Cefixime & Ofloxacin Tablets

Each film coated tablet contains:

Cefixime (as Trihydrate) IP equivalent to Anhydrous Cefixime 200 mg

Ofloxacin IP 200 mg

Excipients q.s.

Colours: Lake of Quinoline Yellow & Titanium Dioxide IP

Film coated tablet

Cefixime (200mg) and Ofloxacin (200mg)

4.1 Therapeutic Indication

For the treatment of patients with typhoid fever and urinary tract infection in adults.

4.2 Posology and method of administration

C Tax-OF adult dose:

1 tablet two times daily.

4.3 Contraindications 

• Persons with a history of hypersensitivity associated with the use of ofloxacin or any member of the quinolone group. Patients with known allergy to cefixime or other cephalosporins.
• Patients with a past history of tendinitis related to fluoroquinolone administration.
• Patients with a history of epilepsy or seizures.
• Children or growing adolescents and in pregnant or breast-feeding women, since animal experiments do not entirely exclude the risk of damage to the cartilage of joints in the growing subject
• Patients with latent or actual defects in G6PD activity

4.4 Special warnings and precautions for use

The drug may cause low blood sugar and mental health related side effects. Low blood sugar levels, also called hypoglycaemia, can lead to coma. The mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. The mental health side effects to be added to or updated across all the fluoroquinolones are:

• Disturbances in attention
• Disorientation
• Agitation
• Nervousness
• Memory impairment
• Serious disturbances in mental abilities called delirium

4.5 Drugs interactions 

• Drugs known to prolong QT interval: C Tax-OF should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. anti-arrhythmics, tricyclic antidepressants, macrolides, and antipsychotics).
• Antacids, Sucralfate, Metal Cations: Co-administered magnesium/aluminium antacids, sucralfate, zinc or iron preparations can reduce absorption. Therefore, ofloxacin should be taken 2 hours before such preparations.
• Theophylline, fenbufen or similar NSAIDs: A pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, NSAIDs, or other agents, which lower the seizure threshold. In case of seizures, treatment with C Tax-OF should be discontinued.
• Glibenclamide: Ofloxacin may cause a slight increase in serum concentrations of glibenclamide.
• Probenecid, cimetidine, furosemide and methotrexate: Caution should be exercised when ofloxacin is co-administered with drugs that affect the tubular renal secretion such as probenecid, cimetidine, furosemide and methotrexate.
• Vitamin K antagonists & Anticoagulants: Increased coagulation tests (PT/INR) and/or bleeding have been reported in patients treated with ofloxacin in combination with a vitamin K antagonist (e.g. warfarin). Coagulation tests should be monitored in patients treated with Vitamin-K antagonists. Cefixime should be administered with caution to patients receiving coumarin-type anticoagulants, e.g. warfarin.
• Other forms of interaction: A false positive direct coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognised that a positive coombs test may be due to the drug.

4.6 Use in special populations

Pregnancy

C Tax-OF should not be used during pregnancy.

Lactation

Breast feeding should be discontinued during treatment with C Tax-OF because of the potential for arthropathy and other serious toxicity in the nursing infants.

Children

C Tax-OF is not indicated for use in children or growing adolescents.

4.7 Effects on ability to drive and use machines

There have been occasional reports of drowsiness/somnolence, impairment of skills, dizziness/vertigo and visual disturbances, which may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery), patients should know how they react to ofloxacin before they drive or operate machinery. These effects may be enhanced by alcohol.

In the case of side effects such as encephalopathy (which may include convulsion, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.

4.8 Undesirable effects

Cefixime: 

• Acute generalized exanthematous pustulosis and Mouth Ulceration has been reported with Cefixime use.
• The most commonly seen adverse reactions reported were gastrointestinal events (30%) in adult patients
• Individual adverse reactions included Diarrhea-16%, Loose or frequent stools- 6%, Abdominal pain-3%, Nausea-7%, Dyspepsia-3%, Flatulence 4%

Ofloxacin:

• Stevens-Johnson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) has been reported with Ofloxacin use.
• The most frequently reported adverse events were nausea- 10%, headache- 9%, insomnia- 7%, external genital pruritus in women- 6%, Dizziness-5%, Vaginitis-5%, Diarrhea-4%, Vomiting 4%

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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

Ofloxacin

Important signs of acute over dosage: CNS symptoms such as confusion, dizziness, impairment of consciousness and seizures, increases QT interval, GIT reactions e.g. nausea and mucosal erosions.

In the case of overdose steps to remove any unabsorbed ofloxacin e.g. gastric lavage, administration of adsorbants and sodium sulphate are recommended; antacids are recommended for protection of the gastric mucosa. A fraction of ofloxacin may be removed from the body with haemodialysis.

No specific antidote exists. Elimination of ofloxacin may be increased by forced diuresis. In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.

