Antibiotics & Anti-Infectives

Category: antiviral
each vial contains:
acyclovir…. . 250mg
quality specification:
chromatographic purity: nlt 99. 5%
pack size: vial

acyclovir: it is deoxiguanosine analog and requires a virus specific enzyme for conversion to the active metabolite that inhibits dna synthesis and viral replication.

composition :	250mg & 500mg
indication :	genital herpes simplex, mucocutaneous h simplex encephalitis, h simplex keratitis, herpes zoster, chicken pox etc.
dosage :	adults: herpes simplex: 200 mg 5 times daily at 4 hrs interval for 5 days herpes zoster: 800 mg 5 times daily 4 hrs interval for 7 days prophylaxis in suppression: 200 mg 4 times daily
children :	(abpve 2 yrs) dose same as adult.
children :	(below 2 yrs) herpes simplex: 100 mg 5 times at 4 hrs interval prophylaxis: 100 mg 4 times daily at 6 hrs interval.
contra-indications :	hypersensitivity, glaucoma, psychiatric diseases, depression etc.
special precautions :	renal impairment necessitates dose reduction. Maintain adequate hydration
paediatrics :	reduced dose necessary. Not recommended in age below 2 years.
pregnancy :	contraindicated orally and parentally.
lactation :	may reduce lactation
purity :	not less than 99%.

Category: Antibiotics and Antiinfectives
Each vial contains:
Ceftazidime….. 250mg , 500mg and 1000mg
Quality Specification:
Chromatographic Purity: NLT 99.5%
Pack Size: vial
 

Composition :	250mg,500mg,1gm
CEFTAZIDIME :	It is a broad spectrum, third generation parenteral cephalosporin effective against many Gram negative organisms.
Indication :	Serious infections of the respiratory tract, E.N.T, skin and soft tissue bone, and joints, biliary and G.I tract. U.T.I. Septicaemia, meningitis.infections in immunocompromised patients
Dosage :
Adults :	1-6 gm daily in divided doses every 8 or 12 hrs
Children (Over 1yr):	30-100 mg/kg body wt per day in 2-3 divided doses. Max 6 gm daily.
Contra-Indications :	Hypersensitivity to penicillins or Cephalosporins
Special Precautions :	Neonates and infants, renal of hepatic impairment, prolong use.
Paediatrics Safe :
Pregnancy & Lactation :	Use with caution
Elderly :	Decrease dose in case of renal impairment
Side–effects :	G.I. disorders, pseudomembranous colitis, candidosis, eosinophilia, neutropenia, leucopenia, thrombocytopenia, rise in liver enzymes and blood urea. Pain at injection site.
Drug interactions :	Aminoglycosides, frusemide used concomitantly leads to nephrotoxicity, Chioramphenicol antagonizes ceftazidime
Purity :	Not less than 99%.

Indication
Used for the treatment of infections caused by aerobic pathogens susceptible to Ceftriaxone.

Including
Lower respiratory tract infections, skin and skin structure infections, urinary tract infections, gonorrhoea (cervical, urethral & rectal), bacterial septicaemia, bone and joint infections, meningitis, surgical prophylaxis etc.
Action
Microbiology
- Ceftriaxone is a semisynthetic broad spectrum cephalosporin antibiotic with bactericidal activity against Gram negative and Gram positive bacteria (including those with beta-lactamases)
Ceftriaxone is usually active against the following pathogens:
- Gram negative anaerobes: E Aerogenes, E Cloacae, E Coli, H Influenzae (including ampicillin resistant strains), Klebsiella SP, N Gonorrhoea (including penicillinase & non penicillinase producing strains), N Meningitis, P Mirabilis, P Vulgaris, M Morganii, S Marcescens, P Aeruginosa (other Pseduomonas SP are usually resistant). Gram positive aerobes: S Aureus (including penicillinase producing strains), S Epidermis (methicillin resistant staphylococci are resistant to cephalosporins, including ceftriaxone), Streptococci SP (most species of group D Streptococci are resistant, including S Faecalis & S Faecium).
Pharmaco-Kinetics:

• Ceftriaxone is poorly absorbed from the gastrointestinal tract
• Following intramuscular administration, peak plasma drug levels are achieved within 2-3 hours
• 33-67% of a dose is excreted as unchanged ceftriaxone in the urine
• The drug is also secreted in the bile and inactive metabolites are also found in the faeces
• In healthy subjects, elimination half lives range from 5.8-8.7 hours in adults, 4.6 hours in children, 7.2-19 hours in neonatals and 4.0-6.6 hours in infants.

