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Genopam
Clonazepam
Genopam
Clonazepam
Indication detailsView
It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Therapeutic classView
Adjunct anti-epileptic drugs, Benzodiazepine hypnotics
PharmacologyView
Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
DosageView
Oral:
Injection:
- Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
- The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
- Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.
Injection:
- Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
- Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.
Side effectsView
The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.
ContraindicationsView
It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
PrecautionsView
When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.
InteractionsView
Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.
Pregnancy & lactationView
Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
Pediatric usageView
Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
Overdose effectsView
Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
ReconstitutionView
Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Gensulin M30
Insulin Human [rDNA] + Isophane Insulin Human
Gensulin M30
Insulin Human [rDNA] + Isophane Insulin Human
Indications
Type 1 DM
Indication detailsView
Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents.
For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients. Treatment of gestational diabetes.
For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients. Treatment of gestational diabetes.
Therapeutic classView
Medium Acting Insulin
PharmacologyView
Insulin Human (rDNA) is human insulin made by recombinant DNA technology. It has the same structure and function as natural insulin. Insulin regulates the glucose metabolism and stimulates the ingestion and utilization of glucose by liver, muscle and fat tissue. It also lowers blood glucose by accelerating glycogenesis and inhibiting gluconeogenesis.
Insulin Human (rDNA) 30/70 & Insulin Human (rDNA) 50/50 start action within 30 minutes after injection, reach peak level within 2-8 hours and last about 24 hours.
Insulin Human (rDNA) 30/70 & Insulin Human (rDNA) 50/50 start action within 30 minutes after injection, reach peak level within 2-8 hours and last about 24 hours.
DosageView
The average range of total daily insulin requirement for maintenance therapy in type 1 diabetic patients lies between 0.5 and 1.0 IU/kg. In pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg, whereas in insulin resistant cases, e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher. Initial dosages for type 2 diabetic patients are often lower, e.g. 0.3 to 0.6 IU/kg/day.
The dosage form, the dosage and the administration time of the insulin are different due to the individual differences of each patient. In addition, the dosage is also affected by food, working style and exercising intensity. Therefore, patients should use the insulin under doctor's instruction.
The dosage form, the dosage and the administration time of the insulin are different due to the individual differences of each patient. In addition, the dosage is also affected by food, working style and exercising intensity. Therefore, patients should use the insulin under doctor's instruction.
AdministrationView
An injection should be followed by a meal or snack containing carbohydrates within 30 minutes. Injection is administered subcutaneously in the upper arm, thigh, buttock or abdominal wall. A subcutaneous injection into the abdominal wall results in a faster absorption than from other injection sites. Insulin Human (rDNA) 30/70 & Insulin Human (rDNA) 50/50 are never to be administered intravenously.
Preparation before use:
Preparation before use:
- Clean your hands.
- Shake or rotate the vial gently to mix the solution uniformly and check if the insulin has the normal appearance.
- In case of using a new vial, flip off the plastic protective cap and wipe the rubber plug with an alcohol swab.
- Draw air into your syringe equal to the amount of insulin needed.
- Puncture the needle into the vial and inject the air.
- Turn the bottle and syringe upside down and withdraw correct dose of insulin into the syringe.
- Before pulling out the needle, check if there are any bubbles remain in the syringe. If so, put the syringe upright and tap the syringe to discharge the air bubbles.
- Choose the area where skin is less tight, such as the upper arm, thigh, buttock or abdomen.
- To avoid tissue damage, choose a site for each injection that is at least 1 cm from the previous injection site.
- Cleanse the skin with alcohol where the injection is to be made.
- Put the needle in such a position as to form 45° angle with the skin.
- Puncture the needle into skin and inject insulin.
- Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected.
- Pull the needle out and apply gentle pressure over the injected site for several seconds.
- Do not rub the injection site.
Side effectsView
Hypoglycemia is the most common adverse effect during insulin treatment and symptoms of hypoglycemia may occur suddenly. Few cases of the allergic reaction such as red and swollen or itching are reported. It usually disappears in a few days. In some instances, the allergy may be caused by other reasons rather than insulin, such as disinfectant and poor injection technique.
ContraindicationsView
Hypoglycemia or the patients who have allergic reaction to insulin or any of the excipients.
PrecautionsView
Inadequate dosing or discontinuation especially in type 1 diabetes, may lead to hyperglycemia. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycemia.
InteractionsView
When using oral contraceptive drug, adrenal cortical hormone, thyroid hormone, etc., the drugs that can result in the rise of blood glucose; you might need to increase the amount of Insulin. When using drugs with hypoglycemic activities, salicylate, sulfanilamide and other anti-depressants, which will result in the decrease of blood glucose, the dosage of insulin should be reduced.
Pregnancy & lactationView
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier. Insulin treatment of the nursing mother presents no risk to the baby.
Overdose effectsView
Excessive use of insulin may lead to hypoglycemia during the treatment. Slight to moderate hypoglycemia may suddenly occur. It is important to get immediate treatment when hypoglycemia occurs. If you have frequent hypoglycemia, you should consult your doctor to discuss possible changes in therapy, diet plans, and/or exercise programs to help you avoid hypoglycemia.
StorageView
Store at 2°C - 8°C in a refrigerator. Do not freeze. In case of insulin for recent use need not be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.
Gensulin N
Insulin Human [Long-Acting]
Gensulin N
Insulin Human [Long-Acting]
Indications
Type 1 DM
Indication detailsView
Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents. For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients. Treatment of gestational diabetes.
Therapeutic classView
Long Acting Insulin
PharmacologyView
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. Insulatard is a long-acting insulin. Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire time of duration is approximately 24 hours.
Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. This process is influenced by several factors (e.g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes). The pharmacokinetics of insulins is therefore affected by significant intra- and inter-individual variation
Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. This process is influenced by several factors (e.g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes). The pharmacokinetics of insulins is therefore affected by significant intra- and inter-individual variation
DosageView
Dosage is individual and determined in accordance with the needs of the patient. The individual insulin requirement is usually between 0.3 and 1.0 IU/kg day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
The physician determines one or several daily injections are necessary. Insulatard may be used alone or mixed with fast-acting insulin. In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals. In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications. Close blood glucose monitoring is recommended.
The physician determines one or several daily injections are necessary. Insulatard may be used alone or mixed with fast-acting insulin. In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals. In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications. Close blood glucose monitoring is recommended.
AdministrationView
For subcutaneous use. Insulatard is usually administered subcutaneously in the thigh. If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used. Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites. Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected. Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy. Insulin suspensions are never to be administered intravenously. Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed. The vials are for use with insulin syringes with corresponding unit scale. When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin
Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected. Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy. Insulin suspensions are never to be administered intravenously. Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed. The vials are for use with insulin syringes with corresponding unit scale. When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin
Side effectsView
Hypoglycemia is the most common adverse effect during insulin treatment and symptoms of hypoglycemia may occur suddenly. Few cases of the allergic reaction such as red and swollen or itching are reported. It usually disappears in a few days. In some instances, the allergy may be caused by other reasons rather than insulin, such as disinfectant and poor injection technique.
ContraindicationsView
Hypoglycaemia, Hypersensitivity to human insulin or to any of the excipients
PrecautionsView
Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia. Usually the first symptoms of hyperglycaemia set in gradually, over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Patients whose blood glucose control is greatly improved e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly Usual warning symptoms may disappear in patients with longstanding diabetes.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Patients whose blood glucose control is greatly improved e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly Usual warning symptoms may disappear in patients with longstanding diabetes.
InteractionsView
A number of medicinal products are known to interact with the glucose metabolism. Physicians must therefore take possible interactions into account and should always ask their patients about any medicinal products they take.
The following substances may reduce insulin requirement: Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta-blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates and alcohol.
The following substances may increase insulin requirement: Thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol. Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia. Octreotide/lanreotide may both decrease and increase insulin requirement. Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
The following substances may reduce insulin requirement: Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta-blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates and alcohol.
The following substances may increase insulin requirement: Thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol. Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia. Octreotide/lanreotide may both decrease and increase insulin requirement. Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
Pregnancy & lactationView
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
Overdose effectsView
A specific overdose of insulin cannot be defined. However, hypoglycaemia may develop over sequential stages
StorageView
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the container cartridge or vial in the outer carton in order to protect from light.
During use: do not refrigerate. Do not store vials above 25°C and cartridges above 30°C. Protect from excessive heat and sunlight.
During use: do not refrigerate. Do not store vials above 25°C and cartridges above 30°C. Protect from excessive heat and sunlight.
Gensulin R
Insulin Human [Fast-Acting]
Gensulin R
Insulin Human [Fast-Acting]
Indications
Type 1 DM
Indication detailsView
Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents. For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients. Treatment of gestational diabetes.
Therapeutic classView
Rapid Acting Insulin
PharmacologyView
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. Insulatard is a long-acting insulin. Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire time of duration is approximately 24 hours.
Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. This process is influenced by several factors (e.g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes). The pharmacokinetics of insulins is therefore affected by significant intra- and inter-individual variation
Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. This process is influenced by several factors (e.g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes). The pharmacokinetics of insulins is therefore affected by significant intra- and inter-individual variation
DosageView
Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar. Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
AdministrationView
For subcutaneous use. Insulatard is usually administered subcutaneously in the thigh. If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used. Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites. Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected. Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy. Insulin suspensions are never to be administered intravenously. Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed. The vials are for use with insulin syringes with corresponding unit scale. When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected. Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy. Insulin suspensions are never to be administered intravenously. Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed. The vials are for use with insulin syringes with corresponding unit scale. When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
Side effectsView
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
PrecautionsView
- If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
- If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
- If you are ill, carry on taking your insulin and consult your doctor.
- If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.
Pregnancy & lactationView
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. This insulin can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby. There are no restrictions on treatment with this insulin during breast-feeding.
Pediatric usageView
Use in children and adolescents: Can be used in children and adolescents.
Use in special patient groups: If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
Use in special patient groups: If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
StorageView
Store in a refrigerator at 2°C-8°C. Keep away from the cooling element. Do not freeze.
Gentabac
Gentamicin Sulfate (Injection)
Gentabac
Gentamicin Sulfate (Injection)
Indications
Urinary tract infection
Indication detailsView
Gentamicin Injection is indicated in the treatment of serious infections caused by susceptible strains of the microorganisms including: Pseudomonas aeruginosa, Proteus sp, Escherichia coli, Klebsiella, Enterobacter, Serratia and Staphylococcus spp.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
Therapeutic classView
Aminoglycosides
PharmacologyView
Gentamicin Sulfate is an aminoglycoside antibiotic. This is a proven bactericidal antibiotic active against a broad spectrum of Gram-negative pathogens including E. coli, Klebsiella, Proteus spp, Enterobacter, Pseudomonas aeruginosa and Serratia species. It is also active against some Gram-positive organisms (e.g. penicillin & methicillin resistant strains of Staphylococcus aureus). In vitro, Gentamicin is also active against Salmonella and Shigella. Gentamicin interferes with bacterial protein synthesis by binding primarily to the 30S sub-units of bacterial ribosomes in susceptible organisms. Cell death results. Other mechanisms of action may contribute to the bactericidal effect of Gentamicin.
DosageView
Gentamicin is given by the intramuscular route normally. But intravenous administration may be used if required. The dosage is the same for either route of administration.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
Side effectsView
Vestibular damage, reversible nephrotoxicity, auditory ototoxicity may occur. Symptoms are dizziness, vertigo, tinnitus, roaring in the ears, rarely hearing loss. Adverse renal effects may be also caused, more frequently in patients with a history of renal impairment treated with larger doses than recommended.
