Sitagliptin Oresund Pharma: Uses, Dosage & Side Effects
A DPP-4 inhibitor (dipeptidyl peptidase-4 inhibitor) in a 25 mg renal-adjusted strength, used to lower blood sugar in adults with type 2 diabetes who have severe kidney impairment or end-stage renal disease
Sitagliptin Oresund Pharma is a prescription-only generic formulation of sitagliptin, a DPP-4 inhibitor used to control blood sugar in adults with type 2 diabetes mellitus. It is supplied as a 25 mg film-coated tablet, the lowest strength of sitagliptin. This strength is specifically intended for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease, including those on haemodialysis or peritoneal dialysis. It is taken once daily, with or without food, and works by enhancing the body’s natural incretin response to meals so that insulin is released when blood sugar rises.
Quick Facts
Key Takeaways
- Sitagliptin Oresund Pharma 25 mg is a DPP-4 inhibitor used to lower blood sugar in adults with type 2 diabetes, particularly those with severe kidney impairment or end-stage renal disease.
- The standard dose is one 25 mg tablet once daily, with or without food, and can be taken without regard to the timing of dialysis sessions.
- Sitagliptin works by blocking the enzyme DPP-4, which preserves active levels of the incretin hormones GLP-1 and GIP and enhances glucose-dependent insulin release.
- Used alone, sitagliptin has a low intrinsic risk of hypoglycemia; the risk rises when combined with sulfonylureas or insulin, which may require dose reduction of those agents.
- Stop the medicine and contact a doctor immediately if severe abdominal pain, a serious allergic reaction, or skin blistering occurs – rare cases of pancreatitis, angioedema, and bullous pemphigoid have been reported with DPP-4 inhibitors.
What Is Sitagliptin Oresund Pharma and What Is It Used For?
Sitagliptin Oresund Pharma contains the active substance sitagliptin (as sitagliptin fumarate), which belongs to a class of medicines known as dipeptidyl peptidase-4 inhibitors, or DPP-4 inhibitors for short. These medicines target the incretin system, a natural hormonal pathway that governs how your body handles blood sugar after eating. When you consume a meal, specialised cells in the gut release incretin hormones – primarily glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). These incretins travel to the pancreas, where they stimulate the beta cells to produce insulin in proportion to the glucose load from your meal.
Under normal circumstances, the enzyme DPP-4 rapidly degrades these incretin hormones, with GLP-1 typically having a half-life of just 1–2 minutes in the bloodstream. Sitagliptin is a highly selective and reversible inhibitor of the DPP-4 enzyme. By blocking this enzyme, sitagliptin allows the active forms of GLP-1 and GIP to circulate for much longer, thereby amplifying their insulin-releasing effect when blood sugar is elevated. The mechanism is glucose-dependent, which means sitagliptin mainly stimulates insulin secretion when blood glucose is high (for example, after meals) and has limited effect when blood sugar is already normal or low.
In addition to enhancing insulin release, sitagliptin suppresses the release of glucagon from the alpha cells of the pancreas. Glucagon is a counter-regulatory hormone that signals the liver to release stored glucose into the bloodstream. By dampening glucagon secretion, sitagliptin further reduces hepatic glucose output and helps prevent post-meal blood sugar spikes. Together, these dual effects – more insulin in response to meals and less glucagon-driven hepatic glucose production – translate into clinically meaningful reductions in both fasting and postprandial blood glucose, typically reflected in a lowering of haemoglobin A1c (HbA1c) by around 0.5–1.0 percentage points.
Understanding Type 2 Diabetes
Type 2 diabetes mellitus is a chronic metabolic disorder characterised by insulin resistance (reduced responsiveness of body tissues to insulin) and progressive dysfunction of the pancreatic beta cells, which results in insufficient insulin secretion to meet the body’s needs. Over time, the combination of these defects leads to chronically elevated blood glucose levels. Without adequate treatment, high blood sugar damages blood vessels, nerves, and organs, eventually leading to complications such as cardiovascular disease, stroke, chronic kidney disease, diabetic retinopathy (vision loss), peripheral neuropathy, and lower-limb ulceration that can require amputation.