Cefixime There is no experience with overdoses with Cefixime. Cefixime is not removed from the circulation in significant quantities by dialysis. No specific antidote exists. General supportive measures are recommended.

5.1 Pharmacodynamic Properties

Cefixime 

• is an oral third generation cephalosporin which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms. Bactericidal action of cefixime results from inhibition of cell-wall synthesis.
• Active against most isolates of the following bacteria both in vitro and in clinical infections:
  • Gram-positive bacteria- Streptococcus pneumonia, Streptococcus pyogenes
  • Gram-negative bacteria - Haemophilus influenza, Moraxella catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae
• In vitro bactericidal activity is seen against isolates of the following microorganisms.
  • Gram-positive bacteria- Streptococcus agalactiae
  • Gram-negative bacteria- Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumonia, Klebsiella oxytoca, Pasteurella multocida, Providencia species, Salmonella species, Shigella species, Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens

Ofloxacin

• Is a quinolone-carboxylic acid derivative with a wide range of antibacterial activity against both gram negative and gram positive organisms.
• The primary mode of action of the quinolones is the specific inhibition of bacterial DNA gyrase. This enzyme is required for DNA replication, transcription, repair and recombination. Its inhibition leads to expansion and destabilisation of the bacterial DNA and hence to cell death.
• Active against most isolates of the following bacteria both in vitro and in clinical infections.
  • Gram-Positive Microorganisms- Staphylococcus aureus (methicillin-susceptible strains), Streptococcus pneumoniae (penicillin-susceptible), Streptococcus pyogenes
  • Gram-Negative Microorganisms- Citrobacter koseri, Enterobacter aerogenes, Escherichia coli, Haemophilus influenza, Klebsiella pneumonia, Neisseria gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa,
  • Other Microorganisms- Chlamydia trachomatis
• In vitro bactericidal activity is seen against isolates of the following microorganisms
  • Gram-positive microorganisms- Staphylococcus epidermidis (methicillin-susceptible strains), Staphylococcus saprophyticu, Streptococcus pneumonia,
  • Gram-Negative Microorganisms- Acinetobacter calcoaceticus, Bordetella pertussis, Pasteurella multocida, Enterobacter cloacae, Haemophilus ducreyi, Klebsiella oxytoca, Moraxella catarrhalis, M. morganii, Proteus vulgaris, Providencia rettgeri, P. stuartii, Serratia marcescens
  • Other microorganisms- Chlamydia pneumoniae, Gardnerella vaginalis, Legionella pneumophila, Mycoplasma pneumoniae, Ureaplasma urealyticum,
  • Anaerobic Microorganisms- Clostridium perfringes

5.2 Pharmacokinetic properties

6.1 Animal Toxicology or Pharmacology

Preclinical effects in conventional studies of safety pharmacology, acute toxicity, repeated dose toxicity, reproductive studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. Joint toxicity was observed at exposure in the human therapeutic range in juvenile rats and dogs. Ofloxacin exhibits a neurotoxic potential and causes reversible testicular alterations at high doses.

Mutagenicity studies showed no evidence for mutagenicity of ofloxacin. However, like some other quinolones Ofloxacin is phototoxic in animals at exposure in the human therapeutic range. The phototoxic, photomutagenic and photocarcinogenic potential of ofloxacin is comparable with that of other gyrase inhibitors.

Preclinical data from conventional genotoxicity studies reveal no special hazard to humans, carcinogen potential has not been investigated.

Reproduction toxicity

Ofloxacin has no effect on fertility, peri- or postnatal development, and therapeutic doses did not lead to any teratogenic or other embryotoxic effects in animals. Ofloxacin crosses the placenta and levels reached in the amniotic fluid are about 30% of the maximal concentrations measured in maternal serum.

Cefixime is a semisynthetic, cephalosporin antibacterial for oral administration. Ofloxacin tablets are a synthetic broad-spectrum antimicrobial agent for oral administration.

Cefixime

Chemical Name: (6R,7R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid, 72-(Z)- [O-(carboxy methyl) oxime] trihydrate

Chemical Formula: C16H15N5O7S2.3H2O

Molecular Weight: 507.50

Structure:

Ofloxacin

Chemical Name: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1- piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine6-carboxylic acid

Chemical Formula: C18H20FN3O4

Molecular Weight: 361.4

Structure:

8.1 Incompatibilities

None

8.2 Shelf-life

Refer on the pack

8.3 Packaging information

A blister strip of 10 tablets.

8.4 Storage and handing instructions

Store below 25°C. Protect from light

Keep out of reach of children.

