Thursday, March 27, 2014
Cefuroxime
Indication
Cefuroxime is indicated in the treatment of
1. Upper respiratory tract
infections: For example, ear, nose and throat infections such as otitis media,
sinusitis, tonsillitis and pharyngitis.
2. Lower respiratory tract
infections: For example, acute bronchitis, acute exacerbations of chronic bronchitis
and pneumonia.
3. Skin and sft tissue
infections: Such as furunculosis, pyoderma and impetigo.
4. Genilo-urinary tract
infections: Such as pyelonephritis, urethritis and cystitis.
5. Gonorrhoea: Acute
uncomplicated gonococcal urethritis and cervicitis.
6. Early lyme disease and
subsequent prevention of late Lyme disease.
Pharmacology
Cefuroxime is a well-characterized and effective antibacterial
agent, which has broad-spectrum bactericidal activity against a wide range of common
pathogens, including β-lactamase producing strains. Cefuroxime has good stability
to bacterial β-lactamase and consequently, is active against many
ampicillin-resistant and amoxycillin-resistant strains.
Composition
Cefuroxime 125 mg tablet: Each film coated tablet
contains Cefuroxime 125 mg as Cefuroxime axetil BP.
Cefuroxime 250 mg tablet: Each film coated tablet
contains Cefuroxime 250 mg as Cefuroxime axetil BP.
Cefuroxime 500 mg tablet: Each film coated tablet
contains Cefuroxime 500 mg as Cefuroxime axetil BP.
Cefuroxime powder for suspension (70 ml): Each 5 ml
reconstituted suspension contains 125 mg Cefuroxime, as Cefuroxime axetil BP.
Cefuroxime 750 mg IM/IV injection: Each vial contains Cefuroxime
750 mg, as Cefuroxime sodium BP.
Cefuroxime 1.5 gm IV injection: Each vial contains
Cefuroxime 1.5 gm, as Cefuroxime sodium BP.
Dosage and Administration
Adults: Most
infections well respond to 250 mg b.i.d. In mild to moderate lower respiratory tract
infections e.g bronchitis 250 mg b.i.d. should be given. For more severe lower
respiratory tract infections or if pneumonia is suspected then 500 mg b.i.d.
should be given.
For urinary tract infections
a dose of 125 mg b.i.d. is usually adequate, in pyelonephritis the recommended dose
is 250 mg b.i.d. A single dose of one gram is recommended for the treatment of uncomplicated
gonorrhea.
Lyme disease in adults and
children over the age of 12 years: The recommended dose is 500 mg b.i.d. for 20
days.
Children:
The usual dose is 125 mg b.i.d. or 10 mg/kg b.i.d. to a maximum of 250 mg
daily.
For otitis media, in
children less than two years of age the usual dosage is 125 mg b.i.d. or 10
mg/kg b.i.d. to a maximum of 250 mg daily and in children over two years of age
250 mg b.i.d. or 15 mg/kg b.i.d. to a maximum of 500 mg daily.
There is no experience in
children under three months of age. The usual course of therapy in seven days. Cefuroxime
should be taken after food for optimum absorption.
Parental Dosage
Adults: Cefuroxime
750 mg to 1.5 g IM or IV every 8 hourly, usually 50 to 10 days.
Preoperative
prophylaxis: For clean contaminated or potentially contaminated surgical procedures,
administer 1.5 g IV prior to surgery ( half to one hour before ). Thereafter,
give 750 mg iV or IM every 8 hours when the procedure is prolonged.
Infants
and Children (>3 months): 50 to100 mg/kg/day in
equally divided doses every 6 to 8 hours. Use 100 mg/kg/day (not to exceed the
maximum adult dose) for more severe or serious infections.
Bone
and Joint Infections: 150 mg/kg/day (not to exceed the maximum
adult dose) in equally divided doses every 8 hours.
Bacterial
meningitis: Initially 200 to 240 mg/kg/day IV in divided
doses every 8 hours.
Direction for Reconstitution
Cefuroxime 750 mg intramuscular Injection: Add 3 ml water
for injection BP and shake gently for dispersion
For 750 mg intravenous
injection: Add 6 ml water for injection BP and shake gently for dispersion.
For 1.5 mg intravenous
injection: Add 16 ml water for injection BP and shake gently for dispersion.
For Suspension: shake the
bottle well before adding water. Then add 35 ml of boiled and cooled water
(with the help of the provided cup from different company) to the bottle. Then
continue shaking the bottle until the powder is dissolved property.
Contraindication
Cefuroxime is
contraindicated in patients with known allergy to Cephalosporins.
Side Effect
Cefuroxime has been
associated with nausea and vomiting in a small number of patients.
Acute Over dosage
Excessively large dosage of
all cephalosporins can cause cerebral irritation and may cause convulsions.
This complication is unlikely to occur in routine practice unless the patient
is in renal failure hemodialysis or peritoneal dialysis can remove Cefuroxime.
Precaution
As with antibiotics,
prolonged use of Cefuroxime may result in the over growth of non-susceptible organisms
(e.g. Canada enterococci, Clostridium difficult), which may require
interruption of treatment.
Use in Pregnancy and Lactation
While all antibiotics should
be avoided in the first trimester if possible. Cefuroxime has been safety used
in later pregnancy to treat urinary and other infections. The placental
transfer of Cefuroxime into the fetus was studied in 20 women and
therapeutically active concentrations were found in the serum of infants for up
to 6 hours after delivery. Cefuroxime is excreted in human milk and
consequently caution should be exercised when Cefuroxime is administered to a
nursing mother.
Drug Interaction
No potentially hazardous
interactions have been reported.
Storage Condition
Tablet:
Store below 30 degree C, protected from light and moisture.
Suspension:
Store below 25 degree C, protected from light and moisture.
Injection:
Store below 25 degree C, protected from light and moisture. Use reconstituted
solution immediately. The reconstituted solution is stable for 2 hours at room
temperature and for 12 hours when refrigerated at 2 degree to 8 degree Celsius.
How Supplied from different companies
Cefuroxime 125 mg tablet: Box containing 20 tablets in blister pack.
Cefuroxime 250 mg tablet: Box containing 20 tablets in blister pack.
Cefuroxime 500 mg tablet: Box containing 20 tablets in blister pack.
Cefuroxime powder for suspension (70 ml): Bottle containing 70 ml suspension (after
reconstitution).
Cefuroxime 750 mg IM/IV injection: Pack of 1 vial containing Cefuroxime 750 mg as
Cefuroxime sodium BP accompanied by a solvent ampoule of 10 ml water for
injection. It also contains a complementary pouch comprised of disposable
syringe (10 ml) needle, alcohol pad and first aid bandage.
Friday, March 21, 2014
Bromazepam
Description
:
Bromazepam
is a global anxiolytic with smooth and supprior efficacy. It is one of the
benzodiazepines having no side-effects like other benzodiazepines. It
effectively manages anxiety and also removes anxiety related various physiological
problems.
Mode of
action:
Bromazepam
binds with the specific site on the GABA receptor/chloride channel complex and
potentiates the effect of GABA, an important inhibitory transmitter in the CNS
which acts by opening chloride ion channels into cells.
Pharmacokinetics:
Peak plasma
concentration of Bromazepam is achieved within two hours after oral
administration. The absolute bioavailability of the unchanged substance is 60%.
On an average 70% of Bromazepam is metabolized in the liver. Bromazepam has an
elimination half-life around 20 hours, but the half-life may be longer in
elderly subjects. The metabolites are excreted in the urine mainly in
conjugated form.
Composition:
Bromazepam
tablet: Each tablet contains Bromazepam BP 3 mg
Indications:
Emotional
disturbances: Anxiety and tension states, as adjuvant therapy for anxiety in
depressed patients, nervous, tension, restlessness, anxiety and tension related
insommia. As an adjuvant to the treatment of an underlying disease responsible
for functional or psychosomatic impairments of various organs caused or
exacerbated by anxiety and tension.
