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Eyetear

Povidone Iodine

Ophthalmic Solution 5% v/v Allopathic Iodine compounds (Anti-septic Preparations)

Indications

Secondarily infected dermatoses

Indication detailsView

Cream or ointment:
Therapeutically: As an adjunct to systemic therapy in the following indications-

Primary or secondary topical infections
Infected surgical incisions
Infected decubitus or stasis ulcers
Pyodermas
Secondarily infected dermatoses
Infected traumatic lesions

Prophylactically:

To prevent microbial contaminations in burns, incisions and other topical lesions
For degerming skin in hyperalimentation, the umbilical area or circumcision
Its use for abrasions, minor cuts, and wounds prevents the development of infections and permits wound healing.

Solution:

For the prevention and treatment of surface infections as well as to degerm the skin, mucous membrane and hyperalimentation procedures
For seborrhea
For preoperative and postoperative scrubbing and washing of hospital operating room and equipments
For preoperative prepping of operative site, including the vagina
For disinfection of wounds, burns, lacerations and abrasions
As a prophylactic anti-infective agent in house, hospital & office procedures
Postoperative application to incisions to help prevent infection
In oral moniliasis (thrush); bacterial and mycotic skin infections, decubitus & stasis ulcers
As a preoperative swab in the mouth & throat

Gargle & Mouthwash: It is a pleasantly flavoured solution which is used:

For the treatment of acute mucosal infections of the mouth and pharynx.
For oral hygiene prior to, during and after dental and oral surgery.

Surgical Scrub: It is a golden surfactant solution, forms rich, golden lather which is used: As an antiseptic skin cleanser for preoperative and postoperative scrubbing and washing by surgeons and operation theatre staff and preoperative preparation of patients' skin

Powder: It is used for topical application in the following indications: Superficial wounds, Minor cuts, Burns, Abrasions, Lacerations, In the treatment and prevention of infections.

Ophthalmic Solution: Povidone is used for the symptomatic treatment of dry eye conditions including keratoconjunctivitis sicca. It is also given as a substitute for tear fluid in case of the unstable tear film or insufficient moistening of the eye surface.

Therapeutic classView

Iodine compounds (Anti-septic Preparations)

PharmacologyView

Povidone Iodine is a complex of iodine and an organic polymer, povidone. This polymerization makes Povidone Iodine superior to ordinary elemental iodine. It prolongs the germicidal activity of iodine by liberating elemental iodine slowly. Consequently it has a lower toxicity than elemental iodine. It gives rapid microbicidal activity against both Gram-positive and Gram-negative bacteria, protozoa, viruses and fungi/yeasts. It is also sporicidal. It is the only microbicide with this broad spectrum of activity. It is non-staining, exerts prolong germicidal action and is also active in the presence of soap, blood, serum, pus, mucosal secretions and water.

DosageView

Cream or ointment:

For the treatment of infection: Apply once or twice daily or at dressing changes for a maximum of 14 days.
For the prevention of infection: Apply once or twice a week for as long as necessary. The affected skin should be cleaned and dried and can be covered with a dressing or bandage.

Solution: Apply full strength as often as needed as paint, spray, or wet soak. Maybe bandaged (where necessary).

Gargle & Mouthwash: Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10 mL for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as advised by the Registered Dental Surgeon/Physician.

Surgical Scrub:

For Preoperative and Postoperative washing by Operating Personnel: Wet hands and forearms with water. Pour about 5 mL of Povidone Iodine Surgical Scrub on the palm of the hand and spread over both hands and forearms. Without adding more water, rub the Scrub thoroughly over all areas for about five minutes. Use a brush if desired. Clean thoroughly under fingernails. Add a little water and develop copious suds. Rinse thoroughly under running water. Complete the wash by scrubbing with another 5 mL of Povidone Iodine Surgical Scrub in the same way.
For Preoperative use on Patients: After the skin area is shaved, wet it with water. Apply Povidone Iodine Surgical Scrub (1 mL is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about five minutes. Rinse off by aid of sterile gauze saturated with water.
For use in the Physician's Office: Use for washing whenever a germicidal soap is required.

Powder: Apply a light dusting of powder to the affected area. When dry, this forms a protective antiseptic layer over the area treated. Or use as advised by the Registered Physician. There are no special dosage recommendations for children or elderly patients.

Ophthalmic Solution: 1 drop 4 times daily or as required, depending upon the severity of the disease, to be instilled into the conjunctival sac.

Side effectsView

Povidone Iodine may cause hypersensitivity reactions and irritation of the skin and mucous membranes. The application of povidone Iodine to severe burns or to large areas otherwise denuded of skin may produce systemic adverse effects such as metabolic acidosis, hypernatraemia, and impairment of renal function. It may interfere with thyroid function tests.

ContraindicationsView

It can cause hypersensitivity reactions. Regular use in patients with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis) or those receiving lithium therapy is to be avoided. In severely burnt patients serum iodide levels should be assessed due to possible hepatic and renal impairment. Povidone Iodine Powder should not be used in serious cavities and in Children under the age of 2 years.

PrecautionsView

Cream or ointment: In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.

Solution: In preoperative prepping, avoid 'pooling' beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.

Gargle & Mouthwash: Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days seek dental or medical advice. It is also not for use in children under 6 years of age. Regular use should be avoided in patients on concurrent lithium therapy.

Surgical Scrub: Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy. It can permanently discolor white gold jewellery and it is recommended that this type of jewellery should be removed before using this product.

Powder: Care must be taken when used on known iodine sensitivity, although do not normally react to Povidone-Iodine. Excess powder can be washed off readily with warm water. It should be used directly from the container. Not to be administered internally.

Ophthalmic Solution: Patients, who experience blurred vision after application of the eye drops, should not drive or use machinery until their vision has cleared. Contact lenses should not be worn during the instillation of the drug. After instillation, there should be an interval of at least 30 minutes before reinsertion.

InteractionsView

It exhibits interaction with strong alkali, sodium thiosulphate, sodium metabisulphite and thiomersal. Use with concurrent lithium therapy has been shown to exhibithypothyroidic effect.

Pregnancy & lactationView

Povidone Iodine Cream, Solution & Powder are not recommended for use during pregnancy because of the possibility of absorption of sufficient iodine to affect the fetal thyroid. American Academy of Pediatrics considers that the use of Povidone-Iodine is usually compatible with breast feeding. Consult Registered Physician. Regular use of Gargle & Mouthwash and Surgical Scrub should also be avoided in pregnant and lactating women.

There is no experience regarding the safety of the Povidone eye drops in human pregnancy or lactation. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.