InteractionsView
Concurrent use with other potentially nephrotoxic or ototoxic drug substances should be avoided. Potent diuretics such as ethacrynic acid or frusemide may potentiate ototoxic effects of gentamicin. As gentamicin is inactivated by solutions containing beta-lactam antibiotics (penicillins & cephalosporins), the two drugs should not be administered simultaneously.
Pregnancy & lactationView
Safety for use in pregnancy and lactation has not been established. Gentamicin crosses the placenta and there is a risk of ototoxicity in the fetus. Gentamicin should only be used where the seriousness of the mother's condition justifies the risk. Small amounts of gentamicin have been detected in breast milk. Therefore it is recommended that breastfeeding be discontinued during therapy unless the expected benefits outweigh any potential risk.
StorageView
Should be stored in cool and dry place
Gentabac
Gentamicin Sulfate (Injection)
Gentabac
Gentamicin Sulfate (Injection)
Indications
Urinary tract infection
Indication detailsView
Gentamicin Injection is indicated in the treatment of serious infections caused by susceptible strains of the microorganisms including: Pseudomonas aeruginosa, Proteus sp, Escherichia coli, Klebsiella, Enterobacter, Serratia and Staphylococcus spp.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
Therapeutic classView
Aminoglycosides
PharmacologyView
Gentamicin Sulfate is an aminoglycoside antibiotic. This is a proven bactericidal antibiotic active against a broad spectrum of Gram-negative pathogens including E. coli, Klebsiella, Proteus spp, Enterobacter, Pseudomonas aeruginosa and Serratia species. It is also active against some Gram-positive organisms (e.g. penicillin & methicillin resistant strains of Staphylococcus aureus). In vitro, Gentamicin is also active against Salmonella and Shigella. Gentamicin interferes with bacterial protein synthesis by binding primarily to the 30S sub-units of bacterial ribosomes in susceptible organisms. Cell death results. Other mechanisms of action may contribute to the bactericidal effect of Gentamicin.
DosageView
Gentamicin is given by the intramuscular route normally. But intravenous administration may be used if required. The dosage is the same for either route of administration.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
Side effectsView
Vestibular damage, reversible nephrotoxicity, auditory ototoxicity may occur. Symptoms are dizziness, vertigo, tinnitus, roaring in the ears, rarely hearing loss. Adverse renal effects may be also caused, more frequently in patients with a history of renal impairment treated with larger doses than recommended.
InteractionsView
Concurrent use with other potentially nephrotoxic or ototoxic drug substances should be avoided. Potent diuretics such as ethacrynic acid or frusemide may potentiate ototoxic effects of gentamicin. As gentamicin is inactivated by solutions containing beta-lactam antibiotics (penicillins & cephalosporins), the two drugs should not be administered simultaneously.
Pregnancy & lactationView
Safety for use in pregnancy and lactation has not been established. Gentamicin crosses the placenta and there is a risk of ototoxicity in the fetus. Gentamicin should only be used where the seriousness of the mother's condition justifies the risk. Small amounts of gentamicin have been detected in breast milk. Therefore it is recommended that breastfeeding be discontinued during therapy unless the expected benefits outweigh any potential risk.
StorageView
Should be stored in cool and dry place
Gentabac
Gentamicin Sulfate (Ophthalmic)
Gentabac
Gentamicin Sulfate (Ophthalmic)
Indications
tympanoplasty
Indication detailsView
Blepharitis, blepharoconjunctivitis, conjunctivitis, dacryocystitis, keratitis, keratoconjunctivitis, acute meibomianitis, and corneal ulcers caused by susceptible organisms. Otorrhea associated with external otitis, chronic suppurative otitis media or subacute purulent otitis media; or postoperative otorrhea, such as that following fenestration, mastoidectomy or tympanoplasty.
Therapeutic classView
Ophthalmic antibacterial drugs
PharmacologyView
Gentamicin sulphate actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30S subunit of bacterial ribosomes and interferes with an initiation complex between mRNA (messenger RNA) and the 30 S subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
DosageView
Eye: 1-2 drops instilled in affected eye up to 6 times a day or more frequently if required (severe infections may require 1-2 drops every 15-20 minutes initially, reducing the frequency of instillation gradually as the infection is controlled).
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
Side effectsView
In patients with dermatoses treated with gentamicin, irritation (erythema and pruritus) had been reported in small number of cases. Itching, redness, swelling or other signs of irritation may develop. With the eye/ear drop bacterial and corneal ulcer have developed during treatment with gentamicin. Most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.
ContraindicationsView
This drug is contraindicated in individuals with a history of sensitivity reaction to any of its components. Use of topical Gentamicin may occasionally allow overgrowth of nonsusceptible organisms, including fungi.
PrecautionsView
If these occurs or if irritation, sensitization develops, treatment with gentamicin should be discontinued and appropriate therapy instituted. Gentamicin ear/eye drops is not for injection. It should never be injected subconjunctivally, nor it should be directly introduced into the anterior chamber of the eye.
InteractionsView
None has been reported so far with topical and Eye/Ear drops.
Pregnancy & lactationView
Consideration should be given the possibility of foetal ototoxicity when gentamicin is applied topically to large denuded areas of skin. For Gentamicin Eye/Ear Drops safety profile in pregnancy is not yet established and should be administered when considered essential.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children. To avoid contamination, do not touch the tip of the container to the eye, eyelid or any surface.
Gentabac HC
Gentamicin + Hydrocortisone Acetate
Gentabac HC
Gentamicin + Hydrocortisone Acetate
Indications
Susceptible infections
Indication detailsView
Gentamicin & Hydrocortisone ear drops is indicated for the treatment of chronic suppurative otitis media, otitis externa and as prophylactic treatment of otitis externa following trauma. Gentamicin & Hydrocortisone ear drops is also indicated for post-operative local use in surgery to infected mastoid cavities.
Gentamicin & Hydrocortisone cream is indicated for redness, itching, and swelling of the skin
Gentamicin & Hydrocortisone cream is indicated for redness, itching, and swelling of the skin
Therapeutic classView
Hydrocortisone & Combined preparations, Ophthalmic steroid - antibiotic combined preparations
PharmacologyView
Gentamicin is an aminoglycoside that binds to 30s and 50s ribosomal subunits of susceptible bacteria disrupting protein synthesis, thus rendering the bacterial cell membrane defective.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
DosageView
Ear Drops-
For Middle Ear Infection: Instill 2-4 drops in the affected ear three to four times a day and at night, or more frequently if required. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for two minutes. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed. For EarCanal Infection: Instill 2-4 drops in the affected ear three to four times a day and at night, or more frequently if required. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for two minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.
Cream-
For redness, itching, and swelling of the skin: Apply to the affected area of the skin two or three times per day.AdministrationView
Ear Drops need to shake well immediately before use.
Side effectsView
Allergic contact dermatitis, Transient irritation, burning, stinging, Increased redness, lacrimation
ContraindicationsView
History of hypersensitivity to aminoglycoside; pregnancy; hepatic impairment.
PrecautionsView
Concurrent use of neuromuscular blocking agents; myasthenia gravis, parkinsonism; conditions predisposing to ototoxicity and nephrotoxicity; lactation. Monitor plasma concentrations of gentamicin in patients receiving high doses or prolonged courses, in infants, elderly, patients with renal impairment, cystic fibrosis or significant obesity. Monitor auditory and renal functions.
InteractionsView
Gentamicin: Additive effect with other neurotoxic and/or nephrotoxic drugs including cephalosporins, methicillin, amphotericin B, ciclosporin, cisplatin, potent diuretics (e.g. ethacrynic acid, furosemide) and neuromuscular blocking agents (e.g. succinylcholine, tubocurarine). May potentiate the effect of anticoagulants (e.g. warfarin, phenindione). May antagonise the effect of neostigmine and pyridostigmine. Increased risk of hypocalcaemia with bisphosphonates. Increased risk of neuromuscular blockade with botulinum toxin. Indometacin may increase the plasma concentration of gentamicin in neonates.
Hydrocortisone: Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
Hydrocortisone: Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
Pregnancy & lactationView
Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Gentacin
Gentamicin Sulfate (Ophthalmic)
Gentacin
Gentamicin Sulfate (Ophthalmic)
Indications
tympanoplasty
Indication detailsView
Blepharitis, blepharoconjunctivitis, conjunctivitis, dacryocystitis, keratitis, keratoconjunctivitis, acute meibomianitis, and corneal ulcers caused by susceptible organisms. Otorrhea associated with external otitis, chronic suppurative otitis media or subacute purulent otitis media; or postoperative otorrhea, such as that following fenestration, mastoidectomy or tympanoplasty.
Therapeutic classView
Ophthalmic antibacterial drugs
PharmacologyView
Gentamicin sulphate actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30S subunit of bacterial ribosomes and interferes with an initiation complex between mRNA (messenger RNA) and the 30 S subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
DosageView
Eye: 1-2 drops instilled in affected eye up to 6 times a day or more frequently if required (severe infections may require 1-2 drops every 15-20 minutes initially, reducing the frequency of instillation gradually as the infection is controlled).
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
Side effectsView
In patients with dermatoses treated with gentamicin, irritation (erythema and pruritus) had been reported in small number of cases. Itching, redness, swelling or other signs of irritation may develop. With the eye/ear drop bacterial and corneal ulcer have developed during treatment with gentamicin. Most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.
ContraindicationsView
This drug is contraindicated in individuals with a history of sensitivity reaction to any of its components. Use of topical Gentamicin may occasionally allow overgrowth of nonsusceptible organisms, including fungi.
PrecautionsView
If these occurs or if irritation, sensitization develops, treatment with gentamicin should be discontinued and appropriate therapy instituted. Gentamicin ear/eye drops is not for injection. It should never be injected subconjunctivally, nor it should be directly introduced into the anterior chamber of the eye.
InteractionsView
None has been reported so far with topical and Eye/Ear drops.
Pregnancy & lactationView
Consideration should be given the possibility of foetal ototoxicity when gentamicin is applied topically to large denuded areas of skin. For Gentamicin Eye/Ear Drops safety profile in pregnancy is not yet established and should be administered when considered essential.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children. To avoid contamination, do not touch the tip of the container to the eye, eyelid or any surface.
Gentasol
Gentamicin Sulfate (Injection)
Gentasol
Gentamicin Sulfate (Injection)
Indications
Urinary tract infection
Indication detailsView
Gentamicin Injection is indicated in the treatment of serious infections caused by susceptible strains of the microorganisms including: Pseudomonas aeruginosa, Proteus sp, Escherichia coli, Klebsiella, Enterobacter, Serratia and Staphylococcus spp.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
Therapeutic classView
Aminoglycosides
PharmacologyView
Gentamicin Sulfate is an aminoglycoside antibiotic. This is a proven bactericidal antibiotic active against a broad spectrum of Gram-negative pathogens including E. coli, Klebsiella, Proteus spp, Enterobacter, Pseudomonas aeruginosa and Serratia species. It is also active against some Gram-positive organisms (e.g. penicillin & methicillin resistant strains of Staphylococcus aureus). In vitro, Gentamicin is also active against Salmonella and Shigella. Gentamicin interferes with bacterial protein synthesis by binding primarily to the 30S sub-units of bacterial ribosomes in susceptible organisms. Cell death results. Other mechanisms of action may contribute to the bactericidal effect of Gentamicin.
DosageView
Gentamicin is given by the intramuscular route normally. But intravenous administration may be used if required. The dosage is the same for either route of administration.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
Side effectsView
Vestibular damage, reversible nephrotoxicity, auditory ototoxicity may occur. Symptoms are dizziness, vertigo, tinnitus, roaring in the ears, rarely hearing loss. Adverse renal effects may be also caused, more frequently in patients with a history of renal impairment treated with larger doses than recommended.
InteractionsView
Concurrent use with other potentially nephrotoxic or ototoxic drug substances should be avoided. Potent diuretics such as ethacrynic acid or frusemide may potentiate ototoxic effects of gentamicin. As gentamicin is inactivated by solutions containing beta-lactam antibiotics (penicillins & cephalosporins), the two drugs should not be administered simultaneously.
Pregnancy & lactationView
Safety for use in pregnancy and lactation has not been established. Gentamicin crosses the placenta and there is a risk of ototoxicity in the fetus. Gentamicin should only be used where the seriousness of the mother's condition justifies the risk. Small amounts of gentamicin have been detected in breast milk. Therefore it is recommended that breastfeeding be discontinued during therapy unless the expected benefits outweigh any potential risk.
StorageView
Should be stored in cool and dry place
Gentian Violet
Gentian Violet
Gentian Violet
Gentian Violet
Indications
Topical antiseptic
Indication detailsView
Topical antiseptic as first aid to help prevent infection in minor cuts, scrapes and burns
Therapeutic classView
Crystal violet/ Gentian violet preparations
PharmacologyView
In aqueous solutions Gentian violet (GV) dissociates into positive (GV+)and negative ions (Cl-) that penetrate through the wall and membrane of both gram-positive and gram-negative bacterial cells. The GV+ interacts with negatively charged components of bacterial cells including the lipopolysaccharide (on the cell wall), the peptidoglycan and DNA. A similar cell penetration and DNA binding process is thought to take place for fungal cells as well. Because Gentian violet is a mutagen and mitotic poison, cell growth is consequently inhibited. A photodynamic action of gentian violet, apparently mediated by a free-radical mechanism, has recently been described in bacteria and in the protozoan T. cruzi. Evidence also suggests that gentian violet dissipates the bacterial (and mitochondrial) membrane potential by inducing permeability. This is followed by respiratory inhibition. This anti-mitochondrial activity might explain gentian violet's efficacy towards both bacteria and yeast with relatively mild effects on mammalian cells.
DosageView
Clean the affected area and apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.
Side effectsView
Redness, irritation, swelling or pain persists or increases of if infection occurs.
ContraindicationsView
Do not apply to an ulcerative lesion as this may cause tattoing of the skin.
PrecautionsView
Stop use if the condition persists or gets worse. Do not use longer than 1 week.
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
Genticin HC
Gentamicin + Hydrocortisone Acetate
Genticin HC
Gentamicin + Hydrocortisone Acetate
Indications
Susceptible infections
Indication detailsView
Gentamicin & Hydrocortisone ear drops is indicated for the treatment of chronic suppurative otitis media, otitis externa and as prophylactic treatment of otitis externa following trauma. Gentamicin & Hydrocortisone ear drops is also indicated for post-operative local use in surgery to infected mastoid cavities.
Gentamicin & Hydrocortisone cream is indicated for redness, itching, and swelling of the skin
Gentamicin & Hydrocortisone cream is indicated for redness, itching, and swelling of the skin
Therapeutic classView
Hydrocortisone & Combined preparations, Ophthalmic steroid - antibiotic combined preparations
PharmacologyView
Gentamicin is an aminoglycoside that binds to 30s and 50s ribosomal subunits of susceptible bacteria disrupting protein synthesis, thus rendering the bacterial cell membrane defective.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
DosageView
Ear Drops-
For Middle Ear Infection: Instill 2-4 drops in the affected ear three to four times a day and at night, or more frequently if required. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for two minutes. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed. For EarCanal Infection: Instill 2-4 drops in the affected ear three to four times a day and at night, or more frequently if required. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for two minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.
Cream-
For redness, itching, and swelling of the skin: Apply to the affected area of the skin two or three times per day.AdministrationView
Ear Drops need to shake well immediately before use.
Side effectsView
Allergic contact dermatitis, Transient irritation, burning, stinging, Increased redness, lacrimation
ContraindicationsView
History of hypersensitivity to aminoglycoside; pregnancy; hepatic impairment.
PrecautionsView
Concurrent use of neuromuscular blocking agents; myasthenia gravis, parkinsonism; conditions predisposing to ototoxicity and nephrotoxicity; lactation. Monitor plasma concentrations of gentamicin in patients receiving high doses or prolonged courses, in infants, elderly, patients with renal impairment, cystic fibrosis or significant obesity. Monitor auditory and renal functions.
InteractionsView
Gentamicin: Additive effect with other neurotoxic and/or nephrotoxic drugs including cephalosporins, methicillin, amphotericin B, ciclosporin, cisplatin, potent diuretics (e.g. ethacrynic acid, furosemide) and neuromuscular blocking agents (e.g. succinylcholine, tubocurarine). May potentiate the effect of anticoagulants (e.g. warfarin, phenindione). May antagonise the effect of neostigmine and pyridostigmine. Increased risk of hypocalcaemia with bisphosphonates. Increased risk of neuromuscular blockade with botulinum toxin. Indometacin may increase the plasma concentration of gentamicin in neonates.
