Zutripro

Zutripro (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride) is a combination of a semisynthetic centrally-acting opioid antitussive (anti-cough), an antihistamine, and an indirect sympathomimetic amine indicated for relief of cough and nasal congestion associated with the common cold and for relief of symptoms including nasal congestion associated with upper respiratory allergies in adults 18 years of age and older. Side effects of Zutripro include lethargy, headache, euphoria, tremor, irritability, drowsiness, dizziness, blurred vision, upset stomach, nausea, constipation, dry mouth/nose/throat, low blood pressure, lightheadedness, weakness, and general feeling of being unwell (malaise).

Zutripro is supplied as a clear, colorless to light yellow, grape-flavored solution containing strengths of 5 mg hydrocodone bitartrate, 4 mg chlorpheniramine maleate, and 60 mg pseudoephedrine hydrochloride in each 5 mL dose. Zutripro is dosed in 5 mL of solution every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to over dosage, especially when half a teaspoon is measured. Zutripro contains hydrocodone bitartrate, which can cause dose-related respiratory depression. Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Zutripro. The use of MAOIs or tricyclic antidepressants with hydrocodone bitartrate, one of the active ingredients in Zutripro Oral Solution, may increase the effect of either the antidepressant or hydrocodone. Patients should be advised to avoid the use of alcohol and other central nervous system depressants while taking Zutripro Oral Solution because additional reduction in mental alertness may occur; patients should not drive or do other tasks if mental alertness is compromised with this drug. Serious side effects include cardiac arrhythmias, ileus, hyper or hypotension and dependence. As with all opioids, administration of Zutripro Oral Solution to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used. Caution should be exercised when Zutripro is administered to nursing mothers. Hydrocodone, chlorpheniramine and pseudoephedrine are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Zutripro Oral Solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Zutripro is not used in children under the age of 18 years old.

Our Zutripro (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Zutripro Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medications, hydrocodone can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Stop taking this medicine and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing;
• a slow heart rate or weak pulse;
• fast heartbeats, dizziness, weakness, tremors, trouble sleeping;
• a seizure;
• a light-headed feeling, like you might pass out;
• severe constipation;
• little or no urination; or
• adrenal gland problems-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

• drowsiness, dizziness;
• lack of energy, coordination problems;
• headache, confusion;
• dry mouth, nausea, vomiting, constipation;
• tremors, fast or irregular heart rate; or
• feeling anxious, restless, nervous, or irritable.

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.

Read the entire detailed patient monograph for Zutripro (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride)

 

Zutripro Professional Information

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

• Addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence]
• Life-threatening respiratory depression [see WARNINGS AND PRECAUTIONS, OVERDOSE]
• Accidental overdose and death due to medication errors [see WARNINGS AND PRECAUTIONS]
• Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]
• Interactions with benzodiazepines and other CNS depressants [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS]
• Paralytic ileus, gastrointestinal adverse reactions [see WARNINGS AND PRECAUTIONS]
• Increased intracranial pressure [see WARNINGS AND PRECAUTIONS]
• Obscured clinical course in patients with head injuries [see WARNINGS AND PRECAUTIONS]
• Cardiovascular and CNS effects [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]
• Severe hypotension [see WARNINGS AND PRECAUTIONS]
• Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
• Adrenal insufficiency [see WARNINGS AND PRECAUTIONS]

The following adverse reactions have been identified during clinical studies, in the literature, or during postapproval use of hydrocodone, chlorpheniramine, and/or pseudoephedrine. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The Most Common Adverse Reactions To ZUTRIPRO Include

Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation tachycardia, arrhythmias including premature ventricular contractions, CNS stimulation including anxiety, restlessness, nervousness, tremor, and irritability.

Other Reactions Include

Anaphylaxis: Anaphylaxis has been reported with hydrocodone, one of the ingredients in ZUTRIPRO.

Body as a whole: Coma, death, fatigue, falling injuries, lethargy, weakness, hyperthermia, ataxia, vertigo.

Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush, atrial fibrillation, myocardial infarction.

Central Nervous System: Facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor.

Dermatologic: Flushing, hyperhidrosis, pruritus, rash. Cases of severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.

Endocrine/Metabolic: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Gastrointestinal: Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi), dysgeusia, ischemic colitis.

Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention.

Hematologic: Agranulocytosis, aplastic anemia, and thrombocytopenia have been reported.

Laboratory: Increases in serum amylase.

Musculoskeletal: Arthralgia, backache, muscle spasm.

Ophthalmic: Miosis (constricted pupils), visual disturbances, mydriasis (dilated pupils), blurred vision, diplopia.

Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression, hyperactivity, ataxia, confusion, hallucinations, hyperexcitability.

Reproductive: Hypogonadism, infertility.

Respiratory: Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, upper respiratory tract infection, thickening of bronchial secretions, tightness of chest and wheezing, dry nose, dry throat, tinnitus.

Other: Drug abuse, drug dependence, opioid withdrawal syndrome.

Read the entire FDA prescribing information for Zutripro (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride)