Hydrocodone Bitartrate And Homatropine Methylbromide
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Questions & Answers
Side Effects & Adverse Reactions
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).
Respiratory Depression:
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 tablets produce 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.
Head Injury and Increased Intracranial Pressure:
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.
Acute Abdominal Conditions:
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.
Pediatric Use:
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).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP are indicated for the symptomatic relief of cough in adults and children 6 years of age and older.
History
There is currently no drug history available for this drug.
Other Information
Hydrocodone Bitartrate and Homatropine Methylbromide Tablet, USP contains hydrocodone
(dihydrocodeinone) bitartrate, a semi synthetic centrally-acting opioid antitussive. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage.
Each Hydrocodone Bitartrate and Homatropine Methylbromide Tablet contains:
Hydrocodone Bitartrate, USP 5 mg
Homatropine Methylbromide, USP 1.5 mg
Hydrocodone Bitartrate and Homatropine Methylbromide Tablets also contain: anhydrous lactose, dicalcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.
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) an may be represented by the following structural formula:
C18H21NO3• C4H6O6• 2½H2O
Hydrocodone Bitartrate
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).
C17H24BrNO3
Homatropine Methylbromide
Sources
Hydrocodone Bitartrate And Homatropine Methylbromide Manufacturers
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Dispensing Solutions, Inc.
![Hydrocodone Bitartrate And Homatropine Methylbromide Tablet [Dispensing Solutions, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hydrocodone Bitartrate And Homatropine Methylbromide | Dispensing Solutions, Inc.
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.
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Novel Laboratories, Inc.
Hydrocodone Bitartrate And Homatropine Methylbromide | Novel Laboratories, Inc.
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.
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Gavis Pharmaceuticals, Llc
Hydrocodone Bitartrate And Homatropine Methylbromide | Gavis Pharmaceuticals, Llc
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 Tablet [Novel Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b203c87c-1108-4eaa-8a57-87be776d8a70&name=f22ba8d7-figure-01.jpg)
![Hydrocodone Bitartrate And Homatropine Methylbromide Tablet [Gavis Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=41ac90b3-f007-4eb2-9d41-ea626ced2017&name=3fd95736-figure-01.jpg)
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