Acetylcysteine 200mg Powder for Oral Solution

1. Name of the medicinal product
Acetylcysteine two hundred mg Powder for Oral Solution

2. Qualitative and quantitative composition
Each sachet consists of Acetylcysteine 2 hundred mg.

Excipient(s) with known impact:

Aspartame (E95l): 26 mg consistent with sachet

Sorbitol (E420): 723.34 mg in step with sachet

Sunset yellow (El 10): 0.66 mg in keeping with sachet

For the entire listing of excipients, see phase 6.1.

Three. Pharmaceutical shape
Powder for oral answer.

White to barely purple powder.

Four. Clinical particulars
Four.1 Therapeutic warning signs
Mucolytic adjuvant in the therapy of respiration problems related to thick, viscous, mucus hypersecretion.

4.2 Posology and approach of management
Posology

Adults and teenagers over the age of 12 years

Two hundred mg (1 sachet) three times an afternoon. Maximum recommended each day dose 600 mg/day.

The period of remedy is depending on the nature and severity of the contamination, and ought to be determined via the doctor treating the patient for adults and teenagers.

Abundant fluid intake helps the mucolytic effect of acetylcysteine.

Method of management

Dissolve the contents of 1 sachet completely in a tumbler containing a bit water just earlier than use, stirring as wanted with a teaspoon.

4.3 Contraindications
Acetylcysteine two hundred mg Powder for Oral Solution ought to now not be used when:

• Hypersensitivity to the active substance, other chemically comparable substance (as an example carbocisteine, erdosteine or mecysteine) or to any of the excipients indexed in section 6.1, is present

• Phenylketonuria is gift, as the product carries aspartame.

Four.4 Special warnings and precautions for use
Patients with bronchial asthma must be intently monitored at some stage in remedy; if bronchospasm takes place, remedy with Acetylcysteine 2 hundred mg Powder for Oral Solution need to be discontinued right now.

Administration of acetylcysteine, in particular at the beginning of treatment, can also liquefy bronchial secretions and, at the identical time, increase their volume. If the affected person is unable to expectorate efficiently, to keep away from retention of secretions postural drainage and tracheal suction should be used.

There are not any studies at the efficacy and safety of acetylcysteine 200 mg 3 times daily in adolescent populace. However, mild to intense unfavourable reactions were mentioned with the usage of IV acetylcysteine in adults and adolescents.

This remedy consists of sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicinal drug.

This medicine carries aspartame, that is a supply phenylalanine. This may be dangerous to human beings with phenylketonuria.

This remedy incorporates a colouring agent known as sundown yellow (E110), which can also motive allergies.

Acetylcysteine can purpose interference with the colorimetric assay approach for the dedication of salicylates.

Acetylcysteine can interfere with tests for ketones in urine.

Upon starting the sachet the powder may also odor of sulphur (rotten egg scent). This is a everyday feature of the energetic substance. Upon addition of water the solution could have a citrus odour.

Four.Five Interaction with different medicinal merchandise and other kinds of interplay
Drug Interactions

Antitussive capsules and acetylcysteine should not be administered concomitantly because decreasing the cough reflex can also cause a construct-up of bronchial secretions.

Activated charcoal may additionally lessen the effect of acetylcysteine.

It is advisable not to combine Acetylcysteine 200 mg Powder for Oral Solution with other medicinal products.

In vitro exams have proven that when cephalosporin antibiotics and acetylcysteine are combined, there's a degree of antibiotic inactivation. It is precautionary to advise the administration of oral antibiotics at the least  hours before or after acetylcysteine.

Concurrent management of nitroglycerin and acetylcysteine reasons significant hypotension and leads to temporal artery dilation with feasible onset of headache.

If concurrent management of nitroglycerin and acetylcysteine is needed, patients have to be monitored and warned for hypotension that may be severe and accompanied by a headache.

