Aspra SR Tablet (Sustained Release)

Aspra SR belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

Clinical advantage of omeprazole mups tablet compared to conventional modified-release omeprazole tablets and pellet-filled omeprazole capsules:

  • Ensures greater bioavailability
  • Ensures uniform emptying of micro pellets from stomach into small intestine facilitates rapid dissolution of enteric coating and drug release resulting in early Tmax and Cmax (peak time and peak plasma concentration)
  • Ensures lesser possibility of dose dumping
  • Is a combination of fast acting and sustained action
  • Ensures uniform drug release
  • Once daily dosing
  • Ensures lesser chance of localized irritation
  • Ensures better and more uniform drug absorption
  • Better than capsules in reducing the esophageal residence time
  • Minimizes fluctuation in plasma concentration of drug

Uses

Each film coated MUPS tablet contains 20 mg Aspra SR enteric coated micro pellets

Aspra SR (Multiple-Unit Pellet System) is indixated in-

  • Duodenal and Gastric ulcers
  • NSAID-induced gastric and duodenal ulcers
  • Reflux Oesophagitis
  • GERD (Gastroesophageal Reflux Disease)
  • Eradication of H. pylori with appropriate antibiotics
  • Zollinger-Ellison Syndrome

MUPS is abbreviation for Multiple-Unit Pellet System. However, from pharmaceutical industry and research perspective, the term in general refers to MUPS compacted into tablets. Thus, the resulting tablets prepared by compaction of modified release coated multiparticulates or pellets are called as MUPS. It is the more recent and challenging technology that combines the advantages of both tablets and pellet filled capsules in one dosage form.

MUPS ensure rapid and uniform gastric emptying and subsequently uniform drug dissolution of pellets in the gastrointestinal tract due to their small size and larger surface, uniform drug absorption is facilitated which results in consistent and controlled pharmacological action.

A further reduction in inter- and intra-subject variability in drug absorption and clinical response is facilitated since the number of pellets per MUPS dosage form is much more than a conventional pellet-filled capsule and possibility of dose dumping(in stomach) and incomplete drug release is further minimized.

Aspra SR is also used to associated treatment for these conditions: Ankylosing Spondylitis (AS), Duodenal Ulcer, Erosive Esophagitis, Gastric Ulcer, Gastro-esophageal Reflux Disease (GERD), Healing, Heartburn, Helicobacter Pylori Infection, NSAID Associated Gastric Ulcers, Osteoarthritis (OA), Rheumatoid Arthritis, Zollinger-Ellison Syndrome, Hypersecretory conditions, Multiple endocrine adenomas

Trade Name Aspra SR
Generic Omeprazole
Other Names OMEP, Omeprazol, Omeprazole, Omeprazolum
Weight 20mg
Type Tablet (Sustained Release)
Formula C17H19N3O3S
Weight Average: 345.416
Monoisotopic: 345.114712179
Protein binding

Approximately 95% bound to human plasma proteins .

Therapeutic Class Proton Pump Inhibitor
Manufacturer Apex Pharmaceuticals Ltd
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:23 am

Dosage

Aspra SR dosage

Adult:

  • GERD (Gastroesophageal Reflux Disease): 20 mg Once daily for 4 weeks
  • Gastric ulcer: 20 mg Once daily for 4-8 weeks; in severe cases Twice daily
  • Duodenal ulcer: 20 mg Once daily for 2-4 weeks; in severe cases Twice daily
  • NSAID-induced ulceration: 20 mg Once daily for 4-8 weeks
  • Reflux esophagitis: 20 mg Once daily for 4-8 weeks; in severe cases Twice daily
  • H. pylori eradication (Aspra SR MUPS tablet with Amoxicillin and Clarithromycin or Metronidazole): 20 mg Twice daily for 1 week
  • Zollinger-Ellison Syndrome: 60 mg Once daily; Usual maintenance, 20-120mg daily

Children:

  • Acid regurgitation in GERD (Gastroesophageal Reflux Disease): 20 mg Once daily for 2-4 week
  • Reflux esophagitis: 20 mg Once daily for 4-8 weeks

Swallow the tablet whole with a glass of water. The tablet must not be chewed or crushed. OR

If the patients have trouble swallowing the tablets, put the tablet into a glass of water (Do not use other liquids). Stir the preparation until the tablets disintegrate. Then drink the liquid within 30 minutes. Stir the mixture just always before drinking.

