What is dextromethorphan and how does it work. What are the common uses of dextromethorphan. How to safely use dextromethorphan for cough relief. What are the potential side effects and precautions for dextromethorphan use. How to choose the right dextromethorphan product for your symptoms. What are the dosage recommendations for dextromethorphan in adults and children. When should you consult a doctor about your cough and dextromethorphan use.

Understanding Dextromethorphan: A Powerful Cough Suppressant

Dextromethorphan, commonly abbreviated as DM, is a widely used antitussive medication found in numerous over-the-counter (OTC) cough and cold remedies. As an effective cough suppressant, it works by acting on the cough center in the brain to reduce the urge to cough. But what exactly is dextromethorphan, and how can it be used safely?

Dextromethorphan is primarily used to alleviate coughs caused by minor throat and bronchial irritation, such as those associated with the common cold or exposure to irritants. It’s important to note that while dextromethorphan can provide relief from coughing, it does not treat the underlying cause of the cough or help clear mucus from the airways.

How Does Dextromethorphan Work?

Dextromethorphan works by suppressing the cough reflex in the central nervous system. It binds to receptors in the brain’s cough center, effectively reducing the sensitivity of the cough reflex and providing relief from persistent coughing. This mechanism of action makes dextromethorphan particularly useful for dry, nonproductive coughs that can disrupt sleep and daily activities.

Common Uses and Applications of Dextromethorphan

Dextromethorphan is primarily used to treat:

• Coughing due to minor throat irritation
• Coughs associated with the common cold
• Coughs caused by inhaled irritants
• Temporary relief of dry, nonproductive coughs

It’s important to note that dextromethorphan is not intended for long-term use or for treating chronic coughs associated with conditions such as asthma, bronchitis, or emphysema. In these cases, it’s crucial to consult a healthcare professional for appropriate treatment.

Dextromethorphan in Combination Products

While dextromethorphan can be found as a single-ingredient product, it is often combined with other active ingredients in multi-symptom cold and flu remedies. These combination products may include:

• Antihistamines for allergy relief
• Decongestants to relieve nasal congestion
• Expectorants to help loosen mucus
• Pain relievers and fever reducers

When using combination products, it’s crucial to read the label carefully to avoid accidentally doubling up on active ingredients, which could lead to potential side effects or overdose.

Dosage Forms and Administration of Dextromethorphan

Dextromethorphan is available in various dosage forms to suit different preferences and needs. These include:

• Liquid-filled capsules
• Chewable tablets
• Dissolving strips
• Oral solutions (liquids)
• Extended-release suspensions
• Lozenges

The choice of dosage form can depend on factors such as convenience, ease of administration, and personal preference. For example, lozenges may be preferred for soothing sore throats while providing cough relief, while liquid formulations might be easier to administer to children or those who have difficulty swallowing pills.

Proper Administration Techniques

To ensure safe and effective use of dextromethorphan, follow these administration guidelines:

1. Always read and follow the directions on the package or prescription label carefully.
2. Use the provided measuring device for liquid formulations to ensure accurate dosing.
3. For dissolving strips, place them on your tongue and allow them to melt before swallowing.
4. Chewable tablets can be chewed or allowed to dissolve in the mouth before swallowing.
5. Shake extended-release suspensions well before each use to ensure even distribution of the medication.
6. Allow lozenges to dissolve slowly in the mouth for optimal effect.

Dosage Recommendations and Safety Considerations

Proper dosing of dextromethorphan is crucial for its safe and effective use. The recommended dosage can vary depending on the specific product, formulation, and age of the user. Generally, dextromethorphan is taken every 4 to 12 hours as needed, but it’s essential to follow the specific instructions provided with the medication.

Adult Dosage Guidelines

For adults and children 12 years and older, typical dosage recommendations are as follows:

• Immediate-release formulations: 10-20 mg every 4 hours or 30 mg every 6-8 hours, not to exceed 120 mg in 24 hours
• Extended-release formulations: 60 mg every 12 hours, not to exceed 120 mg in 24 hours

It’s crucial not to exceed the recommended dosage, as taking too much dextromethorphan can lead to serious side effects or even be life-threatening.

Pediatric Dosage Considerations

Dextromethorphan use in children requires special attention and care. Here are some important guidelines:

• Do not give dextromethorphan to children under 4 years of age.
• For children 4-11 years old, use caution and follow package directions carefully.
• Always use products specifically formulated for children, not adult formulations.
• Use the age-appropriate dosage as indicated on the product label.

When in doubt about the correct dosage for a child, it’s always best to consult with a pediatrician or pharmacist.

Potential Side Effects and Precautions

While dextromethorphan is generally safe when used as directed, it can cause side effects in some individuals. Common side effects may include:

• Dizziness
• Mild drowsiness
• Nausea
• Stomach discomfort

More severe side effects, though rare, can occur, especially with excessive use or in sensitive individuals. These may include:

• Severe dizziness or confusion
• Severe nausea or vomiting
• Allergic reactions (rash, itching, swelling)
• Difficulty breathing

If you experience any severe or persistent side effects, discontinue use and seek medical attention immediately.

Drug Interactions and Contraindications

Dextromethorphan can interact with certain medications and should not be used in some situations. Key precautions include:

• Do not use dextromethorphan if you are taking or have recently taken monoamine oxidase inhibitors (MAOIs).
• Use caution if you are taking selective serotonin reuptake inhibitors (SSRIs) or other medications that affect serotonin levels.
• Avoid use if you have a chronic cough due to conditions like asthma, smoking, bronchitis, or emphysema, unless directed by a healthcare provider.
• Consult a healthcare provider before use if you are pregnant or breastfeeding.

Choosing the Right Dextromethorphan Product

With numerous dextromethorphan-containing products available, choosing the right one can be overwhelming. Here are some factors to consider:

• Single-ingredient vs. combination products: Decide whether you need relief from cough alone or multiple cold symptoms.
• Formulation preference: Consider which dosage form (liquid, tablet, lozenge, etc.) is most convenient and effective for you.
• Duration of action: For nighttime relief, an extended-release formulation might be preferable.
• Additional ingredients: Be aware of other active ingredients in combination products and their potential effects or interactions.

Always read product labels carefully and consult a pharmacist if you’re unsure which product is best suited for your needs.

Popular Brands Containing Dextromethorphan

Dextromethorphan is found in many well-known OTC cough and cold products. Some popular brands include:

• Robitussin
• Delsym
• Mucinex DM
• Vicks DayQuil/NyQuil
• Coricidin HBP
• Store brands (e.g., Walgreens, CVS, Walmart Equate)

Remember that brand name products often have generic equivalents that contain the same active ingredients at a lower cost.

