codeine/pseudoephedrine (Rx)

Brand and Other Names:Notuss-DC
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

codeine/pseudoephedrine

oral liquid: Schedule V

  • (10mg/30mg)/5mL
  • (8mg/30mg)5mL
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Congestion with Cough

5-10 mJ PO q4-6hr; not to exceed 40mL/24 hr

Dosage Forms & Strengths

codeine/pseudoephedrine

oral liquid: Schedule V

  • (10mg/30mg)/5mL
  • (8mg/30mg)5mL
more...

Congestion with Cough

<6 years: Not recommended

6-12 years: 2.5-5 mL PO q4-6hr; not to exceed 20mL/24 hr

>12 years: 5-10mL PO q4-6hr; not to exceed 40mL/24 hr

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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
  • Blurred vision, histamine release

Frequency Not Defined

Codeine (serious)

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

Pseudoephedrine

  • Insomnia
  • Restlessness
  • Tremor
  • Nausea
  • Vomiting
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Warnings

Contraindications

Codeine

  • Hypsesensitivity
  • Absolute: acute abdominal condition, diarrhea associated with toxins, pseudomembranous colitis, respiratory depression
  • Relative: Asthma (acute), inflammatory bowel disease, respiratory impairment

Pseudoephedrine

  • Hypsesensitivity
  • Severe HTN, severe CAD
  • Nonselective MAO inhibitors: risk of hypertensive reaction
  • Newborns, preemies

Cautions

Codeine

  • Caution in cardiac arrhythmias, drug abuse/dependence, emotional lability, gallbladder dz, 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

Pseudophedrine

  • Mild-mod HTN, cardiac disease, hyperthyroidism, hyperglycemia, BPH, DM, glaucoma
  • Many combo formulations are switching to phenylephrine due to restrictions arising from easy conversion to methamphetamine (The Combat Methamphetamine Epidemic Act of 2005 bans OTC sales of cold medicines that contain ingredients commonly used to make methamphetamine such as pseudoephedrine)
  • Lactation
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Pregnancy & Lactation

Pregnancy category: C

Lactation: codeine and pseudoephedrine excreted 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.

more...
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Pharmacology

Mechanism of Action

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

Pseudoephedrine: Alpha adrenergic agonist

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

Bioavailability: 53%

Peak Plasma Time: 0.5-1 hr

Protein Bound: 25%

Excretion: Urine (90%); feces

Pseudoephedrine

Half-Life: 3 hr (children); 9-16 hr (adults)

Onset: 30 min (decongestant)

Duration: 3-8 hr

Peak PlasmaTime: 1.97 hr

Metabolism: Liver, by N-demethylation

Vd: 2.5 L/kg (children); 2.64-3.51 L/kg

Metabolites: inactive

Clearance: 7.3-7.6 mL/min/kg

Excretion: Urine (43-96%)

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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.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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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