Description
Hydrocodone and pseudoephedrine combination is used in adults to relieve cough and nasal congestion (stuffy nose) caused by the common cold.
Hydrocodone is an opioid antitussive (cough suppressant). It acts directly on the cough center in the brain to relieve a cough. Pseudoephedrine is a decongestant, which decreases nasal congestion by narrowing the blood vessels and reducing blood flow to the nasal passages.
When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing cough and nasal congestion should not let the fear of dependence keep them from using opioids to relieve their cough. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms if treatment is stopped suddenly. However, severe withdrawal symptoms can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
This medicine is available only with your doctor's prescription.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Use of hydrocodone and pseudoephedrine combination is not indicated in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and pseudoephedrine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Dihydroergotamine
- Furazolidone
- Iproniazid
- Isocarboxazid
- Linezolid
- Methylene Blue
- Moclobemide
- Naltrexone
- Nialamide
- Phenelzine
- Procarbazine
- Rasagiline
- Safinamide
- Samidorphan
- Selegiline
- Tranylcypromine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Acepromazine
- Aclidinium
- Alfentanil
- Almotriptan
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anileridine
- Apalutamide
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asenapine
- Atazanavir
- Atropine
- Avacopan
- Baclofen
- Belladonna
- Belzutifan
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
- Benzphetamine
- Benzthiazide
- Benztropine
- Berotralstat
- Biperiden
- Boceprevir
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison's disease (adrenal gland problem) or
- Alcohol use disorder, history of or
- Brain tumor or
- Chronic obstructive pulmonary disease (COPD) or
- Diabetes or
- Drug dependence, especially opioid use disorder or dependence, or history of or
- Enlarged prostate (eg, BPH, prostatic hypertrophy) or
- Gallbladder disease or
- Head injury, history of or
- Increased pressure in the head or
- Pancreatitis, acute (swelling of the pancreas) or
- Seizures, history of or
- Thyroid disease—Use with caution. May increase risk for more serious side effects.
- Asthma, acute or severe or
- Heart disease (eg, coronary artery disease), severe or
- Hypertension (high blood pressure), severe or
- Narrow-angle glaucoma or
- Respiratory depression (very slow breathing) or
- Stomach or bowel problems (eg, paralytic ileus), known or suspected or
- Urinary retention (problems with passing urine)—Should not be used in patients with these conditions.
- Hypotension (low blood pressure)—Use with caution. May make this condition worse.
- Kidney disease, severe or
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Measure the oral liquid correctly using the marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Ask your pharmacist for instructions for measuring the correct dose of this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (solution):
- For relief of cough and nasal congestion:
- Adults—5 milliliters (mL) every 4 to 6 hours as needed. However, the dose is usually not more than 4 doses (20 mL) in 24 hours.
- Children—Use is not recommended.
- For relief of cough and nasal congestion:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If your cough does not improve or if it gets worse within 5 days, call your doctor.
It is against the law and dangerous for anyone else to use your medicine. Keep your unused oral liquid in a safe and secure place.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Symptoms of an overdose include: extreme dizziness or weakness, trouble breathing, slow heartbeat or breathing, seizures, and cold, clammy skin. In case of an overdose, call your doctor right away.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or opioids, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.
Using too much of this medicine may cause an overdose, which can be life-threatening. Signs of an overdose include: change in consciousness, cold, clammy skin, dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, loss of consciousness, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, sleepiness or unusual drowsiness, or yellow eyes or skin. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary.
Using opioids for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.
This medicine may cause adrenal insufficiency. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
If you are especially sensitive to the effects of this medicine, do not suddenly stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Blurred vision
- confusion
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting
- fast, slow, or irregular heartbeat
- sweating
- unusual tiredness or weakness
Incidence not known
- Bloating
- bulging soft spot on the head of an infant
- change in the ability to see colors, especially blue or yellow
- decrease in the frequency of urination
- decrease in urine volume
- diarrhea
- difficult or painful urination
- difficult or troubled breathing
- difficulty having a bowel movement
- difficulty in passing urine (dribbling)
- drowsiness
- frequent urge to urinate
- headache
- irregular, fast or slow, or shallow breathing
- loss of appetite
- nervousness
- pale or blue lips, fingernails, or skin
- pounding in the ears
- seizures
- shakiness in the legs, arms, hands, or feet
- stomach cramps or pain
- trembling or shaking of the hands or feet
- trouble with sleeping
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Fear
- mood changes
- nausea
- relaxed and calm feeling
- sleepiness
- unusual drowsiness, dullness, or feeling of sluggishness
Incidence not known
- Itching or skin rash
- weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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