According to the International Diabetes Federation, approximately 537 million adults worldwide were living with diabetes in 2021, and the figure is projected to rise to 783 million by 2045. Type 2 diabetes accounts for about 90% of all cases. The condition is strongly associated with modifiable risk factors such as overweight and obesity, physical inactivity, and diets high in refined carbohydrates and saturated fats, as well as non-modifiable factors including genetic predisposition, age, and certain ethnic backgrounds. Effective management combines lifestyle measures (diet, exercise, weight control) with pharmacological therapy to reach glycaemic targets, typically an HbA1c below 7% (53 mmol/mol) for most adults, as recommended by the American Diabetes Association and the European Association for the Study of Diabetes.
Why the 25 mg Strength Matters – Diabetes and Chronic Kidney Disease
Chronic kidney disease (CKD) is one of the most common complications of type 2 diabetes. Approximately 30–40% of people with long-standing type 2 diabetes develop diabetic kidney disease, and CKD itself is a major independent risk factor for cardiovascular events. Managing blood sugar in patients with advanced CKD is uniquely challenging because many oral glucose-lowering medicines rely on intact renal function for their clearance or are contraindicated in severe kidney impairment.
Sitagliptin is a particularly suitable option in this setting. It is primarily eliminated unchanged by the kidneys (about 79% of a dose), so its clearance falls in step with declining glomerular filtration rate (eGFR). To avoid excessive drug exposure and any associated increase in side effects, the dose must be reduced in parallel. The 25 mg strength of Sitagliptin Oresund Pharma is specifically tailored for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) and end-stage renal disease, including those on haemodialysis or peritoneal dialysis. This allows the glucose-lowering benefits of DPP-4 inhibition to be maintained while keeping plasma drug concentrations within a safe and therapeutic range.
How DPP-4 Inhibitors Fit Into Modern Diabetes Treatment
DPP-4 inhibitors, sometimes called gliptins, are an established second- or third-line option in the pharmacological management of type 2 diabetes after metformin. The 2022 ADA/EASD consensus report and the KDIGO 2022 guideline on diabetes in CKD both recognise sitagliptin as a reasonable choice for patients who need additional glucose lowering but for whom weight neutrality, convenient oral dosing, and a low risk of hypoglycemia are priorities. Sitagliptin has a particularly favourable safety profile across the full spectrum of renal function, from normal kidneys through dialysis-dependent CKD, provided that the dose is adjusted appropriately.
While newer agents such as SGLT2 inhibitors and GLP-1 receptor agonists have demonstrated cardiovascular and renal outcome benefits and are now preferred in many patients at high cardiovascular risk, DPP-4 inhibitors retain an important role. They are especially valuable for patients with advanced CKD where SGLT2 inhibitors may be contraindicated, for patients who cannot afford or tolerate injectable therapies, and for combination regimens in older adults where simplicity and tolerability matter. Sitagliptin was the first DPP-4 inhibitor to receive regulatory approval, authorised by the U.S. FDA in 2006 and in the European Union in 2007. Since then it has been studied in tens of thousands of patients, including the large TECOS cardiovascular outcome trial, and has established a long-term safety record that underpins confidence in generic formulations such as Sitagliptin Oresund Pharma.
What Should You Know Before Taking Sitagliptin Oresund Pharma?
Contraindications
You must not take Sitagliptin Oresund Pharma if you are hypersensitive (allergic) to sitagliptin or to any of the other ingredients listed in the medicine’s package insert. Serious allergic reactions – including anaphylaxis, angioedema (swelling of the face, lips, tongue, or throat), and severe skin reactions such as Stevens-Johnson syndrome – have been reported with sitagliptin in post-marketing surveillance. If you have previously experienced an allergic reaction to any DPP-4 inhibitor (sitagliptin, vildagliptin, saxagliptin, linagliptin, or alogliptin), inform your healthcare provider before starting this medicine.