Composition :	250mg, 0.5gm and 1 gm
Purity :	Not less than 99%

Category: Antibiotics and Anti-Infectives
Each vial contains:-
Cefuroxime - 500 mg and 1.0 gm
Quality Specification:
Chromatographic Purity - NLT 99.5%
Pack Size: vial

Composition :	250mg,500mg,750mg,1 gm
CEFUROXIME: :-	It is resistant to most beta lactamases and is active against a wide range of Gram-positive and Gram-negative organisms. The most important use of cefuroxime is in meningitis caused by H Influezae, Meningo Cocci and Pneumo Cocci because it attains high concentrations in CSF.
Indication :	Respiratory tract, Genito-urinary tract, skin and soft tissue infections, gonorrhoea, acute gonococal urethritis and cervicitis meningitis, prophylaxis against infections in surgical procedures.
Dosage :-	750 mg thrice daily i.m. or i.v.Severe infections : 1.5 gm thrice daily i.v. Total dose 3-6 gm daily
Infants and Children :-	30-100 mg/kg body wt daily in 3-4 divided doses
Neonates :-	30-100 mg/kg body wt in 2-3 divided doses.
Meningitis :	200-240 mg/kg body wt i.v. daily in 3-4 divided doses.
Contra-Indications :-	Patients with known hypersensitivity to cephalosporin antibiotics
Special Precautions :-	Anaphylactic reaction to Pencilins, Pseudo Membranous Colitis
Paediatrics :-	Not safe in children below 3 months
Pregnancy :-	Use with caution
Lactation :-	Use with caution
Side–effects :-	Skin rashes, Eosinophillia and transient increase of Hepatic Enzymes
Drug Interactions :-	Synergy with aminoglycosides
Purity :	Not less than 99%.

Category: Misc. Preparations
Each vial contains:-
Meropenam - 500 mg and 1 gm
Quality Specification:
Chromatographic Purity - NLT 99.5%%
Pack Size: vial

Composition :	125mg, 250mg,500mg,1gm
MEROPENAM :-	It is a synthetic Carbapenem Beta - Lactum Antibiotic. It has a potent bactericidal action against a broad spectrum of aerobic and anerobic bacteria.
Indication :	Pneumonias, gynecological infections, skin and soft structure infections, meningitis, septicaemia and adult febrile neutropenia.
Dosage and administrations :-	Administered as an intravenous injection over approkximately 5 minutes or by intravenous infusion over approximately 15-30 minutes with compatible infusion (50-200ml) fluid.
Adult :-	Pneumonias, UTI, skin and skin structure infections :500mg 8hourly. Nosocomial Pneumonias, peritonitis, septicemia: 1g every 8hours. Meningitis : 2g every 8 hours
Contra-Indications :-	Hypersensitivity to ingredients. Hypersensitivity to pencilins or other beta-lactam antibiotics.
Warning :
Special Precautions :-
Paediatrics :-	Safety is not established in patient with neutropenia or primary/secondary immuno deficiency. Safety is not established in infants under 3 months of age.
Pregnancy :-	Safety is not established
Lactation :-	Safety is not established.
Elderly :-	Safe for elderly with normal renal functions.
Side–effects :-	Serious adverse effects are rare. Local IV injection site reaction, site reaction and neutrophilia. Headache, paresthesia, convulsions, oral and vaginal candidiasis.
Drug Interactions :-	Nephrotoxic drugs, probenocid, sodium valproate etc.
Purity :	Not less than 99%.

Category: Aminoglycosides
Each vial contains:-
Tobramycin - 20mg, 60mg and 80mg
Quality Specification:
Chromatographic Purity - NLT 99.5%
Pack Size: 2ml vial.

