Aritone

Approved Indications:

• Prevention and treatment of vitamin B-complex and vitamin C deficiencies, especially in:
• Inadequate dietary intake
• Increased physiological demand (e.g., pregnancy, lactation, growth)
• Recovery from illness, surgery, or chronic infection
• Supportive therapy in conditions causing malabsorption or increased vitamin loss, including:
• Chronic alcoholism
• Gastrointestinal disorders (e.g., IBD, short bowel syndrome)
• Long-term parenteral or enteral feeding
• Adjunctive treatment in nerve-related conditions, such as:
• Peripheral neuropathy (especially due to B1, B6, or B12 deficiency)
• Neuralgia and neuritis
• Immune support and antioxidant defense, particularly in:
• Acute or chronic infections
• Smokers and individuals under oxidative stress

Clinically Accepted Off-label Uses:

• Adjunct to treatment of megaloblastic anemia (along with folate/B12)
• Prevention of scurvy (Vitamin C deficiency) in at-risk populations
• Nutritional support during antibiotic or antitubercular therapy

Adults:

• Oral: 1 tablet or capsule once or twice daily, preferably with food.
• Typical formulation per tablet/capsule:
• Thiamine (B1): 1.4–2 mg
• Riboflavin (B2): 1.6–2 mg
• Niacinamide (B3): 18–20 mg
• Pantothenic acid (B5): 5–10 mg
• Pyridoxine (B6): 2–5 mg
• Biotin (B7): 30–50 mcg
• Folic acid (B9): 400 mcg
• Cyanocobalamin (B12): 2.4–6 mcg
• Ascorbic acid (Vitamin C): 60–1000 mg

Pediatrics:

• Syrup/Drop: Dose based on age and weight.
• Infants (<1 year): 0.5–1 mL daily
• Children 1–12 years: 1–2 mL or as directed
• Adolescents: Adult dose

Elderly:

• Same as adult dosing; higher B12 and folic acid may be required.

Special Populations:

• Renal impairment: Use with caution in high-dose B6 or vitamin C (risk of accumulation or oxalate nephropathy)
• Hepatic impairment: No specific adjustments; monitor for fat-soluble vitamin co-administration

Route: Oral (tablets, capsules, syrups, drops); occasionally injectable (IM/IV) in hospital settings
Frequency: Once or twice daily
Duration: Based on clinical indication (weeks to months)

B-complex vitamins act as essential cofactors in numerous enzymatic reactions involved in carbohydrate, protein, and fat metabolism. Vitamin B1 (thiamine) supports neural and cardiac function; B2 (riboflavin) is integral to redox reactions; B3 (niacinamide) forms NAD/NADP for energy production; B5 is required for coenzyme A synthesis; B6 (pyridoxine) is vital in neurotransmitter and amino acid metabolism; B7 (biotin) aids in gluconeogenesis and fatty acid synthesis; B9 and B12 are crucial for DNA synthesis and erythropoiesis. Vitamin C functions as an antioxidant and supports collagen synthesis, immune function, and iron absorption. Together, this formulation supports neuromuscular health, metabolism, and tissue repair.

Absorption:

• Well absorbed in the small intestine when taken orally
• Enhanced when taken with food

Distribution:

• Water-soluble; minimal storage (except B12, stored in the liver)
• Wide distribution to tissues and organs

Metabolism:

• B vitamins and vitamin C undergo hepatic metabolism to active forms (e.g., pyridoxal phosphate, methylcobalamin)

Excretion:

• Primarily renal excretion of unmetabolized portions
• Excess excreted in urine (often discolors urine yellow due to riboflavin)

Onset of Action:

• Neurological and hematologic effects may be seen within 2–4 weeks of regular use

Half-life:

• Short (hours to 1 day) except B12 (can be stored for months)

Pregnancy:

• Considered safe when used within Recommended Daily Allowance (RDA) levels
• Often included in prenatal vitamins (B9: 400–800 mcg; B12: 2.6 mcg; C: 85 mg)

Lactation:

• Safe and beneficial; supports maternal stores and infant development
• Vitamin C and B-vitamins are excreted into breast milk in small amounts

Caution:

• Avoid megadoses, especially of vitamin B6 and C, without medical supervision

• Primary Class: Nutritional Supplement
• Subclass: Vitamin B-Complex and Vitamin C Combination

• Known hypersensitivity to any ingredient in the formulation
• Hemochromatosis or hemosiderosis (vitamin C may enhance iron absorption)
• Severe renal impairment (high-dose vitamin C may increase oxalate risk)
• Megaloblastic anemia of unknown cause (do not use B9/B12 without diagnostic workup)

• High-dose Vitamin B6 (>200 mg/day) may cause sensory neuropathy
• Vitamin C >2 g/day may cause kidney stones or GI upset
• Folic acid alone may mask B12 deficiency symptoms, risking irreversible neuropathy
• Patients on chemotherapy or methotrexate may need adjusted folic acid monitoring
• Use caution in G6PD-deficient individuals with high-dose vitamin C

Common:

• Gastrointestinal upset (nausea, diarrhea)
• Yellow urine (from riboflavin)

Less Common:

• Flushing (from niacinamide)
• Metallic taste
• Mild headache

Rare but Serious:

• Allergic reactions (rash, itching, angioedema)
• Peripheral neuropathy (from high-dose B6)
• Kidney stones (from prolonged high-dose vitamin C)

Timing:

• Usually mild and dose-dependent; resolve upon dose adjustment or discontinuation

• Levodopa: High-dose pyridoxine may reduce therapeutic effect (unless with carbidopa)
• Methotrexate, phenytoin: Antagonized by folic acid—requires medical supervision
• Tetracyclines, aminoglycosides: May reduce absorption of B vitamins
• Aspirin or oral contraceptives: Long-term use may lower B6 and folate levels
• Vitamin C enhances iron absorption and may interfere with stool occult blood tests

CYP Involvement:
No significant CYP450 interactions known at nutritional doses

• WHO/UNICEF Guidelines: Continued recommendation for folic acid and vitamin B12 supplementation in pregnancy and early childhood
• USPSTF (2022): Insufficient evidence to support routine vitamin B-complex or C supplementation in healthy adults for disease prevention
• NIH Office of Dietary Supplements (2023): Advises caution with mega-dose B6 due to neuropathy risk
• EFSA (2023): Reinforced upper safe limits for Vitamin C (2000 mg/day) and B6 (100 mg/day)

• Temperature: Store at 15°C to 25°C (59°F to 77°F)
• Humidity: Protect from moisture and keep bottle tightly closed
• Light: Protect from direct light
• Handling: Do not use expired or discolored tablets
• Refrigeration: Not required for oral forms; IV/injectable forms may require cold storage