Products

FRUZEN SUSP

Fruzen Suspension is used to treat symptoms caused by the common cold,flu, allergies, hay fever, or other breathing illnesses (e.g., sinusitis, bronchitis). Decongestants (phenylephrine hydrochloride )help relieve stuffy nose symptoms. Antihistamines( chlorpheniramine maleate ) relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.

For Doctors
COMPOSITION

Each 5 ml of  FRUZEN Suspension contains:

Chlorpheniramine Maleate I.P. …………2 mg
Phenylephrine I.P………………………..5 mg

MACHENISM OF ACTION

chlorpheniramine maleate in FRUZEN SUSP. is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes itchyeyes/nose/throat/skin, cough, runny nose, and sneezing.
chlorpheniramine maleate in FRUZEN SUSP.  works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose.

phenylephrine hydrochloride acts on alpha-receptors causing vasoconstriction of blood vessels in the lining of the nasal passages and sinuses. This leads to shrinkage in turbinate size thereby decreasing resistance to nasal airflow and relieving a blocked nose. Phenylephrine also reduces the production of mucus.
The actions of chlorpheniramine maleate and phenylephrine hydrochloride compliment each other. FRUZEN  Suspension helps to relieve multiple symptoms of rash, watery eyes itchyeyes/nose/throat/skin, cough, runny nose, and sneezing.

INDICATIONS

Common cold, flu, allergies, hay fever Rhino  sinusitis

DOSAGE

Chlorpheniramine-phenylephrine 2 mg-5 mg/5ml Susp:
2 years to 5 years: 2.5 mL every 4 hours. Do not exceed 6 doses in 24 hours.
6 years to 12 years: 5 mL every 4 hours. Do not exceed 6 doses in 24 hours.

Side Effect

Drowsiness, giddiness, thickening of bronchial ,headache, increased irritability or excitement, Secretions, Hypersensitivity reaction such as rashes, anorexia, nausea, vomiting, diarrhea, constipation and epigastric distress etc.

CONTRAINDICATIONS

Patients with known hypersensitivity to any ingredient in this product. Sympathomimetic amines (phenylephrine hydrochloride) are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines(chlorpheniramine maleate) are contraindicated in patients with narrow angle glaucoma, urinary retention, peptic ulcer and during an asthma attack.

PRECAUTIONS

General: Before prescribing medication to suppress or modify cough, identify and provide therapy for the underlying cause of the cough and take caution that modification of cough does not increase the risk of clinical or physiologic complications. Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes mellitus and prostatic hypertrophy.

Information for Patients: Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to antihistamines may experience moderate to severe drowsiness. Patients sensitive to sympathomimetic amines(phenylephrine hydrochloride) may notice mild CNS stimulation. Antihistamines(chlorpheniramine maleate) may impair mental and physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Patients should be warned accordingly.


Pregnancy

Use in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with chlorpheniramine maleate / phenylephrine hydrochloride  Syrup. It is not known whether these products can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to a pregnant woman only if clearly needed.

Lactation
It is not known whether the drugs in chlorpheniramine maleate / phenylephrine hydrochloride /Syrup are excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious side effects in nursing infants, a decision should be made whether to discontinue nursing or discontinue the use of these products, taking into account the importance of the drug to the mother.

WARNINGS

Do not exceed recommended dosage.
Sympathomimetic amines (phenylephrine hydrochloride)  should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure or prostatic hypertrophy (See CONTRAINDICATIONS). Sympathomimetic amines(phenylephrine hydrochloride) may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur.

DRUG INTERACTIONS

Chlorpheniramine Maleate:
♦ Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
phenylephrine hydrochloride:
♦ The co-administration of Monoamine Oxidase Inhibitors (MAOIs) or tricyclic antidepressants and an indirect or mixed-acting sympathomimetic may result in a hypertensive crisis and hence such concomitant use is best avoided.
 ♦ Additionally sympathomimetics may reduce the efficacy of beta-blocking and anti-hypertensive drugs.

ADVERSE EFFECTS

FRUZEN is well tolerated. Side effects are mild and often transient.

Chlorpheniramine Maleate

Drowsiness, dizziness, dry mouth/nose/throat, headache, upset stomach, constipation, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), ringing in the ears, difficulty urinating, vision changes (such as blurred/double vision).Seek immediate medical attention if any of these rare but very serious side effects occur: fast/irregular heartbeat, seizure.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Phenylephrine:
As a class, sympathomimetic amines may also cause headaches, vomiting, diarrhea, insomnia, restlessness and palpitations. However, there have been few reports of these with normal doses of Phenylephrine.

PRESENTATION

Available in Bottle Pack of 60 ml.

For Patients
What is FRUZEN SUSP.(Chlorpheniramine and phenylephrine)?

Chlorpheniramine maleate is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine hydrochloride is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Chlorpheniramine maleate and phenylephrine hydrochloride is a combination medicine used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.
chlorpheniramine maleate and phenylephrine hydrochloride may also be used for purposes not listed in this medication guide.

What is the most important information I should know about FRUZEN SUSP (Chlorpheniramine and phenylephrine)?

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

What should I discuss with my healthcare provider before taking FRUZEN SUSP (Chlorpheniramine and phenylephrine)?

You should not use this medication if you are allergic to chlorpheniramine or phenylephrine.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
•    asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
•    a blockage in your stomach or intestines;
•    kidney or liver disease;
•    high blood pressure, heart disease, coronary artery disease, or recent heart attack;
•    enlarged prostate or urination problems;
•    glaucoma;
•    diabetes;
•    epilepsy or other seizure disorder;
•    pheochromocytoma (an adrenal gland tumor);
•    overactive thyroid; or
•    if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

FDA pregnancy category C. It is not known whether chlorpheniramine and phenylephrine will harm an unborn baby.
It is not known whether chlorpheniramine and phenylephrine passes into breast milk or if it could harm a nursing baby. Antihistamines and decongestants may also slow breast milk production.

How should I take FRUZEN SUSP (Chlorpheniramine and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.
This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention

What should I avoid while taking FRUZEN SUSP (Chlorpheniramine and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Drinking alcohol can increase certain side effects of chlorpheniramine and phenylephrine.
Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.
FRUZEN SUSP (Chlorpheniramine and phenylephrine)side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
•    chest pain, rapid pulse, fast or uneven heart rate;
•    confusion, hallucinations, severe nervousness;
•    tremor, seizure (convulsions);
•    little or no urinating;
•    easy bruising or bleeding, unusual weakness; or
•    dangerously high blood pressure (severe headache, buzzing in your ears, anxiety, shortness of breath).
Common side effects may include:
•    dizziness, drowsiness, blurred vision;
•    dry nose or mouth;
•    nausea, stomach pain, constipation, loss of appetite;
•    problems with memory or concentration; or
•    feeling restless or excited (especially in children).

FRUZEN SUSP (Chlorpheniramine and phenylephrine)dosing information
Usual Pediatric Dose for Allergic Rhinitis:
FRUZEN SUSP (Chlorpheniramine-phenylephrine) 2 mg-5 mg/5ml oral Susp:
2 years to 5 years: 2.5 mL every 4 hours. Do not exceed 6 doses in 24 hours.
6 years to 12 years: 5 mL every 4 hours. Do not exceed 6 doses in 24 hours.