• Counsel patients that antibacterial drugs should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When C Tax-OF is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by C Tax- OF or other antibacterial drugs in the future.
• Advise patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue C Tax-OF treatment. The risk of severe tendon disorders with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants;
• Advise patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.
• Advise patients that peripheral neuropathies have been associated with ofloxacin use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, they should discontinue treatment and contact their physicians
• photosensitivity/phototoxicity has been reported in patients receiving quinolone antibiotics. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, patients should contact their physician.
• if they are diabetic and are being treated with insulin or an oral hypoglycemic drug, to discontinue ofloxacin immediately if a hypoglycemic reaction occurs and consult a physician
• convulsions have been reported in patients taking quinolones, including ofloxacin, and to notify their physician before taking this drug if there is a history of this condition
• if they are diabetic and are being treated with insulin or an oral hypoglycemic drug, to discontinue C Tax-OF immediately if a hypoglycemic reaction occurs and consult a physician
• Patients are advised to inform their physician of any personal or family history of QTc prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents. Patients should notify their physicians f they have any symptoms of prolongation of the QTc interval including prolonged heart palpitations or a loss of consciousness.
• Tell the patients if they get any side effects, talk to the doctor. This includes any possible side effects not listed in this leaflet. Advice patients if they have any further questions, ask the doctor or pharmacist.

05-07-2024

Acebrophylline Prolonged release Tablets

Each uncoated prolonged-release tablet contains:

Acebrophylline……………………………………. 200 mg

Excipients q.s.

Tablet 200 mg

4.1 Therapeutic indication

For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma.

4.2 Posology and method of administration

Adults

Acebrophylline is administered at a recommended dose of 1 tablet once daily.

4.3 Contraindications

Hypersensitivity to xanthine derivatives like theophylline or to ambroxol.

4.4 Special warnings and precautions for use

Acebrophylline should be administered with caution in patients with hypertension, heart diseases, peptic ulcers and severe hypoxemia.

4.5 Drugs interactions

Theophylline should not be administered concurrently with other xanthine preparations and caution is required due to the interaction between theophylline and ephedrine or other sympathomimetic bronchodilators. The concomitant administration of reserpine may result in tachycardia.

4.6 Use in special populations

Pregnancy & Lactation

Although there are no clinical studies in pregnant or lactating women, Acebrophylline should be avoided in these women, unless the benefits outweigh the risks.

4.7 Effects on ability to drive and use machines

Brophyle SR Tablet does not usually affect the ability to drive.

4.8 Undesirable effects

Commonly reported adverse effects with Acebrophylline include abdominal discomfort, stomach/abdominal distension, vomiting, abdominal pain, diarrhea, constipation, heart burn, loss of appetite, esophageal bleeding, rashes, urticaria, itching, drowsiness, difficulty in breathing, leukocytosis and nasal inflammation. If chills and fever occur the drug should be immediately discontinued.

Rarely occurring adverse events include headache, occasional numbness including numbness in arm, insomnia, tachycardia, fatigue, hypertension, albuminuria, glycosuria, hypotension and occasionally hyperglycemia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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

In the event of overdose, the stomach may be emptied by gastric lavage within 2 hrs of overdose. Elimination may also be enhanced by repeated oral doses of activated charcoal. Treatment is symptomatic and supportive.

5.1 Mechanism of Action / Pharmacodynamic Properties

Acebrophylline is an airway mucus regulator with anti-inflammatory actions. It has a multimodal mechanism of action involving effects on the pulmonary surfactant, bronchial secretions, phospholipase A and Phosphodiesterases. Theophylline-7-acetate, as with other xanthine derivatives, has a bronchodilator effect due to inhibition of the intracellular phosphodiesterases, followed by an increase of cyclic adenosine monophosphate levels, which promote the relaxation of bronchial muscles. Acebrophylline produces bronchodilation by specifically inhibiting phosphodiesterase III and IV.

Acebrophylline inhibits phospholipase A, and phosphatidylcholine leading to lesser production of the powerful pro-inflammatory substances like leukotrienes and tumour necrosis factor. By inhibiting the synthesis and release of these inflammatory mediators, Acebrophylline reduces inflammation, a key factor in airway obstruction, especially in chronic forms.

Acebrophylline increases the synthesis and secretion of pulmonary surfactants by acting on two levels of surfactant synthesis: the first involving ambroxol’s established action on phosphocholine-cytidyl-transferase and the second probably because of theophylline-7 acetic acid’s action on choline-kinase.

Ambroxol modifies the mucous gel phase of secretions by decreasing the viscosity and increasing the serous gel phase. It increases the mucociliary clearance by stimulating cilia motility. Thus, it has mucoregulatory, mucosecretory as well as mucokinetic actions, thereby normalizing the quantity & quality of pulmonary secretions.

5.2 Pharmacokinetic properties

On administration of 200 mg SR oral Acebrophylline, the two components of the molecule – ambroxol and theophylline-7-acetate are released in the stomach and absorbed in the intestines, reaching optimal concentrations of ambroxol and very low levels of theophylline- 7- acetic acid.

Thus it appears that the latter is either poorly absorbed or metabolized very fast and is eliminated in a fairly short time. Its low blood levels mean it is not likely to cause the untoward effects seen after theophylline, whose therapeutic window corresponds to much higher plasma concentrations (10-20 mcg/mL). Acebrophylline reaches its peak in serum (mean Cmax 136.458 +/- 7.079 ng/mL) at 1.708 +/- 0.550 hrs.

