Description

A balanced combination of probiotic with B-complex vitamins
LACTOBION FORTE CAPSULES
Composition:
Each hard gelatin capsule contains:
Probiotics:
Lactic Acid Bacillus                                                         100 million spores
Vitamins:
Vitamin B₆ IP                                                                    1 mg
Vitamin B₁₂ IP                                                                  5 mcg
Biotin USP                                                                       10 mcg
Niacinamide IP                                                                 25 mg
Folic Acid IP                                                                    500 mcg
 
Dosage form:
Capsules
ATC classification:
Nutritional supplements
Description: 
Lactobion forte capsules offer a balanced combination of Probiotic with B-complex vitamins. Use of antibiotics often alters healthy gut flora leading to antibiotic resistance and overgrowth of diarrhea causing bacteria (Clostridium difficile). Lactic acid bacillus when introduced into the gastrointestinal gut as a probiotic, promotes the normal microbiota in body. It interacts with the host cells and contributes to energy production through glucose synthesis and degradation. On other side vitamins acts as co-enzymes in various metabolic reactions of the body. Altered gut flora or deficiency of vitamins makes the body susceptible to infections and vitamin deficiency disease states respectively.
Pharmacological action:
Lactic acid Bacillus:
Though lactic acid bacillus (LAB) has a transient nature in gastrointestinal tract, the changes it produces supports the complex gastrointestinal flora. Short chain fatty acids produced by Lactic acid bacillus have distinct physiological effects: they contribute to shaping the gut environment, influence the physiology of the colon,  also used as energy sources by host cells and the intestinal microbiota and they also participate in different host-signaling mechanisms. LAB is known to biosynthesize both gamma-amino-butyrate (GABA), that has relaxing effect on gastrointestinal smooth muscles, and beta-phenylethylamine that controls satiety and mood.
Beneficial effects of ingesting live lactic acid bacteria as a probiotic ranges from promotion of a normal microbiota, prevention of infectious disease, improvement of the digestion of lactose in lactose intolerant individuals, post operative pouchitis, irritable bowel syndrome, stabilization of the gut mucosal barrier, maintenance of normal insulin level in blood and also enhances the absorption of fatty acids through intestine. It has been found that lactic acid bacteria have destructive effects on helicobacter pyroli, the bacteria responsible for gastritis. When used in conjunction with anti-ulcers they are found to improve the efficacy and therapeutic effectiveness of the drug in treating gastric ulcers.
Pharmacokinetics of Lactic acid Bacillus:
Following oral administration, lactic acid bacillus passes through the stomach in its spore form and upon arrival in the duodenum, germinates and multiplies rapidly. It takes up to 4 hours for germination. After germination it gets metabolically active producing lactic acid. However, Lactic acid bacillus is a temporary resident in intestines. Spores are excreted slowly via the feces for approximately 7 days after discontinuation of administration.
Vitamin B₆-Pyridoxine, Folic acid and Vitamin B₁₂ are important co factors in homocysteine metabolism and aid in lowering the plasma levels of homocysteine.  Elevated homocysteine may lead to heart and blood vessel problems. Deficiency of either of vitamins leads to vitamin deficiency anemia.
Vitamin B₆, once absorbed, converts to the co-enzymes, pyridoxamine phosphate and pyridoxal phosphate, which play an essential role in protein metabolism.
Vitamin B₁₂ is present in the body mainly as methylcobalamine, adenosylcobalamine and hydroxocobalamine. Deficiency of vitamin B₁₂ interferes with haemopoiesis and produces megaloblastic anaemia.
Folic acid is required for nucleoprotein synthesis and in the maintenance of normal erythropoiesis. Choline, folic acid and vitamin B₁₂ improve fetal brain development and prevent neural tube defects.
Niacinamide (Vit-B₃) is required for the functioning of the coenzymes nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP). NAD and NADP are necessary for tissue respiration; glycogenolysis; and lipid, amino acid, protein, and purine metabolism. Its deficiency leads to pellagra. It also has putative activity against osteoarthritis and granuloma annulare
Biotin is a water-soluble B-complex vitamin. It functions as a cofactor for carboxylase enzymes involved in liver gluconeogenesis.
Indications:
Lactobion forte is indicated to be prescribed in conjunction with medication given for treating diarrhea and dysentery, gastric and mouth ulcers, cheilosis, Irritable bowel syndrome.
It is indicated during and after antibiotic course or anti-infective course is prescribed for infections.
It is also indicated when NSAIDs are prescribed.
Other indications are fever blisters and canker sores, hepatic encephalopathy, adolescent acne, and vitamin B complex deficiency.
Dosage:
One capsule once daily.
Contraindications:
Lactobion forte is contraindicated in patients with known hypersensitivity to any of the ingredients present in Lactobion forte.
High-dose of niacinamide (doses greater than 500 milligrams/day) is contraindicated in those with liver disease and in those with active peptic ulcer disease.
Side effects:
Vitamins and Probiotics are generally well tolerated.
The most common gastrointestinal side effects with the use of probiotics are flatulence and constipation.
Warnings and Precautions:
General:

• Lactic acid bacillus, the probiotic component of Lactobion constitutes a supplementary energy source for the host therefore it may cause weight gain.
• Ask the doctor before using Lactobion if you have any medical conditions
• Lactobion forte is not recommended for the treatment of severe specific deficiencies of vitamins. In such cases, the underlying cause should be determined and corrected
• Patients being treated with levodopa without concurrently taking the levodopa decarboxylase inhibitor, carbidopa, should avoid doses of vitamin B₆ of 5 milligrams or greater daily.
• The use of vitamin B₆for the treatment of vitamin B₆deficiency, for the prophylaxis of isoniazid-induced peripheral neuropathy, for the treatment of vitamin B₆-dependency disorders requires medical supervision.
• The use of Niacinamide for any medical indication requires medical supervision.
• Niacinamide is to be avoided or to be used with caution in patients with a history of peptic ulcer disease, gastritis, liver disease, gallbladder disease, diabetes and gout.

Drug Interactions:

• Carbamazepine shows drug interactions with niacinamide and vitamin B₆
• Amiodarone, Cycloserine, Ethionamide, Fosphenytoin, Hydralazine, Isoniazid, Pencillamine, Phenobarbital, Phenytoin, Theophylline, Valproic acid, Alcoholic beverages are known to have drug interactions with Vitamin-B₆

Pregnancy and lactation:

• Pregnant and lactating mothers should not exceed the U.S RDA i.e., daily amount of vitamins that the FDA has established as sufficient to maintain the nutritional health of persons in various age groups and categories.
• Dosage could exceed U.S RDA limits only when prescribed by Physicians based on the need of the pregnant or lactating woman.

 
References:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3417654/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4756104/
https://www.researchgate.net/publication/49687659_Beneficial_effects_of_lactic_acid_bacteria_on_human_beings
https://pubchem.ncbi.nlm.nih.gov/compound/folic_acid
https://pubchem.ncbi.nlm.nih.gov/compound/vitamin_B12#section=Top
https://pubchem.ncbi.nlm.nih.gov/compound/pyridoxine_hydrochloride#section=Top
https://pubchem.ncbi.nlm.nih.gov/compound/936
 
Disclaimer:

• Information provided above is for reference purpose only and has been compiled for use by healthcare practitioners. Please consult your physician to understand how the product affects you, its dosages, side-effects and further information.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indications prescribed by your physician.
• Every effort has been made to ensure that the information provided by Pharma Synth Formulations Ltd. (‘PSFL’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. PSFL does not endorse drugs, diagnose patients or recommend therapy and is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. PSFL does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.