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Xylo Plus
Sodium Cromoglicate + Xylometazoline Hydrochloride
Xylo Plus
Sodium Cromoglicate + Xylometazoline Hydrochloride
Indications
Rhinitis
Indication detailsView
This Nasal Spray is indicated for the prophylaxis and treatment of allergic rhinitis (such as hay fever and perennial rhinitis) where this is accompanied by nasal congestion.
Therapeutic classView
Mast Cell Stabiliser
PharmacologyView
Xylometazoline Hydrochloride is a sympathomimetic agent with alpha-adrenergic activity. It produces vasoconstriction thus reducing nasal congestion. This enables patients suffering from colds to breathe more easily through the nose.
Sodium Cromoglicate usually acts through a local effect on the nasal mucosa. It prevents release of the mediators of type-l allergic reactions, including histamine and slow reacting substance of anaphylaxis (SRS-A) from sensitized mast cells after the antigen-antibody union has taken place. The drug does not inhibit the binding of IgE and the specific antigen; instead it suppresses the release of substances (e.g., histamine, SRS-A) in response to this reaction. The drug also inhibits Type-III (late allergic, Arthers) reactions to a lesser extent.
Sodium Cromoglicate usually acts through a local effect on the nasal mucosa. It prevents release of the mediators of type-l allergic reactions, including histamine and slow reacting substance of anaphylaxis (SRS-A) from sensitized mast cells after the antigen-antibody union has taken place. The drug does not inhibit the binding of IgE and the specific antigen; instead it suppresses the release of substances (e.g., histamine, SRS-A) in response to this reaction. The drug also inhibits Type-III (late allergic, Arthers) reactions to a lesser extent.
DosageView
Adults (including the elderly) and children: One spray each nostril four times daily.
AdministrationView
How to use the Nasal Spray-
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/ other nostril for consecutive doses.
- Remove the dust cover.
- Gently pull off the nasal applicator.
- Wash the applicator and dust cover in warm water.
- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
Side effectsView
No serious side effects have been reported. Occasional irritation of the nasal mucosa may occur during the first day of use. In rare cases with Sodium Cromoglicate solutions alone wheezing and tightness of the chest has been reported. Because a lower dose of Xylometazoline is employed in this preparation it causes mild side effects such as nasal irritation, dryness of the nose, sneezing, headache, insomnia, drowsiness and palpitations.
ContraindicationsView
Contraindicated in patients with a known hypersensitivity to any ingredients of the preparation.
PrecautionsView
The prolonged use or abuse of decongestants in general may lead to rebound congestion or drug induced rhinitis.
Pregnancy & lactationView
As with all medicines, caution should be exercised during pregnancy especially during the first trimester.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Xylocef
Cefixime Trihydrate
Xylocef
Cefixime Trihydrate
Indications
Urethritis
Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
- Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
- Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
- Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
- Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
- Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
- ½-1 year: 75 mg daily.
- 1-4 years: 100 mg daily.
- 5-10 years: 200 mg daily.
- 11-12 years: 300 mg daily
- In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.
Xylocef
Cefixime Trihydrate
Xylocef
Cefixime Trihydrate
Indications
Urethritis
Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
- Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
- Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
- Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
- Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
- Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
- ½-1 year: 75 mg daily.
- 1-4 years: 100 mg daily.
- 5-10 years: 200 mg daily.
- 11-12 years: 300 mg daily
- In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.
Xylocon
Oxymetazoline Hydrochloride (Nasal Preparation)
Xylocon
Oxymetazoline Hydrochloride (Nasal Preparation)
Indications
Sinusitis
Indication detailsView
Oxymetazoline Hydrochlorid is indicated for the treatment of nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, upper respiratory allergies, epistaxis and hay fever. It is also used as nasal decongestant in otitis media.
Therapeutic classView
Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations
PharmacologyView
Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. It is used as a topical agent on the nasal mucosa, produces a rapid and long acting vasoconstriction of the arterioles, thus reducing the blood flow and diminishing swelling of the mucosa. This results in improved potency of the airway and better drainage of the nasal sinus.
DosageView
Oxymetazoline nasal spray-
- Adults and children (6 years of age and older): 2 or 3 sprays in each nostril twice daily for 3-5 days.
- Elderly: There is no need for dosage reduction in the elderly for nasal administration.
- Children below 6 years of age: It is not suitable for children below 6 years of age.
- Adults & children 6 years of age: 2-3 drops of 0.05% Nasal Drops in each nostril twice daily in the morning and evening.
- Children 2-5 years of age: 2-3 drops of 0.025% Nasal Drops in each nostril twice daily in the morning and evening
AdministrationView
How to use the Nasal Spray-
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/ other nostril for consecutive doses.
- Remove the dust cover.
- Gently pull off the nasal applicator.
- Wash the applicator and dust cover in warm water.
- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
Side effectsView
Occasionally it may cause local irritation and dryness of the mouth and throat. Temporarily discomfort such as burning, stinging, sneezing or increase in nasal discharge may occur.
ContraindicationsView
It is contraindicated in patients with cardiovascular disease, hyperthyroidism, prostatic enlargement, angle closure glaucoma and hypersensitivity to any of its ingredients.
PrecautionsView
Keep away from the eyes. The spray should not be used for longer than seven days without medical advice. Frequent or prolonged use may cause nasal congestion to recur or worsen.
InteractionsView
Oxymetazoline Hydrochloride Nasal preparation should not be given to patients being treated with MAO inhibitors or within 14 days of ceasing such treatment.
Pregnancy & lactationView
The safety of Oxymetazoline Hydrochloride Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during those periods.
Overdose effectsView
Overdose may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.
StorageView
Keep below 30° C temperature in a dry place, protect from light. Do not refrigerate or freeze. Keep out of the reach of children.
Xylocon
Oxymetazoline Hydrochloride (Nasal Preparation)
Xylocon
Oxymetazoline Hydrochloride (Nasal Preparation)
Indications
Sinusitis
Indication detailsView
Oxymetazoline Hydrochlorid is indicated for the treatment of nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, upper respiratory allergies, epistaxis and hay fever. It is also used as nasal decongestant in otitis media.