The elimination half-life of Acebrophylline is about 6.632 +/- 0.439 hrs. The drug is metabolized in the liver and eliminated renally.

6.1 Animal Toxicology or Pharmacology

No known animal toxicology data

Acebrophylline (Ambroxol theophylline-7-acetate) is the salt obtained by reaction of equimolar amounts of ambroxol, a drug showing mucolytic and expectorant properties, and theophylline-7-acetic acid, a xanthine derivative with specific bronchodilator activity.

Acebrophylline is obtained by targeted salification of the ambroxol base [trans-4(2-amino-3, 5 dibromobenzylamino)cyclohexanol] and theophylline 7 acetic acid. The carboxyl group of theophylline-7-acetic acid is salified with ambroxol’s amine group in a stoichiometric ratio (38.7% acid and 61.3% base) that ensures, after absorption, high plasma levels of ambroxol with low levels of the xanthine derivative which are nevertheless high enough to ensure a carrier effect for ambroxol. This means that one hour after administration lung levels of ambroxol are 45% higher than in subjects treated with ambroxol alone.

Its molecular formula is C₂₂H₂₈Br₂N₆O₅ and its molecular weight is 616.3.

8.1 Incompatibilities

Not applicable

8.2 Shelf-life

Refer on pack

8.3 Storage and handing instructions

Store below 30°C. Protect from light & moisture.

Keep out of reach of children.

• You have been prescribed Brophyle SR Tablet for prevention and treatment of asthma and chronic obstructive pulmonary disease (COPD).
• It should be taken at the same time each day, preferably in the evening after food.
• It does not work right away and should not be used to relieve sudden breathing problems. Always keep a fast-acting (rescue) inhaler with you.
• Your doctor may take regular blood test to monitor potassium level and the level of this medicine in your body.
• Notify your doctor if you have ever been diagnosed with kidney, liver or heart disease, or if you have a smoking history. Your dose may need to be adjusted.
• Do not discontinue use without consulting your doctor, even if you feel better.

16.09.2022

Multivitamin, Multimineral & Antioxidants Capsules

Each soft gelatin capsule contains:

Pyridoxine Hydrochloride IP 1.5 mg

Niacinamide IP 15 mg

Cyanocobalamin IP 0.5 mcg

Folic Acid IP 300 mcg

Choline Bitartrate USP 10 mg

Biotin IP 30 mcg

Betacarotene (30% Dispersion) USP 5 mg

Nickel Sulphate equivalent to Elemental Nickel 15 mcg

Zinc Sulphate Monohydrate IP equivalent to Elemental Zinc 7.5 mg

Sodium Selenite Pentahydrate BP equivalent to Elemental Selenium 30 mcg

Copper Sulphate Pentahydrate BP equivalent to Elemental Copper 2.5 mg

Chromium Picolinate IP equivalent to Elemental Chromium 65 mcg

Manganese Sulphate USP equivalent to Elemental Manganese 1.4 mg

Sodium Molybdate Dihydrate BP equivalent to Elemental Molybdenum 25 mcg

Benfotiamine 2 mg

Sodium Borate BP equivalent to Elemental Boron 150 mcg

Dibasic Calcium Phosphate IP equivalent to Elemental Phosphorous 125 mg

Lycopene Preparations (10%) USP 5 mg

Excipients q.s.

In wheat germ oil virgin & flaxseed oil base.

Approved colours used in the capsule shell.

Appropriate overages of Vitamins added.

Soft gelatin capsule.

4.1 Therapeutic Indications

For Vitamins and Mineral deficiency states in adult patients

4.2 Posology and method of administration

Adults and the Elderly:

One capsule daily. Preferably taken one hour after meals. Do not exceed the stated dose.

The capsule should be swallowed whole with water.

Children under 12 years of age:

Bevon Capsules are not recommended for this age group.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the formulation.

4.4 Special warnings and precautions for use

• Whilst taking Bevon Capsules both protein and energy are also required to provide complete nutrition in the daily diet. No other vitamins, minerals or supplements with or without vitamin A should be taken with this preparation except under medical supervision.
• Do not take Bevon Capsules on an empty stomach. Do not exceed the stated dose. Keep out of the reach of children. If symptoms persist, consult your doctor.
• Evidence from Randomised Control Trials suggests that high doses (20-30 mg/day) β-carotene intake may increase the risk of lung cancer in current smokers and those previously exposed to asbestos. This high-risk population should consider the potential risks and benefits of Bevon Capsules, which contain 5 mg of β-carotene per recommended daily dose, before use

4.5 Drug Interactions

Folic acid can reduce the plasma concentration of phenytoin. Zinc Sulphate reduce the absorption of tetracyclines.