Hydrocortisone: Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
Hydrocortisone: Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
Pregnancy & lactationView
Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Gentin
Gentamicin Sulfate (Injection)
Gentin
Gentamicin Sulfate (Injection)
Indications
Urinary tract infection
Indication detailsView
Gentamicin Injection is indicated in the treatment of serious infections caused by susceptible strains of the microorganisms including: Pseudomonas aeruginosa, Proteus sp, Escherichia coli, Klebsiella, Enterobacter, Serratia and Staphylococcus spp.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
Therapeutic classView
Aminoglycosides
PharmacologyView
Gentamicin Sulfate is an aminoglycoside antibiotic. This is a proven bactericidal antibiotic active against a broad spectrum of Gram-negative pathogens including E. coli, Klebsiella, Proteus spp, Enterobacter, Pseudomonas aeruginosa and Serratia species. It is also active against some Gram-positive organisms (e.g. penicillin & methicillin resistant strains of Staphylococcus aureus). In vitro, Gentamicin is also active against Salmonella and Shigella. Gentamicin interferes with bacterial protein synthesis by binding primarily to the 30S sub-units of bacterial ribosomes in susceptible organisms. Cell death results. Other mechanisms of action may contribute to the bactericidal effect of Gentamicin.
DosageView
Gentamicin is given by the intramuscular route normally. But intravenous administration may be used if required. The dosage is the same for either route of administration.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
Side effectsView
Vestibular damage, reversible nephrotoxicity, auditory ototoxicity may occur. Symptoms are dizziness, vertigo, tinnitus, roaring in the ears, rarely hearing loss. Adverse renal effects may be also caused, more frequently in patients with a history of renal impairment treated with larger doses than recommended.
InteractionsView
Concurrent use with other potentially nephrotoxic or ototoxic drug substances should be avoided. Potent diuretics such as ethacrynic acid or frusemide may potentiate ototoxic effects of gentamicin. As gentamicin is inactivated by solutions containing beta-lactam antibiotics (penicillins & cephalosporins), the two drugs should not be administered simultaneously.
Pregnancy & lactationView
Safety for use in pregnancy and lactation has not been established. Gentamicin crosses the placenta and there is a risk of ototoxicity in the fetus. Gentamicin should only be used where the seriousness of the mother's condition justifies the risk. Small amounts of gentamicin have been detected in breast milk. Therefore it is recommended that breastfeeding be discontinued during therapy unless the expected benefits outweigh any potential risk.
StorageView
Should be stored in cool and dry place
Gentin
Gentamicin Sulfate (Ophthalmic)
Gentin
Gentamicin Sulfate (Ophthalmic)
Indications
tympanoplasty
Indication detailsView
Blepharitis, blepharoconjunctivitis, conjunctivitis, dacryocystitis, keratitis, keratoconjunctivitis, acute meibomianitis, and corneal ulcers caused by susceptible organisms. Otorrhea associated with external otitis, chronic suppurative otitis media or subacute purulent otitis media; or postoperative otorrhea, such as that following fenestration, mastoidectomy or tympanoplasty.
Therapeutic classView
Ophthalmic antibacterial drugs
PharmacologyView
Gentamicin sulphate actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30S subunit of bacterial ribosomes and interferes with an initiation complex between mRNA (messenger RNA) and the 30 S subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
DosageView
Eye: 1-2 drops instilled in affected eye up to 6 times a day or more frequently if required (severe infections may require 1-2 drops every 15-20 minutes initially, reducing the frequency of instillation gradually as the infection is controlled).
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
Side effectsView
In patients with dermatoses treated with gentamicin, irritation (erythema and pruritus) had been reported in small number of cases. Itching, redness, swelling or other signs of irritation may develop. With the eye/ear drop bacterial and corneal ulcer have developed during treatment with gentamicin. Most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.
ContraindicationsView
This drug is contraindicated in individuals with a history of sensitivity reaction to any of its components. Use of topical Gentamicin may occasionally allow overgrowth of nonsusceptible organisms, including fungi.
PrecautionsView
If these occurs or if irritation, sensitization develops, treatment with gentamicin should be discontinued and appropriate therapy instituted. Gentamicin ear/eye drops is not for injection. It should never be injected subconjunctivally, nor it should be directly introduced into the anterior chamber of the eye.
InteractionsView
None has been reported so far with topical and Eye/Ear drops.
Pregnancy & lactationView
Consideration should be given the possibility of foetal ototoxicity when gentamicin is applied topically to large denuded areas of skin. For Gentamicin Eye/Ear Drops safety profile in pregnancy is not yet established and should be administered when considered essential.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children. To avoid contamination, do not touch the tip of the container to the eye, eyelid or any surface.
Gentin
Gentamicin Sulfate (Ophthalmic)
Gentin
Gentamicin Sulfate (Ophthalmic)
Indications
tympanoplasty
Indication detailsView
Blepharitis, blepharoconjunctivitis, conjunctivitis, dacryocystitis, keratitis, keratoconjunctivitis, acute meibomianitis, and corneal ulcers caused by susceptible organisms. Otorrhea associated with external otitis, chronic suppurative otitis media or subacute purulent otitis media; or postoperative otorrhea, such as that following fenestration, mastoidectomy or tympanoplasty.
Therapeutic classView
Ophthalmic antibacterial drugs
PharmacologyView
Gentamicin sulphate actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30S subunit of bacterial ribosomes and interferes with an initiation complex between mRNA (messenger RNA) and the 30 S subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
DosageView
Eye: 1-2 drops instilled in affected eye up to 6 times a day or more frequently if required (severe infections may require 1-2 drops every 15-20 minutes initially, reducing the frequency of instillation gradually as the infection is controlled).
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
Side effectsView
In patients with dermatoses treated with gentamicin, irritation (erythema and pruritus) had been reported in small number of cases. Itching, redness, swelling or other signs of irritation may develop. With the eye/ear drop bacterial and corneal ulcer have developed during treatment with gentamicin. Most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.
ContraindicationsView
This drug is contraindicated in individuals with a history of sensitivity reaction to any of its components. Use of topical Gentamicin may occasionally allow overgrowth of nonsusceptible organisms, including fungi.
