Vasofrinic DH

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Vasofrinic DH uses

Vasofrinic DH consists of Chlorpheniramine Maleate, Hydrocodone Bitartrate, Pseudoephedrine Hydrochloride.

Chlorpheniramine Maleate:



Drug Facts

Active Ingredients (in each 1 mL dropperful) Purpose
Vasofrinic DH (Chlorpheniramine Maleate) Maleate 2 mg Antihistamine
Phenylephrine HCl 5 mg Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product in a child who is

  • now taking a prescription monoamine oxidase inhibitor (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if a child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Ask a doctor before use if a child is taking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • sedatives and tranquilizers may increase drowsiness effect

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

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Directions

Do not exceed recommended dosage.

Children 6 to under 12 years of age: 1 mL (1 dropperful) every 4 hours, not to exceed 6 mL in 24 hours or as directed by a doctor
Children 2 to under 6 years of age: 0.5 mL (1/2 dropperful) every 4 hours, not to exceed 3 mL in 24 hours, or as directed by a doctor
Children under 2 years of age: Consult a doctor

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Applesauce Flavor, Citric Acid, FD&C Blue #1, FD&C Yellow #6, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose

Questions? Comments?

Call 1-800-543-9560

Rev. 05/11

E

NEW

FORMULA

NDC 00485-0096-02

Vasofrinic DH (Chlorpheniramine Maleate)

Pediatric Drops

Antihistamine ▪ Nasal Decongestant

Sugar Free ▪ Alcohol Free ▪ Gluten Free

FOR PROFESSIONAL USE ONLY

Each 1 mL for oral administration

contains:

Vasofrinic DH (Chlorpheniramine Maleate) Maleate

2 mg

Phenylephrine HCl

5 mg

APPLESAUCE FLAVOR

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

2 fl. oz. (60 mL)

Hydrocodone Bitartrate:


1 INDICATIONS AND USAGE

Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is indicated for symptomatic relief of cough and to loosen mucus associated with the common cold.

Important Limitations of Use:

Not indicated for pediatric patients under 18 years of age .

Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is a combination product containing an opioid antitussive and expectorant indicated for:

  • Symptomatic relief of cough and to loosen mucus associated with the common cold.

Important Limitations of Use:

Not indicated for pediatric patients under 18 years of age. ( 8.4)

2 DOSAGE AND ADMINISTRATION

Adults and adolescents 18 years of age and older: 10 mL every 4 to 6 hours, not to exceed 6 doses in 24 hours. ( 2.1)

Measure Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with an accurate milliliter measuring device. ( 5.10)

2.1 Recommended dosage

Adults and adolescents 18 years of age and older: 10 mL every 4 to 6 hours, not to exceed 6 doses (60 mL) in 24 hours.

Administer Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution by the oral route only. Measure Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose .

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3 DOSAGE FORMS AND STRENGTHS

Oral Solution:

Each 5 mL contains Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg .

Oral Solution: Each 5 mL contains Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg.( 3)

4 CONTRAINDICATIONS

Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is contraindicated in:

  • Patients with known hypersensitivity to Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, guaifenesin, or any of the inactive ingredients of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution.
  • Patients receiving MAOI therapy or within 14 days of stopping such therapy .
  • Patients with known hypersensitivity to Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, guaifenesin, or any of the inactive ingredients of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution. ( 4)
  • Patients receiving monoamine oxidase inhibitor (MAOI) therapy or within 14 days of stopping such therapy. ( 4)

5 WARNINGS AND PRECAUTIONS

  • Dose-related respiratory depression: Use with caution.
  • Drug Dependence: Prescribe with caution that is appropriate to the use of other opioids. ( 5.3)
  • Head injury and increased intracranial pressure: Avoid in patients with head injury, intracranial lesions or increased intracranial pressure. ( 5.4)
  • Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery. ( 5.5)
  • Acute abdominal conditions: Use with caution in patients with acute abdominal conditions. ( 5.6)
  • Coexisting conditions: Use with caution in patients with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy, or urethral stricture, or asthma. ( 5.11)

5.1 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants

Concomitant use of opioids, including Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol .

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.

Advise both patients and caregivers about the risks of respiratory depression and sedation if Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is used with benzodiazepines, alcohol, or other CNS depressants .