4.6 Use in Special Populations

Pregnancy and Breastfeeding Bevon Capsules may be administered during pregnancy and lactation at the recommendation of the Physician.

4.7 Effects on ability to drive and use machines

None anticipated.

4.8 Undesirable effects

Immune system disorders: Hypersensitivity reaction (such as rash)

Gastrointestinal disorders: Gastrointestinal disturbances (such as nausea, vomiting and abdominal pain).

Reporting of suspected adverse reactions

• Reporting suspected adverse reactions after authorisation 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 cases of overdosage due to Bevon therapy have been reported. In case of accidental overdose, discontinue use and seek professional assistance immediately. Any symptoms which may be observed due to the ingestion of large quantities of capsules will be due to the fat soluble vitamin content. Gastric lavage may be necessary to remove drug already released into the stomach. Signs and symptoms such as gastrointestinal disorders like diarrhoea may be associated with an overdose of Bevon.

5.1 Pharmacodynamic properties / Mechanism of action

Beta Carotene

β-carotene is the most prominent and efficient member of the group of carotenoids (natural colorants that occur in the human diet). Carotenoids are red, orange, or yellow, fat-soluble compounds. Alpha, beta, and gamma carotene are considered provitamins because they can be converted to active vitamin A. Beta-carotene is converted to retinol, which is essential for vision and growth. ROS-induced oxidative stress is suggested as being basic to several human diseases. β-carotene has a unique type of antioxidant activity. Beta carotene traps free radicals and studies suggest that it may also reduce tumor development. Studies have shown that vitamin A is essential to the normal growth of epithelial tissues.

Pyridoxine Hydrochloride

The active coenzyme form of vitamin B6 (Pyridoxine) is pyridoxal 5 ’-phosphate. Approximately 80% of the body's total vitamin B6 is present as pyridoxal phosphate in muscle. Pyridoxal phosphate is a coenzyme for many enzymes involved in amino acid metabolism. It is also the co-factor for glycogen phosphorylase, where the phosphate group is catalytically important. Vitamin B6 helps the body to make several neurotransmitters. It is needed for normal brain development and function, and helps the body to make the hormones serotonin and norepinephrine, which influence mood, and melatonin, which helps to regulate the body clock. Along with vitamins B12 and B9 (folicacid), B6 helps to control levels of homocysteine in the blood. In addition, vitamin B6 is important in steroid hormone action where it removes the hormone-receptor complex from DNA binding, terminating the action of the hormones. In vitamin B6 deficiency, this results in increased sensitivity to the actions of low concentrations of estrogens, androgens, cortisol and vitamin D.

Folic Acid

Folate is a water-soluble B-vitamin and enzymatic cofactor that is necessary for the synthesis of purine and thymidine nucleotides as well as for synthesis of methionine from homocysteine. Tetrahydrofolate (TH4-folate) is the biologically active form of folic acid. The main role of folic acid in biochemistry is the single-carbon transfer reaction (e.g. transfer of a methyl, methylene, or formyl group). Folic acid is involved in the transformation of certain amino acids as well as in the synthesis of purines and dTMP (2'-deoxythymidine-5'-phosphate) needed for the synthesis of nucleic acid (DNA), required by all rapidly growing cells. In humans, folate deficiency results in serious pathologies, the most important of which are neural tube defects, megablastic anemia, acceleration of the arteriosclerotic process, changes in the central nervous system, and the development of certain types of cancer.

Cyanocobalamin

Vitamin B12 is found only in foods of animal origin. Vitamin B12 is essential for cellular DNA synthesis and hence contributes to functions of various tissues of the body, formation of myelin sheath, more so the rapidly dividing and proliferating cellular systems such as blood and gastric epithelium. The absorbed inert form of cyanocobalamin is converted into two important active forms. One is methylcobalamin-involved in maturation of red blood corpuscles. The second active form is adenosylcobalamin involved in healthy myelination and neuronal integrity. Methylcobalamin deficiency leads to folate trap resulting in megaloblastic anemia. Deficiency of adenosylcobalamin leads to accumulation of large amount of methylmalonyl-CoA resulting in synthesis and incorporation of nonphysiological fatty acids into neuronal lipids, causing, demyelination, axonal degeneration and neuronal death leading to neurological complications.

Zinc Sulphate

Zinc is an essential trace mineral necessary for the proper function of about 300 different enzymes. Therefore, zinc plays a role in virtually all biochemical pathways and physiological processes in the body. Thirty percent of the body's zinc is stored in the bones and 60% in muscles. The other 10% is found in virtually all body tissues. Zinc is important for wound healing, immune system support and to increase fertility (sperm production). It also assists digestion, energy production, growth, cellular repair, collagen synthesis, bone strength, cognitive function, and carbohydrate metabolism (glucose utilization and insulin production). Zinc not only modulates cell-mediated immunity but is also an antioxidant and anti-inflammatory agent. Mild zinc deficiencies are currently thought to cause chronic metabolic derangement leading to or exacerbating immune deficiency, gastrointestinal problems, endocrine disorders, neurologic dysfunction, cancer, accelerated aging, degenerative disease, and more.

