Hydrocodone Bitartrate And Homatropine Methylbromide

⛔ FDA Black Box Warning

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Homatropine Methylbromide Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve Hydrocodone Bitartrate and Homatropine Methylbromide Tablets 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. Assess each patient's risk prior to prescribing Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for the shortest duration that is consistent with individual patient treatment goals , monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment [ see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. Monitor for respiratory depression, especially during initiation of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets therapy or when used in patients at higher risk [ see Warnings and Precautions (5.2) ] . Accidental Ingestion Accidental ingestion of even one dose of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, especially by children, can result in a fatal overdose of hydrocodone [ see Warnings and Precautions (5.2) ]. Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. Dosing errors c

Contraindications

4 CONTRAINDICATIONS Hydrocodone Bitartrate and Homatropine Methylbromide Tablets 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) ]. Hydrocodone Bitartrate and Homatropine Methylbromide Tablets is also contraindicated in patients with: Significant respiratory depression [ see Warnings and Precautions (5.2) ]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions (5.4) ]. Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions (5.9) ]. Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Tablets [ see Adverse Reactions (6) ]. Children younger than 6 years of age. ( 4 ) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Hydrocodone Bitartrate and Homatropine Methylbromide Tablets are 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 Tablets 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 Tablets; however, studies are available with individual active ingredients or related active ingredients ( see Data ). In animal reproduction studies, hydrocodone administered by the subcutaneous route to pregnant hamsters during the period of organogenesis produced a teratogenic effect at a dose approximately 45 times the maximum recommended human dose (MRHD) ( see Data ). Based on the animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diar