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    Rocovas

    Rosuvastatin
    Tablet 10 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

    Indications

    Stroke

    Indication detailsView
    Rosuvastatin is indicated in-
    • Heterozygous Hypercholesterolemia (Familial and Non familial)
    • Homozygous Hypercholesterolemia (Familial)
    • Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
    • Primary prevention of cardiovascular disease
    Therapeutic classView
    Other Anti-anginal & Anti-ischaemic drugs, Statins
    PharmacologyView
    Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
    DosageView
    Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

    HoFH: Starting dose 20 mg/day.

    Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

    Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
    AdministrationView
    Rosuvastatin can be taken with or without food, at any time of day.
    Side effectsView
    Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
    ContraindicationsView
    Rosuvastatin is contraindicated if-
    • Known hypersensitivity to product components
    • Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
    • Pregnant women and women who may become pregnant
    • Nursing mothers
    PrecautionsView
    Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

    Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

    Liver enzymes should be monitored before and during treatment
    InteractionsView
    Remarkable drug interactions of Rosuvastatin are-
    • Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
    • Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
    • Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
    • Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
    • Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
    Pregnancy & lactationView
    The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
    Pediatric usageView
    Use in children: The safety and effectiveness in pediatric patients have not been established.
    StorageView
    Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.

    Rocular

    Brimonidine Tartrate
    Ophthalmic Solution 0.20% Allopathic Drugs for miotics and glaucoma
    Indication detailsView
    Brimonidine Tartrate 0.2% ophthalmic solution is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

    Brimonidine Tartrate 0.15% ophthalmic solution is indicated for the control of intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.

    Brimonidine Tartrate 0.025% ophthalmic solution relieves redness of the eye due to minor eye irritations.
    Therapeutic classView
    Drugs for miotics and glaucoma
    PharmacologyView
    Brimonidine is an α-2 adrenoreceptor agonist that is more selective for the α-2 adrenoreceptor than α-1. Topical administration of Brimonidine Tartrate eye drops decreases intraocular pressure (IOP) in humans. When used as directed Brimonidine Tartrate have the action of reducing elevated IOP with minimal effect on cardiovascular parametres. Brimonidine Tartrate eye drops have a rapid onset of action with the peak ocular hypotensive effect occurring at two hours post-dosing. The duration of effect is 12 hours or greater. Fluorophotometric studies in animals and humans suggest that Brimonidine Tartrate has a dual mechanism of action. Brimonidine Tartrate eye drops lower IOP by reducing aqueous humor production and enhancing uveoscleral outflow.
    DosageView
    0.2% ophthalmic solution: The recommended dose is one drop of 0.2% ophthalmic solution in the affected eye(s) three times daily, approximately 8 hours apart. This ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.

    0.15% ophthalmic solution: The recommended dose is one drop of 0.15% ophthalmic solution in the affected eye(s) three times daily, approximately 8 hours apart.

    0.025% ophthalmic solution: Instill 1 drop in the affected eye(s) every 6-8 hours. Do not use it more than 4 times daily. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.
    Side effectsView
    Adverse events occurring in approximately 10-30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. Events occurring in approximately 3-9% of the subjects, in descending order included corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision and muscular pain. The following adverse reactions were reported in less than 3% of the patients: lid crusting, conjunctival hemorrhage, abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope.
    ContraindicationsView
    Brimonidine Tartrate ophthalmic solution is contraindicated in patients with hypersensitivity to Brimonidine Tartrate. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.
    PrecautionsView
    Although Brimonidine Tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease. Brimonidine Tartrate ophthalmic solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.
    InteractionsView
    Although specific drug interaction studies have not been conducted with Brimonidine Tartrate ophthalmic solution, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant drugs such as beta-blockers (ophthalmic and systemic), antihypertensives and/or cardiac glycosides is advised. Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with Brimonidine Tartrate ophthalmic solution in humans can lead to resulting interference with the IOP lowering effect. No data on the level of circulating catecholamines after administration of Brimonidine Tartrate ophthalmic solution are available. Caution, however, is advised in patients taking Tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.
    Pregnancy & lactationView
    There are no adequate and well-controlled studies in pregnant women. In animal studies, Brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Brimonidine Tartrate ophthalmic solution 0.2% should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk; in animal studies Brimonidine Tartrate was excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
    StorageView
    Store below 30°C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.

    Rocular Plus

    Brimonidine Tartrate + Timolol Maleate
    Ophthalmic Solution 0.2%+0.5% Allopathic Drugs for miotics and glaucoma

    Indications

    Open angle glaucoma

    Indication detailsView
    This eye drop is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
    Therapeutic classView
    Drugs for miotics and glaucoma
    PharmacologyView
    This eye drops is comprised of two components: Brimonidine Tartrate & Timolol Maleate. Brimonidine Tartrate is a selective alpha-2 adrenergic receptor agonist having a dual mechanism of action. It decreases aqueous humor production and increases nonpressure dependent uveoscleral outflow. Timolol Maleate is a β-adrenergic receptor antagonist that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. It lowers IOP by reducing aqueous humor production. Therefore the combination of both drugs gives a rapid onset of action, with peak ocular hypotensive effect seen within two hours of administration.
    DosageView
    Instill 1 drop in the affected eye(s) twice daily.
    Side effectsView
    The most common side effects are allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperaemia, eye pruritus and ocular burning or stinging.
    ContraindicationsView
    Contraindicated in patients with hypersensitivity to any component of this product. Also contraindicated in bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third-degree atrioventricular block, overt cardiac failure and cardiogenic shock.
    PrecautionsView
    Like other topically applied ophthalmic agents, it may be absorbed systemically. Due to the presence of Timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur. Cautions should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular or pulmonary diseases.
    InteractionsView
    Specific drug interaction studies have not been conducted.
    Pregnancy & lactationView
    There are no adequate and well-controlled studies in pregnant women. Combipres should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Timolol has been detected in human milk but it is not known whether Brimonidine Tartrate is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue taking into account the importance of the drug to the mother.
    Pediatric usageView
    Use in children: Safety and effectiveness in children below the age of 2 years have not been established.

    Use in elderly patients: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
    StorageView
    Store at a cool & dry place, protect from light. Do not use longer than 30 days after the first opening of the bottle. Keep out of the reach of children.

