The following Structured Product Label (SPL) was submitted to the FDA by Kvk-tech, Inc. for the product Hydrocodone Bitartrate And Homatropine Methylbromide (NDC 10702-055). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding boxed warning, description, clinical pharmacology, indications and usage, contraindications, risks from concomitant use with benzodiazepines or other cns depressants, respiratory depression, head injury and increased intracranial pressure, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Concomitant use of opioid with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see WARNINGS, PRECAUTIONS – Drug Interactions). Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.
Hydrocodone Bitartrate and Homatropine Methylbromide Tablet, USP contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting opioid antitussive. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage.
Each Hydrocodone Bitartrate and Homatropine Methylbromide Tablet, USP contains:
Hydrocodone Bitartrate, USP 5 mg
Homatropine Methylbromide, USP 1.5 mg
Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP also contain: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate and pregelatinized starch.
The hydrocodone component is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one-tartrate (1:1) hydrate (2:5), a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine, has a molecular weight of (494.50), and may be represented by the following structural formula:
Homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide,endo-; a white crystal or fine white crystalline powder, with a molecular weight of (370.29).
Hydrocodone is a semisynthetic opioid antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, physical and physiological dependence.
Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β-hydroxymetabolites.
Hydrocodone bitartrate and homatropine methylbromide tablets are indicated for the symptomatic relief of cough in adults and children 6 years of age and older.
Hydrocodone bitartrate and homatropine methylbromide tablets should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.
Concomitant use of opioids, including hydrocodone bitartrate and homatropine methylbromide tablets, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedations, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol (see PRECAUTIONS – Drug Interactions ).
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.
Advise both patients and caregivers about the risks of respiratory depression and sedation if hydrocodone bitartrate and homatropine methylbromide tablets are used with benzodiazepines, alcohol, or other CNS depressants (see PRECAUTIONS – Information for Patients ).
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 hydrocodone bitartrate and homatropine methylbromide tablets and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs (see DRUG ABUSE AND DEPENDENCE).
The use of hydrocodone bitartrate and homatropine methylbromide tablets is not recommended for use in children less than 6 years of age because of the risk of fatal respiratory depression (see ADVERSE REACTIONS- Respiratory Depression ). Hydrocodone bitartrate and homatropine methylbromide tablet produces dose-related respiratory depression by directly acting on brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated.
The respiratory depression properties of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.
The administration of hydrocodone bitartrate and homatropine methylbromide tablets or other opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of opioid cough suppressants in a dose-dependent manner. Caution should be exercised when administering hydrocodone bitartrate and homatropine methylbromide tablets to pediatric patients 6 years of age and older because of the potential for fatal respiratory depression. Overdose or concomitant administration of hydrocodone bitartrate and homatropine methylbromide tablets with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered especially in the pediatric population with respiratory embarrassment (e.g., croup) (see PRECAUTIONS).
Safety and effectiveness of hydrocodone bitartrate and homatropine methylbromide tablets in pediatric patients under six have not been established. The use of hydrocodone bitartrate and homatropine methylbromide tablets in children less than 6 years of age has been associated with cases of fatal respiratory depression (see ADVERSE REACTIONS- Respiratory Depression ). Hydrocodone bitartrate and homatropine methylbromide tablets should be used with caution in pediatric patients 6 years of age and older (see WARNINGS-Pediatric Use).
Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is provided.
Hydrocodone bitartrate and homatropine methylbromide tablets should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal functions, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture, asthma, and narrow-angle glaucoma.
Inform patients and caregivers that potentially fatal additive effects may occur if hydrocodone bitartrate and homatropine methylbromide tablets are used with benzodiazepines or other CNS depressants, including alcohol. Because of this risk, patients should avoid concomitant use of hydrocodone bitartrate and homatropine methylbromide tablets with benzodiazepines or other CNS depressants, including alcohol (see WARNINGS, PRECAUTIONS – Drug Interactions).
Hydrocodone may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using hydrocodone bitartrate and homatropine methylbromide tablets should be cautioned accordingly.
The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and homatropine methylbromide tablets may cause an additive CNS depressant effect, profound sedation, respiratory depression, coma, and death and should be avoided (see WARNINGS ).
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressants or hydrocodone.
Studies of hydrocodone bitartrate and homatropine methylbromide tablets in animals to evaluate the carcinogenic and mutagenic potential and the effect on fertility have not been conducted.
Teratogenic Effects: Pregnancy Category C:
Animal reproduction studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide tablets. It is also not known whether hydrocodone bitartrate and homatropine methylbromide tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydrocodone bitartrate and homatropine methylbromide tablets should be given to a pregnant woman only if clearly needed.
Nonteratogenic Effects:
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.
As with all opioids, administration of hydrocodone bitartrate and homatropine methylbromide tablets to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.
It is not known whether this drug is 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 hydrocodone bitartrate and homatropine methylbromide tablets, 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.
Central Nervous System
Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.
Gastrointestinal System
Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of hydrocodone bitartrate and homatropine methylbromide tablets may produce constipation.
Genitourinary System
Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.
Respiratory Depression
Hydrocodone bitartrate and homatropine methylbromide tablets may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see
OVERDOSAGE). Use of hydrocodone bitartrate and homatropine methylbromide tablets in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with hydrocodone bitartrate and homatropine methylbromide tablets in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.
Postmarketing events seen in children under 6 years of age include accidental overdose, bronchopneumonia, coma, cyanosis, death, death neonatal, dyspnea, pulmonary edema, respiratory arrest, and respiratory depression.
