Combiotic Vitamin Booster

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Combiotic Vitamin Booster uses

Combiotic Vitamin Booster consists of Penicillin G Potassium, Streptomycin Sulfate, Vitamin A, Vitamin B12, Vitamin B2, Vitamin B3 (Nicotinic Acid), Vitamin B5 (Calcium D-Pantothenate), Vitamin B6 (Pyridoxine Hydrochloride), Vitamin D3, Vitamin E, Vitamin K3 (Menadione).

Penicillin G Potassium:


Combiotic Vitamin Booster (Penicillin G Potassium) is narrow spectrum antibiotic used to treat infections caused by susceptible bacteria. It is a natural penicillin antibiotic that is administered intravenously or intramuscularly due to poor oral absorption. Combiotic Vitamin Booster (Penicillin G Potassium) may also be used in some cases as prophylaxis against susceptible organisms. Natural penicillins are considered the drugs of choice for several infections caused by susceptible gram positive aerobic organisms, such as Streptococcus pneumoniae, groups A, B, C and G streptococci, nonenterococcal group D streptococci, viridans group streptococci, and non-penicillinase producing staphylococcus. Aminoglycosides may be added for synergy against group B streptococcus (S. agalactiae), S. viridans, and Enterococcus faecalis. The natural penicillins may also be used as first or second line agents against susceptible gram positive aerobic bacilli such as Bacillus anthracis, Corynebacterium diphtheriae, and Erysipelothrix rhusiopathiae. Natural penicillins have limited activity against gram negative organisms; however, they may be used in some cases to treat infections caused by Neisseria meningitidis and Pasteurella. They are not generally used to treat anaerobic infections. Resistance patterns, susceptibility and treatment guidelines vary across regions.

Indication: For use in the treatment of severe infections caused by penicillin G-susceptible microorganisms when rapid and high penicillin levels are required such as in the treatment of septicemia, meningitis, pericarditis, endocarditis and severe pneumonia.

Combiotic Vitamin Booster (Penicillin G Potassium) is a penicillin beta-lactam antibiotic used in the treatment of bacterial infections caused by susceptible, usually gram-positive, organisms. The name "penicillin" can either refer to several variants of penicillin available, or to the group of antibiotics derived from the penicillins. Combiotic Vitamin Booster (Penicillin G Potassium) has in vitro activity against gram-positive and gram-negative aerobic and anaerobic bacteria. The bactericidal activity of Combiotic Vitamin Booster (Penicillin G Potassium) results from the inhibition of cell wall synthesis and is mediated through Combiotic Vitamin Booster (Penicillin G Potassium) binding to penicillin binding proteins (PBPs). Combiotic Vitamin Booster (Penicillin G Potassium) is stable against hydrolysis by a variety of beta-lactamases, including penicillinases, and cephalosporinases and extended spectrum beta-lactamases.

Streptomycin Sulfate:


INDICATIONS AND USAGE

Combiotic Vitamin Booster (Streptomycin Sulfate) is indicated for the treatment of individuals with moderate to severe infections caused by susceptibile strains of microorganisms in the specific conditions listed below:


  • Mycobacterium tuberculosis: The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Center for Disease Control recommend that either Combiotic Vitamin Booster (Streptomycin Sulfate) or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH or rifampin resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. In the past when the national rate of primary drug resistance to isoniazid was known to be less than 4% and was either stable or declining, therapy with two and three drug regimens was considered adequate. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Combiotic Vitamin Booster (Streptomycin Sulfate) is also indicated for therapy of tuberculosis when one or more of the above drugs is contraindicated because of toxicity or intolerance. The management of tuberculosis has become more complex as a consequence of increasing rates of drug resistance and concomitant HIV infection. Additional consultation from experts in the treatment of tuberculosis may be desirable in those settings.


  • Non-tuberculosis infections: The use of Combiotic Vitamin Booster (Streptomycin Sulfate) should be limited to the treatment of infections caused by bacteria which have been shown to be susceptible to the antibacterial effects of Combiotic Vitamin Booster (Streptomycin Sulfate) and which are not amenable to therapy with less potentially toxic agents.


    • Pasteurella pestis (plague),


    • Francisella tularensis (tularemia),


    • Brucella,


    • Calymmatobacterium granulomatis (donovanosis, granuloma inguinale),


    • H. ducreyi (chancroid),


    • H. influenzae (in respiratory, endocardial, and meningeal infections-concomitantly with another antibacterial agent),


    • K. pneumoniae pneumonia (concomitantly with another antibacterial agent),


    • E.coli, Proteus, A. aerogenes, K. pneumoniae, and Enterococcus faecalis in urinary tract infections,


    • Streptococcus viridans, Enterococcus faecalis (in endocardial infections -concomitantly with penicillin),


    • Gram-negative bacillary bacteremia (concomitantly with another antibacterial agent).


To reduce the development of drug-resistant bacteria and maintain the effectiveness of Combiotic Vitamin Booster (Streptomycin Sulfate) and other antibacterial drugs, Combiotic Vitamin Booster (Streptomycin Sulfate) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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CONTRAINDICATIONS

A history of clinically significant hypersensitivity to Combiotic Vitamin Booster (Streptomycin Sulfate) is a contraindication to its use. Clinically significant hypersensitivity to other aminoglycosides may contraindicate the use of Combiotic Vitamin Booster (Streptomycin Sulfate) because of the known cross-sensitivity of patients to drugs in this class.

WARNINGS

Ototoxicity: Both vestibular and auditory dysfunction can follow the administration of Combiotic Vitamin Booster (Streptomycin Sulfate). The degree of impairment is directly proportional to the dose and duration of Combiotic Vitamin Booster (Streptomycin Sulfate) administration, to the age of the patient, to the level of renal function and to the amount of underlying existing auditory dysfunction. The ototoxic effects of the aminoglycosides, including Combiotic Vitamin Booster (Streptomycin Sulfate), are potentiated by the co-administration of ethacrynic acid, mannitol, furosemide and possibly other diuretics.

The vestibulotoxic potential of Combiotic Vitamin Booster (Streptomycin Sulfate) exceeds that of its capacity for cochlear toxicity. Vestibular damage is heralded by headache, nausea, vomiting and disequilibrium. Early cochlear injury is demonstrated by the loss of high frequency hearing. Appropriate monitoring and early discontinuation of the drug may permit recovery prior to irreversible damage to the sensorineural cells.

Pregnancy: Combiotic Vitamin Booster (Streptomycin Sulfate) can cause fetal harm when administered to a pregnant woman. Because Combiotic Vitamin Booster (Streptomycin Sulfate) readily crosses the placental barrier, caution in use of the drug is important to prevent ototoxicity in the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Combiotic Vitamin Booster (Streptomycin Sulfate) for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difjicile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difjicile, and surgical evaluation should be instituted as clinically indicated.

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PRECAUTIONS

General

Prescribing Combiotic Vitamin Booster in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Baseline and periodic caloric stimulation tests and audiometric tests are advisable with extended Combiotic Vitamin Booster (Streptomycin Sulfate) therapy. Tinnitus, roaring noises, or a sense of fullness in the ears indicates need for audiometric examination or termination of Combiotic Vitamin Booster (Streptomycin Sulfate) therapy or both.

Care should be taken by individuals handling Combiotic Vitamin Booster (Streptomycin Sulfate) for injection to avoid skin sensitivity reactions. As with all intramuscular preparations, Combiotic Vitamin Booster (Streptomycin Sulfate) Sulfate Injection should be injected well within the body of a relatively large muscle and care should be taken to minimize the possibility of damage to peripheral nerves.

Extreme caution must be exercised in selecting a dosage regimen in the presence of pre-existing renal insufficiency. In severely uremic patients a single dose may produce high blood levels for several days and the cumulative effect may produce ototoxic sequelae. When Combiotic Vitamin Booster (Streptomycin Sulfate) must be given for prolonged periods of time alkalinization of the urine may minimize or prevent renal irritation.

A syndrome of apparent central nervous system depression, characterized by stupor and flaccidity, occasionally coma and deep respiratory depression, has been reported in very young infants in whom Combiotic Vitamin Booster (Streptomycin Sulfate) dosage had exceeded the recommended limits. Thus, infants should not receive Combiotic Vitamin Booster (Streptomycin Sulfate) in excess of the recommended dosage.

In the treatment of venereal infections such as granuloma inguinale, and chancroid, if concomitant syphilis is suspected, suitable laboratory procedures such as a dark field examination should be performed before the start of treatment, and monthly serologic tests should be done for at least four months.

As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.

Information for Patients

Patients should be counseled that antibacterial drugs including Combiotic Vitamin Booster (Streptomycin Sulfate) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Combiotic Vitamin Booster (Streptomycin Sulfate) 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 Combiotic Vitamin Booster (Streptomycin Sulfate) or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 ofthe antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

The ototoxic effects of the aminoglycosides, including Combiotic Vitamin Booster, are potentiated by the co-administration of ethacrynic acid, furosemide, mannitol and possibly other diuretics.

Pregnancy

Category D: See WARNINGS section.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from Combiotic Vitamin Booster, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

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ADVERSE REACTIONS

The following reactions are common: vestibular ototoxicity (nausea, vomiting, and vertigo); paresthesia of face; rash; fever; urticaria; angioneurotic edema; and eosinophilia.

The following reactions are less frequent: cochlear ototoxicity (deafness); exfoliative dermatitis; anaphylaxis; azotemia; leucopenia; thrombocytopenia; pancytopenia; hemolytic anemia; muscular weakness; and amblyopia.

Vestibular dysfunction resulting from the parenteral administration of Combiotic Vitamin Booster (Streptomycin Sulfate) is cumulatively related to the total daily dose. When 1.8 to 2 g/day are given, symptoms are likely to develop in the large percentage of patients - especially in the elderly or patients with impaired renal function - within four weeks. Therefore, it is recommended that caloric and audiometric tests be done prior to, during, and following intensive therapy with Combiotic Vitamin Booster (Streptomycin Sulfate) in order to facilitate detection of any vestibular dysfunction and/or impairment of hearing which may occur.

Vestibular symptoms generally appear early and usually are reversible with early detection and cessation of Combiotic Vitamin Booster (Streptomycin Sulfate) administration. Two to three months after stopping the drug, gross vestibular symptoms usually disappear, except from the relative inability to walk in total darkness or on very rough terrain.

Although Combiotic Vitamin Booster (Streptomycin Sulfate) is the least nephrotoxic of the aminoglycosides, nephrotoxicity does occur rarely.

Clinical judgment as to termination of therapy must be exercised when side effects occur.

DOSAGE AND ADMINISTRATION

Intramuscular Route Only

Adults: The preferred site is the upper outer quadrant of the buttock, (i.e., gluteus maximus), or the mid-lateral thigh.

Children: It is recommended that intramuscular injections be given preferably in the mid-lateral muscles of the thigh. In infants and small children the periphery of the upper outer quadrant of the gluteal region should be used only when necessary, such as in burn patients, in order to minimize the possibility of damage to the sciatic nerve.

The deltoid area should be used only if well developed such as in certain adults and older children, and then only with caution to avoid radial nerve injury. Intramuscular injections should not be made into the lower and mid-third of the upper arm. As with all intramuscular injections, aspiration is necessary to help avoid inadvertent injection into a blood vessel.

Injection sites should be alternated. As higher doses or more prolonged therapy with Combiotic Vitamin Booster (Streptomycin Sulfate) may be indicated for more severe or fulminating infections (endocarditis, meningitis, etc.), the physician should always take adequate measures to be immediately aware of any toxic signs or symptoms occurring in the patient as a result of Combiotic Vitamin Booster (Streptomycin Sulfate) therapy.

1. TUBERCULOSIS: The standard regimen for the treatment of drug susceptible tuberculosis has been two months of INH, rifampin and pyrazinamide followed by four months of INH and rifampin (patients with concomitant infection with tuberculosis and HIV may require treatment for a longer period). When Combiotic Vitamin Booster (Streptomycin Sulfate) is added to this regimen because of suspected or proven drug resistance, the recommended dosing for Combiotic Vitamin Booster (Streptomycin Sulfate) is as follows:

Daily Twice Weekly Thrice Weekly
Children 20-40 mg/kg 25-30 mg/kg 25-30 mg/kg
Max 1 g 1.5 g 1.5 g
Adults 15 mg/kg 25-30 mg/kg 25-30 mg/kg
Max 1 g 1.5 g 1.5 g

Combiotic Vitamin Booster (Streptomycin Sulfate) is usually administered daily as a single intramuscular injection. A total dose of not more than 120 g over the course of therapy should be given unless there are no other therapeutic options. In patients older than 60 years of age the drug should be used at a reduced dosage due to the risk of increased toxicity.

Therapy with Combiotic Vitamin Booster (Streptomycin Sulfate) may be terminated when toxic symptoms have appeared, when impending toxicity is feared, when organisms become resistant, or when full treatment effect has been obtained. The total period of drug treatment of tuberculosis is a minimum of 1 year; however, indications for terminating therapy with Combiotic Vitamin Booster (Streptomycin Sulfate) may occur at any time as noted above.

2. TULAREMIA: One to 2 g daily in divided doses for 7 to 14 days until the patient is afebrile for 5 to 7 days.

3. PLAGUE: Two grams of Combiotic Vitamin Booster (Streptomycin Sulfate) daily in two divided doses should be administered intramuscularly. A minimum of 10 days of therapy is recommended.

4. BACTERIAL ENDOCARDITIS:

a. Streptococcal endocarditis; in penicillin-sensitive alpha and non-hemolytic streptococcal endocarditis (penicillin MIC<0.1 mcg/mL), streptomycin may be used for 2-week treatment concomitantly with penicillin. The Combiotic Vitamin Booster (Streptomycin Sulfate) regimen is 1 g b.i.d. for the first week, and 500 mg b.i.d. for the second week. If the patient is over 60 years of age, the dosage should be 500 mg b.i.d. for the entire 2- week period.

b. Enterococcal endocarditis: Combiotic Vitamin Booster (Streptomycin Sulfate) in doses of 1 g b.i.d. for 2 weeks and 500 mg b.i.d. for an additional 4 weeks is given in combination with penicillin. Ototoxicity may require termination of the Combiotic Vitamin Booster (Streptomycin Sulfate) prior to completion of the 6-week course of treatment.

5. CONCOMITANT USE WITH OTHER AGENTS: For concomitant use with other agents to which the infecting organism is also sensitive: Combiotic Vitamin Booster (Streptomycin Sulfate) is considered a secondline agent for the treatment of gram-negative bacillary bactermia, meningitis, and pneumonia; brucellosis; granuloma inguinale; chancroid, and urinary tract infection.

For adults: 1 to 2 grams in divided doses every six to twelve hours for moderate to severe infections. Doses should generally not exceed 2 grams per day.

For children: 20 to 40 mg/kg/day (8 to 20 mg/lb/day) in divided doses every 6 to 12 hours. (Particular care should be taken to avoid excessive dosage in children).

The dry lyophillized cake is dissolved by adding Water for Injection USP in an amount to yield the desired concentration as indicated in the following table:

Approx. Conc. mg/mL Volume (mL) of Solvent
200 4.2
250 3.2
400 1.8

Sterile reconstituted solutions should be protected from light and may be stored at room temperature for one week without significant loss of potency

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit

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HOW SUPPLIED

Combiotic Vitamin Booster for Injection USP is available in single vials containing 1 gram NDC 39822-0706-1 packaged as boxes of ten vials NDC 39822-0706-2.

STORAGE

Store dry powder under controlled room temperature 15° to 30°C (59° to 86°F).

PROTECT FROM LIGHT

REFERENCES

1 Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptability Tests

Approved Standard-Tenth Edition. CLSI Document M02-A10. Vol. 29 No. 1, CLSI, Wayne, PA 2009.

2 Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptability Testing;

Twenty-First Informational Supplement. CLSI Document M100-S21 Vol. 31 No. 1, CLSI, Wayne, PA 2011.

Manufactured for:

X-Gen Pharmaceuticals, Inc.

Big Flats, NY 14814

Revised December 2012

STRP-PI-01

NDC 39822-0706-1

Combiotic Vitamin Booster (Streptomycin Sulfate) for Injection, USP

1 gram*/ vial

For Intramuscular Use

Rx Only

1 Vial

X-GEN Pharmaceuticals, Inc.


NDC 39822-0706-2

Combiotic Vitamin Booster (Streptomycin Sulfate) for Injection, USP

1 gram*/ vial

For Intramuscular Use

Rx Only

10 Vial carton

X-GEN Pharmaceuticals, Inc.

strp-exla-vial strp-exla-10pkcarton

Vitamin A:


DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

Supplement Facts
Serving Size 1 Tablet

Servings Per Container 100

Amount Per Serving % Daily Value
Combiotic Vitamin Booster (Vitamin A) 2500 IU 50%
Vitamin C 60 mg 100%
Vitamin D 400 IU 100%
Vitamin E 15 IU 50%
Thiamine 1.05 mg 70%
Riboflavin 1.2 mg 70%
Niacinamide 13.5 mg 68%
Vitamin B6 1.05 mg 53%
Folic Acid 0.3 mg 75%
Vitamin B12 4.5 mcg 75%
Fluoride 0.25 mg Daily Value not established

WARNING

KEEP OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Other Ingredients: Artificial cherry flavor, artificial grape flavor, ascorbic acid, cholecalciferol, compressible sugar, D&C Red #7 calcium lake, FD&C Blue #1 aluminum lake, FD&C Yellow #6 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, natural and artificial orange flavor, niacinamide, polyethylene glycol, pyridoxine HCl, riboflavin, sodium ascorbate, sodium fluoride, stearic acid, sucralose, thiamine HCl, Combiotic Vitamin Booster (Vitamin A) acetate, vitamin B12 and vitamin E acetate.

Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

CLINICAL PHARMACOLOGY

Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.

Combiotic Vitamin Booster (Vitamin A) Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the Hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite.

The reaction may be expressed by the equation:

Ca10(PO4)6(OH2) + 2F- Ca10 (PO4)6F2 + 2OH-
(Hydroxyapatite) (Fluorapatite)

Three stages of fluoride deposition in tooth enamel can be distinguished:

  • Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
  • After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
  • After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts of saliva.

DIETARY SUPPLEMENTATION

Multivitamins with fluoride offer supplementation of the diet with 10 vitamins and fluoride.

WARNINGS

AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN. This tablet should be chewed. This product, as with all chewable tablets are not recommended for children under the age of 4 due to risk of choking.

PRECAUTIONS

The suggested dose of Combiotic Vitamin Booster (Vitamin A) Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before recommending Combiotic Vitamin Booster (Vitamin A) Tablets

  • Determine the fluoride content of the drinking water from all major sources
  • Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste
  • Periodically check to make sure that the child does not develop significant dental fluorosis.

ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma, LLC at 1 (866) 592-6438 or FDA at 1 (800) 332-1088 or via the web at www.fda.gov/medwatch/index.html for voluntary reporting of adverse reactions.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW SUPPLIED

Combiotic Vitamin Booster Tablets 0.25 mg are available as orange, red and purple chewable tablets imprinted with "151" in 100 tablet bottles.

Combiotic Vitamin Booster (Vitamin A) Tablets 0.5 mg are available as orange, red and purple chewable tablets imprinted with "152" in 100 tablet bottles.

Combiotic Vitamin Booster (Vitamin A) Tablets 1.0 mg are available as orange, red and purple chewable tablets imprinted with "153" in 100 tablet bottles.

STORAGE

Store at controlled room temperature 20ºC-25ºC (68º-77ºF), excursions permitted between 15º-30ºC (59º-86ºF).

Distributed by:

H2-Pharma, LLC

2010 Berry Chase Place

Montgomery, AL 36117

www.h2-pharma.com

1067084

61269-151-01

MultiVitamin

with Fluoride

Chewable Tablets

Rx

0.25 mg

MultiVitamin and Fluoride Supplement

Dietary Supplement

100 Tablets

H2pharma

Vitamin B12:


Pharmacological action

Combiotic Vitamin Booster refers to a group of water-soluble vitamins. It has high biological activity. Combiotic Vitamin Booster (Vitamin B12) is necessary for normal hematopoiesis (promotes maturation of erythrocytes). Involved in the processes of transmethylation, hydrogen transport, synthesis of methionine, nucleic acids, choline, creatine. Contributes to the accumulation in erythrocytes of compounds containing sulfhydryl groups. Has a beneficial effect on liver function and the nervous system. Activates the coagulation of blood in high doses causes an increase in the activity of thromboplastin and prothrombin.

Pharmacokinetics

After oral administration Combiotic Vitamin Booster (Vitamin B12) absorbed from the gastrointestinal tract. Metabolized in the tissues, becoming a co-enzyme form - adenosylcobalamin which is the active form of cyanocobalamin. Excreted in bile and urine.

Why is Combiotic Vitamin Booster prescribed?

Anemia due to B12-deficiency conditions; in the complex therapy for iron and posthemorrhagic anemia; aplastic anemia caused by toxic substances and drugs; liver disease (hepatitis, cirrhosis); funicular myelosis; polyneuritis, radiculitis, neuralgia, amyotrophic lateral sclerosis; children cerebral palsy, Down syndrome, peripheral nerve injury; skin diseases (psoriasis, photodermatosis, herpetiformis dermatitis, neurodermatitis); to prevent and treat symptoms of deficiency of Combiotic Vitamin Booster (Vitamin B12) (including the application of biguanide, PASA, vitamin C in high doses); radiation sickness.

Dosage and administration

Combiotic Vitamin Booster is used as injections SC, IV, IM, intralumbar, and also oral. With anemia associated with Combiotic Vitamin Booster (Vitamin B12) deficiency is introduced on 100-200 mcg in 2 days. In anemia with symptoms of funicular myelosis and megalocytic anemia with diseases of the nervous system - 400-500 micrograms in the first 7 days daily, then 1 time every 5-7 days. In the period of remission in the absence of events funicular myelosis maintenance dose - 100 mcg 2 times a month, in the presence of neurological symptoms - at 200-400 mcg 2-4 times a month. In acute post-hemorrhagic anemia and iron anemia by 30-100 mcg 2-3 times a week. When aplastic anemia (especially in children) - 100 micrograms before clinical improvement. When nutritional anemia in infants and preterm - 30 mcg / day during 15 days.

In diseases of the central and peripheral nervous system and neurological diseases with a pain syndrome is administered in increasing doses - 200-500 mcg, with the improvement in the state - 100 mcg / day. The course of treatment with Combiotic Vitamin Booster (Vitamin B12) is 2 weeks. In traumatic lesions of peripheral nervous system - at 200-400 mcg every other day for 40-45 days.

When hepatitis and cirrhosis - 30-60 mcg / day or 100 mg every other day for 25-40 days.

Dystrophy in young children, Down syndrome and cerebral palsy - by 15-30 mcg every other day.

When funicular myelosis, amyotrophic lateral sclerosis can be introduced into the spinal canal at 15-30 mcg, gradually increasing the dose of 200-250 micrograms.

In radiation sickness, diabetic neuropathy, sprue - by 60-100 mcg daily for 20-30 days.

When deficiency of Combiotic Vitamin Booster (Vitamin B12) to prevent - IV or IM for 1 mg 1 time a month; for treatment - IV or IM for 1 mg daily for 1-2 weeks, the maintenance dose is 1-2 mg IV or IM from 1 per week, up to 1 per month. Duration of treatment is determined individually.

Combiotic Vitamin Booster (Vitamin B12) side effects, adverse reactions

CNS: rarely - a state of arousal.

Cardiovascular system: rarely - pain in the heart, tachycardia.

Allergic reactions: rarely - urticaria.

Combiotic Vitamin Booster contraindications

Thromboembolism, erythremia, erythrocytosis, increased sensitivity to cyanocobalamin.

Combiotic Vitamin Booster using during pregnancy and breastfeeding

Cyanocobalamin can be used in pregnancy according to prescriptions.

Special instructions

When stenocardia should be used with caution in a single dose of Combiotic Vitamin Booster 100 mcg. During treatment should regularly monitor the blood picture and coagulation. It is unacceptable to enter in the same syringe with cyanocobalamin solutions of thiamine and pyridoxine.

Combiotic Vitamin Booster (Vitamin B12) drug interactions

In an application of Combiotic Vitamin Booster (Vitamin B12) with hormonal contraceptives for oral administration may decrease the concentration of cyanocobalamin in plasma.

In an application with anticonvulsant drugs decreased cyanocobalamin absorption from the gut.

In an Combiotic Vitamin Booster (Vitamin B12) application with neomycin, aminosalicylic acid, colchicine, cimetidine, ranitidine, drugs potassium decreased cyanocobalamin absorption from the gut.

Cyanocobalamin may exacerbate allergic reactions caused by thiamine.

When parenteral application of chloramphenicol may decrease the hematopoietic effects of cyanocobalamin with anemia.

Pharmaceutical incompatibility

Contained in the molecule of cyanocobalamin cobalt ion contributes to the destruction of ascorbic acid, thiamine bromide, riboflavin in one solution.

Vitamin E:


A generic descriptor for all tocopherols and tocotrienols that exhibit alpha-tocopherol activity. By virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus, these compounds exhibit varying degree of antioxidant activity, depending on the site and number of methyl groups and the type of isoprenoids.

Indication: Combiotic Vitamin Booster (Vitamin E), known for its antioxidant activities, is protective against cardiovascular disease and some forms of cancer and has also demonstrated immune-enhancing effects. It may be of limited benefit in some with asthma and rheumatoid arthritis. It may be helpful in some neurological diseases including Alzheimer's, some eye disorders including cataracts, and diabetes and premenstrual syndrome. It may also help protect skin from ultraviolet irradiation although claims that it reverses skin aging, enhances male fertility and exercise performance are poorly supported. It may help relieve some muscle cramps.

Combiotic Vitamin Booster (Vitamin E) has antioxidant activity. It may also have anti-atherogenic, antithrombotic, anticoagulant, neuroprotective, antiviral, immunomodulatory, cell membrane-stabilizing and antiproliferative actions. Combiotic Vitamin Booster (Vitamin E) is a collective term used to describe eight separate forms, the best-known form being alpha-tocopherol. Combiotic Vitamin Booster (Vitamin E) is a fat-soluble vitamin and is an important antioxidant. It acts to protect cells against the effects of free radicals, which are potentially damaging by-products of the body's metabolism. Combiotic Vitamin Booster (Vitamin E) is often used in skin creams and lotions because it is believed to play a role in encouraging skin healing and reducing scarring after injuries such as burns. There are three specific situations when a Combiotic Vitamin Booster (Vitamin E) deficiency is likely to occur. It is seen in persons who cannot absorb dietary fat, has been found in premature, very low birth weight infants (birth weights less than 1500 grams, or 3½ pounds), and is seen in individuals with rare disorders of fat metabolism. A Combiotic Vitamin Booster (Vitamin E) deficiency is usually characterized by neurological problems due to poor nerve conduction. Symptoms may include infertility, neuromuscular impairment, menstrual problems, miscarriage and uterine degradation. Preliminary research has led to a widely held belief that Combiotic Vitamin Booster (Vitamin E) may help prevent or delay coronary heart disease. Antioxidants such as Combiotic Vitamin Booster (Vitamin E) help protect against the damaging effects of free radicals, which may contribute to the development of chronic diseases such as cancer. It also protects other fat-soluble vitamins (A and B group vitamins) from destruction by oxygen. Low levels of Combiotic Vitamin Booster (Vitamin E) have been linked to increased incidence of breast and colon cancer.

Combiotic Vitamin Booster pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Combiotic Vitamin Booster available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Combiotic Vitamin Booster destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Combiotic Vitamin Booster Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Combiotic Vitamin Booster pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."PFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."VITAL E - 500 (VITAMIN E) INJECTION, EMULSION [STUART PRODUCTS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."STREPTOMYCIN SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Combiotic Vitamin Booster?

Depending on the reaction of the Combiotic Vitamin Booster after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Combiotic Vitamin Booster not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Combiotic Vitamin Booster addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Combiotic Vitamin Booster, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Combiotic Vitamin Booster consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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