Composition :	20mg/2 ml, 60mg/1.5ml, 80mg/2ml
TOBRAMYCIN: :-	It is an aminoglycoside, highly soluble in water & stable for several week in solutions of various pH.
Indications :	Treatment of external infection of the eye and its adnexa caused by susceptible strains of gram-positive, gram-negative & other probable bacteria. Safe & effective in children.
Dosage :-	1-2 drops in the affected eye(s) every 4 hrs.
Adult :-	Pneumonias, UTI, skin and skin structure infections: 500 mg 8 hourly. Nosocomial Pneumonias, peritonitis, septicemia: 1gm every 8 hours. Meningitis: 2g every 8 hours
Contra-Indications :-	Hypersensitivity
Special Precautions :	Not for injection into the eye. If sensitivity reaction occurs, discontinue.
Paediatrics :-	Safety is not established in patient with neutropenia or primary/secondary immuno-deficiency. Safety is not established in infants under 3 months of age.
Pregnancy :-	Safety is not established.
Lactation :-	Safety is not established.
Elderly :-	Safe for elderly with normal renal functions.
Side–effects :-	Localised ocular toxicity and hypersensitivity including itching and swelling and conjuctival erythema
Purity :	Not less than 99%.

It has expanded spectrum, improved pharmacokinetics and better tolerability and drug interaction profiles. It has good activity against mycobacterium avium complex. It has acid stability and rapid oral absorption. It is largely excreted unchanged in bile. It has no interaction with cytochrome P450.

Composition :	100mg, 200 mg
Indications :	Pharyngitis, tonsillitis, sinusitis, otitis media, pneumonias, acute exacerbations of chronic bronchitis, staphylococcal and streptococcal skin and soft tissue infections, chlamydial pulmonary and genital infections and gonorrhoea. Prophylaxis and treatment of MAC infection in AIDS patients. Other uses like typhoid, toxoplasmosis and malaria are being explored.
Safety Profile :	It is comparatively newer antibiotics, should be used carefully with non-sedative antihistaminics.
Adverse Effects :	Mild gastric upset, abdominal pain, headache, dizziness etc.
Drug Interactions :	No interaction with hepatic cytochrome P450 enzyme
Dosage :	500mg OD orally, URTI/LRTI, skin & soft tissue infections: 500mg OD followed by 250mg OD Children :10mg/kg/day for 3 days
Purity :	Not less than 99%.

Category: Antibiotics and Anti- Infectives
Each vial contains:-
Amikacin - 100mg, 250mg and 500mg
Quality Specification:
Chromatographic Purity - NLT 99.5%
Pack Size : vialM

Composition :	100mg/2ml, 250 mg/2ml & 500mg/2ml
Amikacin:	It is semisynthetic aminoglycoside virtually identical to its parent compound kanamycin. Amikacin is effective against a variety of aerobic gram-negative bacilli including those that are resistant to gentamicin and other Aminoglycosides (Escherichia Coli, Pseudomonas Aeruginosa, Indole positive and negative Proteus species Klebsiella, Enterobacter, Serratia, Acinetobacter, Citobacter Freundii and providencia stuarti). It is effective against both penicillinase and non-penicillinase producing Staphylococcus Aureus. Amikacin shows excellent activity against Mycobacterium Tuberculosis and Atypical Mycobacteria.
Indications :	Bacteraemias, septicaemias, respiratory tract, bone and joints, CNS (including meningitis), soft tissue, intra-abdominal infections (including peritonitis), burns and post-operative infections.
Dosage :	IM route for Adults, Children: 15 mg/kg body weight/day in 2 or 3 divided doses. Max of 1.5 gm/day. Neonatals: 10 mg/kg body weight followed by 7.5 mg/kg every 12 hours IV route dosage is identical, injection spread over 2-3 mins or a slow IV infusion spread over a period of 30-60 mins and for infants and neonatals 1-2 hours.
Contra-Indications:	Known hypersensitive to aminoglycoside.
Special Precautions:	Impaired renal function, ensure adequate hydration.
Paediatrics :	Use with caution.
Pregnancy:	Contra-indicated
Lactation:	Contra-indicated
Elderly :	Use with caution.
Side-Effects:	Contra-indicated
Elderly :	Ototoxicity, Nephrotoxicity, Neuromuscular Blockade, Skin rash, Tremors, Eosinophlia, Nausea, Vomiting.
Purity :	Not less than 99%.

It is a semi synthetic, broad spectrum, fourth generation cephalosporin. It exerts its effects by inhibiting the peptidoglycan synthesis in microbial cell wall.