When to Seek Medical Attention

While dextromethorphan can effectively relieve cough symptoms, there are situations where it’s important to consult a healthcare professional. Seek medical attention if:

• Your cough persists for more than 7 days or worsens
• You develop a fever, rash, or persistent headache
• Your cough is accompanied by excessive phlegm or blood
• You experience difficulty breathing or chest pain
• You have a chronic condition such as asthma, COPD, or heart disease

A healthcare provider can determine if your cough is a symptom of a more serious condition and recommend appropriate treatment.

Alternative Cough Remedies

While dextromethorphan is effective for many people, some may prefer alternative or complementary approaches to cough relief. These may include:

• Honey and warm tea for soothing throat irritation
• Humidifiers to add moisture to the air
• Saline nasal sprays to relieve congestion
• Staying hydrated to thin mucus secretions
• Herbal remedies such as thyme or marshmallow root (consult with a healthcare provider before using)

These alternatives can be used alongside or instead of dextromethorphan, depending on individual preferences and the severity of symptoms.

Responsible Use and Storage of Dextromethorphan Products

Proper use and storage of dextromethorphan-containing products are essential for safety and effectiveness. Follow these guidelines:

• Store medications at room temperature, away from heat and moisture.
• Keep all medications out of reach of children and pets.
• Do not use expired products.
• Dispose of unused medications properly, following local guidelines or drug take-back programs.
• Never share your medication with others, even if they have similar symptoms.

By following these practices, you can ensure the safe and effective use of dextromethorphan while minimizing risks to yourself and others.

Preventing Misuse and Abuse

Unfortunately, dextromethorphan has potential for misuse and abuse, particularly among adolescents and young adults. To prevent this:

• Monitor the use of dextromethorphan-containing products in your household.
• Educate family members about the risks of misusing cough medications.
• Consider purchasing products with abuse-deterrent formulations when available.
• Be aware of signs of dextromethorphan abuse, such as changes in behavior, unexplained empty medicine bottles, or excessive purchases of cough medications.

If you suspect someone is misusing dextromethorphan, seek help from a healthcare professional or addiction specialist.

Dextromethorphan: MedlinePlus Drug Information

Dextromethorphan comes as a liquid-filled capsule, a chewable tablet, a dissolving strip, a solution (liquid), an extended-release (long-acting) suspension (liquid), and a lozenge to take by mouth. It is usually taken every 4 to 12 hours as needed. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Dextromethorphan should only be used according to the label or package directions. Do not take more than the recommended amount of dextromethorphan in a 24-hour period. Refer to the package or prescription label to determine the amount contained in each dose. Taking dextromethorphan in large amounts can cause serious side effects or death.

Dextromethorphan comes alone and in combination with antihistamines, cough suppressants, and decongestants. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using 2 or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.

Nonprescription cough and cold combination products, including products that contain dextromethorphan, can cause serious side effects or death in young children. Do not give these products to children younger than 4 years of age. If you give these products to children 4-11 years of age, use caution and follow the package directions carefully.

If you are giving dextromethorphan or a combination product that contains dextromethorphan to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give dextromethorphan products that are made for adults to children.

Before you give a dextromethorphan product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child’s age on the chart. Ask the child’s doctor if you don’t know how much medication to give the child.

If you are taking the liquid, do not use a household spoon to measure your dose. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.

If you are using the dissolving strips, place them on your tongue and swallow after they melt.

If you are taking the chewable tablets you can allow them to melt in your mouth or you can chew them before swallowing.

If you are taking the extended-release suspension, shake the bottle well before each use to mix the medication evenly.

If you are taking the lozenges, allow them to slowly melt in your mouth.

Stop taking dextromethorphan and call your doctor if your cough does not get better within 7 days, if your cough goes away and comes back, or if your cough occurs with a fever, rash, or headache.

Uses, Dosage, and Side Effects – KnowYourOTCs

What is dextromethorphan?

Dextromethorphan is an antitussive (cough suppressant) available in over-the-counter (OTC) medicines that control coughs due to minor throat and bronchial irritation, as may occur with the common cold or inhaled irritants. Dextromethorphan can be the only active ingredient in a cough suppressant medicine or can be found in medicines that treat the multiple symptoms of cough and cold, and cough suppressant lozenges.

What is dextromethorphan used to treat?

• Coughing
• Throat irritation
• Cold symptoms

Common brands containing dextromethorphan:

• Coricidin^®
• Delsym^®
• Dimetapp^®
• Mucinex^®
• Robitussin^®
• Sucrets^®
• Vicks^®
• Store Brands (ex. Walmart’s “Equate” brand or CVS Health’s store brand)

How much dextromethorphan can you take?

Different types of products containing this active ingredient have different strengths. That’s why it is always important to read and follow the Drug Facts label. Most medicines warn against use of an active ingredient for longer than 7-10 days. Stop use and ask a doctor if symptoms persist.

Safety guide for dextromethorphan

Dextromethorphan is approved by the U.S. Food and Drug Administration (FDA) and is safe and effective when used according to the Drug Facts label.

Ask a healthcare provider before use if:

• You are pregnant or breastfeeding.

Do not use if:

• You are currently taking a prescription monoamine oxidase inhibitor (MAOI) (usually contained in drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) or if you stopped taking an MAOI less than two weeks ago.
• You have a chronic cough due to smoking, asthma, bronchitis, or emphysema, or if your cough is accompanied by excessive congestion (mucus), unless a healthcare provider tells you to.
• Do not give a medicine containing dextromethorphan to a child under the age of 4.
• Do not give a cough suppressant lozenge to a child unless able to safely dissolve a lozenge in his or her mouth without choking.

Stop use and ask a doctor if:

• Your cough lasts for more than one week, comes back, or is accompanied by a fever, rash, or persistent headache.
• You take too much. Immediately contact a healthcare provider or the poison control national helpline at 800.222.1222.

What are the side effects of dextromethorphan?

• Drowsiness may occur. You should avoid alcoholic drinks.
• Nervousness or restlessness may occur. You should avoid taking diet pills, caffeine pills, or other stimulants.

Attention Parents: While cough suppressant medicines containing dextromethorphan are non-narcotic and non-addictive, dextromethorphan sometimes is abused by young people in an attempt to get high. Reports indicate that teens looking to get high may take 25 to 50 times the recommended amount on the label to get high. Be aware of the possibility for abuse. More information is available at www.StopMedicineAbuse.org.

Dextromethorphan; Guaifenesin; Phenylephrine oral syrup and solution

What is this medicine?

