Ped-4

The d-isomer of the codeine analog of levorphanol. Ped-4 shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (receptors, N-methyl-D-aspartate) and acts as a non-competitive channel blocker. It is one of the widely used antitussives, and is also used to study the involvement of glutamate receptors in neurotoxicity.

used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (e.g., sinusitis, bronchitis). Ped-4 is a cough suppressant that affects a certain part of the brain (cough center), reducing the urge to cough. Decongestants help relieve stuffy nose symptoms. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.

Ped-4 is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Ped-4 is used to treat a cough.

Ped-4 will not treat a cough that is caused by smoking, asthma, or emphysema.

Ped-4 may also be used for purposes not listed in this medication guide.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule,

Oral, as hydrobromide:

Robafen Cough: 15 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]

Robitussin Lingering CoughGels: 15 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, polyethylene glycol, propylene glycol]

Gel,

Oral, as hydrobromide:

ElixSure Cough: 7.5 mg/5 mL (120 mL) [alcohol free; contains carbomer 934p, propylene glycol, propylparaben; cherry bubblegum flavor]

Liquid,

Oral, as hydrobromide:

Buckleys Cough: 12.5 mg/5 mL (118 mL) [alcohol free, sugar free; contains butylparaben, menthol, propylparaben, saccharin sodium]

Little Colds Cough Formula: 7.5 mg/mL (30 mL) [alcohol free, dye free, saccharin free; contains sodium benzoate; grape flavor]

PediaCare Childrens Long-Act: 7.5 mg/5 mL (118 mL) [contains brilliant blue fcf (fd&c blue #1), saccharin sodium, sodium benzoate]

Robitussin Lingering LA Cough: 15 mg/5 mL (118 mL [DSC]) [contains alcohol, usp, fd&c red #40, menthol, saccharin sodium, sodium benzoate]

Ped-4: 10 mg/5 mL (480 mL [DSC], 3780 mL [DSC]) [alcohol free, dye free, fructose free, sodium free, sorbitol free, sugar free]

Triaminic Long Acting Cough: 7.5 mg/5 mL (118 mL) [alcohol free, dye free, pseudoephedrine free; contains benzoic acid, propylene glycol]

Lozenge, Mouth/Throat, as hydrobromide:

Hold: 5 mg (10 ea)

Hold: 5 mg (10 ea) [cherry flavor]

Trocal Cough Suppressant: 7.5 mg (1 ea [DSC])

Strip,

Oral, as hydrobromide:

Triaminic Long Acting Cough: 7.5 mg (14 ea, 16 ea) [contains alcohol, usp, fd&c red #40; cherry flavor]

Triaminic Long Acting Cough: 7.5 mg (14 ea) [contains alcohol, usp, fd&c red #40, isopropyl alcohol]

Suspension Extended Release,

Oral:

Cough DM: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains fd&c yellow #10 aluminum lake, methylparaben, polysorbate 80, propylparaben, sodium metabisulfite; orange flavor]

Ped-4: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), disodium edta, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben; grape flavor]

Ped-4: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains edetate disodium, fd&c yellow #6 (sunset yellow), methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben; orange flavor]

Ped-4 Cough Childrens: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), edetate disodium, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben, soybean oil; grape flavor]

Ped-4 Cough Childrens: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains edetate disodium, fd&c yellow #6 (sunset yellow), methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben, soybean oil; orange flavor]

GoodSense Cough DM: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (148 mL) [alcohol free, gluten free; contains fd&c yellow #10 aluminum lake, methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]

GoodSense Cough DM Childrens: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free, gluten free; contains fd&c yellow #10 aluminum lake, methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]

Robitussin 12 Hour Cough: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]

Robitussin 12 Hour Cough: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains fd&c yellow #10 (quinoline yellow), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]

Robitussin 12 Hour Cough

Child: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]

Generic: Ped-4 polistirex [equivalent to Ped-4 hydrobromide 30 mg/5 mL] (89 mL)

Syrup,

Oral, as hydrobromide:

Creomulsion

Adult: 20 mg/15 mL (118 mL [DSC])

Creomulsion for Children: 5 mg/5 mL (118 mL [DSC]) [cherry flavor]

Robitussin Childrens Cough LA: 7.5 mg/5 mL (118 mL) [alcohol free; contains fd&c red #40, propylene glycol, saccharin sodium, sodium benzoate; fruit punch flavor]

Silphen DM Cough: 10 mg/5 mL (118 mL) [contains alcohol, usp; strawberry flavor]

Triaminic Long Acting Cough: 7.5 mg/5 mL (118 mL [DSC]) [alcohol free, dye free; contains benzoic acid, edetate disodium, propylene glycol]

Dosing: Adult

Cough suppressant:

Oral: 10 to 20 mg every 4 hours

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Safety and efficacy for the use of cough and cold products in infants and young children limited; the AAP warns against the use of these products for respiratory illnesses in infants and young children (AAP 2018; FDA 2017).

