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Dihydrocodeine BPM Phenyleph HCl

Generic Name: dihydrocodeine bitartrate, brompheniramine maleate and phenylephrine hydrochloride
Dosage Form: oral liquid

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Dihydrocodeine 3mg/ BPM 4 mg/ Phenyleph HCl 7.5 mg/5 mL LIQUID

DESCRIPTION:

Each 5 mL (one teaspoonful) for oral administration contains:
Dihydrocodeine bitartrate*.......................................3 mg
*(WARNING-May be habit forming)
Brompheniramine maleate......................................4 mg
Phenylephrine hydrochloride.................................7.5 mg

Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid also contains:  citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

Dihydrocodeine bitartrate is an antitussive with the chemical name Morphinan-6-ol,4,5-epoxy-3-methoxy-17-methyl-, (5α,6α)-2,3-dihydroxybutanedioate (1:1) (salt).  It has the following structural formula:



Brompheniramine maleate is an antihistamine having the chemical name,2-Pyridinepropanamine,γ-(4-bromophenyl)-N,N-dimethyl-,(±)-,(Z)-2-butenediote (1:1).  It has the following structural formula:




Phenylephrine hydrochloride is an orally effective nasal decongestant.  Chemically it is (-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride.  It has the following structural formula:


Dihydrocodeine BPM Phenyleph HCl - Clinical Pharmacology

Dihydrocodeine is a semi-synthetic narcotic analgesic related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth muscle components.

Brompheniramine maleate is an alkylamine type antihistamine.  This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses.  The drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use, but a significant proportion of patients do experience this effect.

Phenylephrine HCl is a sympathomimetic, which acts predominately on alpha-receptors and has little action on beta-receptors.  It therefore functions as an oral nasal decongestant with minimal CNS stimulation.


Indications and Usage for Dihydrocodeine BPM Phenyleph HCl

Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid is indicated to control cough and provide for temporary relief from congestion associated with the upper respiratory tract.

Contraindications

This product should not be administered to patients with hypersensitivity to dihydrocodeine, codeine, or any other component of this product, or in any condition where opioids are contraindicated including: significant respiratory depression (in unmonitored settings or in the absence of resuscitation equipment), acute or severe bronchial asthma, hypercapnia, or paralytic ileus.

Antihistamines and sympathomimetics are contraindicated in patients receiving antihypertensive or antidepressant drugs containing monoamine oxidase (MAO) inhibitors.  Antihistamines should not be used to treat lower respiratory tract symptoms or be given to premature or newborn infants.

Sympathomimetic agents are contraindicated in patients with severe hypertension, severe coronary artery disease,patients with narrow angle glaucoma, bronchial asthma, urinary retention, peptic ulcer, and during an asthma attack.

This product is contraindicated in women who are pregnant.

Warnings

General
At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur.  Antihistamines may cause excitability, especially in children.  Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be used with caution i the elderly (60 years and older), as they are more likely to exhibit adverse reactions.

Special Risk Patients
Use with caution in debilitated patients,or those with any of the following conditions:  ischemic heart disease; increase intraocular pressure; prostatic hypertrophy; adrenocortical insufficiency (e.g.; Addison's disease); asthma; central nervous system depression or coma; chronic obstructive pulmonary disease; decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis); delirium tremens; diabetes mellitus; head injury; hypotension; hypertension; increased intracranial pressure; myxedema or hypothyroidism; hyperthyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis.  The benefits and risks of opioids in patients taking monamine oxidase (MAO) inhibitors and in those with a history of drug abuse should be carefully considered.  This combination product may aggravate convulsions in patients with convulsive disorders, and, like all opioids, may induce or aggravate seizures i some clinical settings.

Ambulatory Patients
Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid may produce orthostatic hypotension in ambulatory patients, and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

Renal Impairment
Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be used with caution and at reduced dosage in the presence of impaired renal function.

Hepatic Impairment
Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be given with caution to patients with hepatic insufficiency.

Pancreatic/Biliary Tract Disease
Opioids may cause spasms of the sphincter of Oddi and should be used with caution i patients with biliary tract disease including pancreatitis.

Respiratory Depression
Respiratory depression is the most dangerous acute reaction produced by opioid agonist preparations, although it is rarely severe with usual doses.  Opioids decrease the respiratory rate, tidal volume, minute ventilation, and sensitivity to carbon dioxide.  Respiratory depression occurs most frequently in elderly more debilitated patients, usually after large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.  Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be used with caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale and in patients with a substantially decreased respiratory reserve, hyoxia hypercapnia, or respiratory depression.

