Codistar

Codistar sulfate is an opioid analgesic indicated for the management of mild to moderately severe pain where the use of an opioid analgesic is appropriate.

Codistar is an opioid pain medication. An opioid is sometimes called a narcotic.

Codistar is used to treat mild to moderately severe pain.

Codistar may also be used for purposes not listed in this medication guide.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet,

Oral, as sulfate:

Generic: 15 mg, 30 mg, 60 mg

Dosing: Adult

Pain management (analgesic):

Injection [Canadian product]:

Opioid-naive patients: IM, SubQ: 30 to 60 mg every 4 to 6 hours as needed (use the lowest effective dose for the shortest period of time necessary)

Conversion from oral Codistar or another opioid: IM, SubQ: Refer to product labeling for dose conversions.

Oral: Note:

Immediate release (tablet, oral solution [Canadian product]): Initial: 15 to 60 mg every 4 hours as needed; maximum total daily dose: 360 mg/day; patients with prior opioid exposure may require higher initial doses. Note: The American Pain Society recommends an initial dose of 30 to 60 mg for adults with moderate pain (American Pain Society 2016).

Controlled release: Codistar Contin [Canadian product]: Note: Titrate at intervals of ≥48 hours until adequate analgesia has been achieved. Daily doses >600 mg/day should not be used; patients requiring higher doses should be switched to an opioid approved for use in severe pain. In patients who receive both Codistar Contin and an immediate release or combination Codistar product for breakthrough pain, the rescue dose of immediate release Codistar product should be ≤12.5% of the total daily Codistar Contin dose.

Opioid-naive patients: Initial: 50 mg every 12 hours

Conversion from immediate release Codistar preparations: Immediate release Codistar preparations contain ~75% Codistar base. Therefore, patients who are switching from immediate release Codistar preparations may be transferred to a ~25% lower total daily dose of Codistar Contin, equally divided into 2 daily doses every 12 hours.

Conversion from a combination Codistar product (eg, Codistar with acetaminophen or aspirin): See table:

Conversion from another opioid analgesic: Using the patient's current opioid dose, calculate an equivalent daily dose of immediate release Codistar. A ~25% lower dose of Codistar Contin should then be initiated, equally divided into 2 daily doses.

Discontinuation of therapy: When discontinuing chronic opioid therapy, the dose should be gradually tapered down. An optimal universal tapering schedule for all patients has not been established (CDC [Dowell 2016]). Proposed schedules range from slow (eg, 10% reductions per week) to rapid (eg, 25% to 50% reduction every few days) (CDC 2015). Tapering schedules should be individualized to minimize opioid withdrawal while considering patient-specific goals and concerns as well as the pharmacokinetics of the opioid being tapered. An even slower taper may be appropriate in patients who have been receiving opioids for a long duration (eg, years), particularly in the final stage of tapering, whereas more rapid tapers may be appropriate in patients experiencing severe adverse events (CDC [Dowell 2016]). Monitor carefully for signs/symptoms of withdrawal. If the patient displays withdrawal symptoms, consider slowing the taper schedule; alterations may include increasing the interval between dose reductions, decreasing amount of daily dose reduction, pausing the taper and restarting when the patient is ready, and/or coadministration of an alpha-2 agonist (eg, clonidine) to blunt withdrawal symptoms (Berna 2015; CDC [Dowell 2016]). Continue to offer nonopioid analgesics as needed for pain management during the taper; consider nonopioid adjunctive treatments for withdrawal symptoms (eg, GI complaints, muscle spasm) as needed (Berna 2015; Sevarino 2018).

Cough in select patients (off-label use):

Oral: Reported doses vary with a range of 7.5 to 120 mg/day as a single dose or in divided doses; however, evidence is of low quality (ACCP [Bolser 2006]; Smith 2010). Some experts recommend 30 to 60 mg 4 times daily in specific patient populations (eg, lung cancer) (ACCP [Molassiotis 2017]). Additional data may be necessary to further define the role of Codistar in this condition.

Diarrhea (persistent) (palliative care) (off-label use):

Oral: 15 to 30 mg every 4 hours as needed (von Gunten 2013). Additional data may be necessary to further define the role of Codistar in this condition.

Restless leg syndrome (off-label use):

Oral: Initial: 30 mg once daily at bedtime or during the night; may increase to 60 mg if needed; maximum dose: 180 mg in 2 to 3 divided doses. May be used alone or in combination with other medications used to treat RLS (Earley 2003; Sandyk 1987; Silbers 2013; Walters 2001).

Dosing: Geriatric

Refer to adult dosing. Use with caution and consider initiation at the low end of the dosing range; reduced initial dosages may be necessary.