Sitagliptin Oresund Pharma is indicated only for type 2 diabetes mellitus. It must not be used in people with type 1 diabetes because it cannot replace the absolute insulin deficiency that characterises that condition. It is likewise not appropriate for the treatment of diabetic ketoacidosis (DKA), a medical emergency characterised by very high blood sugar, ketones in the blood and urine, dehydration, and metabolic acidosis. DKA requires immediate treatment with intravenous fluids and insulin in a hospital setting.
Warnings and Precautions
Cases of acute pancreatitis, including fatal and non-fatal haemorrhagic or necrotising pancreatitis, have been reported in patients taking sitagliptin. If you experience severe, persistent abdominal pain – typically located in the upper abdomen and sometimes radiating to the back – with or without nausea and vomiting, stop taking Sitagliptin Oresund Pharma immediately and contact your doctor. If pancreatitis is confirmed, sitagliptin should not be restarted.
Before starting Sitagliptin Oresund Pharma, and during the course of treatment, tell your doctor if you have or have had any of the following conditions:
- Pancreatic disease: A past history of pancreatitis increases the risk of recurrence with DPP-4 inhibitor therapy. Your doctor will weigh the benefits and risks carefully before prescribing sitagliptin.
- Gallstones, chronic alcohol use, or very high triglyceride levels: These conditions independently increase pancreatitis risk and warrant additional caution.
- Severe kidney problems and dialysis: Because the 25 mg strength is specifically for severe renal impairment, kidney function should be assessed before starting and periodically thereafter. Sudden worsening of renal function may require further dose adjustment or discontinuation.
- Bullous pemphigoid: Cases of this autoimmune blistering skin disease have been reported with DPP-4 inhibitors. If you develop tense blisters or erosions on the skin, contact your doctor; sitagliptin may need to be discontinued.
- Heart failure: Although sitagliptin itself has not been linked to increased heart failure hospitalisation in the TECOS trial, patients with heart failure and kidney disease are a vulnerable group in whom fluid balance and cardiac function should be monitored.
Sitagliptin alone is unlikely to cause low blood sugar (hypoglycemia) because its mechanism of action is glucose-dependent. However, the risk of hypoglycemia is substantially increased when sitagliptin is combined with a sulfonylurea (such as glimepiride, gliclazide, or glipizide) or with insulin. In patients with advanced CKD – who typically take the 25 mg strength – the risk of prolonged hypoglycemia is amplified because both endogenous insulin clearance and the renal gluconeogenic contribution are altered. Your doctor may reduce the dose of your sulfonylurea or insulin when starting Sitagliptin Oresund Pharma. Learn to recognise early warning signs: sweating, trembling, a racing heartbeat, hunger, blurred vision, confusion, or feeling faint.
Children and Adolescents
Sitagliptin Oresund Pharma is not recommended for children and adolescents under 18 years of age. Clinical studies in paediatric patients aged 10 to 17 years with type 2 diabetes have not demonstrated sufficient efficacy to support routine use in this population. No data are available for children under 10 years, and safety and efficacy have not been established in that age group.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before taking Sitagliptin Oresund Pharma. This medicine should not be used during pregnancy because there are insufficient human data to establish its safety. Animal reproduction studies have not shown direct harmful effects on fertility or embryonic development, but as a precautionary measure all DPP-4 inhibitors are avoided in pregnancy. If you become pregnant while taking sitagliptin, your doctor will switch you to an alternative treatment – typically insulin, which remains the standard of care for diabetes management during pregnancy.
It is not known whether sitagliptin is excreted in human breast milk. Studies in rats have shown that sitagliptin does pass into milk, and the potential effects on a nursing infant are not characterised. As a precaution, Sitagliptin Oresund Pharma should not be used during breastfeeding. Your doctor will help you decide on a suitable alternative while you are nursing.
