Phenylpropanolamine Hydrochloride (4Nazal) 6.25mg/ml Syrup (Oral Drops) 15ml

Generic Name: Phenylpropanolamine Hydrochloride

Brand Name: 4Nazal

Strength: 6.25mg/mL

Form: Syrup

Manufacturer: Azarias Pharmaceutical Laboratories Inc.

Distributed by: Regimed Pharmaceutical Distributor

Classification: Oral Drops

Indication/Uses: 

Phenylpropanolamine Hydrochloride is classified as a decongestant. It works by constricting the blood vessels in the nasal passages, thereby reducing the swelling and congestion of the nasal mucosa, making breathing easier.

As with any medication, it's crucial to adhere to the recommended dosage and usage instructions provided by a healthcare professional or as stated on the medication label. It's essential not to exceed the prescribed dose and to avoid prolonged use, as this can lead to adverse effects such as rebound congestion.

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

Product Description:

Phenylpropanolamine Hydrochloride (4Nazal) 6.25mg/mL Syrup (Oral Drops) 15mL is a medication primarily used as a nasal decongestant. Each milliliter (mL) of the syrup contains 6.25 mg of Phenylpropanolamine Hydrochloride. Phenylpropanolamine is a sympathomimetic drug that works by constricting blood vessels in the nasal passages, which helps to reduce nasal congestion caused by colds, allergies, or sinusitis. This formulation is presented in an oral drop or syrup form for easier administration, especially for individuals who may find it difficult to swallow tablets, including children.

Indications:

Phenylpropanolamine Hydrochloride (4Nazal) Oral Drops Syrup is indicated for:

• Relieving Nasal Congestion: Used to relieve nasal congestion caused by common cold, allergies, or sinusitis.

• Treatment of Rhinitis: For the symptomatic relief of nasal congestion associated with rhinitis (inflammation of the nasal lining).

• Sinus Congestion: Helps to alleviate congestion in the sinus passages.

Dosages:

The dosage of Phenylpropanolamine Hydrochloride (4Nazal) Oral Drops Syrup depends on the age of the patient. It is important to follow the prescribed dosage carefully to avoid potential side effects.

• Adults and Children Over 12 Years:

  • 10 mL (62.5 mg) every 4-6 hours as needed, not to exceed 60 mL (375 mg) per day.

• Children (6–12 Years):

  • 5 mL (31.25 mg) every 4-6 hours as needed, not to exceed 30 mL (187.5 mg) per day.

• Children (2–6 Years):

  • 2.5 mL (15.625 mg) every 4-6 hours as needed, not to exceed 15 mL (93.75 mg) per day.

• Children Under 2 Years:

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

Note: The syrup should be measured using the provided dropper or dosing spoon to ensure accurate dosing. The drops may be taken with or without food.

Side Effects:

Common side effects of Phenylpropanolamine Hydrochloride (4Nazal) Oral Drops Syrup may include:

• Increased Heart Rate (Tachycardia): Phenylpropanolamine can stimulate the heart, leading to a rapid heartbeat.

• Elevated Blood Pressure (Hypertension): It may raise blood pressure, especially with long-term or high-dose use.

• Restlessness or Nervousness: Some individuals may experience restlessness or agitation as a side effect.

• Dizziness: A feeling of lightheadedness or dizziness may occur.

• Headache: Some people may experience headaches while taking this medication.

• Dry Mouth: A dry mouth or throat may occur with the use of this medication.

• Loss of Appetite: This medication may cause a decrease in appetite in some individuals.

Serious side effects (rare but possible) include:

• Severe Hypertension: Significant increase in blood pressure, especially with excessive doses or in individuals with pre-existing hypertension.

• Chest Pain or Palpitations: Due to the stimulant effects on the heart, chest pain or palpitations may occur.

• Allergic Reactions: Rashes, swelling, difficulty breathing, or hives—especially if there is a history of sensitivity to sympathomimetic drugs.

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

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

• Chest pain, palpitations, or irregular heartbeat.

• Severe headache or blurry vision (possible sign of elevated blood pressure).

• Signs of overdose: Symptoms may include nausea, vomiting, excessive drowsiness, or difficulty breathing.

Contraindications:

Phenylpropanolamine Hydrochloride (4Nazal) Oral Drops Syrup should not be used in the following situations:

• Hypersensitivity: If the patient is allergic to phenylpropanolamine or any other ingredient in the formulation.

• Severe Hypertension or Cardiovascular Disorders: This drug can raise blood pressure and should not be used in individuals with high blood pressure, heart disease, or other cardiovascular conditions unless specifically prescribed by a healthcare provider.

• Hyperthyroidism: People with an overactive thyroid (hyperthyroidism) should avoid using phenylpropanolamine due to potential stimulation of the thyroid and heart rate.

• Glaucoma: Phenylpropanolamine can increase intraocular pressure and should not be used by individuals with glaucoma.

• Urinary Retention: Those with urinary retention or prostate problems should not take phenylpropanolamine as it may worsen the condition.

• Monoamine Oxidase Inhibitors (MAOIs): The drug should not be used in combination with MAOIs or within 14 days of stopping an MAOI, as serious side effects can result from this interaction.

• Pregnancy and Breastfeeding: Phenylpropanolamine is generally not recommended during pregnancy and breastfeeding unless the potential benefit justifies the potential risk. Always consult with a healthcare provider.

Warnings and Precautions:

• Blood Pressure Monitoring: Due to its potential to increase blood pressure, patients with hypertension should use this medication with caution, and regular blood pressure monitoring is recommended.

• Heart Disease: Patients with heart conditions, including arrhythmias, should use phenylpropanolamine with caution due to the stimulant effects that can increase heart rate and blood pressure.

• Kidney and Liver Function: Caution is advised in individuals with impaired kidney or liver function, as the drug may accumulate in the body.

• Avoid Alcohol: Alcohol can enhance the sedative effects of the medication and may increase the risk of side effects. It is advisable to avoid alcohol during treatment.

• Overdose Risk: In the event of an overdose, symptoms such as nausea, vomiting, rapid heartbeat, and extreme restlessness may occur. Immediate medical attention should be sought.

Conclusion:

Phenylpropanolamine Hydrochloride (4Nazal) 6.25mg/mL Oral Drops Syrup is an effective nasal decongestant used for treating nasal congestion caused by allergies, colds, or sinusitis. While it provides symptomatic relief, it should be used with caution in individuals with hypertension, heart disease, or other cardiovascular conditions. Accurate dosing is essential to minimize side effects and avoid complications, especially with children. As with any medication, it is important to follow the prescribed dosage and consult a healthcare provider if any unusual symptoms or side effects arise.