Guaifenesin Overdose

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What happens if I overdose Guaifenesin?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.

Proper storage of Guaifenesin immediate-release capsules:

Store Guaifenesin immediate-release capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Guaifenesin immediate-release capsules out of the reach of children and away from pets.

Overdose of Guaifenesin in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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The acute toxicity of Guaifenesin is low and overdosage is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when Guaifenesin was administered by stomach tube in doses up to 5 grams/kg.

In massive over dosage the stomach should be emptied (emesis and/or gastric lavage) and further absorption prevented. Treatment is symptomatic and supportive.

What should I avoid while taking Guaifenesin?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ask a doctor or pharmacist before using any other cold, or cough medicine. Many combination medicines contain Guaifenesin. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an expectorant.

Guaifenesin warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

DOLOPHINE® HYDROCHLORIDE CI/strong>(Guaifenesin Hydrochloride Tablets), 5 mg and 10 mg

WARNINGS:

Keep DOLOPHINE out of the reach of children. Accidental overdose by a child is a medical emergency and can result in death. If a child accidentally takes DOLOPHINE, get emergency help right away.

Do not take a higher dose of DOLOPHINE or take it more often than prescribed. This can lead to an overdose and possible death.

Read the Patient Information that comes with DOLOPHINE before you take it and each time you get a new prescription. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. Share the important information in this leaflet with members of your household.

What Is The Most Important Information I Should Know About DOLOPHINE?

  • DOLOPHINE can cause life threatening breathing problems which can lead to death. These problems are more likely to happen when DOLOPHINE is first started or in someone who is not already taking other narcotic (opioid) pain medicines.
    • Breathing problems from DOLOPHINE may not happen right away after taking a dose. Sometimes breathing problems will happen a while after you take a dose, even after pain has returned. It is very important that you take DOLOPHINE exactly as your doctor has prescribed. Talk to your doctor about your pain. Your doctor can decide if your DOLOPHINE dose needs to be changed.
  • DOLOPHINE can cause life-threatening heart beat problems that can lead to death. Most heart beat problems have happened in people using large doses of DOLOPHINE for pain treatment. Some heart beat problems have happened in people using smaller doses of DOLOPHINE for treatment of narcotic drug addiction.

What is DOLOPHINE?

DOLOPHINE is a prescription medicine that contains methadone, which is a narcotic pain medicine similar to morphine. DOLOPHINE is a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs.

  • Prevent theft and misuse. Keep your DOLOPHINE tablets in a safe place to protect them from theft. Never give DOLOPHINE to anyone else even if they have the same symptoms you have. It may harm them and even cause death. Selling or giving away this medicine is dangerous and against the law.

DOLOPHINE is used:

  1. to treat moderate to severe pain in people that do not respond to non-narcotic pain medicines;
  2. to control withdrawal symptoms in patients being treated for narcotic drug addiction;
  3. for maintenance treatment of narcotic drug addiction along with other social and medical services. Stopping maintenance treatment of narcotic drug addiction with DOLOPHINE may result in a return to narcotic drug use.

Who Should Not Take DOLOPHINE?

Do not take DOLOPHINE if you:

  • have severe asthma or severe lung problems.
  • have a blockage or obstruction in your intestines.
  • are allergic to methadone or anything else in DOLOPHINE. See the end of this leaflet for a complete list of ingredients.

What Should I Tell my Doctor Before I Start Taking DOLOPHINE?

DOLOPHINE may not be right for you. Before starting DOLOPHINE, tell your doctor about all your medical and mental conditions including a history of drug or alcohol abuse or addiction.

Tell your doctor if you:

  • are pregnant or plan to become pregnant. DOLOPHINE may harm your unborn baby.
  • are breast feeding. DOLOPHINE passes through your breast milk and may harm your baby. You should choose to use DOLOPHINE or breastfeed, but not both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with DOLOPHINE. Be especially careful about other medicines that may make you sleepy, such as other pain medicines, anti-depressant medicines, sleeping pills, anxiety medicines, antihistamines, or tranquilizers. Sometimes, the doses of certain medicines (including DOLOPHINE) may need to be changed if they are used together.

Do not take any medicine while using DOLOPHINE until you have first talked to your doctor or pharmacist. They will be able to tell you if it is safe to take other medicines while you are using DOLOPHINE.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist each time you get a new medicine.

How Should I Take DOLOPHINE?