Therapeutic classView
Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations
PharmacologyView
Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. It is used as a topical agent on the nasal mucosa, produces a rapid and long acting vasoconstriction of the arterioles, thus reducing the blood flow and diminishing swelling of the mucosa. This results in improved potency of the airway and better drainage of the nasal sinus.
DosageView
Oxymetazoline nasal spray-
- Adults and children (6 years of age and older): 2 or 3 sprays in each nostril twice daily for 3-5 days.
- Elderly: There is no need for dosage reduction in the elderly for nasal administration.
- Children below 6 years of age: It is not suitable for children below 6 years of age.
- Adults & children 6 years of age: 2-3 drops of 0.05% Nasal Drops in each nostril twice daily in the morning and evening.
- Children 2-5 years of age: 2-3 drops of 0.025% Nasal Drops in each nostril twice daily in the morning and evening
AdministrationView
How to use the Nasal Spray-
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/ other nostril for consecutive doses.
- Remove the dust cover.
- Gently pull off the nasal applicator.
- Wash the applicator and dust cover in warm water.
- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
Side effectsView
Occasionally it may cause local irritation and dryness of the mouth and throat. Temporarily discomfort such as burning, stinging, sneezing or increase in nasal discharge may occur.
ContraindicationsView
It is contraindicated in patients with cardiovascular disease, hyperthyroidism, prostatic enlargement, angle closure glaucoma and hypersensitivity to any of its ingredients.
PrecautionsView
Keep away from the eyes. The spray should not be used for longer than seven days without medical advice. Frequent or prolonged use may cause nasal congestion to recur or worsen.
InteractionsView
Oxymetazoline Hydrochloride Nasal preparation should not be given to patients being treated with MAO inhibitors or within 14 days of ceasing such treatment.
Pregnancy & lactationView
The safety of Oxymetazoline Hydrochloride Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during those periods.
Overdose effectsView
Overdose may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.
StorageView
Keep below 30° C temperature in a dry place, protect from light. Do not refrigerate or freeze. Keep out of the reach of children.
Xylocon
Oxymetazoline Hydrochloride (Nasal Preparation)
Xylocon
Oxymetazoline Hydrochloride (Nasal Preparation)
Indications
Sinusitis
Indication detailsView
Oxymetazoline Hydrochlorid is indicated for the treatment of nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, upper respiratory allergies, epistaxis and hay fever. It is also used as nasal decongestant in otitis media.
Therapeutic classView
Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations
PharmacologyView
Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. It is used as a topical agent on the nasal mucosa, produces a rapid and long acting vasoconstriction of the arterioles, thus reducing the blood flow and diminishing swelling of the mucosa. This results in improved potency of the airway and better drainage of the nasal sinus.
DosageView
Oxymetazoline nasal spray-
- Adults and children (6 years of age and older): 2 or 3 sprays in each nostril twice daily for 3-5 days.
- Elderly: There is no need for dosage reduction in the elderly for nasal administration.
- Children below 6 years of age: It is not suitable for children below 6 years of age.
- Adults & children 6 years of age: 2-3 drops of 0.05% Nasal Drops in each nostril twice daily in the morning and evening.
- Children 2-5 years of age: 2-3 drops of 0.025% Nasal Drops in each nostril twice daily in the morning and evening
AdministrationView
How to use the Nasal Spray-
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/ other nostril for consecutive doses.
- Remove the dust cover.
- Gently pull off the nasal applicator.
- Wash the applicator and dust cover in warm water.
- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
Side effectsView
Occasionally it may cause local irritation and dryness of the mouth and throat. Temporarily discomfort such as burning, stinging, sneezing or increase in nasal discharge may occur.
ContraindicationsView
It is contraindicated in patients with cardiovascular disease, hyperthyroidism, prostatic enlargement, angle closure glaucoma and hypersensitivity to any of its ingredients.
PrecautionsView
Keep away from the eyes. The spray should not be used for longer than seven days without medical advice. Frequent or prolonged use may cause nasal congestion to recur or worsen.
InteractionsView
Oxymetazoline Hydrochloride Nasal preparation should not be given to patients being treated with MAO inhibitors or within 14 days of ceasing such treatment.
Pregnancy & lactationView
The safety of Oxymetazoline Hydrochloride Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during those periods.
Overdose effectsView
Overdose may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.
StorageView
Keep below 30° C temperature in a dry place, protect from light. Do not refrigerate or freeze. Keep out of the reach of children.
Xylogel
Lidocaine Hydrochloride (Jelly)
Xylogel
Lidocaine Hydrochloride (Jelly)
Indications
Pain
Indication detailsView
Lidocaine Jelly is indicated for-
- Surface anaesthesia of the male and female urethra
- Topical treatment of painful urethritis
- Anaesthetic lubrication for endotracheal intubation
- Adequate analgesia in endoscopy.
Therapeutic classView
Local & Surface anesthesia
PharmacologyView
Lidocaine acts mainly by inhibiting sodium influx through sodium specific ion channels in the neuronal cell membrane, in particular the so called voltage-gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is inhibited. The receptor site is thought to be located at the cytoplasmic (inner) portion of the sodium channel. Lidocaine binds more readily to sodium channels in activated state, thus onset of neuronal blockade is faster in neurons that are rapidly firing. This is referred to as state dependent blockade.
DosageView
Urethral anaesthesia:
Endoscopy: Instillation of 200-400 mg is recommended for adequate analgesia and a small amount should be applied on the instrument for lubrication. Debilitated, elderly patients and children should be given doses commensurate with their age and physical condition.
Note: The applicator is sterilized for 5 minutes in boiling water, cooled and attached to the tube. The jelly is instilled slowly as required. The applicator should be detached after each use and keep the tube tightly closed.
- Surface anaesthesia of the male adult urethra: For adequate analgesia in males 400 mg is required.
- Surface anaesthesia of the female adult urethra: Instil 100-200 mg in small portions to fill the whole urethra. In order to obtain adequate anaesthesia, several minutes should be allowed prior to perform in the urological procedure.
Endoscopy: Instillation of 200-400 mg is recommended for adequate analgesia and a small amount should be applied on the instrument for lubrication. Debilitated, elderly patients and children should be given doses commensurate with their age and physical condition.