Cough suppressant:

Oral:

Oral syrup (immediate release):

Children 2 to <6 years: 5 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.

Children 6 to <12 years: 10 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.

Children ≥12 years and Adolescents: 20 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.

Long-acting liquid: Children ≥12 years and Adolescents: 30 mg every 6 to 8 hours as needed; do not exceed 4 doses in 24 hours.

Oral capsule: Children ≥12 years and Adolescents: 30 mg every 6 to 8 hours as needed; do not exceed 4 doses in 24 hours.

Extended-release suspension (Ped-4 polistirex):

Children 4 to <6 years: 15 mg every 12 hours as needed; do not exceed 30 mg in 24 hours.

Children 6 to <12 years: 30 mg every 12 hours as needed; do not exceed 60 mg in 24 hours.

Children ≥12 years and Adolescents: 60 mg every 12 hours as needed; do not exceed 120 mg in 24 hours.

See also:
What is the most important information I should know about Ped-4?

Do not use Ped-4 if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take Ped-4 before the MAO inhibitor has cleared from your body.

Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains Dextromethorphan.

Use Ped-4 orally disintegrating strips as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ped-4 orally disintegrating strips by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Do not remove the strip from the pouch until you are ready to take Ped-4 orally disintegrating strips. Be sure that your hands are dry when you touch the strip.
• Remove the strip from the pouch and place it onto the tongue. The strip dissolves quickly and can be swallowed with saliva. It may be taken with or without water.
• Use the strip right away after you open the pouch. Do not store it for future use.
• If you miss a dose of Ped-4 orally disintegrating strips and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ped-4 orally disintegrating strips.

This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This product should not usually be used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor. This product contains Dextromethorphan. It is a cough suppressant that works by decreasing the feeling of needing to cough.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients. Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

How to use Ped-4

Take this medication by mouth, usually every 4 to 12 hours as needed or as directed by your doctor. If stomach upset occurs, take with food or milk. Use a medication-measuring device to measure your dose of liquid medication. Do not use a household spoon because you may not get the correct dose. If you are taking a suspension, shake the product well before measuring out your dose.

Dosage is based on the product you are taking and your age, medical condition, and response to treatment. If you are using this medication for self-treatment (without a prescription from your doctor), follow the specific dosing instructions on the packaging to find the correct dose for your age.

If your doctor directs you to take this medication daily, take it regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Improper use of this medication (abuse) may result in serious harm (e.g., brain damage, seizure, death). Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.

Tell your doctor if your symptoms persist or worsen after more than 1 week or if you also have fever, chills, headache, or rash. These may be signs of a more serious condition.

See also:
What other drugs will affect Ped-4?

MAO inhibitors (including furazolidone, procarbazine, selegiline) when administered simultaneous with Ped-4 may cause adrenergic crisis, collapse, coma, dizziness, agitation, increased blood pressure, hyperpyrexia, intracranial hemorrhage, lethargy, nausea, cramps, tremor. In combination with tricyclic antidepressants (amitriptyline, etc.) Ped-4 Lafayette Pharmaceutical Laboratory may appeal serotonin syndrome and possible subsequent death. Amiodarone, fluoxetine, quinidine, inhibiting system cytochrome P450, may increase the drug concentration in the blood. Tobacco smoke can lead to increased secretion of glands in the background of inhibition of cough reflex. Some inhibitors of CYP450 (such as quinidine) increase and extended effects of this medicine.

See also:
What are the possible side effects of Ped-4?

Applies to Ped-4: oral capsule, oral capsule liquid filled, oral elixir, oral liquid, oral lozenge/troche, oral solution, oral suspension, oral suspension extended release, oral syrup, oral tablet

In addition to its needed effects, some unwanted effects may be caused by Ped-4 (the active ingredient contained in Ped-4 HBr Adult Formula). In the event that any of these side effects do occur, they may require medical attention.

Severity: Moderate

If any of the following side effects occur while taking Ped-4, check with your doctor or nurse as soon as possible:

Symptoms of overdose:

• Blurred vision
• confusion
• difficulty in urination
• drowsiness or dizziness
• nausea or vomiting (severe)
• shakiness and unsteady walk
• slowed breathing
• unusual excitement, nervousness, restlessness, or irritability (severe)

Minor Side Effects

Some of the side effects that can occur with Ped-4 may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common or rare:

• Confusion
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache
• nausea or vomiting
• stomach pain