Elderly Patients
Older adults frequently have reduced kidney function, often unrecognised because serum creatinine alone is an unreliable marker in the elderly. Since many older patients with type 2 diabetes have CKD, the 25 mg strength is particularly relevant in this age group. No separate dose adjustment is required on the basis of age alone, but the dose must be tailored to the individual’s renal function (eGFR). Elderly patients should be monitored more frequently for hypoglycemia, falls, and signs of volume depletion.
Driving and Operating Machinery
Sitagliptin Oresund Pharma has no or negligible direct effect on your ability to drive or operate machinery. However, dizziness and drowsiness have been reported by some patients, and both could impair reaction time or attention. When sitagliptin is used in combination with a sulfonylurea or insulin, the risk of hypoglycemia – which can cause sudden confusion, lightheadedness, or loss of consciousness – must also be taken into account. Exercise caution when driving or using machinery, particularly at the start of treatment or after any dose change.
Important Information About Ingredients
Sitagliptin Oresund Pharma 25 mg film-coated tablets contain less than 1 mmol (23 mg) sodium per tablet, meaning they are essentially “sodium-free”. This is particularly relevant in patients with advanced CKD who may be on sodium-restricted diets. The tablets also contain pharmaceutical-grade excipients such as microcrystalline cellulose and magnesium stearate; check the complete ingredient list in the product leaflet supplied with your medicine.
How Does Sitagliptin Oresund Pharma Interact with Other Drugs?
Compared with many other glucose-lowering medicines, sitagliptin has a favourable drug-interaction profile. It is not a significant inhibitor or inducer of the major cytochrome P450 enzymes (including CYP3A4, CYP2C8, and CYP2C9), which are responsible for metabolising most prescription drugs. Sitagliptin is also only a weak substrate of P-glycoprotein and organic anion transporter 3 (OAT3). Consequently, clinically relevant pharmacokinetic interactions are uncommon. However, because this medicine is typically given to patients with advanced CKD who are often on multiple other medications (anti-hypertensives, diuretics, phosphate binders, erythropoiesis-stimulating agents), a careful medication review is still warranted at the start of therapy.
Major Interactions
| Interacting Drug | Effect | Clinical Action |
|---|---|---|
| Sulfonylureas (glimepiride, gliclazide, glipizide, glibenclamide) | Additive glucose-lowering effect markedly raises the risk of hypoglycemia, which can be prolonged in CKD | A lower dose of sulfonylurea is usually required when starting sitagliptin. Self-monitoring of blood glucose should be intensified. |
| Insulin (all types) | Increased risk of hypoglycemia when used together, particularly in patients with reduced renal insulin clearance | A lower insulin dose may be needed. Continue self-monitoring; review at follow-up visits. |
| Digoxin | Sitagliptin may slightly increase plasma digoxin levels (AUC ~11%, Cmax ~18%) – a more pronounced relative change in advanced CKD where digoxin clearance is already reduced | Monitor serum digoxin levels when the combination is used, especially at dose initiation. |
| Cyclosporin (a potent P-glycoprotein inhibitor) | Small increase in sitagliptin exposure (AUC ~29%, Cmax ~68%) | No dose adjustment of sitagliptin recommended; overall clinical significance considered minor. |
Minor or Non-Clinically Relevant Interactions
| Medicine | Effect on Sitagliptin | Effect on the Other Medicine |
|---|---|---|
| Metformin | No meaningful change in exposure | No meaningful change; combination is well studied and widely used |
| Simvastatin, atorvastatin, rosuvastatin | No significant change | No significant change in statin pharmacokinetics |
| Warfarin | No significant change | No meaningful change in warfarin exposure or INR |
| Oral contraceptives (ethinylestradiol + norethindrone) | No significant change | Contraceptive efficacy is preserved |
| Rosiglitazone, glyburide | No significant change | No meaningful change |
Always inform your doctor or pharmacist about all medicines you are currently taking, have taken recently, or might take in the near future. This includes prescription medicines, over-the-counter products, herbal supplements, vitamins, and recreational substances. Because patients using the 25 mg strength typically have multiple coexisting conditions, a periodic medication review at each clinic visit helps identify and resolve potential interactions, duplications, or renally inappropriate therapies.
