Hydrocodone Bitartrate And Homatropine Methylbromide

Hydrocodone Bitartrate And Homatropine Methylbromide

Hydrocodone Bitartrate And Homatropine Methylbromide Recall

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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:

image description

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).

image description

C17H24BrNO3

Homatropine Methylbromide

Hydrocodone Bitartrate And Homatropine Methylbromide Manufacturers


  • Dispensing Solutions, Inc.
    Hydrocodone Bitartrate And Homatropine Methylbromide Tablet [Dispensing Solutions, Inc.]
  • Novel Laboratories, Inc.
    Hydrocodone Bitartrate And Homatropine Methylbromide Tablet [Novel Laboratories, Inc.]
  • Gavis Pharmaceuticals, Llc
    Hydrocodone Bitartrate And Homatropine Methylbromide Tablet [Gavis Pharmaceuticals, Llc]

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