From: powerallpharmacy@gmail.com 
  
 SUBUTEX:(buprenorphine) Sublingual Tablets 
  
 DESCRIPTION 
 SUBUTEX (buprenorphine) sublingual tablet is an uncoated oval white flat 
 bevelled edged tablet, debossed with an alphanumeric word identifying the 
 product and strength on one side. It contains buprenorphine HCl, a partial 
 agonist at the mu-opioid 
 receptor, and is available in two dosage strengths, 2 mg buprenorphine and 8 
 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine 
 hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP). Each tablet 
 also contains lactose, 
 mannitol, cornstarch, povidone K30, citric acid, sodium citrate and 
 magnesium 
 stearate. 
  
 Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4, 
 €€-epoxy-3-hydroxy-6-methoxy6€€,14-ethano-14€€-morphinan-7€€-yl] 
 3,3-dimethylbutan-2-ol hydrochloride. It has 
 Buprenorphine HCl has the molecular formula C29 H41 NO4 €€€ HCl and the 
 molecular weight is 504.10. It is a white or off-white crystalline powder, 
 sparingly soluble in water, freely soluble in methanol, soluble in alcohol 
 and 
 practically insoluble in 
 cyclohexane. 
  
  
 INDICATIONS 
 SUBUTEX is indicated for the treatment of opioid dependence and is preferred 
 for induction. SUBUTEX should be used as part of a complete treatment plan 
 to 
 include counseling and psychosocial support. 
  
 DOSAGE AND ADMINISTRATION 
 Drug Addiction Treatment Act 
 Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), 
 prescription use of this product in the treatment of opioid dependence is 
 limited to healthcare providers who meet certain qualifying requirements, 
 and 
 who have notified the 
 Secretary of Health and Human Services (HHS) of their intent to prescribe 
 this 
 product for the treatment of opioid dependence and have been assigned a 
 unique 
 identification number that must be included on every prescription. 
  
 HOW SUPPLIED 
 Dosage Forms And Strengths 
 SUBUTEX sublingual tablet is supplied as an uncoated oval white tablet in 
 two 
 dosage strengths: 
  
 buprenorphine 2 mg, 
 Storage And Handling 
 SUBUTEX sublingual tablet is an uncoated oval white flat bevelled edged 
 tablet, debossed with an alphanumeric word identifying the product and 
 strength on one side (€€€B2€€€ and €€€B8€€€ on 2 mg and 8 mg tablets 
 respectively), supplied in desiccated high 
 density polyethylene (HDPE) bottle: 
  
 NDC 12496-1310-2 (buprenorphine 8 mg/sublingual tablet; content expressed in 
 terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP) - 
 30 
 tablets per bottle 
 Store at 25€€C (77€€F), excursions permitted to 15€€-30€€C (59€€-86€€F). 
  
 Advise patients to store buprenorphine-containing medications safely and out 
 of sight and reach of children and to destroy any unused medication 
 appropriately 
  
 Maintenance: 
 SUBOXONE is preferred for maintenance treatment. 
 Where SUBUTEX is used in maintenance in patients who cannot tolerate the 
 presence of naloxone, the dosage of SUBUTEX should be progressively adjusted 
 in increments / decrements of 2 mg or 4 mg buprenorphine to a level that 
 holds 
 the patient in treatment 
 and suppresses opioid withdrawal signs and symptoms. 
 After treatment induction and stabilization, the maintenance dose of SUBUTEX 
 is generally in the range of 4 mg to 24 mg buprenorphine per day depending 
 on 
 the individual patient. The recommended target dosage of SUBUTEX is 16 mg 
 as a 
 single daily dose. 
 Dosages higher than 24 mg have not been demonstrated to provide any clinical 
 advantage. 
 When determining the prescription quantity for unsupervised administration, 
 consider the patient€€€s level of stability, the security of his or her home 
 situation, and other factors likely to affect the ability to manage supplies 
 of take-home medication. 
 There is no maximum recommended duration of maintenance treatment. Patients 
 may require treatment indefinitely and should continue for as long as 
 patients 
 are benefiting and the use of SUBUTEX contributes to the intended treatment 
 goals. 
 Method Of Administration 
 SUBUTEX must be administered whole. Do not cut, chew, or swallow SUBUTEX. 
 Advise patients not to eat or drink anything until the tablet is completely 
 dissolved. SUBUTEX should be placed under the tongue until it is dissolved. 
  
 For doses requiring the use of more than two tablets, patients are advised 
 to 
 either place all the tablets at once or alternatively (if they cannot fit in 
 more than two tablets comfortably), place two tablets at a time under the 
 tongue. Either way, the 
 patients should continue to hold the tablets under the tongue until they 
 dissolve; swallowing the tablets reduces the bioavailability of the drug. To 
 ensure consistency in bioavailability, patients should follow the same 
 manner 
 of dosing with continued 
 use of the product. 
  
 Proper administration technique should be demonstrated to the patient. 
  
 For More Details: 
 https://www.powerallpharmacy.ca/index.php?main_page=product_info 
 cPath=1_9&products_id=106 
 Whatsapp: +1 (336) 267-4575 
  
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  * Origin: you cannot sedate... all the things you hate (1:229/2)