5.2 Respiratory Depression

Vasofrinic DH bitartrate, one of the active ingredients in Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of Vasofrinic DH (Hydrocodone Bitartrate) bitartrate in adults has been associated with fatal respiratory depression, and the use of Vasofrinic DH (Hydrocodone Bitartrate) bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administering Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution because of the potential for respiratory depression. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated .

5.3 Drug Dependence

Vasofrinic DH (Hydrocodone Bitartrate) can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution. Prescribe and administer Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with the same degree of caution appropriate to the use of other opioid drugs .

5.4 Head Injury and Increased Intracranial Pressure

The respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. The use of Vasofrinic DH Oral Solution should be avoided in these patients.

5.5 Activities Requiring Mental Alertness

Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, one of the active ingredients in Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution. Concurrent use of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur.

5.6 Acute Abdominal Conditions

Vasofrinic DH Oral Solution should be used with caution in patients with acute abdominal conditions since the administration of Vasofrinic DH (Hydrocodone Bitartrate) may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of other anticholinergics with Vasofrinic DH (Hydrocodone Bitartrate) may produce paralytic ileus .

5.7 Co-administration with Anticholinergics

The concurrent use of anticholinergics with Vasofrinic DH (Hydrocodone Bitartrate) may produce paralytic ileus. Exercise caution when using Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution in patients taking anticholinergic medications .

5.8 Co-administration with MAOIs or Tricyclic Antidepressants

Vasofrinic DH Oral Solution should not be used in patients receiving MAOI therapy or within 14 days of stopping such therapy. The use of MAOIs or tricyclic antidepressants with Vasofrinic DH (Hydrocodone Bitartrate) bitartrate may increase the effect of either the antidepressant or Vasofrinic DH (Hydrocodone Bitartrate) .

5.9 Persistent Cough

Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution should not be used in patients with a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus).

5.10 Dosing

Patients should be advised to measure Vasofrinic DH Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions . Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose.

5.11 Coexisting Conditions

Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution should be used with caution in patients with diabetes, thyroid disease, Addison's disease, prostatic hypertrophy or urethral stricture, and asthma.

5.12 Renal Impairment

Vasofrinic DH Oral Solution should be used with caution in patients with severe renal impairment.

5.13 Hepatic Impairment

Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution should be used with caution in patients with severe hepatic impairment .

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6 ADVERSE REACTIONS

Use of Vasofrinic DH (Hydrocodone Bitartrate) bitartrate is associated with the following:

  • Respiratory depression
  • Drug dependence
  • Increased intracranial pressure
  • Decreased mental alertness with impaired mental and/or physical abilities
  • Paralytic ileus

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most common adverse reactions experienced by subjects taking a single dose of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution in the clinical setting include the following: Central Nervous System: headache, dizziness, sedation (somnolence); Gastrointestinal System: nausea, diarrhea; Cardiovascular System: decreased blood pressure; Vascular System: hot flush.

The most common adverse reactions of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution include:

Dizziness, headache, sedation, nausea, and decreased blood pressure. ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact ABER Pharmaceuticals, LLC. at tel: 1-855-461-5102; www.obredon.com or FDA at 1-800-FDA-1088; www.fda.gov/medwatch.

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7 DRUG INTERACTIONS

No specific interaction studies have been conducted with Vasofrinic DH Oral Solution.

  • Opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol): Avoid using with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution; may exhibit additive CNS depression. ( 7.1)
  • MAO inhibitors (MAOIs) or tricyclic antidepressants: Do not use. May increase the effect of either the antidepressant or Vasofrinic DH (Hydrocodone Bitartrate). ( 7.2)
  • Anticholinergic drugs: Use with caution in order to avoid paralytic ileus and excessive anticholinergic effects. ( 7.3)

7.1 Benzodiazepines, Opioids, Antihistamines, Antipsychotics, Anti-anxiety Agents, or Other CNS Depressants (Including Alcohol)

The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants concomitantly with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution may cause an additive CNS depressant effect, profound sedation, respiratory depression, coma, and death and should be avoided .