StorageView

Store below 25°C. Do not freeze. Store in a cool and dry place, protected from light. Keep out of the reach of children. Do not touch the ophthalmic solution dropper tip to any surface as this may contaminate this preparation. Do not use it after one month of the first opening.

Eyetin

Bepotastine Besilate

Ophthalmic Solution 1.50% Allopathic Ophthalmic Anti-allergic preparations

Indications

Conjunctivitis

Indication detailsView

Bepotastine Besilate is indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

Therapeutic classView

Ophthalmic Anti-allergic preparations

PharmacologyView

Bepotastine is direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.

DosageView

The recommended dose is 1 drop into the affected eye(s) twice a day. Safety and effectiveness in children below the age of 2 years have not been established.

Side effectsView

The most common reported side effect occurring in approximately 25% of subjects was a mild taste following instillation. Other side effects occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.

ContraindicationsView

Contraindicated in patients with a history of hypersensitivity reactions to Bepotastine Besilate or any of the other ingredients of this product.

PrecautionsView

To minimize the risk of contamination, do not touch dropper tip to any surface. It should not be used to treat contact lens-related irritation. Patients should be advised not to wear contact lens when using this drop.

InteractionsView

No drug interactions observed but patients who are sensitive to this product molecule should be used with caution.

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Lactation: It is not known if Bepotastine Besilate is excreted in human milk. Caution should be exercised when it is administered to a nursing woman.

Overdose effectsView

If you use more Bepotastine Besilate eye drops than you should, rinse your eye with warm water. Do not put in any more drops until it is time for your next regular dose. Pharmaceutical Precautions

StorageView

Store in a cool, dry place & protected from light. Keep out of reach of children. Do not use more than 4 weeks after opening.

Eyetrop

Tropicamide

Ophthalmic Solution 1% Allopathic Mydriatic and Cycloplegic agents

Indications

Uveitis

Indication detailsView

For mydriasis and cycloplegia for diagnostic procedure, for the treatment of acute and subacute iridocyclitis, chronic iridocyclitis, Adhesions and disruptions of iris and ciliary body, Sclera and iris operations

Therapeutic classView

Mydriatic and Cycloplegic agents

PharmacologyView

Tropicamide binds to and blocks the receptors in the muscles of the eye (muscarinic receptor M4). Tropicamide acts by blocking the responses of the iris sphincter muscle to the iris and ciliary muscles to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle.

DosageView

For refraction: Instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect.

For examination of fundus: Instill one or two drops of 0.5% solution 15 to 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses.

Side effectsView

Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.

ContraindicationsView

Contraindicated in persons showing hypersensitivity to any component of this preparation.

PrecautionsView

The lacrimal sac should be compressed by digital pressure for 2-3 minutes after instillation to avoid excessive systemic absorption.

InteractionsView

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Pregnancy & lactationView

Pregnancy Category C. Tropicamide should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.

StorageView

Store at 15° to 25°C . Do not refrigerate or store at high temperatures. Keep container tightly closed.

Eyevi

Vitamin C, Vitamin E, Lutein, Copper & Zinc

Eye Capsule Allopathic Anti-oxidant Multivitamin Multimineral preparations

Indications

Vitamin or mineral deficiency

Indication detailsView

This preparation is indicated for Age-related Eye Disease. This is an advanced new antioxidant supplement formulated to provide nutritional support for the eye. The formulation contains essential antioxidant vitamins, minerals, and Lutein.

Therapeutic classView

Anti-oxidant Multivitamin Multimineral preparations, Antioxidant vitamins & minerals for eye

PharmacologyView

Vitamin C is highly concentrated in the lens compared to blood. A long term Vitamin C supplement use (10+ years) has been associated with reduced risk of cataract. Vitamin C has an important role in harmful free radicals scavenging activity.

In study, it is found that high serum Vitamin E concentrations have been associated with reduced risk of cataract (exact mechanism of action is not still established). As an antioxidant vitamin, it also plays an important role in harmful free radicals scavenging activity.

Lutein is a carotenoid, specially concentrated in the macula. Clinical and animaldata indicates that this caretenoid could protect the macula from oxidative or light damage.

Although exact mechanism of action is not clear but onelarge study has found that high levels of dietary Lutein is associated with relatively lower risk of AMD (Age-Related Macular Degeneration). Zinc is an essential trace element involved in many enzymes system.

Symptoms of less severe deficiency include distorted or absent perception of taste, smell and poor wound healing. Severe deficiency causes skin lesion, alopecia, diarrhea, increased susceptibility to infection and failure to thrive in children.

Copper plays important role in growth, skeletal integrity, and development of nervous system. As a part of various enzymes, it takes part in numerous metabolic conversions.

DosageView

One capsule, one or two times daily or as directed by the physician

Side effectsView

Large doses of Vitamin C are reported to cause diarrhoea and other gastrointestinal disturbances. Large doses of Vitamin E may cause diarrhoea, abdominal pain, and other gastrointestinal disturbances; fatigue and weakness have also been reported. Side effects of Zinc salt are abdominal pain and dyspepsia.

ContraindicationsView

It is contraindicated in persons with a history of hypersensitivity to any of its ingredients.

PrecautionsView

Vitamin C should be given with care to patients with hyperoxaluria. In patients taking oral anticoagulants or oestrogen, Vitamin E should be given carefully because it has been found to antagonise the effects of vitamin K leading to an increase in blood clotting time in these patient

InteractionsView

No drug interaction has been reported.

Pregnancy & lactationView

Recommended in Pregnancy & Lactation.

StorageView

Store in a dry place below 25° C. Protect from light.

Eylon

Fluorometholone + Tetrahydrozoline

Ophthalmic Solution 0.1%+0.025% Allopathic Ophthalmic Steroid preparations

Indications

Scleritis

Indication detailsView

This eye drops is indicated in acute allergic, noninfectious conjunctivitis & keratitis, severe swelling & hyperaemia, noninfectious inflammation of the anterior segment of the eye (including anterior uveitis, episcleritis & scleritis) and post-operative conditions.

Therapeutic classView

Ophthalmic Steroid preparations

PharmacologyView

Fluorometholone is thought to act by the induction of phospholipase A2 inhibitory proteins which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. On the other hand, Tetrahydrozoline is an alpha agonist which constricts the conjunctival blood vessels and thereby relieves the redness of the eye.

DosageView

Use in adult: Instill 1 drop into the conjunctival sac 2-3 times daily. The dose may be increased for severe and adult patient to 1 drop hourly for first one to two days.

Use in children: Safety & effectiveness in children below 2 years of age have not been established.

