Homatropine

Mechanism-of-action classes: Cholinergic Muscarinic Agonists; Cholinergic Muscarinic Antagonists.

• Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in patients 18 years of age and older. Limitations of Use : Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)] .ICD-10: R05.9

• Hydrocodone bitartrate and homatropine methylbromide is contraindicated for: All children younger than 6 years of age [see Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.4)] . Significant respiratory depression [see Warnings and Precautions (5.2)] .contraindicated

Adults 18 years of age and older: One (1) tablet or 5 mL of the oral solution every 4 to 6 hours as needed; not to exceed six (6) tablets or 30 mL in 24 hours. (2.2) Measure hydrocodone bitartrate and homatropine methylbromide oral solution with an accurate milliliter measuring device. (2.1, 5.5) Do not increase the dose or dosing frequency. (2.1) Prescribe for the shortest duration consistent with treatment goals.(2.3) Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. (2.3) Reevaluate patient prior to refilling. (2.3) 2.1 Important Dosage and Administration Instructions Administer hydrocodone bitartrate and homatropine methylbromide by the oral route only. Always use an accurate milliliter measuring device when administering hydrocodone bitartrate and homatropine methylbromide oral solution to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage [see Warnings and Precautions (5.5)] . For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use. Advise patients not to increase the dose or dosing frequency of hydrocodone bitartrate and homatropine methylbromide because serious adverse events such as respiratory depression may occur with overdosage [see Warnings and Precautions (5.2), Overdosage (10)] .

Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Monitor closely, particularly during initiation of therapy. (5.4) Activities requiring mental alertness : Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. (5.6) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. (5.10) Seizures in patients with seizure disorders : Monitor during therapy. (5.11) Severe hypotension : Monitor during initiation of therapy. Avoid use in patients with circulatory shock. (5.12) Adrenal insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.14) 5.1 Addiction, Abuse, and Misuse Hydrocodone bitartrate and homatropine methylbromide contains hydrocodone, a Schedule II controlled substance. As an opioid, hydrocodone bitartrate and homatropine methylbromide exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)] , which can lead to overdose and death [see Overdosage (10)] . Reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

The following clinically significant adverse reactions are described elsewhere in labeling: Addiction, abuse, and misuse [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.3)] Life-threatening respiratory depression [see Warnings and Precautions (5.2, 5.3, 5.4, 5.8), Overdosage (10)] Accidental overdose and death due to medication errors [see Warnings and Precautions (5.5)] Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.6)] Interactions with benzodiazepines and other CNS depressants [see Warnings and Precautions (5.8), Drug Interactions (7.1, 7.4)] Paralytic ileus, gastrointestinal adverse reactions [see Warnings and Precautions (5.9)] Increased intracranial pressure [see Warnings and Precautions (5.10)] Obscured clinical course in patients with head injuries [see Warnings and Precautions (5.10)] Seizures [see Warnings and Precautions (5.11)] Severe hypotension [see Warnings and Precautions (5.12)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.13)] Adrenal insufficiency [see Warnings and Precautions (5.14)] The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or homatropine. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Pregnancy : Avoid use in pregnant women. May cause fetal harm. (8.1) Lactation : Breast-feeding not recommended. (8.2) Renal Impairment : Use with caution in patients with severe renal impairment. (8.6) Hepatic Impairment : Use with caution in patients with severe hepatic impairment. (8.7) 8.1 Pregnancy Risk Summary Hydrocodone bitartrate and homatropine methylbromide is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.13), Clinical Considerations] . There are no available data with hydrocodone bitartrate and homatropine methylbromide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Published studies with hydrocodone have reported inconsistent findings and have important methodological limitations ( see Data ). Reproductive toxicity studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide; however, studies are available with individual active ingredients or related active ingredients ( see Data ).

Clinical Presentation Hydrocodone Acute overdose 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, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, circulatory collapse, cardiac arrest, and death. Hydrocodone may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2)] . Homatropine Homatropine has broad, nonspecific anticholinergic / antimuscarinic activity that similar to, although less potent than, atropine.

• Mar 23, 1943NDANDA005213Genus
• Jul 5, 1983ANDAANDA088017Actavis Mid Atlantic
• Apr 20, 2011ANDAANDA091528Novel Labs Inc
• Feb 13, 2017ANDAANDA203535Novel Labs Inc
• Feb 21, 2017ANDAANDA207487Abhai Llc
• Aug 7, 2017ANDAANDA207176Avanthi Inc

1. 1Endophthalmitis8516%
2. 2Condition Aggravated7314%
3. 3Eye Pain6913%
4. 4Choroiditis6613%
5. 5Chronic Kidney Disease6412%
6. 6Visual Acuity Reduced6011%
7. 7Intraocular Pressure Increased5911%
8. 8Uveitis5911%
9. 9Drug Ineffective5811%
10. 10Acute Kidney Injury387.2%
11. 11Renal Failure356.6%
12. 12Product Use Issue336.3%
13. 13Nausea295.5%
14. 14Fatigue275.1%
15. 15Pneumonia234.4%

The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Homatropine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia
  Withdrawn · Phase 3 · Interventional · 0 enrolled · EMS
  NCT01408069updated 2021-02-24
• Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy
  Completed · Interventional · 32 enrolled · Universiti Sains Malaysia
  NCT02344732updated 2015-01-26
• Intraoperative Dexamethasone Implant Improves Outcome of Cataract Surgery With Diabetic Macular Edema
  Completed · Phase 4 · Interventional · 20 enrolled · Post Graduate Institute of Medical Education and Research, Chandigarh
  NCT01546402updated 2014-06-18
• The Role of Umbilical Cord Serum Therapy on Improvement of Corneal Epithelial Defect Following Diabetic Vitrectomy
  Unknown · Phase 1 · Interventional · Shahid Beheshti University of Medical Sciences
  NCT01168375updated 2010-07-23

Frequently asked questions

How does Homatropine work?

Mechanism-of-action classes: Cholinergic Muscarinic Agonists; Cholinergic Muscarinic Antagonists.

What is Homatropine used for?

According to FDA labeling, Homatropine carries indications including: Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in patients 18 years of age and older. Limitations of Use : Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Homatropine?

Homatropine is classified as Anticholinergics, Cholinergic Muscarinic Antagonist, Cholinergic Muscarinic Agonists, Cholinergic Muscarinic Antagonists, Decreased Parasympathetic Acetylcholine Activity, Pupillary Dilation.

What are the brand names for Homatropine?

Homatropine is marketed under brand names including Homatropaire, Hycodan, Hydromet.

What are the contraindications for Homatropine?

Homatropine labeling lists contraindications including: Hydrocodone bitartrate and homatropine methylbromide is contraindicated for: All children younger than 6 years of age [see Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.4)] . Significant respiratory depression [see Warnings and Precautions (5.2)] .. Always consult the full prescribing information and a clinician.