What Is the Correct Dosage of Sitagliptin Oresund Pharma?
Always take Sitagliptin Oresund Pharma exactly as your doctor has prescribed. If you are unsure about the correct dose, timing, or how to take the medicine in relation to dialysis sessions, check with your doctor, renal nurse, or pharmacist. Because sitagliptin is available in three strengths (25 mg, 50 mg, 100 mg), it is critical that you take only the strength that matches your renal function – do not substitute strengths without medical advice.
Adults with Severe Renal Impairment or ESRD
Standard Dose for 25 mg Strength
The recommended dose is one 25 mg film-coated tablet once daily, taken by mouth. It may be taken with or without food, at any time of day that best fits your routine. Taking it at the same time each day helps establish a habit and improves adherence. In patients on haemodialysis, the tablet may be taken regardless of the timing of the dialysis session, because sitagliptin is removed only modestly by dialysis (approximately 13.5% during a 3–4 hour session).
Dosage Adjustments Based on Kidney Function
| Kidney Function (eGFR) | Recommended Total Daily Dose | Which Strength |
|---|---|---|
| Normal / mild impairment (eGFR ≥ 45 mL/min/1.73 m²) | 100 mg once daily | 100 mg tablet (other brand) |
| Moderate impairment (eGFR 30–<45 mL/min/1.73 m²) | 50 mg once daily | 50 mg tablet (other brand) |
| Severe impairment (eGFR < 30 mL/min/1.73 m²) | 25 mg once daily | Sitagliptin Oresund Pharma 25 mg |
| End-stage renal disease on haemodialysis or peritoneal dialysis | 25 mg once daily | Sitagliptin Oresund Pharma 25 mg – take without regard to timing of dialysis |
Your doctor will estimate your glomerular filtration rate (eGFR) before prescribing Sitagliptin Oresund Pharma and will reassess it at regular intervals – typically every 3–6 months in advanced CKD – to ensure that your dose remains appropriate. Because kidney function can change rapidly after an acute illness, during hospitalisation, or with volume depletion from vomiting or diarrhoea, a temporary dose review may be required in those circumstances.
Adults with Hepatic (Liver) Impairment
No dose adjustment is required in patients with mild to moderate hepatic impairment. There is no clinical experience with sitagliptin in patients with severe hepatic impairment; however, since sitagliptin is primarily eliminated renally rather than hepatically, severe liver disease is not expected to significantly alter its pharmacokinetics. Caution is advised in this small population.
Children and Adolescents
Paediatric Use – Not Recommended
Sitagliptin Oresund Pharma is not recommended for children or adolescents under 18 years of age. Clinical trials in paediatric patients aged 10 to 17 years with type 2 diabetes did not demonstrate adequate efficacy to support routine use. No data are available for children under 10 years.
Elderly
Use in Older Adults
No dose adjustment is required on the basis of age alone. However, renal function typically declines with age – often silently – so the actual eGFR (not age) should guide dose selection. In elderly patients, kidney function should be assessed at least annually and whenever there is a clinical change.
Missed Dose
If you forget to take a dose, take it as soon as you remember on the same day. If you do not remember until it is nearly time for your next dose, skip the missed dose and take your next tablet at the usual time. Do not take a double dose to make up for a forgotten tablet, because doubling the dose on a single day can increase the risk of side effects, especially in patients with advanced CKD. If you frequently forget doses, ask your pharmacist about practical strategies such as medication reminders, pill organisers, or blister packs.