Side effectsView

Mild burning sensation, reversible increase in intraocular pressure, reactive hyperemia, cataract & corneal defects, glaucoma, systemic effects (chronic use).

ContraindicationsView

It is contraindicated in infectious conjunctivitis or keratitis, injuries or ulcerous processes of the cornea, glaucoma, diseases associated with stromal damage of the cornea or sclera & dry eyes.

PrecautionsView

Avoid prolonged use. This preparation should be used after a careful risk benefit evaluation in case of patients with severe blood circulation diseases, metabolic disturbances, under treatment with MAOIs & other potentially hypertensive drugs, history of cataract, herpes simplex infection, rhinitis sicca.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Fluorometholone & Tetrahydrozoline in pregnancy or while breast-feeding. Therefore, this combination should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.

Overdose effectsView

When the product is used as directed, there is almost no likelihood of an overdose. No information on overdosage with fluorometholone is available. Overdosage with fluorometholone is unlikely to cause acute problems. The symptoms of acute overdosage with tetryzoline are CNS, cardiac and psychiatric disturbances, mydriasis, cyanosis and fever. CNS functions may be inhibited under certain circumstances.

The following measures are possible in case of accidental ingestion and the occurrence of symptoms of intoxication: administration of activated charcoal, gastric lavage, artificial ventilation with oxygen, use of phentolamine to lower blood pressure (5 mg in saline solution, given i.v.). Vasopressors are contraindicated. Antipyretic and anticonvulsive therapy can be administered as necessary.

StorageView

Should not be used after the date marked "EXP" on the pack. This must be kept out of the reach and sight of children.

Eytex

Dexamethasone + Tobramycin

Ophthalmic Solution 0.1%+0.3% Allopathic Ophthalmic steroid - antibiotic combined preparations

Indications

Pink eye

Indication detailsView

This sterile Eye Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Therapeutic classView

Ophthalmic steroid - antibiotic combined preparations

PharmacologyView

Like other amino-glycosides, the bactericidal activity of Tobramycin is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria, but at the present time, very little is known about this action. It is thought that inhibition of protein synthesis is due to an action on ribosome that causes bacterial misreading of messenger RNA. The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also Dexamethasone inhibits the chemo-tactic infiltration of neutrophils into the site of inflammation. The result is that its anti-inflammatory activity is 25 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone.

DosageView

Insert 1 drop into the conjunctival sac 3-5 times per day. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every 2 hours.

Side effectsView

The most frequent side effects to topical ocular Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjuntival erythema. The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsule cataract formation.

ContraindicationsView

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral disease of the cornea and conjunctiva. Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium. Fungal diseases of ocular structures. Untreated purulent infection of the eye. Hypersensitivity to any component of the medication.

PrecautionsView

Shake the bottle well before use. To prevent contamination do not touch the tip of the bottle to affected eye, eyelid or any surface of of the affected eye. Keep the bottle tightly closed after use.

InteractionsView

No specific interaction studies were performed with this combination eye drops. In case of concomitant therapy with other topical ophthalmic medicines, an interval of 10 minutes should be allowed between successive applications.

Pregnancy & lactationView

Safety for use during pregnancy and lactation in humans has not been established

Pediatric usageView

Use in paediatric: Safety and effectiveness in paediatric patients below 2 years have not been established.

Overdose effectsView

Overdose of this eye drops may be flushed from the eye(s) with lukewarm tap water.

StorageView

Store at room temperature. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.

Eytex

Dexamethasone + Tobramycin

Ophthalmic Ointment 0.1%+0.3% Allopathic Ophthalmic steroid - antibiotic combined preparations

Indications

Pink eye

Indication detailsView

This sterile Eye Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Therapeutic classView

Ophthalmic steroid - antibiotic combined preparations

PharmacologyView

Like other amino-glycosides, the bactericidal activity of Tobramycin is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria, but at the present time, very little is known about this action. It is thought that inhibition of protein synthesis is due to an action on ribosome that causes bacterial misreading of messenger RNA. The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also Dexamethasone inhibits the chemo-tactic infiltration of neutrophils into the site of inflammation. The result is that its anti-inflammatory activity is 25 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone.

DosageView

Insert 1 drop into the conjunctival sac 3-5 times per day. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every 2 hours.

Side effectsView

The most frequent side effects to topical ocular Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjuntival erythema. The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsule cataract formation.

ContraindicationsView

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral disease of the cornea and conjunctiva. Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium. Fungal diseases of ocular structures. Untreated purulent infection of the eye. Hypersensitivity to any component of the medication.

PrecautionsView

Shake the bottle well before use. To prevent contamination do not touch the tip of the bottle to affected eye, eyelid or any surface of of the affected eye. Keep the bottle tightly closed after use.

InteractionsView

No specific interaction studies were performed with this combination eye drops. In case of concomitant therapy with other topical ophthalmic medicines, an interval of 10 minutes should be allowed between successive applications.

Pregnancy & lactationView

Safety for use during pregnancy and lactation in humans has not been established

Pediatric usageView

Use in paediatric: Safety and effectiveness in paediatric patients below 2 years have not been established.

Overdose effectsView

Overdose of this eye drops may be flushed from the eye(s) with lukewarm tap water.

StorageView

Store at room temperature. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.

Eytob

Tobramycin (Ophthalmic)

Ophthalmic Solution 0.30% Allopathic Ophthalmic antibacterial drugs

Indications

Ocular infections

Indication detailsView

Tobramycin is a topical antibiotic indicated in the treatment of external bacterial infections of the eye caused by susceptible organisms. Such as,

Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus spp. of group A beta-hemolytic and some nonhemolytic species.

Gram-negative bacteria: E.coli, Pseudomonas aeruginosa, Enterobacter aerogenes, Klebsiella spp., Proteusmirabillis, Proteus vulgaris, Haemophilus influenzae, Morganella morganii, Acinetobacter calcoaceticus, Providentia, Serratia, Salmonella spp and some strains of Neisseria.

Therapeutic classView

Ophthalmic antibacterial drugs

PharmacologyView

Like other aminoglycosides, the bactericidal activity of Tobramycin is taken up into sensitive bacterial cells by an active transport process. Within the cell Tobramycin bind to the 30s, and to some extent to the 50s subunits of the bacterial ribosome, inhibiting protein synthesis and generating errors in the transcription of the genetic code. The manner in which cell death is brought about is imperfectly understood, and other mechanisms may contribute, including effects on membrane permeability.

DosageView

Ophthalmic ointment:

In mild to moderate infection, apply a small amount 2-3 times daily into the conjunctival sac(s).
In severe cases of infection, apply a small amount 3-4 times daily into the conjunctival sac(s) until improvement is obtained, then reduce the dose gradually.