Note: The applicator is sterilized for 5 minutes in boiling water, cooled and attached to the tube. The jelly is instilled slowly as required. The applicator should be detached after each use and keep the tube tightly closed.
Side effectsView
Nervousness, dizziness, blurred vision, tremors, drowsiness, convulsions, unconsciousness, respiratory arrest, hypotension, myocardial depression, bradycardia, cardiac arrest and anaphylactic reactions (cutaneous lesion, urticaria, oedema).
ContraindicationsView
It is contraindicated in patients with a known history of hypersensitivity of local anaesthetics of the amide type.
PrecautionsView
Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. Lidocaine Jelly should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application.
If the dose or site of administration is likely to result in high blood levels, Lidocaine, in common with other local anaesthetics, should be used cautiously in patients with epilepsy, impaired cardiac condition, bradycardia, impaired hepatic function and in severe shock.
The use of oropharyngeal topical anaesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.
If the dose or site of administration is likely to result in high blood levels, Lidocaine, in common with other local anaesthetics, should be used cautiously in patients with epilepsy, impaired cardiac condition, bradycardia, impaired hepatic function and in severe shock.
The use of oropharyngeal topical anaesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.
InteractionsView
Lidocaine should be used with caution in patients receiving antiarrhythmic drugs, such as tocainide since the toxic effects are additive.
Pregnancy & lactationView
There is no, or inadequate, evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative. Lidocaine enters the mother's milk, but in such small quantities that there is generally no risk of affecting the child at therapeutic dose levels.
StorageView
Store below 25°C in a dry place, away from light.
Xyloken
Lidocaine Hydrochloride (Spray)
Xyloken
Lidocaine Hydrochloride (Spray)
Indications
Ventricular arrhythmias
Indication detailsView
Lidocaine is a topical anesthetic used for the following purposes-
- To help prevent pain associated with minor surgical procedures in the ear, nose and throat
- To help prevent pain and or discomfort during dental procedures (e.g., prior to an injection)
- During general anesthesia to prevent coughing
- To help prevent pain during the final stages of childbirth, before the cutting or stitching of the perineum (skin between the vagina and anus)
Therapeutic classView
Local & Surface anesthesia
PharmacologyView
Lidocaine acts mainly by inhibiting sodium influx through sodium specific ion channels in the neuronal cell membrane, in particular the so called voltage-gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is inhibited. The receptor site is thought to be located at the cytoplasmic (inner) portion of the sodium channel. Lidocaine binds more readily to sodium channels in activated state, thus onset of neuronal blockade is faster in neurons that are rapidly firing. This is referred to as state dependent blockade.
DosageView
- Each spray delivers 10 mg of Lidocaine. The maximum dose is 20 sprays (200 mg).
- In dentistry, the normal dose is 1-5 sprays. Two sprays per quarter of the mouth is recommended, with a maximum of 3 sprays per quarter of the mouth over 30 minutes.
- In sinus procedures 3 sprays are used.
- In procedures of the throat and windpipe, up to 20 sprays may be necessary.
- Up to 20 sprays may be necessary in child birth (cesarian procedure).
- Lower doses are used for children aged 3-12 years. Lidocaine 10% Spray is not recommended for children under 3 years.
Side effectsView
Skin rash or irritation, drowsiness, wheezing or difficulty breathing, chest pain, severe rash or itching, increased sweating, numbness.
ContraindicationsView
Should not be given to patients with myasthenia gravis, epilepsy, impaired cardiac condition or liver damage.
PrecautionsView
Patient should be careful driving or operating machinery after use of Lidocaine 10% Spray. Patient may be drowsy and reflexes may be slow. Patient should not eat or drink anything for at least 1 hour after using Lidocaine 10% Spray in the mouth or throat area. Should be careful not to spray Lidocaine 10% Spray near the eyes. If any of the spray does go in the eye, should rinse immediately with lots of water for at least 15 minutes and doctor should be called.
Pregnancy & lactationView
No study available. Can be given to a pregnant woman as per doctor's judgment. Small amount of Lidocaine may pass to a lactating baby, but the amount is insignificant to cause any harm
Overdose effectsView
The first signs that too much Lidocaine 10% Spray has been used usually take the form of light-headedness, drowsiness, dizziness and sometimes blurred vision. In the event of serious over dosage trembling, seizures or unconsciousness may occur.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Xylomet
Xylometazoline Hydrochloride
Xylomet
Xylometazoline Hydrochloride
Indications
Sinusitis
Indication detailsView
Xylometazoline is indicated in-
- Nasal congestion in colds, rhinitis, sinusitis, headache.
- Tubal block and serous otitis media associated with nasal congestion.
Therapeutic classView
Nasal Anti-histamine preparations
PharmacologyView
Nasal congestion is caused by various etiologies, such as rhinosinusitis and allergic or non-allergic rhinitis, leading to congestion of the venous sinusoids lining the nasal mucosa. Activation of α-adrenergic receptors leads to vasoconstriction of the blood vessels of the nasal mucosa and resumption of nasal airflow. As the most abundantly expressed in the human nasal mucosa, α1A- and α2B-adrenoceptors may play the most important role in vasoconstriction of the human nasal mucosa. Xylometazoline is a more selective agonist at α2B-adrenoceptors, with affinity at α1A-, α2A-, α2C-, α1B-, and α1D-adrenoceptors. Xylometazoline decreases nasal resistance during inspiration and expiration and increases the volume of nasal airflow. Compared to oxymetazoline, another imidazoline nasal decongestant, xylometazoline had a slightly faster onset of action although they had a similar duration of action. In one study, subjects with nasal congestion reported relief of earache and sore throat in addition to nasal decongestion: it is speculated that oxymetazoline mediates this effect by causing vasoconstriction of the nasal mucosa that contains the venous sinuses and nasal decongestion allows breathing through the nose, providing relief from sore throat caused by mouth breathing that dries and irritates the throat.
DosageView
Adults: Xylometazoline 0.1%: 2 or 3 drops in each nostril two to three times daily. Xylometazoline 0.1% should not be used for children under the age of 12 years.