    Rocuron

    Rocuronium Bromide
    IV Injection 50 mg/5 ml Allopathic Non depolarizing muscle relaxants

    Indications

    Muscle relaxant in general anaesthesia

    Indication detailsView
    Rocuronium is indicated -
    • As an adjunct to general anesthesia to facilitate tracheal intubation during routine induction, and during rapid sequence induction when suxamethonium is contraindicated
    • To provide skeletal muscle relaxation during surgery
    • As an adjunct in the intensive care unit (ICU) to facilitate intubation and mechanical ventilation
    Therapeutic classView
    Non depolarizing muscle relaxants
    PharmacologyView
    Rocuronium acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium. Rocuronium acts by competitively binding to nicotinic cholinergic receptors. The binding of vecuronium decreases the opportunity for acetylcholine to bind to the nicotinic receptor at the postjunctional membrane of the myoneural junction. As a result, depolarization is prevented, calcium ions are not released and muscle contraction does not occur. Evidence also suggests that nondepolarizing agents can affect ACh release. It has been hypothesized that nondepolarzing agents bind to postjunctional ("curare") receptors and may therefore interfere with the sodium and potassium flux, which is responsible for depolarization and repolarization of the membranes involved in muscle contraction.
    DosageView
    Dosage: Like other neuromuscular blocking agents, Rocuronium should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these agents. The dosage of Rocuronium should be individualized in each patient. The method of anesthesia and the expected duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other medicines that are administered concomitantly and the condition of the patient should be taken into account when determining the dose. The use of an appropriate neuromuscular monitoring technique is recommended for the evaluation of neuromuscular block and recovery. Inhalational anesthetics do potentiate the neuromuscular blocking effects of Rocuronium. This potentiation, however, becomes clinically relevant in the course of anesthesia, when the volatile agents have reached the tissue concentrations required for this interaction. Consequently, adjustments with Rocuronium should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of Rocuronium during long lasting procedures (longer than 1 hour) under inhalational anesthesia. In adult patients the following dosage recommendations may serve as a general guideline for tracheal intubation and muscle relaxation for short to long lasting surgical procedures, and for use in the intensive care unit. 

    Surgical Procedures: Tracheal Intubation: The standard intubating dose during routine anesthesia is 0.6mg Rocuronium Bromide per kg body weight, after which adequate intubation conditions are established within 60 seconds in nearly all patients. A dose of 1.0mg Rocuronium Bromide per kg body weight is recommended for facilitating tracheal intubation conditions during rapid sequence induction of anesthesia, after which adequate intubation conditions are also established within 60 seconds in nearly all patients. If a dose of 0.6mg Rocuronium Bromide per kg body weight is used for rapid sequence induction of anesthesia, it is recommended to intubate the patient 90 seconds after administration of Rocuronium Bromide. In patients undergoing Caesarean section it is recommended to only use a dose of 0.6mg Rocuronium Bromide per kg body weight, since a 1.0mg/kg dose has not been investigated in this patient group. 

    Maintenance Dosing: The recommended maintenance dose is 0.15mg Rocuronium Bromide per kg body weight; in the case of long-term inhalational anesthesia this should be reduced to 0.075-0.1mg Rocuronium Bromide per kg body weight. The maintenance doses should best be given when twitch height has recovered to 25% of control twitch height, or when 2-3 responses to train of four stimulation are present. 

    Continuous Infusion: If Rocuronium Bromide is administered by continuous infusion, it is recommended to give a loading dose of 0.6mg Rocuronium Bromide per kg body weight and, when neuromuscular block starts to recover, to start administration by infusion. The infusion rate should be adjusted to maintain twitch response at 10% of control twitch height, or to maintain 1 to 2 responses to train of four stimulation. In adults under intravenous anesthesia, the infusion rate required to maintain neuromuscular block at this level ranges from 0.3-0.6mg/kg/hr and under inhalational anesthesia the infusion rate ranges from 0.3-0.4mg/kg/hr. Continuous monitoring of neuromuscular block is recommended since infusion rate requirements vary from patient to patient and with the anaesthetic method used. 

    Dosing in Paediatric Patients: Children (1-14 years) and infants (1-12 months) under halothane anesthesia manifest similar sensitivity to Rocuronium Bromide as adults. Onset of action is faster in infants and children than in adults. Clinical duration is shorter in children than in adults. For continuous infusion in paediatrics, the infusion rates, with exception of children, are the same as for adults. For children higher infusion rates might be necessary. For children the same initial infusion rates as for adults are recommended and this should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 or 2 responses to train of four stimulation during the procedure. There are insufficient data to support dose recommendations for the use of Rocuronium Bromide in neonates (0-1 month). The experience with Rocuronium Bromide in rapid sequence induction in paediatric patients is limited. Rocuronium Bromide is therefore not recommended for facilitating tracheal intubation conditions during rapid sequence induction in paediatric patients. 

    Dosing in Geriatric patients and patients with Hepatic and/or Biliary tract disease and/or Renal Failure: The standard intubation dose for geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure during routine anesthesia is 0.6mg Rocuronium Bromide per kg body weight. A dose of 0.6mg per kg body weight should be considered for rapid sequence induction of anesthesia in patients in which a prolonged duration of action is expected. Regardless of the anesthetic technique used, the recommended maintenance dose for these patients is 0.075-0.1mg Rocuronium Bromide per kg body weight, and the recommended infusion rate is 0.3-0.4mg/kg/hr. 

    Dosing in Overweight and Obese Patients: When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body weight) doses should be reduced taking into account ideal body weight. 

    Intensive Care Procedures (Tracheal Intubation): For tracheal intubation, the same doses should be used as described above under surgical procedures. 

    Maintenance Dosing: The use of an initial loading dose of 0.6mg Rocuronium Bromide per kg body weight is recommended, followed by a continuous infusion as soon as twitch height recovers to 10% or upon reappearance of 1 to 2 twitches to train of four stimulation. Dosage should always be titrated to effect in the individual patient. The recommended initial infusion rate for the maintenance of a neuromuscular block of 80-90% (1 to 2 twitches to TOF stimulation) in adult patients is 0.3-0.6mg/kg/hr during the first hour of administration, which will need to be decreased during the following 6-12 hours, according to the individual response. Thereafter, individual dose requirements remain relatively constant. A large between patient variability in hourly infusion rates has been found in controlled clinical studies, with mean hourly infusion rates ranging from 0.2-0.5mg/kg/hr depending on nature and extent of organ failure(s), concomitant medication and individual patient characteristics. To provide optimal individual patient control, monitoring of neuromuscular transmission is strongly recommended. Administration up to 7 days has been investigated. 

    Special Populations: Rocuronium Bromide is not recommended for the facilitation of mechanical ventilation in the intensive care in paediatric and geriatric patients due to a lack of data on safety and efficacy.
    Side effectsView
    In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension. Other are:
    • Anaphylaxis 
    • Residual paralysis 
    • Myopathy 
    • Increased pulmonary vascular resistance
    Although very rare, severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide, have been reported. Anaphylactic/anaphylactoid reactions are: bronchospasm, cardiovascular changes (e.g. hypotension, tachycardia, circulatory collapse - shock), and cutaneous changes (e.g. angioedema, urticaria). These reactions have, in some cases, been fatal. Due to the possible severity of these reactions, one should always assume they may occur and take the necessary precautions. 

    Since neuromuscular blocking agents are known to be capable of inducing histamine release both locally at the site of injection and systemically, the possible occurrence of itching and erythematosus reactions at the site of injection and/or generalized histaminoid (anaphylactoid) reactions (see also under Anaphylactic Reactions above) should always be taken into consideration when administering these agents. In clinical studies only a slight increase in mean plasma histamine levels has been observed following rapid bolus administration of 0.3 0.9mg/kg Rocuronium Bromide.

    Prolonged neuromuscular block: The most frequent adverse reaction to nondepolarizing blocking agents as a class consists of an extension of the agent's pharmacological action beyond the time period needed. This may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency or apnoea. 

