INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
Zamicet® (hydrocodone bitartrate and acetaminophen oral solution) is indicated for the relief of moderate to moderately severe pain. Zamicet® contains 10 mg Hydrocodone Bitartrate, 325 mg Acetaminophen and 6.7% Alcohol per 15 mL. Please see package insert for full prescribing information.
IMPORTANT SAFETY INFORMATION

Rx ONLY
Hepatotoxicity
ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.

Warning: May be habit forming. Zamicet® contains Hydrocodone, which is an opioid agonist and a Schedule II controlled substance with an abuse liability. Zamicet® can be abused in a manner similar to other opioid agonists, legal or illicit. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, these products should be prescribed and administered with caution.

CONTRAINDICATIONS
This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

WARNINGS
Serious Skin Reactions
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Hypersensitivity/Anaphylaxis: There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression. Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of
narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

PRECAUTIONS
General: As with any narcotic analgesic agent, Zamicet® should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture. Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with Zamicet® may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Zamicet® is used postoperatively and in patients with pulmonary disease. Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
Pregnancy: Zamicet® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn.
Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen oral solution and observed closely.
ADVERSE REACTIONS
The most frequently reported adverse reactions include lightheadedness, dizziness, sedation, nausea, and vomiting. Prolonged use may produce constipation.
 
INDICATIONS AND USAGE
Zamicet® (hydrocodone bitartrate and acetaminophen oral solution) is indicated for the relief of moderate to moderately severe pain. Zamicet® contains 10 mg Hydrocodone Bitartrate, 325 mg Acetaminophen and 6.7% Alcohol per 15 mL. Please see package insert for full prescribing information. IMPORTANT SAFETY INFORMATION

Rx ONLY WARNING
Hepatotoxicity
ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.


DOSAGE AND ADMINISTRATION*
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one tablespoonful (15 mL) every four to six hours as needed for pain.The total daily dosage should not exceed 6 tablespoonfuls. The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.20 mL/kg of Zamicet® (providing 0.135 mg/kg of hydrocodone bitartrate and 4.38 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.

CONTRAINDICATIONS
This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

WARNINGS
Serious Skin Reactions: Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Hypersensitivity/Anaphylaxis: There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression. Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
PRECAUTIONS
General: As with any narcotic analgesic agent, Zamicet® should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture. Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with Zamicet® may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Zamicet® is used postoperatively and in patients with pulmonary disease.
Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
Pregnancy: Zamicet® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen oral solution and observed closely.

ADVERSE REACTIONS
The most frequently reported adverse reactions include lightheadedness, dizziness, sedation, nausea, and vomiting. Prolonged use may produce constipation.
Cardio-renal: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension.
Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma.
Endocrine: Hypoglycemic coma.
Gastrointestinal System: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occults blood loss, nausea, peptic ulcer, and vomiting. Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention.
Hematologic: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia.
Hypersensitivity: Allergic reactions. Musculoskeletal: Skeletal muscle flaccidity.
Respiratory Depression: Acute airway obstruction, apnea, dose-related respiratory depression, shortness of breath.
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Skin: Cold and clammy skin, diaphoresis, pruritus, rash.
*
BODY WEIGHT APPROXIMATE AGE DOSE (every 4 to 6 hours) MAXIMUM TOTAL DAILY DOSE
(6 doses per day)
12 to 15 kg
(27 to 34 lbs)
2 to 3 years 2.8 mL (approx.
½ teaspoonful)
16.8 mL (approx.
3¼ teaspoonfuls)
16 to 22 kg
(35 to 50 lbs)
4 to 6 years 3.75 mL (approx.
¾ teaspoonful)
22.5 mL (approx.
4½ teaspoonfuls)
23 to 31 kg
(51 to 69 lbs)
7 to 9 years 5.6 mL (approx.
1 teaspoonful)
33.6 mL (approx.
6½ teaspoonfuls)
32 to 45 kg
(70 to 100 lbs)
10 to 13 years 7.5 mL (approx.
1½ teaspoonfuls)
45 mL (approx.
9 teaspoonfuls)
46 kg and up
(101 lbs and up)
14 years to adult 11.25 mL (approx.
2¼ teaspoonfuls)
67.5 mL (approx.
13½ teaspoonfuls)
adult 15 mL (1 Tablespoonful) 90 mL (6 Tablespoonfuls)
The total daily dosage for children should not exceed 6 doses per day. It is of utmost importance that the dose of Zamicet® be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that caregivers obtain and use a calibrated measuring device.Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage.