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Rx Item-Actoplus Met XR 30/1000mg Tab 30 By Takeda Pharma

NDC No. 64764-0310-30 UPC/GTIN No. 3-64764-31030-1 MPN No. 31030 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Actoplus Met XR 30/1000mg Tab 30 By Takeda Pharma

$783.29$782.99

RX091389 091389 NDC No. 64764-0310-30 UPC/GTIN No. 3-64764-31030-1 MPN No. 31030 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item. Rx Item No. Rx091389 Actoplus Met 30/1000mg Tab 30 By Takeda Pharma Item No. 3091389 NDC No. 64764031030 UPC No. 364764310301 Other Name: Pioglitazone HydroChlor

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Item info. These highlights do not include all the info. needed to use ACTOPLUS MET safely and effectively. See full prescribing info. for ACTOPLUS MET. ACTOPLUS MET (pioglitazone and metformin hydrochloride) tablets for oral use Initial U.S. Approval: 2005 WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS See full prescribing info. for complete boxed warning Congestive Heart Failure Thiazolidinediones, including pioglitazone, which is component of ACTOPLUS MET, cause or exacerbate congestive heart failure in some patients. After initiation of ACTOPLUS MET, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of ACTOPLUS MET must be considered. ACTOPLUS MET is not recommended in patients with symptomatic heart failure. Initiation of ACTOPLUS MET in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. (4, 5.1) Lactic Acidosis Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate:pyruvate ratio; and metformin plasma levels generally greater than mcg/mL. Risk factors include renal impairment, concomitant use of certain drugs, age 65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing info.. If lactic acidosis is suspected, discontinue ACTOPLUS MET and institute general supportive measures in hospital setting. Prompt hemodialysis is recommended. -RECENT MAJOR CHANGES - Boxed Warning 5/2016 Dosage and Administration Recommendations for Use in Renal Impairment 5/2016 Discontinuation for Iodinated Contrast Imaging Procedures 5/2016 Contraindications 5/2016 Warnings and Precautions Lactic Acidosis 5/2016 Hepatic Effects 5/2016 INDICATIONS AND USAGE - ACTOPLUS MET is thiazolidinedione and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type diabetes mellitus when treatment with both pioglitazone and metformin is appropriate. (1, 14) Important Limitations of Use: Not for treatment of type diabet es or diabetic ketoacidosis. DOSAGE AND ADMINISTRATION Individualize the starting dose based on the patient?s current regimen and adjust the dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of pioglitazone 45 mg and metformin 2550 mg. Give in divided daily doses with meals to reduce the gastrointestinal effects due to metformin. Monitor patients for adverse events related to fluid retention after initiation and dose increases. Obtain liver tests before initiation. If abnormal, use caution when treating with ACTOPLUS MET, investigate the probable cause, treat (if possible), and follow appropriately. (2.1, 5.5) Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) Do not use in patients with eGFR below 30 mL/min/1.73 2 Initiation is not recommended in patients with eGFR between 30 45 mL/min/1.73 2 Assess risk/benefit of continuing ACTOPLUS MET if eGFR falls below 45 mL/min/1.73 2 Discontinue if eGFR falls below 30 mL/min/1.73 2 ACTOPLUS MET may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures DOSAGE FORMS AND STRENGTHS Tablets: 15 mg pioglitazone/500 mg metformin HCl and 15 mg pioglitazone/850 mg metformin HCl CONTRAINDICATIONS Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure [see Boxed Warning]. Severe renal impairment: (eGFR below 30mL/min/1.73 2 ). Use in patients with known hy persensitivity to pioglitazone, metformin or any other component of ACTOPLUS MET. Metabolic acidosis, including di abetic ketoacidosis. (4, 5.2) -WARNINGS AND PRECAUTIONS Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class and II may increase risk. Monitor patients for signs and symptoms. Lactic acidosis: See boxed warning. Edema: Dose-related edema may occur. Hypoglycemia: When used with insulin or an insulin secretagogue, lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia. Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt ACTOPLUS MET and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart ACTOPLUS MET if liver injury is confirmed and no alternate etiology can be found. Bladder cancer: Preclinical and clinical trial data, and results from an observational study suggest an incr eased risk of bladder cancer in pioglitazone users. The observatio nal data further suggest that the risk increases with duration of use. Do not use in patients with active bladder cancer. Use caution when using in patients with prior history of bladder cancer. Fractures: Increased incidence in female patients. Apply current standards of care for assessing and maintaining bone health. Macular edema: Postmarketing reports. Recommend regular eye exams in all patients with diabetes according to current standards of care with prompt evaluation for acute visual changes. Vitamin B12 deficiency: Metformin may lower vitamin B12 levels. Monitor hematologic parameters annually. (5.10) Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ACTOPLUS MET or any other antidiabetic drug. (5.11) -ADVERSE REACTIONS Most common adverse reactions (>5%) are upper respiratory tract infection, edema, diarrhea, headache and weight gain. To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-825-3327 and the ACTOPLUS MET website at: www.actoplusmet.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch --DRUG INTERACTIONS Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit ACTOPLUS MET dose to 15 mg/850 mg daily. (2.3, 7.1) CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring. Drugs that are eliminated by renal tubular secretion (e.g. cationic drugs such as cimetidine), ma increase the accumulation of metformin. Consider more frequent monitoring. Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake. Use of insulin secretagogues or insulin use may increase the risk for hypoglycemia and may require dose reduction. Page of 45 -USE IN SPECIFIC POPULATIONS - Nursing mothers: Discontinue drug or nursing, taking into consideration the importance of the drug to the mother. Pediatrics: Not recommended for use in pediatric patients. Geriatric Use: Assess renal function more frequently. Hepatic Impairment: Avoid use in pat ients with hepatic impairment. See 17 for PATIENT COUNSELING info. and Medication Guide Revised: 5/2016

NDC No. 64764-0310-30 UPC/GTIN No. 3-64764-31030-1 MPN No. 31030 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, P
Rx Item-Actoplus Met XR 30/1000mg Tab 30
NDC No. 64764-0310-30 UPC/GTIN No. 3-64764-31030-1 MPN No. 31030 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, P

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Takeda Pharma USA
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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