all things about Vigamox eye drops

COMPOSITION
1 mL of solution contains 5.45 mg moxifloxacin hydrochloride equivalent to 5 mg moxifloxacin base.
Excipients: Sodium chloride, boric acid, hydrochloric acid (E507) and/or sodium hydroxide (E524) (to adjust pH) and purified water.

PHARMACOLOGICAL CLASSIFICATION
A.15.1 Ophthalmic preparations with antibiotics and/or sulphonamides.

PHARMACOLOGICAL ACTION
Pharmacodynamic properties
Moxifloxacin is a fourth-generation fluoroquinolone antibacterial agent active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens, atypical microorganisms and anaerobes.
Mechanisms of Action
Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative microorganisms. Moxifloxacin inhibits the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair, and recombination. The C8-methoxy moiety of moxifloxacin also lessens the selection of resistant mutants of Gram-positive bacteria.
Mechanism(s) of Resistance
In vitro resistance to moxifloxacin develops slowly via multiple-step mutations and occurs at a general frequency between 10-9 to 10-11 for Gram-positive bacteria. Fluoroquinolones, including moxifloxacin, differ in chemical structure and mode of action from beta-lactamantibiotics, macrolides and aminoglycosides, and therefore may be active against bacteria resistant to beta-lactam antibiotics, macrolides and aminoglycosides.
Breakpoints There are no official topical ophthalmic breakpoints for moxifloxacin and although systemic breakpoints have been used, their relevance to topical ophthalmic therapy is doubtful. The systemic breakpoint used for this antibiotic is S <2mg/L, R>4mg/L.

Susceptibility to Moxifloxacin
Commonly susceptible species (i.e., an MIC50 of <4 mg/L for at least 10 strains)
Aerobic Gram-positive micro-organisms:
Corynebacterium speciesStaphylococcus aureus*Staphylococcus epidermidis*Staphylococcus hominisStaphylococcus warneri*Streptococcus mitis Group*Streptococcus pneumoniae*Streptococcus viridans Group*Aerobic Gram-negative micro-organisms:
Acinetobacter species*Escherichia coliHaemophilus influenzae*Pseudomonas aeruginosaSerratia marcescensOther micro-organisms:
Chlamydia trachomatis*
Species for which acquired resistance may be a problem
Aerobic Gram-positive micro-organisms:
None
Aerobic Gram-negative micro-organisms:
None
Other micro-organisms:
None

Inherently resistant organisms
Aerobic Gram-positive micro-organisms:
None
Aerobic Gram-negative micro-organism:
None
Other micro-organisms:
None
*denotes those species which have been satisfactorily demonstrated in clinical studies in at least 10 patients.
VIGAMOX has been studied in patients from newborns to adults, including geriatric patients.
In four randomised, double-masked, multicentre, controlled clinical trialsin which patients were dosed 3 times a day for 4 days, VIGAMOX produced clinical cures in 80% to 94% of patients treated for bacterial conjunctivitis. Microbiological success rates for the eradication of the baseline pathogens ranged from 78% to 97%.
In paediatric patients from birth to one month of age, VIGAMOX produced clinical cure in 80% of patients with bacterial conjunctivitis. The microbiological success rate for the eradication of the baseline pathogens was 92%.
In a randomised, double-masked, multicentre, controlled clinical trial in which patients were dosed twice a day for 3 days, VIGAMOX produced clinical cure in 74% of patients treated for bacterial conjunctivitis. Microbiological success rate for the eradication of the baseline pathogens was 81%.

Pharmacokinetic properties
Following topical ocular administration of VIGAMOX, moxifloxacin was absorbed into the systemic circulation. Plasma concentrations of moxifloxacin were measured in 21 male and female subjects who received bilateral topical ocular doses of VIGAMOX 3 times a day for 4 days. The mean steady-state Cmax and AUC were 2.7 ng/mL and 41.9 ng·hr/mL, respectively. These exposure values are approximately 1,600 and 1,200 times lower than the mean Cmax and AUC reported after well-tolerated therapeutic 400 mg oral doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.