    Myopathy: Myopathy has been reported after the use of various neuromuscular blocking agents in the ICU in combination with corticosteroids.

    Local injection site reactions: During rapid sequence induction of anesthesia, pain on injection has been reported, especially when the patient has not yet completely lost consciousness and particularly when propofol is used as the induction agent. In clinical studies, pain on injection has been noted in 16% of the patients who underwent rapid sequence induction of anesthesia with propofol and in less than 0.5% of the patients who underwent rapid sequence induction of anesthesia with fentanyl and thiopental.
    ContraindicationsView
    Hypersensitivity to Rocuronium or to the Bromide ion or to any of the excipients.
    PrecautionsView
    Instructions for use/handling: Compatibility studies with the following infusion fluids have been performed. In nominal concentrations of 0.5mg/mL and 2.0mg/mL, Rocuronium Bromide has been shown to be compatible with: 0.9% NaCl, 5% dextrose, 5% dextrose in saline, sterile water for injections, Lactated Ringers and Haemaccel. Administration should be commenced immediately after mixing, and should be completed within 24 hours. Unused solutions should be discarded.

    For use/handling: If Rocuronium Bromide is administered via the same infusion line that is also used for other medicines, it is important that this infusion line is adequately flushed (e.g. with 0.9% NaCl) between administration of Rocuronium Bromide and medicines for which incompatibility with Rocuronium Bromide has been demonstrated or for which compatibility with Rocuronium Bromide has not been established.
    InteractionsView
    The following agents have been shown to influence the magnitude and/or duration of action of non-depolarizing neuromuscular blocking agents:

    Effect of other agents on Rocuronium Bromide-

    Increased Effect: Halogenated volatile anesthetics potentiate the neuromuscular block of Rocuronium Bromide. The effect only becomes apparent with maintenance dosing. Reversal of the block with anti-cholinesterase inhibitors could also be inhibited. Long-term concomitant use of corticosteroids and Rocuronium Bromide in the ICU may result in prolonged duration of neuromuscular block or myopathy.

    Other drugs: 
    • Antibiotics: aminoglycoside, lincosamide and polypeptide antibiotics, acylamino-penicillin antibiotics. 
    • Diuretics, quinidine and its isomer quinine, magnesium salts, calcium channel blocking agents, lithium salts, local anaesthetics (lidocaine i.v., bupivacaine epidural) and acute administration of phenytoin 
    • Recurarization has been reported after post-operative administration of: aminoglycoside, lincosamide, polypeptide and acylamino-penicillin antibiotics, quinidine, quinine and magnesium.
    Decreased Effect: Prior chronic administration of phenytoin or carbamazepine. Protease inhibitors (gabexate, ulinastatin) 

    Variable Effect: Administration of other non-depolarizing neuromuscular blocking agents in combination with Rocuronium Bromide may produce attenuation or potentiation of the neuromuscular block, depending on the order of administration and the neuromuscular blocking agent used. Suxamethonium given after the administration of Rocuronium Bromide may produce potentiation or attenuation of the neuromuscular blocking effect of Rocuronium Bromide. 

    Effect of Rocuronium Bromide on other drugs: Rocuronium Bromide combined with lidocaine may result in a quicker onset of action of lidocaine.
    Pregnancy & lactationView
    Pregnancy: For Rocuronium Bromide, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing Rocuronium Bromide to pregnant women.

    Caesarean section: In patients undergoing Caesarean section, Rocuronium Bromide can be used as part of a rapid sequence induction technique, provided no intubation difficulties are anticipated and a sufficient dose of anesthetic agent is administered or following suxamethonium facilitated intubation. Rocuronium Bromide, administered in doses of 0.6mg/kg, has been shown to be safe in parturient undergoing Caesarean section. Rocuronium Bromide does not affect Apgar score, foetal muscle tone nor cardio-respiratory adaptation. From umbilical cord blood sampling it is apparent that only limited placental transfer of Rocuronium Bromide occurs which does not lead to the observation of clinical adverse effects in the newborn.

    Lactation: It is unknown whether Rocuronium Bromide is excreted in human breast milk. Animal studies have shown insignificant levels of Rocuronium Bromide in breast milk. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Rocuronium Bromide should be given to lactating women only when the attending physician decides that the benefits outweigh the risks.
    Overdose effectsView
    In the event of overdosage and prolonged neuromuscular block, the patient should continue to receive ventilatory support and sedation. In this situation there are two options for the reversal of neuromuscular block:

    Sugammadex can be used for reversal of intense (profound) and deep block. The dose of sugammadex to be administered depends of the level of neuromuscular block.

    An acetylcholinesterase inhibitor (e.g. neostigmine, edrophonium, pyridostigmine), with appropriate vagolytic (e.g atropine) can be used at reappearance of T2 or at the first signs of clinical recovery and should be administered in adequate doses. When administration of an acetylcholinesterase inhibiting agent fails to reverse the neuromuscular effects of Rocuronium Bromide, ventilation must be continued until spontaneous breathing is restored. Repeated dosage of an acetylcholinesterase inhibitor can be dangerous.
    StorageView
    Rocuronium Bromide should be stored in the refrigerator at 2-8° C and not be frozen.

    Rocuronium Hameln

    Rocuronium Bromide
    IV Injection 50 mg/5 ml Allopathic Non depolarizing muscle relaxants

    Indications

    Muscle relaxant in general anaesthesia

    Indication detailsView
    Rocuronium is indicated -
    • As an adjunct to general anesthesia to facilitate tracheal intubation during routine induction, and during rapid sequence induction when suxamethonium is contraindicated
    • To provide skeletal muscle relaxation during surgery
    • As an adjunct in the intensive care unit (ICU) to facilitate intubation and mechanical ventilation
    Therapeutic classView
    Non depolarizing muscle relaxants
    PharmacologyView
    Rocuronium acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium. Rocuronium acts by competitively binding to nicotinic cholinergic receptors. The binding of vecuronium decreases the opportunity for acetylcholine to bind to the nicotinic receptor at the postjunctional membrane of the myoneural junction. As a result, depolarization is prevented, calcium ions are not released and muscle contraction does not occur. Evidence also suggests that nondepolarizing agents can affect ACh release. It has been hypothesized that nondepolarzing agents bind to postjunctional ("curare") receptors and may therefore interfere with the sodium and potassium flux, which is responsible for depolarization and repolarization of the membranes involved in muscle contraction.
    DosageView
    Dosage: Like other neuromuscular blocking agents, Rocuronium should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these agents. The dosage of Rocuronium should be individualized in each patient. The method of anesthesia and the expected duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other medicines that are administered concomitantly and the condition of the patient should be taken into account when determining the dose. The use of an appropriate neuromuscular monitoring technique is recommended for the evaluation of neuromuscular block and recovery. Inhalational anesthetics do potentiate the neuromuscular blocking effects of Rocuronium. This potentiation, however, becomes clinically relevant in the course of anesthesia, when the volatile agents have reached the tissue concentrations required for this interaction. Consequently, adjustments with Rocuronium should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of Rocuronium during long lasting procedures (longer than 1 hour) under inhalational anesthesia. In adult patients the following dosage recommendations may serve as a general guideline for tracheal intubation and muscle relaxation for short to long lasting surgical procedures, and for use in the intensive care unit. 

