Active ingredient: Hydrocodone Bitartrate

How often in a day do you take medicine? How many times? Once in a day Twice in a day 3 times in a day 4 times in a day

Hydrocodone Bitartrate uses

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Drug abuse and dependence
• Overdosage
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• How supplied/storage and handling
• Patient counseling information
• Medication guide obredon oral solution (oh-brĕ-don oral solution) (hydrocodone bitartrate and guaifenesin) each 5 ml contains hydrocodone bitartrate, usp, 2.5 mg; and guaifenesin, usp, 200 mg. c-ii
• Hydrocodone Bitartrate reviews

1 INDICATIONS AND USAGE

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 .

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

3 DOSAGE FORMS AND STRENGTHS

Oral Solution:

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

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

4 CONTRAINDICATIONS

Hydrocodone Bitartrate Oral Solution is contraindicated in:

• Patients with known hypersensitivity to Hydrocodone Bitartrate bitartrate, guaifenesin, or any of the inactive ingredients of Hydrocodone Bitartrate Oral Solution.
• Patients receiving MAOI therapy or within 14 days of stopping such therapy .

• Patients with known hypersensitivity to Hydrocodone Bitartrate bitartrate, guaifenesin, or any of the inactive ingredients of 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 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 Hydrocodone Bitartrate Oral Solution is used with benzodiazepines, alcohol, or other CNS depressants .

5.2 Respiratory Depression

Hydrocodone Bitartrate bitartrate, one of the active ingredients in Hydrocodone Bitartrate Oral Solution, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of Hydrocodone Bitartrate bitartrate in adults has been associated with fatal respiratory depression, and the use of Hydrocodone Bitartrate bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administering 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

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 Hydrocodone Bitartrate Oral Solution. Prescribe and administer 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 Hydrocodone Bitartrate Oral Solution should be avoided in these patients.

5.5 Activities Requiring Mental Alertness

Hydrocodone Bitartrate bitartrate, one of the active ingredients in 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 Hydrocodone Bitartrate Oral Solution. Concurrent use of 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

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

5.7 Co-administration with Anticholinergics

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

5.8 Co-administration with MAOIs or Tricyclic Antidepressants

Hydrocodone Bitartrate 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 Hydrocodone Bitartrate bitartrate may increase the effect of either the antidepressant or Hydrocodone Bitartrate .

5.9 Persistent Cough

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 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, 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

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

Hydrocodone Bitartrate Oral Solution should be used with caution in patients with severe renal impairment.

5.13 Hepatic Impairment

Hydrocodone Bitartrate Oral Solution should be used with caution in patients with severe hepatic impairment .

6 ADVERSE REACTIONS

Use of 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 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 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.

7 DRUG INTERACTIONS

No specific interaction studies have been conducted with Hydrocodone Bitartrate Oral Solution.

• Opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants : Avoid using with 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 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 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 Hydrocodone Bitartrate Oral Solution if the patient is taking a prescription MAOI, or for 2 weeks after stopping a MAOI drug. The use of MAOIs or tricyclic antidepressants with Hydrocodone Bitartrate preparations may increase the effect of either the antidepressant or Hydrocodone Bitartrate .

7.3 Anticholinergic Drugs

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 Hydrocodone Bitartrate Oral Solution in pregnant women. Reproductive toxicity studies have not been conducted with Hydrocodone Bitartrate Oral Solution; however, studies are available with an individual active ingredient or related active ingredient. Hydrocodone Bitartrate was teratogenic in hamsters. Codeine, an opiate related to Hydrocodone Bitartrate, increased resorptions and decreased fetal weight in rats. Because animal reproduction studies are not always predictive of human response, Hydrocodone Bitartrate Oral Solution should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

Hydrocodone Bitartrate:

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 Hydrocodone Bitartrate. In a study in which pregnant rats were dosed throughout organogenesis, a dose of codeine approximately 40 times the MRHDD of 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 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 Hydrocodone Bitartrate 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 Hydrocodone Bitartrate Oral Solution is administered to nursing mothers. 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 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 Hydrocodone Bitartrate Oral Solution in pediatric patients under 18 years of age has not been established. The use of 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 Hydrocodone Bitartrate Oral Solution in geriatric populations. Other reported clinical experience with the individual active ingredients of 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

Hydrocodone Bitartrate Oral Solution should be given with caution in patients with severe impairment of renal function.

