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Buprenorphine And Naloxone - Sublingual Film (Buprenorphine And Naloxone)

Trade Name : Buprenorphine and Naloxone

Alvogen Inc.

FILM

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 And Naloxone - Sublingual Film (Buprenorphine And Naloxone) which is also known as Buprenorphine and Naloxone and Manufactured by Alvogen Inc.. It is available in strength of 2; .5 mg/1; mg/1 per ml. Read more

Buprenorphine And Naloxone - Sublingual Film (Buprenorphine And Naloxone) 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

Packaging and Delivery

Validated Cold Chain Shipment

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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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
  • Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a010/2019
  • Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
  • Buprenorphine and naloxone sublingual film contains buprenorphine, a partial-opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ()
  • Buprenorphine and naloxone sublingual film should be used as a part of a complete treatment plan that includes counseling and psychosocial support. ()
  • No data
  • Buprenorphine and naloxone sublingual film is supplied as an orange rectangular sublingual film with white printing in four dosage strengths:
  • Sublingual film:
  • buprenorphine 2 mg and naloxone 0.5 mg,
  • buprenorphine 4 mg and naloxone 1 mg,
  • buprenorphine 8 mg and naloxone 2 mg and
  • buprenorphine 12 mg and naloxone 3 mg.
  • Buprenorphine and naloxone sublingual film is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported n n .
  • 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 the sublingual/buccal administration of the buprenorphine and naloxone sublingual film are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or
  • Table 4 Includes clinically significant drug interactions with buprenorphine and naloxone sublingual film.
  • Benzodiazepines
  • CYP3A4 Inhibitors and Inducers
  • Antiretrovirals
  • Serotonergic Drugs
  • No data
  • Lactation
  • Geriatric Patients
  • Moderate or Severe Hepatic Impairment
  • No data
  • Clinical Presentation
  • Treatment of Overdose
  • 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 film 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 film is an orange film, imprinted with white ink identifying the product and strength. It contains buprenorphine hydrochloride, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist, and naloxone hydrochloride dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone, and 12 mg buprenorphine with 3 mg naloxone. Each sublingual film also contains polyethylene oxide, maltitol, citric acid monohydrate, sodium citrate dihydrate, acesulfame potassium, FD&C yellow #6, lime flavor and white ink. The white ink contains ethyl alcohol, propylene glycol, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, ammonium hydroxide, and titanium dioxide. u00a0
  • Chemically, buprenorphine hydrochloride is (2S)-2-[17-Cyclopropylmethyl-4,5u03b1-epoxy-3-hydroxy-6-methoxy-6u03b1,14-ethano-14u03b1- morphinan-7u03b1-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure:
  • Buprenorphine hydrochloride has the molecular formula CH NO u2022 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.
  • Chemically, naloxone hydrochloride dihydrate 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 2HO and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.
  • No data
  • No data
  • Buprenorphine and naloxone sublingual film is supplied as an orange rectangular film with white printing in child-resistant polyester/foil laminated pouches:
  • Store at 25u00b0C (77u00b0F), excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Store buprenorphine and naloxone sublingual film securely and dispose of properly .u00a0
  • Advise patients to read the FDA-approved patient labeling ().
  • Storage and Disposal
  • Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store buprenorphine and naloxone sublingual film securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home . Inform patients that leaving buprenorphine and naloxone sublingual film unsecured can pose a deadly risk to others in the home.
  • Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused buprenorphine and naloxone sublingual film should be disposed of by removing the buprenorphine and naloxone sublingual film from the foil packaging, and flushing the unused medication down the toilet (if a drug take-back option is not readily available). Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
  • Safe Use
  • Before initiating treatment with buprenorphine and naloxone sublingual film, explain the points listed below to caregivers and patients. Instruct patients to read the Medication Guide each time buprenorphine and naloxone sublingual film is dispensed because new information may be available.
  • Made in USAu00a0
  • Distributed by:Alvogen, Inc.Pine Brook, NJ 07058 USAu00a0
  • PI355-02n
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Revised: 11/2019 PL355-02
  • NDCn- 355
  • Buprenorphine CIIIand Naloxone Sublingual Film
  • 2 mg/0.5 mg
  • Arrayn- Instructions for the Pharmacist:
  • Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.
  • Do not cut, chew or swallow sublingual film.
  • Rx only
  • NDCn- 355
  • Buprenorphine CIIIand Naloxone Sublingual Filmn- Array
  • 2 mg/0.5 mg
  • Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.n- Array
  • Do not cut, chew or swallow sublingual film.
  • Rx onlyu00a0
  • NDCn- 356
  • Buprenorphine CIII and Naloxone Sublingual Filmn- Array
  • 4 mg/1 mgn- Array
  • Instructions for the Pharmacist:
  • Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.
  • Do not cut, chew or swallow sublingual film.
  • Rx only
  • NDCn- 356
  • Buprenorphine CIII and Naloxone Sublingual Filmn- Array
  • 4 mg/1 mg
  • Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.n- Array
  • Do not cut, chew or swallow sublingual film.
  • Rx only
  • NDCn- 357n- Array
  • Buprenorphine CIII and Naloxone Sublingual Film
  • Arrayn- 8 mg/2 mgn- Array
  • Instructions for the Pharmacist:
  • Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.
  • Do not cut, chew or swallow sublingual film.
  • Rx only
  • NDCn- 357
  • Buprenorphine CIII and Naloxone Sublingual Filmn- Array
  • 8 mg/2 mgn- Array
  • Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.
  • Do not cut, chew or swallow sublingual film.
  • Rx only
  • NDCn- 358n- Array
  • Buprenorphine CIII and Naloxone Sublingual Film
  • 12 mg/3 mgn- Array
  • Instructions for the Pharmacist:
  • Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.
  • Do not cut, chew or swallow sublingual film.
  • Rx only
  • NDCn- 358n- Array
  • Buprenorphine CIII and Naloxone Sublingual Filmn- Array
  • 12 mg/3 mgn- Array
  • Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.
  • Do not cut, chew or swallow sublingual film.
  • Rx only

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