    Surgical Procedures: Tracheal Intubation: The standard intubating dose during routine anesthesia is 0.6mg Rocuronium Bromide per kg body weight, after which adequate intubation conditions are established within 60 seconds in nearly all patients. A dose of 1.0mg Rocuronium Bromide per kg body weight is recommended for facilitating tracheal intubation conditions during rapid sequence induction of anesthesia, after which adequate intubation conditions are also established within 60 seconds in nearly all patients. If a dose of 0.6mg Rocuronium Bromide per kg body weight is used for rapid sequence induction of anesthesia, it is recommended to intubate the patient 90 seconds after administration of Rocuronium Bromide. In patients undergoing Caesarean section it is recommended to only use a dose of 0.6mg Rocuronium Bromide per kg body weight, since a 1.0mg/kg dose has not been investigated in this patient group. 

    Maintenance Dosing: The recommended maintenance dose is 0.15mg Rocuronium Bromide per kg body weight; in the case of long-term inhalational anesthesia this should be reduced to 0.075-0.1mg Rocuronium Bromide per kg body weight. The maintenance doses should best be given when twitch height has recovered to 25% of control twitch height, or when 2-3 responses to train of four stimulation are present. 

    Continuous Infusion: If Rocuronium Bromide is administered by continuous infusion, it is recommended to give a loading dose of 0.6mg Rocuronium Bromide per kg body weight and, when neuromuscular block starts to recover, to start administration by infusion. The infusion rate should be adjusted to maintain twitch response at 10% of control twitch height, or to maintain 1 to 2 responses to train of four stimulation. In adults under intravenous anesthesia, the infusion rate required to maintain neuromuscular block at this level ranges from 0.3-0.6mg/kg/hr and under inhalational anesthesia the infusion rate ranges from 0.3-0.4mg/kg/hr. Continuous monitoring of neuromuscular block is recommended since infusion rate requirements vary from patient to patient and with the anaesthetic method used. 

    Dosing in Paediatric Patients: Children (1-14 years) and infants (1-12 months) under halothane anesthesia manifest similar sensitivity to Rocuronium Bromide as adults. Onset of action is faster in infants and children than in adults. Clinical duration is shorter in children than in adults. For continuous infusion in paediatrics, the infusion rates, with exception of children, are the same as for adults. For children higher infusion rates might be necessary. For children the same initial infusion rates as for adults are recommended and this should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 or 2 responses to train of four stimulation during the procedure. There are insufficient data to support dose recommendations for the use of Rocuronium Bromide in neonates (0-1 month). The experience with Rocuronium Bromide in rapid sequence induction in paediatric patients is limited. Rocuronium Bromide is therefore not recommended for facilitating tracheal intubation conditions during rapid sequence induction in paediatric patients. 

    Dosing in Geriatric patients and patients with Hepatic and/or Biliary tract disease and/or Renal Failure: The standard intubation dose for geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure during routine anesthesia is 0.6mg Rocuronium Bromide per kg body weight. A dose of 0.6mg per kg body weight should be considered for rapid sequence induction of anesthesia in patients in which a prolonged duration of action is expected. Regardless of the anesthetic technique used, the recommended maintenance dose for these patients is 0.075-0.1mg Rocuronium Bromide per kg body weight, and the recommended infusion rate is 0.3-0.4mg/kg/hr. 

    Dosing in Overweight and Obese Patients: When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body weight) doses should be reduced taking into account ideal body weight. 

    Intensive Care Procedures (Tracheal Intubation): For tracheal intubation, the same doses should be used as described above under surgical procedures. 

    Maintenance Dosing: The use of an initial loading dose of 0.6mg Rocuronium Bromide per kg body weight is recommended, followed by a continuous infusion as soon as twitch height recovers to 10% or upon reappearance of 1 to 2 twitches to train of four stimulation. Dosage should always be titrated to effect in the individual patient. The recommended initial infusion rate for the maintenance of a neuromuscular block of 80-90% (1 to 2 twitches to TOF stimulation) in adult patients is 0.3-0.6mg/kg/hr during the first hour of administration, which will need to be decreased during the following 6-12 hours, according to the individual response. Thereafter, individual dose requirements remain relatively constant. A large between patient variability in hourly infusion rates has been found in controlled clinical studies, with mean hourly infusion rates ranging from 0.2-0.5mg/kg/hr depending on nature and extent of organ failure(s), concomitant medication and individual patient characteristics. To provide optimal individual patient control, monitoring of neuromuscular transmission is strongly recommended. Administration up to 7 days has been investigated. 

    Special Populations: Rocuronium Bromide is not recommended for the facilitation of mechanical ventilation in the intensive care in paediatric and geriatric patients due to a lack of data on safety and efficacy.
    Side effectsView
    In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension. Other are:
    • Anaphylaxis 
    • Residual paralysis 
    • Myopathy 
    • Increased pulmonary vascular resistance
    Although very rare, severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide, have been reported. Anaphylactic/anaphylactoid reactions are: bronchospasm, cardiovascular changes (e.g. hypotension, tachycardia, circulatory collapse - shock), and cutaneous changes (e.g. angioedema, urticaria). These reactions have, in some cases, been fatal. Due to the possible severity of these reactions, one should always assume they may occur and take the necessary precautions. 

    Since neuromuscular blocking agents are known to be capable of inducing histamine release both locally at the site of injection and systemically, the possible occurrence of itching and erythematosus reactions at the site of injection and/or generalized histaminoid (anaphylactoid) reactions (see also under Anaphylactic Reactions above) should always be taken into consideration when administering these agents. In clinical studies only a slight increase in mean plasma histamine levels has been observed following rapid bolus administration of 0.3 0.9mg/kg Rocuronium Bromide.

    Prolonged neuromuscular block: The most frequent adverse reaction to nondepolarizing blocking agents as a class consists of an extension of the agent's pharmacological action beyond the time period needed. This may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency or apnoea. 

    Myopathy: Myopathy has been reported after the use of various neuromuscular blocking agents in the ICU in combination with corticosteroids.

    Local injection site reactions: During rapid sequence induction of anesthesia, pain on injection has been reported, especially when the patient has not yet completely lost consciousness and particularly when propofol is used as the induction agent. In clinical studies, pain on injection has been noted in 16% of the patients who underwent rapid sequence induction of anesthesia with propofol and in less than 0.5% of the patients who underwent rapid sequence induction of anesthesia with fentanyl and thiopental.
    ContraindicationsView
    Hypersensitivity to Rocuronium or to the Bromide ion or to any of the excipients.
    PrecautionsView
    Instructions for use/handling: Compatibility studies with the following infusion fluids have been performed. In nominal concentrations of 0.5mg/mL and 2.0mg/mL, Rocuronium Bromide has been shown to be compatible with: 0.9% NaCl, 5% dextrose, 5% dextrose in saline, sterile water for injections, Lactated Ringers and Haemaccel. Administration should be commenced immediately after mixing, and should be completed within 24 hours. Unused solutions should be discarded.

    For use/handling: If Rocuronium Bromide is administered via the same infusion line that is also used for other medicines, it is important that this infusion line is adequately flushed (e.g. with 0.9% NaCl) between administration of Rocuronium Bromide and medicines for which incompatibility with Rocuronium Bromide has been demonstrated or for which compatibility with Rocuronium Bromide has not been established.
    InteractionsView
    The following agents have been shown to influence the magnitude and/or duration of action of non-depolarizing neuromuscular blocking agents:

    Effect of other agents on Rocuronium Bromide-

    Increased Effect: Halogenated volatile anesthetics potentiate the neuromuscular block of Rocuronium Bromide. The effect only becomes apparent with maintenance dosing. Reversal of the block with anti-cholinesterase inhibitors could also be inhibited. Long-term concomitant use of corticosteroids and Rocuronium Bromide in the ICU may result in prolonged duration of neuromuscular block or myopathy.

    Other drugs: 
    • Antibiotics: aminoglycoside, lincosamide and polypeptide antibiotics, acylamino-penicillin antibiotics. 
    • Diuretics, quinidine and its isomer quinine, magnesium salts, calcium channel blocking agents, lithium salts, local anaesthetics (lidocaine i.v., bupivacaine epidural) and acute administration of phenytoin 
    • Recurarization has been reported after post-operative administration of: aminoglycoside, lincosamide, polypeptide and acylamino-penicillin antibiotics, quinidine, quinine and magnesium.
    Decreased Effect: Prior chronic administration of phenytoin or carbamazepine. Protease inhibitors (gabexate, ulinastatin) 

    Variable Effect: Administration of other non-depolarizing neuromuscular blocking agents in combination with Rocuronium Bromide may produce attenuation or potentiation of the neuromuscular block, depending on the order of administration and the neuromuscular blocking agent used. Suxamethonium given after the administration of Rocuronium Bromide may produce potentiation or attenuation of the neuromuscular blocking effect of Rocuronium Bromide. 

    Effect of Rocuronium Bromide on other drugs: Rocuronium Bromide combined with lidocaine may result in a quicker onset of action of lidocaine.
    Pregnancy & lactationView
    Pregnancy: For Rocuronium Bromide, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing Rocuronium Bromide to pregnant women.

    Caesarean section: In patients undergoing Caesarean section, Rocuronium Bromide can be used as part of a rapid sequence induction technique, provided no intubation difficulties are anticipated and a sufficient dose of anesthetic agent is administered or following suxamethonium facilitated intubation. Rocuronium Bromide, administered in doses of 0.6mg/kg, has been shown to be safe in parturient undergoing Caesarean section. Rocuronium Bromide does not affect Apgar score, foetal muscle tone nor cardio-respiratory adaptation. From umbilical cord blood sampling it is apparent that only limited placental transfer of Rocuronium Bromide occurs which does not lead to the observation of clinical adverse effects in the newborn.

    Lactation: It is unknown whether Rocuronium Bromide is excreted in human breast milk. Animal studies have shown insignificant levels of Rocuronium Bromide in breast milk. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Rocuronium Bromide should be given to lactating women only when the attending physician decides that the benefits outweigh the risks.
    Overdose effectsView
    In the event of overdosage and prolonged neuromuscular block, the patient should continue to receive ventilatory support and sedation. In this situation there are two options for the reversal of neuromuscular block:

    Sugammadex can be used for reversal of intense (profound) and deep block. The dose of sugammadex to be administered depends of the level of neuromuscular block.

    An acetylcholinesterase inhibitor (e.g. neostigmine, edrophonium, pyridostigmine), with appropriate vagolytic (e.g atropine) can be used at reappearance of T2 or at the first signs of clinical recovery and should be administered in adequate doses. When administration of an acetylcholinesterase inhibiting agent fails to reverse the neuromuscular effects of Rocuronium Bromide, ventilation must be continued until spontaneous breathing is restored. Repeated dosage of an acetylcholinesterase inhibitor can be dangerous.
    StorageView
    Rocuronium Bromide should be stored in the refrigerator at 2-8° C and not be frozen.

    Rocy

    Procyclidine Hydrochloride
    Tablet 5 mg Allopathic Antiparkinson drugs

    Indications

    Sialorrhea

    Indication detailsView
    Procyclidine is used for the adjunctive treatment of all forms of parkinsonian syndrome. It is mainly used for the symptomatic treatment of idiopathic (paralysis agitants), postencephalitic and arteriosclerotic parkinsonian. It is used to control troublesome extrapyramidal symptoms including pseudoparkinsonian, acute dystonic reactions and akathisia induced by neuroleptic drugs such as phenothiazine derivatives.
    Therapeutic classView
    Antiparkinson drugs
    PharmacologyView
    Procyclidine hydrochloride is an antimuscarinic antiparkinsonian agent of relatively low toxicity. It is a synthetic tertiary amine. This drug exerts their antiparkinsonian effect by correcting the relative cholinergic excess which is thought to occur in parkinsonian as a result of dopamine deficiency. It is absorbed from G.I. tract and disappears rapidly from the tissues. After intravenous administration, it acts within 5 to 20 minutes and has a duration of effect up to 4 hours.
    DosageView
    Tablet: This is administered orally, preferably after meals.
    • Parkinsonism: Initially 2.5 mg 3 times a day, then 5 mg 3 times a day and occasionally 5 mg at bedtime. The dosage being adjusted as tolerated or until the total daily dose reaches 20 to 30 mg divided into 3 to 4 doses.
    • Drug induced extrapyramidal symptom: Initially 2.5 mg 3 times a day. The dosage being increased by 2.5 mg increment per day as needed and tolerated.
    IM or IV injection: 5-10 mg, repeated if necessary after 20 minutes; maximum 20 mg daily can be given.
    Side effectsView
    At usual dosage levels dryness of the mouth is generally the only adverse effect. Mydriasis, blurred vision and adverse G.I. effects (nausea, vomiting, epigastric distress, constipation) occur occasionally. An allergic reaction (e.g. rash) or muscular weakness may occasionally occur. High doses may cause vertigo and possibly confusion and hallucination. Adverse effect may usually be minimized by adjustment of dosage and administration after meal.
    ContraindicationsView
    It should be given with caution in children and geriatric patients. It is advisable to be cautious in giving Procyclidine to patients with diarrhoea and cardiovascular disease, glaucoma, urinary retention, hepatic or renal impairment. The safety of using procyclidine during pregnancy has not been established. No data are available on the excretion of this drug in breast milk.
    PrecautionsView
    Precaution should be taken in case of hepatic & renal impairment, children, elderly, pregnancy and lactation condition. Patients with mental disorders occasionally experience a precipitation of a psychotic episode when Procyclidine is administered for the treatment of the extrapyramidal side-effects of neuroleptic. Procyclidine should not be withdrawn abruptly as rebound Parkinsonism symptoms may occur.
    InteractionsView
    The anticholinergic activity of procyclidine may be increased by agents having anticholinergic amantadine. The absorption of ketoconazole may be reduced by concomitant administration of procyclidine.
    Pregnancy & lactationView
    The safe use of this drug in pregnancy, lactation or in women of childbearing age requires that the potential benefits be weighed against the possible hazards to the mother and child.
    Pediatric usageView
    Use in children: Safety and efficacy have not been established in the pediatric age group; therefore the use of Procyclidine hydrochloride is this group requires that the potential benefits be weighed against the possible hazards to children.
    StorageView
    Protect from light and moisture, store below 25°C. Keep out of the reach of children.