Children 6 to 12 years of age: Xylometazoline 0.05%: 2 or 3 drops in each nostril two or three times daily.
Children less than 6 years of age: Xylometazoline 0.05%: 1 drop in each nostril two or three times daily.
Infants less than 3 months: Not to be used in infants less than 3 months.
Children 6 to 12 years of age: Xylometazoline 0.05%: 2 or 3 drops in each nostril two or three times daily.
Children less than 6 years of age: Xylometazoline 0.05%: 1 drop in each nostril two or three times daily.
Infants less than 3 months: Not to be used in infants less than 3 months.
Side effectsView
The following side-effects have occasionally been encountered:
- A burning sensation in the nose and throat
- Local irritation
- Nausea and dryness of the nasal mucosa.
ContraindicationsView
Xylometazoline nasal drops is contraindicated in patients with transsphenoidal hypophysectomy or surgery exposing the dura mater. It is also contraindicated in patients who are hypersensitive to Xylometazoline. Each Xylometazoline nasal drop should be used by one person only to prevent any cross-infection. Patients are advised not to take decongestants for more than seven consecutive days.
PrecautionsView
Xylometazoline Hydrochloride nasal drops for adults (0.1%) should not be used for children below 12 years. Drops should not be used for long time in cases with chronic rhinitis. Prolonged use of the drops may cause rebound congestion and drug induced rhinitis.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Pregnancy category C. Xylometazoline should not be used during pregnancy. The use of Otrivin while breastfeeding should only take place on the instructions of a doctor.
StorageView
Protect from light. For reasons of hygiene, do not use the bottle more than 28 days after opening it.
Xylomet Plus
Sodium Cromoglicate + Xylometazoline Hydrochloride
Xylomet Plus
Sodium Cromoglicate + Xylometazoline Hydrochloride
Indications
Rhinitis
Indication detailsView
This Nasal Spray is indicated for the prophylaxis and treatment of allergic rhinitis (such as hay fever and perennial rhinitis) where this is accompanied by nasal congestion.
Therapeutic classView
Mast Cell Stabiliser
PharmacologyView
Xylometazoline Hydrochloride is a sympathomimetic agent with alpha-adrenergic activity. It produces vasoconstriction thus reducing nasal congestion. This enables patients suffering from colds to breathe more easily through the nose.
Sodium Cromoglicate usually acts through a local effect on the nasal mucosa. It prevents release of the mediators of type-l allergic reactions, including histamine and slow reacting substance of anaphylaxis (SRS-A) from sensitized mast cells after the antigen-antibody union has taken place. The drug does not inhibit the binding of IgE and the specific antigen; instead it suppresses the release of substances (e.g., histamine, SRS-A) in response to this reaction. The drug also inhibits Type-III (late allergic, Arthers) reactions to a lesser extent.
Sodium Cromoglicate usually acts through a local effect on the nasal mucosa. It prevents release of the mediators of type-l allergic reactions, including histamine and slow reacting substance of anaphylaxis (SRS-A) from sensitized mast cells after the antigen-antibody union has taken place. The drug does not inhibit the binding of IgE and the specific antigen; instead it suppresses the release of substances (e.g., histamine, SRS-A) in response to this reaction. The drug also inhibits Type-III (late allergic, Arthers) reactions to a lesser extent.
DosageView
Adults (including the elderly) and children: One spray each nostril four times daily.
AdministrationView
How to use the Nasal Spray-
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/ other nostril for consecutive doses.
- Remove the dust cover.
- Gently pull off the nasal applicator.
- Wash the applicator and dust cover in warm water.
- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
Side effectsView
No serious side effects have been reported. Occasional irritation of the nasal mucosa may occur during the first day of use. In rare cases with Sodium Cromoglicate solutions alone wheezing and tightness of the chest has been reported. Because a lower dose of Xylometazoline is employed in this preparation it causes mild side effects such as nasal irritation, dryness of the nose, sneezing, headache, insomnia, drowsiness and palpitations.
ContraindicationsView
Contraindicated in patients with a known hypersensitivity to any ingredients of the preparation.
PrecautionsView
The prolonged use or abuse of decongestants in general may lead to rebound congestion or drug induced rhinitis.
Pregnancy & lactationView
As with all medicines, caution should be exercised during pregnancy especially during the first trimester.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Xylose
Lactulose
Xylose
Lactulose
Indications
Osmotic laxative
Indication detailsView
Constipation (Chronic Constipation): In every case of chronic constipation, initial treatment should consist of a diet rich in fiber (vegetables, salads, fruits etc.) a generous amount of liquids and much physical exercise. Lactulose is only to be taken when these measures prove insufficient.
Intestinal flora disturbances:
Intestinal flora disturbances:
- In damaged to intestinal flora (e.g. following long-term antibiotic treatment)
- gall bladder diseases
- intestinal diseases ( Colitis, Diverticulosis, Megacolon)
Therapeutic classView
Osmotic purgatives
PharmacologyView
Lactulose is a synthetic disaccharide. Lactulose is metabolized in the colon by the saccharolytic bacteria, producing low molecular weight organic acids (mainly lactic acid), which lowers the pH of the colon contents, promote the retention of water by an osmotic effect; thus increasing peristaltic activity. Lactulose is minimally absorbed; therefore, the pharmacokinetics of the absorbed material are not relevant to the principal therapeutic action.
DosageView
In constipation ( chronic constipation):
- Adults: Initially 3-6 tea-spoons daily, In long-term therapy 1½-6 tea-spoons daily
- Children up to 14 years: Initially 3 tea-spoons daily, In long-term therapy 1-2 tea-spoons daily
- Infants and toddlers: Initially 1-2 tea-spoons daily, In long-term therapy 1 tea-spoon daily
- Adults: 1-2 tea-spoons daily
- Children: 1 tea-spoon daily
- Hyper-ammoniemia in hepatopathy: a maximum of 18-30 tea-spoons daily.
- In portal systemic encephalopathy: hourly doses of 6-9 tea-spoons of Lactulose solution may be used to induce the rapid laxation. When the laxative effect has been achieved, the dose may then be reduced.
