthcare provider for advice before taking TRUSTAN. The source does not give more detailed instructions beyond this.

Note: More detailed pregnancy, fertility and breastfeeding guidance is not specified in the source. Speak to your doctor or pharmacist before use.

Interactions

TRUSTAN can interact with other medicines. Always tell your healthcare provider about all the medicines you take, including complementary or traditional medicines.

Medicines mentioned in the source

Tell your doctor if you are taking:

  • medicines for fungal infections: itraconazole, ketoconazole, voriconazole
  • certain anti-cancer medicines such as erlotinib
  • diazepam
  • epilepsy medicines such as phenytoin and sodium valproate
  • blood-thinning or anti-clotting medicines such as warfarin and clopidogrel
  • cilostazol
  • tacrolimus
  • cisapride
  • HIV medicines such as nelfinavir and atazanavir
  • digoxin
  • medicines for cancer or rheumatoid arthritis such as methotrexate
  • rifampicin
  • medicines for depression such as citalopram, imipramine, clomipramine
  • St John’s Wort
  • antibiotics amoxicillin and clarithromycin when used with TRUSTAN for Helicobacter pylori treatment

Practical points from the source

  • If you take phenytoin, your doctor will need to monitor you when you start or stop TRUSTAN.
  • If you take warfarin or clopidogrel, your doctor may need to monitor you when you start or stop TRUSTAN.
  • If you take a high dose of methotrexate, your doctor may temporarily stop TRUSTAN.
  • Taking TRUSTAN at the same time as nelfinavir or atazanavir is not recommended.

Food and drink

You can take TRUSTAN with food or on an empty stomach.

Alcohol

Guidance about alcohol is not specified in the source.

Laboratory tests

Tell your doctor if you are due to have a Chromogranin A blood test, because the source specifically mentions this.

How to take (Step-by-step)

Always take TRUSTAN exactly as your doctor or pharmacist tells you. Do not share it with anyone else, even if their symptoms seem similar to yours.

How to take the tablets

  • Swallow the tablets whole with a drink of water.
  • Do not chew or crush them.

If you struggle to swallow tablets

You may disperse the tablet in half a glass of non-carbonated water.

Follow these steps:

  1. Put the tablet into half a glass of non-carbonated water.
  2. Do not use any other liquids.
  3. Stir until the tablet breaks up.
  4. Swallow all the tiny pellets without chewing them.
  5. Do not leave the pellets in the water for more than 30 minutes before drinking it.
  6. Rinse the glass with water afterwards and drink that too.

Best routine for daily use

Try to take your medicine at the same time each day. This can help you remember it more easily.

Adults

For GORD

  • Erosive reflux oesophagitis:
    Usual dose is 40 mg once daily for 4 weeks. Your doctor may prescribe another 4 weeks if healing has not happened or symptoms continue.
  • Long-term management after healing to prevent relapse:
    Usual dose is 20 mg once daily.
  • Symptomatic GORD in patients without oesophagitis:
    Usual dose is 20 mg once daily. If symptoms are not controlled after 4 weeks, your doctor will need to investigate further. Once controlled, your doctor may tell you to take it as needed, up to a maximum of one 20 mg tablet each day.

For prevention of ulcers linked to NSAIDs

  • Usual dose is 20 mg or 40 mg once daily.

For Helicobacter pylori-related ulcer treatment

  • Usual dose is:
  • 20 mg TRUSTAN
  • 1 g amoxicillin
  • 500 mg clarithromycin
  • all taken twice daily for 7 days

For Zollinger-Ellison syndrome

  • Usual starting dose is 40 mg twice daily.
  • The dose is then adjusted individually.
  • Treatment continues as long as clinically needed.
  • Doses of up to 120 mg twice daily have been administered.

Adolescents aged 12 to 18 years

For GORD:

  • Erosive reflux oesophagitis:
    40 mg once daily for 4 weeks. Another 4 weeks is recommended if healing has not happened or symptoms continue.
  • Long-term management after healing to prevent relapse:
    20 mg once daily
  • Symptomatic GORD without oesophagitis:
    20 mg once daily. If symptoms are not controlled after 4 weeks, the doctor will need to investigate further. Once symptoms have settled, control may be achieved with 20 mg once daily under medical supervision.

Children

  • TRUSTAN is not recommended for children younger than 12 years.

Older persons

  • TRUSTAN can be used in the elderly.

