Ninjacof 12.5-12.5mg/5ml Liquid

Manufacturer CENTURION LABS Active Ingredient Chlophedianol and Pyrilamine(KLOE fe DYE a nol & pir IL a meen) Pronunciation KLOE fe DYE a nol & pir IL a meen
It is used to ease allergy signs.It is used to relieve coughing.
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Drug Class
Antitussive, Antihistamine
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Pharmacologic Class
Centrally acting antitussive (non-opioid), H1-receptor antagonist (first-generation)
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ninjacof Liquid is a medicine that helps relieve cough, sneezing, and runny nose. Chlophedianol helps calm your cough, and Pyrilamine helps dry up your runny nose and stop sneezing.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize this side effect. When taking the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding bathrooms and areas where it may be exposed to moisture. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about the best way to dispose of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.

What to Do If You Miss a Dose

If you take this medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness or dizziness.
  • Avoid alcohol consumption while taking this medication, as it can increase drowsiness and other side effects.
  • Avoid other medications that cause drowsiness or have anticholinergic effects (e.g., certain allergy medicines, sleep aids) unless directed by your doctor.
  • Stay hydrated to help with dry mouth, a common side effect.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mL (25 mg Chlophedianol, 25 mg Pyrilamine) orally every 4 to 6 hours as needed
Dose Range: 5 - 10 mg

Condition-Specific Dosing:

maximumDailyDose: Not to exceed 40 mL (100 mg Chlophedianol, 100 mg Pyrilamine) in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended for children under 2 years)
Child: 6 to under 12 years: 5 mL (12.5 mg Chlophedianol, 12.5 mg Pyrilamine) orally every 4 to 6 hours as needed, not to exceed 20 mL in 24 hours. Not recommended for children under 6 years.
Adolescent: 12 years and older: Same as adult dosing (10 mL every 4 to 6 hours)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for increased side effects.
Moderate: Consider dose reduction; monitor closely for sedation and anticholinergic effects.
Severe: Avoid use or significantly reduce dose; monitor closely. Both drugs are renally excreted.
Dialysis: Not available; likely not dialyzable to a significant extent. Avoid or use with extreme caution.

Hepatic Impairment:

Mild: Use with caution; monitor for increased side effects.
Moderate: Consider dose reduction; monitor closely for sedation and anticholinergic effects. Both drugs are hepatically metabolized.
Severe: Avoid use or significantly reduce dose; monitor closely.

Pharmacology

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Mechanism of Action

Chlophedianol is a non-narcotic antitussive that acts centrally to elevate the cough threshold, thereby suppressing the cough reflex. Pyrilamine is a first-generation antihistamine that competitively blocks histamine H1 receptors, reducing symptoms like sneezing, rhinorrhea, and watery eyes. It also possesses anticholinergic properties.
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Pharmacokinetics

Absorption:

Bioavailability: Not readily available for specific combination, but both ingredients are well absorbed orally.
Tmax: Chlophedianol: 1-4 hours; Pyrilamine: 1-2 hours
FoodEffect: Minimal or not significant

Distribution:

Vd: Not readily available for combination
ProteinBinding: Pyrilamine: Moderate (approx. 50-70%); Chlophedianol: Not readily available
CnssPenetration: Yes (both ingredients cross the blood-brain barrier, contributing to central effects like sedation)

Elimination:

HalfLife: Chlophedianol: Approximately 20-30 hours; Pyrilamine: Approximately 4-8 hours
Clearance: Not readily available for combination
ExcretionRoute: Renal (primarily urine)
Unchanged: Small percentage of both drugs excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 1-4 hours
DurationOfAction: 4-6 hours (limited by the shorter half-life of pyrilamine for antihistaminic effects, though antitussive effect of chlophedianol may last longer)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- Feeling sleepy
- Feeling nervous and excitable

Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe drowsiness or dizziness that interferes with daily activities
  • Difficulty breathing or shortness of breath
  • Fast or irregular heartbeat
  • Hallucinations or confusion
  • Severe dry mouth, difficulty swallowing, or severe constipation
  • Difficulty urinating
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Respiratory conditions, such as a cough that produces a significant amount of mucus, a persistent cough caused by smoking or exposure to smoke, or lung diseases like asthma or emphysema.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of severely high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have

This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your chance of experiencing severe side effects. Additionally, do not take this medication for a longer duration than specified by your doctor.

Until you are aware of how this medication affects you, it is recommended that you avoid driving and other activities that require alertness. It is also advisable to avoid consuming alcohol while taking this drug.

Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness or slow your reactions, consult with your doctor.