Ophthalmic solution:

In mild to moderate infections: Instill 1or 2 drops into the affected eye(s) every 4 hours.
In severe infections: Instill 2 drops into the affected eye(s) every hour until improvement is observed.

Pediatric use: Safety and effectiveness in children below the age of 1 year have not been established.

Side effectsView

The most frequent side effect of Tobramycin ophthalmic solution is localized ocular toxicity, conjunctival erythema, hypersensitivity including lid itching and swelling.

ContraindicationsView

It is contraindicated in patients who are hypersensitive to Tobramycin or any of the ingredients of the preparation.

PrecautionsView

Minor sensitivity may occur to topically applied aminoglycosides in some patients. If a sensitivity reaction occurs, discontinue use. Prolonged use may result in overgrowth of nonsusceptible organisms and fungi.

InteractionsView

Care should be exercised when tobramycin is given to patients receiving other drugs with neuromauscular blocking agents or ototoxic.

Pregnancy & lactationView

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should only be used during pregnancy, if the potential benefits outweigh the possible risk to the fetus. Drug may excreted into human milk. A decision should be made whether to discontinue nursing or to taking the drug.

Overdose effectsView

Sign and symptoms of overdose may be similar to side effects as described above.

StorageView

Protect from light, store in cool (below 25°C) & dry place. Keep out of reach of children. Used within 4 weeks after first opening.

Ezair

Montelukast Sodium

Tablet 10 mg Allopathic Leukotriene receptor antagonists

Indications

Rhinitis

Indication detailsView

Montelukast Sodium is indicated for:

Prophylaxis and chronic treatment of asthma
Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Therapeutic classView

Leukotriene receptor antagonists

PharmacologyView

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

DosageView

Adults & adolescents (15 years & older)-

Asthma & Allergic Rhinitis: 10 mg/day
Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

Asthma & Allergic Rhinitis: 5 mg/day
Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

Asthma & Allergic Rhinitis: 4 mg/day
Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

AdministrationView

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Side effectsView

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

ContraindicationsView

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

PrecautionsView

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

InteractionsView

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

Overdose effectsView

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

StorageView

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Ezemove

Aceclofenac

Tablet 100 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView

Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.

Therapeutic classView

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

PharmacologyView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

DosageView

Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.

Side effectsView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

ContraindicationsView

Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.

PrecautionsView

Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.

InteractionsView

No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:

Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
Diuretics: may interact the activity of diuretics.
Anticoagulants: may enhance the activity of anticoagulant.
Methotrexate: may increase the plasma level of methotrexate.

Pregnancy & lactationView

The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Pediatric usageView

There are no clinical data on the use of Aceclofenac in children.

StorageView

keep in a dry place away from light and heat. Keep out of the reach of children.

Ezeta

Ezetimibe

Tablet 10 mg Allopathic Ezetimibe

Indications

Obesity

Indication detailsView

Primary Hypercholesterolemia: Ezetimibe co-administered with statin is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia who are not appropriately controlled with a statin alone.
Ezetimibe monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia in whom a statin is considered inappropriate or is not tolerated.

Prevention of Cardiovascular Events: Ezetimibe is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin.

Homozygous Familial Hypercholesterolaemia (HoFH): Ezetimibe co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Homozygous Sitosterolemia (Phytosterolemia): Ezetimibe is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolemia

Therapeutic classView

Ezetimibe

PharmacologyView

Ezetimibe localises at the brush border of the small intestine and inhibits absorption of cholesterol via the sterol transporter, Niemann-Pick C1-Like1 (NPC1L1). This results in decreased delivery of cholesterol to the liver, reduction of hepatic cholesterol stores and increased clearance of cholesterol from the blood.

DosageView

The recommended dose of Ezetimibe is 10 mg once daily. Ezetimibe can be administered with or without food.

Side effectsView

Clinical studies of Ezetimibe (administered alone or with an HMG-CoA reductase
inhibitor) demonstrated that Ezetimibe was generally well tolerated. The overall
incidence of adverse events reported with Ezetimibe was similar to that reported with
placebo, and the discontinuation rate due to adverse events was also similar for Ezetimibe
and placebo.

ContraindicationsView

Hypersensitivity to any component of this medication. The combination of Ezetimibe
with an HMG-CoA reductase inhibitor is contraindicated in patients with active liver
disease or unexplained persistent elevations in serum transaminases.

PrecautionsView

Exclude or treat secondary causes of dyslipidaemia prior to initiating therapy. Renal and hepatic impairment. Pregnancy and lactation.

InteractionsView

Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. In a preclinical study in animals, Ezetimibe increased cholesterol in the gallbladder bile. Coadministration of Ezetimibe with fibrates is not therefore recommended until use in patients is studied.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus

Pediatric usageView

Pediatric Use-

10 to 17 years: No dosage adjustment is required. The clinical experience in pediatric and adolescent patients is however limited. When Ezetimibe is administered with statin, the dosage instructions for statin, in adolescents should be consulted.

Children < 10 years: Ezetimibe is not recommended for use in children below age 10 due to insufficient data on safety and efficacy.

Overdose effectsView

No cases of overdosage with Ezetimibe have been reported. Administration of Ezetimibe,
50 mg/day, to 15 subjects for up to 14 days was generally well tolerated. In the event of
an overdose, symptomatic and supportive measures should be employed.

StorageView

Store in a cool & dry place protected from light and moisture. Keep out of reach of children.

Ezetim

Ezetimibe

Tablet 10 mg Allopathic Ezetimibe

Indications

Obesity

Indication detailsView

Primary Hypercholesterolemia: Ezetimibe co-administered with statin is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia who are not appropriately controlled with a statin alone.
Ezetimibe monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia in whom a statin is considered inappropriate or is not tolerated.

Prevention of Cardiovascular Events: Ezetimibe is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin.

Homozygous Familial Hypercholesterolaemia (HoFH): Ezetimibe co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Homozygous Sitosterolemia (Phytosterolemia): Ezetimibe is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolemia

Therapeutic classView

Ezetimibe

PharmacologyView

Ezetimibe localises at the brush border of the small intestine and inhibits absorption of cholesterol via the sterol transporter, Niemann-Pick C1-Like1 (NPC1L1). This results in decreased delivery of cholesterol to the liver, reduction of hepatic cholesterol stores and increased clearance of cholesterol from the blood.

DosageView

The recommended dose of Ezetimibe is 10 mg once daily. Ezetimibe can be administered with or without food.

Side effectsView

Clinical studies of Ezetimibe (administered alone or with an HMG-CoA reductase
inhibitor) demonstrated that Ezetimibe was generally well tolerated. The overall
incidence of adverse events reported with Ezetimibe was similar to that reported with
placebo, and the discontinuation rate due to adverse events was also similar for Ezetimibe
and placebo.

ContraindicationsView

Hypersensitivity to any component of this medication. The combination of Ezetimibe
with an HMG-CoA reductase inhibitor is contraindicated in patients with active liver
disease or unexplained persistent elevations in serum transaminases.

PrecautionsView

Exclude or treat secondary causes of dyslipidaemia prior to initiating therapy. Renal and hepatic impairment. Pregnancy and lactation.

InteractionsView

Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. In a preclinical study in animals, Ezetimibe increased cholesterol in the gallbladder bile. Coadministration of Ezetimibe with fibrates is not therefore recommended until use in patients is studied.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus

Pediatric usageView

Pediatric Use-

10 to 17 years: No dosage adjustment is required. The clinical experience in pediatric and adolescent patients is however limited. When Ezetimibe is administered with statin, the dosage instructions for statin, in adolescents should be consulted.

Children < 10 years: Ezetimibe is not recommended for use in children below age 10 due to insufficient data on safety and efficacy.

Overdose effectsView

No cases of overdosage with Ezetimibe have been reported. Administration of Ezetimibe,
50 mg/day, to 15 subjects for up to 14 days was generally well tolerated. In the event of
an overdose, symptomatic and supportive measures should be employed.

StorageView

Store in a cool & dry place protected from light and moisture. Keep out of reach of children.

Ezetrol

Ezetimibe

Tablet 10 mg Allopathic Ezetimibe

Indications

Obesity

Indication detailsView

Primary Hypercholesterolemia: Ezetimibe co-administered with statin is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia who are not appropriately controlled with a statin alone.
Ezetimibe monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia in whom a statin is considered inappropriate or is not tolerated.

Prevention of Cardiovascular Events: Ezetimibe is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin.

Homozygous Familial Hypercholesterolaemia (HoFH): Ezetimibe co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Homozygous Sitosterolemia (Phytosterolemia): Ezetimibe is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolemia

Therapeutic classView

Ezetimibe

PharmacologyView

Ezetimibe localises at the brush border of the small intestine and inhibits absorption of cholesterol via the sterol transporter, Niemann-Pick C1-Like1 (NPC1L1). This results in decreased delivery of cholesterol to the liver, reduction of hepatic cholesterol stores and increased clearance of cholesterol from the blood.

DosageView

The recommended dose of Ezetimibe is 10 mg once daily. Ezetimibe can be administered with or without food.

Side effectsView

Clinical studies of Ezetimibe (administered alone or with an HMG-CoA reductase
inhibitor) demonstrated that Ezetimibe was generally well tolerated. The overall
incidence of adverse events reported with Ezetimibe was similar to that reported with
placebo, and the discontinuation rate due to adverse events was also similar for Ezetimibe
and placebo.

ContraindicationsView

Hypersensitivity to any component of this medication. The combination of Ezetimibe
with an HMG-CoA reductase inhibitor is contraindicated in patients with active liver
disease or unexplained persistent elevations in serum transaminases.

PrecautionsView

Exclude or treat secondary causes of dyslipidaemia prior to initiating therapy. Renal and hepatic impairment. Pregnancy and lactation.

InteractionsView

Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. In a preclinical study in animals, Ezetimibe increased cholesterol in the gallbladder bile. Coadministration of Ezetimibe with fibrates is not therefore recommended until use in patients is studied.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus

Pediatric usageView

Pediatric Use-

10 to 17 years: No dosage adjustment is required. The clinical experience in pediatric and adolescent patients is however limited. When Ezetimibe is administered with statin, the dosage instructions for statin, in adolescents should be consulted.

Children < 10 years: Ezetimibe is not recommended for use in children below age 10 due to insufficient data on safety and efficacy.

Overdose effectsView

No cases of overdosage with Ezetimibe have been reported. Administration of Ezetimibe,
50 mg/day, to 15 subjects for up to 14 days was generally well tolerated. In the event of
an overdose, symptomatic and supportive measures should be employed.

StorageView

Store in a cool & dry place protected from light and moisture. Keep out of reach of children.

Ezevent

Montelukast Sodium

Tablet 10 mg Allopathic Leukotriene receptor antagonists

Indications

Rhinitis

Indication detailsView

Montelukast Sodium is indicated for:

Prophylaxis and chronic treatment of asthma
Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Therapeutic classView

Leukotriene receptor antagonists

PharmacologyView

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

DosageView

Adults & adolescents (15 years & older)-

Asthma & Allergic Rhinitis: 10 mg/day
Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

Asthma & Allergic Rhinitis: 5 mg/day
Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

Asthma & Allergic Rhinitis: 4 mg/day
Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

AdministrationView

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Side effectsView

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

ContraindicationsView

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

PrecautionsView

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

InteractionsView

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

Overdose effectsView

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

StorageView

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Ezex

Clobetasone Butyrate

Ointment 0.05% Allopathic Clobetasol / Clobetasone & Combined Preparations

Indications

Seborrhoeic dermatitis

Indication detailsView

Clobetasone preparations are indicated for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. Clobetasone may be used as a maintenance therapy between courses of one of the more active topical steroids.

Therapeutic classView

Clobetasol / Clobetasone & Combined Preparations

PharmacologyView

Clobetasone Butyrate is a topically active corticosteroid, which provides an exceptional combination of activity and safety. It is more effective in the treatment of eczemas than 1% Hydrocortisone, or the less active synthetic steroid preparations that are in common use. It has little effect on hypothalamic-pituitary-adrenal function. All topical corticosteroids can cause cutaneous atrophy if grossly misused. However, study in animal and human models indicates that Clobetasone Butyrate causes less thinning of the epidermis than the other topical steroid tested.

DosageView

Apply to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.

Side effectsView

Local atrophic changes; pigmentation changes & hypertrichosis. Increased liability to infection. Infections may be masked. Acute adrenal insufficiency. Growth retardation in child. Cushingoid symptoms. Amenorrhoea, hyperhidrosis, skin thinning

ContraindicationsView

Pregnancy (in high doses), Presence of acute infections, Treatment of rosacea, Leg ulcers, Acne vulgaris, Widespread plaque psoriasis. Child <1 yr.

PrecautionsView

May be absorbed in sufficient amounts to cause systemic effects when applied topically to large areas, broken skin or under occlusive dressings. Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Not to be used indiscriminately for pruritus. CHF or hypertension. Diabetes mellitus, epilepsy, glaucoma, infectious diseases, ocular herpes simplex, chronic renal failure and uraemia. Active or doubtfully quiescent tuberculosis. Local treatment of eye disorders. Elderly. Prolonged use on the face.

