Clemastine fumarate/phenylpropanolamine hydrochloride

An ethanolamine-derivative, first generation histamine H1 antagonist used in hay fever, rhinitis, allergic skin conditions, and pruritus. It causes drowsiness. [PubChem]

Phenylpropanolamine hydrochloride has been withdrawn in Canada and the United States. In November 2000, the Food and Drug Administration (FDA) issued a public health advisory against the use of the drug.

Clemastine fumarate Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine fumarate Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults.

It should be noted that Clemastine fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.

cold symptoms, rhinitis, sinusitis

Preventing or treating symptoms of hay fever and other upper respiratory allergies or the common cold, such as runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes, and relieving cough. It may also be used for other conditions as determined by your doctor.

Clemastine fumarate is an antihistamine. It works by blocking the action of histamine, reducing the symptoms of an allergic reaction.

Phenylpropanolamine hydrochloride is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. Constriction of blood vessels in your sinuses, nose, and chest allows drainage of those areas, which decreases congestion.

Phenylpropanolamine hydrochloride is used to treat the congestion associated with allergies, hay fever, sinus irritation, and the common cold. Phenylpropanolamine hydrochloride also causes a decrease in appetite and is used in some over-the-counter diet aids.

Phenylpropanolamine hydrochloride has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain Phenylpropanolamine hydrochloride.

Phenylpropanolamine hydrochloride may also be used for purposes other than those listed in this medication guide.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.

Pediatric

For Symptoms of Allergic Rhinitis - The starting dose is 1 teaspoonful (0.5 mg Clemastine fumarate) twice daily. Since single doses of up to 2.25 mg Clemastine fumarate were well tolerated by this age group, dosage may be increased as required, but not to exceed 6 teaspoonfuls daily (3 mg Clemastine fumarate).

For Urticaria and Angioedema - The starting dose is 2 teaspoonfuls (1 mg Clemastine fumarate) twice daily, not to exceed 6 teaspoonfuls daily (3 mg Clemastine fumarate).

Adults and Children 12 Years and Over

For Symptoms of Allergic Rhinitis - The starting dose is 2 teaspoonfuls (1 mgclemastine) twice daily. Dosage may be increased as required, but not to exceed 12 teaspoonfuls daily (6 mg Clemastine fumarate).

For Urticaria and Angioedema - The starting dose is 4 teaspoonfuls (2 mg Clemastine fumarate) twice daily, not to exceed 12 teaspoonfuls daily (6 mg Clemastine fumarate).

Applies to the following strengths: 75 mg; 25 mg; 37.5 mg; 50 mg; 180 mg-75 mg

Usual Adult Dose for:

• Nasal Congestion
• Weight Loss

Usual Pediatric Dose for:

• Nasal Congestion

Additional dosage information:

• Renal Dose Adjustments
• Other Comments

Usual Adult Dose for Nasal Congestion

25 mg orally every 4 hours.

-or-

75 mg orally extended release every 12 hours.

Not to exceed 150 mg/day.

Usual Adult Dose for Weight Loss

25 mg orally 3 times a day, one-half hour before meals.

-or-

75 mg orally extended release once a day in the morning.

The use of Phenylpropanolamine hydrochloride for weight loss should be limited to 12 weeks.

Usual Pediatric Dose for Nasal Congestion

2 to 6 years:

6.25 mg orally every 4 hours. Maximum daily dose is 37.5 mg.

6 to 12 years:

12.5 mg orally every 4 hours. Maximum daily dose is 75 mg.

> 12 years:

25 mg orally every 4 hours.

-or-

75 mg orally extended release every 12 hours.

Not to exceed 150 mg/day.

Renal Dose Adjustments

Because Phenylpropanolamine hydrochloride is eliminated primarily by the kidneys, one-half of the normally recommended dosage should be given. Patients with renal dysfunction should be monitored for signs and symptoms of toxicity when using Phenylpropanolamine hydrochloride.

Other Comments

In November 2000, the Food and Drug Administration (FDA), in response to reports of increased risk of hemorrhagic stroke, requested that all drug companies discontinue marketing products containing Phenylpropanolamine hydrochloride.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about Phenylpropanolamine hydrochloride

• Phenylpropanolamine hydrochloride Side Effects
• During Pregnancy
• Drug Interactions
• Support Group
• 2 Reviews
• Drug class: decongestants

Related treatment guides

• Weight Loss
• Cold Symptoms
• Nasal Congestion

See also:
What is the most important information I should know about Clemastine fumarate?

