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Oseni 25mg/30mg Tablet
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Indications & Clinical Uses
- Oseni 25 mg/30 mg tablets combine alogliptin, a DPP-4 inhibitor, with pioglitazone, a thiazolidinedione, to improve blood sugar control in adults with type 2 diabetes mellitus, used together with diet and exercise.
- It is given as add-on therapy when a single agent is not enough, or to replace separate alogliptin and pioglitazone tablets already being taken at matching doses.
- Oseni is not approved for type 1 diabetes or diabetic ketoacidosis.
- Several Oseni strengths exist pairing 12.5 mg or 25 mg alogliptin with 15 mg, 30 mg or 45 mg pioglitazone, so patients should confirm they have been dispensed the strength their prescriber intended, since the two components cannot be adjusted independently once combined in one tablet.
Side Effects
- The most frequently reported effects (in 4% or more of patients) are nasopharyngitis (common cold-type symptoms), back pain and upper respiratory tract infections; low blood sugar can occur, especially when Oseni is combined with insulin or a sulfonylurea.
- Oseni carries a boxed warning: pioglitazone, one of its two components, can cause or worsen congestive heart failure in some patients, and it must not be used in people with established moderate-to-severe heart failure (NYHA Class III or IV); patients should be monitored for rapid weight gain, shortness of breath or swelling after starting or increasing the dose.
- Rare but serious reactions include acute pancreatitis, severe joint pain, blistering skin reactions (bullous pemphigoid), liver problems and severe allergic reactions.
- Seek urgent care for severe abdominal pain, breathing difficulty, swelling of the face or throat, or persistent skin blistering.
Precautions & Warnings
- Because of the heart failure warning, Oseni should not be started in patients with symptomatic heart failure, and it should be used cautiously, with close monitoring for fluid retention, in anyone with risk factors for heart failure.
- Liver function tests are recommended before starting and if symptoms of liver injury develop, since rare cases of liver failure have been reported.
- Pioglitazone increases the risk of bone fractures in women and has been linked to a possible small increase in bladder cancer risk with longer-term, higher-dose use, so a personal or family history of bladder cancer should be discussed with the prescriber.
- Regular eye examinations are advised because of reports of new or worsening macular oedema.
- Oseni is not recommended in severe renal impairment or in patients on dialysis, and dose adjustment is needed in moderate renal impairment.
Avoid Interactions
- Strong inhibitors of the liver enzyme CYP2C8, such as gemfibrozil, substantially raise pioglitazone levels, so the Oseni dose is limited to a maximum of 25 mg/15 mg when used together; CYP2C8 inducers, such as rifampin, can lower pioglitazone exposure and reduce blood sugar control.
- Combining Oseni with insulin or insulin-releasing medicines (sulfonylureas) increases the risk of low blood sugar (hypoglycaemia), and a lower dose of the other medicine may be needed.
- Topiramate can reduce pioglitazone exposure.
- There is no specific food restriction, but alcohol can affect blood sugar control and should be discussed with a healthcare provider.
- Patients should tell their healthcare provider and pharmacist about all other medicines, herbal products and supplements, especially other diabetes treatments, before starting Oseni.
References
Frequently Asked Questions
Oseni combines alogliptin and pioglitazone to lower blood sugar in adults with type 2 diabetes, alongside diet and exercise. It is used as add-on therapy or to replace matching separate doses of the two individual medicines.
Oseni tablets are taken by mouth once daily, with or without food, at the same time each day. Your prescriber sets the exact alogliptin/pioglitazone strength for you, since several combinations exist.
Common effects include colds, back pain and upper respiratory infections. Oseni carries a boxed warning: its pioglitazone component can cause or worsen heart failure, so report rapid weight gain, swelling or breathlessness right away.
Avoid starting Oseni if you have moderate-to-severe heart failure, because of the boxed warning. Combining it with insulin or sulfonylureas raises low blood sugar risk, and gemfibrozil raises pioglitazone levels, so doses may need adjusting.
Pioglitazone, part of Oseni, has been linked to a possible small increase in bladder cancer with long-term use and to a higher fracture risk in women. Tell your doctor about any personal or family bladder cancer history before starting.
Oseni needs dose adjustment in moderate kidney impairment and is not recommended in severe kidney impairment or dialysis. Liver tests are checked before starting and if symptoms of liver injury, such as unusual tiredness or jaundice, appear.
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