Subutex pill 2 mg/8 mg | Good Quality

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Subutex pill  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.

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Description

SUBUTEX PILL 2 MG/8 MG TABLET

Subutex pill 2 mg 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-4,5?-epoxy-3-hydroxy-6-methoxy6?,14-ethano-14?-morphinan-7?-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure

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.

Subutex pill 2 mg tablet

(buprenorphine) Sublingual Tablets

DESCRIPTION

Subutex pill (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-4,5?-epoxy-3-hydroxy-6-methoxy6?,14-ethano-14?-morphinan-7?-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure:

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 pill 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.

IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS

Subutex pill is administered sublingually as a single daily dose.

Subutex pill does not contain naloxone and is preferred for use only during induction. Following induction, SUBOXONE sublingual film or SUBOXONE sublingual tablet is preferred due to the presence of naloxone when clinical use includes unsupervised administration. The use of Subutex pill for unsupervised administration should be limited to those patients who cannot tolerate SUBOXONE sublingual film or SUBOXONE sublingual tablet; for example, those patients who have been shown to be hypersensitive to naloxone.

Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits.

INDUCTION

Prior to induction, consideration should be given to the type of opioid dependence (i.e., long-or short- acting opioid products), the time since last opioid use, and the degree or level of opioid dependence.

PATIENTS DEPENDENT ON HEROIN OR OTHER SHORT-ACTING OPIOID PRODUCTS

At treatment initiation, the first dose of Subutex pill should be administered only when objective and clear signs of moderate opioid withdrawal appear, and not less than 4 hours after the patient last used an opioid.

It is recommended that an adequate treatment dose, titrated to clinical effectiveness, should be achieved as rapidly as possible. The dosing on the initial day of treatment may be given in 2 mg to 4 mg increments if preferred. In some studies, gradual induction over several days led to a high rate of dropout of buprenorphine patients during the induction period.

In a one-month study, patients received 8 mg of Subutex pill on Day 1 and 16 mg Subutex pill on Day 2. From Day 3 onward, patients received either SUBOXONE sublingual tablet or Subutex pill at the same buprenorphine dose as Day 2 based on their assigned treatment. Induction in the studies of buprenorphine solution was accomplished over 3-4 days, depending on the target dose.

PATIENTS DEPENDENT ON METHADONE OR OTHER LONG-ACTING OPIOID PRODUCTS

Patients dependent upon methadone or other long-acting opioid products may be more susceptible to precipitated and prolonged withdrawal during induction than those on short-acting opioid products; therefore, the first dose of Subutex 2 mg tablet should only be administered when objective and clear signs of moderate opioid withdrawal appear, and generally not less than 24 hours after the patient last used a long-acting opioid product.

There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal signs and symptoms are possible during induction onto buprenorphine. Withdrawal appears more likely in patients maintained on higher doses of methadone (>30 mg) and when the first buprenorphine dose is administered shortly after the last methadone dose.

SUBUTEX 2 MG TABLET MAINTENANCE

  • SUBOXONE is preferred for maintenance treatment.
  • Where Subutex pill is used in maintenance in patients who cannot tolerate the presence of naloxone, the dosage of Subutex pill 2 mg tablet 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 pill 2 mg tablet 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 pill pill 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 pill contributes to the intended treatment goals.

METHOD OF ADMINISTRATION

Subutex pill must be administered whole. Do not cut, chew, or swallow Subutex pill. 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.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness.

Notes

Do not share this medication with others. Sharing it is against the law.

Tell all of your doctors that you use this medication and have regularly used opioids, especially in cases of emergency treatment.

Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

Laboratory and/or medical tests (such as liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. For more details, read the Medication Guide, or consult your pharmacist or local waste disposal company.

Additional information

Qty

120 Tablets, 150 Tablets, 180 Tablets

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