codeine/chlorpheniramine/phenylephrine (Rx)

Brand and Other Names:Novahistine DH
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

dihydrocodeine/chlorpheniramine/phenylephrine

oral liquid: Schedule III

  • (7.5mg/2mg/5mg)/5mL

oral syrup: Schedule V

  • (3mg/2mg/7.5mg)/5mL
  • (3mg/5mg/20mg)/5mL
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Cough and Congestion

5-10 mL PO q4-6hr, up to 40 mL/24 hr

Dosage Forms & Strengths

dihydrocodeine/chlorpheniramine/phenylephrine

oral liquid: Schedule III

  • (7.25mg/2mg/5mg)/5mL

oral syrup: Schedule V

  • (3mg/2mg/7.5mg)/5mL
  • (3mg/5mg/20mg)/5mL
more...

Cough and Congestion

< 2 years: Not recommended

2-6 years: 1.25-2.5 mL PO q4-6hr PRN, up to 10 mL/24 hr

6-12 years: 2.5-5 mL PO q4-6hr, up to 20 mL/24 hr

>12 years: 5-10 mL PO q4-6hr, up to 40 mL/24 hr

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Interactions

Interaction Checker

and codeine/chlorpheniramine/phenylephrine

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Codeine

            • Drowsiness
            • Constipation

            1-10%

            Codeine

            • Bradycardia, hypotension, tachycardia
            • Confusion, dizziness, false feeling of well being, headache, lightheadedness, malaise, paradoxical CNS stimulation, restlessness, weakness
            • Rash, urticaria
            • Anorexia, nausea, vomiting, xerostomia
            • LFT's increased
            • Ureteral spasm, urination decreased
            • Dyspnea
            • Burning at injection site, blurred vision, histamine release

            Frequency Not Defined

            Chlorpheniramine

            • Anticholinergic
            • Somnolence
            • Constipation
            • Diarrhea
            • Nausea
            • Vomiting
            • Blurred vision

            Codeine

            • Hypotension, with IV use
            • Seizure, with excessive doses
            • Anaphylactoid reaction (rare)
            • Respiratory depression

            Phenylephrine

            • Hypertension
            • Severe peripheral and visceral vasoconstriction
            • Pallor
            • Reflex tachycardia
            • Anxiety
            • Dizziness
            • Headache
            • Insomnia,Nervousness
            • Restlessness
            • Metabolic acidosis
            • Gastric irritation
            • Nausea
            • Decreased renal perfusion
            • Extravasation of IV administration may lead to necrosis and sloughing of surrounding tissue
            • Excitability
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            Warnings

            Contraindications

            Codeine

            • Hypersensitivity
            • Acute abdominal condition, diarrhea associated w/ toxins, pseudomembranous colitis, respiratory depression
            • Asthma (acute), inflammatory bowel disease, respiratory impairment

            Chlorpheniramine

            • Acute asthma, sleep apnea

            Phenylephrine

            • Hypsesensitivity
            • Severe HTN, severe CAD
            • Within 14 days of nonselective MAO inhibitor therapy (risk of hypertensive reaction)
            • Newborn, preemies

            Cautions

            Codeine

            • Cardiac arrhythmias, drug abuse/dependence, emotional lability, gallbladder disease, head injury, hepatic impairment, hypothyroidism, increased ICP, prostatic hypertrophy, renal impairment, seizures with epilepsy, urethral stricture, urinary tract surgery
            • Risk of life threatening side effects in nursing babies, especially if mother is an ultra rapid metabolizer of codeine
            • Ibuprofen is more effective than codeine for pain from musculoskeletal injuries in children

            Chlorpheniramine

            • May cause CNS depression (patient should not operate heavy machinery
            • Caution in patients with asthma, thyroid dysfunction, hypertension, ischemic heart disease, increased intraocular pressure, or prostatic hyperplasia/urinary obstruction

            Phenylephrine

            • Caution in diabetes mellitus, cardiovascular disease, prostatic hyperplasia, hyperthyroidism, and increased intraocular pressure
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            Pregnancy & Lactation

            Pregnancy category: C

            Not known whether distributed in breast milk, use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Dihydrocodeine: Narcotic agonist analgesic with antitussive activity, mu receptor agonist

            Chlorpheniramine: Histamine H1-receptor antagonist

            Phenylephrine: Alpha-adrenergic stimulator with weak beta-adrenergic activity; produces systemic vasoconstriction of arteries and arterioles.

            Codeine

            Half-Life: 3-4 hr

            Onset: 30-60 min

            Metabolism: Inactive but metabolized to morphine by CYP2D6 (missing in 5-10% of population)

            Duration: 4-6 hr

            Peak Plasma Time: 0.5-1 hr

            Vd: 3-6 L/kg

            Bioavailability: 53%

            Protein Bound: 25%

            Excretion: Urine (90%), feces

            Chlorpheniramine

            Half-Life: 10-13 hr (children); 14-24 hr (adults)

            Duration: 24 hr

            Onset: 6 hr

            Peak Plasma Time: 2-3 hr

            Protein Bound: 29-37%

            Vd: 4-7 L/kg (children); 6-12 L/kg (adults)

            Metabolism: GI mucosa, liver

            Metabolites: Monodesmethylchlorpheniramine, didesmethylchlorpheniramine

            Excretion: Urine

            Sedative effect: Low

            Antihistamine activity: Moderate

            Anticholinergic acitivity: Moderate

            Phenylephrine

            Half-Life: 2-3 hr

            Duration: 2-4 hr

            Onset: 10-15 min (IM/SC); immediate (IV)

            Vd: 340 L (mean)

            Bioavailability: < 38%

            Peak Plasma Time: 0.75-2 hr

            Metabolism: Hepatic

            Excretion: Urine

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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