When administering this medication to a child, exercise caution, as children may have a higher risk of experiencing excitability. It is crucial to note that different brands of this medication may be suitable for different age groups of children. Therefore, consult with your doctor before giving this medication to a child.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or sedation
  • Dizziness
  • Nausea, vomiting
  • Excitation, restlessness, irritability (especially in children)
  • Hallucinations
  • Seizures
  • Dilated pupils
  • Flushed skin
  • Dry mouth and skin
  • Urinary retention
  • Rapid heartbeat (tachycardia)
  • Coma

What to Do:

If you suspect an overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Be prepared to provide the name of the medication, the amount taken, and the time it was taken.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of hypertensive crisis, severe anticholinergic effects, or increased CNS depression)
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Major Interactions

  • CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, opioids, tricyclic antidepressants): Increased sedation and CNS depression.
  • Other anticholinergic drugs (e.g., atropine, scopolamine, some antipsychotics, other antihistamines): Increased risk of anticholinergic side effects (dry mouth, urinary retention, blurred vision, constipation).
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Moderate Interactions

  • Antihypertensives: May cause additive hypotensive effects.
  • QT-prolonging drugs: While less common with pyrilamine than some other antihistamines, caution with other drugs known to prolong QT interval.
  • Potassium chloride (oral forms): Increased risk of GI lesions due to slowed GI motility.
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Minor Interactions

  • Not readily available for specific minor interactions beyond general additive effects.

Monitoring

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Baseline Monitoring

Symptom assessment (cough, sneezing, rhinorrhea)

Rationale: To establish baseline severity and guide treatment.

Timing: Prior to initiation of therapy

Medical history (especially respiratory conditions, glaucoma, urinary retention, cardiovascular disease)

Rationale: To identify contraindications or conditions requiring caution.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy of symptom relief

Frequency: Daily, as needed

Target: Reduction in cough frequency/severity, reduced sneezing/rhinorrhea

Action Threshold: Lack of efficacy after appropriate trial, consider alternative therapy.

Adverse effects (e.g., sedation, dizziness, dry mouth, urinary retention, blurred vision)

Frequency: Daily, as needed

Target: Absence or mild, tolerable side effects

Action Threshold: Severe or intolerable side effects, consider dose reduction or discontinuation.

Mental status (especially in elderly or renally/hepatically impaired patients)

Frequency: As needed, particularly during initial therapy or dose changes

Target: Alertness, orientation

Action Threshold: Excessive drowsiness, confusion, disorientation.

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Symptom Monitoring

  • Cough frequency and severity
  • Sneezing
  • Runny nose (rhinorrhea)
  • Sedation/drowsiness
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Nausea/vomiting

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Consult a healthcare professional.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly needed.
Second Trimester: Limited data, use with caution.
Third Trimester: Antihistamines, especially first-generation, may cause adverse effects in the newborn (e.g., irritability, tremors) if used close to delivery. Avoid use in the third trimester if possible.
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Lactation

L3 (Moderately Safe). Both Chlophedianol and Pyrilamine are excreted into breast milk. Use with caution. Monitor the infant for drowsiness, irritability, or decreased feeding. Pyrilamine may decrease milk supply due to its anticholinergic effects.

Infant Risk: Potential for infant sedation, irritability, or decreased milk supply.
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Pediatric Use

Not recommended for children under 6 years of age due to potential for serious adverse effects, including respiratory depression and overdose. Use with extreme caution and precise dosing in children 6-12 years. Always use a measuring device provided with the product.

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Geriatric Use

Elderly patients are more susceptible to the sedative and anticholinergic effects (e.g., dry mouth, urinary retention, constipation, confusion) of this medication. Start with the lowest effective dose and monitor closely. Avoid in patients with glaucoma or prostatic hypertrophy.

Clinical Information

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Clinical Pearls

  • This combination product is primarily for symptomatic relief of acute cough and cold symptoms, not for chronic cough or asthma-related cough.
  • Warn patients about potential for significant drowsiness and impaired mental alertness; advise against driving or operating machinery.
  • Educate patients on the importance of accurate dosing, especially in children, using a proper measuring device.
  • Advise patients to avoid concurrent use of alcohol or other CNS depressants.
  • Be mindful of anticholinergic side effects, particularly in elderly patients or those with pre-existing conditions like glaucoma, benign prostatic hyperplasia, or urinary retention.
  • The long half-life of chlophedianol means effects can persist, and accumulation may occur with frequent dosing.
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Alternative Therapies

  • Single-ingredient antitussives (e.g., dextromethorphan, guaifenesin)
  • Single-ingredient antihistamines (e.g., diphenhydramine, chlorpheniramine)
  • Nasal decongestants (e.g., pseudoephedrine, phenylephrine)
  • Saline nasal sprays
  • Humidifiers
  • Honey (for cough relief in adults and children >1 year)
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Cost & Coverage

Average Cost: Not available Not available
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (for generic formulations), Tier 3 or higher (for specific brand-name products)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.