InteractionsView

Potentially hazardous interactions- none has been reported. Potentially useful interactions- none has been reported.

Pregnancy & lactationView

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.

Overdose effectsView

Acute overdosage is very unlikely to occur, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.

StorageView

Store below 30˚ C. Do not freeze. Protect from light.

Ezex

Clobetasone Butyrate

Cream 0.05% Allopathic Clobetasol / Clobetasone & Combined Preparations

Indications

Seborrhoeic dermatitis

Indication detailsView

Clobetasone preparations are indicated for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. Clobetasone may be used as a maintenance therapy between courses of one of the more active topical steroids.

Therapeutic classView

Clobetasol / Clobetasone & Combined Preparations

PharmacologyView

Clobetasone Butyrate is a topically active corticosteroid, which provides an exceptional combination of activity and safety. It is more effective in the treatment of eczemas than 1% Hydrocortisone, or the less active synthetic steroid preparations that are in common use. It has little effect on hypothalamic-pituitary-adrenal function. All topical corticosteroids can cause cutaneous atrophy if grossly misused. However, study in animal and human models indicates that Clobetasone Butyrate causes less thinning of the epidermis than the other topical steroid tested.

DosageView

Apply to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.

Side effectsView

Local atrophic changes; pigmentation changes & hypertrichosis. Increased liability to infection. Infections may be masked. Acute adrenal insufficiency. Growth retardation in child. Cushingoid symptoms. Amenorrhoea, hyperhidrosis, skin thinning

ContraindicationsView

Pregnancy (in high doses), Presence of acute infections, Treatment of rosacea, Leg ulcers, Acne vulgaris, Widespread plaque psoriasis. Child <1 yr.

PrecautionsView

May be absorbed in sufficient amounts to cause systemic effects when applied topically to large areas, broken skin or under occlusive dressings. Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Not to be used indiscriminately for pruritus. CHF or hypertension. Diabetes mellitus, epilepsy, glaucoma, infectious diseases, ocular herpes simplex, chronic renal failure and uraemia. Active or doubtfully quiescent tuberculosis. Local treatment of eye disorders. Elderly. Prolonged use on the face.

InteractionsView

Potentially hazardous interactions- none has been reported. Potentially useful interactions- none has been reported.

Pregnancy & lactationView

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.

Overdose effectsView

Acute overdosage is very unlikely to occur, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.

StorageView

Store below 30˚ C. Do not freeze. Protect from light.

Ezide

Gliclazide

Tablet 80 mg Allopathic Sulfonylureas

Indications

Type 2 DM

Indication detailsView

Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.

Therapeutic classView

Sulfonylureas

PharmacologyView

Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca⁺² transport across the β-cell membranes and decreases hepatic glucose output.

DosageView

Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.

Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.

The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).

If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.

If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.

If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Side effectsView

Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.

Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.

Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.

Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.

Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.

Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.

As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.

Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

ContraindicationsView

Do not take Gliclazide:

if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
if you have insulin-dependent diabetes (type 1)
if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
if you have severe kidney or liver disease
if you are taking medicines to treat fungal infections
if you are breastfeeding

PrecautionsView

Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.

Low blood sugar (Hypoglycaemia) may occur:

if you take meals irregularly or skip meals altogether,
if you are fasting
if you are malnourished
if you change your diet
if you increase your physical activity and carbohydrate intake does not match this increase,
if you drink alcohol, especially in combination with skipped meals,
if you take other medicines or natural remedies at the same time,
if you take too high doses of gliclazide,
if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
if your kidney function or liver function is severely decreased.

if you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness and helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).

If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.

In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).

You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.

Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).

If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.

Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.

Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.

If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.

Gliclazide is not recommended for use in children due to lack of data.

InteractionsView

Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:

other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
antibiotics (sulphonamides, clarithromycin)
medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
medicines to treat fungal infections (miconazole, fluconazole)
medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
medicines to treat depression (monoamine oxidase inhibitors)
painkiller or antirheumatics (phenylbutazone, ibuprofen)
medicines containing alcohol

The blood-glucose-lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:

medicines to treat disorders of the central nervous system (chlorpromazine)
medicines reducing inflammation (corticosteroids)
medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
St John's Wort- Hypericum perforatum- preparations

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as gliclazide especially in elderly patients.

Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).

Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.

Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.

Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:

have frequent episodes of low blood sugar (hypoglycaemia)
have few or no warning signals of low blood sugar (hypoglycaemia)

Gliclazide contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Pregnancy & lactationView

Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.

StorageView

Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Eziflo

Tamsulosin Hydrochloride

Capsule (Modified Release) 0.4 mg Allopathic BPH/ Urinary retention/ Urinary incontinence

Indications

Benign prostatic hyperplasia (BPH)

Indication detailsView

Tamsulosin Hydrochloride is indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).

Therapeutic classView

BPH/ Urinary retention/ Urinary incontinence

PharmacologyView

Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1 A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin hydrochloride capsule 0.4mg is essentially complete (90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when administered with food. Tamsulosin hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin hydrochloride is extensively metabolized by cytochrome P 450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination half-life of Tamsulosin hydrochloride in plasma ranges from five to seven hours. Because of the absorption rate controlled pharmacokinetics with Prostam capsules, the apparent half-life of Tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

DosageView

Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.

Side effectsView

The following adverse reactions have been reported during the use of Tamsulosin: dizziness, abnormal ejaculation and; less frequently headache, asthenia, postural hypotension and palpitations.

ContraindicationsView

Tamsulosin hydrochloride is contraindicated in patients with hypersensitivity to it; history of orthostatic hypotension; severe hepatic insufficiency.

As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur, at the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).

Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic hyperplasia. Digital rectal examination and when the necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards.

PrecautionsView

Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose. Use in patients with micturition syncope is not advised.

Effects on ability to drive and use machines: No data is available on whether Tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness can occur.

InteractionsView

Concurrent administration of other alfa1-adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when Tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant cimetidine brings about a rise and frusemide a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be changed. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug-metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin.

Pregnancy & lactationView

Use of Tamsulosin in pregnancy and lactation is not recommended.

Overdose effectsView

No case of acute overdosage has been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

StorageView

Store in a cool and dry place, below 30°C, protected from light.

Eziflo-D

Tamsulosin Hydrochloride + Dutasteride

Capsule 0.4 mg+0.5 mg Allopathic BPH/ Urinary retention/ Urinary incontinence

Indications

Benign prostatic hyperplasia (BPH)

Indication detailsView

Tamsulosin Hydrochloride & Dutasteride capsule is indicated in-

Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
Reduction in the risk of acute urinary retention and surgery in patients with moderate to severe symptoms of BPH.

