DRUGS & SUPPLEMENTS

Acetylcystein

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Acetylcystein uses


1 INDICATIONS AND USAGE

Acetylcystein is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).

Acetylcystein is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion. (1)

2 DOSAGE AND ADMINISTRATION

Pre-Treatment Assessment Following Acute Ingestion :

Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion.

  • If the time of acetaminophen ingestion is unknown:
    • Administer a loading dose of Acetylcystein immediately.
    • Obtain an acetaminophen concentration to determine the need for continued treatment.
  • If the acetaminophen concentration cannot be obtained (or is unavailable or uninterpretable) within the 8-hour time interval after acetaminophen ingestion or there is clinical evidence of acetaminophen toxicity:
    • Administer a loading dose of Acetylcystein immediately and continue treatment for a total of 17 doses.
  • If the patient presents more than 8 hours after ingestion and the time of acute acetaminophen ingestion is known:
    • Administer a loading dose of Acetylcystein immediately.
    • Obtain acetaminophen concentration to determine need for continued treatment.
  • If the patient presents less than 8 hours after ingestion and the time of acute acetaminophen ingestion is known and the acetaminophen concentration is known:
    • Use the Rumack-Matthew nomogram (Figure 1) to determine whether or not to initiate treatment with Acetylcystein. (2.2)

Nomogram for Estimating Potential for Hepatotoxicity from Acute Acetaminophen Ingestion (2.2):

  • See the Full Prescribing Information for instructions on how to use the nomogram to determine the need for loading and maintenance dosing.

Recommended Adult and Pediatric Dosage (2.3):

  • Acetylcystein is for oral administration only; not for nebulization or intratracheal instillation.
  • Loading dose: 140 mg/kg.
  • Maintenance doses: 70 mg/kg repeated every 4 hours for a total of 17 doses.
  • See Full Prescribing Information for weight-based dosage and preparation and administration instructions.

Repeated Supratherapeutic Acetaminophen Ingestion (2.4):

  • Obtain acetaminophen concentration and other laboratory tests to guide treatment; Rumack-Matthew nomogram does not apply.

2.1 Pretreatment Assessment and Testing Following Acute Acetaminophen Ingestion

The following recommendations are related to acute acetaminophen ingestion. For recommendations related to repeated supratherapeutic exposure see Dosage and Administration (2.4) .

  • Assess the history and timing of acetaminophen ingestion as an overdose.
    • The reported history of the quantity of acetaminophen ingested as an overdose is often inaccurate and is not a reliable guide to therapy.
  • Obtain the following laboratory tests to monitor hepatic and renal function and electrolyte and fluid balance: aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, international normalized ratio (INR), creatinine, blood urea nitrogen (BUN), blood glucose, and electrolytes.
  • Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion. Acetaminophen concentrations obtained earlier than 4 hours post-ingestion may be misleading as they may not represent maximum acetaminophen concentrations.
  • If the time of acute acetaminophen ingestion is unknown:
    • Administer a loading dose of Acetylcystein immediately .
    • Obtain an acetaminophen concentration to determine need for continued treatment .
  • If the acetaminophen concentration cannot be obtained (or is unavailable or uninterpretable) within the 8-hour time interval after acetaminophen ingestion or there is clinical evidence of acetaminophen toxicity:
    • Administer a loading dose of Acetylcystein immediately and continue treatment for a total of 17 doses .
  • If the patient presents more than 8 hours after ingestion and the time of acute acetaminophen ingestion is known:
    • Administer a loading dose of Acetylcystein immediately .
    • Obtain acetaminophen concentration to determine need for continued treatment .
  • If the patient presents less than 8 hours after ingestion and the time of acute acetaminophen ingestion is known and the acetaminophen concentration is known:
    • Use the Rumack-Matthew nomogram (Figure 1) to determine whether or not to initiate treatment with Acetylcystein .

2.2 Nomogram for Estimating Potential for Hepatotoxicity from Acute Acetaminophen Ingestion and Need for Acetylcystein Treatment

If the timing of the acute acetaminophen ingestion is known and the results of the acetaminophen assay are available within 8 hours:

  • Refer to the Rumack-Matthew nomogram to determine whether or not to initiate treatment with Acetylcystein.
  • Initiation of Acetylcystein depends on the acetaminophen concentration and also the clinical presentation of the patient.