Four.6 Fertility, pregnancy and lactation
Pregnancy

Animal studies do no longer suggest direct or indirect harmful consequences with appreciate to reproductive toxicity (see segment 5.Three). As a precautionary measure, it's miles optimum to avoid using Acetylcysteine 2 hundred mg Powder for Oral Solution at some stage in being pregnant.

Breastfeeding

There is insufficient statistics at the excretion of acetylcysteine in human milk. A danger to the newborns/infants cannot be excluded.

Four.7 Effects on potential to force and use machines
No studies at the outcomes at the ability to power or use machines were executed. Acetylcysteine two hundred mg Powder for Oral Solution has no recognised impact on the ability to drive and use machines.

4.8 Undesirable consequences
Adverse reactions are indexed underneath, by means of device organ elegance and frequency.

System Organ Class

Frequency / Adverse Reactions

Uncommon

(≥1/1,000, < 1/one hundred)

Rare

(≥1/10,000, < 1/1,000)

Very uncommon

(< 1/10,000)

Not Known

Immune system problems

Hypersensitivity

Anaphylactic shock, anaphylactic/ anaphylactoid response

Nervous gadget disorders

Headache

Ear and labyrinth issues

Tinnitus

Cardiac issues

Tachycardia

Vascular disorders

Hypotension

Haemorrhage

Respiratory, thoracic and mediastinal disorders

Bronchospasm, dyspnoea

Gastrointestinal problems

Vomiting, diarrhoea, stomatitis, abdominal pain, nausea

Dyspepsia

Skin and subcutaneous tissue problems

Urticaria, rash, angioedema, pruritus

General disorders and management web page situations

Fever

Oedema of the face

The occurrence of great skin reactions consisting of Stevens-Johnson syndrome and poisonous epidermal necrolysis had been suggested in temporal affiliation with using acetylcysteine. In most of those instances suggested as a minimum one more drug become administered at the equal time, which may additionally have probably enhanced the described mucocutaneous results.

In case of recurrence pores and skin and mucosal lesions, medical advice should be sought without delay and using acetylcysteine terminated immediately.

A decreased blood platelet aggregation in the presence of acetylcysteine has been showed through diverse studies. The clinical relevance has no longer yet been clarified so far.

Reporting of suspected destructive reactions

Reporting suspected destructive reactions after authorisation of the medicinal product is important. It permits persevered tracking of the benefit/danger balance of the medicinal product. Healthcare professionals are asked to record any suspected destructive reactions via the Yellow Card Scheme at: www.Mhra.Gov.United kingdom/yellowcard.

Four.Nine Overdose
An acute overdose of acetylcysteine can purpose gastrointestinal signs consisting of nausea, vomiting and diarrhoea.

Treatment of Overdose

Treatment of overdose is to be symptomatic and supportive treatment as indicated with the aid of the patient's scientific condition.

5. Pharmacological houses
Five.1 Pharmacodynamic residences
Pharmacotherapeutic organization: Mycolytics, ATC code: R05CB01

N-acetyl-L-cysteine (NAC), the energetic factor in Acetylcysteine 200 mg Powder for Oral Solution exerts an extreme mucolytic-fluidizing motion on mucous and mucopurulent secretions by way of depolymerizing the mucoproteic complexes and the nucleic acids which confer viscosity to the vitreous and purulent factor of the sputum and different secretions.

Furthermore, acetylcysteine exerts a right away antioxidant action, having a free thiol (- SH) nucleophilic institution this is capable of engage directly with electrophilic companies of oxidant radicals. Of particular interest is the latest finding that acetylcysteine protects α1-antitrypsin enzyme inhibiting elastase from inactivation by way of hypochlorous acid (HOCl), a powerful oxidant agent produced by way of the myeloperoxidase enzyme of activated phagocytes. Due to its molecular structure, acetylcysteine can without problems pass cellular membranes. Inside the mobile, NAC is deacetylated to L-cysteine, an amino acid critical for glutathione synthesis (GSH).