Missed dose

If you miss a dose:

  • take it as soon as you remember
  • if it is nearly time for the next dose, skip the missed dose
  • do not take a double dose
  • if you have forgotten several doses, contact your doctor without delay

If too much is taken

If you take more TRUSTAN than you should:

  • contact your doctor or pharmacist immediately
  • if neither is available, go to the nearest hospital or poison control centre

Helpful adherence tips based on the source

  • Take it at the same time every day.
  • If swallowing is difficult, use the water-dispersing method exactly as instructed.
  • Do not crush or chew the tablet or pellets.

Dosing table

Age group / conditionDoseFrequencyMaximum daily dose
Adults: erosive reflux oesophagitis40 mgOnce daily for 4 weeksNot specified in the source
Adults: long-term management after healed oesophagitis20 mgOnce dailyNot specified in the source
Adults: symptomatic GORD without oesophagitis20 mgOnce daily20 mg daily when used as needed
Adults: prevention of gastric and duodenal ulcers linked to NSAIDs20 mg or 40 mgOnce dailyNot specified in the source
Adults: Helicobacter pylori treatment (with antibiotics)20 mg TRUSTAN + 1 g amoxicillin + 500 mg clarithromycinAll twice daily for 7 daysNot specified in the source
Adults: Zollinger-Ellison syndrome (initial dose)40 mgTwice dailyDoses up to 120 mg twice daily have been administered
Adolescents 12–18 years: erosive reflux oesophagitis40 mgOnce daily for 4 weeksNot specified in the source
Adolescents 12–18 years: long-term management after healed oesophagitis20 mgOnce dailyNot specified in the source
Adolescents 12–18 years: symptomatic GORD without oesophagitis20 mgOnce dailyNot specified in the source

Possible side effects

Like all medicines, TRUSTAN can cause side effects, although not everyone gets them. If your general health becomes worse while taking it, speak to your healthcare provider.

Common

The source describes these as frequent side effects:

  • headache
  • stomach pain
  • diarrhoea
  • wind (flatulence)
  • nausea
  • vomiting
  • constipation

These may be unpleasant, but they are not usually listed as emergencies in the source. If they continue or become troublesome, speak to your doctor or pharmacist.

Less common

The source describes these as less frequent side effects:

  • dizziness
  • burning, prickling or numbness
  • feeling sleepy
  • dry mouth
  • rash, dermatitis, itching, hives
  • swelling of the hands, feet or other parts of the body
  • difficulty sleeping
  • spinning feeling (vertigo)
  • changes in taste
  • blurred vision
  • inflammation in the mouth
  • fungal infection in the digestive tract
  • gastrointestinal infection
  • hair loss
  • skin rash due to sunlight sensitivity
  • depression
  • nervousness
  • confusion
  • low blood sodium
  • muscle pain
  • sore joints
  • feeling ill
  • increased sweating
  • aggression
  • hallucinations
  • decreased consciousness
  • muscle weakness
  • inflammation of the kidney
  • development of breasts in males
  • low magnesium, which may also lower calcium or potassium
  • inflammation of the gut leading to diarrhoea

The source also says that blood tests may show an increase in liver enzymes.

Serious—seek urgent help

Stop taking TRUSTAN and get urgent medical help if you have signs of a serious allergic or severe reaction, such as:

  • sudden wheezing
  • swelling of the hands, feet, ankles, face, lips, mouth or throat
  • difficulty swallowing or breathing
  • rash or itching
  • fainting
  • blistering of the skin, mouth, eyes or genitals
    (the source says this may be a serious allergic reaction known as Stevens-Johnson Syndrome)

Serious—go to a doctor or casualty department immediately

Seek urgent care if you notice:

  • tight chest
  • sudden wheezing or shortness of breath (bronchospasm)
  • fracture of the hip, wrist or spine
  • blood disorders such as low blood cells
  • agranulocytosis or pancytopenia
  • liver problems, including inflammation of the liver, with or without jaundice
    (yellow skin, dark urine, tiredness)

Reporting side effects in South Africa

If you get side effects, you can speak to your doctor, pharmacist or nurse. The source also says side effects can be reported to:

  • SAHPRA
  • Acino Pharma (Pty) Ltd by email or telephone

Storage and disposal

How to store TRUSTAN

  • Keep all medicines out of reach of children.
  • Do not store in a bathroom.
  • Store at or below 30 °C.
  • Keep it in a dry place.
  • Keep the tablets in the original container and keep the container tightly closed.
  • Keep the blisters in the carton until you need them.

