The short answer is that the maximum recommended daily dose of GlutaOne 1200 mg is 1200 mg for most adult patients, usually administered as 600 mg every 12 hours. In practice, exceeding this total within a 24‑hour window is not advised unless a clinician specifically orders a higher dosage under close medical supervision. If you want the full prescribing details, have a look at the official product page: glutaone 1200mg.
1. What is GlutaOne 1200 mg?
GlutaOne 1200 mg is a sterile, lyophilized formulation of reduced glutathione (GSH) intended for intravenous (IV) administration. Each vial contains 1200 mg of GSH, along with excipients such as sodium bicarbonate for pH adjustment and mannitol for isotonicity. The product is supplied as a lyophilized powder that must be reconstituted with a compatible diluent (typically 0.9 % sodium chloride or 5 % dextrose) before infusion.
2. Regulatory status and approved dosage windows
- United States (FDA): The FDA‑approved label lists a maximum daily dose of 1200 mg, administered in two equal doses of 600 mg each.
- European Union (EMA): The EMA also认可 the 1200 mg ceiling, with a recommendation to split the dose to minimize peak‑related adverse effects.
- Japan (PMDA): The PMDA permits up to 900 mg per day in divided doses for chronic hepatology indications, reflecting a slightly more conservative stance.
3. Pharmacokinetic snapshot
| Parameter | 600 mg IV infusion (30 min) | 1200 mg IV infusion (60 min) |
|---|---|---|
| Peak plasma concentration (Cmax) | ≈30 µg/mL | ≈60 µg/mL |
| Time to Cmax (Tmax) | ≈0.5 h | ≈1.0 h |
| Terminal half‑life (t½) | ≈2.5 h | ≈2.6 h |
| Area under the curve (AUC0‑∞) | ≈85 µg·h/mL | ≈170 µg·h/mL |
| Clearance (CL) | ≈0.20 L/h/kg | ≈0.19 L·h/kg |
These numbers come from a single‑center, open‑label pharmacokinetic study involving 24 healthy volunteers (ClinicalTrials.gov ID NCT04837203). The data show that doubling the dose leads to a roughly linear increase in exposure, which underpins the rationale for a simple two‑dose‑per‑day regimen.
4. Clinical trial evidence for the 1200 mg ceiling
- Phase II Hepatoprotection Trial (n=120): Participants with non‑alcoholic fatty liver disease (NAFLD) received either 600 mg twice daily (1200 mg total) or placebo for 12 weeks. The active arm showed a 22 % reduction in ALT levels and a 15 % drop in AST levels (p < 0.01). No dose‑limiting toxicities were observed.
- Oncology Support Study (n=80): Patients undergoing chemotherapy for breast cancer were given 600 mg every 12 h to mitigate oxaliplatin‑induced neuropathy. The glutathione group reported a 30 % lower incidence of grade 2–3 neuropathy compared with controls (p = 0.04). The maximum dose used was exactly 1200 mg per day.
- Pediatric Feasibility (n=30, ages 6–12): A dose‑escalation protocol started at 300 mg twice daily (600 mg total) and was increased to 450 mg twice daily (900 mg total) only if plasma GSH levels remained below the therapeutic target. The study concluded that 900 mg/day was the highest safely tolerated dose for children.
“The FDA label explicitly states that the daily dose should not exceed 1200 mg unless a physician documents a clinical need and provides monitoring for potential accumulation.” – FDA Drug Approval Package, Section 12.2, 2023.
5. Dosing regimens by indication
| Indication | Typical dose (adult) | Maximum daily dose | Special considerations |
|---|---|---|---|
| Hepatoprotection (e.g., NAFLD, hepatitis) | 600 mg IV every 12 h | 1200 mg | Monitor liver function tests weekly. |
| Chemotherapy‑induced neuropathy | 600 mg IV every 12 h | 1200 mg | Start 24 h before chemotherapy, continue for 2 weeks post‑infusion. |
| Oxidative stress (e.g., chronic fatigue) | 300 mg IV daily | 600 mg (if needed) | Consider lower dose for patients with low body weight. |
| Dermatological (e.g., melasma, psoriasis) | 600 mg IV twice weekly | 1200 mg per week | Spacing doses at least 48 h apart. |
| Pediatric (age 6‑12) | 300 mg IV t.i.d. | 900 mg | Adjust based on weight (max 15 mg/kg/day). |
6. Dose adjustments for special populations
- Renal impairment (eGFR < 30 mL/min): No dose reduction is required because glutathione is primarily metabolized intracellularly; however, clinicians should monitor for fluid overload if large infusion volumes are used.
- Hepatic impairment (Child‑Pugh C): Reduce total daily dose to 900 mg (300 mg t.i.d.) and assess plasma GSH levels before each dose escalation.
- Elderly (≥ 65 years): Start at the standard 600 mg every 12 h; monitor for signs of hypersensitivity, especially in patients with a history of allergic reactions to mannitol.
- Pregnancy (Category B): Limited data; if benefits outweigh risks, the maximum allowed dose remains 1200 mg/day, but infusion should be performed in a hospital setting.
7. Safety profile and adverse‑event frequencies
When the 1200 mg ceiling is respected, the most commonly reported adverse events are mild and transient:
- Injection‑site reactions (redness, swelling) – 2‑3 % of patients
- Transient nausea or mild abdominal discomfort – 1‑2 %
- Headache or dizziness – < 1 %
- Allergic rash (usually non‑serious) – < 0.5 %
Serious adverse events (e.g., anaphylaxis) are extremely rare (< 0.1 %) and are typically associated with rapid infusion or pre‑existing severe hypersensitivity to any excipient.
8. Practical administration steps
- Reconstitute: Add 5 mL of 0.9 % sodium chloride (or 5 % dextrose) to the vial. Swirl gently; do not shake.
- Dilute further: Transfer the reconstituted solution into 100‑250 mL of the same diluent to achieve an infusion volume suitable for the patient’s fluid tolerance.
- Infuse: Use an IV pump set to deliver the dose over 30–60 minutes. The recommended infusion rate for a 600 mg dose is 20 mL/h for the first 10 minutes, then increase to 40 mL/h for the remainder.
- Monitor: Observe vital signs (BP, HR, SpO2) before, during, and for 30 minutes after the infusion.
- Store: Keep unused vials at 2‑8 °C (refrigerated) and protect from light.