7.2 MAO Inhibitors or Tricyclic Antidepressants

Do not prescribe Vasofrinic DH Oral Solution if the patient is taking a prescription MAOI (i.e., certain drugs used for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping a MAOI drug. The use of MAOIs or tricyclic antidepressants with Vasofrinic DH (Hydrocodone Bitartrate) preparations may increase the effect of either the antidepressant or Vasofrinic DH (Hydrocodone Bitartrate) .

7.3 Anticholinergic Drugs

Vasofrinic DH (Hydrocodone Bitartrate) should be administered cautiously to persons receiving anticholinergic drugs in order to avoid paralytic ileus and excessive anticholinergic effects .

8 USE IN SPECIFIC POPULATIONS

  • Renal Impairment: Use with caution in patients with severe renal impairment.
  • Hepatic Impairment: Use with caution in patients with severe hepatic impairment. ( 8.7)

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well controlled studies of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution in pregnant women. Reproductive toxicity studies have not been conducted with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution; however, studies are available with an individual active ingredient or related active ingredient. Vasofrinic DH (Hydrocodone Bitartrate) was teratogenic in hamsters. Codeine, an opiate related to Vasofrinic DH (Hydrocodone Bitartrate), increased resorptions and decreased fetal weight in rats. Because animal reproduction studies are not always predictive of human response, Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

Vasofrinic DH (Hydrocodone Bitartrate):

Vasofrinic DH (Hydrocodone Bitartrate) has been shown to be teratogenic in hamsters when given in a dose approximately 27 times the maximum recommended human daily dose (MRHDD) (on a mg/m 2 basis at a single subcutaneous dose of 102 mg/kg on gestation day 8). Reproductive toxicology studies were also conducted with codeine, an opiate related to Vasofrinic DH (Hydrocodone Bitartrate). In a study in which pregnant rats were dosed throughout organogenesis, a dose of codeine approximately 40 times the MRHDD of Vasofrinic DH (Hydrocodone Bitartrate) (on a mg/m 2 basis at an oral dose of 120 mg/kg/day of codeine) increased resorptions and decreased fetal weight; however, these effects occurred in the presence of maternal toxicity. In studies in which rabbits and mice were dosed throughout organogenesis, doses of codeine up to approximately 20 and 100 times, respectively, the MRHDD of Vasofrinic DH (Hydrocodone Bitartrate) (on a mg/m 2 basis at oral doses of 30 and 600 mg/kg/day, respectively), produced no adverse developmental effects.

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.

8.2 Labor and Delivery

As with all opioids, administration of Vasofrinic DH Oral Solution to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

8.3 Nursing Mothers

Caution should be exercised when Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is administered to nursing mothers. Vasofrinic DH (Hydrocodone Bitartrate) is known to be excreted in human milk. No studies have been performed to determine if guaifenesin is excreted into breastmilk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, 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.

8.4 Pediatric Use

Safety and effectiveness of Vasofrinic DH Oral Solution in pediatric patients under 18 years of age has not been established. The use of Vasofrinic DH (Hydrocodone Bitartrate) in children less than 6 years of age is associated with fatal respiratory depression .

8.5 Geriatric Use

Clinical studies have not been conducted with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution in geriatric populations. Other reported clinical experience with the individual active ingredients of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution has not identified differences in responses between the elderly and patients younger than 65 years of age. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Renal Impairment

Vasofrinic DH Oral Solution should be given with caution in patients with severe impairment of renal function.

8.7 Hepatic Impairment

Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution should be given with caution in patients with severe impairment of hepatic function.

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Vasofrinic DH Oral Solution is a Schedule II controlled prescription containing Vasofrinic DH (Hydrocodone Bitartrate) bitartrate and should be prescribed and administered with caution.

9.2 Abuse

Vasofrinic DH (Hydrocodone Bitartrate) can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs.

Abuse of guaifenesin has been linked to the formation of kidney stones composed of the major metabolite β-(2-methoxyphenoxy) lactic acid.

9.3 Dependence

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution should be prescribed and administered with caution.

Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy.

10 OVERDOSAGE

No human overdosage data are available for Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution.

Vasofrinic DH (Hydrocodone Bitartrate):

Overdosage with Vasofrinic DH (Hydrocodone Bitartrate) 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, dizziness, ringing in the ears, confusion, blurred vision, eye problems, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdose, apnea, circulatory collapse, cardiac arrest and death may occur.