    Rofaz TR

    Ferrous Sulfate + Folic Acid + Zinc Sulfate
    Capsule (Timed Release) 150 mg+0.5 mg+61.8 mg Allopathic Iron, Vitamin & Mineral Combined preparation

    Indications

    Iron, Folic Acid and zinc deficiency during pregnancy and lactation

    Indication detailsView
    This is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.
    Therapeutic classView
    Iron, Vitamin & Mineral Combined preparation
    DosageView
    Adult or Elderly: 1 capsule daily. In more severe cases, 2 capsules daily may be required.

    Children    : Aged over 1 year: 1 capsule daily. The capsule may be opened and the pellets to be mixed with soft cool food, but they must not be chewed.
    Side effectsView
    Dark stools are usual during iron therapy and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce a gastrointestinal upset. These timed-release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions
    ContraindicationsView
    Do not use in patients hypersensitive to the components of the product or those with iron overload.
    PrecautionsView
    Care should be taken in patients who may develop Iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Iron & Zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of Zinc may be reduced in the presence of Iron. Absorption of Iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating the administration of each product by several hours. In patients with renal failure a risk of Zinc accumulation could exist.
    Pregnancy & lactationView
    Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.
    Overdose effectsView
    Iron overdosage is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 gm for a child or 5 gm for an adult) and demulcent. If serum Iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8 mg/l in adults, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc Sulphate in gross over dosage is corrosive. Symptoms are those of gastrointestinal irritation leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic Acid have been recommended.

    Symptomatic and supportive measures should be given as required. The timed-release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter-measure.
    StorageView
    Protected from light and moisture, store below 30˚C. Keep out of reach of children.

    Rofecin

    Ceftriaxone Sodium
    IV Injection 2 gm/vial Allopathic Third generation Cephalosporins

    Indications

    Urinary tract infection

    Indication detailsView
    Ceftriaxone is indicated for the treatment of the following major infections:
    • Lower respiratory tract infections
    • Acute Bacterial Otitis Media
    • Skin and skin structure infections
    • Urinary tract infections
    • Gonorrhea
    • Bacterial Septicemia
    • Bone and joint infections
    • Meningitis
    • Prevention of postoperative infections
    • Perioperative prophylaxis of infections associated with surgery
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
    DosageView
    Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
    • Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
    • Uncomplicated gonococcal infections: 250 mg IM as a single dose
    • Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
    Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
    • Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
    • Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
    • Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
    Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.
    AdministrationView
    Preparation of Solutions for Intramuscular / Intravenous Injections:
    • For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
    • For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
    The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).
    Side effectsView
    Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
    ContraindicationsView
    Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
    PrecautionsView
    As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
    InteractionsView
    No drug interactions have been reported.
    Pregnancy & lactationView
    Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
    Pediatric usageView
    Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
    Overdose effectsView
    There is no specific antidote. Treatment of overdosage should be symptomatic.
    StorageView
    Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

    Rofecin

    Ceftriaxone Sodium
    IV Injection 1 gm/vial Allopathic Third generation Cephalosporins

    Indications

    Urinary tract infection

    Indication detailsView
    Ceftriaxone is indicated for the treatment of the following major infections:
    • Lower respiratory tract infections
    • Acute Bacterial Otitis Media
    • Skin and skin structure infections
    • Urinary tract infections
    • Gonorrhea
    • Bacterial Septicemia
    • Bone and joint infections
    • Meningitis
    • Prevention of postoperative infections
    • Perioperative prophylaxis of infections associated with surgery
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
    DosageView
    Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
    • Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
    • Uncomplicated gonococcal infections: 250 mg IM as a single dose
    • Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
    Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
    • Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
    • Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
    • Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
    Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.
    AdministrationView
    Preparation of Solutions for Intramuscular / Intravenous Injections:
    • For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
    • For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
    The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).
    Side effectsView
    Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
    ContraindicationsView
    Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
    PrecautionsView
    As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
    InteractionsView
    No drug interactions have been reported.
    Pregnancy & lactationView
    Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
    Pediatric usageView
    Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
    Overdose effectsView
    There is no specific antidote. Treatment of overdosage should be symptomatic.
    StorageView
    Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

    Rofecin

    Ceftriaxone Sodium
    IV Injection 500 mg/vial Allopathic Third generation Cephalosporins

    Indications

    Urinary tract infection

    Indication detailsView
    Ceftriaxone is indicated for the treatment of the following major infections:
    • Lower respiratory tract infections
    • Acute Bacterial Otitis Media
    • Skin and skin structure infections
    • Urinary tract infections
    • Gonorrhea
    • Bacterial Septicemia
    • Bone and joint infections
    • Meningitis
    • Prevention of postoperative infections
    • Perioperative prophylaxis of infections associated with surgery
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
    DosageView
    Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
    • Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
    • Uncomplicated gonococcal infections: 250 mg IM as a single dose
    • Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
    Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
    • Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
    • Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
    • Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
    Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.
    AdministrationView
    Preparation of Solutions for Intramuscular / Intravenous Injections:
    • For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
    • For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
    The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).
    Side effectsView
    Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
    ContraindicationsView
    Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
    PrecautionsView
    As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
    InteractionsView
    No drug interactions have been reported.
    Pregnancy & lactationView
    Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
    Pediatric usageView
    Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
    Overdose effectsView
    There is no specific antidote. Treatment of overdosage should be symptomatic.
    StorageView
    Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

    Rofecin

    Ceftriaxone Sodium
    IM Injection 1 gm/vial Allopathic Third generation Cephalosporins

    Indications

    Urinary tract infection

    Indication detailsView
    Ceftriaxone is indicated for the treatment of the following major infections:
    • Lower respiratory tract infections
    • Acute Bacterial Otitis Media
    • Skin and skin structure infections
    • Urinary tract infections
    • Gonorrhea
    • Bacterial Septicemia
    • Bone and joint infections
    • Meningitis
    • Prevention of postoperative infections
    • Perioperative prophylaxis of infections associated with surgery
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
    DosageView
    Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
    • Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
    • Uncomplicated gonococcal infections: 250 mg IM as a single dose
    • Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
    Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
    • Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
    • Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
    • Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
    Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.
    AdministrationView
    Preparation of Solutions for Intramuscular / Intravenous Injections:
    • For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
    • For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
    The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).
    Side effectsView
    Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
    ContraindicationsView
    Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
    PrecautionsView
    As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
    InteractionsView
    No drug interactions have been reported.
    Pregnancy & lactationView
    Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
    Pediatric usageView
    Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
    Overdose effectsView
    There is no specific antidote. Treatment of overdosage should be symptomatic.
    StorageView
    Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

