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Frenvas

Atorvastatin Calcium
Tablet 40 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

Indications

Reducing cholesterol levels

Indication detailsView
Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.
  • To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolaemia.
  • To reduce elevated cholesterol and triglycerides in patient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
  • For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
  • For the treatment of patients with dysbetalipoproteinaemia (Fredrickson Type III).
  • To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol level.
  • To reduce total and LDL-cholesterol concentrations patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
DosageView
Primary hypercholesterolaemia and combined hyperlipidaemia-
  • Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
  • Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.
Familial hypercholesterolaemia-
  • Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
  • Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.
Prevention of cardiovascular events-
  • Adults: Initially 10 mg once daily adjusted according to response.
Side effectsView
Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.
ContraindicationsView
Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.
PrecautionsView
Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
InteractionsView
The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.
Pregnancy & lactationView
Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant

Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Pediatric usageView
Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.

Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Overdose effectsView
Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Frenvas

Atorvastatin Calcium
Tablet 20 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

Indications

Reducing cholesterol levels

Indication detailsView
Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.
  • To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolaemia.
  • To reduce elevated cholesterol and triglycerides in patient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
  • For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
  • For the treatment of patients with dysbetalipoproteinaemia (Fredrickson Type III).
  • To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol level.
  • To reduce total and LDL-cholesterol concentrations patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
DosageView
Primary hypercholesterolaemia and combined hyperlipidaemia-
  • Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
  • Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.
Familial hypercholesterolaemia-
  • Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
  • Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.
Prevention of cardiovascular events-
  • Adults: Initially 10 mg once daily adjusted according to response.
Side effectsView
Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.
ContraindicationsView
Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.
PrecautionsView
Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
InteractionsView
The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.
Pregnancy & lactationView
Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant

Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Pediatric usageView
Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.

Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Overdose effectsView
Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Frenxit

Flupentixol + Melitracen
Tablet 0.5 mg+10 mg Allopathic Combined anxiolytics & anti-depressant drugs

Indications

Psychosis

Indication detailsView
Flupentixol and Melitracen tablet is indicated in-
  • Anxiety
  • Depression
  • Apathy
  • Psychogenic depression.
  • Depressive neurosses.
  • Masked depression.
  • Psychosomatic affections accompanied by anxiety and apathy.
  • Menopausal depressions.
  • Dysphoria and depression in alcoholics and drug addicts.
Therapeutic classView
Combined anxiolytics & anti-depressant drugs
PharmacologyView
This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.
DosageView
Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.

Elderly patients: 1 tablet in the morning.

Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.
Side effectsView
In the recommended doses side effects are rare. These could be transient restlessness and insomnia.
ContraindicationsView
  • The immediate recovery phase after myocardial infarction.
  • Defects in bundle-branch conduction.
  • Untreated narrow-angle glaucoma.
  • Acute alcohol, barbiturate and opiate intoxications.
  • This tablet should not be given to patients who have received an MAO-inhibitor within two weeks.
  • Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.
PrecautionsView
If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.
InteractionsView
This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.
Pregnancy & lactationView
This tablet should preferably not be given during pregnancy and lactation.
Overdose effectsView
In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.
StorageView
Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.

Fresh

Fluphenazine + Nortriptyline
Tablet 0.5 mg+10 mg Allopathic Combined anxiolytics & anti-depressant drugs

Indications

Gastric problems

Indication detailsView
This is indicated in
  • Mild to moderate mixed anxiety/depression
  • Emotional disturbance
  • Sleep disorder
  • Gastric problems
Therapeutic classView
Combined anxiolytics & anti-depressant drugs
PharmacologyView
Nortriptyline hydrochloride is a tricyclic antidepressant. Nortriptyline inhibits the uptake of norepinephrine and serotonin at nerve terminals. In contrast to its parent compound amitriptyline which is equally potent in inhibiting the uptake of norepinephrine and serotonin, Nortriptyline has a greater effect on norepinephrine reuptake than on serotonin reuptake.

Fluphenazine is a tranquilizer of the phenothiazine type with piperazine side chain. Fluphenazine primarily acts as a neuroleptic drug whose main therapeutic effect is believed to reside in potent dopamine (specially D2) receptor antagonism.
DosageView
Adults: One tablet 2 to 3 times daily.
Side effectsView
Tardive dyskinesias have been reported in phenothiazine therapy; usually after prolonged courses given at doses adequately to control psychotic illness. Blood dyscrasia, Malignant Neuroleptic syndrome and sudden death have been reported rarely. Agranulocytosis is a rare but potentially fatal adverse effect of Nortriptyline Hydrochloride.
ContraindicationsView
It is contraindicated in :
  • History of gradual epilepsy or organic brain damage
  • Blood dyscrasia
  • Severe cardiac insufficiency
  • Renal or liver damage
  • Patients taking monoamine oxidase inhibitor (MAOI)
  • Younger children
  • Hypersensitivity to any component of the preparation
PrecautionsView
Precautions should be taken in patients with glaucoma, prostate enlargement, cardiac failure and myocardial infarction, and in concurrent administration with CNS depressants. The drug may impair alertness and abilities to drive a car or operate machinery.
InteractionsView
Interactions with barbiturates, alcohol, and narcotic drugs may occur, so central depressants should be administered with caution.
Pregnancy & lactationView
The safety in human pregnancy has not been yet established. The use of this drug in lactation is not recommended, as it is excreted in breast milk.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Freshfil

Carboxymethylcellulose Sodium
Ophthalmic Solution 1% Allopathic
Indication detailsView
It is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
PharmacologyView
Carboxymethylcellulose binds to the surface of corneal epithelial cells via its glucopyranose subunits binding to glucose receptors GLUT-1. The residence time of carboxymethylcellulose bound to corneal cells is approximately 2 hours as indicated by a short-term binding assay. Binding of carboxymethylcellulose to the matrix proteins stimulated corneal epithelial cell attachment, migration, and re-epithelialization of corneal wounds.

This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.
DosageView
Instill 1 drop in the affected eye(s) 4 times a day or as needed.
Side effectsView
Burning, Eye Irritation or Pruritus, Visual disturbance, Ocular discharge were reported with this eye drop.
ContraindicationsView
This eye drop is contraindicated in patients with known hypersensitivity to any ingredient of the product.
PrecautionsView
Concomitant ocular medication should be administered 15 minutes prior to the instillation of this eye drop.
InteractionsView
Not known.
Pregnancy & lactationView
Safe use during pregnancy and lactation has not been established.
Pediatric usageView
Pediatric use: This eye drop should not be used in infants and small children under 3 years.

Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
StorageView
The drug is to be used within 30 days after the first opening. Store at temperature not exceeding 30°C in a dry place. Protect from light. The bottle is to be closed strongly immediately after use. Keep away from the reach of children.

Freshlook

Adapalene + Benzoyl peroxide
Gel 0.1%+2.5% Allopathic Topical retinoid and related preparations

Indications

Acne vulgaris

Indication detailsView
Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Therapeutic classView
Topical retinoid and related preparations
PharmacologyView
Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. Adapalene binds with specific retinoic acid nuclear receptors that normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects.
DosageView
Apply a thin film of Adapalene & Benzoyl peroxide gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Adapalene & Benzoyl peroxide is not for oral, ophthalmic, or intravaginal use.

Pediatric use: The safety and effectiveness of Adapalene and Benzoyl peroxide gel in pediatric patients under the age of 12 years have not been established.
Side effectsView
Erythema, scaling, dryness, and stinging/ burning may occur. Most commonly reported adverse events are dry skin, contact dermatitis, application site burning, application site irritation, and skin irritation.
ContraindicationsView
Should not be administered to individuals who are hypersensitive to any of its component.
PrecautionsView
Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided.
InteractionsView
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted.
Pregnancy & lactationView
There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl peroxide. Animal reproduction studies have not been conducted with the combination gel or Benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, this preparation should be used during pregnancy only if the potential benefit justifies the risk to the fetus. It is not known whether Adapalene or Benzoyl peroxide is excreted in human milk following use. Caution should be exercised when administered to a nursing woman.
StorageView
Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.

Freshtear

Polyethylene Glycol + Propylene Glycol
Ophthalmic Solution 0.4%+0.3% Allopathic Drugs for Dry eyes

Indications

Dry eye

Indication detailsView
This sterile eye drops is indicated for the temporary relief of burning and irritation due to dryness of the eye.
Therapeutic classView
Drugs for Dry eyes
PharmacologyView
The combination of Polyethylene Glycol 400 & Propylene Glycol is clinically proven to reduce both signs and symptoms of dry eye. The mechanism of action is thought to be due to its unique gelling and lubricating system formulated to adjust to each users individual tear pH. When the ingredients of this eye drops combine with natural tears, a soft gel forms a network of protection over the eye surface. Since it promotes a healthy environment in eye surfaces, damaged surface cells of eye can repair more easily.
DosageView
Instill 1 drop 4 times daily in the affected eye(s) or as needed.
Side effectsView
Generally well tolerated. This sterile eye drops should not be used if allergic condition occurs to any ingredients of the product.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to any ingredient in this formulation.
PrecautionsView
Never touch the tip of the container with any surface to avoid contamination. Replace cap after each use.
StorageView
Store in a cool & dry place, protect from light. Do not use longer than one month after the first opening. Keep out of the reach of children