DEXTROMETHORPHAN, GUAIFENESIN, and PHENYLEPHRINE (dex troe meth OR fan, gwye FEN e sin, fen il EF rin) is a combination of a cough suppressant, an expectorant, and a decongestant. It is used to treat cough and congestion. This medicine will not treat an infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Actidom DMX, Actinel DM, Broncotron PED, Dacex-DM, Dexcon-DM, Endacon, GDP-EX, Giltuss, Giltuss Pediatric, Mucinex Children’s Congestion & Cough, Mucinex Children’s Multi-Symptom Cold, Mucinex Fast-Max, Mucinex Multi-Symptom Cold Children’s, Numonyl DX, Q-Tussin CF, Robafen CF, Robitussin Adult Peak Cold, Robitussin CF Adult Peak Multi-Symptom, Robitussin CF Children’s Cough & Cold, TriTuss, Tussafed EX, Tussi-Pres, Tussidex, VanaCof DM, VanaCof DMX, Z-Dex, Zotex, ZTuss DM

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes
• enlarged prostrate
• glaucoma
• heart disease
• high blood pressure
• if you have taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days
• lung or breathing disease, like asthma
• thyroid disease
• an unusual or allergic reaction to dextromethorphan, guaifenesin, phenylephrine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Take with food or milk. Use a specially marked spoon or container to measure your dose. Household spoons are not accurate. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years old for selected conditions, precautions do apply.

Patients over 60 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• ergot alkaloids like dihydroergotamine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• stimulant medicines for attention disorders, weight loss, or to stay awake

This medicine may also interact with the following medications:

• alcohol
• barbiturates like phenobarbital
• certain heart medicines like metoprolol, digoxin, and methyldopa
• diuretics
• doxazosin
• medicines for depression, anxiety, or psychotic disturbances
• medicines for sleep
• medicines to treat blood pressure
• muscle relaxers
• other medicines for cold, cough, or allergy
• some medicines used for sleep during surgery
• tamsulosin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Talk to your doctor if your cough lasts for more than 1 week. If you have a high fever, skin rash, lasting headache, or sore throat, see your doctor.

Drink several glasses of water each day. This will help loosen mucus.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• anxiety, irritable, or excited
• breathing problems
• confusion
• fast, irregular heartbeat
• seizures
• tremor
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• dizziness
• headache
• nausea, vomiting
• stomach upset
• tiredness
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep bottle tightly closed. Protect from light. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Dextromethorphan: Uses, Interactions, Mechanism of Action

Cytochrome P450 2D6	CYP2D6*4	(A;A)	A Allele, homozygote	Effect Directly Studied	Patients with this genotype have reduced metabolism of dextromethorphan.	Details
Cytochrome P450 2D6	CYP2D6*6	(-;-)	T deletion, homozygote	Effect Directly Studied	Patients with this genotype have reduced metabolism of dextromethorphan.	Details
Cytochrome P450 2D6	CYP2D6*3	Not Available	C allele	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*5	Not Available	Whole-gene deletion	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*7	Not Available	2935A>C	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*8	Not Available	1758G>T	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*11	Not Available	883G>C	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*12	Not Available	124G>A	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*13	Not Available	CYP2D7/2D6 hybrid gene structure	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*14A	Not Available	1758G>A	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*15	Not Available	137insT, 137_138insT	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*19	Not Available	2539_2542delAACT	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*20	Not Available	1973_1974insG	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*21	Not Available	2573insC	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*31	Not Available	-1770G>A / -1584C>G  … show all	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*36	Not Available	100C>T / -1426C>T  … show all	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*38	Not Available	2587_2590delGACT	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*40	Not Available	1863_1864ins(TTT CGC CCC)2	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*42	Not Available	3259_3260insGT	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*44	Not Available	2950G>C	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*47	Not Available	100C>T / -1426C>T  … show all	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*51	Not Available	-1584C>G / -1235A>G  … show all	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*56	Not Available	3201C>T	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*57	Not Available	100C>T / 310G>T  … show all	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*62	Not Available	4044C>T	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*68A	Not Available	-1426C>T / -1235A>G  … show all	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*68B	Not Available	Similar but not identical switch region compared to CYP2D6*68A. Found in tandem arrangement with CYP2D6*4.	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*69	Not Available	2988G>A / -1426C>T  … show all	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*92	Not Available	1995delC	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*100	Not Available	-1426C>T / -1235A>G  … show all	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details
Cytochrome P450 2D6	CYP2D6*101	Not Available	-1426C>T / -1235A>G  … show all	Effect Inferred	Poor drug metabolizer, lower dose requirements	Details

Amazon Basic Care 12 Hour Cough DM, Dextromethorphan Polistirex Extended-Release Oral Suspension, Cough Suppressant, 12 Hour Cough Relief, Orange Flavor, 5 Fluid Ounces

Safety Information

Warnings: Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Ask a doctor before use if you have: chronic cough that lasts as occurs with smoking, asthma or emphysema; cough that occurs with too much phlegm (mucus). Stop use and ask a doctor if: side effects occur. You may report side effects to FDA at 1-800-FDA-1088; cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ingredients

Active ingredient (in each 5 mL): dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide. Inactive ingredients D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, glycerin, high fructose corn syrup, methylparaben, natural and artificial orange flavor, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum.

Directions

Directions: shake bottle well before use; measure only with dosing cup provided; do not use dosing cup with other products; dose as follows or as directed by a doctor; adults and children 12 years of age and over: 10 mL every 12 hours, not to exceed 20 mL in 24 hours; children 6 to under 12 years of age: 5 mL every 12 hours, not to exceed 10 mL in 24 hours; children 4 to under 6 years of age: 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours; children under 4 years of age: do not use.

Legal Disclaimer

Statements regarding dietary supplements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease or health condition.

Over-the-Counter Medicines DrugFacts | National Institute on Drug Abuse (NIDA)

What are over-the-counter (OTC) medicines?

Over-the-counter (OTC) medicines are those that can be sold directly to people without a prescription. OTC medicines treat a variety of illnesses and their symptoms including pain, coughs and colds, diarrhea, constipation, acne, and others. Some OTC medicines have active ingredients with the potential for misuse at higher-than-recommended dosages.

How do people use and misuse OTC medicines?

Misuse of an OTC medicine means:

• taking medicine in a way or dose other than directed on the package
• taking medicine for the effect it causes- for example, to get high
• mixing OTC medicines together to create new products

“Behind-the-Counter”

Pseudoephedrine, a nasal decongestant found in many OTC cold medicines, can be used to make methamphetamine. For this reason, products containing pseudoephedrine are sold “behind the counter” nationwide. A prescription is not needed in most states, but in states that do require a prescription, there are limits on how much a person can buy each month. In some states, only people 18 years of age or older can buy pseudoephedrine.

What are some of the commonly misused OTC medicines?

There are two OTC medicines that are most commonly misused.

Dextromethorphan (DXM) is a cough suppressant found in many OTC cold medicines. The most common sources of abused DXM are “extra-strength” cough syrup, tablets and gel capsules. OTC medications that contain DXM often also contain antihistamines and decongestants. DXM may be swallowed in its original form or may be mixed with soda for flavor, called “robo-tripping” or “skittling.” Users sometimes inject it. These medicines are often misused in combination with other drugs, such as alcohol and marijuana.

Loperamide is an anti-diarrheal that is available in tablet, capsule, or liquid form. When misusing loperamide, people swallow large quantities of the medicine. It is unclear how often this drug is misused.

How do these OTC medicines affect the brain?

DXM is an opioid without effects on pain reduction and does not act on the opioid receptors. When taken in large doses, DXM causes a depressant effect and sometimes a hallucinogenic effect, similar to PCP and ketamine. Repeatedly seeking to experience that feeling can lead to addiction-a chronic relapsing brain condition characterized by inability to stop using a drug despite damaging consequences to a person’s life and health.

Loperamide is an opioid designed not to enter the brain. However, when taken in large amounts and combined with other substances, it may cause the drug to act in a similar way to other opioids. Other opioids, such as certain prescription pain relievers and heroin, bind to and activate opioid receptors in many areas of the brain, especially those involved in feelings of pain and pleasure. Opioid receptors are also located in the brain stem, which controls important processes, such as blood pressure, arousal, and breathing.

Opioid Withdrawal Symptoms

These symptoms include:

• muscle and bone pain
• sleep problems
• diarrhea and vomiting
• cold flashes with goose bumps
• uncontrollable leg movements
• severe cravings

What are the health effects of these OTC medicines?

DXM
Short-term effects of DXM misuse can range from mild stimulation to alcohol- or marijuana-like intoxication. At high doses, a person may have hallucinations or feelings of physical distortion, extreme panic, paranoia, anxiety, and aggression.

Other health effects from DXM misuse can include the following:

• hyperexcitability
• poor motor control
• lack of energy
• stomach pain
• vision changes
• slurred speech
• increased blood pressure
• sweating

Misuse of DXM products containing acetaminophen can cause liver damage.

Loperamide
In the short-term, loperamide is sometimes misused to lessen cravings and withdrawal symptoms; however, it can cause euphoria, similar to other opioids.

Loperamide misuse can also lead to fainting, stomach pain, constipation, eye changes, and loss of consciousness. It can cause the heart to beat erratically or rapidly, or cause kidney problems. These effects may increase if taken with other medicines that interact with loperamide. Other effects have not been well studied and reports are mixed, but the physical consequences of loperamide misuse can be severe.

Can a person overdose on these OTC medicines?

Yes, a person can overdose on cold medicines containing DXM or loperamide. An overdose occurs when a person uses enough of the drug to produce a life-threatening reaction or death (Read more on our Intentional vs. Unintentional Overdose Deaths webpage).

As with other opioids, when people overdose on DXM or loperamide, their breathing often slows or stops. This can decrease the amount of oxygen that reaches the brain, a condition called hypoxia. Hypoxia can have short- and long-term mental effects and effects on the nervous system, including coma and permanent brain damage and death.

How can these OTC medicine overdoses be treated?

A person who has overdosed needs immediate medical attention. Call 911. If the person has stopped breathing or if breathing is weak, begin CPR. DXM overdoses can also be treated with naloxone. Read more about naloxone at our Naloxone webpage.

Certain medications can be used to treat heart rhythm problems caused by loperamide overdose. If the heart stops, health care providers will perform CPR and other cardiac support therapies.

Can misuse of these OTC medicines lead to addiction?

Yes, misuse of DXM or loperamide can lead to addiction. An addiction develops when continued use of the drug causes issues, such as health problems and failure to meet responsibilities at work, school, or home.

The symptoms of withdrawal from DXM and loperamide have not been well studied.

How can people get treatment for addiction to these OTC medicines?

There are no medications approved specifically to treat DXM or loperamide addiction. Behavioral therapies, such as cognitive-behavioral therapy and contingency management, may be helpful. Cognitive-behavioral therapy helps modify the patient’s drug-use expectations and behaviors, and effectively manage triggers and stress. Contingency management provides vouchers or small cash rewards for positive behaviors such as staying drug-free. Read more about drug addiction treatment in our Treatment Approaches for Drug Addiction DrugFacts.

Points to Remember

• Over-the-counter (OTC) medicines are those that can be sold directly to people without a prescription. Those that have the potential for misuse include:
  • Dextromethorphan (DXM), a cough suppressant found in many OTC cold medicines
  • Loperamide, an anti-diarrheal
• When misusing DXM, people swallow large quantities of the medicine, sometimes mixing it with soda for flavor, called “robo-tripping” or “skittling.” Loperamide may also be swallowed.
• Short-term effects of DXM misuse can range from mild stimulation to alcohol-or marijuana-like intoxication. Loperamide misuse can cause euphoria, similar to other opioids, or lessen cravings and withdrawal symptoms, but other effects have not been well studied and reports are mixed.
• A person can overdose on cold medicines containing DXM or loperamide.
• Overdose can be treated with CPR and certain medications depending on the person’s symptoms, but the most important step to take is to call 911.
• Misuse of DXM or loperamide can lead to addiction.
• There are no medications to treat DXM or loperamide addiction. Behavioral therapies, such as cognitive-behavioral therapy and contingency management, may be helpful.

Learn More

For more information about OTC medicines, see our:

This publication is available for your use and may be reproduced in its entirety without permission from NIDA. Citation of the source is appreciated, using the following language: Source: National Institute on Drug Abuse; National Institutes of Health; U.S. Department of Health and Human Services.

Guaifenesin/Dextromethorphan – Oral | HealthLink BC

Pronunciation: gweye-FEN-eh-sin/dex-trow-meth-OR-fan

Common Brand Name(s): Benylin DM-E , Robitussin DM

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This combination medication is used to relieve coughs caused by the common cold, bronchitis, and other breathing illnesses. Guaifenesin belongs to a class of drugs known as expectorants. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. Dextromethorphan belongs to a class of drugs known as cough suppressants. It acts on a part of the brain (cough center) to reduce the urge to cough.

If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.)

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

How To Use

Take this medication by mouth with or without food, as directed by your doctor. If you are self-treating, follow all directions on the product package. If you are uncertain about any of the information, ask your doctor or pharmacist

Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion.

Dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this drug more often than directed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

For powder packets, empty the entire contents of the packet onto the tongue and swallow. To prevent a bitter taste, do not chew. If you are taking the capsule form, swallow the capsule whole.

Improper use of this medication (abuse) may result in serious harm (such as brain damage, seizure, death). Do not increase your dose, take it more frequently, or use it for a longer time than directed.

Tell your doctor if your cough returns, or if it is accompanied by fever, severe sore throat, rash, persistent headache, or if it persists or worsens after 7 days. These may be signs of a serious medical problem. Seek immediate medical attention if you think you may have a serious medical problem.

Side Effects

Dizziness, drowsiness, nausea, and vomiting may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, 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.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

• 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.

Precautions

Before taking this drug, tell your doctor or pharmacist if you are allergic to guaifenesin or dextromethorphan; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• breathing problems (such as emphysema, chronic bronchitis, asthma, smoker’s cough)
• cough with blood or large amounts of mucus
• liver problems

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Liquid forms of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, liver disease, or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

The liquid forms and powder packets of this medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if guaifenesin or dextromethorphan passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

Drug Interactions

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.

Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, or 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.

Guaifenesin and dextromethorphan are available in both prescription and nonprescription products. Check the labels of all your medications to make sure you are not taking more than one product containing guaifenesin or dextromethorphan.

Guaifenesin can affect the results of certain lab tests (such as urine levels of certain acids). Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme drowsiness, blurred vision, confusion, hallucinations, slow/shallow breathing, seizures.

Notes

If your doctor prescribed this medication, do not share this medication with others.

Keep all regular medical and laboratory appointments.

This medication is for temporary use only. Do not take this medication for more than 7 days unless your doctor tells you to do so. Tell your doctor if your condition lasts longer than 7 days.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brompheniramine, Pseudoephedrine, and Dextromethorphan | Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: USA

Bromfed DM; Brotapp-DM [OTC]; Neo DM [OTC] [DSC]; Q-Tapp DM [OTC] [DSC]

What is this drug used for?

• The drug is used to treat nasal valve blockages.
• Used to relieve allergy symptoms.
• Used to relieve coughs.

What should I tell my doctor BEFORE taking this drug?

• If you are allergic to brompheniramine, pseudoephedrine, dextromethorphan, or any other ingredient in this drug.
• If you are allergic to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergy and how it manifested itself.
• If you have taken a drug for depression or Parkinson’s disease in the past 14 days. These include isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. An episode of very high blood pressure may occur.
• If you are taking any of the following drugs: linezolid or methylene blue.
• If you have a cough with a lot of mucus.
• If you have a prolonged cough caused by smoking, smoking in your vicinity, or lung problems such as asthma or emphysema.
• If you are breastfeeding. Do not breast-feed while taking this drug.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Tell your doctor and pharmacist about all medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems. You need to make sure that this drug is safe for your medical condition and in combination with other drugs you are already taking.Do not start or stop taking any medication or change the dosage without your doctor’s approval.

What do I need to know or do while taking this drug?

• Tell all healthcare providers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
• Do not take the drug in higher doses than the doctor prescribed. Taking more than the prescribed amount of the drug increases the risk of serious side effects.
• Do not use this drug for longer than your doctor prescribed.
• Avoid driving or other activities that require increased attention until you see how this drug affects you.
• Avoid drinking alcohol while taking this drug.
• Consult your doctor before using marijuana, other forms of cannabis, prescription or over-the-counter drugs that may slow you down.
• If you are 65 years of age or older, use this drug with caution. You may have more side effects.
• Use with caution in children. Consult your doctor.
• Do not use for sleep disorders in children. Consult your doctor.
• This medication is not intended for use in children. Talk to your doctor before giving this drug to a child.
• Tell your doctor if you are pregnant or planning to become pregnant.The benefits and risks of taking this drug during pregnancy will need to be discussed.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, some people with this drug can cause serious and sometimes deadly side effects. Call your healthcare professional or get medical attention right away if you have any of the following signs or symptoms, which may be associated with serious side effects:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.

What are some other side effects of this drug?

Any medicine can have side effects. However, many people have little or no side effects. Call your doctor or get medical help if these or any other side effects bother you or do not go away:

• Dizziness.
• Nervous tension and agitation.
• Sleep disorders.
• Sleepiness.
• Dry mouth.
• Dry nose.
• Thickening of the nasal or pharyngeal mucosa.

This list of potential side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Office.

You can report side effects to the FDA at 1-800-332-1088.You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your healthcare practitioner. Read all the information provided to you. Follow all instructions strictly.

• Take with or without food. Take with food if the medicine causes nausea.
• Care should be taken to measure the doses of the liquid preparation. Use the dispenser that comes with the medicine.If a dispenser is not included in the package, ask your pharmacist for a dosing product for this drug.

What should I do if a dose of a drug is missed?

• If you are taking this medication regularly, take the missed dose as soon as you can.
• If it’s time to take your next dose, do not take the missed dose and then return to your normal drug schedule.
• Do not take 2 doses at the same time or an additional dose.
• In most cases, this drug is used as needed. Do not take this medicine more often than prescribed by your doctor.

How do I store and / or discard this drug?

• Store at room temperature. Do not freeze.
• The lid must be tightly closed.
• Store in a dry place. Do not store in the bathroom.
• Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

• If your health does not improve or even worsens, see your doctor.
• You should not give your medicine to anyone or take someone else’s medicine.
• Some medicines may come with other patient information sheets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• Some medicines may come with other patient information sheets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by the consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are suitable for a particular patient.This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient. Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional.Check with your doctor for complete information on the possible risks and benefits of taking this drug. Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

Guaifenesin and Dextromethorphan: Pediatric Medication

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: USA

Altarussin DM [OTC]; Chest Congestion Relief DM [OTC]; Coricidin HBP Congestion / Cough [OTC]; Cough / Chest Congestion DM [OTC]; Delsym Cgh / Chest Cong DM Child [OTC]; Delsym Cough / Chest Congest DM [OTC]; Diabetic Siltussin-DM Max St [OTC] [DSC]; Diabetic Siltussin-DM [OTC] [DSC]; Diabetic Tussin DM [OTC]; Diabetic Tussin For Children [OTC]; Diabetic Tussin Max St [OTC]; Double-Tussin DM [OTC]; Extra Action Cough [OTC] [DSC]; Fenesin DM IR [OTC]; Geri-Tussin DM [OTC]; GoodSense Mucus Relief DM [OTC]; Guaiasorb DM [OTC]; Guaicon DMS [OTC]; Maxi-Tuss G [OTC]; Maxi-Tuss GMX [OTC]; Mucinex Childrens Freefrom [OTC]; Mucinex Cough Childrens [OTC]; Mucinex Cough For Kids [OTC]; Mucinex DM Maximum Strength [OTC]; Mucinex DM [OTC]; Mucinex Fast-Max DM Max [OTC]; Mucosa DM [OTC] [DSC]; Mucus Relief Cough Childrens [OTC]; Mucus Relief DM Max [OTC]; Mucus Relief DM [OTC]; Mucus Relief DM Cough [OTC]; NeoTuss [OTC] [DSC]; Pediatric Formula Cough / Congst [OTC]; Pharbinex-DM [OTC]; Recofen D [OTC]; Refenesen DM [OTC]; Robafen DM Cgh / Chest Congest [OTC]; Robafen DM Cough Clear [OTC] [DSC]; Robafen DM Cough [OTC]; Robafen DM Peak Cold Cgh / Cong [OTC] [DSC]; Robafen DM [OTC] [DSC]; Robitussin Cold Cough + Chest [OTC] [DSC]; Robitussin Cough + Chest Max St [OTC] [DSC]; Robitussin Cough + Chest Cong DM [OTC]; Robitussin Peak Cold DM [OTC] [DSC]; Robitussin To Go Cgh / Chest DM [OTC] [DSC]; Safe Tussin DM [OTC]; Siltussin DM DAS [OTC]; Siltussin-DM Alcohol Free [OTC]; Tolu-Sed DM [OTC] [DSC]; Triaminic Cough & Congestion [OTC] [DSC]; Tussin DM [OTC]

What is this drug used for?