    Rofecin

    Ceftriaxone Sodium
    IM Injection 500 mg/vial Allopathic Third generation Cephalosporins

    Indications

    Urinary tract infection

    Indication detailsView
    Ceftriaxone is indicated for the treatment of the following major infections:
    • Lower respiratory tract infections
    • Acute Bacterial Otitis Media
    • Skin and skin structure infections
    • Urinary tract infections
    • Gonorrhea
    • Bacterial Septicemia
    • Bone and joint infections
    • Meningitis
    • Prevention of postoperative infections
    • Perioperative prophylaxis of infections associated with surgery
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
    DosageView
    Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
    • Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
    • Uncomplicated gonococcal infections: 250 mg IM as a single dose
    • Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
    Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
    • Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
    • Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
    • Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
    Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.
    AdministrationView
    Preparation of Solutions for Intramuscular / Intravenous Injections:
    • For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
    • For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
    The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).
    Side effectsView
    Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
    ContraindicationsView
    Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
    PrecautionsView
    As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
    InteractionsView
    No drug interactions have been reported.
    Pregnancy & lactationView
    Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
    Pediatric usageView
    Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
    Overdose effectsView
    There is no specific antidote. Treatment of overdosage should be symptomatic.
    StorageView
    Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

    Rofin

    Etoricoxib
    Tablet 120 mg Allopathic Non-steroidal Anti-inflammatory Drugs (NSAIDs)

    Indications

    Rheumatoid arthritis

    Indication detailsView
    Etoricoxib is indicated for the symptomatic relief of-
    • Osteoarthritis (OA)
    • Rheumatoid arthritis (RA)
    • Ankylosing spondylitis, and
    • The pain and signs of inflammation associated with acute gouty arthritis.
    • For the short-term treatment of moderate pain associated with dental surgery.
    Therapeutic classView
    Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    PharmacologyView
    Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.
    DosageView
    Adult and adolescent over 16 years:
    • Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
    • Rheumatoid arthritis: The recommended dose is 90 mg once daily.
    • Ankylosing spondylitis: The recommended dose is 90 mg once daily.
    • Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
    • Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.
    Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
    Side effectsView
    Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.
    ContraindicationsView
    • Hypersensitivity to the active substance or to any of the excipients.
    • Active peptic ulceration or active gastro-intestinai (Gl) bleeding.
    • Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
    • Pregnancy and lactation.
    • Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score 10).
    • Estimated renal creatinine clearance <30 ml/min.
    • Children and adolescents under 16 years of age.
    • Inflammatory bowel disease.
    • Congestive heart failure (NYHA ll-IV).
    • Patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled.
    • Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
    PrecautionsView
    • Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and Gl bleeding.
    • Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with Etoricoxib after careful consideration.
    • Administration of Etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function. Monitoring of renal function in such patients should be considered.
    • Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing edema from any other reason.
    • Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormalliver function test has occurred, should be monitored. If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, Etoricoxib should be discontinued.
    • Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
    • Etoricoxib may mask fever and other signs of inflammation. Caution should be exercised when co-administering Etoricoxib with warfarin or other oral anticoagulants.
    InteractionsView
    With medicine:
    • Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
    • Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
    • Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
    • Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
    • Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
    With food & others: Take without regards to meals.
    Pregnancy & lactationView
    The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.
    Overdose effectsView
    Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.
    StorageView
    Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

    Rofin

    Etoricoxib
    Tablet 90 mg Allopathic Non-steroidal Anti-inflammatory Drugs (NSAIDs)

    Indications

    Rheumatoid arthritis

    Indication detailsView
    Etoricoxib is indicated for the symptomatic relief of-
    • Osteoarthritis (OA)
    • Rheumatoid arthritis (RA)
    • Ankylosing spondylitis, and
    • The pain and signs of inflammation associated with acute gouty arthritis.
    • For the short-term treatment of moderate pain associated with dental surgery.
    Therapeutic classView
    Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    PharmacologyView
    Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.
    DosageView
    Adult and adolescent over 16 years:
    • Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
    • Rheumatoid arthritis: The recommended dose is 90 mg once daily.
    • Ankylosing spondylitis: The recommended dose is 90 mg once daily.
    • Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
    • Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.
    Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
    Side effectsView
    Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.
    ContraindicationsView
    • Hypersensitivity to the active substance or to any of the excipients.
    • Active peptic ulceration or active gastro-intestinai (Gl) bleeding.
    • Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
    • Pregnancy and lactation.
    • Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score 10).
    • Estimated renal creatinine clearance <30 ml/min.
    • Children and adolescents under 16 years of age.
    • Inflammatory bowel disease.
    • Congestive heart failure (NYHA ll-IV).
    • Patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled.
    • Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
    PrecautionsView
    • Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and Gl bleeding.
    • Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with Etoricoxib after careful consideration.
    • Administration of Etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function. Monitoring of renal function in such patients should be considered.
    • Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing edema from any other reason.
    • Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormalliver function test has occurred, should be monitored. If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, Etoricoxib should be discontinued.
    • Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
    • Etoricoxib may mask fever and other signs of inflammation. Caution should be exercised when co-administering Etoricoxib with warfarin or other oral anticoagulants.
    InteractionsView
    With medicine:
    • Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
    • Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
    • Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
    • Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
    • Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
    With food & others: Take without regards to meals.
    Pregnancy & lactationView
    The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.
    Overdose effectsView
    Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.
    StorageView
    Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

    Rofixim

    Cefixime Trihydrate
    Powder for Suspension 100 mg/5 ml Allopathic Third generation Cephalosporins

    Indications

    Urethritis

    Indication detailsView
    Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
    • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
    • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
    • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
    • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
    • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
    DosageView
    The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

    Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

    Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
    • ½-1 year: 75 mg daily.
    • 1-4 years: 100 mg daily.
    • 5-10 years: 200 mg daily.
    • 11-12 years: 300 mg daily
    • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
    Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
    Side effectsView
    The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
    ContraindicationsView
    It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
    PrecautionsView
    The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
    InteractionsView
    Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
    Pregnancy & lactationView
    There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
    Overdose effectsView
    Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
    StorageView
    Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

    Rofixim

    Cefixime Trihydrate
    Capsule 400 mg Allopathic Third generation Cephalosporins

    Indications

    Urethritis

    Indication detailsView
    Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
    • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
    • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
    • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
    • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
    • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
    DosageView
    The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

    Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

    Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
    • ½-1 year: 75 mg daily.
    • 1-4 years: 100 mg daily.
    • 5-10 years: 200 mg daily.
    • 11-12 years: 300 mg daily
    • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
    Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
    Side effectsView
    The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
    ContraindicationsView
    It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
    PrecautionsView
    The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
    InteractionsView
    Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
    Pregnancy & lactationView
    There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
    Overdose effectsView
    Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
    StorageView
    Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

    Rofixim

    Cefixime Trihydrate
    Capsule 200 mg Allopathic Third generation Cephalosporins

    Indications

    Urethritis

    Indication detailsView
    Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
    • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
    • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
    • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
    • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
    • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
    DosageView
    The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

    Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

    Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
    • ½-1 year: 75 mg daily.
    • 1-4 years: 100 mg daily.
    • 5-10 years: 200 mg daily.
    • 11-12 years: 300 mg daily
    • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
    Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
    Side effectsView
    The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
    ContraindicationsView
    It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
    PrecautionsView
    The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
    InteractionsView
    Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
    Pregnancy & lactationView
    There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
    Overdose effectsView
    Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
    StorageView
    Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

    Rofixim-DS

    Cefixime Trihydrate
    Powder for Suspension 200 mg/5 ml Allopathic Third generation Cephalosporins

    Indications

    Urethritis

    Indication detailsView
    Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
    • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
    • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
    • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
    • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
    • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
    DosageView
    The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

    Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

    Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
    • ½-1 year: 75 mg daily.
    • 1-4 years: 100 mg daily.
    • 5-10 years: 200 mg daily.
    • 11-12 years: 300 mg daily
    • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
    Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
    Side effectsView
    The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
    ContraindicationsView
    It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
    PrecautionsView
    The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
    InteractionsView
    Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
    Pregnancy & lactationView
    There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
    Overdose effectsView
    Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
    StorageView
    Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

    Roflast

    Roflumilast
    Tablet 500 mcg Allopathic Antihistamines anti-allergies & hypo-sensitisation

    Indications

    COPD

    Indication detailsView
    Roflumilast is indicated:
    • As add-on therapy to bronchodilator treatment.
    • For the maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis (i.e. patients with a history of chronic cough and sputum) in adult patients with a history of frequent exacerbations.
    Roflumilast should not be used as a rescue medication.
    Therapeutic classView
    Antihistamines anti-allergies & hypo-sensitisation
    PharmacologyView
    Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.
    DosageView
    The recommended dosage for patients with COPD is one 500 mcg tablet daily, with or without food.
    Side effectsView
    General disorders: Fatigue.
    Metabolism and nutrition disorders: Decreased appetite, Weight decreased.
    Musculoskeletal and connective tissue disorders: Back pain, muscle spasms.
    Nervous system disorders: Dizziness, Headache, Tremor.
    Psychiatric disorders: Anxiety, Depression, Insomnia.
    ContraindicationsView
    Hypersensitivity to Roflumilast or to any of the excipients. Moderate to severe liver impairment.
    PrecautionsView
    Not as emergency treatment for relief of acute brochospasm. Monitor body wt regularly. Severe immunological disease, severe acute infections, cancers (except basal cell carcinoma) or patients on immunosuppressants; CHF (NYHA grades III & IV). History of depression associated with suicidal ideation or behavior. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Pregnancy & lactation.
    InteractionsView
    A major step in Roflumilast metabolism is the N-oxidation of Roflumilast to Roflumilast N-oxide by CYP3A4 and CYP1A2. Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with Roflumilast is not recommended. The co-administration of Roflumilast with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase Roflumilast systemic exposure and may result in increased adverse reactions. The co-administration of Roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects.
    Pregnancy & lactationView
    Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Roflumilast should not be used during pregnancy & lactation.
    Pediatric usageView
    Geriatrics ( 65 years of age): There were no overall differences in safety and effectiveness of Roflumilast in the elderly compared to younger patients with COPD. Therefore, no dose adjustment is necessary.

    Pediatrics (<18 years of age): Safety and effectiveness of Roflumilast in children and adolescents below 18 years of age have not been established.

    Hepatic Impairment: Roflumilast is not recommended for use in patients with moderate or severe liver impairment.

    Renal impairment: No dosage adjustment is necessary for patients with renal impairment
    Overdose effectsView
    No case of overdose has been reported in clinical studies with Roflumilast. However, during the Phase I studies of Roflumilast, at an increased rate after a single oral dose of 2500 mcg and a single dose of 5000 mcg,

    The following symptoms were observed: headache, gastrointestinal disorders, dizziness, palpitations, lightheadedness, clamminess and arterial hypotension.

    Missed Dose: Patients should be advised that if they forget to take a tablet at the usual time, they should take the tablet as soon as they remember or continue on the next day with the next tablet at the usual time. Patients should not take a double dose to make up for a forgotten dose.
    StorageView
    Store below 30° C, keep away from light, moisture. Keep out of the reach of children.

    Roflu

    Roflumilast
    Tablet 500 mcg Allopathic Antihistamines anti-allergies & hypo-sensitisation

    Indications

    COPD

    Indication detailsView
    Roflumilast is indicated:
    • As add-on therapy to bronchodilator treatment.
    • For the maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis (i.e. patients with a history of chronic cough and sputum) in adult patients with a history of frequent exacerbations.
    Roflumilast should not be used as a rescue medication.
    Therapeutic classView
    Antihistamines anti-allergies & hypo-sensitisation
    PharmacologyView
    Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.
    DosageView
    The recommended dosage for patients with COPD is one 500 mcg tablet daily, with or without food.
    Side effectsView
    General disorders: Fatigue.
    Metabolism and nutrition disorders: Decreased appetite, Weight decreased.
    Musculoskeletal and connective tissue disorders: Back pain, muscle spasms.
    Nervous system disorders: Dizziness, Headache, Tremor.
    Psychiatric disorders: Anxiety, Depression, Insomnia.
    ContraindicationsView
    Hypersensitivity to Roflumilast or to any of the excipients. Moderate to severe liver impairment.
    PrecautionsView
    Not as emergency treatment for relief of acute brochospasm. Monitor body wt regularly. Severe immunological disease, severe acute infections, cancers (except basal cell carcinoma) or patients on immunosuppressants; CHF (NYHA grades III & IV). History of depression associated with suicidal ideation or behavior. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Pregnancy & lactation.
    InteractionsView
    A major step in Roflumilast metabolism is the N-oxidation of Roflumilast to Roflumilast N-oxide by CYP3A4 and CYP1A2. Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with Roflumilast is not recommended. The co-administration of Roflumilast with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase Roflumilast systemic exposure and may result in increased adverse reactions. The co-administration of Roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects.
    Pregnancy & lactationView
    Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Roflumilast should not be used during pregnancy & lactation.
    Pediatric usageView
    Geriatrics ( 65 years of age): There were no overall differences in safety and effectiveness of Roflumilast in the elderly compared to younger patients with COPD. Therefore, no dose adjustment is necessary.

    Pediatrics (<18 years of age): Safety and effectiveness of Roflumilast in children and adolescents below 18 years of age have not been established.

    Hepatic Impairment: Roflumilast is not recommended for use in patients with moderate or severe liver impairment.

    Renal impairment: No dosage adjustment is necessary for patients with renal impairment
    Overdose effectsView
    No case of overdose has been reported in clinical studies with Roflumilast. However, during the Phase I studies of Roflumilast, at an increased rate after a single oral dose of 2500 mcg and a single dose of 5000 mcg,

    The following symptoms were observed: headache, gastrointestinal disorders, dizziness, palpitations, lightheadedness, clamminess and arterial hypotension.

    Missed Dose: Patients should be advised that if they forget to take a tablet at the usual time, they should take the tablet as soon as they remember or continue on the next day with the next tablet at the usual time. Patients should not take a double dose to make up for a forgotten dose.
    StorageView
    Store below 30° C, keep away from light, moisture. Keep out of the reach of children.