Nospamin Syrup

Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult 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)] . Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)] . …

• Adults 18 years of age and older: One tablet or 5 mL of the oral solution every 4 to 6 hours as needed; not to exceed six tablets or 30 mL in 24 hours
• Measure hydrocodone bitartrate and homatropine methylbromide oral solution with an accurate milliliter measuring device
• Do not increase the dose or dosing frequency
• Prescribe for the shortest duration consistent with treatment goals
• Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology
• Reevaluate patient prior to refilling
• Do not rapidly reduce or abruptly discontinue in a physically-dependent patient 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 ]
• 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. …

• Tablet: 5 mg of hydrocodone bitartrate and 1.5 mg of homatropine methylbromide per tablet, white to off-white, round shaped biconvex tablets, debossed “K” above bisect “55” on one side and plain on the other side [see Description (11)] . …

• Hydrocodone bitartrate and homatropine methylbromide is contraindicated for: All
• Pediatric patients younger than 6 years of age [see Warnings and Precautions , Use in Specific Populations ]
• Significant respiratory depression [see Warnings and Precautions ]
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ] . …

No specific drug interaction studies have been conducted with hydrocodone bitartrate and homatropine methylbromide. Serotonergic Drugs : Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. (7.5) Monoamine Oxidase Inhibitors (MAOIs) : Can potentiate the effects of hydrocodone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping an MAOI. (7.6) Muscle Relaxants : Avoid concomitant use. (7.7) Diuretics : Hydrocodone may reduce the efficacy of diuretics. Monitor for reduced effect. (7.8) Anticholinergic drugs : Concurrent use may cause paralytic ileus. …

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. …

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 …

IN SPECIFIC POPULATIONS 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. …

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, hypoglycemia, circulatory collapse, cardiac arrest, and death. …

9.1 Controlled Substance Hydrocodone bitartrate and homatropine methylbromide contains hydrocodone, a Schedule II controlled substance. 9.2 Abuse Hydrocodone Hydrocodone bitartrate and homatropine methylbromide contains hydrocodone, a substance with a high potential for abuse similar to other opioids including morphine and codeine. Hydrocodone bitartrate and homatropine methylbromide can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions (5.1)] . …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.