Freshtear P

Polyethylene Glycol + Propylene Glycol
Ophthalmic Solution 0.4%+0.3% Allopathic Drugs for Dry eyes

Indications

Dry eye

Indication detailsView
This sterile eye drops is indicated for the temporary relief of burning and irritation due to dryness of the eye.
Therapeutic classView
Drugs for Dry eyes
PharmacologyView
The combination of Polyethylene Glycol 400 & Propylene Glycol is clinically proven to reduce both signs and symptoms of dry eye. The mechanism of action is thought to be due to its unique gelling and lubricating system formulated to adjust to each users individual tear pH. When the ingredients of this eye drops combine with natural tears, a soft gel forms a network of protection over the eye surface. Since it promotes a healthy environment in eye surfaces, damaged surface cells of eye can repair more easily.
DosageView
Instill 1 drop 4 times daily in the affected eye(s) or as needed.
Side effectsView
Generally well tolerated. This sterile eye drops should not be used if allergic condition occurs to any ingredients of the product.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to any ingredient in this formulation.
PrecautionsView
Never touch the tip of the container with any surface to avoid contamination. Replace cap after each use.
StorageView
Store in a cool & dry place, protect from light. Do not use longer than one month after the first opening. Keep out of the reach of children

Freten

Bromazepam
Tablet 3 mg Allopathic Benzodiazepine sedatives

Indications

Panic attack

Indication detailsView
Bromazepam is indicated in-
  • Emotional disturbances, i.e. acute tension and anxiety states. Difficulties in interpersonal contact. Agitation, insomnia, anxious and agitated depressive reactions.
  • Functional disturbances in the cardiovascular and respiratory systems, i.e. pseudoangina pectoris, pericardial anxiety, tachycardia, emotiogenic hypertension, dyspnea and hyperventilation.
  • Disturbances in the gastrointestinal tract, i.e. irritable bowel syndrome, epigastric pain, spasm, bloating diarrhea etc.
  • Disturbances in the urinary tract, i.e. frequency, irritable bladder and dysmenorrhea.
  • Psychosomatic disorder, i.e. psychogenic headache, asthma, gastric and duodenal ulcer.
  • It is also indicated in emotional reactions to chronic organic disease.
Therapeutic classView
Benzodiazepine sedatives
PharmacologyView
Bromazepam is a powerful psychotropic agent. In lower dosage, it selectively reduces tension and anxiety. In higher dosage, it shows sedative and muscle-relaxant properties. Bromazepam binds to the GABA-A receptor producing a conformational change and potentiating its inhibitory effects. Other neurotransmitters are not influenced.
DosageView
Standard dosage: Average dosage for outpatient therapy is 1.5-3 mg up to three times daily. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level.

In severe cases, especially in hospital: 6-12 mg 2 or 3 times daily. The overall treatment generally should not be more than 8-12 weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should be taken with re-evaluation of the patient's status with special expertise.

Elderly and debilitated patients: Elderly patients and those with impaired hepatic functions require lower doses.

Children: Bromazepam is usually not indicated in children, but if the physician feels bromazepam treatment is appropriate, then the dose should be adjusted to their low bodyweight (about 0.1-0.3 mg/kg bodyweight)
AdministrationView
Bromazepam tablets are for oral administration
Side effectsView
Common side-effects include fatigue, drowsiness, muscle weakness, numbed muscle, reduced alertness, confusion, headache, ataxia etc. These phenomena occur predominantly at the start of therapy and usually disappear with prolonged administration. Anterograde amnesia may occur using therapeutic doses.
ContraindicationsView
Bromazepam is contraindicated in patients with known hypersensitivity to bromazepam, severe respiratory insufficiency, severe hepatic insufficiency or sleep apnea syndrome.
PrecautionsView
The use of benzodiazepines and benzodiazepine like agents may lead to the development of physical and psychological dependence upon these products. This dependence depends on the dose and duration of treatment; it is also greater in predisposed patients with a history of alcohol. Once physical dependence has developed, termination of the treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle pain, extreme anxiety, tension, confusion and irritability. Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of the treatment, it is recommended that the dosage be decreased gradually. Bromazepam is not recommended for the primary treatment of sleeplessness caused by psychotic illness. Caution should be exercised while driving cars or using machineries.
InteractionsView
If bromazepam is combined with other centrally active drugs, its sedative effects may be enhanced. These drugs are antidepressants, hypnotics, narcotics, antipsychotics, sedatives, antiepileptic drugs, sedative antihistamines and anesthetics. Co-administration of cimetidine may prolong the eliminiation half-life of bromazepam. Concomitant intake of bromazepam with alcohol should be avoided, because the sedative effect of bromazepam may be intensified by alcohol.
Pregnancy & lactationView
The safety of bromazepam during pregnancy has not been established. As bromazepam is excreted in breast milk, use should be avoided during lactation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Frexit