Preclinical safety data
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic following up to 38 weeks of oral dosing at 500 mg/kg/day.
Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice. Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 21,700 times the highest recommended total daily human ophthalmic dose.
Teratogenic Effects
Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); however, decreased foetal body weights and slightly delayed foetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 4,300 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller foetuses was observed at 100 mg/kg/day.

INDICATIONS
VIGAMOX is indicated for the topical treatment of bacterial conjunctivitis caused by susceptible organisms. (See Pharmacological action, Pharmacodynamic properties for susceptibility to Moxifloxacin).

CONTRA-INDICATIONS
VIGAMOX is contra-indicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the excipients in this medication.

WARNINGS
Special warnings and precautions for use
In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching.
If an allergic reaction to VIGAMOX occurs, discontinue use of the drug. Serious acute hypersensitivity reactions to moxifloxacin or any other product ingredient may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.
Patients should be advised not to wear contact lenses if they have signs and symptoms of a bacterial ocular infection.
Effects on ability to drive and use machines
As with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient should wait until their vision clears before driving or using machinery.

INTERACTIONS
While drug-drug interaction studies have not been conducted with VIGAMOX, they have been performed with the oral product at much higher systemic exposures than are achieved by the topical ocular route. Unlike some other fluoroquinolones, no clinically significant drug-drug interactions between systemically administered moxifloxacin and itraconazole, theophylline, warfarin, digoxin, oral contraceptives, probenicid, ranitidine or glyburide have been observed. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19 or CYP1A2 indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolised by these cytochrome P450 isozymes.

PREGNANCY AND LACTATION
Pregnancy
Since there are no adequate and well-controlled studies in pregnant women, VIGAMOX should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Breast-feeding women
Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when VIGAMOX is administered to a nursing mother.

DOSAGE AND DIRECTIONS FOR USE
Use in adults including the elderly
Instil one drop in the affected eye(s) 3 times a day for 4 days.
No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
Use in children
VIGAMOX has been shown to be safe and effective in paediatric patients including neonates and can be used at the same dose as in adults. There is no evidence that the ophthalmic administration of VIGAMOX has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.
Use in hepatic and renal impairment
Pharmacokinetic parameters of oral moxifloxacin were not significantly altered in patients with mild to moderate hepatic insufficiency (Child Pugh Classes A and B).
Studies were not performed in patients with severe hepatic impairment (Child Pugh Class C). Because of the low systemic exposure by the topical route of administration, no dosage adjustment of VIGAMOX is needed in patients with hepatic impairment.
The pharmacokinetic parameters of oral moxifloxacin are not significantly altered by mild, moderate or severe renal impairment. No dosage adjustment of VIGAMOX is necessary in patients with renal impairment.
Method of administration
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Undesirable effects
In clinical studies involving 1060 subjects, VIGAMOX was administered twice or three times daily. No serious ophthalmic or systemic undesirable effects related to VIGAMOX were reported in clinical studies. The most frequently reported treatment-related undesirable effect was ocular discomfort (4.1%), which was mild in 95.3% of those subjects who experienced it. The discontinuation rate due to ocular discomfort was 0.1%.
The following undesirable effects assessed as definitely, probably or possibly related to treatment were reported during clinical trials with VIGAMOX. Their incidence was either common (1.0% to 10.0%; maximum observed actual incidence of 4.1%), or uncommon (0.1% to less than 1.0%). All other effects were single reports, of which none were serious and related.
Ocular effects
Common: ocular discomfort (burning or stinging upon instillation) and ocular pruritus.
Uncommon: ocular hyperaemia, dry eye and ocular pain.

Systemic effects
Body as a Whole
Uncommon: headache.
Special Senses
Uncommon: taste perversion altered, bitter or bad taste following instillation.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
The limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of VIGAMOX. Intoxication after inadvertent oral ingestion can also be ruled out.

IDENTIFICATION
VIGAMOX is a clear, greenish-yellow solution

PRESENTATION
DROP-TAINER® dispensing system consisting of a bottle with 5 mL fill and dispensing plug, both natural low density polyethylene, with a white polypropylene closure.