The nomogram may underestimate the hepatotoxicity risk in patients with chronic alcoholism, malnutrition, or CYP2E1 enzyme inducing drugs (e.g., isoniazid), and consideration should be given to treating these patients even if the acetaminophen concentrations are in the nontoxic range.

Loading Dose

For patients whose acetaminophen concentrations are at or above the "possible" toxicity line (dotted line in nomogram):

  • Administer a loading dose of Acetylcystein .

For patients with an acute overdose due to an extended-release acetaminophen, if the acetaminophen concentration at 4 hours post ingestion is below the possible toxicity line then obtain a second sample for acetaminophen concentration 8 to 10 hours after the acute ingestion. If the second value is at or above the "possible" toxicity line (dotted line in nomogram):

  • Administer a loading dose of Acetylcystein .

For patients whose values are below the "possible" toxicity line, but time of ingestion was unknown or sample was obtained less than 4 hours after ingestion:

  • Administer a loading dose of Acetylcystein .

For patients whose values are below the "possible" toxicity line and time of ingestion is known and the sample was obtained more than 4 hours after ingestion, do not administer Acetylcystein because there is minimal risk of hepatotoxicity.

Figure 1: Rumack-Matthew Nomogram for Estimating Potential for Hepatotoxicity from Acetaminophen Poisoning – Plasma or Serum Acetaminophen Concentration versus Time (hours) Post-acetaminophen Ingestion (Adapted from Rumack and Matthew, Pediatrics 1975; 55:871−876.)
Figure 1

Maintenance Dose

Determine need for continued treatment with Acetylcystein after the loading dose. Choose ONE of the following based on the acetaminophen concentration:

The acetaminophen concentration is above the possible toxicity line according to the nomogram :

  • Continue Acetylcystein treatment with the maintenance dose for 17 doses .
  • Monitor hepatic and renal function and electrolytes throughout treatment.

The acetaminophen concentration could not be obtained:

  • Continue Acetylcystein treatment with the maintenance dose for 17 doses .
  • Monitor hepatic and renal function and electrolytes throughout treatment.

For patients whose acetaminophen concentration is below the "possible" toxicity line and time of ingestion is known and the sample was obtained more than 4 hours after ingestion:

  • Discontinue Acetylcystein.

The acetaminophen concentration was in the non-toxic range, but time of ingestion was unknown or less than 4 hours:

  • Obtain a second sample for acetaminophen concentration and consider the patient's clinical status to decide whether or not to continue Acetylcystein treatment.
  • If there is any uncertainty as to patient's risk of developing hepatotoxicity, it is recommended to administer a complete treatment course under medical observation with appropriate monitoring.

Continued Therapy After Completion of Loading and Maintenance Doses

In cases of suspected massive overdose, or with concomitant ingestion of other substances, or in patients with preexisting liver disease; the absorption and/or the half-life of acetaminophen may be prolonged. In such cases, consideration should be given to the need for continued treatment with Acetylcystein beyond a total of 17 maintenance doses.

Acetaminophen levels and ALT/AST and INR should be checked after the last maintenance dose. If acetaminophen levels are still detectable, or if the ALT/AST are still increasing or the INR remains elevated; the maintenance doses should be continued and the treating physician should contact a US regional poison center at 1-800-222-1222, or alternatively, a "special health professional assistance line for acetaminophen overdose" at 1-800-525-6115 for assistance with dosing recommendations.

2.3 Recommended Dosage and Preparation and Administration Instructions in Adults and Pediatrics for Acute Acetaminophen Ingestion

  • Acetylcystein is for oral administration only; not for nebulization or intratracheal instillation.
  • After appropriate preparation and dilution, Acetylcystein is interchangeable with 20% Acetylcystein solution, when given at the same Acetylcystein dosage.
  • Adults and Pediatrics: The recommended loading dose of Acetylcystein is 140 mg/kg. Administer a first maintenance dose of 70 mg/kg 4 hours after the loading dose. Repeat 70 mg/kg maintenance dose every 4 hours for a total of 17 maintenance doses.

