Antitussive Hydrocodone and Homatropine Methylbromide (Hydrocodone Bitartrate / Homatropine Methylbromide) - Summary

SUMMARY

ANTITUSSIVE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS 

Hydrocodone bitartrate and homatropine methylbromide tablets contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting narcotic antitussive. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage.

Each hydrocodone bitartrate and homatropine methylbromide tablet for oral administration contains:

Hydrocodone bitartrate, USP 5 mg

Homatropine methylbromide, USP 1.5 mg

Hydrocodone bitartrate and homatropine methylbromide tablets are indicated for the symptomatic relief of cough.

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NEWS HIGHLIGHTS

Published Studies Related to Antitussive Hydrocodone and Homatropine Methylbromide (Hydrocodone / Homatropine)

Characterizing the subjective, psychomotor, and physiological effects of a hydrocodone combination product (Hycodan) in non-drug-abusing volunteers. [2003.01]
RATIONALE: The subjective, psychomotor, and physiological effects of prescription compounds containing the opioid hydrocodone have not been studied in a population of non-drug-abusing people who might be prescribed these compounds for cough or pain relief. OBJECTIVES: To characterize the effects of a hydrocodone combination product, Hycodan, which contains hydrocodone and a peripherally-acting anticholinergic, homatropine, in non-drug-abusing volunteers... CONCLUSIONS: Hycodan at the highest dose tested had effects similar to that of a prototypic mu agonist, morphine. Both drugs produced pleasant (including drug liking) as well as unpleasant subjective effects. Post-session ratings of overall liking and "want to take drug again" were not significant.

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Clinical Trials Related to Antitussive Hydrocodone and Homatropine Methylbromide (Hydrocodone / Homatropine)

Phenylephrine in Spinal Anesthesia in Preeclamptic Patients [Recruiting]
Hypotension remains a common clinical problem after induction of spinal anesthesia for cesarean delivery. Maternal hypotension has been associated with considerable morbidity (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been the vasopressor of choice because of concerns about phenylephrine's potential adverse effect on uterine blood flow. This practice was based on animal studies which showed that ephedrine maintained cardiac output and uterine blood flow, while direct acting vasocontrictors, e. g., phenylephrine, decreased uteroplacental perfusion. However, several recent studies have demonstrated that phenylephrine has similar efficacy to ephedrine for preventing and treating hypotension and may be associated with a lower incidence of fetal acidosis. All of these studies have been performed in healthy patients undergoing elective cesarean delivery.

Preeclampsia complicates 5-6% of all pregnancies and is a significant contributor to maternal and fetal morbidity and mortality. Many preeclamptic patients require cesarean delivery of the infant. These patients often have uteroplacental insufficiency. Given the potential for significant hypotension after spinal anesthesia and its effect on an already compromised fetus, prevention of (relative) hypotension in preeclamptic patients is important. Spinal anesthesia in preeclamptic patients has been shown to have no adverse neonatal outcomes as compared to epidural anesthesia when hypotension is treated adequately. Due to problems related to management of the difficult airway and coagulopathy, both of which are more common in preeclamptic women, spinal anesthesia may be the preferred regional anesthesia technique. Recent studies have demonstrated that preeclamptic patients may experience less hypotension after spinal anesthesia than their healthy counterparts. To our knowledge, phenylephrine for the treatment of spinal anesthesia-induced hypotension has not been studied in women with preeclampsia. The aim of our study is to compare intravenous infusion regimens of phenylephrine versus ephedrine for the treatment of spinal anesthesia induced hypotension in preeclamptic patients undergoing cesarean delivery. The primary outcome variable is umbilical artery pH.

Phenylephrine for Spinal Induced Hypotension [Recruiting]
This study is designed to determine the ED90 for a single dose of phenylephrine for the treatment of spinal induced hypotension in parturients presenting for an elective CD. The ED90 is the effective dose at which 90% of subjects will have a "positive" response to phenylephrine. The primary outcome measure is the ED90 for bolus phenylephrine. Secondary outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia, and the presence of hypertension following administration of phenylephrine.

Phenylephrine Pediatric Pharmacokinetic Study [Recruiting]
To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children, ages 2 to <12 years, and adolescents, ages 12 to <18 years.

Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis. [Not yet recruiting]

Evaluation of a Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis. [Recruiting]

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