Stahist Ad 25-60mg Tablets

Manufacturer MAGNA Active Ingredient Chlorcyclizine and Pseudoephedrine Tablets(klor SYE klih zeen & SOO doe e FED rin) Pronunciation klor SYE klih zeen & SOO doe ee FED rin
It is used to treat nose stuffiness.It is used to ease allergy signs.
đŸˇī¸
Drug Class
Antihistamine/Decongestant Combination
đŸ§Ŧ
Pharmacologic Class
H1-receptor antagonist (1st generation) / Alpha-adrenergic agonist
🤰
Pregnancy Category
Category C
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

This medication is a combination of an antihistamine and a decongestant. The antihistamine helps relieve allergy symptoms like sneezing, runny nose, and watery eyes. The decongestant helps clear up stuffy nose and sinus pressure by shrinking blood vessels in the nasal passages.
📋

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also have access to local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
💡

Lifestyle & Tips

  • Take with food or milk if stomach upset occurs.
  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness or dizziness.
  • Avoid alcohol and other CNS depressants (e.g., sedatives, tranquilizers) as they can increase drowsiness.
  • Stay hydrated to help with dry mouth.
  • Do not take more than the recommended dose or more frequently than prescribed.
  • Inform your doctor or pharmacist about all other medications you are taking, including over-the-counter drugs, vitamins, and herbal supplements, especially MAOIs, blood pressure medications, or other cold/allergy medicines.
💊

Available Forms & Alternatives

Available Strengths:

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 1 tablet (Chlorcyclizine 25mg / Pseudoephedrine 60mg) orally every 4 to 6 hours as needed.
Dose Range: 1 - 4 mg

Condition-Specific Dosing:

Maximum Daily Dose: Do not exceed 4 tablets (100mg Chlorcyclizine / 240mg Pseudoephedrine) in 24 hours.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 12 years of age due to potential for serious adverse effects and lack of established efficacy/safety.
Adolescent: For adolescents 12 years and older, adult dosing may be considered, but caution is advised due to increased sensitivity to sympathomimetic and anticholinergic effects.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment for mild impairment, but monitor for increased side effects.
Moderate: Use with caution. Consider reducing dose or extending dosing interval (e.g., every 6-8 hours) due to pseudoephedrine excretion.
Severe: Contraindicated or use with extreme caution. Significant dose reduction or avoidance is necessary. Pseudoephedrine clearance is significantly reduced.
Dialysis: Pseudoephedrine is partially dialyzable. Chlorcyclizine is not well studied. Avoid use or use with extreme caution and significant dose reduction.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: Use with caution. Chlorcyclizine is metabolized by the liver; monitor for increased sedation or anticholinergic effects.
Severe: Use with caution. Consider dose reduction for chlorcyclizine component. Monitor closely for adverse effects.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Chlorcyclizine is a first-generation antihistamine that acts as an H1-receptor antagonist, competing with histamine for H1-receptor sites on effector cells, thereby preventing histamine-mediated responses such as vasodilation, increased capillary permeability, and pruritus. It also possesses anticholinergic and sedative properties. Pseudoephedrine is a sympathomimetic amine that acts directly and indirectly on adrenergic receptors. It primarily causes vasoconstriction of respiratory tract mucosa by stimulating alpha-adrenergic receptors, leading to reduced swelling and nasal congestion. It also has some beta-adrenergic activity.
📊

Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified for combination; Pseudoephedrine: ~90-100%; Chlorcyclizine: Well absorbed.
Tmax: Pseudoephedrine: 1-2 hours; Chlorcyclizine: 2-6 hours.
FoodEffect: Food may slightly delay absorption but does not significantly affect bioavailability.

Distribution:

Vd: Pseudoephedrine: ~2.5 L/kg; Chlorcyclizine: Not precisely quantified, but widely distributed.
ProteinBinding: Pseudoephedrine: Low (~10-20%); Chlorcyclizine: High (~90%).
CnssPenetration: Chlorcyclizine: Yes (contributes to sedation); Pseudoephedrine: Limited (contributes to CNS stimulation).