Guaifenesin:

Overdosage with guaifenesin can cause depression of the central nervous system. While present in polypharmacy overdoses, one case of overdose with only significant levels of guaifenesin has been reported. Symptoms included slurred speech, shallow respirations, reduced heart rate with rhythm sinus bradycardia, followed by asystole.

Treatment of overdosage consists of discontinuation of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution together with institution of appropriate therapy. Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including Vasofrinic DH (Hydrocodone Bitartrate). Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

11 DESCRIPTION

Vasofrinic DH Oral Solution contains Vasofrinic DH (Hydrocodone Bitartrate) bitartrate (a centrally-acting opioid antitussive) and guaifenesin (an expectorant).

Each 5 mL dose of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution contains: Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg.

Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution also contains: artificial raspberry flavor, citric acid, glycerin, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, and saccharin sodium.

11.1 Vasofrinic DH (Hydrocodone Bitartrate) Bitartrate

Vasofrinic DH (Hydrocodone Bitartrate) Bitartrate is a centrally-acting opioid antitussive and analgesic. It is affected by light and occurs as fine white crystals or crystalline powder which is derived from the opium alkaloid, thebaine. Its chemical name is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5); and may be represented by the following structural formula:

C 18H 21NO 3 - C 4H 6O 6 - 2½H 2O MW= 494.50

HCB Chemical Structure

11.2 Guaifenesin

Guaifenesin is an expectorant and occurs as a white powder. Its chemical name is 3-(2-methoxyphenoxy)-1,2- propanediol, and may be represented by the following structural formula:

C 10H 14O 4 MW= 198.22

GFN Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Vasofrinic DH is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of Vasofrinic DH (Hydrocodone Bitartrate) and other opiates is not known; however, Vasofrinic DH (Hydrocodone Bitartrate) is believed to act directly on the cough center. In excessive doses, Vasofrinic DH (Hydrocodone Bitartrate) will depress respiration. Vasofrinic DH (Hydrocodone Bitartrate) can produce miosis, euphoria, and physical and physiological dependence.

Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. The precise mechanism of action of guaifenesin is not known; however, it is thought to act as an expectorant by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi. In turn, this may increase the efficiency of the cough reflex and facilitate removal of the secretions.

12.3 Pharmacokinetics

Systemic exposure (in terms of peak plasma concentrations and area under plasma concentration versus time curve) of Vasofrinic DH (Hydrocodone Bitartrate) bitartrate and guaifenesin after single dose administration of 10 mL Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution are equivalent to respective reference solutions of 5 mL Vasofrinic DH (Hydrocodone Bitartrate) bitartrate (5 mg/5 mL), and 10 mL guaifenesin (200 mg/5 mL).

Vasofrinic DH (Hydrocodone Bitartrate): Following a single 10 mL oral dose of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution administered to 36 healthy adults (19-74 years), the geometric mean C max and AUC 0-inf for Vasofrinic DH (Hydrocodone Bitartrate) were 12.6 ng/ml and 80.9 ng·hr/ml, respectively. The median time to maximum concentration for Vasofrinic DH (Hydrocodone Bitartrate) was about 1.25 hours. Food has no significant effect on the extent of absorption of Vasofrinic DH (Hydrocodone Bitartrate). The mean plasma half-life of Vasofrinic DH (Hydrocodone Bitartrate) is approximately 5 hours.

Guaifenesin: Following a single 10 mL oral dose of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution administered to 57 healthy adults (19-74 years), the geometric mean Cmax and AUC0-inf for guaifenesin were 3.7 mcg/ml and 4.2 mcg·hr/ml, respectively. The median time to maximum concentration was about 20 minutes. The effect of food on guaifenesin systemic exposure is not considered to be clinically meaningful. The mean plasma half-life of guaifenesin is approximately 1 hour.

Drug interactions

When guaifenesin and Vasofrinic DH (Hydrocodone Bitartrate) were administered in combination, the pharmacokinetics for each component were similar to those observed when each component was administered separately.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproductive studies have not been conducted with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution; however, published information is available for the individual active ingredients or related active ingredients.

