ACC-200

Uses

What is ACC-200® (acetylcysteine) used for?

ACC-200® is a medicinal product containing N-acetylcysteine under the powder form. It is commonly used for:

• Reducing lipoprotein and homocysteine level.
• Preventing alcoholic liver damage.
• Protecting from pollution caused by carbon monoxide, chloroform, urethanes and certain herbicides.
• Reducing toxicity of taking ifosfamide and doxorubicin.

How should I take ACC-200® (acetylcysteine)?

Depending on the dosage form, ACC-200® can be taken by different ways.  Therefore, you should follow directions of your health care provider and make sure that you have already understood them when taking it at home.

For orally taken form, you should:

• Take ACC-200® by mouth as directed by your doctor concerning: dose, schedule.
• Read the label carefully before using ACC-200®.
• Consult your doctor for any information on the label that you do not clearly understand.

How do I store ACC-200® (acetylcysteine)?

ACC-200® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store ACC-200® in the bathroom or the freezer. There may be different brands of ACC-200® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush ACC-200® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using ACC-200® (acetylcysteine)?

Before using ACC-200®, tell your doctor if you have:

• Allergic reaction to excipients using for dosage form containing ACC-200®.
• Allergic reaction to any other medicines, foods, dyes, preservatives, or animals.
• Used any other health conditions, drugs that have a risk of interaction with ACC-200®.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using ACC-200® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking ACC-200®. ACC-200® is pregnancy risk category B, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from ACC-200® (acetylcysteine)?

As taking others medicines, taking ACC-200® can cause some side effects. Most of them are rarely occurring and do not need any supplementary treatment. However, it is always important for you to consult your doctor if you have any problem after taking this medicine.

Some of side effects are listed below:

• Nausea
• Vomiting
• Flushing and skin rash
• Angioedema
• Bronchospasm/respiratory distress
• Hypotension
• Tachycardia or hypertension
• Injection site reactions
• Pruritus
• Cough
• Chest tightness or pain
• Puffy eyes
• Sweating
• Malaise
• Raised temperature
• Vasodilation
• Blurred vision
• Bradycardia
• Facial or eye pain
• Syncope
• Acidosis
• Thrombocytopenia
• Respiratory or cardiac arrest
• Stridor
• Anxiety
• Extravasation
• Arthropathy
• Arthralgia
• Deterioration of liver function
• Generalized seizure
• Cyanosis
• Lowered blood urea

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with ACC-200® (acetylcysteine)?

ACC-200® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products may interact with this drug including:

• Nitroglycerin
• Activated charcoal

Does food or alcohol interact with ACC-200® (acetylcysteine)?

ACC-200® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with ACC-200® (acetylcysteine)?

ACC-200® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Health condition may interact with this drug including:

• Asthma
• Decreased ability to cough

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using ACC-200® (acetylcysteine).

What is the dose of ACC-200® (acetylcysteine) for an adult?

Consult your doctor for information about the dose of ACC-200®.

Recommended doses in some cases are listed below:

• For acetaminophen (Tylenol) overdose, starting at a first high dose of 140 mg/kg of a 5% solution of ACC-200® and can continuing by a seventeen additional doses of 70 mg/kg as a 5% solution given every 4 hours, for a total dose of 1330 mg/kg over 72 hours.
• For unstable angina chest pain, 600 mg of ACC-200® can be prescribed three times daily combining with a nitroglycerin patch.
• For preventing sudden worsening of chronic bronchitis, depending on the dosage form, dose can be varied.
  • 200 mg twice to three times daily
  • 300 mg slow-release twice daily
  • 600 mg controlled-release twice daily

• For treating chronic obstructive pulmonary disease (COPD), 600 mg of ACC-200® can be prescribed once daily added to a standard care for up to 6 months.
• For treating fibrosing alveolitis, 600 mg of ACC-200® can be prescribed three times daily.
• For preventing damage due to taking ifosfamide, 1 to 2 grams of ACC-200® can be prescribed every 6 hours.
• For reducing levels of homocysteine in the blood, 1.2 grams of ACC-200® can be prescribed daily.
• For myoclonus epilepsy, 4-6 grams can be prescribed daily.
• For reducing flu symptoms, 600 mg can be prescribed twice daily.
• For reducing the risk of heart attacks and strokes in patients with end-stage kidney disease, 600 mg can be prescribed twice daily.
• For skin wounds due to hemodialysis treatment, 200 mg four times daily or 600 mg twice daily can be prescribed.
• For trichotillomania (hair-pulling), 1200 mg to 2400 mg daily can be prescribed.

What is the dose of ACC-200® (acetylcysteine) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is ACC-200® (acetylcysteine) available?

N-acetylcysteine is available in in the following dosage forms and strengths:

• Tablet 200 mg
• Sachet 200 mg
• Inhaled solution 10 %, 20 %
• Injection solution: 20%

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of ACC-200®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.