Preparation and Administration Instructions

  • Dissolve the appropriate number of 2.5 gram and/or 500 mg Acetylcystein effervescent tablets in the volume of water indicated in dosing tables and text below, based upon patient weight.
  • Once the tablets are dissolved, administer the oral solution immediately.
  • Solutions should be freshly prepared for each dose and utilized within 2 hours.
  • If the patient vomits an oral dose of Acetylcystein within 1 hour of administration, repeat that dose.
  • If the patient is persistently unable to retain the orally administered Acetylcystein, Acetylcystein may be administered by nasoduodenal tube. An intravenous formulation of Acetylcystein may also be considered.

Patients Weighing 20 kg and Greater

Tables 1 and 2 provide the weight-based loading and maintenance doses, respectively, of Acetylcystein for patients weighing 20 kg and greater. For patients weighing 20 to 59 kg dissolve Acetylcystein tablets in 150 mL of water. For patients weighing 60 kg and greater dissolve Acetylcystein tablets in 300 mL of water.

*No specific studies have been conducted to evaluate the necessity of dose adjustments in patients weighing over 100 kg. Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg.
Dissolve Acetylcystein Tablets in 300 mL of Water
Body weight

(Kg)

Actual Acetylcystein Dose to be Administered

(grams)

Number of Acetylcystein Tablets to Dissolve in Water
2.5 gram tablets 500 mg tablets
100 or greater 15 6 0
90 to 99 14 5 3
80 to 89 13 5 1
70 to 79 11 4 2
60 to 69 10 4 0
Dissolve Acetylcystein Tablets in 150 mL of Water
50 to 59 8 3 1
40 to 49 7 2 4
30 to 39 6 2 2
20 to 29 4 1 3
Dissolve Acetylcystein Tablets in 300 mL of Water
Body weight

(Kg)

Actual Acetylcystein Dose to be Administered

(grams)

Number of Acetylcystein Tablets to Dissolve in Water
2.5 gram tablets 500 mg tablets
100 or greaterNo specific studies have been conducted to evaluate the necessity of dose adjustments in patients weighing over 100 kg. Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg. 7.5 3 0
90 to 99 7 2 4
80 to 89 6.5 2 3
70 to 79 5.5 2 1
60 to 69 5 2 0
Dissolve Acetylcystein Tablets in 150 mL of Water
50 to 59 4 1 3
40 to 49 3.5 1 2
30 to 39 3 1 1
20 to 29 2 0 4

Patients Weighing 1 to 19 kg

Dissolve two 2.5 gram Acetylcystein effervescent tablets in 100 mL of water to create a 50 mg/mL solution. Calculate the loading and maintenance doses using the patient's kilogram weight:

Loading dose: Calculate the dose by multiplying the patient's kilogram weight by 140 mg/kg and dividing by the concentration of the solution (50 mg/mL). The result is the dose in mL for administration using an oral syringe.

Maintenance dose: Calculate the dose by multiplying the patient's kilogram weight by 70 mg/kg and dividing by the concentration of the solution (50 mg/mL). The result is the dose in mL for administration using an oral syringe.

2.4 Recommendations for Repeated Supratherapeutic Acetaminophen Ingestion

Repeated supratherapeutic acetaminophen ingestion (RSI) is an ingestion of acetaminophen at dosages higher than those recommended for extended periods of time. The risk of hepatotoxicity and the recommendations for treatment of acute acetaminophen ingestion (i.e., the Rumack-Matthew nomogram) do not apply to patients with RSI. Therefore, obtain the following information to guide Acetylcystein treatment for RSI.

  • Acetaminophen serum or plasma concentrations. A reported history of the quantity of acetaminophen ingested is often inaccurate and is not a reliable guide to therapy.
  • Laboratory tests to monitor hepatic and renal function and electrolyte and fluid balance: AST, ALT, bilirubin, INR, creatinine, BUN, blood glucose, and electrolytes.

For specific Acetylcystein dosage and administration information in patients with RSI, consider contacting your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

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3 DOSAGE FORMS AND STRENGTHS

Acetylcystein effervescent tablets are supplied as white, round, flat tablets with a lemon mint flavor in the following dosage strengths:

  • 500 mg tablets debossed with "I" on one side.
  • 2.5 gram tablets debossed with "O" on one side.

