Generic Ezetimibe Tablets (Ezedoc 10 mg Tablets) – Product Information
Ezedoc (Generic Ezetimibe tablets) is used along with a low cholesterol/low fat diet and exercise to help lower cholesterol in the blood. Ezetimibe may be used alone or with other medicines (such as "statins" or fibrates). Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Reducing cholesterol may help prevent strokes and heart attacks. Ezetimibe is used in patients who cannot control their cholesterol levels by diet and exercise alone.
We also stock Crestor (Rosuvastatin Calcium tablets) which ia is a medication taken to slow the production of cholesterol in the body and prevent cardiovascular disease.
Name of Drug
Ezedoc Tablets
Manufacturer of Ezedoc Tablets (Generic Ezetimibe Tablets)
Lupin Limited
Website:www.lupin.com
Active Pharmaceutical Ingredient
The active ingredient present in Ezedoc tablets is Ezetimibe. Each Ezedoc tablet contains 10 mg of Ezetimibe.
Mechanism of Action
Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. In a 2-week clinical study in 18 hypercholesterolemic patients, Ezetimibe (Ezedoc 10 mg tablets) reduced intestinal cholesterol absorption by 54%, compared with placebo. Ezetimibe (Ezedoc 10 mg tablets) had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E (in a study of 113 patients), and did not impair adrenocortical steroid hormone production (in a study of 118 patients).
The cholesterol content of the liver is derived predominantly from three sources. The liver can synthesize cholesterol, take up cholesterol from the blood from circulating lipoproteins, or take up cholesterol absorbed by the small intestine. Intestinal cholesterol is derived primarily from cholesterol secreted in the bile and from dietary cholesterol.
Uses of Ezedoc Tablets (Generic Ezetimibe Tablets)
Ezetimibe is a medicine used to lower cholesterol and triglyceride (fat-like substances) in people who have high blood cholesterol. Ezetimibe works by reducing the amount of cholesterol your body absorbs from your intestines. High cholesterol can cause fatty deposits to form in your blood vessels which increases your risk of heart disease. Using this medicine may help prevent medical problems caused by such substances clogging the blood vessels.
Ezedoc Tablets – Dosage
General Dosing Information:
The recommended dose of Ezedoc tablets (Generic Ezetimibe tablets) is 10 mg once daily.Ezetimibe tablets can be administered with or without food.
Concomitant Lipid-Lowering Therapy:
Ezetimibe tablets may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of Ezetimibe tablets may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.
Coadministration with Bile Acid Sequestrants:
Dosing of Ezetimibe tablets should occur either greater than or equal to 2 hours before or greater than or equal to 4 hours after administration of a bile acid sequestrant.
Patients with Hepatic Impairment:
No dosage adjustment is necessary in patients with mild hepatic impairment.
Patients with Renal Impairment:
No dosage adjustment is necessary in patients with renal impairment. When given with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate less than 60 mL/min/1.73 m2), doses of Simvastatin exceeding 20 mg should be used with caution and close monitoring.
Geriatric Patients:
No dosage adjustment is necessary in geriatric patients
Missed Dosage Instructions for Ezedoc Tablets
The recommended dosing regimen is one Ezedoc tablet, once daily. If a dose is missed, the patient should be counseled to resume the usual schedule of one tablet daily.
Contraindications
Ezedoc tablets are contraindicated in persons with a hypersensitivity (allergy) to Ezetimibe or any of the other ingredients of this medicine.
The combination of Ezedoc (Ezetimibe tablets) with an HMG-CoA reductase inhibitor is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases. All HMG-CoA reductase inhibitors are contraindicated in pregnant and nursing women. When Ezetimibe tablets are administered with an HMG-CoA reductase inhibitor in a woman of childbearing potential, refer to the pregnancy category and product labeling for the HMG-CoA reductase inhibitor.
Storage Instructions for Tablets
Store tablets in a cool dry place at 25°C (77°F).Excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.