GSH is a notably reactive tripeptide found ubiquitously within the diverse tissues of animals and is essential for the renovation of functional capacity as well as mobile morphological integrity. It is the most important protecting intracellular mechanism towards oxidant radicals, both exogenous and endogenous, in addition to closer to numerous cytotoxic materials.

These features make Acetylcysteine two hundred mg Powder for Oral Solution especially appropriate for the treatment of acute and continual affections of the respiration gadget, characterized through thick, viscous mucous and mucopurulent secretions.

There is no proof at the efficacy and safety of mucolytics including acetylcysteine in acute bronchitis.

Five.2 Pharmacokinetic properties
Absorption

Following oral management, acetylcysteine is swiftly and almost absolutely absorbed and metabolised within the liver to cysteine (the pharmacologically lively metabolite), diacetylcysteine, cysteine and similarly blended disulphides.

Distribution

Due to the excessive first-pass effect, the bioavailability of orally administered acetylcysteine may be very low (about 10%). In people, most plasma concentrations are executed after 1-three hours with the maximum plasma concentration of the metabolite cysteine inside the variety of approximately 2µmol/l. The protein binding of Acetylcysteine became decided to be about 50%.

Biotransformation

Acetylcysteine and its metabolites arise in 3 one of a kind bureaucracy in the organism: partly in loose shape, in part sure to proteins through labile disulphide bonds and partly as included amino acid. Acetylcysteine is excreted almost exclusively inside the shape of inactive metabolites (inorganic sulphates, diacetylcysteine) via the kidneys. The plasma half of-existence of Acetylcysteine is approximately 1 hour and is specially determined with the aid of the fast hepatic biotransformation. Impaired hepatic function consequently leads to prolonged plasma 1/2-lives of up to 8 hours.

Elimination

Pharmacokinetic studies with intravenous administration of acetylcysteine revealed a distribution quantity of zero.47 l/kg (in general) or zero.59 l/kg (decreased acetylcysteine); the plasma clearance was decided to be zero.11 l/h/kg (in general) and zero.84 l/h/kg (decreased acetylcysteine), respectively. The removal 1/2-life after intravenous management is 30-40 mins at the same time as excretion follows 3-segment kinetics (alpha, beta and terminal gamma segment).

Acetylcysteine crosses the placenta and is detected in cord blood. No facts is to be had concerning excretion in breast milk.

No knowledge is to be had regarding the behaviour of acetylcysteine at the blood-brain barrier in human beings.

5.Three Preclinical protection facts
Acute toxicity research in rats and mice, by means of oral, intraperitoneal and intravenous administration showed acetylcysteine to be of low toxicity. LD50 values greater than 7 g / kg in mice and six g / kg in rats had been mentioned. Chronic toxicity studies with acetylcysteine in rats at doses up to 2000 mg/ kg/ day and dogs at doses as much as 300 mg/ kg / day for durations up to 52 weeks demonstrate that acetylcysteine is nicely tolerated, even at higher doses. In reproductive toxicity studies in rats and rabbits, the oral management of doses as much as 2000 mg / kg / day did no longer show adjustments in reproductive potential, teratogenic consequences or peri/postnatal toxicity.

6. Pharmaceutical details
6.1 List of excipients
Aspartame (E951)

Sorbitol (E420)

Lemon flavour (includes maltodextrin, a shape of glucose)

Sunset yellow (E110)

6.2 Incompatibilities
In the absence of compatibility research, this medicinal product ought to not be mixed with different medicinal merchandise.

6.3 Shelf life
Three years

After reconstitution, the product ought to be administered right now.

6.Four Special precautions for storage
Store inside the unique package to defend from moisture.

6.5 Nature and contents of box
Paper/aluminium/polyethylene sachet containing l g powder for oral answer, packaged in a cardboard box, inside the following p.C. Sizes:

10, 18, 20, 30 sachets.

Not all percent sizes may be marketed.

6.6 Special precautions for disposal and other handling
No special requirements for disposal. Any unused product ought to be disposed of in accordance with nearby requirements.



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