Elimination:

HalfLife: Chlorcyclizine: ~10-20 hours; Pseudoephedrine: 4-6 hours (pH dependent, shorter in acidic urine).
Clearance: Not precisely quantified for combination.
ExcretionRoute: Chlorcyclizine: Primarily renal (as metabolites and unchanged drug); Pseudoephedrine: Primarily renal (unchanged drug).
Unchanged: Chlorcyclizine: <1%; Pseudoephedrine: 55-90%.
âąī¸

Pharmacodynamics

OnsetOfAction: Pseudoephedrine: 15-30 minutes; Chlorcyclizine: 30-60 minutes.
PeakEffect: Pseudoephedrine: 1-2 hours; Chlorcyclizine: 2-6 hours.
DurationOfAction: Pseudoephedrine: 4-6 hours; Chlorcyclizine: 4-6 hours.

Safety & Warnings

âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast heartbeat
Shakiness

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:

Dizziness
Drowsiness
Feeling nervous and excitable
* Trouble sleeping

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness
  • Fast, pounding, or irregular heartbeat (palpitations)
  • Significant increase in blood pressure
  • Difficulty urinating or painful urination
  • Severe nervousness, restlessness, or tremors
  • Hallucinations or confusion
  • Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
📋

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.
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 very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.

Additionally, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins

You should also inform them about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
âš ī¸

Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Do not exceed the recommended treatment duration, and only take this medication for the length of time specified by your doctor.

Until you are aware of how this medication affects you, exercise caution when engaging in activities that require alertness, such as driving, to ensure your safety. Additionally, refrain from consuming alcohol while taking this drug, as it may interact with the medication.

Before using marijuana, other cannabis products, or any prescription or over-the-counter (OTC) medications that may cause drowsiness or impair your reactions, consult with your doctor to discuss potential risks and interactions.

When administering this medication to children, use caution, as they may be at a higher risk of experiencing excitability. If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Severe drowsiness or sedation
  • Excitement, restlessness, or hallucinations (especially in children)
  • Seizures
  • Rapid or irregular heartbeat
  • High blood pressure followed by low blood pressure
  • Dilated pupils
  • Dry mouth and skin
  • Urinary retention
  • Coma

What to Do:

Seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Be prepared to provide the drug name, dose, and time of ingestion.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis.
  • Other sympathomimetics (e.g., other decongestants, appetite suppressants, amphetamines) - risk of additive cardiovascular and CNS stimulant effects.
🔴

Major Interactions

  • CNS Depressants (e.g., alcohol, sedatives, hypnotics, opioids, anxiolytics) - increased sedation and CNS depression.
  • Antihypertensives (e.g., beta-blockers, methyldopa, reserpine, guanethidine) - pseudoephedrine may reduce their hypotensive effects.
  • Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of pseudoephedrine.
  • Digitalis glycosides - increased risk of ectopic pacemaker activity.
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased risk of vasoconstriction.
🟡

Moderate Interactions

  • Anticholinergics (e.g., atropine, certain antipsychotics, TCAs) - additive anticholinergic effects (e.g., dry mouth, urinary retention, blurred vision).
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - may increase pseudoephedrine excretion, reducing its efficacy.
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - may decrease pseudoephedrine excretion, increasing its effects.
đŸŸĸ

Minor Interactions

  • None commonly cited as minor for this combination.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Medical history (cardiovascular disease, hypertension, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy)

Rationale: To identify contraindications or conditions requiring caution due to pseudoephedrine and anticholinergic effects.

Timing: Prior to initiation

Current medications (including OTCs and herbal supplements)

Rationale: To identify potential drug interactions, especially with MAOIs, other sympathomimetics, and CNS depressants.

Timing: Prior to initiation

📊

Routine Monitoring

Symptom relief (nasal congestion, sneezing, rhinorrhea)

Frequency: Daily, as needed

Target: Improved symptoms without excessive side effects

Action Threshold: Lack of efficacy or worsening symptoms may indicate need for alternative therapy or re-evaluation.