STORAGE INSTRUCTIONS
Discard four weeks after first opening.
Keep out of reach of children Do not store above 25°C

all things about Tritospot cream

Composition

Tritospot 15gm/30gm:
Each 100 gm contains:

Hydroquinone	3 gm
Tretinoin	0.02 gm
Hydrocortisone Acetate	1 gm
Eusolex	4 gm

Properties

Tritospot cream is a combination of four effective topical agents for decreasing hyperpigmentation of the skin. Hydroquinone is a depigmenting agent for the skin in conditions such as chloasma,melasma & freckles. The presence of Eusolex as a sunscreening agent reduces the chances of repigmentation of the skin.


Tretinoin stimulates the epithelium to produce a less cohesive horny layer which is more easily peeled off. Hydrocortisone helps improve results and at the same time reduces inflammation which may occur.

Indications

For the gradual bleaching of hyperpigmented skin conditions such as:
Chloasma

Melasma

Freckles

Senile lentigines

Other unwanted areas of melanin hyperpigmentation

Contra-indication

Prior history of sensitivity or allergic reaction to any of the ingredients of the product.

Side effects

Occasional hypersensitivity may occur, in which case the medication should be discontinued and the physician notified immediately.

Dosage

Tritospot cream should be applied to the affected area and rubbed in well twice daily or as directed by a physician.

Drug interactions

Concur rent use of peroxide products should be avoided.

Precaution

Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effect if not used as directed.-

Sensitivity test should be done by applying a small amout to an unbroken patch of skin and checked in 24 hours.

Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advisable.

Contact with eyes should be avoided.

After clearing and during application or maintenance therapy, direct sun exposure for long periods should be avoided on bleached skin.

Treatment should be limited to relatively small areas of the body.

Not to be used during pregnancy and lactation.

Must not be applied to more than 10% of the body surface.

Must not be used for children less than 2 years old.

Duration of treatment should be limited to 2 months with a maximum of 4 months.

Must be used under the supervision of a physician.

Storage

Store between 15- 30°C

Keep out of reach of children

Package

Tube of 15 & 30 gm cream

all informations about levoxin eye drops

Composition: Each ml contains 5mg Levofloxacin (as hemihydrate)

Antibacterial Activity:
- Levoxin® Eye Drops 0.5% is a sterile topical ophthalmic solution. Levofloxacin is the L-isomer of the racemic mixture Ofloxacin which has potent antibacterial activity. Unlike Ofloxacin or Ciprofloxacin, Levoxin® Eye Drops exhibits bactericidal effect against Gram +ve bacteria, in addition to Gram –ve and atypical pathogens.
- Levoxin® Eye Drops, which belongs to Fluoroquinolone structure and is active against bacteria resistant to aminoglycosides. The mechanism of action of Levofloxacin involves the inhibition of bacterial topoisomerases IV and DNA gyrase
- The antibacterial spectrum of Levoxin® Eye Drops include:

Aerobic Gram Positive Bacteria
- Different species of staphylococci e.g.:
• Staph. aureus (including penicillinase producer)
• Staph. epidermidis
• Staph. saprophyticus

- Different species of streptococci e.g.:
• S. pneumoniae (including penicillin resistant species)
• S. pyogenes
• S. viridans
• S. faecalis

Other Gram positive bacteria e.g.
- Listeria monocytogenes
- Mycobacterium tuberculosis

Aerobic Gram negative bacteria
- Haemophilus influenzae
- Morganella morganii
- Legionella pneumophilla
- Providencia spp.
- Klebsiella pneumoniae
- Salmonella spp.
- Escherichia coli
- Proteus mirabilis
- Moraxella catarrhalis
- Shigella spp.
- Neisseria gonorrhea
- Yersinia spp.
- Pseudomonas aeruginosa
- Enterobacter spp.
- Atypical bacteria
- Anaerobic bacteria
- Chlamydia trachomatis
- Bacteroides fragilis
- Chlamydia pneumoniae
- Clostridium perfringens
- Mycoplasma pneumoniae

Properties: Pharmacological Properties:
Levoxin® 0.5% topical ophthalmic solution has excellent penetration into the plasma and tears and its concentration exceeds the minimum inhibitory concentration for different ocular pathogens.