Do not store it or any other medicine in the bathroom or near a sink. Keep away from children or pets.
Warnings and Precautions to be taken when using Ezedoc Tablets (Generic Ezetimibe Tablets)
Concurrent administration of Ezetimibe (Ezedoc tablets) with a specific statin or Fenofibrate should be in accordance with the product labeling for that medication.
Consider discontinuing Ezetimibe and/or statin if AST or ALT elevations persist above 3x upper normal limit.
Ezetimibe with or without a statin may result in myopathy and rhabdomyolysis. If this is suspected or confirmed, ezetimibe and any statin or fibrate should be discontinued immediately.
Ezetimibe is not recommended in patients with moderate to severe hepatic impairment.
Before using Ezedoc tablets please inform your doctor about all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies.
Side Effects of Ezedoc Tablets (Generic Ezetimibe Tablets)
The most commonly reported Ezetimibe (Ezedoc tablets) side effects with an incidence greater than or equal to 2% and greater than placebo in the ezetimibe monotherapy controlled clinical trial were: upper respiratory tract infection (4.3%), diarrhea (4.1%), arthralgia (3.0%), sinusitis (2.8%), and pain in extremity (2.7%).
The serious side effects include Liver enzyme abnormalities and Rhabdomyolysis and myopathy.
The following additional adverse reactions have been identified during post-approval use of Ezetimibe (Ezedoc tablets): Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria; erythema multiforme; arthralgia; myalgia; elevated creatine phosphokinase; myopathy/rhabdomyolysis; elevations in liver transaminases; hepatitis; abdominal pain; thrombocytopenia; pancreatitis; nausea; dizziness; paresthesia; depression; headache; cholelithiasis; cholecystitis.
Ezedoc Tablets (Generic Ezetimibe Tablets) – Drug Interactions
The drug Interactions of Ezedoc tablets (Generic Ezetimibe tablets) are given below:
Caution should be exercised when using Ezetimibe and Cyclosporine concomitantly due to increased exposure to both ezetimibe and cyclosporine. Cyclosporine concentrations should be monitored in patients receiving ezetimibe and cyclosporine.
The efficacy and safety of coadministration of Ezetimibe with fibrates other than Fenofibrate have not been studied. Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis.
If cholelithiasis is suspected in a patient receiving Ezetimibe and Fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.
Concomitant cholestyramine administration decreased the mean area under the curve (AUC) of total ezetimibe approximately 55%. The incremental LDL-C reduction due to adding Ezetimibe to cholestyramine may be reduced by this interaction.
If Ezetimibe is added to warfarin, a coumarin anticoagulant, the International Normalized Ratio (INR) should be appropriately monitored.
Ezedoc Tablets (Generic Ezetimibe Tablets) Overdosage
During clinical studies, administration of Ezetimibe tablets (Ezedoc tablets), 50 mg/day to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hypercholesterolemia for up to 56 days, was generally well tolerated.
A few cases of overdosage with Ezetimibe tablets have been reported; most have not been associated with adverse experiences. Reported adverse experiences have not been serious. In the event of an overdose, symptomatic and supportive measures should be employed.
Ezetimibe tablets (Ezedoc tablets) During Pregnancy
Ezetimibe (Ezedoc tablets) is classified by the US FDA as Pregnancy Category C.
There are no adequate and well-controlled studies of Ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
In oral (gavage) embryo-fetal development studies of Ezetimibe conducted in rats and rabbits during organogenesis, there was no evidence of embryolethal effects at the doses tested (250, 500, 1000 mg/kg/day).
All statins are contraindicated in pregnant and nursing women. When Ezetimibe (Ezedoc tablets) is administered with a statin in a woman of childbearing potential, refer to the pregnancy category and product labeling for the statin. It is not known whether is excreted in human milk.
Buy Ezedoc Tablets (Generic Ezetimibe Tablets) Online at Only $0.85 a Pill
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