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Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate (Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate)

Trade Name : buprenorphine hydrochloride and naloxone hydrochloride dihydrate

West-Ward Pharmaceuticals Corp

TABLET

Strength 2.5 mg/1mg/1

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate (Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate) which is also known as buprenorphine hydrochloride and naloxone hydrochloride dihydrate and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 2; .5 mg/1; mg/1 per ml. Read more

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate (Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • u00a0
  • 5.2
  • Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.
  • Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and are indicated for the maintenance treatment of opioid dependence. ()
  • Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ()
  • No data
  • 2.3n- 2.4
  • Buprenorphine and Naloxone Sublingual Tablets, USP are supplied as speckled-peach to peach, flat faced beveled edge tablets in two dosage strengths:
  • Sublingual Tablet:
  • Buprenorphine and Naloxone Sublingual Tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reportedn
  • Hypersensitivity to buprenorphine or naloxone. ()
  • No data
  • Addiction, Abuse, and Misuse
  • Respiratory Depression
  • Unintentional Pediatric Exposure
  • Neonatal Opioid Withdrawal Syndrome
  • Adrenal Insufficiency
  • Risk of Opioid Withdrawal with Abrupt Discontinuation
  • Risk of Hepatitis; Hepatic Events
  • Precipitation of Opioid Withdrawal Signs and Symptoms
  • Risk of Overdose in Opioid-Nau00efve Patients
  • The following serious adverse reactions are described elsewhere in the labeling:
  • Adverse events commonly observed with administration of buprenorphine/naloxone are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. ()
  • Table 3 includes clinically significant drug interactions with Buprenorphine and Naloxone Sublingual Tablets.
  • Table 3. Clinically Significant Drug Interactions
  • Benzodiazepines:
  • CYP3A4 Inhibitors and Inducers:
  • Antiretrovirals:
  • Serotonergic Drugs:
  • No data
  • Lactation:
  • Geriatric Patients:
  • Moderate and Severe Hepatic Impairment:
  • No data
  • Clinical Presentation
  • The manifestations of acute overdose include pinpoint pupils, sedation, hypotension, respiratory depression, and death.
  • Treatment of Overdose
  • In the event of overdose, the respiratory and cardiac status of the patient should be monitored carefully. When respiratory or cardiac functions are depressed, primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Oxygen, IV fluids, vasopressors, and other supportive measures should be employed as indicated.
  • In the case of overdose, the primary management should be the re-establishment of adequate ventilation with mechanical assistance of respiration, if required. Naloxone may be of value for the management of buprenorphine overdose. Higher than normal doses and repeated administration may be necessary. The long duration of action of Buprenorphine and Naloxone Sublingual Tablets should be taken into consideration when determining the length of treatment and medical surveillance needed to reverse the effects of an overdose. Insufficient duration of monitoring may put patients at risk.
  • Buprenorphine and Naloxone Sublingual Tablets, USP are available in two dosage strengths intended for sublingual administration as follows: 2 mg buprenorphine with 0.5 mg naloxone free bases and 8 mg buprenorphine with 2 mg naloxone free bases. Each tablet also contains citric acid anhydrous, corn starch, FD & C yellow no. 6, lactose monohydrate, lemon-lime flavor, magnesium stearate, mannitol, povidone, purified water, sodium citrate dehydrate and sucralose.
  • Chemically, buprenorphine HCl is (6R, 7R, 14S)-17-Cyclopropylmethyl-7,8-dihydro-7-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-O--methyl-6,14-ethano-17-normorphine hydrochloride. It has the following chemical structure:
  • Buprenorphine hydrochloride USP has the molecular formula CHNO u2022 HCl and the molecular weight is 504.1. It is a white to almost white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane.
  • Chemically, naloxone HCl dihydrate USP is 17-Allyl-4, 5 u03b1-epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure:
  • Naloxone hydrochloride dihydrate has the molecular formula CHNO u2022 HCl u2022 2H0 and the molecular weight is 399.87. It is a white to slightly off-white powder or almost white crystalline powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.
  • No data
  • Carcinogenicity
  • A carcinogenicity study of buprenorphine/naloxone (4:1 ratio of the free bases) was performed in Alderley Park rats. Buprenorphine/naloxone was administered in the diet at doses of approximately 7, 31, and 123 mg/kg/day for 104 weeks (estimated exposure was approximately 4, 18, and 44 times the recommended human sublingual dose of 16/4 mg buprenorphine/naloxone based on buprenorphine AUC comparisons). A statistically significant increase in Leydig cell adenomas was observed in all dose groups. No other drug-related tumors were noted.