Indications: Levoxin® 0.5% eye drops is indicated mainly for the treatment of bacterial conjunctivitis and other different bacterial infections.
Contra-Indictions: Levoxin® Eye Drops 0.5% is contraindicated in patients with a history of hypersensitivity to Levofloxacin or any of its components.
Levoxin® Eye Drops 0.5% is not for ocular injection.

Dosage & Administration: For adults and children above 1year 
Instill one to two drops in the affected eye every 2 hours while awake, up to 8 times per day, and then reduce frequently as infection is controlled.


How supplied: Levoxin® Eye Drops 0.5% is supplied in a bottle with a controlled dropper tip containing 5ml isotonic solution of Levofloxacin 5mg/ml.

Also available:
Levoxin® Tablets: Each Tablet contains Levofloxacin 500 or 250mg in packs of one strip of 5 tablets.
Levoxin® Vials: Each Vial contains Levofloxacin 500mg in packs of 100ml bottle for slow intravenous administration (at least one hour)

Ferrocal and all things about it

Composition Each Capsule contains Calcium Carbonate 500 mg Vitamin C 60 mg Vitamin D3 400 I.U. Iron 10 mg Folic Acid 0.5 mg Zinc 15 mg Properties FerroCAL composed of an advanced & balanced formula of Calcium, Vitamin D3, Vitamin C, Iron, Folic Acid and Zinc. A Formula which is required by the human body, when demands for these components increase, specially during pregnancy & lactation, menopause, old age, malnutrition and malabsorption. In pregnant women, Calcium demand increases with the pregnancy progress. *Calcium, is essential for human life. Apart from being a major constituent of bones and teeth, Calcium is important for nerve conduction, muscle contraction, heartbeat, blood coagulation, energy production and maintenance of immune function. Among other things, severe Calcium deficiency may lead to abnormal heartbeat , dement muscle spasm and convulsions. There are many groups at risk of marginal Calcium deficiency such as women: in child-bearing age, pregnant & lactating women, elderly people, post menopausal women, people on diet and inactive people. There is evidence that Calcium supplementation is beneficial in decreasing the incidence of bone fractures & osteoporosis in pregnant or post menopausal women. *Vitamin D3, essential of bone metabolism, It regulates the intestinal absorption of both Calcium and Phosphates, which are important for bones & teeth formation and maintenance. When Vitamin D3 intake is inadequate, Calcium absorption is reduced. Osteomalacia, muscle weakness, hypocalcemia and hypophosphatemia are Vitamin D3 deficiency diseases. *Vitamin C, is responsible for regeneration of epithelial tissues, cartilage, osteoid tissue, capillaries & blood vessels and lymphoid tissues. It is also responsible for Spermatogenesis and Oogenesis. Moreover, it enhances the intestinal absorption of iron. Vitamin C also contributes in making gums and teeth healthy. It is also needed for the synthesis of bile acids. In addition, researches have indicated the role of Vitamin C in the synthesis of several important hormones and neuro-transmitters, folic acid metabolism, immune function, antioxidant function and wound healing. Doctors recommend that pregnant & lactating women increase their Vitamin C intake, in order to guarantee the mother's needs. *Iron, plays an important role in oxygen and electron transport. It provides a fundamental structure of haemoglobin, myoglobin, haemenzymes and many co-factors involved in enzymes activities, protecting the body from developing anaemias. During the Child-bearing years, females must replace the iron lost in pregnancy and during ordinary menstruation. The needs during the coarse of pregnancy are great, to cover the fetal and maternal needs and there is no way that one can obtain this great amount only from dietary intake, and should be taken by iron supplementation. *Folic Acid, deficiency occurs mainly in pregnant women and usually associated with signs & symptoms e.g. diarrhea, glossitis, G.I. distress and anaemia. There is an increased incidence of anaemia, prematurity and low birth weight infants, when folic acid deficiency occurs in pregnant women. *Zinc, recently proven to have an important role in wound healing, specially after surgery, besides being important element in formation of hundred of enzymes and co-enzymes, which are essential for carbohydrates and protein metabolism. Moreover, Zinc protects against growth retardation, skin aging, hair fall, immune disorder and dermatitis. Dosage Unless otherwise prescribed by the physician, the usual dose is: One Capsule daily, preferable after meal. Packing Box of 2 Strips, 7 Capsule in each. Store below 30oC protect from light. Keep out of the reach of childre

