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Description

suboxone 8 mg buprenorphine and naloxone

suboxone 8 mg buprenorphine and naloxone is a medicine that contains two active substances, buprenorphine and naloxone. It is available as sublingual tablets containing 2 mg buprenorphine and 0.5 mg naloxone, 8 mg buprenorphine and 2 mg naloxone, or 16 mg buprenorphine and 4 mg naloxone. ‘Sublingual’ means that the tablet is placed under the tongue where it dissolves.

What is suboxone 8 mg used for?

Suboxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction. Suboxone is used in adults and children over
15 years of age, who are also receiving medical, social and psychological support. The medicine can only be obtained by ‘special’ prescription. This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.

N8 LOGO (Suboxone 8 mg / 2 mg)

Generic Name: buprenorphine/naloxone

Pill with imprint N8 LOGO is Orange, Six-sided and has been identified as Suboxone 8 mg / 2 mg. It is supplied by Reckitt Benckiser Pharmaceuticals, Inc. Suboxone is used in the treatment of opiate dependence and belongs to the drug class narcotic analgesic combinations. Risk cannot be ruled out during pregnancy. Suboxone 8 mg / 2 mg is classified as a Schedule 3 controlled substance under the Controlled Substance Act (CSA).

Suboxone

Generic Name: buprenorphine/naloxone

Imprint: N8 LOGO

Strength: 8 mg / 2 mg

Color: Orange

Size: 11.00 mm

Shape: Six-sided

Drug Class: Narcotic analgesic combinations

Pregnancy Category: C – Risk cannot be ruled out

CSA Schedule: 3 – Moderate abuse potential

Labeler / Supplier: Reckitt Benckiser Pharmaceuticals, Inc.

National Drug Code (NDC): 12496-1306

Inactive Ingredients:

• lactose anhydrous
• mannitol
• corn starch
• povidone k30
• citric acid monohydrate
• sodium citrate
• FD&C Yellow No. 6
• magnesium stearate
• acesulfame potassium

Before taking this medicine

You should not use Suboxone if you are allergic to buprenorphine or naloxone (Narcan).

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• enlarged prostate, urination problems;
• liver or kidney disease;
• abnormal curvature of the spine that affects breathing;
• problems with your gallbladder, adrenal gland, or thyroid;
• a head injury, brain tumor, or seizures; or
• alcoholism, drug addiction, mental illness.

HOW SUPPLIED / STORAGE AND HANDLING

SUBOXONE sublingual film is supplied as an orange rectangular film with a white printed logo in child-resistant
polyester/foil laminated pouches:
• NDC 12496-1202-3 (buprenorphine 2 mg/naloxone 0.5 mg/film; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP) – 30 films per carton.

• NDC 12496-1204-3 (buprenorphine 4 mg/naloxone 1 mg/film; content expressed in terms of free base, equivalent to 4.32 mg buprenorphine hydrochloride USP and 1.22 mg naloxone hydrochloride dihydrate USP) – 30 films per carton.

• NDC 12496-1208-3 (buprenorphine 8 mg/naloxone 2 mg/film; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP) – 30 films per carton.

• NDC 12496-1212-3 (buprenorphine 12 mg/naloxone 3 mg/film; content expressed in terms of free base, equivalent to 12.96 mg buprenorphine hydrochloride USP and 3.66 mg naloxone hydrochloride dihydrate USP) – 30 films per carton.

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F)
Store SUBOXONE sublingual film securely and dispose of properly

Common side effects of SUBOXONE sublingual film include:

• Nausea
• Vomiting
• Drug withdrawal syndrome
• Headache
• Sweating
• Numb mouth
• Constipation
• Swollen and/or painful tongue
• The inside of your mouth is more red than normal
• Intoxication (feeling lightheaded or drunk)
• Disturbance in attention
• Irregular heart beat (palpitations)
• Decrease in sleep (insomnia)
• Blurred vision
• Back pain
• Fainting
• Dizziness
• Sleepiness