Levall 5.0

 
Generic Name: guaifenesin, hydrocodone, and phenylephrine

Brands: Atuss G, Donatussin DC, Entex HC, Levall 5.0, Tussafed-HC, Tussafed-HCG

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What is the most important information I should know about Levall 5.0?

· Use caution when driving, operating machinery, or performing other hazardous activities. Levall 5.0 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 Levall 5.0.

· Levall 5.0 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 Levall 5.0 is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

 

What is Levall 5.0?

· Guaifenesin is an expectorant. Guaifenesin loosens phlegm and increases the lubrication of the lungs allowing for a productive cough and decreased chest congestion.

· 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.

· Levall 5.0 is used to treat cough and nasal congestion associated with the common cold, sinus infections, the flu, and bronchitis.

· Levall 5.0 may also be used for purposes other than those listed in this medication guide.

 

What should I discuss with my healthcare provider before taking Levall 5.0?

· Do not take Levall 5.0 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 drug interaction could occur, leading to serious side effects.

· Before taking Levall 5.0, 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 Levall 5.0, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

· Levall 5.0 is in the FDA pregnancy category C. This means that it is not known whether Levall 5.0 will be harmful to an unborn baby. Do not take Levall 5.0 without first talking to your doctor if you are pregnant or could become pregnant during treatment.

· Levall 5.0 passes into breast milk and may be harmful to a nursing baby. Do not take Levall 5.0 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 Levall 5.0. Your doctor may prescribe a lower dose of this medication.

 

How should I take Levall 5.0?

· Take Levall 5.0 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.

· Levall 5.0 can be taken with or without food.

· To ensure that you get a correct dose, measure the liquid form of Levall 5.0 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 Levall 5.0 is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

· Store Levall 5.0 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 Levall 5.0 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 Levall 5.0?

· Use caution when driving, operating machinery, or performing other hazardous activities. Levall 5.0 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 Levall 5.0.

· Levall 5.0 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 Levall 5.0 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.

 

What are the possible side effects of Levall 5.0?

· If you experience any of the following serious side effects, stop taking Levall 5.0 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 Levall 5.0 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 Levall 5.0 is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

 

What other drugs will affect Levall 5.0?

· Do not take Levall 5.0 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 drug interaction could occur, leading to serious side effects.

· Levall 5.0 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 without first talking to your doctor.

· Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking Levall 5.0 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 Levall 5.0. 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 Levall 5.0 written for health professionals that you may read.

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