Therapeutic classView

BPH/ Urinary retention/ Urinary incontinence

PharmacologyView

Tamsulosin & Dutasteride is a combination of two drugs with complementary mechanisms of action to improve symptoms in patients with Benign Prostatic Hyperplasia (BPH). Tamsulosin Hydrochloride, an antagonist of alpha_1A-adrenoreceptors and Dutasteride, a dual 5 alpha reductase inhibitor (5ARI). Treatment of BPH with alpha₁-adrenoreceptor blocking agents and 5ARIs results in an improvement in urine flow rate and a reduction in symptoms of BPH.

Tamsulosin: An alpha1-adrenoreceptor blocking agent that affects the dynamic component of BPH by inhibiting alpha₁-adrenoreceptors in the stromal prostatic smooth muscle and bladder neck. Blockade of these adrenoreceptors can cause smooth muscles in the bladder neck and prostate to relax. Specifically, Tamsulosin exhibits selectivity for both alpha _1A and alpha _1D receptors over the alpha_1B-adrenoreceptor subtype. These three adrenoreceptor subtypes have a distinct distribution pattern in human tissue. Whereas approximately 70% of the alpha₁-receptors in human prostate are of the alpha _1A subtype, the human bladder contains predominantly the alpha _1D subtype while blood vessels express predominantly alpha _1B subtype. It is further believed that blockade of the alpha _1D subtypes in the human obstructed bladder may be responsible for reducing detrusor overactivity and subsequent relief of storage symptoms.

Dutasteride: A synthetic 4-azasteriod compound is a competitive and specific inhibitor of both Type I and Type II 5 alpha-reductase isoenzymes that affects the static component of BPH by inhibiting the conversion of Testosterone to Dihydrotestosterone (DHT) by the enzyme 5 alpha-reductase. 5 alpha-reductase exists as 2 isoforms, Type I and Type II, both of which are present in the prostate. It has been observed that compared to normal tissue, the expression of both isoenzymes are increased in BPH tissue. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride lowers DHT levels and leads to a reduction in prostatic volume, thereby treating an underlying cause of BPH. Dutasteride does not bind to the human androgen receptor.

DosageView

Adults (including elderly): The recommended dose is one capsule (Tamsulosin Hydrochloride 0.4 mg & Dutasteride 0.5 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. Where appropriate, this capsule may be used to substitute concomitant Tamsulosin Hydrochloride and Dutasteride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from Tamsulosin Hydrochloride or Dutasteride monotherapy to this capsule may be considered.

Renal impairment: The effect of renal impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment.

Hepatic impairment: The effect of hepatic impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of this capsule is contra-indicated.

Side effectsView

The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders and dizziness. The percentages of subjects with ejaculation disorders, decreased libido and impotence were higher in the combination therapy group compared with either monotherapy groups.

ContraindicationsView

Tamsulosin-Dutasteride combination is contra-indicated in women and children and adolescents, patients with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, Tamsulosin (including Tamsulosin- induced angio-edema), soya, peanut or any of other the excipients, patients with a history of orthostatic hypotension and patients with severe hepatic impairment.

PrecautionsView

Combination therapy should be prescribed after careful benefit risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment options including monotherapies.

Cardiac failure: In two 4-year clinical studies, the incidence of cardiac failure was higher among subjects taking the combination of Dutasteride and an alpha blocker, primarily Tamsulosin, than it was among subjects not taking the combination. In these two trials, the incidence of cardiac failure was low (1%) and variable between the studies.

Effects on prostate specific antigen (PSA) and prostate cancer detection: Digital rectal examination, as well as other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH, must be performed on patients prior to initiating therapy with Tamsulosin-Dutasteride combination and periodically thereafter. Serum prostate-specific antigen (PSA) concentration is an important component in the detection of prostate cancer. Tamsulosin-Dutasteride combination causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients receiving Tamsulosin-Dutasteride combination should have a new PSA baseline established after 6 months of treatment. It is recommended to monitor PSA values regularly thereafter. Any confirmed increase from lowest PSA level while on Tamsulosin-Dutasteride combination may signal the presence of prostate cancer or noncompliance to therapy with Tamsulosin-Dutasteride combination and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5 alpha-reductase inhibitor. In the interpretation of a PSA value for a patient taking Tamsulosin-Dutasteride combination, previous PSA values while on Dutasteride treatment should be sought for comparison. Treatment with Tamsulosin-Dutasteride combination does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established. Total serum PSA levels return to baseline within 6 months of discontinuing treatment. The ratio of free to total PSA remains constant even under the influence of Tamsulosin-Dutasteride combination. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing Tamsulosin-Dutasteride combination therapy, no adjustment to its value appears necessary.

Prostate cancer and high grade tumours: Results of one clinical study in men at increase risk of prostate cancer revealed a higher incidence of Gleason 8-10 prostate cancers in Dutasteride treated men compared to placebo. The relationship between Dutasteride and high grade prostate cancer is not clear. Men taking Tamsulosin-Dutasteride combination should be regularly evaluated for prostate cancer risk including PSA testing.

Renal impairment: The treatment of severely renally impaired patients (creatinine clearance of less than 10 ml/min) should be approached with caution as these patients have not been studied.

Hypotension: Orthostatic- As with other alpha-blockers, a reduction in blood pressure can occur during treatment with Tamsulosin, as a result of which, rarely, syncope can occur. Patients beginning treatment with Tamsulosin-Dutasteride combination should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have resolved. In order to minimize the potential for developing postural hypotension the patient should be haemodynamically stable on alpha-blocker therapy prior to initiating use of PDE5 inhibitors. Symptomatic: Caution is advised when alpha adrenergic blocking agents including Tamsulosin are coadministered with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil). Alpha adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.

Intraoperative Floppy Iris Syndrome: Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with Tamsulosin. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with Tamsulosin-Dutasteride combination in patients for whom cataract surgery is scheduled is therefore not recommended. Discontinuing Tamsulosin 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established. Leaking Capsule: Dutasteride is absorbed through the skin, therefore, women, children and adolescents must avoid contact with leaking capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.

Hepatic impairment: Tamsulosin-Dutasteride combination has not been studied in patients with liver disease. Caution should be used in the administration of Tamsulosin-Dutasteride combination to patients with mild to moderate hepatic impairment.

Breast neoplasia: Breast cancer has been reported in men taking Dutasteride in clinical trials and during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of Dutasteride.