Niacinamide

Niacin was discovered as a nutrient during studies of pellagra. It is not strictly a vitamin since it can be synthesized in the body from the essential amino acid tryptophan. Two compounds, nicotinic acid and nicotinamide, have the biologic activity of niacin; its metabolic function is as the nicotinamide ring of the coenzymes NAD and NADP in oxidation-reduction reactions. Nicotinamide has important role in DNA repair mechanism.

Biotin

Biotin (Vitamin B7 or H) is a water soluble B vitamin that is essential for bodily health. It helps the body to process fat and sugars, and it helps form a critical process in fat production in the body. Biotin is involved in a number of carboxylase reactions. Biotin is often recommended as a dietary supplement for healthy skin, hair and nails. Biotin deficiency is characterized by development of a fine scaly dermatitis, hair loss, conjunctivitis, ataxia and delayed development.

Sodium Molybdate Dihydrate

Molybdenum belongs to a group of essential microelements. Molybdenum-containing enzymes catalyze basic metabolic reactions in the nitrogen, sulfur, and carbon cycles and are important for variety of metabolic pathways.

Copper Sulphate Pentahydrate

Copper is a trace element present in all tissues and is required for cellular respiration, peptide amidation, neurotransmitter biosynthesis, pigment formation, and connective tissue strength. Copper is a cofactor for numerous enzymes and plays an important role in central nervous system development. Copper is essential for brain development during foetal and post-natal growth, and maintenance of brain health throughout life (including effective anti-oxidative defence), efficient communication between nerve cells, maintenance of healthy skin and connective tissue, wound healing, structural integrity and function of heart and blood vessels, growth of new blood vessels, proper structure and function of circulating blood cells, formation of the cells of immune system, maintenance of a healthy and effective immune response and generation and storage of energy in the mitochondria.

Sodium Selenate

Selenium is incorporated into selenoproteins that have a wide range of pleiotropic effects, ranging from antioxidant, immune functions and anti-inflammatory effects to the production of active thyroid hormone. Low selenium status has been associated with increased risk of mortality, poor immune function, and cognitive decline. Selenium supplementation has antiviral effects, is essential for male and female reproduction, and reduces the risk of autoimmune thyroid disease. Prospective studies have generally shown some benefit of higher selenium status on the risk of various cancers.

Chromium Picolinate

Chromium is a critical cofactor in the action of insulin. Results from some trials have indicated that chromium supplementation increases muscle gain and fat loss associated with exercise and improves glucose metabolism and the serum lipid profile in patients with or without diabetes. Low chromium levels can increase blood sugar, triglycerides, cholesterol levels, and increase the risk for a number of conditions, such as diabetes and heart disease.

Manganese Sulphate

Manganese is an essential element for humans and is required for growth, development, and maintenance of health. Manganese is necessary for a variety of metabolic functions including those involved in skeletal system development, energy metabolism, activation of certain enzymes, nervous system function, immunological system function, and reproductive hormone function. It is an antioxidant that protects cells from damage due to free radicals. Manganese also plays an essential role in regulation of cellular energy, bone and connective tissue growth and blood clotting. In the brain, Manganese is an important cofactor for a variety of enzymes, including the antioxidant enzyme superoxide dismutase, as well as enzymes involved in neurotransmitter synthesis and metabolism.

Choline Bitartrate

Choline is a component of phosphatidylcholine, acetylcholine, lecithin, sphingomyelin, cell membranes, plasma lipoproteins and platelet activating factors. Lecithin and sphingomyelin participate in signal transduction, an essential process for cell growth, regulation and function.

Benfotiamine

Thiamine (Vitamin B1) is considered as an essential micronutrient for humans. Due to the low bioavailability of the hydrosoluble forms of thiamine, its liposoluble preparations (benfotiamine) are preferentially used. Benfotiamine, a lipid-soluble analogue of vitamin B1, is a potent antioxidant that is used as a food supplement. Once thiamine enters the cells, it is phosphorylated by thiamine pyrophosphokinase (TPPK), and converted into the coenzyme thiamine pyrophosphate (TPP), the active form of thiamine. TPP is a relevant cofactor for various enzymes fundamental for glucose metabolism. Recent evidences have shown that the administration of thiamine or lipid-soluble derivatives, such as benfotiamine, has positive effects in the diabetic patients. Numerous studies have shown that benfotiamine inhibits three major pathways that lead to the formation of toxic substances such as advanced glycation end products (AGEs).

