Mucovit-C Efervesan Tablet 1200 Mg

Mucovit-C Efervesan Tablet 1200/400 mg is a Turkish pharmaceutical product formulated to address respiratory conditions characterized by thick, tenacious mucus. This effervescent tablet combines two active ingredients-acetylcysteine (1200 mg) and ascorbic acid (400 mg)-to deliver potent mucolytic and antioxidant effects. The following comprehensive review explores its pharmacology, clinical uses, safety, administration, and practical considerations, providing an in-depth understanding for clinicians, pharmacists, and patients.

Executive Summary

Mucovit-C Efervesan Tablet 1200/400 mg is an advanced mucolytic and antioxidant therapy indicated for bronchopulmonary diseases with increased mucus viscosity. The high-dose combination of acetylcysteine and ascorbic acid not only facilitates mucus clearance but also supports immune function and tissue repair.

This review delves into the scientific rationale behind the formulation, its pharmacokinetics and pharmacodynamics, clinical indications, detailed instructions for use, contraindications, drug interactions, and side effect profile. Special attention is given to dosing in special populations, storage requirements, and the clinical evidence supporting its use. The report concludes with a synthesis of current knowledge and recommendations for safe, effective therapy.

General Description

Mucovit-C Efervesan Tablet 1200/400 mg is a white, round effervescent tablet intended for oral administration after dissolution in water. It is designed to be rapidly absorbed and to act locally and systemically to reduce mucus viscosity and support respiratory health. The product is available in blister packs of 20 or 30 tablets, each accompanied by a patient information leaflet detailing its use, precautions, and safety information.

Active Ingredients

Each tablet contains:

• Acetylcysteine: 1200 mg

• Ascorbic Acid (Vitamin C): 400 mg

These ingredients are complemented by excipients such as citric acid, sodium bicarbonate, sorbitol, sodium chloride, lemon flavor, and aspartame, which aid in tablet dissolution and palatability.

Pharmacological Properties

Acetylcysteine: Mechanism of Action

Acetylcysteine is a derivative of the amino acid cysteine and is classified as a mucolytic agent. Its primary action is to cleave the disulfide bonds within mucin glycoproteins, thereby depolymerizing and reducing the viscosity of mucus. This facilitates the expectoration of thick, tenacious secretions commonly seen in chronic bronchitis, bronchiectasis, cystic fibrosis, and other obstructive pulmonary diseases. Acetylcysteine also acts as a precursor to glutathione, a key endogenous antioxidant, and thereby helps mitigate oxidative stress associated with chronic inflammation and infection.

The pharmacokinetics of oral acetylcysteine reveal rapid absorption through the intestinal mucosa, peak plasma concentrations within 1–3 hours, and low oral bioavailability (approximately 10%) due to first-pass metabolism in the liver. The drug is metabolized to cysteine and excreted primarily via the kidneys, with a half-life of about 5.6 hours for the parent compound and up to 18 hours for effervescent formulations.

Ascorbic Acid: Mechanism of Action

Ascorbic acid, or vitamin C, is an essential water-soluble vitamin with potent antioxidant properties. It is required for collagen synthesis, tissue repair, and the enzymatic production of certain neurotransmitters. In the context of respiratory disease, ascorbic acid helps neutralize free radicals generated during inflammation and infection, supports the immune response, and promotes epithelial healing.

Oral ascorbic acid is rapidly absorbed in the small intestine, with bioavailability ranging from 70% to 90% at standard doses, though it decreases with higher intakes due to saturable transport mechanisms. It is widely distributed in body tissues and excreted renally, with a variable half-life depending on plasma concentration.

Clinical Indications

Mucovit-C Efervesan Tablet 1200/400 mg is indicated for the treatment of bronchopulmonary diseases characterized by increased and viscous mucus production. These include:

• Chronic bronchitis: To facilitate the clearance of thick mucus and reduce cough severity.

• Bronchiectasis: To aid in the expectoration of purulent secretions and reduce infection risk.

• Cystic fibrosis: As an adjunct to standard therapy for mucus clearance.

• Other respiratory conditions: Where excessive or tenacious mucus impairs ventilation and increases the risk of infection.

It is important to note that Mucovit-C is not an antitussive and should not be used to suppress cough reflex, which is necessary for mucus clearance.

Dosage and Administration

Standard Dosage

For adults and adolescents over 14 years of age, the recommended dosage is one effervescent tablet (1200/400 mg) once daily, dissolved in a glass of water (approximately 200 mL), and consumed immediately after dissolution. The tablet should not be chewed or swallowed whole.

Duration of Therapy

The usual duration of treatment is 4–5 days unless otherwise directed by a healthcare provider. Prolonged use should be under medical supervision, especially in patients with chronic conditions.