Acetylcystein tablets contain the inactive ingredient sodium bicarbonate which may be clinically relevant in some patients .

Effervescent tablets: 500 mg and 2.5 grams (3)

4 CONTRAINDICATIONS

None.

None (4)

5 WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions, Including Urticaria: Discontinue Acetylcystein unless deemed essential to patient management and the reactions can be otherwise controlled.
  • Risk of Upper Gastrointestinal Hemorrhage: Consider the risk/benefit for patients at risk of hemorrhage (e.g., those with esophageal varices, peptic ulcers, etc.) versus the risk of developing hepatic toxicity, and treat with Acetylcystein accordingly.(5.2)

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including generalized urticaria have been observed in patients receiving oral Acetylcystein for acetaminophen overdose. If hypersensitivity reactions occur, Acetylcystein should be discontinued unless it is deemed essential for patient management and the reactions can be otherwise controlled.

5.2 Risk of Upper Gastrointestinal Hemorrhage

Occasionally severe and persistent vomiting occurs as a symptom of acute acetaminophen overdose. Treatment with Acetylcystein may aggravate the vomiting and increase the risk of upper gastrointestinal hemorrhage in at risk patients (e.g., those with esophageal varices, peptic ulcers, etc.). Consider the risk/benefit for patients at risk of hemorrhage versus the risk of developing hepatic toxicity, and treat with Acetylcystein as needed.

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6 ADVERSE REACTIONS

The following adverse reactions are described, or described in greater detail, in other sections of the labeling:

  • Hypersensitivity Reactions
  • Risk for Upper Gastrointestinal Hemorrhage

The most common adverse reactions have been identified from clinical studies or postmarketing reports of Acetylcystein. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most common adverse reactions were nausea, vomiting, other gastrointestinal symptoms, and rash with or without fever.

Most common adverse reactions are nausea and vomiting, other gastrointestinal symptoms, and rash with or without fever. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Arbor Pharmaceuticals LLC at 1- 866-516-4950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Limited published case reports and case series on Acetylcystein use during pregnancy are insufficient to inform a drug-associated risk of birth defects and miscarriage. However, there are clinical considerations . In animal reproduction studies, no teratogenic effects were observed with oral administration of Acetylcystein to pregnant rats and rabbits during organogenesis at doses up to 0.6 times the maximum recommended human dose of about 560 mg/kg (total dose on first day of treatment) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Acetaminophen and Acetylcystein cross the placenta. Delaying treatment in pregnant women with acetaminophen overdose and potentially toxic acetaminophen plasma levels may increase the risk of maternal and fetal morbidity and mortality.

Data

Animal Data

No teratogenic effects were observed in embryo-fetal development studies in rats at oral doses up to 2000 mg/kg/day (0.6 times the maximum recommended human dose based on body surface area) or in rabbits at oral doses up to 1000 mg/kg/day (0.6 times the maximum recommended human dose based on body surface area) administered during organogenesis.

8.2 Lactation

Risk Summary

There is no information regarding the presence of Acetylcystein in human milk, or the effects of Acetylcystein on the breastfed infant or on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Acetylcystein and any potential adverse effects on the breastfed infant from Acetylcystein or from the underlying maternal condition.

8.4 Pediatric Use

Pediatric approval, including dosing, is not based on adequate and well-controlled clinical studies. Pediatric dosing recommendations are based on clinical experience .

8.5 Geriatric Use

Clinical studies of Acetylcystein did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with Acetylcystein has not identified differences in the responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

8.6 Patients Sensitive to High Sodium Intake

Acetylcystein tablets contain sodium. Consider the total sodium content from dietary and non-dietary sources in patients who may be sensitive to excess sodium intake, such as those with congestive heart failure, hypertension, or renal impairment.

At the recommended dosage an average sized adult (60 kg) may receive a total of 7 grams of sodium (304.3 mEq) on the first day of treatment, 5.3 grams of sodium (230.4 mEq) on the second day of treatment, and 4.4 grams of sodium (191.3 mEq) on the third day of treatment.