Overdose
If you or someone else has taken more than the prescribed dose of Sitagliptin Oresund Pharma, contact your doctor, call a poison control centre, or go to the nearest emergency department immediately. In controlled clinical studies, single doses of sitagliptin up to 800 mg in healthy volunteers were generally well tolerated, but any accidental overdose should still be assessed promptly. Supportive care and monitoring of blood glucose, electrolytes, ECG, and kidney function are recommended. Sitagliptin is modestly dialysable (approximately 13.5% over a 3–4 hour haemodialysis session), so dialysis is not an efficient primary removal method in overdose.
Stopping Treatment
Do not stop taking Sitagliptin Oresund Pharma without first consulting your doctor, even if you feel well. Sitagliptin helps keep your blood sugar within the target range, and discontinuation without replacement therapy can lead to a rebound in blood glucose. Your doctor may stop or switch the medicine if pancreatitis develops, if you enter pregnancy or planning pregnancy, or if a different drug class becomes more appropriate for your evolving clinical situation. Any decision to stop therapy should be made together with your healthcare team.
What Are the Side Effects of Sitagliptin Oresund Pharma?
Like all medicines, Sitagliptin Oresund Pharma can cause side effects, although not everyone will experience them. The frequency and nature of side effects can vary depending on whether sitagliptin is used alone or combined with other diabetes medicines, and on the patient’s underlying health status. Because the 25 mg strength is typically used in patients with advanced CKD, extra attention is paid to signs of volume imbalance, electrolyte disturbances, and hypoglycemia in this population. The information below summarises the side effect profile documented in clinical trials and post-marketing surveillance of sitagliptin.
- Severe, persistent pain in the upper abdomen that may radiate to the back, with or without nausea and vomiting — possible signs of pancreatitis
- A serious allergic reaction — rash, hives, blisters or peeling skin, swelling of the face, lips, tongue, or throat, or difficulty breathing or swallowing (anaphylaxis or angioedema)
- Widespread painful, tense blisters on the skin — a possible sign of bullous pemphigoid
Side Effect Frequency Overview
Very Common
May affect more than 1 in 10 people
- Low blood sugar (hypoglycemia) – when used together with a sulfonylurea and metformin, or with insulin
Common
May affect up to 1 in 10 people
- Low blood sugar (hypoglycemia) – when used alone or combined with metformin
- Headache
- Upper respiratory tract infection
- Nasopharyngitis (stuffy or runny nose and sore throat)
- Osteoarthritis and joint pain
- Pain in arms or legs
- Nausea
- Flatulence (wind)
- Constipation
- Swollen hands or legs (peripheral oedema) – when combined with pioglitazone
- Influenza-like symptoms – when combined with insulin
Uncommon
May affect up to 1 in 100 people
- Dizziness
- Dry mouth
- Drowsiness (somnolence)
- Itching (pruritus)
- Stomach pain
- Diarrhoea
- Vomiting
Rare
May affect up to 1 in 1,000 people
- Decreased platelet count (thrombocytopenia)
Not Known
Frequency cannot be estimated from available data
- Acute pancreatitis, including haemorrhagic and necrotising forms
- Kidney problems (sometimes requiring dialysis)
- Severe allergic reactions (anaphylaxis, angioedema, Stevens-Johnson syndrome)
- Bullous pemphigoid (blistering skin condition)
- Interstitial lung disease
- Rhabdomyolysis (severe muscle breakdown)
- Joint pain that is severe or disabling (arthralgia)
- Muscle pain (myalgia)
- Back pain
- Liver enzyme elevations
Side Effects in the Context of Advanced CKD
Patients prescribed the 25 mg strength usually have established chronic kidney disease, and many additional symptoms common in CKD – such as fatigue, reduced appetite, itching, muscle cramps, and restless legs – are often wrongly attributed to the medication. Your nephrologist or diabetologist can help distinguish drug-related side effects from those caused by the underlying kidney disease. If a new or worsening symptom emerges after starting sitagliptin, a temporary dose interruption under medical supervision can help clarify the cause.