all informations about alzental

Composition Suspension (1ml) 1 Tablet Albendazole 20 mg 200 mg Properties and Mode of Action ALZENTAL a benzimidazole carbamate derivative, is an anthelmintic with activity against most nematode and some other worms. Activity against some larval stages and ova has also been demonstrated. ALZENTAL’s anthelmintic activity is considered to be dependent on the inhibition or destruction of cytoplasmic microtubules in the worm’s intestinal or absorptive cells. Inhibition of glucose uptake and depletion of glycogen stores follow as do other inhibitory effects Ieading to death of the worm. Indications ALZENTAL is a broad spectrum anthelmintic used in the treatmemt of single and mixed infections as: Enterobiasis Ascariasis Hookworms Trichuriasis Strongyloidiasis Taeniasis Capillariasis Cysticercosis Toxocariasis Trichostrongyliasis Trichinosis Echinococcosis (Hydatid disease) Dosage and Administration Adults and Children Above 2 years of age: Enterobiasis, Ascariasis, Hookworm, Trichuriasis: 400 mg as a single dose. Treatment may be repeated in 3 weeks. Cysticercosis: 15 mg/kg body weight/day for 30 days. Strongyloidiasis and Taeniasis: 400 mg is given daily for 3 consecutive days. This may be repeated after 3 weeks if necessary. Capillariasis: 200 mg twice daily for 10 days. Echinococcosis (Hydatid disease): (Over 60 kg body weight): 800 mg/day in divided doses for 28 days. This is followed by 2 weeks drug free interval, to be repeated for 2-3 cycles. For inoperable cases up to 5 cycles may be given. (Under 60 kg body weight): 10-15 mg/kg body weight daily for 28 days. Children Up to 2 years of age: Enterobiasis, Ascariasis, Hookworm, Trichuriasis: 200 mg as a single dose. Treatment may be repeated in 3 weeks. Precautions ALZENTAL may cause elevation in hepatic enzymes. Patients receiving high doses of ALZENTAL such as those with Hydatid disease, should be supervised closely with blood counts and liver function being monitored. Contra_indications Pregnancy. Hypersensitivity to Albendazole. Side effects Incidence is rare and reversible: e.g.nausea, vomiting, diarrhoea, leucopenia, elevated transaminases. Presentation ALZENTAL Suspension :Bottle of 20 ml. ALZENTAL Tablets : Box of 1 blister of 2 tablets.

all things about epimag

Composition Each 100 g contains: Magnesium citrate            42.49 g Properties and Mode of Action  by alkalinizing urine, minimizes the precipitation of uric acid in the urinary tract during therapy with serum uric acid lowering agents; thus avoiding the danger of mechanical obstruction and urate stone formation. Indications Prevention of urate stone formation in gout and other hyperuricemic states where serum uric acid lowering agents are used. Dosage and Administration One sachet in half a glass of water 3 - 4 times daily. One dose should be kept for bedtime. Precautions Magnesium salts are to be used with caution in impaired renal function. Drug Interactions Oral magnesium salts decrease the absorption of tetracyclines, so, administration should be separated by a number of hours. Contra_indications Cases of abdominal pain, nausea, vomiting or acute surgical abdomen. Cases with rectal fissures, intestinal obstruction or perforation. Side effects Nausea- diarrhea or abdominal cramps. Presentation Box of 10 sachets of 5 g each.

All informations about Betoptic eye drops

Action And Clinical Pharmacology: Betaxolol is a cardioselective (beta-1-adrenergic) receptor blocking agent. It does not have significant membrane-stabilizing (local anesthetic) activity and is devoid of intrinsic sympathomimetic action.