PrecautionsView
If these occurs or if irritation, sensitization develops, treatment with gentamicin should be discontinued and appropriate therapy instituted. Gentamicin ear/eye drops is not for injection. It should never be injected subconjunctivally, nor it should be directly introduced into the anterior chamber of the eye.
InteractionsView
None has been reported so far with topical and Eye/Ear drops.
Pregnancy & lactationView
Consideration should be given the possibility of foetal ototoxicity when gentamicin is applied topically to large denuded areas of skin. For Gentamicin Eye/Ear Drops safety profile in pregnancy is not yet established and should be administered when considered essential.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children. To avoid contamination, do not touch the tip of the container to the eye, eyelid or any surface.
Gentin
Gentamicin Sulfate (Topical)
Gentin
Gentamicin Sulfate (Topical)
Indications
Bacterial skin infections
Indication detailsView
Indicated for Burn, Eczema, Seborrhetic dermatitis, Ecthyma, Excoriation, Folliculitis, Furunculosis, Insect bites and stings, Lacerations and abrasions, Paronychia, Pyoderma gangrenosum, Skin cysts and abscesses, Stasis ulcers and infected skin ulcers, Bacterial, fungal or viral superinfection, Sycosis barbae, minor surgical wounds, infected contact dermatitis caused by susceptible organisms.
Therapeutic classView
Topical Antibiotic preparations
PharmacologyView
Gentamicin Sulphate is an aminoglycoside antibiotic. It is a proven bactericidal antibiotic active against Gram-positive & Gram-negative pathogens including E. coli, Klebsiella, Proteus, Pseudomonas aeruginosa and penicillin resistant strains of Staph. aureus. In common with other aminoglycoside antibiotics, it appears to interfere with protein synthesis of the bacterial cell.
DosageView
Apply 3 times daily. Before application, the area should be washed with soap and water and dried thoroughly. If crusts present, it should be removed before the application of ointment to provide maximum contact with the infecting organisms.
Side effectsView
Itching, redness, swelling or other signs of irritation.
ContraindicationsView
Gentamicin injection and Gentamicin ointment are contraindicated to patients hypersensitive to Gentamicin. It is contraindicated in pregnancy and myasthenia gravis.
PrecautionsView
Gentamicin Ointment should not be applied to patients hypersensitive to Gentamicin.
Pregnancy & lactationView
Pregnancy Category D. Small amounts of Gentamicin have been detected in breast milk. So, it is recommended that breastfeeding should be discontinued during treatment.
StorageView
Store below 30°C and protected from light.
Gentin
Gentamicin Sulfate (Injection)
Gentin
Gentamicin Sulfate (Injection)
Indications
Urinary tract infection
Indication detailsView
Gentamicin Injection is indicated in the treatment of serious infections caused by susceptible strains of the microorganisms including: Pseudomonas aeruginosa, Proteus sp, Escherichia coli, Klebsiella, Enterobacter, Serratia and Staphylococcus spp.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
Therapeutic classView
Aminoglycosides
PharmacologyView
Gentamicin Sulfate is an aminoglycoside antibiotic. This is a proven bactericidal antibiotic active against a broad spectrum of Gram-negative pathogens including E. coli, Klebsiella, Proteus spp, Enterobacter, Pseudomonas aeruginosa and Serratia species. It is also active against some Gram-positive organisms (e.g. penicillin & methicillin resistant strains of Staphylococcus aureus). In vitro, Gentamicin is also active against Salmonella and Shigella. Gentamicin interferes with bacterial protein synthesis by binding primarily to the 30S sub-units of bacterial ribosomes in susceptible organisms. Cell death results. Other mechanisms of action may contribute to the bactericidal effect of Gentamicin.
DosageView
Gentamicin is given by the intramuscular route normally. But intravenous administration may be used if required. The dosage is the same for either route of administration.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
Side effectsView
Vestibular damage, reversible nephrotoxicity, auditory ototoxicity may occur. Symptoms are dizziness, vertigo, tinnitus, roaring in the ears, rarely hearing loss. Adverse renal effects may be also caused, more frequently in patients with a history of renal impairment treated with larger doses than recommended.
InteractionsView
Concurrent use with other potentially nephrotoxic or ototoxic drug substances should be avoided. Potent diuretics such as ethacrynic acid or frusemide may potentiate ototoxic effects of gentamicin. As gentamicin is inactivated by solutions containing beta-lactam antibiotics (penicillins & cephalosporins), the two drugs should not be administered simultaneously.
Pregnancy & lactationView
Safety for use in pregnancy and lactation has not been established. Gentamicin crosses the placenta and there is a risk of ototoxicity in the fetus. Gentamicin should only be used where the seriousness of the mother's condition justifies the risk. Small amounts of gentamicin have been detected in breast milk. Therefore it is recommended that breastfeeding be discontinued during therapy unless the expected benefits outweigh any potential risk.
StorageView
Should be stored in cool and dry place
Gentin HC
Gentamicin + Hydrocortisone Acetate
Gentin HC
Gentamicin + Hydrocortisone Acetate
Indications
Susceptible infections
Indication detailsView
Gentamicin & Hydrocortisone ear drops is indicated for the treatment of chronic suppurative otitis media, otitis externa and as prophylactic treatment of otitis externa following trauma. Gentamicin & Hydrocortisone ear drops is also indicated for post-operative local use in surgery to infected mastoid cavities.
Gentamicin & Hydrocortisone cream is indicated for redness, itching, and swelling of the skin
Gentamicin & Hydrocortisone cream is indicated for redness, itching, and swelling of the skin
Therapeutic classView
Hydrocortisone & Combined preparations, Ophthalmic steroid - antibiotic combined preparations
PharmacologyView
Gentamicin is an aminoglycoside that binds to 30s and 50s ribosomal subunits of susceptible bacteria disrupting protein synthesis, thus rendering the bacterial cell membrane defective.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
DosageView
Ear Drops-
For Middle Ear Infection: Instill 2-4 drops in the affected ear three to four times a day and at night, or more frequently if required. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for two minutes. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed. For EarCanal Infection: Instill 2-4 drops in the affected ear three to four times a day and at night, or more frequently if required. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for two minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.