Postmarketing events seen in patients older than 6 years of age include accidental overdose, cardio-respiratory arrest, death due to drug toxicity, non-accidental overdose, and overdose.
Dermatological
Skin rash, pruritus.
Hydrocodone bitartrate and homatropine methylbromide tablets are a Schedule II opioid. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of opioids; therefore, hydrocodone bitartrate and homatropine methylbromide tablets should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and homatropine methylbromide tablets are used for a short time for the treatment of cough. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy.
Signs and Symptoms
Serious 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. The ingestion of very large amounts of hydrocodone bitartrate and homatropine methylbromide tablets may, in addition, result in acute homatropine intoxication.
Treatment
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.
Adults and Adolescents 12 years of Age and Older
One (1) tablet every 4 to 6 hours as needed; do not exceed six (6) tablets in 24 hours.
Children 6 to 11 Years of Age
One-half (1/2) tablet every 4 to 6 hours as needed; do not exceed three (3) tablets in 24 hours.
Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP are available as white to off-white, round shaped biconvex tablets, debossed “K” above bisect “55” on one side and plain on the other side and is available in:
Bottles of 30 NDC 10702-055-03
Bottles of 90 NDC 10702-055-09
Bottles of 100 NDC 10702-055-01
Bottles of 1000 NDC 10702-055-10
Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature].
Preserve in a tight, light-resistant container, as defined in USP, with a child-resistant closure (as required).
Manufactured by:
KVK-Tech, Inc.
110 Terry Drive
Newtown, PA 18940
Manufacturer’s code: 10702
Item ID #: 6199/06 Rev.: 08/17
Hydrocodone Bitartrate and Homatropine Methylbromide tablets, USP CII
(HIGH-droe-KOE-dohn by-TAR-trate and hoe-MAT-troe-peen METH-ill-BROE-mide)
What is the most important information I should know about hydrocodone bitartrate and homatropine methylbromide tablets?
o increased sleepiness o shallow breathing
o confusion o limpness
o difficulty breathing o your baby has difficulty breastfeeding
What are hydrocodone bitartrate and homatropine methylbromide tablets?
Who should not take hydrocodone bitartrate and homatropine methylbromide tablets?
Before you take hydrocodone bitartrate and homatropine methylbromide tablets, tell your healthcare provider about all of your medical conditions, including if you:
• have a drug dependence • plan to have surgery
• have lung or breathing problems • drink alcohol
• have had a head injury • have kidney or liver problems
• have pain in your stomach-area (abdomen) • have diabetes
• have a history of severe or persistent cough • have thyroid problems, such as hypothyroidism
• have prostate problems • have Addison’s disease
• have problems with your urinary tract (urethral stricture) • have glaucoma (increased pressure in eyes)
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking hydrocodone bitartrate and homatropine methylbromide tablets with certain other medicines can cause side effects or affect how well hydrocodone bitartrate and homatropine methylbromide tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you:
How should I take hydrocodone bitartrate and homatropine methylbromide tablets?
What should I avoid while taking hydrocodone bitartrate and homatropine methylbromide tablets?
What are the possible side effects of hydrocodone bitartrate and homatropine methylbromide tablets?
Hydrocodone bitartrate and homatropine methylbromide tablets may cause serious side effects, including:
• sleepiness
• confusion
• nausea and vomiting
• difficulty urinating
• trouble breathing
These are not all the possible side effects of hydrocodone bitartrate and homatropine methylbromide tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store hydrocodone bitartrate and homatropine methylbromide?
General information about the safe and effective use of hydrocodone bitartrate and homatropine methylbromide tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use hydrocodone bitartrate and homatropine methylbromide tablets for a condition for which it was not prescribed. Do not give hydrocodone bitartrate and homatropine methylbromide tablets to other people, even if they have the same symptoms that you have.
You can ask your pharmacist or healthcare provider for information about hydrocodone bitartrate and homatropine methylbromide tablets that is written for health professionals.
What are the ingredients in hydrocodone bitartrate and homatropine methylbromide tablets?
Active ingredient: hydrocodone bitartrate and homatropine methylbromide.
Inactive ingredients in hydrocodone bitartrate and homatropine methylbromide tablets: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate and pregelatinized starch.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured By:
KVK-TECH, INC.
110 Terry Drive
Newtown, PA 18940
Item ID #: 6199/06 Rev: 08/17
Package Label - Principal Display Panel – 30-Count Bottle for 5 mg/1.5 mg Tablet
NDC 10702-055-03
Hydrocodone Bitartrate and Homatropine Methlybromide Tablets, USP CII
5 mg/1.5 mg
30 Tablets Rx only
KVK-TECH, INC.
Package Label - Principal Display Panel – 1000-Count Bottle for 5 mg/1.5 mg Tablet
NDC 10702-055-09
Hydrocodone Bitartrate and Homatropine Methlybromide Tablets CII
5/1.5 mg
90 Tablets Rx only
KVK-TECH, INC.
Package Label - Principal Display Panel – 1000-Count Bottle for 5 mg/1.5 mg Tablet
NDC 10702-055-01
Hydrocodone Bitartrate and Homatropine Methlybromide Tablets CII
5/1.5 mg
100 Tablets Rx only
KVK-TECH, INC.
Package Label - Principal Display Panel – 1000-Count Bottle for 5 mg/1.5 mg Tablet
NDC 10702-055-10
Hydrocodone Bitartrate and Homatropine Methlybromide Tablets CII
5/1.5 mg
1000 Tablets Rx only
KVK-TECH, INC.
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