Antitussive Hydrocodone and Homatropine

Name: Antitussive Hydrocodone and Homatropine

Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP

Rx Only

Adverse Reactions

Central Nervous System:

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.

Gastrointestinal System:

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.

Genitourinary System:

Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.

Respiratory Depression:

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.

Dermatological:

Skin rash, pruritus.

Package label.principal display panel

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 
hydrocodone bitartrate and homatropine methylbromide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43386-350
Route of Administration ORAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg
HOMATROPINE METHYLBROMIDE (HOMATROPINE) HOMATROPINE METHYLBROMIDE 1.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code N;350
Contains     
Packaging
# Item Code Package Description
1 NDC:43386-350-01 100 TABLET (TABLET) in 1 BOTTLE
2 NDC:43386-350-05 500 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091528 02/16/2011
Labeler - GAVIS Pharmaceuticals, LLC (829838551)
Registrant - GAVIS Pharmaceuticals, LLC (829838551)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, inc. 793518643 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim 551147440 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Noramco, Inc. 057234486 API MANUFACTURE
Revised: 04/2011   GAVIS Pharmaceuticals, LLC

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
  • Nausea
  • vomiting
Incidence not known
  • Drowsiness
  • fear or nervousness
  • itching skin or rash
  • mood changes
  • relaxed and calm
  • sleepiness
  • 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.

Precautions

Warning: May be habit forming.

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