Cardiovascular Safety
The TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) study – a large randomised trial of 14,671 patients with type 2 diabetes and established cardiovascular disease – demonstrated that sitagliptin did not increase the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalisation for unstable angina) compared with placebo, when added to usual care. There was also no increased risk of hospitalisation for heart failure, a signal that has been reported for some other DPP-4 inhibitors. This provides strong reassurance about cardiovascular safety, including in patients with reduced renal function.
If you experience any side effect – whether listed above or not – tell your doctor, pharmacist, or nurse. You can also report side effects directly to your national pharmacovigilance authority (for example, the Yellow Card Scheme in the UK, the FDA MedWatch programme in the US, or the equivalent authority in your country). By reporting side effects, you help provide more information on the safety of this medicine for everyone.
How Should You Store Sitagliptin Oresund Pharma?
Keep this medicine out of the sight and reach of children. The 25 mg tablets resemble many other common medicines and should be stored safely, particularly if children or vulnerable adults live in the household.
Do not use Sitagliptin Oresund Pharma after the expiry date stated on the blister foil and outer carton after the abbreviation “EXP” or “Exp.”. The expiry date refers to the last day of the stated month. Expired tablets may not retain the intended potency and should not be taken even if they appear physically intact.
Storage conditions for Sitagliptin Oresund Pharma 25 mg film-coated tablets are as follows: store below 30 °C, protected from moisture. Keep the tablets in the original blister or bottle until just before taking them, as this protects against humidity and light. Refrigeration is not required, and the tablets should not be frozen.
If a tablet looks discoloured, crumbly, or otherwise different from what you normally see, do not take it – show it to your pharmacist. Do not dispose of expired or unused medicines in wastewater or household waste. Take them to your community pharmacy or municipal take-back scheme for safe destruction. These measures protect the environment by preventing active drug residues from entering water and soil, and reduce the risk of accidental exposure by children or pets.
What Does Sitagliptin Oresund Pharma Contain?
Active Ingredient
Each film-coated tablet of Sitagliptin Oresund Pharma 25 mg contains sitagliptin fumarate equivalent to 25 mg of sitagliptin free base. The exact mass of sitagliptin fumarate per tablet is slightly higher than 25 mg to account for the salt portion of the molecule; the therapeutically active dose is always expressed in milligrams of the free base.
Inactive Ingredients (Excipients)
The tablet core typically contains the following excipients (your specific pack leaflet is the authoritative source and should always be checked):
- Microcrystalline cellulose (E460) – bulking agent
- Calcium hydrogen phosphate anhydrous (E341) – bulking agent and binder
- Croscarmellose sodium (E468) – tablet disintegrant
- Magnesium stearate (E470b) – lubricant
- Sodium stearyl fumarate – lubricant
The film coating typically contains:
- Hypromellose (E464) – film former
- Titanium dioxide (E171) – white pigment
- Macrogol / polyethylene glycol (E1521) – plasticiser
- Talc (E553b) – anti-tacking agent
- Red and yellow iron oxide (E172) – pigments, giving the tablet its characteristic pink colour
Tablet Appearance
| Strength | Colour | Shape & Approximate Size | Markings |
|---|---|---|---|
| 25 mg | Light pink | Round, biconvex, approx. 6 mm diameter | Plain on both sides (may vary by pack – see carton for details) |
Sitagliptin Oresund Pharma 25 mg film-coated tablets are supplied in aluminium/PVC blister packs or HDPE bottles with a desiccant. Typical pack sizes are 14, 28, 56, 84, 90, and 98 film-coated tablets. Not all pack sizes may be marketed in every country.
Marketing Authorisation Holder
Öresund Pharma AB, Sweden. Manufactured according to European Good Manufacturing Practice (GMP) standards. For complete and country-specific authorisation, packaging, and batch information, consult the patient information leaflet supplied with your medicine or your national medicines authority database (such as the EMA SmPC portal in the European Union).