Precaution

Aspra SR tablet should be used carefully if the patient has severe liver dysfunction and severe renal impairment.

Interaction

Aspra SR is metabolized through CYP2C19 . When starting or stopping treatment with Aspra SR should be taken into account potential interactions with medicines which are CYP2C19 metabolized.

Food Interaction

  • Take before a meal. Allow 30-60 minutes before a meal.

Volume of Distribution

Approximately 0.3 L/kg, corresponding to the volume of extracellular water .

Half Life

0.5-1 hour (healthy subjects, delayed-release capsule)
Approximately 3 hours (hepatic impairment)

Clearance

Healthy subject (delayed release capsule), total body clearance 500 - 600 mL/min

Geriatric plasma clearance: 250 mL/min

Hepatic impairment plasma clearance: 70 mL/min

Pregnancy & Breastfeeding use

Not known to be harmful. Aspra SR can be used during pregnancy. Aspra SR is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

Contraindication

Aspra SR is contraindicated in those patients who have known hypersensitivity to any other components of the formulation.

Storage Condition

Store in a cool (below 30° C) and dry place, protected from light and moisture.

Aspra SR contains Omeprazole see full prescribing information from innovator Monograph

FAQ

What is Aspra SR used for?

Aspra SR is used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription Aspra SR is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD.

What are the side effects of taking Aspra SR?

Aspra SR side effects are Rare:

  • Back, leg, or stomach pain
  • bleeding or crusting sores on the lips
  • blisters
  • bloody or cloudy urine
  • chills
  • continuing ulcers or sores in the mouth
  • difficult, burning, or painful urination
  • fever
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • itching, skin rash
  • joint pain
  • loss of appetite
  • muscle aches or cramps
  • pain
  • red or irritated eyes
  • redness, tenderness, itching, burning, or peeling of the skin
  • sore throat
  • sores, ulcers, or white spots on the lips, in the mouth, or on the genitals
  • unusual bleeding or bruising
  • unusual tiredness or weakness

How long should I take Aspra SR?

Aspra SR is a delayed-release 20mg tablet, taken once a day (every 24 hours) for 14 days before eating. You should not take it for more than 14 days or repeat a 14-day course more often than every 4 months unless directed by a doctor. Do not crush, break, or chew the tablet.

Is it bad to take Aspra SR every day?

Sometimes you might need to take it for longer, even for many years. Some people do not need to take Aspra SR every day and take it only when they have symptoms. Once you feel better (often after a few days or weeks), you can stop taking it. But taking Aspra SR in this way is not suitable for everyone.

What foods neutralize stomach acid?

Foods that may help reduce your symptoms

  • Vegetables. Vegetables are naturally low in fat and sugar, and they help reduce stomach acid.
  • Ginger.
  • Oatmeal.
  • Noncitrus fruits.
  • Lean meats and seafood.
  • Egg whites.
  • Healthy fats.

How long before a meal should you take Aspra SR?

Take Aspra SR powder for oral suspension on an empty stomach at least 1 hour before a meal.

What can I take instead of Aspra SR?

These include proton pump inhibitors such as esomeprazole, omeprazole, pantoprazole and lansoprazole. The others are antacids such as Maalox, Mylanta and Tums; and H2 (histamine) receptor antagonists such as famotidine, and cimetidine.

Can Aspra SR make me gassy?

Common side effects may include: stomach pain, gas; nausea, vomiting, diarrhea; or. headache.

