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SUBLOCADE

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Overview

What is SUBLOCADE?

SUBLOCADE (buprenorphine extended-release) injection is a clear, viscous, colorless to yellow to amber, sterile solution . It is designed to deliver buprenorphine at a controlled rate over a one month period.

The active ingredient in SUBLOCADE is buprenorphine free base, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist.

Buprenorphine is dissolved in the ATRIGEL® delivery system at 18% by weight.

The ATRIGEL® delivery system is a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, -methyl-2-pyrrolidone (NMP).

SUBLOCADE is provided in dosage strengths of 100 mg and 300 mg. presents the delivered amounts of the raw materials and the approximate delivered volume for the two dosage strengths.

The molecular weight of buprenorphine free base is 467.6, and its molecular formula is CHNO. Chemically, buprenorphine is (2S)-2-[17-(Cyclopropylmethyl)-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-γl]-3,3-dimethylbutan-2-ol. The structural formula is:



What does SUBLOCADE look like?



What are the available doses of SUBLOCADE?

Injection: 100 mg/0.5 mL and 300 mg/1.5 mL provided in a prefilled syringe with a 19 Gauge 5/8-inch needle. ()

What should I talk to my health care provider before I take SUBLOCADE?

Lactation

Geriatric Patients

Moderate to Severe Hepatic Impairment

How should I use SUBLOCADE?

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.

SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.

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.


What interacts with SUBLOCADE?

Sorry No Records found


What are the warnings of SUBLOCADE?

Sorry No Records found


What are the precautions of SUBLOCADE?

Sorry No Records found


What are the side effects of SUBLOCADE?

Sorry No records found


What should I look out for while using SUBLOCADE?

SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system .


What might happen if I take too much SUBLOCADE?


How should I store and handle SUBLOCADE?

Storage and HandlingSIMPONI must be refrigerated at 2 °C to 8 °C (36 °F to 46 °F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Do not use SIMPONI beyond the expiration date (EXP) on the carton or the expiration date on the prefilled syringe (observed through the viewing window) or the prefilled SmartJect autoinjector.Storage and HandlingSIMPONI must be refrigerated at 2 °C to 8 °C (36 °F to 46 °F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Do not use SIMPONI beyond the expiration date (EXP) on the carton or the expiration date on the prefilled syringe (observed through the viewing window) or the prefilled SmartJect autoinjector.SUBLOCADE is available as a sterile, clear, viscous, colorless to yellow to amber solution in a single dose, prefilled syringe with safety needle. SUBLOCADE, 100 mg/0.5 mL – NDC 12496-0100-1 SUBLOCADE, 300 mg/1.5 mL – NDC 12496-0300-1 SUBLOCADE is available as a sterile, clear, viscous, colorless to yellow to amber solution in a single dose, prefilled syringe with safety needle. SUBLOCADE, 100 mg/0.5 mL – NDC 12496-0100-1 SUBLOCADE, 300 mg/1.5 mL – NDC 12496-0300-1 SUBLOCADE is available as a sterile, clear, viscous, colorless to yellow to amber solution in a single dose, prefilled syringe with safety needle. SUBLOCADE, 100 mg/0.5 mL – NDC 12496-0100-1 SUBLOCADE, 300 mg/1.5 mL – NDC 12496-0300-1


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

SUBLOCADE Injection contains buprenorphine. Buprenorphine is a partial agonist at the mu- opioid receptor and an antagonist at the kappa-opioid receptor.

Non-Clinical Toxicology
SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system .

Although the pressor activity of desmopressin acetate is very low compared to its antidiuretic activity, large doses of desmopressin acetate tablets should be used with other pressor agents only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigene and carbamazepine) should be performed with caution.

Intravenous injection presents significant risk of serious harm or death as SUBLOCADE forms a solid mass upon contact with body fluids. Occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, could result if administered intravenously . Do not administer intravenously or intramuscularly.

The following adverse reactions are discussed in more detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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