Codeine Sulfate

Name: Codeine Sulfate

Indications

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

Warnings

Included as part of the PRECAUTIONS section.

Interactions for Codeine Sulfate

Drugs Associated with Serotonin Syndrome

Risk of serotonin syndrome when used with other serotonergic drugs.400 May occur at usual dosages.400 Symptom onset generally occurs within several hours to a few days of concomitant use, but may occur later, particularly after dosage increases.400 (See Advice to Patients.)

If concomitant use of other serotonergic drugs is warranted, monitor patients for serotonin syndrome, particularly during initiation of therapy and dosage increases.400

If serotonin syndrome is suspected, discontinue codeine, other opiate therapy, and/or any concurrently administered serotonergic agents.400

Specific Drugs

Drug

Interaction

Comments

Anticholinergic agents

Possible paralytic ileusf

Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), SNRIs (e.g., desvenlafaxine, duloxetine, milnacipran, venlafaxine), tricyclic antidepressants (TCAs), mirtazapine, nefazodone, trazodone, vilazodone

Risk of serotonin syndrome400

TCAs: Opiates may potentiate antidepressant effectc

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, the antidepressant, and/or any concurrently administered opiates or serotonergic agents400

TCAs: Use with caution; reduce dosage of codeinec

Antiemetics, 5-HT3 receptor antagonists (e.g., dolasetron, granisetron, ondansetron, palonosetron)

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, the 5-HT3 receptor antagonist, and/or any concurrently administered opiates or serotonergic agents400

Buspirone

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, buspirone, and/or any concurrently administered opiates or serotonergic agents400

CNS depressants (e.g., opiate agonists, general anesthetics, tranquilizers, phenothiazines, sedatives/hypnotics, alcohol)

Additive CNS effectsa d e f

Reduce dosage of one or both agentsd e f

Cyclobenzaprine

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, cyclobenzaprine, and/or any concurrently administered opiates or serotonergic agents400

Dextromethorphan

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, dextromethorphan, and/or any concurrently administered opiates or serotonergic agents400

5-HT1 receptor agonists (triptans; e.g., almotriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan)

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, the triptan, and/or any concurrently administered opiates or serotonergic agents400

Lithium

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, lithium, and/or any concurrently administered opiates or serotonergic agents400

MAO inhibitors (e.g., isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, tranylcypromine)

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, the MAO inhibitor, and/or any concurrently administered opiates or serotonergic agents400

St. John’s wort (Hypericum perforatum)

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, St. John’s wort, and/or any concurrently administered opiates or serotonergic agents400

Tryptophan

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, tryptophan, and/or any concurrently administered opiates or serotonergic agents400

Codeine Sulfate Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration.a b e f g

Onset

Onset occurs in 15–30 minutes.a b Peak analgesic effects occur within 2 hours;g peak antitussive effects within 1–4 hours.i

Duration

Analgesic effects persist for 4–6 hours.b g Antitussive effects may persist for 4 hours.i

Distribution

Extent

Rapidly distributed into various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen, and kidney.g Distributed into milk.b Readily crosses the placenta.c

Protein Binding

Not bound to plasma proteins.g

Elimination

Metabolism

Metabolized in liver, principally by CYP3A4 and to a lesser extent (10%) by CYP2D6 to O-demethylated morphine, the active metabolite.b 108 109 110 112

Metabolism of codeine influenced by CYP2D6 polymorphism; genetic differences in drug metabolism affect drug response.108 109 110 112 114 Individuals may be described as poor, extensive, or ultrarapid metabolizers of CYP2D6 substrates.108 109 110 112 114

Elimination Route

Excreted mainly in urine with negligible amounts of codeine and its metabolites found in feces.b g

Half-life

About 2.5–3 hours.f g

Special Populations

Individuals who carry the genotype associated with ultrarapid metabolism of CYP2D6 substrates (approximately 1–7% of Caucasians, 10–30% of Ethiopians and Saudi Arabians) convert codeine to morphine more rapidly and completely than other individuals; ultrarapid metabolizers are likely to have higher than expected serum concentrations of morphine.107 108 110 112 114

Stability

Storage

Oral

Tablets

Tight, light-resistant containers at <40°C (preferably 15–30°C).b

Solution

Tight, light-resistant containers at <40°C (preferably 15–30°C).h Protect from freezing.h

Actions

  • Principal pharmacologic effects are on CNS and intestines.c d e

  • Mild analgesic effect.b d e f Acts at several sites within the CNS involving several systems of neurotransmitters to produce analgesia; precise mechanism of action not fully elucidated.c

  • Suppresses cough reflex by direct effect on cough center in medulla of brain.a

  • Exerts drying effect on respiratory tract mucosa and increases viscosity of bronchial secretions.a

  • Antitussive activity is less than that of morphine (on a weight basis).a

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Subject to control under the Federal Controlled Substances Act of 1970.d e

Codeine Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Crystals

Bulk

Powder

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Acetaminophen and Codeine Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

120 mg/5 mL Acetaminophen and Codeine Phosphate 12 mg/5 mL*

Acetaminophen and Codeine Phosphate Oral Solution (C-V)

Suspension

120 mg/5 mL Acetaminophen and Codeine Phosphate 12 mg/5 mL

Capital and Codeine (C-V)

Valeant

Tablets

300 mg Acetaminophen and Codeine Phosphate 15 mg*

Acetaminophen and Codeine Phosphate Tablets (C-III)

300 mg Acetaminophen and Codeine Phosphate 30 mg*

Acetaminophen and Codeine Phosphate Tablets (C-III)

Tylenol with Codeine No. 3 (C-III)

Janssen

300 mg Acetaminophen and Codeine Phosphate 60 mg*

Acetaminophen and Codeine Phosphate Tablets (C-III)

Tylenol with Codeine No. 4 (C-III)

Janssen

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Guaifenesin and Codeine Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

100 mg/5 mL Guaifenesin and Codeine Phosphate 10 mg/5 mL*

Cheratussin AC (C-V)

Qualitest

Guaiatussin AC (C-V)

Hi-Tech

Guaifenesin AC Cough Syrup (C-V)

Guaifenesin and Codeine Phosphate Oral Solution (C-V)

Robafen AC (C-V)

Major

200 mg/5 mL Guaifenesin and Codeine Phosphate 8 mg/5 mL

Codar GF (C-V)

Respa

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Other Codeine Phosphate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

30 mg with Acetaminophen 300 mg, Butalbital 50 mg, and Caffeine 40 mg*

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules (C-III)

Fioricet with Codeine (C-III)

Actavis

30 mg with Acetaminophen 325 mg, Butalbital 50 mg, and Caffeine 40 mg*

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules (C-III)

30 mg with Aspirin 325 mg, Butalbital 50 mg, and Caffeine 40 mg*

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules (C-III)

Fiorinal with Codeine (C-III)

Actavis

Solution

6.33 mg/5 mL with Brompheniramine Maleate 1.33 mg/5 mL and Pseudoephedrine Hydrochloride 10 mg/5 mL

Rydex (C-V)

Centurion

8 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL

Codar AR (C-V)

Respa

8 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Tricode AR (C-V)

Respa

8 mg/5 mL with Guaifenesin 200 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Tricode GF (C-V)

Respa

8 mg/5 mL with Pseudoephedrine Hydrochloride 30 mg/5 mL

Codar D (C-V)

Respa

9 mg/5 mL with Chlorcyclizine Hydrochloride 12.5 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Statuss Green (C-V)

Magna

9 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL

Z-Tuss AC (C-V)

Magna

9 mg/5 mL with Dexchlorpheniramine Maleate 1 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL

Pro-Red AC (C-V)

Pro-Pharma

9 mg/5 mL with Guaifenesin 200 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Z-Tuss E (C-V)

Magna

9 mg/5 mL with Pyrilamine Maleate 8.33 mg/5 mL

Pro-Clear AC (C-V)

Pro-Pharma

10 mg/5 mL with Brompheniramine Maleate 4 mg/5 mL and Phenylephrine Hydrochloride 7.5 mg/5 mL

Poly-tussin AC (C-V)

Poly

10 mg/5 mL with Chlorcyclizine Hydrochloride 9.375 mg/5 mL

Poly-tussin (C-V)

Poly

10 mg/5 mL with Chlorcyclizine Hydrochloride 9.375 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Poly-tussin D (C-V)

Poly

10 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL

EndaCof-C (C-V)

Larken

10 mg/5 mL with Guaifenesin 100 mg/5 mL and Pseudoephedrine Hydrochloride 22.5 mg/5 mL

Lortuss EX (C-V)

Poly

10 mg/5 mL with Guaifenesin 100 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL*

Cheratussin DAC (C-V)

Qualitest

Guaifenesin DAC Syrup (C-V)

10 mg/5 mL with Phenylephrine Hydrochloride 5 mg/5 mL and Promethazine Hydrochloride 6.25 mg/5 mL*

Promethazine VC with Codeine Syrup (C-V)

10 mg/5 mL with Phenylephrine Hydrochloride 7.5 mg/5 mL

Ala-Hist AC (C-V)

Poly

10 mg/5 mL with Promethazine Hydrochloride 6.25 mg/5 mL*

Promethazine Hydrochloride with Codeine Phosphate Oral Solution (C-V)

10 mg/5 mL with Pseudoephedrine Hydrochloride 30 mg/5 mL and Pyrilamine Maleate 15 mg/5 mL

Neo AC (C-V)

Laser

10 mg/5 mL with Pseudoephedrine Hydrochloride 30 mg/5 mL and Triprolidine Hydrochloride 1.25 mg/5 mL

Triacin-C (C-V)

STI Pharma

Tablets

16 mg with Aspirin 325 mg and Carisoprodol 200 mg*

Carisoprodol, Aspirin, and Codeine Phosphate Tablets (C-III)

Soma Compound with Codeine (C-III)

Meda

Also commercially available in combination with other antihistamines, decongestants, and expectorants.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Codeine Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder

Oral

Solution

30 mg/5 mL*

Codeine Sulfate Oral Solution (C-II)

Tablets

15 mg*

Codeine Sulfate Tablets (C-II)

30 mg*

Codeine Sulfate Tablets (C-II)

60 mg*

Codeine Sulfate Tablets (C-II)

Indications and Usage for Codeine Sulfate

Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve 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.

Drug Interactions

Table 1 includes clinically significant drug interactions with Codeine Sulfate Tablets.

Table 1: Clinically Significant Drug Interactions with Codeine Sulfate Tablets

Inhibitors of CYP3A4

Clinical Impact:

The concomitant use of Codeine Sulfate Tablets with CYP3A4 inhibitors, may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Codeine Sulfate Tablets is achieved [see Warnings and Precautions (5.5)].

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower codeine levels, greater norcodeine levels, and less metabolism via CYP2D6 with resultant lower morphine levels [see Clinical Pharmacology (12.3)], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to codeine.

Intervention:

If concomitant use of CYP3A4 inhibitor is necessary, consider dosage reduction of Codeine Sulfate Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.

If a CYP3A4 inhibitor is discontinued, consider increasing the Codeine Sulfate Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.

Examples:

Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir)

CYP3A4 Inducers

Clinical Impact:

The concomitant use of Codeine Sulfate Tablets and CYP3A4 inducers can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [see Clinical Pharmacology (12.3)], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence [see Warnings andPrecautions (5.5)].

After stopping a CYP3A4 inducer, as the effects of the inducer decline, codeine plasma concentrations may increase with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels [see Clinical Pharmacology(12.3)], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

Intervention:

If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy and signs of opioid withdrawal and consider increasing the Codeine Sulfate Tablets dosage as needed.

If a CYP3A4 inducer is discontinued, consider Codeine Sulfate Tablets dosage reduction and monitor for signs of respiratory depression and sedation at frequent intervals.

Examples:

Rifampin, carbamazepine, phenytoin

Inhibitors of CYP2D6

Clinical Impact:

Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Codeine Sulfate Tablets and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced analgesic efficacy or symptoms of opioid withdrawal, particularly when an inhibitor is added after a stable dose of Codeine Sulfate Tablets is achieved [see Clinical Pharmacology (12.3)].

After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the codeine plasma concentration will decrease but the active metabolite morphine plasma concentration will increase, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression [see Clinical Pharmacology (12.3)].

Intervention:

If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of Codeine Sulfate Tablets and monitor patients closely at frequent intervals.

If concomitant use with CYP2D6 inhibitors is necessary, follow the patient for reduced efficacy or signs and symptoms of opioid withdrawal and consider increasing the Codeine Sulfate Tablets as needed.

After stopping use of a CYP2D6 inhibitor, consider reducing the Codeine Sulfate Tablets and monitor the patient for signs and symptoms of respiratory depression or sedation.

Examples

Paroxetine, fluoxetine, bupropion, quinidine.

Benzodiazepines and Other Central Nervous System (CNS) Depressants

Clinical Impact:

Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.

Intervention:

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see Warnings and Precautions (5.6)].

Examples:

Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.

Serotonergic Drugs

Clinical Impact:

The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.

Intervention:

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Codeine Sulfate Tablets if serotonin syndrome is suspected.

Examples:

Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Monoamine Oxidase Inhibitors (MAOIs)

Clinical Impact:

MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.8)].

Intervention:

Do not use Codeine Sulfate Tablets in patients taking MAOIs or within 14 days of stopping such treatment.

If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.

Examples:

Phenelzine, tranylcypromine, linezolid.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics

Clinical Impact:

May reduce the analgesic effect of Codeine Sulfate Tablets and/or precipitate withdrawal symptoms.

Intervention:

Avoid concomitant use.

Examples:

Butorphanol, nalbuphine, pentazocine, buprenorphine.

Muscle Relaxants

Clinical Impact:

Codeine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Intervention:

Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Codeine Sulfate Tablets and/or the muscle relaxant as necessary.

Diuretics

Clinical Impact:

Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.

Intervention:

Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.

Anticholinergic Drugs

Clinical Impact:

The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

Intervention:

Monitor patients for signs of urinary retention or reduced gastric motility when Codeine Sulfate Tablets are used concomitantly with anticholinergic drugs.

Medication Guide

Codeine Sulfate (koe’ deen sul’ fate) Tablets USP CII

Codeine Sulfate Tablets are:

• 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. • 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.

Important information about Codeine Sulfate Tablets:

• Get emergency help right away if you take too much Codeine Sulfate Tablets (overdose). When you first start taking Codeine Sulfate Tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. • Taking Codeine Sulfate Tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. • Never give anyone else your Codeine Sulfate Tablets. They could die from taking it. Store Codeine Sulfate Tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away Codeine Sulfate Tablets is against the law.

Important Information Guiding Use in Pediatric Patients:

• 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.

Do not take Codeine Sulfate Tablets if you have:

• 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.

Before taking Codeine Sulfate Tablets, tell your healthcare provider if you have a history of:
• Head injury, seizures • Problems urinating • Abuse of street or prescription drugs, alcohol addiction, or mental health problems. • Liver, kidney, thyroid problems • Pancreas or gallbladder problems • Have been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines

Tell your healthcare provider if you are:

• Pregnant or planning to become pregnant. Prolonged use of Codeine Sulfate during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. • Breastfeeding. Not recommended; may harm your baby. • Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Codeine Sulfate with certain other medicines can cause serious side effects that could lead to death.

When taking Codeine Sulfate Tablets:

• 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. • After you stop taking Codeine Sulfate Tablets, dispose the unused Codeine Sulfate Tablets in accordance with the local state guidelines and/or regulations.

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.

The possible side effects of Codeine Sulfate Tablets:

• Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. • If you are a nursing mother taking Codeine Sulfate Tablets and your breastfeeding baby has: increased sleepiness, confusion, difficulty breathing, shallow breathing, limpness, or difficulty breastfeeding.

These are not all the possible side effects of Codeine Sulfate. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

For more information, please call West-Ward Pharmaceuticals at 1-800-962-8364.

This Medication Guide has been approved by the U.S. Food and Drug Administration

10005657/10

Revised August 2017

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