Cardiovascular
and respiratory systems: Pseudo angina pectoris, precordial anxiety, tachycardia,
emotiogenic hypertension, dyspnea and hyperventilation; Gastrointestinal tract:
irrible bowel syndrome, ulcerative colitis, epigastric pain, spasm, meteorism
and diarrhea.
Urogential
tract: Irritable bladder, urinary frequency, dysmenorrhoea; Other psychosomatic
disturbances: Psychogenic headache, psychogenic dermatoses.
Bromazepam
is also suitable for treatment of
anxiety and tension states due to chronic organic diseases and as an adjuvant
to psychotherapy in psychoneuroses, acute alcohol withdrawal, adjunct for the
relief of muscle spasm.
Dosage and
Administration :
1.50mg to 12
mg three times daily according to condition or patient response and side-effect profile.
Average
outpatient dosage: 1.5 mg to 3 mg three times daily.
Severe
cases: 6 mg to 12 mg two to three times daily.
Contraindications:
Bromazepam
should not be used in case of hypersensitivity of benzodiazepines, respiratory depression,
severe hepatic impairment, myasthenia gravis and infant.
Side
Effects:
Drowsiness,
lightheadedness in the next day; confusion, ataxia and ammesia may occur.
Use in
pregnancy and lactation:
The
administration of Bromazepam is rarely justified in woman of childbearing potential.
Bromazepam should be avoided during
breast-feeding.
Precautions:
Bromazepam
should be used cautiously in respiratory diseases, muscle weakness and history
of alcohol or drug abuse.
Drug
Interactions:
Phenothiazines,
barbiturates, MAO inhibitors and psychoactive drugs may potentiate the action of
Bromazepam and should not usually be given concurrently.
Overdosage:
Manifestations
of overdoage include somnolence, confusion and respiratory and cardiovascular depression
with coma in severe cases.
Storage:
Store in a
cool and dry place, protected from light and children’s.
Ciprofloxacin
Ciprofloxacin : Which is a synthetic anti-infective agent. Ciprofloxacin
Has broad spectrum of activity. It is active against most
gram-negative aerobic bacteria including enterobacteriaceae and pseudomonas
aeruginosa. Ciprofloxacin is also active against gram-positive aerobic bacteria
including penicilinase producing and methicilin resistant staphylococci,
although many strains of streptococci are relatively resistant to the drug. The
bactericidal action of Ciprofloxacin results from interference with the enzyme
DNA gyrase needed for the synthesis of bacterial DNA. Following oral
administration it is rapidly and well absorbed from the G.I tract. It is widely
distributed into body tissues and fluids. The half-life is about 3.5 hours.
About 30% to 50% of an oral dose of Ciprofloxacin is excreted in the urine
within 24 hours as unchanged drug and biologically active metabolites.
Indication: Ciprofloxacin is used adults for the treatment of
urinary tract infections, lower respiratory tract infections, shin and soft
tissue infections, bone and joint infections and G.I infections, caused by
susceptible gram-negative and gram-positive aerobic bacteria. It is also used
for the treatment of uncomplicated gonorrhea caused by penicillinase producing
neisseria gonorrhea. Ciprofloxacin 750 tablet is specially indicated for the
treatment of pseudomonal infections of lower respiratory tract, severe
infections particularly due to pseudomonas, staphylococcus and streptococci.
Ciprofloxacin 750 is also indicated in surgical prophylaxis.
Composition:
Ciprofloxacin-250 each film coated tablet contains
Ciprofloxacin USP 250 mg as hydrochloride.
Ciprofloxacin-500 each film coated tablet contains Ciprofloxacin
USP 500 mg as hydrochloride.
Ciprofloxacin-750 each film coated tablet contains
Ciprofloxacin USP 750 mg as hydrochloride.
Ciprofloxacin-XR 1 gm each film coated extended release
contains Ciprofloxacin USP 1 gm as hydrochloride.
Ciprofloxacin-250 powder for suspension: Each 5 ml
contains Ciprofloxacin USP 250 mg as hydrochloride.