Hypotensive Effect
Dihydrocodeine, like all opioid analgesics, may cause hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted blood volume or who receive concurrent therapy with drugs such as phenothiazines or other agents which compromise vasomotor tone.  This combination product should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Drug Dependence and Abuse Potential
Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid contains dihydrocodeine, and is a Schedule V controlled substance.  Dihydrocodeine can produce drug dependence of the codeine type and has the potential of being abused.  This product should be prescribed and administered with the appropriate degree of caution. (see DRUG ABUSE AND DEPENDENCE)

Monitoring
Since, dihydrocodeine is metabolized by the liver; the effects of this combination product should be monitored closely in patients with hepatic insufficiency.

Precautions

General
This combination product should be used with caution in elderly or debilitated patients or those with any of the following conditions:  adrenocortical insufficiency (e.g., Addison's disease); asthma; central nervous system depression or coma; chronic obstructive pulmonary disease; decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis); delirium tremens; diabetes; head injury; hypotension; hypertension; increased intracranial pressure; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis.  The benefits and risks of opioids in patients taking monoamine oxidase inhibitors and in those with a history of drug abuse should be carefully considered.  This combination product may aggravate convulsions in patients with convulsive disorders, and like all opiods, may induce or aggravate seizures in some clinical settings.

Information for Patients/Caregivers

Patients receiving Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be given the following information:

  1. Patients should be advised that Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid may impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
  2. Patients should be advised to report adverse experiences occurring during therapy.
  3. Patients should be advised not to adjust the dose of Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid without consulting the prescribing professional.
  4. Patients should not combine Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid with alcohol or other central nervous system stimulants.
  5. Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of opioids and other drug used during pregnancy on themselves and their unborn child.
Patients should be advised that Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid is a potential drug of abuse.  They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

Drug Interactions

General
Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids.

Other Central Nervous System Depressants
Patients receiving other opioid analgesics, sedatives or hypnotics, muscle relaxants, general anesthetics, centrally acting anti-emetics, phenothiazines or other tranquilizers, or alcohol concomitantly with this combination product may exhibit additive depressant effects on the central nervous system.  When such combined therapy is contemplated, the dose of one or both agents should be reduced.  Concomitant use of dihydrocodeine and antihistamines with alcohol and other CNS depressants may have an additive effect.

Monoamine Oxidase Inhibitors
Dihydrocodeine,like all opioids, interact with monoamine oxidase inhibitors causing central nervous system excitation and hypertension.  MAO inhibitors and beta-adrenergic blockers increase the effects of sympathomimetics.  They may also prolong and intensify the anticholinergic effects of antihistamines.

USE IN SPECIFIC POPULATIONS

Pregnancy
Teratogenic Effects Pregnancy Category C
Animal reproduction studies have not been conducted with Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid.  It is now known whether this combination product can cause fetal harm when administered to pregnant women or can affect reproduction capacity in males and females.  This combination product should be given to pregnant women only if clearly needed, especially during the first trimester.

Nonteratogenic Effects
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent.  The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever.  The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.  There is not consensus on the best method of managing withdrawal.  Chlorpromazine 0.7-1.0 mg/kg q6h, phenobarbital 2 mg/kg q6h, and paregoric 24 drops/kg q4h, have been used to treat withdrawal symptoms in infants.  The duration of therapy is 4 to 28 days, with the dosages decreased as tolerated.


Labor and Delivery

Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid is not recommended for use by women during and immediately before labor and delivery because oral opioids may cause respiratory depression in the newborn.

Nursing Mothers

It is not know whether this drug is excreted in human milk.  Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

This product is not recommended for use in children under 6 years of age.  Children under two years may be more susceptible to respiratory arrest, coma and death.  Use of antihistamines is not recommended in infants.  This age group may be at a higher risk than other age groups because of an increased susceptibility to anticholinergic effects, such as CNS excitation, and an increased tendency toward convulsions.  In older children taking antihistamines, a paradoxical reaction characterized by hyper excitability may occur.  Very young children may be more sensitive to the effects, especially the vasopressor effects of sympathomimetic amines.

Geriatric Use

Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be given with caution to elderly patients as they are more likely to exhibit adverse reactions.

Adverse Reactions

Most Frequently Observed
The most frequently observed adverse reactions with dihydrocodeine include light-headedness, dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation, pruritus, and skin reactions.  With the exception of constipation, tolerance develops to most of these effects.

Other Reactions
Other reactions that have been observed with dihydrocodeine or other opioids include respiratory depression, orthostatic hypotension, cough suppression, confusion, diarrhea, miosis, abdominal pain, dry mouth, indigestion, anorexia, spasm of biliary tract, and urinary retention.

Physical and psychological dependence are possibilities.

Hypersensitivity Reactions
Hypersensitivity reactions (including anaphylactoid reactions), hallucinations, vivid dreams, granulomatous interstitial nephritis, severe narcosis and acute renal failure have been reported rarely during dihydrocodeine administration.  Other adverse reactions observed with the ingredients in Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid include lassitude, nausea, giddiness, dryness of the mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children).

