BEROCCA PN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BEROCCA PN (BEROCCA PN).
BEROCCA PN is a multivitamin formulation providing B-complex vitamins and vitamin C. These vitamins act as cofactors in various metabolic pathways: B1 (thiamine) in carbohydrate metabolism; B2 (riboflavin) in redox reactions; B3 (niacin) in NAD/NADP synthesis; B5 (pantothenic acid) in CoA synthesis; B6 (pyridoxine) in amino acid metabolism; B12 (cyanocobalamin) in DNA synthesis and myelin formation; C (ascorbic acid) as an antioxidant and cofactor in collagen synthesis.
| Metabolism | Vitamins are metabolized via various pathways: B1 is phosphorylated; B2 converted to FMN/FAD; B3 to NAD/NADP; B5 incorporated into CoA by pantothenate kinase; B6 phosphorylated to pyridoxal phosphate; B12 binds to intrinsic factor and is metabolized in the liver; C is metabolized by oxidation and hepatic conjugation. |
| Excretion | Renal: 60-80% as unchanged vitamins (B-complex, vitamin C) and metabolites; biliary/fecal: 20-40% via bile, with enterohepatic recirculation for some B vitamins. |
| Half-life | Variable by component: thiamine ~20 min (plasma), pyridoxine ~15-20 days (tissue-bound), cyanocobalamin ~6 days (plasma) to 400 days (hepatic stores); clinical context: daily dosing required for water-soluble vitamins due to rapid renal clearance. |
| Protein binding | Low to moderate: thiamine ~10%, pyridoxine ~60% (albumin), cyanocobalamin ~90% (transcobalamins), ascorbic acid ~25% (albumin); overall 30-50% bound. |
| Volume of Distribution | Variable by component: thiamine ~0.3-0.4 L/kg, pyridoxine ~0.6 L/kg, cyanocobalamin ~0.1 L/kg (due to high protein binding); overall Vd ~0.5 L/kg, indicating distribution into total body water. |
| Bioavailability | Oral: variable 50-90% (thiamine ~5-10% due to saturable transport, pyridoxine ~80%, cyanocobalamin ~1-2% without intrinsic factor); IM/IV: 100%. |
| Onset of Action | IV: immediate (within minutes) for B vitamins and vitamin C; IM: 15-30 min; oral: 30-60 min (absorption time). |
| Duration of Action | Water-soluble vitamins: 4-8 hours for plasma levels, but tissue stores extend effects for days (e.g., pyridoxine up to 2 weeks); clinical note: repeat dosing every 24-48 hours for deficiency states. |
1 mL (100 mg thiamine, 2 mg riboflavin, 100 mg niacinamide, 5 mg pyridoxine, 10 mg D-panthenol) intramuscularly or intravenously once daily; alternatively, 1-2 mL weekly for maintenance.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment required; B vitamins are water-soluble and generally safe. Monitor for accumulation of pyridoxine in severe renal impairment (eGFR < 15 mL/min). |
| Liver impairment | No specific adjustment for Child-Pugh classification; use caution in severe hepatic impairment due to potential for vitamin accumulation, but no dose modification standard. |
| Pediatric use | Weight-based: 0.1-0.2 mL/kg intramuscularly or intravenously once daily; maximum 1 mL daily. Alternative: 0.5-1 mL weekly for prophylaxis. |
| Geriatric use | No specific dose adjustment; standard adult dosing applies. Monitor renal function and consider reduced dose in elderly with renal impairment (see renal adjustment). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BEROCCA PN (BEROCCA PN).
| Breastfeeding | Vitamins and minerals in BEROCCA PN are normal constituents of breast milk. No adverse effects expected at recommended doses. M/P ratio not systematically studied; water-soluble vitamins equilibrate with maternal plasma. Excretion of fat-soluble vitamins in milk dose-dependent. Avoid excessive doses, especially vitamin A and D. |
| Teratogenic Risk | BEROCCA PN contains vitamins and minerals. At recommended doses, no teratogenic risk identified. Water-soluble vitamins (B1, B2, B6, B12, C, niacin, pantothenic acid, biotin) cross placenta but excess excreted; fat-soluble vitamins (A, D, E) at high doses: Vitamin A >10,000 IU/day associated with fetal malformations in first trimester; Vitamin D >4000 IU/day may cause hypercalcemia and fetal anomalies; Vitamin E has limited safety data. Use recommended dietary allowance doses only. |
■ FDA Black Box Warning
No FDA black box warning for BEROCCA PN.
| Serious Effects |
["Known hypersensitivity to any component","Severe hepatic or renal impairment (relative)"]
| Precautions | ["Hypersensitivity reactions may occur","Contains cyanocobalamin which may cause hypokalemia or thrombocytosis in pernicious anemia patients","Large doses of pyridoxine (B6) can cause sensory neuropathy","Use with caution in renal impairment (may accumulate excipients like propylene glycol)"] |
| Food/Dietary | No specific food interactions. However, the medication is intended to supplement dietary deficiencies; a balanced diet rich in B vitamins is recommended. Avoid excessive alcohol consumption, as it can interfere with vitamin B absorption and utilization. |
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| Fetal Monitoring | No specific monitoring required for standard doses. With high-dose vitamin A or D, monitor maternal serum levels, fetal ultrasound for anomalies, and renal function. For prolonged use, assess maternal vitamin levels to avoid toxicity. |
| Fertility Effects | No known adverse effects on fertility at recommended doses. Adequate vitamin and mineral status is essential for normal reproductive function. Excessive doses of vitamin A may impair fertility; zinc deficiency may affect conception. |
| Clinical Pearls | BEROCCA PN is a parenteral multivitamin formulation that provides vitamins B1, B6, B12, and niacinamide. It is indicated for prophylaxis or treatment of vitamin B complex deficiencies, especially in patients unable to take oral supplements. Administer by deep intramuscular injection only; intravenous administration may cause severe anaphylactic reactions. Monitor for hypersensitivity, especially in patients with history of allergies. Avoid in patients with Leber's disease (optic nerve atrophy due to B12 deficiency) as B12 may aggravate. Contains benzyl alcohol; avoid in neonates and premature infants due to risk of 'gasping syndrome'. |
| Patient Advice | This medication is given as an injection into your muscle, usually by a healthcare professional. · Do not receive this injection if you have a known allergy to any of its ingredients, including benzyl alcohol. · Inform your doctor if you have a history of allergies, especially to vitamins or preservatives. · Side effects may include pain at the injection site, nausea, dizziness, or allergic reactions such as rash, itching, or difficulty breathing. · Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. · Keep all appointments for your injections; do not miss a dose. |