• Helps to loosen mucus, so it can be easily removed by coughing.
• Used to relieve coughs.

What do I need to tell my doctor BEFORE my child takes this drug?

• If your child is allergic to this drug, any of its ingredients, other drugs, foods, or substances. Tell your doctor about the allergy and how your child has it.
• If your child has any of the following health conditions: a cough with a lot of phlegm, a prolonged cough caused by the child’s smoking, smoking in the immediate vicinity of the child, or lung problems such as asthma.
• If your child has been taking drugs for depression or some other medical condition in the past 14 days. These include isocarboxazid, phenelzine, and tranylcypromine. An episode of very high blood pressure may occur.
• If your child is receiving any of the following: linezolid or methylene blue.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Talk to your doctor or pharmacist about all medications your child is taking (prescription and over-the-counter, natural products, and vitamins) and any health concerns. You need to make sure that this drug is safe for your child’s illness and in combination with other drugs he is already taking. You should not start, stop, or change the dosage of any drug your child is taking without talking to the doctor.

What do I need to know or do while my child is taking this drug?

• Tell all health care providers for your child that your child is taking this drug. These are your child’s doctors, nurses, pharmacists and dentists.
• Do not give your child more than the prescribed amount of this drug. Taking more than the prescribed amount of this drug may increase the risk of very serious side effects.
• Do not give this drug to your child for longer than the doctor prescribed.
• If your child is on a low sodium or salt free diet, consult a doctor. Some of these preparations contain sodium.
• If your child has PKU, talk to your doctor. Some foods contain phenylalanine.
• Some forms of this drug may not be suitable for use in children of all ages.If you have any questions, please consult your doctor.

If your daughter is pregnant or breastfeeding:

• Consult a doctor if your daughter is pregnant, pregnant, or breastfeeding. The benefits and risks for your daughter and her child will need to be discussed.

What side effects should I report to my child’s healthcare provider right away?

WARNING / CAUTION: Although rare, this drug can cause very serious and sometimes deadly side effects in some people.Call your child’s doctor right away or get medical attention if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.

What are some other side effects of this drug?

Any drug can have side effects. However, many people have little or no side effects. Call your child’s doctor or get medical help if your child is concerned about any side effects or if they persist.

This list of possible side effects is not exhaustive. If you have any questions about side effects, talk to your child’s doctor.Talk to your child’s doctor about side effects.

You can report side effects to the National Health Office.

What is the best way to give this drug?

Give this drug to your child as directed by the doctor. Read all the information provided to you. Follow all instructions strictly.

All forms of issue:

• Give this drug with or without food.If the drug causes stomach upset, give it with food.
• Try to have your child drink lots of non-caffeinated liquids every day, unless directed by a doctor to drink less liquids.

Tablets and capsules:

• Give this drug with a full glass of water.

Liquid:

• Doses of liquid preparation should be measured with caution. Use the dispenser that comes with the medicine.If a dispenser is not included in the package, ask your pharmacist for a dosing product for this drug.

Extended-release tablets:

• Have your child swallow whole. Tell your child not to chew, crush, or crush the tablet.
• Give this drug with a full glass of water.

Granules:

• Empty the contents of the bag onto the child’s tongue and make sure he swallows it.To avoid an unpleasant aftertaste, ask your child to swallow without chewing.

What if my child misses a dose of a drug?

• If the child is taking the drug regularly, give the missed dose as soon as you remember.
• If it is time for your child to take the next dose, do not take the missed dose and then return to your child’s normal schedule.
• Do not give a double dose at the same time or additional doses.
• In most cases, this drug is used as needed. Do not give your child the drug more often than the doctor tells you to.

How do I store and / or discard this drug?

• Store at room temperature in a dry place. Do not store in the bathroom.
• Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs.Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

• If your child’s symptoms or health conditions do not improve, or if they get worse, see your child’s doctor.
• Do not share your child’s medication with others or give anyone else’s medication to your child.
• Some medicines may come with other patient information sheets. If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other healthcare professional.
• If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by the consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are suitable for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional. Check with your doctor for complete information on the possible risks and benefits of taking this drug.Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

💊 OMSER-DM instructions for use

OMSER-DM caps No. 30

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Information about the points of distribution of medicines to privileged categories of citizens in the city ofKaliningrad and the region

Copy from the original – Claims of the superiority of a generic drug must be confirmed clinically

Claims of superiority of a generic drug must be confirmed clinically

Now in our country there are a number of lawsuits with the participation of pharmaceutical companies regarding the introduction of generic drugs (MP) to the market, i.e. e. copies of drugs, or generics, although the original drugs are still subject to patents protecting the rights of developers. Patent holders are forced to seek protection in court, where one can often hear statements that there are significant advantages of the generic over the original (reference) drug.

For example, that a generic drug has “increased biological activity” compared to the original drug. Or that, in the production of generic drugs, the “milling and sieving” steps are replaced by the “freeze and lyophilization” steps, thereby “dramatically reducing the cost of the production process as a whole.” This is how the opinion is formed that a generic drug may have characteristics that distinguish it from the original drug for the better.

And on this basis, the patent protection of the original drug does not seem to suffer because of its own patent for an “improved invention” for a copy preparation.Is it possible? “RG” asked its question to representatives of the medical and scientific community.

– When I hear the assertion that a copy medicine is better than the original drug, I recall the famous saying: “You cannot be more Catholic than the Pope”, – the chief clinical pharmacologist of the health committee of the St. Petersburg government, candidate of medical sciences Alexander Khadzhidis ironically. – When registering a generic drug, our legislation does not require a full cycle of research, because it has already been carried out by the manufacturer of the original drug.That is why, in fact, the copy is always much cheaper than the original. But here it comes to the ridiculous: the manufacturer of the copy claims to have improved the original. What’s the catch? According to the legislation, it is allowed that, according to pharmacokinetic or biological equivalence, a backlash of up to 20 percent is allowed for a generic drug. But since we have replaced the definition of “original drug” with the concept of “reference drug”, the new generic drug can be compared not with the original drug, that is, the drug registered for the first time in the world, but with the reference drug.And it can also be a drug first registered in Russia, that is, also a generic. And the new generic drug in terms of effectiveness may differ from the original drug by more than 20 percent. But if you also introduce some new ingredients into its composition, then this is a completely different drug, and for its registration it is necessary to carry out a full cycle of preclinical (DKI) and clinical trials (CI). And there can be no “improved” copies in comparison with the original – this is nonsense.