Dosing: Pediatric

Note: Codistar 30 mg/5 mL oral solution has been discontinued in the US for more than 1 year. Doses should be titrated to appropriate analgesic effect; use the lowest effective dose for the shortest period of time:

Pain management; analgesia: Limited data available: Note: Use is contraindicated in pediatric patients <12 years of age and for postoperative management in pediatric patients 12 to 18 years of age who have undergone tonsillectomy and/or adenoidectomy. Avoid Codistar use in all pediatric patient populations in which it is contraindicated and in pediatric patients 12 to 18 years of age who have other risk factors that increase risk for respiratory depression associated with Codistar (eg, conditions associated with hypoventilation like postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, use of other medications known to depress respiratory drive); in rare cases in which Codistar-containing product is the only option, consider genotype testing prior to use; use extra precaution; monitor closely for adverse effects. Codistar has been associated with reports of life-threatening or fatal respiratory depression in children and adolescents; multifactorial causes have been identified; of primary concern are unrecognized ultrarapid metabolizers of CYP2D6 who may have extensive conversion of Codistar (prodrug) to morphine and thus increased opioid-mediated effects. Avoid Codistar use in pediatric patient populations in which it is contraindicated; in rare cases in which Codistar-containing product is the only option, consider genotype testing prior to use; use extra precaution; monitor closely for adverse effects (AAP [Tobias 2016]; Dancel 2017; Gammal 2016; Goldschneider 2017; Poonai 2015).

Children and Adolescents:

Oral: 0.5 to 1 mg/kg/dose every 4 to 6 hours as needed; maximum single dose: 60 mg/dose (APS 2016)

See also:
What is the most important information I should know about Codistar?

Codistar Sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy​​.

Codistar Sulfate is contraindicated in patients with known hypersensitivity to Codistar or any components of the product. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to Codistar.

Codistar Sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment​​.

Codistar Sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.

Codistar Sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus.

Use: Labeled Indications

Pain management: Management of mild- to moderately-severe pain

Limitations of use: Reserve Codistar for use in patients for whom alternative treatment options (eg, nonopioid analgesics, opioid combination products) are ineffective, not tolerated, or would be otherwise inadequate.

Off Label Uses

Cough in select patients

In a metaanalysis of trials evaluating the treatment of chronic cough, the use of Codistar demonstrated efficacy in patients with this condition.

See also:
What other drugs will affect Codistar?

When this drug applied simultaneously with:

- drugs have a depressing effect on the central nervous system (including those with opioid analgesics, barbiturates, benzodiazepines, clonidine) it is possible an increase the action of Codistar.

- derivatives of morphine it may increased the inhibitory action on the respiratory center; ibuprofen - analgesic effect is enhanced; carbamazepine - it may increased the analgesic effect is apparently due to increased formation of Codistar metabolite normorphine, which has a stronger effect.

- quinidine the analgesic effect of Codistar decreased or almost disappeared.

- Codistar increases the effect of ethanol on psychomotor function.

See also:
What are the possible side effects of Codistar?

Applies to Codistar: oral solution, oral syrup, oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by Codistar. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Codistar:

Incidence not known:

• Bloating
• blurred vision
• chills
• cold, clammy skin
• confusion
• constipation
• darkened urine
• difficult or troubled breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• fast, weak pulse
• feeling of warmth
• fever
• indigestion
• irregular, fast or slow, or shallow breathing
• lightheadedness
• loss of appetite
• nausea
• no blood pressure or pulse
• no breathing
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale or blue lips, fingernails, or skin
• redness of the face, neck, arms, and occasionally, upper chest
• shortness of breath
• stopping of the heart
• sweating
• unconsciousness
• unusual tiredness or weakness
• vomiting
• wheezing
• yellow eyes or skin

If any of the following symptoms of overdose occur while taking Codistar, get emergency help immediately:

Symptoms of overdose:

• Bluish lips or skin
• change in consciousness
• chest pain or discomfort
• constricted, pinpoint, or small pupils (black part of the eye)
• decreased awareness or responsiveness
• extreme sleepiness or unusual drowsiness
• loss of consciousness
• no blood pressure or pulse
• severe sleepiness
• slow or irregular heartbeat

Minor Side Effects

Some of the side effects that can occur with Codistar may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Drowsiness
• relaxed and calm

• Abdominal or stomach pain or cramps
• blurred or loss of vision
• diarrhea
• disturbed color perception
• double vision
• dry mouth
• false or unusual sense of well-being
• fear or nervousness
• feeling of constant movement of self or surroundings
• halos around lights
• headache
• hives or welts
• itching skin
• night blindness
• overbright appearance of lights
• redness of the skin
• sensation of spinning
• shakiness
• skin rash
• sleeplessness
• trouble sleeping
• tunnel vision
• unable to sleep
• weight loss

An opioid analgesic related to morphine but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough. [PubChem]