Expiry and disposal

  • Do not use TRUSTAN after the expiry date on the label.
  • Return unused medicine to your pharmacist.
  • Do not throw unused medicine into drains or sewerage systems, such as the toilet.

What the medicine contains

Active ingredients

  • TRUSTAN 20 mg contains 20 mg esomeprazole (as magnesium trihydrate)
  • TRUSTAN 40 mg contains 40 mg esomeprazole (as magnesium trihydrate)

Other ingredients

The source lists the following other ingredients:

  • crospovidone
  • glycerol monostearate
  • hypromellose
  • hydroxypropylcellulose
  • iron oxide
  • magnesium stearate
  • methacrylic acid-ethyl acrylate copolymer
  • microcrystalline cellulose
  • macrogol
  • polysorbate 80
  • synthetic paraffin
  • sugar spheres (sucrose and maize starch)
  • sodium stearyl fumarate
  • talc
  • triethyl citrate
  • titanium dioxide

Sugar content

  • TRUSTAN 20 mg contains 28 mg sucrose
  • TRUSTAN 40 mg contains 30 mg sucrose

Pack information and appearance

What the tablets look like

  • TRUSTAN 20 mg is a light pink, oval coated tablet marked “20 mg” on one side and AEH on the other side.
  • TRUSTAN 40 mg is a pink, oval coated tablet marked “40 mg” on one side and AEI on the other side.

Pack sizes

TRUSTAN gastric resistant tablets are available in cartons containing blister strips. These cartons may contain:

  • 3
  • 7
  • 14
  • 15
  • 28
  • 30
  • 50
  • 56
  • 60
  • 98
  • 100 tablets

They are also available in white plastic bottles with screw caps, with or without child resistance and a tamper-proof ring, containing:

  • 2
  • 5
  • 7
  • 14
  • 15
  • 28
  • 30
  • 56
  • 60
  • 100 tablets

Practical FAQs (based ONLY on the source)

Can I take TRUSTAN with food?

Yes. The source says you can take TRUSTAN with food or on an empty stomach.

Can I crush the tablet if I cannot swallow it?

No. The source says do not chew or crush the tablets. If swallowing is difficult, you can disperse the tablet in half a glass of non-carbonated water and swallow the pellets without chewing them.

What must I do if I miss a dose?

Take the missed dose as soon as you remember. If it is nearly time for the next dose, skip the missed dose. Do not take a double dose. If you have missed several doses, contact your doctor without delay.

What must I do if I take too much?

Get help straight away. Contact your doctor or pharmacist immediately. If neither is available, go to the nearest hospital or poison control centre.

Can children take TRUSTAN?

It is not recommended for children under 12 years. There is no experience with TRUSTAN in younger children.

Can older people use TRUSTAN?

Yes. The source states that TRUSTAN can be used in the elderly.

Can I drive while taking TRUSTAN?

Possibly, but you need to be careful. TRUSTAN may cause dizziness and blurred vision, and it has a moderate influence on driving and using machines. Only drive when you know how it affects you.

Can I take it with my other medicines?

Not always. TRUSTAN has several listed interactions, including with some HIV medicines, antifungals, epilepsy medicines, blood thinners and others. Always tell your healthcare provider about everything you are taking, including traditional or complementary medicines.

Can I use TRUSTAN in pregnancy or while breastfeeding?

The source says you should ask your doctor, pharmacist or another healthcare provider for advice before using TRUSTAN if you are pregnant, breastfeeding, think you may be pregnant or are planning a baby. More detail is not specified in the source.

Can I drink alcohol while taking this?

Not specified in the source.

Plain-language summary

If you are taking TRUSTAN, it is there to reduce stomach acid and help with conditions such as reflux, acid-related irritation, certain ulcers, Helicobacter pylori-related ulcer treatment, and excess acid conditions. Take it exactly as prescribed, swallow the tablet whole if you can, and if you struggle to swallow, use only the non-carbonated water method described in the source. You can take it with or without food.

Seek medical help promptly if you develop difficulty breathing, swelling, black stools, vomiting blood, severe diarrhoea, signs of kidney problems, jaundice, or severe skin blistering or rash. Keep the medicine below 30 °C, dry, tightly closed, and out of children’s reach. If anything about your dose or side effects worries you, speak to your doctor or pharmacist rather than guessing.

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