Side effectsView
Occasionally flatulence, cramp and abdominal discomfort can occur at the beginning of treatment; this is rapidly eliminated by reducing the dose. Overdose can result in diarrhoea. In abuse, loss of electrolytes (primarily potassium).
ContraindicationsView
Hypersensitivity to either galactose and or lactose; galactose-free diet, gastro-cardial symptom complex, suspected intestinal obstruction.
PrecautionsView
Lactulose should be administered with care to patients who are intolerant to lactulose. The dose used in the treatment of (pre) coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.
InteractionsView
There is no significant drug interactions with lactulose. The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse.
Pregnancy & lactationView
US FDA Pregnancy Category of Lactulose is B. Studies show that Lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by registered physician.
Overdose effectsView
There have been no reports of accidental overdosage. In the event of acute overdosage it is expected that diarrhoea and abdominal cramps would be the major symptoms.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xylovin
Xylometazoline Hydrochloride
Xylovin
Xylometazoline Hydrochloride
Indications
Sinusitis
Indication detailsView
Xylometazoline is indicated in-
- Nasal congestion in colds, rhinitis, sinusitis, headache.
- Tubal block and serous otitis media associated with nasal congestion.
Therapeutic classView
Nasal Anti-histamine preparations
PharmacologyView
Nasal congestion is caused by various etiologies, such as rhinosinusitis and allergic or non-allergic rhinitis, leading to congestion of the venous sinusoids lining the nasal mucosa. Activation of α-adrenergic receptors leads to vasoconstriction of the blood vessels of the nasal mucosa and resumption of nasal airflow. As the most abundantly expressed in the human nasal mucosa, α1A- and α2B-adrenoceptors may play the most important role in vasoconstriction of the human nasal mucosa. Xylometazoline is a more selective agonist at α2B-adrenoceptors, with affinity at α1A-, α2A-, α2C-, α1B-, and α1D-adrenoceptors. Xylometazoline decreases nasal resistance during inspiration and expiration and increases the volume of nasal airflow. Compared to oxymetazoline, another imidazoline nasal decongestant, xylometazoline had a slightly faster onset of action although they had a similar duration of action. In one study, subjects with nasal congestion reported relief of earache and sore throat in addition to nasal decongestion: it is speculated that oxymetazoline mediates this effect by causing vasoconstriction of the nasal mucosa that contains the venous sinuses and nasal decongestion allows breathing through the nose, providing relief from sore throat caused by mouth breathing that dries and irritates the throat.
DosageView
Adults: Xylometazoline 0.1%: 2 or 3 drops in each nostril two to three times daily. Xylometazoline 0.1% should not be used for children under the age of 12 years.
Children 6 to 12 years of age: Xylometazoline 0.05%: 2 or 3 drops in each nostril two or three times daily.
Children less than 6 years of age: Xylometazoline 0.05%: 1 drop in each nostril two or three times daily.
Infants less than 3 months: Not to be used in infants less than 3 months.
Children 6 to 12 years of age: Xylometazoline 0.05%: 2 or 3 drops in each nostril two or three times daily.
Children less than 6 years of age: Xylometazoline 0.05%: 1 drop in each nostril two or three times daily.
Infants less than 3 months: Not to be used in infants less than 3 months.
Side effectsView
The following side-effects have occasionally been encountered:
- A burning sensation in the nose and throat
- Local irritation
- Nausea and dryness of the nasal mucosa.
ContraindicationsView
Xylometazoline nasal drops is contraindicated in patients with transsphenoidal hypophysectomy or surgery exposing the dura mater. It is also contraindicated in patients who are hypersensitive to Xylometazoline. Each Xylometazoline nasal drop should be used by one person only to prevent any cross-infection. Patients are advised not to take decongestants for more than seven consecutive days.
PrecautionsView
Xylometazoline Hydrochloride nasal drops for adults (0.1%) should not be used for children below 12 years. Drops should not be used for long time in cases with chronic rhinitis. Prolonged use of the drops may cause rebound congestion and drug induced rhinitis.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Pregnancy category C. Xylometazoline should not be used during pregnancy. The use of Otrivin while breastfeeding should only take place on the instructions of a doctor.
StorageView
Protect from light. For reasons of hygiene, do not use the bottle more than 28 days after opening it.
Xylovin
Xylometazoline Hydrochloride
Xylovin
Xylometazoline Hydrochloride
Indications
Sinusitis
Indication detailsView
Xylometazoline is indicated in-
- Nasal congestion in colds, rhinitis, sinusitis, headache.
- Tubal block and serous otitis media associated with nasal congestion.
Therapeutic classView
Nasal Anti-histamine preparations
PharmacologyView
Nasal congestion is caused by various etiologies, such as rhinosinusitis and allergic or non-allergic rhinitis, leading to congestion of the venous sinusoids lining the nasal mucosa. Activation of α-adrenergic receptors leads to vasoconstriction of the blood vessels of the nasal mucosa and resumption of nasal airflow. As the most abundantly expressed in the human nasal mucosa, α1A- and α2B-adrenoceptors may play the most important role in vasoconstriction of the human nasal mucosa. Xylometazoline is a more selective agonist at α2B-adrenoceptors, with affinity at α1A-, α2A-, α2C-, α1B-, and α1D-adrenoceptors. Xylometazoline decreases nasal resistance during inspiration and expiration and increases the volume of nasal airflow. Compared to oxymetazoline, another imidazoline nasal decongestant, xylometazoline had a slightly faster onset of action although they had a similar duration of action. In one study, subjects with nasal congestion reported relief of earache and sore throat in addition to nasal decongestion: it is speculated that oxymetazoline mediates this effect by causing vasoconstriction of the nasal mucosa that contains the venous sinuses and nasal decongestion allows breathing through the nose, providing relief from sore throat caused by mouth breathing that dries and irritates the throat.
DosageView
Adults: Xylometazoline 0.1%: 2 or 3 drops in each nostril two to three times daily. Xylometazoline 0.1% should not be used for children under the age of 12 years.
Children 6 to 12 years of age: Xylometazoline 0.05%: 2 or 3 drops in each nostril two or three times daily.
Children less than 6 years of age: Xylometazoline 0.05%: 1 drop in each nostril two or three times daily.