Why should not lie down after taking Aspra SR?

Do not lie down immediately after taking medicine, to make sure the pills have gone through the esophagus into the stomach. Notify your healthcare provider if you experience painful swallowing or feel that the medicine is sticking in your throat.

Why is Aspra SR taken before meals?

When therapy with Aspra SR or lansop- razole is indicated, medication should be taken before a meal for optimal control of daytime gastric acidity. the parietal cell is maximally stimulated as it is after a meal.

How do I cure GERD permanently?

Try to:

  • Maintain a healthy weight.
  • Stop smoking.
  • Elevate the head of your bed.
  • Don't lie down after a meal.
  • Eat food slowly and chew thoroughly.
  • Avoid foods and drinks that trigger reflux. ..
  • Avoid tight-fitting clothing.

Is it safe to take Aspra SR long term?

If you take Aspra SR for more than 3 months, the levels of magnesium in your blood may fall.

Low magnesium can make you feel tired, confused, dizzy and cause muscle twitches, shakiness and an irregular heartbeat. If you get any of these symptoms, tell your doctor.

Taking Aspra SR for more than a year may increase your chances of certain side effects, including:

  • bone fractures
  • gut infections
  • vitamin B12 deficiency – symptoms include feeling very tired, a sore and red tongue, mouth ulcers and pins and needles

If you take Aspra SR for longer than 1 year, your doctor will regularly check your health to see if you should carry on taking it.

Should I stop taking Aspra SR if I have diarrhea?

Stop using Aspra SR and call your doctor at once if you have: severe stomach pain, diarrhea that is watery or bloody; new or unusual pain in your wrist, thigh, hip, or back; seizure (convulsions);

How long does it take for stomach acid to return to normal?

For most people acid levels return to normal within one to two weeks.

Are there any side effects when I stop taking Aspra SR?

When Aspra SR is stopped, a common side effect is rebound acid secretion, where the acid secretion in your stomach increases significantly. This should return to normal within 2 weeks.

Is Aspra SR safe in pregnancy?

Usually, Aspra SR is safe to take during pregnancy.

Is Aspra SR safe during breastfeeding?

Usually, omeprazole is safe to take during breastfeeding.

How does Aspra SR work?

Aspra SR (Omeprazole) is a type of medicine called a proton pump inhibitor (PPI). Proton pumps are tiny substances in the lining of the stomach that help it make acid to digest food. Omeprazole prevents proton pumps working properly. This reduces the amount of acid the stomach makes.

When will I feel better after taking Aspra SR?

You should start to feel better within 2 to 3 days. It may take up to 4 weeks for Aspra SR to work properly, so you may still have some acid symptoms during this time. If you're self-treating, tell your doctor if you feel no better after taking Aspra SR for 2 weeks. They may want to do tests or change you to a different medicine.


Can I take painkillers with Aspra SR?

Yes, it's safe to take painkillers such as paracetamol or ibuprofen at the same time as Aspra SR. It's best to take ibuprofen with, or just after, a meal so it does not upset your stomach.

Are there other medicines like Aspra SR?

There are 4 other medicines that are similar to Aspra SR. They are:

  • lansoprazole
  • esomeprazole
  • pantoprazole
  • rabeprazole

Can I take Aspra SR with an antacid?

You can take Aspra SR with an antacid (for example, Gaviscon) if you need to, but leave a gap of 2 hours between them.

Will Aspra SR affect my fertility?

There's no clear evidence to suggest that taking Aspra SR will reduce fertility in either men or women. But speak to a pharmacist or your doctor if you're trying to get pregnant. They may want to review your treatment.

Will Aspra SR affect my contraception?

Aspra SR does not affect any type of regular contraception, including the combined pill. But if Aspra SR makes you sick (vomit), your contraceptive pills may not protect you from pregnancy. If this happens, follow the instructions in the leaflet that comes with your contraceptive pills.