Flupentixol + Melitracen
Tablet 0.5 mg+10 mg Allopathic Combined anxiolytics & anti-depressant drugs

Indications

Psychosis

Indication detailsView
Flupentixol and Melitracen tablet is indicated in-
  • Anxiety
  • Depression
  • Apathy
  • Psychogenic depression.
  • Depressive neurosses.
  • Masked depression.
  • Psychosomatic affections accompanied by anxiety and apathy.
  • Menopausal depressions.
  • Dysphoria and depression in alcoholics and drug addicts.
Therapeutic classView
Combined anxiolytics & anti-depressant drugs
PharmacologyView
This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.
DosageView
Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.

Elderly patients: 1 tablet in the morning.

Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.
Side effectsView
In the recommended doses side effects are rare. These could be transient restlessness and insomnia.
ContraindicationsView
  • The immediate recovery phase after myocardial infarction.
  • Defects in bundle-branch conduction.
  • Untreated narrow-angle glaucoma.
  • Acute alcohol, barbiturate and opiate intoxications.
  • This tablet should not be given to patients who have received an MAO-inhibitor within two weeks.
  • Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.
PrecautionsView
If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.
InteractionsView
This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.
Pregnancy & lactationView
This tablet should preferably not be given during pregnancy and lactation.
Overdose effectsView
In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.
StorageView
Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.

Frisium

Clobazam
Tablet 10 mg Allopathic Benzodiazepine hypnotics

Indications

Tension

Indication detailsView
Acute and chronic anxiety states which may produce the following symptoms in particular: anxiety, tension, restlessness, excitement, irritability, sleep disturbances from emotional causes, psychovegetative and psychosomatic disorders (for example, in the cardiovascular or gastrointestinal area), and emotional instability.

In patients with depression or anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines alone, can precipitate suicide in such patients. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.

In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.

As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
Therapeutic classView
Benzodiazepine hypnotics
PharmacologyView
Clobazam binds at distinct binding sites associated with the chloride ionopore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionopore is open. As a result, hyper polarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.
DosageView
General Dosage: Dosage and duration of treatment must be adjusted to the indication, the severity of the condition and the individual clinical response. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.

Treatment of anxiety states-

Adults and adolescents over 15 years of age: The initial dose is usually 20 mg clobazam daily. If necessary, the daily dose may be increased. Generally, it is recommended that a total daily dose of 30 mg is not exceeded.

Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A maintenance dose of 10 to 15 mg clobazam daily is frequently sufficient.

Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5 to 10 mg clobazam is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.

Secondary dosage adjustment: After the improvement of the symptoms, the dose may be reduced.

Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.

Duration of treatment: The duration of treatment must be as short as possible. The patient must be reassessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-of process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a re-evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.

Discontinuation of treatment: It is strongly recommended that after prolonged treatment clobazam is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.

Treatment of epilepsy in combination with one or more other anticonvulsants-

Adults and adolescents over 15 years of age: It is recommended that administration be started at small doses (5 to 15 mg daily), if necessary, increasing the dose gradually to a maximum daily dose of about 80 mg.

Children from 3 to 15 years of age: It is recommended that normally treatment be started at 5 mg daily. A maintenance dose of 0.3 to 1.0 mg/kg body weight daily is usually sufficient. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.

Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.

Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.

Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.

Discontinuation of treatment: At the end of treatment- to include cases in which response to therapy has been poor- it is strongly recommended that clobazam is not withdrawn suddenly but rather that the dose is reduced gradually; otherwise an increased susceptibility to seizures as well as other withdrawal symptoms may occur.
AdministrationView
The tablets can be administered whole, or crushed and mixed in applesauce. The 10 mg tablets can be divided into equal halves of 5 mg. Clobazam can be given with or without food.
Side effectsView
Metabolism and nutrition disorders: Common: decreased appetite

Psychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.

Nervous system disorders: Very common: somnolence, especially at the beginning of treatment and when higher doses are used; Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder (particularly with high doses or in long-term treatment, and are reversible), headache, tremor, ataxia.

Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)

Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)

Gastrointestinal disorders: Common: dry mouth, nausea, constipation

Skin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);

Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weakness

General disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermia

Investigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
ContraindicationsView
Clobazam must not be used-
  • In patients with hypersensitivity to clobazam or any of the excipients of Clobazam.
  • In patients with myasthenia gravis (risk of aggravation of muscle weakness).
  • In patients with severe respiratory insufciency (risk of deterioration).
  • In patients with sleep apnoea syndrome (risk of deterioration).
  • In patients with severe impairment of liver function (risk of precipitating encephalopathy).
  • In breast-feeding women Benzodiazepines must not be given to children without careful assessment of the need for their use.
  • Clobazam must not be used in children between the ages of 6 months and 3 years, other than in exceptional cases for anticonvulsant treatment where there is a compelling indication.
PrecautionsView
Serious Skin Reactions: Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the post-marketing experience. A majority of the reported cases involved the concomitant use of other drugs, including antiepileptic drugs that are associated with serious skin reactions. SJS/TEN could be associated with a fatal outcome. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment. Clobazam should be immediately discontinued when SJS/TEN is suspected. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.

Respiratory depression: Clobazam can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Clobazam is contraindicated in patients with severe respiratory insufficiency.

Muscle weakness: Clobazam can cause muscle weakness. Clobazam is contraindicated in patients with myasthenia gravis.

Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.

Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.

Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Clobazam, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.

CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylclobazam are expected to be increased as compared to extensive metabolizers. Dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).

Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for clobazam in these studies. Cases of suicidal behavior have been reported with clobazam in post-marketing surveillance. All of these cases had confounding factors.

Concomitant use of CYP2C19 inhibitors: The concomitant use of clobazam with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylclobazam (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of clobazam may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality
InteractionsView
Alcohol: Concomitant consumption of alcohol can increase the bioavailability of clobazam by 50% and therefore lead to increased clobazam effects.

Central nervous system depressant drugs: Especially when clobazam is administered in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant drugs, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.

Opioids: The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids.

Anticonvulsants: If clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication. In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration. Phenytoin plasma levels may rise if patients receive concomitant treatment with clobazam. Where possible, it is recommended that blood levels of concomitantly administered valproic acid or phenytoin be monitored. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethyl clobazam. Stiripentol increases plasma levels of clobazam and its active metabolite N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol, and then once new steady-state concentration has been reached, i.e. after 2 weeks approximately.

Narcotic analgesics: If clobazam is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.

Muscle relaxants: The effects of muscle relaxants and nitrous oxide may be enhanced.

CYP 2C19 inhibitors: Strong and moderate inhibitors of CYP2C19 may result in increased exposure to N-desmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., cannabidiol containing medicinal products, fuconazole, fuvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g. omeprazole).

CYP 2D6 substrates: Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.
Pregnancy & lactationView
Pregnancy: Clobazam is not recommended during the first trimester of pregnancy and in women of childbearing potential not using contraception. Clobazam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have demonstrated reproductive toxicity. Clobazam crosses the placenta. In the post-marketing safety database, limited data on exposed pregnancies are available with clobazam. A large amount of data collected from cohort studies has not demonstrated evidence of the occurrence of malformations following exposure to benzodiazepines during the first trimester of pregnancy. However, in certain epidemiological case-control studies, an increased incidence of cleft lip and palate was observed with benzodiazepines. Cases of reduced fetal movement and fetal heart rate variability have been described after administration of benzodiazepines during the second and/or third trimester of pregnancy. Administration of clobazam during the late phase of pregnancy or during childbirth can result in the occurrence of neonatal respiratory depression (including respiratory distress and apnea), which may be associated with other disorders such as sedation signs, hypothermia, hypotonia, and feeding difficulties (which may result in poor weight gain) in the newborn (signs and symptoms of the so-called "floppy infant syndrome"). Moreover, infants born to mothers who have taken benzodiazepines over longer periods during the later stages of pregnancy may have developed physical dependence and may be at risk of developing a withdrawal syndrome in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended. Women of childbearing potential should be informed of the risks and benefits of the use of Clobazam during pregnancy. If a woman plans a pregnancy or becomes pregnant, carefully evaluate the risks and benefits and whether treatment with Clobazam should be discontinued. If Clobazam treatment is to be continued, use Clobazam at the lowest effective dose.

Lactation: Clobazam must not be used in breastfeeding women, since clobazam passes into breast milk.
StorageView
Do not use the medicine later than the date of expiry. Store below 30° and protect from light. Keep out of the reach of children.

