In a randomized, double-blind, placebo-controlled monotherapy trial of 14 weeks duration, patients already on sulfonylurea therapy underwent a 3-week washout period then were randomized to Glimepir >Clinical Studies ( 14.1)]. The overall incidence of possible hypoglycemia (defined by the presence of at least one symptom that the investigator believed might be related to hypoglycemia; a concurrent glucose measurement was not required) was 4% for Asoride tablets 1 mg, 17% for Asoride tablets 4 mg, 16% for Asoride tablets 8 mg and 0% for placebo. All of these events were self-treated.
In a randomized, double-blind, placebo-controlled monotherapy trial of 22 weeks duration, patients received a starting dose of either 1 mg Glimepir >Clinical Studies ( 14.1) ]. The overall incidence of possible hypoglycemia (as defined above for the 14-week trial) for Asoride vs. placebo was 19.7% vs. 3.2%. All of these events were self-treated.
Glimepir >Clinical Studies ( 14.1) ].
In clinical trials, allergic reactions, such as pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occurred in less than 1% of Glimepir >Warnings and Precautions ( 5.2) ].
Elevated Serum Alanine Aminotransferase (ALT)
In 11 pooled placebo-controlled trials of Asoride, 1.9% of Asoride-treated patients and 0.8% of placebo-treated patients developed serum ALT greater than 2 times the upper limit of the reference range.
Tell your doctor and pharmacist if you are allergic to Asoride or any other drugs.
Inform your doctor and pharmacist what prescription and non-prescription medications you are taking, especially antibiotics, anticoagulants (‘blood thinners’) such as warfarin (Coumadin®), dexamethasone (Decadron®), diuretics (‘water pills’), estrogens, isoniazid (INH), MAO inhibitors , medications for high blood pressure or heart disease, niacin, oral contraceptives, phenytoin (Dilantin®), prednisone, probenecid (Benemid®), and vitamins.
Moreover, you should tell your doctor if you have or have ever had kidney disease or ketoacidosis.
If you are pregnant, plan to become pregnant, or are breast-feeding while taking Asoride, call your doctor immediately.
Also, if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Asoride.
What should I do if I forget a dose?
Take the missed dose of Asoride as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
It is strongly advised not to take a double dose to make up for a missed one.
What side effects can this medication cause?
More common side effects
The more common side effects that can occur with Asoride include:
- low blood sugar (hypoglycemia). Symptoms may include:
- trembling or shaking
- nervousness or anxiety
- lightheadedness or dizziness
- fast heart rate or palpitations
- intense hunger
- fatigue or tiredness
- unexplained weight gain
If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.
What is the dosage for Asoride?
Like other medicines used to treat diabetes, the dose of Asoride is individualized using periodic measurements of blood sugar to determine the best dose. The usual starting dose is 1 or 2 mg given orally once daily with breakfast or the first major meal of the day. The dose may be increased by 1-2 mg in 1-2 weeks interval up to 8mg maximum based on blood sugar response and given once daily.
What Are Side Effects Associated with Using Asoride?
Common side effects of Asoride include:
- low blood sugar (hypoglycemia)
- allergic skin reactions
- reddening of the skin
- severe itching
- decreased immunity
- low red blood cells
- reduced blood cells (aplastic anemia)
- reduced white blood cells (leukopenia)
- deficiency in the blood of red cells, white cells and platelets (pancytopenia)
- low blood platelet count (thrombocytopenia)
- reduction of bile flow (cholestasis)
- elevation of liverenzyme levels
- kidney enzyme deficiency reactions
- disulfiram-like reactions (flushing, fast heartbeat, nausea, thirst, chest pain, spinning sensation , and low blood pressure)
- low sodium levels
- weight gain
Rare side effects of Asoride include:
Post marketing side effects of Asoride reported include:
- serious hypersensitivity reactions, including severe allergic reaction, rapid swelling (angioedema), and Stevens-Johnson Syndrome
- destruction of red blood cells (hemolytic anemia) in patients with and without G6PD deficiency
- liver impairment (reduction of bile flow, jaundice), as well as hepatitis, which may progress to liver failure
- blistering skin lesions (porphyria cutanea tarda), sensitivity to light reactions and allergic inflammation of the blood vessels
- reduced white blood cells (leukopenia), reduced immunity (agranulocytosis), reduced blood cells (aplastic anemia), and pancytopenia
- thrombocytopenia (including severe cases with platelet count under 10,000/mcl) and thrombocytopenic purpura
- kidney enzyme deficiency (hepatic porphyria) reactions and disulfiram-like reactions (flushing, fast heartbeat, nausea, thirst, chest pain, vertigo and low blood pressure)
- low sodium levels (hyponatremia) and water retention (Syndrome of Inappropriate Antidiuretic Hormone), most often in patients on other medications or have medical conditions known to cause low sodium or increase release of antidiuretic hormone
- distortion of taste (dysgeusia)
- hair loss (alopecia)
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Besides the drug, you’ll need to purchase the following:
There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.
Fatal heart problems warning: Asoride may increase your risk of fatal heart problems compared to treatment with diet alone or diet plus insulin. Ask your doctor if this drug is right for you.
This drug comes with several warnings.
2.1 Recommended Dosing
Asoride tablets should be administered with breakfast or the first main meal of the day.
The recommended starting dose of Glimepir >Warnings and Precautions ( 5.1) and Use in Specific Populations ( 8.5, 8.6) ].
After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient’s glycemic response. Uptitration should not occur more frequently than every 1 to 2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia .
The maximum recommended dose is 8 mg once daily.
Patients being transferred to Asoride tablets from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1 to 2 weeks and should be appropriately monitored for hypoglycemia.
When colesevelam is coadministered with Asoride, maximum plasma concentration and total exposure to Asoride is reduced. Therefore, Asoride tablets should be administered at least 4 hours prior to colesevelam.
AMARYL should be administered with breakfast or the first main meal of the day.
The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily .
After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia .
The maximum recommended dose is 8 mg once daily.
Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.
When colesevelam is coadministered with Asoride, maximum plasma concentration and total exposure to Asoride is reduced. Therefore, AMARYL should be administered at least 4 hours prior to colesevelam.
Serious side effects
Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
- severe low blood sugar (less than 35 to 40 mg/dL). Symptoms may include:
- mood changes, such as irritability, impatience, anger, stubbornness, or sadness
- confusion, including delirium
- lightheadedness or dizziness
- blurred or impaired vision
- tingling or numbness in your lips or tongue
- weakness or fatigue
- lack of coordination
- nightmares or crying out in your sleep
- anaphylaxis. This is a severe and possibly a life-threatening allergic reaction. Symptoms may include trouble breathing, swelling of your throat or tongue, hives, or difficulty swallowing.
- angioedema. This involves swelling of your skin, the layers under your skin, and your mucous membranes (ins >
Asoride oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.
To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.
Examples of drugs that can cause interactions with Asoride are listed below.
It is not known whether AMARYL is excreted in human milk. During pre- and post-natal studies in rats, significant concentrations of Asoride were present in breast milk and the serum of the pups. Offspring of rats exposed to high levels of Asoride during pregnancy and lactation developed skeletal deformities consisting of shortening, thickening, and bending of the humerus during the postnatal period. These skeletal deformations were determined to be the result of nursing from mothers exposed to Asoride. Based on these animal data and the potential for hypoglycemia in a nursing infant, a decision should be made whether to discontinue nursing or discontinue AMARYL, taking into account the importance of AMARYL to the mother.