Antitussive Hydrocodone and Homatropine
Name: Antitussive Hydrocodone and Homatropine
- Antitussive Hydrocodone and Homatropine tablet
- Antitussive Hydrocodone and Homatropine drug
- Antitussive Hydrocodone and Homatropine side effects
- Antitussive Hydrocodone and Homatropine effects of
- Antitussive Hydrocodone and Homatropine pediatric dose
- Antitussive Hydrocodone and Homatropine mg
Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP
Central Nervous System:
Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.
Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of hydrocodone bitartrate and homatropine methylbromide tablets may produce constipation.
Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.
Hydrocodone bitartrate and homatropine methylbromide tablets may produce doserelated respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE). Use of hydrocodone bitartrate and homatropine methylbromide tablets in children less than 6 years of age has been associated with fatal respiratory depression.
Overdose with hyodrocodone bitartrate and homatropine methylbromide tablets in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.
Postmarketing events seen in children under 6 years of age include accidental overdose, bronchopneumonia, coma, cyanosis, death, death neonatal, dyspnea, pulmonary edema, respiratory arrest, and respiratory depression.
Postmarketing events seen in patients older than 6 years of age include accidental overdose, cardio-respiratory arrest, death due to drug toxicity, non-accidental overdose, and overdose.
Skin rash, pruritus.
Package label.principal display panel
|HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
hydrocodone bitartrate and homatropine methylbromide tablet
|Labeler - GAVIS Pharmaceuticals, LLC (829838551)|
|Registrant - GAVIS Pharmaceuticals, LLC (829838551)|
|Novel Laboratories, inc.||793518643||MANUFACTURE|
|Boehringer Ingelheim||551147440||API MANUFACTURE|
|Noramco, Inc.||057234486||API MANUFACTURE|
For the Consumer
Applies to homatropine / hydrocodone: oral solution, oral syrup, oral tablet
Along with its needed effects, homatropine / hydrocodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking homatropine / hydrocodone:Incidence not known
- Decrease in the frequency of urination
- decrease in urine volume
- difficulty in passing urine (dribbling)
- painful urination
Get emergency help immediately if any of the following symptoms of overdose occur while taking homatropine / hydrocodone:Symptoms of overdose
- Difficult or troubled breathing
- irregular, fast or slow, or shallow breathing
- pale or blue lips, fingernails, or skin
Some side effects of homatropine / hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- fear or nervousness
- itching skin or rash
- mood changes
- relaxed and calm
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Usual Pediatric Dose for Cough
6 years to 12 years:
2.5 mL of syrup (1.5 mg-5 mg/5 mL) or one-half tablet (1.5 mg-5 mg) orally every 4 to 6 hours as needed. Do not exceed 3 tablets or 15 mL in 24 hours.
> 12 years:
5 mL of syrup (1.5 mg-5 mg/5 mL) or I tablet (1.5 mg-5 mg) orally every 4 to 6 hours as needed. Do not exceed 6 doses (6 tablets or 30 mL) in 24 hours.
Warning: May be habit forming.