Fritt

Naproxen Sodium
Tablet 500 mg Allopathic Drugs for Osteoarthritis

Indications

Systemic lupus erythematosus (SLE)

Indication detailsView
Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.
DosageView
Naproxen Tablet-
  • Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
  • Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
  • Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.
Naproxen Suspension-
  • For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.
Naproxen Gel-
  • Is to be applied 2-6 times a day as required and is not recommended for use in children.
Side effectsView
Most frequently reported side effects include following:
  • Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
  • Central Nervous System: Headache, vertigo, drowsiness.
  • Dermatological: Pruritus (itching), purpura.
  • Cardiovascular: Edema, palpitation.
  • Others: Visual disturbances, hearing disturbances.
ContraindicationsView
Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
InteractionsView
ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Pregnancy & lactationView
US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Fritt

Naproxen Sodium
Tablet 250 mg Allopathic Drugs for Osteoarthritis

Indications

Systemic lupus erythematosus (SLE)

Indication detailsView
Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.
DosageView
Naproxen Tablet-
  • Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
  • Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
  • Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.
Naproxen Suspension-
  • For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.
Naproxen Gel-
  • Is to be applied 2-6 times a day as required and is not recommended for use in children.
Side effectsView
Most frequently reported side effects include following:
  • Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
  • Central Nervous System: Headache, vertigo, drowsiness.
  • Dermatological: Pruritus (itching), purpura.
  • Cardiovascular: Edema, palpitation.
  • Others: Visual disturbances, hearing disturbances.
ContraindicationsView
Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
InteractionsView
ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Pregnancy & lactationView
US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Frodex

Ambar Momiyaee
Tablet Herbal Herbal and Nutraceuticals

Indications

Erectile dysfunction

Indication detailsView
Ambar Momiyaee-
  • Combats erectile dysfunction.
  • Is an ideal aphrodisiac and nervine tonic.
  • Restores sex hormone and depleted sexual power.
  • Relieves limpness and weakness after coitus.
  • Enhances retentive power.
  • Tones up the vital organ of the body.
  • Removes mental depression.
  • Its continuous use serves as a good general tonic.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Ambar Momiyaee is a research product of Hamdard Laboratories and time tested aphrodisiac. Ambar Momiyaee is being used successfully to treat the patients of erectile dysfunction in different Hamdard clinics of the subcontinent for long time. It acts as nervine tonic and continuous use serves as a good general tonic.
DosageView
1 tablet twice daily to be taken with milk or as prescribed by the physician.
Side effectsView
No significant side effect has been observed in proper dosage.
ContraindicationsView
It is contraindicated for women and children.
PrecautionsView
Keep out of reach of the children.
StorageView
Store at cool and dry place, protect from light.

Frucard

Furosemide + Spironolactone
Tablet 20 mg+50 mg Allopathic Potassium-sparing diuretics

Indications

Hypertension

Indication detailsView
Frusemide & Spironolactone combination is indicated in-
  • Essential hypertension
  • Chronic congestive heart failure
  • Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
  • Swelling due to excess fluid retention (edema)
  • Hyperaldosteronism
  • Resistant edema associated with secondary hyperaldosteronism
Therapeutic classView
Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists
PharmacologyView
Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced
DosageView
Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.
Side effectsView
Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.
ContraindicationsView
Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.
PrecautionsView
Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.
InteractionsView
When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.
Pregnancy & lactationView
Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Frucard

Furosemide + Spironolactone
Tablet 40 mg+50 mg Allopathic Potassium-sparing diuretics

Indications

Hypertension

Indication detailsView
Frusemide & Spironolactone combination is indicated in-
  • Essential hypertension
  • Chronic congestive heart failure
  • Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
  • Swelling due to excess fluid retention (edema)
  • Hyperaldosteronism
  • Resistant edema associated with secondary hyperaldosteronism
Therapeutic classView
Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists
PharmacologyView
Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced
DosageView
Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.
Side effectsView
Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.
ContraindicationsView
Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.
PrecautionsView
Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.
InteractionsView
When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.
Pregnancy & lactationView
Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Fructin

Fructose
IV Infusion 10%w/v Allopathic
Indication detailsView
Fructose is used intravenously as a carbohydrate nutrient. It is converted to liver glycogen and metabolized more rapidly than dextrose without requiring insulin and thus may be used in diabetic patients. Fructose is indicated in patients requiring fluid replacement and caloric feeding. It is better "nitrogen sparer" than glucose.
DosageView
The volume and rate of infusion of fructose IV solution will depend upon the requirements of the patient and the judgement of attending physician. But the rate of infusion of fructose should not exceed 0.5-1 gm/kg body weight per hour.The usual recommended flow rate for adult is 30-75 drops per minute infused intravenously.
AdministrationView
  • Check infusion set and infusion solution prior to use.
  • Pull moderately to tear off the protective cover of the Eurocap.
  • Hold lightly the Eurocap but not the bottle body.
  • Open the flow regulator fully and hold the giving set on the top white area, but not the memorane venting region.
  • Insert the spike of the administration set to the Eurocap and fit the connector of the administration set firmly to the needle.
  • Gradually allow the fluid to flow down to the needletip and close.
  • Remove the protective cover of the needle.
  • Locate the venpuncture site and clean the site with an antiseptic solution, and then insert the needle.
  • Securely tape the puncture site.
  • Securely tape the wings and tubing
  • Start infusion while adjusting drip speed.
Side effectsView
Intravenous administration of fructose may cause lactic acidosis and hyperuricemia.The rapid infusion of fructose results in facial flushing, abdominal pain and sweating.
ContraindicationsView
Fructose is contraindicated in certain inborn errors of fructose metabolism, methyl alcohol poisoning, hyperuricemia, liver failure, and lactic acidosis.
PrecautionsView
Fructose should not be given to patients with hereditary fructose intolerance. It should be given with caution to patients with impaired kidney function or severe liver damage. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Fructose