If sodium intake is a concern, please refer to Table 3 for the amount of sodium in each tablet and to Tables 1 and 2 for the recommended dosage in adults and pediatrics based on body weight in order to calculate the amount of sodium administered to an individual patient .

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11 DESCRIPTION

Acetylcystein is an antidote for the treatment of acetaminophen overdose. It is the N-acetyl derivative of the naturally-occurring amino acid, cysteine. Acetylcystein is a white crystalline powder that is freely soluble in water, alcohol, practically insoluble in chloroform and in ether with the molecular formula C5H9NO3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcystein has the following structural formula:

Acetylcystein (acetylcysteine) effervescent tablets for oral solution contain 500 mg or 2.5 grams of Acetylcystein. The following are inactive ingredients: sodium bicarbonate, maltodextrin, lemon flavor, sucralose, peppermint flavor, and edetate disodium.

The amount of sodium in each tablet of Acetylcystein is shown in Table 3.

Tablet Strength Sodium Bicarbonate (mg)inactive ingredient Sodium (mg) Sodium (mEq)
500 mg 320 mg 88 mg 3.8 mEq
2.5 grams 1600 mg 438 mg 19 mEq
Chemical Structure
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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Acetylcystein has been shown to reduce the extent of liver injury following acetaminophen overdose. Acetaminophen doses of 150 mg/kg or greater have been associated with hepatotoxicity. Acetylcystein probably protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite of acetaminophen.

12.3 Pharmacokinetics

Absorption

After administration of a single oral dose of 11 grams of Acetylcystein (dissolved in 300 mL of water) to 29 healthy adult subjects, the mean Cmax (CV%) was 26.5 (29) mcg/mL and mean (CV) AUCinf was 186 (29) hr∙mcg/mL. The median (range) time to reach Cmax (Tmax) was 2 (1 to 3.5) hours.

Distribution

The steady-state volume of distribution (Vd) following administration of an intravenous dose of Acetylcystein was 0.47 liter/kg. The protein binding for Acetylcystein ranges from 66% to 87 %.

Elimination

Metabolism

Acetylcystein (i.e., N-acetylcysteine) undergoes extensive first pass metabolism and is postulated to form cysteine and disulfides (N,N-diacetylcysteine and N-acetylcysteine). Cysteine is further metabolized to form glutathione and other metabolites.

Excretion

After a single oral dose of [35S]-acetylcysteine 100 mg, between 13 to 38% of the total radioactivity administered was recovered in urine within 24 hours. In a separate study, renal clearance was estimated to be approximately 30% of total body clearance.

In healthy subjects given a single oral dose of 11 grams of Acetylcystein, the mean (CV%) terminal plasma half-life (T1/2) was 18.1 (22%) hours.

Specific Populations

Hepatic Impairment

Following a 600 mg intravenous dose of Acetylcystein to subjects with mild (Child Pugh Class A, n=1), moderate (Child-Pugh Class B, n=4) or severe (Child-Pugh Class C; n=4) hepatic impairment and 6 healthy matched controls, mean T1/2 increased by 80%. Also, the mean CL decreased by 30% and the systemic Acetylcystein exposure (mean AUC) increased 1.6-fold in subjects with hepatic impairment compared to subjects with normal hepatic function. These changes are not considered to be clinically meaningful.

Renal Impairment

Hemodialysis may remove some of total Acetylcystein.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Carcinogenicity studies in laboratory animals have not been performed with Acetylcystein.

Mutagenesis

Acetylcystein was negative in the Ames test.

Impairment of Fertility

In a fertility study of Acetylcystein in rats, intravenous administration of 1000 mg/kg/day (0.3 times the recommended human oral dose based on body surface area) caused a profound reduction of fertility in females, which was correlated with morphological changes in oocytes and severe impairment of implantation (18 of 20 mated females had no implantations). The reversibility of this effect was not evaluated. No effects on fertility were observed in female rats at intravenous doses up to 300 mg/kg/day (0.1 times the recommended human oral dose based on body surface area), or in male rats at intravenous doses up to 1000 mg/kg/day. Mating was unaffected in this study.