– The statement that a generic drug may have some new characteristics compared to the original drug is complete nonsense, – was briefly the deputy director of the N.N.Dm. Rogacheva, Doctor of Medicine Alexey Maschan. – If certain substances are added to the composition of the drug that “improve” it, then this is a completely different drug, and it must go through the entire cycle of research, which is required by law. In this case, the generic drug cannot be registered as a copy drug.

“The fact that original medicinal products are the most studied drugs is of practical value,” recalled Alexander Hadzhidis. – When using them, you can get exactly such a therapeutic effect, which is described in the instructions drawn up on the basis of research on the original drug.Therefore, original drugs will always have a clinical advantage, but their disadvantage is the high price, which includes all research costs. And the manufacturer of generics, according to the law, may not spend money on CI – it is enough to conduct studies on pharmacokinetic equivalence on a small number of patients. Therefore, our market is full of replica drugs.

Analogues are introduced to the market, although patents are still valid for original drugs

– The basis for simplified registration of reproduced drugs is the coincidence of the qualitative and quantitative composition of active substances, the same (within certain limits) dosage form and route of administration, – explains the development and registration of medicines for medical use by the Scientific Consulting Center Ravil Niyazov.- The positive results of bioequivalence studies make it possible to extrapolate the safety and efficacy profile of the original drug to the reproduced one. It is also required to show that the impurity profile of the reproduced drug is not worse than the reference one and that the excipients used and their amount are standard for the route of administration, duration of use and group of patients – for example, for children. If all of these criteria are met, the copy manufacturer can qualify for simplified registration.

If a company claims to have improved the pharmacokinetic characteristics, bioavailability of a drug, or optimized its pharmacodynamic properties, then this contradicts the concept of bioequivalence and requires additional DTCs or CIs to prove that these improvements provide advantages in terms of safety and efficacy. But in this case, the drug can no longer be recognized as reproduced, and its originality must still be proved through full-scale preclinical and clinical studies.

Discussion

Maria Koroleva, medical director of the Sandoz company:

– According to the legislation, the generic drug must be equivalent or comparable to the reference one in a number of characteristics – dosage form, composition, route of administration and use. Different dosage forms are considered equivalent, but having the same modes of administration and use, having comparable pharmacokinetic characteristics and pharmacological action, and also ensuring the achievement of the required clinical effect.Thus, a generic drug may have additional characteristics that do not affect the pharmacokinetics, efficacy, and safety profile, but are significant and add value to the patient. This can be the exclusion from the composition of the drug of any auxiliary substance that can cause allergic reactions, or the selection of substances due to which the tablet acquires properties that facilitate the treatment process. For example, it can be a tablet that the patient can dissolve without being dissolved in water.Or the manufacturer organizes the production process in such a way that the package of the drug is enough for the full course of treatment and there is no need to buy a second package. One of the strategic directions of the Sandoz company is the creation of just such drugs with additional value for the patient, more convenient to use and allowing to reduce treatment costs.

Oleg Prokofiev, director of registration of the Takeda company:

– The reproduced drug is not a complete analogue of the original one, i.e.because, despite the need for its compliance with the original drug in terms of the content and characteristics of the active substance, there will always be differences in the composition (or amount) of excipients. Registration of generics is carried out on the basis of data in comparison with the original drug, as well as information taken from available scientific sources on the preclinical and clinical use of the drug. The only intrinsic CI in most cases is the study of bioequivalence of generic drugs.In the case of biosimilars, partially own data on DKI and CI of the drug are provided. However, as is the case, it is impossible to register indications that differ from the original drug. But the law does not prohibit the generic manufacturer from conducting their own preclinical and clinical studies in search of new indications. As it does not prohibit and register indications that differ from the indications of the originator, but solely on the basis of their own CI. In reality, this is extremely rare, i.e.Because practically all the properties of the molecule are known to the developer of the original drug, and its use in other therapeutic indications, as a rule, is not justified.

Natalya Chukreeva, Director of Pharmaceutical Activities, Servier EAEU, Doctor of Pharmacy:

– The legislation of Russia and the EAEU defines a reproduced drug as having the same qualitative and quantitative composition of active substances in the same dosage form, as the reference (in the EAEU – the original).Its bioequivalence or therapeutic equivalence to the reference medicinal product must be confirmed by appropriate studies. At the same time, the generic drug is not a copy of the reference drug and is the result of its own pharmaceutical development. However, Russian, European and EAEU rules determine that differences between a generic and a reference drug can only be in inactive components (not determining the properties of efficacy and safety), as well as in the appearance of the dosage form and the type of packaging materials.

Anton Alikhanov: Uninterrupted supply of medicines to pharmacies

This was announced by the head of the region at a meeting with the heads of pharmacies on Friday, October 30.

The meeting was also attended by Deputy Prime Minister Ilya Barinov, Minister of Health Alexander Kravchenko, Chief Federal Inspector for the Kaliningrad Region Sergey Eliseev, heads of regional departments of the FAS Artur Demkov, Rospotrebnadzor Elena Babura, territorial body of Roszdravnadzor Alla Velikaya.

At the moment, there are 158 business entities operating in the region, licensed for retail trade in the field of pharmacy. Employees of the regional branch of Roszdravnadzor call and visit pharmacies every day to check the availability of drugs. According to Alla Velikaya, the number of complaints about the lack of a number of medicines is increasing daily. She also reminded executives that this could serve as the basis for administrative punishment.

As the owners of pharmacies retorted, in such an epidemic situation it is impossible to keep medicines, fearing verification, they should be brought to the end consumer.

Ilya Barinov also noted that selling antibiotics without a prescription is a violation of federal law.

Elena Babura clarified whether personal protective equipment is sufficient. The representatives of the pharmacy chains announced a large stock of necessary masks and gloves, antiseptics and a noticeable decrease in prices in relation to the spring period.

Pharmacy managers noticed that drugs for the treatment of a new coronavirus infection are not available not only at points of sale, but also in warehouses and distributors.The owners constantly, including at night, monitor the availability of drugs for ordering and purchase as soon as possible.

Labeling of goods remains one of the problems. According to Ilya Barinov, at the federal level they are aware of the problem and promise to find a solution within a week.

In addition, Governor Anton Alikhanov promised to contact pharmaceutical factories that produce key antiviral / antibacterial drugs to expedite the shipment of drugs to the region.

“Together we will be able to establish an uninterrupted supply of medicines to pharmacies. Thank you all for the information provided, this will help determine the range of problems that need to be solved, contact the manufacturers to find out the reasons. Try to “grab” the necessary drugs to the regional market, we will actively help in this direction, ”the head of the region emphasized.