Fructose
IV Infusion 10%w/v Allopathic
Indication detailsView
Fructose is used intravenously as a carbohydrate nutrient. It is converted to liver glycogen and metabolized more rapidly than dextrose without requiring insulin and thus may be used in diabetic patients. Fructose is indicated in patients requiring fluid replacement and caloric feeding. It is better "nitrogen sparer" than glucose.
DosageView
The volume and rate of infusion of fructose IV solution will depend upon the requirements of the patient and the judgement of attending physician. But the rate of infusion of fructose should not exceed 0.5-1 gm/kg body weight per hour.The usual recommended flow rate for adult is 30-75 drops per minute infused intravenously.
AdministrationView
  • Check infusion set and infusion solution prior to use.
  • Pull moderately to tear off the protective cover of the Eurocap.
  • Hold lightly the Eurocap but not the bottle body.
  • Open the flow regulator fully and hold the giving set on the top white area, but not the memorane venting region.
  • Insert the spike of the administration set to the Eurocap and fit the connector of the administration set firmly to the needle.
  • Gradually allow the fluid to flow down to the needletip and close.
  • Remove the protective cover of the needle.
  • Locate the venpuncture site and clean the site with an antiseptic solution, and then insert the needle.
  • Securely tape the puncture site.
  • Securely tape the wings and tubing
  • Start infusion while adjusting drip speed.
Side effectsView
Intravenous administration of fructose may cause lactic acidosis and hyperuricemia.The rapid infusion of fructose results in facial flushing, abdominal pain and sweating.
ContraindicationsView
Fructose is contraindicated in certain inborn errors of fructose metabolism, methyl alcohol poisoning, hyperuricemia, liver failure, and lactic acidosis.
PrecautionsView
Fructose should not be given to patients with hereditary fructose intolerance. It should be given with caution to patients with impaired kidney function or severe liver damage. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Frudema

Furosemide
Tablet 40 mg Allopathic Loop diuretics

Indications

Tumor lysis syndrome

Indication detailsView
Furosemide is indicated in-
  • Fluid retention associated with chronic congestive cardiac failure (if diuretic treatment is required).
  • Fluid retention associated with acute congestive cardiac failure.
  • Fluid retention associated with chronic renal failure.
  • Maintenance of fluid excretion in acute renal failure, including that due to pregnancy or burns.
  • Fluid retention associated with nephrotic syndrome (if diuretic treatment is required).
  • Fluid retention associated with liver disease (if necessary to supplement treatment with aldosterone antagonists).
  • Hypertension.
  • Hypertensive crisis (as a supportive measure).
  • Support of forced diuresis.
Therapeutic classView
Loop diuretics
PharmacologyView
Furosemide is a monosulphonyl diuretic. It is an effective diuretic that retains its activity even in low glomerular filtration rate (GFR). Furosemide has a distinctive action on renal tubular function. It affects a peak diuresis far greater than that observed with other agents. Other features are (I) prompt onset of action (II) inhibition of sodium and chloride transport in the ascending limb of the loop of Henle and (III) independence of their action from acid-base balance changes. Furosemide acts primarily to inhibit electrolyte reabsorption in the thick ascending limb of the loop of Henle. Furosemide is readily absorbed from the gastrointestinal tract and considerable proportions are bound to plasma proteins. It is rapidly excreted in the urine. With an hour after intravenous injection, its effect is evident in about 5 minutes and last for about 2 hours.
DosageView
Furosemide 40 mg Tablet-
Edema:
  • Adults: The initial adult dose is 40 mg daily, reduced to 20 mg daily or 40mg on alternate days. In some patients daily doses of 80mg or higher (given in divided doses) may be required. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). For resistant edema, 80-120 mg daily. In patients with clinically severe edematous states the dose of furosemide may be carefully titrated up to 600 mg/day. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.
  • Children: Neonate: 0.5-2 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
  • Child 1 month-12 years: 0.5-2 mg/kg 2-3 times daily (every 24 hours if postmenstrual age less than 31 weeks); higher doses may be required in resistant edema; max. 12 mg/kg daily, not to exceed 80 mg daily.
  • Child 12-18 years:20-40 mg daily, increased in resistant edema to 80-120 mg daily.
  • Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.
Hypertension:
  • Adults: The usual initial dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
  • Children: The usual dose is 1 - 3 mg/kg body weight daily up to a maximum dose of 40mg/day.
  • Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.
Furosemide 250 mg Tablet: For selected patients with advanced chronic renal failure, diuretic therapy may be started with Furosemide orally. If conventional doses (80 to 160 mg orally) fail to produce an adequate diuresis, a single dose of 250 mg is given as a starting dose. If a satisfactory diuresis does not ensue within 4-6 hours, the initial dose may be doubled to 500 mg. The criterion of optimal dosage is a urinary output of at least 2.5 liters per day. A maximum daily dose of 1000 mg should not be exceeded.