Vasofrinic DH (Hydrocodone Bitartrate):

Carcinogenicity studies were conducted with codeine, an opiate related to Vasofrinic DH (Hydrocodone Bitartrate). In 2 year studies in F344/N rats and B6C3F1 mice, codeine showed no evidence of tumorigenicity at dietary doses up to 70 and 400 mg/kg/day, respectively (approximately 23 and 65 times, respectively, the MRHDD of Vasofrinic DH (Hydrocodone Bitartrate) on a mg/m 2 basis).

Guaifenesin:

Carcinogenicity, genotoxicity, or reproductive toxicology studies have not been conducted with guaifenesin

14 CLINICAL STUDIES

Efficacy studies were not conducted with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution. Efficacy of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is based on demonstration of bioequivalence to the individual comparator products .

16 HOW SUPPLIED/STORAGE AND HANDLING

Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is supplied as a clear, raspberry flavored liquid containing 2.5 mg Vasofrinic DH (Hydrocodone Bitartrate) bitartrate and 200 mg guaifenesin in each 5 mL. It is available in:

White HDPE bottles of 16 fl oz. (473 mL): NDC 69166-523-16 (raspberry flavored)

White HDPE bottles of 4 fl oz. (118 mL): NDC 69166-523-04 (raspberry flavored)

Store solution at 20° to 25°C (68° to 77°F).

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

17 PATIENT COUNSELING INFORMATION


Overdosage

Advise patients not to increase the dose or dosing frequency of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution because serious adverse events such as respiratory depression may occur with overdosage .

Dosing

Advise patients to measure Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is measured. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose .

Interactions with Benzodiazepines and Other Central Nervous System Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol.

Because of this risk, patients should avoid concomitant use of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with benzodiazepines or other CNS depressants, including alcohol .

Activities Requiring Mental Alertness

Advise patients to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution may produce marked drowsiness .

Drug Dependence

Caution patients that Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution contains Vasofrinic DH (Hydrocodone Bitartrate) bitartrate and can produce drug dependence .

For Medical Information

Contact Medical Affairs Department

Phone: 1-855-461-5102

Manufactured for:

Accelis Pharma

East Windsor, NJ 08520

ACELLIS logo

MEDICATION GUIDE

Vasofrinic DH Oral Solution (Oh-brĕ-don Oral Solution)

(hydrocodone bitartrate and guaifenesin) Each 5 mL contains Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg. C-II

What is the most important information I should know about Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?

  • Taking Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with benzodiazepines, or other central nervous system depressants, including alcohol can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
  • Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution can cause you to be drowsy. Do not drive a car or operate machinery until you know how Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution affects you. Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution can slow your thinking and motor skills, and may affect your vision.
  • Women who breastfeed should talk to their healthcare provider before taking Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution.
  • Call your healthcare provider or get emergency medical help right away if anyone taking Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution has any of the symptoms below:
    • increased sleepiness
    • confusion
    • difficulty breathing
    • shallow breathing
    • limpness
    • your baby has difficulty breastfeeding
  • Keep Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, get emergency medical help right away.
  • Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution can cause serious side effects, including death.
  • Take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution exactly as prescribed by your healthcare provider. If you take the wrong dose of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, you could overdose and die.
  • Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is not for children under 18 years of age.

What is Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?

  • Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is a prescription medicine used to treat a cough and to loosen mucus associated with the common cold, in patients 18 years and older. Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution contains two medicines, Vasofrinic DH (Hydrocodone Bitartrate) and guaifenesin. Vasofrinic DH (Hydrocodone Bitartrate) is a narcotic cough suppressant. Guaifenesin is an expectorant.
  • Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is a federal controlled substance (C-II) because it contains Vasofrinic DH (Hydrocodone Bitartrate) that can be abused or lead to dependence. Keep Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution in a safe place to prevent misuse and abuse. Selling or giving away Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is not for children under 18 years of age. It is not known if Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is safe and effective in children.

Who should not take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?

  • Do not take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution if you are allergic to any of the ingredients in Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution. See the end of this Medication Guide for a complete list of ingredients. You may have an increased risk of having an allergic reaction to Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution if you are allergic to certain other opioid medicines.
  • Do not take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution if you take a medicine for depression called a Monoamine Oxidase Inhibitor (MAOI)
    • Do not take an MAOI within 14 days after you stop taking Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution.
    • Do not start Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution if you stopped taking an MAOI in the last 14 days.