Infants less than 3 months: Not to be used in infants less than 3 months.
Children 6 to 12 years of age: Xylometazoline 0.05%: 2 or 3 drops in each nostril two or three times daily.
Children less than 6 years of age: Xylometazoline 0.05%: 1 drop in each nostril two or three times daily.
Infants less than 3 months: Not to be used in infants less than 3 months.
Side effectsView
The following side-effects have occasionally been encountered:
- A burning sensation in the nose and throat
- Local irritation
- Nausea and dryness of the nasal mucosa.
ContraindicationsView
Xylometazoline nasal drops is contraindicated in patients with transsphenoidal hypophysectomy or surgery exposing the dura mater. It is also contraindicated in patients who are hypersensitive to Xylometazoline. Each Xylometazoline nasal drop should be used by one person only to prevent any cross-infection. Patients are advised not to take decongestants for more than seven consecutive days.
PrecautionsView
Xylometazoline Hydrochloride nasal drops for adults (0.1%) should not be used for children below 12 years. Drops should not be used for long time in cases with chronic rhinitis. Prolonged use of the drops may cause rebound congestion and drug induced rhinitis.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Pregnancy category C. Xylometazoline should not be used during pregnancy. The use of Otrivin while breastfeeding should only take place on the instructions of a doctor.
StorageView
Protect from light. For reasons of hygiene, do not use the bottle more than 28 days after opening it.
Xynocard SR
Nitroglycerin (Oral preparation)
Xynocard SR
Nitroglycerin (Oral preparation)
Indications
Severe hypertension
Indication detailsView
Nitroglycerin is indicated for the prophylaxis of angina pectoris. The onset of action is not sufficiently rapid for this form to be useful in aborting an acute anginal episode.
Therapeutic classView
Nitrates: Coronary vasodilators
PharmacologyView
Nitroglycerin causes relaxation of vascular smooth muscle, producing a vasodilator effect on both peripheral arteries and veins. Dilation of veins promote peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure (preload) and relaxation of arteries reduce systemic vascular resistance and arterial pressure (afterload).
DosageView
Dosage should always to be adjusted according to the requirement and response obtained by the individual patient and the severity of the anginal pain. For adults, one Nitroglycerin 2.6 mg sustained released tablet or capsule in morning and evening. This should be taken empty stomach.
Side effectsView
Headache may occur at the onset of treatment but will usually subside after a few days. If the headache persists dosage should be decreased. Other side effects include tachycardia, postural hypotension and syncope, cyanosis and methaemoglobinaemia.
ContraindicationsView
Nitroglycerin is contraindicated in patients with a known hypersensitivity to nitroglycerin, other organic nitrates, or nitrites or to the excipients of the medicine. It is also contraindicated in patients with acute myocardial infarction, marked anaemia, head trauma, cerebral haemorrhage, or closed angle glaucoma.
PrecautionsView
Nitroglycerin should be used with caution in patients who are predisposed to closed-angle glaucoma. As with other drugs for the treatment of angina pectoris, abrupt discontinuation of therapy may lead to exacerbation of symptoms. When discontinuing long term treatment, the dosage should be reduced gradually over several days, and the patient carefully monitored. The use of nitroglycerin during the early days of acute myocardial infarction requires particular attention to hemodynamic monitoring and clinical status to avoid the hazards of hypotension and tachycardia.
InteractionsView
Nitroglycerin dilates peripheral blood vessels and may increase the antihypertensive properties of vasodilators, calcium antagonists, beta-adrenergic blockers. Concomitant use of nitrates with tricyclic antidepressants and alcohol may cause high blood pressure. Concomitant use of nitrates with phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, vardenafil and tadalafil cause fall in blood pressure. Aspirin decreases the clearance and enhances the hemodynamic effects of nitroglycerin. Nitroglycerin may reduce the pharmacologic effects of heparin when used concomitantly. Nitrates increase the bioavailability of dihydroergotamine.
Pregnancy & lactationView
Nitroglycerin should not be used during pregnancy or lactation unless considered essential by the physician.
StorageView
Store in a cool and dry place away from light and heat. Keep all medicines out of the reach of children.
Xynofen SR
Ketoprofen (oral & injection)
Xynofen SR
Ketoprofen (oral & injection)
Indications
Rheumatic disorders
Indication detailsView
The indications of ketoprofen are based on its anti-inflammatory, analgesic and antipyretic properties. Ketoprofen is indicated for symptomatic treatment of:
- Rheumatoid arthritis
- Degenerative joint diseases
- Musculoskeletal and joint disorders such as tendinitis, sprain
- Pain, regardless of the origin, such as dental pain, headache and primary dysmenorrhea.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic actions. In addition to the inhibition of prostaglandin synthesis, it stabilizes lysosomal membranes in vitro and in vivo, inhibits leukotriene synthesis in vitro at high concentrations, and also exhibits antibradykinin activity in vivo. Ketoprofen produces analgesia by inhibiting the synthesis of prostaglandins peripherally and centrally. It has also been suggested that Ketoprofen causes the suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) leading to its antipyretic effect.
Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.
Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.
DosageView
Anti-inflammatory dosage: The recommended starting dose is 150 to 300 mg/day in 3 divided doses. Once the maintenance dosage has been established (usually 100 to 200 mg/day), the patient may be tried on a twice daily dose regimen. Alternatively, switching to the once daily form at the same dosage may be considered. The recommended maximum daily dose is 300 mg.
Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.
Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.
AdministrationView
The oral forms should be taken with fluids, preferably with food.