Sodium Borate

Boron is a trace element which has an important influence on both calcium and magnesium metabolism. Boron is concentrated in the bone, spleen and thyroid indicating boron's functions in bone metabolism and suggesting its potential role in hormone metabolism. Boron is thought to be useful to increase muscle mass; increase muscle strength; maintain bone density; improve calcium absorption and decrease body fat. According to the USFDA, boron is a trace mineral that helps bones to develop and grow normally. Boron supplementation prevent atherosclerosis, improve brain function and cognitive functioning, reduce HDL cholesterol, affect thyroid hormone levels, alleviate harmful effects of vitamin D, magnesium, and potassium deficiency in postmenopausal bone loss, play a role in the prevention of osteoporosis and prevent calcium loss in postmenopausal women.

Nickel Sulphate

Nickel is a trace mineral that is required by body, but only in very small amount. Small amounts of nickel are found in DNA and RNA. Nickel plays a role in the circulation of some proteins and contributes to the production of hormones, lipids, and cell membranes. Nickel is also used to break down glucose for energy.

Dibasic Calcium Phosphate

Next to calcium, phosphorus is the most abundant mineral in the body. These 2 important nutrients work closely together to build strong bones and teeth. Phosphorus, an essential mineral, is naturally present in many foods and available as a dietary supplement. Phosphorus is a component of bones, teeth, DNA, and RNA. About 85% of phosphorus can be found in bones and teeth, but it is also present in cells and tissues throughout the body. The health benefits of phosphorous include healthy bone formation, provide strength to bones and teeth, improved digestion, regulated excretion, protein formation, hormonal balance, improved energy extraction, cellular repair, optimized chemical reactions and proper nutrient utilization. Phosphorus deficiency (hypophosphatemia) is rare in the United States and is almost never the result of low dietary intakes. The effects of hypophosphatemia can include anorexia, anemia, proximal muscle weakness, skeletal effects (bone pain, rickets, and osteomalacia), increased infection risk, paresthesias, ataxia, and confusion. In most cases, hypophosphatemia is caused by medical conditions, such as hyperparathyroidism, kidney tubule defects, and diabetic ketoacidosis.

Lycopene

Lycopene, a non-provitamin A carotenoid prominently present in red fruits such as tomatoes, exhibits several health benefits. Its potent antioxidant properties protect cells from oxidative stress, thereby reducing the risk of carcinogenesis, cardiovascular pathologies, diabetes and neurodegenerative ailments. Lycopene's potential in modulating lipid metabolism, particularly by attenuating low-density lipoprotein (LDL) cholesterol levels, thus confers cardioprotective effects. Lycopene's antioxidant and anti-inflammatory properties may aid in glycemic control and mitigating diabetic complications. It also exhibits a protective effect on ocular health by preventing age-related macular degeneration and cataractogenesis. Additionally, it is a nutraceutical that protects against a wide variety of heart, liver, bone, skin, nervous, and reproductive system diseases.

5.2 Pharmacokinetic properties

Beta Carotene

Except when liver function is impaired, Vitamin A is readily absorbed. β-carotene (as in Bevon Capsules) is Provitamin A and is the biological precursor to Vitamin A. It is converted to Vitamin A (Retinol) in the liver; retinol is emulsified by bile salts and phospholipids and absorbed in a micellar form. Part is conjugated with glucuronic acid in the kidney and part is metabolised in the liver and kidney, leaving 30 to 50% of the dose for storage in the liver. It is bound to a globulin in the blood. Metabolites of Vitamin A are excreted in the faeces and the urine.

Pyridoxine Hydrochloride

Pyridoxine is absorbed from the gastro-intestinal tract and converted to the active pyridoxal phosphate which is bound to plasma proteins. It is excreted in the urine as 4-pyridoxic acid.

Cyanocobalamin

Cyanocobalamin is absorbed from the gastro-intestinal tract and is extensively bound to specific plasma proteins. A study with labelled Vitamin B12 showed it was quickly taken up by the intestinal mucosa and held there for 2-3 hours. Peak concentrations in the blood and tissues did not occur until 8-12 hours after dosage with maximum concentrations in the liver within 24 hours. Cobalamins are stored in the liver, excreted in the bile and undergo enterohepatic recycling. Part of a dose is excreted in the urine, most of it in the first eight hours.

Dibasic Calcium Phosphate

The body contains from 600-800 g of phosphorus, over 80% of which is present in the bone as phosphate salts, mainly hydroxyapatite crystals. The phosphate in these crystals is available for exchange with phosphate ions in the extra-cellular fluids.

Folic Acid

Folic acid is absorbed mainly from the proximal part of the small intestine. Folate polyglutamates are considered to be deconjugated to monoglutamates during absorption. Folic acid rapidly appears in the blood where it is extensively bound to plasma proteins. Some folic acid is distributed in body tissues, some is excreted as folate in the urine and some is stored in the liver as folate.

Zinc Sulphate

Zinc is poorly absorbed from the gastro-intestinal tract. It is widely distributed throughout the body. It is excreted in the faeces with traces appearing in the urine.

Biotin

Following absorption, biotin is stored in the liver, kidney and pancreas.