Ocular: When instilled in the eye, betaxolol reduces elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma. When used as a solution, the onset of action occurs within 30 minutes and the maximal effect is usually attained approximately 2 hours after instillation. Although the time of onset of action, and time of maximal effect for the suspension have not been determined, controlled double masked studies show that the magnitude and duration of the ocular hypotensive effect of betaxolol 0.5% solution and betaxolol 0.25% suspension were clinically equivalent.

A single dose provides a 12-hour reduction in intraocular pressure (IOP) and twice daily administration maintains the IOP below 22 mm Hg in most patients.

Betaxolol has no effect on pupil size or accommodation.

Systemic: Ophthalmic betaxolol is virtually devoid of systemic effects. Following oral administration, the elimination half-life of betaxolol is 14 to 22 hours, and it is metabolized mainly to inactive substances which are excreted in the urine. Although betaxolol is absorbed systemically, ophthalmic doses do not ordinarily produce pharmacologically active tissue levels and thus, despite its cardioselective beta blocking activity, it has minimal, if any, effect on heart rate or blood pressure.

Betaxolol has a low affinity for b2-adrenergic receptors, and ophthalmic doses have no significant effect on pulmonary function as measured by forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC. Ophthalmic doses do not inhibit the effect of isoproterenol, a beta-adrenergic stimulant, on pulmonary function. Therefore, ophthalmic betaxolol may be used in the treatment of patients with glaucoma or ocular hypertension who have coexisting reactive airway disease.

Indications And Clinical Uses: For lowering intraocular pressure in the treatment of ocular hypertension or chronic open angle glaucoma. May be used alone or in combination with other IOP-lowering medication.
Contra-Indications: Hypersensitivity to any component of this product.
Although ophthalmic betaxolol has minimal systemic effects, as with all beta-adrenergic blocking agents, it should not be used in patients with sinus bradycardia, atrioventricular block greater than first degree, cardiogenic shock, or patients with overt cardiac failure.
Precautions: General: Patients who are receiving a beta-adrenergic blocking agent orally and ophthalmic betaxolol should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta blockade.

Although ophthalmic betaxolol has demonstrated a low potential for systemic effects, it should be used with caution in patients with bradycardia, and those with diabetes (especially labile diabetes) because of possible masking of hypoglycemia. Consideration should be given to the gradual withdrawal of all beta-adrenergic blocking agents in patients suspected of developing thyrotoxicosis, and also prior to general anesthesia, because of the reduced ability of the heart to respond to beta-adrenergically mediated sympathetic reflex stimuli (see Drug Interactions).

Betaxolol, a cardioselective beta-blocker, has produced only minimal effects in patients with reactive airway disease; however, caution should be exercised in the treatment of patients with excessive restriction of pulmonary function.

In patients with angle-closure glaucoma the immediate treatment objective is to reopen the angle by constriction of the pupil with a miotic agent. Betaxolol has no effect on the pupil; therefore ophthalmic betaxolol should be used with a miotic to reduce elevated intraocular pressure in angle-closure glaucoma.

As with the use of other antiglaucoma drugs diminished responsiveness to ophthalmic betaxolol after prolonged therapy has been reported in some patients. However, in one long-term study in which 250 patients treated with betaxolol ophthalmic solution have been followed for up to 3 years, no significant difference in mean intraocular pressure has been observed after initial stabilization.

Drug Interactions: Although ophthalmic betaxolol used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with epinephrine has been reported occasionally.

Close observation of the patient is recommended when a beta-blocker is administered to patients receiving oral beta-adrenergic blocking drugs or catecholamine-depleting drugs such as reserpine because of possible additive effects. Caution should be exercised in patients using concomitant adrenergic psychotropic drugs.

Pregnancy: There have been no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly indicated.

Lactation: It is not known whether betaxolol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ophthalmic betaxolol is administered to nursing women.

Children: Clinical studies to establish the safety and efficacy in children have not been performed .

Adverse Reactions: The following adverse reactions have been reported in clinical trials of up to 3 years of patient experience with betaxolol ophthalmic preparations.