Furosemide Syrup: Furosemide Liquid has an exceptionally wide therapeutic range, the effect being proportional to the dosage. Furosemide Liquid is best given as a single dose either daily or on alternate days. The usual initial daily dose is 40 mg. This may require adjustment until the effective dose is achieved as a maintenance dose. In mild cases, 20 mg daily or 40 mg on alternate days may be sufficient, whereas in cases of resistant edema, daily doses of 80 mg and above may be used as one or two daily, or intermittently. Severe cases may require gradual titration of the furosemide dosage up to 600 mg daily. The recommended maximum daily dose of furosemide administration is 1,500 mg.

Furosemide Injection-
Edema:

Adults: Doses of 20-50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg.

By slow intravenous injection:
  • Neonate: 0.5-1 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
  • Child 1 month-12 years: 0.5-1 mg/kg repeated every 8 hours as necessary;maximum 2 mg/kg (max. 40 mg) every 8 hours.
  • Child 12-18 years: 20-40 mg repeated every 8 hours as necessary; higher doses may be required in resistant cases.
By continuous intravenous infusion:
  • Child 1 month-18 years: 0.1-2 mg/kg/hour (following cardiac surgery, initially 100 micrograms/kg/hour, doubled every 2 hours until urine output exceeds 1 mL/kg/hour).
  • Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.
Hypertension:
  • Adults: Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg. Children: Parenteral doses for children range from 0.5-1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
  • Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.
Side effectsView
As with other diuretics, electrolytes and water balance may be disturbed as a result of diuresis of prolonged therapy. Prolonged use can produce alkalosis. It may also cause uric acid retention and may rarely produce acute gout. Furosemide may provoke hyperglycemia and glycosuria.
ContraindicationsView
Furosemide is contraindicated in anuria, electrolyte deficiency and pre-comatose states associated with liver cirrhosis. Hypersensitivity to furosemide or sulphonamides.
PrecautionsView
Patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention. A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such furosemide.

Driving a vehicle or performing other hazardous tasks: Some adverse effects (e.g. an undesirably pronounced fall in blood pressure) may impair the patient's ability to concentrate and react, and, therefore, constitute a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).
InteractionsView
A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. Serum lithium levels may be increased when lithium is given concomitantly with furosemide. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such as furosemide.
Pregnancy & lactationView
Pregnancy category C. Furosemide should be cautiously used in cardiogenic shock complicated by pulmonary oedema and in the first trimester of pregnancy. Blood pressure and pulse during rapid diuresis should be monitored. Caution should be observed in patients liable to electrolyte deficiency. In case of nursing mother, furosemide may inhibit lactation or may pass into breast milk. In that case it should be used with caution.
Overdose effectsView
Signs and symptoms: The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss, e.g. hypovolaemia, dehydration, haemoconcentration, cardiac arrhythmias (including AV block and ventricular fibrillation).

Management: No specific antidote to furosemide is known. If ingestion has only just taken place, attempts may be made to limit further systemic absorption of the active ingredient by measures such as gastric lavage or those designed to reduce absorption (e.g. activated charcoal).
StorageView
Protect from light. Do not use it 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.

Frulac

Furosemide + Spironolactone
Tablet 40 mg+50 mg Allopathic Potassium-sparing diuretics

Indications

Hypertension

Indication detailsView
Frusemide & Spironolactone combination is indicated in-
  • Essential hypertension
  • Chronic congestive heart failure
  • Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
  • Swelling due to excess fluid retention (edema)
  • Hyperaldosteronism
  • Resistant edema associated with secondary hyperaldosteronism
Therapeutic classView
Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists
PharmacologyView
Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced
DosageView
Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.
Side effectsView
Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.
ContraindicationsView
Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.
PrecautionsView
Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.
InteractionsView
When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.
Pregnancy & lactationView
Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.