Side effectsView
- Blood and lymphatic system disorders- Rare: haemorrhagic anaemia; Unknown: agranulocytosis, thrombocytopenia, bone marrow failure, hemolytic anemia, leucopenia
- Immune system disorders- Unknown: anaphylactic reactions (including shock) Psychiatric disorders; Unknown: depression, hallucinations, confusion, mood altered
- Nervous system disorders- Uncommon: headache, dizziness, somnolence, Rare: paraesthesia; Unknown: aseptic meningitis, convulsions, dysgeusia, vertigo
- Eye disorders- Rare: vision blurred
- Ear and labyrinth disorders- Rare: tinnitus
- Cardiac disorders- Unknown: exacerbation of heart failure, atrial fibrillation
- Vascular disorders- Unknown: hypertension, vasodilatation, vasculitis (including leukocytoclastic vasculitis)
- Respiratory, thoracic and mediastinal disorders- Rare: asthma; Unknown: bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs)
- Gastrointestinal disorders- Common: dyspepsia, nausea, abdominal pain, vomiting; Uncommon: constipation, diarrhoea, flatulence, gastritis; Rare: stomatitis, peptic ulcer; Unknown: exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage and perforation, pancreatitis
- Hepatobiliary disorders- Rare: hepatitis, transaminases increased
- Skin and subcutaneous disorders- Uncommon: rash, pruritis; Unknown: photosensitivity reaction, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis Renal and urinary disorders- Unknown: renal failure acute, tubulointerstitial nephritis, nephritic syndrome, renal function tests abnormal
- General disorders and administration site conditions- Uncommon: oedema Metabolism and nutritional disorders; Unknown: hyponatremia, hyperkalemia Investigations; Rare: weight increased.
ContraindicationsView
Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as asthmatic attacks or other allergic-type reactions to ketoprofen, ASA or other NSAIDs. Severe, rarely fatal, anaphylactic reactions have been reported in such patients. Ketoprofen is also contraindicated in the following cases:
- Severe heart failure
- Active or history of peptic ulcer/hemorrhage
- History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
- Severe hepatic insufficiency
- Severe renal insufficiency
- Third trimester of pregnancy
- Rectitis or history of proctorrhagia (rectal administration)
PrecautionsView
Oral Forms: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. At the start of treatment, renal function must be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition.
Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.
As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.
In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.
If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.
Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.
As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.
In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.
If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.
InteractionsView
Not recommended drug associations Other NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates: Increased risk of gastrointestinal ulceration and bleeding. Anticoagulants Increased risk of bleeding.
- Heparin
- Vitamin K antagonists (such as warfarin)
- Platelet aggregation inhibitors (such as ticlopidine, clopidogrel)
- Thrombin inhibitors (such as dabigatran)
- Direct factor Xa inhibitors (such as apixaban, rivaroxaban, edoxaban)
- Lithium: Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAID therapy.
- Methotrexate at doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (>15 mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.
- Drug associations requiring precautions for use Medicinal products and therapeutic categories that can promote hyperkalemia (i.e. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular-weight or unfractioned), cyclosporin, tacrolimus and trimethoprim): The risk of hyperkalemia can be enhanced when the drugs mentioned above are administered concomitantly.
- Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
- Diuretics: Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started.
- ACE inhibitors and Angiotensin II Antagonists: In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.
- Nicorandil: In patients concomitantly receiving nicorandil and NSAIDs, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and hemorrhage.
- Cardiac glycosides: A pharmacokinetic interaction between ketoprofen and digoxin has not been demonstrated. However, caution is advised, in particular in patients with renal impairment, since NSAIDs may reduce renal function and decrease renal clearance of cardiac glycosides.
- Cyclosporin: Increased risk of nephrotoxicity.
- Tacrolimus: Increased risk of nephrotoxicity.
- Methotrexate at doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.
- Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required.
- Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.
- Drug associations to be taken into account Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).
- Thrombolytics: Increased risk of bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
- Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
Pregnancy & lactationView
During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and second trimester of pregnancy should be avoided. During the third trimester of pregnancy: Prodenid is contraindicated during the last trimester of pregnancy. Ketoprofen is not recommended in nursing mothers.
Pediatric usageView
Elderly: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.
Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.
Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
Overdose effectsView
Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. If renal failure is present, hemodialysis may be useful to remove circulating drug.
StorageView
Protect from light. Store below 30°C. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
Xynor
Ornidazole
Xynor
Ornidazole
Indications
Trichomoniasis
Indication detailsView
Ornidazole is indicated for Amoebiasis (Intestinal and hepatic), Giardiasis, Trichomoniasis, Bacterial vaginosis, Treatment of susceptible anaerobic infections
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Ornidazole is a 5-nitroimidazole derivative active against protozoa and anaerobic bacteria. It is converted to reduction products that interact with DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms.
DosageView
Amoebiasis:
Bacterial vaginosis: 3 tablets of 500 mg each as a single dose or one tablet of 500 mg once daily for 5-7 days.
- Adults: 500 mg twice a day for 5 days.
- Children: 10-25 mg per kg body weight in two divided doses.
- Adults: 1.5 gm once a day for 3 days.
- Children: 40 mg per kg body weight, once a day for 3 days.
- Adults: 1.5 gm once daily for 1-2 days.
- Children: 40 mg per kg body weight for 2 days.
Bacterial vaginosis: 3 tablets of 500 mg each as a single dose or one tablet of 500 mg once daily for 5-7 days.
Side effectsView
Side effects of Ornidazole have been mainly limited to the gastrointestinal tract (nausea, vomiting, epigastric pain) and central nervous system (dizziness, headache, lassitude). Unlike other nitroimidazoles, Ornidazole does not interact with alcohol, although this requires further study.
Leukopenia has been described occasionally during therapy. Adverse central nervous system (CNS) effects of Ornidazole have mainly included headache, dizziness, lassitude or somnolence, fatigue and weakness. Adverse CNS effects of Ornidazole may be less than that happens with metronidazole. Seizures have not been reported with Ornidazole in studies available to date.
Leukopenia has been described occasionally during therapy. Adverse central nervous system (CNS) effects of Ornidazole have mainly included headache, dizziness, lassitude or somnolence, fatigue and weakness. Adverse CNS effects of Ornidazole may be less than that happens with metronidazole. Seizures have not been reported with Ornidazole in studies available to date.
ContraindicationsView
Previous hypersensitivity to Ornidazole and to other nitroimidazoles. Ornidazole is contraindicated in central nervous system disorders, particularly in epilepsy or in peripheral neuropathy.
PrecautionsView
In patient with ataxia, vertigo, and mental confusion, Ornidazole should be prescribed with caution. During prolonged treatment with Ornidazole, blood dyscrasia namely mild leukopenia have been reported rarely. In case leukopenia occurs, the decision to discontinue the therapy should depend upon the gravity of infection.