Antihistamines are contraindicated in patients hypersensitive to the drug or to other antihistamines of similar chemical structure.

Antihistamines should not be used in newborn or premature infants. Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

See also:
What is the most important information I should know about Phenylpropanolamine hydrochloride?

Decreased kidney function.

Decreased liver function.

Children under 10 years of age, unless on the advice of a doctor.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Use Clemastine fumarate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clemastine fumarate may be taken with or without food.
• Use Clemastine fumarate exactly as directed on the package, unless instructed differently by your doctor. If you are taking Clemastine fumarate without a prescription, follow any warnings and precautions on the label.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Clemastine fumarate and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Clemastine fumarate.

Clemastine fumarate is used to treat allergic rhinitis (infection of nose, throat or chest), hay fever (allergy caused by pollen or dust), perennial rhinitis (inflammatory condition of the nose characterised by nasal obstruction, sneezing, itching, or runny nose), vasomotor rhinitis (non-allergic infection of nose, throat or chest), allergic dermatoses (infection of skin, hair, nails and skin gland), pruritus (itching of skin), atopic eczema (itchy skin rash), contact dermatitis (skin rash or irritation caused by touching allergic substance), angioneurotic edema (swelling) and drug allergies.

Phenylpropanolamine hydrochloride is used to relieve blocked nose or sinuses caused by common cold and seasonal nasal allergies (hay fever). It is also used to decrease appetite for weight control.

See also:
What other drugs will affect Clemastine fumarate?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

See also:
What other drugs will affect Phenylpropanolamine hydrochloride?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you take this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

You should not take other medicines that contain paracetamol in combination with this medicine, as this can easily result in exceeding the maximum recommended daily dose of paracetamol. Many cold and flu remedies and over-the-counter painkillers contain paracetamol, so be sure to check the ingredients of any other medicines before taking them with this one. Migraleve yellow can be taken four hours after taking Migraleve pink if you still have a migraine, but make sure you do not exceed the maximum dose recommended in the information leaflet.

This medicine should be used with caution in people taking a monoamine oxidase inhibitor (MAOI), for example the antidepressants phenelzine, tranylcypromine or isocarboxacid. Ask your doctor or pharmacist for advice before taking this medicine if you have taken an MAOI in the last 14 days.

Cholestyramine reduces the absorption of paracetamol from the gut. It should not be taken within an hour of taking paracetamol or the effect of the paracetamol will be reduced.

Metoclopramide and domperidone may increase the absorption of paracetamol from the gut.

Long-term or regular use of paracetamol may increase the anti-blood-clotting effect of warfarin and other anticoagulant medicines, leading to an increased risk of bleeding. This effect does not occur with occasional painkilling doses. If you are taking an anticoagulant medicine and you are also taking co-codamol regularly, your blood clotting time (INR) should be regularly monitored.

In the unlikely event that this medicine makes you feel drowsy, this may be enhanced by other medicines that can cause drowsiness, such as the following:

antipsychotics, eg haloperidol

barbiturates, eg phenobarbital, amobarbital

benzodiazepines, eg diazepam, temazepam

other opioids, eg morphine, dihydrocodeine

sedating antihistamines, eg chlorphenamine, hydroxyzine

sleeping tablets, eg zopiclone

tricyclic antidepressants, eg amitriptyline.

See also:
What are the possible side effects of Clemastine fumarate?

Drowsiness, dizziness, headache, constipation, stomach upset, blurred vision, trouble walking/clumsiness, or dry mouth/nose/throat may occur. These effects may decrease as your body adjusts to the medication. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. Clemastine fumarate can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.

If your doctor has prescribed this drug, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (e.g., hallucinations, irritability, nervousness, confusion), ringing in the ears, trouble urinating.

Tell your doctor right away if any of these rare but very serious side effects occur: easy bruising/bleeding, 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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also:
What are the possible side effects of Phenylpropanolamine hydrochloride?

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Constipation.

Skin rash.

Codeine can cause drowsiness, although at the dose contained in this medicine this is very unlikely. However, if you do find this medicine makes you feel sleepy or dizzy you should not drive or operate machinery and avoid alcoholic drink.

The side effects listed above may not include all of the side effects reported by the medicines’s manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.