  • Take DOLOPHINE exactly as prescribed. Follow your doctors directions exactly. Your doctor may change your dose based on your reactions to the medicine. Do not change your dose unless your doctor tells you to change it. Do not take a higher dose of DOLOPHINE or take it more often than prescribed. This can lead to an overdose and possibly death.
  • If you take too much DOLOPHINE or overdose, call 911 or your local emergency number right away.
  • Review your medical conditions regularly with your doctor to determine if you still need DOLOPHINE, or if the dose needs to be adjusted.
  • When starting treatment with DOLOPHINE for narcotic drug dependence, you should be aware that your dose of methadone will "hold" for longer periods of time as treatment goes on.
  • Stopping DOLOPHINE. Ask your doctor for instructions on how to stop this medicine slowly to avoid uncomfortable symptoms. You should not stop taking DOLOPHINE all at once if you have been taking it for more than a few days.
  • Tell all health professionals that treat you that you take DOLOPHINE.
  • After stopping treatment with DOLOPHINE, flush the unused tablets down the toilet.

What Should I Avoid While Taking DOLOPHINE?

  • Do not drive, operate heavy machinery, or do other possible dangerous activities until you know how DOLOPHINE affects you. DOLOPHINE can make you sleepy. Ask your doctor when it is okay to do these activities.
  • Do not drink alcohol while using DOLOPHINE. It may increase the chance of having dangerous side effects.
  • Do not take other medicines with DOLOPHINE without first talking with your doctor.

What are the Possible Side Effects of DOLOPHINE?

  • DOLOPHINE can cause life threatening breathing and heart problems which can lead to death See "What Is The Most Important Information I Should Know About DOLOPHINE?"
    • Call your doctor or get medical help right away if you:
      • have trouble breathing
      • have extreme drowsiness and breathing slows down
      • have slow shallow breathing (little chest movement with breathing)
      • fast or slowed heartbeat
      • feel faint, very dizzy, confused, have palpitations (irregular heart beat) or any other unusual symptoms

These can be symptoms that you have taken too much (overdose of) DOLOPHINE, or the dose is too high for you. They can also be symptoms of a serious heart reactionstrong>These symptoms can lead to serious problems or death if not treated right away.

Some common side effects of DOLOPHINE are lightheadedness, dizziness, drowsiness, nausea, vomiting and sweating. Other side effects include weakness, headache, constipation, itching, and dry mouth.

Talk to your doctor about any side effects that bother you or that do not go away.

These are not all the possible side effects of DOLOPHINE. For a complete list, ask your doctor or pharmacist.

How Should I Store DOLOPHINE Tablets?

General Information About DOLOPHINE.

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflet. Do not use DOLOPHINE for a condition for which it was not prescribed. Do not give DOLOPHINE to other people, even if they have the same symptoms you have. DOLOPHINE can harm other people and even cause death. Sharing DOLOPHINE is against the law.

This leaflet summarizes the most important information about DOLOPHINE. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about DOLOPHINE that is written for healthcare professionals, or you can visit www. Roxane.com or call 1-800-962-8364.

What are the Ingredients in DOLOPHINE?

Active Ingredient: methadone hydrochloride, USP

Inactive Ingredients: magnesium stearate, microcrystalline cellulose, and starch.

What should I discuss with my healthcare provider before taking Guaifenesin?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Guaifenesin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Guaifenesin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of Guaifenesin in children with use in other age groups, Guaifenesin is not expected to cause different side effects or problems in children than it does in adults. However, check with your doctor before using Guaifenesin in children who have a chronic cough, such as occurs with asthma, or who have an unusually large amount of mucus or phlegm with the cough. Children with these conditions may need a different kind of medicine. Also, Guaifenesin should not be given to children and infants younger than 2 years of age unless you are directed to do so by your doctor.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of Guaifenesin in the elderly with use in other age groups, Guaifenesin is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Guaifenesin precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.

Pregnancy:

Teratogenic Effects—Pregnancy Category C: Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, these products should not be used in pregnant patients unless, in the judgment of the physician, the potential benefits outweigh possible hazards.

Nursing Mothers: It is not known whether Guaifenesin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these products are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Laboratory Test Interactions: Guaifenesin or its metabolites may cause color interference with the VMA (vanillylmandelic acid) test for catechols. It may also falsely elevate the level of urinary 5-HIAA (5-hydroxyindoleacetic acid) in certain serotonin metabolite chemical tests because of color interference.

What happens if I miss a dose of Guaifenesin?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

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


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References

  1. DailyMed. "GUAIFENESIN; HYDROCODONE BITARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DrugBank. "Guaifenesin". http://www.drugbank.ca/drugs/DB00874 (accessed September 17, 2018).
  3. MeSH. "Expectorants". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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