Frequently Asked Questions
Sitagliptin Oresund Pharma 25 mg is used to treat type 2 diabetes mellitus in adults. It belongs to the DPP-4 inhibitor class and helps control blood sugar by increasing insulin secretion after meals and reducing glucagon release. The 25 mg strength is specifically intended for patients with severe kidney impairment (eGFR below 30 mL/min/1.73 m²) or end-stage renal disease on dialysis, where the dose must be reduced to prevent drug accumulation.
Sitagliptin is primarily cleared by the kidneys, so the correct dose depends on kidney function. Sitagliptin Oresund Pharma 25 mg is specifically formulated for patients with severe kidney impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease on haemodialysis or peritoneal dialysis. Higher strengths (50 mg and 100 mg) used in patients with better renal function are available under other brand names or as different generic products.
The usual dose is one 25 mg film-coated tablet once daily by mouth, with or without food. If you are on haemodialysis or peritoneal dialysis, the tablet can be taken regardless of the timing of dialysis sessions because only a small fraction of sitagliptin is removed by dialysis. Take it at the same time each day to help you remember.
Rare cases of acute pancreatitis, including severe haemorrhagic or necrotising forms, have been reported in patients taking sitagliptin. If you experience severe, persistent pain in the upper abdomen that may radiate to the back, with or without nausea and vomiting, stop the medicine and contact your doctor or emergency services immediately. If pancreatitis is confirmed, sitagliptin should not be restarted.
No. Sitagliptin Oresund Pharma should not be used during pregnancy due to limited safety data, and it is not recommended during breastfeeding as it is not known whether sitagliptin passes into human breast milk. If you are pregnant, planning a pregnancy, or breastfeeding, your doctor will switch you to an alternative treatment – typically insulin, which is the standard of care for diabetes during these periods.
Sitagliptin Oresund Pharma contains the same active ingredient (sitagliptin) as Januvia® (the originator brand by MSD/Merck) and, as a generic, has been authorised on the basis of bioequivalence. Both medicines work in the same way as DPP-4 inhibitors. The choice between the originator and a generic such as Sitagliptin Oresund Pharma is typically driven by cost, availability in your country, and your pharmacy’s stock.
Sitagliptin is generally regarded as weight-neutral. Unlike sulfonylureas, insulin, or thiazolidinediones, DPP-4 inhibitors are not typically associated with significant changes in body weight. In clinical trials, patients taking sitagliptin showed little to no change in weight compared with placebo, which is one of its clinical advantages in type 2 diabetes management.
Take the missed dose as soon as you remember on the same day. If it is nearly time for your next dose, skip the missed dose and take the next tablet at the usual time. Do not take a double dose to compensate, as this can increase the risk of side effects. If you frequently forget doses, consider using a pill organiser, a phone alarm, or a blister pack dispensed by your pharmacist.
References
- European Medicines Agency (EMA). Sitagliptin – Summary of Product Characteristics. Last updated 2025. Available at: www.ema.europa.eu
- American Diabetes Association (ADA). Standards of Care in Diabetes – 2025. Diabetes Care. 2025;48(Supplement 1).
- Davies MJ, Aroda VR, Collins BS, et al. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753–2786.
- Green JB, Bethel MA, Armstrong PW, et al. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes (TECOS). N Engl J Med. 2015;373(3):232–242.
- Arjona Ferreira JC, Corry D, Mogensen CE, et al. Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial. Am J Kidney Dis. 2013;61(4):579–587.
- Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int. 2022;102(5S):S1–S127.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- U.S. Food and Drug Administration (FDA). Sitagliptin Prescribing Information. Revised 2024. Available at: www.fda.gov
- International Diabetes Federation (IDF). IDF Diabetes Atlas, 10th Edition. Brussels: IDF; 2021.
- British National Formulary (BNF). Sitagliptin. National Institute for Health and Care Excellence (NICE). Accessed 2025.
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