Composition :	250mg,500mg,1gm,2 gm
Indications :	Moderate to severe pneumonia, septicaemia, UTI, skin & skin structure infections, intra-abdominal infections.
Contraindications :	Impaired hepatic function. Impaired hypertension, hypersensitivity.
Safety Profile :	Pregnancy, lactation, pediatric dose adjustment required.
Drug Interactions :	Aminoglycoside & other antibiotic may increase the nephrotoxicity & ototoxicity.
Dosage :	Febrile neutropenia thrice a day 1-2 gm IV, other 1-2 gm IV.
Purity :	Not less than 99%

It is a cyclic polypeptide containing 11 amino acids. It is a potent immunosuppressive agent, which in animals prolong survival of allogenic transplants involving skin, heart, kidney, pancreas, bone marrow, small intestine and lung. The effectiveness of cyclosporine is due to specific and reversible inhibition of immunocompetent lymphocytes in the Go or G phase of the cell cycle.

Composition :	5gm/50ml
Indications :	Orally used for prevention of graft rejection after kidney, liver, heart, lung, pancreas. By IV infusion used in bone marrow transplant.
Contraindications :	Hypersensitivity. Warnings - Cyclosporine when used in higher doses can cause hepatotoxicity and nephrotoxicity. Vaccinationus are less effective with its use.
Safety Profile :	Elderly, thyrotoxicosis, renal or hepatic diseases and acute myocardial infection.
Adverse Effects :	Hypertension, renal dysfunction hirsutism, acne, tremor, convulsions Gum hyperplasia, Diarrhoea, parasthesias, Flushing, leucopenia, hepatotoxicity and abdominal discomfort.
Drug Interactions :	Nephrotoxicity is potentiated by Vancomycin, Trimethoprim with Sulfamethoxazole, Aminoglycosides, Melphalan, Amphotericin B, Azapropazon, Diclofenac, Ketoconazole, Cimetidine, Ranitidine and Tracolimus. Blood levels of cyclosporine are increased by Nicardipine, Verapamil, Ketoconazole, Fluconazole, Itraconazole, Danazole, Bromocriptine, Metoclopramide, Erythromycin and Methylprednisolone. Blood levels of cyclosporine are decreased by Rifampicin, Phenytoim, Phenobarbitol and Carbemazepine.
Dosage :	Orally (First dose is given in the amount of 10-15 mg/kg/ 4-12 hours before transplantation. This dose is continued daily for 1-2 weeks after which a maintenance dose of 2-6 mg/kg/day is continued) I.V.inf : Starting dose one day before the transplantation. 3-5 mg/kg/day. Continue for 2 weeks after transplant. Then oral maintenance dose of 12.5mg./kg/day in two divided doses for six month to a year.
Purity :	Not less than 99%.

Category Macrolides
Each vial contains:-
Teicoplanin - 200mg and 400mg
Quality Specification:
Chromatographic Purity - NLT 99.5%
Pack Size: vial.

Composition :	200mg & 400mg
Teicoplanin:	It is a glycopeptide antibiotic. It is predominantly bactericidal both against aerobic and anaerobic gram positive bacteria.
Indications:	Severe infections caused by gram positive bacteria, prophylaxis against gram positive endocarditis in dental surgery to high risk heart patients. Intra peritoneal administration to treat peritonitis in partients undergoing chronic ambulatory peritoneal dialysis.
Contra indications:	Hypersensitivity to glycopeptide antibiotics
Side effects:	Pain, phlebitis, abscess at the site of injection, hyper-sensitivity reaction, elevated liver enzymes, transient increase in serum cretinine, eosinophillia, thrombocytopenia, nausea, vomiting,diarrhea etc.
Purity :	Not less than 99%

Vancomycin is an antibiotic used to treat certain heart, bone, joint, lung (respiratory tract), skin, blood, or urinary tract infections. Vancomycin injection can prevent heart infection (endocarditis) in penicillin-allergic patients who are having dental work or surgery.

Composition :	500mg & 1gm
Indications :	Antibiotic for Pseudomembranous Enterocolitis, meningitis.
Contraindications :	Hypersensitivity.
Adverse Effects :	Fever, rashes, redness, hushing etc.
Drug Interactions :	Additive action with other nephrotoxic drugs
Dosage :	Adult : 250-500 mg after 6 hr, Children : 40mg/kg in 4 divided doses, Neonates: 15mg/kg.
Purity :	Not less than 99%