Phenylpropanolamine (Sinudrin) 12.5mg / 5ml Syrup 60ml

Generic Name: Phenylpropanolamine

Brand Name: Sinudrin

Strength: 12.5mg / 5mL

Form: Syrup

Manufacturer: Diamond Laboratories, Inc.

Distributed by: Rilem Pharma Corp.

Classification: Nasal Decongestant

Indication/Uses: 

Phenylpropanolamine is a decongestant that works by constricting blood vessels in the nasal passages. This constriction reduces swelling and congestion in the nasal mucosa, making it easier to breathe.

It's important to note that phenylpropanolamine should be used only as directed by a healthcare professional or as indicated on the medication label. It should not be used for longer than recommended, as prolonged use may lead to rebound congestion or other adverse effects.

If symptoms persist or worsen despite using phenylpropanolamine, or if there are any concerns about its use, it's essential to consult a healthcare provider for further evaluation and advice. Additionally, certain individuals, such as those with certain medical conditions or taking certain medications, may need to avoid or use phenylpropanolamine with caution, so it's important to discuss its use with a healthcare provider before starting treatment.

Product Description:

Phenylpropanolamine (Sinudrin) 12.5mg/5mL Syrup 60mL is an oral liquid medication containing 12.5 mg of phenylpropanolamine per 5 mL. Phenylpropanolamine is a sympathomimetic drug used primarily as a nasal decongestant. It works by constricting the blood vessels in the nasal passages, leading to reduced swelling and congestion. This syrup formulation is ideal for patients, including children or adults, who may have difficulty swallowing tablets. It is commonly used to relieve nasal congestion associated with common colds, allergic rhinitis, and sinusitis.

Indications:

Phenylpropanolamine (Sinudrin) Syrup is indicated for:

• Nasal Congestion: To relieve nasal congestion caused by the common cold, sinusitis, or allergic rhinitis.

• Sinus Congestion: Helps alleviate the discomfort and blockage caused by inflammation of the sinuses.

• Allergic Rhinitis: Symptomatic relief of symptoms such as a blocked or runny nose due to allergies.

• Cold Symptoms: Provides temporary relief from symptoms associated with the common cold, including nasal congestion and pressure.

Dosages:

The dosage of Phenylpropanolamine (Sinudrin) Syrup depends on the patient's age. It is important to follow the prescribed dose to minimize potential side effects.

• Adults and Children Over 12 Years:

  • 10 mL (25 mg) every 4 to 6 hours, as needed, but do not exceed 60 mL (150 mg) per day.

• Children 6 to 12 Years:

  • 5 mL (12.5 mg) every 4 to 6 hours, as needed, but do not exceed 30 mL (75 mg) per day.

• Children 2 to 6 Years:

  • 2.5 mL (6.25 mg) every 4 to 6 hours, as needed, but do not exceed 15 mL (37.5 mg) per day.

• Children Under 2 Years:

  • Phenylpropanolamine should not be used in children under 2 years of age unless directed by a healthcare provider due to safety concerns.

Note: The syrup should be measured accurately using the provided dosing spoon or dropper. It can be taken with or without food. It is important not to exceed the recommended daily dosage.

Side Effects:

Common side effects of Phenylpropanolamine (Sinudrin) Syrup include:

• Increased Heart Rate (Tachycardia): Phenylpropanolamine may stimulate the heart, causing an increased heart rate.

• Elevated Blood Pressure (Hypertension): Use of this medication can raise blood pressure, especially in those with pre-existing hypertension.

• Restlessness or Nervousness: Some individuals may experience feelings of restlessness or agitation.

• Headache: A mild headache may occur.

• Dizziness: Dizziness or lightheadedness may occur in some individuals, particularly when standing up quickly.

• Dry Mouth: A sensation of dry mouth or throat may develop.

• Loss of Appetite: Decreased appetite may occur in some individuals.

Less common but more serious side effects can include:

• Severe Hypertension: A significant increase in blood pressure, particularly with high doses or prolonged use.

• Chest Pain or Palpitations: Symptoms such as chest discomfort or irregular heartbeat may occur.

• Allergic Reactions: Rash, hives, swelling, or difficulty breathing in case of severe allergic reactions.

If any of the following serious side effects occur, seek immediate medical attention:

• Severe allergic reactions: Difficulty breathing, swelling of the face, lips, tongue, or throat.

• Chest pain, rapid or irregular heartbeat.

• Severe headache, blurred vision (possible signs of very high blood pressure).

• Signs of overdose: Nausea, vomiting, agitation, or rapid heartbeat. Immediate medical attention is required.

Contraindications:

Phenylpropanolamine (Sinudrin) Syrup should not be used in the following situations:

• Hypersensitivity: If the patient has a known allergy to phenylpropanolamine or any of the ingredients in the syrup.

• Hypertension: Individuals with high blood pressure or other cardiovascular conditions should avoid using this medication unless prescribed by a healthcare provider. Phenylpropanolamine can raise blood pressure, which could be dangerous for those with pre-existing hypertension.

• Heart Disease: Those with heart disease, including arrhythmias or other heart conditions, should avoid phenylpropanolamine due to its potential stimulant effects.

• Glaucoma: Patients with glaucoma should not use this medication as it may increase intraocular pressure.

• Thyroid Disorders: Individuals with hyperthyroidism (overactive thyroid) should avoid phenylpropanolamine as it may increase heart rate and other symptoms of hyperthyroidism.

• Urinary Retention: Those with urinary retention, prostate problems, or other urinary issues should avoid using this medication.

• Monoamine Oxidase Inhibitors (MAOIs): Phenylpropanolamine should not be used in combination with MAOIs, or within 14 days of stopping an MAOI, due to a potentially dangerous interaction.

• Pregnancy and Breastfeeding: Phenylpropanolamine should not be used during pregnancy and breastfeeding unless prescribed by a healthcare provider, as its safety in these situations has not been well established.

Warnings and Precautions:

• Blood Pressure Monitoring: Due to the potential to elevate blood pressure, patients with pre-existing hypertension should use phenylpropanolamine with caution. Regular blood pressure monitoring is recommended during treatment.

• Heart Disease: Patients with any form of cardiovascular disease, including arrhythmias, should exercise caution. Phenylpropanolamine may exacerbate heart-related issues by increasing heart rate and blood pressure.

• Kidney and Liver Function: Caution should be used in patients with impaired liver or kidney function, as phenylpropanolamine may accumulate and cause additional side effects in these populations.

• Avoid Alcohol: Alcohol can enhance the sedative effects of phenylpropanolamine and increase the risk of side effects, so it should be avoided during treatment.

• Overdose Risk: Symptoms of overdose may include agitation, rapid heart rate, nausea, and vomiting. Seek medical attention immediately if overdose is suspected.

• Use in Children: Phenylpropanolamine should be avoided in children under 2 years unless specifically directed by a healthcare provider. For children over 2 years, dosages should be followed strictly, and overuse should be avoided.

Conclusion:

Phenylpropanolamine (Sinudrin) 12.5mg/5mL Syrup is an effective decongestant used to relieve nasal and sinus congestion due to colds, allergies, or sinusitis. This syrup formulation is ideal for patients who need an easy-to-administer liquid form of medication. However, it should be used with caution in individuals with high blood pressure, heart disease, or other cardiovascular conditions, and it should not be used in young children or in combination with certain medications. It is crucial to follow the recommended dosage to minimize the risk of side effects. Always consult with a healthcare provider if you have any concerns or experience side effects during treatment with this medication.