Blood pressure and heart rate

Frequency: As clinically indicated, especially in patients with pre-existing cardiovascular conditions or those reporting palpitations/nervousness.

Target: Within patient's normal range

Action Threshold: Significant increase (e.g., >20 mmHg systolic, >10 mmHg diastolic) or sustained tachycardia warrants discontinuation and medical evaluation.

CNS effects (sedation, dizziness, nervousness, insomnia)

Frequency: Daily, as needed

Target: Minimal to no impairment of daily activities

Action Threshold: Excessive sedation, agitation, or insomnia warrants dose reduction or discontinuation.

Anticholinergic effects (dry mouth, blurred vision, urinary retention)

Frequency: Daily, as needed

Target: Tolerable or absent

Action Threshold: Severe or bothersome symptoms, especially urinary retention, require discontinuation and medical attention.

đŸ‘ī¸

Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Nervousness
  • Insomnia
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Palpitations
  • Increased blood pressure
  • Headache

Special Patient Groups

🤰

Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Pseudoephedrine has been associated with gastroschisis in some studies, particularly in the first trimester, though data are conflicting. Chlorcyclizine data in pregnancy are limited.

Trimester-Specific Risks:

First Trimester: Pseudoephedrine: Potential association with gastroschisis (abdominal wall defect); avoid if possible. Chlorcyclizine: Limited data, but generally avoided.
Second Trimester: Use with caution; generally considered safer than first trimester, but still weigh risks vs. benefits.
Third Trimester: Use with caution; pseudoephedrine may cause maternal hypertension or fetal tachycardia. Antihistamines may cause CNS depression in neonates if used close to delivery.
🤱

Lactation

Not recommended. Both chlorcyclizine and pseudoephedrine are excreted into breast milk. Chlorcyclizine, a first-generation antihistamine, can cause drowsiness, irritability, or other adverse effects in the infant and may decrease milk supply. Pseudoephedrine can also decrease milk supply, especially in mothers with established lactation.

Infant Risk: Moderate to High (sedation, irritability, decreased milk supply).
đŸ‘ļ

Pediatric Use

Generally not recommended for children under 12 years of age due to the risk of serious adverse effects, including CNS stimulation, seizures, and cardiovascular events, particularly with pseudoephedrine. First-generation antihistamines like chlorcyclizine can cause paradoxical excitation or profound sedation in young children. Always consult a pediatrician for appropriate dosing and alternatives for children.

👴

Geriatric Use

Use with extreme caution. Elderly patients are more susceptible to the anticholinergic effects (e.g., urinary retention, constipation, confusion, dry mouth, blurred vision) and sympathomimetic effects (e.g., hypertension, tachycardia, nervousness, insomnia) of this combination. Start with the lowest effective dose and monitor closely for adverse effects. Avoid in patients with prostatic hypertrophy, glaucoma, or significant cardiovascular disease.

Clinical Information

💎

Clinical Pearls

  • This combination is effective for allergic rhinitis with significant nasal congestion.
  • Warn patients about potential for drowsiness and advise against driving or operating machinery.
  • Counsel patients to avoid alcohol and other CNS depressants.
  • Carefully screen for contraindications, especially MAOI use, severe hypertension, and narrow-angle glaucoma.
  • Advise patients with prostatic hypertrophy about the risk of urinary retention.
  • Pseudoephedrine is a List I chemical and is subject to federal and state regulations regarding sales limits and record-keeping.
  • Consider single-agent therapy (e.g., non-sedating antihistamine or nasal steroid) if only one symptom predominates or if side effects are intolerable.
🔄

Alternative Therapies

  • Nasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis
  • Second-generation antihistamines (e.g., loratadine, cetirizine, fexofenadine) for allergy symptoms without sedation
  • Topical decongestants (e.g., oxymetazoline, phenylephrine nasal spray) for nasal congestion (short-term use only)
  • Oral phenylephrine (less effective than pseudoephedrine)
  • Saline nasal sprays/washes
💰

Cost & Coverage

Average Cost: $15 - $40 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (for generic formulations)
📚

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.