InteractionsView
Like other imidazoles, Ornidazole has a mild potential to cause disulfiramlike reactions. Concomitant administration of oral anticoagulants may increase the risk of haemorrhage due to diminished hepatic metabolism. Ornidazole has been reported to decrease the clearance of 5-fluorouracil.
Pregnancy & lactationView
Adequate clinical trials have not been conducted. Ornidazole should be prescribed only if the potential benefit justifies the potential risk to fetus/neonate.
Pediatric usageView
Renal Impairment Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic Impairment Severe: Double the interval between doses.
Hepatic Impairment Severe: Double the interval between doses.
StorageView
Store at room temperature and protect from light and moisture.
Xynovir
Tenofovir Disoproxil Fumarate
Xynovir
Tenofovir Disoproxil Fumarate
Indications
HIV infection
Indication detailsView
This is indicated for the treatment of:
- Chronic hepatitis B virus infection in adults
- HIV infected adults in combination with other anti retroviral agents
Therapeutic classView
Drugs for HIV / Anti-retroviral drugs, Hepatic viral infections (Hepatitis B)
PharmacologyView
Tenofovir Disoproxil Fumarate, an acyclic nucleotide analogue of adenosine monophosphate, is a pro-drug of Tenofovir. It shows activity against hepatitis B virus polymerase and HIV reverse transcriptase after phosphorylation to the active diphosphate form. Tenofovir diphosphate inhibits viral polymerase (reverse transcriptase) by directly competing with the natural substrate deoxyribonucleotide and by causing DNA chain termination after its incorporation into viral DNA.
DosageView
The recommended dose of Tenofovir in chronic hepatitis B virus infection in adults 18 years of age and older with adequate renal function is 300 mg once daily with or without food.
Side effectsView
The most common side effects are nausea, vomiting, diarrhea and flatulence.
ContraindicationsView
Tenofovir is contraindicated in patients with known hypersensitivity to Tenofovir or any component of the product.
PrecautionsView
Co-administration with other drugs: Tenofovir should not be administered concurrently with Emtricitabine & Tenofovir combination or Adefovir Dipivoxil.
Lactic Acidosis & Severe Hepatomegaly with Steatosis: Though the risk of occurrence of lactic acidosis is low for Tenofovir, treatment should be suspended in any patient who develops lactic acidosis or hepatotoxicity.
Exacerbation of hepatitis after discontinuation of treatment: Discontinuation of Tenofovir
therapy may be associated with severe acute exacerbation of hepatitis.
Lactic Acidosis & Severe Hepatomegaly with Steatosis: Though the risk of occurrence of lactic acidosis is low for Tenofovir, treatment should be suspended in any patient who develops lactic acidosis or hepatotoxicity.
Exacerbation of hepatitis after discontinuation of treatment: Discontinuation of Tenofovir
therapy may be associated with severe acute exacerbation of hepatitis.
InteractionsView
Co-administration of Tenofovir with anti-retroviral, entecavir, lamivudine, methadone, oral contraceptives, ribavirin and tacrolimus did not result in significant drug interactions. The effects of co-administration of Tenofovir with other drugs that are renally eliminated or are known to affect renal function have not been evaluated.
Pregnancy & lactationView
Pregnancy: Pregnancy category B. It should be used during pregnancy only if clearly needed.
Lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breast feed if they are taking Tenofovir.
Lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breast feed if they are taking Tenofovir.
Pediatric usageView
Pediatric use: Safety and effectiveness of Tenofovir in pediatric patients below the age of 18 years have not been established.
Geriatrics use: Clinical studies of Tenofovir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.
Renal Impairment: Haemodialysis patients: 300 mg once every 7 days or after a cumulative total of 12 hr of dialysis.
Geriatrics use: Clinical studies of Tenofovir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.
Renal Impairment: Haemodialysis patients: 300 mg once every 7 days or after a cumulative total of 12 hr of dialysis.
- CrCl (10-29 mL/min): 300 mg 72-96 hrly.
- CrCl (30-49 mL/min): 300 mg 48 hrly.
Overdose effectsView
There is no experience of Tenofovir overdose reported in patients
StorageView
Store in a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.
Xyotil
Olmesartan Medoxomil
Xyotil
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Xyotil
Olmesartan Medoxomil
Xyotil
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Xyotil Plus
Olmesartan Medoxomil + Hydrochlorothiazide
Xyotil Plus
Olmesartan Medoxomil + Hydrochlorothiazide
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil & Hydrochlorothiazide combination is indicated for the treatment of hypertension.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume with consequent increases in plasma renin activity, increases Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume with consequent increases in plasma renin activity, increases Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
DosageView
Hypertension: The usual starting dose is 20/12.5 mg one tablet once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets 40/25 once daily.
Side effectsView
The common side-effects are nausea, headache, dizziness, hyperuricemia, upper respiratory tract infection and urinary tract infection. Other adverse effects are chest pain, back pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, diarrhea.
ContraindicationsView
The combination of Olmesartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
PrecautionsView
- Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance like hypokalemia, hyponatremia and hypochloremic alkalosis.
- Hyperuricemia may occur in certain patients receiving thiazide therapy.
- Impaired renal function.
InteractionsView
Olmesartan: No significant drug interactions were reported in studies in which Olmesartan Medoxomil was co-administered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers. Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by those enzymes are not expected.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
- Alcohol, Barbiturates or Narcotics: Potentiation of orthostatic hypotension may occur.
- Antidiabetic drugs (oral agents and Insulin): Dosage adjustment of the antidiabetic drug may be required.
- Other antihypertensive drugs: Additive effect.
- Corticosteroids, ACTH.
- Lithium.
Pregnancy & lactationView
Safety and effectiveness in nursing mother & pregnancy have not been established. The drug should be discontinued during these conditions.
Pediatric usageView
Renal Impairment Patients: The usual regimens of therapy with this may be followed provided the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, this preparation is not recommended.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Overdose effectsView
Olmesartan: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia. Supportive treatment should be instituted.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration) resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration) resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
StorageView
Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.