Hydrocodone and pseudoephedrine

Hydrocodone and pseudoephedrine combination is used in adults to relieve cough and nasal congestion (stuffy nose) caused by the common cold.

Hydrocodone is a narcotic antitussive (cough suppressant). It acts directly on the cough center in the brain to relieve cough. Pseudoephedrine is a decongestant, which decreases nasal congestion by narrowing the blood vessels and reducing blood flow to the nasal passage.

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 narcotics to relieve their cough. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

hydrocodone and pseudoephedrine is available only with your doctor's prescription.

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 hydrocodone and pseudoephedrine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hydrocodone and pseudoephedrine 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 hydrocodone and pseudoephedrine.

Pregnancy

Breast Feeding

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.

Interactions with Medicines

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 hydrocodone and pseudoephedrine, 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 hydrocodone and pseudoephedrine 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
• Nalmefene
• Naltrexone
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using hydrocodone and pseudoephedrine 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.

• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amineptine
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Anileridine
• Aprepitant
• Aripiprazole
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzphetamine
• Boceprevir
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clorazepate
• Clozapine
• Cocaine
• Codeine
• Conivaptan
• Cyclobenzaprine
• Dasabuvir
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Eletriptan
• Enflurane
• Erythromycin
• Escitalopram
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosaprepitant
• Fospropofol
• Frovatriptan
• Furazolidone
• Granisetron
• Guanethidine
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iobenguane I 123
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methyldopa
• Methylene Blue
• Midazolam
• Midodrine
• Milnacipran
• Mirtazapine
• Moclobemide
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nialamide
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ombitasvir
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Palonosetron
• Papaveretum
• Paregoric
• Paritaprevir
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Piperacetazine
• Pipotiazine
• Piritramide
• Posaconazole
• Prazepam
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Rasagiline
• Remifentanil
• Remoxipride
• Ritonavir
• Rizatriptan
• Saquinavir
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine

Interactions with Food/Tobacco/Alcohol

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 hydrocodone and pseudoephedrine 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 hydrocodone and pseudoephedrine, 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 hydrocodone and pseudoephedrine. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or
• Asthma or
• Diabetes or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Head injury, history of or
• Problems with passing urine or
• Stomach or bowel problems (eg, paralytic ileus) or
• Thyroid disease—Use with caution. May increase risk for more serious side effects.

• Heart disease (eg, coronary artery disease), severe or
• Hypertension (high blood pressure), severe or
• Narrow angle glaucoma or
• Urinary retention—Should not be used in patients with these conditions.

• 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.

It is very important that your doctor check your progress while you are using hydrocodone and pseudoephedrine. 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 symptoms do not improve or if they get worse, call your doctor.

Do not use hydrocodone and pseudoephedrine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

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.

hydrocodone and pseudoephedrine 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.

hydrocodone and pseudoephedrine may make you dizzy or drowsy. Make sure you know how you react to hydrocodone and pseudoephedrine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

hydrocodone and pseudoephedrine 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 narcotics, 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 hydrocodone and pseudoephedrine.

Using narcotics 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 hydrocodone and pseudoephedrine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, fever, high-pitched cry, irritability, shakiness or tremor, vomiting, weight loss, or failure to gain weight.

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
• Chest pain or pressure.
• Feeling confused.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Hallucinations (seeing or hearing things that are not there).
• Mood changes.
• Seizures.
• Very bad belly pain.
• Trouble passing urine.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Very hard stools (constipation).
• Feeling very tired or weak.
• Feeling very sleepy.
• This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.

Hydrocodone-pseudoephedrine has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted on this combination product. There are no controlled data on this combination product in human pregnancy. Hydrocodone-pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk.

There are no data on the excretion of hydrocodone and pseudoephedrine into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue hydrocodone and pseudoephedrine, taking into account the importance of hydrocodone and pseudoephedrine to the mother.