Codeine sulfate

What is Codeine sulfate?

• Codeine sulfate (Tuzistra XR), is an opioid agonist, available for oral administration.

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Codein - Codeine

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What are the uses of this medicine?

• Codeine sulfate, is a strong prescription pain medicine that contains an opioid (narcotic) that is used to manage mild to moderate pain, where treatment with an opioid is appropriate, and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.

Limitations of use:

• An opioid pain medicine that can put you at risk for overdose and death.
• Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Codeine Sulfate Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):

• Have not been tolerated, or are not expected to be tolerated.
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

How does this medicine work?

• The sulfate salt form of codeine, a naturally occurring phenanthrene alkaloid and opioid agonist with analgesic, antidiarrheal and antitussive activity.
• Codeine sulfate mimics the actions of opioids by binding to the opioid receptors at many sites within the central nervous system (CNS).
• Stimulation of the mu-subtype opioid receptor stimulates the exchange of GTP for GDP on the G-protein complex and subsequently inhibits adenylate cyclase.
• This results in a decrease in intracellular cAMP and leads to a reduction in the release of neurotransmitters such as substance P, GABA, dopamine, acetylcholine and noradrenaline.
• The analgesic effect of codeine sulfate is likely due to its metabolite morphine, which induces opening of G-protein-coupled inwardly rectifying potassium (GIRK) channels and blocks the opening of N-type voltage-gated calcium channels, thereby resulting in hyperpolarization and reduced neuronal excitability.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Severe asthma, trouble breathing, or other lung problems.
• A bowel blockage or have narrowing of the stomach or intestines.
• An allergy to Codeine Sulfate Tablets or any of the ingredients.

• Do not give Codeine Sulfate Tablets to a child younger than 12 years of age.
• Do not give Codeine Sulfate Tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• Avoid giving Codeine Sulfate Tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• bupropion (Aplenzin, Wellbutrin, Zyban)
• cyclobenzaprine (Amrix)
• diuretics ('water pills')
• lithium (Lithobid)
• medications for cough, cold, or allergies
• medications for anxiety or seizures
• medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig)
• mirtazapine (Remeron)
• 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi)
• selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft)
• serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor)
• tramadol (Conzip)
• trazodone (Oleptro)
• tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil).
• monoamine oxidase (MAO) inhibitors or if you have stopped taking them within the past 2 weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).

• Tell your doctor what herbal products you are taking, especially St. John's wort and tryptophan.

Is this medicine FDA approved?

• Codeine sulfate is a medication, available as tablet; oral, brand codeine sulfate strength 15mg FDA approved on Jun 13, 2014.

How should this medicine be used?

Recommended dosage:

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
• Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with Codeine Sulfate Tablets. Consider prescribing naloxone based on the patient’s risk factors for overdose.
• Initiate treatment with 15 to 60 mg every 4 hours as needed.
• Do not abruptly discontinue Codeine Sulfate Tablets in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.

Administration:

• Do not change your dose. Take Codeine Sulfate Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 4 hours as needed. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking Codeine Sulfate Tablets regularly, do not stop taking codeine sulfate without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused Codeine Sulfate Tablets by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of Codeine Sulfate Tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag and throwing the bag in your trash.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 15 mg, 30 mg, and 60 mg

This medicine is available in fallowing brand namesː

• Tuzistra XR

What side effects can this medication cause?

The most common side effects of this medicine include:

• Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, drowsiness, lightheadedness, dizziness, sedation, shortness of breathe and sweating.

Less common,but serious side effects may include:

• Respiratory Depression
• Adrenal Insufficiency
• Severe Hypotension
• Neonatal Opioid Withdrawal Syndrome
• Addiction, Abuse, and Misuse

What special precautions should I follow?

• As an opioid, Codeine Sulfate Tablets exposes users to the risks of addiction, abuse, and misuse. Assess each patient’s risk prior to prescribing Codeine Sulfate Tablets, and monitor all patients regularly for the development of these behaviors and conditions.
• Serious, life-threatening, or fatal respiratory depression may occur with use of Codeine Sulfate Tablets. Monitor for respiratory depression, especially during initiation of Codeine Sulfate Tablets or following a dose increase.
• Accidental ingestion of even one dose of Codeine Sulfate Tablets, especially by children, can result in a fatal overdose of codeine.
• Prolonged use of Codeine Sulfate Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
• Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
• Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible.
• Codeine Sulfate Tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. Avoid the use of Codeine Sulfate Tablets in patients with circulatory shock.
• In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), Codeine Sulfate Tablets may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Codeine Sulfate Tablets.
• Codeine Sulfate Tablets are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
• The codeine in Codeine Sulfate Tablets may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during Codeine Sulfate Tablets therapy.
• Do not abruptly discontinue Codeine Sulfate Tablets in a patient physically dependent on opioids. When discontinuing Codeine Sulfate Tablets in a physically-dependent patient, gradually taper the dosage.
• While taking Codeine Sulfate Tablets DO NOT:
• Drive or operate heavy machinery, until you know how codeine sulfate affects you. Codeine sulfate can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with codeine sulfate may cause you to overdose and die.
• There is no information on the effects of codeine on milk production. Because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with Codeine Sulfate.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.
• Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.
• Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated.
• Cardiac arrest or arrhythmias will require advanced life-support techniques.
• Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose.
• For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist.
• Because the duration of opioid reversal is expected to be less than the duration of action of codeine in Codeine Sulfate Tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished.
• In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome.
• If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

Can this medicine be used in pregnancy?

• Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome.
• Available data with Codeine Sulfate Tablets are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Can this medicine be used in children?

• Do not give Codeine Sulfate Tablets to a child younger than 12 years of age.
• Do not give Codeine Sulfate Tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• Avoid giving Codeine Sulfate Tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• codeine sulfate

Inactive ingredients:

• microcrystalline cellulose
• silicon dioxide
• starch, corn
• stearic acid

Who manufactures and distributes this medicine?

Distributed by:

• Hikma Pharmaceuticals USA Inc.
• Berkeley Heights, NJ

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
• Protect from moisture.
• Dispense in a tight, light-resistant container as defined in the USP/NF.
• Blisters are not child-resistant.
• Use child-resistant closure if dispensing to outpatient.
• Store Codeine Sulfate Tablets securely and dispose of properly.

• Dailymed label info on Codeine sulfate
• FDA Codeine sulfate

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