Cream-
For redness, itching, and swelling of the skin: Apply to the affected area of the skin two or three times per day.AdministrationView
Ear Drops need to shake well immediately before use.
Side effectsView
Allergic contact dermatitis, Transient irritation, burning, stinging, Increased redness, lacrimation
ContraindicationsView
History of hypersensitivity to aminoglycoside; pregnancy; hepatic impairment.
PrecautionsView
Concurrent use of neuromuscular blocking agents; myasthenia gravis, parkinsonism; conditions predisposing to ototoxicity and nephrotoxicity; lactation. Monitor plasma concentrations of gentamicin in patients receiving high doses or prolonged courses, in infants, elderly, patients with renal impairment, cystic fibrosis or significant obesity. Monitor auditory and renal functions.
InteractionsView
Gentamicin: Additive effect with other neurotoxic and/or nephrotoxic drugs including cephalosporins, methicillin, amphotericin B, ciclosporin, cisplatin, potent diuretics (e.g. ethacrynic acid, furosemide) and neuromuscular blocking agents (e.g. succinylcholine, tubocurarine). May potentiate the effect of anticoagulants (e.g. warfarin, phenindione). May antagonise the effect of neostigmine and pyridostigmine. Increased risk of hypocalcaemia with bisphosphonates. Increased risk of neuromuscular blockade with botulinum toxin. Indometacin may increase the plasma concentration of gentamicin in neonates.
Hydrocortisone: Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
Hydrocortisone: Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
Pregnancy & lactationView
Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Gento
Gentamicin Sulfate (Topical)
Gento
Gentamicin Sulfate (Topical)
Indications
Bacterial skin infections
Indication detailsView
Indicated for Burn, Eczema, Seborrhetic dermatitis, Ecthyma, Excoriation, Folliculitis, Furunculosis, Insect bites and stings, Lacerations and abrasions, Paronychia, Pyoderma gangrenosum, Skin cysts and abscesses, Stasis ulcers and infected skin ulcers, Bacterial, fungal or viral superinfection, Sycosis barbae, minor surgical wounds, infected contact dermatitis caused by susceptible organisms.
Therapeutic classView
Topical Antibiotic preparations
PharmacologyView
Gentamicin Sulphate is an aminoglycoside antibiotic. It is a proven bactericidal antibiotic active against Gram-positive & Gram-negative pathogens including E. coli, Klebsiella, Proteus, Pseudomonas aeruginosa and penicillin resistant strains of Staph. aureus. In common with other aminoglycoside antibiotics, it appears to interfere with protein synthesis of the bacterial cell.
DosageView
Apply 3 times daily. Before application, the area should be washed with soap and water and dried thoroughly. If crusts present, it should be removed before the application of ointment to provide maximum contact with the infecting organisms.
Side effectsView
Itching, redness, swelling or other signs of irritation.
ContraindicationsView
Gentamicin injection and Gentamicin ointment are contraindicated to patients hypersensitive to Gentamicin. It is contraindicated in pregnancy and myasthenia gravis.
PrecautionsView
Gentamicin Ointment should not be applied to patients hypersensitive to Gentamicin.
Pregnancy & lactationView
Pregnancy Category D. Small amounts of Gentamicin have been detected in breast milk. So, it is recommended that breastfeeding should be discontinued during treatment.
StorageView
Store below 30°C and protected from light.
Gento
Gentamicin Sulfate (Ophthalmic)
Gento
Gentamicin Sulfate (Ophthalmic)
Indications
tympanoplasty
Indication detailsView
Blepharitis, blepharoconjunctivitis, conjunctivitis, dacryocystitis, keratitis, keratoconjunctivitis, acute meibomianitis, and corneal ulcers caused by susceptible organisms. Otorrhea associated with external otitis, chronic suppurative otitis media or subacute purulent otitis media; or postoperative otorrhea, such as that following fenestration, mastoidectomy or tympanoplasty.
Therapeutic classView
Ophthalmic antibacterial drugs
PharmacologyView
Gentamicin sulphate actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30S subunit of bacterial ribosomes and interferes with an initiation complex between mRNA (messenger RNA) and the 30 S subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
DosageView
Eye: 1-2 drops instilled in affected eye up to 6 times a day or more frequently if required (severe infections may require 1-2 drops every 15-20 minutes initially, reducing the frequency of instillation gradually as the infection is controlled).
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
Side effectsView
In patients with dermatoses treated with gentamicin, irritation (erythema and pruritus) had been reported in small number of cases. Itching, redness, swelling or other signs of irritation may develop. With the eye/ear drop bacterial and corneal ulcer have developed during treatment with gentamicin. Most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.
ContraindicationsView
This drug is contraindicated in individuals with a history of sensitivity reaction to any of its components. Use of topical Gentamicin may occasionally allow overgrowth of nonsusceptible organisms, including fungi.
PrecautionsView
If these occurs or if irritation, sensitization develops, treatment with gentamicin should be discontinued and appropriate therapy instituted. Gentamicin ear/eye drops is not for injection. It should never be injected subconjunctivally, nor it should be directly introduced into the anterior chamber of the eye.
InteractionsView
None has been reported so far with topical and Eye/Ear drops.
Pregnancy & lactationView
Consideration should be given the possibility of foetal ototoxicity when gentamicin is applied topically to large denuded areas of skin. For Gentamicin Eye/Ear Drops safety profile in pregnancy is not yet established and should be administered when considered essential.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children. To avoid contamination, do not touch the tip of the container to the eye, eyelid or any surface.