Sovenor Dosage

• Dosage of Sovenor in details
• Sovenor interactions
• Sovenor reviews

Dosage of Sovenor in details

Dosage and Titration: The lowest Sovenor 5 mg should be used as the initial dose in all patients.

During initiation, titration, and treatment with Sovenor, patients may continue their existing NSAID or acetaminophen regimen as needed.

The dose of Sovenor should not be increased at less than 3-day intervals when steady-state levels are attained. Changes in Sovenor dosage may be individually titrated based on the need for supplemental PRN analgesia and the patient's analgesic response to Sovenor.

To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches be applied at the same time, regardless of patch strength.

Titration should continue every 3-7 days until adequate analgesia is achieved.

If adequate pain control cannot be achieved with Sovenor, therapy should be discontinued and the patient converted to an appropriate analgesic regimen as determined by a physician.

Discontinuation: After removal of Sovenor, plasma concentrations decrease gradually. This should be considered when therapy with Sovenor is to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24 hours after removal of Sovenor.

Conversion From Opioids: Sovenor can be used as an alternative to treatment with other opioids. Such patients should be started on the lowest available dose Sovenor 5 mg and continue taking short-acting supplemental analgesics during titration, as required.

Children: The safety and efficacy of Sovenor in patients under 18 years of age has not been established.

Renal Impairment: No special dose adjustment of Sovenor is necessary in patients with renal impairment.

Hepatic Impairment: There is no need for dosage adjustment when using Sovenor in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment may accumulate Sovenor during Sovenor treatment. Consideration of alternate therapy should be given, and Sovenor should be used with caution, if at all, in such patients.

Elderly: No dosage adjustment of Sovenor is required in elderly patients.

Administration: Sovenor should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. Sovenor should be applied to a relatively hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped with scissors, not shaven.

Application sites should be rotated whenever a patch is replaced or added. Application sites should be re-used at no less than 3-week intervals.

If the application site must be cleaned, it should be done with clear water only. Soaps, alcohol, oils, lotions, or abrasive devices should not be used. The skin must be dry before the transdermal patch is applied.

Sovenor should be worn continuously for 7 days. Sovenor should be pressed firmly in place at the application site, making sure contact is complete, especially around the edges. If the edges of the patch begin to peel off, the edges may be taped down with suitable skin tape. If a transdermal patch falls off, a new one should be applied. Bathing, showering, or swimming should not affect the patch. While wearing Sovenor, patients should be advised to avoid exposing the Sovenor site to direct external heat sources such as heating pads, electric blankets, heat lamps, etc., as an increase in absorption of Sovenor may occur. The effects of the use of Sovenor while in hot tubs and saunas have not been studied.

Patch Application: Applying the Patch: Step 1: Each patch is sealed in a pouch. Just before use, open the pouch by tearing where indicated. Take out the patch.

Step 2: The sticky side of the patch is covered with a silvery protective foil. Carefully peel off half the foil. Try not to touch the sticky part of the patch.

Step 3: Stick the patch onto the chosen area of the skin and remove the remaining foil.

Step 4: Press the patch against the skin with the palm of the hand and count slowly to 30. Make sure that the whole patch is in contact with the skin, especially at the edges.

Step 5: Find a calendar that will help to remember to change the patch every 7th day. Mark the day when the first patch was put on and make a note of the time of day.

Wearing the Patch: Sovenor should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. Application sites should be re-used at no less than 3-week (21 days) intervals.

If a transdermal patch falls off before it needs changing, a new patch should be applied.

Changing the Patch: Take the old patch off.

Fold it in half with the sticky side inwards. Put the used patch into its original pouch. Then put the pouch in the bin used for the household rubbish. Even used patches contain some active medicine that may harm children or animals, so make sure the used patches are always kept well away from them. Throw it away carefully, out of the reach and sight of children.

Stick a new patch on a different appropriate skin site. The patient should not apply a new patch to the same site for the following 3-4 weeks.

Mark the day and time of application on the calendar.

Remember to change the patch at the same time of day each time.

What other drugs will affect Sovenor?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Sovenor can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with Sovenor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

See also:

Sovenor drug interactions (in more detail)

Sovenor interactions

Cytochrome P450 3A4 (CYP3A4) Inhibitors And Inducers

Sovenor is metabolized to norbuprenorphine primarily by CYP3A4; therefore, potential interactions may occur when Sovenor is given concurrently with agents that affect CYP3A4 activity. The effects of co-administered inducers or inhibitors have been established in studies using transmucosal Sovenor; the effects on Sovenor exposure in patients treated with Sovenor have not been studied, and the effects may be dependent on the route of administration.

Patients who transfer to Sovenor treatment from a regimen of transmucosal Sovenor used concomitantly with CYP3A4 inhibitors (e.g., azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, and HIV protease inhibitors [e.g. ritonavir, indinavir, and saquinavir]) should be monitored to ensure that the plasma Sovenor level provided by Sovenor is adequate. If patients already on Sovenor require newly-initiated treatment with CYP3A4 inhibitors, the patients should be monitored for signs and symptoms of overmedication. If the concomitant medication cannot be reduced or discontinued, it may be necessary to remove the Sovenor implants and treat the patient with a formulation of Sovenor that permits dose adjustments. Conversely, if a patient has been stabilized on Sovenor in the setting of concomitant medication that is a CYP3A4 inhibitor, and the concomitant medication is discontinued, the patient should be monitored for withdrawal. If the dose of Sovenor is not adequate in the absence of the concomitant medication, that patient should be transitioned back to a formulation of Sovenor that permits dose adjustments.