8.7 Hepatic Impairment

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

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

9.2 Abuse

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 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- lactic acid.

9.3 Dependence

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, 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 Hydrocodone Bitartrate Oral Solution.

Hydrocodone Bitartrate:

Overdosage with 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 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 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

Hydrocodone Bitartrate Oral Solution contains Hydrocodone Bitartrate bitartrate and guaifenesin (an expectorant).

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

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 Hydrocodone Bitartrate Bitartrate

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

Hydrocodone Bitartrate is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of Hydrocodone Bitartrate and other opiates is not known; however, Hydrocodone Bitartrate is believed to act directly on the cough center. In excessive doses, Hydrocodone Bitartrate will depress respiration. 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 Hydrocodone Bitartrate bitartrate and guaifenesin after single dose administration of 10 mL Hydrocodone Bitartrate Oral Solution are equivalent to respective reference solutions of 5 mL Hydrocodone Bitartrate bitartrate (5 mg/5 mL), and 10 mL guaifenesin (200 mg/5 mL).

Hydrocodone Bitartrate: Following a single 10 mL oral dose of Hydrocodone Bitartrate Oral Solution administered to 36 healthy adults (19-74 years), the geometric mean C _max and AUC _0-inf for Hydrocodone Bitartrate were 12.6 ng/ml and 80.9 ng·hr/ml, respectively. The median time to maximum concentration for Hydrocodone Bitartrate was about 1.25 hours. Food has no significant effect on the extent of absorption of Hydrocodone Bitartrate. The mean plasma half-life of Hydrocodone Bitartrate is approximately 5 hours.

Guaifenesin: Following a single 10 mL oral dose of 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 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 Hydrocodone Bitartrate Oral Solution; however, published information is available for the individual active ingredients or related active ingredients.

Hydrocodone Bitartrate:

Carcinogenicity studies were conducted with codeine, an opiate related to 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 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 Hydrocodone Bitartrate Oral Solution. Efficacy of Hydrocodone Bitartrate Oral Solution is based on demonstration of bioequivalence to the individual comparator products .

16 HOW SUPPLIED/STORAGE AND HANDLING

Hydrocodone Bitartrate Oral Solution is supplied as a clear, raspberry flavored liquid containing 2.5 mg 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 Hydrocodone Bitartrate Oral Solution because serious adverse events such as respiratory depression may occur with overdosage .

Dosing

Advise patients to measure 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 Hydrocodone Bitartrate Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol.

Because of this risk, patients should avoid concomitant use of 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 Hydrocodone Bitartrate Oral Solution may produce marked drowsiness .

Drug Dependence

Caution patients that Hydrocodone Bitartrate Oral Solution contains 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

Hydrocodone Bitartrate Oral Solution

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

What is the most important information I should know about Hydrocodone Bitartrate Oral Solution?

• Taking 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.
• Hydrocodone Bitartrate Oral Solution can cause you to be drowsy. Do not drive a car or operate machinery until you know how Hydrocodone Bitartrate Oral Solution affects you. 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 Hydrocodone Bitartrate Oral Solution.
• Call your healthcare provider or get emergency medical help right away if anyone taking Hydrocodone Bitartrate Oral Solution has any of the symptoms below:
  • increased sleepiness
  • confusion
  • difficulty breathing
  • shallow breathing
  • limpness
  • your baby has difficulty breastfeeding
• Keep 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 Hydrocodone Bitartrate Oral Solution, get emergency medical help right away.
• Hydrocodone Bitartrate Oral Solution can cause serious side effects, including death.
• Take Hydrocodone Bitartrate Oral Solution exactly as prescribed by your healthcare provider. If you take the wrong dose of Hydrocodone Bitartrate Oral Solution, you could overdose and die.
• Hydrocodone Bitartrate Oral Solution is not for children under 18 years of age.

What is Hydrocodone Bitartrate Oral Solution?

• 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. Hydrocodone Bitartrate Oral Solution contains two medicines, Hydrocodone Bitartrate and guaifenesin. Hydrocodone Bitartrate is a narcotic cough suppressant. Guaifenesin is an expectorant.
• Hydrocodone Bitartrate Oral Solution is a federal controlled substance (C-II) because it contains Hydrocodone Bitartrate that can be abused or lead to dependence. Keep Hydrocodone Bitartrate Oral Solution in a safe place to prevent misuse and abuse. Selling or giving away 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.
• Hydrocodone Bitartrate Oral Solution is not for children under 18 years of age. It is not known if Hydrocodone Bitartrate Oral Solution is safe and effective in children.

Who should not take Hydrocodone Bitartrate Oral Solution?

• Do not take Hydrocodone Bitartrate Oral Solution if you are allergic to any of the ingredients in 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 Hydrocodone Bitartrate Oral Solution if you are allergic to certain other opioid medicines.
• Do not take 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 Hydrocodone Bitartrate Oral Solution.
  • Do not start Hydrocodone Bitartrate Oral Solution if you stopped taking an MAOI in the last 14 days.

Before you take 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 Hydrocodone Bitartrate Oral Solution will harm your unborn baby. You and your healthcare provider should decide if you should take Hydrocodone Bitartrate Oral Solution while you are pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Hydrocodone Bitartrate Oral Solution passes into your breast milk. You and your healthcare provider should decide if you will take 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 Hydrocodone Bitartrate Oral Solution with certain other medicines can cause side effects or affect how well 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 Hydrocodone Bitartrate bitartrate may increase the effect of either the antidepressant or Hydrocodone Bitartrate.

How should I take Hydrocodone Bitartrate Oral Solution?

• Take Hydrocodone Bitartrate Oral Solution exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Hydrocodone Bitartrate Oral Solution to take and when to take it. Do not change your dose without talking to your healthcare provider.
• Administer 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 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 Hydrocodone Bitartrate Oral Solution, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Hydrocodone Bitartrate Oral Solution?

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

What are the possible side effects of Hydrocodone Bitartrate Oral Solution?

Hydrocodone Bitartrate Oral Solution may cause serious side effects, including:

• See “What is the most important information I should know about 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 Hydrocodone Bitartrate Oral Solution exactly as your healthcare provider tells you to take it. Stopping Hydrocodone Bitartrate Oral Solution suddenly could cause withdrawal symptoms.
• Bowel problems including constipation or stomach pain.

The most common side effects of Hydrocodone Bitartrate Oral Solution include:

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

These are not all the possible side effects of 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 Hydrocodone Bitartrate Oral Solution?

• Store 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 Hydrocodone Bitartrate Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of Hydrocodone Bitartrate Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Hydrocodone Bitartrate Oral Solution for a condition for which it was not prescribed. Do not give 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 Hydrocodone Bitartrate Oral Solution that is written for health professionals.

What are the ingredients in Hydrocodone Bitartrate Oral Solution?

Active ingredients: 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

Hydrocodone Bitartrate available forms, composition, doses:

• N/A

Indications and Usages:

ATC codes:

• N/A

ICD-10 codes:

• N/A

Hydrocodone Bitartrate destination | category:

• Human:
• Analgesics (opioid)
• Antitussives
• Cough and cold preparations

Drugs with same active ingredients (Pharmaceutical companies):

• Biocodone    (UCB Pharma)
• Hydrocodone Bitartrate
• PMS-Hydrocodone    (Pharmascience)
• Robidone    (Wyeth)

References

1. Dailymed."HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. "HYDROCODONE". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Hydrocodone Bitartrate?

Depending on the reaction of the Hydrocodone Bitartrate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Hydrocodone Bitartrate 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 Hydrocodone Bitartrate 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.

Review

sdrugs.com conducted a study on Hydrocodone Bitartrate, 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 Hydrocodone Bitartrate 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.

Visitor reports

Visitor reviews

There are no reviews yet. Be the first to write one!

Your name:  Email:  Spam protection:  < Type 20 here

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