Ocular: Betaxolol has been well tolerated. Discomfort of short duration may be experienced by some patients upon instillation and occasional tearing has been reported. Instances of decreased corneal sensitivity erythema itching sensation corneal punctate staining, keratitis, anisocoria and photophobia have been reported. Based on comparative studies, there is an increased incidence of blurred vision upon instillation of Betoptic S compared with Betoptic.

Systemic: Systemic reactions following topical administration of betaxolol have been reported rarely (e.g., CNS: insomnia and depressive neurosis).

Symptoms And Treatment Of Overdose : Symptoms: No data are available on overdosage of humans. However, anticipated symptoms include symptomatic bradycardia, hypotension, bronchospasm, acute cardiac failure and heart block (second or third degree).

A 10 mL container of 0.5% betaxolol ophthalmic solution would contain 50 mg of betaxolol. Betaxolol at 40 mg twice daily is reported to be an effective and safe systemic dosage for hypertension. Thus, an individual would ingest an amount of betaxolol from one container which is less than the maximum daily oral dose of betaxolol.

Since the oral LD50 in animals ranged from 350 to 1 050 mg/kg, a 10 kg child would only receive 5 mg/kg if the child ingested 10 mL of 0.5 % betaxolol ophthalmic solution. An acute toxic response is thus extremely remote.

Treatment: Should an overdosage occur, the following is suggested:

Ocular: Flush eye with lukewarm tap water.

Systemic: Gastric lavage.

Symptomatic bradycardia: Use atropine sulfate i.v. in a dosage of 0.25 mg to 2 mg to induce vagal blockage. If bradycardia persists, i.v. isoproterenol HCl should be administered cautiously. In refractory cases the use of a transvenous cardiac pacemaker may be considered.

Hypotension: Use sympathomimetic pressor drug therapy, such as dopamine, dobutamine or levarterenol. In refractory cases, the use of glucagon HCL has been reported to be useful.

Bronchospasm: Use isoproterenol HCl. Additional therapy with aminophylline may be considered.

Acute cardiac failure: Conventional therapy with digitalis, diuretics, and oxygen should be instituted immediately. In refractory cases the use of i.v. aminophylline is suggested. This may be followed if necessary by glucagon HCl which has been reported to be useful.

Heart block (second or third degree): use isoproterenol HCl or a transvenous cardiac pacemaker.

Dosage And Administration: The usual dose is 1 drop of betaxolol ophthalmic suspension in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering response may require a few weeks to stabilize. Clinical follow-up should include a determination of the intraocular pressure during the first month of treatment. Thereafter, intraocular pressures should be determined on an individual basis at the judgment of the physician.

When a patient is transferred from a single antiglaucoma agent, continue the agent already used and add 1 drop of betaxolol in the affected eye(s) twice a day. On the following day, discontinue the previous antiglaucoma agent completely and continue with betaxolol ophthalmic solution or suspension.

Because of diurnal variations of intraocular pressure in individual patients, satisfactory response to twice a day therapy is best determined by measuring intraocular pressure at different times during the day. Intraocular pressure of less than 22 mm Hg may not be optimal for control of glaucoma in each patient; therefore, therapy should be individualized.

If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine, other miotics, epinephrine or systemically administered carbonic anhydrase inhibitors can be instituted.

When a patient is transferred from several concomitantly administered antiglaucoma agents, individualization is required. Adjustment should involve one agent at a time made at intervals of not less than 1 week. A recommended approach is to continue the agents being used and add 1 drop of betaxolol ophthalmic suspension in the affected eye(s) twice a day. On the following day, discontinue one of the other antiglaucoma agents. The remaining antiglaucoma agents may be decreased or discontinued according to the patient's response to treatment. The physician may be able to discontinue some or all of the other antiglaucoma agents.

Special Instructions: Patients should be instructed to avoid contamination of the dropper tip.

The Betoptic S suspension must be well shaken before use.

Availability And Storage: Each mL of sterile, isotonic, aqueous suspension contains: betaxolol 0.25% (0.28% betaxolol HCl) with benzalkonium chloride (as preservative), mannitol, poly (styrene- divinyl benzene) sulfonic acid, carbomer 934P, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. Drop-Tainer dispensers of 5 and 10 mL. Store at room temperature.