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Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
Prepared to a prescriber's order for one patient. Not FDA-approved.
This is a compounded capsule containing methadone hydrochloride, prepared to a prescriber's order for one patient. Compounded preparations are not FDA-approved. Methadone is a Schedule II controlled substance.
These listings cover every salt or ester form of each drug in the FDA National Drug Code Directory.
FDA-approved products containing methadone are listed in tablet, concentrate, solution and injection forms. No finished methadone product of any kind is listed in capsule form.
This is a solid, nonaqueous dose form. Under USP <795>, nonaqueous preparations carry longer default beyond-use dates than water-containing ones. The date printed on the label is the one to follow.
Methadone hydrochloride is a Schedule II opioid agonist taken by mouth or given by injection, which a pharmacy may compound on a prescriber's order.
Methadone hydrochloride is a synthetic opioid that acts mainly on mu opioid receptors in the brain and spinal cord, with effects similar to morphine; some data suggest it also blocks NMDA receptors. Manufactured products include methadone hydrochloride tablets, dispersible tablets (Diskets, Methadose dispersible), oral solution, oral concentrate (Methadose) and injection. The SpecGx tablet label lists management of severe and persistent pain that needs an opioid and cannot be handled with other options, plus detoxification and maintenance treatment of opioid addiction alongside social and medical services. Methadone for opioid addiction is subject to federal opioid treatment program rules (42 CFR 8.12). A prescriber might order methadone compounded in a strength or form that is not manufactured. Compounded preparations are not FDA-approved and require a prescription.
Methadone labels carry a boxed warning for: addiction, abuse and misuse; life-threatening respiratory depression; accidental ingestion, which can be fatal, especially in children; profound sedation, coma or death when combined with benzodiazepines, other sedatives or alcohol; neonatal opioid withdrawal syndrome after use in pregnancy; the opioid analgesic REMS; life-threatening QT prolongation and heart rhythm problems; and drug interactions through liver enzymes (CYP3A4, 2B6, 2C19, 2C9, 2D6) that can raise methadone levels. The boxed warning also states that methadone for detoxification or maintenance treatment of opioid addiction may be dispensed only by certified opioid treatment programs (42 CFR 8.12). Do not use it with significant breathing problems, acute or severe asthma without monitoring, a known or suspected bowel blockage, or a methadone allergy. Serotonin syndrome can occur with antidepressants, triptans and other serotonergic drugs. Tell your prescriber about every medicine and supplement you take, and ask about naloxone or nalmefene rescue medicine. LactMed reports that breastfed infants can become sleepy or have breathing problems, that several deaths of breastfed infants exposed to methadone in milk have been reported, and that other agents are preferred for pain control during breastfeeding; women stable on methadone maintenance in pregnancy are encouraged to breastfeed unless another reason prevents it. Get emergency help for extreme drowsiness, trouble breathing or seizures. For other side effects, talk to your prescriber or pharmacist.
Methadone is a mu-opioid agonist; the label notes data suggesting NMDA receptor antagonism of unknown clinical contribution. Oral bioavailability ranges from 36 to 100%, with peak plasma levels at 1 to 7.5 hours. It is 85 to 90% bound to alpha-1 acid glycoprotein and is N-demethylated by CYP3A4, 2B6, 2C19, 2C9 and 2D6 to the inactive metabolite EDDP. Terminal half-life ranged from 8 to 59 hours across studies, and tissue storage can prolong action despite low plasma levels. Labeled indications (SpecGx methadone hydrochloride tablets): severe and persistent pain requiring an opioid when alternatives are inadequate, not for as-needed use; detoxification and maintenance treatment of opioid addiction, subject to 42 CFR 8.12. StatPearls notes use for neonatal abstinence syndrome, which is not an FDA-approved indication. Dosing and titration are per prescriber; StatPearls describes a narrow therapeutic index, PDMP review, and a baseline ECG with follow-up. Monitor patients with QT risk factors during initiation and titration. Methadone is Schedule II. Under DEA rules, electronic prescribing of controlled substances is voluntary; the CMS EPCS Program requires prescribers to issue at least 70% of their qualifying Medicare Part D Schedule II to V prescriptions electronically each year, with an automatic exception for prescribers who issue 100 or fewer, and states may set their own requirements (Rhode Island, for example, requires electronic prescriptions for Schedule II to V).
Swallow each capsule whole with a glass of water, unless your label says otherwise. Do not crush, chew or open the capsule unless your pharmacist tells you it is safe to do so. Take it at the times shown on your prescription label. If you miss a dose or are unsure how to take it, call the pharmacy.
Capsules are nonaqueous, so under USP <795> they usually carry a beyond-use date of up to 180 days when no other stability data apply. Keep the vial tightly closed at room temperature, away from heat, moisture and direct light, and out of reach of children. Discard any capsules left after the beyond-use date on the label.
This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
This preparation is a controlled substance. Additional prescribing, refill, and shipping restrictions apply, and the states Bayview can dispense it to are narrower than for non-controlled preparations.
Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.
Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.
Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.
Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.
Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.
Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.
Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.
Take 1 capsule by mouth