Dosage and
Administration
Ciprofloxacin may be given orally without regard to
meals. Patients receiving Ciprofloxacin-should be well hydrated and should be
instructed to drink fluids liberally. Because of the risk of crystalluria. It
is recommended that the usual dosage of the drug should not be exceeded. For
the treatment of urinary tract infections, the usual adult oral dosage of
Ciprofloxacin for mild to moderate infections is 250 mg every 12 hours and the
adult dosage for complicated infections, caused by organisms not highly
susceptible to drug is 500 mg every 12 hours. The usual adult oral dosage of
Ciprofloxacin for infectious diarrhea is 500 mg every 12 hours. The usual adult
dosage for mild to moderate lower respiratory tract, skin and soft tissue or
bone and joint infections is 500 mg every 12 hours; a dosage of 750 mg every 12
hours may be needed, especially in bone and joint infections or when infections
are severe or complicated. In severe infections particularly due to
pseudomonas, staphylococcus and streptococci, the higher dosage of
Ciprofloxacin 750 tablet twice daily should be used. For surgical prophylaxis a
single dose of Ciprofloxacin 750 is given 60-90 minutes before the procedure.
For the treatment of uncomplicated urethral, endocervical or rectal gonorrhea
caused by penicillinase producing strains of neisseria gonorrhea (PPNG) or
non-penicillinase producing strains of the organism, adults should receive a
single 500 mg oral dose of Ciprofloxacin followed by oral doxycycline therapy
for possible coexisting Chlamydia infection in the treatment of chancroid, 500
mg orally twice daily for 3 day’s is required. The duration of therapy depends
on the type and severity of infection and should be determined by the clinical
and bacteriologic response of the patients. For most infections, therapy should
be continued for at least 48 hours after the patients become asymptomatic.
Theusual duration is 1-2 weeks but severe or complicated infections may require
more prolonged therapy, Ciprofloxacin-therapy may need to be continued for 4-6
weeks or longer for the treatment of bone and joint infections, infectious
diarrhea generally is treated for 3-7 day’s, although less prolonged therapy
may beadequate. Modification of the usual dosage Ciprofloxacin-generally is
unnecessary in patients with creatinine clearance greater than 50 ml/minute. In
patients with creatnine clearance of 50 ml/minute or less, doses and/or
frequency of administration of Ciprofloxacin should be modified in response to
the degree of renal impairment and the site and severity of infection. Adults
with creatinine clearance of 30-50 ml/minute can receive 250-500 mg of
Ciprofloxacin every 12 hours and adults with creatinine clearance of 5-29
ml/minute can receive 250-500 mg every 18 hours. Patients with severe
infections and severe renal impairment may be given 750 mg of Ciprofloxacin
every 12 or 18 hours. However, these patients should be monitored carefully and
serum Ciprofloxacin concentrations determined periodically.
Precaution and
Warning: It should be used with caution in patients
with suspected or known CNS disorders such as arteriosclerosis or epilepsy or
other factors which predispose to seizures and convulsion
Information for
patients:
Ciprofloxacin may be talen with or without meals and to
drink fluids liberally.
Concurrent administration of Ciprofloxacin should be
avoided with magnesium/aluminum antacids or sucralfate or with other products
containing calcium, iron or zinc. These products may be taken two hours after
or six hours before Ciprofloxacin.
Ciprofloxacin should not be taken concurrently with milk
or yogurt alone, since absorption of Ciprofloxacin may be significantly reduced.
Dietary calcium is a part of a meal, however, does not significantly affect the
Ciprofloxacin absorption.
Pregnancy, Lactation
and Children: Not to be used in pregnancy
and nursing stage. Though not recommended for the children where benefit
out-weighs risk a dosage of 7.5-15 mg/kg/day in two divided doses can be given
Contraindication: Patients with a history of hypersensitivity to
Ciprofloxacin or to other quiolones.
Adverse reaction: Adverse effects include nausea and other gastrointestinal disturbances, headache,
dizziness and skin rashes. Crystalluria has occurred with high doses.
Storage Condition: Store below 30 degree C. Protect from light and
moisture. Keep away from children’s reach.