To report ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Abuse and Dependence

Misuse, Abuse, and Diversion of Opioids
Under the provisions of the Controlled Substance Act this product has been placed in Schedule V.  Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused.  Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral opioid medications.  Symptoms of dihydrocodeine withdrawal consist of irritability, restlessness, insomnia, diaphoresis, anxiety and palpitations.

Overdosage

An overdose of Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid is a potentially lethal poly-drug overdose situation.  In the event of an overdose seek medical attention or consult a Poison Control Center immediately.

Signs and Symptoms
Symptoms of overdosage include pinpoint pupils, respiratory depression, extreme somnolence progressing to stupor, loss of consciousness, or coma, skeletal muscle flaccidity, cold and clammy skin and other symptoms common with narcotic overdosage.  Convulsions, cardiovascular collapse, and death may occur.  A single case of acute rhabdomyolysis associated with an overdose of dihydrocodeine has been reported.

Treatment
Immediate treatment of an overdosage of Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid includes support of cardiorespiratory function and measures to reduce drug absorption.  Vomiting should be induced with syrup of ipecac, if the patient is alert and has adequate laryngeal reflexes.  Oral activated charcoal should follow.  The first dose should be accompanied by an appropriate cathartic.  Gastric lavage may be necessary.  Hypotension is usually hypovolemic and should be treated with fluids.  Endotracheal intubation and artificial respiration may be necessary.  The pure opioid antagonist naloxone or nalmefene is a specific antidote against respiratory depression that results from opioid overdose.  Opioid antagonists should not be given in the absence of clinically significant respiratory or circulatory depression secondary to opioid overdose.  They should be administered cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including dihydocodeine.  In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome.  The prescribing information for the specific opioid antagonist should be consulted for details of their proper use.

DOSAGE AND ADMINISTRATION*

Adults and Children 12 years of age and older:
1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls (30 mL) in a 24 hour period.

Children 6 to 12 years of age:  1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls (15 mL)
in a 24 hour period.

Not recommended for children under 6 years of age.

*In mild cases or in particularly sensitive patients, less frequent  or reduced doses may be appropriate and adequate.

How is Dihydrocodeine BPM Phenyleph HCl Supplied

Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid is a grape-flavored liquid supplied in a 16 oz. bottles, NDC 49769-489-16.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.  IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage:  Store at 20° -25°C (68° -77°F); excursions permitted to 15° -30°C (59° -86°F). [See USP Controlled Room Temperature.] Protect from freezing.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Rx only

Manufactured for:
Kylemore Pharmaceuticals, LLC
Port St. Joe, FL  32456

Iss. 09/10  489-10

PRODUCT PACKAGING:

The packaging below represents labeling currently used;

Principal display panel and side panel for 473 mL label;

NDC 49769-489-16

Dihydrocodeine 3 mg/
BPM 4 mg/
Phenyleph HCl 7.5 mg/5 mL
LIQUID

Antitussive / Antihistamine / Decongestant

Each 5 ml (1 teaspoonful) for oral administration contains:
Dihydrocodeine Bitartrate*..............................3 mg
*(WARNING-May be habit forming)
Brompheniramine Maleate..............................4 mg
Phenylephrine HCl.......................................7.5 mg

Grape Flavor

CV
Rx Only

16 fl. oz. (473 mL)

KYLEMORE

DOSAGE AND ADMINISTRATON*:
Adults and Children 12 years of age and older:  1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls (30 mL) in a 24 hour period.

Children 6 to 12 years of age:  1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls (15 mL) in a 24 hour period.
Not recommended for children under 6 years of age.

*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.

Refer to the attached package insert for full prescribing information.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.  IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container, as defined by the USP/NF, with a child-resistant closure.

This bottle not to be dispensed to consumer.

Store at 20° -25°C (68° -77°F); excursions permitted to 15° -30°C (59° -86°F). [See USP Controlled Room Temperature.] Protect from freezing.

Manufactured for:  Kylemore Pharmaceuticals, LLC
Port St. Joe, FL  32456          Iss. 09/10     489-20










DIHYDROCODEINE/ BPM/ PHENYLEPH HCL 
dihydrocodeine bitartrate, brompheniramine maleate, phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49769-489
Route of Administration ORAL DEA Schedule CV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dihydrocodeine Bitartrate (Dihydrocodeine) Dihydrocodeine Bitartrate 3 mg  in 5 mL
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate 4 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 7.5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid  
Glycerin  
Propylene Glycol  
Water  
Sodium Citrate  
Saccharin Sodium  
Sorbitol  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:49769-489-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/13/2010 12/31/2012
Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 04/2011
 
Kylemore Pharmaceuticals, LLC
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