In a reproduction study of Acetylcystein, male rats were treated orally for 15 weeks prior to mating and during the mating period. A slight non-dose related reduction in fertility was observed at oral doses of 500 and 1000 mg/kg/day (0.1 and 0.3 times the recommended human dose, respectively, based on body surface area).

16 HOW SUPPLIED/STORAGE AND HANDLING

Acetylcystein effervescent tablets are supplied as white, round, flat tablets with a lemon mint smell packaged in 2-count peelable foil blister packs in the following dosage strengths:

  • 500 mg tablets debossed with "I" on one side; Each carton containing 2-count blister packs (24338-700-02)
    • NDC 24338-700-10: 10 pack carton containing 20 tablets
  • 2.5 gram tablets debossed with "O" on one side; Each carton containing 2-count blister packs (24338-725-02)
    • NDC 24338-725-10: 10 pack carton containing 20 tablets

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) Protect from moisture. Store tablets in original blister package until use.

Dilutions of Acetylcystein should be used freshly prepared and utilized within two hours.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions, including generalized urticaria may occur and to report any signs or symptoms to their healthcare provider immediately .

Manufactured for:

arbor

PHARMACEUTICALS, LLC

Atlanta, GA 30328

Made in Switzerland by Alpex Pharma SA.

CET-PI-02

Rev. 04/2017

Patient Information

Acetylcystein® (SEE-tuh-lev)

(acetylcysteine) effervescent tablets for oral solution

What is Acetylcystein?

Acetylcystein is a prescription medicine used to prevent or lessen liver damage in people who have taken too much acetaminophen (overdose).

Before taking Acetylcystein, tell your healthcare provider about all of your medical conditions, including if you:
  • have or have had bleeding in your esophagus (esophageal varices).
  • have or have had stomach ulcers.
  • have high blood pressure, kidney or heart problems, or have been told to lower the amount of salt (sodium) in your diet.
  • are pregnant or plan to become pregnant. It is not known if Acetylcystein will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Acetylcystein passes into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take Acetylcystein or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements.
How should I take Acetylcystein?
  • Take Acetylcystein exactly as your healthcare provider tells you to.
  • Your healthcare provider will tell you how much Acetylcystein to take and when to take it. Do not stop taking Acetylcystein unless your healthcare provider tells you to.
  • Your healthcare provider may change your dose if needed.
  • Acetylcystein tablets should be dissolved in water before taking. Do not take Acetylcystein tablets until they are dissolved in water.
  • Acetylcystein should only be taken by mouth and after being dissolved in water.
What are the possible side effects of Acetylcystein?

Acetylcystein may cause serious side effects, including:

  • allergic reactions. Stop taking Acetylcystein and tell your healthcare provider right away if you have any signs and symptoms of an allergic reaction including: rash, hives, swelling of your face, eyes, lips, tongue or throat, trouble swallowing or breathing
  • risk of bleeding in your esophagus and stomach
The most common side effects of Acetylcystein include: nausea, vomiting, stomach problems, rash (with or without a fever)

These are not all of the possible side effects of Acetylcystein.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Acetylcystein?
  • Store Acetylcystein at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Acetylcystein and all medicines out of reach of children.
General information about the safe and effective use of Acetylcystein.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Acetylcystein for a condition for which it was not prescribed. Do not give Acetylcystein to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about Acetylcystein that is written for health professionals.

What are the ingredients in Acetylcystein?

Active ingredient: Acetylcystein

Inactive ingredients: sodium bicarbonate, maltodextrin, lemon flavor, sucralose, peppermint flavor, and edetate disodium

Manufactured for:

arbor

PHARMACEUTICALS, LLC

Atlanta, GA 30328

Made in Switzerland

For more information, call 1-866-516-4950

This Patient Information has been approved by the U.S. Food and Drug Administration Issued: January 2016

Acetylcystein pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Acetylcystein available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Acetylcystein destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Acetylcystein Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Acetylcystein pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CETYLEV (ACETYLCYSTEINE) TABLET, EFFERVESCENT [ARBOR PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Acetylcystein?

Depending on the reaction of the Acetylcystein after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Acetylcystein not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Acetylcystein addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Acetylcystein, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Acetylcystein consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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