№ lp_1_2_68589
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Regulatory and clinical drug monograph presenting approval history, formulation characteristics, dosing guidance, abuse-related considerations, and trial-based efficacy and safety data for extended-release hydrocodone.
Generic name: Hydrocodone extended-release
Trade name: Zohydro ER®
Dosage form: Extended-release capsules
Manufacturer: Pernix Ireland Pain Limited
NDCs: 43376-310-60; 43376-315-60; 43376-320-60; 43376-330-60; 43376-340-60; 43376-350-60
Regulatory authority: U.S. Food and Drug Administration
FDA approval: 2013; reformulated version approved January 2015
Indication: Severe pain requiring around-the-clock, long-term opioid treatment when alternatives are inadequate
Administration: Twice daily
Initial dosing: 10 mg every 12 hours in opioid-naïve patients
Dose titration: Increments of 10 mg every 12 hours every 3–7 days
Maximum dose: Not established
Abuse-deterrent status: Not originally abuse-deterrent; reformulated with BeadTek™ technology
Risk management: Subject to class-wide REMS requirements for extended-release/long-acting opioids
Clinical evidence: 12-week randomized, double-blind, placebo-controlled trials in chronic low back pain
Jurisdictional consideration: Evaluated for inclusion on the Massachusetts formulary under Chapter 258 of the Acts of 2014
Regulatory actions: Massachusetts dispensing ban via executive order prior to reformulation
Price: 8 / 10 USD
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Drug Information Common to the Class of Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)
Year: 2021
Region / City: United States
Subject: Medicine, Pharmacology
Document Type: Drug Information
Agency / Institution: Food and Drug Administration (FDA)
Author: FDA
Target Audience: Healthcare professionals, physicians, pharmacists
Period of Effectiveness: Not specified
Approval Date: Not specified
Date of Revisions: Not specified
Summary of Product Characteristics for Miraba-S Tablets (Mirabegron Extended-Release 25 mg and Solifenacin Succinate 5 mg)
Name of the medicinal product: Miraba-S Tablets
Active substances: Mirabegron (Extended-Release) 25 mg; Solifenacin succinate 5 mg
Pharmaceutical form: Film coated tablet
Description: Yellow coloured, round, biconvex, film coated tablet
Therapeutic indications: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Posology: One tablet daily; may increase to two tablets daily after 4 to 8 weeks based on efficacy and tolerability
Dose adjustments: Maximum once daily in severe renal impairment (CLcr 15–29 mL/min or eGFR 15–29 mL/min/1.73 m2) or moderate hepatic impairment (Child-Pugh Class B); not recommended in ESRD or severe hepatic impairment
Method of administration: Swallowed whole with water, with or without food; not chewed, divided, or crushed
Contraindications: Hypersensitivity to mirabegron, solifenacin succinate, or any excipients
Special warnings and precautions: Risk of increased blood pressure, urinary retention, angioedema, and interactions with CYP2D6 substrates
Drug interactions: CYP2D6 substrates (e.g., metoprolol, desipramine, thioridazine, flecainide, propafenone); digoxin; warfarin
Fertility: No human data available; no treatment-related effects observed in animals
Pregnancy: No adequate studies in pregnant women
Lactation: No information on presence in human milk or effects on breastfed child
Effects on ability to drive and use machines: Mirabegron has negligible influence; solifenacin may cause blurred vision, somnolence, and fatigue
Undesirable effects: Dry mouth, urinary tract infection, constipation, tachycardia, hypertension, urinary retention, angioedema
Reporting of suspected adverse reactions: Healthcare professionals advised to report adverse reactions
Topics: Hydrocodone Zohydro Extended-Release