Administration Guidelines

Mucovit-C can be taken with or without food. Adequate hydration is recommended during therapy, as increased fluid intake supports the mucolytic action and promotes mucus clearance. If the patient is also receiving antibiotics, Mucovit-C should be administered at least two hours before or after the antibiotic dose to avoid potential interactions.

Special Populations

• Children under 14 years: Safety and efficacy have not been established; use is not recommended.

• Elderly patients: No specific dose adjustment is required, but clinical monitoring is advised due to the lack of extensive safety data in this population.

• Renal or hepatic impairment: Use with caution, as both acetylcysteine and ascorbic acid are metabolized and excreted through these organs. In advanced liver disease, the half-life of acetylcysteine may be prolonged.

Key Information

Side Effects

The most frequently reported side effects are gastrointestinal in nature, including nausea, vomiting, abdominal discomfort, and diarrhea. Some patients may also experience runny nose, mild headache, fever, or a sensation of clamminess. These adverse effects are generally mild and self-limiting.

Serious Adverse Effects

Rare but serious reactions include hypersensitivity (manifesting as rash, urticaria, angioedema, or anaphylaxis) and bronchospasm, particularly in asthmatic individuals. There have also been occasional reports of elevated liver enzymes and hepatotoxicity, especially in patients with pre-existing liver disease.

Overdose

In the event of overdose, supportive and symptomatic treatment is indicated. Symptoms of overdose may include severe gastrointestinal upset, diarrhea, and, rarely, metabolic disturbances. There is no specific antidote, but acetylcysteine itself is used as an antidote for acetaminophen poisoning at different dosages.

Contraindications

Mucovit-C should not be used in patients with known hypersensitivity to acetylcysteine, ascorbic acid, or any excipients in the formulation. It is also contraindicated in individuals with active peptic ulcer disease, severe asthma (due to risk of bronchospasm), or a history of kidney stones associated with hyperoxaluria or aciduria.

Drug Interactions

Antibiotics

Concurrent use of Mucovit-C with antibiotics is common in respiratory infections. However, it is recommended to administer Mucovit-C at least two hours before or after antibiotic dosing to minimize any potential interaction that could affect the absorption or efficacy of either medication.

Nitroglycerin

Acetylcysteine may potentiate the vasodilatory effects of nitroglycerin, leading to increased risk of hypotension and headache. Patients on nitroglycerin therapy should be closely monitored if Mucovit-C is prescribed.

Anticoagulants

High doses of ascorbic acid may interact with oral anticoagulants such as warfarin, potentially affecting INR and bleeding risk. Monitoring of coagulation parameters is advised in patients on concurrent therapy.

Other Drug Interactions

Ascorbic acid is known to interact with a variety of medications, including certain antiepileptics, chemotherapeutic agents, and iron supplements. A comprehensive medication review should be conducted before initiating Mucovit-C.

Pharmacokinetics and Metabolism

Acetylcysteine

After oral administration, acetylcysteine is rapidly absorbed, with peak plasma concentrations occurring within 1–3 hours. However, its oral bioavailability is low (around 10%) due to significant first-pass hepatic metabolism. The drug is extensively metabolized to cysteine, which is further converted to glutathione and other metabolites. Acetylcysteine and its metabolites are excreted primarily via the kidneys, with a terminal half-life of 5.6 hours for the parent compound and up to 18 hours for effervescent formulations.

Ascorbic Acid

Ascorbic acid is absorbed in the small intestine via active transport mechanisms. Its bioavailability is high at standard doses but decreases with larger intakes due to saturable absorption. Ascorbic acid is widely distributed in body tissues, with the highest concentrations found in leukocytes, adrenal glands, and the pituitary gland. It is metabolized in the liver to dehydroascorbic acid and other inactive metabolites, with renal excretion as the main route of elimination. The half-life varies depending on plasma concentration and tissue saturation.

Clinical Benefits and Rationale

Mucolytic Action

Acetylcysteine’s ability to break disulfide bonds in mucin glycoproteins results in a marked reduction in mucus viscosity, making secretions easier to expectorate. This is particularly beneficial in chronic bronchitis, bronchiectasis, and cystic fibrosis, where thick mucus impairs airway clearance and predisposes to infection.

Antioxidant and Immune Support

Both acetylcysteine and ascorbic acid possess antioxidant properties, scavenging reactive oxygen species generated during inflammation and infection. Ascorbic acid further supports immune function by enhancing leukocyte activity, promoting epithelial repair, and facilitating iron absorption from the diet.

Symptom Relief and Quality of Life

By facilitating mucus clearance and reducing oxidative stress, Mucovit-C helps alleviate cough, improve breathing, and enhance overall quality of life in patients with chronic respiratory diseases. The addition of ascorbic acid may also shorten the duration and severity of respiratory infections, though evidence for this effect is mixed and may depend on baseline vitamin C status.

Special Populations

Pediatric Use

Mucovit-C Efervesan Tablet 1200/400 mg is not recommended for children under 14 years of age due to insufficient safety and efficacy data in this population. Lower-dose formulations may be available for pediatric use, but should only be administered under medical supervision.

Geriatric Use

While no specific dose adjustment is required for elderly patients, caution is advised due to the potential for comorbidities and polypharmacy. Monitoring for adverse effects and drug interactions is recommended.

Renal and Hepatic Impairment

Patients with advanced renal or hepatic impairment should use Mucovit-C with caution. Acetylcysteine is metabolized in the liver and excreted by the kidneys, and ascorbic acid can increase oxalate excretion, potentially precipitating kidney stones in susceptible individuals. Dose adjustment or alternative therapies may be necessary in these populations.

Pregnancy and Lactation

There is limited data on the use of high-dose acetylcysteine and ascorbic acid in pregnancy and lactation. Animal studies have not demonstrated teratogenic effects, but human data are insufficient. Use during pregnancy and breastfeeding should be limited to cases where the potential benefits outweigh the risks, and only under medical supervision.

Storage and Handling

Mucovit-C Efervesan Tablet should be stored below 25°C, in its original packaging, away from moisture and direct light. The product should be kept out of reach of children. Tablets should not be used beyond their expiration date or if there are signs of damage or deterioration in the packaging.

Patient Counseling and Practical Considerations

Patients should be instructed to dissolve the tablet completely in a glass of water and consume the solution immediately. The tablet should not be chewed or swallowed whole. Adequate hydration is essential to maximize the mucolytic effect. If a dose is missed, patients should not double the next dose but continue with the regular schedule. Patients should be advised to report any signs of allergic reaction, persistent gastrointestinal symptoms, or respiratory distress promptly.

Comparative Formulations

Mucovit-C is available in several strengths, including 600/200 mg, 900/300 mg, and 1200/400 mg per tablet. The choice of formulation depends on the severity of symptoms, patient age, and comorbidities. The 1200/400 mg strength is intended for adults and older adolescents with significant mucus production or more severe disease.

Clinical Evidence and Efficacy

Several clinical studies support the efficacy of acetylcysteine as a mucolytic agent in chronic respiratory diseases. Acetylcysteine has been shown to reduce the frequency and severity of exacerbations in chronic bronchitis, improve pulmonary function in bronchiectasis and cystic fibrosis, and enhance mucus clearance in a variety of pulmonary conditions. The addition of ascorbic acid provides antioxidant support, although its role in reducing the incidence or duration of respiratory infections remains a subject of ongoing research.

Recommendations and Next Steps

For clinicians, careful assessment of patient history, comorbidities, and concurrent medications is advised before prescribing Mucovit-C. Patient education on correct administration and recognition of adverse effects is crucial. Further research into long-term outcomes, pediatric applications, and comparative efficacy with other mucolytic agents will help refine its use in clinical practice.

For patients, adherence to prescribed dosing, maintaining hydration, and promptly reporting side effects will optimize outcomes. Mucovit-C should be stored as directed and kept out of reach of children.

As respiratory diseases continue to pose significant health burdens, especially in chronic and aging populations, the need for effective, well-tolerated mucolytic therapies like Mucovit-C remains high. Its combination of mucolytic and antioxidant actions positions it as a compelling option for those struggling with persistent, thick respiratory secretions.

Conclusion

Mucovit-C Efervesan Tablet 1200/400 mg is a robust, dual-action therapy for bronchopulmonary diseases marked by thick, tenacious mucus. Its high-dose acetylcysteine content ensures effective mucolysis, while ascorbic acid provides essential antioxidant and immune support. The product is well-suited for adults and adolescents over 14 years with chronic or acute respiratory conditions requiring enhanced mucus clearance. Safety is generally favorable, with gastrointestinal symptoms being the most common adverse effects. Serious reactions are rare but warrant immediate medical attention.

Appropriate patient selection, adherence to dosing guidelines, and awareness of contraindications and drug interactions are essential for maximizing therapeutic benefit and minimizing risk. Mucovit-C should not be used in children under 14, those with severe renal or hepatic impairment, or individuals with a history of allergy to its components.

In summary, Mucovit-C Efervesan Tablet 1200/400 mg represents a valuable addition to the therapeutic arsenal for respiratory diseases with mucus retention, offering both symptomatic relief and potential improvements in quality of life. Ongoing research into the synergistic effects of acetylcysteine and ascorbic acid may further clarify its role in respiratory medicine and beyond.