InteractionsView

There have been no drug interaction studies for Dutasteride-Tamsulosin combination.

Effects of other drugs on the pharmacokinetics of Dutasteride: Use together with CYP3A4 and/or P-glycoprotein-inhibitors: Dutasteride is mainly eliminated via metabolism. In vitro studies indicate that this metabolism is catalysed by CYP3A4 and CYP3A5. No formal interaction studies have been performed with potent CYP3A4 inhibitors. However, in a population pharmacokinetic study, Dutasteride serum concentrations were on average 1.6 to 1.8 times greater, respectively, in a small number of patients treated concurrently with verapamil or diltiazem (moderate inhibitors of CYP3A4 and inhibitors of P-glycoprotein) than in other patients. Long-term combination of Dutasteride with drugs that are potent inhibitors of the enzyme CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of Dutasteride. Further inhibition of 5-alpha reductase at increased Dutasteride exposure, is not likely. However, a reduction of the Dutasteride dosing frequency can be considered if side effects are noted. It should be noted that in the case of enzyme inhibition, the long half-life may be further prolonged and it can take more than 6 months of concurrent therapy before a new steady state is reached. Administration of 12 g cholestyramine one hour after a 5 mg single dose of Dutasteride did not affect the pharmacokinetics of Dutasteride.

Effects of Dutasteride on the pharmacokinetics of other drugs: In a small study (N=24) of two weeks duration in healthy men, Dutasteride (0.5 mg daily) had no effect on the pharmacokinetics of Tamsulosin or terazosin. There was also no indication of a pharmacodynamic interaction in this study. Dutasteride has no effect on the pharmacokinetics of warfarin or digoxin. This indicates that Dutasteride does not inhibit/induce CYP2C9 or the transporter P-glycoprotein. In vitro interaction studies indicate that Dutasteride does not inhibit the enzymes CYP1A2, CYP2D6, CYP2C9, CYP2C19 or CYP3A4. Tamsulosin: Concomitant administration of Tamsulosin Hydrochloride with drugs which can reduce blood pressure, including anaesthetic agents, PDE5 inhibitors and other alpha-1 adrenergic blockers could lead to enhanced hypotensive effects. Tamsulosin-Dutasteride should not be used in combination with other alpha-1 adrenergic blockers. Concomitant administration of Tamsulosin Hydrochloride (0.4 mg) and cimetidine (400 mg every six hours for six days) resulted in a decrease in the clearance (26%) and an increase in the AUC (44%) of Tamsulosin Hydrochloride. Caution should be used when Tamsulosin-Dutasteride is used in combination with cimetidine. A definitive drug-drug interaction study between Tamsulosin Hydrochloride and warfarin has not been conducted. Results from limited in vitro and in vivo studies are inconclusive. Caution should be exercised with concomitant administration of warfarin and Tamsulosin Hydrochloride. No interactions have been seen when Tamsulosin Hydrochloride was given concomitantly with either atenolol, enalapril, nifedipine or theophylline. Concomitant furosemide brings about a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be adjusted. In vitro neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitryptyline, diclofenac, glibenclamide and simvastatin change the free fraction of Tamsulosin in human plasma. Neither does Tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinon. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions, involving amitriptyline, salbutamol and glibenclamide. Diclofenac however, may increase the elimination rate of Tamsulosin.

Pregnancy & lactationView

Tamsulosin-Dutasteride combination is contra-indicated for use by women. There have been no studies to investigate the effect of Tamsulosin-Dutasteride combination on pregnancy, lactation and fertility. The following statements reflect the information available from studies with the individual components. Fertility: Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. The possibility of reduced male fertility cannot be excluded. Effects of Tamsulosin Hydrochloride on sperm counts or sperm function have not been evaluated.

Pregnancy: As with other 5 alpha reductase inhibitors, Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male foetus, inhibit the development of the external genitalia of the foetus. Small amounts of Dutasteride have been recovered from the semen in subjects receiving Dutasteride. It is not known whether a male foetus will be adversely affected if his mother is exposed to the semen of a patient being treated with Dutasteride. As with all 5 alpha reductase inhibitors, when the patient’s partner is or may potentially be pregnant it is recommended that the patient avoids exposure of his partner to semen by use of a condom. Administration of Tamsulosin Hydrochloride to pregnant female rats and rabbits showed no evidence of foetal harm.

Lactation: It is not known whether Tamsulosin or Dutasteride are excreted in human milk.

Overdose effectsView

No data are available with regard to over dosage of Tamsulosin-Dutasteride combination. The following statements reflect the information available on the individual components.

Dutasteride: In volunteer studies, single daily doses of Dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for Dutasteride, therefore, in suspected over dosage symptomatic and supportive treatment should be given as appropriate.

Tamsulosin: Acute overdose with 5 mg Tamsulosin Hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after over dosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

StorageView

Store in a cool and dry place, protected from light.

Ezipas

Tamsulosin Hydrochloride

Capsule (Modified Release) 0.4 mg Allopathic BPH/ Urinary retention/ Urinary incontinence

Indications

Benign prostatic hyperplasia (BPH)

Indication detailsView

Tamsulosin Hydrochloride is indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).

Therapeutic classView

BPH/ Urinary retention/ Urinary incontinence

PharmacologyView

Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1 A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin hydrochloride capsule 0.4mg is essentially complete (90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when administered with food. Tamsulosin hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin hydrochloride is extensively metabolized by cytochrome P 450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination half-life of Tamsulosin hydrochloride in plasma ranges from five to seven hours. Because of the absorption rate controlled pharmacokinetics with Prostam capsules, the apparent half-life of Tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

DosageView

Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.

Side effectsView

The following adverse reactions have been reported during the use of Tamsulosin: dizziness, abnormal ejaculation and; less frequently headache, asthenia, postural hypotension and palpitations.

ContraindicationsView

Tamsulosin hydrochloride is contraindicated in patients with hypersensitivity to it; history of orthostatic hypotension; severe hepatic insufficiency.

As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur, at the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).

Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic hyperplasia. Digital rectal examination and when the necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards.

PrecautionsView

Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose. Use in patients with micturition syncope is not advised.

Effects on ability to drive and use machines: No data is available on whether Tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness can occur.

InteractionsView

Concurrent administration of other alfa1-adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when Tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant cimetidine brings about a rise and frusemide a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be changed. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug-metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin.

Pregnancy & lactationView

Use of Tamsulosin in pregnancy and lactation is not recommended.

Overdose effectsView

No case of acute overdosage has been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

StorageView

Store in a cool and dry place, below 30°C, protected from light.