Before you take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, tell your healthcare provider about all of your medical conditions, including if you:

    • have a drug dependence
    • have lung or breathing problems
    • have had a head injury
    • have pain in your stomach-area (abdomen)
    • have a history of severe or persistent cough
    • have prostate problems
    • have problems with your urinary tract(urethral stricture)
    • plan to have surgery
    • drink alcohol
    • have kidney or liver problems
    • have diabetes
    • have thyroid problems, such as hypothyroidism
    • are pregnant or plan to become pregnant. It is not known if Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution will harm your unborn baby. You and your healthcare provider should decide if you should take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution while you are pregnant.
    • are breastfeeding or plan to breastfeed. It is not known if Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution passes into your breast milk. You and your healthcare provider should decide if you will take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with certain other medicines can cause side effects or affect how well Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

  • take pain medicines such as narcotics
  • take cold or allergy medicines that contain antihistamines or cough suppressants
  • take medicines for mental illness (anti-psychotics, anti-anxiety)
  • drink alcohol
  • take medicines for depression, including monoamine oxidase inhibitors (MAOIs) and tricyclics
  • The use of MAOIs or tricyclic antidepressants with Vasofrinic DH (Hydrocodone Bitartrate) bitartrate may increase the effect of either the antidepressant or Vasofrinic DH (Hydrocodone Bitartrate).

How should I take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?

  • Take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution to take and when to take it. Do not change your dose without talking to your healthcare provider.
  • Administer Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution by the oral route only.
  • Ask your pharmacist to give you a measuring device to help you measure the correct amount of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
  • If you take too much Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?

  • Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution can cause you to be drowsy. Do not drive a car or operate machinery while you take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution until you know how it affects you.
  • Avoid drinking alcohol while taking Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?

Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution may cause serious side effects, including:

  • See “What is the most important information I should know about Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?”
  • breathing problems (respiratory depression) which can lead to death. Call your healthcare provider or get emergency treatment right away if you are sleeping more than usual, have shallow or slow breathing, or confusion.
  • Physical dependence or abuse. Take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution exactly as your healthcare provider tells you to take it. Stopping Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution suddenly could cause withdrawal symptoms.
  • Bowel problems including constipation or stomach pain.

The most common side effects of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution include:

  • Sleepiness
  • Confusion
  • nausea and vomiting
  • difficulty urinating
  • trouble breathing

These are not all the possible side effects of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?

  • Store Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C).
  • Safely throw away medicine that is out of date or no longer needed.
  • Keep Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution for a condition for which it was not prescribed. Do not give Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution that is written for health professionals.

What are the ingredients in Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?

Active ingredients: Vasofrinic DH (Hydrocodone Bitartrate) Bitartrate and Guaifenesin

Inactive ingredients: artificial raspberry flavor, citric acid, glycerin, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, and saccharin sodium

Manufactured for:

Accelis Pharma, East Windsor, NJ 08520

For more information, go to www.obredon.com or call 1-855-461-5102.

This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 09/2016

Pseudoephedrine Hydrochloride:



Active ingredients (in each caplet)...Purpose

Guaifenesin 400 mg...Expectorant

Vasofrinic DH (Pseudoephedrine Hydrochloride) hydrochloride 60 mg...Nasal decongestant

Uses

For temporarily relief of nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis), and to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Uses

  • temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Do not exceed recommended dosage.

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urinating due to an enlarged prostate gland

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

  • adults and children 12 years and older, 1 caplet every 4 to 6 hours, not more than 4 caplets in 24 hours
  • children 6 to under 12 years, ½ caplet every 4 to 6 hours, not more than 2 caplets in 24 hours
  • children under 6 years, consult a physician

Inactive ingredients

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and starch

Questions?

1-800-324-1880, 7:30am - 4:00pm Central, Mon.-Fri., or visit us at www.bfascher.com

Vasofrinic DH

Vasofrinic DH pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Vasofrinic DH available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Vasofrinic DH destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Vasofrinic DH Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Vasofrinic DH pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."WAL-FINATE (CHLORPHENIRAMINE MALEATE) TABLET [WALGREEN COMPANY]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Vasofrinic DH?

Depending on the reaction of the Vasofrinic DH after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Vasofrinic DH not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Vasofrinic DH addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Vasofrinic DH, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Vasofrinic DH consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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