Recodex

Contraindications

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What is the most important information I should know about Recodex?

Recodex is contraindicated in:

Undesirable effects

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What are the possible side effects of Recodex?

Adverse reactions listed below have been reported in the literature for Codeine (Recodex) and Chlorpheniramine (Recodex) and may be expected to occur with Recodex. Also included are events which occurred during clinical pharmacokinetic studies (in a total of 147 healthy adult volunteers with either single or multiple dose exposure) with Recodex and judged by the investigator to be related to study treatment. There are insufficient data to support a statement regarding distribution of adverse events by gender, race and age.

Asthenia, feeling of relaxation, redness or flushing of the face, unusual tiredness or weakness.

Allergic laryngospasm, atelectasis, bronchospastic allergic reaction, hives, itching, swelling of face.

Fast, slow, or pounding heartbeat, hypertension, hypotension, orthostatic hypotension, palpitation, shock-like state, syncope.

Dermatitis, excessive perspiration, urticaria, erythema, pruritus, rash.

Changes in glucose utilization, decreased lactation, early menses, glycosuria, gynecomastia, hypoglycemia, increased appetite, increased libido, pheochromocytoma stimulation.

Abdominal distension, abdominal pain, acute pancreatitis, constipation, diarrhea, dry mouth, dyspepsia, epigastric distress, loss of appetite, nausea, vomiting; also observed with opioids: decreased gastric motility with increased likelihood of esophageal reflux.

Dysuria, irritative bladder symptoms, urinary frequency, urinary hesitancy, urinary retention, ureteral spasm.

Blurred, double, or other visual disturbances; confusion; dizziness; depression; drowsiness and sedation; headache; euphoria; facial dyskinesia; false sense of well-being; feeling faint, lightheadedness, general feeling of discomfort or illness; may cause excitability, especially in children; nervousness, agitation and restlessness; minimal sedation; somnolence; also observed with antihistamine agents: insomnia, dyskinesia, irritability, tremor.

Dryness of pharynx and respiratory passages, laryngismus, nasal stuffiness, wheezing or troubled breathing, respiratory depression.

Ears: labyrinthitis, tinnitus, vertigo; eyes: blurred vision, diplopia, hypermetropia, lacrimation increased, mydriasis, photophobia.

Drug fever.

Therapeutic indications

Recodex is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.

Important Limitations of Use

Not indicated for pediatric patients under 18 years of age.

Chlorpheniramine (Recodex) is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Codeine (Recodex) is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

Chlorpheniramine (Recodex) and Codeine (Recodex) is a combination medicine used to treat runny nose, sneezing, itching, watery eyes, and cough caused by allergies, the common cold, or the flu.

Chlorpheniramine (Recodex) and Codeine (Recodex) will not treat a cough that is caused by smoking, asthma, or emphysema.

Chlorpheniramine (Recodex) and Codeine (Recodex) may also be used for purposes not listed in this medication guide.

Name of the medicinal product

Special warnings and precautions for use

Use Recodex suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Recodex suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Drinking extra fluids while you are taking Recodex suspension is recommended. Check with your doctor for instructions.
• If you miss a dose of Recodex suspension and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Recodex suspension.

This combination product is used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (e.g., sinusitis, bronchitis). This product contains a narcotic cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, this product is not recommended to treat cold symptoms in children younger than 6 years. Some products (including some long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Giving more than the recommended dose or using this medication along with other cough-and-cold products has resulted in serious (even fatal) side effects, including slowed/stopped breathing. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients. Ask about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray). Do not use this product to make a child sleepy.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication may be taken with food or milk if stomach upset occurs. Do not take the sustained-release products more often than every 12 hours.

If you are using the liquid form, use a medication measuring device or spoon to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well before each dose.

If you are using the extended-release capsules, swallow them whole. Do not crush or chew extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

If you are using a sustained-release liquid that contains hydrocodone polistirex, do not mix the liquid with other liquids or medications. Doing so can destroy the long action of the drug and may increase side effects.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time (more than a few weeks) or in high doses. In such cases, withdrawal symptoms (such as anxiety, restlessness, sweating, shaking chills, nausea, vomiting, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit forming). Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.

When used for an extended time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Inform your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with fever, rash, or persistent headache. These may be symptoms of a serious medical problem and should be checked by a doctor.

Dosage (Posology) and method of administration

Recodex should be orally administered in a dose of 10 mL every 12 hours, not to exceed 2 doses (20 mL) in 24 hours.

Administer Recodex by the oral route only, with or without food. Shake well before use. Measure with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose.

Recodex is a pink to reddish pink, cherry-flavored liquid oral suspension.

Extended-release oral suspension contains: Codeine (Recodex) polistirex, which contains 14.7 mg of Codeine (Recodex) (equivalent to 20 mg Codeine (Recodex) phosphate), and Chlorpheniramine (Recodex) polistirex, which contains 2.8 mg of Chlorpheniramine (Recodex) (equivalent to 4 mg Chlorpheniramine (Recodex) maleate) per 5 mL.

Recodex is supplied as a pink to reddish pink, cherry-flavored liquid oral suspension containing Codeine (Recodex) polistirex, providing 14.7 mg of Codeine (Recodex) (equivalent to 20 mg Codeine (Recodex) phosphate), and Chlorpheniramine (Recodex) polistirex, providing 2.8 mg Chlorpheniramine (Recodex) (equivalent to 4 mg Chlorpheniramine (Recodex) maleate) per 5 mL. It is available in bottles of 16 fluid oz. (473 mL) NDC 69442-480-01.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F).

Shake well. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.

Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed.

Vernalis Therapeutics, Inc. Revised: April 2015

Interaction with other medicinal products and other forms of interaction

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What other drugs will affect Recodex?

Drug interaction studies have not been conducted with Recodex.

The use of opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol) concomitantly with Recodex may cause an additive CNS depressant effect and should be avoided.

Do not prescribe Recodex if the patient is taking a monoamine oxidase inhibitor (MAOI) (i.e., certain drugs used for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping a MAOI drug. The use of MAOIs or tricyclic antidepressants with Codeine (Recodex) preparations may increase the effect of either the antidepressant or Codeine (Recodex).

Codeine (Recodex) and Chlorpheniramine (Recodex) should be administered cautiously to persons receiving other anticholinergic drugs in order to avoid paralytic ileus and excessive anticholinergic effects.

Additive adverse effects resulting from cholinergic blockade (e.g., xerostomia, blurred vision, or constipation) may occur when anticholinergic drugs are administered with Chlorpheniramine (Recodex).

Codeine (Recodex) is metabolized by the CYP2D6 and CYP3A4 isoenzymes. The concurrent use of drugs that preferentially induce Codeine (Recodex) N-demethylation (via CYP3A4) may increase the plasma concentrations of Codeine (Recodex)'s inactive metabolite norcodeine. Drugs that inhibit Codeine (Recodex) O-demethylation (via CYP2D6) may decrease the plasma concentration of Codeine (Recodex)'s active metabolites, morphine and morphine-6-glucuronide. The contribution of these active metabolites to the overall antitussive effect of Codeine (Recodex) is not known but should be considered.

Adverse event reports in the literature suggest a possible drug interaction involving increased serum phenytoin levels and phenytoin toxicity when Chlorpheniramine (Recodex) and phenytoin are co-administered. The exact mechanism for this interaction is not known, however it is believed that Chlorpheniramine (Recodex) may inhibit the hepatic metabolism of phenytoin. Patients should be monitored for evidence of phenytoin toxicity such as ataxia, hyperreflexia, nystagmus and tremor when these two drugs are co-administered.

Recodex is a Schedule III controlled prescription product containing Codeine (Recodex) and should be prescribed and administered with caution.

Codeine (Recodex) can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of Recodex, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs.

Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, Recodex should be prescribed and administered with caution.

Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy.