Products Of Vysali Pharmaceuticals

Ampicillin Sodium

SODAMPEN

1g & 500 mg
Powder for injection (iv/im)

FORMULATION

Each vial contains Ampicillin (as As sodium) 1g.

MECHANISM OF ACTION

Ampicillin sodium is a semi synthetic penicillin with an
extended spectrum of antimicrobial activity against most of the Gram ^+ve organism
as well as many Gram ^–ve bacilli. Ampicillin may also be less
susceptible to inactivation by some of the b
lactamase produced by these organisms. Ampicillin is effective against Non-penicillinase
producing Gram ^–ve organisms, Ampicillin is active against most of
the bacteria sensitive to Pencillin-G; but in addition it is active against some
Gram ^–ve bacilli,which are penicillin resistant. Ampicillin has
thus been referred to as a broad spectrum penicillin.

INDICATIONS

Ø
Ampicillin is effectively used in

Ø
Urinary tract Infection

Ø
Typhoid fever and other salmonalla infection

Ø
Respiratory tract infection

Ø
Bacterial meningitis

Ø
Billiary infection

Ø
Other surgical infection

Ø
Venereal disease

Ø
Brucellosis

CONTRAINDICATIONS

Ampicillin is contraindicated in patients known to be
sensitive to Penicillins and it should be used with caution in patients with
known history of allergy.

ADVERSE DRUG REACTIONS

Ampicillin may be cross allergic with oher penicillins, and
in sensitized patients it may evoke any hypersensitivity reactions. Skin rashes
are the most common side effect and are either urticarial or maculopapular.
Ampicillin therapy can cause gastro-intestinal side effect such as nausea and
diarrhoea, but these are not usually serious. These symptoms are usually seen in
children. In adults , diarrhoea may occur in 5-20% of
treated patients and is more common in older age groups. Blood disorders
such as thrombocytopenia occurs in some patients due to Ampicillin therapy.

STORAGE

Ampicillin injection should be stored in a temperature not
exceeding 30^oC.

CAUTION

Foods, drugs, devices and cosmetic act prohibits dispensing
without prescription

Benzylpenicilin

CRYSTACIN

1,000,000 I.U.
powder for injection (im\iv)

FORMULATION

Each vial contains benzylpenicilin (as sodium)
1,000,000I.U.

MECHANISM OF ACTION

It is an narrow spectrum, bactisidal antibiotic having a
rapid on set of action and
maintains effective bactisidal concentration
for 6hr. penicillins act by inhibiting the bacterial cellwall synthesis.

INDICATIONS

Benzylpencillin injection is indicated in the following
cases :

Ø
Bacterial endocarditis

Ø
Skin infection

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Actinomycosis

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Gonococcal arthritis

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Endocarditis

Ø
Anthrax

Ø
Meningitis

Ø
Dental prophylaxis

Ø
Rheumatic fever

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Urinary tract infection

Ø
Gonorrhoea

CONTRAINDICATIONS

It is contraindicated in patients with history of hyper
sensitivity to penicillin. Skin rashes of all types contact dermatitis, fever,
acute glossitis, serum sickness, angioedema, eosinophilia, anaphylaxis and
Arthus phenomenon may occur in allergic individuals. No toxic effect reported.

PRECAUTIONS

1.
Sensitivity test should be carried out before administration of
penicillin

2.
While using it along with aminoglycoside antibiotic it should not be
mixed with them.

3.
care is necessary while using sodium salts of penicillin in patients with
impaired renal function and congestive cardiac failure.

ADVERSE DRUG REACTIONS

STORAGE

Injection should be stored in temperature not exceeding 30^oC

CAUTION

Gentamicin sulfate

GENTROBEX

40mg /ml solution
for injection i.m / i.v

FORMULATION

Each vial contains Gentamicin sulfate 40mg.

MECHANISM OF ACTION

Gentamicin sulfate is a broad spectrum antibiotic which is
effective against a wide range of Gram ^+ve and Gram^-ve
bacteria. It is an ideal choice of treatment in infection of resistant strains
of pseudomonas aerogenosa. It is a bactericidal and acts by interfering with the
synthesis of bacterial proteins.

The principal use of gentamicin is for treatment of sever
systemic and urinary infections caused by organisms insensitive to the other
less toxic antibiotics.

INDICATIONS

Ø
Septicaemia and other sever infections due to aerobic Gram-^ve
bacilli.

Ø
Urinary tract infections

Ø
Staphylococcal infections

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Bacterial endocarditis

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Gastroeteritis

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Chemoprophylaxis in abdominal surgery

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Biliary tract infections

ADVERSE DRUG REACTIONS

Renal damage, partial or total deafness and vestibular
dysfunction have been reported following parenteral administrations of
Gentamicin for a few days. The severity and persistence of the symptoms normally
disappearing when the drug is withdrawn, the ototoxicity is irreversible
provided the recommended doses are not exceeded, Nephrotoxic and ototoxic
symptoms are unlikely to appear in patients with normal renal functions.

Warning

Contains: Sodium metabisulphite, a sulfite that may cause
allergic type reaction including anaphylactic symptoms and life threatening or
less sever asthatic episodes in certain susceptible individuals.

STORAGE

Store at temperature not exceeding 30^oC.

CAUTION

Our New Product Clementin

Clementin

Clementin Drug Description

[Amoxicillin/Clavulanate

Clementin is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the -lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S 3H2O and the molecular weight is 419.46. Chemically, amoxicillin is (2S, 5R, 6R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl) acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[ 3.2.0] heptane-2-carboxylic acid trihydrate.

Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a -lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of -lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid mediated -lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5 and the molecular weight is 237.25. Chemically clavulanate potassium is potassium (Z)-( 2R, 5R)-3-( 2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[ 3.2.0] -heptane-2-carboxylate.

Clementin - Clinical Pharmacology

Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of Clementin. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While Clementin can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. In one study, the relative bioavailability of clavulanate was reduced when Clementin was dosed at 30 and 150 minutes after the start of a high fat breakfast. The safety and efficacy of Clementin have been established in clinical trials where Clementin was taken without regard to meals.

Mean * amoxicillin and clavulanate potassium pharmacokinetic parameters are shown in the table below: Dose * and regimen AUC0-24 (µg. hr/ mL) Cmax (µg/ mL) amoxicillin/ clavulanate potassium amoxicillin (± S. D.) clavulanate potassium (± S. D.) amoxicillin (± S. D.) clavulanate potassium (± S. D.) 250/ 125 mg q8h 26.7 ± 4.56 12.6 ± 3.25 3.3 ± 1.12 1.5 ± 0.70 500/ 125 mg q12h 33.4 ± 6.76 8.6 ± 1.95 6.5 ± 1.41 1.8 ± 0.61 500/ 125 mg q8h 53.4 ± 8.87 15.7 ± 3.86 7.2 ± 2.26 2.4 ± 0.83 875/ 125 mg q12h 53.5 ± 12.31 10.2 ± 3.04 11.6 ± 2.78 2.2 ± 0.99 * Mean values of 14 normal volunteers (n= 15 for clavulanate potassium in the low-dose regmens).

Peak concentrations occurred approximately 1.5 hours after the dose. * Administered at the start of a light meal. Amoxicillin serum concentrations achieved with Clementin are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. The half-life of amoxicillin after the oral administration of Clementin is 1.3 hours and that of clavulanic acid is 1.0 hour. Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of a single Clementin 250 mg or 500 mg tablet. Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.

Clementin - Indications & Dosage

DOSAGE AND ADMINISTRATION

Since both the Clementin 250 mg and 500 mg tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), 2 Clementin 250 mg tablets are not equivalent to 1 Clementin 500 mg tablet. Therefore, 2 Clementin 250 mg tablets should not be substituted for 1 Clementin 500 mg tablet.

Dosage: Adults

The usual adult dose is 1 Clementin 500 mg tablet every 12 hours or 1 Clementin 250 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be 1 Clementin 875 mg tablet every 12 hours or 1 Clementin 500 mg tablet every 8 hours. Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30>

They should receive an additional dose both during and at the end of dialysis. Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)

Pediatric Patients:Pediatric patients weighing 40 kg or more should be dosed according to the adult recommendations. Due to the different amoxicillin to clavulanic acid ratios in the Clementin 250 mg tablet (250/ 125) versus the Clementin 250 mg chewable tablet (250/ 62.5), the Clementin 250 mg tablet should not be used until the pediatric patient weighs at least 40 kg or more.

Administration

Clementin may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Clementin is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Clementin should be taken at the start of a meal.

HOW SUPPLIED Clementin 250 MG TABLETS

Each white oval filmcoated tablet, debossed with Clementin on 1 side and 250/ 125 on the other side, contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

white capsule-shaped tablet, debossed with Clementin 875 on 1 side and scored on the other side, contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

Clementin 125 MG/ 5 ML (125 mg amoxicillin/ 31.25 mg clavulanic acid) FOR ORAL SUSPENSIONN 75 mL bottle or 100 mL bottle

Clementin 250 MG/ 5 ML (250 mg amoxicillin/ 62.5 mg clavulanic acid) FOR ORAL SUSPENSION: ... 100 mL bottle NDC 0029-6090-22........... 150 mL bottle

Clementin 400 MG/ 5 ML (400 mg amoxicillin/ 57 mg clavulanic acid) FOR ORAL SUSPENSION:

The number of bacteriologically evaluable patients was comparable between the two dosing regimens.

Clementin produced comparable bacteriological success rates in patients assessed 2 to 4 days immediately following end of therapy. The bacteriologic efficacy rates were comparable at one of the follow-up visits (5 to 9 days post-therapy) and at a late post-therapy visit (in the majority of cases, this was 2 to 4 weeks post-therapy), as seen in the table below: 875 mg q12h 500 mg q8h 2 to 4 days 81%, n= 58 80%, n= 54 5 to 9 days 58.5%, n= 41 51.9%, n= 52 2 to 4 weeks 52.5%, n= 101 54.8%, n= 104

As noted before, though there was no significant difference in the percentage of adverse events in each group, there was a statistically significant difference in rates of severe diarrhea or withdrawals with diarrhea between the regimens.

INDICATIONS AND USAGE

Clementin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

Lower Respiratory Tract Infections caused by -lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Otitis Media caused by -lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Sinusitis caused by -lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Skin and Skin Structure Infections caused by -lactamase-producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp.

Urinary Tract Infections caused by -lactamase-producing strains of Escherichia coli, Klebsiella spp. and Enterobacter spp.

While Clementin is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to Clementin treatment due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and -lactamase-producing organisms susceptible to Clementin should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against Streptococcus pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and Clementin. (See Microbiology subsection.)

Bacteriological studies, to determine the causative organisms and their susceptibility to Clementin , should be performed together with any indicated surgical procedures. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies to determine the causative organisms and their susceptibility to Clementin when there is reason to believe the infection may involve any of the -lactamase-producing organisms listed above. Once the results are known, therapy should be adjusted, if appropriate.

Clementin - Warnings & Precautions

WARNINGSSERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC)REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/ OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH CLEMENTIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, CLEMENTIN SHOULD BE DISCONTINUED AND THE APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Clementin, and has ranged in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic associated colitis." After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis

.

Clementin should be used with caution in patients with evidence of hepatic dysfunction.

Hepatic toxicity associated with the use of Clementin is usually reversible.

On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide).

These have generally been cases associated with serious underlying diseases or concomitant medications. (See CONTRAINDICATIONS and ADVERSE REACTIONS? Liver.) PRECAUTIONSGeneral While Clementin possesses the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of organ system functions, including renal, hepatic and hematopoietic function, is advisable during prolonged therapy. A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin class antibiotics should not be administered to patients with mononucleosis. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued and/ or appropriate therapy instituted. Drug Interactions: Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Clementin may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid cannot be recommended. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

There are no data with Clementin and allopurinol administered concurrently. In common with other broad-spectrum antibiotics, Clementin may reduce the efficacy of oral contraceptives.

Vysali Pharmaceuticals Edappally

Vysali the world of Antibiotics ,,,,,,,,,,,,,,,,,,,,,,,,,,

For all oral antibiotics

Drugs

A drug is any chemical or biological substance, synthetic or non-synthetic, that when taken into the organism's body, will in some way alter the functions of that organism. This broad definition can be taken to include such substances as food. However more strict applications of the word prevail in everyday life. In these cases the word "drug" is usually used to refer specifically to medicine, vitamins, entheogenic sacraments, consciousness expanding or recreational drugs. Many natural substances such as beers, wines, and some mushrooms, blur the line between food and drugs, as when ingested they affect the functioning of both mind and body. The word "drug" is etymologically derived from the Dutch/Low German word "droog", which means "dry", since in the past, most drugs were dried plant parts[citation needed].
Drugs are usually distinguished from endogenous biochemicals by being introduced from outside the organism. For example, insulin is a hormone that is synthesized in the body; it is called a hormone when it is synthesized by the pancreas inside the body, but if it is introduced into the body from outside, it is called a drug.

Medication

A medication or medicine is a drug taken to cure and/or ameliorate any symptoms of an illness or medical condition, or may be used as preventive medicine that has future benefits but does not treat any existing or pre-existing diseases or symptoms.
Dispensing of medication is often regulated by governments into three categories — over-the-counter (OTC) medications, which are available in pharmacies and supermarkets without special restrictions, behind-the-counter (BTC), which are dispensed by a pharmacist without needing a doctor's prescription, and Prescription only medicines (POM), which must be prescribed by a licensed medical professional, usually a physician.
Most over-the-counter medications are generally considered to be safe enough that most people will not hurt themselves if they are taken as instructed[citation needed]. In the UK, BTC medicines are called pharmacy medicines which can only be sold in registered pharmacies, by or under the supervision of a pharmacist. However, the precise distinction between OTC and prescription drugs depends on the legal jurisdiction.
Medications are typically produced by pharmaceutical companies and are often patented to give the developer exclusive rights to produce them, but they can also be derived from naturally occurring substance in plants called herbal medicine. Those that are not patented (or with expired patents) are called generic drugs since they can be produced by other companies without restrictions or licenses from the patent holder.
Drugs, both medications and recreational can be administered in a number of ways:
Orally, as a liquid or solid (pill), that is absorbed through the stomach.
Inhaled, (breathed into the lungs), as a vapor.
Injected as a liquid either intramuscular or intravenous (put under the skin, into a vein or muscle tissue with the use of a hypodermic needle).
Rectally as a suppository, that is absorbed by the colon.
Vaginally as a suppository, primarily to treat vaginal infections.
Bolus, a substance into the stomach to dissolve slowly.
Many drugs can be administered in a variety of ways.

Drug abuse

Drug abuse has a wide range of definitions related to taking a psychoactive drug or performance enhancing drug for a non-therapeutic or non-medical effect. Some of the most commonly abused drugs include alcohol, amphetamines, barbiturates, cocaine, methaqualone, opium alkaloids, and minor tranquilizers. Use of these drugs may lead to criminal penalty in addition to possible physical, social, and psychological harm, both strongly depending on local jurisdiction.[2] Other definitions of drug abuse fall into four main categories: public health definitions, mass communication and vernacular usage, medical definitions, and political and criminal justice definitions

Drug addiction

Drug addiction is a condition characterized by compulsive drug intake, craving and seeking, despite what the majority of society may perceive as the negative consequences associated with drug use.[2]
Although being addicted implies drug dependence, it is possible to be dependent on a drug without being addicted. People that take drugs to treat diseases and disorders, which interfere with their ability to function, may experience improvement of their condition.
Such persons are dependent on the drug, but are not addicted. One is addicted, rather than merely dependent, if one exhibits compulsive behavior towards the drug and has difficulty quitting it.
To qualify as being dependent a person must
Take a drug regularly
Experience unpleasant symptoms if discontinued, which makes stopping difficult.
Substance abuse can occur with or without dependency, and with or without addiction. Substance abuse is any use of a substance, which causes more harm

Vysali (Pharmaceutical company)

A Vysali, or pharmaceutical company, or drug company, is a commercial business whose focus is to research, develop, market and/or distribute drugs, most commonly in the context of healthcare. They can deal in generic and/or brand medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs. From its beginnings at the start of the 19th Century, the pharmaceutical industry is now one of the most successful and influential, attracting both praise and controversy.

Rahul Soman

Production Pharmacist

sorry seeee u latter