Mucomelt Forte
Mucomelt Forte Uses, Dosage, Side Effects, Food Interaction and all others data.
Acetylcysteine has a mucolytic activity through its free sulfhydryl group. It acts directly on the mucoproteins to open the disulfide bonds and thus lowers the viscosity of the mucous and facilitates its removal by the muco-cillary action and expectoration. Acetylcysteine improves the phagocytic capacity of the alveolar macrophages, thus protecting lungs from a variety of insults. Acetylcysteine is a precursor to glutathione, the most important intra & extra-cellular antioxidant (the safest & most convenient)
Acetylcysteine is indicated for mucolytic therapy and in the management of acetaminophen overdose. It has a short duration of action as it is given every 1-8 hours depending on route of administration, and has a wide therapeutic window. Patients should be counselled regarding diluting oral solutions in cola for taste masking, the risk of hypersensitivity, and the risk of upper gastrointestinal hemorrhage.
Cefixime is a semi-synthetic, broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic, kills bacteria by interfering in the synthesis of the bacterial cell wall. Cefixime is highly stable in the presence of beta-lactamase enzymes. Cefixime has marked in -vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms including beta lactamase producers.
Clinical efficacy of Cefixime has been demonstrated in infections caused by commonly occurring pathogens including Gram-positive organism Streptococcus pneumoniae, Streptococcus pyogenes, Gram-negative organism Escherichia coli, Proteus mirabilis, Klebsiella spp., Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative), Salmonella typhi and Enterobacter species.
Cefixime, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.
Trade Name | Mucomelt Forte |
Generic | Cefixime + Acetylcysteine |
Weight | 200mg |
Type | Tablet |
Therapeutic Class | |
Manufacturer | Venus Remedies Ltd |
Available Country | India |
Last Updated: | September 19, 2023 at 7:00 am |
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Uses
Acetylcysteine is used for an adjunctive treatment for patients with abnormal, viscid or inspissated mucus secretions associated with conditions such as-
Acute and chronic bronchopulmonary disorders (e.g. pneumonia, bronchitis, emphysema, tracheobronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis, primary amyloidosis of the lung) Atelectasis caused by mucus obstruction Pulmonary complications of cystic fibrosis Pulmonary complications of thoracic and cardiovascular surgery Post-traumatic chest conditions.
It is effective in all respiratory airways disease causing formation of a dense secretion that cannot be or can only partially be expectorated such as acute and chronic bronchitis, laryngitis, sinusitis, tracheitis, infuenza & bronchial asthma. Acetylcysteine is also used for the treatment of Paracetamol overdose. Treatment option is optimal if given within 8 hours of Paracetamol ingestion.
Cefixime is used for the following infectious diseases -
Respiratory Tract Infections:
Pneumonia
Sinusitis
Pharyngitis and Tonsillitis
Acute Bronchitis and Acute Exacerbations of Chronic
Bronchitis (AECB)
Otitis Media
Typhoid Fever
Urinary Tract Infections
Uncomplicated gonorrhea (cervical/urethral)
Mucomelt Forte is also used to associated treatment for these conditions: Acetaminophen Overdose, Chronic Rhinitis, Corneal Diseases, Corneal ulceration, Crusting Rhinitis, Keratopathy, Rhinitis, Sinusitis, Vasomotor Rhinitis, Acute Rhinitis, Subacute Rhinitis, Airway secretion clearance therapyAcute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae, Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenzae, Bacterial Sinusitis, Community Acquired Pneumonia (CAP), Gonorrhea of anus, Lyme Disease, Salmonella Infections, Salmonella Typhi Infection, Shigella Infection, Streptococcal Pharyngitis, Streptococcal tonsillitis, Uncomplicated Urinary Tract Infections, Bacterial otitis media, Bacterial rhinosinusitis, Uncomplicated Gonorrhea
How Mucomelt Forte works
A number of possible mechanisms for the mucolytic activity of acetylcysteine have been proposed. Acetylcysteine's sulfhydryl groups may hydrolize disulfide bonds within mucin, breaking down the oligomers, and making the mucin less viscous. Acetylcysteine has also been shown to reduce mucin secretion in rat models. It is an antioxidant in its own right but is also deacetylated to cysteine, which participates in the synthesis of the antioxidant glutathione. The antioxidant activity may also alter intracellular redox reactions, decreasing phosphorylation of EGFR and MAPK, which decrease transcription of the gene MUC5AC which produces mucin.
In the case of acetaminophen overdoses, a portion of the drug is metabolized by CYP2E1 to form the potentially toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI). The amount of NAPQI produced in an overdose saturates and depletes glutathione stores. The free NAPQI promiscuously binds to proteins in hepatocytes, leading to cellular necrosis. Acetylcysteine can directly conjugate NAPQI or provide cysteine for glutathione production and NAPQI conjugation.
Like all beta-lactam antibiotics, cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefixime interferes with an autolysin inhibitor.
Dosage
Mucomelt Forte dosage
Acetylcysteine Tablet:
The dispersible tablet should be dissolved in 1/2 glass of water before use (preferably in the evening). The duration of treatment should be 5 to 10 days in the acute phase. It may be continued in the chronic state for up to 6 months or according to the advice of the physician.
As a mucolytic:
- Adults: 600 mg daily as a single dose.
- In Paracetamol overdose: Initially 140 mg/kg, followed by 70 mg/kg every 4 hours for an additional 17 doses. As an antidote, Acetylcysteine is reported to be very effective when administered within 8 hours of Paracetamol overdose, with the protective effect diminishing after this time. Initiation of treatment after a lapse of 15 hours has previously been thought to be ineffective, but recent studies suggest that beneficial results may still be obtained.
Acetylcysteine Respirator Solution:
The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for injection, Sodium Chloride for inhalation, sterile water for injection, or sterile water for inhalation.
As a mucolytic:
Adult:
- 5-10 ml of 10% or 20% solution by nebulizer every 6-8 hr PRN.
Children:
- 1-11 months: 1-2 ml of 20% or 2-4 ml of 10% solution by nebulizer every 6-8 hr PRN.
- 12 months-11 years: 3-5 ml of 20% or 6-10 ml of 10% solution by nebulizer every 6-8 hr PRN.
- Below 12 years: 5-10 ml of 10/20% solution by nebulizer every 6-8 hr PRN.
Diagnostic Bronchograms: 1-2 ml of 20% or 2-4 ml of 10% solution 2-3 times by nebulization or by instillation intratracheally prior to procedure.
Nebulization tent or croupette: This form of administration requires very large volumes of the solution, occasionally as much as 300 ml during a single treatment period. If a tent or croupette must be used, the recommended dose is the volume of acetylcysteine (using 20%) that will maintain a very heavy mist in the tent or croupette for the desired period. Administration for intermittent or continuous prolonged periods, including overnight, may be desirable.
Direct Instillation: When used by direct instillation, 1-2 ml of a 20% solution may be given as often as every hour. When used for the routine nursing care of patients with tracheostomy, 1-2 ml of a 20% solution may be given every 1-4 hours by instillation into the tracheostomy.
The usual treatment of Cefixime is 7 days. This may be continued for up to 14 days according to the severity of infection.
Cefixime Capsule
Adult and child over 12 years: 200 or 400 mg daily as a single dose or in two divided doses.
Cefixime Suspension
Child over 6 months: 8 mg/kg daily as a single dose or in 2 divided doses
Direction for Reconstitution of Suspension
• To prepare 50 ml suspension, 25 ml boiled and cooled water is required.
• To prepare 40 ml suspension, 20 ml boiled and cooled water is required.
• To prepare 30 ml suspension, 15 ml boiled and cooled water is required.
• To prepare 50 ml DS suspension, 25 ml boiled and cooled water is required.
Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half of the total amount of water and shake well. Add remainder of water, and then shake again.
Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 14 days.
Side Effects
Generally, Acetylcysteine is well tolerated. However, mild effects such as nausea, headache, tinnitus, urticaria, stomatitis, rhinorrhoea, chills, fever, bronchospasm may be observed. Occasional cases of nausea and dyspepsia, rare cases of urticaria may be observed.
Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials are mild and self limiting in nature.
Gastro-intestinal disturbance: Diarrhea (if severe diarrhea occurs, Cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported. CNS disturbances: Headache, dizziness.
Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase.
Toxicity
Patients experiencing an overdose may present with vomiting, nausea, bronchospasm, periorbital angioedema, and hypotension. Treat patients with symptomatic and supportive measures. Hemodialysis may remove some acetylcysteine from circulation as it is somewhat protein bound.
Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and vomiting.
Precaution
Acetylcysteine should be given in caution in asthma patients.
Cefixime should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min)
Interaction
After taking Acetylcysteine orally it increases the bioavailability of Amoxicillin, but shows no effect on Doxycycline and reduces the absorption of Cefalexin. Acetylcysteine seems to increase the effects of Nitroglycerin.
Increased prothrombin time (with or withot bleeding) with anticoagulants (e.g. warfarin). Increased plasma carbamazepine concentrations with concomitant use. Increased bioavailability with nifedipine. Increased serum concentration with probenecid.
Volume of Distribution
The volume of distribution of acetylcysteine is 0.47 L/kg.
Elimination Route
An 11 g dose in the form of an effervescent tablet for solution reaches a mean Cmax of 26.5 µg/mL, with a Tmax of 2 hours, and an AUC of 186 µg*h/mL.
About 40%-50% absorbed orally whether administered with or without food, however, time to maximal absorption is increased approximately 0.8 hours when administered with food.
Half Life
The mean terminal half life of acetylcysteine in adults is 5.6 hours and in pre-term neonates is 11 hours.
3-4 hours (may range up to 9 hours). In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours.
Clearance
Acetylcysteine has a mean clearance of 0.11 L/hr/kg.
Elimination Route
An oral dose of radiolabelled acetylcysteine is 13-38% recovered in the urine in the first 24 hours, while 3% is recovered in the feces.
Pregnancy & Breastfeeding use
Pregnancy Category B. Caution should be taken in case of pregnancy & lactation while using Acetylcysteine.
Pregnancy: Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Lactation: It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.
Use in Elderly
No special precautions are necessary. No dosage adjustment is required for elderly
Contraindication
Known hypersensitivity to active ingredient. Also contraindicated in patients suffering from phenylketonuria and peptic ulcer.
Patients with known hypersensitivity to cephalosporin antibiotics, children under 6 months.
Special Warning
Use in Children: Safety and effectiveness of cefixime in children aged less than 6 months have not been established. For children younger than 12 years or weighing less than 50 kg, the usual dose is 8 mg/kg/day.
Use in elderly: No special precautions are necessary. Old age is not an indication for dose adjustment.
Dosage in renal impairment:
- Creatinine clearance: 20 ml/min or greater: normal dose
- Creatinine clearance: <20 ml/min or chronic ambulatory peritoneal dialysis
- Haemodialysis: daily dose should not exceed 200 mg.
Acute Overdose
Accidental overdose of Acetylcysteine may cause nausea, vomiting or diarrhea.
Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
Storage Condition
Protect from light & moisture, store below 25° C. Keep all medicines out of the reach of children.
Store in a cool and dry place below 30ºC
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