Tags: Alikhanov, pharmacies, medicines

Cure for reality / Article

FILM

Once Upon a Time at Hollywood (Once Upon a Time… in Hollywood, 2019)

Meet Rick Dalton – the star of the NBC series Bounty Law. And this is Cliff Booth, stuntman, stunt double, driver and assistant to Rick. Rick Dalton has known better times. He was the hero of the films Tanner and McCluskey’s 14 Fists. But now it’s 1969: Rick is happy with almost any job and is even ready to moderate fawning in search of it. Producer Marvin Shores, sipping cognac on ice, invites him to go to Rome to star in a series of spaghetti westerns. Before it’s too late.But Rick is not in a hurry yet: in his sleeve tests in the pilot of the new series. Cliff has nowhere to rush: for the past nine years he has been working exclusively for Rick.

Around, not noticing the little problems of little people, Hollywood is making noise and excitement, exploding with premieres, luxurious parties and acid trips. Rick’s new neighbor is Roman Polanski himself with a beautiful wife: wow, if we have such a neighbor, maybe it will still work out! The hungover Rick Dalton in sunglasses is in a hurry to star in the series, Cliff Booth in a luxurious Cadillac goes to exchange glances with a hippie girl, Sharon Tate in white go-go boots goes to watch a movie with him, Charles Manson strolls around Polanski’s house.And all this – accompanied by the roar of huge motors, flashes of neon signs, movie firecrackers and authentic melodies of the 60s.

I myself have not tested the music, but people with ear and knowledge claim that this music is precisely the end of the 60s: no Tarantino anachronisms you are used to, or even, forgive my Latin, counterpoints. In general, this film can be called the most non-Tarantino of the nine. But there is still an anachronism in him – this is Margot Robbie. There are women in 90,812 of theirs’ 90,813 villages, whom you can simply take, put in a time machine and send half a century back – the people there will not notice anything.Well, maybe put on a beatley jacket. Margot is one of those women. You can name a few more names, but Margot Robbie is also very similar to Sharon Tate – a spectacular film beauty during the heyday of Hollywood.

Despite her beauty, Margot is an outstanding actress. Do not believe me – watch the film “Tonya Against All”. Tarantino only uses appearance:

appearing in the frame, Sharon Tate either smiles, or dances, or both at the same time. She has only a few very simple lines and two close-up feet, and this is hardly an accident.Surely Quentin is well aware of the role of actresses not the very first plan in Hollywood and the Hollywood surroundings of the sixties.

Maybe that’s why little Trudy, Rick Dalton’s partner (or better to say, partner) in the pilot, in the best dialogue of the film expresses disregard for the above feminitive and calls herself an actor. The conversation between Trudy and Rick turned out to be sincere and sparkling, but also not habitually Tarantino, not at all like verbiage about foot massage. By the way, the dirty feet of a friendly hippie performed by Margaret Qualley join Margot’s feet.Quentin 56, the first massage happened in 1994, but time has no power over true fetishes. Finishing with the female characters, we note the cameo roles of Maya Hawke – the daughter of Uma Thurman, as well as the hardly recognizable Dakota Fanning. Eh, where are you, where are you, nine-year-old Pita Ramos, what the damned Hollywood did to you!

The main men of the film played together for the first time. Brad Pitt joked that he was simply removed from the ban on approaching Leonardo DiCaprio. And how did it work out?

First, it’s beautiful.I managed to stay straight after watching Rocketman, but even I can see and understand everything. Both Leo and Brad wear handsome men from their young nails, but now, when they have diminished in sugaryness, have sunburned and added to their maturity, they cannot take their eyes off at all.

Secondly, Leonardo DiCaprio has an integral and understandable character: an actor who has fallen into a career crisis. Like George Valentine in The Artist, Rick Dalton tries to drown his pride in alcohol, but unlike George, he does it well.His last days on the Hollywood stages are spent trying to come to terms with the transition from the main squad to the bench, trying to reconcile his brutal alter ego with a wounded ego. Brad’s character looks simpler and represents the “real” in the hypocritical (by definition, and not in a negative sense) world of the film industry, but he also keeps skeletons in the closet and cockroaches in his head, just barely walks them.

Quentin made a movie about cinema and about the neighborhood. Since Quentin is not only an amateur and irrepressible consumer of cinema, but also his professional, it is better for you, dear viewer, to be a cinephile.

And even better – a cinephile with a roll in the sixties. And ideally also a specialist. For example, I didn’t have any problems with references, links, rolls, quotes, allusions and, forgive my French, homages. I didn’t understand anything at all. From my dislike of old cinema, you can especially highlight the disregard for westerns and the sixties in general, so stories about Steve McQueen and the like fly from one ear to another without touching the brain.

So if you are a cinephile, enjoy every minute, and if you, like me, wonder for an hour and a half, roll your eyes, smile at the dude and the poseur Bruce Lee, just admire Margot and Leo.

A flamethrower hung on the wall will certainly fire in the third act, but with more delicate weapons, not everything is so obvious. Well at least Tarantino did not do without selfies, which are much easier to recognize. With a sense of deep satisfaction, I managed to capture two, Inglourious Basterds and Pulp Fiction.

Better yet, Quentin Tarantino, like the Colt from his favorite Westerns, has made everyone equal. Absolutely everyone – those who enjoyed and those who endured – will have an amazing ending.To feel the full power of the main Dream Factory falling on you, you need to fulfill the only precondition – at least superficially familiarize yourself with the history of Sharon Tate and the sect of Charles Manson. Cinephiles already know her, so this is more for us – cinephobes, amateurs and just amateurs. A small price to pay for a great Tarantino treat.

New items for the coming weekend

Still, I really want to know how the domestic manufacturer copes with science fiction.Therefore, our choice is “There”. And yours, perhaps:

Angel of Mine (2019)

Foto: Magna Entertainment

Kim Farrant, director of the undeservedly underestimated film “Alien Land,” presents a heartbreaking new drama to the viewer. Lizzie cannot come to terms with the loss of her daughter, who died in a fire (and who could?). A few years later, she accidentally meets a strange girl and takes her for her daughter. But the girl also has real parents.Starring Noomi Rapace and Yvonne Strahovski.

Angry Birds Movie 2 (The Angry Birds Movie 2, 2019)

Foto: Sony Pictures Animation

Hurry to see! The War of Three Zs begins! Angry Birds team up with Green Pigs to confront Zeta, the inhabitant of the frozen island. After years of internecine strife, this is very difficult. But what can you do to stop the scumbag and his freezing.

After the Wedding (2019)

Isabelle has dedicated her life to helping others.So she would have sat quietly for herself in an Indian orphanage, but that was not the case. To receive the multimillion-dollar donation from the patron Teresa, she needs to come to New York in person. And where New York is, there are secrets, passions and drama. To begin with, Isabelle recognizes Teresa’s husband as an old acquaintance. And this acquaintance is not just a frivolous affair.

Light of My Life (2019)

Foto: Black Bear Pictures

A dramatic weekend ends the post-apocalyptic story by Casey Affleck (aka starring).