CYP3A4 inducers may induce the metabolism of Sovenor and, therefore, may cause increased clearance of the drug which could lead to a decrease in Sovenor plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome. It is not known whether the effects of CYP3A4 inducers are dependent on the route of administration of Sovenor. Patients who transfer to Sovenor treatment from a regimen of transmucosal Sovenor used concomitantly with CYP3A4 inducers should be monitored to ensure that the plasma Sovenor level provided by Sovenor is not excessive. If patients already on Sovenor require newly-initiated treatment with CYP3A4 inducers, the patients should be monitored for withdrawal. If the dose of Sovenor is not adequate in the absence of the concomitant medication, and the concomitant medication cannot be reduced or discontinued, that patient should be transitioned back to a formulation of Sovenor that permits dose adjustments. Conversely, if a patient has been stabilized on Sovenor in the setting of concomitant medication that is a CYP3A4 inducer, and the concomitant medication is discontinued, the patient should be monitored for signs and symptoms of over-medication. If the dose provided by Sovenor is excessive in the absence of the concomitant inducer, it may be necessary to remove the Sovenor implants and treat the patient with a formulation of Sovenor that permits dose adjustments.

Antiretrovirals

Three classes of antiretroviral agents have been evaluated for CYP3A4 interactions with Sovenor, though these evaluations have not been specifically performed with Sovenor. Nucleoside reverse transcriptase inhibitors (NRTIs) do not appear to induce or inhibit the P450 enzyme pathway; thus no interactions with Sovenor are expected.

Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are metabolized principally by CYP3A4. Efavirenz, nevirapine, and etravirine are known CYP3A4 inducers, whereas delaviridine is a CYP3A4 inhibitor. Significant pharmacokinetic interactions between NNRTIs (e.g., efavirenz and delavirdine) and Sovenor have been shown in clinical studies, but these pharmacokinetic interactions did not result in any significant pharmacodynamic effects. It is recommended that patients who are on Sovenor treatment have their dose monitored if NNRTIs are added to their treatment regimen. Studies have shown some antiretroviral protease inhibitors (PIs) with CYP3A4 inhibitory activity (e.g., nelfinavir, lopinavir/ritonavir, ritonavir) have little effect on Sovenor pharmacokinetics and no significant pharmacodynamic effects. Other PIs with CYP3A4 inhibitory activity (e.g., atazanavir and atazanavir/ritonavir) resulted in elevated levels of Sovenor and norbuprenorphine and patients in one study reported increased sedation. Symptoms of opioid excess have been found in post-marketing reports of patients receiving Sovenor and atazanavir with and without ritonavir concomitantly. If treatment with atazanavir with and without ritonavir must be initiated in a patient already treated with Sovenor, the patient should be monitored for signs and symptoms of over-medication. It may be necessary to remove the Sovenor implants and treat the patient with a formulation of Sovenor that permits dose adjustments.

Benzodiazepines

There have been post-marketing reports of coma and death associated with the concomitant use of Sovenor and benzodiazepines. In many, but not all, of these cases, Sovenor was misused by self-injection. Studies have shown that the combination of benzodiazepines and other Sovenor products altered the usual ceiling effect on Sovenor-induced respiratory depression, making the respiratory effects of Sovenor appear similar to those of full opioid agonists. Sovenor should be prescribed with caution to patients taking benzodiazepines or other drugs that act on the CNS, regardless of whether these drugs are taken on the advice of a physician or are being abused. Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines while taking Sovenor, and should also be cautioned to use benzodiazepines concurrently with Sovenor only as directed by their physician.

Serotonergic Drugs

The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation, and during dose adjustment of the serotonergic drug. Discontinue Sovenor if serotonin syndrome is suspected.

Drug Abuse And Dependence

Controlled Substance

Sovenor contains Buprenorphine, a Schedule III narcotic under the Controlled Substances Act.

Under the Drug Addiction Treatment Act (DATA) codified at 21 United States Code (U.S.C.) 823(g), use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe or dispense this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

Abuse

Sovenor, like morphine and other opioids, has the potential for being abused and is subject to criminal diversion. Each Sovenor implant contains 74.2 mg of Sovenor and can come out or protrude, resulting in the potential for accidental exposure or intentional misuse, abuse, and diversion. Healthcare Providers should contact their state professional licensing board or state controlled substances authority for information on how to prevent and detect misuse, abuse, and diversion of Sovenor.

Abuse of Sovenor poses a risk of overdose and death. This risk is increased with the concomitant abuse of Sovenor and alcohol and other substances, especially benzodiazepines.

Proper assessment of the patient, periodic re-evaluation of therapy, and proper handling and storage of Sovenor are appropriate measures that help to limit misuse, abuse, and diversion of opioid drugs.

Monitor all patients receiving Sovenor and provide or refer patients who have conditions indicative of diversion or progression of opioid dependence and addictive behaviors to more intensive and structured treatment for substance use.

Dependence

Sovenor is a partial agonist at the mu-opioid receptor and chronic administration produces physical dependence of the opioid type, characterized by moderate withdrawal signs and symptoms upon abrupt discontinuation or rapid taper. The withdrawal syndrome is typically milder than seen with full agonists and may be delayed in onset.

Patients treated with Sovenor who experience a delay between removal of implants and insertion of new implants should be maintained on their previous dose of sublingual Sovenor. Patients who elect to discontinue Sovenor treatment without continuing on other Sovenor treatment should be monitored for withdrawal. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.

References

1. DailyMed. "BUPRENORPHINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. FDA/SPL Indexing Data. "40D3SCR4GZ: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Analgesics, Opioid". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology