Nalex-DH

Generic Name: hydrocodone and phenylephrine (high droe KOE dohn and fen ill EH frin)
Brand Name: Lortuss HC, Nalex-DH

What is Nalex-DH (hydrocodone and phenylephrine)?

Hydrocodone is a narcotic. It is a pain reliever and a cough suppressant.

Phenylephrine is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in the body. Constriction of blood vessels in the sinuses and nose decreases congestion.

Hydrocodone and phenylephrine is used to treat cough and nasal congestion associated with the common cold, sinus infections, the flu, and bronchitis.

Hydrocodone and phenylephrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Nalex-DH (hydrocodone and phenylephrine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Hydrocodone and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking hydrocodone and phenylephrine.

Hydrocodone and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.

Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if hydrocodone and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

What should I discuss with my healthcare provider before taking Nalex-DH (hydrocodone and phenylephrine)?

Do not take hydrocodone and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), or selegiline (Eldepryl) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking hydrocodone and phenylephrine, tell your doctor if you have

  • epilepsy or another seizure disorder;

  • been diagnosed with sleep apnea (periods of not breathing during sleep);

  • thyroid problems;

  • asthma;

  • a head injury;

  • Addison's disease;

  • diabetes;

  • glaucoma;

  • bladder problems or difficulty urinating;

  • an enlarged prostate;

  • high blood pressure, irregular heartbeats, or any type of heart disease;

  • kidney problems; or

  • liver problems.

You may not be able to take hydrocodone and phenylephrine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Hydrocodone and phenylephrine is in the FDA pregnancy category C. This means that it is not known whether hydrocodone and phenylephrine will be harmful to an unborn baby. Do not take hydrocodone and phenylephrine without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Hydrocodone and phenylephrine passes into breast milk and may be harmful to a nursing baby. Do not take hydrocodone and phenylephrine without first talking to your doctor if you are breast-feeding a baby.

If you are over 65 years of age, you may be more likely to experience side effects from hydrocodone and phenylephrine. Your doctor may prescribe a lower dose of this medication.

How should I take Nalex-DH (hydrocodone and phenylephrine)?

Take hydrocodone and phenylephrine exactly as directed by your doctor. If you do not understand the directions on your prescription bottle, ask your pharmacist, nurse, or doctor to explain the instructions to you.

Hydrocodone and phenylephrine can be taken with or without food.

Take the oral tablets and capsules with a full glass of water.

To ensure that you get a correct dose, measure the liquid form of hydrocodone and phenylephrine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication or take it for longer than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if hydrocodone and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

Store hydrocodone and phenylephrine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a hydrocodone and phenylephrine overdose may include extreme drowsiness, dizziness, headache, seizures, dry mouth, cold and clammy skin, flushing, nausea, vomiting, difficult or decreased breathing, and unconsciousness.

What should I avoid while taking Nalex-DH (hydrocodone and phenylephrine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Hydrocodone and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking hydrocodone and phenylephrine.

Hydrocodone and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking hydrocodone and phenylephrine without first talking to your pharmacist or doctor. Other medications may also contain hydrocodone, phenylephrine, or other similar drugs, and you may accidentally take too much of these medicines.

Nalex-DH (hydrocodone and phenylephrine) side effects

If you experience any of the following serious side effects, stop taking hydrocodone and phenylephrine and seek emergency medical attention or contact your doctor immediately:

  • a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

  • confusion, hallucinations, or unusual behavior.

Other, less serious side effects may be more likely to occur. Continue to take hydrocodone and phenylephrine and talk to your doctor if you experience

  • dizziness, drowsiness, or sleepiness;

  • restlessness or irritability;

  • blurred vision;

  • constipation;

  • dry mouth;

  • nausea, vomiting, or decreased appetite;

  • muscle twitches;

  • sweating;

  • itching; or

  • decreased urination.

Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if hydrocodone and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Nalex-DH (hydrocodone and phenylephrine)?

Do not take hydrocodone and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), or selegiline (Eldepryl) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Hydrocodone and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking hydrocodone and phenylephrine without first talking to your pharmacist or doctor. Other medications may also contain hydrocodone, phenylephrine, or other similar drugs, and you may accidentally take too much of these medicines.

Drugs other than those listed here may also interact with hydrocodone and phenylephrine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

  • Your pharmacist has more information about hydrocodone and phenylephrine written for health professionals that you may read.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.04. Revision Date: 2010-12-15, 5:01:39 PM.

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