Maxiliv Tablet

Glutathione tablet

Each film coated tablet contains

Glutathione……………………………………………500 mg

Tablet 500 mg

4.1 Therapeutic indication

• Alcoholic fatty liver
• Alcoholic liver fibrosis
• Alcoholic liver cirrhosis
• Hepatitis

4.2 Posology and method of administration

Adults: One Maxiliv tablet (500 mg) once or twice daily.

4.3 Contraindications

Patients who show hypersensitivity to reduced glutathione.

4.4 Special warnings and precautions for use

• Administer Maxiliv tablet under the supervision of a doctor.
• Keep out of reach of children.
• If unusual symptoms such as eruption, pale face, blood pressure drop, or difficulty in breathing occur during therapy, discontinue the drug immediately.

4.5 Drugs interactions

Vitamin K, Vitamin B12, Calcium pantothenate and antihistamines can affect the bioavailability of glutathione.

4.6 Use in special populations

Pregnancy and Lactation

Maxiliv tablet should not be administered to a pregnant and lactating woman unless clinical benefit outweighs the risks.

Geriatric

Appropriate dose reduction is required during therapy.

4.7 Effects on ability to drive and use machines

It is not known whether Maxiliv Tablet alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.

4.8 Undesirable Effects

According to the scientific literature, there are no risks or side effects of oral administration glutathione. However, there have been anecdotal reports of transitory increase in flatulence, gastrointestinal irritation which diminishes after several days of consistent use.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com

Website: https://www.zuventus.com/drug-safety-reporting

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

No specific antidote is available for the treatment of glutathione overdosage. Symptomatic treatment should be provided.

5.1 Mechanism of Action/ Pharmacodynamic properties

Glutathione is an extremely important cell protectant which directly quenches reactive hydroxyl free radicals, other oxygen-centered free radicals, and radical centers on DNA and other biomolecules. It is an essential cofactor for many enzymes which require thiol-reducing equivalents, and helps to keep redox-sensitive active sites on enzymes in the necessary reduced state. Higher-order thiol cell systems like metallothioneins, thioredoxins, and other redox regulator proteins are ultimately regulated by reduced form of glutathione (GSH) levels and the ratio of GSH/GSSG (oxidized GSH).

GSH/GSSG balance is crucial for homeostasis, stabilizing the cellular biomolecular spectrum, and facilitating cellular performance and survival. GSH and its metabolites also interface with energetics and neurotransmitter syntheses, through several prominent metabolic pathways. GSH availability down-regulates the pro-inflammatory potential of leukotrienes and other eicosanoids. Recently discovered S-nitroso metabolites, generated in-vivo from GSH and NO (nitric oxide) further diversify GSH’s impact on metabolism.

5.2 Pharmacokinetic properties

A 6-month randomized, double-blinded, placebo-controlled trial of oral GSH (250 or 1,000 mg/day) on GSH levels in blood, erythrocytes, plasma, lymphocytes and exfoliated buccal mucosal cells was conducted in 54 non-smoking adults.

GSH levels in blood increased after 1, 3 and 6 months versus baseline at both doses. At 6 months, mean GSH levels increased 30-35 % in erythrocytes, plasma and lymphocytes and 260 % in buccal cells in the high-dose group (P < 0.05). GSH levels increased 17 and 29 % in blood and erythrocytes, respectively, in the low-dose group (P < 0.05). In most cases, the increases were dose and time dependent, and levels returned to baseline after a 1-month washout period. A reduction in oxidative stress in both GSH dose groups was indicated by decreases in the oxidized to reduced glutathione ratio in whole blood after 6 months.

6.1 Animal Toxicology or Pharmacology

No known animal toxicology data

Glutathione (GSH) is a physiological tripeptide- a chain of three amino acid- cysteine, glycine and glutamic acid. It is used for the detoxification of electrophilic metabolites. It is a very efficient free radical scavenger, preventing damage to important cellular components caused by reactive oxygen species such as free radicals and peroxides.

Chemical Name: (2S)-2-Amino-4-[1-(carboxymethyl)carbamoyl-(2R)-2- sulfanylethylcarbamoyl] butanoic acid.

Molecular Formula: C₁₀H₁₇N₃O₆S

Molecular Weight: 307.32 g/mol

8.1 List of excipients

8.2 Incompatibilities

8.3 Shelf life

8.4 Special precautions for storage

• Inform your doctor if you have past or current history of asthma.
• Seek immediate medical attention if you have difficulty in breathing after taking the drug.
• Tell your doctor if you are or planning to become pregnant or are breastfeeding.
• Do not take if allergic to glutathione, milk protein or any of its ingredients.
• Do not take if patients had organ transplantation.
• Avoid if suffering from asthma.
• Do not take if patient is Pregnant and breastfeeding women.

28.11.2024