Sodium Selenate

Although it has been established that selenium is essential to human life, very little information is available on its function and metabolism.

Chromium Picolinate

Most chromium compounds are soluble at the pH of the stomach, but less soluble hydroxides may form as pH is increased. The environment of the gastrointestinal tract and ligands provided by foods and supplements are important for mineral absorption.

Sodium Molybdate Dihydrate

In humans, molybdenum is known to function as a cofactor for four enzymes: Sulfite oxidase catalyzes the transformation of sulfite to sulfate, a reaction that is necessary for the metabolism of sulfur-containing amino acids (methionine and cysteine). In humans, molybdenum is known to function as a cofactor for four enzymes: Sulfite oxidase catalyzes the transformation of sulfite to sulfate, a reaction that is necessary for the metabolism of sulfur-containing amino acids (methionine and cysteine).

Nickel Sulphate

Nickel plays a role in the circulation of some proteins and contributes to the production of hormones, lipids, and cell membranes. Nickel is also used to break down glucose for energy. Nickel serve as a cofactor or structural component of specific metalloenzymes of various functions, including hydrolysis and redox reactions and gene expression. Also serve as a cofactor facilitating ferric iron absorption or metabolism. Nickel is necessary for the biosynthesis of the hydrogenase, carbon monoxide dehydrogenase, and of factor F-430. Nickel is a constituent part of all organs of vertebrates. Small amounts of nickel are found in DNA and RNA. Nickel therefore performs a vital function in metabolism and it is an essential element.

Sodium Borate

Studies with humans indicate that about 90 percent of boron is absorbed in the normal intake range. Most dietary boron is hydrolysed within the gut to yield B(OH)3 which, as a neutral compound, is easily absorbed. Boron chemistry suggests it is transported in the blood as B(OH)3. Specifically, because boron forms labile complexes in aqueous solution, transport is probably as free boric acid rather than a complex. The blood boron concentration is dependent on dietary intake as primarily shown by animal studies.

Benfotiamine

Thiamine is absorbed from the gastro-intestinal tract and is widely distributed to most body tissues. Amounts in excess of the body's requirements are not stored but excreted in the urine as unchanged thiamine or its metabolites.

Niacinamide

Nicotinic acid is absorbed from the gastro-intestinal tract, is widely distributed in the body tissues and has a short half-life.

Copper

Copper is absorbed from the gastro-intestinal tract and its major route of excretion is in the bile.

Manganese Sulphate

Manganese salts are poorly absorbed.

Choline Bitartrate

Very little information is available on its function and metabolism.

Lycopene

Lycopene absorption occurs via passive diffusion or facilitated by scavenger receptor class B type 1 (SR-B1) in enterocytes, potentially alongside other carotenoids. Partial cleavage by enzymes like Beta-Carotene Oxygenase 1 (BCO1) and Beta-Carotene Oxygenase 2 (BCO2) in enterocytes may occur. Transport involves packaging into chylomicrons, then release into the lymph and portal circulation. Lycopene primarily associates with LDL and is distributed to various organs, notably accumulating in the liver but also present in adipose tissue, adrenal glands, testes, ovaries, kidneys, lungs, skin, and the prostate. Lycopene and its metabolites are primarily eliminated from the body through fecal excretion, a smaller portion may be excreted via urine.

6.1 Animal toxicology or Pharmacology

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the prescribing information.

Bevon capsules contain a comprehensive formula of vitamins, minerals and antioxidants specially designed to support health and well-being in adults by unlocking energy and strengthening immunity. Most vitamins, minerals and trace elements are not produced by human body and hence are dependent on dietary supply of these nutrients. Since vitamins, minerals and trace elements are involved in many metabolic processes in the body, an adequate supply of these vital substances contribute to physical and mental well-being.

8.1 Incompatibilities

No major incompatibilities are known.

8.2 Shelf life

24 Months

8.3 Packaging information

A blister strip of 15 capsules.

8.4 Storage and handling instructions

Store in a cool & dry place. Protect from light.

Keep out of reach of children.

Do not take Bevon Capsules:

• if you are allergic (hypersensitive) to any of the ingredients of Bevon Capsules
• if you suffer from hypercalcaemia (high level of calcium in the blood)
• Do not give Bevon Capsules to children aged under 12.

Take special care with Bevon Capsules

Before you are given Bevon Capsules tell your doctor, dietician or pharmacist if:

• you are pregnant or thinking of becoming pregnant
• you are a smoker

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before taking Bevon Capsules.

Taking other medicines

Tell your doctor if you are taking or have recently taken/used any of the following medicines as they may interfere with Bevon Capsules:

• Phenytoin (used to treat epilepsy)
• Tetracycline antibiotics (used to treat infections) such as doxycycline and minocycline.

Please tell your doctor if you are taking or have recently taken/used any other medicines including other vitamin or mineral products medicines obtained without a prescription.

06/10/2021