Zutripro

No human overdosage data are available for ZUTRIPRO® Oral Solution.

Hydrocodone

Overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

Pseudoephedrine

Overdosage with sympathomimetics such as pseudoephedrine may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscle weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusion and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsion, coma, and respiratory failure.

Chlorpheniramine

Manifestations of chlorpheniramine overdosage may vary from central nervous system depression to stimulation. Central toxic effects are characterized by agitation, anxiety, delirium, disorientation, hallucinations, hyperactivity, sedation, and seizures. Severe overdosage may produce coma, medullary paralysis, and death. Peripheral toxicity includes hypertension, tachycardia, dysrhythmias, vasodilation, hyperpyrexia, mydriasis, urinary retention, and diminished gastrointestinal motility. Dry mouth, pharynx, bronchi, and nasal passages may be observed.

Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia.

An adult ingested 400 mg chlorpheniramine with no reported serious adverse effects. Toxic psychosis, a possible class effect from overdose of sedating antihistamines, has been reported with accidental overdose of chlorpheniramine.

Treatment of overdosage consists of discontinuation of ZUTRIPRO® Oral Solution together with institution of appropriate therapy. Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

Hemodialysis is not routinely used to enhance the elimination of chlorpheniramine from the body. Urinary excretion of chlorpheniramine is increased when the pH of the urine is acidic; however, acid diuresis is NOT recommended to enhance elimination in overdose, as the risks of acidemia and acute tubular necrosis in patients with rhabdomyolysis far outweigh any potential benefit.

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 medicines, hydrocodone can slow your breathing. Death may occur if breathing becomes too weak.

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

• severe drowsiness, dizziness, or weakness;

• noisy breathing, sighing, shallow breathing;

• a slow heart rate or weak pulse;

• tremors, irregular heartbeats, trouble sleeping;

• severe anxiety, confusion, fear;

• severe constipation, stomach pain;

• a seizure; or

• a light-headed feeling, like you might pass out.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

• trouble breathing;

• drowsiness;

• mood changes;

• nausea, vomiting; or

• little or no urination.

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.

In the U.S.

• Hydron PSC
• Hyphed
• Notuss-Forte
• Zutripro

In Canada

• Vasofrinic Dh

Available Dosage Forms:

• Liquid
• Tablet
• Suspension
• Solution
• Syrup
• Capsule

Therapeutic Class: Antitussive, Opioid/Antihistamine/Decongestant Combination

Pharmacologic Class: Chlorpheniramine

Chemical Class: Hydrocodone

• It is used to prevent nose stuffiness.
• It is used to ease allergy signs.
• It is used to relieve coughing.

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.
• Very bad headache.
• 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.
• Trouble controlling body movements.
• Restlessness.
• This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.

Administer Zutripro Oral Solution by the oral route only. Measure Zutripro Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see Warnings and Precautions (5.10)].

Adults 18 Years of Age and Older

5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours.

No human overdosage data are available for Zutripro Oral Solution.

Hydrocodone:

Overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

Pseudoephedrine:

Overdosage with sympathomimetics such as pseudoephedrine may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscle weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusion and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsion, coma, and respiratory failure.

Chlorpheniramine:

Manifestations of chlorpheniramine overdosage may vary from central nervous system depression to stimulation. Central toxic effects are characterized by agitation, anxiety, delirium, disorientation, hallucinations, hyperactivity, sedation, and seizures. Severe overdosage may produce coma, medullary paralysis, and death. Peripheral toxicity includes hypertension, tachycardia, dysrhythmias, vasodilation, hyperpyrexia, mydriasis, urinary retention, and diminished gastrointestinal motility. Dry mouth, pharynx, bronchi, and nasal passages may be observed.

Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia.

An adult ingested 400 mg chlorpheniramine with no reported serious adverse effects. Toxic psychosis, a possible class effect from overdose of sedating antihistamines, has been reported with accidental overdose of chlorpheniramine.

Treatment of overdosage consists of discontinuation of Zutripro Oral Solution together with institution of appropriate therapy. Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

Hemodialysis is not routinely used to enhance the elimination of chlorpheniramine from the body. Urinary excretion of chlorpheniramine is increased when the pH of the urine is acidic; however, acid diuresis is NOT recommended to enhance elimination in overdose, as the risks of acidemia and acute tubular necrosis in patients with rhabdomyolysis far outweigh any potential benefit.

Efficacy studies were not conducted with Zutripro Oral Solution. Efficacy of Zutripro Oral Solution is based on demonstration of bioequivalence to the individual reference products [see Pharmacokinetics (12.3)].

NDC 63717-876-16

Zutripro® CII
(Hydrocodone Bitartrate,
Chlorpheniramine Maleate and
Pseudoephedrine HCl) Oral Solution

5 mg/4mg/60 mg per 5 mL

Contains:

Hydrocodone
Bitartrate
5 mg/5 mL
WARNING: May be habit forming.

Chlorpheniramine
Maleate
4 mg/5 mL

Pseudoephedrine
Hydrochloride
60 mg/5 mL

PHARMACIST: Dispense the enclosed
Medication Guide to each patient.

Rx Only

HAWTHORN
PHARMACEUTICALS, INC.

16 fl oz (480 mL)

Do not take Zutripro if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use Zutripro before the MAO inhibitor has cleared from your body. You should not use Zutripro Oral Solution if you are allergic to chlorpheniramine, hydrocodone, or pseudoephedrine.

To make sure you can safely take Zutripro, tell your doctor if you have any of these other conditions:

• asthma, COPD, sleep apnea, or other breathing disorder;

• liver or kidney disease;

• heart disease or high blood pressure;

• diabetes;

• a thyroid disorder;

• curvature of the spine;

• a history of head injury or brain tumor;

• epilepsy or other seizure disorder;

• low blood pressure;

• glaucoma;

• gallbladder disease;

• Addison's disease or other adrenal gland disorders;

• enlarged prostate, urination problems;

• mental illness; or

• a history of drug or alcohol addiction.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep Zutripro in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether Zutripro will harm an unborn baby. Hydrocodone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using Zutripro. It is not known whether chlorpheniramine, hydrocodone, or pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use Zutripro without telling your doctor if you are breast-feeding a baby.