  • Carcinogenicity studies of buprenorphine were conducted in Sprague-Dawley rats and CD-1 mice. Buprenorphine was administered in the diet to rats at doses of 0.6, 5.5, and 56 mg/kg/day (estimated exposure was approximately 0.4, 3, and 35 times the recommended human daily sublingual dose of 16 mg on a mg/m basis) for 27 months. As in the buprenorphine/naloxone carcinogenicity study in rat, statistically significant dose-related increases in Leydig cell tumors occurred. In an 86-week study in CD-1 mice, buprenorphine was not carcinogenic at dietary doses up to 100 mg/kg/day (estimated exposure was approximately 30 times the recommended human daily sublingual dose of 16 mg on a mg/m basis).
  • Mutagenicity
  • The 4:1 combination of buprenorphine and naloxone was not mutagenic in a bacterial mutation assay (Ames test) using four strains of and two strains of . The combination was not clastogenic in an cytogenetic assay in human lymphocytes or in an IV micronucleus test in the rat.
  • Buprenorphine was studied in a series of tests utilizing gene, chromosome, and DNA interactions in both prokaryotic and eukaryotic systems. Results were negative in yeast () for recombinant, gene convertant, or forward mutations; negative in u201crecu201d assay, negative for clastogenicity in CHO cells, Chinese hamster bone marrow and spermatogonia cells, and negative in the mouse lymphoma L5178Y assay.
  • Results were equivocal in the Ames test: negative in studies in two laboratories, but positive for frame shift mutation at a high dose (5 mg/plate) in a third study. Results were positive in the Green-Tweets () survival test, positive in a DNA synthesis inhibition test with testicular tissue from mice, for both and incorporation of [H]thymidine, and positive in unscheduled DNA synthesis test using testicular cells from mice.
  • Impairment of Fertility
  • Dietary administration of buprenorphine in the rat at dose levels of 500 ppm or greater (equivalent to approximately 47 mg/kg/day or greater; estimated exposure approximately 28 times the recommended human daily sublingual dose of 16 mg on a mg/m basis) produced a reduction in fertility demonstrated by reduced female conception rates. A dietary dose of 100 ppm (equivalent to approximately 10 mg/kg/day; estimated exposure approximately 6 times the recommended human daily sublingual dose of 16 mg on a mg/m basis) had no adverse effect on fertility.
  • Clinical data on the safety and efficacy of Buprenorphine and Naloxone Sublingual Tablets were derived from studies of buprenorphine sublingual tablet formulations, with and without naloxone, and from studies of sublingual administration of a more bioavailable ethanolic solution of buprenorphine.
  • Buprenorphine and Naloxone Sublingual Tablets were studied in 575 patients, buprenorphine sublingual tablets (buprenorphine without naloxone) in 1,834 patients and buprenorphine sublingual solutions in 2,470 patients. A total of 1,270 women received buprenorphine in those clinical trials. Dosing recommendations are based on data from one trial of both tablet formulations and two trials of the ethanolic solution. All trials used buprenorphine in conjunction with psychosocial counseling as part of a comprehensive addiction treatment program. There were no clinical studies conducted to assess the efficacy of buprenorphine as the only component of treatment.
  • In a double-blind placebo- and active-controlled study, 326 heroin-addicted subjects were randomly assigned to either Buprenorphine and Naloxone Sublingual Tablets, 16/4 mg per day; buprenorphine sublingual tablets, 16 mg per day; or placebo sublingual tablets. For subjects randomized to either active treatment, dosing began with one 8 mg buprenorphine tablet on Day 1, followed by 16 mg (two 8 mg tablets) of buprenorphine on Day 2. On Day 3, those randomized to receive Buprenorphine and Naloxone Sublingual Tablets were switched to the combination tablet. Subjects randomized to placebo received one placebo tablet on Day 1 and two placebo tablets per day thereafter for four weeks. Subjects were seen daily in the clinic (Monday through Friday) for dosing and efficacy assessments. Take-home doses were provided for weekends. Subjects were instructed to hold the medication under the tongue for approximately 5 to 10 minutes until completely dissolved. Subjects received counseling regarding HIV infection and up to one hour of individualized counseling per week. The primary study comparison was to assess the efficacy of Buprenorphine and Naloxone Sublingual Tablets and buprenorphine sublingual tablets individually against placebo sublingual tablet. The percentage of thrice-weekly urine samples that were negative for non-study opioids was statistically higher for both Buprenorphine and Naloxone Sublingual Tablets and buprenorphine sublingual tablets than for placebo sublingual tablets.
  • In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomized to receive the ethanolic sublingual solution of buprenorphine at 8 mg/day (a dose which is roughly comparable to a dose of 12 mg/3 mg per day of Buprenorphine and Naloxone Sublingual Tablets or 12 mg per day of buprenorphine sublingual tablets), or two relatively low doses of active control, one of which was low enough to serve as an alternative to placebo, during a 3 to 10 day induction phase, a 16-week maintenance phase and a 7-week detoxification phase. Buprenorphine was titrated to maintenance dose by Day 3; active control doses were titrated more gradually.
  • Maintenance dosing continued through Week 17, and then medications were tapered by approximately 20% to 30% per week over Weeks 18 to 24, with placebo dosing for the last two weeks. Subjects received individual and/or group counseling weekly.
  • Based on retention in treatment and the percentage of thrice-weekly urine samples negative for non-study opioids, buprenorphine was more effective than the low-dose of the control, in keeping heroin addicts in treatment and in reducing their use of opioids while in treatment. The effectiveness of buprenorphine, 8 mg per day was similar to that of the moderate active control dose, but equivalence was not demonstrated.
  • In a dose-controlled, double-blind, parallel-group, 16-week study, 731 subjects were randomized to receive one of four doses of buprenorphine ethanolic solution: 1 mg, 4 mg, 8 mg, and 16 mg. Buprenorphine was titrated to maintenance doses over 1 to 4 days and continued for 16 weeks. Subjects received at least one session of AIDS education and additional counseling ranging from one hour per month to one hour per week, depending on site.
  • Based on retention in treatment and the percentage of thrice-weekly urine samples negative for non-study opioids, the three highest tested doses were superior to the 1 mg dose. Therefore, this study showed that a range of buprenorphine doses may be effective. The 1 mg dose of buprenorphine sublingual solution can be considered to be somewhat lower than a 2 mg tablet dose. The other doses used in the study encompass a range of tablet doses from approximately 6 mg to approximately 24 mg
  • Buprenorphine and Naloxone Sublingual Tablets, USP
  • 2 mg/0.5 mg are supplied as speckled-peach to peach, flat faced beveled edge tablets with product identification u201c54u201d [above] u201c122u201d on one side and plain on the other.
  • NDC 0054-0188-13: Bottle of 30 Tablets
  • 8 mg/2 mg are supplied as speckled-peach to peach, flat faced beveled edge tablets with product identification u201c54u201d [above] u201c375u201d on one side and plain on the other.
  • NDC 0054-0189-13: Bottle of 30 Tablets
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Dispense in a tight, light-resistant container as defined in USP.
  • Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [].
  • Store Buprenorphine and Naloxone Sublingual Tablets securely and dispose of properly n .
  • Advise patients to read the FDA-approved patient labeling (Medication Guide).
  • Buprenorphinen- (bueu201d pre noru2019 feen) and Naloxone (nal oxu2019 one) Sublingual Tablets CIII
  • Rx Only
  • IMPORTANT:
  • Read this Medication Guide that comes with Buprenorphine and Naloxone Sublingual Tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor. Talk to your doctor or pharmacist if you have questions about Buprenorphine and Naloxone Sublingual Tablets.
  • Share the important information in this Medication Guide with members of your household.
  • What is the most important information I should know about Buprenorphine and Naloxone Sublingual Tablets?
  • What are Buprenorphine and Naloxone Sublingual Tablets?
  • Who should not take Buprenorphine and Naloxone Sublingual Tablets?
  • Do not take Buprenorphine and Naloxone Sublingual Tablets
  • What should I tell my doctor before taking Buprenorphine and Naloxone Sublingual Tablets?
  • Buprenorphine and Naloxone Sublingual Tablets may not be right for you. Before taking Buprenorphine and Naloxone Sublingual Tablets, tell your doctor if you:
  • Tell your doctor about all the medicines you take
  • Sometimes the doses of certain medicines and Buprenorphine and Naloxone Sublingual Tablets may need to be changed if used together. Do not take any medicine while using Buprenorphine and Naloxone Sublingual Tablets until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines while you are taking Buprenorphine and Naloxone Sublingual Tablets.
  • Be especially careful about taking other medicines that may make you sleepy
  • Know the medicines you take. Keep a list of them to show your doctor or pharmacist each time you get a new medicine.
  • How should I take Buprenorphine and Naloxone Sublingual Tablets?
  • What should I avoid while taking Buprenorphine and Naloxone Sublingual Tablets?
  • What are the possible side effects of Buprenorphine and Naloxone Sublingual Tablets?
  • Buprenorphine and Naloxone Sublingual Tablets can cause serious side effects including:
  • Common side effects of Buprenorphine and Naloxone Sublingual Tablets include:
  • Tell your doctor about any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of Buprenorphine and Naloxone Sublingual Tablets. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Buprenorphine and Naloxone Sublingual Tablets?
  • How should I dispose of unused Buprenorphine and Naloxone Sublingual Tablets?
  • General information about the safe and effective use of Buprenorphine and Naloxone Sublingual Tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take Buprenorphine and Naloxone Sublingual Tablets for a condition for which it was not prescribed. Do not give Buprenorphine and Naloxone Sublingual Tablets to other people, even if they have the same symptoms you have. It may harm them and it is against the law.
  • This Medication Guide summarizes the most important information about Buprenorphine and Naloxone Sublingual Tablets. If you would like more information, talk to your doctor or pharmacist. You can ask your doctor or pharmacist for information that is written for health professionals.
  • For more information call 1-800-962-8364.
  • What are the ingredients in Buprenorphine and Naloxone Sublingual Tablets, USP?
  • Active ingredients:
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • For information, please call 1-800-962-8364.
  • 10005416/08
  • Revised November 2019
  • NDC 0054-0188-13
  • Rx only
  • NDC 0054-0189-13
  • Rx only

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